cyrilzakka/clinical-trials huggingface dataset:
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
* Must have the following atopic dermatitis criteria:

  1. Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
  2. Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.
  3. Moderate to severe AD (affected BSA \>=10 %, IGA \>=3, and EASI \>=12 at the screening and baseline visits).

Exclusion Criteria:

* History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
* Infected with hepatitis B or hepatitis C viruses.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
* Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated

This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma that has never been treated
* Visual Acuity 20/60 or better in each eye

Exclusion Criteria:

* Eye surgery within 3 months
* Any refractive eye surgery
* Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease \[COPD\], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction \[heart attack\])
* Eye inflammation or eye infection within 3 months
* Eye trauma within 6 months
* Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study
Targeting Leukotrienes in Kidney Disease

Diabetic kidney disease (DKD) is associated with significant morbidity and mortality. Identifying new treatments for DKD to be used alone or in combination with other therapies is a high priority. Inflammation plays a key role in DKD and targeting pro-inflammatory lipid mediators called leukotrienes may represent a promising therapy for DKD. The current proposal will investigate whether montelukast, a leukotriene antagonist, reduces proteinuria and improves vascular function and arterial stiffness in patients with DKD.


Eligibility Criteria:
Inclusion Criteria:

* CKD stage 3
* urine albumin to creatinine ratio 200-5000 mg/g
* blood pressure \<140/90 mmHg
* use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks
* history of diabetes type 1 or 2
* BMI \<40 kg/m2
* Stable antihypertensive regimen for at least one month prior to enrollment
* Stable diabetes regimen for at least one month prior to enrollment
* Sedentary or recreationally active (\<2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)
* Able to provide consent

Exclusion Criteria:

* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Uncontrolled hypertension
* Factors judged to limit adherence to interventions (e.g. history of medication noncompliance, noncompliance with follow up visits, significant cognitive impairment, etc.)
* Anticipated initiation of dialysis or kidney transplantation within 3 months
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Allergy to aspirin
* Severe hepatic impairment (Child-Pugh Class C)
* History of major psychiatric disorder
* Use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction)
* Current use of SGLT2 inhibitor
* Current use of phenobarbital, rifampin or carbamazepine.
Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide for 7 days on top of standard care compared to patients who receive standard care and placebo.

Patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide or placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent from patient or legal representative.
2. Male or female, aged ≥ 18 years;
3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
4. Signs of respiratory failure requiring oxygen therapy
5. Hospitalized for up to 36h with non-invasive ventilation
6. Negative result for pregnancy test (if applicable).

Exclusion Criteria:

1. Participating in another RCT in the past 12 months;
2. Known allergy to nitazoxanide
3. Severely reduced LV function;
4. Severely reduced renal function;
5. Pregnancy or breast feeding;
6. Use of hydroxychloroquine and/or azithromycin in the past 15 days;
7. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
Children and Adolescents With Marfan Syndrome: 10,000 Healthy Steps and Beyond

Marfan patients are at risk of sudden death due to weakening of the wall of the large blood vessel leading from the heart (aorta). The wall of the aorta weakens and dilates which can rupture, leading to death, and sometimes during intense exercise.

There is some evidence in Marfan patients that a stiffer aorta increases risk for rupture.

For some time, clinical care has focused on what type of exercise these patients should avoid due to risk for aortic dissection. Little clinical emphasis has been placed on encouraging patients to engage in routine and safe exercise such as walking. Informed by this evidence, the investigators propose to collaboratively investigate whether regular exercise improves aortic health in adolescent Marfan patients.

Marfan syndrome is an inherited disorder of the connective tissue, which provides material and support for the skeleton, muscles, and blood vessels. Marfan patients are at risk of sudden death due to weakening of the wall of the large blood vessel leading from the heart (aorta). The wall of the aorta weakens and dilates which can rupture, leading to death, and sometimes during intense exercise.

Typically, the weakening process starts when elastin fibers in the aorta become fragmented. There is some evidence in Marfan patients that a stiffer aorta increases risk for rupture.

For some time, clinical care has focused on what type of exercise these patients should avoid due to risk for aortic dissection. Little clinical emphasis has been placed on encouraging patients to engage in routine and safe exercise such as walking. These young patients also frequently choose sedentary lifestyles, most likely due to limitations imposed by parents as well as adolescents' own perceptions of what is safe for them and their physical capabilities. Another complicating factor is that these patients often experience difficulty coping with their diagnosis. Informed by this evidence, the investigators propose to collaboratively investigate whether regular exercise improves aortic health and coping skills in adolescent Marfan patients.

Eligibility Criteria:
Inclusion Criteria:

1. 10-19 years of age,
2. MFS by revised Ghent criteria,
3. Cardiac clearance to exercise by the primary cardiologist.

