Kornimate/medical-research-clean huggingface dataset:
viral activation transfusion study (vats)

Conditions: Acquired Immunodeficiency Syndrome; Blood Transfusion; Cytomegalovirus Infections; HIV Infections

Summary: the purpose of the trial was to determine if transfusion of allogeneic blood to hiv-1 infected persons led to immune activation and consequent induction of hiv-1 or /or cytomegalovirus (cmv) replication, and whether this adversely affected clinical prognosis.

background: the initiative was approved by the nhlbi aids ad hoc working group and given concept clearance by the september 1993 national heart, lung, and blood advisory council. the initiative was released in january 1994. design narrative: patient enrollment started in august 1995. patients scheduled for transfusion were entered into the study at the time of their first transfusion and randomized to receive leukopoor red cells filtered within 24 hours of collection or unmanipulated blood components. patients received blood as per their treatment arm as needed for one or two years. patients were stratified to those with cd4 counts below 50 /mm3 (most patients) and those with cd4 counts above that level. primary endpoints were overall survival and a change in hiv viremia after the 1st transfusion. the secondary endpoint was the occurrence of a new aids-defining complication. a substudy looked at donor lymphocytes in the immunosuppressed recipients to help determine why aids patients don't seem to get post-transfusion graft-vs-host disease. the patient recruitment time was extended for one year because of low accrual. with new drugs, especially protease inhibitors, the proportion of patients needing transfusion has decreased. the patients are less severely ill and their disease produces less anemia. furthermore, the new drugs don't have anemia as a side effect. the trial ended in january, 2000. the study completion date listed in this record was obtained from the "completed date" entered in the query view report system (qvr).

Eligibility criteria:
hiv-infected patients with cd4 counts below 250 who clinically needed red blood cell transfusions.
epilepsy-related brain tumors register

Conditions: Epilepsy

Summary: epilepsy is defined by a cerebral disorder characterized by a lasting predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological and social consequences of this affection. the definition of epilepsy requires the occurrence of at least one epileptic seizure. 1% of the population suffers from epilepsy. the most common causes are genetic and vascular, 10% of epileptic syndromes are caused by a tumor. the incidence of brain tumors in people with epilepsy is approximately 4%. among patients with brain tumor (s), the frequency of epilepsy is 30% or more depending on type of tumeur. 30-50% of brain tumors are revealed by an epileptic seizure and 10 to 30% of patients with brain tumor (s) will develop seizures during their evolution. the main objective is to evaluate the frequency of epileptic seizures according to the type of brain tumor.


Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 years * patient hospitalized or seen in consultation in the department of neurology within the hospital group paris saint-joseph * diagnosis of primary or secondary brain tumor, radiologically and / or histologically * epilepsy revealing or occurring in a patient developing a brain tumor * francophone patient exclusion criteria: * pre-existing and known epilepsy before the diagnosis of brain tumors * epilepsy occurring within 2 weeks postoperatively * anteriority of taking antiepileptic treatment * patient under tutorship or curatorship * patient deprived of liberty * patient with comprehension disorders making it impossible to understand the protocol * patient or relative opposing the use of his data
efficacy of nitrous oxide in ocd: pilot study

Conditions: Obsessive-Compulsive Disorder

Summary: this study investigates whether the commonly used and well-tolerated inhaled anesthetic nitrous oxide can rapidly improve symptoms of ocd.

obsessive-compulsive disorder (ocd) is a chronic and disabling disorder characterized by recurrent intrusive thoughts and associated compulsive behaviors that is estimated to affect more than 3 million individuals in the us each year. this study seeks to explore whether a single inhalation of nitrous oxide gas may bring about rapid symptom relief in ocd.

