Kornimate/medical-research-clean huggingface dataset:
development and validation of a health-related quality of life instrument

Conditions: Cancer

Summary: this study aims to develop a health related quality of life (hrqol) patient reported outcome (pro) for patients receiving immune checkpoint modulator (icm) therapy. this instrument could be used to in clinical trials to evaluate hrqol for patients treated with novel icms and icm combinations that might ultimately influence decisions about regulatory approval, as well as improved understanding of chronic treatment effects on patient well-being, understanding reasons for treatment non-adherence, and developing strategies to improve adherence and evaluating clinical outcomes.

immune checkpoint modulators (icms) are associated with significant adverse events. currently there are no validated patient reported outcome (pro) tools to assess health related quality of life (hrqol) specifically in patients receiving icms. hrqol is a multidimensional concept of a patient's perceived well-being that can be affected by disease and treatment. there is an urgent need to assess the impact of icms on hrqol, to better understand the balance between efficacy and toxicity with these agents. this study aims to develop a health related quality of life (hrqol) patient reported outcome (pro) for patients receiving immune checkpoint inhibitor (icm) therapy (fact-icm). the core domains of the fact-icm will include physical, emotional, family and social, and functional well being. in addition, the proposed study will develop a toxicity sub-scale related to resultant toxicities from icm therapy. the hrqol will be developed through focus groups and interviews with patients treated with icms, and clinicians treating patients with icms, to understand how treatment with icms impacts hrqol, as well as explore general experiences, insights and concerns of those receiving icm therapies.

Eligibility criteria:
inclusion criteria: patient criteria * cancer diagnosis (any type, advanced or metastatic stage); * treatment with an agent or agents that modulate an immune checkpoint (any line of therapy); * age ≥ 18; * english-speaking; * ecog ps 0-3 * able to complete questionnaires independently * able to provide informed consent. * completed treatment within a year of enrolment clinician criteria * must either treat patients with icms or manage side effects of patients treated with icms * be able to attend interviews and participate in discussions as part of the study

Keywords: icms immune checkpoint modulators
prophylactic coagulation for the prevention of bleeding in endoscopic mucosal resection of large sessile colonic polyps

Conditions: Adenomatous Polyp of Large Intestine

Summary: the hypothesis of this study is that prophylactic coagulation therapy with coagulation forceps to visible vessels within the mucosal defect for colonic endoscopic mucosal resection (emr) will reduce the rate of delayed bleeding when compared with current established standard emr technique.

delayed bleeding from the site of the resection remains one of the most common complications following emr, occurring in up to 12% of patients. the purpose of the study is to prevent such bleeding with the use of a technique known as: "coagulation therapy." this therapy involves using a small dose of heat energy that results in clotting(coagulation) of a blood vessel. it is already used widely in the stomach and we intend using this on a lower setting to blood vessels that are exposed after the resection.

Eligibility criteria:
inclusion criteria: * patients referred to westmead hospital endoscopy unit for endoscopic removal of a large sessile colonic polyp sized \>20mm * age \>18 years * able to give informed consent to involvement in trial exclusion criteria: * pregnancy: currently pregnant or attempting to become pregnant * lactation: currently breastfeeding * taken clopidogrel within 7 days * taken warfarin within 5 days * had full therapeutic dose unfractionated heparin within 6 hours * had full therapeutic dose low molecular weight heparin (lmwh) within 12 hours * known clotting disorder
evaluation of many men, many voices, an std/hiv prevention intervention for black msm

Conditions: HIV Infections; Sexually Transmitted Diseases

Summary: the purpose of this program evaluation is to determine whether the "many men, many voices" hiv/std prevention intervention is effective in reducing hiv sex risk behaviors and increasing hiv testing among african-american men who have sex with men (msm), who may or may not self-identify as gay. the intent of this program is to support the evaluation of an existing intervention and provide feedback to the implementing organization for improved program effectiveness, not to conduct research.

