Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics, safety, and efficacy of dolutegravir dispersible tablets in young children living with hiv

Conditions: Pediatric HIV Infection

Summary: the purpose of this study is to evaluate steady-state pharmacokinetics of dtg dispersible tablets in children with hiv infection weighing from 6 to below 20 kg and to determine the dose of dtg that achieves adult target pk parameter(trough concentration; auc24h)

after being informed about the study and potential risks, all legal guardians giving written informed consent will undergo check eligibility to enroll the study entry. patients will be sort into 3 weight band groups 6 to below 10 kg, 10 to below 14 kg, and 14 to below 20 kg. arts will be switched to dtg dispersible tablet and abc/3tc once daily will be prescribed according to weight band dosage. total of 7 time point of blood sampling for plasma dtg concentrations will be measure at 7-14 day after medication switch. patient will be follow up as schedule for total 24 week to assess safety, and efficacy of dtg dispersible tablet combine with abc/3tc.

Eligibility criteria:
inclusion criteria: * children living with hiv weighing 6 to below 20 kg * naïve to integrase inhibitors exclusion criteria: * currently active opportunistic infection * liver dysfunction (sgpt below 100 iu/ml) * renal dysfunction (gfr below 60 ml/min) * currently using medication that interacts with dtg

Keywords: dolutegravir dispersible tablet pharmacokinetics weight below 20 kg
rectal cancer survivorship: impact of low anterior resection syndrome (lars) on the quality of life

Conditions: Rectal Cancer; Low Anterior Resection Syndrome

Summary: quality of life and risk factors for developing major lars are explored. therapeutic options were explored in the cohort experiencing major lars

quality of life and risk factors for developing major lars are explored using the eortc qlq c30. therapeutic options were explored in the cohort experiencing major lars

Eligibility criteria:
inclusion criteria: * low anterior resection for rectal cancer between 2006-2016 * adults exclusion criteria: * abdomino perineal resection * patients who do not understand dutch
brexpiprazole as combination therapy with sertraline in the treatment of adults with post-traumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: this will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder.


Eligibility criteria:
inclusion criteria: * male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent. * participants who have post-traumatic stress disorder (ptsd), diagnosed according to diagnostic and statistical manual of mental disorders, 5th edition (dsm-5), and confirmed by the mini international neuropsychiatric interview (mini). * onset of symptoms meeting the dsm-5 criteria for ptsd symptoms for a minimum of 6 months prior to screening. exclusion criteria: * the index traumatic event that led to the development of ptsd took place \> 9 years before screening. * the index traumatic event occurred before age 16. * participants who have experienced a traumatic event within 3 months of screening. * participants who are receiving disability payments because of ptsd or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.

Keywords: ptsd
mk-2206 in recurrent nasopharyngeal carcinoma

Conditions: Recurrent Nasopharyngeal Carcinoma

Summary: to evaluate the activity and safety of mk-2206 in patients with recurrent or metastatic nasopharyngeal carcinoma (npc)


Eligibility criteria:
inclusion criteria: * aged \> 18 year, able to give written informed consent. * history of histologically or cytologically confirmed non-keratinizing npc that has recurred at locoregional and/or distant sites, and is not amenable to potentially curative radiotherapy or surgery. * patients must have progressed within 24 months of receiving one or two prior line of chemotherapy for recurrent disease, of which at least one line must contain platinum drugs such as cisplatin, carboplatin or oxaliplatin. * adequate organ reserve: neutrophils \>1.5x109/l, platelets ≥100 x109/l, hemoglobin ≥9 g/dl, serum alanine aminotransferase (alt) \< 2.5 x upper limit of normal (uln) or alt\< 5 x uln in the presence of liver metastases, serum bilirubin \< 2.5 x uln, serum creatinine \< 1.5 x uln. * presence of measurable disease as per response evaluation criteria in solid tumors (recist ver 1.1). exclusion criteria: * chemotherapy, radiotherapy (except to bone metastases) or investigational treatment within 4 weeks of enrollment. * patients with diabetes or in risk for hyperglycemia should not be excluded from trials with mk-2206, but the hyperglycemia should be well controlled before the patient enters the trial. * cardiovascular: baseline qtcf \> 450 msec (male) or qtcf \>470 msec (female) left bundle branch block, 2nd or 3rd degree av block, bifascicular block, sick sinus syndrome, wolff-parkinson-white syndrome, significant sinus bradycardia (\< 50bpm) . however, patients with asymptomatic right bundle branch block or 1st degree av block, in the absence of known cardiac disease (e.g. coronary, valvular) are not excluded.. * uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
combined tdcs and vision restoration training in post-acute stroke: an exploratory efficacy and safety study

