cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.


Eligibility Criteria:
Inclusion Criteria:

* Sexually naïve and agree to abstain from sex during the study
* Moderate to severe menstrual-related pelvic pain
* Regular spontaneous menstrual cycles

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Treatment with an oral contraceptive within the previous 3 months
* Previous treatment failure with an extended oral contraceptive regimen
Benefit of Single Port-surgery in Sleeve Gastrectomy

Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch and mortality

The single port surgery is the natural evolution of laparoscopy. To date only few studies have evaluated the feasibility of this technique in sleeve gastrectomy. The investigators want to demonstrate the non-inferiority in terms of morbidity-mortality of use single trocar in sleeve gastrectomy compared the multiport technique. Moreover it should highlight the non-inferiority in terms of anatomical quality, reduction of excess weight lost, reduction of comorbidities, decrease post operative pain, improved quality of life and evaluate medico-economic impact of these technique to validating this new surgical approach for bariatric surgery. The study will be multicentric with 6 university center (Montpellier, Amiens, Lille, Creteil, Poissy and Montsouris Institut). 388 patients will be included in the tow group of the prospective randomise study.

Eligibility Criteria:
Inclusion Criteria:

* BMI\> 35 kg/m2 with comorbidity (s) or\> 40 kg/m2
* Patients aged 18 to 65 years
* Discussion and decision sleeve gastrectomy multidisciplinary meeting
* Free, informed and written consent
* Affiliation to a social security or other assurance

Exclusion Criteria - Anesthetics

Exclusion Criteria:

* Uncontrolled severe infection
* Liver disease other than obesity pathology
* Pregnancy (positive hCG)
* Large hiatal hernia
* Esophagitis uncontrolled
* History of gastric bypass and gastric surgery other than gastric banding
* Saving Justice guardianship
* Participation in another ongoing study
* Cognitive or severe mental illness
* Severe and non-stabilized eating disorders
* Addiction to alcohol and psychoactive substances"
Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients

In SICU, Siriraj hospital there were no protocols place for the management of pain. All decisions were made according the attending physicians.

There were no information about incidence of inappropriate pain management in SICU due to lack of validated tool for assessment.

To date, Thai-version of BPS and CPOT were validated, the incidence of inappropriate pain management in SICU, Siriraj hospital should be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years.
* Expected duration of mechanical ventilation of more than 24 hours.

Exclusion Criteria:

* Quadriplegia.
* Receiving neuromuscular blocking medications.
* Coma or severe brain injury
* Neurosurgery/ CVT patients/ trauma patients
Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study

This is an Open-Label Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of KT-301 (formerly US-APR2020) in Subjects With CKD IV Who Completed the US-APR2020-01 Study

Kidney diseases are a global public health problem that affects over 200 million people worldwide. It is estimated that about 30 million adults in the United States have Chronic Kidney Disease (CKD) and most are undiagnosed. In addition, CKD represents the ninth leading cause of death in the United States. Kidney diseases also represent great socioeconomical cost worldwide. In the United States, treating Medicare beneficiaries with CKD costed over $79 billion, and treating people with End Stage Kidney Disease (ESKD) costed an additional $35 billion in 2016. To date, there is no cure for CKD.

CKD is accompanied by altered pathogenic gut bacteria, inflammation, and accumulation of uremic toxins in the blood. These blood uremic toxins can diffuse passively into the bowel. Scientific research has shown that probiotic bacteria could metabolize various uremic toxins such as urea, uric acid and creatinine. In addition, by supplementing the gut microbiome with probiotic bacteria, it is possible to metabolize the nitrogenous waste products and other toxins which diffuse into the gut, and thus lower levels of inflammation and blood uremic toxins.

KT-301 (formerly US-APR2020) is a probiotic formulation of bacteria intended to restore the gut bacteria balance to improve the removal of uremic toxins in the bowel in CKD patients.

This is an open label, multicenter, rollover extension study to provide KT-301 to subjects who were previously enrolled into and completed the placebo-controlled study, US-APR2020-01. Subjects will roll over to the long-term extension study at the last visit of the US-APR-2020-01 study. All subjects who completed the US-APR2020-01 study will be eligible to enroll in this study.

The purpose of this open-label study is to evaluate the long-term safety and efficacy of the live biotherapeutic product, KT-301, in the management of patients with CKD Stage IV.

Eligibility Criteria:
Inclusion Criteria:

* Completion of US-APR2020-01 study
* Adults between the ages of 18-80 years

Exclusion Criteria:

* Did not participate in the placebo-controlled study US-APR2020-01
* Withdrew from US-APR2020-01 study prior to completing the 6 months treatment for any reason
* Unwilling or unable to visit the site for the follow-up visits
Model 4965 Post-Approval Study

Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).

