Kornimate/medical-research-clean huggingface dataset:
a study of hs-10516 in patients with vhl syndrome associated tumors

Conditions: Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma

Summary: the aim of the phase ia portion is to identify the maximum tolerated dose or maximum acceptable dose mtd/mad of hs-10516. the phase ib portion will evaluate the preliminary efficacy of hs-10516 in patients with vhl syndrome associated tumors.

this is a phase ia/ib open label multicenter study of hs-10516 in chinese patients aged 18 years or older with vhl syndrome associated tumors. hs-10516 as a single agent, is administrated orally once daily. the aim of phase ia, a dose escalation study, is to identify the mtd/mad of hs-10516. the goal of phase ib, a dose expansion study, is to evaluate the safety, pharmacokinetics and antitumor efficacy of hs-10516.

Eligibility criteria:
inclusion criteria: 1. male or female from 18 to 80 year-old 2. patients with advanced clear cellrenal cell carcinoma or von hippel-lindau syndrome associated tumors 3. has an eastern cooperative oncology group performance status of 0-1 4. has a life expectancy of ≥ 12 weeks 5. should use adequate contraceptive measures throughout the study 6. females subject must not be pregnant at screening 7. has the ability to understand and willingness to sign a written informed consent before the performance of the study. exclusion criteria: 1. recieved or being received treatment as follows: 1. hypoxia-induced factor inhibitors 2. traditional chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment. 3. cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment 4. colony-stimulating factors (csfs) within 4 weeks before the first dose of study treatment 5. local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment. 6. major surgery within 4 weeks prior to the first dose of study treatment. 2. has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen 3. has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy 4. has another malignancy or a history of another non-vhl syndrome associated malignancy 5. has inadequate bone marrow reserve or organ dysfunction 6. has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment 7. has severe infections within 4 weeks prior to the first dose of study treatment 8. has digestive system diseases may influencing adme of study drug 9. has a history of severe hypersensitivity reaction, or proven allergic to hs-10516 or its metabolin 10. has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision

Keywords: von hippel lindau syndrome vhl syndrome rcc pnet cns hemangioblastoma
effects of wb-ems and dietetic treatment on cancer patients

Conditions: Cancer; Cancer Cachexia; Weight Loss; Muscle Loss; Muscle Weakness

Summary: this study evaluates the effects of a 12-week whole-body electromyostimulation (wb-ems) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment


Eligibility criteria:
inclusion criteria: * malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or graft-versus-host-disease after bone marrow transplantation * ongoing or planned curative or palliative anti-cancer therapy exclusion criteria: * simultaneous participation in other nutritional or exercise intervention trials * acute cardiovascular events * use of anabolic medications * epilepsy * severe neurological diseases * skin lesions in the area of electrodes * energy active metals in body * pregnancy * acute vein thrombosis

Keywords: whole-body electromyostimulation cachexia cancer skeletal muscle mass nutrition
cognitive-motor training in parkinson disease

Conditions: Parkinson Disease

Summary: literature reviews showed the cognitive-motor training that combines cognitive tasks may enhance cognitive functions more effectively than individual interventions. stepping-based cognitive-motor training has been shown to improve cognitive functions, balance, and gait performance in older adults. however, there is insufficient research evidence on the impact and correlation of this training mode on the walking ability, executive functions, and brain activity changes in people with pd. therefore, this study is designed to investigate the effects of stepping-based cognitive-motor training on the walking ability, executive functions, and brain activity in people with pd.


Eligibility criteria:
inclusion criteria: * diagnoses of idiopathic parkinson disease * stable dopaminergic medicine ≥ 2 weeks * able to walk 10 meters without aid * mini-mental status examination ≥ 24 points * no uncorrected visual or auditory disorders * education at least junior high school * no other disease may affect balance exclusion criteria: * other medical diagnoses of neurological, musculoskeletal, or cardiopulmonary disorders * history of brain surgery (e.g. deep brain stimulation)

Keywords: cognitive-motor training executive function gait electroencephalography
a survey of clinical practice of adjuvant treatment of breast cancer using exemestane (aromasin®) in postmenopausal hr+ patients

Conditions: Breast Cancer

Summary: observational survey aiming to evaluate the tolerability of aromasin and the ways in which it is used in clinical practice in france (as adjuvant endocrine therapy).

it was hypothesized that 200 participating doctors would provide the survey with sufficient statistical precision to meet the objectives, with each participating doctor recruiting up to 6 patients. an initial sample of 1000 doctors should be contacted (letter, phone). these 1000 doctors will initially be chosen at random from a file held by pfizer of doctors who have agreed to take part in a pfizer survey. these doctors will be experienced and qualified in the treatment and management of patients with non-metastatic, surgically-treated breast cancer (medical oncologists, gynaecologists, and medical oncologists/ radiation oncologists). they are practicing in general hospitals, teaching hospitals, crlcc cancer centres and private clinics treating patients with breast cancer. study recruitment was stopped due to difficulty in enrolling the targeted number of patients on december 3, 2010. there were no safety concerns involved in the decision to stop enrollment.

