Kornimate/medical-research-clean huggingface dataset:
antiretroviral therapy for acute and chronic hiv infection

Conditions: Acute HIV Infection; Chronic HIV Infection

Summary: the purpose for this protocol is to provide safe and effective standard art to search 010 and search 013 participants. participants are enrolled in an acute hiv infection study (search 010 protocol: 'establish and characterize an acute hiv infection cohort in a thai high-risk population') or in a study of chronic hiv infection (search 013 protocol 'characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of hiv negative and hiv positive thais').

to compare systemic and tissue compartments (genital secretion, cns, gut and lymph node) outcomes among individuals who initiate hiv treatment during acute vs. chronic hiv infection. the outcomes will be compared by stages of infection and antiretroviral regimens. participants are enrolled in an acute hiv infection study (search 010 protocol: 'establish and characterize an acute hiv infection cohort in a thai high-risk population') or in a study of chronic hiv infection (search 013 protocol 'characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of hiv negative and hiv positive thais') with the latter serving as controls for the acutely infected individuals.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. enrolled in the search 010 or 013 protocols with documentation of acute or chronic protocol defined hiv-1 infection and chooses to initiate or continue art 3. understand the study and sign informed consent form. persons who cannot read will have the consent form read and explained to them by a member of the study staff and they can give informed consent by using their thumb print 4. availability for follow-up for the planned study duration exclusion criteria: 1. persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.

Keywords: acute hiv infection chronic hiv infection
schema, emotion, and behavior therapy for children

Conditions: Autism Spectrum Disorder

Summary: the study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (cbt) relative to a standard community treatment, in youngsters with autism spectrum disorder (asd). the individual cbt program has been tailored over the last five years to the clinical needs of high-functioning youth with asd.

autism spectrum disorder (asd) is among the most common childhood developmental disorders. a key goal in the field is the discovery of methods that reduce core autism symptoms. core autism symptoms include social-cognitive impairments, pragmatic language deficits, and repetitive and rigid behaviors. the core symptoms tend to be stable and resistant to intervention. most treatments involve group-based social skills training (sst), with limited effects. no treatment for core autism symptoms in school-aged children with asd meets american psychological association guidelines for possible efficacy. cognitive behavioral therapy (cbt) offers a novel approach for addressing core autism symptoms in higher functioning school-age youngsters. initial results suggest that individual cbt may also be promising for reducing core autism symptoms (wood et al., 2009b; drahota, wood et al., 2011). the treatment is based on a contemporary model of memory retrieval competition, employing strategies for enhancing the retention of adaptive conceptual and behavioral responses and the suppression of idiosyncratic beliefs and behaviors in daily social contexts, emphasizing the use of deep semantic processing to enhance memory retrieval. we are proposing a randomized controlled trial to examine the efficacy of individual cbt relative to a standard community treatment in youngsters with asd.

Eligibility criteria:
inclusion criteria: * meets research criteria for a diagnosis of autism, based on child scores on the adi-r and ados tests. * if taking medication, have maintained a stable dose for 1 month prior to baseline assessment. * between the ages of 9-13 years. * the child's teacher consents to participate in the study to play a modest role in helping implement the intervention and facilitate the school observation assessment. exclusion criteria: * iq less than 85. * the child starts taking new medication(s) or current medication dose changes either (a) less than 1 month prior to the diagnostic evaluation, or (b) during the study period. * the child is participating in an intensive early intervention program for autism such as applied behavior analysis or floortime. * for any reason the child or parents appear unable to participate in the treatment program.

Keywords: intervention autism treatment sensitivity school aged cognitive behavioral therapy
a study of ray1225 in participants with impaired kidney function

