cyrilzakka/clinical-trials huggingface dataset:
Surgical Approach for Retrorectal Tumors Cohort

Aim of the study :

To evaluate postoperative outcomes of all surgical approach for retrorectal tumors.

Methods :

From 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in two referral tertiary center were prospectively collected.

Considering our exlusion criterias, data from XX patients were analyzed. The cohort was separated into 2 groups according to tumor localization regarding the third sacral vertebra.

Short and longterm outcomes were compared between the two groups.

Primary outcome :

90 days postoperative morbidity rate

Retro-rectal tumors are a group of heterogeneous and rare lesions. The actual incidence has been estimated to be approximately one case per 40,000 admissions. It is most often a benign tumor that affects young women and the origin is congenital in 60% of cases. The most common benign lesion is a tailgut cyst. Chordoma is the most common malignant lesion. They are mostly asymptomatic or pauci-symptomatic. This is why their diagnosis is regularly accidentaly after a morphological examination such as an abdominal ultrasound or a CT scan. MRI is the gold standard for determining the structure of the lesion, its origin, its topography, its extension in relation to adjacent organs, parameters that are essential to define the type of surgery and its approach.

When a retro-rectal tumor is diagnosed, the standard treatment is surgical resection. A biopsy is not helpful if there is no suspicion of a degenerate lesion. Usually, lesions located under the third sacral vertebra (S3) are approached by dorsal transsacrococcygeal, perineal or combined approach (abdominal and perineal approach) while those located above S3 the approach is abdominal (laparotomy or laparoscopy). As these lesions are, in the majority of cases, benign, the functional impact of surgery is essential. Based on our experience in minimally invasive surgery and in particular in retro-rectal tumors, laparoscopy has become our first-line approach regardless of the location of the lesion compared to S3. Our hypothesis is that the minimally invasive approach is reliable, safe and allows satisfactory histological results to be obtained while limiting postoperative pain and functional sequelae.

Eligibility Criteria:
Inclusion criteria:

* Patient presenting a retrorectal tumor
* Surgical procedure between 01/01/2005 and 31/12/2020

Exclusion criteria:

* age \< 18 years old
* Patients presenting a rectal tumor
* Patients presenting a rectal duplication
Physicians in Training and Critical Care Nurses Performance in Medical Code Events: Effect of Simulation-Based Training

METHODS:

Subjects:

All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents and all hospital ICU nurses (approximately 400 subjects) will be undergoing evaluation and training in CPR techniques according to their department training policy.

Study Assessment Tool:

An objective assessment tool has been developed and tested in medical code scenarios during training sessions recently done in the simulation lab. The tool has five domains: Airway, Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists of 3-8 tasks and skills (attachment A).

Design:

* Phase I: In groups of five to six subjects, residents and nurses will undergo baseline assessment in CPR techniques in the simulation lab. Subject will be presented with a clinical scenario that includes cardiopulmonary arrest. Subjects will be scored by observers based on the previously described assessment tool and will be video recorded.
* Phase II: All study subjects who completed phase I assessment will undergo standardized debriefing and demonstration of proper CPR techniques after reviewing their individual baseline videotape followed by repeated demonstration in CPR techniques during a clinical scenario with cardiopulmonary arrest in the simulation lab. Knowledge retention will be assessed periodically.
* Phase III: Rates of survival to hospital discharge and survival at 24 hours in hospitalized patients after cardiopulmonary arrest collected by the CPR committee and QA department longitudinally for one year after completion of project training (phase II) will be reviewed and compared to the same period one year earlier (CPR outcome data are being collected since 2005 at St. Luke's-Roosevelt Hospitals).


Eligibility Criteria:
Inclusion Criteria:

* Physicians in training and nurses

Exclusion Criteria:

* Physicians in training and nurses refusing to have their data included in final analysis
Study to Evaluate the Safety and Pharmacokinetics of CKD-331

Phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers

An open-label, randomized, single-dose, 2-sequence, 4-period, cross-over, phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
5. Those who agree to contraception during the participation of clinical trial.
6. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who have no medical history of digestive disease, cardiovascular disease, endocrine disease, respiratory system, blood·tumor disease, infection disease, nephrology disease, genitourinary disease, neuron disease, skeletal disease, immunological disease, otolaryngological disease, dermatological disease, ophiological disease
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
5. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
6. Those who exceed an alcohol and cigarette consumption than below criteria Alcohol

   * Man: 21 glasses/week
   * Woman: 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) Smoking: 20 cigarettes/day
7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.
Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangiopancreatography

To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP.

There are only 3 studies available that have tried to evaluate factors influencing the yield of brush cytology. Two of the 3 studied one parameter. The third study, which is also the largest, reported on 199 samples which the authors evaluated in a retrospect fashion. We plan to conduct a larger study assessing several other factors that have not been studied before. The study findings would help develop strategies to improve sensitivity of brush cytology specimens. This would ultimately result in more effective use of health care resources and improve patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ERCP Patients

Exclusion Criteria:

* Non ERCP Patients
Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation

For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues.

About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3).

With the recent development of the Proceed Ventral Patch (PVP), new elements have been introduced to overcome some of these issues.

The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the intra-abdominal position in the treatment of small ventral hernias.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Written informed consent
* Umbilical, primary ventral hernias smaller than 3cm diameter

Exclusion Criteria:

* Hernias larger than 3cm
* Recurrence
* Children
* Emergency cases
* Incisional hernias
Preventing Lack of Iodine During Pregnancy

The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on neuro-cognitive development of children followed up until two years.

374 patients with pregnancy less 12 weeks amenorrhea

Patients randomized in 2 parallel groups (each group with 187 patients)

* one group with 200 µg of potassium iodide
* one group with placebo

Follow up during 3 years with :

* a selection visit, an inclusion with randomization before 12 weeks amenorrhea
* and follow up visit at the 5th month and 8th month of pregnancy, the day of birth, and 6, 12, and 24 months " post partum "

Eligibility Criteria:
Inclusion Criteria:

* Patients with pregnancy less 12 weeks amenorrhea , with clinically normal pregnancy, unique or twiny
* Patients who agree to take part in the study and able to sign an Informed Consent Form

Exclusion Criteria:

* Patients receiving a treatment for thyroid affection, or with thyroid pathology
* Patients with a chronic pathology like insulin dependent diabetes or arterial hypertension
* Patients with a treatment supplying iodine or having had a gynecologic exam with a iodine solution in the last 30 days
* Patients taking part in another clinical test or in the last 30 days
* Patients with depressive antecedent before pregnancy or taking antidepressant treatment
* Psychiatric troubles that may interfere with the clinical evaluation
* Patients under special supervision or trusteeship
* No social security cover
Artificial Intelligence Assisted Insulin Titration System

This is a single-center, open-labeled, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System in patients with Type 2 Diabetes Mellitus.

The study enrolls 44 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin for at least 3 months. They are randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group receive insulin regimen set by the AI assisted system and patients in Control group receive insulin regimen set by physicians. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University and consist of a 7-day intervention period. Patient allocation will be stratified by HbA1c, BMI and previous total insulin doses.The primary endpoint is the percentage of time of sensor glucose measurements in targeted range (3.9-10 mmol/L) during the 7-days trial period.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18-75 years old;
* Subjects who had been diagnosed with type 2 diabetes;
* Subjects who are on treatment with insulin for at least 3 months;
* HbA1c: 7.0%-11.0%.

