Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of ledipasvir/sofosbuvir fixed dose combination +/- ribavirin in adolescents and children with chronic hcv-infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objective of the pk lead-in phase of the study is to evaluate the steady state pharmacokinetics (pk) and confirm the dose of ledipasvir/sofosbuvir (ldv/sof) fixed dose combination (fdc) in hepatitis c virus (hcv)-infected pediatric participants. the pk lead-in phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of ldv/sof fdc in hcv-infected pediatric participants. the treatment phase will be initiated by age cohort after confirmation of age-appropriate ldv/sof fdc dosage levels. participants from the pk lead-in phase will immediately rollover into the treatment phase with no interruption of study drug administration. the primary objective of the treatment phase is to evaluate the antiviral efficacy, safety, and tolerability of ldv/sof fdc +/- ribavirin (rbv) for 12 or 24 weeks in pediatric participants with hcv. during screening, participants will receive placebo to match ldv/sof fdc to assess ability to swallow tablets.


Eligibility criteria:
key inclusion criteria: * consent of parent or legal guardian required * chronic hcv infection * screening laboratory values within defined thresholds key exclusion criteria: * history of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol. * co-infection with hiv, acute hepatitis a virus, or hepatitis b virus * clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage) * pregnant or nursing females * known hypersensitivity to study medication * use of any prohibited concomitant medications as within 28 days of the day 1 visit note: other protocol defined inclusion/exclusion criteria may apply.
the china laparoscopic right hemicolectomy snapshot

Conditions: Right Hemicolectomy; Colon Cancer

Summary: the main objective is to explore the current practice of right hemicolectomy for colon cancer located in the ascending colon and hepatic flexure in selected chinese high quality and high volume centres. this study will identify a potential area to improve the level of standard care and serve as a reference cohort to which planned standardization and addition of innovative aspects can be compared to


Eligibility criteria:
inclusion criteria: * segmental right sided hemicolectomy (including extended) * cancer stage 1-3 (ct-staged) * no prior abdominal surgery exclusion criteria: * stage ct4b, perforated disease * acute obstruction * emergency surgery * right hemicolectomy or ileocaecal resection as part of a large procedure such as subtotal colectomy or panproctocolectomy * patients with inflammatory bowel disease (crohn's disease or ulcerative colitis)
the effect of different focusing methods on muscle activity

Conditions: Knee Injuries and Disorders

Summary: the aim of this study is to compare the effects of different focusing methods on muscular activity

after the first data collecting ( demographic data, inclusion criteria) surface electromyography emg evaluations will be taken from 6 muscles( vastus medialis, rectus femoris, vastus lateralis, biceps femoris, semitendinosus, gluteus medius). these recordings will be taken in 3 different circumstances: 1- without a focusing method 2- with an external focus and 3- with an internal focus

Eligibility criteria:
inclusion criteria: * being between the ages of 18-25 * having a body mass index between 18.5-24.9 exclusion criteria: * having trauma/surgery involving the lower extremity in the last 6 months or having any disorder affecting hip and knee muscle function * foot posture index score not being between 0 and +5 * hamstring flexibility- sit and reach test score greater than +5 cm * restricted ankle dorsiflexion angle (it will be expected to be at least 5 degrees more than neutral)

Keywords: single leg squat muscular activity knee alignment
a study comparing sb8 and avastin® in patients with advanced non-squamous non-small cell lung cancer

Conditions: Lung Cancer; Non-small Cell Lung Cancer

Summary: this study is designed to establish biosimilarity of sb8, a proposed biosimilar product of bevacizumab, to eu-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (nsclc).

standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between sb8 and bevacizumab.

Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years 2. ecog performance status of 0-1 3. histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer 4. at least one measurable lesion according to recist v1.1. 5. able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters exclusion criteria: 1. diagnosis of small cell carcinoma of the lung or squamous cell carcinoma 2. sensitizing egfr mutations or alk rearrangements 3. increased risk of bleeding determined by investigator based on radiographic / clinical findings 4. history of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of nsclc.

Keywords: nsclc bevacizumab avastin
palliative care of children with end-stage heart failure

Conditions: Congenital Disorders

Summary: palliative care in pediatric oncology and neurology is well described in the literature. there is a lack of information on the care of children terminally ill due to heart failure. a significant number of children are diagnosed with terminal heart failure for which palliative care is required. objective: to describe palliative care of children over one year of age with end-stage heart failure, including need for and types of pain control, hospice use, need for and use of home nursing and quality of life issues.

methods: retrospective chart review of all children over one year of age diagnosed with end-stage heart failure between january 1, 1995 and december 31, 2005 at children's healthcare of atlanta, egleston hospital, followed by sibley heart center cardiology. patient variables taken from the medical charts will include: diagnosis age, gender medications prior surgery or transplantation associated conditions such as muscular dystrophy, renal failure practice variables taken from the medical charts will include: hospice care provided home inotropic infusions medications administered for pain social work/psychology evaluation dnr status statistics: number of patients receiving home nursing, involved in hospice, treated with pain medications, home oxygen or home inotropes.

