cyrilzakka/clinical-trials huggingface dataset:
Effects of Aerobic Training in End Stage Renal Disease Patients

The investigators raised the hypothesis that exercise training would be associated with improvement in exercise tolerance and VO2 kinetics in hemodialysis patients.

End-stage renal disease (ESRD) is associated with several hemodynamic and peripheral muscle abnormalities which could slow the kinetics of O2 uptake(VO2)and diminished tolerance to incremental exercise. Although previous studies have shown that aerobic training is able to accelerate VO2 kinetics in several disease populations, little is known if these positive findings are also applicable to hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

The sample included end stage renal disease patients undergoing hemodialysis, three times per week totaling 12h weekly, for at least 6 months in the Nephrology Unit at the University Hospital of the Federal University of Juiz de Fora, State of Minas Gerais, Brazil. No patient had been involved in any kind of exercise training in the preceding 6 months

Exclusion Criteria:

* unstable angina;
* uncontrolled arrhythmia;
* uncompensated heart failure;
* uncontrolled hypertension (systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 120 mmHg);
* diabetes mellitus;
* severe respiratory diseases;
* acute infection;
* severe renal osteodystrophy;
* neurological or musculoskeletal disturbances
Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty

The original concept of a quadratus lumborum block (QLB) indicated for analgesia after abdominal surgery was first described by Blanco in 2007. Also referred to as a posterior transversus abdominis plane (TAP) block, the QLB consists in deposition of local anesthetic on either the posterior or the anterolateral border of the quadratus lumborum muscle. TAP blocks have already been proved effective in urologic, abdominal, and gynecologic procedures by blocking the sensory nerve supply to the anterior abdominal wall thus reducing the amount of postoperative analgesic medication. The main advantages of QLB compared to the TAP block is a wider sensory block area and a longer duration of analgesia. This is due to the extension of local anesthetic agents beyond the TAP plane to the thoracic paravertebral space(4).

Previous reports have shown that QLB is effective in providing pain relief after various abdominal operations. However, there are no published reports on QLB for postoperative pain after abdominoplasty. This prospective, randomized, double-blinded, controlled study aims to evaluate the analgesic efficacy, opioids consumption and quality of recovery of QLB in patients undergoing abdominoplasty. Patients scheduled to have abdominoplasty will be randomized to receive bilateral QLB with either ropivacaine 0.2% or normal saline. Post-operative cumulative analgesic medication consumption, pain severity at rest and on movement, as well as quality of recovery will be evaluated and compared in both groups.


Eligibility Criteria:
Inclusion Criteria:

1. Standard abdominoplasty procedure
2. Written informed consent
3. Age ≥ 18 years
4. Female

Exclusion Criteria:

1. Patient's refusal
2. Allergies to any study medication
3. Inability to comprehend or participate in scoring scales
4. Deformations that could possibly affect the spread of the local anesthetic in the quadratus lumborum muscle plane
5. Quadratus lumborum muscle plane not seen in ultrasound examination
6. Coagulopathy or on anticoagulants
18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.


Eligibility Criteria:
Inclusion Criteria:

* The patient completed 24 weeks of treatment in Study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population.
* The patient was compliant with taking study medication in Study 016.
* The patient is willing to participate in the study and signed an approved Informed Consent form.

Exclusion Criteria:

* The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
* The patient has shown clinically significant deterioration during participation in Study 016, and has reached Hoehn and Yahr Stage V.
* The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.
Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation

The use of tacrolimus in the long term as part of the immunosuppressive regimen after transplantation is associated to complications such as chronic nephrotoxicity, impaired glucose metabolism (diabetes mellitus) and an increase of the incidence of neoplasia. The conversion from a tacrolimus based therapy to a sirolimus based therapy associated with mycophenolate mofetil could improve the incidence of such complications. The aim of this study is to assess the risk/benefit ratio of this switch performed in stable renal transplant recipient between 12 months and 36 months after transplantation. The incidence of a composite endpoint (worsening of GFR evaluated by MDRD formula, incidence of cancer and diabetes) will be assessed 24 months after conversion.

Two doses of Sirolimus will be evaluated accorded to the CYP 3A5 genotype. Patients carrying at least CYP 3A5 \*1 allele will receive 4 mg per day whereas the others (CYP 3A5 \*3/\*3) will receive 2 mg.