Exclusion Criteria:

* Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state;
* Subjects who change the insulin regimens during hospitalization;
* BMI ≥ 45kg/m2;
* Women who are pregnant or nursing;
* Subjects with severe cardiac, hepatic, renal or general diseases;
* Subjects with psychiatric disorders or impaired cognitive function;
* Subjects with severe edema, infections or peripheral circulation disorders;
* Patients treated with surgery during hospitalization;
* Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.
Yoga for Fibromyalgia

Fibromyalgia is a common, costly and debilitating illness which affects mostly women. Fibromyalgia patients report widespread musculoskeletal pain, fatigue, stiffness, and distress. Several consensus statements indicate that optimal care combines medication, exercise, and psychology. Yoga is a popular mind/body discipline which holds promise for reducing fibromyalgia symptoms. The aim of this pilot study is to evaluate the effects of an innovative program, Yoga of Awareness, in which yoga poses are complemented by meditation and breathing exercises, presentations on healthy coping, and group discussions. Fifty-six women with fibromyalgia will be recruited and randomly divided into two groups. One group will receive the yoga program right away, and the other group will wait 3 months before receiving the program. Information about fibromyalgia symptoms and functioning will be collected from both groups before and immediately after the first group receives the yoga program. When results from the 2 groups are compared, the investigators expect patients who received the yoga program will have greater gains in fibromyalgia symptoms, physical function and pain coping capacities then those waiting to receive the program. If this study shows the yoga program is effective, the investigators will use this data in 2010 to apply to the National Institutes of Health for a more complete study of its benefits.


Eligibility Criteria:
Inclusion Criteria:

* women ≥21 years of age
* diagnosed with fibromyalgia by ACR criteria for at least 1 year
* on a stable regimen of pharmacologic and/or non-pharmacologic treatment for FM ≥3 months

Exclusion Criteria:

* reside \>70 miles from the research site
* unavailable to attend the intervention at one of the scheduled times
* currently engaged in intensive yoga practice (practice \>3 days/wk)
* score \>29 on the Beck depression scale modified for fibromyalgia
* currently undergoing disability application or involved in litigation
* elective surgery scheduled during the study period
* physically disabled in a manner that precludes meaningful participation in the intervention (eg, quadriplegic paralysis)
* do not speak English
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.


Eligibility Criteria:
Inclusion Criteria:

1. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
2. Other key inclusion criteria, as specified in the protocol.

Exclusion Criteria:

1. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Other conditions and criteria, as specified in the protocol.
Sham CPAP vs. Straight CPAP for Chronic Cough

Chronic cough is an important clinical problem in primary care and sub-specialty practice. Besides the distress experienced by patients with chronic cough, significant healthcare resources are expended to understand the role of gastroesophageal reflux, asthma and post-nasal drip in understanding their contribution to cough.

Obstructive sleep apnea (OSA) is common in patients with chronic cough. More importantly, treatment of OSA with continuous positive airway pressure (CPAP) has led to improvement in cough for chronic cough patients. Mechanisms by which OSA therapy with CPAP can improve cough includes beneficial effects on reflux and airway inflammation.

The aim of this study is to definitively establish that CPAP therapy for treatment of OSA in chronic cough patients improves cough. While these patients with chronic cough are not routinely screened and treated for OSA, this study aims to evaluate these chronic cough patients with screening questionnaires for OSA and if necessary with polysomnography and randomize them to either CPAP or sham CPAP for 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Cough of more than 2 month duration
* Not active smoker with history of stoppage of smoking for more than 6 months
* Evaluation and treatment by other providers for suspected gastroesophageal reflux disease (GERD), upper airway cough syndrome (UACS), or cough-variant asthma (CVA) for at least 1 month
* Normal chest radiography or computed tomography (CT) scans (patients with up to 2 lung nodules less than 3 mm will be allowed if there is no history of malignancy elsewhere)
* Normal spirometry with predicted diffusing capacity of the lung for carbon dioxide (DLCO) more than 50% predicted. Pulmonary Function Test criteria: no evidence of airflow limitation (FEV1/FVC \> 0.7) or significant chest restriction (FVC \> 70% predicted) with predicted DLCO more than 50% predicted

Exclusion Criteria:

