Kornimate/medical-research-clean huggingface dataset:
analytical treatment interruption in a patient with hiv post allogeneic stem cell transplantation from a ccr5 delta32 homozygous donor

Conditions: HIV-1-infection

Summary: patients who have human immunodeficiency virus-1 (hiv-1) infection, who also had a stem cell transplant may have achieved cure of their hiv infection. once the patients blood shows no detectable levels of hiv virus in their blood collected from a process called leukapheresis, they will be closely monitored while discontinuing their hiv treatment which is know as antiretroviral therapy or, art. they will be tested regularly and monitored for up to 52 weeks at which point they may be considered cured of their hiv.

on week -1, a hiv vl and cd4 count will be drawn. if vl remains undetectable, at study week 0, and no other exclusion criteria noted, subject will discontinue art and enter ati phase of the study. hiv-1 plasma vl will be monitored every 2 weeks for 52 weeks, then patient returns under the care of their hiv provider. cd4 t cell count will be monitored every 4 weeks. depressions symptom check with phq-9 check monthly with study visits. since patients might be cured and at risk of acquiring hiv during the period of treatment interruption, they will be offered prep on demand (truvada) to be used no more than once a month (with notification of study pi when it happens). when prep on demand is used, we will ask patient to come in for art drug level measurement same week. if patient meets any of the restart art criteria during the interruption phase, they will discontinue the ati phase of study and re-start art and enter the follow up art phase. if subject maintains undetectable plasma hiv vl (assay quantification threshold 20 copies/ml), they will remain off art and continue to be monitored until restart criteria are met. if patient meets the restart criteria, they will be followed for 12 months post re-initiation of therapy by their hiv provider. the first month post restart of therapy will require weekly visits, followed by monthly visits thereafter until hiv vl is back \<50 copies/ml. leukapheresis (per previously approved protocol that patient consented to) will be performed at 6 months and 12 months post ati if in continued viral remission.

Eligibility criteria:
inclusion criteria: * positive hiv testing * has undergone a stem cell transplant exclusion criteria: * under 18 years of age * unwilling to comply with protocol

Keywords: stem cell transplant hiv proof of cure
individualized, target-driven treatment of children with idiopathic short stature

Conditions: Idiopathic Short Stature

Summary: to demonstrate that an individualized, formula-based genotropin regimen for children with idiopathic short stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 sds) during 24 months of treatment. the endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment


Eligibility criteria:
inclusion criteria: * prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females * naive to growth hormone treatment exclusion criteria: * abnormal karyotype. small gestational age and skeletal dysplasia.

Keywords: iss human growth hormone
safety and efficacy study of salvage chemotherapy (r-eshap) to treat relapsed and refractory aggressive non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: aggressive non-hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-hodgkin's lymphoma. this study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, eshap (r-eshap). our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful r-eshap therapy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of aggressive non-hodgkin's lymphoma * refractory to the first line chemotherapy or relapsed * expression of cd20 on lymphoma cells * measurable lesions on imaging studies exclusion criteria: * blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration * circulating lymphoma cells equal to or more than 25,000/microliter * hepatic dysfunction * renal insufficiency * cardiac dysfunction or arrhythmia * sever infection (bacterial, viral) * cns involvement * other malignancies * pregnancy or breast feeding

Keywords: aggressive non-hodgkin's lymphoma salvage chemotherapy rituximab
incontinent urinary diversion using an autologous neo-urinary conduit

Conditions: Bladder Cancer

Summary: the purpose of this study is to see if the neo-urinary conduit(nuc), which is made in the laboratory from a combination of a patient's own cells and other materials can be used to form a conduit to safety allow urine flow from the kidneys to outside the body after radical cystectomy in patients with bladder cancer.

the nuc under investigation is a regenerative medicine product comprised of the patient's own smooth muscle cells, procured from a fat biopsy. tengion has developed appropriate culture conditions to reproducibly generate the necessary quantities of smc in vitro from autologous adipose tissue biopsies. the nuc is produced at tengion's good manufacturing practices (gmp) qualified clinical production facility. in this process, smooth muscle cells (smc) obtained from an adipose tissue biopsy are propagated ex-vivo for approximately 3 - 4 weeks. at the end of this process, the smcs are seeded onto the surface of a biodegradable pga/plga mesh scaffold to form the nuc. the nuc is shipped to the investigative site for surgical implantation. over time, the nuc should facilitate the regeneration of urinary tract tissue.

