cyrilzakka/clinical-trials huggingface dataset:
Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

In recent years, there has been increased focus on cognitive side effects of sleep-inducing medications that may contribute to unusual behavior during unexpected awakenings during the night. Concerns regarding these side effects have led to a class Food and Drug Administration (FDA) warning for all sleep-inducing medications. Almorexant is an experimental sleep-inducing medication in a new class of medications that is being extensively developed by multiple pharmaceutical companies. Medications in this class block wake/arousal centers in the brain that function with proteins called hypocretins. The goal of this study is to evaluate the impact on cognitive performance of almorexant vs. zolpidem (an approved sleep aid) or placebo.

Up to 216 healthy volunteers will be enrolled to participate in the 10 day study. After screening procedures have been completed (at SFVAMC), Days 1 - 7 will take place in subjects' homes, where their sleep/wake activity will be monitored. Days 8 - 10 will take place at Moffitt Hospital. On Day 10, subjects will take one dose of either almorexant 100mg, almorexant 200mg, zolpidem 10mg, or placebo. Cognitive tests will be administered to subjects throughout Day 10. Subjects will return for follow-up safety labs within 5 - 12 days of dosing with study medication. Based on animal studies, it is anticipated that subjects who take almorexant will be less cognitively impaired than those who take zolpidem.

Eligibility Criteria:
To participate in the study, participants must:

* Be between the ages of 19 and 39
* Be in good physical health
* Be a good sleeper with consistent bedtimes and wake times
* Not have problems falling or staying asleep
* Be a non-smoker
* Meet our other study criteria
Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases

Tonsillar tissue is a significant organ for the performing of immune systems in children. The Endoplasmic Reticulum (ER), is an organelle needed for the care of a stable function of the cells. The purpose of the study was to explore the correlation among ER stress and tonsillar tissue disorders and to explain the structure of diseases related to the immune system.

A prospective study was conducted on 46 children aged who underwent tonsillectomy for chronic tonsillitis or tonsil hypertrophy. Tonsil tissues were evaluated in terms of ER stress markers and apoptosis markers by Real-time PCR and Western blot methods.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent tonsillectomy surgery with the clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy.

Exclusion Criteria:

* Systemic diseases
* Other otolaryngological disorders
Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty


Eligibility Criteria:
Inclusion Criteria:

1. Patients who undergo unilateral primary total joint arthroplasty
2. Patient willing and able to complete postoperative surveys

Exclusion Criteria:

1. Patients who undergo revision total joint arthroplasty
2. Patients who undergo bilateral total joint arthroplasty
3. Patients currently taking melatonin supplementation
4. Patient has history of substance abuse (drug or alcohol)
5. Patient is a workman's comp patient or patient has current litigation pending
6. Patient has an allergy to melatonin
7. Patient has a history of delirium/psychiatric/depression/on antidepressants
8. Patient has a history of insomnia/ on sleep aid medication
9. Anyone on warfarin
10. Sleep apnea
11. Patient discharged to SNF or rehab
12. Patients who have inflammatory conditions
13. Shift work or night work
Scheduled Triple-lumen Central Venous Catheter Exchange: A Prospective Controlled Randomized Study

CVC Pros and Cons of scheduled Triple-lumen Central Venous Catheter Exchange: A Prospective Controlled Randomized Study


Eligibility Criteria:
Inclusion Criteria:

1. Patients who require the placement of a central venous catheter for medical purposes and have an absence of infection.
Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women

To determine the pharmacokinetic profile of generic lopinavir/ritonavir tablets To investigate the possible influence of pregnancy and duration of pregnancy To determine the antiviral activity and safety of generic lopinavir/ritonavir® Compare pharmacokinetics parameters before and after pregnancy.

