Kornimate/medical-research-clean huggingface dataset:
study to gather information about proper dosing and safety of the oral fxia inhibitor bay 2433334 in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot has formed somewhere in the human body (but not in the heart) travelled to the brain.

Conditions: Acute Non-cardioembolic Ischemic Stroke

Summary: the purpose of this study is to try to find the best dose of the new drug bay 2433334 to give to participants and to look at how well bay 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. bay 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral fxia inhibitor.


Eligibility criteria:
inclusion criteria: * participant must be 45 years of age and older at the time of signing the informed consent * non-cardioembolic ischemic stroke with * persistent signs and symptoms of stroke lasting for ≥ 24 hours or * acute brain infarction documented by computed tomography (ct) or mri and * with the intention to be treated with antiplatelet therapy during the study conduct * imaging of brain (ct or mri) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation) * severity of index event nearest the time of randomization: * part a: minor stroke (defined as national institutes of health stroke scale (nihss) ≤ 7) can be enrolled * part b: participants with minor or moderate stroke and nihss ≤ 15 can be enrolled. participants undergoing thrombolysis or endovascular therapy (mechanical thrombectomy) can be enrolled but at the earliest 24 hours after the intervention * randomization within 48 hours after the onset of symptoms of the index event (or after patients were last known to be without symptoms in case of wake-up stroke) * ability to conduct an mri either before randomization or within 72 hours after randomization exclusion criteria: * prior ischemic stroke within last 30 days of index event * history of atrial fibrillation or suspicion of cardioembolic source of stroke * dysphagia with inability to safely swallow study medication * contraindication to perform brain mri * part a only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event * active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization.
the effects of various concentrations of ropivacaine on the onset and duration of ankle blocks

Conditions: Hallux Valgus; Anesthesia

Summary: peripheral nerve blocks are essential in ensuring effective regional anesthesia and postoperative analgesia in forefoot surgery for hallux valgus repair. many factors influence the onset and duration of peripheral nerve blocks. in the advent of ultrasound-guided nerve blocks, the accuracy in administering la has significantly improved, potentially reducing the required dosage, which is also associated with less risk for toxicity. however, the effect of the concentration of la on the onset time and duration of ultrasound-guided ankle blocks for forefoot surgery has not yet been studied. this poses a clinically relevant dilemma regarding the necessity of administering lower or higher concentrations of ropivacaine to achieve a clinically relevant faster onset time and longer duration of an ankle block.

this study aims to evaluate the differential effects of 0.25%, 0.5%, and 1% ropivacaine on the onset time and duration of ultrasound-guided ankle blocks in patients having forefoot surgery for anesthesia and postoperative analgesia. we hypothesize that the use of 1% ropivacaine for ultrasound guided ankle blocks will result in a significantly faster onset time and a longer sensory block duration, and thus analgesia, compared to the use of 0.25% and 0.5% ropivacaine in patients having forefoot surgery. the primary outcome is the difference in the duration of the sensory blocks. the secondary outcomes are the difference in onset time of the sensory block, motor function, the postoperative pain scores, opioid consumption, and proportion of failed blocks.

Eligibility criteria:
inclusion criteria: * provide signed and dated informed consent * age 18 to 75 years, scheduled for elective forefoot surgery for hallux valgus repair under unilateral ankle block at zol genk * asa physical i-ii-iii * able to ambulate (ability to walk independently, with or without assistive devices) * able to learn and perform study sensory and motor assessment by exhibiting sensitivity to pinprick, cold, and light touch (tested beforehand with pinprick/cold/ light touch sensation test) as the patient will have to perform these sensory and motor assessments by him/herself at home at postoperative day 0 to 2 exclusion criteria: * language barrier * preexisting lower extremity neuropathy * contraindications to ankle block (local infection, edema, burn, soft tissue trauma, or distorted anatomy with scarring in the area of block placement) * contraindications for use of nsaids * allergy to local anesthetics * uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessment * weight below 50 kg based on a maximum dose of 3 mg/kg ropivacaine and a maximum dose of 150 mg ropivacaine. * preoperative use of opioids or gabapentin less than 3 days before surgery * contraindications for use of paracetamol * contraindications for use of tramadol

