Kornimate/medical-research-clean huggingface dataset:
gamma-glutamyl transpeptidase (ggt): a potential diagnostic marker for helicobacter pylori infections

Conditions: HELICOBACTER PYLORI INFECTIONS

Summary: the investigators hypothesis: presence of anti-ggt (antibody against ggt) indicates h. pylori infection.

subjects will be requested to provide 1-5g of their solid/semi-solid stool sample, to be collected within 24 hours prior to their scheduled visit for urea breath test. patients should not have been treated for h. pylori prior to stool collection. stool samples will be tested using elisa for the presence of the h. pylori ggt antigen using monoclonal antibodies against ggt. stool samples will also be tested for the presence of h. pylori dna using pcr and western blot analysis respectively. presence of the ggt antigen in stool will be compared between h. pylori-positive and h. pylori-negative patients. rapid urease test results will be used as the gold standard of h. pylori diagnosis. the sensitivity and specificity of the stool antigen test will be established.

Eligibility criteria:
inclusion criteria: * the subject is greater than 21 years of age. * the subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study. * the subject must be willing and able to comply with scheduled visits and other study procedures. exclusion criteria: * subjects who have been taking antibiotics over the past 1 month will be excluded from study.

Keywords: focus of study : helicobacter pylori infections
single center study evaluating the possible effect of virtual reality spectacles on pain following total knee replacement surgery

Conditions: Pain Post Joint Arthroplasty

Summary: the trial aims to evaulate the possiblity that use of virtual reality spectacles will affect post operative pain in total knee arthroplasty patients. the trial is a single center open label design. patients will be randomized into two arm study comparing the effect of the use of virtual reality spectacles on pain levels and analgesic consumption in the perioperative period. the controls shall receive standard post operative care. the endpoints are vas levels and analgesic use.

evaluation procedure this is a single center, interventional, randomized, unblinded two arm study assessing pain and analgesic use in post knee arthroplasty patients. the randomization ratio is 2:1 intervention to control. both groups will receive routine post operative care. the intervention group will be treated with virtual reality spectacles. the control group will receive routine post operative care. pain levels will be assessed using vas and analgesic use.

Eligibility criteria:
inclusion criteria: * patients undergoing total knee arthroplasty gender indifferent, aged over 18 years old * patient with ability to see in three dimensions exclusion criteria: * inability to comply with the study protocol * single eye vision * blindness
closing uterine incision during c-section using barbed suture (stratafix) or vicryl suture.

Conditions: Cesarean Section

Summary: a randomized prospective single blinded trial. the investigator seek to evaluate the surgical outcome of stratafix barbed suture compared to standart vicryl sutures in reducing the suturing time during c-section.

a randomized prospective single blinded trial. the investigator seek to evaluate the surgical outcome of stratafix barbed suture compared to standart vicryl sutures in reducing the suturing time during c-section. in addition, the need of additional sutures to control bleeding after the 2- layer closure will be estimated.these will be the primary outcome measures. the secondary outcome measures will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative infection (endometritis) and wound infection..

Eligibility criteria:
inclusion criteria: • pregnant patients with an obstetrical indication for delivery by cesarean section exclusion criteria: • patients with blood clotting disorders.

Keywords: cesarean section c- section suture
ascorbic acid and ibuprofen in infants with hypoxic ischemic encephalopathy

Conditions: Hypoxic Ischemic Encephalopathy; Perinatal Asphyxia

Summary: oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. animal studies demonstrated potential benefits to the brain when using both of vitamin c and ibuprofen. the efficacy of these 2 drugs when combined in protecting the human brain has not been studied. we aimed in this study to test the hypothesis that a combination of anti-oxidants (vitamin c) and anti-inflammatory (ibuprofen) drugs can decrease the brain injury in perinatal asphyxia and improve outcomes when given to infants immediately after birth.