Eligibility Criteria:
Inclusion Criteria:

* Recipient age ≥18 and ≤ 75 ans.
* Patients having received a first or second renal transplant from a cadaveric or living related donor between 12 and 24 months prior the inclusion.
* Peak panel reactive antibody (PRA) \< 30 %
* Patients with a stable renal function during the 3 months prior to inclusion (variation of serum creatinine lower than 20 %)
* Creatinine clearance ≥ 40 ml/mn/1.73 m26.
* Patients receiving as a stable immunosuppressive treatment associating: Mycophenolate mofetil (MPA AUC \> 30 mg.h/L) and Tacrolimus with a trough level \> 4 ng/ml, with or without corticoids

Exclusion Criteria:

* Multiorgan recipients
* Patients receiving cyclosporine
* Pregnancy
* Recipients of ABO incompatible graft
* Use of other immunosuppressive drugs.
* Historical peak reactive antibody ≥ 30 %
* Past medical history of humoral rejection, 2 episodes of acute cellular rejection
* Past medical history of sub-clinical rejection on routine allograft biopsy
* Calculated creatinine clearance \< 40 ml/mn/1.73 m2
* 24h proteinuria \> 1 g/24H
* Patients with severe diarrhea
* HTLV1 or HIV positivity
* Known hypersensitivity to tacrolimus, mycophenolate mofetil, or sirolimus.
* Total white blood cells \< 2500/mm3 or hemoglobin \< 9 g/dl
Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period

The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.


Eligibility Criteria:
Inclusion Criteria:

* All reproductive age women who express a desire for the LNG-IUS (Mirena©) at routine questioning at their 36-38 week prenatal appointment or upon admission to labor and delivery are eligible for our study.

Exclusion Criteria:

* Contraindications to the LNG-IUS include: Pregnancy or suspicion of pregnancy, Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity, Postpartum endometritis within the past 3 months, Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear, untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections, acute liver disease or liver tumor, hypersensitivity to any component of the product, known or suspected carcinoma of the breast. Any of these conditions would exclude the patient from our study.
* Delivery \<36 weeks
* Intrapartum chorioamnionitis (defined as maternal fever \>100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
* Postpartum Hemorrhage (defined as \>500cc EBL for spontaneous vaginal delivery)
* Cesarean delivery if randomized to IPP or EP placement
PET Response During Chemoradiation of Lung Cancer

A prospective observational study to determine the prognostic value of the timing of 50% reduction in metabolic activity (T50) during CCRT for NSCLC for treatment outcome (PFS).

This is a single-centre observational study. Patients with proven locally advanced NSCLC will be treated with concurrent chemoradiotherapy according to the standard clinical protocol of the NKI-AVL. During treatment, the biological behaviour of the tumour will be monitored with serial quantitative FDG (fluorodeoxyglucose) PET/CT scans. From these images, the time during treatment where a 50% reduction in FDG uptake relative to day 1 is reached (T50) will be derived. The T50 of progression-free surviving patients will be compared with that of relapsed or deceased patients, in order to find a value that predicts early treatment failure. An additional FDG PET/CT scan at the same day as regular follow up CT scan will be made, two months after treatment, to have a baseline after treatment for follow up.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically proven NSCLC
* T2-4 N0-3 M0 disease (stage II or III, inoperable)
* Scheduled for standard concurrent chemoradiation
* Primary tumour minimal diameter 3 cm
* Primary tumour SUVmax \> 5 on routine diagnostic pre-treatment FDG (Fludeoxyglucose) PET/CT
* WHO performance 0-1
* Written informed consent according to GCP (Good Clinical Practice) and national regulations

Exclusion Criteria:

* Age \< 18 years, incapacitated subjects
* Pregnant or lactating women
* Diabetes mellitus requiring medication
* Participation in dose escalation studies
* Other neoplasms in the last 3 years, with metastases
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of dry eye as defined by the protocol
* Central corneal staining

Exclusion Criteria:

* Ongoing ocular disease that may interfere with study parameters
* Inability to stop using topical ophthalmic medications throughout the duration of the study
* Inability to stop the use of contact lenses for the duration of the study
The Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT

The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.

To evaluate the efficacy and safety of electroanatomic imaging (CARTO) compared to conventional fluoroscopically guided activation mapping (Conventional) method in patients with Atrial Fibrillation and Substrate-dependent Ventricular Tachycardia To evaluate cost-effectiveness of CARTO 3D image system compared to conventional method in the same study subjects

Eligibility Criteria:
Inclusion Criteria:

* patients with AF or substrate-dependent VT

Exclusion Criteria:

* administering with anticoagulants
An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes

This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, Southwest Ethiopia.

