Kornimate/medical-research-clean huggingface dataset:
'olap' (olaparib regulatory post-marketing surveillance)

Conditions: Ovarian Cancer; Breast Cancer; Prostate Cancer; Pancreatic Cancer

Summary: the objectives of this study are to assess safety and effectiveness of lynparza tablet (olaparib, hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug according to the approved indications in south korea

primary objective: to assess the safety of the study drug for patients prescribed with the study drug under the approved indications in south korea secondary objective: to assess effectiveness of the study drug for patients prescribed with the study drug under the approved indication in south korea exploratory objective: to assess effectiveness of the study drug for ovarian cancer patients diagnosed as homologous recombination deficiency (hrd) positive via locally available validated hrd test and prescribed with the study drug under the approved indication in south korea

Eligibility criteria:
inclusion criteria: 1. eligible for the study drug treatment according to the approved label in south korea 2. provision of signed and dated written informed consent by the patient or legally acceptable representative exclusion criteria: 1. history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug 2. prior exposure to any polyadenosine 5'diphosphoribose polymerase (parp) inhibitors, including the study drug 3. pregnant and/or breast feeding 4. current participation in any interventional trial 5. other off-label indications according to the approved label
integrating hypertension and cardiovascular diseases care into existing hiv services package in botswana (intercare)

Conditions: HIV Infections; Hypertension

Summary: the intercare research project proposes to leverage a successful national art program to develop an effective package to improve the uptake of established effective hypertension and cvd risk factors management interventions among plwhiv in botswana and other low- and middle-income countries. being the first project of its kind in botswana, if successful, the intercare package could be readily rolled out to health facilities nationwide to diagnose, treat, track, and support the estimated 25-30% batswana with hypertension.

the intercare research project is in 2 phases: 1. phase 1 is a pilot study to refine the 3 interventions mentioned above. this formative phase will take place between september 2021 and november 2022. clinics staff will receive training on the management of cvd (and hypertension in particular) in-person or online. attendees feedback will be sought to improve the curriculum prior to being rolled-out in the next phase of this research project. in parallel, the intercare study team will work with the 2 clinics information technology teams to adapt the existing electronic health records with cvd-specific flags, medication lists and laboratory panels. finally, up to 288 participants (plwhiv) and their treatment partners will be enrolled from those 2 clinics patients lists to pilot the overall intercare package. the results and experiences from the pilot stage will be assessed and collated to make improvements to each of the 3 intervention in the package. this final set of improved interventions will be the basis of the second phase of the intercare research project. phase 1 was successfully completed in november 2022. 2. the intercare package will be tested as a cluster randomised trial in 14 clinics around botswana: 7 clinics will receive the intercare package while the remaining 7 clinics will not received any intervention, continuing with the local standard of care, with a target combined recruitment target of 4652 participants overall, to be followed up for 24 months. phase 2 is anticipated to take place from january 2023 to july 2025.

Eligibility criteria:
inclusion criteria for participants: * adults aged 20-75 years old * documented hiv-infection on art * confirmed diagnosis of hypertension or elevated blood pressure \>140/90mmhg versus \>130/80mmhg if they have underlying diabetes mellitus or chronic kidney disease * receiving regular care at the selected clinics exclusion criteria: ● positive for hiv-related dementia inclusion criteria for participants' treatment partners: * adults aged 18 years of age or older * selected to be a treatment partner by participant.
microflare protocol in poor responders

Conditions: Female Infertility Due to Diminished Ovarian Reserve

Summary: the effect of use of the microflare down regulation protocol on the outcome of the ivf/icsi cycles in poor responders

the microflare as a method of down regulation protocol can be used to prepare the females suffering from poor ovarian reserve to undergo ivf/icsi cycles. in this study we are trying to outline its effect on the clinical pregnancy rate as a main primary outcome, and to compare its use with the addition of growth hormone to the same protocol.

Eligibility criteria:
inclusion criteria: * females fulfilling the criteria of the eshre consensus 2011: at least two of the following three features must be present: (i) advanced maternal age (≥40 years) or any other risk factor for por; (ii) a previous por (≤3 oocytes with a conventional stimulation protocol); (iii) an abnormal ovarian reserve test (i.e. afc ,5-7 follicles or amh ,0.5 -1.1 ng/ml). exclusion criteria: * women who suffer from any other cause of infertility other than poor ovarian reserve * refusal of the patient to consent for using her data in the study.

