cyrilzakka/clinical-trials huggingface dataset:
RCE With FMT in the Treatment of Childhood Constipation

Constipation is the most common complaint in childhood gastrointestinal disease, affecting an estimated 20% of the global children.The treatment strategies consist of diet control, behavioral intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects, the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, and the use of PEG increases the risk of fecal incontinence. Additional treatment interventions are still necessary.Enema can act directly on the rectum and distal colon to quickly relieve symptoms of fecal impaction which is considered one of main source of intractable constipation. Children with fecal impaction who received enema had fewer fecal incontinence and diarrhea than children who received PEG. There have been lots of evidence that enema is effective in fecal impaction in children with functional constipation.But there are still cases of recurrences noted after enema. Fecal bacteria transplantation (FMT) is a new treatment method emerging in recent years, which is widely used in the treatment of functional gastrointestinal diseases. FMT has been proved to play a very prominent role in correcting intestinal flora disorders. By transplanting exogenous flora into the intestinal tract of patients, FMT can inhibit bacterial reproduction, regulate intestinal environment and cascade the body immunity, so as to achieve the therapeutic effect of disease.

Retrograde colonic enema with FMT, an new method, provides the possibility for the treatment of childhood constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by retrograde colonic enema with FMT. Therefore, we designed a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of retrograde colonic enema with FMT in the treatment of childhood constipation.


Eligibility Criteria:
Inclusion criteria:

* 4-14 years old;
* Roman IV criteria for childhood constipation;
* After a course of PEG and a course of Chinese medicine treatment was ineffective;
* Barium enema showing fecal impaction.

Exclusion criteria:

* Congenital and/or acquired intestinal diseases, such as congenital megacolon, intestinal stenosis, polyps, Crohn's disease, tuberculosis, inflammation, and tumors;
* Anorectal diseases, such as anal atresia, fistula, abscess, and tumor;
* Neurological diseases, such as brain and spinal cord diseases;
* genetic metabolic diseases;
* psychosocial and behavioral diseases;
* other systemic diseases;
* Refused to participate in.
Impact of Hemo-dialysis Therapy on Blood Levels of Treprostenil in End Stage Renal Disease Patients With Pulmonary Hypertension

Remodulin (Treprostenil sodium) is synthetic prostacyclin analog available as a solution for administration in the intravenous route. It is approved for treatment of class I - pulmonary hypertension functional capacity stage III-IV. A key factor for the success of pulmonary hypertension therapy is maintaining near constant blood level of a given medications along the day. A sudden decrease in the blood levels might lead to rebound phenomenon; abrupt increase in the pulmonary artery pressure which might lead to acute right ventricular failure and even to sudden death. As some PHT patients suffer are on hemo-dialysis therapy due to end-stage renal disease there is a need to document the variation of the blood level along the dialysis cycle.

After giving informed consent 10 ml of blood will be drawn from the study population at the following occasions.

* Baseline measurement immediately before starting HD therapy.
* During the hemo-dialysis therapy - every one hour.
* After the end of the hemo-dialysis therapy - every one hour (a total of four measurements) to record recovery of Treprostenil blood levels.

Eligibility Criteria:
Inclusion Criteria:patients with PAH who receive chronic (more than 3 months) Treprostenil treatment administered intravenously as a single agent therapy who maintain chronic hemo-dialysis therapy. Patients must be in stable condition for at least one month. Patients other than class I PAH will be not included in this study.

Exclusion Criteria:

* none
Cryoablation Versus Radiofrequency Ablation

The purpose of this retrospective study is to describe why and when we used cryo and why we crossed over when we used both RFA and cryo. It is also to determine if there is some predictor that would make us say one patient would be better served with one technique than another and to describe our overall acute success rate and then our 6-month recurrence rate with cryo ablation and compare it to our known success rate with RFA.

Cryotherapy (Cryo) is a new ablation energy source used instead of the radiofrequency (RFA) method for ablation of septal pathways. In the past year, we have used cryo approximately 50 times, however 50% of the cryo procedures crossed over from RFA to cryo or cryo to RFA. It appears to me that cryo use should be as an adjunct therapy to RFA instead of replacement of RFA.

I would like to describe why and when we used cryo and why we crossed over when we used both RFA and cryo. I would like to determine if there is some predictor that would make us say one patient would be better served with one technique than another. I would also describe our overall acute success rate and then our 6-month recurrence rate with cryo ablation and compare it to our known success rate with RFA. All of this can be done with a chart review.