As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.

Eligibility Criteria:
Inclusion Criteria:

* Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB

AND one of the following (A, B, or C) must also apply:

A. Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.

B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:

* product is market-released
* complete implant and follow-up data, including product-related adverse events, are available
* subject or appropriate legal guardian authorizes release of subject study data to SLS C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead.

Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.

Exclusion Criteria:

* Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
* Subjects who are, or will be inaccessible for follow-up at a SLS center
* Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
* Subjects with exclusion criteria required by local law (EMEA only)
Personalized CRT - MPP Post Approval Study

The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).

Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities receiving appropriate license or regulatory approval during the conduct of the PAS were included and contributed to the PAS objectives upon commercial release. CRT is an established pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized biventricular (BiV) pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced event, both ventricles are stimulated to synchronize their contraction. The MPP feature is designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either before or after the LV paces, with the order determined by the programmed Ventricular Pacing Configuration.

The MPP PAS was a global, prospective, observational multi-center study. Patients implanted with an eligible CRT Quad system were enrolled and followed in the Product Surveillance Registry per the expected standard of care practices of their care provider.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible CRT device
* Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Early Mobilization With and Without Chest Physiotherapy in Chronic Bronchitis Patients.

It will be a randomized control trial study in which data are collected from hospital. A sample of 26 patients will divided into two group. One group of 13 patients will receive early mobilization and other group of 13 patients will receive early mobilization and chest physiotherapy only. All subject will receive 30 minute two session per day till two weeks. Outcome will be measured with MRC dyspnea scale and Pulmonary function test with spirometry to measure FEV1 and FEV1/FVC and quality of life will be checked by using ST. GEORGE'S respiratory questionnaire. Data will be analyzed by using SPSS version 21.

It will be a randomized control trial study in which data are collected from Jinnah hospital Lahore. A sample of 26 patients will be included and divided into two group. One group of 13 patients will receive early mobilization with chest physiotherapy and other group of 13 patients will receive early mobilization only. All subject will receive 30 minute two session per day till two weeks. Outcome will be measured with MRC dyspnea scale and Pulmonary function test with spirometry to measure FEV1 and FEV1/FVC and quality of life will be checked by using ST. GEORGE'S respiratory questionnaire. Data will be analyzed by using SPSS version 21.

Eligibility Criteria:
Inclusion Criteria:

* Both gender of age 45-70 years
* Patient diagnosed with chronic bronchitis (admitted patients)
* Taking bronchodilators

Exclusion Criteria:

* • Patient having any other condition cardiovascular, diabetes mellitus and neurological conditions

  * Patient history of radiotherapy
  * Unconscious ICU patients
  * Patient received any pre-admitted Physiotherapy protocol
Systematic Lymph Node Sampling and Analysis in Patients With Pancreatic Cancer

Prospective investigation of the ratio between malignant and total number of lymph nodes in predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A national Danish project.

Lymph nodes will be sampled from the following stations in patients with adenocarcinomas of the pancreas Group 6: Infrapyloric lymph nodes (IP) Group 8: Lymph nodes around the common hepatic artery (CHA) Group 12: Lymph nodes of the hepatoduodenal ligament (HDL) Group 13: Posterior pancreaticoduodenal lymph nodes Group 14: Lymph nodes around the superior mesenteric artery (SMA) Group 17: Anterior pancreaticoduodenal lymph nodes

Eligibility Criteria:
Inclusion Criteria:

Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla)

Exclusion Criteria:

Patients with non-adenocarcinoma tumors of the pancreas or periampullary region
Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.

Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent causes of chronic liver disease worldwide. The current strategy proposed by the EASL/EASO/EASD European guidelines for the screening of nonalcoholic fatty liver disease (NAFLD) in high-risk population such as type 2 diabetes and patients with obesity leads to an over-referral in hepatology clinics. The proposed study will investigate the optimal strategy for the screening of NAFLD-related advanced fibrosis in patients at high risk of fibrotic NAFLD, such as patients with T2DM or obesity by maximizing the positive predictive value (PPV) using non-invasive blood and elastography-based biomarkers in endocrinology/diabetology clinics in order to reduce the over-referral to hepatology clinics.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 40 and 80 years old,
* Patients with diagnosis of T2DM\* or obesity (defined according to World Health Organization as a BMI≥ 30 kg/m2)
* Patient with hepatic steatosis determined by conventional abdominal ultrasound as defined by the EASL/EASO/EASD European guidelines.
* Patient who agrees to be included in the study and who signs the informed consent form,
* Patient affiliated to a healthcare insurance plan.

