cyrilzakka/clinical-trials huggingface dataset:
Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B

This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.

A total of 116 HBeAg-positive patients were recruited from 12 hospitals in China, and randomized to two groups. The combination group (n= 57) received PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 24 weeks. The control group (n = 59) received placebo and adefovir. Both groups received adefovir continuously for additional 24 weeks. The primary endpoint was the loss of HBeAg at 48 weeks. The secondary endpoints included 1) loss of hepatitis B virus ( HBV) DNA, 2) HBeAg seroconversion and 3) alanine aminotransferase (ALT) normalization etc. at week 4, 12, 24, 36 and 48. The number of CD4＋and CD8＋T cells was also determined during 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B for more than 6 months
* ALT \> 2 × Upper Limit Normal (ULN)
* Serum bilirubin \< 2 × ULN.
* Positive HBeAg and HBV-DNA between 1.00E＋05 IU/ml and 9.99E＋09 IU/ml.
* Informed Consent Form (ICF) signed.

Exclusion Criteria:

* Hepatitis A,C,D,E or HIV infection.
* Autoimmune hepatitis.
* Hepatic cirrhosis.
* Serum creatinine \> 1.5 × ULN or Ccr \< 50 ml/min, Haemoglobin \< 110g/L (male) or \< 100g/L (female), Platelet\< 80 E＋09/L, Serum albumin ≤ 32g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte \< 1.0 E＋09/L, Prothrombin time\>ULN＋3 seconds, Cholinesterase\<2500U/L.
* Hepatitic carcinoma or Alpha Fetal Protein (AFP) \> 100ng/ml
* Patients with other severe diseases combined, which could affect the therapy.
* Patients accepted other clinical trial within 6 months before the first administrated.
* Patients accepted immunomodulating or anti-viral treatment within 6 months before the trial.
* Patients with autoimmune disease.
* Thymosin allergy.
* Pregnant or breast feeding.
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer

Prostate cancer is the second most common cancer in men. Those in the intermediate/high-risk categories typically receive androgen deprivation therapy (ADT) and radiotherapy. ADT greatly reduces androgen production as prostate cancer is dependent on testosterone and dihydrotestosterone for its growth.The side effects of ADT therapy are extensive and include changes in body composition (muscle loss, bone loss and fat gain), strength, mood, physical function, sexual function and increased cardiovascular risk and fatigue. Many of these side effects can be influenced by exercise training, both resistance training and aerobic training. However, the most appropriate exercise regime for men undergoing ADT has received little research attention.

Although many interventions for prostate survivors emphasise resistance exercise to maintain muscle mass and strength. Arguments could equally be made for programmes emphasising aerobic exercise for fatigue, anxiety, cardiovascular risk reduction and indeed overall survival.

Comparisons of programmes that emphasise each exercise mode are clearly required.

Therefore the overall purpose of this feasibility and pilot randomised control trial is to determine the feasibility and preliminary effectiveness of an aerobic emphasised exercise program (AE) verses a resistance emphasise exercise program (RE) in a rehabilitation setting, over 6 months, for prostate cancer men undergoing Androgen Deprivation Therapy (ADT).

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age with a histologically diagnosed prostate cancer
* Prescribed ADT (Androgen deprivation Therapy)
* Self-reported not to be partaking in regular exercise (structured aerobic or resistance training ≥ 2 sessions/week) in the past 3 months.
* Medically cleared to exercise by their oncologist

Exclusion Criteria:

* Prior exposure to ADT \>12 months
* Prior hypogonadism
* Established metastatic bone disease
* Established Osteoporosis
* Musculoskeletal/Cardiovascular and/or Neurological disease that could put them at risk from exercise as judged by the attending physician.
Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a 10-day or 14-day course of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.

After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.

According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65.
* Patients with H.pylori infection (Positive for any of the following: H.pylori culture, histopathology test, rapid urease test, 13C/14C-urea breath test, stool H.pylori antigen test).
* Patients whose birth place and residence within five years of birth are Shandong Province.
* Patients who have never received H. pylori eradication treatment.

