cyrilzakka/clinical-trials huggingface dataset:
Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial

This study aims to establish the efficacy of transdermal glyceryl trinitrate as a nitric oxide donor in addition to dinoprostone for induction of cervical ripening in the third trimester through progression in the Bishop's score during 24 hour period.

Objectives: The primary outcome of the study is to compare the changes occurring to the cervix through the progression in the Bishop's score between NO donor (nitroglycerine patch) vs placebo; in combination with a well-established method of induction (Dinoprostone).

The secondary objective of the study is to observe and report possible fetal and maternal side effects that may be associated. This will establish the safety and tolerability of NO donors.

Research Question: Does the usage of Nitroglycerine skin patch enhance cervical ripening and facilitate induction of labor by Dinoprostone?

Null hypothesis: Nitroglycerine skin patch does not cause advantage for ripening of the cervix nor facilitate the process of labor induction.

Alternative hypothesis : Nitroglycerine skin patch has favorable effect in enhancing cervical ripening and the outcome of induction of labor.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton living full-term fetus.
2. Cephalic presentation,
3. Bishop score less than 5,
4. Assuring fetal monitoring,
5. The mother does not have PROM,

Exclusion Criteria:

1. Expected fetal anomaly (eg. by ultrasound),
2. Abnormal presentation,
3. Multiple pregnancy,
4. Non assuring fetal CTG,
5. Fetus more than 90th percentile of expected weight,
6. Previous maternal obstructed labor or previous cesarean section,
7. Maternal obstetric or medical complication,
8. Structural anomaly of the uterus
Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload

This study aims to compare two medications, acetazolamide and metolazone, along with loop diuretics, to see which one works better and is safer for patients with ADHF who have volume overload. By comparing these medications, we hope to learn which one can help these patients the most. This will help doctors choose the best treatment for patients with ADHF and volume overload.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with ages ≥ 18 years old, and less than 65 years old.
* For both elective and emergency hospital admissions, patients with a clinical diagnosis of ADHF must exhibit at least one clinical sign indicative of volume overload. These signs may include edema (score 2 or higher), ascites confirmed through echography, or pleural effusion confirmed by chest X-ray or echography or rales on auscultation, or jugular venous pressure greater than10 mm Hg.

Exclusion Criteria:

* Patient diagnosed with acute kidney injury upon hospital admission based on the presence of any of the following criteria: an increase in SCr by at least 0.3 mg/dL within 48 hours, an increase in SCr to at least 2 times the baseline value, known or presumed to have occurred within the prior 7 days, and a urine volume less than 0.5 ml/kg/hour for a duration of 6 hours.
* Patients with acute pulmonary edema caused by increased afterload and fluid redistribution to the lungs in the absence or with minimal fluid accumulation.
* Anticipated exposure to nephrotoxic agents (such as contrast dye) during hospitalization.
* Patients who exhibit anuria or are undergoing renal replacement therapy or ultrafiltration.
* Patients with eGFR less than 30 mL/min/1.73m² at the time of screening.
* Expected use of intravenous inotropes, vasopressors, or nitroprusside during the study.
* Prior cardiac transplantation and/or utilization of a ventricular assist device.
* Blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg at the time of recruitment.
* Patients who are pregnant or breastfeeding.
* Administration of acetazolamide or metolazone within the one-month period preceding randomization.
* The usage of any diuretic agent during the treatment phase is not specified in the study protocol, except for mineralocorticoid receptor antagonists.
Post-exercise Protein Intake for Active Children

Today, there is an important lack of knowledge on the effects of dietary protein on protein metabolism after physical activity in children. Here, the investigators will measure changes in whole body protein metabolism using minimally invasive techniques and stable isotope methodology at rest and after physical activity with the intake of milk protein.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and physically active (as determined by medical and activity questionnaire)
* 10-12 years of age
* Within approximately 2 years of estimated age of peak height velocity (PHV)
* Minimum aerobic fitness of 35 ml/kg/min as assessed by the McMaster All-out Progressive Continuous Cycling Protocol
* Having obtained his/her informed assent
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Post-pubertal
* Taking any medication
* Smoker
* Undergoing medical treatment or investigations
* Body mass index \> 24
* Suffer from chronic diseases (with regular intake of drugs, medical history)
* Vegetarians
* Vaccination in the last 4 months
* Any know food allergies or intolerance
* Pregnancy
* Special diet or weight loss program (e.g. Atkins diet)
* Acute illness
* Fever, cold, flu
* Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts).
Risk of Celiac Disease and Age at Gluten Introduction

The purpose of this study is to determine whether age at introduction of gluten-containing cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development in infants with a first-degree relative affected by CD.