Conditions: Hemianopia; Stroke

Summary: the purpose of this study is to determine whether non-invasive transcranial direct current stimulation (tdcs) is effective in increasing rehabilitation effects after stroke in visual cortex.

visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (vrt), but when combined with transcranial direct current stimulation (tdcs) which alters brain excitability, vision restoration can be potentiated in the chronic stage. because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tdcs/vrt treatment. 19 post-acute stroke homonymous hemianopia patients were randomly assigned to either 10 sessions of combined rea-tdcs (2ma, 10 daily sessions of 15-20 min) and vrt, or sham-tdcs and vrt. the primary outcome criterion was the pre-post change in perimetric detection thresholds. secondary outcome is neurophysiological changes in eeg measures (vep, connectivity, spectral power, ...)

Eligibility criteria:
inclusion criteria: * posterior cerebral artery stroke * visual field defect * lesion age 4 weeks up to 6 month max. exclusion criteria: * electrical implants * metal artefacts in head * epilepsy * visual neglect
gaze contingent feedback in social anxiety disorder

Conditions: Phobia, Social

Summary: the purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of social anxiety disorder (sad)

the study examines giving social anxious participants gaze-contingent feedback as a novel attention training procedure. half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.

Eligibility criteria:
inclusion criteria: * a signed consent form * men and women between the ages of 18 and 60. * meeting a current diagnosis of social anxiety disorder (sp) according to the dsm-iv * a minimum of a 1-year duration of sp * sp as the primary diagnosis: in cases of co-morbidity, sp will be deemed as the most distressing and clinically significant condition among the co-morbid disorders * stable pharmaco-therapy: participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure. exclusion criteria: * psychotic episode in the past or the present time. * co-morbidity with any neurological disorder (i.e., epilepsy, brain injury). * another psychotherapeutic treatment during the study. * usage of neuroleptic medication. * change in medication status during the study. * substantial usage of drugs or alcohol in the present time. * poor judgment capacity (i.e., children under 18 and special populations).
treatment of high altitude polycythemia by acetazolamide

Conditions: High Altitude Polycythemia

Summary: the prevalence of high altitude polycythemia (or chronic mountain sickness) is between 8 and 15% in the high altitude regions of south america. there is no pharmacological treatment available. after a first preliminary study in 2003 demonstrating the beneficial effects of acetazolamide in reducing hematocrit in these patients, after 3 weeks of treatment, we want to confirm this effect and implement a treatment protocol of 3 month-duration.

chronic mountain sickness (cms) is characterized by an excessive number of red cells in the blood of persons living permanently above the altitude of 2,500m. the symptoms of this very incapacitating disease are : headaches, chronic asthenia, digestive troubles, sleep disturbances. the hemoglobin concentration is higher than 21 g/dl of blood. in addition, patients show a pulmonary hypertension of variable degree, as well as a systemic hypertension. this disease affects essentially males, but women are also concerned after menopause. the evolution of the disease is always very dramatic, towards a cardiac failure and cerebral vascular stroke. the prevalence is between 8% and 15% on the andean altiplano . no pharmacological treatment is available. a preliminary study was performed (richalet et al. ajrccm, 2005) that demonstrated the efficiency of acetazolamide (a carbonic anhydrase inhibitor) in reducing the hematocrit and the erythropoetin concentration,and increasing nocturnal oxygen saturation in patients suffering from cms, after 3 weeks of treatment. we plan to perform a double-blinded placebo-controlled study to evaluate the efficiency of a 3-month treatment with daily 250 mg acetazolamide to reduce the hematocrit and hemoglobin concentrations and ameliorate the clinical symptoms of 55 patients suffering from cms and living at high altitude (cerro de pasco, peru).

Eligibility criteria:
inclusion criteria: * patients with chronic mountain sickness and hb \> 21g/dl exclusion criteria: * patients smokers * patients with respiratory or cardiovascular or renal disease

Keywords: high altitude hypoxia pulmonary hypertension polycythemia hypoventilation
goldencaretm for the treatment of bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: goldencare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial vaginosis (bv). standard treatment for bv is metronidazole. although the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. the study hypothesis is that goldencare will cure bv. this is a proof of concept study to collect preliminary evidence of the safety and efficacy of goldencare.

goldencare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial vaginosis(bv). standard treatment for bv is metronidazole. although the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. the study hypothesis is that goldencare will cure bv. this is a proof of concept study to collect preliminary evidence of the safety and efficacy of goldencare.

Eligibility criteria:
inclusion criteria: * written informed consent * female aged 18 years or older * subject has clinical bacterial vaginosis with 4 of 4 positive amsel's criteria * negative pregnancy test * for 7 day treatment period, subject agrees to refrain from using douches and intravaginal products (i.e. feminine deodorant sprays, spermicides, nonoxynol-9 products, tampons, and condoms). subject also agrees to refrain from taking oral or intravaginal antibiotics (unless enrolled in comparator arm),or antifungal agents during the entire study period. exclusion criteria: * subject has another infectious or noninfectious cause of vulvovaginitis such asymptomatic candidiasis, trichomonas vaginalis, chlamydia trachomatis, neisseria gonorrhoeae, herpes simplex, human papilloma virus, atrophic vaginitis, lichen sclerosus, or genital warts.

Keywords: bacterial vaginosis bv
intracellular tight junction permeability in schizophrenia: focus on zonulin

Conditions: Schizophrenia; Celiac Disease

Summary: the purpose of this protocol is to collect serum zonulin levels in people with schizophrenia. this one time visit will collect zonulin levels, antibodies to gliadin (tissue transglutaminase and antigliadin antibodies) and other information that may relate to increased intracellular tight junction permeability as it related to the immune and stress system and the immune association with kynurenic acid pathway 50. data will be collected for use in future grant applications and published reports.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia or schizoaffective disorder * male or females between ages of 18 to 75 years exclusion criteria: * score below 10/12 on the evaluation to sign consent (esc)
a real-world comparative study of donanemab (ly3002813) plus usual care versus usual care alone in us participants with early symptomatic alzheimer's disease

Conditions: Alzheimer Disease

Summary: the main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic ad. the study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. the study will last about 273 weeks and may include up to 28 visits.


Eligibility criteria:
inclusion criteria: participants * are under care for presumed mild cognitive impairment (mci) or mild dementia stage of ad (note: neither a biomarker-based diagnosis of ad nor a diagnosis in electronic health records \[ehr\] is required prior to screening) * have a telephone interview for cognitive status (tics) score of ≥21 * presence of amyloid beta (aβ) pathology supported by biomarker results (e.g., p-tau, amyloid positron emission tomography (pet), and/or cerebrospinal fluid \[csf\]). (note: a historical biomarker may be used for eligibility if performed within 12 months of study entry) * have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and * have ehr data available for linkage and are willing to allow access to ehr data for the duration of the study. exclusion criteria: * have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (adls) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (note: mixed dementias with amyloid pathology are permitted) * have current or recent serious or unstable illness (other than ad) that, in the investigator's opinion, could interfere with the ability of the participant or study partner to complete the study (e.g., life expectancy of less than 36 months, requirement for long-term (\>12 months) institutional-level care, serious psychiatric illness, etc.) * are currently enrolled or intend to enroll in a clinical trial of another investigational product, and * have contraindications to donanemab, magnetic resonance imaging (mri), or amyloid pet tracers. (donanemab group only).
effect of stimulation of the prefrontal cortex on language production in aphasic patients

Conditions: Aphasia

Summary: the purpose of this study is to investigate whether transcranial direct current stimulation (tdcs) of the prefrontal cortex (pfc) influences lexical access and language production. the experimental paradigm will assess the impact of prefrontal stimulation by tdcs versus sham tdcs (s-tdcs) over the pfc of patients with chronic post-stroke aphasia during three language production tasks and a nonverbal executive functions task.

background: language processing is a complex brain function supported by a large network, including domain-specific language areas as well as domain-general cognitive-control networks (friederici \& gierhan, 2013). noninvasive brain stimulation, such as transcranial direct current stimulation (tdcs), is increasingly being used as a promising therapeutic tool for psychiatric and neurological diseases (tortella et al., 2015; flöel, 2014). in the language domain, several studies revealed that tdcs over languagespecific areas induces changes in cortical function that enhances the recovery of language abilities in patients with post-stroke aphasia (torres, drebing \& hamilton, 2013; monti et al., 2013). beneficial effects of tdcs have also been found for stimulation over more domain-general cognitive control regions. although research on non-invasive brain stimulation and aphasia reveals promising results, studies investigating the modulation of cognitive control-networks on lexical access are rare. given the importance of a successful interplay between prefrontal and domain-specific language areas, possible therapeutic effects of tdcs over the prefrontal cortex (pfc) in aphasia can be of high value for rehabilitation and basic research. procedure: a planned total of 30 patients will be included. in a first visit, the severity of aphasia, the medical history as well as inclusion/exclusion criteria will be evaluated. after this visit, patients will undergo two tdcs sessions (one tdcs and one s-tdcs session) with a one week interval between the sessions. each session consists of an online (during stimulation) and an offline assessment (within 30 minutes after stimulation). three language tasks and a nonverbal executive function task will be conducted online as well as offline in each of the two sessions (tdcs and s-tdcs).

Eligibility criteria:
inclusion criteria: * chronic aphasia due to ischemic or haemorrhagic stroke (\> 6 months post-stroke) * french as dominant language * right-handedness * left hemisphere lesion with intact bilateral pfc exclusion criteria: * diagnosed dementia or psychiatric comorbidity * epileptic seizure within the last 12 months * metallic head implants * pacemaker * inability to understand procedures or insufficient language production abilities * pregnancy * strong headache on the days of the tdcs sessions * consumption of alcohol and/or unprescribed drugs on the days of the tdcs sessions or on the day before

Keywords: transcranial direct current stimulation aphasia language production prefrontal cortex
cross cultural adaptation and validation of orthognathic quality of life questionnaire (oqlq)

Conditions: Health-related Quality of Life; Dentofacial Deformities

Summary: the aim of this study was to develop a spanish version of the orthognathic quality of life questionnaire (oqlq) that is conceptually equivalent to the original questionnaire, as well as acceptable, reliable, valid, and responsive for use in chilean patients with dentofacial deformities.the cross cultural adaptation process was carried out according to the recommended standard methodology with direct and back-translation.

a prospective longitudinal multicenter study of adult patients diagnosed with dentofacial deformity was carried out, self-administrating oqlq, ohip-14 (oral health impact profile), and sf-36 (short form 36 health survey) during the presurgery visit in order to examine construct validity. to evaluate reproducibility, questionnaires were re-administered 4 weeks later to subjects with a stable dental condition. responsiveness was assessed among subjects followed up until 3 months after surgery and finally changes in health-related quality of life was assessed comparing baseline pre-surgery to 3 and 6 months post-surgery.

Eligibility criteria:
inclusion criteria: * adults patients over 18 years old with dentofacial deformity. exclusion criteria: * patients with congenital abnormalities such as craniofacial syndrome or cleft lip/palate and sequels due to maxillofacial trauma were excluded

Keywords: health-related quality of life orthognathic surgery dentofacial deformities
validity and reliability of 30sfpw test patients with tka

Conditions: Knee Osteoarthritis

Summary: walking speed after total knee arthroplasty (tka) can be used as a simple tool to monitor postoperative recovery. there are different protocols for gait assessment in patients with tka. the 30 second fast walk test (30sfw) is a simple, low-cost and easy-to-apply assessment method that requires very little equipment in clinical settings. 30sfw is a reliable, valid test of walking ability in patients with knee osteoarthritis (oa). objective: to investigate the reliability and validity of the 30sfw test in the evaluation of gait in patients with tka.


Eligibility criteria:
inclusion criteria:patients who had primary tka surgery at least six months ago, being diagnosed with preoperative knee oa, and volunteering to participate in the research - exclusion criteria:had a previous orthopedic, neurological, or systemic disease that effects walking or standing, body mass index of 40 kg / m2 and over, having any other surgery on the same limb that effect walking, and revision tka. -

Keywords: total knee arthroplasty, knee, 30-second fast-paced walk test, validity, reliability.
randomized control trial on postoperative weight bearing after high tibial osteotomy (hto)

Conditions: Osteoarthritis, Knee

Summary: the study analyzes the consequences of weight bearing after an hto in a population of young patient with medial osteoarthritis (immediate weight bearing versus two month weight bearing). the two options are usually used so the protocol belongs to the intermediate care evaluation category. the iks (international knee society) score at one year follow up is the first outcome. the aim of the study is to highlight that the option early weight bearing (immediately in postoperative) is equal to the option delayed weight bearing.


Eligibility criteria:
inclusion criteria: * age: 40 to 65 years old * patients with medial osteoarthritis of knee of level 1 or 2 from ahlback's classification with high tibial osteotomy indication * one sided indication * well understanding of information note by patient, non-opposition to perform the research * affiliation to a national health insurance program exclusion criteria: * age \ 65 years old * medial osteoarthritis of knee of level superior to 2 * bilatéral indication * patient opposition * non affiliation to a national health insurance program * law protected patients * pregnancy and breast feeding

Keywords: osteotomy weight bearing opening wedge