cyrilzakka/clinical-trials huggingface dataset:
Non Invasive Evaluation of Fluid Responsiveness in Septic Patient

The study aims to evaluate the accuracy of fluid responsiveness assessment with non-invasive cardiometry compared to ultrasound guided inferior vena cava (IVC) collapsibility for management of critically ill septic patients with hemodynamic instability.

Prospective Randomized observational comparative single blinded study will be conducted at intensive care unit at Benha University Hospitals after obtaining approval of the ethical committee and informed written consent from first degree relatives will be issued. The blindness will be performed to the patients.

The study will be conducted according to CONSORT 2010 statement. Enrolment of eligible patients will occur within 8 h of meeting the criteria for septic shock. All patients will be randomized using the computer-generated software of randomization and sealed closed envelopes to allocate them to one of two groups (30 patients each). Routine measurements and investigations will be taken at admission to intensive care unit; history, vital signs, routine laboratory investigation.

Eligibility Criteria:
Inclusion Criteria:

1. ASA class I and II
2. Age 18-65 years old of both genders.
3. Fulfilment criteria of sepsis as defined according to the standard Surviving Sepsis Campaign criteria using the Sequential (sepsis-related) Organ Failure Assessment (SOFA) score (SOFA score ≥ 2 indicated organ dysfunction).
4. Patients within 8 h of meeting the criteria for septic shock.

Exclusion Criteria:

1. Lack of consent
2. Age below 18 and above 65 years old.
3. acute coronary syndrome
4. major cardiac dysrhythmia,
5. valvular or congenital heart disease
6. Massive bilateral pleural effusion
7. Severe anaemia
8. End-stage kidney disease (ESKD) patients with Creatinine clearance (CrCl) \<50ml/min.
9. Child B and Child C hepatic patients
10. impaired systolic function according to the ejection fraction (EF) (EF \< 40% indicated impaired systolic function)
11. Severe ARDS (acute respiratory distress syndrome).
12. Tense ascites
13. Mechanical ventilation.
Promoting Infant Mental Health in Foster Care

This study will evaluate the effectiveness of the Promoting First Relationships (PFR) program versus an Early Education Support (EES) program in promoting infant well-being, preventing emotional and behavioral problems, countering developmental delay, and reducing placement instability in young foster care children.

Infants who enter foster care are at risk for developing multiple social and emotional problems later in life. These behavioral issues often result in foster children being placed with multiple different families during their childhoods. In turn, an unstable family life can lead to serious conduct disorders and mental health problems. The infants' loss of their first attachment relationship heightens the risks for developing these problems, even if the quality of care was poor prior to removal. Infants' reactions to this loss, combined with other vulnerabilities, complicate the development of new secure attachments to their foster care families. Garnering a secure attachment relationship between foster parents and foster infants may reduce the infant's risk for developing problematic mental health and conduct issues. PFR is a family therapy intervention focused on aiding foster care parents to cultivate secure attachments with their foster infants. This study will evaluate the effectiveness of the PFR program versus an EES program in promoting attachment security and infant well-being, preventing emotional and behavioral problems, countering developmental delay, and reducing placement instability in young foster care children.

Participants in this single-blind study will be randomly assigned to receive either PFR or EES. Both interventions will be administered by a trained staff member of a community agency. Participants assigned to PFR will receive ten weekly home visits that will focus on promoting the development of a secure attachment between foster parents and infants. EES will consist of three monthly home visits, during which infants will be assessed and referred for additional care if necessary. EES participants will not receive any training. Outcomes will be assessed at 1, 6, and 12 months post-intervention for all participants.

Eligibility Criteria:
Inclusion Criteria:

* Transitioned into foster care, currently within foster care, or from foster care in past three months prior to study entry in Pierce County, WA
* Primary caregiver is foster care provider, kin caregiver, or biological parent

Exclusion Criteria:

* Foster care provider is not English-speaking
Syngo NATIVE Contrast Enhanced 3D MRA on 3T Verio Magnet

The purpose of the study is to compare non-contrast abdominal MR Angiogram (MRA) syngo NATIVE sequence performed on a 3T Verio Siemens magnet to a standard contrast-enhanced MRA performed as part of routine clinical care in patients with normal renal function to determine if the non-contrast NATIVE sequence is a viable alternative to contrast enhanced MRA in patients with renal insufficiency. There are no interventions--this is an observational study.

