cyrilzakka/clinical-trials huggingface dataset:
Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

The purpose of this study is evaluate if abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Another kidney biopsy will not be required as part of the study. Candidates must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Candidates can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male and female subjects ages ≥ 6 years
* Subjects resistant to corticosteroids, calcineurin inhibitors (cyclosporine and tacrolimus), sirolimus, mycophenolate mofetil (MMF), mycophenolic acid (MPA), or cyclophosphamide or intolerant to at least 2 of these
* UPCR ≥ 3 at screening
* FSGS or MCD confirmed by renal biopsy
* eGFR ≥ 45 for children and adults
* Concomitant use of angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at stable doses for at least 2 weeks or have intolerance documented in the source documents maintained at the site

Exclusion Criteria:

* Kidney diseases other than FSGS or MCD
* Collapsing FSGS
* Systemic lupus erythematosus
* Diabetes mellitus, both type 1 and type 2
* Clinically significant congestive heart failure
* Post renal transplantation, including relapsing post-transplant FSGS
* Body mass index (BMI): \> 40 in subjects ≥ 18 years of age and ≥ 99% percentile for subjects \< 18 years of age

Other protocol defined inclusion/exclusion criteria may apply
iTBS Effect on M1 Plasticity, Blood Glucose, and Cardiovascular Response

Transcranial magnetic stimulation is a medical device that can alter motor cortical (M1) excitability through the scalp via various protocols. Among these, intermittent theta-burst stimulation (iTBS) is a novel protocol that enhances the M1 excitability for several minutes beyond stimulation. The changes in M1 excitability might in turn be accompanied by other physiological responses in the human body. This study will explore the effect of iTBS protocol on M1 plasticity, heart rate, blood pressure, and blood glucose in healthy young adults in comparison to sham stimulation.


Eligibility Criteria:
Inclusion criteria:

* Healthy young adults (18-35 years old)
* Right-handed
* Fully vaccinated against COVID-19

Exclusion criteria:

* Subjects with contraindications to TMS based on the screening 13-item questionnaire for TMS candidacy
* Smokers
* Obese (BMI ≥ 30)
* Highly active subjects
* Active or previous lab-confirmed COVID-19 with long symptoms
A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.

The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 80 years of age, and gender not limited。
2. Within 48 hours of stroke onset of ischemic stroke (diagnosis standard by the Chinese medical association of the fourth national conference on cerebrovascular disease);
3. The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
4. The degree of nerve function defect score (NIHSS) score 4 to 24 points, body movement component (NIHSS score paragraphs 5 and 6) total score 2 points or higher;
5. Understand and voluntarily signed informed consent.

Exclusion Criteria:

1. Head imaging studies have confirmed that, encephalitis, brain tumor, brain abscess and cause similar symptoms of disease, or confirm with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
2. The serious disturbance of consciousness (Ia NIHSS score 2 points or higher);
3. With hemorrhagic disease or have a bleeding tendency, or have a lower limb venous thrombosis;
4. Serious abnormal liver and kidney function, liver function laboratory indexes of ALT \> 3 ULN, renal laboratory ULN Cr \> 1.5);
5. A history of mental illness or dementia patients;
6. Severe organ or other systemic disease, accompanied by any organ or system of malignant tumor, or ongoing anti-tumor treatment, the estimated lifetime \< 3 months;
7. Significant drug or alcohol abuse;
8. Allergic constitution, as well as to two or more drugs or food allergies;This medicine ingredients allergy or known;
9. Have pregnancy (check blood HCG positive screening tests, namely HCG \> 5 miu/mL), during the test preparation is pregnancy or lactation in women;
10. In the past three months in other clinical trials;
11. Researchers do not determine poor adherence, or any other suitable for patients to participate in this study.
The Evaluation for Prognostic Factors After Catheter Ablation of Atrial Fibrillation: Cohort Study

1. Purpose of the study

1) To explore clinical recurrence associated clinical factors including age, sex, clinical, electrophysiological, anatomical, imaging, and serologic characteristics.

2) To develop simulation model to predict clinical recurrence and the efficacy of catheter ablation 2. Scientific evidence of the study

1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
4. clinical outcome after catheter ablation is affected not only by age, sex and underlying disease, but also by electrophysiologic, imaging, serologic and electroanatomical remodeling of the heart. However, there are few studies concerning these multifactorial variables.

