cyrilzakka/clinical-trials huggingface dataset:
Comparison of Absorbable Sutures in Perineal Laceration Repair

The purpose of this study is to determine the difference in pain scales between absorbable suture types for second-degree perineal laceration repair.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Able to sign informed consent
* Vaginal laceration that requires sutures but does not involve the anal sphincter (third-degree tear) or rectal mucosa (fourth-degree tear)

Exclusion Criteria:

* Inability to speak and understand English or Spanish
* Previous diagnosis of vulvodynia, dyspareunia, or other chronic vulvar pain syndrome
* Extensive perineal warts or vulvar varicosities
Evaluation of Glycemic Changes During Exercise in Children With Type 1 Diabetes

The objectives of the study are: 1) to evaluate the effects of moderate exercise on SG evolution without insulin dose modification in patients with T1D under continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare differences between these 2 groups; 2) to evaluate the impact of insulin dose modification (bolus, basal, reduction or increase, based on SG evolution profile obtained after first exercise) before and/or during moderate exercise on T1D children under CSII and MDI regimen, and compare differences between these 2 groups.

Intervention and procedures:

a) The patients will first be assigned to standardized moderate-to-vigorous exercise for SG determination; b) similar exercise will then be repeated with preemptive adaptation of insulin dose (tailored on SG evolution during first exercise) for determination of potential influences on SG evolution.

Intervention Plan:

* At first visit (day \[\>18h\] before exercise): setting of a Continuous Glucose Monitoring System
* At second visit: moderate-to-vigorous exercise with treadmill.
* At third visit (2 days after exercise): removal of CGMS
* At fourth visit (day \[\>18h\] before fifth visit): setting of a Continuous Glucose Monitoring System
* At fifth visit: moderate exercise with treadmill, and insulin dose modification (basal rate, bolus, reduction, increase)
* At sixth visit (2 days after exercise): removal of CGMS
* Total number of visits: 6
* The exercises will be performed between 1 and 2 hours after breakfast or after lunch; the second exercise will be performed ≥2 weeks after the first exercise.

Controls:

* Moderate exercise with and without modification of insulin dose in MDI patients (by comparison with CSII patients). MDI patients will be matched to CSII patients according to gender, age, BMI (±0.5 z-score) and HbA1C levels (±1%) to exclude any bias in patient allocation.
* Moderate exercise without modification of insulin dose at first visit (by comparison with modification of insulin dose).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T1D (according to the ISPAD 2011 guidelines)
* T1D outside of partial remission phase (defined according to the IDAA1C definition \[Diabetes Care 2007\], being equal to A1C (%) + \[4 x insulin dose (units per kilogram per 24 h)\] and at least \> 2 years after T1D diagnosis (defined as the first day of insulin therapy)

Exclusion Criteria:

* Non-type 1 diabetes
* Severe neonatal asphyxia (defined as Apgar score 3 or less after 5 min), children born small for gestational age, chronic systemic disease, active malignancy, hypothyroidism, hypopituitarism, developmental delay, bladder dysfunction, obesity, carnitine deficiency, β-oxidation defect, cardiac malformations, dysrhythmia
* Intake of drugs interfering with insulin sensitivity (e.g. corticosteroids, GH).
* HbA1C \>9.5% at the time of enrollment in the study.
Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet

The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.

A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer in the age of 19-45
2. Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20%
3. Subject without a hereditary problems, chronic disease and morbid symptom
4. Subject who sign on an informed consent form willingly

Exclusion Criteria:

1. Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
2. Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy)
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives
4. Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
5. Sitting systolic blood pressure \> 140mmHg or \< 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or \< 60mmHg, pulse ≥ 100 beats per minute
6. Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin \> 2 x upper limit of normal range
7. Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
8. The history of drug abuse or drug abuse showed a positive for urine drug test
9. Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 1 month
10. Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
11. Taking drugs have received any other investigational drug within 3 months prior to the first dosing
12. Whole blood donation within 2 months prior to the first dosing or component blood donation within 1 months prior to the first dosing or blood transfusion within 1 month
13. Continuously taking excessive alcohol (\> 21 units/week; 1 unit = 10g of pure alcohol) or cannot stop drinking from 24 hours before admission to discharge
14. Cigarette \> 10 cigarettes a day on average for recent 3 months
15. Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
16. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason
Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy

The investigator will study the possibility of in situ heating of the liquid containing the chemotherapy, so as to avoid the need for an external pumping system with its complexity, and its associated risks and costs.