Eligibility criteria:
inclusion criteria: * male and female subjects 18 - 80 years of age * patients undergoing radical cystectomy for treatment of bladder cancer clinically staged as no greater than t2, n0 * indicated and agreed between physician investigator and patient to have an incontinent conduit as the diversion mechanism of choice post cystectomy exclusion criteria: * history of other cancer within the past 5 years (except non metastatic prostate or non melanoma skin cancer) * evidence of cancer metastasis * history of any pelvic radiation or non-pelvic radiation within past 5 years * debilitating cardiac or pulmonary disease * expected need for chemotherapy within 3 months post cystectomy * life expectancy less than 2 years

Keywords: bladder cancer radical cystectomy incontinent urinary diversion
iastm versus prt in patients with chronic pf

Conditions: Chronic Plantar Fasciitis

Summary: the goal of this clinical trial\] is to compare between the effect of instrument assisted soft tissue mobilization and positional release technique in patients with chronic plantar fasciitis the main question\[s\] it aims to answer are: 1. is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on pain pressure threshold in patients with chronic plantar fasciitis? 2. is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on foot function level in patients with chronic plantar fasciitis?

design of the study: pretest - posttest randomized controlled trial. subjects selection: sixty patients their age range from 30-50 years of both genders with chronic plantar fasciitis will participate in this study according to sample size calculation.

Eligibility criteria:
inclusion criteria: 1. clinically diagnosed cases of plantar fasciitis not less than 3 months. 2. heel pain felt maximally over plantar aspect of heel. 3. pain in the heel on the first step in the morning. 4. their age ranging from 30-50 years. 5. body mass index range from (18.5 to 24.9 kg/m2). exclusion criteria: 1. subjects can't tolerate close physical contact. 2. athletes. 3. subjects with skin infections. 4. subjects with recent fracture with incomplete bony union. 5. subjects with acute inflammatory or infectious process. 6. subjects with hematoma. 7. subjects with osteoporosis. 8. subjects with foot deformity. 9. subjects that take medications that may increase blood clotting. 10. surgery to the ankle or foot.

Keywords: positional release technique instrument assisted soft tissue mobilization
pet imaging with cu-64 labeled trastuzumab in her2+ metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to learn more about how a new study agent works inside the body. the study agent is a protein called 64cu-trastuzumab. this is a radioactive tracer that was developed at mskcc to target her2 protein on cancer cells. a radioactive tracer is a small amount of radioactive dye that follows something else that is not radioactive in this study the study agent, 64cu-trastuzumab, is the tracer and what's being followed is trastuzumab (herceptin™). by giving you this tracer after you have treatment with trastuzumab (herceptin™), we will be able to use pet scans to show us which parts of your body and tumor sites the herceptin goes to. this will help us to understand better how herceptin works in the body to fight cancer.


Eligibility criteria:
inclusion criteria: * registered patient at mskcc * age ≥18 years * patients with her2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (\>2.0) by fluorescence in situ hybridization (fish)) * measurable or evaluable disease * currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care * karnofsky performance score ≥ 60 * signed informed consent exclusion criteria: * previous grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy * claustrophobia/pain leading to inability to lie still for the duration of the scanning procedure. * pregnancy test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material. * inability to provide written informed consent. * patients with liver metastases as the only site of distant disease * patients with known sensitivity or contraindication to herceptin.

Keywords: cu-64 labeled trastuzumab
the influence of qigong wuqinxi on health status of the community-dwelling older adults

Conditions: Sleep Quality; Chronic Pain

Summary: pain and sleep disturbance are common symptoms of community-dwelling older adults observed in traditional chinese medical(tcm) clinics. acupuncture or other medical treatments have their side effects and usage limitations, so it is expected that other non-medical interventions can relieve the symptoms. the purpose of this study was to test the effect of qigong wuqinxi intervention on pain, sleep quality, tcm body constitution and tongue features of the community-dwelling older adults.

methods: using cluster randomised clinical trial , two community care sites in sanmin district, kaohsiung city were selected. community-dwelling older adults who are over 65 years old and have the ability to communicate in mandarin and taiwanese were recruited . those who had severe mental illness, moderate to severe dementia (level 2 or above on the clinical dementia assessment scale) and barthel index score \<60 were excluded. there were 63 valid cases divided into experimental group(n=32) and control group(n=31). the experimental group practiced qigong wuqinxi 50 minutes three times a week for 12 weeks; meanwhile, the control group maintained routine daily activities. the two groups of participants were tested before and after the intervention period with the following research tools: 1) the brief pain inventory, (bpi), 2) pittsburgh sleep quality index (psqi), 3) body constitution questionnaire (bcq), 4) automatic tongue diagnosis system (atds). the research data were analyzed with spss 19 software package for descriptive statistics, chi-square test, independent t test and paired t test.