Keywords: poor responders poor ovarian response ivf/icsi microflare protocol growth hormone oral contraceptive pills
acute study on muscle soreness, damage, and performance

Conditions: Soreness, Muscle; Performance Enhancing Product Use; Damage Muscle

Summary: the acute study will evaluate pre- and post-exercise ingestion of a multi-ingredient supplement in a randomized, double-blind, placebo-controlled, crossover design. participants will complete one enrollment visit, in which they will sign a consent form and complete a health history questionnaire. participants will complete two interventions, with three visits each (6 visits total), in which a treatment beverage (pre/post supplement, or non-caloric placebo) will be consumed within 30 minutes prior to exercise and within 15 minutes post-exercise, in random order. total time from enrollment to completion will be at least 14 days. testing visits will be separated by a minimum of 7 days of rest to allow for recovery and washout, based on a half-life of ≤8 hours for all ingredients present in the supplement.


Eligibility criteria:
inclusion criteria: * participant is an adult between the ages of 25-50 years * participant has a recorded bmi of 20-35 kg/m2 * participant exercises less than 3 hours per week for at least 8 weeks preceding the study * participant has provided written and dated informed consent to participate in the study * participant is willing to and able to comply with the protocol * participant is apparently healthy and no reported metabolic disorders, heart disease, arrhythmias, thyroid disease, renal, hepatic, autoimmune or neurological diseases, as determined by a health history questionnaire * participant agrees to maintain current diet and exercise routine during the study * participant agrees to refrain from taking any anti-inflammatory supplement 48 hours prior to exercise (acute) or medications to prevent any further nutritional or drug related protection against exercise induced muscle damage * participant has a resting (seated for 5 minutes) blood pressure of systolic pressure between 140-90 mmhg and a diastolic pressure between 90-50 mmhg exclusion criteria: * participant is currently enrolled in a separate clinical trial or weight loss program involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement * participant is using, or has consistently used one of the following dietary supplements within 12 weeks prior to enrollment: beta-alanine, creatine, hmb, carnosine, vitamin d * participant has consistently consumed whey protein/plant protein and/or 1,000 mg of fish oil within the previous 4 weeks prior to enrollment * participant has gained or lost ≥ 8 lbs in the previous month * participant has a known allergy or sensitivity to the placebo or active ingredients * participant has used tobacco more than three days per week (on average) in the previous 6 months, or refuses to abstain from all tobacco use for the duration of the study * participant is pregnant or planning to become pregnant * participant has any musculoskeletal condition prohibiting them from participation
robust i pilot study, re-establishing flow via drug coated balloon for the treatment of urethral stricture disease

Conditions: Stricture Urethra

Summary: robust i study is a feasibility study for evaluating the safety and efficacy of dcb.

the study is designed to determine the safety and effectiveness for drug coated balloon (dcb). up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of us. due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. subjects will be followed up post-treatment to one year and then annually for up to 5 years. the annual follow up after the first year is optional.

Eligibility criteria:
inclusion criteria: 1. male subjects ≥ 18 years' old 2. visual confirmation of stricture via cystoscopy or urethrogram 3. single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm 4. one to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) including dviu (direct vision internal urethrotomy), but no prior urethroplasty 5. significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent uti's. 6. ipss score of 13 or higher 7. lumen diameter \<12f by urethrogram 8. able to complete validated questionnaire independently 9. qmax \<10 ml/sec exclusion criteria: 1. strictures greater than 2.0 cm long. 2. subjects that have more than 1 stricture. 3. sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel 4. subjects who have a suprapubic catheter and are unable to complete study required testing, such as uroflowmetry 5. previous urethroplasty within the anterior urethra 6. stricture due to bacterial urethritis or untreated gonorrhea 7. stricture dilated or incised within the last 3 months 8. presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula. 9. presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as bph at the discretion of the clinical investigator 10. previous radical prostatectomy 11. previous pelvic radiation 12. diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months. 13. diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dl 14. use of alpha blockers, beta blockers, oab (overactive bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (stable dose is defined as having the same medication and dose in the last six months.) 15. use of botox (onabotulinumtoxina) in urinary system within the last 12 months

Keywords: reduced urine flow rate low peak flow rate urinary tract infections
effect of salt solution immersion bath on cancer in vivo.

