cyrilzakka/clinical-trials huggingface dataset:
Marrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot Study

Osteogenesis imperfecta (OI) is a genetic disease for which there is currently no known cure. OI causes the osteoblasts (bone-forming cells in the body) to grow poorly, which slows the growth of children with the disease and causes their bones to bend and break easily. Some forms of osteogenesis imperfecta may cause severe disability and even death. In previous research studies performed at St. Jude, it was found that children treated with bone marrow transplant (infusion of healthy immature blood-forming cells) began to grow faster, had more minerals (material that helps make the bones strong) in their bones, and broke their bones less often than before the bone marrow transplant. Several months after the bone marrow transplant however, body growth once again began to slow down. In this research study, children with osteogenesis imperfecta will receive another infusion of bone marrow cells but without any chemotherapy. The marrow cells will come from the same bone marrow donor as their previous bone marrow transplant. It is hoped that by removing the CD3+ cells (a type of white blood cells that attack other cells that are not like themselves) from the donated bone marrow, the subject's body will be infused quite safely and that body growth and bone strength will increase. The CD3+ cells will be removed from the donor bone marrow by use of a machine called the CliniMACS System. This machine has not been approved for use in the United States by the Food and Drug Administration (FDA). The use of this device is considered experimental.


Eligibility Criteria:
Inclusion Criteria:

* Must have been previously enrolled on TOIT protocol at St. Jude Children's Research Hospital
* Must have original bone marrow donor available and willing to participate as a donor
* Normal liver function
* Hemoglobin \>10gm/dl
Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

Programmed ingestion of turmeric has no adverse effects and reduces plasma level of hs-CRP, IL-6 and TNF-α accompanying with increases albumin levels in hemodialysis patients. Turmeric can be considered as an effective anti-inflammatory supplement in hemodialysis patients.

Hemodialysis patients over 18 years were recruited after fulfilling the inclusion criteria.Seventy-one hemodialysis patients were randomized into two groups: the trial group (n =35 ) and the controls (n =36 ); a randomization numeric table was used for allocation sequence . Trial group received turmeric and control group received placebo for 12 weeks. Biochemical determinations included levels of serum albumin (Alb), potassium (K) ,blood urea nitrogen (BUN), serum creatinine (Cr), IL-6 level, TNF- α , and liver function tests and hs-CRP at the start and end of the study were measured.

Eligibility Criteria:
Inclusion Criteria:• Males or females undergoing maintenance hemodyalisis,

* Age ≥18 year
* Clinically stable and receiving adequate hemodialysis defined by a single pool Kt/V≥1.20 or no less than 3 dialysis sessions per week with a total dialysis time ≥12 hour per week for at least 3 month before enrollment,
* Diabetic patients must be willing to commence insulin therapy if deemed necessary for plasma glucose control.

Exclusion Criteria:

* Active malignant disease (defined as less than 5 year since receiving a diagnosis of being malignancy-free)

  * Critical illness as defined by the need for respiratory or circulatory support (in an intensive care unit)
  * Active vasculitis
  * Severe congestive heart failure (New York Heart Association class IV)
  * Severe chronic systemic infectious or inflammatory disease
  * Liver disease (defined as serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of normal)
  * Known or suspected allergy to trial product(s) or related products
  * Treatment with immunosuppressive agents or receipt of any investigational drug within one month preceding screening
  * Recent or current use of anti-inflammatory corticosteroids agents
  * A scheduled renal transplantation within the trial period
Impact of Pharmacist Post-discharge Phone Calls on Hospital Readmission and Patient Medication Literacy and Adherence

A significant portion of avoidable healthcare expenditures has been attributed to preventable hospital readmissions; thus, reducing hospital readmission rates has become a national healthcare agenda item. Despite much study of this topic, efforts to date have not been especially fruitful in either predicting which patients will require hospital readmission. Preventing readmissions has been even more difficult.

We recently examined a pharmacist intervention that assessed patients' medication literacy and adherence at hospital admission. In this retrospective data, low medication adherence levels were predictive of hospital readmission. There was a non-significant trend between low medication literacy and increased hospital readmissions.

We have now decided to prospectively study this intervention. Prospective study will allow for several improvements on our prior work.

1. We have consulted the literature to more carefully examine existing instruments to measure medication adherence and literacy. Based on this review, and based on our prior results, we have made adjustments to these instruments which should improve reliability, validity, and granularity.
2. In our retrospective work, our intervention of pharmacist counseling was not randomized. Although there were large differences in readmission rates between the patients selected to receive counseling and those who were not thought to require it, there may have been unmeasured confounding variables. Randomizing this intervention will greatly enhance the likelihood that we are comparing two similar groups of patients.


