Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of generic gpo saquinavir and norvir® versus invirase® and norvir®

Conditions: HIV Infections

Summary: the previous two studies of generic gpo saquinavir failed to prove bioequivalence. in this study the bio-equivalence will be investigated in healthy thai volunteers, to see whether the generic gpo saquinavir shows bioequivalence when boosted with norvir®. if the generic formulation is bioequivalent subsequent studies may follow in hiv-1 positive patients.

the primary objective is to establish bioequivalence of "ritonavir boosted generic gpo saquinavir", with invirase® and norvir® as the reference drug. the secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers.

Eligibility criteria:
inclusion criteria: * written informed consent * healthy male 18-45 years old * documented negative test for hiv-1 infection \< 1 wk prior to start of study and with no risk of hiv exposure in the last 6 months * bmi 18-25 * normal physical examination * normal cbc, bun, cr, ast, alt, total bilirubin, no evidence of active or chronic hbv or hcv infection exclusion criteria: * history of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the study. * relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. * inability to understand the nature and extent of the study and the procedures required. * participation in a drug study within 60 days prior to the first dose. * febrile illness within 3 days before the first dose. * use of concomitant medication * smoke cigarettes not more than 10 cigarettes a day. * drink alcohol not more than 2 units a day. * discontinue smoking and alcohol for at least 1 month before enrollment. * take other medication regularly * involvement in any drug addiction. * heart disease, hypertension, liver disease, kidney disease, gi disease, allergic disease or other diseases which may interfere with the pk of study drugs

Keywords: bioequivalence ritonavir boosted generic gpo saquinavir saftey pharmacokinetics
overcoming barriers to accessing genetic medicine

Conditions: Genetic Disease; Genetic Predisposition

Summary: to learn about patient barriers to accessing genetic medicine, we will analyze anonymous posts from a membership-based online community \[inspire.com\], and investigate how these barriers differ for various populations. we will then test whether these barriers can be addressed by providing online access to a genetic counselor to answer patient questions for one group of patients (virtual advisory board group) and compare to that of a control group who does not have access to a genetic counselor (virtual peer-to-peer board group).

genomic medicine has the potential to advance diagnoses, predict risk, support prevention efforts, and inform treatment decision-making. though technologies for measuring genetic variants have improved and become more cost-effective, clinical integration of genomic medicine has been surprisingly slow. for genomic medicine to be successfully implemented across specialties and across demographics, the systemic barriers that patients experience need to be identified and addressed. online health support is becoming an increasingly important part of healthcare as more patients use digital health networks. in the first part of this study, an analysis of online communication in a membership-based online support community \[inspire.com\] will identify systemic, structural and individual barriers to accessing genomic medicine. a genetic counselor will be informed to these results and will be part of the intervention arm of the study. to assess the extent to which online health networks can directly help genomic medicine implementation, participants will join one of two virtual discussion boards (a virtual advisory board and a virtual peer-to-peer discussion board). in the intervention arm, the virtual advisory board will have a genetic counselor answer patient questions online about genomic medicine once every week for a period of three months. in the control arm, participants will answer and comment on each others' questions in the virtual peer-to-peer discussion board. we hypothesize that after six months, patients who participate in the virtual advisory board are more likely to self-report receiving genomic medicine than those in the control arm. after completion of the study, participants in the peer-to-peer discussion board, we will give online access to the genetic counselor to answer any questions

Eligibility criteria:
inclusion criteria: member of inspire.com genetic disease genetic predisposition to disease - exclusion criteria: not member of inspire.com no genetic disease no genetic predisposition to disease -
stem cell study for long covid-19 neurological symptoms

Conditions: Post-Acute COVID-19 Syndrome

Summary: the purpose of this research study is to test the safety and benefit of a human cord blood derived stem cell infusion as a treatment for individuals with post covid-19 neurological problems. participants in the study will have 6 clinic visits over a 12 to 14 mo. period with each visit lasting 2 to 6 hours. participants will receive 1 stem cell infusion at study visit #3. participants will have a brain pet and mri scan at the baseline and 6mo. post-infusion visits. follow-up safety assessments will be conducted at 6mo. and 1yr. after the stem cell infusion.

this is a non-randomized, phase 1/2a dose escalation study using allogenic cord tissue msc's in adults with chronic neurological symptoms following an acute covid-19 infection.

