cyrilzakka/clinical-trials huggingface dataset:
Effect of Helicobacter Pylori Eradication on Gastroesophageal RefIux Disease (GERD)

Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and symptoms improvement

HeIicobacter PyIori (H.pyIori) is a gram-negative spiral shaped bacterium that affects up to 50% of the population worldwide, with a higher prevalences in the developing countries,Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus, resulting in a significant economic burden in direct and indirect costs and adversely affects the quality of life.GERD is caused by multiple different mechanisms that can be intrinsic, structural, or both, leading to the disruption of the esophago-gastric junction barrier resulting in exposure of the esophagus to acidic gastric contents, Clinically, GERD typically manifests with symptoms of heartburn and regurgitation. It can also present in an atypical fashion with extra-esophageal symptoms such as chest pain, dental erosions, chronic cough, laryngitis, or asthma.The relationship between H. pylori and gastroesophageal reflux disease (GERD) is still unclear, and the effect of H. pylori eradication on GERD treatment is unknown.Several studies have shown the inverse relationship between the occurrence of GERD and H.pyIori infection, in particular an increased severity of the disease is documented in patients with pre-existing symptoms .It has been showed that a markedly resolution of dyspepsia in patients at whom the eradication therapy was successful when compared with subjects with a persistent infection

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed as GERD clinically and endscopically.

Exclusion Criteria:

* NO exclusion criteria
Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study

Endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. It is characterized by impaired endothelium-dependent dilation and is primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and inflammation. Finding dietary/dietary supplement-oriented approaches to improving endothelial function is of public health interest.

A randomized double-blind placebo controlled 4-way crossover study will be conducted to determine if acute consumption of a proprietary polyphenol extract (156 mg / 222 mg / 333 mg) will have a dose dependent response on endothelium-dependent flow-mediated dilation (ED-FMD) in fasting conditions, in comparison to a placebo (maltodextrin) in male smokers (20 - 45 years; n=20).FMD and blood pressure will be assessed at 0 \& 2 hour timepoints following consumption of a single dose of polyphenol extract, accompanying blood samples will be collected to assess a range of endpoints including nitric oxide metabolites, angiotensin and polyphenols metabolites. Endothelium-independent vasodilation will also be measured 2 hours post consumption.


Eligibility Criteria:
Inclusion Criteria:

* At least two of the following risk markers; a BMI 25-30, waist circumference \>94 cm, high normal blood pressure defined as either systolic 85-89 mmHg or diastolic 130-139 mmHg and have a normal ECG.

Exclusion Criteria:

* An individual who has tested positive (self reported) 2 weeks before the study period.
* A COVID-19 vaccinated individual who while receive the 1st or 2nd dose or booster 2 weeks before V0 or during the study period, due to the potential interaction of vaccine on markers assessed
Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography

Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography.


Eligibility Criteria:
Inclusion Criteria:

* Patients (age 19\~80 yrs, ASA Class I\~III) who are scheduled for elective endoscopic retrograde cholangiopancreatograph

Exclusion Criteria:

* Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Underlying renal (serum Cr \>2mg/dL) or cardiac disease (NYHA class III or IV) Hypotension (SBP \<90mmHg) or hypoxemia (SpO2 \<90%) assessed prior to procedure
Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis

The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.

Goals:

1. to investigate in a randomized controlled trial:

   * which proportion of JIA patients in remission can successfully discontinue etanercept compared to JIA patients in remission who continue etanercept;
   * if time in remission on etanercept is an important factor in retaining remission after discontinuation of etanercept.
2. to investigate in alle JIA patients who discontinue etanercept (including the control group):

   * predicting factors (patient or disease characteristics, including time in remission, and MRP8/MRP14) for successfully discontinuation of etanercept;
   * the disease course after discontinuation of etanercept (time to flare) and the effect of restarting etanercept after flaring.