The use of a heating cable (prototype hereinafter called Thermowire, made by the company EFS, which is in charge of its development) was patented and tested in pigs in two studies that included 15 animals altogether (in 7 of which the heating cable was used). The aim of the first study was the purely safety aspects, while the efficacy to obtain hyperthermia, the quality and the homogeneity of the hyperthermia and its effect on the tissue penetration of the chemotherapy were evaluated in a second study. The results obtained justify transfer to use in humans in the context of a clinical trial so as to obtain CE certification.


Eligibility Criteria:
Inclusion Criteria:

* Patients with national health insurance cover
* With scheduled hyperthermic intraperitoneal chemotherapy (HIPEC) because of known peritoneal disease (primary or secondary)
* Who have provided written consent

Exclusion Criteria:

* Persons under guardianship
* Persons under 18 years old
* Pregnant or breast-feeding women
* Allergy to latex
* Abandon of HIPEC following surgical exploration
Effectiveness of an Oral Health Literacy Intervention on Oral Health Behaviors and Plaque Index in Orthodontic Patients

This study aims to evaluate the effectiveness of a novel psychologic-based oral health instruction program (OHL program) by comparing oral health behaviors (OHB) and plaque index (PI) scores between intervention and control groups at three key time points-pre-intervention, post-intervention, and follow-up-enabling a comprehensive assessment of the intervention's impact and and persistence over time. The study hypothesizes that (1) the OHL program will lead to greater improvements in OHL compared to a traditional control group and (2) these effects will be sustained through the follow-up period.

Participants in the intervention group received the OHL program, while those in the control group received traditional oral hygiene instruction. Both groups had data collected at baseline, post-intervention, and at a 3-week follow-up.

The outcomes were oral health behavior (OHB) and plaque index (PI), compared at three time points: baseline (initial), post-intervention (final), and at a 3-week follow-up. Additionally, as a manipulation check, oral health literacy (OHL) levels were assessed at all three intervals.

Demographic information, OHL, and OHB were measured using standardized questionnaires from previous research. The 31-item OHL scale assessed five elements: 1) access, 2) understanding, 3) evaluation, 4) application, and 5) communication of oral health information and services. A 14-item scale evaluated OHB across three domains: 1) oral hygiene practices, 2) dietary choices, and 3) utilization of dental services.

In addition, clinical assessments of plaque were conducted using the Silness and Löe plaque index (PI, 1964). Plaque was evaluated on four surfaces of each tooth (mesial, distal, buccal, and lingual) using a WHO probe. Scores ranged from 0 to 3, reflecting the absence to a large amount of plaque accumulation, based on their established criteria. A single oral examiner recorded the plaque scores for each surface, and the average score for each tooth was calculated. The total score was then summed and divided by the total number of teeth examined, providing an overall plaque index for each individual. There were no outcome changes after trial commencement.

Eligibility Criteria:
Inclusion Criteria:

* participants undergoing fixed orthodontic treatment, free from non-communicable chronic diseases (such as diabetes mellitus, hypertension, and heart disease), capable of reading, writing, and providing informed consent, and willing to participate in the oral health program.

Exclusion Criteria:

* reluctance to provide health information, inability to complete assessments, or withdrawal from the program at any stage.
Shulman Fasciitis Prevalence Study in Alsace

Shulman fasciitis or eosinophilic fasciitis (EF) is a rare inflammatory disease, usually benign but disabling, described by Shulman in 1974. The diagnosis is suggested by the clinic, confirmed by MRI and confirmed by histology, there really no published diagnostic criteria validated for this rare disease. The low number of cases reported in the literature reflects the difficulty of studying the epidemiology of this disease, to establish and evaluate therapeutic strategies and to assess prognosis. Work on this subject are few. To our knowledge, no study has previously used to estimate the incidence and prevalence of this disease. Therefore, the investigators want to determine the prevalence of FEs in Alsace in 2016 by a study "capture-recapture" using several independent sources of identification of cases in order to have recent epidemiological data and learn more about this disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Patients suffering from fasciitis Shulmande and living in Alsace at 1 January 2016