Background: Maternal, newborn, infant's morbidity and mortality are unacceptably high in sub-Saharan Africa including Ethiopia. Despite considerable efforts made in maternal and child health care, poor maternal, neonatal and child health problems remained a significant public health concern globally and particularly in low and middle-income countries. Community-based Interventions and strategies for improving maternal, newborn, and child health care have been recommended through a continuum of care approach. However, few efforts have been made to identify synergies and integrate different intervention packages across the country.

Objective: This study aims to assess the effectiveness of an integrated community-based intervention package in improving maternal, neonatal and infant health outcomes in Jimma Zone, Southwest Ethiopia: a cluster randomized controlled trial.

Methods: This is a parallel-arm, single-blind, cluster randomized controlled trial conducted in the Dedo and Seka Chekorsa districts of the Jimma zone. After excluding 10 kebeles from each district to be considered as a buffer zone, we will assign 26 kebeles to the intervention arm and 26 to the control arm. A total of 624 pregnant women in their third trimester who reside in the kebeles assigned to the intervention clusters will be identified and enrolled (312 in intervention and 312 in control groups). The intervention includes Behavioral Change Communication, and male involvement. Various multidisciplinary professionals and experts regularly monitor the overall process of the research and intervention activities. The effect of the intervention in comparison with the routine care will be assessed by fitting mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes. In all analyses, adjustment will be made for clustering at the kebele level and covariate. All tests will be two-sided and the level of significance will be set at alpha \< 0.05.

Budget: A total of 579,888.4ETB will be required. Key words: community-based intervention, maternal, neonatal, infant, health outcome, randomized controlled trial

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the third trimester
* Live in the selected cluster

Exclusion Criteria:

* Serious illness or clinical complications requiring hospitalization
* Maternal death
* Newborn death
* Stillbirth
* Twin gestation
* Preterm birth (at \<37 weeks)
The Role of Artificial Intelligence in Endoscopic Diagnosis of Esophagogastric Junctional Adenocarcinoma：A Single Center, Case-control, Diagnostic Study

This is a single center, case-control, diagnostic study.The aim of this study is to use deep learning methods to retrospectively analyze the imaging data of gastrointestinal endoscopy in Qilu Hospital, and construct an artificial intelligence model based on endoscopic images for detecting and determining the depth of invasion of esophagogastric junctional adenocarcinoma.This study will also compare the established AI model with the diagnostic results of endoscopists to evaluate the clinical auxiliary value of the model for endoscopists.The research includes stages such as data collection and preprocessing, artificial intelligence model development, model testing and evaluation. The gastroscopy image dataset constructed by this research institute mainly includes three modes of endoscopic imaging: white light endoscopy, optical enhancement endoscopy (OE), and narrowband imaging endoscopy (NBI).


Eligibility Criteria:
Inclusion Criteria:

* This study included endoscopic images of patients aged 18 and above who underwent endoscopic examination or treatment
* All patients in the case group need to be pathologically confirmed as esophageal gastric junction adenocarcinoma, and a pathologist has conducted a standardized pathological evaluation of the tumor classification of the lesion, including the overall appearance, size, differentiation type, depth of infiltration, presence or absence of lymphatic/vascular invasion, surgical margin status, etc.
* The endoscopic images of the control group patients need to be confirmed by biopsy pathology or at least two experienced endoscopists (with operating experience\>5000 cases) to jointly confirm that they have clear benign manifestations

Exclusion Criteria:

* The patient has a previous history of endoscopic treatment or surgery for the esophageal gastric junction.
* Necessary clinical information cannot be provided during the research process (patient age, gender, lesion characteristics, endoscopic manifestations, endoscopic images, etc.)
* Low quality endoscopic images, such as those severely affected by bleeding, aperture, blurring, defocusing, artifacts, or excessive mucus after biopsy.
Aspirin Versus Metformin in Pregnancies at High Risk of Preterm Preeclampsia: a 3-arm Randomized Controlled Trial

This is a prospective, multicenter, randomized controlled, double-blind trial of three treatment arms: (1) aspirin 75 mg/day vs. (2) aspirin 150 mg/day vs. (3) aspirin 75 mg/day with metformin 1.5 g/day from the first trimester to compare the incidence of preterm preeclampsia with delivery at \<37 week's gestation between the treatment arms, in order to determine the optimal therapeutic intervention for the prevention of preterm preeclampsia among Chinese women at high-risk of preeclampsia.

