cyrilzakka/clinical-trials huggingface dataset:
FAUCS Surgery: Learning Curve for Resident

In the last decades, caesarean section (CS) rates are getting higher in all over the world.

This encourages us to improve operative techniques. In January 2018, investigators have introduced in the study unit: The French Ambulatory C section (FAUCS). This innovative approach appeares to provide a shorter recovery time, with a hospital discharge the day after surgery in 90% and then a better experience of childbirth.

The diffusion of this technique requires its integration to the curriculum of residency.

In this study, investigators will determine the mean number of procedures needed for trainees to master FAUCS.

Caesarean section (CS) is of the most commonly performed operations worldwide. This encourages a permanent search to improve the operative techniques for a better childbirth experience. The MisgavLadach (MLC), caesarean section is the gold standard for caesarean section. Thus so, it is included During the first years of obstetrics curriculum.

In January 2018, investigators have introduced The French Ambulatory C section (FAUCS) in the study unit. It is an innovative approach for CS. combining a left paramedian incision , an extra peritoneal access to the uterus and a purse-string double-layer closure of the uterus. Since that date, two doctors practice it regularly. However, the diffusion of this technique requires its integration into the curriculum of residency. Currently, there is no study on the learning procedure of FAUCS.

In our study, investigators will determine the mean number of procedures needed for trainees to master FAUCS.

Once the resident will master the procedure, investigators will study his skills evolution every 5 surgeries performed alone.

Eligibility Criteria:
Inclusion Criteria:

* trainee in obstetrics and gynecology.
* trainee subscribed for a training programm in the suty unit during the study period

Exclusion Criteria :

* Trainee in obstetrics and gynecology subscribed in atraining program elswhere from the sutudy unit during the study period
* trainee who refused to participate in the study
A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

For Substudy 1:

* Participant who achieve clinical response in Study M14-431 or Study M14-433.
* Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

For Substudy 2:

* Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
* Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Exclusion Criteria:

For Substudies 1 and 2:

* Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
* Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
* Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
* Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).
Enhancing Post-Stroke Dysphagia Rehabilitation

The goal of this clinical trial is to investigate the effects of a combined swallowing intervention (Neuromuscular Electrical Stimulation (NMES) + Neuromuscular Taping (NMT) + swallowing exercises) on swallowing function and quality of life in post-stroke dysphagia patients. The main questions it aims to answer are:

• Does the combination of swallowing exercises, NMES \& NMT have a greater improvement in dysphagia rehabilitation when compared to either NMES or NMT alone? Researchers will compare the effects of intervention between the three groups (NMES and swallowing exercises, NMT and swallowing exercises, and NMES with NMT and swallowing exercises).

Participants will:

* Receive a combined dysphagia rehabilitation comprised of swallowing exercises, Neuromuscular Electrical stimulation, and/or Neuromuscular Taping.
* Visit the clinic once every 5 days a week for 10 therapy sessions.
* Undergo baseline and post-intervention evaluation procedures.

This proposed study will be conducted using a prospective, three-group, randomized controlled trial. The participants for this study will be recruited from the post-acute and rehabilitation units who are diagnosed with post-stroke dysphagia at Hamad Medical Corporation hospitals in the State of Qatar.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 - 75 years old,
* Diagnosed with swallowing disorders between one day and six months post-stroke,
* Able to attend 10 therapy sessions,
* Have never received any swallowing treatment before participating in this study.

Exclusion Criteria:

* Post-stroke patients with severe cognitive impairment,
* Patients who have swallowing disorders due to other etiologies,
* Patients who need traditional swallowing therapy other than Expiratory Muscle Strength Training (EMST) and Chin Tuck Against Resistance (CTAR). - Skin disorders in the submental area and anterior neck,
* Medical conditions that may affect participation,
* A defibrillator and use precision electrical biomedical devices (e.g. pacemaker, etc.).
Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger

The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.


