Kornimate/medical-research-clean huggingface dataset:
pilot feasibility study of a sjögren's syndrome self-management app

Conditions: Sjogren's Syndrome

Summary: this study investigates the feasibility of a fully remote effectiveness evaluation of a self-management smartphone application for those with sjogren's syndrome.

the aim of this study is to pilot and assess the feasibility of a fully remote effectiveness evaluation of a smartphone self-management app for those living with sjogren's syndrome. the fully-remote evaluation will involve minimal contact with researchers. potential participants will be recruited internationally online through social media and mailing lists for sjogren's syndrome support groups. adverts will direct people to download the self-management app on app stores (apple app store and google play). the app has been designed to automate all study procedures, by guiding users through the following processes: screening, informed consent, randomisation, and the collection of outcome data through in-app surveys sent at 0, 5, and 10 weeks. users will be randomised to receive the full intervention or a control: * intervention group: full version of the app containing multiple behavioural components: symptom and lifestyle information, energy management, goal setting, managing difficult times, assertiveness and communication skills. * control group: minimal version of the app containing only the symptom and lifestyle information component. to pilot and assess the feasibility of the planned methodology, and inform the design of a future definitive randomised control trial of the app, the primary objectives of this study are to: characterise users (i.e. international recruitment and consent rates), and test screening, randomisation and data collection procedures (i.e. outcome measure completion rates and score variability). the secondary objectives are to explore app engagement patterns (using log data) and the acceptability of the study procedures and the app (using remote semi-structured interviews).

Eligibility criteria:
inclusion criteria: * over 18 years of age * diagnosed with either primary or secondary sjogren's syndrome (self-report) * own an iphone or android smartphone exclusion criteria: * none

Keywords: self-management smartphone autoimmune rheumatology
choroideremia gene therapy clinical trial

Conditions: Choroideremia

Summary: phase ii gene therapy study, involving a total of 6 male patients with choroideremia. the study will be conducted at the bascom palmer eye institute, university of miami. patients will be required to attend a total of 11 study visits over a 24 month period with an additional 3 year follow-up.

this is a phase ii, open label study involving patients with a clinical phenotype of choroideremia and a confirmed chm genotype. following consent, patients will be required to attend an initial screening visit (visit 1). within 2 weeks of the screening visit patients will undergo a surgical procedure (visit 2) under general anesthesia which will include a standard vitrectomy, retinal detachment and administration of a subretinal injection of aav2-rep1 (1x1011 genome particles). patients will be required to attend a further 9 study visits (visits 3-11) over a 24 month period for functional, and anatomical assessments as well as monitoring of adverse events. the primary endpoint is the change from baseline in visual acuity in the study eye, compared to control eye. secondary study endpoints are, change from baseline in autofluorescence evaluation, microperimetry readings and other anatomic and functional outcomes (all in the study eye compared to control eye). secondary endpoints also include safety assessments to be conducted throughout the study. the fellow eyes of these patients will be utilized as controls in this study and will receive no study treatment.

Eligibility criteria:
inclusion criteria: * 18 years and older * male * able to give informed consent * genetically confirmed diagnosis of choroideremia * active disease visible clinically within the macula region * best-corrected visual acuity equal to or worse than 20/32 but better than or equal to 20/200 in the study eye. exclusion criteria: * female * under the age of 18 * history of amblyopia in the study eye * men unwilling to use barrier contraception methods * relevant grossly asymmetrical disease or other ocular morbidity which might confound use of the fellow eye as a long-term control * any other significant ocular and non-ocular disease/disorder or retinal surgery * contraindication to use of medications or contrast agents * participated in research study involving an investigational product in the past 12 weeks * having had gene or cellular therapy at any time prior to this study.

Keywords: choroideremia, gene therapy
the antibiotic guardian study- clinical evaluation of a novel, rapid diagnostic for gonorrhoea and mycoplasma infections.