Juvenile Idiopathic Arthritis (JIA) is the most common cause of chronic arthritis in children. Etanercept has proven to be an effective treatment for JIA. Considering the risk of occurrence of long-term side-effects and to prevent the burden of the weekly injections and costs, it is a logical step to discontinue etanercept after reaching remission (no disease activity for at least six months). Especially since there are concerns about the long-term effect of suppressing the immune system with etanercept. However, little is known about if successful discontinuation is possible or when to stop. Risk is that the disease might flare (reactivate) again.

For this study, JIA patients in remission will be selected from the ABC-register (an observational study including all Dutch JIA patients who use etanercept). Eligible patients will be randomized to stop etanercept or continue it for another 9 months. Patients are followed with standard visits evaluating disease activity until 12 months after discontinuation of etanercept. In case of a disease flare etanercept therapy will be reintroduced immediately and the patient will be treated according to the insight of their treating physician. Expected is that JIA patients who were in remission for more than 12 months before discontinuation have a better chance to retain remission.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Juvenile Idiopathic Arthritis (all subtypes) by the International League of Associations of Rheumatology (ILAR) criteria
* On etanercept therapy
* No MTX or low dose MTX (maximum 10 mg/m2)
* 3 or more months in remission according to the criteria of Wallace (i.e. 9 or more months of inactive disease)
* Age ≥4 and \<18 years at start of study
* Written informed consent from parents and patients 12 years and over

Exclusion Criteria:

* Systemic corticosteroids (up to 9 months prior to inclusion)
* Intra-articular corticosteroids (up to 6 months prior to inclusion)
* Synthetic DMARDs besides low dose MTX (up to 9 months prior to inclusion)
* Biologic DMARDs besides etanercept (up to 9 months prior to inclusion)
Motor Control in Chronic Fatigue Syndrome and Fibromyalgia

This project is a comprehensive study, with main focus on motor control, comparing patients with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome (FMS). Focus of the present project will be on detailed movement analysis in a movement laboratory and involve functional tasks such as walking and standing. Investigations will also comprise muscle activity, reaction time and fine motor control.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic fatigue syndrome or fibromyalgia

Exclusion Criteria:

* patients who already had been treated.
Prismatic Correction for Improving Near Visual Acuity in Patients With Maculopathy

patients with maculopathy reported in low vision clinic are tested for prismatic glasses for near vision. The pre and post visual acuity was recorded.

Diagnosed patient of maculopathy who was visited in low vision clinic are divided in two groups , one is control group (prescribed simple near vision glasses) and other is interventional group(prescribed prismatic glasses). Both groups were follow up after one month to check the improvement in near visual acuity

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed patients of maculopathy refer to low vision clinic
2. Patients with both genders
3. VA from LogMAR 1.0 to LogMAR 0.3

Exclusion Criteria:

1. Maculopathy patients with other ocular disease
2. VA worsen the LogMAR 1.0
3. Patients with mental illness and other physical lmitations
Physical Activity and Preterm Birth With Cervical Dynamics

this RCT is designed to investigate the influence of physical activity on the risk f preterm birth for women with cervical dynamics.


Eligibility Criteria:
Inclusion Criteria:

pregnant women between 24-34 weeks of gestation singleton cervical length\<25 mm willing to download an application which traces physical activity on medical indication for reducing activity

Exclusion Criteria:

refusal to participate medical advise to minimize activity (symphysiolysis) maternal morbidity fetal compromise vaginal bleeding rapture of membranes severe preeclampsia twins pregnancy

-
Liberal Transfusion Strategy in Elderly Patients

In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac surgery will be registered
* Registered patients will be randomised only if they indeed develop severe anaemia (if Hb level falls ≤ 9 g/dl) during surgery (=day 0) or day 1, 2, or 3 after surgery

Exclusion Criteria:

* preoperative Hb level ≤ 9 g/dl
* chronic kidney disease requiring dialysis
* suspected lack of compliance with follow-up procedures
* participation in other interventional trials
* expected death within 3 months
* inability to provide informed consent with absence of a legally authorised representative/ legal guardian
* temporary inability to provide informed consent
* previous participation in our trial
* patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses)
* preoperative autologous blood donation.
Azithromycin+Amoxicillin/Clavulanate vs Amoxicillin/Clavulanate in COVID19 Patients With Pneumonia in Non-intensive Unit

