cyrilzakka/clinical-trials huggingface dataset:
The Impact of Resistance Training on Type 2 Diabetes Patients.

The purpose of this study is to determine whether the long-term effects of high-intensity progressive resistance training could improve glucose and lipid metabolism in chinese type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* established type 2 diabetes

Exclusion Criteria:

* severe joint cardiovascular and respiratory system disease, uncontrolled hypertension (160/90 mmHg), severe diabetic nephropathy and neuropathy
* with severe liver and kidney dysfunction
* with mental system disease
* pregnant women or nursing mothers
BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy

The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010 (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered 3 times per week for 1 week.

The secondary objectives of this study in this study population are as follows: To explore the duration of the effect of BG00010 in improving pain; To explore the dose response curve on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum exposure to BG00010.

During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.

Eligibility Criteria:
Key Inclusion Criteria:

* Body weight ≤133 kg.
* Leg pain radiating, diagnosed as being due to painful lumbar radiculopathy or lumbosacral radiculopathy, the diagnosis of which occurred within ≥6 months and ≤5 years of the time of randomization.
* Objective, documented evidence of painful lumbar radiculopathy involvement
* Lower back pain
* Leg pain
* Male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.

Key Exclusion Criteria:

* History of or positive test result at screening for human immunodeficiency virus, or for hepatitis C virus antibody, or current Hepatitis B infection.
* Clinically significant diseases or conditions as determined by the investigator.
* Major surgery within 30 days prior to the Screening Visit or that is scheduled to occur during the study.
* Previous participation in a study with neurotrophic factors (e.g., nerve growth factor).
* Participation in a study with another investigational drug or approved therapy for investigational use within 3 months prior to Day 1.
* Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment

NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions

The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

This clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of a tibia nonunion.
2. Male or female between ages of 18 and 75 years old, inclusive

Exclusion Criteria:

1. Subject has open wounds or underlying osteomyelitis.
2. Subject has associated multiple traumas, and/or fractures that are not anatomically reduced or lose reduction at later time points.
3. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
4. Subject has an implanted unipolar pacemaker.
5. Subject has active cancer.
6. Subject has severe peripheral vascular disease (ABI \<0.4)
Evidence for Potassium Restriction in Hemodialysis

EvoKe-HD is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia. Contrary to the traditional recommendations limiting the intake of high-potassium whole foods, such as fruits and vegetables, the investigators propose to switch the focus to foods containing potassium that is readily absorbed by the body (high bioavailability), such as potassium from additives, processed meats, milk, fruit juices and sugary drinks.

Sixty adults receiving hemodialysis treatments with blood potassium levels ≥ 5.2 mmol/L on two occasions or more in the past three months will be randomly assigned to either the novel dietary counselling or the traditional approach. Both groups will meet with the renal dietician again once a month for 20 to 30 minutes, but the content of the recommendations will be different. The intervention and follow-up period will last six months. The investigators will record pre-dialysis potassium, bicarbonate, phosphorus, calcium and parathormone levels, blood pressure, volume status, hospitalizations, medication, and dialysis prescription changes monthly and assess nutritional status and satisfaction with food at the beginning and at the end of the study.

The study will be successful if 30% or more of the eligible patients agree to participate and complete the 6-month assessment.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years or older
* Receiving hemodialysis 3 times/week for ≥ 3 months
* Has at least two pre-dialysis serum potassium levels ≥5.2 mmol/L on any analysis in the past 3 months
* Can speak and understand French or English
* Has not missed more than 1 dialysis session in the previous 3 months.
* Is capable of providing informed consent.

Exclusion Criteria:

* Is not expected to survive beyond 6 months
* Does not control their dietary intake (e.g., residents of high-dependency nursing homes)
* Significant cognitive impairment precluding understanding of the dietary recommendations.
Intervention With Omega Fatty Acids in High-risk Patients

In order to reduce cardiovascular risk, current European guidelines recommend a diet low on saturated fatty acid through replacement with polyunsaturated fatty acids (PUFA). Polyunsaturated fatty acids can be classified into omega-3 and omega-6. However the results from recent meta-analyses investigating coronary risk outcomes did not clearly support a low intake of saturated fatty acids and a high intake of omega-3 or omega-6. The aim of this study is to investigate the short term effects of a high intake of PUFAs on microvascular function, lipids, inflammation and other cardiovascular risk factors in inactive patients with increased waistline.