Conditions: Sexually Transmitted Diseases, Bacterial; Antibiotic Resistant Infection

Summary: primary research question: are novel molecular tests for rapid detection of mycoplasma and gonorrhoea infections and antimicrobial resistance sensitive and specific in symptomatic patients attending a sexual health clinic? secondary research question: are novel molecular tests for detection of antimicrobial resistance in mycoplasma and gonorrhoea infections more accurate than standard laboratory culture techniques?

this clinical study aims to clinically evaluate a novel, rapid molecular diagnostic for mycoplasma and gonorrhoea infections. this diagnostic detects both infection and also detects any antimicrobial resistance. these tests detect these organisms and provide information about antimicrobial resistance in a laboratory, but are not widely used in sexual health clinics in the uk and have not been clinically evaluated in symptomatic patients in detail. our primary objective is to determine if the novel molecular test for rapid detection of mycoplasma and gonorrhoea infections and antimicrobial resistance is sensitive and specific in symptomatic patients attending a sexual health clinic. our secondary research objective is to determine whether the novel molecular test for detection of antimicrobial resistance in mycoplasma and gonorrhoea infections more accurate than standard laboratory culture techniques. eligible participants will be aged between 16 and 99 years and attend a sexual health clinic at cwm taf morgannwg sexual health department. they will be symptomatic. participants will have routine swabs performed as per routine sexual health care, following gaining participant consent in writing. waste urine and discharge from vaginal swabs will be utilised in the study. samples will be given a unique study number and sent to the normal nhs laboratory for analysis as per routine care. left-over samples of urine and swabs will be pseudo-anonymised and then transported to the academic laboratory for analysis with the novel diagnostic with the unique study id. results from routine tests for mycoplasma and gonorrhoea detection and for antimicrobial resistance will be compared to results of the novel diagnostic. this study has had a substantial amendment reviewed and passed by an ethics committee, due to covid disruptions in healthcare. it has changed from an interventional study to an observational study.

Eligibility criteria:
inclusion criteria: * patients that are sexually active. * patients that are symptomatic with: * dysuria * urethral discharge * vaginal discharge * rectal discharge * dysparenia (pain during sex) * pelvic pain * testicular pain * post-coital bleeding (bleeding after sex) * vulval/glans/perianal pain. exclusion criteria: * pregnancy. * aged under 16 years. * sexual assault case. * patients with very severe symptoms that need admission to a ward or referral for urgent gynaecology or urology interventions. * patients lacking capacity to consent.
a phase 2 study of xl820 in adults with advanced gist resistant to imatinib and/or sunitinib

Conditions: Gastrointestinal Stromal Tumors; Gastrointestinal Neoplasms

Summary: the purpose of this study is to evaluate the clinical benefit of the kit inhibitor xl820 in subjects with advanced gastrointestinal stromal tumors (gist) who are resistant to or intolerant of imatinib and/or sunitinib.


Eligibility criteria:
inclusion criteria: * patients with metastatic or locally advanced or unresectable gist who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib * ecog (eastern cooperative oncology group) performance status ≤2 * must have measurable disease per recist (response evaluation criteria in solid tumors) * recovery from toxicity from prior therapy to common terminology criteria for adverse events (ctcae) v3.0 grade ≤1 or to subject's baseline status * adequate organ and marrow function * sexually active subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months following discontinuation of study drugs. * female subjects of childbearing potential must have a negative pregnancy test at enrollment. exclusion criteria: * therapy with imatinib or sunitinib within 14 days before the first dose of study drug * chemotherapy, immunotherapy, targeted therapy, chemoembolization, or any investigational drug for the treatment of gist after the last dose of imatinib or sunitinib * anticoagulation with warfarin or coumarin-related compounds * radiation to ≥25% of bone marrow within 28 days of study entry * treatment with other investigational agents within 28 days of the first dose of xl820 * known central nervous systems metastases * uncontrolled or intercurrent illness * pregnancy or breast-feeding * active bacterial or viral infection requiring systemic treatment

Keywords: gist gastrointestinal cancer
early treatment with ivermectin and losartan for cancer patients with covid-19 infection

