cyrilzakka/clinical-trials huggingface dataset:
Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis

The researchers will investigate gut microbiome in Korean patients with ulcerative colitis and normal control subjects using metagenomic analysis to elucidate the significant difference between two groups This study will help to understand the association between gut microbiome and inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Between the age of 19 and 75 years
* willing to consent/undergo necessary procedures
* clinically active or inactive Ulcerative colitis

Exclusion Criteria:

* Inability to provide informed consent or
* Clinically severe or fulminant ulcerative colitis
* Previous abdominal surgery
* Pregnancy
* Clinically or laboratory-confirmed gastroenteritis for at least 3 months before sampling
* the use of antibiotics in the past a month before sampling
* the use of probiotics in the past a month before sampling
* Severe cardiovascular or pulmonary disease
* Severe convulsive disorder and current use of anti-convulsive medication
* Malignancy
* Transplantation
Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread

This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes will be considered.

Wheat cereals are known to be capable of triggering wheat allergy and celiac disease. The prevalence of both diseases is about 1%. Recently, another clinical entity was described, the non-celiac wheat sensitivity (NCWS). The origin and mechanisms of NCWS are unclear at present, but the existence of this new disease entity has been proven by double-blind placebo-controlled challenge tests. Three different grain components have been proposed as triggers of NCWS, gluten, α-amylase trypsin inhibitors or fermentable carbohydrates (FODMAPs).

It is reported that individuals with self-diagnosed NCWS quite often tolerate spelt products much better, even though spelt shows a higher gluten content than bread wheat products. Therefore, the question arises whether this putative spelt tolerance can be confirmed on an objective basis and whether the underlying molecular mechanisms can be elucidated. So far, human study addressing such questions are lacking.

This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes on wheat sensitivity will be revealed.

For this purpose, the trial involves individuals with self-diagnosed wheat sensitivity and spelt tolerance. Six different kinds of bread will be tested, including 4 wheat and spelt breads, each of them produced following a traditional or a conventional way. Aim of this part is to objective bread wheat and spelt intolerance in a defined population. To find out whether FODMAPs or gluten affect the tolerance of bread, two additional breads will be tested, a gluten-free bread with added gluten and a gluten-free bread with added FODMAPs.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 ≤70 years
* Signed declaration of consent
* Willingness to adhere to the prescribed diet for the duration of the study
* Subjective bread wheat intolerance
* No known spelled intolerance
* No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)
* No participation in another clinical trial (current or within the past 30 days)
* Gluten-containing diet at least 6 weeks before the start of the study

Exclusion Criteria:

* Taking intestinal therapeutics, antibiotics, immunosuppressants or similar
* Pregnancy / lactation
* Relevant violations of the nutritional protocol
* Occurrence of relevant diseases (possibly individual decision)
* Revocation of consent
* Accommodation in a clinic or similar facility based on an official or judicial order
Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube

This is a randomized controlled and non-inferiority trial in comparison of intraperitoneal laparoscopic radical prostatectomy without drainage tube between intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.

This trial is a prospective, single-centre, randomized controlled, and non-inferiority study in which all men with localized prostate cancer. This study aims to determine whether intraperitoneal laparoscopic radical prostatectomy without drainage tube is non-inferior to intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. age: more than 18 years old, less than 85 years old;
2. Patient who pathologically diagnosed with prostate cancer and plan to undergo radical laparoscopic surgery for prostate cancer;
3. fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria:

1. patients with surgical contraindications who cannot accept surgery;
2. patients with non-laparoscopic radical resection of prostate cancer;
3. patients with previous pelvic radiation therapy and complicated abdominal surgery;
4. patients judged by the investigator to be unsuitable to participate in the clinical trial;
The Effect of Tele-Nursing on Parents of Circumcised Children

Circumcision is applied in many regions of the world for cultural, social, religious and medical reasons. Considering the frequency of circumcision in the World is 30%, this rate is close to 100% in Turkey.

Circumcision is applied in many regions of the world for cultural, social, religious and medical reasons. Considering the frequency of circumcision in the World is 30%, this rate is close to 100% in Turkey. It will be done to determine the effect of the tele-nursing service applied to the parents of circumcised children after discharge on the anxiety and care satisfaction of the parents.