black men who have sex with men (msm) in the united states experience disproportionately high rates of hiv and other sexually transmitted infections (stis); however, the number of evidence-based interventions for black msm is limited. this study evaluated the efficacy of many men, many voices (3mv), a small-group hiv/sti prevention intervention developed by black msm-serving community-based organizations and a university-based hiv/sti prevention and training program. the study sample included 338 black msm of hiv-negative or unknown hiv serostatus residing in new york city. participants were randomly assigned to the 3mv intervention condition (n = 164) or wait-list comparison condition (n = 174). relative to comparison participants, 3mv participants reported significantly greater reductions in any unprotected anal intercourse with casual male partners; a trend for consistent condom use during receptive anal intercourse with casual male partners; and significantly greater reductions in the number of male sex partners and greater increases in hiv testing. this study is the first randomized trial to demonstrate the efficacy of an hiv/sti prevention intervention for black msm.

Eligibility criteria:
inclusion criteria: * black men who have sex with other men (i.e., self-identify as gay or bisexual or same gender-loving, or sexually active with other men and do not identify as gay or bisexual, or have sexual or emotional attraction to other men) * 18 years of age or older * self-report their hiv serostatus as negative or unknown * willing to attend an intervention retreat (without their primary partner) * willing to discuss male-to-male sex * resident of the new york metropolitan area and plan to reside in that area for at least 6 months * not previously participated in a many men, many voices intervention program exclusion criteria: * individuals indicating an hiv positive serostatus * under 17 years of age * individuals not meeting the inclusion criteria specified above

Keywords: adult hiv infections / pc [prevention & control] homosexuality, male humans male risk-taking safe sex sexual behavior hiv
long-term administration study of snd 919 tablets in parkinson's disease

Conditions: Parkinson Disease

Summary: to evaluate the efficacy and safety of long-term treatment with pramipexole tablets (bi sifrol®) in parkinson's disease (phase iii study).

the efficacy and safety of long-term treatment with pramipexole (bi sifrol®) were evaluated in parkinson disease patients in an open-label non-controlled design. the treatment was initiated at 0.125 mg bid (after breakfast and supper). the dose was increased stepwise with due caution regarding the symptoms and safety of each patient, up to 1.5 mg tid (after each meal). the treatment period was set at 56 weeks, followed by a stepwise dosedecreasing period (maximum 4 weeks). study hypothesis: comparison(s):

Eligibility criteria:
inclusion criteria: patients with a diagnosis of parkinson's disease (including juvenile parkinsonism) (1) patients meeting all of the following inclusion criteria 1. patients of at least 20 years of age 2. in- or outpatients of either sex. 3. patients in any stage on the modified hoehn and yahr severity scale exclusion criteria: * patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour. * patients with subjective symptoms derived from orthostatic hypotension. * patients with hypotension (systolic blood pressure \<100 mmhg) * patients with concomitant illness such as severe cardiac, renal, and hepatic disease * patients with a current or past history of epilepsy * pregnant, possibly pregnant, or lactating women * patients receiving any other investigational products or who have received any other investigational product within 6 months of the study. * patients who judged incompetent to give consent * others judged by the investigator or co-investigator to be ineligible as subjects.
correlation of volumetric brain analysis with development at 18 months

Conditions: Child Development

Summary: the study will correlate the volumes of the brain obtained from magnetic resonance imaging (mri) scans done at term gestation for infants born prematurely who weighed less than 1000 grams at birth with their corresponding development at 18 months corrected age.


Eligibility criteria:
inclusion criteria: * all premature infants born \< 1000 grams who had mri scans of the brain at term gestation exclusion criteria: * any known genetic or chromosomal abnormalities
ovarian reserve after cancer: longitudinal effects

Conditions: Effects of Chemotherapy; Premature Ovarian Failure

Summary: women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.

a total of 7 study visits will be completed at 3 month intervals including 1 visit prior to treatment, and at least 2 visits after completion of treatment. duration of study participation is 18-30 months, depending on length of treatment. review and documentation of cancer therapy will be abstracted from the clinical oncology chart by the oncology offices caring for the patient. treatment will be summarized in terms of chemotherapeutic type, duration and cumulative dose; total radiation dose and location; history and type of bone marrow transplantation; and any surgery. any attempts at fertility preservation or use of gonadotropin releasing hormone agonist treatment during cancer therapy will be captured as well.