This will be done through a retrospective study.

Eligibility Criteria:
Inclusion Criteria:

* charts between January 1 and 2004 to December 31, 2004
* pediatric population
* those who were ablated

Exclusion Criteria:

-
Evaluation on Visual Outcome of TMS

The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) can improve the visual outcomes in patients with visual impairment. The main question it aims to answer is:

• Does TMS improve the visual outcome in patients who suffer from visual impairment? Researchers will compare TMS to the control group who will not receive effective TMS treatment) to see if TMS works to improve the visual outcomes of the patients.

Participants will

* Undergo TMS treatment or no effective TMS for consecutive 5 days.
* Visit the clinic once every 2 weeks for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

* Post cataract surgery or clear lens
* Best-corrected visual acuity less than 0.1logMAR

Exclusion Criteria:

* Diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment;
* Diagnosed with ocular diseases that affect observation of visual function;
* History of epileptic seizures;
* Long term use of psychotropic drugs；
* Metal implants in the body.
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Greece

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for intensive chemotherapy in Greece.

Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled.

Around 100 participants will be enrolled in the study in approximately 15 sites in Greece.

Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 30 months.


Eligibility Criteria:
Inclusion Criteria:

* Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) label.
* Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.

Exclusion Criteria:

- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects

This trial is conducted in China. The aim of this clinical trial is to assess the safety , tolerability and pharmacokinetics profiles of GB001 by single ascending dose and multiple ascending doses in healthy subjects after topical buccal delivery.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females aged 18 to 45 years, with a body mass index(BMI) 19-26kg/m2 and body weight no less than 45 kg (female) or 50 kg (male).
2. The results in the screening examinations (including general physical examination, vital signs, laboratory examinations, electrocardiogram, chest radiograph, etc.) are in the normal range, or are abnormal without clinical significance assessed by the investigator.
3. Subjects and their sexual partners agree to take effective contraceptive measures during the study period and at least 3 days after the end of the study.
4. Understanding and willing to comply strictly with the clinical trial protocol, complete all test procedures required in this trial, understand and sign informed consent form.

Exclusion Criteria:

1. Those allergic to GB001 peptide or any other drugs, or suffered from allergic disease or allergic constitution.
2. Any obvious clinical symptoms or abnormal test results with clinical significance suggested organ or system illness, unsuitable for inclusion in this trial in the investigator's judgement.
3. Subjects has obvious oral lesions or diseases, such as erosion of oral mucosa, ulcer or obvious periodontitis.
4. The weekly alcohol intake in 90 days before screening is more than 21 units (male) and more than 14 units (female) , or the subject is unwilling to stop drinking whenever required for the trial procedure.
5. Subject who smoke more than 10 cigarettes per day or is unwilling to stop smoking whenever required for the trial procedure.
6. Subject with a history of drug abuse, or those with positive urine screening test for drug abuse.
7. Subject who use of any other drugs within 30 days prior to screening, including prescription drugs, non-prescription drugs, biologicals, vitamins, minerals and nutritional supplements.
8. Blood loss or blood donation more than 400 mL within 90 days prior to screening.
9. Received major surgery within 90 days prior to screening, or participated in any other drug/device clinical trial.
10. Pregnant or lactating women; or female subject of childbearing age have a positive serum pregnancy test result during the screening.
11. Subject with dizzy needle or difficulty in venous blood collection.
12. Subject unsuitable for the trial in the judgement of the investigator.
Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation

Comparison of biliary complications in right lobe living donor liver transplantation patients undergoing biliary reconstructions using microscope versus surgical loupes .

Liver transplantation (LT) is the most effective treatment modality in patients with end-stage liver disease and it is also established as a viable treatment option in the field of oncology. Living donor liver transplantation (LDLT) using the right lobe (RL) is a major achievement despite its technical challenges, which has created a significant increase in graft supply. While a secure bile duct anastomosis is one of the basic principles of a successful liver transplant procedure, biliary reconstruction remains the Achilles' heel of LDLT because of the high incidence of posttransplant biliary complications associated with significant recipient morbidity and mortality. Some of these complications are related to technical difficulties due to multiple small biliary orifices, particularly in right lobe grafts. In our center, we have been using microsurgical reconstruction technique for duct-to-duct biliary anastomosis in such grafts. The routine use of this technique has been shown to significantly decrease biliary complications in single-center retrospective studies. However, prospective controlled studies comparing microsurgical and standard biliary reconstruction techniques are lacking. In this study, our objective is to compare posttransplant complications of the two techniques of biliary reconstruction in RL LDLT.

