Kornimate/medical-research-clean huggingface dataset:
partners prep program

Conditions: HIV Infections

Summary: through close collaboration with the ugandan ministry of health, the investigators plan to provide prep for hiv-negative members of hiv serodiscordant couples by launching prep delivery within 12 public art clinics in kampala, uganda. intervention delivery will be launched in a staggered fashion among clinics through a stepped wedge cluster randomized trial providing a rigorous research opportunity to measure the effect of the intervention on prep and art initiation and adherence. to measure these outcomes using clinic records and biomarkers, the program will enroll approximately 1440 hiv serodiscordant couples. additionally, the program will collect qualitative and quantitative data to determine if prep-taking is a modeled behavior that facilitates art use and characterize the way that prep and art use interact within couples and estimate the programmatic costs of the integrated prep and art strategy.


Eligibility criteria:
inclusion criteria: for both members of the couple * age ≥18 years * able and willing to provide informed consent * sexually active with each other * willing to engage with the clinic system as a couple for hiv-positive members of the couples (index participants) * hiv-positive, according to national hiv testing algorithm * recent diagnosis as a member in an hiv serodiscordant couple * not currently enrolled in an hiv treatment clinical trial for hiv-negative members of the couples (partner participants) * hiv-negative, according to national hiv testing algorithm * recent diagnosis as a member in an hiv serodiscordant couple * not currently enrolled in an hiv treatment clinical trial * not currently using prep * eligible for prep, according to who or ugandan national guidelines exclusion criteria: - otherwise not eligible based on the above inclusion criteria
study evaluating the addition of sildenafil to bosentan therapy in pulmonary arterial hypertension

Conditions: Hypertension, Pulmonary

Summary: this study will examine the effects of add-on sildenafil to bosentan monotherapy in patients with pulmonary arterial hypertension. patients on bosentan monotherapy will be followed every 6 months to assess if they have met the pre-defined treatment goals. if a patient fails to achieve these treatment goals or fails to maintain them, sildenafil will be added to their existing bosentan monotherapy. patients will be assessed 6 months after start of combination therapy for changes in 6mwt, borg dyspnea scale, who functional class, quality of life.


Eligibility criteria:
inclusion \& exclusion criteria
testing spectrosense eva system for detection of breast cancer by analyzing volatile organic compounds (vocs) in exhaled air

Conditions: Breast Cancer

Summary: volatile organic compounds (voc) in human breath are captured and analyzed by the spectrosense eva system, which is combination of a gas chromatography (gc) and software algorithm. the objective is to obtain a set or sets of voc bio-markers that will provide the best discrimination between breast cancer sick population and healthy population. the gold standard for identifying sick/healthy population is biopsy proven breast cancer.


Eligibility criteria:
breast cancer group: inclusion criteria: * age from 18 years old * breast cancer positive biopsy * before any treatment * signed informed patient consent exclusion criteria: * age under 18 years old * neoadjovant treatment * post surgery for breast cancer * a history of any other cancer type, except skin cancer that is not melanoma healthy group: inclusion criteria: * healthy women * no history of breast cancer * signed informed patient consent exclusion criteria: * history of breast cancer * breast cancer background in the family * a history of any other cancer type, except skin cancer that is not melanoma
quality of life and depression in dialysis patients

Conditions: Chronic Kidney Disease Stage 5

Summary: the aim of this study is to evaluate quality of life (qol) and depression in peritoneal dialysis patients compare to hemodialysis patients and assess hydration effect on qol and depression over time.

in dialysis patients, low qol and depression affects clinical outcomes such as morbidity and mortality. therefore at the point of treating dialysis patients, it is important to provide not only physical health but also psychosocial health. qol could be decided by physical health (i.e. sign and symptom, laboratory results, death) and psychological health (i.e. fatigue, pain, consciousness of health and satisfaction). and also generally it is well known that physical and psychological functions in dialysis patients are decreased. and especially depression is common disease in dialysis patients. it is also well known that about from 25 to 50 percent of dialysis patients have depression which could result in low qol moreover hospitalization, complication, and mortality. but there is no qol and depression study with hydration status. therefore the investigators would like to explore it. the objective of the study is to evaluate quality of life (qol) and depression in dialysis patients and assess the hydration effect on qol and depression over time

