cyrilzakka/clinical-trials huggingface dataset:
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment

The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.

Gout is caused by high levels of uric acid in the body, and is associated with a broad range of conditions including heart disease, chronic kidney disease and high blood pressure. Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form in the body and settle in joints and other organs.

Approximately 40-60% of patients with hyperuricemia and gout have some degree of renal impairment. Hyperuricemia has long been associated with renal disease, and chronic hyperuricemia as seen in gout can lead to deposition of urate crystals resulting in diminished renal function.

This study will evaluate the effect of febuxostat on the renal function of patients with hyperuricemia and gout and moderate to severe renal impairment.

All participants must have an average sitting blood pressure measurement less than 160 mmHg systolic and less than 95 mmHg diastolic. All participants must meet the American Rheumatism Association (ARA) diagnostic criteria for gout (subjects with tophi were excluded). Participants are expected to return to the site for approximately 10 visits.

Eligibility Criteria:
Inclusion Criteria:

* Must have a serum urate greater than 7 mg/dL and a serum creatinine greater than or equal to 1.5 mg at Day -21
* Must have a history or presence of gout defined as having one or more of the American Rheumatism Association criteria for the diagnosis of gout (the criteria related to tophi have been excluded for the purpose of the study)
* Must have an estimated Glomerular Filtration Rate (eGFR) of 15 or greater, or less than or equal to 50 mL/min, AND a serum creatinine greater than 1.5 mg/dL at Screening Visit Day -21

Exclusion Criteria:

* Has secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ transplant)
* Has tophaceous gout
* Has a history of xanthinuria
* Has received aspirin greater than 325 mg/day within 35 days prior to Day 1/Randomization Visit
* Has known hypersensitivity or allergy to allopurinol or any component in its formulation
* Has known hypersensitivity to febuxostat or colchicine or any components in their formulation
* Has myocardial infarction or stroke within the 90 days prior to the Screening Visit
* Has alanine aminotransferase and/or aspartate aminotransferase values greater than 2.0 times the upper limit of normal
* Has end stage renal disease or is likely to be a candidate for dialysis over the 1 year study period
* Has a serum creatinine less than or equal to 1.5 mg/dL, or an estimated Glomerular Filtration Rate at Day -21 Screening Visit less than 15 mL/min or greater than 50 mL/min as calculated by the central laboratory
* Is required to take excluded medications
Gluteus Medius Latent Trigger Point and Muscle Strength in Healthy Subjects

This study aimed to investigate the relationship between latent MTrPs and gluteus medius muscle strength in a group of healthy adults.

Latent myofascial trigger points (MTrPs) do not cause spontaneous pain; however, they may lead to a limited range of motion and muscle weakness. We hypothesized that latent MTrPs might decrease gluteus medius muscle strength in healthy individuals. Forty-eight healthy men will be included in the study. Trigger point examination for the gluteus medius will be performed bilaterally. Subjects with one or more trigger points on the dominant side and those without any trigger points will be assigned to two groups. Muscle strength for gluteus medius will be assessed with a manual muscle tester using the "break test" technique on both sides. The subjects and the examiners will be blinded. For statistical analysis, the independent sample t-test was used to compare the intergroup differences.

Eligibility Criteria:
Inclusion Criteria:

* Patient age: 18-40 years.
* Absence of musculoskeletal complaints related to the lumbar, sacroiliac, and hip area.
* Absence of bilateral latent MTrP in the gluteus medius muscle.
* Latent trigger point in the gluteus medius muscle on the dominant side with palpation.

Exclusion Criteria:

* A history of medical treatment, physical therapy, injection therapy, or surgical treatment related to the lumbar, sacroiliac, and hip area.
* History of trauma, or malignancy or being pregnant, or if the patient is in the lactation period.
* Bilateral latent MTrP in the gluteus medius muscle.
* Presence of latent MTrP on the non-dominant side.
Immediate Effect of Tai Chi Exercise in Healthy Volunteers

Tai Chi has been widely practiced as a Chinese martial art that focuses on slow sequential movements, providing a smooth, continuous and low intensity activity. It has been promoted to improve balance and strength and to reduce falls in the elderly, especially those 'at risk'. The potential benefits in healthy younger age cohorts and for wider aspects of health have received less attention.

