cyrilzakka/clinical-trials huggingface dataset:
Cryolipolysis and Subcision for Treatment of Cellulite

This study intended to investigate and compare the changes that may occur in response to cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational in the treatment of cellulite. It has previously been used for fat reduction on love handles or back fat. During cryolipolysis, the system drew fat tissue into an applicator then exposes the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite. Subcision is a process used to treat scars left behind by acne or other skin diseases and has been noted to improve moderate to severe cellulite. Subcision is a simple surgical procedure that is performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. This study was a pilot study designed to determine feasibility of these procedures.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks.
* All subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (Stage 2 or 3 of Nurnberger-Muller grading scale of cellulite7).
* Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

* Pregnant or lactating
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder.
* Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria.
* Subjects who have active skin disease or skin infection in treatment area.
* Subjects who are allergic to lidocaine or prilocaine.
* Subjects who are allergic to both cephalexin (and penicillin) AND levofloxacin (or another quinolone antibiotic).
* Subjects who have history of abnormal scarring.
Phase 2 Trials of NA-931 to Study Subjects Who Are Obese With at Least One Weight-related Comorbid Condition

This is a Phase 2 randomized, double-blind, placebo-controlled, parallel arm study of NA-931 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

This is a Phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of NA-931 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years of age at the time of signing the informed consent
2. Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI \<50 kg/m2

Exclusion Criteria:

1. History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation
2. Self-reported body weight change of 5% or more within 3 months of screening
3. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
4. Current or past diagnosis of chronic pancreatitis
5. Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
6. Any Glucagon-Like Peptide 1 (GLP-1) receptor agonist or GLP-1/ Glucose-dependent Insulinotropic Polypeptide (GIP) dual agonist within 6 months of Screening
7. Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
US-guided Thoracic Spinal Epidural Anesthesia VS GA for Abdominal and Breast Surgeries

Ultrasound-guided combined thoracic segmental spinal epidural anesthesia in comparison with general anesthesia in upper abdominal and breast surgery.

The first group (S) will be given ultrasound-guided thoracic segmental spinal anesthesia at the level of T10 interlaminar space, patients will be in sitting position, a combined spinal epidural tray will be used. In this group, SonoSite C60x/5-2 MHz M-Turbo Convex Probe ultrasound Transducer to identify the T10 interlaminar space and after complete sterilization, the investigator will introduce the epidural needle in a Paramedian in plan approach till the epidural space. The spinal needle is then introduced through the epidural needle not more than 0.5 cm beyond the Dura matter. 2cc of heavy Marcaine plus 25 ug fentanyl are injected through the spinal needle. The epidural catheter is then threaded through the Touhy needle after withdrawal of the spinal needle to keep only 4cm up in the epidural space.

Eligibility Criteria:
Inclusion Criteria:

* All upper abdominal and laparoscopic surgeries
* ASA I-III CLASS
* Age between 18 and 60

Exclusion Criteria:

Contraindication of regional ASA More than III Age less than18 or more than 60 Psychological troubles
Efficacy and Safety of Sotalol in Children With Arrhythmia

This study aims to investigate the efficacy and safety of oral sotalol alone or combination with other anti-arrhythmic medicines in the treatment of arrhythmias in children. The study will regularly monitor the Holter, electrocardiogram (ECG), Echocardiography (Echo), blood routine, urine routine, serum ion, liver and kidney function, troponin I, hypersensitive troponin T, N-terminal pro-brain natriuretic peptide (NT pro-BNP), etc, before and after receive sotalol therapy. Compare the degree of arrhythmia improvement in patients and the side effects after oral sotalol.

Monitoring the Holter, ECG, Echocardiography , blood routine, urine routine, serum ion, liver and kidney function, troponin I, hypersensitive troponin T, NT pro-BNP beforehand. Eligible patients should stop all anti-arrhythmia drugs and digitalis, tricyclic antidepressants, beta blockers or calcium antagonists for at least 5 half-lives, and then do Holter. Randomly grouped. Judging the results according to the situation before and after oral sotalol.