Eligibility criteria:
inclusion criteria: * 65-85 year olds * have the ability to communicate in mandarin and taiwanese and can answer questions orally exclusion criteria: * severe mental illness, * moderate to severe dementia (clinical dementia assessment scale level 2 or above) * almost unable to perform daily activity by self. (barthes scale \<60)

Keywords: qigong wuqinxi chronic pain sleep quality traditional chinese medical body constitution tongue features community-dwelling older adults
assessment of the skin-concentration of vildagliptin 50 mg every 12 hours for 10 days in healthy subjects and patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study will look at the skin accumulation of vildagliptin and its two major metabolites, lay151 and laf237-o-glucuronide, after vildagliptin 50 mg given orally twice a day for 10 days in both healthy volunteers and patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * healthy volunteers and patients with type 2 diabetes * non-smoking, caucasian and african american, male and female (postmenopausal, surgically sterile or using double-barrier method of contraception) subjects between 30 and 65 years of age (inclusive) * type 2 diabetics on metformin and/or sufonylurea exclusion criteria: * history of type 1 diabetes or insulin use * history of coagulation abnormalities * history of abnormal heart conditions * pregnancy or breastfeeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: diabetes mellitus type 2 diabetes vildagliptin pharmacokinetics
comparison of the effects of green exercise programs on metabolic syndrome parameters in elderly individuals

Conditions: Metabolic Syndrome

Summary: the aim of this study is to compare the effects of exercise programs that only aerobic exercise and combination aerobic exercise and resistance exercises on the metabolic syndrome parameters in the green exercise concept.

one hundred twenty volunteer participants aged 65 years over will be included in the study. participants will be randomly divided into three groups as aerobic, aerobic and resistance and control group. while a group will receive only aerobic exercise, the other group group will receive both aerobic and resistance exercises and one of the group will receive no exercise. exercises will be held in an open and green area. at the beginning of the treatment and at the end of the twelfth week hemoglobin a1c (hba1c), triglyceride, hdl cholesterol, ldl cholesterol, total cholesterol and blood glucose will be evaluated.

Eligibility criteria:
inclusion criteria: * people aged over 65 years * be fit to participate in exercise program after the first cardiac examination by the physician * individuals whose blood lipids, hg a1c and glucose values were checked within 3 months * according to the international physical activity assessment questionnaire, those who are physically inactive * having a score above 24 in the minimental test exclusion criteria: * having neuromuscular disease * serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) * having an orthopedic disease that interferes with walking * having a score below 24 in the minimental test

Keywords: metabolic syndrome exercise geriatrics
ethanol and cannabinoid effects on simulated driving and related cognition: sub-study ii

Conditions: Cannabis; Alcohol Effect; Driving Under the Influence of Alcohol and Other Drugs

Summary: the overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

to study the effects of oral ethanol (target bac of \~0.04g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized cannabis (\~450 mg cannabis plant material at a thc concentration of \~1.7%; roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.

Eligibility criteria:
inclusion criteria: * males or females 21 to 55 years of age (extremes included). * occasional current cannabis users. * experience with drinking 2 or more standard drinks of alcohol at least once in lifetime. * able to provide informed consent. exclusion criteria: * cannabis naïve. * alcohol naïve. * positive pregnancy screen * hearing deficits.
prasugrel switching study in patients with acute coronary syndrome (acs) who underwent percutaneous coronary intervention (pci)

Conditions: Acute Coronary Syndrome (ACS)

Summary: this phase iv, multicenter trial is designed to assess the efficacy of prasugrel in preventing the formation of blood clots in taiwanese patients with acs who have been treated with pci.