We undertook a prospective study to establish the incidence of CD autoimmunity related to the timing of gluten exposure in at-risk infants. Infants at family risk for CD (at least one first-degree relative affected) are enrolled in this prospective, multicentre, intervention study conducted in Italy. Infants are randomly assigned to introduce gluten at either 4-6 or 12 months (groups A and B, respectively) and then enter a follow-up period of 5 years. Duration of breastfeeding and types of formulas, adherence to the dietary plan, amount of gluten administered, and clinical data are collected by phone or direct interview at 4, 7, 9, and 12 months of age. HLA (Human Leucocyte Antigene) status and CD serology (anti-transglutaminase and other autoantibodies) are tested at 15, 24, 36 and 60 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Newborn in a family where a first-degree relative is already affected with biopsy-proven CD
Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease

The purposes of this study is to standardize the process of formulating exercise prescriptions for coronary heart disease（CHD）, verify the safety and effectiveness of exercise prescriptions, and establish a database of exercise prescriptions for CHD, with a view to providing new solutions for cardiac rehabilitation.

This study conducted a comparative study on the therapeutic effect and safety of exercise prescriptions for patients with coronary heart disease with different risk stratifications. The purposes of this study is to standardize the process of formulating exercise prescriptions for coronary heart disease（CHD）, verify the safety and effectiveness of exercise prescriptions, and establish a database of exercise prescriptions for CHD, with a view to providing new solutions for cardiac rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years old with a diagnosis of coronary heart disease，NYHA class I-III HF patients.

Exclusion Criteria:

* acute myocardial infarction within 2 weeks
* Uncontrolled tachycardia (heart rate at rest \>120bpm
* Uncontrolled polypnea（breath rate at rest \>30 breath per minute
* Uncontrolled respiratory failure （SPO2 ≤90%）
* Uncontrolled hyperglycemia (Random blood glucose\>18mmol/L)
* Uncontrolled malignant arrhythmia with hemodynamic instability
* Uncontrolled septic shock and septicopyemia
* Uncooperation of the patients
AGN-242428 in the Treatment of Plaque Psoriasis

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of AGN-242428 in adult participants with moderate to severe plaque-type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6 months before study with a Physician's Global Assessment (PGA) score ≥ 3 at screening and baseline
* Severity of disease must be at least moderate, defined as Psoriasis Area and Severity Index (PASI) ≥ 12 and % body surface area (BSA) ≥ 10
* Participant is a candidate for phototherapy or systemic therapy for psoriasis
* Body weight of at least 55 kilograms (kg) (121 (pound) lbs)

Exclusion Criteria:

* Non-plaque forms of psoriasis (erythrodermic, guttate, pustular) or drug-induced psoriasis
* Psoriasis which has not been stable for the 4 weeks prior to screening and which is unstable at Study Day 1
* History of Gilbert's, Rotor, or Dubin-Johnson syndromes or any other disorder of bilirubin metabolism
* History of active mycobacterium tuberculosis (TB) infection or untreated or inadequately treated latent TB
* Positive QuantiFERON test for TB infection at screening
* Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to baseline
* Positive drug and/or alcohol test at screening (with the exception of marijuana). Retesting in the case of a positive alcohol test is allowed at the discretion of the sponsor
* Current treatment or history of treatment with any anti-Tumor Necrosis Factor alpha (TNFα) biologic therapy within 3 months or 5 half-lives of study, and/or all other biologics within 6 months of study (Day 1)
* Efficacy failure on 2 or more biologic agents for the treatment of psoriasis when the failures occurred within 1 year of the initiation of the therapy of the first biologic agent
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBL) exceeding 1.5 times the upper limit of normal (ULN) at screening.
Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Fulfill 2010 ACR/EULAR criteria for RA Aletaha et al 2010 at Screening
* Active disease defined as ≥ 2 swollen joints (of 58 evaluable joints) and ≥ 2 tender joints (of 60 evaluable joints) despite stable MTX ≤ 25 mg/week and/or hydroxychloroquine ≤ 400 mg/day treatment for at least 2 months prior to randomization

Exclusion Criteria:

* Prior or previous use of (specific dosages and intervals prior to study start may apply): other investigational drugs, B-cell depleting therapy (e.g. rituximab), monoclonal antibodies (mAb), i.v. / s.c. Ig, thymoglobulin, i.v. or oral cyclophosphamide, oral cyclosporine, soluble cytokine receptors, azathioprine.
* Currently receiving prednisone \>10 mg/day (or equivalent oral glucocorticoid) or dose adjustment within 2 weeks prior to randomization
* Active viral, bacterial or other infections requiring systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
* Receipt of live/attenuated vaccine within a 2-month period before randomization
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception from screening and for 4 months after stopping of investigational drug
Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients

Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients.