The present study documented prospective changes in balance and vascular responses for a community sample of adults.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 25 years old
* Have given written informed consent
* Have a high school level of education
* Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.
* Have an active interest in exploring and developing their spiritual lives
* Cigarette smokers must agree to abstain from smoking on session days
* Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours
* Agree that for one week before each session, refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators.

Exclusion Criteria:

* Women who are pregnant or nursing
* Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality
* Epilepsy with history of seizures
* Insulin-dependent diabetes
* Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
PD-L1 PET-imaging During CAR T-cell Therapy

This is a single-center, single-arm pilot trial designed to evaluate the expression of PD-L1 in patients with Large B-cell lymphoma (LBCL) and its role in non-responsiveness to chimeric antigen receptor (CAR) T-cell therapy in a non-invasive manner. Moreover, within this trial 89Zr-atezolizumab PET/CT imaging as a tool to distinguish lymphoma activity from a treatment-related inflammatory signal (histiocytic/sarcoid-like reaction) in patients with an end-of-treatment positive FDG PET/CT signal will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed LBCL and associated subtypes, defined by WHO 2016 classification
* Tumor lesion(s) of which a histological biopsy can safely be obtained according to Standard clinical care procedures.
* Measurable disease, as defined by Lugano criteria.
* If has history of central nervous system (CNS) disease, then must have no signs or symptoms of CNS disease, no active disease on magnetic resonance imaging (MRI) and absence of large cell lymphoma in cerebral spinal fluid (CSF) on cytospin preparation and flow cytometry, regardless of the number of white blood cells.
* If has history of cerebral vascular accident (CVA), the CVA event must be 12 months prior to apheresis and any neurological deficits must be stable.
* Signed informed consent.
* Age \>18 at the time of signing informed consent.
* Life expectancy \>12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Ability to comply with the protocol.

Exclusion Criteria:

* Signs or symptoms of active infection within 2 weeks prior to 89Zr-atezolizumab injection, unless treated to resolution.
* Prior CD19-directed CAR T-cell therapy or other bi-specific antibodies targeting CD19 receptor (e.g.blinatumomab).
* History of severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of 89Zr-atezolizumab, or that may affect the interpretation of the results or render the patient at high risk for complications.
A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer

The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with carboplatin and etoposide followed by BMS-833923 alone in subjects with extensive-stage Small Cell Lung Cancer (SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed small cell lung cancer, without prior chemotherapy treatment
* Men and Women at least 18 years old
* Eastern Cooperative Oncology Group (ECOG) status 0-2

Exclusion Criteria:

* Significant cardiovascular disease
* Prior treatment of small cell lung cancer is not permitted, except for palliative radiation to a limited field excluding the chest (e.g. for painful metastasis).
* Symptomatic brain metastases
* Women pregnant or breastfeeding
* Women of childbearing potential (WOCBP) unwilling/unable to use acceptable method to avoid pregnancy
* Uncontrolled medical disorder or active infection
* Concurrent therapy with any other investigational product
Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

To assess the effect of long-term treatment by Genotonorm on linear growth


Eligibility Criteria:
Inclusion Criteria:

* All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
* All patients who have stopped during one year will be included if a signed written informed consent

Exclusion Criteria:

* Endocrine disease, except well substituted hypothyroidism
* Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
Idiopathic Pulmonary Fibrosis: a Case-control Study

To determine risk factors for idiopathic pulmonary fibrosis.

BACKGROUND:

Idiopathic pulmonary fibrosis is a progressive and generally fatal disease that causes fibrosis of the pulmonary interstitium. While many environmental agents cause diseases clinically similar, the etiology of idiopathic pulmonary fibrosis suggests that environmental agents could incite the tissue injury that results in the disease; furthermore, host characteristics could have an important role in determining the magnitude of the host response to the agent initiating injury.