The global pandemic of novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China, in December 2019, and has since spread worldwide.1 As of April 14, 2020, there have been more than 1.5 million reported cases and 124 000 deaths in more than 200 countries. A recent open-label nonrandomized French study reporte that addition of azithromycin to hydroxychloroquine in 6 patients resulted in numerically superior viral clearance (6/6, 100%) compared with hydroxychloroquine monotherapy (8/14, 57%) or control (2/16, 12.5%). Azithromycin alone has never been tested, whereas azithromycin has immunomodulating and anti-inflammatory properties that could theoretically prevent or limit secondary worsening. Our hypothesis is that azithromycin combined with amoxicillin/clavulanate will be superior to amoxicillin/clavulanate alone to obtain viral clearance at Day 6 in COVID-19 patients with pneumonia and hospitalized in a non-intensive care unit ward.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 ans,
* Patient with positive SARS-CoV-2 RT-PCR on nasopharyngeal sample at randomization or within the previous 48 hours,
* Patient with pneumonia diagnosed by thorax CT-scan or echography,
* Patient able to take per os medication,
* Written and signed consent of the patient,
* Patients affiliated with or benefitting from a social security scheme.

Exclusion Criteria:

* Patient hospitalized in intensive care unit,
* Patient who received more than 24 hours of antibiotic treatment for the ongoing episode,
* Chronic renal failure with a Glomerular Filtration Rate \< 20ml/min,
* Severe hepatic failure,
* Severe chronic cardiac insufficiency,
* Allergy to macrolides,
* Electrocardiogram showing corrected QT prolongation greater than 470 ms in men and 480 ms in women.
* Life-threatening presentation expected to lead to possible imminent death (based on provider assessment)
Evaluation of Fetal Cardiac Function and Vascular Hemodynamics in Intrauterine Growth Restriction

Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal mortality and morbidity and is characterized by complex hemodynamic changes involving placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence of these modifications in relation to other hemodynamic changes of the fetal arterial and venous circulations is unknown.

The aim of this study was to evaluate cardiac function and other hemodynamic changes in a group of fetuses with IUGR and clinical impact on perinatal outcome .


Eligibility Criteria:
Inclusion Criteria:

* Singleton fetus with normal fetal anatomy documented a detailed sonogram.
* Fetal abdominal circumference \<5th percentile for gestational age.
* Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.

Exclusion Criteria:

* evidence of fetal infection
* chorioamnionitis
* fetal anomalies
* abnormal fetal karyotype
* patient withdrawal from the study and/or unavailability for follow-up.
Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH

This will be multi-centered, triple blinded, randomized, four parallel treatments assigned study to compare clinical efficacy of commercially available dentifrices with placebo for immediate and sustained relief from Dentin Hypersensitivity after short term use.

Condition or disease: Dentin hypersensitivity Intervention/Treatment: Product 1; Fluoro-Calcium-Phospho-silicate based BioMin F Product 2; Pro-Argin formula based Colgate Sensitive Pro-Relief Product 3; Strontium Acetate based Sensodyne Rapid Action Product 4; Sodium Fluoride based Colgate Total

It is a randomized controlled clinical trial with non invasive topical intervention in 140 adult patients of 18 to 60 years age, that will be selected randomly after screening and diagnosis of dentin hypersensitivity, in dental Out Patient Department of Periodontology. Written informed consent will be obtained. Participants will be allocated randomly into four equal study arms for parallel treatment assignment with dentifrices named BioMin F, Colgate Sensitive Pro-Relief Trade Mark,Sensodyne rapid action Trade Mark and Colgate Total Trade Mark dentifrices. Colgate total Trade Mark dentifrices does not claim pain relief in Dentin Hypersensitivity. Interim efficacy will be assessed immediately after topical application on sensitive teeth, in one minute, after 5 minutes, on day three and week 4 respectively. Dentin hypersensitivity will be tested with mechanical stimulus, evaporative air blast stimulus and water jet stimulus. It will be measured on Visual Analogue Scale and Schiff cold air sensitivity scale (SCASS). Statistical analysis will be done using ANOVA in Statistical Package for Social Sciences software 21.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with at least two teeth sensitive to cold, touch and air blow stimulus
* Sensitive teeth anterior to molars either due to erosions or abrasions with or without associated gingival recession
* Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold Air Sensitivity Scale on screening.