Eligibility criteria:
inclusion criteria: * any patient between 1 - 18 years of age (inclusive) any patient with end stage heart disease treated at egleston hospital, children's healthcare of atlanta followed by sibley heart center cardiology exclusion criteria: * those who do not meet inclusion criteria

Keywords: pediatric palliative care end stage heart failure
gynecomastia extension study

Conditions: Gynecomastia

Summary: the purpose of this study is to look at the effect of anastrozole (zd1033, arimidex™) in reducing gynecomastia in pubertal boys treated with placebo in trial 1033us/0006 (another anastrozole study).


Eligibility criteria:
inclusion criteria: * subjects must have entered trial 1033us/0006 and completed 6 months of treatment and one month of follow-up. * subjects must have gynecomastia, with one breast measuring at least 3 cm in diameter. exclusion criteria: * subjects who have been given medications known to cause gynecomastia within the previous 3 months

Keywords: gynecomastia anastrazole arimidex pubertal males boys
the effects of jerusalem artichoke and fermented soybean powder mixture supplementation on glucose control

Conditions: Prediabetes; Newly Diagnosed Type 2 Diabetes

Summary: the purpose of this randomized, double-blind, placebo-controlled study was to determine whether jerusalem artichoke and fermented soybeans powder mixture is effective in the control of blood glucose level in subjects with prediabetes or newly diagnosed type 2 diabetes.

the objective of this clinical study was to evaluate the effect of jerusalem artichoke and fermented soybean powder mixture supplementation on blood glucose. a randomized, double-blinded, placebo-controlled study was conducted on 60 subjects with impaired fasting glucose (ifg), impaired glucose tolerance (igt) or newly diagnosed type 2 diabetes. the subjects were randomly assigned to either a group ingesting 40 g jerusalem artichoke and fermented soybean powder mixture supplementation daily or a placebo group for 12-week. we assessed fasting and postprandial levels of glucose.

Eligibility criteria:
inclusion criteria: 1. all subjects were with prediabetes (ifg or igt) or newly diagnosed type 2 dm (t2dm) no taking medicine. ifg was defined as fasting glucose between 100 and 125 mg/dl and igt was defined as 2-h ogtts glucose levels 140-199 mg/dl. newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dl or 2-h ogtts level ≥ 200 mg/dl. exclusion criteria: 1. glucose lowering medications or insulin injections; 2. abnormal liver or renal function; 3. chronic stomach and intestines disease; 4. chronic alcoholism; 5. pregnancy or intending to become pregnant during time of study. 6. complications; 7. an occupation that could be dangerous if hypoglycemia should occur.
efficacy and safety of rth258 versus aflibercept - study 1

Conditions: Neovascular Age-Related Macular Degeneration; Choroidal Neovascularization

Summary: the purpose of this study is to compare brolucizumab (rth258) ophthalmic solution for intravitreal (ivt) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic solution for ivt injection (2 mg) in subjects with untreated active choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd) in the study eye.

subjects were randomized to brolucizumab 3 mg, brolucizumab 6 mg,and aflibercept 2 mg in a 1:1:1 ratio. subjects in all treatment arms received 3 monthly loading doses (day 0, week 4 and week 8), followed by a maintenance regimen, until the end of the study (week 96/exit). all subjects attended pre-specified visits every 4 weeks. subjects in the brolucizumab 3 mg and brolucizumab 6 mg arms followed a q12w/q8w maintenance regimen. within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). if disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) ("q12w/q8w regimen"). once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study. subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study. results reported up to week 48 are based on the database locked for the primary analysis at week 48. results reported after week 48 are based on the database locked at the end of study (final analysis).

Eligibility criteria:
key inclusion criteria: * provide written informed consent * active choroidal neovascularization (cnv) lesions secondary to age-related macular degeneration (amd) that affected the central subfield in the study eye at screening; * total area of cnv comprising \>50% of the total lesion area in the study eye at screening; * intraretinal and/or subretinal fluid affecting the central subfield of the study eye at screening; * best corrected visual acuity (bcva) between 78 and 23 letters, inclusive, in the study eye at screening and baseline using early treatment diabetic retinopathy study (etdrs) testing. key exclusion criteria: * any active intraocular or periocular infection or active intraocular inflammation in either eye at baseline; * central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at screening; * subretinal blood affecting the foveal center point and/or \>50% of the lesion of the study eye at screening; * any approved or investigational treatment for neovascular age-related macular degeneration (namd) in the study eye at any time; * retinal pigment epithelial rip/tear in the study eye at screening or baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline; * pregnant or nursing women; women of child-bearing potential; * stroke or myocardial infarction in the 90-day period prior to baseline.

