cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery

The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.

The purpose of this study is to investigate whether the patients with morbid obesity requiring a surgical approach by Laparoscopic Sleeve Gastrectomy could be operated according to a "day-case surgery" modality.

The sequence of this study is the following:

1. patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.
2. medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.
3. during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study
4. after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.
5. the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)
6. the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.
7. follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.

Eligibility Criteria:
Inclusion Criteria:

* sufficient understanding
* good observance of medical prescription
* availability of a responsible adult for the first operative night
* patients living nearby the hospital (1 h maximum away)
* telephonic accessibility
* between 18 and 60 years old adults
* body mass index less than 60 kg/m2
* obesity requiring bariatric surgery
* surgery validated by an obesity-related staff

Exclusion Criteria:

* patient under administrative or legal protection
* obesity without HAS criteria
* cardiovascular comorbidity
* pulmonary comorbidity
* curative anticoagulant therapy
* bad diabetes control
* body mass index higher than 60 kg/m2
Scapular Flap Versus Obturator

The aim of this study was to evaluate and compare quality of life (QoL) outcomes of scapular island flap versus maxillary obturator reconstruction after partial maxillectomy. patients indicated for maxillectomy were allocated randomly to two equal-sized groups. Control group patients underwent reconstruction with a surgical obturator, while intervention group patients underwent scapular island flap reconstruction


Eligibility Criteria:
Inclusion Criteria:

* n0 lymph node
* older than 18ys

Exclusion Criteria:

* patients who recived radiotherapy
A Study of Disposable Transnasal Esophagoscope

This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety and tolerance.

A disposable, transnasal esophagoscope, E.G. ScanTM was developed by IntroMedic Co. Ltd. (Seoul, Korea). This device was designed to allow patient to undergo endoscopy with minimum pain without sedation. This endoscopy system consists of thin probe with a CMOS camera, controller and simple display system. This system is light enough to carry and does occupy much space, and thus, it can be used at patient bed sides in intensive care units, in emergency rooms, and even in doctor's offices.

Eligibility Criteria:
Inclusion Criteria:

1. aged 20 years or older
2. endoscopy indicated for reflux symptoms (heartburn, epigastric soreness and/or regurgitation), dyspepsia (epigastric discomfort, bloating, early satiety), or non-cardiogenic chest pain, or known or suspected to have esophageal varices, infectious esophagitis, or other esophageal disease based on their medical history
3. a written informed consent form

Exclusion Criteria:

1. history or symptoms of severe rhinitis and sinusitis
2. symptoms of acute respiratory inflammation at the time of examination
3. abnormal anatomy of the nasal cavity or nasopharynx due to nasal tumors or previous nasopharyngeal surgery
4. taking anticoagulants such as coumadin
5. patients for whom a EGD could not be performed
Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment

Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Arterial hypertension (SBP \< 160 mmHg and DBP \< 100 mmHg)
* Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation)

Inclusion criteria for the control arm (treated by ACEi):

* Patients over 18 years of age
* Arterial hypertension (SBP \< 160 mmHg and DBP \< 100 mmHg)
* Patients, who tolerate ACEi treatment

Exclusion Criteria:

* Cholestasis, severe hepatic insufficiency
* Allergy to telmisartan
* Gravidity or lactation

Exclusion criteria for the arm of patient treated by ACEi:

* Cholestasis, severe hepatic insufficiency
* Allergy to ACEi
* Gravidity or lactation
Online Cognitive Behavioral Intervention Program for Hong Kong People With Depression

The purpose of this study is to develop a culturally and linguistically appropriate online cognitive behavioral intervention program-- with therapist guidance -- for Hong Kong Chinese adults suffering from major depressive disorder with mild to moderate depressive symptoms, and examine the effectiveness of this program in reducing their depressive symptoms and improving their mental health. The 3- and 6-month maintenance effect after 3 months and 6 months will also be tested.

Previous studies have demonstrated that online cognitive behavioral therapy can significantly reduce depressive symptoms and improve mental health for people with depression. This project will develop an online cognitive behavioral intervention program (including both an online platform and a smartphone application) for Hong Kong people with depression. Blended mode will be delivered service, which include 8-week online program, 2 face-to-face sessions and 2 telephone follow-ups by a clinical psychologist. The program will be evaluated in its effectiveness in reducing depressive and anxiety symptoms, psychological distress, negative thoughts and negative emotions and increasing positive thoughts and positive emotions.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong resident
* Has mild to moderate depressive symptoms
* No suicidal risk in the past 3 months
* Receive no face-to-face counselling since program commencement
* Has access to a computer/smartphone with internet access
* Has a valid email address

Exclusion criteria:

* Has severe or no depressive symptoms
* Has suicidal risk in the past 3 months
* Currently receiving other psychological treatment
* Suffer from severe psychiatric conditions, such as bipolar disorder or schizophrenia
* Has no computer or smartphone with internet access
* Has no valid email address
M-TACE Treatment for Unresectable Hepatocellular Carcinoma

This study aims to investigate the safety and efficacy of transarterial chenmoembolization（TACE） combined with microspheres for unresectable hepatocellular carcinoma(HCC).


Eligibility Criteria:
Inclusion Criteria:

1. 18≤Age\<80 on day of signing informed consent.
2. Have histologically confirmed diagnosis or radiological diagnosis of HCC with at least one \>3cm targeted lesion.
3. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease, BCLC stage A disease but refuse a surgical or ablation therapy.
4. Have a Child-Pugh Class A/B（\<7） liver score.
5. Have a performance status of 0 or 1 using the ECOG.
6. Have a predicted life expectancy of greater than 3 months.

Exclusion Criteria:

1. The targeted lesions have received TACE or other locoregional therapy within 3 months.
2. Tumor burden over 70% of the liver volume.
3. Lesions can not be measured by mRECIST.
4. Has a diagnosed additional malignancy.
5. Patients with Hb\<9.0g/dL, WBC\<1.0×10\^9/L， TB\>3mg/dL，ALT/AST\>5 UL, ALB\<2.8g/dL， INR\>2.3, Cr \>2mg/mL or CCr\<30mL/min.
6. Severe heart, lung or cerebral disease.
The Effect of Vagus Nerve Stimulation on Sportive Performance.

Performance is defined as the physiological potential required for an individual's physical activity. The sportive activity that he creates with his potential is defined as the sportive performance level of the individual. There are many factors that determine athletic performance. These factors are; environmental factors such as heredity, physical structure, training level, technical capacity and mental adequacy, quality of training areas, nutritional quality, suitability in weather conditions. All these factors affect the planning of multidisciplinary and interdisciplinary approaches that affect the performance of the athlete.

Autonomic regulation is very important for the reorganization of the athlete's performance. Auricular vagus nerve stimulation (VNS) is a non-invasive method. With this method, autonomic nervous system regulation can be done practically. In the literature, there are no studies examining the effect of VNS on recovery and performance in athletes.

In this study, the effects of auricular vagus nerve stimulation on performance and recovery were investigated, which was designed as a randomized controlled trial, a single session of VSU was applied to 60 male professional athletes (30 experimantal, 30 control). The normal application waveform was biphasic asymmetric, with a pulse duration of 300 microseconds and a frequency of 25 hertz, for 20 minutes and continuously.

Eligibility Criteria:
Inclusion Criteria:

* Being an athlete who continues an active sports life.
* Not have an ongoing injury that prevents participation in the study
* To make a medium and high level weekly training period.

Exclusion Criteria:

* Having a systemic or neurological disease affecting the autonomic nervous system.
* Be younger than 18 years old and over 40 years old.
* Loss of sensation affecting the inner and outer ear, etc. have the disease.
* Having any acute systemic disease to exercise.
A Pilot Study of Migraine and Appetite Behaviour in Children

The purpose of this study is to determine whether there is an association between migraine in children and certain patterns of appetite or eating behaviour that may lead to later obesity.

