cyrilzakka/clinical-trials huggingface dataset:
Yoga Intervention for the Improvement of Cancer-Related Stress in Cancer Survivors

This clinical trial develops and test a yoga intervention in improving cancer-related stress in cancer survivors. The online hatha yoga intervention of breathing and movement incorporates both restorative poses, breathing techniques, guided meditation and may reduce stress levels and improve overall quality of health in cancer survivors.

PRIMARY OBJECTIVE:

I. To develop and test the feasibility of a standardized 12-week online hatha yoga intervention (n=30) of breathing and movement incorporating both restorative poses, breathing techniques, guided meditation.

SECONDARY OBJECTIVES:

I. To evaluate the yoga intervention in relation to self-reported levels of stress and quality of life in cancer survivors (n=30).

II. Feasibility of collecting blood and saliva at baseline and post-intervention for stress biomarkers, including cortisol and norepinephrine.

EXPLORATORY OBJECTIVE:

I. To determine how behavior change, quality of life (QoL), and biomarkers of adrenergic stress, inflammation, and immunosuppression are affected by a 12-week online yoga program completed by cancer survivors.

OUTLINE:

Patients receive online yoga intervention once a week (QW) for 12 weeks.

After completion of study, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years of age
* Have been diagnosed with a cancer and have finished treatment
* Have been cleared for physical activity by a physician or nurse practitioner (physician or nurse practitioner name and date clearance received)
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Unwilling or unable to complete the assessment in English
* Are pregnant or nursing
* Are unwilling or unable to follow protocol requirements
* Have skeletal instabilities and/or cardio-pulmonary comorbidities
* Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region

Haifa bay region is located close to a major industrial zone. The aim of the study is to evaluate the health status of school children living in Haifa bay region.The health status will be evaluated using health questionnaires and spirometry.

Haifa bay is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in Haifa bay region.

The health status will be evaluated while using health questionnaires and spirometry.

Objective: To evaluate the respiratory health of Haifa bay region children with comparatives, with respect to local air pollution levels.

Material and Methods: Children from Haifa bay region from 10 different communities (1200 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form.

First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be filled in by the parents.

Second step: Spirometry checking of the children. In parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the Haifa District Municipality Association for the Environment (HDMAE). The station provides half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM 10) pollutants over the entire investigation window. Additional meteorological data are also collected.

Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region.

The prevalence of pulmonary disease will be evaluated according to the risk maps The health status of the children will be documented from the children's primary clinic files as well.

Eligibility Criteria:
Inclusion Criteria:

* Living in Haifa bay region, Israel.
* Parents signed informed consent.

Exclusion Criteria:

* Children that their parents did not signed the informed consent
* Chronic disease except of asthma: Diabetes mellitus, Cystic Fibrosis, Cardiac diseases, Renal, Rheumatic and Chronic Gastrointestinal diseases, Mental retardation.
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).

This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Eligibility Criteria:
Inclusion Criteria:

1. The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition.
2. Patient will be \<18 years of age.
3. Direct bilirubin \> 2.0mg/dl
4. The patient must have failed standard therapies to prevent progression his/her liver disease.

Exclusion Criteria:

1. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency).
2. Patients who are allergic to eggs/shellfish
3. Patients who have severe hemorrhagic disorders.
Hear Me Read 2021 Clinical Trial

The purpose of this study is to evaluate if the effects of in-person speech-language therapy with a novel digital storybook intervention platform (Hear Me Read) improves vocabulary, speech and language, and literacy outcomes in young children who are deaf or hard of hearing compared with in-person therapy alone.

For this study, 50 children, who are deaf/hard of hearing, and their caregiver will be enrolled into 2 separate 6-month intervention periods, for a total of 12 months of participation. There are two intervention periods in this study, Intervention Period 1 (SLT) and Intervention Period 2 (SLT+Digital). Each one lasts about 6 months and every participant will participate in both intervention periods.

Intervention Period 1 is the speech-language therapy (SLT) only intervention. During this intervention, the child will go to speech therapy as normally prescribed by their speech language pathologist. There will be standardized reading time that is prescribed at 20 minutes, 3 times a week and will be completed at home by the child and caregiver.

Intervention Period 2 is the speech-language therapy with the Hear Me Read (SLT+Digital) intervention. During this intervention, the child will continue to go to speech therapy as they typically would, but will be asked to use the Hear Me Read app. There will be standardized reading time that is prescribed at 20 minutes, 3 times a week and will be completed at home by the child and caregiver using the Hear Me Read app.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children ages 3.0-5.11 (5 years and 11 months) at time of initial assessment and:
* Bilateral Sensorineural or mixed hearing loss at least (PTA≥30dB)
* Auditory neuropathy in both ears

Exclusion Criteria:

* English not primary language
* Standard score CLS \>2 SD from normal on CELF-P3
Brachytherapy in Treating Patients With Recurrent Prostate Cancer

RATIONALE: Radiation therapy uses high-energy radiation to damage tumor cells. Brachytherapy uses radioactive material that is placed directly into or near the tumor. Brachytherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating patients who have recurrent prostate cancer that has not responded to standard therapy.

