cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis

Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation. The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of UDCA, and has been approved by state food and drug administration in China for treatment of cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded, double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* aged 18-70 years
* increase in alkaline phosphatase for 2 folds or more
* positive anti-mitochondrial antibody (AMA) with presence of antibodies against the pyruvate dehydrogenase complex (AMA-M2)；AMA-negative patients should be diagnosed as PBC with histologic evidence.

Exclusion Criteria:

1. patients who had been treated with UDCA, immunosuppressive medications within 3 months.
2. patients who had evidence of extrahepatic biliary obstruction
3. patients coinfection with HBV or HCV
4. patients with one of the followings: 1) hemoglobin(HB): \<11 g/dl in male, \<10 g/dl in female 2) white blood cell count \<3000/mm3 3) neutrophile granulocyte \<1500/mm3 4) platelet \<50000/mm3; 5) serum albumin \<3.3 g/dl 6) alanine aminotransferase(ALT)≥10×ULN and/or aspartate aminotransferase(ALT)≥10×ULN; 7) ALT≥5×ULN and/or AST≥5×ULN coexisting with immunoglobulin G (IgG) ≥2×ULN; 8) total bilirubin ≥4×ULN; 9) prothrombin time (PT) prolong 3 seconds or more, or PTA ≦60%; 10) creatinine ≥4×ULN.
5. patients with evidence of decompensated liver disease(ascites, gastrointestinal bleeding, hepatic encephalopathy et al.)
6. definitely diagnosed as hepatocellular carcinoma(HCC), probable HCC, AFP\>100ng/ml.Patients with AFP\>2×ULN while \<100ng/ml should re-test 2 weeks later.
7. Body Mass Index \>28 kg/m2
8. drug or alcohol abuse.
9. patient with severe disease of heart, lung, kidney, alimentary canal, neural system, autoimmune disease or tumor
10. patient had or on the scheduled of organ transplantation;
11. patient for whom the follow-up is considered impossible
12. pregnant or nursing woman
Effect of an Educational Intervention on Cardiac Patients' Participation Rate in Cardiac Rehabilitation Programs

The main aim of the study is to determine the effectiveness of an educational intervention designed to increase attendance of coronary artery bypass grafting (CABG) patients at Cardiac Rehabilitation Programs (CRPs) on actual CRP participation rate and; examine patient-related factors (demographic, health, psychosocial, awareness) influencing patients' attendance at CRPs. We hypothesized that the proportion of CABG patients participating in CRPs will increase significantly to 20-30% following the educational intervention employed.

Coronary heart disease (CHD) is a major cause of disability and economic burden in western societies. Ample evidence exists to suggest that participation of these patients in structured Cardiac Rehabilitation Programs (CRPs) is beneficial in terms of improved prognosis and quality of life. Despite inclusion of cardiac rehabilitation (CR) in the Medical Insurance Basket (MIB) as a treatment for patients after an acute myocardial infarction (MI), for those after coronary artery bypass grafting (CABG), and more recently for patients suffering from congestive heart failure, only a small proportion (5%-7.5%) of patients take part in CRPs in Israel. Several factors have been identified as barriers to CRP in Israel, two of which are lack of patients motivation to participate in CRPs stemming, in part, from lack of awareness regarding the importance of CR and its availability and; Lack of motivation of medical staff to refer patients to CR resulting from a unawareness of the importance of CR and its availability across Israel, to name a few. The present study accords with such recommendations, by proposing a simple intervention designed to improve patients' and medical staff's awareness to the importance of CR participation. It is expected that CRP participation will significantly increase to 20-30% following the educational intervention employed.

This intervention will provide the basis for the implementation of an intervention to increase CRP participation in cardiac patients at a national level.

In addition to increasing the proportion of CABG patients attending at CRPs, the study aims to measure the effect of CRP participation on subsequent 1-year health and behavior related outcomes, and 3-year mortality. We expect to find differences in outcome measures between participating patients and those who do not.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Coronary Artery Bypass Grafting with or without valve replacement

Exclusion Criteria:

* Institutionalized patients
* Patients with severe co-morbidities for whom cardiac rehabilitation (CR) is contra-indicated
* Patients who sustained a severe surgical complication preventing them from participating in CR (general stroke with severe disability)
* Patients residing farther than 30 km from a rehabilitation center
Postural Garment Versus Exercises for Women With Cervical Pain

This study aim to compare a new postural garment (Posture Plus Force ®) versus exercises in women with non specific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work related musculoskeletal disorders.

OBJECTIVE: To investigate the effects of a postural garment versus exercises in nurses with non-specific cervical pain.