Migraine is a chronic neurological disorder characterized by recurrent episodes of headache and associated symptoms. The condition affects approximately 11% of the child population and it can impose considerable burdens on the sufferer either due to the headache itself, or associated co-morbidities such as psychological stress, obesity, sleep problems, etc. Increasing attention is focussing on the shared genetic, environmental and neurobiological mechanisms of migraine co-morbidities to gain further insights into improving outcomes.

We are interested in studying eating behaviours in children with migraine since there is evidence that altered patterns of eating behaviour (and underlying changes in appetite) are seen in migraineurs although not studied systematically. Altered appetite and eating behaviours may be a mechanism for the emerging association between obesity (or degree of adiposity) and migraine severity, detected in both adult and paediatric studies to varying extents. Studying the putative association between migraine, degree of adiposity and patterns of eating behaviour in children may help to tease out causal mechanisms, since both migraine and obesity often evolve over the course of childhood.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents between 5 years and 16 years of age.
* Clinical diagnosis of migraine (for cases).
* Controls are recruited from children referred with headache, who do not receive diagnosis of migraine.

Exclusion Criteria:

* Adolescents 17 years or over.
* Secondary migraine-like disorder e.g., post-craniotomy headache.
Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin

The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit.

Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.

Although oral antibiotics have been the mainstay of treatment of inflammatory acne for 30 years, studies comparing their efficacy have little scientific value.

Evidence-based dermatology proves minocycline to be an effective treatment for acne vulgaris while the patient remains on the medication; however, the relapse rate of acne after a course of antibiotics has never been established.

The relapse rate would appear to be significant, as repeated courses and long-term antibiotic use are commonly prescribed in practice. The increasing problem of drug resistance has raised issues of the suitability of such long term antibiotic treatment and this overuse is probably a contributing factor of multiple drug resistance in our society.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written consent
* Either sex
* Any age
* Diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on the face.

Exclusion Criteria:

* Known hypersensitivity to tetracyclines
* Use of any oral antibiotics in the previous 3 months
* Pregnancy, breast-feeding or lactating
* Inability or unwillingness to comply with the requirements of the protocol, or agree to the use of their data as determined by the investigator.
* Concomitant medical condition which, in the investigator's opinion, may confound the study results or interfere with study assessments or outcomes.
* Patients with severe acne on the chest, back or trunk.
Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

Laryngeal Dystonia (LD), also commonly referred to as spasmodic dysphonia, is a neurological voice disorder characterized by involuntary dystonic contractions of the laryngeal muscles. Current treatments such as botox and voice therapy only provide temporary relief and thus, the investigators are exploring new strategies to provide long-term, sustained improvement.

Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the implantation of electrodes to deliver electrical stimuli to specific brain regions. It is the standard surgical treatment for many other movement disorders such as Parkinson's disease, essential tremor, and primary dystonia. This trial has been designed to test the hypothesis that DBS can improve the vocal dysfunction of LD.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed isolated laryngeal dystonia (adductor spasmodic dysphonia)
* Able to give informed consent
* Patients who fall into the age range of 18-75 years old
* Patients with inadequate medical and BTX management of spasmodic dysphonia

Exclusion Criteria:

* Dystonia present in other body parts (i.e- eyes, neck, limbs) in addition to larynx
* History of laryngeal denervation surgery for spasmodic dysphonia
* History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.
* History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).
* Incompetent adults or those unable to communicate.
Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons

This is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese monolingual (Spanish-speaking only) men and women.


Eligibility Criteria:
Inclusion Criteria:

* Monolingual Spanish Speaking
* Obese (BMI \>= 30)

Exclusion Criteria:

* Pregnancy
* Current cardiac disease
* Serious neurologic illnesses
Delphinus SoftVue™ ROC Reader Study

The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma.

This reader study will include approximately 32 radiologist readers and a sample of approximately 200 breast screening cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phases B, C, and D. The reader study image case set will be enriched with cancer cases.