If the NATIVE sequence proves to be a viable alternative to contrast enhanced MRA it will provide imaging physicians with the diagnostic tool to assess vascular disease in patients with renal insufficiency without placing them at risk for additional co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

Over age 18 Signed informed consent Referred for standard of care MRA

Exclusion Criteria:

No contra-indications for MRI/MRA ie implants which could interfere with magnets Renal insufficiency which would preclude use of contrast-enhanced contrast for a standard of care MRA
Effects of Gardemont S.A Food Supplement on Upper Respiratory Illness

General:Prospective, randomized, double blind controlled trial of the food supplement GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with upper respiratory infection.

Hypothesis: The food supplement GOLDTRAIN PLUS will be superior to placebo in shortening the time to recovery from the disease symptoms.

Study design and outcome measures:Study population of 182 generally healthy subjects with acute respiratory infection randomized in 1:1 ratio to active supplement versus placebo treatment, with randomization stratified by site. The study supplement administration will be continued for 7 days, and patient global assessment (PGA) will be the main primary measurement tool, based on a self-reporting questionnaire filled and monitored every 12 hours for 7 consecutive days. Throat and nasal swabs determining type of viral infection, will be taken at inclusion of patient and a number of blood tests at the end of treatment to look for any adverse effects of the medication.

Analysis and conclusion: All data-from the filled questionnaires, clinical follow up and laboratory studies will be analyzed by multivariate analysis to determine the efficacy of the supplement and its correlation to the clinical and laboratory parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Age eligible (18 ≤ Age ≤ 90)
3. Respiratory infection with or without fever-

Exclusion Criteria:

1. Evidence of the bacterial infection
2. Symptoms suggestive of other than respiratory system illness (i.e. diarrhea, abdominal pain, skin rash, urinary symptoms).
3. Hospitalisation is planned
4. Surgery within previous 2 months
5. Pregnancy (women at childbirth age should have a urine beta-HCG test performed)
6. Subject with known renal dysfunction (creatinine ≥ 2 mg/dL)
7. Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ ULN
8. Participation in the active follow-up phase of another clinical study of an investigational drug or device
9. Known hypercalcemia -
The Drug-drug Interaction of SP2086 and Simvastatin

The purpose of the study is to investigate the potential interaction between SP2086 and Simvastatin after the multiple oral doses treatment in healthy adult volunteers.

This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Simvastatin in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences. The A sequence was that SP2086 was taken at 40mg qd on Day1-Day 10; Simvastatin will be administered orally (by mouth) as 200mg on Day 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd on Day6-Day10. There were 5 days washout period between A and B. The total time of this trial was 27 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
* Had signed the informed consent himself or herself voluntarily.

Exclusion Criteria:

* Have the abnormal lab or other examination results and the change have clinical significance.
* History of or current clinically significant medical illness as determined by the Investigator.
* Have a family history of thyroid cancer, submandibular gland cancer or long QT syndrome
* Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide.
* History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs.
* History of severe unconsciousness hypoglycemia
* History of any surgery prior to screening in 6 months.
* History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month.
* History of participate any drug or medical device prior to screening in 3 months.
* Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins).
* 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion.
* The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive.
* Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
* Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
Prognosis of Paroxysmal Kinesigenic Choreoathetosis in Korea

The aim of this study is to assess the prognosis of paroxysmal kinesigenic choreoathetosis (PKC) in Korean.

PKC is a hyperkinetic movement disorder including dystonia, chorea, athetosis, or ballism, which are characteristically triggered by a sudden movement from rest. The prevalence of this disorder is estimated to be 1 in 150,000 population. Males are more commonly affected than females, and the age of onset is typically in childhood or adolescence. PKC is mainly a familial disorder with autosomal dominant inheritance and incomplete penetrance, but it can occur sporadically. The PRRT2 (proline-rich transmembrane protein 2) gene is believed to be the major causative gene.

The prognosis of PKC is usually favorable. The severity and frequency of the attacks are reduced by anticonvulsant medication such as carbamazepine, and the number of the attacks decreases at the age of 20-30 years. However, there has been little study of long-term prognosis of PKC, and no study has been conducted in Korean population.