Keywords: amd cnv ivt
safety and efficacy of laser therapy in gynaecology

Conditions: Herpes Genitalis; Genital Wart; Lichen Sclerosus; Cervical Intraepithelial Neoplasia; Labial Reduction Surgery; Episiotomy Scar; Bartholin Cyst; Hidradenitis Suppurativa

Summary: the aim of this study is to retrospectively evaluate the effectiveness and safety of er:yag laser for treatment of different gynecological indication, e.g. genital lesions, bartholin's cyst, condyloma, episiotomy scars, lesions of hydradenitis suppurativa and use of laser in genital surgery used in private practice.


Eligibility criteria:
inclusion criteria: * patients with any of the selected gynecology indications, treated with laser in the period 2013-2018 * signed informed consent exclusion criteria: * n/a
study evaluating changes in total drug load and seizure frequency using vimpat® (lacosamide) in combination therapy

Conditions: Focal Epilepsy With and Without Secondary Generalization

Summary: this observational study aims to investigate how vimpat® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of vimpat® to their treatment regimen.


Eligibility criteria:
inclusion criteria: * the patient has not received vimpat® more than 7 days prior to start of non-interventional study (nis) * the patient must have a diagnosis of epilepsy with partial-onset seizures with or without secondary generalization * based on the physician's clinical judgment, it is in the patient's best interest to be prescribed adjunctive vimpat® (ie, the decision to prescribe vimpat® is made by the physician) * patient must be at least 18 years of age * the patient must have had at least one seizure within the last 3 months prior to enrolment

Keywords: lacosamide vimpat focal epilepsy drug load aed sp1065
effect of genotyping for cyp450 polymorphisms versus intense clinical monitoring on antipsychotic drug treatment

Conditions: Schizophrenia

Summary: the purpose of this study is to determine whether genotyping for cyp2d6 and 2c19 polymorphisms or intense clinical monitoring of treatment and adverse effects improves the antipsychotic treatment in patients with schizophrenia. this study is designed as a three-armed prospective randomized controlled clinical trial and includes 300 patients with schizophrenia. patients are followed for a period of one year. during the study period the following effect measures are registered: * time to discontinuation of all antipsychotic medications * number of changes in medication dose * number of changes in medication * compliance (patients´ adherence to medical treatment) * clinical symptoms * adverse effects


Eligibility criteria:
inclusion criteria: * diagnosed with schizophrenia * able to give written informed consent exclusion criteria: * genotyped prior to inclusion

Keywords: pharmacogenetics compliance antipsychotic drugs schizophrenia
the postoperative analgesic effect of combination with dexmedetomidine in fentanyl-based intravenous patient controlled analgesia compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy

Conditions: Postoperative Pain

Summary: the aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based intravenous patient controlled analgesia (pca) improves postoperative pain compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy.


Eligibility criteria:
inclusion criteria: 1. asa class i-ii 2. obtaining written informed consent from the parents 3. aged 20-65 years who were undergoing radical open gastrectomy exclusion criteria: 1. abdominal surgery previously 2. patient who refuse the patient controlled analgesia 3. unstable angina or congestive heart failure 4. uncontrolled hypertension (diastolic bp\>110mmhg) 5. coagulopathy 6. hepatic failure 7. renal failure 8. bradycardia on ekg (under 50 bpm) 9. ventricular conduction abnormality 10. drug hyperactivity 11. neurological or psychiatric illnesses 12. mental retardation 13. patients who can't read the consent form due to illiterate or foreigner 14.infection 15. pregnant 16. obesity (bmi \> 30kg/m2)
a critical illness recovery navigator for alcohol

Conditions: Alcohol Use Disorder (AUD)

Summary: excessive alcohol consumption is common in patients admitted to the intensive care unit (icu). among patients who survive an icu admission, excessive alcohol consumption is associated with a higher risk of being admitted the hospital. in this study, the investigators will compare an intervention designed to address excessive drinking in icu survivors to usual care. this intervention combines motivational interviewing (mi) and shared decision making (sdm). mi and sdm share several core components including the development of a therapeutic alliance and promotion of autonomy. mi can be employed in the context of motivating a patient to change their drinking. once this decision has been made, sdm can be employed to help a patient decide amongst multiple reasonable treatment options. the investigators long-term goal is to test whether mi-sdm is better than usual care and whether multiple sessions of mi-sdm are better than a single session. this pilot clinical trial will demonstrate the feasibility of conducting a larger efficacy study to test these hypotheses.