DESIGN NARRATIVE:

In this case control study, cases were ascertained at the multiple collaborating centers and controls were identified by telephone screening. A telephone interview was conducted to collect information needed to test hypotheses concerning cigarette smoking, occupational exposure, indoor exposures, other environmental factors, and host factors. To limit disease misclassification, two pathologists experienced with interstitial diseases of the lung reviewed histopathological material from all cases to exclude entities other than interstitial lung fibrosis and to fully characterize the cases clinically. The mortality of this large series of cases was also described.

Eligibility Criteria:
No eligibility criteria
Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

The purpose of this study is to evaluate the effectiveness of reducing HIV transmission among sero-discordant couples by applying comprehensive intervention components.

A cluster-randomized controlled trial was carried out in forty counties from 16 cities. The strategy of Social Marketing was applied to influence sero-discordant couples' behavioral changes including safer sexual intercourses, regular HIV testing for the negative partners, antiretroviral therapy initiation.

Eligibility Criteria:
Inclusion Criteria:

* Couples are required to have a stable relationship and live together in the last 3 months;
* Older than 18 years and younger than 60 years; without regard to CD4 count;
* Open cohort(any newly diagnosed serodiscordant couples who are eligible for treatment will be included during the study period).

Exclusion Criteria:

* Couples are not have a stable relationship or do not live together in the last 3 months;
* Younger than 18 years old.
Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease

To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease

Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tACS at the First Affiliated Hospital of Anhui medical university. Patients were randomly allocated to tACS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tACS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and symptom assessments. Each patient would be treated for continuous 14 days by tACS.

Before the tACS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two months after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.

Eligibility Criteria:
Inclusion Criteria:

1. Subject diagnosed with early Alzheimer's disease or related diseases according to NIA-AA criteria.
2. Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia.
3. CDR score ≤ 2.
4. Subject under treatment by IAChE for at least 3 months.
5. psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months.

Exclusion Criteria:

1. CDR \> 2
2. Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
3. History of head injury,stroke,or other neurologic disease.
4. Organic brain defects on T1 or T2 images.
5. History of seizures or unexplained loss of consciousness.
6. Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
7. Family history of medication refractory epilepsy.
8. History of substance abuse within the last 6 months.
Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation

The purpose of this study is to evaluate factor levels of the pro coagulant factors II, VII, IX, X, and the anticoagulant factors protein C and S in healthy volunteers during the intake of elevated levels of vitamin K in order to investigate whether there is any evidence that high dose vitamin K intake increases plasma coagulation factor activity.

1. Recruit 8 male healthy individuals with no prior history of arterial or venous thrombosis (2 each from each of the following age ranges: 20-34, 35-49, 50-64, \>65).
2. Visit 1: Measure baseline activity levels of Factor II, Factor VII, Factor IX, Factor X, and levels of D-Dimer, TAT complexes, protein C and S activities. Also measure thrombin generation potential. Collaboration with a research laboratory will be sought to also determine factor VIIa levels.
3. Visit 2: Measure activity of Factor II, Factor VII, Factor IX, Factor X, levels of D-Dimer, TAT complexes, protein C and S activities and thrombin generation potential at the end of the 2 week period.
4. Have each individual consume 20 mg of Vitamin K2 orally per day for two weeks.
5. Visit 3: Measure Factor II, Factor VII, Factor IX, Factor X, D-Dimer, TAT complexes, protein C and S activities and thrombin generation potential at the end of the 2 week period.
6. Total length of study is 4 weeks.
7. Analyze the data sets for changes in levels / activities due to Vitamin K supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male

Exclusion Criteria:

* prior history of arterial or venous thrombosis
Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis

Lumbar spinal stenosis is a common degenerative disease in the elderly. Patients are often accompanied by paresthesias and decreased musculoskeletal system functions, resulting in disability and increasing the burden of medical care. The balance and walking ability of such patients are affected by the compressed nerves, so it is necessary to reorganize the nerve sensory systems to compensate for the disability caused by lumbar stenosis. It is necessary to strengthen the training of sensory integration ability, but it has not been Studies have investigated which treatments or surgery can improve sensory integration in patients with lumbar stenosis. Therefore, this study will develop a clinical tool to objectively evaluate sensory integration, quantify the sensory integration ability of patients with lumbar stenosis and neurological claudication; The influence and mechanism of the balance ability.