Eligibility criteria:
inclusion criteria: * age 18-65 * primary diagnosis of ocd * sufficient severity of ocd symptoms * ability to tolerate a treatment-free period * capacity to provide informed consent exclusion criteria: * psychiatric or medical conditions that make participation unsafe * pregnant or nursing females * concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)

Keywords: ocd nitrous oxide
the optimal surveillance frequency for stage ii/iii gastric cancer

Conditions: Gastric Cancer

Summary: due to lacking of evidence on surveillance for gastric cancer (gc), this study aimed to determine the optimal postsurgical surveillance strategy for stage ii/iii gc patients and compare its cost-effectiveness with traditional surveillance strategies.

background the development of existing follow-up strategies is mainly based on experts' consensus and researches on recurrence patterns due to the lack of direct evidence and unified standards. on the one hand, it is unreasonable to carry out the same postsurgical surveillance for all stage ii/iii gc patients. additionally, in addition to the early detection of recurrence, the optimal follow-up strategy should also balance cost and effectiveness. there were no criteria for the arrangement of follow-up in different guidelines, and the optimal postoperative follow-up strategy for patients with stage ii/iii gc remains unclear. methods prospectively collected data from stage ii/iii gc patients (n=1,661) who underwent gastrectomy at fujian medical university union hospital (fjmuuh) between january 2010 and october 2015. for external validation, two independent cohorts were included, which were composed of 380 stage ii/iii gc patients who underwent gastrectomy at the mayo clinic between july 1991 and july 2012 and 270 stage ii/iii gc patients at the qinghai university affiliated hospital (quah) between may 2010 and oct 2014. random survival forest models were used to predict dynamic recurrence hazards and to construct individual surveillance strategies for stage ii/iii gc. cost-effectiveness were assessed by markov model.

Eligibility criteria:
inclusion criteria: * (1) eastern cooperative oncology group (ecog) scores of 0 (asymptomatic) or 1 (symptomatic but completely ambulatory); (2) pathologically confirmed agc (pstage ii and iii, except pt4b); (3) no distant metastasis or invasion of adjacent organs (e.g., pancreas, spleen, liver, and colon) detected intra- or post-operatively; and (4) d2 lymph node dissection of gastric cancer. exclusion criteria: * (1) american society of anesthesiologists (asa) grade \>2; (2) remnant gastric or neuroendocrine cancer; (3) history of neoadjuvant chemotherapy; (4) palliative surgery; and (5) death within 30 days after surgery.

Keywords: gastric cancer surveillance cost-effectiveness real-world study
pk comparison of gl2701 with finasteride and tamsulosin in combination

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: to compare the relative bioavailability and pharmacokinetic characteristics of a newly single pill combination of finasteride and tamsulosin with a conventional combination of finasteride and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

this single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover study was conducted to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed formulation with a conventional formulation in healthy subjects. for this, a single-center, randomized, single-dose, open-label, 2-period and 2-sequence crossover study with a 14-day washout period was conducted in 26 healthy volunteers. plasma samples for the analysis of finasteride/tamsulosin were collected up to 48 h after drug administration. participants received either reference (in combination of of 0.2mg tamsulosin and 5mg finasteride) or test drug formulation (single pill combination of 0.2mg tamsulosin and 5mg finasteride) in the first period and the alternative formulation in the second period. plasma concentrations of both tamsulosin and finasteride were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. pharmacokinetic parameters, including cmax and auc, were determined by noncompartmental analysis. analysis of variance (anova) was carried out using log-transformed cmax and auc, and the mean ratios and their 90% confidence intervals (ci) were calculated. according to regulatory requirements set forth by korea and the us food and drug administration, products meet the criteria for bioequivalence if the 90% cis of the mean ratios for cmax and auc are within the range of 0.80 to 1.25.

Eligibility criteria:
inclusion criteria: * males age 20 to 45 years * body weight \> 50 kg with 18\~29 kg/m2 body mass index (bmi) * signed and dated informed consent form which meets all criteria of current fda and kfda regulations exclusion criteria: * subjects with acute conditions. * presence of history affecting adme * clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality * hepatitis b, hepatitis c, or hiv infection revealed on the laboratory findings * any other acute or chronic disease * a history of hypersensitivity to donepezil * a history of alcohol or drug abuse * participation in another clinical trial within 3 months * smoked \>10 cigarettes daily * consumption over 5 glasses daily of beverages containing xanthine derivatives * use of any medication having the potential to affect the study results within 10 days before the start of the study. * ast or alt \> 1.25 of upper normal limit * total bilirubin \> 1.5 of upper normal limit * systolic blood pressure \< 90 mmhg * calculated clcr using cockroft-gault equation \< 50 ml/min