Eligibility criteria:
inclusion criteria: * apgar score at 5 minutes \< 6 * profound metabolic or mixed acidosis with ph \< 7 in the initial blood gas * evidence of encephalopathy such as coma, seizures or hypotonia * evidence of multi-system compromise, in addition to encephalopathy exclusion criteria: * major congenital anomalies * early sepsis * gastrointestinal bleeding * thrombocytopenia

Keywords: interleukin 1-beta interleukin 6 vitamin c hie neonates
anidulafungin in treating immunocompromised children with neutropenia

Conditions: Infection; Neutropenia; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia. purpose: this phase i/ii trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused by chemotherapy or aplastic anemia.

objectives: * determine the safety, tolerability, and pharmacokinetics of anidulafungin in immunocompromised children with neutropenia. * determine the frequency of deeply invasive fungal infections in children receiving this drug for early empirical therapy. outline: this is a dose-escalation, open-label, multicenter study. patients are assigned to 1 of 2 groups according to age (2 to 11 years vs 12 to 17 years). patients receive anidulafungin iv once daily over 45-120 minutes. in both groups, cohorts of 6 patients receive escalating doses of anidulafungin. treatment continues for up to 28 days or until patients recover from neutropenia or become eligible for standard empirical antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection. patients are followed at 7-9 days. projected accrual: a total of 25 patients (approximately 12 per group) were accrued for this study.

Eligibility criteria:
disease characteristics: * neutropenia due to cytotoxic chemotherapy or aplastic anemia * duration expected to be 10 days * absolute neutrophil count less than 500/mm\^3 or less than 1,000/mm\^3 and expected to fall below 500/mm\^3 within 72 hours * no deeply invasive fungal infection confirmed prior to study entry patient characteristics: age * 2 to 17 performance status * not specified life expectancy * not specified hematopoietic * see disease characteristics hepatic * ast or alt no greater than 5 times upper limit of normal (uln) * bilirubin no greater than 2.5 times uln renal * creatinine clearance at least 30 ml/min other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception during and for at least 30 days after study participation * no prior anaphylaxis attributed to the echinocandin class of antifungals * no other concurrent medical condition that would preclude study participation prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * more than 4 weeks since prior investigational drugs * no prior participation in this clinical trial * no prior anidulafungin * no other concurrent investigational drugs * no other concurrent systemic antifungal agents (e.g., amphotericin, systemic azoles, or triazole antifungal agents) * concurrent oral, nonabsorbable azoles and topical antifungal agents (e.g., nystatin and/or azole formulations) allowed * concurrent broad-spectrum antibiotics allowed

Keywords: infection neutropenia unspecified childhood solid tumor, protocol specific
acute effects of dietary medium-chain fatty acids on lipid profile

Conditions: Healthy Nutrition; Diet, Healthy

Summary: in the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (mct) and long chain fatty acids (lct),, respectively. in addition oxygen uptake was measured to study energy turnover.

four participants ingested mct or lct oil on two test days with one-week period between the experimental days. the day prior to the experimental days, the participants consumed a eucaloric control diet, and abstained from alcohol and vigorous physical activity to ensure similar conditions on experimental days. on the test days, participants arrived by passive transport in the overnight fasted state (12 h) at 8 a.m., and a catheter was inserted into an antecubital vein. following 30 min in supine rest, an overnight-fasted, basal venous blood sample was obtained. subsequently, participants ingested the same test drink as in study 1 (containing 35g of mct or lct oil diluted in 100g of low-fat, low-carbohydrate cocoa milk) within five min. 100 ml water was provided together with the test drink. venous blood samples were drawn every 30 min for the first two hours and every 60 minutes for the last two hours following intake. participants rested in a bed throughout the test day. this this process was repeated on the second test day.

Eligibility criteria:
inclusion criteria: healthy males bmi:20-27 recreationally physical active non-smoker no medicine - exclusion criteria: * high habitual intake of mct-rich foods as coconut, coconut oil and dairy products

Keywords: medium-chain fatty acids lipidomics acute intervention
is diverting loop ileostomy necessary in completion proctectomy with ileal pouch anal- anastomosis: a multicentre, randomized study of the getaid chirurgie group. ideal trial

Conditions: Ulcerative Colitis; Ileostomy - Stoma

Summary: defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (ipaa) performed for inflammatory bowel disease (ibd). however, most surgical teams do protect systematically ipaa by an ileostomy. total proctocolectomy with ipaa is the gold standard for surgical management of ulcerative colitis (uc). this demanding procedure is often performed in 2 or 3 stages, namely subtotal colectomy, completion proctectomy with ipaa and defunctioning ileostomy closure. subtotal colectomy with double stoma is first performed to allow nutritional support, reduce inflammation and stop immunosuppressive agents. completion proctectomy with ipaa is then performed on a healthier patient. hence, the need for a systematic defunctioning ileostomy is questioned. no study addressed specifically the question of completion proctectomy, whereas it concerns 36% to 42% of patients undergoing ipaa. globally, the overall 6-month morbidity rate is 55% in case of stoma creation vs. 30% otherwise in ipaa. moreover, defunctioning ileostomy has several drawbacks including an additional surgical procedure (stoma closure), a worse quality of life before closure, and the risk of dehydration that may require readmission. following stoma closure, the risk of anastomotic leakage is around 4%. overall, during the stoma period, 8% of patients will require reoperation. finally, the risk of incisional hernia is 15-20% at the ex-ileostomy site. therefore, the aim of this trial is to assess the need for a systematic defunctioning ileostomy after completion proctectomy with ipaa.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years, * patients presenting with ulcerative colitis or indeterminate colitis requiring completion proctectomy * patients who have given informed consent exclusion criteria: * indication for total proctocolectomy in one-stage or traditional 2-stage fashion * crohn's disease, * pelvic radiotherapy, * indication for total mésorectum excision * vulnerable patient under the french laws
amber-hfpef: assessment of ck-4021586 in a multi-center, blinded evaluation of safety and tolerability results in hfpef

Conditions: Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

Summary: this is a phase 2 dose-finding study in adult participants with symptomatic hfpef.


Eligibility criteria:
inclusion criteria: * males and females ≥ 40 years and ≤ 85 years of age at screening. * diagnosed with hf with nyha functional class ii or iii. * screening echocardiography with lvef ≥ 60%. * screening nt-probnp ≥ 300 pg/ml for participants in sinus rhythm and ≥ 900 pg/ml for participants with comorbid atrial fibrillation or flutter. * body mass index \< 40 kg/m2. * participants on beta-blockers, angiotensin-converting enzyme (ace)/angiotensin ii receptor blocker (arb) or angiotensin receptor/neprilysin inhibitor (arni), or sodium-glucose contransporter-2 (sglt2)-inhibitors must be on stable doses for more than 4 weeks prior to screening. * participants on a glucagon-like peptide-1 (glp-1) agonist must be on a stable dose for more than 24 weeks prior to screening with no anticipated plans to change dose during this study. exclusion criteria: * history or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the investigator or the medical monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: symptomatic heart failure with preserved ejection fraction hfpef heart failure ck-4021586 ck-586 amber-hfpef amber cardiac myosin inhibitor cmi cy 9021
pilot study for tce imaging of the esophagus using an ofdi capsule with a compact imaging system

Conditions: Barrett's Esophagus

Summary: the goal of this research is to test a distal scanning capsule and a compact redesigned version of the ofdi imaging system in healthy and be subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

ten healthy volunteer subjects and ten volunteers with a previous diagnosis of barrett's esophagus (be) will be enrolled in the study. the capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis. images of the esophagus will be acquired in real time to be analyzed later.

Eligibility criteria:
inclusion criteria: * a previous diagnosis of be (not an inclusion criteria for healthy volunteers) * subjects must be over the age of 18 but less than 70 year of age. * subjects must be able to give informed consent * subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure. exclusion criteria: * subjects over 70 years of age * subjects with the inability to swallow pills and capsules. * subjects with a strong gag reflex * esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule. * pregnancy. if the subject is unsure, she will be asked to take a pregnancy test.

Keywords: device ofdi tethered capsule endomicroscopy
intermittent preventive treatment of malaria in schoolchildren

Conditions: Malaria; Intermittent Preventive Treatment

Summary: this will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. the primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (aq+sp), dihydroartemisinin-piperaquine (dp), and placebo, to sp for intermittent preventive treatment (ipt) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. this will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.

the study will be carried out among children aged ≥ 8 to \< 14 years (boys) and ≥ 8 to \< 12 years (girls) attending primary schools in tororo district. schools will be selected using convenience sampling with the assistance of the district and the education sector. the target population includes children attending primary schools in uganda. the accessible population includes the children attending the participating primary schools in classes 3-7 in tororo district. children who meet the selection criteria for participation in the study will be randomized to treatment with one of the four study regimens and will be followed for 42 days. repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled day that a student is ill) and will include assessment for the occurrence of adverse events. treatment efficacy outcomes will be assessed using revised who outcome classification criteria. acceptability of treatment regimens will be assessed using a questionnaire administered to participating students on day 7. the primary outcome measure is risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up.

Eligibility criteria:
inclusion criteria: * age ≥ 8 to \< 14 years (boys), ≥ 8 to \< 12 years (girls) * student enrolled at participating school in classes 3-7 * provision of informed consent from parent or guardian * provision of assent by student exclusion criteria: * known allergy or history of adverse reaction to study medications * onset of menstruation (girls) * fever (≥ 37.5°c axillary) or history of fever in the previous 24 hours * evidence of severe malaria or danger signs * haemoglobin \< 7.0 gm/dl * parasite density \> 10,000/ul

Keywords: malaria intermittent preventive treatment efficacy safety tolerability schoolchildren uganda
outcomes of high-risk non-muscle invasive bladder cancer treated with blue light resection

Conditions: Bladder Cancer

Summary: comparing white-light cystoscopy (wlc) and blue-light cystoscopy (blc) in turbt for high risk (hr) non-muscle invasive bladder cancer (nmibc) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. enhanced visualization with blc may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. patients will be randomized to either wlc turbt or blc turbt, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (mrd) burden evaluation using urine next-generation sequencing.

objectives are as follows: primary i) comparison of the reduction in mrd burden score between pre-resection and post-resection urine samples across blc and wlc resection arms of the study, and among patients with a high-grade tumor at time of resection ii) comparison of the reduction in mrd burden score between pre-resection and post-resection urine samples across blc and wlc resection arms of the study, and among all evaluable study participants. secondary i) among all evaluable study participants: recurrence-free survival (rfs) at 12 and 24 months using post-turbt and three month surveillance urine sample time points in blc and wlc arm. ii) among patients undergoing intravesical induction: recurrence-free survival (rfs) at 12 and 24 months using post-turbt and three month surveillance urine sample time points in blc and wlc arm.

Eligibility criteria:
inclusion criteria: * patients undergoing turbt for radiographic or cystoscopic positive tumor * 18+ years old * upper tract evaluated using standard of care throughout duration of the study * induction intravesical therapy initiated within four weeks of turbt exclusion criteria: * variant histology consisting of less than 50% urothelial carcinoma * history, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer * prior history of pelvic radiation * active urinary tract infection (uti) * patients who are noncompliant with the study protocol

Keywords: blue light cystoscopy cysview
study comparing bevacizumab + temsirolimus vs. bevacizumab + interferon-alfa in advanced renal cell carcinoma subjects

Conditions: Renal Cell Carcinoma

Summary: primary objective: comparison of independently assessed progression free survival (pfs) in subjects administered bevacizumab + temsirolimus vs. those administered bevacizumab + interferon-alfa. secondary objectives: safety, investigator assessed pfs, objective response rate (independently assessed), and overall survival.


Eligibility criteria:
inclusion criteria: * histologically and/or cytologically confirmed to have advanced renal cell carcinoma (rcc) * majority component of conventional clear-cell type is mandatory * at least 1 measurable lesion (per recist) exclusion criteria: * prior systemic treatment for rcc * evidence of current or prior central nervous system (cns) metastases * cardiovascular disease * pregnant or nursing women * additional criteria applies

Keywords: temsirolimus renal cell carcinoma kidney cancer urogenital cancer