cyrilzakka/clinical-trials huggingface dataset:
NMDA Modulation in Major Depressive Disorder

Most of the current antidepressants for major depressive disorder (MDD) are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. NMDA hypofunction has been implicated in the pathophysiology of depression. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of an NMDA enhancer (NMDAE) in the treatment of MDD in the adults.

Major depressive disorder (MDD) is a complex and multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Many patients have significant side effects after treatment with antidepressants which hamper the motivation for treatment and medication adherence. NMDA hypofunction has been implicated in the pathophysiology of depression. MDD is often associated with cognitive deficits which are not necessarily recovered by current antidepressants. The NMDA receptor regulates synaptic plasticity, memory, and cognition. In our previous studies, cognitive improvement has been observed with treatment of NMDA enhancers. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of NMDAE in the treatment of MDD in the general adults by comparing with sertraline (a selective serotonin reuptake inhibitor \[SSRI\]) and placebo. The investigators will enroll non-elderly adult patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigators will biweekly measure clinical performances and side effects. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The efficacy of three groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Have a DSM-5 (American Psychiatric Association) diagnosis of MDD
* 17-item Hamilton Rating Scale for Depression total score ≥ 18
* Free of antidepressant drugs for at least 2 weeks
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* Current substance abuse or history of substance dependence in the past 6 months
* History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
* Bipolar depression, schizophrenia or other psychotic disorder
* Moderate-severe suicidal risks
* Severe cognitive impairment
* Initiating or stopping formal psychotherapy within six weeks prior to enrollment
* A history of severe adverse reaction to SSRIs
* A treatment-resistant history (that is, they have failed to respond to two or more different classes of antidepressants with adequate dosage and treatment duration
* A history of previously received electroconvulsive therapy
* Inability to follow protocol
Resistance to Methotrexate in Patients With Acute Lymphoblastic Leukemia in Relapse or Remission

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.

PURPOSE: This laboratory study is looking at resistance to methotrexate in patients with acute lymphoblastic leukemia in relapse or remission.

OBJECTIVES:

* Determine the mechanisms of intrinsic and acquired methotrexate resistance using in vitro assays of matched initial diagnosis, relapsed, and nonrelapsed (control) leukemic blast samples from patients with acute lymphoblastic leukemia in relapse or remission.
* Determine if the mechanisms of acquired methotrexate resistance are related to dosage or timing of methotrexate administration or other clinical factors in these patients.

OUTLINE: Random samples of frozen leukemic blasts from relapsing patients at initial diagnosis and relapse are selected. A corresponding sample from nonrelapsing patients (control) at initial diagnosis is also randomly selected.

Reduced folate carrier (RFC) and dehydrofolate reductase (DHFR) expression is measured using a quantitative reverse transcriptase-polymerase chain reaction assay of prepared RNA. DHFR gene amplification is measured by a dot blot analysis of prepared DNA. Results of these assays are used to determine if a particular mechanism of acquired methotrexate resistance is associated with a particular subset of acute lymphoblastic leukemia patients. Data are collected regarding the actual timing and dosage of methotrexate received by each patient and are correlated with the mechanisms of resistance.

PROJECTED ACCRUAL: A total of 135 paired samples will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Acute lymphoblastic leukemia (ALL) in relapse, including all risk groups and leukemia subtypes, with frozen leukemic blast samples stored from the time of initial diagnosis and relapse
  * Non-relapsing ALL (as control)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Diagnostic Accuracy of Body Temperature Measurement in Geriatric Patients

Retrospective analysis of a quality measurement project examining the quality of vital parameter measurement in consecutive patients \>= 75 years presenting to the emergency department.

Primary goal of the study is to evaluate the diagnostic accuracy of body temperature measurement using different methods to diagnose infection in patients \>= 75 years presenting to the emergency department. The secondary goal is to compare the reliability of tympanal and temporal artery thermometry with rectal temperature measurement.


Eligibility Criteria:
Inclusion Criteria:

* \>= 75 years
* given informed consent

Exclusion Criteria:

* patients who do not speak the German language
* patients with unstable cardiorespiratory status
* presence of contraindications to one of the temperature measurement methods
Parent-Reported Symptom Assessments in Children Taking Multiple Medications

This study plans to learn about how to measure symptoms (like tiredness or rash) in children with special healthcare needs who take 5 or more medications. Sometimes symptoms change in severity over time or new symptoms develop. This can happen after a new medication is started. This can also happen after the dose of an existing medication is changed. The Investigators believe that parents will be able to provide the best assessment of any symptoms that their child might be experiencing. This study asks parents to report any symptoms their child is currently experiencing.