Eligibility Criteria:
Inclusion Criteria:

1. Age 0 day to 14 year-old
2. Diagnosis of tachycardia (paroxysmal supraventricular tachycardia, paroxysmal atrial tachycardia, ventricular tachycardia, idiopathic ventricular tachycardia, premature ventricular contraction) and had an episode within 3 months; Premature Ventricular Contractions (PVC) (total 10000 times/d, or\>5000 times/d with multiple source PVC, or total \> 3000 times/d but with paired PVC+ multiple source PVC, or ventricular tachycardia);
3. Although PVC≤ 10000 times/d, but there are obvious symptoms such as palpitation, chest tightness, fatigue, dizziness and other symptoms that need improvement.
4. Signed informed consent before the trial
5. Good compliance

Exclusion Criteria:

1. Heart failure that is ineffective in conventional treatment;
2. Left ventricular ejection fraction (LVEF) ≤ 50%;
3. Suffering from bronchial asthma;
4. Resting sinus heart rate (HR) in newborns \<90 bpm; -8 yrs \<80 bpm; ≥ 8 yrs \<60 bpm;
5. Corrected QT Interval (QTc) ≥ 450ms;
6. II ° -III ° atrioventricular block (AVB);
7. Severe liver, renal dysfunction, acute myocardial infarction, acute myocarditis, electrolyte imbalance have not been corrected;
8. The child has undergone major surgery in the past 4 weeks;
9. The child has participated in other clinical trials in the past 4 weeks;
10. The child has digestive, nervous, circulatory, kidney or liver disease
Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy

* Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous cystadenoma)
* Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)
* Primary Outcome Measure : Anti-adhesion Rate
* Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)


Eligibility Criteria:
Inclusion Criteria:

1. The patients who sign the written informed consent
2. Women aged between 18 and 44
3. The patients who are able to participate in clinical trial during the period of study
4. The patients without abnormal figures at the screening laboratory examination
5. The patients expecting ovarian cystectomy for benign ovarian tumor(mature cystic teratoma, Mucinous cystadenoma, serous cystadenoma)

Exclusion Criteria:

1. The patients who took treatments with medical products which might be barrier to evaluate the effectiveness
2. The patients who took medicine like other anti-adhesion, absorbable hemostat and dose of steroid, immunosuppressants
3. The patients with severe drug allergy
4. The patients with infectious disease on abdominal or pelvic cavity
5. The patients who previously participated in another clinical trials within the past 30 days
6. The patients considered inappropriate for the study
7. The pregnant
8. The patients with severe renal disease
9. The patients with severe systemic diseases
Effects of TBS on Reading in Adult Struggling Readers

The purpose of this project is to understand how reading is related to brain function. To do this, participants will perform some reading tasks and then have magnetic resonance imaging (MRI) brain scans. Participants will then receive transcranial magnetic stimulation (TMS) to the reading areas of the brain, followed by a second MRI brain scan. This will temporarily activate reading abilities. We want to better understand how the reading system in the brain functions.

Subjects will come in for up to 2 sessions, each lasting between 1 - 4 hours. Subjects will complete reading and cognitive tasks associated with reading, and receive TMS as well as 2 MRI brain scans, in order to assess brain regions important to reading.

Initial, basic screening including MRI and TMS safety screening will be conducted over the phone during the recruitment phone call and/or screening forms will be emailed to prospective subjects for their review. Those individuals that qualify will be scheduled for session 1. Session 1 will take between 1 and 3 hours. Subjects who pass health/MRI/TMS screening will complete cognitive/reading screening measures as well as the demographic information survey. They will also be trained on the MRI and TMS procedures. If all screening criteria is met, subjects will be asked to return for a second session which will include the MRI and TMS portions of the study.