Exclusion Criteria:

1. Ventricular dysfunction,
2. Prior history of aortic surgery.
The Effect of Demographic, Mental, and Physical Activity Profiles Towards Burnout in Frontline Healthcare Workers Facing COVID-19 Pandemics in Dr. Soetomo General Hospital Surabaya

This was a randomized controlled trial study to measure the effect of intervention of Zumba dance towards psychological and biological markers in hospital residents managing COVID-19 patients

A study to compare the effect of Zumba dance exercise towards psychological and biological markers in control and intervention groups of residents managing COVID-19 patients. Psychological markers were assessed using State Trait Anxiety Inventory (STAI), Brief Resilience Scale (BRS), and Maslach Burnout Inventory (MBI) questionnaires. Biological markers being measured were neutrophil to lymphocyte ratio (NLR), CD4, Interleukin-6 (IL-6), and salivary cortisol. Measurements were done at the beginning of self-isolation after shift and 2 weeks after self-isolation.

Eligibility Criteria:
Inclusion Criteria:

* Residents of anesthesiology and internal medicine department at Dr. Soetomo General Hospital Surabaya
* Residents managing COVID-19 patients in the special isolation room

Exclusion Criteria:

* Residents that did not fill in the questionnaires completely
* Residents with comorbidities (diabetes, hypertension, heart disease or autoimmune disorders)
* Residents that were infected with COVID-19
* Residents currently or previously diagnosed with psychosis
* Residents refusing to participate in the study.
Correlation Between Various Inflammatory Markers and Vascular Inflammation Measured by 18FDG-PET

Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. Various inflammatory markers such as LpPLA2,MCP-2 and hsCRP are well-known prognostic factors for the cardiovascular event.

18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between various inflammatory markers and vascular inflammation detected by 18FDG-PET.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients for visiting routine medical check in our clinic

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* Diabetes
* Stage 2 hypertension (resting blood pressure, ≥160/100 mmHg)
* Malignancy
* Severe renal or hepatic disease
* Subjects taking medications that might affect inflammation such as NSIAD and statin
Genetic Analysis of Familial Brain Aneurysms

This study will investigate cerebral (brain) aneurysms and their possible inheritance patterns in families. It will try to determine how often brain aneurysms occur in families in which more than one member has had an aneurysm and to find the gene or genes that contribute to their development.

People in families in which more than one family member had a cerebral aneurysm are eligible for this 1-day study. They will undergo the following procedures:

* Blood will be drawn (no more than 3 to 4 tablespoons) for research to identify genes that contribute to the development of brain aneurysms.
* A magnetic resonance angiograph (MRA) scan will be done to examine a specific brain area where aneurysms typically occur. Magnetic resonance imaging uses a strong magnetic field and radio waves to produce images of the brain and detect abnormalities.

If a more detailed picture of the brain is needed than can be obtained with MRA, a more specific MRA scan will be done using a contrast dye to enhance the images.

Patients may be invited to participate in related NIH research studies.

This study is designed to explore the genetics of familial cerebral aneurysms. Families in which more than one person has had a known cerebral aneurysm will be studied. Family histories will be obtained and participants identified who are willing to come to the NIH Clinical Center for an MRAngiograph and venipuncture. DNA will be isolated and linkage studies undertaken to identify loci involved in the etiology of familial cerebral aneurysms, using standard linkage approaches.

Eligibility Criteria:
INCLUSION CRITERIA:

Participants and their relatives that are affected or at a higher risk for cerebral aneurysms will be enrolled in this protocol.

EXCLUSION CRITERIA:

For the MR Angiograph portion of the study, any participant that is not able to sign the Clinical Center consent form due to metal implants, pregnancy, claustrophobia, or an allergy to gadolinium as a contrast will be excluded from the imaging part of the study.
Randomized Clinical Trial, Open, Multicenter Parallel, no Suspension Inferiority Prophylactic Treatment With Valganciclovir in Kidney Transplant CMV-seropositive Cellular Immunity to Develop CD8 + CMV-specific Treatment After Induction Thymoglobulin.

Hypothesis: Valganciclovir prophylaxis can be discontinued before 3 months in CMV-seropositive renal transplant recipients receiving induction thymoglobulin when developing CMV-specific cellular immunity after transplantation.

Objective Meet the efficacy and safety of valganciclovir prophylaxis suspend in CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific transplant, receiving Thymoglobulin induction and maintain cellular immunity-specific CD8 + CMV after transplantation.

Design: noninferiority clinical trial (study A) in CMV-seropositive kidney transplant recipients with CMV-specific cellular immunity pretransplant (Quantiferon reactive CMV) received induction with thymoglobulin

Patients meeting inclusion criteria will be randomized to:

* Control Arm: valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS (Transplantation 2013:96:333-360).
* Experimental arm: prophylaxis with valganciclovir and determination of CMV-specific cellular immunity day +15, +30, +45 and +60. Prophylaxis was discontinued when the patient developed CMV-specific cellular immunity. Patients who did not develop CMV specific immunity continue prophylaxis until day +90.