40 patients will be included in the study. They will be randomly allocated in the equal groups.İn group 1 biliary anastomosis will be performed using surgical loupes and İn group 2 biliary anastomosis will be performed using microscope. The patients will be followed for one year after the transplant to compare biliary complications.

Eligibility Criteria:
Inclusion Criteria:

* 1.Primary Adult Living donor liver transplant 2.Right lobe grafts with a single biliary orifice

Exclusion Criteria:

* 1.Bile duct diameter \< 3mm 2.Biliary costructions with a hepaticojejunostomy 3.Right lobe grafts with multipl biliary orifice
Retrospective Study to Estimate the Current Status of Patients With Non-Obstructive coroNary Artery Disease

The study will estimate the current status of participants with non-obstructive coronary artery disease confirmed via coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* Participants who had typical or atypical angina symptom before Coronary Angiography examination
* Underwent CAG between 01 Jan 2013 and 31 Dec 2015
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participant with history of percutaneous coronary intervention or coronary artery bypass surgery
* Participant with history of myocardial infarction
* Participant with history of cardiac transplant or valve surgery
* Presenting with Acute myocardial infarction for coronary angiography
* CAG showed myocardial bridge and coronary stenosis greater than or equal to 50 percent during systole period
* Incomplete or missing data in CAG report
* Other protocol defined exclusion criteria could apply
Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation

The goal clinical trial is to evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation in primary lung cancer and metastatic lung cancer. The main question it aims to answer are:Evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation.

Participants will undergo percutaneous or transbronchial argon-helium cryoablation.


Eligibility Criteria:
Inclusion Criteria:

* Primary or metastatic lung cancer with definite pathological diagnosis
* Not suitable for thoracotomy due to serious or serious lung or systemic diseases
* Peripheral lung cancer involves pleura and chest wall, and cannot be completely removed after surgery
* There are indications for surgical resection, but the patient refuses to operate
* Single tumor, maximum diameter ≤ 5cm
* Or the number of tumors ≤ 3 and the maximum diameter ≤ 3cm
* ECOG-PS score ≤ 2
* The expected survival period is more than three months
* Those who have not participated in other clinical verifications within 3 months
* Subjects voluntarily signed the informed consent form

Exclusion Criteria:

* Serious cardio-cerebral disease or other mental diseases
* Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis
* Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder and multiple pulmonary bullae
* Have a history of immunodeficiency, including HIV test (enzyme-linked immunosorbent assay and Western blotting) positive
* Chemotherapy, radiotherapy, interventional therapy, ablation and surgical treatment within 30 days before surgical treatment
* There is a tendency to severe bleeding, and the platelet is less than 50 × 109/L and severe disorder of coagulation function
* Coagulation index (PT, TT, APTT)\>2.5 times of the upper normal limit
* Malignant pleural effusion on the same side of the ablation focus was not well controlled
* Poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorder
* Those who have extensive extrapulmonary metastasis and are not suitable for ablation treatment
* Those who often use sedatives, sleeping pills, tranquilizers or other addictive drugs
* Pregnant or lactating women
* Those who can not judge the curative effect
* Other conditions determined by the researcher to be unsuitable for the group, such as inability to tolerate cryoablation, difficulty in follow-up, and other serious diseases
The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

The role of preoperative oral immunonutrition in major vascular surgery.

The mean purpose of this study was to determine the prevalence of post-operative infection complications after major vascular surgery in group of patients with preoperative oral immunonutrition.

This group was compared to a control group.

