cyrilzakka/clinical-trials huggingface dataset:
Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease

Chronic Kidney Disease (CKD) is associated with bone changes and very high fracture rates. A component of bone is marrow. Bone marrow fat is increased in patients with CKD compared to those in the normal population of the same age. It is not clear if there will be changes in the marrow fact content in those with CKD on Pioglitazone. In people with normal kidney function, thiazolidinedione group of drugs have had variable effects on bone marrow fat content, as measured by MRS. This is important as changes in marrow fat are likely related to changes in the bone in patients with chronic kidney disease.

If patients consent to participate in the ancillary study of marrow fat changes with pioglitazone, those that are randomized to placebo or 15 mg pioglitazone for 12 months (per the criteria in the main study) will also undergo magnetic resonance spectroscopy (MRS) of the lumbar spine at L1, L2 and L3. MR spectroscopy of the lumbar spine (if they choose as this is ancillary study) will be performed 3 times over the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* Included subjects will be those who consent to the study of Pioglitazone in ADPKD (Protocol number 1308084213). Therefore inclusion and exclusion criteria are the same as for that study. Subjects will NOT be offered participation in the bone marrow fat study till after they consent for the FDA approved study. Subjects who withdraw from the FDA approved study will be withdrawn from this protocol.

Inclusion/Exclusion Criteria for NCT#02697617

* Male or female ADPKD patients aged 18-55
* eGFR at or above ≥ 50 ml/min/1.73 m2 by 4 parameter MDRD or CKD-Epiformulas
* normal liver enzymes (ALT/AST)
* fasting blood glucose between 70 and120
* for female patients, a willingness to use double contraception to avoid pregnancy while in study
* able to give informed consent
* In the opinion of the investigator, high likelihood of progressive kidney disease

Exclusion Criteria:

* diabetes, defined as any of the following: fasting blood sugar \> 130 times two, HgbA1C \> 7, on any blood sugar lowering medication, or past diagnosis of diabetes not occurring during pregnancy
* uncontrolled hypertension, defined as systolic \> 150, diastolic \> 90 despite an attempt by physician to titrate medications
* history of impaired systolic function (ejection fraction \< 50%) by previous ECHO or known ischemic cardiovascular disease
* findings suggestive of a kidney disease other than ADPKD
* systemic illness requiring immunosuppressive or anti-inflammatory agents
* congenital absence of a kidney or history of a total nephrectomy
* history of cyst reduction or partial nephrectomy
* history of renal cyst aspiration within the previous year
* History of bladder cancer, or gross hematuria
* inability to undergo MRI due to implantable devices or foreign objects that preclude MRI
* active renal transplant
* allergy or sensitivity to any of the components of the test materials
* institutionalized
* currently pregnant or plans to become pregnant during the study
Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications

Retinol-binding protein 4 (RBP4) may affects obesity development and the development of obesity-related diseases including insulin resistance, type 2 diabetes, steatohepatitis and cardiovascular disease. This study aims to examine the involvement of RBP4 in patients with diagnosed diabetes, diabetic cardiovascular disease, pre-diabetes (pre-DM) and healthy controls during the progression of T2DM, and to evaluate the ability of RBP4 to predict cases of diabetes with an elevated risk of cardiovascular complications . Along with animal experiment.

A total of 500 Chinese patients admitted to the First Affliated Hospital of Xi'an Jiaotong University (Xi'an, China) between March 2020 and March 2022 were recruited to investigate the RBP4 profles. Peripheral blood samples are drawn at the initial medical examination, in the morning after a fast of at least 8 h, and immediately stored at -80˚C until the sphingolipid measurements were performed.

Blood pressure, WC, hip circumference (HC), body weight and body height were measured by a trained physician. The participants enrolled in the study provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

T2DM:

* Fasting plasma glucose (FPG)≥7.0 mmol/l;
* 2 h plasma glucose (2hPG) ≥11.1 mmol/l;
* glycated hemoglobin (HbA1c) level ≥6.5%;
* random plasma glucose ≥11.1 mmol/l plus symptoms of hyperglycemia;
* T2DM diagnosed previously.

Pre-DM was defned as follows:

* FPG ≥5.6-6.9 mmol/l
* 2hPG 7.8-11.0 mmol/l
* HbA1c 5.7-6.4%.

Exclusion Criteria:

* type 1 diabetes
* liver or kidney disorders.
Irreversible Electroporation(IRE) For Unresectable Renal Tumors

The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.

