cyrilzakka/clinical-trials huggingface dataset:
Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT)

Behçet's disease (BD) is a systemic vasculitis that affects, especially, young people.

Although its etiology remains unexplained, data suggest that the inflammatory response during BD results from a disruption of the homeostasis of innate and adaptive immune responses in genetically predisposed people. The microbiota could play a triggering role in BD, in particular the salivary and dental plaque microbiota. The aim of the Behçetbiot study is therefore to establish microbial profiles of dental plaque, pathological (on the mouth ulcer) and non-pathological mucous membrane, salivary and digestive and to compare them with control subjects not suffering from BD, related to the first degree, of the same socio-cultural level and to determine whether dysbiosis is correlated with a local and systemic pro-inflammatory response, by measuring salivary level of pro-inflammatory cytokines and blood level of CRP, fibrinogen, orosomucoïd and haptoglobin, and to compare them with controls.

All patients and their controls are sampled for stool, saliva, dantal plaque, oral mucosa, genital mucosa and blood during an annual follow-up visit or if they are hospitalised.

Plaque, oral mucosa, genital mucosa salivary and blood will be collected during an annual follow-up visit.

For stool samples, the collection material will be provided to the patient and they will be able to take the sample at home and bring it to the clinic, or send them via a carrier within 3 days.

All the samples related to the study will be taken in the internal medicine in Clermont-Ferrand (France) or Pitie Salpêtrière, department of internal medecine, Paris,France or ophthalmology departments in Clermont-Ferrand.

All sample will be stocked in biological center in Clermont-Ferrand before analyze.

Microbiota analyzes will be realise at M2iSH laboratoty, inflammatory cytokines will be analyze in Clermont-Ferrand immunology laboratory, and pro-inflammatory parameters will be analyse in biochimy laboratory in Clermont-Ferrand.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the International criteria for the classification of Behçet's disease, revised in 2013)
* Patient who had developed the disease in the 5 years preceding the study.

Exclusion Criteria:

* Pregnant or breastfeeding women, or women who may be pregnant or breastfeeding.
* Subject placed under judicial protection.
* Patient had received antibiotic or probiotic or symbiotic therapy in the 6 weeks preceding inclusion
Acetic Acid Colonoscopy Enhancement Study

The purpose of this study is to compare the additional diagnostic yield obtained by using the acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy.

Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures limited to the examination of the right colon.

Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.

Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for serrated lesions. Secondary outcome measures will include adenoma detection rate in the right colon or other locations, characteristics of polyps detected, including size and histological results.

Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is \>40 years old
2. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
3. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

1. Patients with a history of colonic resection;
2. Patients with inflammatory bowel disease;
3. Patients with a personal history of polyposis syndrome;
4. Patients with suspected chronic stricture potentially precluding complete colonoscopy;
5. Patients with diverticulitis or toxic megacolon;
6. Patients with a history of radiation therapy to abdomen or pelvis;
7. Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

The study team propose to investigate the feasibility and pilot a Telephone Cognitive Behavioral Therapy intervention for those identified to be at risk for chronic pain following surgery.


Eligibility Criteria:
Inclusion Criteria:

1) \>18 years of age, 2) scheduled for hernia repair, breast surgery, amputation, thoracotomy, cholecystectomy, cardiac surgery, splenectomy, orthopedic, urological or vascular surgery, 3) Rural dwelling

Exclusion Criteria:

1) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
Effects of Warm Water on GI System in Laparoscopic Cholecystectomy Patients

Objective: The study was carried out to determine the effect of drinking warm water on GIS functions in patients who underwent laparoscopic cholecystectomy surgery.

Method: The research was completed in Kahramanmaraş Necip Fazıl City Hospital with 100 patients, 50 of whom were in the Study Group (WG) and 50 were in the Control Group (KG). The patients in CG were given warm water to drink at the 2nd hour after surgery. On the other hand, patients in KG were allowed to drink warm water after bowel sounds started and gas was produced. Patients in both groups were 2,4,8,12 after surgery. hours were evaluated in terms of GIS functions. Statistical analysis was done in SPSS 22.0 for Windows package program. A p\<0.05 value was accepted for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* having surgery

Exclusion Criteria:

* not meeting the sampling criteria
* Refused to participate Canceled surgery
Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions

To compare the single-dose Bioavailability of Tranylcypromine and Parnate

To compare the relative Bioavailability of Tranylcypromine 10 mg tablets with that of PARNATE 10mg tablets in normal,healthy, men and women under fasting conditions

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be normal, healthy adult men and women who volunteer to participate.
* Is the individual healthy, nonsmoking, normal adult man or woman who volunteers to participate?
* Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, exclusive?
* Is she willing to avoid pregnancy by abstaining from sexual intercourse, or by the use of barrier methods. (diaphragm, condom, foams/jellies, sponge), and IUD, or has she has been surgically sterile or post- menopausal at least six months prior to entering into the study?
* Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
* Has/s/he provided written informed consent?
* A no answer to any of the above questions indicates taht the individual is ineligible for enrollment.