3. Study population


Eligibility Criteria:
Inclusion Criteria:

* patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Exclusion Criteria:

* patients who do not agree with study inclusion
* permanent AF refractory to electrical cardioversion
* AF with valvular disease ≥ grade 2
* patients with left atrial diameter greater than 60mm
* patients with age less than 19
Efficacy of Ultrasound-guided Injection of 5% Dextrose for Meralgia Paresthesia

Meralgia paresthetica (MP) is one of the most common peripheral entrapment neuropathies of the lower limbs. It is characterized by paresthesia, pain, tingling, numbness, hypersensitivity, or other abnormal skin sensations on the anterolateral aspect of the thigh. The condition results from compression of the lateral femoral cutaneous nerve (LFCN) along its course, often occurring as the nerve exits the pelvis.The injection of 5% dextrose (D5W) under ultrasound guidance is a novel treatment method for peripheral nerve entrapment. However, there is limited evidence about the efficacy of this method for patients with MP. The investigators found D5W was more safe and effective than corticosteroids for patients with MP. Thus, this study aimed to evaluate the 6-month efficacy of ultrasound-guided injection of D5W for MP patients.


Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18 and 80 years;
* those diagnosed with MP based on clinical and physical examination, with symptoms persisting for at least 3 months;
* a high-resolution ultrasound revealing LFCN compression as it exited the pelvis.

Exclusion Criteria:

* MP resulting from trauma, surgery or occupying lesions affecting the LFCN;
* pregnancy;
* concurrent presence of rheumatic immune diseases, hypothyroidism, or diabetes mellitus;
* a known history of allergy to lidocaine or corticosteroids;
* L2/3 lumbar radiculopathy;
* patients who had undergone local injection or surgery for MP within 3 months
Treatment of Knee Osteoarthritis: Neuromuscular Electrical Stimulation and Low-level Laser.

* The purpose of this study is to determine the effects of low-level laser therapy in combination with neuromuscular electrical stimulation on neuromuscular (muscular strength and morphology) and functional parameters (pain and functional tests) in elderly with knee osteoarthritis.
* The hypothesis is that the association of low-level laser therapy with neuromuscular electrical stimulation could reduce joint pain associated with the inflammation and consequently potentiates the effects of electrical stimulation on the muscular system.

* Participants was randomized into one of three intervention groups (intervention period = 8 weeks after a 4 weeks control period in all groups).
* Electrical stimulation group (18-32 min of pulsed current, stimulation frequency of 80Hz (Hertz), pulse duration of 200μs and stimulation intensity fixed near to maximal tolerated),
* Laser group (low-level laser therapy dose of 4-6J (Joules) per point, six points at the knee joint)
* Combined group (electrical stimulation and low-level laser therapy).

Eligibility Criteria:
Inclusion Criteria:

* elderly.
* symptomatic knee osteoarthritis.
* radiographic diagnostic of Grade 2 or 3 knee osteoarthritis.

Exclusion Criteria:

* a body mass index higher than 40 Kg/m2.
* a diagnosis of hip, ankle, or toe osteoarthritis.
* the use of crutches for locomotion.
* participation in a strength-training programme or physiotherapy treatment for knee osteoarthritis in the past six months.
* neurological or cognitive disorders.
* rheumatoid arthritis.
* electronic implants.
* previous or upcoming surgery (within three months).
* any cardiorespiratory, neuromuscular, or metabolic disease that could represent an absolute contraindication or a contraindication to the performance of maximum strength tests.
A Study Comparing Sems Placement With and and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

Background and rationale Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered.

Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents. EST may facilitate insertion of self expandable metal stent (SEMS) and also help avert the development of pancreatitis from stent-related occlusion of the pancreatic duct. On the other hand, ES is also independently associated with pancreatitis, bleeding, and perforation.

Latest European guidelines indicate that EST is not necessary for inserting single plastic or metal biliary stents, nevertheless a more recent meta analysis showed that ES may decrease the rate of PEP.

Population and patient selection criteria All the patient referred for endoscopic retrograde cholangiopancreatography (ERCP) due to malignant bile duct obstruction.

Study design and study duration Prospective randomized, multicenter study. 18 months.

Description of study treatment/product/intervention All the patients will be randomly assigned to undergo ERCP with (Group A) or without (Group B) ES before biliary SEMS placement.

All the endoscopic procedures will be performed by experienced endoscopist in the endoscopy suite.

All the procedure will be conducted under deep sedation. SEMS placed will be fully covered.

Objectives To assess the need for EST before SEMS placement in patients with malignant bile duct obstruction.