Eligibility criteria:
inclusion criteria for exposed population: * postmenarchal females to be treated with chemotherapy * between the ages of 11-35 years, * with a uterus and at least one ovary inclusion criteria for unexposed population: * healthy postmenarchal females * no prior or planned exposure to chemotherapy * between the ages of 11-35, * with a uterus and at least one ovary * regular menstrual cycles (21-35 days) exclusion criteria for all subjects: * positive pregnancy test at enrollment * lactation within the previous 1 month, * previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer. * previous diagnosis of an illness associated with premature ovarian failure (turner's syndrome, fragile x permutation carrier) * endocrine disorder associated with irregular menstrual cycles (cushing's disease, thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia). additional exclusions for the unexposed population: * a history of infertility, defined as at least 12 months of unprotected intercourse without conception * polycystic ovary syndrome (pcos)

Keywords: new diagnosis of cancer chemotherapy oncofertility alkylating agent fertility preservation fertility after cancer late effects
long-term outcomes of ataluren in duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Disease; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn

Summary: this study is a long-term study of ataluren in participants with nonsense mutation duchenne muscular dystrophy.

this study is a randomized, double-blind, placebo-controlled, 72-week study, followed by a 72-week open-label period. the purpose is to characterize the long-term effects of ataluren-mediated dystrophin restoration on disease progression. participants will be randomized in a 1:1 ratio to ataluren or placebo. participants will receive blinded study drug three times daily (tid) at morning, midday, and evening for 72 weeks, after which all participants will receive open-label ataluren for an additional 72 weeks (144 weeks in total). study assessments will be performed at clinic visits every 12 weeks during the double-blind period and every 24 weeks during the open-label period. the total sample size of \~250 subjects will include \~160 subjects who meet the criteria for inclusion in the primary analysis population (age 7 to 16 years old, baseline six minute walk distance (6mwd) greater than or equal to (\>=) 300 meters, supine to stand \>= 5 seconds). the study will be conducted in the united states and other countries around the world.

Eligibility criteria:
inclusion criteria: * male sex * age ≥5 years * phenotypic evidence of duchenne muscular dystrophy * nonsense point mutation in the dystrophin gene * use of systemic corticosteroids (prednisone/prednisolone or deflazacort)for a minimum of 12 months immediately prior to start of study treatment, with no significant change in dosage or dosing regimen for a minimum of 3 months immediately prior to start of study treatment * 6mwd ≥150 meters * ability to perform timed function tests within 30 seconds * willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions. exclusion criteria: * any change in prophylaxis treatment for cardiomyopathy within 1 month prior to start of study treatment. * ongoing intravenous (iv) aminoglycoside or iv vancomycin therapy. * prior or ongoing therapy with ataluren. * known hypersensitivity to any of the ingredients or excipients of the study drug * exposure to another investigational drug within 6 months prior to start of study treatment, or ongoing participation in any interventional clinical trial. * history of major surgical procedure within 12 weeks prior to start of study treatment, or expectation of major surgical procedure during the 72-week placebo-controlled treatment period. * requirement for daytime ventilator assistance or any use of invasive mechanical ventilation via tracheostomy. * uncontrolled clinical symptoms and signs of congestive heart failure * elevated serum creatinine or cystatin c at screening.

Keywords: duchenne muscular dystrophy dystrophinopathy nonsense mutation premature stop codon becker muscular dystrophy dmd/bmd ptc124 ataluren
memory during inhalation anesthesia performed with or without bispectral index (bis) in patients undergoing thyroidectomy

Conditions: Thyroidectomy

Summary: the purpose of this study is 1) to investigate whether the use of bis as a guide to the administration of inhaled anesthetic (sevoflurane or desflurane) compared with the use of hemodynamic parameters (blood pressure and heart rate) would affect the occurrence of implicit memory and /or dreams recall and 2) to check whether the occurrence of implicit memory and/or dreams recall is related with mac (minimal alveolar concentration) of inhalational anesthetics and/or preoperative anxiety levels.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years * class-asa physical status i-ii exclusion criteria: * psychiatric or neurological disorders and/or hearing disorders * obesity (body mass index \> 30) * drug addiction, alcoholism * patient with difficulty in understanding italian language and/or education level below middle school
safety and efficacy of oncoxin in hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma

to assess therapeutic efficacy and safety of oncoxin in hepatocellular carcinoma to see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of oncoxin to see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of oncoxin to see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of oncoxin to see if there is improved survival in hepatocellular carcinoma patients after administration of oncoxin