Eligibility Criteria:
Inclusion Criteria:

* Male or female PKC patients who were18 years of age and older
* Subjects were diagnosed as paroxysmal kinesigenic choreoathetosis (PKC)
* Subjects were enrolled voluntarily and understood the contents of this trial

Exclusion Criteria:

* Existence of lesions on the brain
* Existence of neurological deficit that suspected lesions on the brain
* Existence of epileptiform discharges on electroencephalogram
* Subjects with secondary PKC which was caused by other disorder or illness
* Existence of illness or problems which made difficult to be enrolled to this trial judged by clinicians
Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron

To compare the anti-nausea and vomiting effect between glycopyrronium and ondansetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium to prevent postoperative nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists classification I-III
* Receive general anesthesia
* Voluntarily receive postoperative intravenous controlled analgesia

Exclusion Criteria:

* Puerpera or lactation women
* Allergy or existing contraindication to glycopyrronium and ondansetron
* Participate in other clinical drug trials within three months
* Can not follow with the study procedure
A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours

This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics in patients with advanced solid tumor followed by an expansion phase in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* In the dose-escalation phase: patients with advanced solid tumors refractory to standard treatment, intolerant of standard treatment, or for which no standard therapy exists.

In the dose-expansion phase: histologically- or cytologically-confirmed advanced or metastatic biliary tract cancer (BTC), esophagus cancer(EC) (squamous cell carcinoma) or squamous cell carcinoma of the head and neck (SCCHN). - men or women. - Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. - Adequate organ and marrow function. - Subjects must have at least 1 measurable lesion. - Available archived tumor tissue sample. - Willingness to provide consent for biopsy samples.

Exclusion Criteria:

* Any prior Grade ≥ 3 irAE while receiving immunotherapy - Prior exposure to any anti-PD-1 or anti-PD-L1 antibody - Active or prior documented autoimmune disease within the past 2 years - History of primary immunodeficiency - Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment - Women who are pregnant or lactating - Uncontrolled intercurrent illness - Known history of tuberculosis - Known to be human immunodeficiency virus (HIV) positive - Hepatitis B or C infection - Other invasive malignancy within 5 years
Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)

This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of ACDN-01.

This is an open-label, single ascending dose study of ACDN-01 in adult participants with ABCA4-related retinopathy. The study is designed to evaluate the safety, tolerability, and evidence of biological effect of SAD levels (low, medium, and high) of ACDN-01 when delivered subretinally.

Participants will be followed on study for 2 years for the primary safety and preliminary efficacy endpoints, after which they will continue in the study in a 3-year long-term follow-up period, for a total study duration of 5 years.

Eligibility Criteria:
Key Inclusion Criteria:

* Presence of mutations in the ABCA4 gene
* ABCA4 retinopathy phenotype (Stargardt disease type 1 or cone-rod dystrophy)
* Area of atrophy located in the macula of the study eye
* BCVA of 20/80 (0.6 logMAR) or worse

Key Exclusion Criteria:

* The presence of pathogenic or likely pathogenic mutations in other genes known to cause cone-rod dystrophy or Stargardt maculopathy
* Retinal disease other than ABCA4-related retinopathy
* Presence of a medical condition (systemic or ophthalmic), psychiatric condition, including substance abuse disorder, or physical examination or laboratory finding that may in the opinion of the principal investigator and sponsor preclude adherence to the scheduled study visits, safe participation in the study, or affect the results of the study.
Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders (TMD)

This is a single-blinded, randomized controlled trial to explore the effectiveness of acupuncture in the treatment of the pain due to TMD using the latest diagnostic criteria combined with subjective and objective indexes.

This is a single-blinded, randomized controlled clinical trial. A total of 60 participants will be randomly assigned to two different groups. The treatment group will receive acupuncture with real penetration of the needle, while participants in the control group will be treated with the Park sham needle. All participants will be given for 4 weeks of treatment and 4 weeks of follow-up.The primary end-point is the reducing in intensity of pain due to TMD, which will be evaluated before treatment, 4 weeks after treatment and follow-up (4 weeks after treatment) by using 0-10 visual analogue score. Secondary end points include Graded Chronic Pain Scale Version 2.0(GCPS 2.0),Jaw Functional Limitations Scale - 20-item (JFLS-20),Depression, Anxiety and Stress Scales (DASS-21),Pittsburgh sleep quality index (PSQI),Pressure Pain Threshold (PPT),Surface electromyogram(sEMG).