This study is planned to be carried out in Bursa Kestel State Hospital, Surgery Service, between October 2022 and January 2024. This study will consist of a control and an experiment group. This study is planned to be done as a single blind randomised control trial and will use equal samples block randomisation design. The study is planned to carry out with 84 parents, 42 parents in each group.Samples number is calculated via G-power pogramme.

Control grup: The control group in the study will be the parents of children who received routine care in the surgical service and had circumcision operation.After acceptance of the child's admission to the ward, parents will be asked to complete the Beck Anxiety Scale. Beck Anxiety Scale and Health Care Satisfaction Scale will be applied to the parents again after the discharge training given routinely in the service. Control grup will be called on the postoperative 4th day after discharge and asked to fill in the Beck Anxiety Scale and Health Care Satisfaction Scale.

The intervention group: The intervention group: in the study will be the parents of children who received routine care in the surgical service and tele-nursing service, who had undergone circumcision operation.After the admission of the child in the service, the Beck Anxiety Scale will be applied to measure the anxiety levels of the parents at the first hospitalization. After the routine discharge training in the service, the Beck Anxiety Scale and Health Care Satisfaction Scale will be applied to the parents again. Then, the parents will be called on the 1st postoperative day and training will be provided. On the postoperative 2nd, 3rd and 4th days, counseling will be provided. on the postoperative 4th day Parents will be asked to fill in the Beck Anxiety sScale and Health Care Satisfaction scale.

Eligibility Criteria:
Inclusion Criteria:

* Parents whose children will be circumcised,
* At least one parent as a caregiver during the surgical process,
* Parents who are able to read and write -Parents have no communication problems, -
* Parents who can access a smartphone,

Exclusion Criteria:

* Parents who have a childs with a special condition who has difficulties in understanding and perceiving
Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have had documentation supporting the diagnosis of acromegaly, including elevated GH and/or IGF-1 levels
* The patient is treated with pegvisomant, because of IGF-1 level remaining above ULN when treated with somatostatin analogue, on a daily basis for at least 3 months and has normal (age and sex adjusted) IGF-1 level, or IGF-1 level above the upper limit of normal (ULN) after treatment with pegvisomant 30 mg per day, OR the patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months including 3 months at the highest marketed dose and has a serum IGF-1 level above ULN, 28 days after the last injection
* At the end of the run-in period, The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1 level between ULN and 1.2 x ULN and a serum GH nadir \> 1 µg/L (assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel 120 mg OR the patient is diabetic and has a serum IGF-1 level above 1.2 ULN, 28 days after the 3rd injection of lanreotide Autogel 120 mg

Exclusion Criteria:

* The patient has undergone pituitary surgery or radiotherapy within 6 months prior to study entry, or it is anticipated that it will be done during the study
* The patient has already been treated with a somatostatin analogue associated with a GH antagonist
* The patient has received dopamine agonist within 6 weeks prior to the study entry
* The patient has abnormal hepatic function at study entry (defined as AST, ALT, GGT, alkaline phosphatase, prothrombin time or total bilirubin above 2 ULN)
* The patient is at risk of pregnancy or is lactating
Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus clearance during a typical bronchial drainage session in adults, stable CF patients.

It is a multicenter study. 4 different Spain Cystic Fibrosis Foundations are included in the study (Madrid, Valencia, Murcia and Aragón). All patients will perform three different arms of treatment in a crossover randomization. Each arm of treatment will be apply only in one session. The wash-out period will be one week. Before starting the trial, all patients will perform a control session without any intervention, only the outcome measures will be assess.