Eligibility criteria:
inclusion criteria: * dialysis patients, age from 18 years to 75 years * incident continuous ambulatory peritoneal dialysis(capd) or automated peritoneal dialysis(apd) patients who don't have any experience of dialysis treatment before this study * prevalent peritoneal dialysis(pd) patients who are getting peritoneal dialysis treatment more than 6 months * prevalent hemodialysis (hd) patients who are getting haemodialysis treatment more than 6 months * the subjects who are eligible for 1 year follow up * written informed consent before any trial related activities * eligible patients to complete questionnaire exclusion criteria: * prognosis for survival less than 3 months * kidney transplantation less than 15 months * ineligible patients for questionnaire * any malignancies and ascites * any condition which could interfere with the patient's ability to comply with the study protocol * ineligible to measure bcm 1. pacemaker, defibrillator 2. pregnancy or lactation period 3. amputation 4. artificial joint

Keywords: quality of life depression bcm (body composition minitor) hydrational status
continuous positive airway pressure for the treatment of stroke

Conditions: Acute Ischemic Stroke; Sleep Apnea

Summary: new stroke therapies are needed. this study seeks to provide the preliminary data needed to plan a future study that will evaluate the efficacy of using continuous positive airway pressure (cpap) to treat stroke patients who have sleep apnea. our goal is to use this therapy to reduce stroke symptom severity.

background sleep apnea occurs in 60-96% of stroke survivors and is associated with poor functional recovery and higher post-stroke mortality. among patients without stroke, continuous positive airway pressure (cpap) is a safe and effective treatment for sleep apnea. this feasibility pilot study is a step in planning a future efficacy trial of cpap for patients with acute ischemic stroke. objectives the primary objectives are, among acute ischemic stroke patients, to: (1) determine the feasibility of performing polysomnography; (2) refine the process for providing cpap within 48-hours of stroke onset; and (3) determine the effect of cpap on blood pressure. methods this randomized controlled feasibility study will enroll 100 acute ischemic stroke patients. intervention patients (n=60) receive cpap within 48 hours of stroke onset and continuing for up to 30 days. at 30 days post-enrollment, the intervention patients undergo unattended polysomnography. control (n=40) patients receive unattended polysomnography at baseline and after 30 days. significance cpap represents an important new potential therapy for acute stroke. cpap may reduce both the neurological symptom severity of the acute stroke and prevent stroke recurrence.

Eligibility criteria:
inclusion criteria: acute ischemic stroke with nih stroke scale \>=2 - exclusion criteria: respiratory distress; copd requiring oxygen; primary intracranial hemorrhage on admission brain imaging; time from symptom onset to sleep study or cpap treatment \>72 hours or time from hospital admission to sleep study or cpap treatment \>48 hours; life expectancy less than 6 months; inability to provide informed consent; inability to communicate in english; residence outside the greater new haven area; or any condition where the monitoring required by the study would constitute a risk to the patient or impair his or her care. -

Keywords: acute ischemic stroke sleep apnea continuous positive airway pressure
a study to assess the efficacy and safety of asp1941 in japanese type 2 diabetes patients

Conditions: Type 2 Diabetes Mellitus

Summary: this study is to compare the efficacy and safety of asp1941 with placebo in japanese patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients for at least 12 weeks * hba1c value between 7.0 and 10.0% * body mass index (bmi) 20.0 - 45.0 kg/m2 * investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment exclusion criteria: * type 1 diabetes mellitus patients * serum creatinine \> upper limit of normal * proteinuria (albumin/creatinine ratio \> 300mg/g) * dysuria and/or urinary tract infection, genital infection * significant renal, hepatic or cardiovascular diseases * severe gastrointestinal diseases

Keywords: blood glucose asp1941 diabetes mellitus
ozurdex monotherapy trial

Conditions: Uveitis, Posterior; Uveitis, Intermediate; Panuveitis

Summary: this study will investigate the efficacy and safety of ozurdex® (dexamethasone intravitreal implants; dex, allergan, inc. irvine, ca) as monotherapy for the treatment of non-infectious intermediate-, posterior- or panuveitis. this is a prospective randomized controlled clinical trial taking place at the university of ottawa eye institute, ottawa, ontario, canada, and other possible centers in canada. consecutive consenting subjects who meet inclusion/exclusion criteria will be selected to participate in this study. the subjects must have either non-infectious intermediate, posterior, or panuveitis. the subjects will be randomly chosen to be part of one of two groups; one group will receive dex as monotherapy and the other group will receive oral prednisone. approximately 84 eyes (42 per arm) will take part in study. the primary outcome will measure the proportion of eyes with a vitreous haze score of 0 six months post initial treatment. secondary measures will include best corrected visual acuity (bcva), central retinal thickness (crt) measured by spectral-domain optical coherence tomography (sd-oct), time to vitreous haze resolution and time to failure defined at number of months with dex implant until an adjunct therapy is indicated. baseline measurements will be recorded within 1 month prior to treatment in both groups, with follow up measurements collected at 0, 1, 2, 4, 6 and 12 months post-operatively.


Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of non-infectious intermediate, posterior, or panuveitis in at least one eye * active uveitic disease at screening/baseline defined by the presence of at least 1 of the following parameters: 1) active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2) ≥ 1+ vitreous haze (nei/sun criteria) exclusion criteria: * presence of isolated anterior uveitis * evidence of macular edema due to diabetes, retinal vein occlusion or any other ocular conditions * confirmed or suspected active ocular disease or infections * intraocular surgery in the past 6 months * history of glaucoma * intraocular pressure (iop) of \>21 mmhg at screening/baseline or confirmed normal-tension glaucoma * intravitreal or periocular injection within 6 months prior to screening. * unable to tolerate systemic corticosteroids * prior topical corticosteroid within 1 month of screening * prior non-steroidal anti-inflammatory, systemic steroids, or immunomodulatory therapy (e.g. methotrexate) within 1 month of screening * for women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study
acupuncture for the immune system in radiation cancer patients

Conditions: Gastrointestinal Neoplasms; Urogenital Neoplasms

Summary: purpose/goal: to investigate how long course radiation therapy (rt), both with or without chemotherapy, affects the immune system, and to determine if acupuncture can modify these effects in patients undergoing curative radiation therapy for gastrointestinal (gi) or genitourinary (gu) cancers. clinical or research questions: 1. does rt reduce immune biomarkers in treated subjects? 2. which biomarkers are most affected by treatment? 3. is acupuncture a feasible option to help ameliorate any biomarker effects? 4. does rt affect subject symptoms? 5. is acupuncture a feasible option to help ameliorate any symptom effects?

research indicates that patients undergoing curative rt for various cancers experience adverse immune effects, as indicated by reduced biomarker levels and activity. rt has been observed to cause a striking reduction in total lymphocyte count, affecting mainly the t-cells. furthermore, the reduction in the lymphocyte count after rt has been correlated with poorer outcome for bladder cancer, head and neck cancer, uterine cancer, and brain metastases. research into the use of complementary and alternative medicine (cam) has been conducted to determine the utility of these treatments in addressing the unmet needs of many patients with cancer. there is preliminary evidence that acupuncture, in particular, is successful at improving many cancer and treatment associated effects. earlier studies have indicated that acupuncture can play a role in regulating immune system response to various morbidities, including chemotherapy induced immunosuppression. however, little research has examined is potential for radiation therapy patients this pilot study aims to assess a wide range of general immune biomarkers to identify biomarkers most affected by rt. through use of a symptom assessment survey, changes in self reported symptoms will also be recorded. the feasibility of acupuncture as a strategy to ameliorate any adverse immune or symptom effects will also be examined. this information could be very useful in planning future studies on rt and the immune system, or the potential immune benefits of acupuncture.

Eligibility criteria:
inclusion criteria: * patients who will receive ≥ 4 weeks of curative intent long course rt for a gi or gu malignancy * patients may or may not have received / be receiving adjuvant chemotherapy * anticipated survival of at least 12 months * able to visit the bcca vic for treatment and 2 follow up visits exclusion criteria: * scheduled to receive rt for a period of less than 4 weeks * expected survival period is less than 12 months * are on anticoagulants

Keywords: radiotherapy acupuncture immune system
vitamin d and outcome in cardiac surgery

Conditions: Cardiovascular Disease

Summary: we will use a retrospective data analysis to evaluate the association of the two vitamin d metabolites 25-hydroxyvitamin d and 1,25-dihydroxyvitamin d with clinical outcome in cardiac surgical patients. the occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. in addition, we will assess the association of the two vitamin d metaboolites with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. moreover, in-hospital stay will be assessed according to vitamin d metabolite levels.

