cyrilzakka/clinical-trials huggingface dataset:
TIPS Combined With Variceal Embolization for the Prevention of Variceal Rebleeding in Patients With Cirrhosis

The purpose of this study is to determine whether TIPS combined with variceal embolization are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.

Variceal bleeding is one of the leading causes of death in patients with cirrhosis. Patients with cirrhosis surviving a variceal bleeding are at high risk of rebleeding (over 60% at 1 year), and mortality from each rebleeding episode is about 20%.

Placement of TIPS is a well-established technique that is highly effective in preventing recurrent variceal bleeding, especially if the TIPS is created with an expanded polytetrafluoroethylene (ePTFE)-covered stent, which has a significantly lower risk of shunt dysfunction than does TIPS created with bare stents. But the risk of hepatic encephalopathy greatly increases and the risk of recurrent variceal bleeding after TIPS placement remains an issue. Besides an insufficient decrease in portosystemic pressure gradient after TIPS creation alone, fragile variceal vessels also are considered a risk factor for recurrent bleeding.

Accordingly, TIPS combined with variceal embolization has been advocated to achieve the best result possible in preventing recurrent variceal bleeding. However, in recent American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus, no treatment strategies were clearly recommended maybe because the exact efficacy of this strategy remains unclear and high-quality randomized controlled trials still lacks.

So the investigators hypothesized that embolization of these collateral vessels may increase the blood flow within the shunt and into the liver, which can theoretically decrease the incidence of shunt dysfunction and encephalopathy, even can prolong the patients' survival.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Dignosis of cirrhosis (clinical or by liver biopsy)
* Admission due to variceal bleeding occurred 5 to 42 days prior and standard treatment for secondary prophylaxis failed
* Age 18 to 75 years

Exclusion Criteria:

* Hepatic carcinoma and/or other malignancy diseases
* Portal vein thrombosis (≥50% of the lumen)
* Child-Pugh score\>13 points
* Spontaneous recurrent hepatic encephalopathy
* Budd-Chiari syndrome
* Large spontaneous portosystemic shunts
* Sepsis
* Spontaneous bacterial peritonitis
* Uncontrollable hypertension
* Serious cardiac or pulmonary dysfunction
* Renal failure
* With TIPS contraindications
* Previous TIPS or collateral embolization,
* Pregnancy or breast-feeding
* History of organ transplantation
Outcome of Induced Atypical Atrial Flutter

Background: Atypical atrial flutter (AAF) is an increasingly relevant clinical problem. Despite advancements in mapping and ablation techniques, the general management of these patients remain challenging especially when mapping cannot be performed during ongoing arrhythmia. There are no data whether induction of AAF is a feasible approach in these cases.

Methods: The investigators retrospectively analyzed patients who underwent catheter ablation of AAF and compared procedural results between patients with ongoing tachycardia when starting the procedure and patients with induced AAF.

For this retrospective study, the investigators analyzed patients undergoing ablation of AAF between April 2018 and January 2021 that were identified from the ablation database at the West German Heart and Vascular Center, Essen. All patients were followed up in the outpatient clinic as part of the clinical standard routine or contacted by telephone to assess the occurrence of clinical recurrence of any arrhythmia. In case the documentation was not performed at the institution, relevant documents and ECGs were requested and reviewed.

This single-center cohort study was conducted at the University Hospital Essen, Germany, in accordance with the Declaration of Helsinki and its amendments and was approved by the institutional review board of the University of Essen (number 21-10341-BO). Written informed consent was obtained from all study participants.

The primary study endpoint was to evaluate the outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. Furthermore, the investigators analyzed the type of recurrence during follow-up as well as the occurrence and results of repeat ablations at the institution. The investigators also evaluated if the recurrent AAF form was the same or de-novo compared to the AAF during previous procedure.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* symptomatic atypical atrial flutter and electrophysiological study with ablation

Exclusion Criteria:

* inability to comply with follow up
* participation in another trial that may interfere
Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe

The purpose of this study is to determine whether omega-3 fatty acids are effective in the prevention of psychosis in individuals at ultra-high risk for psychosis.

PURPOSE is a randomized double-blind placebo-controlled study. Main objective is to assess the effectivity of omega-3 fatty acid treatment in the prevention of psychosis. The primary outcome measure is the rate of transition to psychosis as determined through CAARMS. Subjects in the age range of 13-20 years with a higher chance of developing psychosis, as determined by the CAARMS, are treated for 6 months with omega-3 fatty acids or placebo. This study in conducted at 14 sites in 9 countries.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the subject. For individuals younger than 18 years of age the parents / legal representatives need to give consent, and the subject can provide assent (whether the latter is required depends on local laws and regulations).
* UHR diagnosis as made using the Comprehensive Assessment of At-Risk Mental States (CAARMS) (Yung et al., 2005). Subjects have to meet one or more of the following criteria: (a) attenuated psychotic symptoms, (b) brief limited intermittent psychotic symptoms (a history of one or more episodes of frank psychotic symptoms that resolved spontaneously within 1 week in the past year), or (c) either the presence of schizotypal personality disorder or a family history of psychosis in a first-degree relative, all three together with a recent decline in function.

