Kornimate/medical-research-clean huggingface dataset:
evaluation of long-acting injectable (lai) and teen clubs in adolescents (attune).

Conditions: Hiv

Summary: this is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (art) on viral suppression and retention in care among adolescents living with hiv and receiving care in south africa.

this study aims to deploy peer-navigated support (psychosocial support, hiv education, appointment reminders, adherence support, sexual and reproductive health, and healthcare navigation) to facilitate viral suppression and retention in care as adolescents living with hiv transition into adult care. the study population includes adolescents from south africa aged 12 to less than 19 years, living with hiv, aware of their hiv status and receiving art for at least six months. in stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18 months in three 6-month steps across 12 clinics will be evaluated. in addition, during stage 1, user and key stakeholder preferences will be evaluated for the uptake and use of long-acting injectable art, perform a costing and economic analysis and a program evaluation of the public health impact of the intervention. in stage 2, an individually-randomised trial will be nested in a subset of clinics to evaluate long-acting injectable art in adolescents with hiv. the study procedures include a peer navigation intervention in stage 1, alongside a user and key stakeholder preferences evaluation for the uptake and use of long-acting injectable art and a cost and economic evaluation. the study duration is three years (about 7 visits). the stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 18 months to assess the sustainability of the intervention. the nested individually-randomised trial of long-acting art will be conducted during the second 18-month period.

Eligibility criteria:
inclusion criteria: * aged between 12 - 19, at enrolment * living with hiv * aware of their hiv status * receiving art for at least six months * able to read and/or speak english, isizulu, sepedi, afrikaans, xhosa, or sesotho * willing and able to consent to study activities * willing and able to get parental consent for study activities * (stage 1, objective 2 only) age ≥ 18 years and caregiver of an adolescent with hiv * (stage 1, objective 2 only) age ≥ 18 years and provides clinical services or is a policy maker involved in adolescents with hiv exclusion criteria: * inability to read and/or speak english, isizulu, sepedi, afrikaans, xhosa, or sesotho * severe mental or physical illness preventing participation in informed consent activities.

Keywords: peer navigation long acting injectables antiretroviral therapy
speech treatment for minimally verbal children with asd and cas

Conditions: Developmental Verbal Dyspraxia; Autism Spectrum Disorder

Summary: comorbid childhood apraxia of speech (cas) may be one factor that limits speech development in some minimally verbal children with autism. cas is a disorder affecting speech movement planning. this study tests whether cas-specific treatment, appropriately modified for minimally verbal children with autism, improves their speech.

although one in four children with autism remain minimally verbal past age five, not all the factors that limit spoken language in these minimally verbal children are known. one powerful contributor may be a motor speech disorder, childhood apraxia of speech (cas). cas is an impairment in the ability to plan and sequence for speech, which makes speech inconsistent and imprecise. this project proposes to investigate whether cas makes the speech of minimally verbal children with autism unintelligible, and then to test whether treating the cas improves children's speech. first, a cohort of 20 minimally verbal children with both autism and cas is identified. the prediction is that the more severe the cas, the more inconsistent and imprecise a child's speech, and therefore the lower their intelligibility will be. then, a set of mono- and bisyllabic words is selected that contain the disordered movements that each child shows and use those in treatment. treatment will take the form of 15 one-hour sessions where speech practice is embedded in a naturalistic, play-based milieu that is centered on each child's own developmental level. it will involve principles of motor learning (intensive practice of a few words, sometimes all in a row and sometimes mixed up). different types of cues (touch cues, simultaneous production, etc.) will also be employed to help children say their words correctly, fading back these supports as the child's speech improves. both of these techniques have been shown to be effective for treating cas. our outcome measures will include both (1) "by-ear" assessments of intelligibility and (2) acoustic and kinematic measurements of children's speech after 15 treatment sessions. the findings will inform clinical practice for minimally verbal children with autism and may lead to the development of novel interventions for this severely affected population.