Eligibility criteria:
inclusion criteria: postmenopausal patients, defined as: natural menopause for at least 1 year, surgical ovariectomy, chemotherapy-induced amenorrhoea for at least 2 years. patients who have had surgical treatment for histologically confirmed breast cancer that was nonmetastatic at the time of the initial diagnosis. patients whose tumour was hormone receptor positive (hr+, er+ and/or pr+). patients initiated on aromasin at least 2 months before inclusion but not more than 1 year. exclusion criteria: patients for whom aromasin treatment is contraindicated. presence of metastasis or a contralateral tumour. another adjuvant endocrine therapy. another concomitant antineoplastic treatment (except for herceptin®). participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

Keywords: observational epidemiological cohort cross-sectional prospective multicenter survey france.
effects of home visits on medication adherence in children and youth with hiv

Conditions: HIV Infections

Summary: adherence to complex medication regimens is critical to successful treatment of hiv infection. unfortunately, adherence to medical regimens with conventional interventions averages 50% in chronic disease. we have observed that adherence barriers that were unrecognized by providers in the clinic setting have been detected during home visits. it is possible that recognition and interventions to resolve adherence barriers observed during home visits may improve adherence. this proposal will test the hypothesis that home-visits which identify previously unrecognized adherence barriers and provide support and education will increase medication adherence among children and youth with hiv infection and improve the patient/health care provider relationship. specific aims of the study are: 1. determine the impact of a series of home-visits on adherence to medication regimens for hiv infected youth and children. 1a. adherence to medical regimens will be assessed before and after the series of home-visits using a self-report questionnaire and microelectronic monitoring system (mems) or in-home pill count. 1b. for each of these measures a percentage of adherence will be calculated and compared from a baseline to after the final home visit and after the six month follow up period. 2. assess the changes in patient satisfaction from baseline to after the home-visits using a questionnaire completed by the patient/family. 3. incorporate a pilot study to assess the changes in the provider's knowledge of the patient's family characteristics and home circumstances relevant to adherence following the home visits.


Eligibility criteria:
inclusion criteria: * hiv positive * english speaking * live in denver metro area * taking \>=1 antiretroviral medication

Keywords: hiv
pet-fdg in myocarditis

Conditions: Myocarditis; Viral Myocarditis

Summary: this study evaluates the diagnostic performance of 18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose (fdg) positron emission tomography/computed tomography (pet/ct) with rest perfusion imaging for the diagnosis of myocarditis. patients with clinical suspicion of myocarditis will be recruited and undergo a rest myocardial perfusion scan and a fdg pet/ct scan following a myocardial suppression protocol.

myocarditis is characterized by myocardial inflammation, which can lead to fibrosis and heart failure. fdg pet/ct, with appropriate suppression protocol including high-fat-low-carbohydrate diet, fasting, and iv heparin, can be use to detect myocardial inflammation. it is frequently used for the diagnosis of inflammation in cardiac sarcoidosis. after the initial inflammatory phase, inflammation resolves and fibrosis can seen. resting perfusion imaging will allow identification of fibrosis. the combination of fdg pet/ct and rest perfusion imaging could allow detection of the various phases of myocarditis; inflammation and fibrosis.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. clinical suspicion of myocarditis due to findings such as: 1. symptoms and signs of myocarditis such as dyspnea, orthopnea, palpitation, and chest pain, without other identifiable cause 2. new onset of cardiovascular symptoms with recent history of viral disease or previous myocarditis 3. unexplained new onset of left ventricular dysfunction 4. unexplained elevated troponin 5. magnetic resonance imaging findings suggestive of myocarditis, such as late gadolinium enhancement and edema 6. biopsy findings compatible with myocarditis 3. women of childbearing potential must have a negative urine or blood pregnancy test 4. capable of giving informed consent and the consent must be obtained prior to any study related procedures 5. subject's with body mass index inferior or equal to 45 kg/m2 exclusion criteria: 1. female subject who is pregnant or breastfeeding and unwilling to stop for 24h 2. claustrophobia or inability to lie still in a supine position for imaging purposes 3. unwillingness or inability to provide informed consent
european home mechanical ventilation registry