An increasing number of children with complex chronic conditions (CCCs) who have intractable illnesses or multi-organ dysfunction are exposed to daily polypharmacy. Parents of children with polypharmacy often administer 5 or more medications each day, sometimes for months, including high-risk medications prescribed by many different specialists in multiple settings of care. While medications can be life-saving, polypharmacy increases the risk of additive adverse effects, drug-drug interactions, and can lead to serious adverse drug events (ADEs). Pediatric ADEs result in over 4.3 million estimated ambulatory visits annually, including \>150,000 pediatric emergency room visits. Despite the risks associated with polypharmacy, little is known about how polypharmacy escalates and how polypharmacy should be managed. To enable children to thrive at home using medications while minimizing unwanted symptoms, this proposal aims to implement a prospective, parent-reported symptom assessment system to guide and monitor pharmaceutical care for high-risk children. Strategies to improve recognition of problematic symptoms will have a substantial impact on the health of children.

Eligibility Criteria:
Inclusion Criteria:

* Neurological impairment
* 5 or more scheduled medications
* English- or Spanish-speaking

Exclusion Criteria:

* Receives primary care outside outside of the Children's Hospital Colorado Network of Care
Anticoagulation in Emergency General Surgery

While DOACs are increasing in use in the EGS patient population, the risk of bleeding and the reversal of these agents to reduce hemorrhage is still evolving. Given the paucity of data regarding the impact of DOACs in this patient population, it becomes empiric to identify bleeding patterns and outcomes in the EGS population taking DOACs. We hypothesize that patients taking a DOAC will have a higher bleeding incidence and need for an unplanned intervention secondary to hemorrhage in EGS patients undergoing an urgent or emergent operation when compared to patients taking warfarin and antiplatelets.

Emergency general surgery (EGS) represents illnesses of diverse pathology with urgent/emergent treatment needs being the common denominator.A characteristic feature of EGS is its limitation in patient preparation. It is difficult and often impossible to eliminate certain patient dependent factors to reduce the operative risk. It has been reported that the annual case rate in the EGS population is (1,290 per 100,000) higher than the sum of all cancer diagnoses. The EGS burden is substantial and continues to increase. The elderly patient population represents 48% of the overall EGS population. With the increase in the prevalence of atherosclerotic disease in the elderly there has been an increase in the use of antiplatelets and anticoagulants.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are confirmed to be taking dabigatran, rivaroxaban, apixaban, warfarin and antiplatelet therapy (aspirin, clopidogril, ticagrelor) undergoing an urgent or emergent surgical intervention by the emergency general surgery service within 24 hours of arrival to the hospital
* 18 years of age or over

Exclusion Criteria:

* Prisoners
* Pregnant patients
* Those who received an index operation at an outside facility and were transferred
* Under 18 years of age
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)

The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The safety of SCH 900271 in this participant population will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides \[TG\])
* must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
* must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent

Exclusion Criteria:

The participant will be excluded from entry if ANY of the criteria listed below are met:

* use of any investigational drug within 30 days of study entry
* female of childbearing potential or lactating
* postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
* homozygous familial hypercholesterolemia
* congestive heart failure New York Heart Association (NYHA) Class III or IV
* uncontrolled hypertension on or off therapy
* cardiac arrhythmia requiring medication
* clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)
* Type 1 Diabetes Mellitus
* Type 2 Diabetes Mellitus
* history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study
* gastrointestinal ulcer within 3 months of study entry
* history of coagulopathy
* history of gout
* known active or chronic hepatic or biliary disease.
* known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
* body mass index \>40 kg/m\^2
* taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 \[COX-2\] inhibitors are allowed)
* taking more than 100 mg aspirin per day
* being treated with corticosteroids (oral, intramuscular, or intravascular)
* more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis

The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).