Eligibility criteria:
inclusion criteria: * meets criteria for autism spectrum disorder * able to correctly repeat at least 2 syllables * meets criteria for childhood apraxia of speech * lives in an environment where child is exposed to english at least 50% of the time exclusion criteria: * poorly controlled seizures * factors such as blindness or deafness that contribute to minimally verbal status * lives in an environment where english is not spoken at least 50% of the time * child experiences behavioral challenges that preclude participation in the study

Keywords: childhood apraxia of speech autism motor speech disorder speech development
compare the knob-tipped knife with the needle knife in difficult biliary cannulation

Conditions: Endoscopic Retrograde Cholangiopancreatography; Bile Duct Diseases

Summary: the aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (cbd)cannulation.

precut sphincterotomy is an alternative technique used to facilitate cbd cannulation following the failure of conventional bile duct cannulation. needle knife papillotomy is the most widely practiced precut technique. however,pre-cutting the papilla with a needle-knife is difficult, requiring experience and dexterity to control the axis and depth of the cut. due to the increased rate of complications associated with this procedure, including pancreatitis, hemorrhage, and perforation, it was recommended to be performed only by experienced endoscopists. the knob-tipped knife, a novel instrument utilizing a 2mm or 1.5mm cutting knife, is usually used for endoscopic submucosal dissection (esd). its knob-shaped tip and nonadjustable length make the knife less likely to slip and penetrate the tissue during the resection. since the process of precut papillotomy is similar to esd, the precutting procedure with the knob-tipped knife may be easier to be performed, as well as be safer. the efficacy and safety of this instrument in precut papillotomy have not been reported. we therefore assessed the efficacy and safety of the knob-tipped knife in precut papillotomy in difficult cbd cannulation.

Eligibility criteria:
inclusion criteria: * intact papilla and deep cannulation of the bile duct * a standard wire-guided cannulation \>10 minutes, or pancreatic contrast injections ≥3, or pancreatic deep wire pass ≥5 exclusion criteria: * ampullary tumors * billroth ii or roux-en-y anatomy * prior endoscopic sphincterotomy(est) or biliary stent * choledochoduodenal fistulae
interest of behavioural reeducation in dysfunctions of masticatory apparatus. relations between parafunctions and dysfunctions of mastixatory apparatus

Conditions: Temporomandibular Disorders

Summary: if etiologies of temporomandibular disorders (tmd) are various, parafunctions become more and more important. treatment of patients presenting tmd is based on conservative and reversible therapeutics. the behavioural reeducation of these patients which aims at decreasing their parafunctions is a treatment often performed.


Eligibility criteria:
inclusion criteria: * male and female over 18, * patient who was informed about the protocol and who did not refuse to take part in the programme, * patient who suffers of dysfunctions of masticatory apparatus: myofascial pain, joint clicking or crepitations, disc deplacement with reduction, mandibular limitation and/or deviation, * patient who presents more or less obvious parafunctions, which are associated or not to other etiologies * patient consulting for the 1st time for tmd exclusion criteria: * persons over 18 who are under legal protection (guardianship), persons who are deprived of their freedom, * patient who is already followed in the consultation of dysfunctions of masticatory apparatus and who is under treatment, * patient who is under treatment of occlusal splint (not in the framework of the consultation of tmd * patient with pains other than orofacial pains (cephalalgia, neuralgia, vascular algia of the face, migraine), * patient who needs a treatment other than a behavioural reeducation (pharmacological treatment, occlusal splint , addressed to another therapist, prosthetic treatment)
outcome of covid-19 patients after extracorporeal membrane oxygenation for acute respiratory distress syndrome

Conditions: COVID-19; Extracorporeal Membrane Oxygenation Complication; Acute Respiratory Distress Syndrome

Summary: this study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ecmo) therapy for severe acute respiratory syndrome (ards) in covid-19 patients.

we evaluated the outcome of adult patients with coronavirus disease 2019 (covid-19)-related acute respiratory distress syndrome (ards) requiring the use of extracorporeal membrane oxygenation (ecmo).

Eligibility criteria:
inclusion criteria: * pcr-confirmed or suspected covid-19 infection with ards who require any ecmo therapy exclusion criteria: * none
comparison of meopa + paracetamol versus morphine treatment in acute coronary syndrome analgesia.

Conditions: Acute Coronary Syndrome

Summary: in the management of acute coronary syndromes with st-segment elevation (stemi), early analgesia reduces the effects of hyperadrenalism which increases the size of myocardial infarction. in order to reduce pain intensity, the recommendations advocate emergency use of morphine. in stemi patients, other analgesic treatments could provide analgesia that is at least as effective as morphine. the equimolar oxygen/nitrous oxide mixture (meopa) is widely used in emergency medicine and has minor secondary effects that are very rapidly reversible when inhalation is discontinued. used in association with paracetamol, it could be an at least equally effective alternative to the use of morphine.