HAART in pregnant HIV-infected serves two goals, preventing mother to child transmission and providing adequate treatment for the mother. Levels of HIV RNA at delivery and the use of antiretrovirals (ARV) are independently associated with decreased transmission\[1\]. With a HAART regimen the transmission rate can be reduced till under the 2 %\[1, 2\]. Possibly suitable drugs which can be used during pregnancy is lopinavir/ritonavir based regimens. In Thailand, aluvir is not available therefore a generic lopinavir/ritonavir tablet formulation will be used in our study.

In order to prove adequate levels of lopinavir/ritonavir, we will record 12-hour PK at third trimester. Second trimester and post-partum 12-hour PK are optional. Furthermore, we will collect safety and efficacy throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Documented positive test for HIV-1 infection
* Subject is at least 18 and not older than 40 years of age at the day of the first dosing of study medication
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Pregnant for a maximum of 30 weeks at the day of first dosing of study medication

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* Inability to understand the nature and extent of the trial and the procedures required.
* Abnormal serum transaminases or creatinine, determined as levels being \> 3 times upper limit of normal.
* Concomitant use of medications that interfere with Generic lopinavir/ritonavir pharmacokinetics
* Active hepatobiliary or hepatic disease (N.B. chronic hepatitis B/C co-infection is allowed)
* Documented previous virological failure of a lopinavir/ritonavir containing regimen or documented resistance to lopinavir/ritonavir prior to dosing
Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads

This study aims to assess the differences in tolerability of differently manufactured wheat breads in a target group of individuals with suspected wheat sensitivity. Additionally, it will be verified, if the absence of a response to oral exposure to defined bread types is associated with an absence of mucosal changes following CLE-assisted mucosal provocation with bread.

Nowadays, more than 20% of people in industrialized countries suffer from a food intolerance or food allergy, with wheat and gluten intolerances on the rise. Besides the well-known conditions celiac disease and wheat allergy, another clinical entity called non-celiac wheat sensitivity (NCWS) was described, which is not yet widely understood. Resulting from inconsistent diagnostic criteria the prevalence of NCWS varies from 0.5% to 13%.

Due to the lack of validated diagnostic criteria and/or appropriate biomarkers for diagnosis of NCWS, it can currently only be suspected by exclusion of other diseases. To verify suspected NCWS, a double-blind placebo-controlled food challenge with wheat is recommended. A confocal laser endomicroscopy (CLE) with endoluminal provocation can also provide meaningful results on the individual intestinal mucosal response to specific allergens.

Furthermore, it is as yet unclear whether NCWS is triggered by gluten, FODMAPs, or other wheat components such as α-amylase trypsin inhibitors. Bread manufacturing processes can influence the composition of bread and the presence of possible triggers of intolerance reactions.

This study aims to investigate the tolerability of differently manufactured wheat breads in individuals with suspected NCWS. Additionally, we expect this approach to improve the currently inadequate diagnosis of NCWS, as well as to provide a better understanding of the underlying mechanisms.

Therefore, individuals with suspected NCWS are included in the trial. Five different types of bread will be tested, including 3 differently manufactured wheat breads, a gluten free bread and a gluten free bread with added wheat flour. Aim of this part is to test a possible psychological factor in NCWS symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 ≤75 years
* Signed declaration of consent
* Willingness to adhere to the prescribed diet for the duration of the study
* Chronic gastrointestinal symptoms for at least 6 months
* Anamnestic wheat sensitivity
* No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)
* No or stable medication for at least 3 months
* No participation in another clinical trial (current or within the past 30 days)

Exclusion Criteria:

* Taking intestinal therapeutics, antibiotics, immunosuppressants, anti-allergic medication or similar
* Pregnancy / lactation
* Occurrence of relevant diseases (possibly individual decision)
* Revocation of consent
* Concurrent participation in another clinical study
Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)