Exclusion Criteria:

* refusal to participate in the study
A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants
* Must have a normal or clinically-acceptable 12-lead ECG at screening
* Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1

Exclusion Criteria:

* Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study
* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases
* History of major surgery within 8 weeks before the first dose administration

Other protocol-defined inclusion/exclusion criteria apply
Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication

The aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin.


Eligibility Criteria:
Inclusion Criteria:

Eligible population among those older than 18 y.o, systemically healthy, with a diagnosis of OAC (OroAntral Communication), or with a strong pre-extractive radiographic suspicion of potential OAC, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) .

Exclusion Criteria:

i) received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.
The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy

Oxaliplatin is a chemotherapeutic agent, which is generally used in treatment of colorectal cancer. The dose limiting side effect of oxaliplatin is neurotoxicity. In this study we aimed to determine whether glutamine has role in prevention of oxaliplatin induced neuropathy.

Our study population includes the colorectal cancer patient who is going to have mFOLFOX6 (modified, Folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil l 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours) regimen. We randomly assigned the patients into two groups. We administered glutamine at dose of 3x10 gr/day to one patient group concomitantly with mFOLFOX6 regimen and other group had no additional intervention. We performed questionnaire, neurological examination and EMG (Electromyography) before and after 4th cycle of mFOLFOX6 regimen in both patient groups. We planned to compare the neurological signs, symptoms and EMG action potentials between mFOLFOX6+Glutamine and only mFOLFOX6 group. We aimed to search the role of glutamine as a prophylactic agent against oxaliplatin induced neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 - 65 years
* Operated and non operated colorectal cancer patients
* Patient administering mFOLFOX 6 ( Folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours)

Exclusion Criteria:

* Patients who had chemotherapy in last 6 months
* Diabetes Mellitus
* Sensorimotor polyneuropathy
* Anemia
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus

Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH), are a frequent complication of type 2 diabetes and obesity. This disease has been linked with an increased morbidity and mortality, in particular cardiovascular disease and hepatic complications (cirrhosis and hepatocellular carcinoma). NAFLD is covered different liver damage in ascending order: steatosis, Non-Alcoholic SteatoHepatitis (NASH), fibrosis, and finally cirrhosis. Mostly, fibrosis has a determining role in the patient's status health. The fibrosis prevalence rate may reach up to 15 % of people with type 2 diabetes. The purpose of the study is to screen hepatic fibrosis for patient with type 2 diabetes.

To be sure of the status of the disease, the gold standard procedure remains liver biopsy. However, it's an invasive procedure and it's a challenge to perform this kind of medical procedure to every patient with NAFLD. Some alternative procedure exists, called FibroScan that gives some indication of liver fibrosis status. Unfortunately, every diabetologist hasn't this equipment in his medical office. The investigators propose to evaluate two non-invasive biological fibrosis tests, called eLIFT and FibroMeter. The results of these two diagnostic tests will be compared to FibroScan and to liver biopsy results.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years old,
* Type 2 diabetes mellitus for more than 6 months,
* BMI \> 25 kg/m2,
* Waist circumference \> 94 cm (male) or 80 cm (female).
* Patient benefiting from a social security system.

Exclusion Criteria:

* Medical follow up for liver disease,
* Decompensated cirrhosis,
* Health status that does not allow the participation of the patient,
* Hospitalisation for acute complication: sepsis, infection, foot's ulcer, acute coronary syndrome,...
* HbA1c \> 11,0 %,
* Pregnancy.
* Patient under guardianship or curatorship or protection of justice
* Involvement refusal.
Outcomes of Endoscopic Operation in COVID-19 Infection: Cohort Study.