OBJECTIVES: I. Determine the dosimetry and toxicity of interstitial colloidal phosphorus P32 (cP32) in patients with locally recurrent prostate cancer that has failed conventional therapy. II. Determine the maximum tolerated dose of interstitial cP32 when combined with interstitial macroaggregated albumin (infusional brachytherapy) in these patients. III. Determine the therapeutic response rate to acceptable single doses of cP32 in these patients.

OUTLINE: This is a dose escalation study of colloidal phosphorus P32 (cP32). Patients receive cP32 and macroaggregated albumin via interstitial infusion using ultrasound localization. Cohorts of 3 patients receive escalating doses of cP32 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 4 patients experience dose limiting toxicities. Additional patients are treated at the MTD. Patients are followed at 1, 2, 4, and 6 weeks; then at 2, 4, 8, 12, 16, 20, and 24 months; and then every 6 months thereafter until death.

PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for phase I of the study and a total of 40 patients will be accrued for phase II of the study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven locally recurrent prostate cancer that has failed conventional therapy (i.e., external beam radiotherapy, radioactive seed implants, and hormonal therapy) Must be confirmed clinically with elevated PSA and/or ultrasound Prostates between 2-5 cm in diameter (i.e., volumes of 4-65 cm3) preferred Prostates greater than 5 cm allowed, but 2 needles required for good distribution of study drug No clinical/radiographic evidence of metastatic disease No history of injury to urethra, bladder, or rectum

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,900/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic: Not specified Renal: Blood urea nitrogen no greater than 25 mg/dL Creatinine no greater than 1.5 mg/dL

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: Not specified
Virtual Nephrologist Pilot

To develop, pilot, and refine a virtual healthcare agent that will educate patients with advanced chronic kidney disease and their caregivers about kidney transplantation.

Over 35 million Americans endure the burdens of chronic kidney disease (CKD). Black Americans face particularly high rates of CKD due to environmental and genetic factors, including systemic racism and inadequate access to specialty providers and effective therapies. The optimal management of advanced CKD poses many challenges for patients, especially those with low health literacy, because of the complexity of medical management and treatment options. For many patients with advanced CKD, pursuing kidney transplantation has major advantages. Compared to chronic dialysis, kidney transplantation improves quality of life and length of life, and offers greater capacity to participate in important activities such as employment. Unfortunately, many patients do not gain sufficient information about kidney transplant or have misconceptions and fears about transplant. This knowledge gap exists in part because many patients have limited access to nephrology care and due to time constraints and ineffective education during nephrology visits. New media technologies can address this need by enabling patients to interact with a virtual health care assistant that both empowers patients to direct the communication toward their own information needs and communicates with patients using language and norms that are comfortable. We will develop a virtual healthcare assistant to interact with, educate and counsel patients and their caregivers about kidney transplantation. The tool will provide content developed by the National Kidney Foundation, the leading patient-facing organization focused on kidney disease. Informed by patient partnerships, the tool will address in particular the needs and concerns of Black Americans with kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* 18 y/o able to provide consent
* Advanced CKD
* English speaking
* Penn Medicine patient

Exclusion Criteria:

* Vulnerable populations
Alpers Huttenlocher Natural History Study

This is a natural history study of Alpers Huttenlocher Syndrome. Patients will be followed over time to assess clinical symptoms for the purpose of expanding knowledge of this disorder in the medical community.

The study team will conduct outpatient visits to the medical center on a 6 month basis, or as patients are able. The patients or their caregivers will complete medical and symptom questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* All individuals of any age with confirmed Alpers Huttenlocher Syndrome (AHS) or siblings of confirmed AHS patients are eligible to participate. AHS requires the presence of polymerase gamma 1 (POLG) pathological mutations, either homozygous or compound heterozygote mutations, and the presence of epilepsy and either, developmental regression or hepatopathy. If POLG mutations are not demonstrated, AHS requires the presence of refractory seizures, developmental regression, and hepatopathy as well as two or more other clinical and laboratory findings including elevated cerebrospinal fluid (CSF) protein, neuroimaging showing lactate peaks, reduced N-acetyl aspartate with hyperintensities on T2/FLAIR in the thalamus and posterior head regions, optic atrophy/cortical blindness, quantitative mtDNA reduction (\>30% ) in muscle and/or liver, non-specific electron transport chain (ETC) enzyme deficiencies.
* All patients must agree to participate in the North American Mitochondrial Disease Consortium (NAMDC) Clinical Registry

Exclusion Criteria:

* Patient does not have confirmed AHS and is not the sibling of a patient with confirmed AHS
* Not willing to participate in the NAMDC clinical Registry
Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension

Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren, amlodipine and angiotensin II concentrations, and renin activity and concentration in plasma.

Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine.


