cyrilzakka/clinical-trials huggingface dataset:
AZD0585 Phase III Long-term Study in Japan

This study is a randomised, double-blind phase III long-term study to evaluate efficacy and safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients with hyperlipidemia accompanied by hypertriglyceridemia .


Eligibility Criteria:
Key Inclusion Criteria:

* Japanese men or women, ≥20 years of age.
* Subjects must meet all of the following criteria;

  1. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL
  2. %TG change between Visit 2 and Visit 3 must be within 30%
  3. %LDL-C change between Visit 2 and Visit 3 must be within 25%

Key Exclusion Criteria:

* Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.
* Known lipoprotein lipase impairment or deficiency, or Apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
* Current or history of pancreatitis.
* Type I diabetes mellitus, use of insulin, or haemoglobin A1c \>10% at Visit 1.
Randomized Clinical Trial of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus Genotype 1 (TNT)

The purpose of the study is to study the combination of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1.

In this open-label, single-center, head-to-head non-inferiority trial, treatment-naive or pegylated interferon treatment-experienced patients with GT1 infection were randomized to receive once-daily SOF 400 mg plus DCV 60 mg or SIM 150 mg for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR Never taken DAAs for HCV Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications No Liver Cirrhosis Liver fibrosis Metavir F3 APRI \> 1,5 FIB4 \> 3,25

Exclusion Criteria:

Infection with HCV other than GT-1 or subjects with mixed infections of any genotype Liver Cirrhosis Evidence of decompensated liver Subjects Infected with HIV-1 Hepatitis B virus (HBV) coinfection Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair Current or known history of cancer Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy Pregnancy or impossibility to use birth control methods by the couple, or breastfeeding Regular use of: erythromycin, clarithromycin, rifampicin, rifabutin, telithromycin, itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole, dexamethasone, cisapride, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), silymarin (Silybum marianum) and some antiarrhythmic drugs such as amiodarone
Comparing Two Techniques of Haemostasis After Cervical Conization

The LEEP conization is commonly used for cervical pathologies treatment. The techniques for hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is no consensus about the best technique and there is not much information that validates the use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after LEEP conization for management of cervical lesions.

A randomized clinical trial was conducted at Gynecology Oncology Department/Barretos Cancer Hospital for patients with indication of LEEP conization. After local IRB approval, patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2). The Monsel's solution was used in all patients. Intraoperative and postoperative outcomes will be evaluated: operative time, intraoperative and postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as well as short-term outcome were recorded and compared using Chi-square test, Fisher exact test and t-test where appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Indication of cervical conization.

Exclusion Criteria:

* We excluded patients who were not treated by our department physicians or if the patient did not return for follow-up.
Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy

Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations (muscle strength deficit, mobility and proprioception), intra-articular and chronic pain.

Design: Case-control study. Objective: To observe the differences between patients with hemophilic ankle arthropathy and their healthy peers, regarding dorsiflexion, dorsiflexion strength, biomechanical analysis of gait and balance, and functionality.

Patients: 10 patients with hemophilic ankle arthropathy and 12 healthy subjects without ankle joint damage.

Measurement instruments and study variables: dorsiflexion (range of motion), dorsiflexion strength (dynamometry), biomechanical analysis of gait and balance (RS SCAN® model platform), and functionality (2 Minute Walk Test).

Expected results: Analyze the main differences and their relationship based on the clinical and independent variables of patients with hemophilia, compared to their healthy peers.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A and B.
* Over 18 years.
* With medical diagnosis of ankle arthropathy.
* With clinical evaluation by Hemophilia Joint Health Score.
* In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
* No previous hemarthrosis of the ankles in the 3 months prior to evaluation.

Exclusion Criteria:

* Patients with inhibitors (antibodies against FVIII or FIX).
* Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests.
* Failure to sign the informed consent document
Tissue Inhibitor of Metalloproteinases 2 Level in Patients Undergoing Cardiac Surgery

Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Identification of relevant biomarkers may lead to early diagnosis and improve patient outcomes and health care costs. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Tissue Inhibitor of Metalloproteinases 2 (TIMP2) is associated with ischemia-reperfusion injury. In this study, relationship between TIMP2 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of TIMP2 for early prediction of CSA-AKI was further evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients (≥18 years old) underwent on-pump cardiac surgery
* admitted to ICU immediately after surgery

Exclusion Criteria:

* Patients younger than 18 years
* with prior AKI
* end-stage kidney disease
* need for chronic hemodialysis
* pregnant patients
* unable to give written consent for participation
Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

This trial is conducted in the United States of America (USA). The study will compare A1C reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to patients receiving exenatide twice daily. Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1C: At least 8%
* Patients that were never treated with insulin before
* Current therapy with metformin and a sulfonylurea.