By enrolling patients with renal tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for renal tumors .

Eligibility Criteria:
Inclusion Criteria:

* unresectable kidney tumors
* patients refused surgical therapy
* Karnofsky-index \>70%
* Age ≥ 18 and ≤ 80 years
* life expectancy ≥ 12 month
* compliance of the patient taking part in a study
* informed consent

Exclusion Criteria:

* violation against one or more inclusion criteria
* an estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73 m2
* QT-interval \>550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
* active infection or severe health interference, that make taking part in a study unfeasible
* pregnancy, lactation period
* general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
* psychiatric disorders that make taking part in a study or giving informed consent unfeasible
* haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
* thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time \>50
* untreated urinary retention
* severe hepatic dysfunction
* any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
* taking part in another clinical study for renal tumor.
Laboratory Study of Cancer & Immune Cells in Ascites Fluid of Ovarian Cancer Patients to Test Alternative Therapies

Ascites samples from women undergoing surgery for ovarian cancer will be collected for use in translational research.

The purpose of this study is to collect ascites fluid obtained from ovarian cancer patients during cytoreductive surgery or paracentesis at the University of New Mexico Hospital or Cancer Center. Cancer cells and immune cells from the ascites fluid will be used to test novel immunotherapies for ovarian cancer treatment and to establish patient derived xenograft models to perform preclinical testing on a cancer cell population that better models the heterogeneity in patient disease

Eligibility Criteria:
Inclusion Criteria:

* All female participants, regardless of ethnicity, who are undergoing cytoreductive surgery for ovarian cancer are eligible for this study
* All participants will be eighteen years old or older
* Patients must be suspected of having a pathological diagnosis or clinical suspicion of ovarian cancer and be scheduled for surgery for tumor resection.
* Ability to understand and the willingness to sign a written informed consent document.
* Pathologic confirmation of a diagnosis of epithelial adenocarcinoma of the ovary, fallopian tube, or primary peritoneal cancer (serous, mucinous, clear cell, endometrioid, undifferentiated, mixed, transitional cell)
* Women of childbearing potential must have a negative qualitative serum pregnancy test ≤ 2 weeks prior to study entry.
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  * Has not undergone a hysterectomy or bilateral oophorectomy; or
  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

* We do not intend to include participants if they are unable to provide informed consent for this study themselves (e.g. mentally ill patients who require health care proxies to consent for any medical intervention), or vulnerable populations such as prisoners.
* Minors under age eighteen.
* Pregnant women.
* Final pathologic diagnosis that does not confirm invasive epithelial ovarian, tubal, or primary peritoneal cancer
Changes in Tissue Oxygenation Following Regional Anesthesia

Adequate tissue oxygenation is required for effective white blood cell function and bactericidal activity. Decreased tissue oxygenation is a risk factor for perioperative wound infections. Regional anesthetic techniques result in a functional sympathetic block and may increase tissue oxygenation. The purpose of this study is to evaluate changes in tissue oxygenation using a non-invasive Near-infrared spectroscopy (NIRS) device. The current study will evaluate changes in tissue oxygenation following regional anesthetic techniques (peripheral nerve blockade and neuraxial techniques such as caudal block) in pediatric patients).

Regional anesthesia will induce a sympathetic blockade and improve tissue oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a surgical procedure who have consented to a regional block.

Exclusion Criteria:

* None
Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in Asia, South America and the United States of America (USA).

The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 6 months
* Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
* Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
* HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
* Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2

Exclusion Criteria:

* Any contraindication to insulin detemir or insulin glargine according to the local labelling
* Receipt of any investigational product within 4 weeks
* Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
* Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction

The main objective is to compare a fibrinolytic strategy with an interventional strategy initiated as early as possible, preferably in the pre-hospital phase, with respect to resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7 days after inclusion.

Patients in the fibrinolytic group received an intravenous injection of 30 mg enoxaparin followed by subcutaneous injections of 1 mg/kg body weight every 12 hours during hospital stay.

Patients in the invasive group were given an intravenous injection of enoxaparin of (0.75 mg/kg body weight) and abciximab as a intravenous bolus (0.25 mg/kg body weight) followed by a 12 hour infusion (10 microg/minute).

Secondary outcome measures were death, myocardial infarction and stroke alone or as a composite at 30 days.