Conditions: Cancer

Summary: this study evaluates the effectiveness of hypertonic saline bath in reducing the cancer nodules' size, number and suvmax.

many previous studies have shown that the cancer cells are over-hydrated, and that hyponatraemia exists in many cases of cancer. the cancer cell's viability depends on angiogenesis and formation of blood vessels that carry water and nutrient to the rapidly-dividing cancer cells. this study tests the hypothesis that disrupting the water content of blood could lead to increasing its tonicity and hence withdrawing water from the cancer cells by osmosis, which can result in disrupting the growth of the cancer cell itself. this disruption of blood water content can be achieved using osmotic pressure differential via immersing the whole body in hypertonic saline solution for a certain amount of time, thus making the blood more hypertonic relative to the cells of the body and of the cancer, leading to water withdrawal from the cells of the body and of the cancer. while body's cells can sustain temporary dehydration, cancer cells could be negatively affected.

Eligibility criteria:
inclusion criteria: * patients with pet/ct scan-confirmed cancer (any type, any location and any stage) who have poorly responded to at least one cycle of conventional and standard therapy (chemotherapy, radiation or drug therapy) . * age 5 to 80 years old * life expectancy of at least 1 year * can understand and read english * lives in calgary alberta exclusion criteria: patients with the following medical conditions will be excluded: 1. kidney diseases 2. dialysis 3. fever 4. on blood thinners or with any coagulation disorder 5. history of stroke 6. hypernatraemia 7. hypotension (low blood pressure) 8. hypovolemia/dehydration 9. tachycardia (rapid heart rate) 10. epilepsy 11. open wounds 12. any medical condition that might cause the patient to lose consciousness 13. participants who cannot tolerate thirst during the 30 minutes bath. 14. participants who are not residents of calgary alberta canada with a valid alberta health card.
acupressure in reducing post-tbi fatigue

Conditions: Fatigue

Summary: fatigue is a common symptom experienced by patients with traumatic brain injury (tbi). prior works have demonstrated that it may profoundly impact the ability to return to productive activity and cognitive functions. however, few interventions have been applied in this population.the purpose of the current will be to test the effect of acupressure on fatigue reduction after traumatic brain injury.

fatigue is a pervasive and critical long-lasting symptom experienced by patients with traumatic brain injury (tbi) and can persist up to months or years after head injury. however, thus far, only few non-pharmacological interventions, such as mindfulness, are implemented in reducing fatigue in tbi survivors. prior works have suggested that acupressure can significantly improve fatigue in different populations, such as cancers survivors and patients with hemodialysis. therefore, we would like to test whether acupressure effectively improve fatigue after tbi.

Eligibility criteria:
inclusion criteria: * diagnosed with traumatic brain injury over 6 months with initial gcs (admitted gcs) from 3-12. * aged between 20-65 years * are able to communicate in chinese and mandarin * are able to complete the questionnaires * complain of tiredness and cannot be restored even after a rest. * no physical disability and visual impairment exclusion criteria: * with skin lesion * had diagnosis of neuropathy and paraesthesia prior to study.
evaluation of the ambulatory medical assistance nurse program in chronic lymphocytic leukemia

Conditions: Chronic Lymphoid Leukemia

Summary: the emergence of targeted therapy (ibrutinib, venetoclax, acalabrutinib) has revolutionized the management practices of chronic lymphoid leukemia due to their effectiveness. however, targeted therapy induces a significant additional cost compared to treatment with immunochemotherapy and their use can be problematic due to the frequent occurrence of side effects, which can be serious. in order to improve the current management of patients treated with targeted therapy, the aim of this study is to evaluate the ambulatory medical assistance nurse program. ambulatory medical assistance is based on regular telephone calls to patient's homes by a specialist nurse and consists of the monitoring, detection and early management of possible adverse effects of targeted therapy, in link with the hematologist. the main objective of this clinical research is to determine efficiency of the ambulatory medical assistance nurse program.

this research is a prospective randomized multicenter comparative study in 2 parallel groups (1: 1) : patients benefiting from the ambulatory medical assistance nurse program in addition to conventional care versus patients benefiting from conventional care. for each patient, data will be collected during 2 years.