Eligibility Criteria:
Key Inclusion Criteria:

* Meets all of the following conditions

  * Definite or probable PBC as defined by at least 2 of the 3 following criteria:

    * Serum alkaline phosphatase (ALP) \> the upper limit of normal (ULN)
    * Presence of anti-mitochondrial antibodies (AMA) in serum (≥ 1:40 on immunofluorescence)
    * Liver histological findings consistent with PBC including nonsuppurative, destructive cholangitis affecting mainly the interlobular bile and septal bile ducts
  * Serum ALP \> 1.67 x ULN and/or total bilirubin \>ULN but ≤ 2 x ULN
  * Ursodeoxycholic acid (UDCA) use at a stable dose for at least 12 months or intolerant of UDCA with no UDCA use for at least 12 months before screening
* Screening FibroSURE/FibroTest® \< 0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis. In adults with Gilbert's syndrome or hemolysis, FibroSURE/FibroTest will be calculated using direct bilirubin instead of total bilirubin.

Key Exclusion Criteria:

* Alanine aminotransferase (ALT) \> 5 x ULN
* Total bilirubin \> 2 x ULN
* International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
* Other causes of liver disease including viral, metabolic, alcoholic, and other autoimmune conditions. Participants with hepatic steatosis may be included if there is no evidence of nonalcoholic steatohepatitis (NASH) in the opinion of the investigator or on liver biopsy.
* Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment
* Cirrhosis of the liver as defined by any of the following:

  * Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak stage ≥ 5)
  * History of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
  * Liver stiffness \> 16.9 kPa by FibroScan®

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
in Vitro Evaluation of the Anti-fibrotic Activity of Adipose Tissu-derived Stromal Vascular Fraction Used as a Medicinal Treatment for Scarred Vocal Folds

This is a single-center, prospective study, aimed at investigating the anti-fibrotic in vitro activity of the stromal vascular fraction of patients with scarred vocal cord.

This single-center, prospective study will last 28 months and will be carried out in two stages:

1. Comparison of the in vitro anti-fibrotic activity and production/management circuit of different cell therapy products derived from adipose tissue obtained from healthy donors (n=8) \[secondary objective\] during the first 12 months of the project.
2. Evaluate the association between the in vitro anti-fibrotic activity of fraction vascular fraction (FVS) samples and the clinical improvement obtained with the same sample autologously injected into a patient in the CELLCORDES2 trial (minimum recruitment n=10, CELLCORDES2 biocollection) \[primary objective\]. This second stage will be carried out between M12 and M24 to optimize the number of patients to be included.

Eligibility Criteria:
Inclusion criteria for patients included in the CELLCORDES 2 clinical trial

* Voice Handicap Index \> 50/120
* Scarring, congenital (sulcus) or post-phonosurgery vocal cords
* Vibratory anomalies in the middle third of one or both vocal cords on stroboscopy
* A minimum of six months after the initial surgery
* Patients aged 18 to 70 years
* Good general health
* Negative pregnancy test and contraception for women of childbearing age Signature of consent for the storage and use of biological samples

Inclusion criteria for Healthy donnors:

* Liposuction surgery for aesthetic reasons
* BMI between 18 and 27
* No chronic diseases
* Non-opposition to the use of surgical waste for research purposes after freezing in a biological collection

Exclusion criteria: For all patients:

* Refusal or inability to comply with the study procedures
* Minors
* Pregnant or breastfeeding women
* Legally protected adults (under guardianship or curatorship)
* Individuals residing in a healthcare or social establishment emergency situations
* Individuals deprived of liberty
* Detainees
* Individuals not covered by a social security scheme
* Use of an experimental drug in the last three months
* Contraindication to local anesthesia
* Anticoagulant treatment
* Coagulation disorders (TP \< 65%, TCA \> 1.2)
* Premenopausal women of childbearing age without contraception
* Lack of or refusal of informed consent

Exclusion criteria for Patients in the CELLCORDES 2 clinical trial:

* Patients refusing pre- and post-operative speech therapy
* History of malignant lesions or severe dysplasia on the scarred vocal cord
* History of laryngeal papillomatosis
* Active infectious diseases
* Positive serology for HIV1 and 2, p24 Ag, HCV Abs, HBs Ag, HbC Abs, HTLV and II Abs, TPHA
* Need for perioperative antibiotic prophylaxi
Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

To measure and quantify the postprandial glucose variations in response to a meal in the healthy 6-12 months old child and correlate this response with the composition of this meal.

14 full-term infants (boys and girls) aged six to twelve months and fed a diversified diet including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations will be recruited. Children will be recruited in the Lausanne Childrens hospital and only be included in the study whenin good general health.