Hypothesis It is hypothesised that timing of tracheostomy to day 9-11 is independently linked to a higher number of days, alive without invasive mechanical ventilation and several secondary outcomes when adequate methods to neutralize waiting time and immortal time bias are used.

Data sources Existing data provided for another project will be used.

Statistical methods:

A cohort study with a target trial emulation (1) on a dataset with cloned individuals assigned to different treatment strategies (i.e. tracheostomy at different timings). Censoring at deviation from assigned strategy or death (2). Adjustment for confounding will be used.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* admitted to an intensive care unit in Sweden from 2020 to 2021
* Main discharge diagnosis COVID-19 (ICD-10, U07.1)
* Invasive mechanical ventilation

Exclusion Criteria:

* No Swedish personal identification number.
Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty

The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.


Eligibility Criteria:
Inclusion Criteria:

* recurrent inguinal hernia
* willing to participate

Exclusion Criteria:

* unwilling to participate
* bilateral hernia
* preference towards either treatment arm
BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery

The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the use, in the immediate postoperative period, should lead to define the role of each technique and lead to a optimal rationalization of patients management with acute respiratory failure after surgery.

Main objective: to determine, if the initiation of OPTIFLOW™ system immediate after cardio/ thoracic surgery with acute respiratory failure or immediate after post extubation in patients at risk, is not less than the start a VNI per BIPAP Vision ®system. In terms of reintubation rates, refusal to continue the technique, or switch to another technique proposed.

Secondary objectives:

* To assess changes in the sensation of dyspnea
* To analyze the skin tolerance and the comfort in this population
* To analyze the evolution of hemodynamic and respiratory parameters
* To compare the number of bronchoscopy performed during the patient's stay in intensive care unit
* Assess the number of postoperative pneumonia and antibiotic consumption
* To determine whether the initiation of any treatment changes in the immediate postoperative length of stay in intensive care and comprehensive.

Eligibility Criteria:
Inclusion Criteria:

* Patients after cardiac/thoracic surgery with acute respiratory failure defined by the presence of the following criteria:

  * report PaO2/FiO2 \<300
  * Respiratory rate\> 25 for at least 2 hours
  * Getting involved accessory respiratory muscles
  * paradoxical breathing Or
* In immediate after extubation, the patient will be eligible if present in the withdrawal test:

  * SaO2 \<90% in 12 L of O2 during a trial of spontaneous ventilation tube on
  * PaO2 \<10 kPa at a FiO2 ≥ 50% during a VS trial + pressure support
  * The presence of a risk factor: Obesity (BMI\> 30), FEVG \<40%, Failed extubation prior, stridor

Exclusion Criteria:

* Previous history of SAS
* Patient tracheotomy
* Comas non hypercapnic
* bradypnea
* Cardiac arrest
* Gastric Surgery recent
* Restlessness, lack of cooperation
* Nausea, vomiting
* Hemodynamic instability
The Influence of Chlorella Supplementation on Running Performance

Algae, such as chlorella, are gaining popularity as a nutritious additive to whole food or as a supplement. They contain a variety of beneficial nutrients like vitamins, minerals, healthy fats, and amino acids, which can have positive effects on our health and possibly athletic performance. Chlorella, specifically, is a type of single-celled green algae that you can easily find in health stores worldwide. While there's some evidence suggesting that chlorella supplementation might improve submaximal and maximal performance for cyclists, it's unclear if it has the same impact on runners. To investigate this, the investigators aim to conduct a double-blind randomised placebo controlled study to see if taking chlorella daily for 3-weeks can enhance different aspects of running performance, both during low/moderate and intense exercise, among individuals who regularly engage in running.