Eligibility criteria:
inclusion criteria: * men and women over the age of 18 * patients with chronic lymphoid leukemia and starting treatment with targeted therapy: ibrutinib, venetoclax or acalabrutinib, alone or in combination with obinutuzumab or rituximab in 1l or r/r according to the indications of the marketing authorization. * be able to understand the objective and the constraints related to the research * patient having signed the consent form * patient with social security affiliation or equivalent * person able to speak on the phone exclusion criteria: * patient who has already benefited from ambulatory medical assistance nurse program with a previous treatment * pregnant women * patients under judicial protection

Keywords: targeted therapy ambulatory medical assistance chronic lymphoid leukemia real-world costs
study to evaluate adverse events and change in disease activity in adult and adolescent participants with acute hepatitis c virus (hcv) infection on treatment with oral tablets of glecaprevir (gle)/pibrentasvir (pib)

Conditions: Hepatitis C Virus (HCV)

Summary: hcv infection is a global health problem. hcv mainly affects liver cells and causes the liver to become inflamed and damaged. this study will evaluate how safe and effective glecaprevir/pibrentasvir (gle/pib) is in adult and adolescent participants with acute hcv infection. gle/pib is an approved drug for the treatment of chronic hcv. around 283 participants at least 12 years of age with acute hcv infection will be enrolled in approximately 70 sites worldwide. participants will receive oral tablets of gle/pib once daily (qd) for 8 weeks and will be followed for 12 weeks after the end of treatment. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * evidence of acute hcv infection prior to enrollment, defined as a physician diagnosis of acute hcv infection, quantifiable hcv ribonucleic acid (rna) at screening, and at least 1 of the following: * negative anti-hcv antibody, hcv rna and/or hcv core antigen followed by a positive hcv rna or hcv core antigen all within an 8-month period prior to screening; or * negative anti-hcv antibody, hcv rna and/or hcv core antigen followed by a positive hcv rna or hcv core antigen all within an 11-month period prior to screening; and risk behavior for hcv infection within 6 months prior to positive hcv rna or hcv core antigen; or * clinical signs and symptoms compatible with acute hepatitis \[alanine aminotransferase (alt) \> 5 × upper limit of normal (uln) and/or jaundice\] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive hcv rna or hcv core antigen all within an 8-month period prior to screening; and risk behavior for hcv infection within 6 months prior to positive hcv rna or hcv core antigen; or * negative anti-hcv antibody with a positive hcv rna or hcv core antigen within a 5-month period prior to screening. * absence of hepatocellular carcinoma (hcc), for participants with cirrhosis, or with indeterminate cirrhosis status, as indicated by a negative ultrasound, computed tomography (ct) scan or magnetic resonance imaging (mri) within 3 months prior to screening or a negative ultrasound at screening. participant who has a positive ultrasound result suspicious of hcc followed by a subsequent negative ct scan or mri or biopsy result will be eligible for the study. * participants documented as having no cirrhosis or as having compensated cirrhosis. exclusion criteria: * participants with prior treatment, including interferon for this hcv infection. * history of liver decompensation.

Keywords: acute hcv infection hcv genotype 1-6 hepatitis c glecaprevir pibrentasvir mavyret
a study to investigate the effect of sff on glucose and insulin responses

Conditions: Postprandial Glycemic Response

Summary: this goal of this clinical study is to investigate the postprandial glycemic and insulinemic response in healthy adults after the consumption of: 1. sugars from fiber in comparison with dextrose 2. sugars from fiber incorporated into chocolate chips in comparison with regular chocolate chips


Eligibility criteria:
inclusion criteria: 1. individuals, 20-65 years of age, inclusive. 2. body mass index (bmi) between 19 and 35 kg/m², inclusive, at screening. 3. willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. 4. willing to maintain current dietary supplement and non-exclusionary medication use throughout the trial. 5. willing to avoid the consumption of alcohol, unusual food intake, and unusual physical activity 24h prior to each study visit. failure to follow will result in rescheduled visit. 6. understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected. health information to the study investigator. exclusion criteria: 1. failure to meet any one of the inclusion criteria. 2. known history of gastrointestinal disease (e.g., diverticulitis, crohns disease, coeliac disease etc.), bariatric surgery, aids, hepatitis, a history or presence of clinically important endocrine (including type 1 or type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, or biliary diseases, or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results. 3. use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results. 4. major trauma or surgical event within 3 months of screening. 5. unwillingness or inability to comply with the experimental procedures and to follow inquis safety guidelines. 6. known intolerance, sensitivity or allergy to test foods. 7. extreme dietary habits, as judged by the investigator (i.e. atkins diet, very high protein diets, etc.). 8. history of cancer in the prior two years, except for non-melanoma skin cancer. 9. exposure to any non-registered drug product within 30 d prior to screening. 10. self-reported pregnancy or breastfeeding.