To evaluate immediate (periprocedural) and delayed (30 days) post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.

Statistical methods, data analysis A sample size analysis to detect superiority at 5% significance level and a power of 80% showed that 500 patients had to be enrolled in each group.

Continuous variables such age will be reported in terms of their mean and range, and t-test will be done to test their main difference.

X square test or Fisher exact test will be carried out for statistical analysis to compare rates of total complications between the two groups and rates of pancreatitis, bleeding, stent migration and perforation.

Wilcoxon Mann-Withney test will be used for comparison of means between 2 continuous variables. A single-tailed P value of less than 0,05 is considered significant.

Study time table Project starting date: 15-7-2015 Project completion of patients accrual: 15-10-2016 Project completion of data collection: 15-11-2016 Project data analysis: 15-2-2017 Project presentation of scientific report: 15-4-2017


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for endoscopic retrograde cholangiopancreatography
* Malignant bile duct obstruction
* Signed written informed consent
* Age \> 18

Exclusion Criteria:

* Inability to provide inform consent
* Pregnancy or lactation
* Suspected perforation of the GI tract
* Anatomical alterations due to previous surgery (Billroth surgery)
* Coagulation alterations
Pethidine Analgesia on Labor Duration

Although opioid analgesics are used to treat labor pain, there are still concerns about their side effects.

The researchers in this study; aimed to evaluate the effect of pethidine on active phase duration of labor, labor pain and maternal-neonatal.

50 mg pethidine will be administered intramuscularly to the cases to be included in the study group. The patients in the control group will be given placebo injections.

Vital signs of all cases included in the study will be checked at 0, 5, 15, 30, 45 and 60 minutes. Pain will also be assessed by Visual Analogue Scale (VAS) before injection and at the 1st and 2nd hour after injection. Delivery times, maternal side effects, neonatal apgar scores and fetal findings will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* nullipar-multiparous patients;
* singleton pregnancies 37- 41 weeks (by the last menstrual period).

Exclusion Criteria:

* maternal respiratory rate \< 8 /min,
* maternal bradycardia (\<60 bpm),
* major fetal congenital anomalies,
* uterine scar presence from previous pregnancies,
* malpresentation,
* antepartum hemorrhage,
* multiple pregnancy,
* labor induction,
* chronic systemic disease,
* rupture fetal membranes,
* epidural analgesia.
Quality of Life and Pain Changes Due to DRG Stimulation for Chronic Pain

ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.

Objectives The primary objective is changes in pelvis and/or lower limb pain following dorsal root ganglion (DRG) stimulation. Pain levels will be determined using a 10-point Visual Analog Scale (VAS) with 10= Extreme Pain and 0= No Pain.

The null hypothesis is there will be no change in the subjects' self-reported pain levels from baseline to 52 weeks post-stimulator implantation. The alternate hypothesis is a significant change in pain levels.

Secondary objectives include changes in physical health, quality of life, and pain-related prescription medication usage. Each subject's overall quality of life will be measured with the National Institute of Health's PROMIS Global Health survey v1.2. Physical activity changes will be assessed using the NIH PROMIS Pain Interference 6a SF v1.0 and Pain Intensity 3a scale v1.0. Finally, patients will be asked the name, dosage, and frequency of use of any pelvic and/or lower limb pain-related prescription medications they are currently using.

Design and Outcomes This is a prospective observational single-arm study to access the primary outcome variable of pelvic and/or lower limb pain Intervention and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre and post-operative pain, physical activity levels, quality of life, and medication use. Subjects will be followed for 12 months following their DRG stimulation implant surgery.

Sample Size and Population This study will last for 4 years starting July 1, 2017. There will be no maximum subject population size. We aim for a minimum population size of 500 in order to give statistical significance with results. Subjects will be stratified by area of chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed orthopedic surgery or procedure by their healthcare provider.
* Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief.
* Willing and able to adhere to the protocol of the study including the survey timeline.
* Between the ages of 18-85 years.

Exclusion Criteria:

* Inability or unwillingness to give written informed consent.
Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma

To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma

Subjects first undergo an 18F-FDG test, followed by 68Ga-NOTA-FAPI04 or 18F-NOTA-FAPI04 test in groups.Investigate the standardized uptake value(SUV) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion, the ratio of the standardized uptake value(SUVR) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion within each time window to that of the normal corresponding tissue.