in a retrospective data analysis, we will evaluate the association of vitamin d metabolites (circulating 25-hydroxyvitamin d and 1,25-dihydroxyvitamin d) with macce (major cardiac or cerebrovascular event) in cardiac surgical patients. the occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. approximately 4,000 data sets from mid of 2012 until the end of 2013 will be analyzed. in all patients, we will also assess the association of vitamin d metabolite levels with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. moreover, in-hospital stay will be assessed according to vitamin d status

Eligibility criteria:
inclusion criteria: * cardiac surgical patients aged 18 years and older exclusion criteria: * age \< 18 years * heart transplant recipients * pacemaker or defibrillator implantation

Keywords: vitamin d 25-hydroxyvitamin d 1,25-dihydroxyvitamin d macce mortality cardiac cerebrovascular
study of obeldesivir in nonhospitalized participants with covid-19

Conditions: COVID-19

Summary: the goal of this clinical study is to test if obeldesivir (gs-5245) is safe and effective for the treatment of coronavirus disease 2019 (covid-19) in participants who have a standard risk of developing severe illness. this study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.


Eligibility criteria:
key inclusion criteria: * severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (pcr), rapid antigen test, or an approved alternative assay. serologic tests will not be accepted. * willing and able to complete the coronavirus disease 19 (covid-19) symptom questionnaire prior to first dose and daily throughout the study period. * initial onset of covid-19 signs/symptoms ≤ 3 days before randomization with ≥ 2 of the following targeted symptoms, at moderate or higher severity, present at randomization. * stuffy or runny nose. * sore throat. * shortness of breath (difficulty breathing). * cough. * low energy or tiredness. * muscle or body aches. * headache. * chills or shivering. * feeling hot or feverish. * not currently hospitalized or requiring hospitalization. key exclusion criteria: * any risk factors for progression to severe disease. * planning to receive a direct acting antiviral or monoclonal antibody against sars-cov-2 for the treatment of covid-19. * received any direct acting antiviral drug or monoclonal antibody against sars-cov-2 for the treatment of covid-19 \< 28 days or \< 5 half-lives, whichever is longer, before randomization. * received any convalescent covid-19 plasma or other antibody-based anti-sars-cov-2 prophylaxis at any time prior to study entry. * received an covid-19 vaccine (including booster dose) \< 120 days before randomization. * self-reported covid-19 diagnosis \< 120 days before randomization. * anticipated need for hospitalization \< 48 hours after randomization. * new oxygen requirement \< 24 hours before randomization. * known influenza, or any other suspected or confirmed concurrent active systemic infection other than covid-19 that may interfere with the evaluation of response to the study drug. * known history of chronic liver disease, limited to cirrhosis, nonalcoholic steatohepatitis, alcoholic liver disease, and autoimmune hepatitis. * undergoing dialysis, or known history of chronic kidney disease. * persistent symptoms from previous covid-19 illness that may interfere with the evaluation of response to the study drug. * pregnant or breastfeeding. * unwilling to use protocol-mandated contraception. * any other factor, including inability to complete the patient-reported outcome (pro) questionnaire for the primary endpoint, making the individual, in the opinion of the investigator, unsuitable to participate in the study. * concurrent participation/enrollment in a separate therapeutic clinical study. note: other protocol defined inclusion/exclusion criteria may apply.
effect of right lateral position on ventilated preterm neonates

Conditions: Gastro Esophageal Reflux

Summary: objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates. study design: this randomized controlled trial was conducted on 60 ventilated preterm neonates \< 35 weeks. they were randomized into 2 groups; one group composed of 30 neonates that were nursed in right lateral position for 6 hours while the other group composed of 30 neonates that were nursed in supine position for 6 hours. tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured.

objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates. study design: this randomized controlled trial was conducted on 60 ventilated preterm neonates \< 35 weeks. they were randomized into 2 groups; one group composed of 30 neonates that were nursed in right lateral position for 6 hours while the other group composed of 30 neonates that were nursed in supine position for 6 hours. tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured. ventilatory settings were observed before and during the intervention and neonates were followed up for development of bronchopulmpnary dysplasia (bpd).

Eligibility criteria:
inclusion criteria: * a total of 60 preterm neonates \ 30ml/kg/day via nasogastric tube. exclusion criteria: * neonates with perinatal asphyxia, intracranial hemorrhage grade 3 or 4, periventricular leukomalacia, major congenital anomalies, gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis , receiving xanthine derivatives, h2 blockers, prokinetics, proton pump inhibitors or sedatives were excluded.