Kornimate/medical-research-clean huggingface dataset:
(peak) a phase 3 randomized trial of cgt9486+sunitinib vs. sunitinib in subjects with gastrointestinal stromal tumors

Conditions: Advanced Gastrointestinal Stromal Tumors; Metastatic Cancer

Summary: this is a phase 3, open-label, international, multicenter study of cgt9486 in combination with sunitinib. this is a multi-part study that will enroll approximately 442 patients. part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of cgt9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for gist and 2) evaluating the potential for drug-drug interactions between cgt9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (tkis) for gists. the second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of cgt9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. additionally, a drug-drug interactions substudy will investigate the potential for cgt9486 to be a cyp3a4 inducer in approximately 16 patients who have received at least one prior line of therapy for gist.


Eligibility criteria:
key inclusion criteria: 1. histologically confirmed locally advanced, metastatic, and/or unresectable gist. molecular pathology report must be available for part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization. 2. documented disease progression on or intolerance to imatinib 3. subjects must have received the following treatment: ddi substudy/part 1a: treatment with ≥1 prior lines of therapy for gist part 1b: treatment with ≥2 prior tki for gists part 2: prior treatment with imatinib only 4. have at least 1 measurable lesion according to mrecist v1.1 (part1a, part 1b, part 2) 5. ecog - 0 to 2 6. have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits key exclusion criteria: 1. known pdgfr driving mutations or known succinate dehydrogenase deficiency 2. clinically significant cardiac disease 3. major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug 4. gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption 5. any active bleeding excluding hemorrhoidal or gum bleeding 6. seropositive for hiv 1 or 2, or positive for hepatitis b surface antigen or hepatitis c virus (hcv) antibody. 7. active, uncontrolled, systemic bacterial, fungal, or viral infections at screening 8. received strong cyp3a4 inhibitors or inducers 9. received sunitinib within 3 weeks (part 1a, part 1b, ddi substudy)

Keywords: sunitinib solid tumors gastrointestinal stromal tumors gastrointestinal kit kinase inhibitors growth inhibitors cgt9486 unresectable metastatic gist bezuclastinib plx9486 midazolam drug-drug interaction
prevention of injuries by an exercise program - a rct

Conditions: Patellofemoral Pain Syndrome; Exertional Lower Leg Pain

Summary: overuse injuries are a major concern for physical active individuals. study hypothesis is that an exercise programme based on known intrinsic risk factors can prevent overuse injuries in soldiers undergoing basic military training.

purpose: overuse injuries are a major concern for physical active individuals engaged in endurance type activities. this is especially true for soldiers during basic military training or subjects with a sedentary lifestyle taking up exercise to prevent disease, as they are vulnerable for sustaining an overuse injury. contradictory to traumatic injuries, little is known about the prevention of overuse injuries using a training program. this study evaluates the preventive effect of a training program based on known intrinsic risk factors for the occurrence of anterior knee pain and shin pain in soldiers undergoing basic military training. we also evaluate the effect on physical performance. methods: from december 2004 - march 2006 1000 soldiers undergoing basic military training divided into 24 platoons are cluster randomised into a prevention-training (pre) group or a placebo-training (pla) group. the pre group will perform exercises based on known intrinsic risk factors namely strength, flexibility and coordination of the lower extremity, while the pla group will perform exercises for the upper body. both programmes consists of 5 exercises and will be performed 3 times a week during a 12 weeks period. all subjects will prospectively be examined by the same observer, who will be blinded to the allocation. outcome: primary outcome: reduction in anterior knee pain and shin pain.

Eligibility criteria:
inclusion criteria: * basic military training in the royal danish guards. * passed military medical board. exclusion criteria: * injury before start of intervention

Keywords: prevention exercise overuse anterior knee pain syndrome exertional lower leg pain prospective risk factors hip
trial investigating the characteristics of knismesis - a lever to explore allodynia in neuropathic pain

Conditions: Healthy

Summary: also known as a "moving itch", knismesis is a mildly annoying sensation caused by a light movement on the skin, such as from a crawling insect. its underlying mechanism rely on spatial summation, i.e. amplification of the signal due to summation of stimulated fields, like it is for dynamic allodynia in neuropathic pain. this physiological study aims at determining the physical factors of the cutaneous stimulation inducing knismesis as well as the effect of confounding factors. the main area of exploration will be the back, because of its size and the possibility to blind the participant. the information collected, along with animal data in surrogate models, would help to better understand neuropathic pain in the future.

this is a physiological proof-of-concept, also aiming to validate a functional exploration model in healthy volunteers. each participant will undergo a battery if psychometric then psychophysics tests, presented sequentially. however, most of the main study tests (knismesis) will be admistered in a random order (crossover). the primary endpoint is to characterise, in the healthy human, the physical determinants of the cutaneous stimulation inducing knismesis: length of the pathway, speed, direction, intensity, continuity break of the contact, hairiness, body site, or distraction by other cutaneous stimuli. the secondary endpoint is to study the relationship between the individual sensitivity to spatial summation (knismesis) and other individual sensitivities or profiles.