Eligibility criteria:
inclusion criteria: * is within the age limits and has signed informed consent * weighs at least 50 kg * had a previous diagnosis of acs (ua, stemi, or nstemi), underwent pci, and received one of the following treatments: * clopidogrel md of 75 mg and aspirin 81-100 mg for 2-8 weeks following clopidogrel loading dose (ld) of 300 mg or 600 mg at the time of pci * ticagrelor md of 90 mg twice daily (bid) and aspirin 81-100 mg for 1-4 weeks and switching to clopidogrel md of 75 mg and aspirin 81-100 mg for 2-4 weeks following ticagrelor ld of 180 mg at the time of pci * clopidogrel md 75 mg and aspirin 81-100 mg for 2-8 weeks following ticagrelor ld of 180 mg at the time of pci * or based on investigator's judgment with at least 2 weeks continued use of clopidogrel md and aspirin 81-100 mg per day before switching to prasugrel and maximum 8 weeks p2y12 inhibitors md treatment (prasugrel is not allowed) * is willing and able to abide by the rules of the research unit and study restrictions * if a woman of child-bearing potential, has a negative serum pregnancy test at screening * agrees to use at least one method of contraception during the study exclusion criteria: * has active bleeding, significant risk of hemorrhage, or unusual susceptibility to bleed * had previous hemorrhagic stroke at any time, or transient ischemic attack (tia) or ischemic stroke within 3 months before the informed consent date * has known allergies or hypersensitivity to prasugrel, aspirin, or any of their excipients * has significant hypertension at screening or baseline assessment * has hemoglobin levels \<10.5 g/dl or hematocrit levels \<30% * has severe left ventricular systolic dysfunction, ejection fraction \<30% * is currently undergoing hemodialysis * has evidence of severe hepatic disease or any of the following: serum alanine transaminase or aspartate transaminase ≥3 times the upper limit of normal (uln); or bilirubin ≥2 times the uln at screening * has any clinical laboratory result performed at screening that is determined to be detrimental to the patient or could compromise the study as determined the investigator * has previously participated in this study or in another interventional trial that is not compatible with this study * has evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse as determined by the investigator

Keywords: percutaneous coronary intervention (pci) st elevation myocardial infarction (stemi) non-st elevation myocardial infarction [nstemi] unstable angina (ua) prasugrel acs-pci
lipid-lowering effect of a plant stanol ester supplement product

Conditions: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Summary: purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on ldl cholesterol.


Eligibility criteria:
inclusion criteria: * male and female over 18 years old * serum ldl cholesterol \> 3.0 mmol/l * bmi \< 35 * subjects must voluntarily sign the informed consent exclusion criteria: * subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy) * subjects with any hepatic or renal disorder according to medical history * subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening * subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening * subjects who have history of temporal ischemic attack or stroke within six months prior to screening * subjects who have a history of cancer or other malignant disease within the past five years * subjects who are consuming more than 15 portions of alcohol / week * subjects who are pregnant or lactating * subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention * subjects with intolerance to any ingredient of the test product
the sea change study: a self management intervention for head and neck cancer survivors

Conditions: Head and Neck Cancer

Summary: this study aims to test the feasibility of implementing the self-management after cancer of the head and neck group intervention (sea-change), designed to promote quality of life and participation in life activities and reduce distress in people who have completed primary treatment for head and neck cancer as compared to usual care.

head and neck cancer (hnc) and its treatment are associated with specific challenges such as facial disfigurement and impairments in speech, breathing and swallowing, and can have a negative impact on well-being. self-management interventions can provide people with skills to deal with health-related problems, maintain life roles, and manage negative emotions, and have been found to increase confidence, improve quality of life, and reduce health service use across a range of chronic conditions. the aim of this study is to pilot a self-management intervention (sea-change) designed to promote quality of life and participation in life activities, and reduce distress in people who have completed primary treatment for hnc as compared to usual care. the study includes: (1) a pilot randomised study to assess the feasibility and acceptability of the intervention and its related procedures; (2) a qualitative process evaluation of the intervention; and (3) a systematic decision-making process regarding progression to a definitive trial. the expected outcome is a self-management intervention that is feasible and acceptable to hnc survivors and has the potential to realise both health benefits and economic gains.

Eligibility criteria:
inclusion criteria: * had a pathologically confirmed diagnosis of an invasive primary tumour in the head and neck (oral cavity, salivary glands, nasal cavity, sinuses, middle ear, pharynx and larynx); * have undergone and completed treatment by surgery, chemotherapy, radiotherapy or a combination thereof; * are aged 18 or older at the time of their hnc diagnosis; * are within 12 months of having completed their primary treatment; and * have provided written informed, consent. exclusion criteria: * are unable to read or speak english; * had a second invasive primary cancer other than non-melanoma skin cancer diagnosed after the hnc (as these patients are likely to be more focused on the treatment of their second cancer rather than self-management of their hnc); * are unable to provide informed consent (e.g., if they have dementia/alzheimer's disease); or * have other known medical condition or other reason why they would be unable to take part.

Keywords: head and neck cancer self-management intervention pilot randomised control trial behavioural intervention quality of life