Eligibility Criteria:
Inclusion Criteria:

* Trigger finger Quinell grade IIb-V in digit I-V

Exclusion Criteria:

* Former treatment of Trigger finger in affected digit
* Dupuytrens contracture in affected digit
* Allergies or intolerance to used medications
* Rheumatoid Arthritis
* Insulin dependent Diabetes Mellitus
* Amyloidosis
* Mucopolysaccharidosis
* Already included in study with another digit
Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis

Chronic hepatitis B (CHB) is a common infectious disease affecting up to 2 billion people worldwide. Around 650 thousand people died of liver failure, cirrhosis and primary liver cancer caused by chronic hepatitis B every year. 3%-5% compensatory liver cirrhosis develop to decompensated cirrhosis and suffer from series symptoms such as fatigue, edema, portal hypertension, splenomegaly, hemorrhage, hepatic encephalopathy, hepatorenal syndrome and so on. Chronic hepatitis B is closely related to the imbalance of intestinal microbiota, and the intestinal microbiota of patients is significantly different from healthy people. The response of patients to hepatitis B virus can be influenced by reconstructing intestinal flora, while Intestinal microbiota transplantation(IMT) is a significant method to achieve it. In a previous study using IMT to treat HBeAg positive chronic hepatitis B patients combined with antiviral therapy, 80% of them has reached HBeAg clearance. The investigators propose a randomized trial of IMT in patients with HBV induced cirrhosis. Patients will be randomized to either control group or IMT group over a 12 months period.

A group of 60 patients with HBV induced cirrhosis will be recruited for study, which involved a 4 times IMT with gastroduodenoscopy and the time interval is generally 2 weeks. Participants can keep taking their present treatment. All participants will be assessed at baseline, after 3 months, 6 months, 12 months from baseline in order to evaluate the possible changes in:

(1)Imaging changes: Color Doppler ultrasound of portal vein, CT/MRI, Fibroscan score of liver fibrosis and steatosis, Grading of varicosity under gastroscopy(GI); (2)Basic information and symptoms; (3)Biochemical indexes: Liver function, four items of liver fiber, lipid metabolism, blood routine, coagulation function, blood ammonia, inflammation, oxidative stress, urine routine; sugar metabolism indicators (blood glucose, glycosylated hemoglobin, insulin level and insulin resistance level).

(4) Changes of gut microbiota: The changes of gut microbiota will be assessed by High-throughput sequencing (16S rRNA) on baseline, 3 months, 6 months and 12 months after treatment samples to assess changes associated with IMT.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent as appropriate, able to keep treatment
* 18 to 50 years of age
* Chronic hepatitis B, definitely diagnosed as hepatic fibrosis/cirrhosis through Fibroscan/Biopsy of liver biopsy

Exclusion Criteria:

* Drug treatment(immunosuppressive drugs, biological agents, high dose vitamins or other immunosuppressive drugs
* Other immune related diseases
* Gastrointestinal organic lesions such as gastroesophageal reflux disease, inflammatory bowel disease, intestinal tumor
* Medical or social condition which in the opinion of the principal investigator would interfere with or prevent regular follow up
* Participating in other clinical trials
Comparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial

To date, focused and radial types of ESWT have been effectively used in calcaneal spur. However, studies directly addressing a comparison between radial and focused types of ESWT in calcaneal spur have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on calcaneal spur.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of plantar calcaneal spur
* be aged ≥18 at the time of diagnosis
* be give informed consent

Exclusion Criteria:

* have not completed the assessment process.
* foot deformity
* psychological disease
Contrast-Enhanced Whole-Heart Coronary Magnetic Resonance Angiography at 3.0-T: A Multicenter Trial

The multicenter study evaluates the diagnostic performance of 3.0 T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease.

This is a multicenter trial evaluated the diagnostic ability of 3.0 T contrast-enhanced whole-heart coronary MRA to detect significant coronary artery stenosis among patients with suspected CAD.

A total of 272 patients will be prospectively enrolled from 8 cities in China.

Eligibility Criteria:
Inclusion Criteria:

* Suspected CAD, scheduled for DSA
* Sinus rhythm

Exclusion Criteria:

* Contraindications to MR examination: pacemaker, intraauricular implants, intracranial clips, thoracotomy, claustrophobia, orthopnea
* Acute coronary syndrome
* Atria fibrillation
* Coronary stents
* Bypass grafts
* Renal insufficiency (estimated glomerular filtration rate assessed by creatinine clearance \<60 ml/min/1.73 m2)
Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal

Hyper- and hyposexuality occur frequently in a variety of psychiatric disorders and are difficult to treat. While there is meta-analytic evidence for the significant effect of non-invasive brain stimulation on drug and food craving, no study has investigated the potential of this technique to modulate sexual behavior. The efficacy of a single session of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left or right dorsolateral prefrontal cortex (DLPFC) to reduce sexual arousal was tested against a sham stimulation.