Session 2 will take place on a separate day and consist of renewal of the health/MRI/TMS screening forms prior to the MRI scan or TMS administration. The baseline MRI portion of the session will last approximately 1.5 hours including screening, training, and scan time. The MRI scan will be followed by the TMS portion which will last approximately 45 minutes. The post-TMS MRI will take place immediately following the TMS session and will last approximately 45 minutes. Reading assessments will be administered before the baseline MRI and again after TMS stimulation/before post-TMS MRI, each lasting approximately 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Must meet the study reading criteria based on their reading and reading-related screening test results
* native speakers of English
* Right handed
* minimum of low average intellectual functioning (SS\>=80) on at least one subscale on the Wechsler Abbreviated Scale of Intelligence-2

Exclusion Criteria:

* hearing deficits (\>25dB at 500+ Hz), visual deficits (\>20/40), serious emotional problems, certain neurological conditions (e.g., uncontrolled seizure disorders)
* Braces on teeth, a cardiac pacemaker; hearing aid; other metal in their body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects
* TMS or MRI Screening and Contraindication Forms which do not pass technician review
Peer Assisted Breastfeeding Education Program

It was aimed to evaluate the effect of the Peer Supported Breastfeeding Education Program given during the antenatal period on the breastfeeding knowledge and attitude levels, breastfeeding self-efficacy and breastfeeding levels of postpartum women. For this purpose, the hypotheses created in our study are as follows.

1. H1: Breastfeeding knowledge and attitudes of mothers in the PABEP group are significantly higher than those in the control group.
2. H1: Breastfeeding proficiency levels of mothers in the PABEP group are significantly higher than those in the control group.
3. H1: Breastfeeding success of mothers in the PABEP group is significantly higher than the control group, according to the breastfeeding evaluation results.


Eligibility Criteria:
Inclusion Criteria:

* being in the antenatal period
* having their first pregnancy
* not having received breastfeeding counseling before.

Exclusion Criteria:

* mothers with previous birth history
* previously educated women
Pharmacokinetics of Plant-based Ingredient

The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males, age at start of the study 20 and 50 years
* Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2
* Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases)
* Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening

Exclusion Criteria:

* Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism
* Any history of gastro-intestinal disorders (including frequent diarrhoea for example)
* Blood donation in the past 2 months
* Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study
* Reported intense sporting activities \> 10 h/w
* Consumption of \> 21 alcoholic drinks in a typical week
* Not being used to eat breakfast
* Reported use of any nicotine containing products in the six months preceding the study and during the study itself
* Use of medication which interferes with study measurements
* Reported dietary habits: medically prescribed diet, slimming diet
* Not used to eat 3 meals a day
* Vegetarian
* Reported weight loss/gain (\>10%) in the last six month before the study;
* Allergy or intolerance to food products and aversion to food products;
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

The INTRUDE trial aims at assessing the efficacy of an fMRI-based neurofeedback procedure on drug-resistant auditory hallucinations. Hallucinations are complex and transient mental states associated with subtle and brain-wide patterns of activity for which we were recently able to validate an fMRI multivariate decoder. Based on this progress, we can track patients' hallucinatory status using real-time fMRI. We will test whether schizophrenia patients with drug-resistant hallucinations can be trained to maintain the brain state associated with a no-hallucination condition using appropriate strategies and thus reduce overall severity. We will refer to a double-blind randomized placebo-controlled design. A total of 86 patients will be enrolled and equally split in an active neurofeedback group (n=43) and a sham group (n=43), matched for sex, age and PANSS scores. Each patient will benefit from 4 runs of either active or sham neurofeedback. The primary outcome measure will be the mean decrease of AHRS scores relative to baseline, and at 1 month post-treatment. We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia (according to the DSM-5 classification)
* Frequent auditory hallucinations (SAPS item #1 ≥ 4)
* Stable medication for at least 30 days
* Absence of chronic neurological disorder (including seizure)
* Able to provide free written consent to participate in the research

Exclusion Criteria:

* Pregnancy
* Contraindication to MRI scan
* Claustrophobia
* No social insurance
Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants

The purpose of this study is to determine if there is a relationship between time spent out the targeted oxygen saturation range in preterm infants is associated with long-term outcomes such as Retinopathy of Prematurity.