Eligibility Criteria:
Inclusion Criteria:

* Waist circumference ≥ 94 cm in men and ≥ 80 cm in women
* Physical inactivity (\< 2 h vigorous/active exercise training per week)

Exclusion Criteria:

* Regular use of certain prescription medications at baseline
* Severe psychiatric illness
* Pregnancy
* Pacemaker or implantable cardioverter defibrillator
* Cigarette smoking
* Previous coronary intervention
* Concomitant use of dietary supplements
* Use of omega-3 supplements at baseline
* Alcohol or drug abuse or any condition associated with poor compliance.
* Scheduled hospitalisation during the course of the study.
* Participation in a clinical trial in the last 12 weeks, or prior randomisation.
* Blood donation within the preceding 12 weeks.
* Diabetes Mellitus Type 1 or type 2
* Triglycerides \> 5 mmol/l
* Previous bariatric surgery
* Malabsorption disorder
The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness

Choroidal thickness represents blood-flowing of eyes. The investigators detect the choroidal thickness of the young participant using SD-OCT to see the effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness.

34 young, healthy participants were included in this study; They were randomly divided into two groups by age and gender matched.100 mg Longevinex® capsule was given to the study group and 100mg placebo capsule to the control group. All participants underwent OCT scanning with spectral domain optic coherence tomography (SD-OCT) at baseline and 1 h following Longevinex® or placebo administration. The choroidal thickness was measured manually by the Heidelberg Eye explore software(version 5.3.3.0, Heidelberg Engineering) with a vertical line to the retinal pigment epithelial layer.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 23-28 years of age. nonsmokers.
2. Patients were considered to be healthy on the basis of electrocardiogram (ECG), and clinical laboratory safety tests (haematology, plasma biochemistry, urinalysis and hepatitis B, hepatitis C and HIV serology) performed at screening.
3. Avoid ingesting grapefruit, grapefruit juice or other grapefruit juice containing products, and any herbal-based nutrient supplement or prescribed medications( grapefruit, cranberry, blueberry products, peanuts and peanut butter, grape and grape products, and red wine ) during the same period of time.
4. patients should abstain from alcohol-containing beverages at least two days prior to and during the study.

Exclusion Criteria:

1. Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period and uncontrolled diabetes mellitus
2. Participation in another simultaneous medical investigation or trial Renal failure requiring dialysis or renal transplant or liver dysfunction History of other disease,or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications.
3. IOP over 30 mmHg.
4. Any previous retinal laser photocoagulation to the study eye in treatment naive. Any previous intravitreal injection in study eye (triamcinolone or other) in treatment naive.
5. Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery).
6. Intracapsular cataract extraction (posterior capsule needs to be present).
7. Aphakia or absence of the posterior capsule in the study eye, Structural damage to the center of the macula in the study eye preexisting to CRVO likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s).
Online Spanish Cognitive Intervention Program for Spanish-Speaking Latino/Hispanic Subarachnoid Hemorrhage Patients

The purpose of this research study is to examine the effectiveness of an online Spanish cognitive intervention program in Latino/Hispanic Spanish-speaking subarachnoid hemorrhage patients. In particular, the researchers will examine whether cognitive impairments associated with a subarachnoid hemorrhagic event improve after completing the online cognitive intervention program. Secondary outcomes of the research study include examining whether there is an improvement in research participants' quality of life and psychological functioning as a result of the online Spanish cognitive intervention program.

40 Spanish-speaking research participants who have sustained a subarachnoid hemorrhage in the last 6 months will participate in the current research study. Participants will be randomly assigned to one of two groups: 1) Cognitive intervention group (n = 20) or 2) Control group (n = 20).

Eligibility Criteria:
Inclusion Criteria:

* History of a subarachnoid hemorrhage within the last 6-months. Must be confirmed by medical records and/or neurointerventionist radiologist
* 18 years and older
* Primarily Spanish-Speaking
* Able to read in Spanish
* Able to use a computer

Exclusion Criteria:

* History of neurological conditions (e.g., Alzheimer's disease, epilepsy, traumatic brain injury, brain tumor, encephalitis, meningitis, Parkinson's disease) other than subarachnoid hemorrhage
* History of neurodevelopment disorder (e.g., autism spectrum disorders, attention deficit-hyperactivity disorder)
* History of learning disabilities
* History of psychiatric illness (e.g., depression, anxiety, bipolar disorder, schizophrenia)
* Alcohol or illicit substance abuse or dependence
* Currently on medication(s) that may impact performance on the neuropsychological evaluation or online cognitive intervention program
* Severe expressive aphasia
* Upper extremities or vision problems that prevent participant from adequately using a computer or completing the neuropsychological evaluation
* Unable to commit to participate for the entire study including returning for one-year follow-up neuropsychological evaluation
Impact of Telephone Call on Bowel Preparation Quality in Colonoscopies