Conditions: Cancer; COVID; Coronavirus Infection

Summary: ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of covid-19

this is a randomized, doubled-blind and placebo-controlled phase ii study that will evaluate the efficacy of the early use of ivermectin plus losartan in cancer patients who present with recent diagnosis of covid-19. the trial will enroll 176 patients with previous diagnosis of active cancer (88 in each arm) and the aim of the study is to assess the efficacy of these drugs combination to decrease the incidence of covid-19 severe complications. patients will receive single dose ivermectin of 12mg after the confirmed diagnosis of covid-19, followed by 15 days of losartan. we believe that the association of anti-viral activity of the ivermectin plus the extracellular blockade of the receptor used by the virus will decrease the overall viremia and subsequently improve clinical outcomes.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years of age * ability to understand and sign informed consent * biopsy-proven diagnosis of previous cancer (solid or hematologic disease) * participants must be diagnosed with active malignancy, defined as the presence of metastatic disease; or patient undergoing curative treatment during cancer treatment, regardless of the therapeutic modality. * confirmed diagnosis of covid-19 by the presence of a positive pcr test or positive serological test and / or diagnosis presumed by the presence of flu-like symptoms associated to suggestive findings on ct scan. * ecog performance status 0 to 2 * patients must have an assessment of adequate organ function within 28 days prior to enrollment, evidenced by: * hemoglobin ≥ 9.0 g / dl * leukometry\> 2,000 / mm3 * absolute neutrophil count ≥ 1,500 / mm3 * platelet count ≥ 100,000 / mm3 * creatinine clearance ≥ 30 ml / min. creatinine clearance (crcl) should be calculated according to the cockcroft-gault formula. * total bilirubin \<3 x the upper limit of normal (uln), except for patients with known gilbert's syndrome. * aspartate aminotransaminase (ast) \<3.0 x lsn. * alanine aminotransaminase (alt) \<3.0 x uln. exclusion criteria: * currently taking an angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb). * patients who presents with severe conditions at the time of diagnosis requiring icu admission. * prior reaction or intolerance to an arb or ace inhibitor. * blood pressure less than 110/70 mmhg at presentation * potassium greater than 5.0 meq / l * pregnancy or breastfeeding * prior reaction to ivermectin. * patient currently enrolled in another research protocol

Keywords: cancer covid-19 losartan ivermectin
phase 2b study of aln-rsv01 in lung transplant patients infected with respiratory syncytial virus (rsv)

Conditions: Respiratory Syncytial Virus Infections

Summary: to evaluate the efficacy and safety of aln-rsv01 plus standard of care in rsv infected lung transplant patients


Eligibility criteria:
inclusion criteria: * single or bilateral lung transplant recipients * confirmed rsv infection * greater than 90 days post current lung transplant * rejection free for a minimum of 30 days exclusion criteria: * known viral, bacterial, or fungal respiratory co-infection at the time of rsv diagnosis * bronchiolitis obliterans syndrome (bos) grade 3 or any bos with fev1 that has not been stable for at least 3 months * use of alemtuzumab within 9 months prior to screening, anti-thymocyte globulin (atg) within 90 days of screening or prednisone or equivalent as maintenance therapy * active treatment for acute graft rejection

Keywords: aln-rsv01 rsv respiratory syncytial virus
effect of svv guided fluid therapy on blood loss and postoperative outcomes

Conditions: Bladder Cancer

Summary: the purpose of this study is to investigate the effect of stroke volume variation (svv) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.

the purpose of this study is to investigate the effect of stroke volume variation(svv) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy. patients were randomized to fluid management to maintain \<10% svv (group a), or to undergo fluid management during radical cystectomy to maintain svv 10-20% (group b). intraoperative blood loss and hemodynamic parameters, perioperative laboratory data, and postoperative complications were compared between two groups.

Eligibility criteria:
inclusion criteria: * bladder cancer patients who received radical cystectomy * patients with american society of anesthesiologists physical status scale classification 1, 2 * patients who agree with written informed consent exclusion criteria: * patients with history of arrhythmia, heart failure patients * patients with history of renal failure patients * patients with history of abdominal surgery * patients who received emergency operation * patients who do not agree with study

Keywords: stroke volume variation radical cystectomy blood loss postoperative complications
preventing drug abuse among sexual minority youth

Conditions: Substance Abuse

Summary: the planned randomized clinical trial will longitudinally test a tailored, web-based drug abuse prevention program with a nationwide sample of 15- to 17-year-old sexual minority youth (youth who identify as gay, lesbian, bisexual, or unsure of their sexual orientation).

the randomized controlled trial will include at least 890 sexual-minority youth from the united states. study participants will be 15- to 17-year-old youth recruited from facebook/instagram. all youth will complete pretest measures online. intervention-arm youth will then interact with the 9-session program; youth in the control arm will have access to an attention-placebo website. all youth will then complete posttest measures (immediately following intervention completion and estimated to be approximately 5 months after study onset) and 1-, 2-, and 3-year follow-up measures. across posttest and annual follow-up measurement occasions, data analyses will examine rates of 30-day drug use between study arms. the investigators will also examine intervention effects on mediator variables associated with drug use and assess the extent to which changes in mediator variables explain differences in drug use between arms. youth assigned to the intervention arm will have access to 9 intervention sessions delivered online. the sessions will be housed on a website with entertainment features youth seek: life hacks, features on lgbtq leaders, fortunes, horoscopes, inspiring quotes, and health-related resources. to ensure that youths' expectations for study participation are equivalent across arms and to account for the non-active components of the experimental intervention, the investigators designed the attention-placebo arm. youth assigned to the attention-placebo arm will have access to the website with entertainment features: life hacks, features on lgbtq leaders, fortunes, horoscopes, inspiring quotes, and health-related resources.