Exclusion Criteria:

* Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale)
* Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks
* Localized or generalized gingivitis or pulpitis with heavy calculus
* Periodontal surgery in the preceding three months
* Patients using any desensitizing tooth paste or mouth wash up to six weeks before study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in routine.
* Pregnant or breastfeeding females.
Lymphedema in Endometrial Cancer

Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo staging surgery.

Data analysis and risk/safety issues: The proposed study will consist of a convenience sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period. The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference with its 95% exact confidence intervals between pre-and post-operative lower extremity lymphedema measurements and quality of life questionnaires will be estimated.


Eligibility Criteria:
Inclusion Criteria:

1. women older than 18 years old,
2. endometrial cancer,
3. suitable candidates for surgery,
4. scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC),
5. no severe physical or mental comorbidity

Exclusion Criteria:

1. metastatic disease,
2. laparotomy
Cyclosporine A in Cardiac Arrest

The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Witnessed out-of-hospital cardiac arrest
* Non shockable cardiac rhythm

Exclusion Criteria:

* Evidence of trauma
* Evidence of pregnancy
* Duration of no flow more than 30 minutes
* Rapidly fatal underlying disease
* Allergy to cyclosporin A
Evaluating Interventions for Alcohol Use Disorder

The purpose of this study is to investigate how behavioral treatments for alcohol use disorders affect behavior change.


Eligibility Criteria:
Inclusion Criteria: Study inclusion criteria are such that study participants must:

1. meet a Diagnostic and Statistical Manual-IV (DSM-IV) alcohol abuse or dependence diagnosis based on the Diagnostic Interview Schedule - IV (DIS-IV);
2. consume a weekly average of at least 24 standard drinks during the baseline period to include at least 5 episodes of heavy drinking;
3. agree not to seek additional alcohol or other substance abuse treatment during the study period;
4. be at least 18 years of age; and
5. be sufficiently proficient in their English speaking ability to interact effectively with the research interviewer.

Exclusion Criteria:

* Individuals assessed as having a drug diagnosis that is more severe than their alcohol diagnosis (e.g., cocaine dependence and alcohol abuse, IV drug use),
* a serious psychiatric diagnosis (e.g., uncontrolled schizophrenia or major depression) as well as those meeting criteria for organic brain impairment, as measured by the mini-mental status examination section of the DIS-IV will be precluded from study participation.

In addition,

* individuals reporting current enrollment in a substance abuse treatment program,
* mandated to substance abuse treatment by a court order, or
* severely socially unstable (e.g., homeless) also will be precluded from study participation.
Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT ( KETZEREI )

Acute kidney injury (AKI) is a well-recognized complication in critically ill patients, which often leads to the necessity of mechanical kidney support (CRRT).

In current therapeutic regimes, CRRT is used to strictly prevent azotaemia. Thus recent clinical observations, as well as data from animal testing suggest a link between controlled azotaemia and faster renal recovery in AKI patients.

The aim of the study is to improve renal recovery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years)
* Critically ill patients with AKI + in need of CRRT
* Written informed consent

Exclusion Criteria:

* Chronic dialysis dependency
* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m²
* severe liver cirrhosis (Child-pugh C)
* severe acidosis (pH \< 7,20 at study enrolment)
* severe hyperkalaemia (\> 6mmol/l)
* Pregnancy or breastfeeding
* persons held in an institution by legal or official order
* Dependency on the investigator or center