Objective 1. To develop a sensory integration assessment tool for patients with lumbar stenosis, in order to explore the distribution ratio of sensory system weights between them and healthy elders of the same age without lumbar stenosis under different balance disturbance stimuli.

Objective 2. To explore the distribution ratio of sensory system weights and long-term tracking of changes in sensory system weights in patients with lumbar stenosis and neurological claudication who received sensory integration training after spinal decompression surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 50 and 79 years old
2. Patients with lumbar stenosis and neurological claudication diagnosed according to MRI
3. Timed sit-stand-walk test greater than 9 seconds
4. Can stand independently for more than 30 seconds

Exclusion Criteria:

1. previous lumbar surgery
2. neurological disorder such as stroke or spinal cord injury
3. metabolic disease such as diabetes mellitus
4. vestibular disease such as Meniere's disease.
Transfusion in Cardiac Valve Surgery

This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups.

Patients are randomly assigned to restrictive-threshold group and liberal-threshold group before cardiac group. Patients are included in this research when their Hct meets 24% during CPB.

Arterial blood gas analysis will be done in 0.5h, 1.5h, 2.5h, 3.5h...after CPB start and 0.5h before CPB finish.

Arterial blood gas analysis will be done every 4h in intensive care unit(ICU) and everyday in general ward.

Restrictive-threshold group: The transfusion threshold is Hemoglobin(Hb) ≤ 6.0g/dL or Hct ≤ 18% during CPB; postoperative Hb ≤ 7.0g/dL or Hct ≤ 21% in ICU or general ward.

Liberal-threshold group: The transfusion threshold is Hb ≤ 8.0g/dL or Hct ≤ 24% during CPB; postoperative Hb ≤ 10.0g/dL or Hct ≤ 30% in ICU or general ward.

If the Hb or Hct fall below the threshold at any time, 2 unit of blood cells is administered as soon as possible. Test Hb or Hct again, if is under the threshold 2 unit blood cells will be given until reach the threshold.

Eligibility Criteria:
Inclusion Criteria:

* All cardiac valve surgical patients undergoing CPB, isolated valve procedures Informed consent obtained

Exclusion Criteria:

* Pregnant or maternal women Age less than 18 years or more than 80 years Undergo coronary artery bypass or large cardiac vessels procedure Emergencies Have been attended other researches Unable to receive blood for religious reasons Drug addict or malignant tumor patient
Systolic Pressure Index in Assessing the Risk of Cardiovascular Events

To investigate whether the presence of a Systolic pressure index (\<0.9 or\> 1.4) is a marker of risk of cardiovascular events after peri-operative high-risk surgery outside the cardiac and vascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* age\> 40 years
* surgery set :
* Visceral surgery: gastrectomy or colectomy, abdomino-perineal amputation, pancreatic surgery, liver surgery, esophageal surgery
* In urological surgery: nephrectomy, total prostatectomy, cystectomy
* In thoracic surgery: pneumonectomy, lobectomy
* In orthopedic surgery: total hip replacement and total knee prosthesis

Exclusion Criteria:

* pathology making it impossible to measure Systolic Pressure Index
* life expectancy less than 6 months
* emergency surgery
Long-acting G-CSF for Febrile Neutropenia

This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular treatment rather than long-acting G-CSF. The primary end is the incidence of FN in every course of chemotherapy. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.


Eligibility Criteria:
Inclusion Criteria:

* Willing to accepted debulking surgeries and adjuvant chemotherapy
* Good performance status
* Aged 18 years or older
* Signed an approved informed consents
* No immunosuppressive disease

Exclusion Criteria:

* Not meeting all of the inclusion criteria