All women with singleton pregnancies who are attending for their routine hospital visit at 11-13 weeks' gestation will be invited to undergo screening for preeclampsia. We use a Bayes theorem-based method that combines maternal characteristics, medical and obstetric history together with mean arterial pressure (MAP) and serum placental growth factor (PlGF) level. Women who are deemed high-risk following first trimester combined screening (cutoff corresponding to a screen positive rate of 10%, e.g ≥1 in 80) will be invited to participate in the 3-arm randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* Live fetus at 11-13 weeks' gestation
* High-risk for preterm preeclampsia at 11-13 weeks by the algorithm combining maternal characteristics, medical and obstetric history, MAP and serum PlGF
* Informed and written consent

Exclusion Criteria:

* Age \<18 years old
* Multiple pregnancies
* Treatment with low-dose aspirin and metformin at the time of screening
* Pregnancies complicated by major fetal abnormality identified during the first trimester
* Women with learning difficulties, or serious mental illness
* Bleeding disorders such as Von Willebrand's disease
* Active peptic ulceration or gastrointestinal bleeding
* Hypersensitivity to aspirin, metformin hydrochloride and other biguanides
* Treatment with long term nonsteroidal anti-inflammatory medication
* Hyperemesis gravidarum
* Renal, liver or heart failure
* A serious medical condition
* Concurrent participation in another drug trial or at any time within the previous 28 days
* Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
Prevalence of Pathologic Gambling in the Workforce: a Cross-sectional Study in Brittany, France

Introduction: To date, very few studies about links between work and addictive disorders concern behavioral addictive disorders such as gambling. Such behaviours may be adaptative strategy for unsatisfied workers. The common physiopathology of addictive disorders allows us to hypothesize that it is possible that such troubles at work could promote gambling. Our aim was to evaluate the prevalence of gambling among workers and its links with work.

Patients and methods: We performed a descriptive cross-sectional monocentric study among all workers who consulted one physician between November 2016 and April 2017, from an occupational health service in Brittany, France. The first step was to ask whether they have gambled during the last year and if it was related to their occupation. The second step was a screening for risky gamblers (using the "Lie or Bet" questionnaire) among these and then to assess more precisely the severity (using the Indice Canadien du Jeu Excessif, ICJE questionnaire).


Eligibility Criteria:
Inclusion Criteria:

* all employees coming in consultation in occupational medicine, between the 2016-11-01 and the 2017-04-30, with the investigator, having given their consent and replied to the questionnaires were included.

Exclusion Criteria:

* Employees who did not speak the French language and those who refused to participate in the study were excluded. The number of refusals to participate and their reason were identified by the investigator. In addition, for employees who came to consult several times during the collection period, we only included the data from the first visit, in order to avoid overrepresentation.
Shaving Satisfaction in Males With Skin Irritation From Shaving

The purpose of this research study is to evaluate the improvement in overall shave satisfaction, the appearance of skin irritation from shaving, and the razor related inflammation of the hair follicles when using a new razor technology in a regular shaving regimen as well as a new razor technology in a shaving regimen that includes a pre-shave gel, cleansing brush and shaving gel.

A secondary objective is to show improvement in the satisfaction of the shaving experience, symptoms such as bumps and irritation, and quality of life (QOL), when adding the 556 Razor, or the 556 Razor with a regimen of pre-shave gel, cleansing brush, and shave gel to the shaving regimen of males with shaving skin irritation. Shaving irritation severity will be correlated to shave satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Males with at least a two year history of the symptoms of skin irritation from shaving.
2. Must be age 20-60 years of age (inclusive).
3. Must wet shave using just a prep and blade razor at least 3 or more times per week, and be willing to shave at least 5 times per week during the study
4. Must have Mild to moderate symptoms of skin irritation from shaving based on IGA rating scales. There must be the presence of some razor bumps but there are no lesion count inclusion requirements.

Exclusion Criteria:

1. Changes in the use of systemic (oral antibiotics) within the last 4 weeks. Stable use of oral antibiotics for any condition are allowed
2. Changes in the use of topical prescriptions
3. Individuals who do not wet shave with a bladed razor, or who use electric shavers.
4. Individuals who have removed a beard within last two months.