Eligibility criteria:
inclusion criteria: * patients with hcc irrespective of etiology, age, gender and status of underlying liver disease. * patients with hcc who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy. * patients with hcc who have evidence of tumor metastasis * patients with hcc who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy. * patients with hcc in whom all possible treatment options have been exhausted. exclusion criteria: * patients with hcc who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy. * patients with hcc who have no evidence of tumor metastasis * patients with hcc who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy. * patients with hcc who are voluntarily unwilling to be included in the trial

Keywords: oncoxin safety of oncoxin therapeutic efficacy of oncoxin improvement of quality of life with oncoxin survival benefit with oncoxin
role of anti-platelet in treatment of acute ischemic stroke

Conditions: Stroke

Summary: role of anti-platelet in treatment of acute ischemic stroke to determine the safety of immediate anti-platelet therapy .that is started as soon as possible within the first 24 hours of the onset of symptoms.

in 2015, stroke was the second most frequent cause of death after coronary artery disease, accounting for 6.3 million deaths (11% of the total).studies have reported a 30-day recurrence rate of 1.1 to 15 % after stroke and as high as 17% after transient ischemic attack .therefore, early initiation of antiplatelet agents in ischemic stroke and patients is important to prevent stroke recurrence and is tracked as a quality measure by organizations that accredit stroke centers . intravenous thrombolysis with alteplase is the mainstay medical treatment for acute ischemic stroke. given intravenously within 4.5 hours of symptom onset, to reopen occluded intracerebral arteries. as in fact most patients with ischemic stroke present to the emergency department beyond the approved time window for thrombolytic or other revascularization therapies beside their high cost and at this time, there are no approved urgent therapies for most of these patients in addition, those who present with rapidly resolving deficit or low national institutes of health stroke scale score are generally not considered for thrombolytic treatment, although approximately one third of them may be at high risk for neurological deterioration and recurrent vascular events.this study will evaluates the safety and efficacy of clopidogrel and aspirin in treatment of patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy with acute ischemic stroke and transient ischemic attack within 24 hours of symptoms onset.

Eligibility criteria:
inclusion criteria: 1. age of the patients is 40 years or older. 2. patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy presenting after 6hours of onset of symptoms. 3. patients presented with clinical symptoms of acute stroke or tia with onset less than 24 hours before starting any treatment. 4. the diagnosis of stroke or tia basing on clinical examination using national institute of health stroke scale (nihss) by a stroke specialist exclusion criteria: 1. any history of ich or systemic hemorrhage. 2. any evidence of hemorrhage on baseline ct brain imaging. 3. patients presented with failed medical or surgical thrombectomy. 4. international normalized ratio (inr) more than 1.5. 5. history of allergy to aspirin or clopidogrel or both of them. 6. platelets count less than 100,000/mm3. 7. hematocrit less than 30 mg/dl . 8. glucose less than 50 mg/dl or greater than 400 mg/dl.to exclude hypoglycemia induced focal neurological deficit.
soluble st2 and cardiovascular outcome

Conditions: Cardiovascular Disease

Summary: cardiac surgery induces hemodynamic stress on the myocardium, and this process can be associated with significant cardiovascular morbidity and mortality. soluble suppression of tumorigenicity 2 (sst2) is biomarker of myocardial remodeling and fibrosis; however, little is known regarding their potential association with cardiovascular events. this study aimed to investigate the release of sst2 and its association with cardiovascular events undergoing cardiac surgery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * congenital heart disease requiring surgery * valvular heart disease requiring surgery * arrhythmia requiring surgery * aortic dissection requiring surgery * coronary heart disease requiring surgery exclusion criteria: * age \<18 years * pregnancy * severe renal dysfunction (creatinine \>200µmol/l) * not capable of understanding or signing informed consent.