Eligibility criteria:
inclusion criteria: 1. admission to the intensive care unit; 2. age 18 years or older; 3. resolution of critical illness, defined as the intention of the treating team to discharge the patient or downgrade their admission level from the icu to a progressive care unit or the floor; 4. resolution of delirium, defined by: * a riker agitation sedation scale score of 0, * a negative cam icu, and * confirmation from the treating team (nurse, physicians) that the patient is not delirious. 5. audit-c score of 3 or greater for women and 4 or greater for men. exclusion criteria: 1. prisoner; 2. pregnant; 3. unable to speak or write in english; 4. unable to provide informed consent; 5. unable to provide a home or cell phone number plus at least one additional way to be contacted (mail, email, friend or family); 6. expected survival less than 6 months.
effect of nmba on surgical conditions in thr

Conditions: Surgery; Postoperative Pain

Summary: during total hip replacement arthroplasty (tha), the hip joint first must be luxated in order to have access to the joints. a lot of force and torque must be carried out on the joint to perform this manipulation. this is both difficult for the surgeon and may cause additional tissue damage and postoperative pain. after placement of the prosthesis and reduction of the joint, the tension of the hip joint must be evaluated by the surgeon to ascertain the adequacy of the prosthesis. during luxation, minimal muscle tension would be ideal, while after reduction of the joint, normal muscle tension is desired to permit assessment of the mechanics of the hip joint. the aim of the study is to investigate whether deep neuromuscular block, combined with a reversal before mechanics assessment improves surgical conditions, surgical time, and postoperative patient comfort.

2x20 patients are randomised: rocuronium-group (r-group) and placebo-group (p-group). all patients receive standardised multimodal intravenous analgesia. after standardised induction of anasthesia and patient positioning, the patient is administered either placebo or rocuronium 0.9 mg/kg, followed by continuous infusion of either placebo or rocuronium 0.4 mg/kg/h. 1 minute before reduction of the hip joint, the patient is administered either sugammadex (r-group) or placebo (p-group) for full reversal of the neuromuscular block. during the surgery, time points are recorded for: incision, start luxation of the joint, start reduction of the joint, start skin closure. the surgeon is blinded for patient allocation. at three moments (after luxation, just before reduction of the joint, and after assessment of joint mechanics), the surgeon is asked to appraise the surgical conditions on an analogue scale. postoperative analgesic consumption and pain scores are recorded. vas scores for knee pain and hip pain are assessed before surgery, at the moment of discharge from the post-anesthesia care unit (=d0), the morning after surgery (=d1), at d2, and at d7.

Eligibility criteria:
inclusion criteria: * signed informed consent * eligible for primary tha * bmi \<35 exclusion criteria: * neurological or psychiatric disorders * intolerance or allergy against investigational drugs or any of the drugs used in the standardized analgetics scheme (acetaminophen, diclofenac, ketamine, clonidine, lidocaine)

Keywords: muscle tension skeletal muscle relaxants arthroplasties, hip replacement rocuronium sugammadex
the effect of vision therapy/orthoptic on motor & sensory status of the 3 to 7 years old strabismic patients

Conditions: Strabismus

Summary: vision therapy (vto) is a group of non-surgical treatment helping patients in 3 subjects;1)increasing the the visual acuity 2)improving the mechanical skills resulting in increasing the power of extraocular muscles,biocular vision,peripheral vision 3) increasing the perceptual skills making the brain to percept the colour and visual memory better.in this study we are going to compare the effect of vision therapy /orthoptic on motor \& sensory of the 3 to 7 years old strabismic patients


Eligibility criteria:
inclusion criteria: * 3\<age\<7 * congenital isotropia exclusion criteria: * muscular disease * general ocular and systemic disease * seizure * visual acuity \< 60/20 * nystagmus * follow up less than 3 months after surgery
standing cognition and co-morbidities of pots evaluation

Conditions: Postural Tachycardia Syndrome; Ehlers-Danlos Syndrome

Summary: the purpose of this study is to evaluate cognition in patients with postural tachycardia syndrome (pots) while lying down and standing and to assess the prevalence of hypermobile ehlers-danlos syndrome in pots.


Eligibility criteria:
inclusion criteria: * previously diagnosed with pots, or healthy control * age between 13-60 years * participants may be any race, ethnicity, sex, or gender * able and willing to provide informed consent exclusion criteria: * inability to give, or withdrawal of, informed consent * age ≤ 13 or ≥ 61 years * prisoners * unable to stand

Keywords: postural tachycardia syndrome cognition