Eligibility Criteria:
Inclusion Criteria:

* ECOG score 0 or 1
* subjects with lymphoma or suspected tumor subjects who have recently (within 2 months) planned to receive pathological biopsy or tumor surgery
* expected survival ≥12 weeks
* blood routine, liver and kidney function meet the following criteria: blood routine: WBC≥4.0×109L or neutrophils ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L;PT and APTT ULN 1.5 or less;Liver and kidney function: t-bil ≤1.5×ULT(upper limit of normal value), ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT
* at least one measurable target lesion according to RECIST1.1
* women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period
* able to understand and sign the informed consent voluntarily, with good compliance.

Exclusion Criteria:

* severe abnormalities of liver and kidney function;
* women preparing for pregnancy, pregnancy and lactation;
* cannot lie supine for half an hour;
* refuse to join the clinical researcher;
* suffering from claustrophobia or other mental illness;
* conditions that other researchers considered inappropriate for the study.
Effects of Physical Activity on Disease Risk Factors

Obesity is associated with increased risk of heart disease and diabetes (Kim et al., 2010). Appalachian children in Athens County, Ohio, experience higher rates of obesity compared to the national average (20.9% vs. 15.4%), which increases their risk of obesity-related diseases (Montgomery-Reagan, Bianco, Heh, Rettos, \& Huston, 2009). Although physical activity (PA) is known to improve fitness and adiposity (Gutin \& Owens, 2011; Yin et al., 2009), very little is known about the effects of PA on the progression of chronic disease risk factors (biomarkers) for obesity-related diseases in children, such as inflammatory markers, lipids, and glucose/insulin. This lack of knowledge is due to a limited understanding of the number of calories burned during children's free-play PA. This study will assess the impact of a PA program (ACT) of known energy cost on obesity-related disease markers in 2nd-4th grade children compared to a sedentary control group (SED). The study will recruit children from an after-school program in Athens County elementary schools. Baseline and posttest data will include measures of height, weight, body composition, blood pressure, and physical activity levels. Following baseline measures, children will be randomized into either the ACT or SED group for 8 weeks. The ACT group will play recess-type games previously determined to expend ≥100 calories in 30 minutes. The SED group children will play sedentary-type activities during the same time period. It is hypothesized that the ACT group children will demonstrate significant improvements in PA after 8 weeks compared to the SED group children and that these improvements will be related to positive changes in body weight and body composition.


Eligibility Criteria:
Inclusion Criteria:

* Attends participating after school program

Exclusion Criteria:

* cardiorespiratory, metabolic, and neurological disorders and physical impairments that would prevent them from being physically active, and were not taking any medications that would affect metabolism
INCB047986 in Rheumatoid Arthritis

The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis.

This will be a double-blind, placebo-controlled study with 4 parallel treatment groups. Subjects will be screened for up to 28 days before study drug administration to ensure that all eligibility criteria are met. On Day 1, subjects will be randomized to 1 of 4 dose groups of 15 subjects each (INCB047986 4 mg, 8 mg, 12 mg, or placebo QD). Study drug will be self administered on Days 1 through 28. A follow-up telephone call to the subject to assess safety will occur at Day 42. A final safety and efficacy evaluation will be performed at the Day 58 visit.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 75 years, inclusive.
* Body mass index between 18 and 40 kg/m\^2, inclusive.
* Subjects must have a diagnosis of rheumatoid arthritis (RA) of at least 6 months' duration at the time of screening and must satisfy the ACR/European League Against Rheumatism (EULAR) 2010 Classification Criteria (Appendix B).
* Subjects must have active moderate to severe RA as determined by the following:

  * ≥ 6 tender joints (28 joint count),
  * ≥ 4 swollen joints (28 joint count), and
  * CRP level ≥ 6 mg/L.
* Subjects must have a negative tuberculosis (TB) test (QuantiFERON®-TB Gold test or purified protein derivative (PPD)) at screening.

Exclusion Criteria:

* Current or recent history of severe and/or progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
* Current or recent history (\< 30 days before screening and/or \< 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
* Onset of RA before the age of 16 years.
* History of known or currently suspected inflammatory disease other than RA
* Current regimen of prednisone or equivalent with an average daily dose of \> 10 mg or having been treated with a stable daily dose ≤ 10 mg for \< 6 weeks.
* Previous treatment with at Janus kinase (JAK) inhibitor.
* Significant impairment of bone marrow function present at screening
* Receipt of any live vaccine within 2 months before screening or anticipated need for a live vaccine within the 2 months after last dose of study drug.