the investigators wish to compare the use of morphine according to current recommendations with the use of meopa associated with intravenous paracetamol in the management of patients with stemi. the investigators hypothesize that the association of meopa and paracetamol, which is easy to use in a pre-hospital setting, will give patients pain relief as effectively as morphine. this alternative treatment would avoid the use of morphine, whose potentially damaging consequences on myocardial function have been suggested by experimental studies and by an observational study. the physician of the mobile emergency team (smur) verifies the inclusion and non- inclusion criteria for the study. the patient must present stemi defined in accordance with the recommendations and chest pain of intensity ≥ 4 on the nrs. the specific treatment for stemi will be given before inclusion in the study, with the exception of analgesic treatment. in particular, inclusion in the study must not delay the initiation of strategies of recanalization and reperfusion. the smur physician in charge of the patient will administer the treatment defined by randomization. after 30 minutes, the patient will be managed in accordance with the recommendations and will be hospitalized, generally in a cardiology intensive care unit. at one month, the clinical research technician will record the patient's vital status and collect the patient's hospital records.

Eligibility criteria:
inclusion criteria: * patient with stemi \< 12 h treated before hospital admission and pain ≥ 4 on the numerical rating scale. exclusion criteria: * acute severe hemodynamic, respiratory or neurological failure * heart failure: killip class iii and iv * known allergy to morphine or nitrous oxide * patient who has already received morphine or meopa before the arrival of the hospital team during the 4 hours preceding the pre-hospital intervention * contraindications to nitrous oxide * patient unable to assess pain intensity on the numerical rating scale * patient under legal guardianship * pregnancy * patient transported by air ambulance

Keywords: premixed nitrous oxide and oxygen pain prehospital setting acute coronary syndrome
a phase iiib open-label, comparative study to evaluate saquinavir soft gel capsule (sgc) treatment in combination with other antiretrovirals in hiv-1 infected antiretroviral-naive patients

Conditions: HIV Infections

Summary: to determine the proportion of patients whose plasma hiv-1 rna level falls below the level of detection (\< 400 copies/ml) at week 16 and 24 of study therapy. to determine the absolute change in plasma hiv-1 rna and in absolute cd4 cell count during the 24 weeks of study treatment. to collect safety data on the treatment regimens. to determine the percentage of patients without sqv soft gel capsules resistance-associated mutations at week 24.

patients are randomized to receive 1 of 3 study regimens: group a - saquinavir (sqv) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (rtis), group b - sqv sgc plus delavirdine plus rti, and group c - sqv sgc plus nelfinavir plus rti (or sqv sgc plus ritonavir plus 2 rtis).

Eligibility criteria:
inclusion criteria patients must have: * hiv rna \>= 5000 copies/ml by amplicor assay. * signed, informed consent from parent or legal guardian for patients less than 18 years old. previous treatment with antiretrovirals.

Keywords: hiv-1 drug therapy, combination hiv protease inhibitors rna, viral dosage forms saquinavir reverse transcriptase inhibitors anti-hiv agents viral load
efficacy study of additional chemotherapy after concurrent chemoradiation in non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: non-small cell lung cancer(nsclc) is the leading cause of death in korean men after stomach cancer. surgical resection plays a main role for curative treatment. however, less than 20 % of the nsclc patients have been found in stage i-ii disease. in inoperable stage iiia/b disease, the recommended treatment is combined chemotherapy and radiation therapy. various kinds of combination of 2 modalities have been used either in sequential or concurrent setting. concurrent chemoradiotherapy(ccrt) have been recognized to have better survival than radiation therapy alone or sequential therapy, but additional consolidation chemotherapy after ccrt is not yet to be determined for the beneficial role in survival gain. docetaxel is an anticancer drug and has synergistic anticancer effect in various cancer with cisplatin, another anticancer drug. in the present study, randomised trial will be performed to confirm the efficacy of the consolidation chemotherapy with docetaxel and cisplatin after completing ccrt with the same chemotherapeutic agents in stage iii inoperable nsclc on progression free survival and overall survival.


Eligibility criteria:
inclusion criteria: * histologically proven non-small cell lung cancer * presence of measurable disease by recist * inoperable stage iiia or iiib, proven by ct or mri (except wet t4). however, n2 or n3 should be confirmed by pet or pathology. (for t4, pet is optional) * 18 years of age or older * ecog performance status 0-1 * no prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy * serum hgb ≥ 10 gm/dl, platelet ≥ 100,000/μl, absolute neutrophil count ≥ 1,500/μl * serum creatinine ≤1.25 x unl or creatinine clearance ≥60 mlml/min * serum bilirubin ≤ 1.5 x unl, ast (sgot) and alt (sgpt) ≤ 2.5 x unl, alkaline phosphatase ≤ 5 x unl * fev1\> 0.8 l * patients must sign an informed consent exclusion criteria: * carcinoid tumor, small cell carcinoma of lung * patients with any distant metastasis * history of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment) * pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women * women and men of childbearing potential who have no willing of employing adequate contraception
zoledronic acid in ms-patients with osteoporosis

Conditions: Osteoporosis; Multiple Sclerosis

Summary: this study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg intravenous (i.v.) relative to placebo in multiple sclerosis (ms) patients with osteoporosis and to support the optimal use of zoledronic acid for this indication. primary objective is the change of bone mineral density (bmd) at lumbar spine (l1-l4) and total hip region assessed by t-score at month 12 relative to screening as measured by dual x-ray absorptiometry (dxa). this double-blind period will be followed by a 52-week open-label treatment phase to assess long-term efficacy and safety of zoledronic acid in these patients.