Eligibility Criteria:
Inclusion Criteria:

≥10 chronic prescription medications On anticoagulants Diagnosis of CHF, AMI On narrow therapeutic index drugs E.g. valproic acid, phenytoin, lithium, digoxin History of transplant AND not admitted by transplant team

Exclusion Criteria:

Trauma patients Pediatric patients History of transplant and admitted to the transplant team Patients admitted from or discharged to a SNF or hospice Non-English speaking patients
Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease

The purpose of this study is to examine the effect of mitochondria derived oxidative stress on vascular function in patients with moderate to severe Chronic Kidney Disease.

Chronic Kidney Disease (CKD) patients are at increased risk of cardiovascular disease. Endothelial dysfunction, characterized by a reduced bioavailability in nitric oxide, is an independent predictor of cardiovascular disease in CKD. Increased oxidative stress is a potential cause of endothelial dysfunction in this patient cohort. This study investigates the role that mitochondrial derived oxidative stress plays in CKD related vascular dysfunction. In a controlled, double blinded trial, Stage 3-5 CKD patients will be randomly assigned to receive a 4 week daily dose of a mitochondria targeted antioxidant (MitoQ) or a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Stage 3 - 5 Chronic Kidney Disease

Exclusion Criteria:

* History of cardiovascular disease;
* Current pregnancy;
* Uncontrolled hypertension;
* Uncontrolled hyperlipidemia;
* Current hormone replacement therapy;
* Current use of tobacco products;
* Elevated liver enzymes;
* Current autoimmune disease;
* Daily use of of antioxidants \>300mg
Gaining Optimism After Weight Loss Surgery (GOALS) I

This study examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery.

This study will test a positive psychology-motivational interviewing (PP-MI) intervention for physical activity promotion in patients who have had bariatric surgery within the past 6-12 months. The investigators will enroll 12 participants. Study participation includes attending three study visits (two at baseline, one after the intervention) and receiving a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a Fitbit activity tracker. Primary outcomes are feasibility and acceptability of the intervention and study procedures. Secondary outcomes include pre-post changes in physical activity and other psychological, behavioral, and physiological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18+)
* History of bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two academic medical centers within the past 6-12 months
* Interest in increasing physical activity
* Low physical activity, defined as \<200 minutes/week self-reported moderate- to-vigorous physical activity
* Access to telephone for study sessions
* Able to read and speak English

Exclusion Criteria:

* Cognitive deficits precluding participation or informed consent
* Illness likely to lead to death in the next 6 months
* Inability to be physically active (e.g., severe arthritis)
* Participation in another program targeting physical activity besides their standard offerings at the surgery center.
Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable and efficacious.

The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.

Eligibility Criteria:
Inclusion Criteria:

* Gestation up to 63 days
* General good health
* Willingness to provide contact information for follow-up
* Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination

Exclusion Criteria:

* Ectopic pregnancy
* Intrauterine device (IUD) in place
A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

The primary objective of this study is to evaluate the PK of AMG 510 alone and in combination with either famotidine or omeprazole in healthy participants under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Effects of Vitamin D Supplementation on Muscle Function Among Grave's Disease Patients

Introduction:

A deficit in vitamin D may be involved in the development and presentation of Graves' disease (GD). Lack of vitamin D and GD are linked to deteriorating quality of life (QoL) and weakening of the muscles. Our goal was to look at the possible advantages of vitamin D supplementation for the improvement of thyroid-related QoL and muscle function in GD patients, as well as the possible drawbacks of anti-thyroid drugs (ATD).

Methodology:

A multicenter randomized controlled experiment with single-blinding was carried out with 48 patients who had been diagnosed with Graves' illness. The participants were split into two groups n=24 patients in each group. In addition to standard ATD, Group A received either 70 μg (2800 IU) of vitamin D daily or a corresponding placebo. Investigator measured muscular function and isometric strength at baseline, three, and nine months.


Eligibility Criteria:
Inclusion Criteria:

* Grave's Disease
* either starting or about to start anti-thyroid medication (ATD)

Exclusion Criteria:

* Chronic granulomatous disease
* hypercalcemia
* poor renal function (eGFR \< 45 ml/min)
* the presence of malignant disease
The Effect of Contrast Agent on Endothelial Function in Healthy Men

Contrast medium is essential for diagnosis of many diseases. However, recent studies showed that contrast agents can induce renal injury and is associated with poor long-term clinical outcome, especially in diabetes. To date, no data are available on the relationship between contrast medium and endothelial function. Endothelial dysfunction is known to precede atherosclerosis and is considered a risk marker for future development of cardiovascular disease. Therefore, we hypothesized that contrast agents may induce endothelial dysfunction in healthy men. In addition, we hypothesized that contrast induced endothelial dysfunction via free radicals. Thus, we also test alpha-lipoic acid whether or not protect endothelial dysfunction induced by contrast agents.