Exclusion Criteria:

* History of recurrent, severe hypoglycemia
* Hepatic insufficiency: ALT, AST or alkaline phosphatase \> 2.5 times upper limits of laboratory's normal
* Renal insufficiency: serum creatinine \> 1.3 mg/dL (males) or \> 1.2 mg/dL (females)
* Severe gastrointestinal disease, including gastroparesis
Columbia Shoulder Study (CSS)

This prospective study will evaluate the Bigliani/Flatow prosthesis. The aims of this study are to establish the safety, effectiveness, and value of the prosthetic system, and to collect information from expert shoulder surgeons as to features of the implants, instruments, and techniques which may be further improved. In this study, the investigators hypothesize that this prosthetic device will significantly improve long-term patient-based outcomes, functional status and quality of life.

Over the last two decades, total shoulder joint replacement - or arthroplasty - has become a commonly performed procedure for the treatment of painful arthritis of the shoulder, and numerous studies have demonstrated its success. During this time, much has been learned about the efficacy, as well as the complications, of the procedure, and since its introduction in the 1950's, shoulder arthroplasty has undergone an evolution in design. The value of such innovations has not yet been determined and will depend on the results of long term follow-up studies. The purpose of this study is to provide follow-up information and design modification directives.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or over.
* Patient must have signed The Informed Consent and Release of Medical Information forms.
* The patient can be a man, postmenopausal woman, or a woman who is likely to become pregnant but is using adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraception or a combination of a condom and spermicide).
* Patient needs a total shoulder arthroplasty (humeral head and glenoid).
* Patient has a diagnosis of primary osteoarthritis.

Exclusion Criteria:

* Obstacles, which pose an inordinately high surgical risk, in the judgment of the certified surgeon.
* Class IV or higher anesthetic risk.
* Patient has a recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair the compliance with the study protocol.
* Patient has had a shoulder fracture.
* Patient had previous shoulder surgeries with the exception of an arthroscopic debridement procedure.
* The patients has a massive rotator cuff tear (rupture \>3 cm or total cicatrisation) demonstrated at time of the surgery that precludes the total shoulder replacement.
Open Label Study of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in either DMD114117 or DMD114044
* Continued use of glucocorticoids
* Willing and able to comply with all protocol requirements
* Able to give informed consent
* French subjects: Eligible for inclusion only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

* Subject experienced a serious adverse event or who met safety stopping criteria that remains unresolved from DMD114117 or DMD114044, which in opinion of the investigator could have been attributable to study medication and is ongoing,
* Use of anticoagulants, antithrombotics or antiplatelet agents, previous treatment with investigational drugs,except GSK2402968, within 1 month of the first administration of study medication,
* Current or anticipated participation in any investigational clinical studies,
* History of significant medical disorder which may confound the interpretation of either efficacy or safety data e.g. current history of renal or liver disease/impairment, history of inflammatory disease.
The Follow up of Chinese Young Children With Melamine-Related-Calculus

The purpose of this study is to investigate the lesions, clinical features and outcome in young children with melamine-related-calculus.

1. To investigate the outcome of melamine-related-calculus.

   * The change of calculus.
   * The change of obstruction features,including hydronephrosis and ureterectasia.
   * The change of the urinalysis.
2. To investigate the change of renal function in children with melamine-related-calculus during the follow up.

   * Creatinine, urea and uric acid.
   * α and β2 microglobulin.
3. To analysis the factors might be associated with the outcome.

   * The characteristics of patients: age, gender, and so on.
   * The characteristics of calculus: location, size, and so on.

Eligibility Criteria:
Inclusion Criteria:

* children with melamine-related-calculus: with a history of melamine contaminated products
* the parents leave the detailed information for contact and willing to be recalled

Exclusion Criteria:

* children with other congenital renal abnormality
* children with hypercalciuria
* children have abnormality of parathyroid gland
Vegan or Animal Protein Ingestion on the Recovery of Muscle Function Following Exercise

This study will assess the effect of daily post-exercise vegan (pea) and animal (whey) protein ingestion compared to placebo over 7 days of recovery from strenuous exercise. Muscle strength and soreness will be measured daily, and mechanisms underpinning recovery will be investigated in muscle biopsies taken 3, 24 and 48 hours after exercise.

Strenuous exercise can cause muscle soreness and reduced muscle strength. It is widely acknowledged that nutritional supplements derived from animal protein sources, including whey from milk, aids recovery when taken immediately after strenuous exercise. However, the effect of vegan protein supplements are less understood, and how they affect recovery of strength and soreness is not known. This is an important area of research due to the increasing demand for plant-based protein.