FreeStyle® Libre Pro Interstitial Glucose Meter will be applied on the last day before discharge from the hospital after skin preparation with anesthetic cream (Emla®) during hospitalization and measurements will be recorded during 2-5 days.

It is not intended to measure capillary or venous blood glucose levels during this study. However, if blood is collected during hospitalization, blood glucose will be measured in parallel with the interstitial glucose measured with the device.

The child will follow his usual diet without modifications. The amount of food consumed by the child as well as the length of the meals will be recorded by the parents. For meals made by the parents they will be asked to keep a sample not seen to analyze their carbohydrate content. The total carbohydrate content will be measured .

Eligibility Criteria:
Inclusion Criteria:

* Term infants (boys and girls)
* 6 to 12 months old
* In good general health
* Nourished with diverse nutrition including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations
* Infant child: if the child is breastfed partially, it can be included in the study. In this case, only samples of a food supplement will be collected for evaluation of the composition.
* Hospitalized at the Lausanne Children's Hospital for non-severe reasons that do not affect or suspect to affect glucose metabolism
* Measures of feeding (time and compositions with samples) feasible for 3 consecutive days by the parents at home

Exclusion Criteria:

* Child born premature
* One or both parents with type 2 diabetes or gestational diabetes
* Child totally breastfed
* Chronic skin condition such as eczema, excessive dryness.
* Allergy known to adhesive plaster
* Infectious diseases affecting the skin (eg chickenpox, scarlet fever,)
* disorders of cutaneous microcirculation
* Infants suffering from diseases affecting nutrition or digestion (diarrheal gastroenteritis) and children undergoing antibiotic treatment that may affect gastrointestinal absorption
* Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or Diathermy Therapy
Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas

L-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and 12 % leiomyosarcomas). Approval for the induction of trabectedin into the treatment armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas (Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009). Significant activity has been described for the use of gemcitabine and especially the combination of gemcitabine and docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007). However, the combination of gemcitabine and docetaxel is associated with significant toxicity. Pulmonary toxicity and refractory peripheral oedema are the most common severe adverse events. The aim of the present phase I study will be to examine safety data of this promising treatment combination of gemcitabine and trabectedin in L-sarcomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed L-sarcomas (leiomyosarcoma and liposarcoma)
* Measurable disease according to RECIST 1.1
* Any treatment line except adjuvant setting: evidence of primary metastatic situation or disease progression within the last 6 months (based on RECIST 1.1) in computed tomography or magnetic resonance imaging
* Any prior treatment possible
* Age \>= 18 years
* WHO PS =\< 1
* Effective contraception during study medication and up to 3 months from treatment discontinuation
* Signed informed consent form

Exclusion Criteria:

* Surgical intervention \< 4 weeks
* Pregnancy or lactation
* Known allergic reaction to trabectedin or gemcitabine or one of their components
* The following laboratory values:

Absolute neutrophil count \< 1.5 x 103/mm3 Platelets \< 100.000/mm3 Hb \< 9 g/dL Serum creatinine \>= 2.5 mg/dl SGOT and/or SGPT and/or alkaline phosphatase and/or CPK \> 2.5 x ULN Total bilirubin \> 1 x ULN except in the case of Gilbert's syndrome

* Participation in another study (four weeks before and during the study)
* Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales

The objectives of this study are to characterise immune responses in people with CoV-SARS-2 infection and use this knowledge to advance vaccine design, treatment options, and diagnostic reagents. Eligible participants will include people diagnosed with SARS-CoV-2 infection, and may include recently returned travellers and non-travellers in the community presenting to tertiary hospital healthcare facilities. Recruitment will be opportunistic, and sampling intensity may vary depending on the phase of the outbreak. Participants can be enrolled at any timepoint (up to 6 months) following diagnosis of SARS-CoV-2 infection (COVID-19). Blood samples and clinical data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Main cohort

  1. Diagnosed with CoV-SARS-2 infection
  2. 16 years of age or older
  3. Have provided informed consent Paediatric cohort

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  1. Diagnosed with CoV-SARS-2 infection
  2. Less than 16 years of age
  3. Informed consent provided by parent or caregiver

     Exclusion Criteria:

     Main cohort

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  1. 15 years of age or younger
  2. Inability or unwillingness to provide informed consent or abide by the requirements of the study Paediatric cohort

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  1. 16 years of age or older
  2. Inability or unwillingness of parent or caregiver to provide informed consent or abide by the requirements of the study -