Keywords: benign prostatic hyperplasia (bph) pharmacokinetics bioequivalence finasteirde tamsulosin
a research study looking at how oral semaglutide works in people with type 2 diabetes in japan, as part of local clinical practice

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how rybelsus® works in people with type 2 diabetes and to see if rybelsus® can lower their blood sugar levels, and to get side-effects information. participants will get rybelsus® as prescribed to them by the study doctor. the study will last for about 8-10 months. participants will be asked to complete a questionnaire about how they take their rybelsus® tablets. participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * diagnosed with type 2 diabetes mellitus * the decision to initiate treatment with commercially available oral semaglutide has been made by the patient/legally acceptable representative (lar) and the treating physician based on local label before and independently from the decision to include the patient in this study * male or female, age above or equal to 20 years at the time of signing informed consent * available glycated haemoglobin (hba1c) value greater than or equal to 90 days prior to the 'informed consent and treatment initiation visit' (visit 1) or hba1c measurement taken in relation with the 'informed consent and treatment initiation visit' (visit 1) if in line with local clinical practice * treatment naïve to injectable glucose-lowering drug(s). an exception is short-term insulin treatment for acute illness for a total of less than 14 days exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * treatment with any investigational drug within 30 days prior to enrolment into the study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
efficacy and safety of lorundrostat in subjects with uncontrolled and resistant hypertension

Conditions: Hypertension

Summary: this is a phase 3 trial to evaluate the bp-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (aht) medications.

this study is a phase 3 trial to evaluate the bp-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (aht) medications, one of which must be a thiazide or thiazide-like diuretic. the study consists of a 2-week screening period with a 2-week single-blind run-in period followed by a 12-week randomized, double-blind, placebo-controlled, parallel arm period. following the randomized period subjects will be offered an opportunity to participate in an open-label extension (ole) study. any subject electing to not participate in the ole will undergo an end of study (eos) visit, which will occur after end of treatment (eot), to complete their participation in the study.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age at the time of signing the informed consent form (icf) 2. at screening and randomization: aobp sbp of ≥135 and ≤180 mmhg plus aobp dbp of ≥65 and ≤110 mmhg, or aobp dbp of ≥90 and ≤110 mmhg 3. taking between 2 and 5 aht medications, 4. history of hypertension lasting at least 6 months prior to screening 5. body mass index (bmi) of ≥18 kg/m2 at screening exclusion criteria: 1. women who are pregnant, plan to become pregnant, or are breastfeeding 2. participation in a study involving any investigational device or small-molecule drug within 4 weeks or 6 months for biologic (antibody) drugs prior to the screening visit 3. egfr \<45 ml/min/1.73m2 at screening, calculated using the chronic kidney disease epidemiology collaboration (ckd-epi) formula 4. serum potassium \>5.0 mmol/l at screening or \>4.8 mmol/l at randomization 5. serum sodium \<135 mmol/l (corrected for hyperglycemia) at screening. 6. history of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the screening visit.

Keywords: blood pressure hypertension hypertensive resistant hypertension uncontrolled hypertension
drug delivery devices for osteomyelitis

Conditions: Osteomyelitis

Summary: fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of the lower extremities were included in the retrospective investigation. the patients were assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate and antibiotic-loaded pmma or the control group of the antibiotic-loaded pmma. hematological parameters, eradication of infection, rate of infection recurrence and reoperation rate were evaluated during the follow-up.


Eligibility criteria:
inclusion criteria: * the retrospective study included patients with chronic post-traumatic or postoperative osteomyelitis and excluded patients suffering from hematogenous osteomyelitis or acute post-traumatic or postoperative osteomyelitis. exclusion criteria: * other kinds of osteomyelitis.
a study to evaluate the efficacy and safety of telitacicept in subjects with active primary sjogren's syndrome

Conditions: Primary Sjogren's Syndrome

Summary: the purpose of this study is to evaluate the efficacy and safety of subcutaneous telitacicept versus placebo in subjects with active primary sjogren's syndrome.

this is a phase ⅲ, multi-center, randomized, double-blind, placebo-controlled study. subjects with active primary sjogren's syndrome (pss) will be randomized to receive subcutaneous telitacicept 80 mg, telitacicept 160 mg or placebo weekly for a total of 48 weeks. subjects are allowed to be transferred to another group after week 24 by the investigator so that those randomized to the placebo group are able to receive either telitacicept 80 mg or telitacicept 160 mg afterwards. subjects who are randomized to telitacicept 80 mg and telitacicept 160 mg groups will remain in the previous treatment group even if the investigator chooses to transfer them. subjects and investigators are blinded throughout the study.