Exclusion Criteria:

* Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 3 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
* Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
* Patients with active gastrointestinal bleeding.
* Patients with a history of upper gastrointestinal surgery.
* Patients allergic to treatment drugs.
* Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
* Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
* Patients whose current residence is not in Shandong Province.
* Patients whose re-check 13C/14C-urea breath test is negative before the start of the test.
* Patients who are unwilling or incapable to provide informed consents.
Lung Volume Reduction Coils for Emphysema in Alpha-1 Antitrypsin Deficiency

The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating improvement in lung function, exercise capacity, and quality of life relative to their baseline status.


Eligibility Criteria:
Inclusion Criteria:

1. Patient \> 18 years of age, diagnosed with AATD emphysema
2. CT scan indicates bilateral heterogeneous or non-severe homogeneous emphysema, with sufficient lung parenchyma for coil deployment, in accordance with manufacturer recommendations (see section 5.2.4.1).
3. Patient has post- bronchodilator FEV1 less than or equal to 45% predicted
4. Total Lung Capacity \> 100%
5. Residual Volume (RV) \>175% predicted
6. Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
7. Patient has read, understood and signed the Informed Consent form
8. Patient is willing and able to attend all required follow-up visits
9. Patient is willing and able to undergo bilateral LVRC treatment
10. Patient has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy

Exclusion Criteria:

1. Patient has a change in FEV1 \> 20% post-bronchodilator.
2. Patients DLCO \< 20% predicted
3. Patient has a history of recurrent clinically significant respiratory infection
4. Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure \>50mmHg and or evidenced by echocardiogram
5. Patient has an inability to walk \>140 meters (150 yards) in 6 minutes
6. Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc.
7. Patient is pregnant or lactating
8. Patient has an inability to tolerate bronchoscopy under moderate sedation or anesthesia
9. Patient has clinically significant bronchiectasis
10. Patient has giant bullae \> 1/3 lung volume
11. Patient has had previous LVR surgery, lung transplant or lobectomy
12. Patient has been involved in other pulmonary drug or device studies with 30 days prior to this study
13. Patient is taking \> 20mg prednisone (or similar steroid) daily
14. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or coumadin) or has not been weaned off prior to procedure
15. Patient has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
16. Patient has severe homogeneous emphysema by CT scan.
Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.

This trial is a double-blinded cross-over design comparing donepezil with placebo in 40 subjects with idiopathic Parkinson's disease who report frequent falls or near falls (\>2/week). The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.

Eligibility Criteria:
Inclusion Criteria:

* Age over 21
* Diagnosis of Parkinson's disease
* Treated with dopaminergic medication for at least 1 year

Exclusion Criteria:

* Must be ambulatory (can use walker or cane)
* No obvious remediable cause of falls
* Falls are on basis of non-CNS etiologies (cardiogenic, orthopedic, peripheral neuropathy, etc)
* Dementia present (MMSE \< 25)
* Not taking cholinergic or anticholinergic medications 10 days prior to screening visit
* No Warfarin use
A Long Term Effect of Collaborative Care on Depression Treatment in a Community Dwelling Elderly

Suicide is a significant cause of death in Korea. According to the report compiled by the Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in the United Kingdom, and 19.1 in Japan (Organisation for Economic Co-operation and Development, 2008). Especially, suicide rate is incredibly higher in elderly. Most persons who commit suicide have a diagnosed psychiatric disorder. Among them, 60% had Depression when they committed suicide. Therefore, this study aimed the impact of a care management intervention on depression treatment and reducing suicidal ideation in elderly patients with depression.


Eligibility Criteria:
Inclusion Criteria:

* 60 and older
* current major or minor depression

Exclusion Criteria:

* severe cognitive dysfunction
* severe auditory dysfunction
* history of psychosis
Carotene and Retinol Efficacy Trial

The Carotene and Retinol Efficacy Trial (CARET) was a randomized, double-blind, placebo-controlled trial of the cancer prevention efficacy and safety of a daily combination of 30 mg of beta-carotene and 25,000 IU of retinyl palmitate in 18,314 persons at high risk for lung cancer. CARET began in 1985, and the intervention was halted in January 1996, 21 months ahead of schedule, with the twin conclusions for definitive evidence of no benefit and substantial evidence of a harmful effect of the intervention on both lung cancer incidence and total mortality. CARET continued to follow and collect endpoints on their participants through 2005. During the active intervention phase of CARET, serum, plasma, whole blood, and lung tissue specimens were collected on participants. These biospecimens make up the CARET Biorepository.