To test this hypothesis, we employed a randomized, double-blind, sham-controlled crossover study design. Nineteen healthy male participants received high-frequency rTMS over the left DLPFC, high-frequency rTMS over the right DLPFC and sham rTMS (each 10 Hz; 110% resting motor threshold; 60 trains with 50 pulses) in randomized and counterbalanced order with a one-week interval between stimulation sessions to avoid carryover effects. Participants were exposed to neutral and sexual cues before and after each intervention and rated their sexual arousal after each block of cue presentation.


Eligibility Criteria:
Inclusion Criteria:

* motor threshold below 55%
* informed consent
* male
* 18-50 years
* heterosexual
* right handedness

Exclusion Criteria:

* contraindication for TMS
* somatic or mental illnesses
* intake of psychoactive drugs
* left handedness
* homo- or bisexual
* paraphilia
Evaluation of Serial Troponin and Cardiac Multimarkers at the Point of Care in the Emergency Department

This is a multi-center study to assess the diagnostic accuracy of the Troponin I assay in the Biosite Triage Cardio3 Panel at the point-of-care (POC) in adults presenting to the emergency department with possible acute myocardial infarction (AMI).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at time of enrollment
* Presenting to the ED within 6 hours from onset of chest discomfort (pain, pressure, tightness, etc) consistent with a possible diagnosis of AMI or ACS and with an initial ECG non-diagnostic for injury (or injury equivalent resulting in emergent reperfusion therapy). (NOTE: Subjects who have chest discomfort that is episodic or stuttering in nature may be included if the ED presentation is within 6 hours of symptom onset.)
* Experiencing at least 30 minutes of chest pain or other anginal equivalent symptoms. (Note: Subjects who have symptoms of shorter duration due to pharmacologic intervention may be included.)

Exclusion Criteria:

* Patient (or Legal Representative) unable or unwilling to provide written informed consent.
* Patient unwilling or unlikely to comply with study procedures, including protocol-specified blood sampling or telephone follow-up at 30 days and 6 months.
* Vulnerable populations as deemed inappropriate for study by site principal investigator.
* ST-elevation or other ECG criteria that result that is diagnostic for AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics6.
* Pulmonary Edema requiring CPAP, BIPAP, or mechanical ventilation
* Tachyarrhythmias (SVT, V-Tach, rapid atrial fib)
* End Stage Renal Disease on Hemodialysis
* Cardiac Arrest prior to arrival
* Implantable Defibrillator firing prior to arrival
* Hemodynamically unstable patients
* Trauma injury to the chest
Feasibility Clinical Study of the Alma System in Treating Primary Postpartum Hemorrhage

Feasibility clinical study of the Alma System in treating primary postpartum hemorrhage (PPH).

10 subjects, first in woman trial with ethics committee oversight. Women who experienced postpartum hemorrhage will be treated with the Alma System, which aims to rapidly reduce or stop the bleeding by targeting the primary cause: uterine atony.

The primary objective is to verify the safety of the Alma System in humans by: 1. Ensuring the absence of serious adverse events (SAEs) related to the use of the Alma System during and after the procedure. 2. Evaluating any observable damage to the uterus, cervix, or vagina due to the use of the Alma System. 3. Evaluating the occurrence of uterine inversion or folding during the use of the Alma System.

The secondary objectives include evaluating: 1. The ability to easily place the Alma System trans-vaginally. 2. The ability to connect the Alma System to a vacuum source and maintain the desired negative pressure. 3. The ability of the Alma System to contract the uterus to a level that reduces or stops blood loss and avoids further non-surgical and surgical intervention. 4. The time from insertion and start of negative pressure to a visible reduction in blood loss.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Female, 18 years of age or older at time of consent.
2. Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
3. Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placenta with failure to obtain contraction and/or Subjects who have lost blood post-vaginal delivery \> = 500 ml and lost blood post-cesarian delivery \> = 1000 ml and according to the Investigator's judgment, require an intervention.
4. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.

Exclusion Criteria:

1. Subjects who do not provide informed consent to participate in the clinical investigation.
2. Subjects who deliver at a uterus size \< 34 weeks.
3. Subjects who have lost \> 1000 ml of blood for vaginal birth and \> 2000 ml for caesarian delivery.
4. Subjects who have abnormal PT, PTT and INR.
5. Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
6. PPH that the investigator determines to require more aggressive treatment, including any of the following:

   * Hysterectomy;
   * B-lynch suture;
   * Uterine artery embolization or ligation;
   * Hypogastric ligation;
   * Known uterine anomaly;
   * Ongoing intrauterine pregnancy.
7. Placental abnormality including any of the following:

   * Known placenta accreta;
   * Retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior c-section and placenta previa);
   * Retained placenta without easy manual removal.
8. Known uterine rupture
9. Unresolved uterine inversion.
Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers

Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria:

* Subjects with clinically significant medical history
* Subjects with history of drug abuse or addicted
Genetic Epidemiology of Hypertriglyceridemia

To determine prospectively the role of elevated plasma triglyceride (TG) as a risk factor for 20-year coronary heart disease (CHD) mortality in familial combined hyperlipidemia (FCHL) and familial hypertriglyceridemia (FHTG), the familial forms of hypertriglyceridemia. Also, to perform genetic epidemiologic studies of recently identified lipoprotein risk factors for CHD, including Atherogenic Lipoprotein Phenotypes (ALP) based on subclasses of low-density lipoproteins (LDL), Lipoprotein(a) (Lp(a)) and apolipoprotein (apo) B plasma levels, and apo E isoforms.

BACKGROUND:

The study provided valuable new data on the role of triglyceride as a risk factor for coronary heart disease and on the genetic epidemiology of lipoprotein risk factors, using the only existing sample of families with hypertriglyceridemia that could be studied prospectively.

DESIGN NARRATIVE:

Using a sample of 101 families identified and studied in Seattle in the early 1970s, the study sought to determine if 20-year CHD mortality and all-cause mortality were increased in siblings and offspring of probands from families with familial combined hyperlipidemia and familial hypertriglyceridemia, compared to a group of married-in spouse controls. The study also sought to determine if elevated plasma triglycerides at baseline predicted 20-year CHD mortality in these family members. Based on new blood samples from these same families, the inheritance of LAP phenotypes was investigated, the association of elevated plasma Lp(a) and apo B levels with parental CHD mortality was examined, and the association of lipid levels with apo E isoforms was investigated. A repository of frozen white blood cells and plasma aliquots for future genetic studies was established.. These hypotheses were addressed by determining the vital status of 1009 family members in the 101 families, carefully classifying the cause of death as CHD or not for deceased family members, and by obtaining new blood samples from three generations of these families, including both local and non-local relatives. New personal and family history medical questionnaires were also completed for each participant.

The study was renewed in FY 1997 through June 30, 2001. The study has three new specific aims: to elucidate the genetic basis of small, dense, low-density lipoprotein, to map the chromosomal location(s) of gene(s) influencing this phenotype using a whole genome screen; to reveal common genetic influences (pleiotropic effects) on combinations of interrelated lipoprotein risk factors; and to evaluate familial CVD risk by determining the association between CVD in the proband generation and lipoprotein phenotypes, including lipoprotein(a) in the younger offspring generation in specific forms of familial hyperlipidemia.

Eligibility Criteria:
No eligibility criteria
European Calciphylaxis Registry Network

Observational, registry, prospective, non-interventional collection of CUA patient data. Patient treatment is carried out within clinical routine, at the discretion of the physicians and according to existing treatment guidelines. Participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients.

Calcific uremic arteriolopathy (CUA, calciphylaxis) is a rare disease (ORPHA280062) with dramatically high mortality characterized clinically by the occurrence of painful debilitating cutaneous lesions and ulcerations. Median survival time is about 1.5 years. Many uncertainties still exist about risk factors and optimal therapy. CUA mainly occurs in patients with severe renal insufficiency or ESRD.

The aim of the present initiative is to establish an international (European) observational registry for CUA patients. This registry will help to reach a critical mass of CUA patients, will allow novel insights into pathophysiology, and will help establishing systematically an overview upon risk factors and long-term outcome of CUA patients. The design of the international registry is supposed to adopt the structure of the presently running nation-wide German calciphylaxis registry.

The investigators plan to initiate a registry in which treating physicians can provide data upon demographics, clinical picture, comorbidities, medical treatments and laboratory data at the time of diagnosis and serial follow-up time points. In addition investigators will build-up a biobank for full blood, serum and plasma samples as well as tissue samples.

The registry will allow investigations regarding potential subgroups of patients (proximal versus distal forms of CUA), geno-phenotype correlations, description of international state-of-the-art treatment, and identification of preventive tools, risk factors and biomarkers for estimation of prognosis.

Furthermore, the registry will be the nidus for further scientific exchange between experts and clinicians on the field of uremic vascular calcification.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed CUA according to the judgement of locally treating physicians, who have the option to ask for external diagnostic advice from the country-specific sub-investigators
* Male or female aged \> 18 years
* Written informed consent prior to study participation
* The subject is not mentally or legally incapacitated

Exclusion Criteria:

• The subject is not able to give informed consent