Data on use of health care resources, loss of production and health-related quality of life were collected during one year. Cost-effectiveness was determined by comparing costs and quality-adjusted survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting within 6 h after onset of chest pain lasting for more than 30 min and with significant ST-segment elevation on ECG.

Exclusion Criteria:

* BP \>180/110
* Known bleeding disorder
* Cardiogenic shock
* CPR\>10 min
* Ongoing anticoagulant therapy
* Renal insufficiency
* Weight \>120 kg
MRI Findings in Throwing Shoulders of Waterpolo Players

MRI examination of 60 shoulders of waterpolo players (30 throwing shoulders as well as the opposite side) and 15 healthy probands as control group (30 shoulders of non waterpolo players. The correlation of MRI alteration and clinical symptomatic findings in both groups will be investigated. The clinical examination is performed by 2 board certified orthopedic surgeons and based on the Constant Murley Score.


Eligibility Criteria:
Inclusion Criteria:

* Study shoulders of elite waterpolo players
* Study shoulders of healthy non throwing persons
* Age between 18-35 years
* Male
* Given informed consent

Exclusion Criteria:

* Previous shoulder surgery
* Goal keeper
* Metallic implants
* Pacemaker
* Tattoos with metallic colors
Ruxolitinib and Chidamide for Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma

The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.

Haploidenticl Peripheral blood Stem Cell Transplantation should be offered to eligible patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma whenever feasible. To further improve the outcome of transplantation patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma, we developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. In this study, we tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma undergoing allogeneic peripheral blood stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. high risk Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma with the indications for allogeneic transplantation;
2. Have haploidentical donors
3. All patients should aged 12 to 65 years;
4. Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal;
5. Renal function: creatinine ≤the upper limit of normal;
6. Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
8. Have signed informed consent.

Exclusion Criteria:

1. pregnant women;
2. Patients with mental illness or other states unable to comply with the protocol;
Alcohol Metabolism and Disease Risk in Asians

The primary pathway of alcohol metabolism involves two main enzymes, alcohol and aldehyde dehydrogenase. Several genes that encode these enzymes have variants that alter the rate of alcohol metabolism and increase levels of acetaldehyde. The variant ALDH2\*2 allele is associated with the flushing response (i.e., Asian glow) and is found almost exclusively in individuals of east Asian descent. Although having variant ALDH2 alleles is protective against heavy drinking and alcohol use disorders, for those who do drink, these variants also are associated with elevations in risk for several health problems. The premise of this study is that we can affect early drinking behavior through personalized communication about these health-related risks.


Eligibility Criteria:
Inclusion Criteria:

* All participants will be of Asian heritage (i.e. Chinese/Taiwanese, Japanese, Korean, Vietnamese).
* About half of the sample will be incoming first-year undergraduates
* About half of the sample will be current undergraduates who self-report having flushed when they first started drinking alcohol
Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI

Around 80% of people with spinal cord injury (SCI) develop chronic neuropathic pain (CNP). This is a debilitating condition with major negative impacts on people's quality of life. Many treatment options have been offered (invasive stimulation, drugs) but provide limited effects and many secondary effects. There is a critical need to develop a new generation of therapies. Transcranial magnetic stimulation (TMS) is a non-invasive and painless brain stimulation technique that allows researchers to explore and change brain excitability that has shown promising effects in neuropathic pain. However there is not enough evidence of what are the long lasting effects of the different protocols. In this study, 30 SCI subjects with CNP in their hands will participate in the study. The objective is to evaluate the efficacy of real versus sham repetitive transcranial magnetic stimulation (rTMS) and investigate 1) short and long term effects on pain and 2) the behavioral and neurophysiological qualities of responders and non-responders to this treatment.This will be a randomized sham controlled trial with two groups: real or sham high frequency repetitive TMS protocol (20Hz). The protocol will be done daily for two weeks. Clinical, functional and neurophysiological evaluations will be assessed at baseline, post intervention and at 6-week follow up.


Eligibility Criteria:
Inclusion criteria:

* presence of chronic neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord.
* cervical lesion.
* CNP in the upper extremity.
* pain intensity of at least 4 out of 10 in the numerical rating scale (NRS) in the NPS both screening (baseline) and randomization (pre-evaluation).both screening (baseline) and randomization (pre-evaluation).
* stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial.
* complete or incomplete lesion.