Bowel preparation regimens typically incorporate dietary modifications along with oral cathartics. Inadequate bowel preparation can result in failed detection of prevalent neoplastic lesions and has been linked to an increased risk of procedural adverse events. Previous studies have suggested that patient compliance is important to ensure proper bowel cleansing. Patient counseling along with written instructions that are simple and easy to follow and in their native language should be provided to patients.

Thus, interventions that improve the quality of bowel preparation could have a great benefit regarding colonoscopy results. Little in the literature that studies the impact of enhanced patient education on bowel preparation quality.

In this study we aim to determine the impact of patient education using telephone call one day prior to outpatient colonoscopy on bowel preparation quality.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing outpatient colonoscopy

Exclusion Criteria:

* History of previous inadequate bowel preparation
* History of colorectal surgeries
* Patient who did not sign the consent
* Patients with dementia
* Patients with Swallowing difficulties
Safety and Efficacy of BAF312 in Dermatomyositis

This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .

The study was prematurely terminated based on the results of an interim analysis where BAF312 did not demonstrate superior efficacy over placebo and a dose-response relationship was not observed. There were no safety concerns. Approximately 56 participants were planned to be randomized. A total of 17 participants were enrolled and randomized by the time the study was terminated.

Eligibility Criteria:
Key Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.

* Patients who have been defined as "definite" or "probable" based on the criteria of Bohan and Peter (Bohan and Peter 1975) for dermatomyositis at least 3 months before screening
* Patients must have active disease as defined by muscle weakness
* Patients may be on a stable dose of corticosteroid (up/equal to 20 mg once daily prednisone equivalent)
* Patients currently treated with oral or subcutaneous MTX must have been a stable dose of no more/equal to than 25 mg per week
* Patients currently treated with Azathioprine must have been a stable maintenance dose of no more/equal to 3 mg/kg/day
* Negative cancer screening conducted in the 12 months prior to screening visit

Key Exclusion Criteria

* Dermatomyositis patients having overlap myositis or any other type of myositis including paraneoplastic myositis, drug-induced myopathy, necrotizing myositis
* Preexisting severe cardiac or pulmonary conditions, malignancy of any organ system or significant eye diseases.
* Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.
* Pregnant or nursing (lactating) women
Operations Research to Improve Newborn Health

This study is designed to look at how operations are carried out in relation to improving the health and survival of newborn babies in India.

The proposed study aims to evaluate the impact of a basic package of obstetric and neonatal care practices implemented by CARE-India as part of their ten-year, two-phase Integrated Nutrition and Health Program (INHP). Building on the lessons learned from the Integrated Nutrition and Health Project I (INHP I) in seven Indian states during 1996-2001, CARE-India has designed INHP II, which focuses on six technical interventions. CARE-India aims to implement this program in 100,000 villages across eight states of India by the year 2006. One of the technical interventions is a focused package of newborn care to be implemented at the community level to improve the health and survival of the newborns, including improvements in care-seeking for maternal and newborn conditions. The services and behaviors promoted include:

1. antenatal care,
2. iron-folate supplementation,
3. tetanus toxoid vaccination,
4. maternal nutrition and rest,
5. birth planning,
6. essential newborn care,
7. immediate and exclusive breastfeeding,
8. prevention of hypothermia,
9. aseptic cord care, and
10. identification and referral of cases with danger signs for both pregnancy/delivery complications and newborn conditions.

The services are provided by first-line community-based health workers.

CARE-India invited Johns Hopkins Bloomberg School of Public Health (JHBSPH) to help evaluate their newborn program in an operations research mode. JHBSPH's role is limited to assisting CARE with the design and evaluation of newborn intervention.

Eligibility Criteria:
Inclusion Criteria:

* Newborn

Exclusion Criteria:

* Infant/child
Cause and Importance of the Age-dependent Sarcopenia

The goal of this cross-sectional study is to evaluate the difference in cytokine profiling approach and mitochondrial function between geriatric sarcopenic patients (group 1) and geriatric non-sarcopenic patients (group 2) and healthy (group 3) geriatric participants.