DESIGN: Randomized cross over clinical trial with a 3 months sequence treatment and a 3 months washout period..

PARTICIPANTS: Nurses and allied health professionals with cervical pain aged 21 to 55 years.

INTERVENTIONS:

Participants are allocated at random to receive interventions in two groups:

* P+ : a postural garment (Posture Plus Force - FGP srl ® - Italy) to be worn from 2 to 4 hours per day, during 90 days.
* Ex: five physiotherapy sessions to learn stretching and strengthening exercises (20 minutes) with instructions to continue at home on a daily basis for 90 days.

The subjects in each group will be cross over after three months of wash out period.

MAIN OUTCOME MEASURES:

The primary outcomes are postural control and pain intensity. Pictures on sagittal and frontal plane as well as measurements of static posturography with a scan (SpinalMouse ®) are conducted at T0 (pre-intervention), T1 immediately after garment fitting for P+ group and after the 5th session for Ex group, T30, T60 and T90 at day 30, day 60 and day 90 of follow-up. Pain is measured by visual analogue scale (VAS) on the same assessment days.

STATISTICAL ANALYSIS:

Statistical analysis is conducted following intention-to-treat principles, and the treatment effects calculated using linear mixed models.

Eligibility Criteria:
Inclusion Criteria:

* Nurses and health allied professionals females with cervical pain
* Voluntarily signed informed consent
* Able to wear the garment and to do exercises and follow up assessments

Exclusion Criteria:

* Pregnancy
* Malignancy or other severe disease
* Cervical pain with significant extremity symptoms and/or neurological dysfunction (cervical radiculopathy and cervical spondylotic myelopathy)
* Unable to perform exercises
* Unwilling to do follow up assessments
* Psychiatric disorders
Influence of Kinesiology Taping Application on Severity of Signs and Symptoms in Breast Engorgement.

The aim of the research is to asses the efficacy of kinesiology taping application in breast engorgement in early postpartum stage.

Kinesiology application will be performed by women's health physiotherapist. Patient's perceived improvement and milk outflow following application will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* cesarian section or vaginal delivery
* delivery between 37 and 41 gestational week
* signs and symptoms of breast engorgement (significant increase of breast between 2nd and 10th day postpartum, pain, obstructed milk outflow)
* VAS 4 and more
* volume of milk outflow less than 20ml
* 6 point self-rated engorgement scale between 3 and 6

Exclusion Criteria:

* age less than 18 and more than 45
* patients after extensive surgical breast intervention or having breast implants
* allergy to kinesiology taping
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

This is a randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.

Prevention of colorectal cancer is a major health care issue because of the high incidence of this cancer. So far, pharmaceutical chemoprevention has not gained widespread acceptance due to side effects of the chemopreventive agents used. Nutraceuticals such as polyphenols from tea plants have demonstrated remarkable therapeutic and preventive effects in molecular, epidemiological and clinical trials. However, controlled trials demonstrating the efficacy of nutraceuticals fo the prevention of colorectal cancer are largely missing.

The investigators present this randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.

Patients who underwent polypectomy for colonic polyps will be randomized after a one month verum run-in period to receive either 150mg EGCG two times daily or placebo over the course of three years. The beneficial safety profile of decaffeinated green tea extract, the quantifiable and known active content EGCG, and the accumulating evidence on its cancer preventive potential require in our view a validation of this compound for the "nutriprevention" of colorectal adenoma. Good accessibility and low costs might render this nutraceutical a top candidate for a wider use as food supplement in colon cancer prevention.

Eligibility Criteria:
Inclusion Criteria:

* Between 50-80 years of age
* Histologically confirmed colorectal adenomas or serrated lesions removed during colonoscopy within the last 6 months
* Good performance status (ECOG \< 2) at study entrance
* Written informed consent.

Exclusion Criteria:

* History of hereditary nonpolyposis colorectal cancer (HNPCC) or familial adenomatous polyposis (FAP)
* History of colon or rectal cancer, other concomitant cancers with the exemption of basalioma or curative treated cancers without actual anticancer medication.
* Intestinal malabsorption, short bowel syndrome or surgical bowel interventions leading to malabsorption
* Liver failure (hepatitis, cirrhosis, elevation of liver enzymes ALT, AST or bilirubin to more than 2.5 fold of the reference levels)
* Inflammatory bowel disease
* Regular intake of NSAIDs (also Cox2 inhibitors) for more than 3 months per year except of low-dose aspirin (100 mg per day)
* Immunosuppressive medication
* Impaired capacity to consent or who are impaired in swallowing a pill
* Regular consumption of green tea extract as nutritional supplement (with a content of EGCG of more than 100mg per day) of longer than 6 months during the past two years
* Allergic reactions towards green tea
Assessing the Validity of the PAP Problems Triage Tool in Patients With PAP Treatment for Obstructive Sleep Apnea

The intended use of the Positive Airway Pressure (PAP) Problems Triaging Tool (TT) is to appropriately triage patients with a PAP-associated problem(s) to a specific intervention(s) based on patient responses. Thus, the proposed research will validate the tool, determine optimal scoring thresholds, and explore the utility of the tool as an indicator for intervention. Our central hypothesis is that the PAP Problems TT will identify treatment barriers that if unaddressed, are predictive of treatment non-adherence.