Keywords: ropivacaine peripheral nerve block locoregional anesthesia onset duration sensory block
a multicenter, open-label, randomized, 24-week study to compare the safety and activity of indinavir sulfate, 800 mg q 8 h versus 1,200 mg q 12 h in combination with zidovudine and 3tc

Conditions: HIV Infections

Summary: to demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (zdv) (or stavudine, d4t) and lamivudine (3tc) for 24 weeks to protease inhibitor- and 3tc-naive hiv-1-seropositive patients. to characterize the steady-state pharmacokinetic profiles of indinavir, zdv (or d4t), and 3tc in the presence of each other, for both the control and test regimen groups.

patients are randomized to 1 of 2 arms: arm a: indinavir plus zdv plus 3tc. arm b: indinavir (test dose) plus zdv plus 3tc. note: d4t may be substituted for zidovudine for toxicity management. patients are stratified based on prior use of nucleoside analogs (naive vs experienced to zdv, dideoxyinosine \[ddi\], dideoxycytidine \[ddc\], and d4t) and screening viral rna results (lower than 50,000 copies/ml vs more than 50,000 copies/ml).

Eligibility criteria:
inclusion criteria patients must have: * hiv-1 seropositive status. * cd4 count greater than 100 cells/mm3. * viral rna above 10,000 copies/ml. * consent from parent or guardian if less than 18 years of age. exclusion criteria prior medication: excluded: * prior therapy with protease inhibitors. * prior therapy with 3tc.

Keywords: hiv-1 drug therapy, combination zidovudine hiv protease inhibitors lamivudine indinavir reverse transcriptase inhibitors
ct 327 in the treatment of atopic dermatitis

Conditions: Mild to Moderate Atopic Dermatitis

Summary: this study will look at how safe and effective, a novel agent, ct 327 cream is in treating patients with mild to moderate atopic dermatitis (ad). patients will be treated twice daily for 14 days on specific lesions of ad and safety and symptoms of ad will be assessed throughout the treatment period.


Eligibility criteria:
inclusion criteria: * male and female subjects aged \>18 year * written informed consent * mild to moderate ad at baseline (easi score of at least 2 or 3) * active ad (visible eczema, erythema and pruritus) * presence of at least four target lesions (symmetrically) at inclusion (ideally at the elbow flexions and knee bends) exclusion criteria: * if female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (iud); contraceptive injection, implant or patch * if female, are pregnant or lactating, or intend to become pregnant during the study period * allergy to test drug or excipients * usage of topical corticosteroids or other topical treatments for ad within the last two weeks prior to study entry (including calcineurin inhibitor, topical h1 and h2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment * within 4 weeks prior to study entry, have received systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light). * presence of major medical illness requiring systemic therapy including cancers * clinical diagnosis of bacterial infection of the skin including impetigo and abscesses * any clinical relevant ecg abnormality * have any clinically significant abnormal clinical laboratory test results at screening * received any investigational drug or taking part in any clinical study within three months prior to this study * history of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
prospective identification and validation of "brcaness" profile in ovarian epithelial cancer

Conditions: Ovarian Neoplasms

Summary: this is an observational prospective study. patients diagnosed with advanced epithelial ovarian cancer (stage ic or higher) since 2008 will be asked to participate in this study by signing an informed consent. tumour samples will be reviewed to confirm the diagnosis and to select the best regions for tissue sampling to perform the following molecular studies: array-based comparative genomic hybridization and next generation sequencing. detected mutations will be analysed by sanger sequencing. fish probes will be designed and tested on the samples.