Study participants (group 1\&2) are assessed during the hospital stay and age-matched controls (group 3) will be recruited through Flyers.

The investigators aim to isolate and cryopreserve peripheral blood mononuclear cells (PBMCs) from whole blood to perform functional assays on mitochondrial respiratory capacity and ROS. Furthermore, the investigators will investigate the association between biomarkers and frailty, quality of life, functional performance, fatigue and risk of depression.

The investigators hypothesize that this profiling approach will allow the evaluation of the progression of age-dependent sarcopenia and uncover novel therapeutic targets.

Eligibility Criteria:
Inclusion Criteria:

* Age between 60 and 85 years
* Informed written consent
* Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
* Life expectancy of \> 3 months according to treating doctor
* without implanted Defibrillation
* without acute Sepsis
* without neurodegenerative diseases, especially amyotrophic lateral sclerosis (ALS) and Huntington

Exclusion Criteria:

* Age \< 60 years or \> 85 years
* Lack of informed written consent
* Low cognitive status according to Mini-Mental State Examination (MMSE \< 24 points)
* Life expectancy of \< 3 months according to treating doctor
* Implanted Defibrillation
* Acute Sepsis
* neurodegenerative diseases, especially amyotrophic lateral sclerosis (ALS) and Huntington
Serum Parameter Prior and After EUS-guided Fine Needle Aspiration of the Pancreas

Endoscopic ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in clinical routine.

The aim of this study is to determine the levels of serum lipase, serum amylase and the tumor marker CA 19-9 prior and after EUS-FNA. In animal experiments on dogs, an increase of all three parameters was observed after surgery on the pancreas. For humans, these clinically important data are not yet available .

It is assumed that the probability of pancreatitis with increased activity of lipase and amylase will rise with the number of puncture procedures as well as the size of the puncture needle. In addition, the post-interventional assessment of the tumor marker CA 19-9 could result in a false positive assumption of malignant neoplastic pancreatic lesion.


Eligibility Criteria:
Inclusion Criteria:

* independent indication for pancreatic EUS-FNA
* age ≥ 18 years
* patient able to give informed consent

Exclusion Criteria:

* Contraindications for EUS-FNA
* pregnancy
* no informed consent available
* known stenosis of esophagus or duodenum
* relevant coagulation disorders
FDFG Versus SMAS Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome

After parotidectomy, Frey's syndrome and facial disfigurement are the most common encountered complications. Free dermal fat graft (FDFG) and the superficial musculoaponeurotic system (SMAS) flap, have very promising results. In this study, the functional and esthetic outcome from their usage were compared.

Parotidectomy is the standard procedure for treatment of many parotid lesions, however it carries a lot of drawbacks. Facial asymmetry and Frey's syndrome are the most annoying complications to the patients. Insertion of inter-positioning grafts at parotidectomy bed can decrease these complications significantly. Free dermal fat graft (FDFG) and the superficial musculoaponeurotic system (SMAS) flap, have very promising results. In this study the investigators have compared the functional and esthetic outcome from their usage.

Seventy-eight patient underwent parotidectomy for various causes. The patients were divided randomly in 2 groups each group 39 patients. In one group FDFG was inserted at the parotidectomy bed, while in the other group SMAS flap was performed. Preoperative, operative, and postoperative data were recorded and analyzed.

The normality of distribution of variables was verified by Wilks -Shapiro test. The data were expressed as Number (No), percentage (%) mean (x̅) and standard deviation (SD). Chi-square test (χ2) was used to study association between qualitative variables. Whenever any of the expected cells were less than five, Fischer's Exact test was used. Student's t-test is a test of significance used for comparison of quantitative variables between two groups of normally distributed data, while Mann Whitney's test was used for comparison of quantitative variables between two groups of not normally distributed data. Two-sided P value was set to be significant if \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for superficial parotidectomy

Exclusion Criteria:

* Less than 18 years of age
* Proved malignant parotid tumor
Warfarin - How Good Are we at Maintaining Target Range ?

Patients with atrial fibrillation are often anticoagulated with Warfarin. Warfarin has a narrow therapeutic window requiring frequent monitoring. This study aims to investigate the incidence of adverse events in the "real world" for patients receiving Warfarin for lone atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Prescription for Warfarin
* Atrial Fibrillation

Exclusion Criteria:

* Other conditions associated with increased risk of embolisation e.g. rheumatic valve disease, atrial mixoma.
* Conditions with increased risk of bleeding.