cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis

The purpose of this study is to see if Zemplar, a vitamin D medication, safely and effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.


Eligibility Criteria:
Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism
Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity

To evaluate the possibility that erythropoietin with early iron supplementation may induce retinopathy of prematurity or worsen this disease. In addition risk factors for the development of ROP will be checked.


Eligibility Criteria:
Inclusion Criteria:

* all premature infants with birth weight of 1250 grams or less

Exclusion Criteria:

* none
Assessing Bioavailability of CoQ10 Supplementation in Burn Patients

To test the hypotheses that plasma and intracellular coenzyme Q10 levels will decline after burn injury and that ubiquinol supplementation will increase plasma and intracellular coenzyme Q10 levels in burn patients.

To test the hypothesis that ubiquinol supplementation ameliorates mitochondrial dysfunction/disintegrity and metabolic derangements, and decreases circulating alarmins (a.k.a. endogenous DAMPs) in burn patients as compared with placebo.

Based on previous clinical studies and our preliminary preclinical data, we want to test the hypotheses that plasma and intracellular coenzyme Q10 levels are decreased after burn injury and that coenzyme Q10 (ubiquinol) supplementation reverses or ameliorates insulin resistance, metabolic derangements, mitochondrial dysfunction, and increased circulating DAMPs in burn patients. The aforementioned previous studies and preliminary data warrant a small-scale clinical study to evaluate coenzyme Q10 status, and bioavailability and efficacy of coenzyme Q10 (ubiquinol) supplementation in burn patients. Coenzyme Q10 (ubiquinol) supplementation could represent a novel, safe and low-cost strategy to improve the clinical outcome of burn patients. We are conducting a randomized, double-blind, placebo-controlled intervention study with anticipated enrollment of 50 subjects. Adult burn patients with 5% or greater of total body surface area (TBSA) burn at the Massachusetts General Hospital (MGH) Burn Center will be approached to consider study participation. All enrolled patients will be randomized to receive coenzyme Q10 (ubiquinol) supplementation or placebo. Blood samples will be used for evaluation of coenzyme Q10 concentration, mitochondrial DNA copy number, non-mitochondrial DAMPs (e.g., cell-free total DNA), and defective neutrophil migration.

Eligibility Criteria:
Inclusion Criteria:

* Ages eligible for study: 18 years and older, and below 85 yeas old
* Burn patients with 5% or greater of total body surface area burn
* Nutrition support: routine oral and/or enteral nutrition
* Enrolled within one week after burn injury
* Patient or guardian who is capable of giving full informed consent.
* Anticipated stay in the MGH Burn Unit: 5 days or more

Exclusion Criteria:

* \< 5% TBSA burn
* Patients required full parenteral nutrition without oral or enteral nutrition support.
* Patients with liver disease (bilirubin greater than 3)
* Patients with thyroid disorders (thyroid disease which currently require treatment)
* Patients with malignancy under treatment
* Patients with mental illness who have impaired decision-making capacity (Mental illness defined by the presence of psychotropic medications and/or the diagnosis of psychiatric illness at the time of admission.) Patients with mental illness can be included unless it is determined by the psychiatrist covering the burn unit that they are unable to consent for themselves for other aspects of their care and treatment.)
* Patients with HIV\*
* Pregnancy (as determined by routine admission labs)
Long Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis

There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there are no data available regarding long-term effects of this multimodal program. The aim of this study is to investigate the long-term impact of a rehabilitation program 3 month after finishing on exercise capacity and physical activity.


Eligibility Criteria:
Inclusion Criteria:

* want to start a rehabilitation program in "Schoen Klinik Berchtesgadener Land"
* patients with idiopathic pulmonary fibrosis (vital capacity \> 50% pred.)

Exclusion Criteria:

* exacerbation in the last 4 weeks
Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)

This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.

Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years;
* Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) during previous treatment with imatinib mesylate at least 600 mg daily for at least 8 weeks, as per two independently assessed prestudy computerized tomography (CT) scans;
* Presence of at least one measurable (per RECIST)
* Progressing tumor lesion not previously treated with radiotherapy or embolization and evaluable by CT scan or magnetic resonance imaging (MRI);
* Karnofsky performance status ≥ 60;
* imatinib treatment terminated at least 7 days before study day 1;
* Adequate hepatic, renal, and cardiac function.

Exclusion criteria:

* Prior malignancy (other than GIST, in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years; cardiac disease including myocardial infarction, unstable angina, and congestive heart failure (New York Heart Association class \> II),
* uncontrolled hypertension (systolic \> 145 mmHg or diastolic \> 85 mmHg),
* History of arterial thrombosis or deep vein thrombosis (including pulmonary embolus) within 1 year of study day 1;
* Absolute neutrophil count \< 1.5x109/L, platelet count \< 100x109/L, hemoglobin \< 9.0 g/dL;
* Prior treatment with motesanib diphosphate or other KIT (except imatinib) or VEGF inhibitors.
* The study was approved by the institutional review board of each participating institution, and all patients provided written informed consent before any study-related procedures were performed.
Yoga@Work for Reducing Musculoskeletal Pain in Neck and Shoulder

Work-related musculoskeletal disorders (MSDs) are disorders of muscles, tendons, joints and nerves which can affect all body parts, although the neck, upper limb and back are the most common areas.