This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to be conducted in conformance with Good Clinical Practices. This trial will investigate the effects of single doses of preladenant and placebo on the dyskinesia and antiparkinsonian actions of a levodopa infusion. The study will examine 10 mg ("low dose") or 100 mg ("high dose") study drug, given as single, oral administrations in conjunction with intravenous (IV) levodopa infusion and oral carbidopa.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a diagnosis of idiopathic PD based on history, exam and any relevant laboratory tests
* Participants must have been treated with levodopa for one or more years
* Participants must have motor fluctuations that can be measured as a 10% change in tapping speed between "on" and "off" and concurrent motor Unified PD Rating Scale (UPDRS) must also show a 20% improvement when "on"
* Participants must have dyskinesia when "on" measured as at least 2 in one or more body parts on scale using 0 (absent) to 4 (severe) for four limbs, trunk, neck and face (total 7 body parts and 28 points)
* Participant must be free of any clinically significant disease that would interfere with the study evaluations
* Female participants must be postmenopausal and/or surgically sterilized and have a negative serum pregnancy test at the screening visit and a negative urine or serum pregnancy test upon each admission to the study center
* Premenopausal, unsterilized female participants have to agree to use a medically accepted method of contraception
* Male participants must agree to use a medically accepted method of contraception as or abstain from sexual intercourse during the trial and for 2 months after stopping the medication.

Exclusion Criteria:

* Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are lactating
* Participants with dementia (mini-mental state examination \[MMSE\] \<23), hallucinations, confusion, major psychiatric disorders, and unstable medical conditions
* Participants with any stable surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
* Participants with a positive screen for drugs of abuse
* Participants who are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
* Participants who are currently participating in another medical interventional clinical study or have participated in a medical interventional clinical study within 30 days and who have previously received this compound.
Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion Positive Locally Advanced Rectal Cancer

Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.

It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) were enrolled in this trial. All EMVI+ LARC will receive the study regimen every 2 weeks for 6 cycles. MRI will be performed after 3 cycles of chemotherapy to assess clinical response.MRI was performed to assess clinical response after chemotherapy. Patients with mesorectal fascia-positive or ycT4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (TME).If the tumor response is good enough(partial response or complete response), the patient will receive another 3 cycles of FOLFOXIRI then surgery. On the contrary, if the tumor shows poor response(stable disease or progressive disease) or with mesorectal fascia-positive or ycT4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. All patients will receive 6 cycles of mFOLFOX6 or 4 cycles XELOX as adjuvant chemotherapy after TME.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 to 75 years at diagnosis;
2. ECOG status 0 or 1;
3. Signed informed consent; able to comply with study and/or follow- up procedures;
4. Diagnosis of rectal adenocarcinoma;
5. Distal border of the tumor must be located \< 12 cm from the anal verge;
6. MRI examination diagnosed EMVI-positive;
7. Tumor amenable to curative resection;
8. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: (1) Neutrophilic granulocytes ≥ 3.0 x10\^9/L, Platelet count ≥ 75 x 10\^9/L, Hemoglobin (Hb) ≥ 90g/L; (2) bilirubin ≤1.5 x the upper limit of normal (ULN),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN; (3) Serum creatinine ≤ 1.5 x ULN.
9. No renal disease that would preclude study treatment or follow-up

Exclusion Criteria:

1. Hypersensitivity to fluorouracil, oxaliplatin or irinotecan;
2. Patient had received pelvic radiotherapy;
3. Patient had received systemic chemotherapy;
4. History of invasive colon or rectal malignancy, regardless of disease-free interval;
5. Had metastatic disease;
6. Patient had second malignant disease within 5 years;
7. Uncontrolled co-morbid illnesses or other concurrent disease;
8. Patients refused to signed informed consent.
9. Pregnant and Nursing women;
Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen

To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.


Eligibility Criteria:
Inclusion Criteria:

* Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
* Subjects who obtain a minimum sum score, considering SAR related symptoms (mean value), as defined by the protocol

Exclusion Criteria:

* Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
* Have used forbidden concomitant medications as defined by the protocol
A Long-Term Follow-Up Study of Participants Exposed to REACT

The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).

This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 80 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (RMCL-002, REGEN-003, REGEN-004) will be monitored for up to five years with alternating in clinic and phone visits.