Secondary purpose was to evaluate the effect of preoperative oral immunonutrition on postoperative mortality (30 days), the medium length of stay in the hospital and the cost of treatment in the two groups


Eligibility Criteria:
Inclusion Criteria:

* Intervention planned since at least 5 days before surgery
* Duration of hospitalization of at least 5 days

Exclusion Criteria:

* Pregnant or lactating woman
* Patient with severe renal insufficiency
* Patient under 18 years old
* Patient infected with HIV,hépatitis B or C
Correlations Phenotype / Genotype in Down Syndrome

The purpose of this study is to correlate phenotype and genotype of Down syndrome patients in order to identify the biochemical reactions involved in their mental retardation and their other phenotypic characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Down syndrome patients
* age: 8years and older
* assessment by the psychometric tests
* possible blood tests

Exclusion Criteria:

* no exclusion criteria
Influence of Combined Double-Bundle ACL Reconstruction With Lateral Retinacular Release to Prevent Patellofemoral Malalignment in Isolated ACL Rupture

Anterior knee pain which might be due to patellofemoral malalignment is an inevitable post operative complication after an ACL reconstruction (ACLR). We combined the double bundle ACLR technique with lateral release technique to prevent patellofemoral malalignment post ACLR.


Eligibility Criteria:
Inclusion Criteria:

* unilateral isolated total ACL rupture
* normal BMI

Exclusion Criteria:

* flexion contracture more than 200, presence of anterior knee pain before surgery, Q angle \>140 in males and \>170 in females, presence of a patellar tilting, rupture of other ligaments, and muscular dysfunction.
Effects of a 10 Component Dietary Supplement on Health and the Quality of Life

This open-label field trial evaluates the effects of treatment with a multi-pathway dietary supplement (Stem Cell 100+) that has been commercially available for several years. The objective of the intervention trial is to determine if normal subjects over 35 years of age experience any observable health benefits from the dietary supplement as to their blood pressure, pulse rate, blood cholesterol, lung capacity, stress levels, or self reported changes in markers of overall health and life expectancy.

Currently, only dietary restriction has been verified to slow the rate of aging and to promote general health. This trial is designed to see whether a complex supplement (Stem Cell 100+) that targets multiple longevity pathways could also have positive effects on several markers of successful aging and good health. Multipath causes of aging include: stem cell function, telomere loss, chronic stress, inflammation, insulin-like growth factors, autophagy, vascular loss, neural dysfunction, and oxidative stress. The goal of the study was to test the effects of this novel multipath intervention strategy in a clinical trial of healthy people using health markers such as blood pressure, cholesterol status, lung function, stress levels, and self-reported health status. Hundreds of published animal and human clinical studies have been done with each of the individual active ingredients in the formulation, which target many critical causes of aging.

Based on their published animal studies showing extension of life span in a model animal and their laboratory work on adult human stem cells, the investigators believe that Stem Cell 100+ will provide evidence of efficacy in addressing multiple index markers of health and life expectancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* No history of serious cardiovascular, cancer, or neural disease.
* Normal health for age
* Willing to have blood drawn at baseline and after trial
* Willing to submit to evaluation testing of blood pressure, lung testing, stress testing.
* Willing to take online self reported survey of health at end of trial

Exclusion Criteria:

* History of metastatic cancer, heart attack, dementia, or other life-threatening disease
* Any subject who is not capable of responding to a self-reported online questionnaire
* Pregnant
Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia

This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.

This study analyses both Protein Expression and emotional alterations during hypobaric hypoxia in volunteers of different groups.

15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Helathy

Exclusion Criteria:

* Ear problems
Efficacy of Psychotherapy Treatment of Children With Tics

The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme compared to an alternative treatment which aims at the activation of resources in children and adolescents aged 8 to 18 years with tic disorders.

The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme (THICS, Woitecki \& Döpfner, 2014) compared to an intervention aimed at the activation of resources (STARK, Perri et al., 2014) for children and adolescents with tic disorders. This habit reversal treatment programme was developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and has already been evaluated in a pilot-study (Woitecki \& Döpfner, 2011, 2012). The activation of resources treatment programme was also developed at this Department and is currently evaluated in different studies. Effects are expected in both interventions, but a larger effect is expected in the THICS treatment

Eligibility Criteria:
Inclusion Criteria:

* 8-18 years
* Diagnosis of chronic motor or vocal Tic (F95.1) or Tourette-Syndrome (F95.2)
* YGTSS total score F95.2\>13, F95.1\>9
* Tics are the main problems
* Intelligence IQ\>80
* If medication, then has been stable for at least one months in medicated patients
* No change in medication treatment is planned
* Ability to participate in weekly outpatient treatment
* Acceptance of randomization

Exclusion Criteria:

Diagnosis of Autism Spectrum Disorder or Psychosis Parallel continuous psychotherapy of tics or comorbid -