Eligibility Criteria:
Inclusion Criteria:

* healthy men
* 20 yr \< = age \< = 30 yr
* 20 \< = body mass index \< = 25

Exclusion Criteria:

* age \< 20 yr or \> 30 yr
* dysfunction for liver, renal, and heart.
* other diseases such as diabetes, hypertension, thyroid disease
Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy

The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Modified Atkins diet is of special importance in resource constraint settings with paucity of trained dieticians. However, there is paucity published data on the use of the modified Atkins diet in refractory epilepsy in young children. This study aims to evaluate the efficacy and tolerability of the modified Atkins diet in refractory epilepsy in young children.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 9 months to 3 years.
2. Seizures persisting at least three per week for \> 1 month despite the appropriate use of at least 2 Anti-epileptic drugs.

Exclusion Criteria:

1. Known or suspected inborn error of metabolism, as evidenced by: Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination And/ or 2 or more of the following biochemical abnormalities High blood ammonia (\>80mmol/L), High arterial lactate (\>2 mmol/L), metabolic acidosis (pH \<7.2), hypoglycaemia (blood sugar \<40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
2. Motivational or psychosocial issues in the family which would preclude compliance
3. Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
4. Severe acute malnutrition.
Dentin Bridge Formation After Indirect Pulp Capping With Bioactive Glass Incorporated in Resin Composite and Its Adhesive in Comparison With Light Cured Calcium Hydroxide

The aim of this study is to evaluate the effect of application of bioactive glass in different protocols on the formation of dentin bridge after indirect pulp capping using resin composite with its adhesive both are containing bioactive glass.


Eligibility Criteria:
Inclusion Criteria:

* Active carious lesion in deep dentin of molars.
* Absence of cavitated lesions at the buccal or lingual surfaces as determined by clinical and radiographic examination.
* Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and abnormal tooth mobility;
* Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure;
* The extension of the carious lesion should be such that complete caries removal would risk pulp exposure, as determined by clinical and radiographic assessment;
* Absence of radiolucencies at the interradicular or periapical regions, or thickening of the periodontal spaces, that would indicate the presence of irreversible pulp pathologies or necrosis;
* Absence of internal or external root resorption.
* Co-operative patients approving the trial.

Exclusion Criteria:

* Patients with systemic medical conditions
* pregnant females
* Teeth with spontaneous pain or sensitivity to percussion.
* Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
* Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty

Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty:

WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis

Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis

Eligibility Criteria:
Inclusion Criteria:

* Age = 55-85 years
* Osteoarthritis of knee joint (degree III or IV)
* Physical status (ASA I or II)
* Body mass index \< 45 kg/m²
* Written informed consent

Exclusion Criteria:

* Age \<55 or \> 85years
* Osteoarthritis knee joint (degree I or II)
* Physical status (ASA III or IV)
* Body mass index ≥ 45 kg/m²
* Unable to provide written consent
* Malignant disease
* Rheumatoid disease
* Infectious disease
* Coagulation disorder
* History of deep vein thrombosis or pulmonary embolism
* Peripheral arterial disease
* Immune deficiency
* Medication (Glucocorticoid, Aspirin, Heparin, Cumardine, Wafarin)
* Neurological dysfunction
* Liver insufficiency
* Coronary heart disease
* Immobility
"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia

To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia


Eligibility Criteria:
Inclusion Criteria:

1. Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or
2. Patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion criteria 1 or 2)
3. Lansky index \> 60%
4. Mild (\<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4).
5. Left ventricular ejection fraction \> 39%
6. To grant informed consent in accordance with the current legal regulations.
7. Presence of a compatible haploidentical donor (father or mother or brother).

Exclusion Criteria:

1. Patients with history of bad therapeutical compliance
2. Patients not valid after psycho-social evaluation
3. Positive HIV serology
Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.

OBJECTIVES: I. Determine the response rate (complete or partial) to rituximab in previously untreated patients with stage III or IV CD20+ B-cell follicular small cleaved cell non-Hodgkin's lymphoma. II. Determine the response rate (complete or partial) to rituximab in patients with relapsed CD20+ Hodgkin's disease. III. Determine the time to progression and time to chemotherapy in these patients after treatment with rituximab.

OUTLINE: Patients are stratified according to disease (follicular small cleaved cell non-Hodgkin's lymphoma vs relapsed Hodgkin's disease). Patients receive rituximab IV over 4-6 hours on day 1 weekly for 4 weeks. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 21-32 patients will be accrued for each arm of this study within 7-10.5 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage IIIA or stage IVA B-cell follicular small cleaved cell non-Hodgkin's lymphoma Tumor cells express CD20 No prior chemotherapy or radiotherapy Stable disease that would otherwise be observed OR Histologically proven relapsed Hodgkin's disease of any stage Tumor cells express CD20 Bidimensionally measurable disease Masses (e.g., enlarged lymph nodes) must be at least 1.5 cm X 1.5 cm by CT, MRI, or x-ray Splenic enlargement considered measurable if spleen palpable at least 3 cm below the left costal margin No CNS lymphoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: No more than 5,000 circulating tumor cells Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception during and for at least 12 months following study HIV negative No other active malignancies

PRIOR CONCURRENT THERAPY: See Disease Characteristics