Eligibility Criteria:
Inclusion Criteria:

* The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol.

Exclusion Criteria:

* The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.
Lethal Congenital Malformations: Palliative Therapy From An Islamic Point of View

To prove that palliative therapy can be practised for congenital lethal malformations within the Islamic Code of Ethics.

After defining lethal malformation no respiratory support is offered and newborns are provided with compassionate care.

This is a prospective observational study where all abnormal antenatal ultrasounds are discussed in a weekly prenatal meeting and plans are drawn for management of these abnormal fetal findings. Lethal malformations are defined as conditions which will end in death regardless of supportive care. Cases are discussed extensively and parents are involved in management decisions. When a decision of non- intervention is reached for a lethal malformation consent of the family is obtained and a plan of non monitoring for the mother is documented together with no resuscitation for the newborn. Families who do not consent to such plan are offered full support for the pregnant mother and her newborn. A record of all cases is kept available together with the management plan so that the appropriate action is taken when the the pregnant lady presents for admission. All babies with lethal malformations are recorded whether stillborn or live born and their diagnosis is confirmed. Survival time is recorded for each case.

Eligibility Criteria:
Inclusion Criteria:All babies with abnormal fetal ultrasounds -

Exclusion Criteria: Normal babies who die in the neonatal period because of other causes not associated with lethal malformations

-
Aminoglycosides in Early Sepsis

Norwegian guidelines for empirical antibiotic therapy in suspected community acquired sepsis recommend the combination of narrow spectrum betalactam and aminoglycoside as the first choice, but broad spectrum betalactams are considered equally appropriate, effective, and safe. However, fear of renal complications due to gentamicin and concern for lacking evidence for efficiency commonly leads to the use of broad spectrum betalactam therapy, a larger driver of antibiotic resistance.

In patients with suspected community acquired sepsis, the investigators hypothesize that empirical combination therapy with narrow spectrum betalactams and aminoglycosides is safe and non-inferior to empirical therapy with broad spectrum betalactams. More specifically, the investigators hypothesize that the proportion of patients with acute kidney injury or death will be similar between these two treatment groups. Furthermore, the investigators hypothesize that the aminoglycoside-based regimen has lesser impact on the gut microbiome. Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required but failed to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In this context, novel initiatives aiming at reducing use of antibiotics are direly needed.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized
* Adults 18 year or older
* Clinical suspicion of community acquired sepsis with indication for empirical antibiotic therapy
* National Early Warning Score 2 (NEWS2) ≥ 5
* Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations

Exclusion Criteria:

* Established chronic kidney failure (eGFR \< 30 ml/min/1.73m2)
* Presentation with septic shock with multiorgan failure
* Suspicion of condition necessitating specific antimicrobial therapy (e.g. atypical pneumonia, fungal infection, parasitic infection, mycobacterial infection)
* Recent use of nephrotoxic drugs (e.g. cisplatin)
* Suspected or confirmed carrier of extended spectrum betalactamase (ESBL) producing bacteria
* Multiple myeloma
* Renal transplantation
* Myasthenia gravis
* Known hypersensitivity to any of the study drugs
* Pregnancy
* Any condition where gentamicin in the opinion of the investigator poses an unacceptable risk
Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.

The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.

Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

In order to set up an optimal patient path within the Group of hospitals of Loire territory, the working group composed of doctors from different specialities of the department considered it important to carry out a randomised study evaluating the effectiveness of a healthcare organisation combining:

* an adapted and supervised physical activity intervention (1 month hospital initiation then 2 months in town)
* therapeutic education sessions for the patient with motivational interviews Compared to usual clinical practice (adapted physical activity adapted in autonomy at home + therapeutic patient education sessions with motivational interviews).

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
* French writing and speaking
* Sedentary or low level of activity (less than 150 minutes of regular physical activity per week at the time of inclusion)
* Signature of informed consent

Exclusion Criteria:

* Cardiac or respiratory diseases that contraindicate the practice of physical activity
* Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
* Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason