Kornimate/medical-research-clean huggingface dataset:
reduce the severity of dgf in recipients of a deceased donor kidney

Conditions: Delayed Graft Function

Summary: the major objective is to demonstrate the safety and efficacy of ang-3777 in improving graft function and reducing the severity of delayed graft function (dgf) in recipients at high risk of dgf after receiving a deceased donor renal allograft.


Eligibility criteria:
inclusion criteria: 1. all patients must provide written informed consent using an institutional review board/independent ethics committee (irb/iec) approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits. 2. males and females ≥ 18 years of age. 3. renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation. 4. patient is to be the recipient of a first kidney transplant from a deceased donor. 5. study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney. 6. body mass index \< 40 based on dry weight. dry weight and height parameters obtained within 7 days prior to study entry may be used.. 7. estimated donor organ cold ischemia time less than 30 hours (for pmp kidneys less than 40 hours). exclusion criteria 1. scheduled for multiple organ transplantation or prior recipient of a transplanted organ. 2. recipient of an abo-incompatible kidney. 3. recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc. 4. recipient of a kidney preserved by normothermic pulsatile machine perfusion. 5. has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy. 6. currently participating in or has participated in an investigational drug or medical device study within 30 days or five drug half-lives, whichever is longer, prior to enrollment into this study. patients cannot be given another investigational agent during the course of this study (through day 360). patients may participate in another concurrent study only if that study is a non-interventional, observational investigation. 7. concurrent sepsis or active bacterial infection. 8. has an active malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma in situ of the skin that has been adequately treated.

Keywords: dgf delayed graft function renal transplantation deceased donor kidney bb3 kidney transplantation acute kidney injury
phase i/ii study of high-dose calcitriol plus temodar for patients with metastatic melanoma

Conditions: Metastatic Melanoma

Summary: rationale: drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug. calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor. purpose: this phase i/ii trial is studying the best dose of calcitriol, the side effects of calcitriol when given together with temozolomide, and to see how well they work in treating patients with metastatic stage iv melanoma.

\* phase i: patients receive oral calcitriol on days 1 and 15 and oral temozolomide on days 2-8 and 16-22. treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. responding patients continue therapy for up to 6 courses in the absence of unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. * phase ii: patients receive temozolomide and calcitriol at the mtd as in phase i. after completion of study treatment, patients are followed every 3 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed malignant melanoma * any primary tumor site * stage iv disease * cns metastases allowed * measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral ct scan * must have had at least 1 prior systemic therapy * negative pregnancy test * fertile patients must use effective contraception * patients with no prior systemic therapy are eligible provided they are not candidates for high-dose interleukin-2 * recovered from all toxic effects of prior therapy * more than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy * more than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy * fertile patients must use effective contraception exclusion criteria: * life expectancy less than 4 months * known hiv positivity * evidence of active infection requiring antibiotic therapy * other malignancy within the past 5 years except surgically resected basal cell or squamous cell skin cancer * significant medical disease which, in the opinion of the investigator, may interfere with study completion * pregnant or nursing * negative pregnancy test * prior temozolomide or dacarbazine * investigational agent within 4 weeks prior to study entry * concurrent magnesium-containing antacids, digitalis, bile-resin binding drugs, or calcium supplements

Keywords: stage iv melanoma recurrent melanoma
the impact of improved vagal function on periaqueductal gray connectivity

Conditions: Postural Tachycardia Syndrome

Summary: this study is being to see if participating in breathing exercise training and practicing this training will help with postural tachycardia syndrome (pots). the information may help doctors to learn more about how the different parts of people's brains communicate.


Eligibility criteria:
inclusion criteria: * age 18-50 years * diagnosis of pots, orthostatic intolerance (with or without syncope), syncope, or near-syncope * can speak and read in english * upcoming new patient vcu comprehensive autonomics center clinic visit scheduled at least 1 week in the future exclusion criteria: * inflammatory arthritis, connective tissue or auto-immune disorder * any chronic neurological disorder besides pots, orthostatic intolerance (with or without syncope), syncope, or near-syncope * patients who have already had a new patient clinic visit where they were exposed to breathing exercise education * evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising ast or alt, or end-stage with coagulopathy), poorly controlled significant cardiovascular (chf), respiratory, endocrine (diabetes - a1c \> 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.) * neuropathy, central nervous system disorder (e.g., cerebral palsy, developmental delay, seizure disorder, ms, stroke, etc.) * treatment with a drug or medical device within the previous 30 days that has not received regulatory approval * use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented) * current substance or alcohol abuse * any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days * any on-going or pending medical, health or disability related litigation, or current pursuit of disability * any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented) * chronic use of narcotics for pain * claustrophobia or any metal hardware that may interfere with mri * investigators and study staff
mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery

Conditions: Rectal Adenocarcinoma; Rectum Neoplasm; Rectum Carcinoma; Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Surgical Site Infection; Surgery--Complications

Summary: mobile2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. primary endpoint is comprehensive complication index within 30 days from surgery.


Eligibility criteria:
inclusion criteria: * patients scheduled for anterior rectal resection with primary anastomosis exclusion criteria: * emergency operation * bowel obstruction * existing stoma * other reason preventing mechanical bowel preparation * allergy to neomycin or metronidazole * age \< 18 years * lack of co-operation exclusion criteria after randomization: * patient did not undergo surgery * anterior resection was not performed * colonic anastomosis was not performed
macugen (pegaptanib sodium) alone, versus macugen in combination with pdt (photodynamic therapy) with visudyne (verteporfin) in patients with age-related macular degeneration (amd)

Conditions: Age-Related Macular Degeneration

Summary: the purpose of the trial is to compare whether macugen (pegaptanib sodium) in combination with pdt with visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to macugen alone. patients must be recently diagnosed with predominantly classic wet amd and must be eligible for pdt.


Eligibility criteria:
inclusion criteria: * subjects of either gender; aged 50 years or greater. * subfoveal choroidal neovascularization (cnv) due to amd with predominantly classic lesion composition * best corrected visual acuity in the study eye between 20/40 and 20/200 exclusion criteria: * any prior pdt with visudyne to the study eye * any previous amd thermal laser therapy to the study eye

Keywords: amd age-related macular degeneration macular degeneration macugen photodynamic therapy pdt visudyne pegaptanib sodium verteporfin predominantly classic age-related macular degeneration (amd)
low back pain - what's next? stratified care compared to current practice

Conditions: Low Back Pain

Summary: background studies in the united kingdom find the stratified care model of the start back tool (sbt) to be superior to usual care in primary care low back pain (lbp) patients. however, considerations on differences in health care and social systems across countries are required before taking steps towards any recommendations of implementing stratified care into other health care services. objective to investigate the effectiveness of the stratified care model of the sbt, when embedded into the regional disease management programs on lbp in primary care as compared to current best practice care.

methods the study is a two-armed randomized controlled trial in danish primary health care setting. in total 700 patients are included in the study. the patients are randomised automatically by a developed database to; 1) stratified care (treatment matched to stratification according to sbt) or 2) control treatment (treatment based solely on clinical reasoning). all data including patient consent is collected and monitored using a web-based data management system.

Eligibility criteria:
inclusion criteria: * patients found eligible for referral to physiotherapy by the general practitioner (gp) * 18 years and above * understand danish language. exclusion criteria: * serious pathology (malignancy, inflammatory arthritis, etc.), * serious nerve root compression (cauda equina, paresis \<3), * influential comorbidity, psychiatric illness, personality disorder, spinal surgery during the last 6 months, pregnancy, or already receiving physiotherapy treatment.

Keywords: start back tool stratified care targeted treatment
effectiveness of precede model for health education on changes and level of control in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Cardiovascular Risk Factor

Summary: background: individual health education is considered to be essential in the overall care of patients with type 2 diabetes (dm2), although there is some uncertainty regarding its metabolic control benefits. there have been very few randomized studies on the effects of individual education on normal care in dm2 patients with a control group, and none of these have assessed the long-term results. therefore, this study aims to use this design to assess the effectiveness of the precede (predisposing, reinforcing, enabling, causes in educational diagnosis, and evaluation) education model in the metabolic control and the reduction of cardiovascular risk factors, in patients with type 2 diabetes. methods: an open community randomized clinical trial will be carried out in 8 urban community health centers in the northeastern madrid (spain). six hundred patients with dm2 will be randomized in two groups: precede or conventional model for health promotion education. the main outcome measures is glycated hemoglobin a1c, body mass index (bmi), blood pressure, lipids and control criteria during the 2-year follow-up period.

assignment to the health promotion education (hpe) will be random, three centers will use conventional hpe (the control group) and the remaining five will use precede-type hpe. eligible patients are selected from a list of dm2 patients by each professional using random sampling, until the predetermined sample size is attained. conventional hpe is defined according to the recommendations of the spanish ministry of health national conference on diabetes mellitus, and was complemented by the criteria for good care of the madrid primary healthcare service for the promotion of healthy lifestyles among adults for 2004-2007

Eligibility criteria:
inclusion criteria: * older than 30 years of age, with previously diagnosed dm2 (cardinal clinical, plus random blood glucose \> 200 mg/dl or oral glucose of \> 200 mg/dl at 2 h, twice, or plasma fasting glucose of \> 126 mg/dl on two occasions or being diagnosed previously, received specific treatment for dm2) exclusion criteria: * gestational diabetes * patients involved in clinical trials * patients with life expectancy less than 1 year (according to clinical judgment) * patients who refused to participate * homebound patients patients meeting criteria for inclusion and not meeting any exclusion criteria were invited to participate, and were included after accepting and signing an informed consent form.

Keywords: health promotion education type 2 diabetes mellitus cardiovascular risk factors spain
study to learn more about the safety and effectiveness of rivaroxaban (xarelto) when given together with acetylsalicylic acid to indian people with narrowing of the arteries of the heart (cad) and/or with reduced blood flow in the arteries of the legs and arms with symptoms (symptomatic pad)

Conditions: Prevention of Atherothrombotic Events; Coronary Artery Disease (CAD); Symptomatic Peripheral Artery Disease (Symptomatic PAD)

Summary: this is an observational study in which data from indian people with coronary artery disease and / or symptomatic peripheral artery disease who will be receiving the drug rivaroxaban (xarelto) are studied. coronary artery disease (cad) is a condition where the arteries that bring blood and oxygen to the heart become hardened and narrow. peripheral artery disease (pad) is a condition with reduced blood flow in the arteries of the legs and arms. people with cad and / or pad with symptoms may receive rivaroxaban from their doctors to prevent problems (for example, stoke) caused by blood clots and hardening of the arteries. in this study researcher want to gather more information on the safety and the effectiveness of rivaroxaban when given together with the drug acetylsalicylic acid (also known as "aspirin") to people with cad and / or pad with symptoms in the routine practice in india. researchers are especially interested whether patients under treatment experience any events such as minor or major bleedings, stroke, sickness of the heart or blood vessels. in addition, information on why and when treating doctors decide to start or stop the treatment with rivaroxaban and acetylsalicylic acid is of interest to the researchers. the study plans to enroll about 300 male or female patients who are at least 18 years old and are already treated with the two drugs or at least with rivaroxaban.


Eligibility criteria:
inclusion criteria: * adult (≥18 years) patient. * diagnosis of cad or pad. * treatment with rivaroxaban 2.5mg tablet, co administered with acetylsalicylic acid (asa), for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events within 4 weeks prior to enrolment. also patients already on rivaroxaban treatment for acs, who are subsequently fulfilling criteria for cad, are allowed to be enrolled within 4 weeks of this decision being made. * patients who are willing to participate in this study (signed informed consent). exclusion criteria: * contra-indications according to the local marketing authorization. * patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5mg given for cad/pad. * participation in an interventional trial.
study of the safety and efficacy of sti-5656 (abivertinib maleate) in subjects hospitalized due to covid-19

Conditions: Covid19

Summary: a phase 2, placebo-controlled study of the safety and efficacy of sti-5656 (abivertinib maleate) in subjects hospitalized due to covid-19

this is a phase 2, randomized, double-blind, placebo-controlled study of the safety and efficacy of sti-5656 (abivertinib maleate) in subjects hospitalized due to covid-19 in brazil. subjects are randomized 3:1 sti-5656 to placebo. subjects receive either 100 mg of sti-5656 or placebo daily for 7 days. standard of care will be maintained for all subjects throughout the study.

Eligibility criteria:
inclusion criteria: * confirmed positive for covid-19 by rt-pcr assay or equivalent * subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board (irb) or independent ethics committee (iec) approved consent form prior to participating in any study related activity. however, if obtaining written informed consent is not possible, other procedures as provided in the march 27, 2020 (updated on july 2, 2020) fda guidance on conduct of clinical trials of medical products during covid-19 pandemic, question 10, may be used * able to swallow capsules * willing to follow contraception guidelines exclusion criteria: * pregnant or breast feeding * suspected uncontrolled active bacterial, fungal, viral, or other infection other than covid-19 * treatment with a strong cytochrome p450 3a4 inhibitor or inducer within 7 days prior to day 1 * received anti-rejection or immunomodulatory drugs within 14 days prior to day 1 * concurrent participation in another clinical trial involving therapeutic interventions (observation studies are acceptable) * any condition that confounds the ability to interpret data from the study * any significant medical condition, laboratory abnormality, or psychiatric illness that would interfere with or prevent the subject from participating in the study

Keywords: covid-19
a study evaluating safety, pk, and efficacy of tafasitamab and parsaclisib in participants with relapsed/refractory non hodgkin lymphoma (r/r nhl) or chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma

Summary: the purpose of this single-arm, open-label, phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended phase 2 dose (rp2d) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with r/r b-cell malignancies.


Eligibility criteria:
inclusion criteria: * histologically confirmed r/r b-cell malignancy: dlbcl (thrlbcl, ebv-positive dlbcl of the elderly, grade 3b fl, hgbl with myc and bcl2 and/or bcl6 rearrangements, transformed lymphoma); mcl ((with cyclin d1 overexpression or t(11;14); fl (grade 1, 2, 3a); mzl (extranodal, nodal, splenic) ; cll, or sll * willingness to undergo biopsy * at least 2 prior systemic treatment regimens, including prior treatment with an anti-cd20 antibody (all cohorts) or prior treatment with a btk inhibitor (cll/sll) * relapsed, progressive, or refractory nhl or cll * for nhl/sll: radiographically measurable nodal or extranodal disease (all cohorts except cll) * ecog-ps 0 - 2 * lvef ≥ 50% * adequate renal, hepatic, bone marrow function exclusion criteria: * any other histological type of lymphoma * primary or secondary cns lymphoma * anticancer and/or investigational therapy within the past 30 days or 5 half-lives * allogeneic stem cell transplantation within the past 6 months, or asct within 3 months before c1d1 * previous treatment with cd19-targeted therapy or pi3k inhibitors * clinically significant cardiac disease * other malignancy within the past 3 years * active graft-versus-host disease * stroke or intracranial hemorrhage within the past 6 months * chronic or current active infectious disease * positive virus serology for hcv, hbv, hiv * currently pregnant or breastfeeding

Keywords: relapsed or refractory leukemia tafasitamab parsaclisib mor00208 incmor00208
efficacy of vitamin d treatment in pediatric patients hospitalized by covid-19

Conditions: Covid19; Vitamin D; Children, Only

Summary: open controlled clinical trial. hospitalized pediatric patients with covid-19 will be included. upon admission to hospital serum determination of vitamin d, interleukins, ferritin and dimer d will be performed. subsequently, randomization will be performed to identify which group the patient belongs. adverse effects will be evaluated on a daily basis. serum levels of interleukin (il) -2, 6, 7,10, ferritin and dimer-d will be taken at the beginning of hospitalization and on the 7th day after admission. it will be recorded if the patient presents deterioration of the respiratory function that requires endotracheal intubation and / or admission to intensive care and / or if he dies, and at what time of hospitalization does this outcome occur. the study will culminate when the patient is discharged from hospitalization.

hospitalized pediatric patients with covid-19 will be included. the diagnosis of covid-19 performed through rt-pcr. upon admission to hospital, a serum determination of vitamin d, interleukins, ferritin and dimer-d will be performed. subsequently, randomization will be performed to identify which group the patient belongs to. in case of being in the vitamin d group, in children under 12 months they will be given 1000u and in children over 12 months they will be given 2000u every 24 hours orally. adverse effects will be evaluated on a daily basis. subsequently, serum levels of interleukin (il) -2, 6, 7,10, ferritin and dimer-d will be taken on day 7 of admission. it will be recorded if the patient presents deterioration of the respiratory function that requires endotracheal intubation and / or admission to intensive care and / or if he dies, and at what time of hospitalization does this outcome occur. the study will culminate when the patient is discharged from hospitalization. on the day of hospital discharge, a blood sample will be taken to determine vitamin d.

Eligibility criteria:
inclusion criteria 1. age over 1 month and under 17 years 2. confirmed diagnosis of covid-19 infection with the results of real-time pcr 3. that they agreed to participate in the study. 4. that the patient tolerates the enteral route exclusion criteria 1. have received vitamin d in the four weeks prior to hospitalization.