Exclusion Criteria:

* Any clinically significant medical condition that may influence the results of the trial or affect the ability to take part in a trial.
* Laboratory screening values considered clinically relevant by a medical doctor for transaminases, thyroid hormones or coagulation parameters
* Current or past DSM-IV diagnosis of psychosis, as measured with K-SADS-PL
* Current treatment with an antipsychotic or mood-stabilising agent
* Intake of an antipsychotic or mood-stabilising agent in the two weeks prior to study inclusion
* Intake of an antipsychotic agent equivalent to a total haloperidol use of \>50 mg in the six months prior to study inclusion
* A first-degree relative (i.e. parents, offspring or siblings) participating in this study
* UHR diagnosis on the basis of attenuated psychotic symptoms that are entirely explained by acute intoxication
* Current aggression or dangerous behaviour (PANSS G14 score 5 or above)
* Current suicidality / self-harm (PANSS G6 score 7)
* Current DSM-IV diagnosis of alcohol or substance dependence as measured with K-SADS-PL
* Any current or previous neurological disorder, including epilepsy
* History of head injury resulting in unconsciousness lasting at least 1 hour
* IQ \< 70
* More than 4 weeks of regular omega-3 supplementation (\>2 daily capsules standard strength providing \>600 mg combined EPA/DHA) within the last 6 months.
Evaluation of Yoga for Substance Use Risk Factors in a School Setting

This study will evaluate the efficacy of yoga taught during school to positively influence risk and protective factors of substance use and the initiation and severity of substance use. The study hypothesis is that, compared to a control group participating in regular physical education classes, subjects who participate in 32 yoga sessions across an academic year will improve in negative internalizing behaviors and self-regulatory skills that are known risk and protective factors for substance use. This study will also test the hypothesis that the yoga intervention will reduce both severity of substance use and the degree of substance use initiation.

The long-term, programmatic goal of this research is to advance prevention of addictive behaviors especially substance use in normal adolescent psychological development. The overall goal of this proposal is to pilot test a novel, preventive intervention for adolescent substance use. More specifically, it will evaluate the efficacy of yoga taught during school to positively influence risk and protective factors of substance use and the initiation and severity of substance use.

This study involves a group randomized, controlled trial of yoga compared to physical education-as-usual for one school year, with a 6-month and 1-year follow-up, in order to accomplish the following specific aims:

Specific Aim 1 - To evaluate the efficacy of a school-based yoga program for reducing negative internalizing behaviors (negative mood, perceived stress, impulsivity) which are risk factors for adolescent substance use.

Specific Aim 2 - To evaluate the efficacy of this yoga program for promoting self-regulatory skills as protective factors against substance use in adolescence.

Specific Aim 3 - To conduct a preliminary evaluation of the efficacy of this yoga program for reducing substance use initiation and severity of use.

Eligibility Criteria:
Inclusion Criteria:

* Registered for physical education class
Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial

The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation.

The study was performed out at outpatient clinic of Pediatric Gastroenterology at the Federal University of São Paulo (São Paulo, Brazil), located in the southeastern region of Brazil. It is a public referral hospital for pediatric gastroenterology attendance in the Metropolitan area of the São Paulo and in Brazil. In general, the patients go to consultation after a referral from a primary care center.

Study design and sample size The design was a randomized double-blind trial, placebo-controlled study. Sample size was calculated by the formula of comparison of two proportions, using clinical improvement as a primary outcome. It had been previously calculated that a minimum of 14 patients in each group will give a power of 80% to detect a effect size of 50% with significance at the level of 5% (one-sided).

Eligibility Criteria:
Inclusion Criteria:

* Patients over two years of age at first consultation and chronic functional constipation were included. Chronic constipation was defined by the occurrence of any of the following, for at least 2 weeks, independently of stool frequency: passage of hard, scybalous, pebble-like or cylindrical cracked stools, straining or painful defecation, passage of large stools that may clog the toilet, or stool frequency less than 3 per week.