All infants who had a birth weight of less than 1500 grams or less than 32 weeks gestation admitted to our neonatal intensive care unit (NICU) were eligible for the study. All infants were placed on Nellcor N600 pulsoximetry. Saturation data in two-second sampling from N600 OXIMAX pulse oximeters (Covidian, CA) was collected using a modified Nellcor® Oxinet® III system (Covidian, CA and Cardiopulmonary, Milford, CT) Alarm limits were set at 83% and 93% while infants required oxygen supplementation and 85% to 100% when neonates were in room air. Desaturation events were defined as number of times the saturation fell below the low saturation limit set on the monitor (83% if oxygen requirement \>21%, 85% if patient on room air). High saturation events were defined as the number of times the patient's saturation was above the upper saturation limit (93% if oxygen requirement \>21%)

The data collection system summarized each day in tabular form including average SPO2, number of low and high SPO2 events, duration of events in minutes, and the percentage of time infants spent outside of the intended saturation range. Primary outcome was threshold ROP requiring laser ablation. Data on ROP was collected during hospitalization and after discharge until resolution of ROP by pediatric ophthalmologist blinded to the study results. Secondary outcomes included bronchopulmonary dysplasia, length of hospitalization, sepsis, focal bowel perforation, necrotizing enterocolitis (stage 2 or greater), patent ductus ligation, intracranial hemorrhage, and number of red blood cell and platelet transfusions.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \<1500 grams or \<32 weeks gestation

Exclusion Criteria:

* None
Comparison of MAG and Fish Oil Efficacy

A potential application for unstructured monoacylglycerol (MAG) containing long chain polyunsaturated fatty acids (LC-PUFA)can be to provide essential fatty acids to humans who chronically consume lipases inhibitor such as Orlistat® for weigh lowering reasons. Indeed, it is predictable that chronic consumption of Orlistat® led to a depletion of essential fatty acids with time, therefore unstructured MAG containing LC-PUFA can be an option as a source of LC-PUFA for patients under Orlistat® treatment and hypothetically for subjects with other type of maldigestion/malabsorption. Potential applications of such concept are therefore related to disease conditions comprising low lipid digestion due to lipase activity insufficiency.

In the present study, in order to see the response information for eicosapentanoic acid (EPA) delivery, EPA will be provided either as a mixture of free monoacylglycerols or as triacylglycerol (TAG). The erythrocyte and plasma fatty acid composition from subjects under Orlistat® consumption will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Sex female
* Body Mass Index (BMI) ≥ 30kg/m2 and \< 40kg/m2
* Subjects willing to undergo treatment with Orlistat® (Xenical).
* Having obtained her written informed consent before any study related procedure including the pre-inclusion period.

Subject exclusion criteria:

* Binge eating disorder
* Any other weight loss treatment(s) within the last 3 months
* Vegetarians
* History of metabolic, cardiovascular, hepatic or renal diseases
* Obstructed bile duct
* Diseases that could interfere with intestinal absorption History of abdominal / gastric surgery (except appendicectomy)
* Use of drugs or illicit substances
* Consumption of alcohol \> 50 gr/week
* Any other clinically significant abnormalities on screening laboratory evaluation (creatinine, Na, K, urique acide, ASAT, ALAT, Ph. Alc., yGT, Glycemia, total cholesterol, HDL, LDL, triglycerides) concentrations \> 2.5 fold normal range
* Pregnant or lactating mothers
* Allergy to fish oil or other components (for e.g., gelatin or excepients of the capsule)
* Use of any other supplements containing fish oil for the duration of the trial or 3 month before inclusion in trial.
* Smokers
* Having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study
* Bleeding disorders
* Subject who cannot be expected to comply with the study procedures.
* Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.
Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides

Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together with a supportive helper T cell response (PeviPRO). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes
* Aged between 18 and 45 years
* Free of obvious health problems
* With a BMI between 18.5 and 29.9 are included if they give written informed consent

Exclusion Criteria:

* Chronic or acute illness
* Immunosuppression
* HCV and/or HBV infection
* history of allergic disease
* Pre-existing immune response against peptide of the vaccines