Eligibility criteria:
main inclusion criteria: 1. written informed consent provided. 2. males and females, 18-70 years of age. 3. fulfilled the classification criteria of pss according to acr/eular (2016). 4. anti-ssa antibody tested positive at screening. 5. essdai score ≥ 5 at screening. main exclusion criteria: 1. secondary sjogren's syndrome. 2. severe organ involvement related to pss in the opinion of the investigator, including but not limited to a) severe vasculitis (not cutaneous vasculitis) affecting the kidney, gastrointestinal system, cardiac, pulmonary or central nervous system (cns); b) active cns or peripheral nervous system involvement requiring high dose corticosteroids; c) severe kidney involvement, e.g. gfr \ 2 mg/dl, or proteinuria \> 3g/d; d) severe pulmonary involvement, e.g. shortness of breath at rest, fvc \< 60% or dlco \< 40%; e) muscle diseases requiring high dose corticosteroids; f) lymphoma. 3. received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening. 4. received live vaccine within 28 days prior to randomization. 5. active hepatitis or history of severe liver diseases. 6. hiv positive. 7. patients with malignant tumors. 8. received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer. 9. nursing or pregnant female, or male or female who prepared for parenthood during the study. 10. any condition that, in the opinion of the investigator, makes it unsuitable for the subject to participate, e.g., poorly controlled high blood pressure, diabetes, heart failure or mental illness.

Keywords: primary sjogren's syndrome pss rc18
clinical outcomes of bio-ma and proroot mta in endodontic treatment

Conditions: Clinical Outcome; Endodontic Disease

Summary: the purpose of this study is to compare the endodontic outcomes of bio-ma and proroot mta in pulpotomy, orthograde mta apical barrier, root perforation repair, endodontic microsurgery.

the patients were recruited at the endodontic clinic, faculty of dentistry, mahidol university, thailand. each treatment was provided following the standard protocol. the calcium silicate based material (bio-ma or proroot mta) was randomly selected and used in the treatment. the patients were periodically recalled at 6 to 12 months. the outcome of the three treatments based on the clinical and radiographic criteria was assessed by the calibrated examiners and interpreted as ''healed/healing" or ''disease.''

Eligibility criteria:
inclusion criteria: * teeth treated with pulpotomy, orthograde mta apical barrier, root perforation repair or endodontic microsurgery exclusion criteria: * teeth with un-restorable condition * teeth with crack or fracture * teeth with external or internal root resorption * teeth with chronic periodontitis with marginal bone loss more than 5 mm
fibromyalgia study in adults

Conditions: Fibromyalgia Syndrome, Primary

Summary: a study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. a total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 european countries. male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the american college of rheumatology (acr) criteria, are eligible for study entry. subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. the primary endpoint is improvement in pain score by 12 weeks of treatment. an 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. in addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. safety of the treatment regimen will be assessed throughout the study.


Eligibility criteria:
inclusion criteria: * diagnosis of primary fibromyalgia as defined by the american college of rheumatology (acr). * females of childbearing potential will only be eligible if taking adequate contraceptive measures. * other co-existent chronic pain conditions such as osteoarthritis, will not exclude the subject if the pain associated with the condition is less severe than the pain of fibromyalgia. * only subjects experiencing moderate/severe pain (pain intensity score \>= 4 on the pain numerical rating scale) will be eligible for this study. * subjects that are generally well. * have the ability to discontinue prohibited medications for the duration of the study. exclusion criteria: * subjects with 'flare' of arthritic conditions. * evidence of clinically significant medical conditions including cardiovascular conditions (e.g. postural hypotension, and raised blood pressure, ecg abnormalities). * history of drug and/or alcohol abuse or major depression.

Keywords: pain intensity numerical rating scale fibromyalgia