The CARET Biorepository is a valuable resource for population-based studies of the major human cancers. During CARET's twenty years of follow-up (1985-2005), we have received reports of 1,445 participants with lung cancer, 901 with prostate cancer, 433 with breast cancer, 334 with bladder cancer, 332 with colon cancer, and 1,429 with other cancers. CARET is one of the few trials that has prospectively collected serum, plasma, whole blood, blood spots (for DNA), and lung cancer tumor specimens, as well as smoking history and serial food frequency questionnaires (in some individuals for up to 12 years) in populations at high risk for lung cancer. This wealth of information in over 18,000 individuals makes the CARET Biorepository a special resource for cancer researchers.


Eligibility Criteria:
Inclusion Criteria:

* Asbestos-exposed men who were:

  * current smokers or quit within 15 years prior to enrollment
  * had first exposure to asbestos on the job at least 15 years prior to enrollment
  * had chest X-ray positive for changes compatible with asbestos exposure according to ILO criteria; or had been employed in a protocol-defined high-risk trade for at least 5 years, at least 10 years prior to enrollment.
* Heavy Smokers, men and women:

  * cigarette smoking history of 20+ pack-years
  * either current smokers or had quit within previous 6 years

Exclusion Criteria:

* Pre-menopausal women
* History or cirrhosis or hepatitis within 12 months prior to enrollment
* Taking \> 5500 IU daily vitamin A supplement
* Taking any beta-carotene supplement
* History of cancer within 5 years prior to enrollment
* SGOT \> than 2.5X upper limit of normal, or alkaline phosphatase \> 1.5X upper limit of normal
* taking less than 50% of study vitamins during the enrollment period between the First and Second Visits.
Effect of Liraglutide on the Beta-cell Responsiveness in Subjects With Type 2 Diabetes Compared to a Healthy Control Group

This trial is conducted in the United States of America (USA). The aim of this trial is to assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months
* Body Mass Index (BMI): 24-35 kg/m\^2 inclusive

Exclusion Criteria:

* SUBJECTS WITH TYPE 2 DIABETES
* Receipt of any investigational drug within three months prior to this trial
* Recurrent severe hypoglycemia as judged by the investigator
* Cardiac disease
* Use of any drug (except an OAD (oral anti-diabetic drug)) that in the investigator's opinion could interfere with the blood glucose level
* Haemoglobin maximum 10 g/L
* HbA1c above 12%
* Loss of more than 400 mL blood during the 3 months prior to trial start
* HEALTHY SUBJECTS
* Receipt of any investigational drug within 3 months prior to this trial
* Clinically relevant cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
* Use of any drug that in the investigator's opinion could interfere with the blood glucose level
* Haemoglobin max. 10 g/L
* HbA1c at least 6%
Analysis and Valuation of the Expertise of Use of the Close Friends of People Victims of Traumatic Brain Injury

Post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the close friends of people victims of traumatic brain injury.

Collection of the expertise of use of the close friends of people victims of traumatic brain injury. The objective of the work is to collect, to describe, to analyze the corpus of knowledge of the close friends and to transcribe it in two registers, theoretical and practical..

Eligibility Criteria:
Inclusion Criteria:

* Victim of a grave or moderate traumatic brain injury.
* Living at home or in institution
* Seen in consultation in the UH of Angers in neurology and/or in the center of rehabilitation specialized the Capuins and/or followed by Arch Anjou and/or sent by the associations of families.
* 18 - 65 years at the time of the inclusion
* Moderate or grave traumatic brain injury, defined by the score of initial Glasgow 13 and/or a hospitalization of at least 48 hours in intensive care.
* Existence of at least a referent Close friend(relation) : parent(relative), child, spouse, professionnal or other.
* Obtaining of the informed consent of the cranial traumatized, the close friend and the guardian if necessary.