Eligibility criteria:
inclusion criteria: - ability to answer french questionnaires. · bmi between 19 and 30 kg/m2 at inclusion. exclusion criteria: * pregnancy or breastfeeding. * natural intolerance to tickling. * any cutaneous, ocular or neurological disease contraindicating the psychophysical tests. * any disease or medical history that could expose the subject to unacceptable risk during the study. * any medication intake within 7 days before testing. * history of drug or alcohol abuse. * involvement in another concomitant research protocol. * major dorsal hairiness. * inability to undergo the tests. * legal protection. * concomitant involvement in another clinical research. * refusal to participate.

Keywords: neurophysiology psychophysics sensory thresholds neurons pain, neuropathic
effect of cyclic loading (vibration) on orthodontic tooth movement

Conditions: Malocclusion

Summary: to gather data indicating whether or not the orthoaccel device speeds tooth movement in people who use orthodontics (braces).

this is a randomized, blinded study that will follow 32 patients for up to six months. patients will have a minimum of 3 mm of extraction space that needs to be closed by moving the anterior teeth or canine distally. patients will have standard orthodontic treatment and temporary anchorage devices for tooth movement and space closure. half the patients will receive a functioning device and half the patients will receive a sham-device. patients will use the device for 20 minutes daily; the device has a mouthpiece for the patient to lightly bite into plus a connected enclosure that stays outside the mouth. the enclosure provides a light vibration.

Eligibility criteria:
inclusion criteria: * permanent dentition between the ages of 12 and 40 * minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines * good oral hygiene and compliance exclusion criteria: * any compromised medical or dental condition * patient currently involved in any other study * lives significantly outside san antonio, tx * use of bisphosphonates * pregnant females

Keywords: orthodontic extraction device space closure orthodontic malocclusion
biologic basis of increased susceptibility of smokers to pulmonary infection with mycobacterium tuberculosis

Conditions: Tuberculosis; Chronic Obstructive Pulmonary Disease

Summary: identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers to pulmonary tb (mtb) by testing the hypothesis that smoking reprograms am polarization towards a distinct phenotype associated with impaired host defense function against mtb and that normalization of that phenotype via therapeutic modulation of the alveolar macrophage (am) polarization or smoking cessation can restore the anti-mtb host defense function of am.

samples from non-smokers with tb, smokers with tb and smokers with copd and tb will be collected in qatar under jirb 14-00055. all subjects will be undergoing a clinical bronchoscopy as part of their disease evaluation and will be asked to give additional samples for research. all "in vivo" processing of specimens from subjects with tb will be performed in qatar. mycobacterium tuberculosis infection (mtb) continues to have a detrimental impact of public health worldwide. based on the epidemiological evidence linking smoking, copd and mtb, and our preliminary data we hypothesize that smoking reprograms alveolar macrophages (am) polarization towards a distinct phenotype associated with impaired host defense function against myobacterium tuberculosis (mtb) and that normalization of that phenotype via therapeutic modulation of the alveolar macrophages (am) polarization or smoking cessation can restore the anti-mtb host defense function of am.

Eligibility criteria:
smokers and non-smokers with tb inclusion criteria: * must provide informed consent * current smokers and non-smokers * undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease * diagnosis of pulmonary tuberculosis without extra-pulmonary tb, confirmed by at least one of the following: * symptoms consistent with tb * chest xray and or chest ct with tb * positive ppd test * positive sputum test exclusion criteria: * females who are pregnant or nursing * history of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic smokers with tb and copd inclusion criteria: * must provide informed consent * current smokers with copd * undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease * diagnosis of pulmonary tuberculosis without extra-pulmonary tb, confirmed bu at least one of the following: * symptoms consistent with tb * chest xray and or chest ct consistent with tb * positive ppd test * positive sputum test exclusion criteria: * non-smokers * females who are pregnant or nursing * history of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic
renal physiology during continuous renal replacement therapy

Conditions: AKI; Continuous Renal Replacement Therapy; Dialysis; Intensive Care; Renal Blood Flow; Renal Failure; Blood Pressure