During the study period the patients' pharmacological treatment remained unchanged

Eligibility Criteria:
Inclusion Criteria:

* Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l)
* Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk);
* Chronic sputum production, at least ≥ 15 ml /24h
* Familiar and trained in the use of autogenic drainage technique (at least 6 months) and resistive inspiratory manoeuvre (at least three previous sessions)
* To be able to provide written, informed consent

Exclusion Criteria:

* Lung function: Forced expiratory volume in 1 second \< 30 % pred . ; Forced vital capacity \< 40 % pred.
* Active haemoptysis during the previous month
* Supplemental oxygen or non-invasive ventilation (NIV)
Resistance Training with Blood Flow Restriction in Hemophilia

The main objectives of this study are to evaluate safety and chronic effects of a low-load resistance exercise intervention (elbow flexions and extensions, and knee extensions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of hemophilia A or B and undergoing prophylaxis;
* willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations;
* approval by their hematologist to participate in the exercise program;
* age between 18 and 60 years;
* informed consent signed.

Exclusion Criteria:

* the inability to attend exercise sessions at least twice a week for 8 consecutive weeks;
* non adherence to instruction on proper exercise technique;
* surgical procedures performed 6 weeks prior to or during the exercise program; - participation in any other form of exercise, not previously done, during the study;
* changes in medication during the study;
* a major bleeding episode that posed a risk or prevented exercise;
* another hemostatic defect;
* need for major surgery;
* withdrawal of informed consent.
Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats

This study focuses on detecting the possible beneficial effect of Lactoferrin (Lf) administration on the kidney and the heart of glycerol-induced rhabdomyolysis (RM) in rats and its relation to ferroptosis and AMPK/Nrf2/ HO-1 signalling pathway. The main questions it aims to answer are:

1. Is Lf administration 30 min. before or after RM induction in rats beneficial to kidneys and heart?
2. When administered to glycerol-induced rats, does Lf act by upregulating the AMPK/Nrf2/ HO-1 signalling pathway and inhibiting ferroptosis?


Eligibility Criteria:
Inclusion Criteria:

* • Twenty-four healthy male Wistar Albino rats weighing from 250 to 300 g

Exclusion Criteria:

* No exclusion criteria as this study is used to detect effects of drugs on experimental rats.
An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients

Eosinophils play a key role in the pathogenesis of eosinophilic oesophagitis. Therapies that suppress eosinophil recruitment and activation may give a benefit. Mepolizumab is a humanised monoclonal antibody against interleukin-5 (IL-5). This study will evaluate the ability of mepolizumab to decrease the recruitment and infiltration of eosinophils into the oesophagus, thereby reducing the inflammation and symptoms of EE (eosinophilic oesophagitis) in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Document evidence/presence of Oesophagitis prior to commencing trial drug.
* a)Histological evidence of Oesophagitis: greater than 20x eosinophils per high power field (X400) on histology of esophageal mucosal biopsy
* b. at least one episode of dysphagia per week
* c.Inadequate response to routine EE treatment
* D. No other known causes of oesophagitis, or esophageal or generalized eosinophilia
* Not pregnant or nursing

Exclusion criteria:

* History of seasonal worsening of EE symptoms or requirement of Esophageal dilation.
* Churg-Strauss Syndrome
* Wegener's Granulomatosis
* Lymphoma, hematological malignancy, advanced and metastatic solid tumors
* Active H. pylori infection.
* Any previous treatment with anti-hIL-5, anti-IgE monoclonal antibody or other biological agents.
Timing of CHolecystectomy in Severe PAncreatitis

The goal of this clinical trial is to compare outcomes for interval or early laparoscopic cholecystectomy in patients with moderately severe and severe pancreatitis. The main question\[s\] it aims to answer are:

* To establish whether there is a difference in surgical outcomes comparing patients diagnosed with severe or moderately severe pancreatitis on which early cholecystectomy was performed versus performing interval cholecystectomy.
* The primary endpoint will be to evaluate major complications, defined as a Clavien-Dindo score greater than or equal to III/V.
* Secondary endpoints include evaluating minor complications (defined as a Clavien-Dindo score below III/V), biliary disease recurrence, mortality, postoperative hospital stay and postoperative admittance into an intensive care unit.

Participants will be randomly assigned to either group: early cholecystectomy during the pancreatitis hospitalization or interval cholecystectomy scheduled 4 weeks after clinical resolution of pancreatitis.