Exclusion Criteria:

* Evidence of other causes of chronic liver disease:
* History of ingestion of medications known to produce steatosis in the previous 6 months.
* Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
* Presence of regular and/or excessive use of alcohol (defined as \>30g/day for males and \>15g/day for females) for a period longer than 2 years at any times in the last 10 years
* The subject is a pregnant or nursing female
* Life expectancy less than 5 years
* History of known HIV infection
* History of type 1 diabete
* BMI ≥ 40 kg/m2
* Mentally unbalanced patients, under supervision or guardianship,
* Patient deprived of liberty,
* Patient who does not understand French/ is unable to give consent,
* Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study.
A Weight Management Intervention for Overweight Chinese Cancer Survivors

This study aims to conduct a feasibility trial to examine the feasibility and acceptability of conducting a randomized controlled trial that evaluates the effect of the weight management intervention on anthropometric measures (body weight and BMI), dietary quality, physical activity levels, physical and psychosocial functioning, self- efficacy for weight loss and quality of life.

The primary aim of the proposed study is to assess the feasibility and acceptability of conducting a randomized controlled trial (RCT) that evaluates an adaptive weight management intervention, tailored to Chinese cancer survivors with overweight/obesity after the completion of cancer survivorship care, to improve anthropometric measures (body weight and BMI), dietary quality, physical activity levels, physical and psychosocial functioning, self-efficacy for weight loss and quality of life. According to the Consolidation Standards of Reporting Trials (CONSORT) guidelines for reporting feasibility trials, hypothesis setting for a feasibility trial is not recommended, given that pilot trials are often underpowered to detect difference which instead should be the aim of the main trial.

Eligibility Criteria:
Inclusion Criteria:

* Chinese cancer survivors attending the one-off face-to-face survivorship care clinic
* who are Cantonese- or Mandarin- speaking
* aged 18 or above
* diagnosed with early-stage disease (stage 0-II)
* have completed primary and adjuvant treatments such as chemotherapy and radiotherapy
* and with a BMI ≥ 23 kg/m2, as indicative as overweight or obesity using Asia-Pacific BMI cutoffs at 3-months reassessment

Exclusion Criteria:

* Non-Chinese survivors with advanced or metastatic disease
* who have communication difficulties, mobility impairment or cognitive disabilities
A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers

The study is being conducted to evaluate safety, tolerability and preliminary efficacy of SHR-A1811 for Injection in combination with Fluzoparib Capsule for HER2-expressing advanced solid tumors of patients. To explore the reasonable dosage of dosage regimen of combination therapy for HER2-expressing advanced malignant tumors of patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥18 years at the time of signing the ICF.
2. At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors.
3. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
4. Life expectancy ≥12 weeks.
5. Adequate organ functions as defined.
6. Swallow the drug pills normally.

Exclusion Criteria:

1. patients with active meningeal metastasis, or brain metastasis without surgical treatment or radiotherapy.
2. Cancerous ascites and pleural effusion with clinical symptoms, which need puncture and drainage.
3. Prior malignancy (other than current malignant tumor) within 5 years before the first dose of study treatment.
4. History of autoimmune diseases.
5. Not well controllable and serve cardiovascular disease.
6. Prior lung disease with clinical significance.
7. Occurrence of ≥ grade 2 of bleeding event within 4 weeks before the first dose, or currently receiving the anticoagulation.
8. Active Hepatitis B and Hepatitis C; or serve infection with medication control.
9. The grade of toxicity from the prior anti-cancer therapy not decrease to ≤ 1.
10. Occurrence of intestinal obstruction and gastrointestinal perforation within 3 months before the first dose.
The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique

Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.

This is a multicenter, double-blined, randomized controled clinical trial. 98 patients from 2 clinical center will be recruited with primary knee osteoarthritis, undergoing a primary TKA. The patients will be randomly divided into two groups , the measured resection group and the gap balance group.And the gap balance technique in this study will be achieved with a ligament tensor used during TKA. Femoral component rotation will be assessed from the preoperative and postoperative CT scans.

Eligibility Criteria:
Inclusion Criteria:

* Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications

Exclusion Criteria:

* There are surgical contraindications Varus or valgus alignment exceeds 20 degrees
Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients

This is a study to look at the effectiveness, tolerability, and safety of one dose of rasagiline in advanced Parkinson's disease (PD) patients who have been treated with Levodopa/Carbidopa therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol.
* Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0.
* Patients must be willing and able to give informed consent.

Exclusion Criteria:

* Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133.
* Premature discontinuation from study TVP 1012/133 for any reason.
* A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).