Summary: approximately 50% of patients in the intensive care unit (icu) develop acute kidney injury (aki) and more than 10% need dialysis. there is no treatment for aki. care is aiming for optimization of circulation and blood flow to the kidneys and avoiding nephrotoxic agents. there is conflicting data concerning whether early or late dialysis is harmful for the kidneys. no one has examined the physiological changes in the kidney when starting dialysis and which blood pressure that leads to most optimal physiological conditions for the kidneys during dialysis. in this descriptive study of 20 icu patients suffering from aki we aim to investigate renal physiology when starting continuous renal replacement therapy (crrt) and also at different target blood pressures using retrograde renal vein thermodilution technique. in parallel we will also investigate and validate this invasive method with contrast enhanced ultrasound of the kidneys.


Eligibility criteria:
inclusion criteria: aki, according to kdigo, stage 2 or 3 but with preserved urine production. treated in the icu at sahlgrenska university hospital written, signed informed consent male and female subjects ≥18 years exclusion criteria: emergency need for dialysis allergy to contrast media (used for ceus)
seroprevalence of sars-cov-2 in asymptomatic frontline covid-19 hcws

Conditions: Covid19

Summary: this study is about the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of covid-19 infection.

coronaviruses (covs) are enveloped, single positive-strand rna viruses belonging to the large subfamily coronavirinae, which can infect mammals and several other animals.the continued spread of coronavirus disease 2019 (covid-19) has prompted widespread concern around the world, and the world health organization (who), on 11 march 2020, declared covid-19 a pandemic. studies on severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. currently, the antibody responses against sars-cov-2 remain poorly understood and the clinical utility of serological testing is unclear. little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in covid-19 patients. asymptomatic cases are common but to date there are scarce epidemiological surveys that provide a clear percentage of asymptomatic cases. a large number of healthcare workers have been infected with the virus worldwide, presenting with severe symptoms to no symptoms at all, in which case being diagnosed on contact tracing only. the seropositivity rate in previously undiagnosed healthcare workers has been reported in different regions of the world. in a combined study of three hospitals of turkey, the seropositivity rate of the previously undiagnosed hcws was 2.7%. a study done in china revealed 17.5 % seropositivity rate. this study will aim to comprehensively review the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of covid-19 infection.

Eligibility criteria:
inclusion criteria: * all hcws who had been working in high exposure areas of covid 19 exclusion criteria: * any hcw of high exposure areas of covid 19 who suffered from covid 19 themselves diagnosed on pcr or clinically
preoperative prediction of acute kidney injury after cardiac surgery

Conditions: Acute Kidney Injury

Summary: although acute kidney injury (aki) frequently complicates cardiac surgery, methods to determine aki risk are lacking. renal functional reserve (rfr), the capacity of the intact nephron mass to increase glomerular filtration rate (gfr), represents maximal filtration capacity. we hypothesized that preoperative rfr would predict postoperative aki.

acute kidney injury (aki) is a frequent complication in patients undergoing cardiac surgery with an estimated prevalence of 36%. however, clinicians have limited tools to preoperatively identify patients at risk for aki and/or progression to chronic kidney disease, particularly in patients with normal resting glomerular filtration rate (rgfr). renal functional reserve (rfr) describes the capacity of the intact nephron mass to increase gfr from baseline in response to stimuli (e.g., protein load). we hypothesized that the presence or absence of rfr could separate patients at risk for developing aki from patients with better-preserved renal function and a more favorable short- and long-term prognosis despite identical rgfr. the aim of this study is to examine whether preoperative assessment of rfr is able to predict risk for aki after cardiac surgery.

Eligibility criteria:
inclusion criteria: 1. subjects older than 18 years 2. subjects undergoing elective cardiac surgery 3. subjects who signed informed consent forms exclusion criteria: 1. pregnancy 2. chronic kidney disease ≥ stage iii 3. solitary kidney 4. diabetes mellitus type 1 5. recent cardiac arrest 6. liver failure or cirrhosis 7. total parenteral nutrition 8. hemoglobin \<11 g/dl 9. sepsis 10. history of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency 11. transplant donor or recipient 12. active autoimmune disease with renal involvement 13. rhabdomyolysis 14. prostate hypertrophy with international prostate symptom score ≥20 15. neoplasm withdrawal criteria: all patients included in the study were to be followed up until the scheduled end of the study. data collection could be terminated prior to the scheduled time only under the following conditions: * general criteria 1. a patient or his/her legal representative may refuse further participation in the study at any time (withdrawal of consent), 2. the investigator may withdraw a patient from the participation in the study at any time for the following reasons: * a severe protocol violation, * the development of incidents/near-incidents/other severe clinical complications related to the study protocol * criteria related to the study 1. subjects who could not stop taking angiotensin-converting enzyme inhibitors and/or angiotensin ii receptor blockers a minimum of 48 hours before the protein load. 2. subjects who received non-steroidal anti-inflammatory drugs within the 48 hours before the protein load. 3. subjects who received intravenous radiocontrast agents within the 72 hours before the protein load.
study to evaluate the efficacy of sdp-4 in subjects with dry eye disease (ded) (sdp-4-cs202)

Conditions: Dry Eye

Summary: sdp-4-cs202 is a phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of sdp-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. once concentration (1%) of sdp-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation bid.