This study is a one-group observational design that uses a TT questionnaire and abstraction of PAP use data from a clinically available interface (Somnoware™). Consecutive adults with OSA and recommended to PAP treatment at the Fontana Medical Sleep Center will be invited to the study. Once the patient has been prescribed PAP therapy and has indicated their willingness to participate the TT will be sent digitally from Somnoware™. Participants will receive the TT in accordance to the next time interval defined by the study protocol. A randomly selected sub-group of participants will automatically receive an animated education video delivered digitally from Somnoware™. These videos will provide targeted information for self-managing the endorsed PAP problem.

Diagnostic polysomnogram (PSG) or home sleep apnea test (HSAT) data will be abstracted from Somnoware™. Daily PAP data will be abstracted from Somnoware™ for the first 35-days of PAP use. Demographic data will also be abstracted at day 35 (from the patient's clinical intake questionnaire and electronic health record).

Eligibility Criteria:
Inclusion Criteria:

* Kaiser Permanente Member (KP insured)
* OSA diagnosis by polysomnogram or Home Sleep Apnea Test with Apnea Hypopnea Index ≥ 15 events/hour
* PAP naïve
* Able to consent to participate
* Fluent or proficient with English
* Accepts PAP for home treatment

Exclusion Criteria:

* Chronic respiratory failure requiring Oxygen supplementation
* PAP device other than a PAP or AutoPAP (i.e., bilevel PAP)
* Pregnant
National Observational Study of Clinical Practices in Deceased Organ Donation

This is a 1-year national prospective cohort study that observes the medical management of consented deceased organ donors at hospitals across Canada with a high volume of deceased donation.

This prospective cohort study enrols consecutive adult deceased organ donors with a waiver of research consent and collects various data related to deceased donor care in the ICU from the time of consent for donation to the time of organ recovery. Clinical data includes donor characteristics, type of donation (after neurological death or cardiocirculatory death), resuscitation methods, cardiopulmonary monitoring techniques, medications, blood work, mechanical ventilation, diagnostic imaging, complications, and methods of death declaration. Various clinical data on deceased donors are collected prospectively from the time of consent for organ donation up to and including the day of organ recovery.

The Canada-DONATE study is designed to develop a national platform for future clinical trials in deceased donor care. The main objectives include:

1. Establish specialized organ donation research teams at participating ICUs.
2. Observe, record, and describe ICU practices in deceased donor care (e.g., donor resuscitation, organ suitability assessments, death declaration) which are likely to vary by site, region and province and will be very important to inform clinical care protocols for future RCTs.
3. Engage and work with ODOs from each province to foster data sharing and develop procedures to enhance efficiency in future RCTs.
4. Investigate the comparative effectiveness of various ICU interventions in deceased donor care to improve the conversion of consented donors to actual donors and to improve the number of transplants per donor.
5. Produce specific knowledge translation tools that will serve in the future as clinical tools to enhance ICU care and research tools to facilitate RCTs.

Eligibility Criteria:
Inclusion Criteria:

* Admitted into a critical care area (ICU, CCU, ER)
* Consent has been obtained for Organ Donation

Exclusion Criteria:

* Admitted into a paediatric critical care area (NICU, PICU)
Early Periprosthetic Joint Infection and Outcome Debridement, Antibiotics and Implant Retention

Introduction Periprosthetic joint infection (PJI) is a severe complication to hip arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant retention (DAIR) is recommended in early PJI in association with stable implants. Few studies have evaluated the outcome of DAIR in this fragile population.The purpose of this study was to analyze risk factors for PJI and the short-term outcome of DAIR in FNF patients treated with a hip arthroplasty.

Methods A consecutive series of patients had been treated with either a total hip arthroplasty or a hemi hip arthroplasty for a displaced FNF at our institution. Data were retrospective analysed.