Exclusion criteria:
The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers

The participants are divided into subjects or controls based on the BMI taken during the first trimester of pregnancy upon recruitment. Participants with a BMI of ≥23kg/m2 were recruited as subjects (labelled as obese group) and those with BMI of 18.5-23kg/m2 were recruited as controls. Total gestational weight gain was calculated based on the difference between third trimester weight and first trimester weight. All participants who fulfilled the inclusion and exclusion criteria were recruited after informed consent. Demographic data of all participants were recorded. At first trimester, the participants' weight and height were recorded for calculation of BMI. At every trimester visit, the following were recorded: i) blood pressure using sphygmomanometer after 15 minutes of rest ii) mid-stream urine for presence of proteinuria iii) weight. The participants were followed up until the point of delivery. Occurrence of adverse pregnancy outcome, fetal outcome, and birth weight were documented. The pregnancy outcomes measured in this study included the need of primary caesarian section, the occurrence of pregnancy-induced hypertension (PIH), pre-eclampsia, and gestational age at delivery. The neonatal outcomes measured in this study included neonatal intensive care unit (NICU) admission, stillbirth, preterm delivery, occurrence of macrosomia and low birth weight, and neonatal birth weight.


Eligibility Criteria:
Inclusion Criteria:

* First trimester of pregnancy
* Aged 18 years or older
* Able to come for follow up at least once per trimester

Exclusion Criteria:

* Underlying diabetes mellitus
* Gestational diabetes mellitus diagnosed via OGTT
* Known genetic disorders affecting growth at time of recruitment
* Known congenital anomalies at time of recruitment
* Conceived via artificial insemination
* Hepatitis B/C/HIV infection
Decrease Implantation Site INFECTION (DISINFECTION I): a Randomized Controlled Trial

Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted We investigated recent trends and possible causes of the increasing numbers of Cardiovascular implantable electronic device infections.

There are many studies on the preventive use of Antibiotics or povidone iodine to Cardiovascular implantable electronic device (CIED) infections.

But, studies of prophylactic use of hydrogen peroxide is still limited.

We had planned research on effects of preventive using hydrogen peroxide before cardiac devices insertion.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for cardiac devices Implantation

Exclusion Criteria:

* under the age of 18
* Hydrogen peroxide allergy
* take an antibiotic
* History of infection within 30 days
The Natural History and Treatment of Acute Hepatitis C Virus (HCV) in HIV-positive Individuals

The aim of the study is to investigate the epidemiology, natural history and treatment outcomes of acute hepatitis C (HCV) infection. Given the current pattern of case reporting, the cohort will be largely made up of human immunodeficiency virus (HIV)-positive patients, but HIV-negative patients with acute hepatitis C (AHC) will also be enrolled to enable comparisons to be made as appropriate and possible.

In a multi-center, prospective, open cohort study, patients with documented acute hepatitis C infection will be followed prospectively over an initial time-period of 3 years after diagnosis of acute hepatitis C infection to investigate:

1. epidemiology

   * to describe the characteristics of patients who have acquired acute HCV infection, including examination of regional differences in modes of transmission, behavioural factors, concomitant sexually transmitted diseases, clinical presentation and associated laboratory test results.
   * characterization of the HCV strains circulating within the community using phylogenetic analysis
2. natural history

   * determination of the rate of spontaneous viral clearance, and the clinical, immunological, host genetic and viral factors associated with viral clearance
   * progression of liver disease after acute hepatitis C; including the use of non-invasive liver fibrosis markers to estimate rates of liver fibrosis progression
3. treatment strategies

   * describe the outcome of different treatment strategies for acute HCV infection, although it is acknowledged that there will be no random allocation of treatment strategies.
   * investigate factors associated with treatment response including time to initiation of therapy, duration of therapy, the use of ribavirin and genetic factors.

Eligibility Criteria:
Inclusion Criteria:

* Documented current or past acute hepatitis C infection with detectable HCV-RNA (PCR-assay) with an estimated duration of 52 weeks at diagnosis as defined below:

  * First HCV RNA positive AND
  * Prior negative anti-HCV antibody or HCV RNA test within 12 months OR
  * Rise of liver transaminases above 2.5 x upper limit of normal (ULN) within the past 12 months with prior normal transaminases during the year before AND
  * Exclusion of other causes of acute hepatitis

Exclusion Criteria:

* Acute liver disease other than hepatitis C
* Inability to provide written informed consent
* Younger than 18 years of age