Eligibility criteria:
inclusion criteria: * have ded in both eyes, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to visit 1/screening requiring the use of artificial tears. * total score ≥ 40 and ≤ 70 on the sande questionnaire at visits 1 and 2. * tear break-up time (tbut) of ≤ 6 seconds in both eyes at visits 1 and 2. * anesthetized schirmer's test tear volume ≥ 3 mm and \<10 mm in both eyes (only at visit 1). * best-corrected visual acuity (bcva) of +0.7 logmar or better in each eye as assessed by logmar chart at visits 1 and 2. exclusion criteria: * ocular surface corneal disease other than ded. * diagnosis of sjögren's disease. * lid margin disorder other than meibomian gland dysfunction (mgd) * presence of any ocular condition (e.g., pterygium) that in the investigator's opinion could affect study parameters. * any previous reconstructive or cosmetic eyelid surgery * any previous invasive glaucoma and/or corneal surgery * corneal refractive surgery in the 12 months prior to visit 1/screening. * cataract extraction within 90 days prior to visit 1/screening. * cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to visit 1/screening or planned during the study. * contact lens wear. * use of ophthlamic corticosteroids, nsaids, antibiotics, antihistamines, iop lowering medication, in the 30 days prior to visit 1/screening * serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments
improved and simplified staining technique for dysplasia detection in colitis

Conditions: Colitis; Colonic Dysplasia; Inflammatory Bowel Diseases; Colonoscopy; Surveillance

Summary: comparing chromoendoscopy to a digital staining technique and white light in patients with ibd attending scheduled surveillance colonoscopy

in this study we will attempt to compare dye based chromoendoscopy to wli (white light), nbi( narrow band imaging) and txi( texture and colour enhancement imaging). high definition colonoscopy is used. we aim to compare all these dye/lights to each other and find the best and simplest method to help to diagnose dysplasia more efficient and easier.

Eligibility criteria:
inclusion criteria: - person schedules to ibd- surveillance colonoscopy. exclusion criteria: * total colectomy. * not well prepared bowel. bbps under 2 at any segement. * pregnancy.
changes in weight, body composition and metabolic parameters after discontinuing dolutegravir or tenofovir disproxil

Conditions: Hiv; HIV Infections; HIV Lipodystrophy; Osteoporosis; Renal Insufficiency; Weight Gain; Obesity

Summary: randomized controlled parallel open-label study in persons living with hiv. the aim is to study weight changes in patients switching from a dolutegravir and tenofovir disoproxil containing regimen to either a dolutegravir or tenofovir disoproxil free regimen.

randomized controlled parallel open-label study in persons living with hiv and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion. participants (n=126) are randomized to continue 3 drug-regimen dolutegravir/tenofovir disoproxil/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention 1) or to three-drug regimen with doravirine/tenofovir disoproxil/lamivudine. follow-up is 48 weeks. data is collected at baseline and week 48. primary outcome is changes in weight from baseline of more than 2 kg. secondary outcomes are virus persistent viral suppression, changes in body composition and metabolism, changes in bone metabolisme and renal function, changes in liver elasticity and fat infiltration.

Eligibility criteria:
inclusion criteria: * individuals ≥ 18 years old with diagnosed hiv and at least 6 months of ongoing treatment with dolutegravir/ doravirin/lamivudine will be included. patients must have a plasma viral load (hiv-rna) \< 50 copies/ml at inclusion. for women of childbearing potential: negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period exclusion criteria: * patients will be excluded in case of pre-existing viral resistance mutations to lamivudine, dolutegravir, tenofovir or doravirine the presence of hepatitis b antigen (hbsag) or hbv dna, cancer within past 5 years, pregnancy or breastfeeding. any case of diabetes, cardiovascular disease or other chronic illness must be considered stable as assessed by the treating physician.

Keywords: hiv antiretroviral therapy antiretroviral therapy adverse events weight gain body composition fat distribution