The goal of this observational study is to determine 30-day mortality and post endoscopic surgery complications in patients with COVID-19 infection who undergo endoscopic surgery.This results will inform future risk stratification, decision making and improve patient's clinical care.This study is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing any type of endoscopic surgery in an operating theatre and these patients had COVID-19 infection either at the time of surgery or within 30 days of surgery.

Exclusion Criteria:

* If COVID-19 infection is diagnosed \>30 days after discharge, the patient should not be included.
Randomized Controlled Trial to Evaluate the Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari Method) for Treating Lower Limb Varicose Veins

This clinical trial aims to assess the efficacy and safety of the SALFOAM 3% method, which involves saline wash, polidocanol 3% foam injection, and extrinsic compression using Lidstop®, in comparison with the conventional Tessari method for the treatment of lower limb varicose veins. The primary objective is to determine whether the SALFOAM 3% method results in better or equivalent vein occlusion rates and fewer adverse effects, such as hyperpigmentation, compared to the standard treatment.

Chronic venous disease (CVD) is prevalent in approximately 38% of the adult population in Brazil, posing significant public health challenges due to its potential complications, including ulcerations and reduced quality of life. The SALFOAM 3% method is a novel approach that combines saline wash prior to polidocanol 3% foam sclerotherapy and extrinsic compression with Lidstop®, aiming to improve outcomes by reducing adverse effects such as hyperpigmentation and enhancing patient quality of life. This randomized controlled trial will compare the efficacy, safety, and quality of life outcomes of patients treated with the SALFOAM 3% method versus those treated with the conventional Tessari method for lower limb varicose veins.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older with clinically confirmed varicose veins in the lower limbs by ultrasonography.
* All Fitzpatrick skin types (I-VI).
* Ability to provide written informed consent.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Known allergy or adverse reaction to polidocanol or similar agents.
* Active infection in the area of treatment.
* Immunosuppressed patients.
* Severe coagulopathies or a history of recent deep vein thrombosis or pulmonary embolism.
* Diagnosis of patent foramen ovale.
* CEAP classification VI (active venous ulcers).
* Use of medications that may interfere with the study outcomes.
* Inability to comply with the study protocol or refusal to participate.
The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic Hepatitis B Virus (HBV) Infection

Abstract

Telbivudine is a potent inhibitor of HBV but, due to a low genetic barrier to resistance, a high incidence of resistance has been observed in patients with high baseline levels of replication and in those with detectable HBV DNA after 24 weeks of therapy (A1). Telbivudine might be used in patients with good predictors of response (HBV DNA \<2 X 106 IU/ ml, i.e. approximately 107 copies/ ml, or 6.3 log 10 IU/ ml at baseline) with verification of HBV DNA suppression below detection in real time PCR assay at 24 weeks.(EASL Guidelines for HBV 2009) The therapy of Pegylated-interferon-alpha-2a is considered as the standard of care for patients with chronic hepatitis b viral infection. However, recent study by Buster et al showed that a sustained viral response (SVR less than 2000 iu.ml at 6 months after treatment)) is obtained in 8 % of patients with genotype D, 30% genotype A, and 20-25% genotypes B or C (47). Vitamin D is a potent immune-modulator; and has been shown to improve SVR in combination with peg interferone in patients with chronic HCV viral infection (48). The impact of vitamin D on virologic response rates of interferon-based treatment of CHB is unknown. The aim of this study therefore was to assess whether Vitamin D, added to the conventional peg therapy in CHB, or to nucleotide analogues could improve the treatment efficacy


Eligibility Criteria:
Inclusion Criteria:

* patients were eligible if they had been HBsAg positive for at least 6 months,
* patients were HBeAg positive or negative,
* patients had increased serum ALT levels between 1 and 10 times the upper limit of normal (ULN),
* patients had serum HBV-DNA levels greater than 1.0 x 10E5 copies/mL (2.0 X 10E4 IUmL), and
* patients had findings on a liver biopsy within the preceding 12 months that were consistent with the presence of chronic hepatitis B.

Exclusion Criteria:

* decompensated liver disease,
* antiviral therapy within 6 months before randomization,
* viral co-infections (hepatitis C virus, hepatitis delta virus, or human immunodeficiency virus), or
* pre-existent neutropenia or thrombocytopenia.