The peer-reviewed literature about workplace prevention describes a variety of interventions that have been implemented and evaluated.but only few studies show sustainable positive effects on symptom outcomes.

Yoga@Work program was developed to self manage pain around neck and shoulder areas among office workers.


Eligibility Criteria:
Inclusion Criteria:

* Office workers
* Willing to participate and give consent
* non specific neck and shoulder pain

Exclusion Criteria:

* neck injury
* Trauma
* Cancer related pain
* psychiatric disorder/ medication
* Pregnancy
The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.

This RCT will enroll 74 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.

Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.

Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.

There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.

Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Ability to provide informed consent
* Chronic kidney disease stage 3 and 4
* On ACE inhibitor or ARB for albuminuria if tolerated
* Assessed during eligibility screen:
* Albuminuria \>30 mg/g creatinine
* 25(OH) vitamin D level \>12.5 and \<75 nmol/L

Exclusion Criteria:

* On vitamin D in past 4 weeks
* Plans to relocate out of New York City in the next 6 months
* 25 (OH) Vitamin D level \<12.5 nmol/L
* HIV infection
* History of hypercalcemia or kidney stones
* Serum phosphate \>5.5 mg/dl in past 3 months
* Serum calcium \>10.0 mg/dl in past 3 months
* SBP \>160 DBP \>100 at screening visit
* Transplanted organ
* Cancer
* Polycystic kidney disease
* Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
Role of Vitamin D in Innate Immunity to Tuberculosis

The investigators proposed a pilot study preparatory to developing a randomized trial of vitamin D for the prevention of TB infection. The specific aims are presented below:

1. To recruit subjects, obtain consent, distribute vitamin D supplements to the children in the schools, obtain blood samples and transport them to the United States.
2. To test the hypothesis that daily vitamin D supplementation will increase plasma levels of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages tested in vitro.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects will be children age 12 to 15 years inclusive in public school, located in Songino-Khairhan district, who are residents of Ulaanbaatar, and whose parents have given informed consent and who accent to participate in the study.

Exclusion Criteria:

* Individuals with pre-existing calcium, parathyroid conditions, or type I diabetes, sarcoidosis, or who require chronic diuretic therapy including calcium channel blockers, or who are cognitively impaired.
A Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study

The purpose of this study is to compare the use of an electronic incontinence identification system with nursing home support (Tena Identifi) versus usual care on the quality, resource use and outcomes of continence care for older residents of nursing care homes.

This is a prospective, quasi-experimental, controlled study with a mixed methods design with qualitative and quantitative components.

Eligibility Criteria:
Inclusion Criteria:

* Nursing homes: A facility which:

  * provides care for residents over the age of 65 years
  * has an existing policy for continence care
  * is registered with the appropriate Provincial authorities
  * engages in recording of the RAI- MDS v2.0
* Residents: Nursing home residents over the age of 65 requiring a continence assessment upon entry to the nursing home or requiring a reassessment because of either a change in clinical status or provincial requirement shall be eligible for entry

Exclusion Criteria:

* Residents

  * at the end of life,
  * with profound behavioural disturbances likely to render the use of the Tena Identifi system impractical
  * an identifiable, potentially reversible cause for their urinary incontinence (e.g.: acute urinary tract infection)
  * with double incontinence dominated by faecal incontinence
* Staff and Managers - Staff who did not take the training on the Identifi system or managers whose units that did not participate in the study will be ineligible for the focus group.
Are Medical Personnel Can Correctly Recognize the Chest Sounds?

The study aims to validate the interpretation of breath sounds by medical personnel

task of the participants in the study to determine the chest sound based on specific sounds

Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese

In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

Registry criteria: Patients treated in the investigators hospital using teriparatide. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (\< young adult mean 65%).

Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants

Eligibility Criteria:
Inclusion Criteria:

* severe osteoporotic patients

Exclusion Criteria:

* cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, teriparatide)
A Pilot Stress Management Intervention Study for High Risk Children With Asthma

The purpose of the proposed study is to conduct a randomized controlled pilot trial of a school-based stress management and coping skills training program among a sample of economically disadvantaged urban 8- to 12-year-old school children with physician-confirmed asthma. The investigators aim (1) to establish feasibility of this approach by recruiting from different schools and (2) to learn whether individuals assigned to receive the intervention show improvements in psychological function, decreases in lung inflammation, and related improvements in asthma health when compared with disease severity-matched peers who receive education-only or standard care.