CHISPA is a randomized controlled, parallel-group, superiority clinical trial. An intention- to-treat analysis will be performed. It seeks to evaluate differences between patients taken to early cholecystectomy during hospital admission (72 hours after randomization) versus delayed cholecystectomy (30 +/- 5 days after randomization). Primary endpoint is major complications associated to laparoscopic cholecystectomy defined as a Clavien-Dindo score of over III/V during the first 90 days after the procedure. Secondary endpoints include recurrence of biliary disease, mortality, minor complications (Clavien-Dindo score below III/V), days of postoperative hospital stay, and days admitted in an intensive care unit postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, diagnosis of pancreatitis according to Atlanta guidelines, moderately severe or severe pancreatitis (APACHE score ≥8 on admittance)
* Biliary pancreatitis diagnosed on imaging (be it ultrasound, magnetic resonance imaging and/or tomography)
* Recovery of pancreatitis by tolerance of oral intake (defined as 24 hours of food consumption of any consistency without emetic episodes and pain defined as 4/10 on the visual analogue score of pain) and written informed consent.

Exclusion Criteria:

* Pregnancy
* History of cholecystectomy
* Planned open cholecystectomy
* Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage)
* Chronic pancreatitis,
* More than one episode of pancreatitis
* Active malignant disease
* Septic shock
* Choledocholithiasis not resolved by ERCP, post-ERCP perforation and post-ERCP concomitant pancreatitis.
National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)

National cohort study of effectiveness and safety of SARS-CoV-2 vaccines (ENFORCE is an equivalence trial to evaluate the effectiveness and safety of multiple new SARS-CoV-2 vaccines approved for use in the EU, and which are being offered at participating units.

The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.

A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).

First phase will enrol 10,000 persons initiating vaccination (assuming 4 vaccines). If more vaccines become available additional 2,500 persons per vaccine will be included. Subsequent phases with larger sections of the population included may be implemented.

Participants will have 6 study visits and be followed for 2 years after the first vaccination, which offers the participants an extra close follow up on vaccine effectiveness. Safety data will be collected at study visits until 3 months after the first vaccination. Research samples will be collected at each study visit during the two year follow-up

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained before any trial related procedures are performed
2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan)
3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)

Exclusion Criteria:

1. Male and female under the age of 18
2. Any subgroup of individuals for which the vaccines are contraindicated
3. Previous SARS-CoV-2 vaccination
Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV).

CSV constitutes an important type of ischemic stroke due to a generalized hypo-perfusion of brain. Few treatment methods are available except some beneficial effect shown with nimodipine. The potential treatment effect of RIPC on protection of brain from cerebral small vessel disease has not been investigated. The investigators designed this randomized, double-blind, controlled clinical trial to examine (1) whether RIPC has a beneficial effect on brain lesions of CSV, and (2) whether RIPC can protect patients of CSV from cognitive deterioration. There are 2 arms in this trial: One arm is RIPC treatment, the other one is sham RIPC treatment. Brain lesions will be quantified by volumetric MRI, and Xe-CT will be used to evaluate cerebral blood perfusion. Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 40-80 years;
2. Ischemic cerebrovascular event onset, if any, must be within 6 months;
3. TCD and carotid ultrasound exclude vascular narrow that can cause hemodynamic changes (usually \>50% narrow lumen);
4. MRI confirmed the presence of lacunar infarction and / or generalized white matter lesions;
5. Written consent was obtained from the subject.

Exclusion Criteria:

1. History of intracranial hemorrhage;
2. Significant bleeding from other parts of the body;
3. History of atrial fibrillation;
4. History of myocardial infarction within six months;
5. Moyamoya disease or vasculitis;
6. Hereditary small vessel disorders, such as CADASIL, FABRY, and mitochondrial encephalo-myopathy;
7. Significant bleeding-coagulation dysfunction;
8. Abnormal blood pressure, glucose and/or lipids after restrict treatment regimen;
9. Severe liver/kidney disease, cancer or critical illness of internal medicine and surgery.
Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)

Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.

A non-probability sampling method will be used. Subjects will be requested to enroll in the registry after having completed or discontinued participation in a Phase 2 or 3 study involving vicriviroc.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have participated in a Phase 2 or 3 study involving vicriviroc, and must have received, but are no longer receiving study medication.

Exclusion Criteria:

* Unwillingness to participate in the registry or give informed consent.