Eligibility Criteria:
Inclusion Criteria:

* Recreationally active
* 18-40 years of age

Exclusion Criteria:

* Regular and structured involvement in resistance training
* Inactive participants
* Habitual dietary protein intake \<0.8g/kg bw/day and \>2.0g/kg bw/day
* Use of nutritional supplements
* Any diagnosed metabolic conditions (diabetes), cardiovascular disease or hypertension
* Current musculoskeletal injury
* Use of anti-inflammatory medicines
* Individuals with non -removable metallic implants (including heart pacemaker, cochlea implants, medication pumps, surgical clips, plates or screws) or claustrophobia
* Individuals with an allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation

The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4

The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device programmer will print the voltage sensing of the implanted lead in real-time. The printout will be examined for the presence of far-field sensing artifacts.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with an active implantable CRM device
* Subjects \> 18 years of age
* Subjects who are ambulatory not requiring assistance for ambulation
* Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB

Exclusion Criteria:

* Subjects who are pregnant or lactating or who have been pregnant within the past three months
* Subjects who have tattoos on the back in the electrode patch placement region
* Subjects who have had a past allergic reaction to adhesives
* Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Korean Coronary Overlapping Stenting Registy

The Korean Coronary Overlapping Stenting Registry is a multicenter database which includes percutaneous intervention using drug-eluting stents from cardiovascular centers in eight affiliated hospitals of The Catholic University of Korea

The Korean Coronary Overlapping Stenting Registry is a multi-center, real-world of drug-eluting stent overlap.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Drug-eluting stent overlap

Exclusion Criteria:

* Overlap with previous stent
* Cardiogenic shock
Low Molecular Weight Heparin for Hemodialysis Anticoagulation

Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as anticoagulation during hemodialysis (HD) therapy. In this study the investigators have compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.

In this prospective, randomized, cross-over study the investigators compared the safety, clinical efficacy of Clexane (enoxaparin sodium; Sanofi-Aventis) with unfractionated heparin in 27 chronic HD patients. Group A received Clexane (enoxaparin sodium; Sanofi-Aventis) and were followed up for 3 months and then crossed over to Unfractionated heparin for a further 3-month period. Group B received Unfractionated heparin first and then crossed over to Clexane, each followed up for 3 months. Heparin anticoagulation, clinical clotting and hemorrhage were evaluated by visual inspection after blood draining of the air trap.

Eligibility Criteria:
Inclusion Criteria:

* patients in end stage renal failure requiring maintenance dialysis were recruited into the study

Exclusion Criteria:

* Patients with known bleeding disorders
* Subjects receiving oral or other forms of anticoagulant therapy (e.g. warfarin, aspirin) or drugs that could affect heparin activity (e.g. digitalis, tetracyclines, and antihistamines) were also excluded. Subjects continued their usual medication (including lipid-lowering therapy ) and were treated in the normal manner by their caring physicians during the study.
Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea

To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the diagnostic criteria of Western medicine for IBS-D;
* aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
* voluntarily signed the informed consent;
* local resident who could ensure follow-ups, with basic reading ability.

Exclusion Criteria:

* Patients with IBS-C, -M, and uncertain forms;
* accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
* gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases);
* undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
* with history of abdominal surgery (e.g., cholecystectomy);
* with an allergy history of tested drugs or severe allergy history of food;
* pregnant and lactating female;
* with a history of neurological or psychiatric disorders;
* or participating in other clinical trial.
Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

The purpose of this study is to investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.

Purpose: To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.

Methods: Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium, respectively. General anesthesia was induced 3.5 min later, train of four stimulation was monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of fasciculations, intubating conditions, time and extent to maximal depression of twitch and time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively, serum potassium before the induction, at the time of endotracheal intubation, and 5 min after intubation were recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia
* 20 - 65 years old
* without acid-base imbalance and electrolyte disturbance
* with normal hepatic and renal function

Exclusion Criteria:

* Patients with known hyperkalemia
* Patients with increased intraocular pressure
* Patients with increased intracranial pressure
* Patients with symptoms of gastroesophageal reflux
* Patients with anticipated airway difficulties
* Patients with malignant fever
* Patients with neuromuscular disease
* Patients with burn or crush injuries
* Patients with taking drugs known to alter the action of neuromuscular blockers
* Patients with with a body mass index exceeding 30
Asymptomatic and Pre-symptomatic Transmission of SARS-CoV-2 in a Community Congregant Setting

The overall aim of this study is to measure how transmission of COVID-19 occurs in communities - including the role of super spreaders and/or identifying conditions that may increase transmission risk, with a focus on congregant situations. In order to identify how presence of symptoms and behavior affects the transmissibility of the virus, the investigators will measure SARS-CoV-2 in exhaled breath of asymptomatic and symptomatic persons using polyvinyl alcohol (PVA) test strips embedded in face masks (Face Mask Sampling- "FMS") - an innovative, non-invasive method for detection of SARS-CoV-2 in exhaled air.


Eligibility Criteria:
Inclusion Criteria:

* Individuals age ≥ 18 years of any gender tested positive for SARS-CoV-2 by a molecular reference test (PCR test or antigen test) \[INDEX PATIENTS\]
* Individuals age ≥ 18 years and known to be contacts of the index patients \[CONTACTS\]

Exclusion Criteria:

* \< age 18 years old, unable to wear a face mask due to underlying condition, not able to consent, pregnancy. In addition, signs of severe disease present at time of enrollment (e.g. difficulty breathing, pain when breathing, tightness of chest or developing irregular heart beat).