Eligibility Criteria:
Inclusion Criteria:

* In grades 3 through 8 and attending one of the 11 participating public schools
* Age 8 through 14 years
* Qualify for the free or reduced cost school lunch program in Pennsylvania (families that receive food stamps or have an annual income of \< $40,900).
* Meets National Heart Lung and Blood Institute (NHLBI, 2007) criteria for any asthma diagnosis EXCEPT mild, intermittent asthma, as confirmed by the study physician using NHLBI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf, page 40).
* Has a parent or legal guardian who is willing to participate in the study
* Fluent in English (i.e., have commonly used English in everyday speaking and reading for at least 10 years)

Exclusion Criteria:

* History of a chronic illness in addition to asthma (determined by parent or guardian report)
* Prescribed medications other than for asthma
* Mental retardation or significant developmental delay
* Inability to speak or understand English
* A diagnosis of mild, intermittent asthma as determined using NHLBI (2007) criteria (see above)
* Age less then 8 years or greater than 14 years
* Not in grades 3 through 8
* Not qualifying for free or reduced cost school lunches in Pennsylvania
* No parent or legal guardian who is willing to participate
Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients

Tobacco consumption is a major public health problem, ranking second in the leading cause of morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized patients is evaluated around 20% and the management of tobacco reduction/cessation is an major issue for the course and outcome of many disorders.

Recent recommendations published by the French National Health Authority ("Haute Autorité de Santé", HAS) call for the involvement of all health professionals in helping patients to stop smoking and hospitalized patients are identified as a specific target. In addition, the meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco cessation) were those that include all patients, starting during the hospitalization with a specific follow-up of at least one month, and with the addition of nicotine replacement therapy. This combination increased the odds of successful tobacco cessation by 54%.

The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on tobacco smoking consumption in a population of hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\>= 18 years), tobacco smokers, hospitalized in one of the participating unit during the inclusion period.
* For the sake of coherence with the literature, only subjects who smoked at least one cigarette a day in the previous 30 days before the hospitalization will be considered as "smokers".
* Affiliated to the national health system
* Signed informed consent

Exclusion Criteria:

* Patients enrolled in an addiction treatment during their hospitalization stay
* Cognitive deficit that makes the informed consent and the telephone interview impossible
* Aphasia
* Patient who does not speak French
* Life expectancy below 6 months
Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax

Hepatic hydrothorax (HH) is a pleural effusion that develops in a patient with cirrhosis and portal hypertension in the absence of cardiopulmonary disease (Lv et al., 2018). Several factors are known to contribute to the development of effusion; the most accepted mechanism of which is the direct delivery of ascitic fluid from the peritoneal cavity to the pleural cavity by "positive" intra-abdominal pressure and a "negative" intrathoracic pressure of the pleural cavity through microscopic congenital diaphragmatic defects (Han et al., 2022).


Eligibility Criteria:
Inclusion Criteria:

* Patients who met the following inclusion criteria were enrolled:
* Liver cirrhosis (with or without hepatocellular carcinoma).
* Hepatic hydrothorax (bilateral or unilateral).

Exclusion Criteria:

* patients with a pleural effusion due to a condition other than HH.
* who had a diagnosis of tuberculosis pleurisy, parapneumonic effusion, inflammatory pleuritis, other neoplasms, and congestive heart failure.
Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS

Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy.

The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.

All patients eligible will undergo baseline assessment consisting of antropometric, hormonal, and ultrasonographic assessments. Successively, patients enrolled will be allocated in three different strategies (strategy A, B, and C).

A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies: clomiphene followed by clomiphene plus metformin followed by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy C).

In all patients, the same regimen will be used to administered clomiphene, metformin, and gonadotropins.Both clomiphene and metformin will be administered at incremental doses in each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol.

During the study, the clinical and reproductive outcomes, and adverse experiences will be evaluated in each woman.

Eligibility Criteria:
Inclusion Criteria:

* Polycystic ovary syndrome (using ESHRE/ARSM 2004 criteria)

Exclusion Criteria:

* Age \<18 or \>35 years
* Severe obesity (BMI \>35)
* Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
* Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs
* Previous use of ovulation induction agents
* Intention to start a diet or a specific program of physical activity
* No uterine bleeding after progesterone challenge test
* Organic pelvic diseases
* Previous pelvic surgery
* Suspected peritoneal factor infertility
* Tubal or male factor infertility or sub-fertility
Compliance and Administration Technique in Topical Drug Therapy of Glaucoma

Clinic-based evaluation of patients compliance with topical medications in the treatment of glaucoma. Also assessing effectiveness of delivery techniques among these patients.


Eligibility Criteria:
Inclusion Criteria:

glaucoma 18 years of age or older

Exclusion Criteria:

Recent ocular surgery
Effects of Aromatherapy on Patients Undergoing Chemotherapy for Breast Cancer

The objective of this study was to investigate the effects of aromatherapy on sleep quality and anxiety in patients undergoing chemotherapy for breast cancer.


Eligibility Criteria:
Inclusion Criteria: 1) patients diagnosed with breast cancer and receiving chemotherapy; 2) suffering from sleep disorders or PSQI score greater than 5; 3) not using medications such as antidepressants and hypnotics that may affect the observation results; 4) age older than 18 years and volunteered to participate in this study.

Exclusion Criteria: 1) Asthma or severe respiratory disease; 2) Allergy to lavender; 3) Cognitive or communication disorders; 4) Breast cancer combined with severe organ dysfunction.