Eligibility Criteria:
Inclusion Criteria:

* Displaced femoral neck fracture
* Treated with a primary hip arthroplasty
Study of Ataluren (PTC124) in Hemophilia A and B

Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are essential for blood clotting. The lack of FVIII/FIX can produce bleeding episodes that cause damage of the bone, muscles, joints, and tissues. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of the disease in approximately 10-30% of participants with hemophilia and results in severe manifestations. Ataluren (PTC124) is an orally delivered, investigational drug that acts to overcome the effects of the premature stop codon, potentially enabling the production of functional FVIII/FIX. This study is a Phase 2a trial evaluating the safety and efficacy of ataluren in participants with HA or HB due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase FVIII/FIX activity levels.

In this study, participants with hemophilia A or hemophilia B due to a nonsense mutation were treated with an investigational drug called ataluren (PTC124). Evaluation procedures to determine if a participant qualifies for the study was performed within 14 days prior to the start of treatment. Eligible participants who elected to enroll in the study then participated in a 28-day treatment period. Within the 28-day period, ataluren (PTC124) treatment was to be taken for 2 cycles of 14 days each 3 times per day with meals at a dose level of 5, 5, 10 milligrams/kilograms (mg/kg) in the first cycle and a dose level of 20, 20, 40 mg/kg in the second cycle. After the first 14-day cycle, study doses were changed to 10 mg/kg (morning), 10 mg/kg (midday), and 20 mg/kg (evening) and the doses were administered for 1 cycle only. Then, there was an interval of approximately 14 days without treatment. During the study, ataluren (PTC124) efficacy, safety, and pharmacokinetics were evaluated periodically with measurement of FVIII/FIX activity and inhibitor levels, other blood tests, and urinalysis.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Age ≥18 years
* Presence of a nonsense mutation as the sole disease-causing mutation in the FVIII or FIX gene
* At least 20 prior treatments with FVIII or FIX concentrates
* Willingness and ability to comply with scheduled visits, drug administration plan, study restrictions, and study procedures

Exclusion Criteria:

* Known hypersensitivity to any of the ingredients or excipients of the study drug
* Any history of prior anti-FVIII/FIX inhibitors
* Unable or unwilling to forego prophylactic FVIII/FIX concentrate use during the screening and on-study periods (Note: Participants were allowed use of FVIII/FIX concentrates for treatment of bleeding episodes while on study)
Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.

Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients.

Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.


Eligibility Criteria:
Inclusion Criteria:

all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.

Exclusion Criteria:

distorded axes or laxity requiring the establishment of constrained prosthesis
Endovascular Versus Open Repair of the Common Femoral Artery

Even though the indication for endovascular therapy has been enlarged, open repair of common femoral artery is still considered as the treatment of choice. A recent pilot study showed that endovascular repair of the CFA seems to be a safe technique of revascularization with acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in press). TECCO, a French randomized and controlled trial, has been set up to compare open and endovascular procedures for the treatment of CFA atherosclerotic lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 90 years-old
* De novo atheromatous common femoral artery stenosis
* Symptomatic lesions (Rutherford stages 3, 4, 5 and 6)
* Haemodynamically significant lesion
* Written informed consent

Exclusion Criteria:

* Restenosis
* Non-atheromatous lesions (dysplasia, post-traumatic, inflammatory)
* external iliac thrombosis and / or common femoral side to treat
* Contraindication to open surgery or endovascular treatment
* Contraindication to anesthesia
* Indication of aorto-femoral, ilio-femoral, femoral-popliteal or femoro-tibialis bypass to associate with the common femoral revascularization
* Indication of a surgical approach to the external iliac artery through a retroperitoneal
* Asymptomatic lesions
* Life expectancy less than one year
* Refusing patient
* Inability to monitor during the test period
* Participation in another clinical trial
* Pregnant Women
* No written informed consent
The Relationship Between Preoperative Levels of Ionized Magnesium and Risk of Acute Kidney Injury After Cardiac Surgery

Detection the relationship between preoperative ionized magnesium levels and the risk of acute kidney injury after cardiac surgery.

Acute kidney injury (AKI) is a major medical problem that is of particular concern after cardiac surgery. The reported prevalence of cardiac surgery-associated acute kidney injury (CSA-AKI) is up to 30% and is independently associated with an increase of morbidity and mortality .So this study is for measuring preoperative ionized magnesium levels of patients who will undergo cardiac surgeries then measuring postoperative serum creatinine, BUN and urine output to detect if they developed AKI or not and if there is a relationship between the post cardiac surgery AKI and preoperative ionized magnesium levels.

Eligibility Criteria:
Inclusion Criteria:

1. patients more than or equal 18 yrs.
2. patients undergoing cardiac surgery between July 2023 and July 2024

Exclusion Criteria:

1. patients with known Kidney disease.
2. patients less than 18 yrs