Exclusion Criteria:

* Does the individual have a history of allergy or hypersensitivity to tranylcypromine?
* Does/ s/he have clinically significant laboratory abnormalities that would interface with the conduct or interpretation of the study or jeopardize his/her safety?
* Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interface with the conduct or interpretation of the study or jeopardize his/her safety?
* Is she nursing?
* Does s/he have serious psychological illness?
* Does s/he have significant history ( within the past year) or clinical evidence of alcohol or drug abuse?
* Does s/he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-1 , or hepatitis B or C screen, or a positive pregnancy test?-Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the alst blood sample has been taken?
* Is s/he unable to refrain from the ingestion of smoked meat, cheese (except cream cheese and cottage cheese), wine and beer during periods beginning 48 hours prior to study initiation and ending seven days after the last blood sample has been taken in study period two?
* Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
* Is s/he unable to refrain from the use of all concomitant medications during the study?
* Ha s/he donated or lost blood, or participated in a clinical study which involved the with drawl of a large volume of blood (480mL or more), during the six week period preceding study initiation?
* Has s/he donated an investigational drug during the 30 day period preceding study initiation?
* A yes answer to any of the above questions indicates that the individual is ineligible for enrollment.
Chlorophyllin Tablets for Urinary Bleeding Following Radiation Therapy for Cancers of Pelvic Organs

To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.

Radiation therapy to the pelvis is a commonly used treatment modality for urological, gynaecological and rectal cancers. Intensity modulation and image guidance have improved the delivery of radiation therapy in recent times. However, this does not eliminate the risk of radiation-induced damage to the adjacent healthy tissue - in this consideration, the bladder. Hemorrhagic cystitis accounts for 5-7% of emergency urology admissions. The procedure for the management of radiation cystitis proceeds from non-invasive oral drugs and HBOT to minimally invasive treatment like intravesical therapy and angioembolization, to more morbid procedures like cystectomy and urinary diversion. Although these treatment modalities have shown some success, most patients continue to have recurrent/persistent hematuria. There is a need to explore options of other oral/intravesical agents which can aid in mucosal healing and stop hematuria with lasting effects. Sodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from green plant pigment, chlorophyll. It is a semi-synthetic mixture of sodium copper salts derived from chlorophyll. Chlorophyllin scavenges radiation-induced free radicals and reactive oxygen species. Research at BARC has shown that chlorophyllin prevents radiation-induced toxicity in normal hematopoietic tissues and normal epithelial cells. A phase 1 clinical study in healthy volunteers indicate that CHL is safe and tolerable in humans and has not shown any severe adverse events. The purpose of this study is to evaluate the safety and efficacy of oral sodium copper chlorophyllin in hemorrhagic cystitis secondary to radiation therapy for pelvic malignancy.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age with a history of radiotherapy for pelvic malignancy in the past more than 3 months back.
* Any grade of radiation-induced cystitis as per RTOG criteria (RTOG Grade 1-4 equivalent to CTCAE Grade 1-3).
* Adequate liver function defined as ALT/ALT ≤ 3 times ULN and total bilirubin ≤ 2 times ULN. Elevated transaminases up to 5 times ULN is allowed in patients with liver metastasis.
* Adequate renal function defined as creatine clearance ≥ 30 mL/min (By Cockcroft-Gault formula).

Exclusion Criteria:

* Known hypersensitivity or contraindications against sodium chlorophyllin.
* Hemodynamically unstable patients not responding to initial resuscitation.
* Patients with life-threatening hemorrhagic cystitis requiring urgent invasive intervention (CTCAE grade 4).
Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance

This is a single-center, randomized, placebo-controlled pilot study to evaluate the effects of high intensity interval training (HIIT) and daily administration of BasisTM for 3 weeks, in 18-35 year old males.