Analysis: The incidence of CMV disease according to the strategy used was calculated using Kaplan-Meier curves that were compared using the log-rank test.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant CMV-Seropositive
* CD8+ Tcell CMV especific pretransplant (CMV-reactive quantiferon pretrasplant)
* \> 18 years (adult)
* Receiving Thymoglobulin induction therapy
* Receiving Valganciclovir prophylaxis
* Written informed consent for trial entry

Exclusion Criteria:

* Multivisceral transplants including kidney-pancreas.
* HIV-infected Patients
* Patients who can not comply with the monitoring protocol.
A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation

The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine. However, the advantage of a calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* renal transplant recipients

Exclusion Criteria:

* Recipients of HLA-identical living-donor renal transplants;
* multi-organ transplant;
* known hypersensitivity to Campath-1H, Rituximab, CellCept, or prednisone;
Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)

The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without Yasmin in the body, in healthy volunteers not using hormonal contraception.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteer
* Age: 18 - 38 years inclusive
* Body mass index (BMI)1: ≥ 19 and \< 28 kg/m²
* Regular cyclic menstrual periods at screening OR when using combined oral contraceptives during the recruitment period reporting of natural cyclic menstrual periods prior to their use
* Willingness to use non-hormonal methods of contraception during the complete trial OR previous tubal ligation

Exclusion Criteria:

* incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, excretion and effect of the study drugs will not be normal
* known or suspected sex-steroid influenced malignancies
* endometrial hyperplasia; genital bleeding of unknown origin; uterus myomatosus
* known or suspected tumors of the liver and pituitary
* presence or history of severe hepatic disease as long as liver function values have not returned to normal
* severe renal insufficiency or acute renal failure
* thrombophlebitis, venous / arterial thromboembolic diseases; presence or history of prodromi of a thrombosis
* other conditions that increase susceptibility to thromboembolic diseases
* known neuropsychiatric diseases, especially known or suspected epilepsy, and/ or deficient status of folate or vitamin B12
* use of any other medication within 2 cycles before first study drug administration which could affect the study aim
* use of potassium sparing drugs; use of folic acid containing supplements or medicines or use of any medication within 2 cycles before first study drug administration known to interfere with folate metabolism
* inadequate folate and/or Vitamin B12 status , clinically relevant deviations in red cell folate concentrations
Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children

Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum.

The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.

Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.

Eligibility Criteria:
Inclusion Criteria:

* Functional Constipation
* Fecal Incontinence
* Parental Agreement

Exclusion Criteria:

* After surgery on lower gastrointestinal tract
* Diagnosis of inflammatory bowel disorders
* Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures
* Lack of parental agreement
Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome

The goal of this clinical trial is to determine the effects of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. The main questions it aims to answer are:

Does Coenzyme Q10 alter oxidative stress, inflammation and hyperandrogenism in women with Polycystic ovary syndrome.

Participants will take Coenzyme Q10 200mg, once daily for a period of 3 months. The participants will be reassessed after 12 weeks by measuring Malondialdehyde MDA, C-reactive protein CRP, Sex hormone binding globulin SHBG.


Eligibility Criteria:
Inclusion Criteria:

* Married Patients that presented with anovulatory infertility due to PCOS.
* Unmarried Patients that presented with symptoms due to PCOS
* All patients should fulfill Rotterdam criteria for PCOS

Exclusion Criteria:

* Male factor infertility ( oligospermia or aspermia)
* Tubal factor infertility (abnormal hysterosalpingography)
* Diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function
* Autoimmune and Inflammatory disorders
* Abnormal serum prolactin level
* Smokers
* Alcoholic beverage use
* Use of anti diabetic, anti-obesity drugs, insulin or vitamin and mineral supplements
Epidemiology of Aeromedical Evacuation

Increasing air travel has resulted in a significant increase in aeromedical evacuation over the past decade. However there is only a small amount of epidemiological data available on the diagnosis, costs and transport characteristics of aeromedical evacuation cases. In the present study Cases of aeromedical evacuation by a relief organization (Workers' Samaritan Federation Germany) were analyzed based on the following criteria: age, sex and diagnosis of the patient, ventilation mode, days of illness before transport, type of transport, flight routes, flying time, flight distance, type of aircraft, type and distance of connecting transport from the destination airport to the final hospital, total cost per repatriation, and costs per flight-minute of each transport type.


Eligibility Criteria:
Inclusion Criteria:

* medical emergency and aeromedical evacuation / repatriation

Exclusion Criteria:

* none