Conditions: Pulmonary Disease, Chronic Obstructive; Amyotrophic Lateral Sclerosis; Spinal Cord Injury; Muscular Dystrophies; Obesity Hypoventilation Syndrome; Kyphoscoliosis; Congenital Central Hypoventilation Syndrome; Duchenne Muscular Dystrophy; Myopathies; Myotonic Dystrophy

Summary: the european home mechanical ventilation registry (ehmvr) will enable a thorough evaluation of hmv by documenting the characteristics of hmv patients and their treatment. this will facilitate a prospective, observational study to identify the primary indications for hmv, describe patterns of hmv use in european countries, and characterize changes in the initiation and utilization of hmv over time. the registry will target all adult individuals who have an indication for hmv. in the ehmvr, patient data from routine clinical care will be documented using an electronic case report form (ecrf). the ecrf will record: patient demographic data; diagnostic information (including primary diagnosis, 6-minute walk time, the presence of depression, and quality of life); blood gases; ventilation treatment (including type of ventilator, modes and settings, interfaces used); follow-up data (including failure rates, side effects, technical issues). an initial pilot phase will be launched with the aim to enrol at least 200 patients over a 6-month period to determine the feasibility of the registry. steering committee members and their institutions will be the main participants in the pilot phase. after completion of the pilot phase, the registry will be expanded across europe with the goal of enrolling approximately 10,000 patients over 5 years.

the data (baseline and follow-up) should be collected as part of routine clinical care. in clinical practice, after hmv initiation, the first control examination (follow-up number one) with nocturnal diagnostics should take place within the first 4-8 weeks. annual follow-up is required, and it is recommended that subsequent control visits should be performed 1-2 times a year. each patient will be included for 5 years (total duration of the registry).

Eligibility criteria:
inclusion criteria: * patients aged ≥18 years with an indication to receive hmv as part of routine clinical care * patient is able to fully understand the study information and is willing to give informed consent * patient, or the patient's legal guardian, signing the consent form exclusion criteria: - no exclusion criteria have been defined because only data from routine clinical care are needed, plus a separate healthcare questionnaire
a study of brain receptor occupancy in healthy subjects

Conditions: Alcohol Dependence

Summary: to measure the occupancy of brain kappa opioid receptors after single oral doses of ly2456302.


Eligibility criteria:
inclusion criteria: * healthy male or female * have clinical laboratory tests within normal reference ranges * have arterial and venous access sufficient to allow blood sampling exclusion criteria: * currently enrolled in, or discontinued within the last 30 days from a clinical trial * history of severe allergies or multiple adverse drug reactions * have an abnormal ecg at screening visit * have abnormal sitting blood pressure * have an increased risk of seizures * current suicidal ideation * positive test for hiv, hepatitis c, or hepatitis b * women who are breast feeding * smoke more than 10 cigarettes per day, or equivalent * drink more than 5 cups of coffee per day, or equivalent * have a history of head injury * unable to undergo a mri * suffer from claustrophobia
a study of ibandronate (bondronat) in participants with malignant bone disease

Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis

Summary: this study will assess the efficacy and safety of ibandronate (bondronat), administered intravenously (iv) or orally (po), in participants with malignant bone disease and moderate to severe pain. participants will be randomized to receive ibandronate either as a 6-mg iv infusion every 3 to 4 weeks or a 50-mg tablet po daily. pain response and karnofsky performance index (kpi) will be measured at intervals throughout the study. the anticipated time on study treatment is 4 months and the target sample size is 150 individuals.


Eligibility criteria:
inclusion criteria: * adults at least 18 years of age * malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (gi) tract, ovary, or bladder * bone pain defined as a brief pain inventory (bpi) most acute pain score greater than or equal to 4 * radiologically confirmed bone disease disease exclusion criteria: * previous treatment with ibandronate (bondronat) within previous 2 months * severely impaired renal function * known brain metastases
lymph node yield in colon cancer resection specimens

Conditions: Colon Cancer; Lymph Node Metastases

Summary: in this study, we aimed to develop a predictive model of lymph node yield in a series of colon cancer resection specimens with detailed anatomic and surgical technique data.

lymph node yield in colon resection specimens has been associated with the accuracy of staging and cancer outcomes. it has been proposed that the more central the mesenteric vascular ligation, the greater the nodal yield. however, the optimal number of harvested nodes is still a matter of debate. we prospectively evaluated the relation between specimen properties such as lenght, area, tumor location and pedicle length to the number of harvested nodes and rate of node positivity.