The study will consist of a screening visit, baseline visit, followed by treatment and HIIT phase (3 weeks) and a post-supplementation, follow-up visit (this will occur 48 h (or more) after the final HIIT session). Following the screening phase, subjects who meet entry criteria will be randomly assigned to 1 of 2 treatment groups: recommended dose of BasisTM (250 mg Nicotinamide Riboside and 50 mg Pterostilbene) per day or matching-placebo in a 1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 year old males
* Body mass index between 18.5-30 kg.m-2
* Ability to give informed consent
* Recreationally active (defined in the present study as exercising once a week or more).

Exclusion Criteria:

* Those regularly conducting HIIT or highly trained in endurance events (e.g. triathlete)
* Currently taking supplements known to affect metabolism (e.g. ibuprofen, stimulants, vitamins, NR)
* Taking prescribed medication
* Consuming a vegan diet
* Consuming a high fat, low carbohydrate diet
* Habitual consumption of protein and/or dairy supplements (e.g. whey protein)
* Smokers
Improvement of Liver Function in Liver Cirrhosis Patients After Autologous Mesenchymal Stem Cell Injection:a Phase I-II Clinical Trial

The methods for separation of mesenchymal stem cell were established in 2001. These cells can differentiate to osteocytes, hepatocytes, chondrocytes, myocytes and etc,. In this study the investigators try to separate mesenchymal stem cell from end stage liver disease, then these cells will be differentiated to progenitor of hepatocytes, finally , the investigators injected these cells into portal vein under ultrasound guide. The investigators determine the effects of injected cells in reestablishment of liver function.


Eligibility Criteria:
Inclusion criteria:

* MELD score of at least 10
* Patent portal vein on color Doppler examination of the liver
* Normal alpha-feto protein serum levels
* Age more than 18
* Filling inform consent by patients and first degree family members

Exclusion criteria:

* Any evidence of hepatocellular carcinoma on liver ultrasound studies
* Patients want to exclude from study
The Effects of the Use of Virgin Mary Herb in Childbirth

This is a study to see if the use of virgin mary herb during birth has an effect on fear, pain and duration during birth. Virgin mary herb is a dry plant and it is believed that when added to water during birth, it makes birth easier.

Objective: Midwives mostly develop nonpharmacological methods to cope with fear and pain management during birth in order not to interfere with the flow of birth. There are limited studies on traditional birth methods in Turkey. The aim of this study is to examine the effect of the use of the Virgin Mary Herb, one of the traditional methods applied during birth, on fear of birth and pain felt during birth. Material and Method: The universe of the study consists of all pregnant women who were admitted to the Birth Unit of a City Hospital in Istanbul between March 2023 and December 2023. A power analysis was conducted to determine the number of people to be included in the study sample. The power of the test was calculated with the G\*Power 3.1 program. In order to exceed the 95% value in determining the power of the study; a total of 84 people, 42 people in groups, should be reached at a significance level of 5% and an effect size of 0.732 (df=82; t=1.66). The study aimed to reach a total of 100 people, with the condition of including 50 people in each group, considering the high power of the test and the losses. Data were collected between September 5, 2024 and December 31, 2024. 50 intervention groups and 50 control groups were included in the study, and all pregnant women received midwifery care. The intervention group was additionally shown the opening of the Virgin Mary Herb in water.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old,
* Being able to understand and speak Turkish,
* Being primiparous,
* Not having a chronic disease,
* Having completed the 37th week of pregnancy,
* Not having passed the 42nd week of pregnancy,
* Being in a cephalic presentation,
* Having reached 4cm cervical dilatation,

Exclusion Criteria:

* Multiparous pregnancy,
* Application of labor induction,
* Being a high-risk pregnancy,
* Having received childbirth preparation training,
* Being an immigrant,
* Use of non-pharmacological methods other than Virgin Mary
Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Multicenter Clinical Trial

The aim of the present study is to test whether or not the use of translucent monolithic zirconia crowns bonded to a titanium base abutment perform similar to porcelain-fused-to-metal crowns on single implants in the posterior region.

In the majority of studies on implant-supported restorations, a considerable rate of fractures of the veneering ceramic was reported. The clinical data is restricted to full-ceramic implant-supported reconstructions in the anterior region. No clinical data is available on the performance of full-ceramic restorations in the molar region.

The use of translucent monolithic zirconia for implant-supported crowns (without veneering ceramic) may reduce the technical complication rate and allow for sufficient aesthetic results in the molar region. To date, no clinical trial investigating monolithic zirconia crowns for single molar implants is available.