Eligibility criteria:
inclusion criteria: * teenagers between the ages of 15-17 years old * identify as lesbian, gay, bisexual, or unsure of sexual orientation * speak and read english * access to a private desktop, laptop, or tablet with broadband internet access exclusion: - lives outside the united states of america

Keywords: sexual minorities prevention web-based intervention substance use longitudinal randomized controlled trial adolescence
step 1: research study investigating how well semaglutide works in people suffering from overweight or obesity

Conditions: Metabolism and Nutrition Disorder; Overweight or Obesity

Summary: this study will look at the change in participants' body weight from the start to the end of the study. the weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. in addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. participants will need to take 1 injection once a week. the study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. the study has two phases: a main phase and an extension phase.the main phase will last for about 1.5 years. participants will have 15 clinic visits and 10 phone calls with the study doctor. extension phase: approximately 300 participants will continue in the extension phase in the following countries only: canada, germany, the uk and selected sites in the us and japan. these participants will be in the study for about 2.5 years.they will not receive treatment, but will attend another 5 follow-up visits with the study doctor.


Eligibility criteria:
inclusion criteria: main phase: * male or female, age greater than or equal to 18 years at the time of signing informed consent * body mass index (bmi) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * history of at least one self-reported unsuccessful dietary effort to lose body weight extension phase: * informed consent for the extension phase obtained before any trial related activities for the extension phase * on randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo exclusion criteria: main phase: * glycated haemoglobin (hba1c) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * a self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records extension phase: * female who is pregnant or intends to become pregnant during the extension phase * any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial
a safety study of sgn-cd19a for b-cell lymphoma

Conditions: Burkitt Lymphoma; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell; Precursor B-cell Lymphoblastic Leukemia-Lymphoma

Summary: this is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of sgn-cd19a in patients with relapsed or refractory b-lineage non-hodgkin lymphoma (b-nhl)


Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma grade 3, diffuse large b-cell lymphoma (dlbcl), including transformed follicular histology, burkitt lymphoma, or b-lineage lymphoblastic lymphoma * relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. patients with dlbcl or follicular lymphoma grade 3 must have also received intensive salvage therapy. * eastern cooperative oncology group status of 0 or 1 * measurable disease exclusion criteria: * allogeneic stem cell transplant (sct)

Keywords: antibodies, monoclonal antibody-drug conjugate antigens, cd19 b-lineage lymphoblastic lymphoma burkitt lymphoma diffuse large b-cell lymphoma mantle cell lymphoma b-cell lymphoma drug therapy monomethylauristatin f follicular lymphoma grade 3
evaluation of the effects of diosmin/hespiridin combination on the clinical outcomes in patients with polycystic ovary syndrome

Conditions: Poly Cystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is one of the most prevalent disorders worldwide. insulin resistance, inflammation and disturbance in sex hormone levels are the main contributing factors of this disease.the majority of studies addressing the status of chronic low-grade inflammation in pcos have focused on the measurement of c-reactive protein (crp) followed by stimulation of interleukin 6 (il-6) and tumor necrosis factor (tnf-alpha). daflon 500 mg tablets (containing 90% of diosmin and 10% of hesperidin) is used in patients to treat varicose veins, venous ulcers, hemorrhoids and lymphatic insufficiency. it has anti-diabetic, anti-inflammatory, microcirculatory, and antioxidant effects. so the aim of the work is to investigate the effect of diosmin/hesperidin in the management of pcos through evaluation of oxidative stress and inflammation, improvement of signs and symptoms through patients' follow-up, improvement of pcos status by sonography and hormonal levels, measuring of anti-diabetic effect by measuring, fasting insulin, homa-ir and measuring the improvement of patient's quality of life by using the women health questionnaire (whq).


Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of pcos aged in the range from18-40 (premenopausal adults) diagnosed with pcos according to rotterdam criteria by an expert gynecologist; (1) oligo-ovulation and/or anovulation (2) clinical and biochemical hyperandrogenism and (3) polycystic ovaries on ultrasonography exclusion criteria: * 1-pregnant and nursing women 2-menopause women 3-diabetic patients 4-adrenal hyperplasia 5-adrenal tumor 6-thyroid dysfunction 7-women on confounding medications which affect ovarian function