Conditions: Kidney Impairment

Summary: the purpose of this study is to assess how fast ray1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≥18 to ≤28kg/m2 and total body weight \>50 kg(male) or \>40kg(female) at screening (calculated as a function of measured height and weight according to the formula, bmi = kg / m2 where m2 is height in meters squared); 2. ability to understand and willingness to sign a written informed consent form; participants with normal renal function only: 3. normal physical examination, vital signs, 12-lead ecg, chest x-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant； 4. glomerular filtration rate (gfr)≥ 90 ml/min and \<130 ml/min ； 5. age, bmi, and sex comparable to those of subjects of renal impairment； participants with severe renal impairment only: 6. diagnosis of ckd (any indicators of renal impairment or gfr \< 60 ml/min/1.73 m2 for more than 3 months)； exclusion criteria: 1. participants with an allergic disposition (multiple drug and food allergies) or who, have known allergies to ray1225 or related compounds; 2. have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; 3. participants who donated blood or bleeding profusely (\> 400 ml) in the 3 months or donated blood or bleeding profusely (\> 200 ml) in the 1 months; 4. pregnant or lactating women, or women of childbearing age with a positive pregnancy test 5. participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks participants with severe renal impairment only: 6. participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period; 7. hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm hg or diastolic blood pressure ≥ 100mm hg) 8. new york heart association (nyha) class iii or iv congestive heart failure 9. alanine aminotransferase (alt) ≥ 2×uln, aspartate aminotransferase(ast) ≥ 2×uln; serum total bilirubin \> 1.5×uln;
prevalence and characteristics of transthyretin amyloidosis in patients with left ventricular hypertrophy of unknown etiology

Conditions: Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Summary: the main purpose of this study is to determine the prevalence of attr cardiomyopathy among patients admitted due to left ventricular hypertrophy (lvh) \>15mm of unknown etiology by using a 99mtc-tracer scintigraphy based protocol


Eligibility criteria:
inclusion criteria: * patient signed inform consent. * males and females. * age ≥50 years. * left ventricular hypertrophy (lvh) defined as end-diastolic lv maximum wall thickness (mwt) ≥15mm in echocardiogram. * plan to undergo or recently underwent radionuclide bone scintigraphy and/or spect with any of the following radio labelled tracers: 99mtc-dpd or 99mtc-pyp or 99mtc-hmdp. exclusion criteria: * etiological diagnosis explaining the lvh (p.e. sarcomeric hcm, myeloma, fabry disease, sarcoidosis, any type of amyloidosis (aa, al, ttr) * severe aortic stenosis defined as aortic valve area (ava) \< 1.0 cm2

Keywords: scintigraphy gammagraphy ttr attr hypertrophic cardiomyopathy (hcm) hcm
ranibizumab for recalcitrant wet age-related macular degeneration in eyes previously switched from bevacizumab and/or ranibizumab to aflibercept.

Conditions: Recalcitrant Wet Age-related Macular Degeneration

Summary: the purpose of the study is to determine the effectiveness of ranibizumab 0.5 mg or 1.0 mg in subjects who were previously treated with bevacizumab and subsequently switched to aflibercept. these subjects have demonstrated a sub-optimal therapeutic response to the previous therapies; therefore, the study aims to see if ranibizumab may have a greater treatment effect.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age greater than or equal to 50 years * best-corrected etdrs va between 20/25 to 20/320 * total area of subretinal hemorrhage and/or fibrosis comprising less than 50% of lesion * any neovascular lesion type of armd having previously received at least 3 doses 1.25 mg of bevacizumab and/or ranibizumab (minimum 3 monthly injections) followed by 3 monthly doses of aflibercept 2.0 mg (with last injection being within 8 weeks) with evidence of recalcitrant armd, defined by at least one of the following: persistent subretinal fluid with or without intraretinal cystic edema on sd-oct and/or leakage on fluorescein angiography exclusion criteria: * pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an iud, or contraceptive hormone implant or patch * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * participation in another simultaneous medical investigation or trial * history of prior vitrectomy surgery * previous treatment with photodynamic therapy, radiation, or any other intravitreal drug delivery, such as dexamethasone or triamcinolone * subretinal hemorrhage involving the central fovea \> 1 disc area, subfoveal atrophy * cnvm secondary to causes other than armd * previous retinal pigment epithelial tear
predictors for recurrence of atrial fibrillation after electrical cardioversion

Conditions: Atrial Fibrillation

Summary: in patients with persistent atrial fibrillation (af), electrical cardioversion is very effective in restoring sinus rhythm if modern, biphasic cardioverters are used. however, approximately 50 per cent of the successfully cardioverted patients experience a recurrence of af within a few weeks. therefore, valid predictors for af recurrence would be of great clinical relevance, to avoid unnecessary procedures. in the pre-electric study, we will investigate the predictive value of potential new biomarkers with respect to af recurrence within 30 days after electrical cardioversion. we will investigate serum and plasma biomarkers, electrocardiological markers and echocardiographic variables in this respect. the study will be undertaken as a prospective cohort study at bærum hospital, vestre viken hospital trust, with national and international collaborators.