Eligibility criteria:
inclusion: * written informed consent to participate in the trial * definite diagnosis of multiple sclerosis (ms) as defined by 2005 revised mcdonald criteria * ms-subtype: relapsing-remitting ms (rrms), secondary progressive ms (spms), primary progressive ms (ppms) * expanded disability status scale (kurtzke's scale; edss) score between 2.5 to 6.5 (including both) * bone mineral density (bmd) t-score of less or equal to -2.0 and more or equal to -4.0 at the lumbar spine (l1-l4 with at least 2 evaluable vertebrae) and/or total hip region and/or femoral neck in recent dual x-ray absorptiometry (dxa)-scan (\< or = 3 months) * sufficient ability to read, write and communicate comprehensibly and comply to study procedures * no immunomodulatory treatment for ms within the last 30 days or stable and well tolerated therapy with any beta-interferon formulation, or glatirameracetate or fingolimod for at least 30 days immediately prior to baseline exclusion criteria: * contraindications against calcium and vitamin d and zoledronic acid according to the summary product characteristics * more than one osteoporotic fracture * concomitant medication with influence on bone mineral density (eg. enzyme- inducing antiepileptics like carbamazepin, phenytoin, phenobarbital, primidon) * any neurological disorder other than ms which is known to affect bone mineral density (e.g. muscular dystrophy, severe paresis for other reasons than ms, degenerative nervous disorder, stroke) * women who are pregnant or breast feeding, or menstruating and capable of becoming pregnant. * baseline renal insufficiency * 25-oh vitamin d level \< 10 ng/ml at screening * serum calcium levels \> 2.75 mmol/l (11.0 mg/dl) or \< 2.00 mmol/l (8.0 mg/dl) at screening * other protocol-defined inclusion/exclusion criteria may apply

Keywords: multiple sclerosis osteoporosis zoledronic acid
a safety, pk, pd and food effect study of urc102 in healthy adults and patients with renal impairment

Conditions: Healthy, Renal Impairment

Summary: a phase 1 clinical trial to evaluate safety, pk/pd profiles and food effects of urc102 in patients with renal impairment and healthy people.

this trial will evaluate 1. in patients with renal impairment: the safety, pharmacokinetics and pharmacodynamics after single oral administration of urc102 under fasted conditions. 2. in healthy adult subjects: the safety, pharmacokinetics and pharmacodynamics of 2 single doses of urc102 in the morning after fasting or after a high-fat breakfast. the 2 doses will be separated by a washout period.

Eligibility criteria:
inclusion criteria: for test group 1 and 2 - subjects with renal impairment 1. age 19\~65 2. bmi 18.0\~30.0 kg/m\^2 (body mass index) 3. 30 ≤ egfr \< 60 ml/min/1.73m\^2 (estimated glomerular filtration rate) 4. voluntarily given written informed consent for control group - healthy subjects 1. age ≥ 19 2. bmi 18.0\~30.0 kg/m\^2 3. egfr ≥ 90 ml/min/1.73m\^2 4. voluntarily given written informed consent exclusion criteria: for test group 1 and 2 - subjects with renal impairment 1. medical history * subjects with lactic acidosis or marked hepatotoxicity * not controlled diabetes, hypertension, dyslipidemia * requiring dialysis 2. clinical examination * ast, alt \> 2, bilirubin total, γ-gtp \> 1.5, ck \> 2 times the upper limit of normal ranges (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, creatine phosphokinase) * positive serologic results 3. drug hypersensitivity and drug abuse for control group - healthy subjects 1. medical history * history of chronic liver disease, hepatic encephalopathy, ascites, or upper gastrointestinal bleeding * subjects with lactic acidosis or marked hepatotoxicity 2. clinical examination * ast, alt \> 2, bilirubin total, γ-gtp \> 1.5, ck \> 2 times the upper limit of normal ranges * positive serologic results 3. drug hypersensitivity and drug abuse