Eligibility criteria:
inclusion criteria: the surgical patients with a histologic diagnosis of colonic neoplasm, colectomy of any type, including the right hemicolectomy, the left hemicolectomy, the sigmoid resection, segmental colon resection exclusion criteria: * rectal or rectosigmoid cancer colectomy beyond the inclusion criteria for colectomies patients younger than 18 previous colon resection emergency colon resection familial adenomatous polyposis or ulcerative colitis

Keywords: ileocolic pedicle colon cancer staging
is 10 injections of bladder botox less painful than 20 injections?

Conditions: Overactive Bladder

Summary: the purpose of this research study is to help determine if 10 injections of botox ® 100 units is less painful than 20 injections of botox ® 100 units based on effectiveness in reducing urge incontinence episodes. study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

this study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor botox® toxin for the treatment of refractory overactive bladder.

Eligibility criteria:
inclusion criteria: * female gender * at least 18 years of age * have already decided to undergo intradetrusor botox® injections for treatment of refractory overactive bladder. * able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization). * understands and is willing to undergo follow up and complete questionnaires as described in this protocol * able to give informed consent exclusion criteria: * male gender * neurological conditions (examples: cerebral vascular accident within 6 months prior to treatment, parkinson's disease, multiple sclerosis, and spina bifida). * acute urinary tract infection * treatment with botox® toxin for other conditions * allergy to botox® toxin * hematuria that has not been worked up * known bladder malignancy * previous history of bladder augmentation * currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding * currently taking aminoglycoside antibiotics * post-void residual (pvr) \>150 cc (measured by bladder scan or by catheterization) prior to enrollment * history of chronic pain or pain syndromes

Keywords: overactive bladder botox/onabotulinumtoxina pain oab non-neurogenic overactive bladder
prophylactic antibiotic treatment for laparoscopic inguinal hernia mesh repair: necessary or not?

Conditions: Hernia, Inguinal

Summary: the purpose of this study is to find out whether it is necessary to prophylactically treat patients undergoing laparoscopic inguinal hernia repairs with antibiotics. our hypothesis is that it is not necessary to pretreat patients with antibiotics if the operation is minimally invasive with a mesh placed at the defect.

the investigators plan to follow up at least 100 patients who did not receive antibiotics prior to their inguinal hernia repair and compare their outcome to 100 patients who did receive prophylaxis. the investigators mainly will be analyzing the incidence of surgical site infections as evidenced by swelling, redness, pain, warmth or other signs deemed by the surgeon.

Eligibility criteria:
inclusion criteria: * elective laparoscopic inguinal hernia repair, unilateral or bilateral exclusion criteria: * those requiring antibiotics for the surgery; * those patients who have experienced surgical site infections from previous surgeries

Keywords: inguinal hernia mesh repair prophylactic antibiotics herniorrhaphy laparoscopic inguinal hernia repair
a study to assess the safety, tolerability, and efficacy of monthly subcutaneous administration of ion904 in participants with uncontrolled hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the effect of ion904 on plasma angiotensinogen (agt) in participants with uncontrolled hypertension.

this is a phase 2, multicenter, double-blind, randomized, placebo-controlled study. it will include up to approximately 48 participants with mild to moderate hypertension who have uncontrolled blood pressure (˃ 130 - ≤ 170 millimeters of mercury \[mmhg\] systolic) and have been on one or more anti-hypertensive medications for at least one month. following an up to 4-week screening period, eligible participants will receive multiple doses of ion904 during a 13-week treatment period, followed by a 13-week post-treatment follow-up period.

Eligibility criteria:
general inclusion criteria: 1. males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (wocbp), she uses a highly effective contraceptive method. aged 18 - 75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent 2. body mass index (bmi) ≤ 45.0 kilograms per square meter (kg/m\^2) at screening 3. history of uncontrolled hypertension (htn) on one or more antihypertensive medications without changes in antihypertensive regimen within 4 weeks of screening and will be required to maintain this regimen throughout the treatment period general exclusion criteria: 1. history of secondary htn including, but not limited to any of the following: renovascular htn (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug induced htn 2. unstable/underlying known cardiovascular disease defined as: * any history of congestive heart failure (new york heart association \[nyha\] class iii-iv) * any history of previous myocardial infarction, coronary revascularization, unstable or stable angina pectoris ˂ 6 months prior to screening * any hemodynamically unstable atrial or ventricular arrhythmias * significant uncorrected valvular heart disease * any history of stroke or transient ischemic attack \< 6 months prior to screening 3. a cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening