Kornimate/medical-research-clean huggingface dataset:
advanced glaucoma intervention study (agis)

Conditions: Glaucoma

Summary: to assess the long-range outcomes of sequences of interventions involving trabeculectomy and argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma.

in advanced glaucoma, medication alone no longer reduces intraocular pressure adequately, and the eye has field defects. before 1980, some type of filtering surgery, such as trabeculectomy, was the usual method of intervention. since then, laser trabeculoplasty has become a popular alternative. sometimes the first intervention chosen succeeds in controlling pressure for many years; at other times, the success lasts only a few weeks or months. because success is limited, some patients, over time, need to undergo a sequence of surgical interventions. little is known about which sequence gives the best long-range outcome. the advanced glaucoma intervention study (agis) is designed to provide a comprehensive assessment of the long-range outcomes of medical and surgical management in advanced glaucoma. the study uses visual function status to compare two intervention sequences in managing the disease. eligible eyes are randomly assigned to one of two intervention sequences: (1) trabeculectomy, followed by argon laser trabeculoplasty (alt) should trabeculectomy fail, followed by a second trabeculectomy should alt fail; or (2) alt, followed by trabeculectomy should alt fail, followed by another trabeculectomy should the first trabeculectomy fail. antifibrotic agents may be used as an adjunct to trabeculectomy, but only in eyes with a previous history of invasive surgery. eyes that fail the entire assigned sequence of interventions are managed at the discretion of the agis physician in collaboration with the patient. interventions are supplemented with medical treatment as needed. a total of 789 eyes with advanced glaucoma have been enrolled. all patients are being followed under a standardized protocol for a minimum of 5 years to determine degree of visual function loss, failure rates of interventions, rates of complications, and need for supplemental therapy. after the initial intervention, followup examinations are scheduled at 1 week, 4 weeks, 3 months, 6 months, and every 6 months thereafter. after second and third interventions, followup examinations are scheduled at 1 and 4 weeks. additional visits are scheduled as necessary for the management of the disease. the primary outcome variable in agis is average percent of eyes with decrease of vision, where decrease of vision is a substantial decline of either visual field or visual acuity attributable to the effect of glaucoma. secondary outcome variables include sustained decrease of vision, failure of interventions, number of prescribed glaucoma medications, and level of intraocular pressure. an ancillary study is assessing filtering bleb encapsulation.

Eligibility criteria:
men and women between the ages of 35 and 80 with open-angle glaucoma that was not successfully controlled by medication were eligible for enrollment.
posterior tibial artery bypass for iliofemoral artery injury associated with massive blood loss and shock

Conditions: Iliofemoral Artery Injury; Shock

Summary: traumatic disruption of iliofemoral arterial segment is often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply to the ipsilateral lower extremity, as well as with high mortality. the investigators describe a bypass technique. it can provide adequate blood supply to the lower extremity of the injury side. due to a minimum amount of additional blood loss, it is a low risk procedure for salvage of the extremity and even patient's life.

patients were selected on the basis of the following: (1) closed injuries to the lower abdomen and/or pelvis; (2) serious hemorrhagic shock; (3) loss of blood supply to the ipsilateral lower extremity; (4) high-risk emergency artery reconstruction. the instruments used to measure sensibility of the foot were the semmes-weinstein (sw) monofilament test 24 and the static two-point discrimination (2pd) test 25. the weight-bearing area of the first metatarsal head and the dorsum of the first metatarsal head were assessed. active range of motion (rom) of the hip, knee, and ankle joints was measured with a goniometer. the muscle strength was test using medical research council (mrc) scale. the cold intolerance of the leg was measured using the self-administered cold intolerance severity score (ciss) questionnaire 26. the maximum score is 100 and is grouped into 4 ranges (0-25, 26-50, 51-75, and 76-100) corresponding to mild, moderate, severe, and extreme severity, respectively.

Eligibility criteria:
inclusion criteria: 1. closed injuries to the lower abdomen and/or pelvis; 2. serious hemorrhagic shock; 3. loss of blood supply to the ipsilateral lower extremity; 4. high-risk emergency artery reconstruction. exclusion criteria: 1. bleeding can be easily control through an open wound; 2. mild shock without life threatening conditions; 3. good blood supply to the ipsilateral lower extremity; 4. low-risk emergency artery reconstruction.

Keywords: posterior tibial artery bypass iliofemoral artery injury shock reconstruction
inspiratory muscle training with powerbreath device in patients with als

Conditions: Amyotrophic Lateral Sclerosis

Summary: abstract: context/background: people affected by amyotrophic lateral sclerosis (als) see their own life totally disturbed after the diagnosis. this disease also courses, apart from the functional and depressing worsening, with internal damage manifested by a cardio respiratory deterioration. there are not many clinical studies publications about this disease given that is considered a weird illness with short prognosis. objectives: to examine the effects of the inspiratory muscle training (imt) on respiratory muscle strength, heart rate variability (hrv), quality of life and mood in patients with als. methods: 20 volunteer patients, male and female, with als, bulbar or spinal will take part of the cuasi-experimental study and they will be divided into two groups: an experimental group (n = 10) and a control group (n = 10). the maximum inspiratory pressure (pim), the hrv, the quality of life and mood will be measured. the participants of experimental group will conduct 30 inspirations per day, 15 in the morning and 15 in the evening, 5 days per week, through 8 weeks. the resistance of the training in the experimental group will be increase acording to the pim measured at the first visit. during the first week, the resistance will be at 30% of pimax, weeks 2 and 3 at 40%, weeks 4 and 5 at 50% and the last 3 weeks at 60%. after 8 weeks, all participants will fill up again all scales and post training measurements will be taken.


Eligibility criteria:
inclusion criteria: - subjects with als exclusion criteria: * pimax more than 30mmh2o * score higher than 2 in gds reisberg scale * using already respiratory devices during the day (except night cpaps support) more than 14h/day. * unstable medical disease for the last 3 years. * use of imt contraindicated for medical reasons.

Keywords: amyotrophic lateral sclerosis maximum inspiratory pressure diaphragm
omuyambi: traditional healer support to improve hiv viral suppression in rural uganda

Conditions: HIV Infections

Summary: this study aims to test a new approach to support people living with human immunodeficiency virus (hiv) in uganda. traditional healers (th) will be trained to provide counselling and testing for hiv, help patients start antiretroviral therapy quickly, and offer guidance on taking medications and staying in hiv care. this support will be given in addition to the regular care provided at clinics. the main goal of the study is to see if this new approach can help more people in rural areas achieve viral suppression.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * reactive point-of-care (poc) oral swab rapid hiv self-test (ex. oraquick© hiv1/2 antibody testing) at the th location or previously diagnosed with hiv (verified by the hiv clinic), and case adherence index score ≤10 * baseline viral load measurement of \>200 copies/ml * primary residence in mbarara or rwampara district * agrees to study procedures, including that plwh will go to one of the five pre-determined hiv clinics if they choose to receive hiv care, and in-person visits at baseline, 12- and 24-months with study nurse exclusion criteria: * unwilling or unable to participate in study procedures or provide written informed consent

Keywords: traditional healer community health
registry for the use of a software for automatic detection of the evolution of aneurysmal volume and graft migration after evar (endovascular aneurysm repair)

Conditions: Aneurysm Aortic

Summary: the objective of this registry is to find and validate a correlation between morphological indicators such as volume sac evolution, graft migration or length between anatomical landmarks with aneurysm rupture risk or complications such as endoleaks requiring re-intervention... secondary objectives are the validation of the reproducibility and accuracy of a dedicated fully automated software enabling abdominal aortic aneurysm (aaa) segmentation to measure aaa diameter, volume evolution and growth over time, proximal and distal sealing zones analyze as well as device migration and integrity after evar on computed tomography angiography (cta). this validation is in comparison with semi-automated analyse controlled by physician.


Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age * infra-renal abdominal aortic aneurysm (aaa) treated with evar * ≥50mm * or ≥5mm increase in 6 months * or surviving ruptured aaa * legal capacity to make own decisions, informed of the nature of the registry, has signed non opposition form available for set-up and proper implementation of follow-up visits throughout the duration of the registry exclusion criteria: * advancing alzheimer's disease or socially dependent patient * opposition to the use of their data for this research * life expectancy supposed to be inferior to 2 years pregnant female

Keywords: abdominal aortic aneurysm ct scan semi-automated analyses software
effect of food on pc14586 in healthy volunteers and the pk of pc14586 in healthy japanese volunteers

Conditions: Healthy Volunteers

Summary: this is a 2-part phase 1 cross-over study to assess the effects of food on the pharmacokinetics of pc14586 in healthy volunteers. the pharmacokinetics of pc14586 at a clinically relevant dose in japanese participants will also be studied.

pc14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the p53 y220c mutation. this phase 1 trial will be conducted in 2 parts (part 1 - pilot and part 2 - pivotal) to assess the pharmacokinetics of pc14586 in healthy volunteers including japanese participants.

Eligibility criteria:
inclusion criteria: * healthy, non-smoking male and female caucasian/ non-asian or japanese human volunteers * 18 to 55 years of age * able to swallow tablets. inclusion criteria for japanese participants only: * japanese and born in japan (1st generation) * the parents and grandparents of the participant are ethnically japanese and born in japan * has undergone no significant change in lifestyle since leaving japan * has lived \< 10 years outside of japan exclusion criteria: * clinically significant medical history as determined by the pi. * any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs. * a p53 y220c mutation. * blood pressure \>140 mm systolic or \>90 diastolic. * smoked or used other nicotine-containing products during the previous 3 months. * history of alcohol and/or illicit drug abuse within the previous 5 years. * hepatitis b surface antigen (hbsag), hepatitis c antibody or human immunodeficiency virus (hiv). * positive blood test for ethanol. * positive urine drug test. * pregnancy or breastfeeding. * unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical site. * has donated blood within 2 months prior to admission. * has used over-the-counter (otc) medications (including vitamins), prescription medications or herbal remedies from 14 days prior to admission. * has used an investigational drug within 30 days prior to screening.

Keywords: y220c pc14586 pmv pharma pmv food effect pharmacokinetics japanese
bleeding in patients undergoing cabg (coronary artery bypass graft) during dual antiplatelet therapy

Conditions: Acute Coronary Syndrome

Summary: the aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a p2y12 receptor blocker (clopidogrel, prasugrel, ticagrelor)


Eligibility criteria:
inclusion criteria: consecutive patients undergoing acute cabg with or without valve replacement within 7 days after last intake of dual antiplatelet therapy exclusion criteria: concomitant oral anticoagulants dialysis surgery employing hypothermic cardiac arrest

Keywords: cabg dual antiplatelet therapy aspirin clopidogrel prasugrel ticagrelor
pms promotes the recovery of patients after heart valve replacement

Conditions: Heart Valve Diseases

Summary: acute gastrointestinal injury (agi) is related to poor outcomes in patients after heart valve replacement. the purpose of this study is to evaluate the effect of the probiotic mixture supplementation (pms) in patients after heart valve replacement by preventing acute gastrointestinal injury (agi).

patients with heart valve diseases often have chronic cardiac insufficiency. accumulating evidence supports a relationship between the complexity and diversity of the gut microbiota and heart failure. bacterial colonization and translocation of their toxins to the bloodstream due to altered intestinal permeability are directly correlated with systemic inflammation. the activation of pro-inflammatory pathways and chronic inflammation was hypothesized as a major contributing factor in the pathogenicity and progression of heart failure (hf) patients undergoing heart valve replacement with cardiopulmonary bypass (cpb) are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to agi. agi is related to poor outcomes of critically ill patients through many underlying mechanisms. it can leads to infectious complications, multiple organ dysfunction syndromes (mods), and even death. on the other hand, the supply of probiotics, the good bacteria, is beneficial, despite still having a few controversial results. therefore, it is important to carefully assess the efficacy of probiotics in the prevention of agi and other complications in patients undergoing heart valve replacement surgery with cpb, as well as to evaluate the safety of its use.

Eligibility criteria:
inclusion criteria: * moderate to severe congestive heart failure (chf) (nyha functional class iii to iv) * patients with heart valve diseases undergoing cpb cardiac surgery * age \> 18 years and ≤ 70 years exclusion criteria: * patients with severe low left ventricular function: lvef ≤ 30% * patients with infective endocarditis * have received major gastrointestinal surgery (including gallbladder and appendectomy) within 5 years * inflammatory bowel disease (ibd), including ulcerative colitis, crohn's disease, or colitis * acute gastroenteritis * clostridium difficile or helicobacter pylori infection * chronic constipation * peptic ulcer * polyps in the stomach or intestines * gastrointestinal neoplasms * abdominal hernia * irritable bowel syndrome * acute or chronic cholecystitis, hepatitis * used antibiotics and probiotics in the past 1 month * patients used antidiarrheals, laxatives, or prebiotics within 1 week * pregnant or pregnant during follow-up * failure to give informed consent (e.g. severe cognitive impairment) * the patient has been enrolled in other ongoing clinical trials

Keywords: heart valve diseases probiotics microbiomes cardiac surgery
a study to investigate the safety and efficacy of bol-303224 in the treatment of bacterial conjunctivitis

Conditions: Acute Bacterial Conjunctivitis

Summary: this is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye. exclusion criteria: * pregnant or nursing females. * use of any antibiotic within 72 hours of enrollment. * any disease conditions that could interfere with the safety and efficacy evaluations of the study drug. * participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.
a study of tq05105 tablets in subjects with hemophagocytic lymphohistiocytosis（hlh）

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: this is a phase i study of tq05105 tablets in subjects with hemophagocytic lymphohistiocytosis.tq05105 is a jak2 inhibitors and can be used to treat jak2 target-related diseases. the activation of the jak/stat pathway is related to abnormal proliferation, obstruction of apoptosis, and differentiation disorder of leukemia cells which is caused by genetic abnormalities and viral infection.


Eligibility criteria:
inclusion criteria: * 1.18 years and older; eastern cooperative oncology group (ecog) performance status of 0 to 3; life expectancy ≥ 3 months. 2. diagnosed as new or relapsed hlh according to the hlh-2004 criteria. 3.has received other treatments for hlh before two weeks ago, surgery before four weeks ago. 4. adequate laboratory indicators. 5. no pregnant or breastfeeding women, and a negative pregnancy test. 6. understood and signed an informed consent form. exclusion criteria: * 1. has diagnosed and/or treated additional malignancy within 5 years prior to randomization. with exception of non-melanoma, skin cancer, and carcinoma in situ. 2. has participated in other anticancer drug clinical trials within 4 weeks. 3. has multiple factors affecting oral medication. 4. has drug abuse history that unable to abstain from or mental disorders. 5. has active hepatitis b or c, or immunodeficiency. 6. diagnosed as hepatic failure. 7. has arteriovenous thrombosis events within 4 weeks. 8. has active bleeding, or a persistent decrease in hemoglobin. 9. has received long-term and large-dose glucocorticoids or other immunosuppressive drugs within 28 days before signed the informed consent form. 10. has uncontrolled cardiovascular disease. 11. has uncontrolled hypertension. 12. has serious systemic infections. 13. according to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
anti-reflux endoscopic tx using apc (area) in gerd patients: (the area study)

Conditions: Gastro Esophageal Reflux

Summary: this will be a randomized clinical trial examining the efficacy and safety of arat (intervention group) in patients with chronic gerd symptoms (typical symptoms of gerd, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months. patients must have a positive ph test and a negative manometry (no treatment) procedure.


Eligibility criteria:
inclusion criteria: * chronic gerd symptoms (at least 1 typical symptom of gerd, i.e. heartburn or acid reflux/regurgitation at least twice a week) for last 6 months * objective evidence of reflux disease (positive ambulatory ph study.) exclusion criteria: * patients unable to or unwilling to participate or consent. * age \ 80 years. * allergic or intolerant to ppi medications. * large hiatal hernia \> 3 cm and hill grade iv. * barrett's esophagus. * esophageal stricture with any prior intervention. * major motility disorder. * eosinophilic esophagitis. * gastroparesis documented by abnormal gastric emptying time. * previous fundoplication, myotomy or linx surgery. * cirrhosis with esophageal and/or gastric varices.
treatment choices for improving adherence and outcome

Conditions: Major Depression

Summary: this study will determine the effectiveness of offering primary care patients their preferred treatment versus one that is less desirable in improving treatment adherence and outcome.

this study investigates whether offering primary care patients treatment that is congruent with their preferred first choice improves adherence and outcomes, in comparison to offering treatment that is not congruent with their preferred first choice. all subjects are offered a treatment with demonstrated efficacy, namely either the antidepressant medication escitalopram or interpersonal psychotherapy for 5 months. we hypothesize that patients who receive congruent treatment will be more likely to initiate treatment, adhere to treatment, and achieve depression remission.

Eligibility criteria:
inclusion criteria: * age 21-99 * english-speaking * dsm-iv criteria for major depression exclusion criteria: * unable to give informed consent * mmse\<24 * dsm-iv diagnosis of bipolar disorder, psychotic disorder, current alcohol or substance abuse * active suicide ideation * aphasia * acute or severe medical illness * currently receiving either antidepressant medication or psychotherapy
changing pediatric office systems nationally to address parental tobacco use

Conditions: Tobacco Dependence

Summary: the proposed study is a cluster randomized controlled trial designed to test the sustainability of a previously developed, tested, effectively implemented tobacco control strategy-the cease intervention, employing state of the art tobacco dependence treatment for parents who smoke.

the cease intervention works within existing systems of care to address parental smoking. based on national guidelines and extensive qualitative research obtained in pilot testing, elements of cease can be tailored to work with particular practices' staffing, resources, and physical configuration. cease integrates evidence-based tobacco-use screening, cessation assistance, and referral to outside services into visits with families in pediatric clinics. elements include (1) identification of smokers and self-assessment of quitting preferences; (2) counseling (brief motivational messaging elements include collaborative goal setting, set quit date, personal barriers to quitting, problem-solving strategies, implementing smoke-free homes and cars, and social support, strategies shown to increase satisfaction with the pediatric visit.(3) medication (nrt prescription and free 1 week supply (while supplies last)-including for those cutting down to quit as recommended in latest guidelines); (4) quitline enrollment via faxed enrollment form; and (5) review of cease action sheets at each visit until the family is smoke-free. we train practices in the adoption, implementation, and maintenance of the intervention. a more detailed training manual discusses additional in-depth strategies for maximizing billing and reimbursement, materials for seasonal cessation opportunities and supporting employees' own cessation efforts.

Eligibility criteria:
inclusion criteria: * parents or guardians who smoke or who are former smokers (quit in the last 2 years), are present at the visit, and whose child (any age) is seen by a pediatrician in a participating practice. * "smoker" will be defined as answering "yes" to the screening question: "have you smoked a single cigarette, even a puff, in the past 7 days?" * "former smoker" will be defined as answering "no" to the screening question: "have you smoked a single cigarette, even a puff, in the past 7 days?" and "yes" to the screening question: "have you quit smoking in the last 2 years?" exclusion criteria: * parents under age 18 * parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention) * non-consenting individuals * non-english speakers * prior enrollment in the study during a previous healthcare visit.

Keywords: tobacco control, tobacco treatment, pediatrics, parents