Eligibility Criteria:
Inclusion Criteria:

1. Pain disorders in accordance with Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
2. Pain in the jaw, temple, in the ear, in front of ear or headache in the temple at any sides, and pain or headache modified (remission or aggravation) with movement at least 3 months.
3. Cooperated in completing the clinical trial successfully without language and mental disorders.

Exclusion Criteria:

1. Conditions that result in regional pain in temporomandibular joint.
2. Autoimmune diseases that result in regional pain in the temporomandibular joint.
3. Mental illness or substance abuse.
4. Pregnant women.
A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

The purpose of this study is to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Japanese male or females of non-childbearing potential, ages 50-85
* Diagnosis of probable Alzheimer's disease, consistent with criteria from both: (1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
* Mini-Mental Status Exam score of 16-26 inclusive
* Rosen-Modified Hachinski Ischemia score \< or = 4

Exclusion Criteria:

* Diagnosis or history of other dementia or neurodegenerative disorders
* Diagnosis or history of clinically significant cerebrovascular disease
* Specific findings on magnetic resonance imaging (MRI): cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
* History of autoimmune disorders
* History of allergic or anaphylactic reactions
Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined by the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aletaha D et al, 2010)
* Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at Screening
* Subject must have moderate to severe RA disease at Screening and Baseline defined as:

  1. Screening (all criteria required)

     * ≥ 4 swollen joints (of 28 prespecified joints)
     * Disease Activity Score \[Erythrocyte Sedimentation Rate\] (DAS28\[ESR\]) \> 3.2
     * C-Reactive Protein (CRP) concentration ≥ 10 mg/L (or 1.0 mg/dL) or Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hr
  2. Baseline (both criteria required)

     * ≥ 4 swollen joints (of 28 prespecified joints)
     * Disease Activity Score \[Erythrocyte Sedimentation Rate\] (DAS28\[ESR\]) \> 3.2
* Subject must have inadequately responded previously to Methotrexate (MTX)
* Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has used the same MTX regimen for a minimum of 28 days prior to Baseline

Exclusion Criteria:

* Subject has previously received any biological Disease Modifying Antirheumatic Drug (DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase, phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine kinase
* Diagnosis of any other inflammatory arthritis
* Infected with Tuberculosis (TB) or high risk of acquiring TB infection
* Subjects with concurrent acute or chronic viral hepatitis B or C infection
* Subjects with a history of chronic or recurrent infections or subjects at high risk of infection
* Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological DMARDs excluding study medications, experimental therapy, IA hyaluronic acid
Chronic Illness Care Management (CICM) Study In Primary Care

The purpose of the study is to determine whether the quality of life of patients with multiple chronic conditions cared for by primary care physicians will improve due to the introduction of a chronic illness management intervention.

There is international recognition for the need of introducing improvement in chronic illness care. However, primary care physicians face a host of challenges for providing the best possible care to their patients. One of these problems is the lack of proper administrative systems. There is evidence indicating that tailored out reach facilitation is an effective means to improve practice performance. Traditionally, the approach to care for chronically ill patients revolved mostly around the treatment of a specific chronic condition in an ad hoc basis. It is more common in family medicine for the patient to have several chronic conditions. There is also evidence showing that better health outcomes are obtained when the patients' life circumstances, desires and expectations are taken into consideration. Various models of chronic illness care have emerged that are patient center while attempting to be comprehensive. Our approach, following the Australian model, seeks to introduce systems/administrative innovations at the practice level, intended also to increase the involvement of patients with multiple chronic conditions on its own care, throw tailored out reach facilitation and care planning tools for physicians, in order to improve chronic illness management in primary care settings.

Eligibility Criteria:
Inclusion Criteria:

* Patient should suffer from any two or more chronic illnesses
* Patient should have been seen in the GP's office at least six to seven times in the previous year
* Patient should be 50 years of age or older

Exclusion Criteria:

* Suffering from dementia or a major psychiatric condition, being terminally ill, not being competent to give informed consent for participating in the study, or the doctors considers that the patient will not benefit from the intervention.