* Pregnancy
* Recent pneumonia (less than 6 months)
* Congestive heart failure, acute or chronic renal disease, jaundice or chronic liver disease, pulmonary embolism, stroke or neurodegenerative disease, malignancy
* Use of supplemental oxygen or positive airway pressure therapy (if patients have been diagnosed with obstructive sleep apnea in the past but were non-compliant with positive airway pressure therapy, they will not be excluded)
* Use of opiates for cough suppression (opiate use for pain suppression can be included)
* Alcoholism, drug dependence (including chewing tobacco) or illicit drug use
* Esophageal cancer or laryngeal surgery
* Craniofacial abnormalities that preclude CPAP placement
Technical Feasibility of the cfDNA Test for Non-invasive Cytogenetic Analysis of Early Miscarriages Versus the Gold Standard Microarray

Among the 15% of couples who experience a spontaneous early miscarriage (SEM) during their pregnancy, approximately 2 to 5% will suffer from recurrent SEM. It is only after the third SM that they will be offered a workup to look for a predisposition to SEM. This workup does not currently include a search for foetal chromosomal abnormalities that could be considered causal for this event. These anomalies are responsible for approximately 50% of SEM and their detection could lead to an explanation for half of the couples currently without a diagnosis after a standard workup. The diagnosis of chromosomal abnormalities can be made by karyotype analysis or by Cytogenetic Microarray Analysis (CMA) on the product of conception. Unfortunately, karyotyping has a high failure rate due to poor cell culture of samples that are often degraded or of low quantity. The CMA is not always feasible due to the absence of analyzable feto-placental material linked to the use of a drug strategy for its elimination.

The study of cell-free DNA of syncytiotrophoblastic origin (cfDNA) circulating in the maternal plasma could be a solution as it is for non-invasive prenatal screening of trisomy 21. cfDNA is detectable from 6 to 8 weeks of amenorrhea and released in the maternal blood as long as placental tissue is present in the uterus, can be easily obtained by maternal venous sampling. If maternal blood sampling is performed before complete removal of the product of conception, then detection of foetal chromosomal abnormalities would be possible. Thus, if failure rates of CMA and cfDNA techniques are comparable, cfDNA could be preferred as it applies for miscarriages for whom no fetoplacental material can be obtained.

This study therefore proposes to compare the failure rates of the two technologies (CMA and cfDNA) for the detection of chromosomal abnormalities in recurrent SEM.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has suffered a miscarriage and requires a curettage to collect the product of conception
* Patient consenting to constitutional cytogenetic analysis on cfDNA and product of conception
* Patient of legal age
* Patient affiliated to a Social Security system.

Exclusion Criteria:

* Venous sampling impossible
* Miscarriage before 8 weeks of pregnancy (unusable cfDNA)
* Patient does not understand French
* Patient under legal protection
Effects of Core Stability Exercise With Pregnancy Support Belt in Pubic Symphysis Dysfunction.

Symphysis pubic dysfunction is a well-known clinical problem encountered by many females during pregnancy, yet it has not received much attention in the research literature. As pubic symphysis dysfunction at times presents with severe pain while performing day to day activities and also affects significantly on quality of life in antenatal period, but its effective management remains difficult to determine as no standardized treatment protocols are available. This study may add to the growing body of knowledge in the management of SPD, that if the core stability exercise alone or with the pregnancy support belts yield comparable outcomes and if one technique is superior to the other, which should be the alternative choice of therapy.

The study will be a randomized clinical trial and will be conducted in Women Care Clinic, Bahawalpur. This study will be completed in time duration of 10 months after the approval of synopsis. Non-probability convenience sampling technique will be used and participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive core stability exercises and group B will receive core stability exercises along with pregnancy support belt. The data will be assessed at the baseline and after 6th week of treatment. After data collection, the data will be analyzed by using SPSS version 25.

Eligibility Criteria:
Inclusion Criteria:

Age 25-35 years females Have pain in the region of pubic symphysis, with or without radiation to the groin.

Have pain during stair climbing, turning over in bed, standing on one leg. Have tenderness on palpation of symphysis pubis. Have positive active straight leg raise (ASLR) test result

Exclusion Criteria:

Medical conditions preventing use of pregnancy support belts. Pregnant females having SPD but with absolute contraindications to exercise. Posterior (lumber spine or sacroiliac joint) pain that was considered worse than the symphysis pubis pain