After signing the consent form, we will invite you to come to the ISEH laboratory on Tottenham Court Road so we can take some basic baseline readings. This should last up to 60 minutes and will also include a V̇o2max Test (visit 1). After this, you will be randomly allocated either start on chlorella or placebo first. After supplementation (for visit 2 and 3) you will be required to perform a submaximal running test which will entail running at 60% GET (gas exchange threshold), 80% GET, and 75% of the change from peak. This will then be shortly followed by an incremental test to fatigue.

You will then be required to undergo the exact same supplementation period on the alternative supplement with the same exercise test performed.

You will be required to come into the laboratory a total of 3 times. Each visit should take roughly 1 - 1.5 hours.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-50.
* Run regularly (3-4 times a week).
* Train with a purpose to compete.
* Consider running to be your main sport.
* Be comfortable running continuously for over 30-minutes at moderate intensity.
* Represent a local running club.

Exclusion Criteria:

* Individuals taking blood thinners.
* Known allergies to algae/mould and iodine.
* Any illness/conditions identified on PARQ (please see attached PARQ)
* Taking immunosuppressant medication
Early Treatment Diabetic Retinopathy Study (ETDRS)

To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in delaying or preventing progression of early diabetic retinopathy to more severe stages of visual loss and blindness.

To help determine the best time to initiate photocoagulation treatment in diabetic retinopathy.

To monitor closely the effects of diabetes mellitus and of photocoagulation on visual function.

To produce natural history data that can be used to identify risk factors and test etiologic hypotheses in diabetic retinopathy.

ETDRS was a multicenter, randomized clinical trial designed to evaluate argon laser photocoagulation and aspirin treatment in the management of patients with nonproliferative or early proliferative diabetic retinopathy. A total of 3,711 patients were recruited to be followed for a minimum of 4 years to provide long-term information on the risks and benefits of the treatments under study.

The eligibility criteria for the ETDRS were designed to include a broad range of macular edema severity, from a few small hard exudates within a disc diameter of the fovea with normal visual acuity to extensive cystoid spaces with a visual acuity of 20/200. All study patients had one eye randomly assigned to immediate photocoagulation and the other eye to deferral of photocoagulation until high-risk proliferative retinopathy developed. During followup, additional photocoagulation was allowed for any degree of macular edema within the eligibility range, but additional photocoagulation was required only for edema involving or threatening the center of the macula. The term "clinically significant macular edema" was coined to designate this level of severity.

The trial use of aspirin therapy was based on clinical observation and on aspirin's possible mechanisms of action. Previous observations of diabetic patients who were taking large doses of aspirin for rheumatoid arthritis showed that the prevalence of retinopathy in this group was lower than the prevalence that would be expected in the diabetic population at large. Evidence suggested that diabetic patients have altered platelet aggregation and disaggregation, which may contribute to the capillary closure seen in retinopathy. This abnormality is reversed by aspirin in vitro . However, because of aspirin's other possible mechanisms of action and its well-known side effects, such as allergic, idiosyncratic, and intolerance reactions, the use of this therapy in the ETDRS was carefully controlled and monitored.

Eligibility Criteria:
Men and women between the ages of 18 and 70 years with moderate or severe nonproliferative diabetic retinopathy or mild proliferative retinopathy in both eyes, with no previous photocoagulation treatment, and with visual acuity of 20/40 or better (20/200 or better if macular edema is present) were eligible for this study.
Treatment of Chronic Renal Failure With Adipose Tissue-derived Mesenchymal Stem Cells

To investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its treatment effects on chronic renal failure.

This study aims to investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its effect on oxidative stress, inflammation and mitochondrial damage.We intend to use blood oxygen level-dependent magnetic resonance imaging(BOLD-MRI), emission computed tomography(ECT) and enhanced magnetic resonance imaging to monitor renal oxygenation, tissue perfusion and renal function.Ultimately, we evaluate the treatment effects of AMSCs on chronic renal failure through these observations mentioned above.We hope to delay the progression of renal function in patients with chronic renal failure, and save huge social cost for dialysis by these research.

Eligibility Criteria:
Inclusion Criteria:

* Enroll the chronic renal failure patients without dialysis in the department of nephrology of Affiliated Hospital of Xuzhou Medical University from January 2017 to December 2018.
* The patients enrolled were not treated with drugs that affect the renal blood flow and oxygen consumption, such as ACEI, ARB, calcium channel blockers, diuretics, vasodilators and other related factors within 2 weeks.

Exclusion Criteria:

* Exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis.
* Eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).