Eligibility criteria:
inclusion criteria: * patients diagnosed with advanced epithelial ovarian cancer (stage ic or higher). exclusion criteria: * non
group psychotherapy for patients with hidradenitis suppurativa: effects in quality of life

Conditions: Hidradenitis

Summary: the aim of this study is to determine the benefits of group psychotherapy on quality of life for people with hidradenitis suppurativa receiving medical and surgical treatment versus a control group (awaiting group) treated with medical and surgical treatment, without psychotherapy.

further investigations studies are needed to determine the efficacy of psychological interventions for people with hidradenitis suppurativa. the aim of this study is to determine the benefits of group psychotherapy on quality of life for people with hidradenitis suppurativa receiving medical and surgical treatment versus a control group (awaiting group) treated with medical and surgical treatment, without psychotherapy. this is an experimental randomized trial with control group. quality of life, symptoms: pruritus, odor and pain, distress and the illness will be measured before and after the intervention using psychological and quality of life questionnaires, and dermatological evaluations for 120 subjects. the investigators expect that the experimental group scores at the end of the psychotherapy program will be less than 4 points in visual analog scale (vas) for pruritus, odor and pain. the dermatology quality of life index (dqli) expected to be less than 4 points from the initial score, and the patients are expected to present less than 7 points in hospital anxiety and depression scale (hads). the experimental group scores will be less than the control group for quality of life, symptoms and distress.

Eligibility criteria:
inclusion criteria: * men and women at least 18 years old at the time of selection. * subjects diagnosed with hidradenitis suppurativa. * subjects that are in dermatological treatment. * patients should be able to understand and communicate with the investigator. exclusion criteria: * subjects suffering from a serious concomitant illness. * subjects with a mental illness. * subjects who are performing psychiatric treatment. * subjects who are performing psychotherapy sessions both individual and group. * patients who have alcohol dependence or drug abuse. * subjects that present legal incapacity or limited legal capacity. * subjects presenting illiteracy or language barriers.

Keywords: quality of life psychotherapy hidradenitis treatments
diagnosis and treatment of sleep apnea in cerebrovascular disease

Conditions: Obstructive Sleep Apnea; Stroke; Transient Ischemic Attack; Hypertension

Summary: sleep apnea is common among veterans with cerebrovascular disease (stroke or transient ischemic attack \[tia\]), leads to hypertension, and is associated with recurrent stroke and death. although continuous positive airway pressure (cpap) safely treats sleep apnea, few veterans with cerebrovascular disease are diagnosed with sleep apnea or offered treatment.

the project sought to evaluate whether a diagnostic and therapeutic intervention strategy among veterans with cerebrovascular disease and hypertension using unattended polysomnography and auto-titrating cpap with a targeted adherence evaluation and educational protocol resulted in: an improved rate of diagnosed sleep apnea, an improved rate of treated sleep apnea, and improved blood pressure control.

Eligibility criteria:
inclusion criteria: stroke or transient ischemic attack hypertension exclusion criteria: * prior diagnosis of sleep apnea or other sleep disorder * life expectancy \< 6 months or hospice * non-english speaker * unable/unwilling to use mask * inability to give informed consent * oxygen dependent copd * chronic renal failure with dialysis * active suicidal ideation

Keywords: sleep apnea hypertension brain ischemia
a research study comparing active drug in the blood in healthy participants following dosing of the current and a new formulation (c) semaglutide tablets

Conditions: Healthy Volunteers; Type 2 Diabetes

Summary: in this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. besides semaglutide, the current version of the tablet contains 300 mg snac and 3 helping agents, while the new version of the tablet contains 300 mg snac and only one helping agent. both are for the treatment of diabetes. currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. semaglutide cannot yet be prescribed as a tablet. the aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. for this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. participants will get semaglutide in the current tablet formulation and in a new formulation - in which order they receive the two different formulations is decided by chance. participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment for a total of 12 weeks). the tablets should be taken in the morning together with half a glass of water (120 ml), after an overnight fast of at least 6 hours (no food or drinks). furthermore, water is not allowed from 2 hours before dosing. after dosing participants must wait 30 minutes before they may eat or drink. at home, they must take their breakfast 30-45 minutes after dosing.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. * body mass index between 20.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive). * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * glycated haemoglobin (hba1c) equal to or above 6.5 % (48 mmol/mol) at screening. * use of tobacco and nicotine products, defined as any of the below: * smoking more than 5 cigarettes or the equivalent per day * not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s) * history (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). * presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. * personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject). * history (as declared by the subject) or presence of pancreatitis (acute or chronic).
arthroscopic repair of partial thickness articular side rotator cuff tears using transtendon versus conversion repair techniques