Exclusion Criteria:

* Lack of consent to participate in the study
Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia

Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Eligibility Criteria:
Inclusion Criteria:

* Male or female in good general health
* Must have presbyopia

Exclusion Criteria:

* History of allergic reaction to the study drug or any of its components
* Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results
Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention

The objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent to the everolimus-eluting family stents (durable polymer everolimus-eluting Xience or Promus stents) in a population-based setting with coronary artery stenosis treated with percutaneous coronary intervention


Eligibility Criteria:
Inclusion Criteria:

* All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents

Exclusion Criteria:

* Age \< 18 years
* Not able to consent to study participating (eg. intubated patients)
* Unstable circuit or in cardiogenic shock and therefore not able to understand the information and purpose of the study
* Do not speak Danish
* Already included in the SORT OUT XII study
* Life expectancy \<1 year
* Allergic to study related treatment
Open-label Extension for Phase 3 Clinical Trials of Simufilam

The goal of this open-label extension study is to assess long-term safety and tolerability of simufilam 100 mg in subjects who have completed the RETHINK-ALZ or REFOCUS-ALZ Phase 3 clinical trials.

This is a multi-national, multi-center, fixed-dose, 52-week, open-label extension study. After completing participation in either RETHINK-ALZ (PTI-125-06) or REFOCUS-ALZ (PTI-125-07), subjects will have the option to participate in this study. After the subject provides consent and the Investigator confirms the subject satisfies both inclusion and exclusion criteria, the study drug will be administered at the research site on Study Day 1 and subsequent visits will be scheduled.

We anticipate up to 1600 subjects may enroll in this study. Approximately up to 150 clinical sites in the USA, Canada, South Korea, and Australia will have the option to participate in this collaborative research effort.

For subjects electing to participate, the clinical and laboratory assessments from the Week 76 (REFOCUS-ALZ) or Week 52 (RETHINK-ALZ) End-of-Treatment visit will serve as Baseline Visit assessments for the open-label study on Study Day 1. All subjects will return in 4 weeks and every 12 weeks thereafter for safety assessments. At all post-baseline visits, subjects will report any adverse events since their last visit. In addition to adverse event monitoring, safety will be evaluated at every visit by vital signs, brief examinations, clinical laboratory tests (biochemistry, hematology, and urinalysis) and the Columbia Suicide Severity Rating Scale (C-SSRS). Study drug use since the last visit will be assessed and a new bottle of study drug will be dispensed.

The emerging subject safety assessments will be monitored throughout the study by an independent Data Safety Monitoring Board (DSMB).

Eligibility Criteria:
Inclusion Criterion:

* Completed RETHINK-ALZ (PTI-125-07) or REFOCUS-ALZ (PTI-125-06).
* Clinical presentation continues to be consistent with Alzheimer's disease.
* Availability of a study partner.

Exclusion Criteria:

* Residence in a skilled nursing facility requiring 24-hour care.
* Evidence of a neurologic condition other than AD that significantly contributes to the subject's dementia.
* Current clinically significant psychiatric diagnosis other than AD.
* Unstable, clinically significant medical condition other than AD.
* Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study.
Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients

Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.

The study aimed to evaluate and compare patency rate and complications of standard arteriovenous grafts (SAVGs) and immediate-access arteriovenous grafts (IAAVGs) in end stage renal disease (ESRD) patients for one year after the intervention. Patients were randomly divided into two groups: SAVGs group and IAAVGs group. Patients with ESRD with no chance for native AVF were examined clinically and by duplex ultrasonography preoperatively. Follow up was for one year. Primary end points were the success rate, complications rate (hematoma, pseudo-aneurysm, graft site infection, systemic bacteremia), time of first cannulation. Secondary end points were primary and secondary patency within one year.

Eligibility Criteria:
Inclusion Criteria:

* Adult hemodialysis patients

Exclusion Criteria:

* Significant cardiorespiratory comorbidities.
* Peripheral vascular disease.
* Pregnancy or lactation.
* Severe bleeding disorders.