Eligibility criteria:
inclusion criteria: 1. adults between 18 and 55 years of age. 2. documented history of covid-19 infection with resulting neurological sequela. 3. post-covid-19 functional status score of grades 3 or 4. 4. chronic neurological symptoms defined as anxiety/depression, pain syndromes, sleep disorders, and /or memory disorders ("brain fog") persisting 6 months after an acute covid-19 infection. 5. ability to obtain consent from the subject. 6. ability to communicate in english or spanish (required for validated neurocognitive outcome testing). exclusion criteria: 1. known history of: 1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, 2. recently treated infection, 3. renal disease or altered renal function (screening serum creatinine \> 1.5 mg/dl), 4. hepatic disease or altered liver function (screening sgpt \> 150 u/l and/or t. bilirubin \>1.3 mg/dl), 5. cancer, 6. immunosuppression (screening wbc \< 3, 000 cells/ml), 7. hiv+, 8. chemical or etoh dependency that in the opinion of the investigator would preclude participation in the study, 9. acute or chronic lung disease requiring significant medication/oxygen supplementation, 10. bleeding disorders including immune-mediated heparin-induced thrombocytopenia, 11. hypercoagulable disorders (protein c, s, atiii deficiencies), factor v leiden, 12. known sensitivity to heparin, lovenox, and pork products, 13. individuals with mechanical prosthetic heart valves. 2. pulse oximetry oxygen saturation \<93% on room air. 3. other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation. 4. for women of childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study. 5. previous or concurrent participation in an interventional drug or biological study. 6. inability to undergo the diagnostic tests (pet/dt-mri) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments. 7. unwilling or unable to return for follow-up study visits. 8. prisoner/incarcerated.

Keywords: post covid-19 neurological injuries
cardiac complication after vascular surgery

Conditions: Aortic Aneurysm, Abdominal; Ventricular Arrythmia; Peripheral Arterial Disease; Cardiac Complication

Summary: the vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. the leading clinical presentation is acute hemodynamic decompensation. however, one of the possible pathomechanisms might be repolarization disturbances. many of perioperative risk factors of cardiac complications are modifiable. the identification may help in the global perioperative risk reduction. aim: the aim of the study was an identification of the factors which may release clinically overt repolarization disturbances. methods: the study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. the authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.

vascular surgery is thought as the highest risk procedure in the context of cardiac complications. the range may include acute coronary syndrome, acute circulatory failure, severe arrhythmias, syncope and sudden cardiac death. the patient population is considered as a high risk, too. popular calculators used for risk stratifications are based on preoperative patient's history and some general laboratory results. however, general status of the patient changes dynamically during vascular procedures leading to acquired increased risk. for this reason, sole preoperative risk prediction based on standard calculators is unsuitable and suboptimal. advanced monitoring systems may record some temporary disturbances (e.g. ventricular repolarization disturbances), which may be asymptomatic. the clinical significance in postoperative risk prediction of such observations remains undefined. on the other hand, many of perioperative cardiac complications are caused by modifiable factors. the identification may help in the global perioperative risk reduction.

Eligibility criteria:
inclusion criteria: * adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure exclusion criteria: * heart stimulation, * atrioventricular and intraventricular conduction defects, * atrial fibrillation recorded before of the study, * antiarrhythmic drug treatment (except beta-blockers), * unoptimal patient general status (uncontrolled diabetes, active infection) * reoperation * emergency operations

Keywords: vascular surgery repolarization disturbances cardiac complications high risk patient high risk procedure
a study of valsartan used to treat hypertension for up to 13 months in hypertensive children ages 6 - 16 years of age

Conditions: Hypertension

Summary: drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. this study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.


Eligibility criteria:
inclusion criteria: * children have systolic blood pressure at a level =\>95th percentile for age/gender/height * consent from parent(s)/guardian(s) must be granted exclusion criteria: * blood pessure is =\>5% higher than 99th percentile for age * serious, clinically significant findings upon physical examination, and laboratory and other assessments other protocol-defined inclusion/exclusion criteria will also apply.

Keywords: pediatric hypertension pediatric valsartan
monocentric study on the use of teriparatide in children with hypoparathyroïdism

Conditions: Hypoparathyroidism

Summary: pediatric hypoparathyroidism is an orphan disease. conventional management combines native and active vitamin d, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. the use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy. the objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.


Eligibility criteria:
inclusion criteria: * patients with hypoparathyroidism * patients treated with teriparatide * patients followed in the reference center for calcium and phosphate metabolism diseases of lyon. * for children under 18: patient and parent (s) / parent having been informed of the study and having expressed their non-opposition exclusion criteria: * no social security support

Keywords: hypoparathyroidism teriparatide
a multicenter extension trial to evaluate the safety of testosterone gel

Conditions: Adult Male Hypogonadism

Summary: this is a multicenter extension trial in adult hypogonadal males. the purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.