Eligibility criteria:
inclusion criteria: * patients \> 18 years referred for electrical cardioversion for persistent atrial fibrillation * signed, informed consent exclusion criteria: * patients \< 18 years * patients with paroxysmal atrial fibrillation * patients unwilling to participate or without consent competence

Keywords: electrical cardioversion
evaluation of sr 31747a versus placebo in androgen-independent non metastatic prostate cancer

Conditions: Prostatic Neoplasm

Summary: to evaluate the efficacy of sr31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with time to clinical progression as main objective and psa parameters, tumor response, survival , safety,tumor-related symptoms deterioration quality of life, pk analysis as secondary objectives


Eligibility criteria:
inclusion criteria: * prior confirmed histological diagnosis of prostatic carcinoma. * rising psa while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; psa must be at least 4ng/ml at the time of study entry. * no distant metastases as evidenced by bone scan (+ or - centered x-ray or mri), and spiral thoracoabdominopelvic ct scan. * effective castration throughout the study. any prior anti-androgen therapy should be stopped with documented continued elevation of psa 4 weeks after the cessation of flutamide (6 weeks for bicalutamide). * serum testosterone levels \< 50ng/dl at the time of progression and throughout the study. * age \> or = to 18 years. * extensive metabolizer by cyp2d6 genotyping. * karnofsky performance status \> or = to 70% and life expectancy \> 6 months. * adequate hematological, renal and liver function. * signed written informed consent exclusion criteria: * poor metabolizers by cyp2d6 genotyping. * prior palliative radiotherapy or any prior chemotherapy or experimental therapy. * more than one line of any prior anticancer treatment with estrogen (estrogen or estramustine) if discontinued at least 4 weeks before study entry. * concomitant administration of biphosphonate or chronic corticosteroids. * presence of progressive symptoms not adequately controlled with non opioid medications * concomitant use of medications known to be cytochrome p450 2d6 inhibitors as listed in protocol appendice * previous malignancies except if there has been a disease-free interval of at least 5 years and except curatively treated non-melanoma skin cancer * other serious illness or medical condition, which would not permit the patient to be managed according to the protocol.
misaver® stem cell treatment for heart attack (acute myocardial infarction)

Conditions: Myocardial Infarction

Summary: the objective of the present study is to establish the safety and efficacy of misaver® stem cell treatment after a heart attack (acute myocardial infarction)


Eligibility criteria:
inclusion criteria: * patients aged 20\~80 * acute myocardial infarction 1 to 10 days * cardiac enzyme ck-mb or troponin \> 2x of high-end normal value * st-elevation on ekg (stemi) * presence of regional wall motion abnormality * left ventricular ejection fraction (lvef) of ≤40% * hemodynamically stable past 24 hour * participants with adequate pulmonary function * peripheral artery oxygen saturation ≥97% * karnofsky performance status scores of ≥60. exclusion criteria: * age \ 80 * pregnant or breast feeding * positive adventitious infections (such as hiv, hepatitis ) * revascularization via coronary artery bypass surgery is required * coronary revascularization procedures is anticipated during the 6-month study period * severe aortic or mitral valve narrowing * evidence of life-threatening arrhythmia on baseline electrocardiogram (ecg) * short of breath unable to receive pci examination or treatment * malignant tumor * hematopoietic dysplasia * severe organ disease * with less than 1 year of life expectancy * chronic kidney disease with ccr\<20ml/min * kidney disease on renal dialysis

Keywords: heart attack
comparison between soft tissue mobilization and strengthening exercises in management of local neck syndrome

Conditions: Chronic Pain; Neck Pain

Summary: a single-blinded, parallel-group randomized controlled trial was conducted at the national institute of rehabilitation medicine, pakistan, from april to july 2016, on 30 females who were recruited through non-probability convenient sampling technique and randomly allocated to the experimental and control group.

the experimental group received stm and neck isometric strengthening exercises, whereas the control group received neck isometrics strengthening exercises only. numeric pain rating scale (nprs) was used to assess the pain intensity, while neck disability index (ndi) was used to assess the neck-related disability. the data was collected pre-, during, and post-intervention. repeated measure analysis of variance (rm anova) was used to analyze within the group changes, while independent t-test was used to analyze the differences between the groups. data were analyzed by using spss version 21. this study describes the comparative effectiveness of stm when used as adjunct to strengthening exercises and when strengthening exercises are used alone for the management of tns. according to the results of this study, stm in combination with neck isometric strengthening exercises as well as exercises alone were effective for managing neck pain and functional disability when a comparison was made within the groups.