Conditions: Rotator Cuff Tears

Summary: this study aims to compare the functional results of patients who underwent two different arthroscopic methods for the management of articular-sided partial-thickness rotator cuff tears (pt-rcts). the present study aims to compare the functional results following the repair of pt-rcts using the conversion versus the trastendon techniques

this is a prospective randomized study carried out at a tertiary trauma center between october 2022 and june 2023. the research ethical committee authorized this study protocol \[(institutional review board (irb) number: n-383-2023)\], and all participants signed an informed consent prior to joining the study. this study included 50 patients with pt-rcts who underwent arthroscopic repair using either the conversion technique (25 patients) in group a or the transtendon technique (25 patients) in group b. the random assignment of all patients to enter either group was computerized using simple randomization.

Eligibility criteria:
the inclusion criteria were: * patients suffering symptomatic pt-rcts exceeding 50% of the tendon thickness, documented by preoperative magnetic resonance imaging (mri) and confirmed by arthroscopy intraoperative. * failure of nonoperative management for at least 3 months. the exclusion criteria were: * prior shoulder surgery. * severe concomitant pathologies including glenohumeral arthritis, advanced subscapularis tear, and biceps tendon rupture. * associated bankart lesion. * patients with uncontrolled diabetes mellites.

Keywords: partial thickness rotator cuff tear; transtendon technique; conversion technique.
randomized controlled study comparing colon evaluation with the pure-vu system to a standard colonoscopy in patients who are high risk for inadequate bowel preparation

Conditions: Gastrointestinal Disease; Colorectal Cancer

Summary: the primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after pure-vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care.

total of 88 subjects (44 per arm) at high risk for inadequate colon preparation will be randomized and undergo procedure either in the control arm (standard of care) or with the pure-vu system. subjects will be enrolled at up to 4 clinical sites in the united states. primary endpoint- a comparison between the two study arms (i.e., pure-vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the bbps scoring index (bowel preparation adequacy defined as bbps \>2 in each segment) the following secondary endpoints will be determined: 1. assess the willingness of consented subjects to pay for pure-vu prior to colonoscopy 2. colonoscopy procedural measures for intervention and control arms 3. endoscopists' experience 4. safety assessment for all subjects on the day of procedure per endoscopist 5. post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy 6. assess the willingness of consented subjects to pay for the pure-vu system 1-3 days after colonoscopy follow-up call will be conducted 1-3 business days after the procedure to verify that there has been no change in their clinical status and record their willingness to use the pure-vu system in the future.

Eligibility criteria:
inclusion criteria: 1. adults \> age 22 2. elective outpatient colonoscopy by participating gastroenterologist 3. stool clarity grade 1-3 at presentation for colonoscopy exclusion criteria: 1. not competent to consent 2. bleeding disorder - known or suspected 3. hereditary gastrointestinal cancer syndrome 4. known pt inr \> 1.5 5. know elevated ptt 6. anti-platelet agent or anticoagulant (other than aspirin or nonsteroidal agent) which has not been stopped for the colonoscopy 7. known platelet count \< 50,000 8. known absolute neutrophil count \< 1,000 9. history of surgical colon resection 10. pre-colonoscopy intent to enter terminal ileum 11. prior incomplete colonoscopy due to technical \& non-bowel preparation related reasons 12. regular use of non-topical steroid 13. pregnant 14. prisoner or institutionalized for any reason 15. psychiatric illness greater than mild 16. colonoscopy without anesthesia administered (mac) sedation 17. diverticulitis 18. active inflammatory bowel disease (crohn's, ulcerative colitis, or indeterminate) 19. known or suspected colon stricture

Keywords: colonoscopy