Eligibility criteria:
inclusion criteria: * completion of the phase 3 protocol (nct01665599) exclusion criteria: * use of another investigational product * use of any medications that could be considered anabolic or interfere with androgen metabolism * use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone * use of another testosterone product * chronic use of any drug of abuse
special investigation for vizimpro tablets (secondary data collection study; safety and efficacy of vizimpro under japanese medical practice)

Conditions: EGFR Mutation-positive Inoperable or Reccrent NSCLC

Summary: secondary data collection study: safety and efficacy of vizimpro under japanese medical practice


Eligibility criteria:
inclusion criteria: * patient with egfr mutation-positive inoprable or recurrent nsclc who have not received vizimpro(dacomitinib hydrate) exclusion criteria: * exclusion criteria is not provided in this study

Keywords: vizimpro egfr mutation-positive inoperable or recurrent nsclc non-small cell lung cancer
the effects of dietary erythritol on platelet reactivity and vascular inflammation

Conditions: Platelet Aggregation, Spontaneous; Vascular Thrombosis

Summary: the purpose is to conduct a dietary intervention study in which human participants will consume beverages sweetened with erythritol or aspartame, each for 2 weeks, in a randomized crossover design

there is a strong correlation between plasma erythritol concentrations and adverse cardiovascular events in high risk individuals. it has also been demonstrated that consumption of dietary erythritol leads to high levels of plasma erythritol. there is in vitro evidence that erythritol at comparable concentrations promotes platelet activation. however, there is no direct evidence that links human consumption of erythritol with the onset of platelet activation and adhesion leading to inflammation. the investigators seek to fill this evidence gap by conducting a randomized crossover dietary intervention study in which human participants will consume beverages sweetened with erythritol or aspartame, each for two weeks.

Eligibility criteria:
inclusion criteria: * bmi ≥ 27 kg/m2 exclusion criteria: * • history of blood clot, transient ischemic attack (tia), stroke, angina, heart attack, or peripheral vascular disease, or current cancer diagnosis. * pregnant or lactating women * current, prior (within 12 months), or anticipated use of medications for treatment of hyperlipidemia, high blood pressure or diabetes, or any medication that in the opinion of the investigators will confound results. * unwilling to forego the use of anti-inflammatory medication during study. * unwilling to forego the use of marijuana during the study. * use of tobacco. * strenuous exerciser (\>4 hours/week at a level more vigorous than walking). * surgery or medication for weight loss. * diet exclusions: food allergies or dietary restrictions that may undermine compliance to dietary protocol, routine ingestion of more than 2 sugar-sweetened beverages or 2 alcoholic beverage/day. unwillingness to consume artificial or noncaloric sweeteners. habitual consumption (\>10 gram/day) of beverage or foods that contain erythritol. recent or current weight loss diet.

Keywords: platelet activation vascular inflammation erythritol aspartame dietary intervention
tucaresol as add-on to haart (highly active antiretroviral therapy) in chronic hiv-1 infected adults

Conditions: HIV Infection

Summary: this is a pilot study designed to determine a dose and schedule of tucaresol that can be administered to hiv-1 infected subjects on haart (highly active antiretroviral therapy) with viral suppression without occurrence of significant adverse events and that results in significant changes in cell mediated immunity.


Eligibility criteria:
inclusion criteria: * currently on licensed triple combination therapy, which is defined as two nucleoside analogues (2 nrti) (excluding abacavir) and a protease inhibitor (pi) (including boosted pi regimens) or non nucleoside reverse transcriptase inhibitor (nnrti). * must be on the same treatment for at least 3 months prior to study without plans to alter therapy for the next 3 months. plasma hiv-1 rna (ribonucleic acid)\< 50 copies/ml at screening with a documented history of continuous suppression defined as: the last two readings \< 50 copies/ml for a period of at least 3 months prior to screening. * documented cd4+ lymphocyte cell count =350 cells/ml at screening with at least one reading =350 cells/ml in the preceding 3 months and cd4 nadir \>200 cells/ml. hbsag (human hepatitis b virus surface antigen) and hcv-ab (human hepatitis c virus antibody) negative. exclusion criteria: * history of hyperimmune or allergic reactions to drug treatment within 3 months prior to study.