The primary outcome of the study is the technical complication rate. This outcome represents an indicator for the prosthetic success of the implant-supported crown. The main biological secondary outcomes are marginal bone level, histological signs of inflammation, and presence of pathogenic bacteria. Further outcomes are crown survival, wear of the crown and of the antagonist.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Male and female patients from 18-80 years of age
* Presence of a Straumann Tissue Level implant with a regular platform (4.8 mm diameter platform) in the maxillary or mandibular molar region
* Need for a single implant-supported crown
* Implant position enabling screw-retained crown
* Presence of antagonist

Exclusion Criteria:

* Women who are pregnant at the date of inclusion
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Smoking more than 15 cigarettes a day
* Poor oral hygiene (Plaque Index over 30%)
* Bruxism
The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements in Patients With Metabolic Syndrome

Metabolic syndrome is a condition which is recognized by abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. Curcumin has beneficial effects such as antioxidant and anti-inflammatory effects. nanomcielle curcumin will be used in this study because of the low bioavailability , fast metabolism and low absorption of curcumin powder. Therefore, this study is planned to determine the effects of supplementation of nanomicelle curcumin on glycemic control, serum lipid profile ,blood pressure and anthropometric measurements in patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* 25\<body mass index \>40
* waist circumference \>102 cm in men or \>88 cm in women
* Fasting blood glucose \>100 mg/dL
* Triglycerides (TG) \> 150 mg/dL
* High density lipoprotein cholesterol (HDL-C) \<50 in women or \<40 in men
* Systolic blood pressure (SBP) \>130 mmHg and diastolic blood pressure (DBP) \>85mmHg

Exclusion Criteria:

* insulin administration for diabetes control
* hypo- or hyperthyroidism,
* renal failure or other chronic diseases
* pregnancy and breastfeeding
* taking weight loss supplements and obeying unusual weight loss plans
Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions

Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be performed safely without increased risk of bleeding or release of inflammatory mediators. This will reduce the need for allogeneic blood products as well as crystalloid and colloid infusions and thus decrease the length of ventilation and intensive care duration for these infants.


Eligibility Criteria:
Inclusion Criteria:

* 1. Weight \< or = 20Kg;
* 2. Cardiac surgery with CPB at URMC;
* 3. informed consent

Exclusion Criteria:

* 1. weight \> 21 Kg;
* inability to obtain consent;
* non-English speaking
RSV Observational Study 2

Respiratory Syncytial Virus (RSV) is a virus that causes chest infections. It is the single most important cause of severe respiratory illness in infants and young children, and severe RSV infection early in life is associated with an increased risk of later developing asthma. RSV also causes severe disease in elderly and immune-compromised adults, and the amount of RSV disease in the elderly is similar to that from seasonal flu. The virus is transmitted in the secretions of the upper respiratory tract of infected individuals and by contact with contaminated surfaces (such as toys). Hospital outbreaks, especially on paediatric and neonatal wards, are not uncommon.

Infection by RSV does not develop a natural long-lasting protection against re-infection (like, for example, measles does). In the USA nearly all children by 24 months of age have been infected at least once with RSV, and about half will have experienced two infections. There is no effective anti-viral drug to treat an infection and the only way of managing cases of severe infection is through supporting organs, such as the lungs, to withstand and recover from the illness.

There remains a real need to develop an effective vaccine to prevent severe infections caused by RSV. A better understanding of the way the immune system responds to RSV in children would aid the development of such a vaccine.

The purpose of this study is to increase our understanding of how the immune system responds to RSV. Only limited data is available on some important components of the immune response and this study is designed to measure these in more detail. This is done using a single blood sample.

A total of 35 children are anticipated to be recruited to this study, at ages when we expect to see differences in the immune response to RSV;

* 5 infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV
* 20 infants aged between 6 and 12 months (Group 2), who will have had exposure to one single RSV season in the winter of 2011/12
* 10 children aged between 3 and 6 years (Group 3), who have been exposed to RSV over several winter seasons


Eligibility Criteria:
Inclusion Criteria:

* Parent or guardian is willing and able to give informed consent for participation in the study
* Age suitable for Group 1, 2 or 3 as defined in above (Section 6.2)
* Delivery at 36 weeks gestation or later
* Having a blood sample for clinical reasons

Exclusion Criteria:

* Parent or guardian unable or unwilling to give informed consent for participation in the study
* Any impaired function of the immune system, by medication or pathological process, which could augment or impair the immune response to RSV
* Concurrent acute or chronic infection
* Any chronic illness which, in the opinion of the Investigator, may lead to incorrect or inaccurate immunology data
* History of immunoprophylaxis with Palivizumab
* Delivery prior to 36 weeks gestation