Eligibility Criteria:
Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. All readers must meet the following base Inclusion Criteria:

* Hold a current United States medical license
* Be American Board of Radiology Certified
* Be MQSA-qualified
* Be experienced in reading DM images on a monitor
* Be experienced in reading Breast Ultrasound images on a monitor
* Have completed a Financial Disclosure showing no Conflicts of Interest
* Have provided a current curriculum vitae (CV)
* Have provided a signed Readers' Agreement
* Have provided written Informed Consent

All qualified and confirmed readers will complete a multi-module SoftVue™ training program prior to their participation in a reading session for this study.
Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

The perineal body is commonly injured during labor. It is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear. The aim of the randomized trial is to evaluate the results of such an operation compared with conservative treatment.

A randomized controlled trial which aims to evaluate objective and subjective outcomes following perineorraphy compared with pelvic floor exercise after vaginal delivery. 70 women seeking help for improperly healed perineal tear following vaginal delivery, matching our inclusion- and exclusion criteria, will be randomised into two different treatment groups, 35 to operative treatment, perineorraphy, and 35 to conservative treatment, tutored pelvic floor exercise. Assessment pre-and 6 months postoperatively will include clinical evaluation and condition specific validated questionnaires. Surgical characteristics and adverse events during follow-up are also registered.

Eligibility Criteria:
Inclusion Criteria:

* women with 2nd or 3rd degree laceration during vaginal delivery seeking for help because of troublesome symptoms from the pelvic floor
* height of perineum 2 cm or less.
* A least 6 months post partum
* stopped "exclusive breastfeeding"
* no indication for other gynecological surgical procedure

Exclusion Criteria:

* history of 4th degree laceration
* connective tissue disorder (Systemic lupus erythematosus, Sjögrens syndrome, Polymyalgia rheumatica, Marfans syndrome, Ehlers-Danlos syndrome)
* current use of systemic corticosteroids
* diabetes mellitus
* suspect occult sphincter tear on ultrasound
* history of previous urogynecological operation
Influence of Sodium Bicarbonate on Time-to-exhaustion at Critical Power in Endurance Athletes

During endurance exercise in the heavy and severe intensity domains, the rate at which metabolites that have been associated with the fatigue process (e.g. Pi, ADP, H, and extracellular K) accumulate increases. possibly leading to exercise cessation. Sodium bicarbonate, as a nutritional supplement, has gained attention over the past decades, because it might delay of offset fatigue. To date, there is a controversial discussion about which delivery mode (amount and frequency) might be best in optimizing endurance performance. Since the high ion load consequent to multiple ingestions might increase plasma volume, and consequently decrease bicarbonate concentrations, single acute ingestion could be more beneficial. However, in multi-day competitions or tournaments it might be necessary to use the supplement on a daily basis. Here, the investigators aim at investigating the effects of single dose or multiple dose (on five consecutive days) administration of bicarbonate vs. placebo increases endurance performance and acid-base homeostasis in trained male endurance athletes.


Eligibility Criteria:
Inclusion criteria: - male

* no cold or temperature at beginning or during the study
* between 18 and 45 years of age
* active in endurance sports (3 to 5 times per week a moderate to hart training)
* non-smoker
* no known cardiovascular or orthopedic problems
* no known limitations of kidney function
* no bearer of a cardiac pacemaker
* no medications with direct influence on the measurements. The whole intake of medicaments has to be declared in the health questionnaire by the participant.
* requirements of the health questionnaire fulfilled

Exclusion criteria: - female

* male and age under 18 or over 45 years
* cold or temperature at the beginning or during the study
* untrained (less than 3 moderate trainings per week)
* smoker
* cardiovascular or orthopedic problems
* limitations of the kidney function
* bearer of a cardiac pacemaker
* medication with direct influence on the measurements. The whole intake of medicaments has to be declared in the health questionnaire by the participant.
* requirements of the health questionnaire not fulfilled