Keywords: hiv-1 infection tucaresol viral suppression
the effect of mediclore as an anti-adhesion agent and safety in full-endoscopic spine surgery: a preliminary study

Conditions: Lumbar Disc Disease; Epidural Fibrosis; Failed Back Surgery Syndrome

Summary: the goal of this clinical trial is to compare efficacy and safety of mediclore as anti-adhesion agent in patient who undergo endoscopic lumbar discectomy. the main question\[s\] it aims to answer are: * efficacy (patient-reported outcomes, epidural fibrosis) * safety (complications) participants will received mediclore at surgical site after finish the operation in experimental group and normal saline in control group. researchers will compare to see if experimental group have better patient-reported outcomes (pros) after surgery with no different in complications rate.

this study is a randomized clinical trial arrange in king chulalongkorn memorial hospital. participant will be randomly assigned into 2 groups by computer-generated sequence. patients based-line characteristic data, patient-reported outcomes (vas back/leg, odi and eq-5d) and a results of straight leg raising test will be collected. participant will undergo a endoscopic lumbar discectomy by a singer spine surgeon. in experimental group, 1.5 cc. of mediclore (poloxamer-based thermosensitive anti-adhesive agent) will be applied in after finish the operation. in control group normal saline 1.5 cc. will be applied instead. participants will proceed to regular follow-up protocol which include 1, 3 and 6 months visit at out-patient department. all of the pros and a result of a straight leg raising test will be collected at each visit. mri will be performed at 3 month after the surgery. the amount of epidural fibrosis will be evaluated according to ross's method.

Eligibility criteria:
inclusion criteria: * lumbar disc herniated patients * failed proper conservative treatment more than 6 months exclusion criteria: * previous history of lumbar spine surgery or lumbar epidural steroid injection * infection or malignancy * allergic to any given components * lactation and pregnency
coronary ct angiography in non st-elevation myocardial infarction

Conditions: Non-ST Elevated Myocardial Infarction

Summary: non st-elevation myocardial infarction (nstemi) represents 70-75% of all myocardial infarctions. current guidelines recommend invasive angiography and this patient group represents a major burden on the invasive catheterization laboratories and the health care system. the coronary pathology found in nstemi-patients varies substantially, ranging from structurally normal vessels, non-obstructive atherosclerosis to severe multivessel disease. 30-40 % of patients with nstemi undergoing invasive coronary angiography do not undergo revascularization. if these patients could be identified by a non-invasive method like coronary ct angiography (ccta), an invasive procedure with the potential risk for complications could be avoided. furthermore, less patients would need transfer to an invasive center. both for patients and for health care costs this would be of major benefit. the quality of ccta images has improved during the years, and radiation dose has decreased. due to technological development it is now possible to perform high quality coronary ccta with a very low radiation dose (1-1.5 msv) compared to a radiation dose of 3-4 msv for invasive coronary angiography. the overall aim of the project is to define a subpopulation of nstemi patients that preferably should undergo ccta as the first step in imaging of the coronary arteries and thus potentially be saved from an unnecessary invasive investigation. this would result in less patient discomfort, less patient risk and reduced health care costs. patients with a clinical indication for invasive angiography according to current guidelines will undergo ccta prior to the invasive investigation. the ability of ccta to identify those with no need for revascularization will be assessed using invasive angiography as the gold standard.


Eligibility criteria:
inclusion criteria: * admitted to a local hospital with nstemi type 1 or type 2 based on clinical criteria * indication for invasive coronary angiography according to current guidelines exclusion criteria: * indication for immediate (\< 2 hours) invasive strategy according to guidelines * grace score \> 140 * not willing to provide written informed consent * previous coronary revascularization * estimated glomerular filtration rate \< 30 ml/min/1,73m2 * allergic reactions to contrast agents impeding for safe examinations * \> 2 hypokinetic segments on echocardiography

Keywords: coronary angiography angiography, ct nstemi ccta ct-ffr
anisometropia amblyopia improved by perceptual learning and patching

Conditions: Anisometropic Amblypia

Summary: to compare the effects of perceptual learning with patching on improving visual acuity and contrast sensitivity in payient with anisometropic amblyopia.

patients with anisometropic amblyopia were randomized to patching or perceptual learning group. corrected amblyopic logmar visual acuity and contrast sensitivity function were measured at four-weekly intervals until visual acuity stabilized or amblyopia resolved. improvement in visual acuity, contrast sensitivity, and the resolution of amblyopia were compared between groups.

Eligibility criteria:
inclusion criteria: * anisometropia without strabismus * an interocular acuity difference of at least 0.2 logmar in children (3-7 years of age) or in older children and adult patients without a history of patching or atropine penalization * all patients wore their spectacle at least one year exclusion criteria: * a history of prior spectacle correction * a history of patching or optical penalization * the existence of an ocular disease that could contribute to decreased visual acuity * learning difficulties * the presence of strabismus

Keywords: perceptual learning occlusion therapy