Eligibility Criteria:
Inclusion criteria:

PART 1:

* Male and female patients 20 to 65 years of age with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
* For patients with a history of treated hypertension, mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) had to be ≥ 120/80 mmHg and ≤ 160/100 mm Hg. For patients with newly diagnosed, untreated hypertension msSBP/msDBP had to be ≥ 135/85 mmHg and ≤ 160/100 mm Hg
* Pulse rate 40 - 90 bpm

PART 2:

* Male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
* Systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. Vital signs had to be within the following ranges:

  1. Patients with history of treated hypertension: msSBP/msDBP ≥ 135/85 mmHg and \< 160/100 mmHg at baseline
  2. Patients with newly diagnosed, untreated hypertension: msSBP/msDBP ≥ 135/85 mmHg and \< 160/100 mmHg at screening and baseline.

Exclusion criteria:

PART 1

* Hypertension Grade 2 (msSBP ≥ 160 mmHg) or Grade 3 (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg) WHO classification
* Current treatment with three or more antihypertensive drugs.

PART 2

* Hypertension Grade 2 (msSBP ≥ 160 and/or msDBP ≥ 100 mmHg).
* Current treatment with three or more antihypertensive drugs.

Other protocol-defined inclusion/exclusion criteria applied
Goal Direct Therapy to Prevent Acute Kidney Injury

This is an randomised controlled trial to investigate an strategy based in a protocol in prevention of acute kidney injury after cardiac surgery.

This is a prospective, randomized controlled trial to assess the influence of use of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) in the development of the Acute Kidney Injury in the postoperative period of cardiac surgery. Patients undergoing cardiac surgery at the Heart Institute (InCor) - Brazil, will be randomized and in accordance with a list of random numbers, generated by a computer program, will be allocated in one of the groups (GDT or standard).

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery with Cardiopulmonary Bypass (CPB); Age greater than 18 years; Chronic kidney disease stages 3 and 4 (GFR less than 60 mL/min and greater than 15 mL/min); Sign the informed consent form.

Exclusion Criteria:

* Chronic renal insufficiency (GFR less than 15 mL/min); Heart surgery without CPB; Aortic procedures; Heart transplant or congenital heart disease; Prior use of Intra-Aortic Balloon Pump; Decompensated heart failure; Participation in other research protocol.
Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes

This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for more than 1 year
* Subject treated by any kind of insulin regimen and whatever the number of injections
* HbA1c = 7.5% and = 10%

Exclusion Criteria:

* Type 2 diabetes
* Treatment by oral anti-diabetic drugs
* Severe medical conditions
Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)

This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.

On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and follow-up of the already enrolled subjects was continued. On July, 22th 2010 , the study was amended to shorten the long-term follow-up to one year after active treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who have received 1 or 2 prior regimens, at least 1 of which should have contained administration of rituximab (either as a single agent or in combination).
* Age 18 years or older.
* ECOG performance status \<= 2.
* ANC \>= 1.5 x 10\^9/L (1500/mL) and platelets \>= 75 x 10\^9/L (75,000/mL), serum creatinine \<= 1.5 x ULN and urine protein to creatinine ratio of \<= 0.5, total bilirubin \<= 1.5 x ULN, AST and ALT \<= 2.5 x ULN.
* At least 1 measurable disease lesion that is \>= 1.5 cm x 1.5 cm by CT or MRI, in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated.

Exclusion Criteria:

* Subjects with clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
* Subjects whose disease is rituximab refractory, meaning that they did not have a CR or PR, or that they experienced disease progression within 6 months from the initiation of the rituximab or rituximab containing treatment regimen administered immediately preceding study enrollment.
Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China

The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory men aged ≥ 30 years and ≤ 90 years old at the time of signing the informed consent.
* Men at the time of screening will be required to have lumbar spine or total hip BMD T-score ≤ -2.5 or T-score ≤ -1.5 and a history of a fragility fracture.
* Have to have at least two intact vertebrae at baseline (L1-L4).

Exclusion Criteria:

* Any condition that could affect bone metabolism such as Paget's disease of bone, osteomalacia including secondary causes of osteoporosis (subjects with low testosterone levels are allowed).
* Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed.
* Participants with a history of any cancer (cured basal cell or squamous cell cancers are allowed).
* Any condition that in the opinion of the investigator would not allow the subject to complete 1 year study and comply with the requirement of the study protocol.
* Hypogonadism requiring testosterone replacement therapy unless on a stable dose for at least 12 months.
* Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Systemic glucocorticoids: ≥ 7.5 mg prednisone equivalent per day for more than 14 days within 3 months before randomization. Any bone anabolic treatment within 1 year. Anabolic steroids or testosterone: any use within 6 months before randomization.
* Oral bisphosphonates treatment.
* Known to have tested positive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or cirrhosis of the liver.
* Received any solid organ or bone marrow transplant or is on chronic immunosuppression for any reason.
* Oral/dental conditions that would require an intervention including tooth extraction during the course of the study.
* Currently receiving treatment in another investigational device or drug study, or less than 1 month since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Vitamin D levels \< 20 ng/mL (subjects are allowed into the study after vitamin D levels are corrected and subjects re-screened).
* Albumin-adjusted serum calcium levels \< 8.5 mg/dl or \> 10.5 mg/dl.