Eligibility criteria:
inclusion criteria :• age above 30 and below 75 years * patients having local neck pain included * female included * with chronic neck syndrome (\> month) exclusion criteria: * age below 30 and more than 75 years * patients having radiating pain excluded * male excluded. * with acute neck syndrome (\< 3 month)

Keywords: assessment neck pain pain measurements patient outcome assessment treatment outcome
pgl4001 efficacy assessment in reduction of symptoms due to uterine leiomyomata

Conditions: Uterine Fibroids

Summary: phase iii, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of pgl4001 for the treatment of uterine myoma.

the target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.the main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with pgl4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Eligibility criteria:
inclusion criteria: * be a pre-menopausal woman between 18 and 50 years inclusive. * have a body mass index (bmi) ≥ 18 and ≤ 40. * have fsh levels ≤ 20 miu/ml * have excessive uterine bleeding due to myoma. * have regular menstrual cycles * have a myomatous uterus \< 16 weeks with at least one myoma ≥ 3 cm in diameter. * if of childbearing potential the subject must be practicing a non-hormonal method of contraception. exclusion criteria: * has a history of or current uterine, cervical, ovarian or breast cancer. * has a history of or current endometrium atypical hyperplasia or adenocarcinoma. * has a known severe coagulation disorder. * has a history of or current treatment for myoma with a selective progesterone receptor modulator (sprm). * has abnormal hepatic function at study entry. * has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study. * has a current (within twelve months) problem with alcohol or drug abuse. * is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
clinical study of bym338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas

Conditions: Cachexia

Summary: a safety \& efficacy clinical study of the investigational medicinal product bym338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas


Eligibility criteria:
key inclusion criteria: 1. patients must sign an informed consent before assessment 2. patients with pathologically and/or clinically confirmed diagnosis of stage iv non-small (squamous or non-squamous) cell lung cancer (nsclc) or stage iii/iv adenocarcinoma of the pancreas. 3. patients with stage iv nsclc will be receiving or completed or discontinued standard chemotherapy or be chemotherapy-naive by choice. 4. patients with stage iii/iv pancreatic adenocarcinoma will be receiving standard chemotherapy or no chemotherapy. if patients are receiving chemotherapy, a change in chemotherapy is not expected. 5. greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation. simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2 week period. 6. body mass index (bmi) ≤ 30 kg/m2. 7. life expectancy of at least 4 months. 8. able to communicate well and comply with the requirements of the study, including by phone and written logs. key exclusion criteria: 1. patients who have received investigational anti-neoplastic therapy within 3 weeks of screening 2. evidence of inadequate organ or brain function, as defined by lab tests and imaging 3. patients with severe and/or uncontrolled medical conditions that could interfere with the study (e.g. heart conditions, high blood pressure, diabetes, infection) uncontrolled pain or any other non-stable illness 4. pregnant or lactating women. 5. women capable of becoming pregnant must use highly effective contraception during the study and for 8 weeks after stopping treatment. all female patients must have negative pregnancy test results throughout the study 6. patients unwilling or unable to follow instructions. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: wasting syndrome emaciation lung cancer adenocarcinoma pancreatic cancer
bioss study (bioss lim c stent registry in bifurcated lesions)

Conditions: Coronary Artery Disease

Summary: the bioss lim c pharmacoactive stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . the objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.

the bioss lim c pharmacoactive stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . the objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.

Eligibility criteria:
inclusion criteria: * age over 18 years. * clinical indication of coronary angioplasty in bifurcated lesion. * bifurcated lesions with both distal branches at least 2 mm in diameter. * the lesion must be located in the main branch, with a severe stenosis by visual estimation at some point in the main branch, with or without involvement of the lateral branch. * express acceptance and signature of informed consent. exclusion criteria: * express rejection of the patient to participate in the study. * exclusive involvement of the lateral branch (medina lesion 001). * contraindication for antiplatelet treatment. * lesions due to restenosis. * lesions in saphenous grafts. * total chronic occlusions. * cardiogenic shock.

Keywords: drug-eluting stent dedicated bifurcation stent cobalt-chromium sirolimus-eluting stent