Exclusion Criteria:

* The exclusion criteria applied were organic constipation, regular use of dietary fiber in the preceding 30 days or drugs causing constipation.
Exploratory Clinical Study on the Efficacy and Safety of Lactobacillus Johnsonii in the Treatment of Patients with Premature Ovarian Insufficiency

The goal of this clinical trial is to explore the effectiveness and safety of Lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with premature ovarian insufficiency (POI). The main questions it aims to answer are: ① To explore the effectiveness and safety of Lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with POI; ② To explore the potential mechanism of action of Lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with POI. Participants who meet all the inclusion criteria will be enrolled in the study and randomly assigned in a 1:1 ratio to either the Lactobacillus johnsonii group or the placebo group.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 and 39 years;
2. Irregular menstruation or amenorrhea for \> 4 months;
3. At least two serum baseline follicle-stimulating hormone (FSH) levels \> 25 IU/L (with an interval of more than 4 weeks between measurements);
4. Willing to voluntarily participate in this study, sign the informed consent form, and comply with the investigation and follow-up;
5. Not having participated in other clinical trials within the past 3 months.

Exclusion Criteria:

1. Use of antibiotics or probiotics, prebiotics, and live bacterial preparations within the past month or during the intervention period;
2. Received hormone replacement therapy within the past 2 months;
3. Chromosomal abnormalities and genetic defects;
4. Iatrogenic premature ovarian insufficiency;
5. Stage IV endometriosis;
6. Uncontrolled endocrine diseases or autoimmune diseases;
7. Organic gastrointestinal diseases;
8. Infectious diseases of the reproductive, urinary, or digestive systems;
9. Severe cardiovascular, respiratory, renal, hematologic, endocrine, neurological, psychiatric, or other systemic diseases that the investigator believes may interfere with the study evaluation;
10. History of venous thromboembolism;
11. Allergic or intolerant to the components of the investigational probiotic product;
12. Allergic to two or more types of food/medications;
13. Refusal to provide written informed consent;
14. Other conditions deemed unsuitable for participation in the study by the investigator.
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children

Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.


Eligibility Criteria:
Inclusion Criteria:

* • Children who were between 2 to 6 years old

  * Definite diagnosis of OME with symptoms and examination

Exclusion Criteria:

* • Currently were using corticosteroids or prophylactic monteleukast

  * Chronic pulmonary or cardiac diseases or immune deficiency
  * Allergic rhinitis
  * Hypersensitivity to monteleukast or corticosteroids
  * Avoidance of parents to fill the written informed consent
Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects

A Phase I Study to investigate the safety, tolerability \& pharmacokinetics of co-administered single doses of OZ439 and Piperaquine to healthy subjects.

Placebo-controlled, double-blind, five-cohort, 2-period (per cohort) dose-escalation study.

For each subject, the study included a screening evaluation (within 21 days of the 1st dose), dosing on 2 separate occasions (Period 1 and Period 2) and a follow-up visit (6 weeks following the final dose).

Within each cohort, subjects were randomised into two sequences to receive OZ439 in Period 1 and OZ439 plus piperaquine in Period 2 (sequence 1, 8 subjects) or OZ439-matching placebo in Period 1 and OZ439/piperaquine matching placebos in Period 2 (sequence 2, 4 subjects).

Safety and tolerability were evaluated: Physical examination, ECG assessments including a full baseline matched profile of ECG tracings, vital signs, laboratory evaluations, in particular liver function tests and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males \& females, 18-55 years old
* BMI 18 to 30kg/m2; total body weight \>50kg
* Healthy, determined by pre-study medical history, physical examination vital signs, 12 Lead ECG
* Females of non-childbearing potential.
* Males must agree to use a double barrier method of contraception
* Lab tests at screening within the reference ranges

Exclusion Criteria:

* Any condition that could affect drug absorption, e.g. gastrectomy, diarrhea
* Clinically relevant abnormalities in ECG
* Family history of sudden death or of congenital prolongation of QTc interval - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia
* Electrolyte disturbances
* History of drug or alcohol abuse, tobacco users
* Participation in evaluation of any drug for 3 months before the study
* Administration of ANY systemic medication/herbal product within 14 days of first dose of study drug.
* unaccustomed strenuous exercise within 7 days of any study visit
* Alcohol consumption within 24 hours of any study visit
* Consumption of any fruit juice or food containing grapefruit within 7 days
* Positive test for HIV-1, HBsAg or HCV
* Positive urine drug screen at Screening or admission
* Severe allergies/multiple drug allergies
* Volunteers who have donated blood or experienced significant blood loss within 90 days of screening
* Hemoglobin below lower limit of the reference range
* Clinically relevant abnormal lab values indicative of physical illness
Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis

The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Rheumatoid arthritis
* Therapy failure with at least one biological agent from anti-TNF-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-IL6 (tocilizumab; 3 months); T-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-CD20 (rituximab; 6 months at optimal dose); Anti IL-1 (anakinra; 3 months)
* Disease Activity Score (DAS) DAS28 ≥ 3.2
* Subject has provided written informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Inflammatory arthritis other than rheumatoid arthritis
* History of invasive cancer
* Immunodeficiency (HIV infection, Immunosuppressive therapy)
* Active bacterial or viral infections, in particular HCV or HBV.
* Surgery not older than 4 weeks.
* Unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment.
* Contraindication to an apheresis
Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

this is open labelled randomize control trial among women with PCOS. PCOS, an endocrine condition, affects 5%-15% of premenopausal women. PCOS is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. Metformin is now an option for PCOS. The clinical reactions to metformin are limited and varied. Novel SGLT2 inhibitors treat type 2 diabetes with weight loss, insulin resistance reduction, and cardiovascular benefits. There is little evidence on SGLT2 inhibitor effectiveness in PCOS patients.


Eligibility Criteria:
Inclusion Criteria:

1. All women participants belong to the reproductive age group, i.e., 18 to 45 years will be included in the study.
2. All those women of BMI of greater than 25 kg/m2 will be included in this study
3. Women with a diagnosis of PCOS by using two (hyperandrogenism and oligo-anovulation) out of three (oligo-anovulation, hyperandrogenism and polycystic ovaries) Rotterdam criteria 2 which confirm hyperandrogenism (acne, seborrhea, hair loss on the scalp, increased body or facial hair) on clinical judgement will be included in the study
4. Those who documented and self-reported oligomenorrhea (cycle length greater than 35 days and nine or fewer periods per year) will be included. or
5. Those who report amenorrhea (absence of menses for a period of 3 months) will be inclusion criteria of the study.

6- PCO Women with or without comorbidity or Multimorbidity specifically, Hypothyroidism, Diabetes, Hypertension.

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Exclusion Criteria:

1. Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or androgen- secreting tumors will be streaked from participating.
2. In addition to this, Pregnancy or intent to become pregnant, breastfeeding, documented use of oral hormonal contraceptives and hormone- releasing implants, clomiphene citrate or oestrogen modulators, gonadotropin-releasing hormone (GnRH) modulators and Minoxidil will be excluded.
3. History or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study
4. Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study.

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Cytisine Versus Varenicline for Smoking Cessation

To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Māori (or family of Māori) who smoke and are motivated to quit.

Cytisine, a natural product, found in plants such as the Golden Rain and New Zealand Kowhai, partially blocks the effects of nicotine on the brain. Cytisine has been used as a smoking cessation treatment in several Central and Eastern European countries since the 1960s, is inexpensive compared to other cessation medications and has few known side effects. New Zealand research has shown cytisine to be more effective than nicotine replacement therapy at helping people quit smoking. Using a clinical trial design (N=2140) the investigators plan to investigate whether cytisine is at least as good as varenicline (the most effective, but most expensive, smoking cessation medication currently available in New Zealand) for helping Māori/family of Māori who smoke, to quit.

Eligibility Criteria:
Inclusion Criteria:

* daily tobacco smokers
* self-identify as Māori (indigenous New Zealander) or whānau (family) of Māori
* want to stop smoking in the next two weeks
* are at least 18 years of age
* are able to provide verbal consent
* reside in the Lakes District Health Board, Eastern Bay of Plenty or Tokoroa region at the time of enrolment
* have daily access to a mobile phone with text capability and/or email and access to the internet via computer or smartphone
* are eligible for subsidised varenicline under special authority conditions

Exclusion Criteria:

* are pregnant or breastfeeding
* are current users of other smoking cessation therapies (e.g. nicotine replacement therapy \[NRT\], buproprion \[Zyban\], clonidine, nortriptyline, e-cigarettes)
* are enrolled in another smoking cessation programme or another smoking cessation study
* have a contraindication for cytisine or varenicline
* have used varenicline or cytisine in the past 12 months
* have another person in their household involved in the trial
* have moderate or severe renal impairment,
* are being treated for active or latent TB
* have been treated for a heart attack, stroke, or severe angina within the last two weeks
* have uncontrolled high blood pressure (\> 150 mmHg systolic, \> 100 mmHg diastolic)
* have a history of seizures
A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis

The purpose of this study is to determine patient variables, physician presenter variables, and information variables that might affect clinical decision making in asymptomatic carotid stenosis. The hypothesis is that information variables are the most significant determinant of clinical decision making.


Eligibility Criteria:
Inclusion Criteria:

* No known history of carotid stenosis

Exclusion Criteria:

* History of dementia
* Unable to read English