Kornimate/medical-research-clean huggingface dataset:
a study of tmc435 in participants with genotype 1 hepatitis c virus (hcv) infection

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate the efficacy and safety of tmc435 in combination with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis c virus (hcv)-infected participants who are treatment-naive or treatment-experienced (prior relapser or non-responder to interferon-based therapy) in japan.

this is an open-label study (all people involved know the identity of the intervention) to evaluate the efficacy and safety of tmc435 (also referred to as jnj-38733214-aaa) in combination with the standard of care therapy (soc: peginterferon \[pegifn\] alfa-2b and ribavirin) in adult, genotype 1 hepatitis c virus (hcv)-infected participants who are treatment-naive (never received treatment for hcv), prior relapsers (relapsed after previous interferon \[ifn\]-based therapy), or non-responders (failed to respond to previous ifn-based therapy) in japan. the study objective is to evaluate the efficacy, safety, and pharmacokinetics of tmc435. a sufficient number of participants who are treatment-naive, prior relapsers to treatment with ifn-based therapy, and prior non-responders to treatment with ifn-based therapy will be enrolled and assigned to 1 of 3 panels (referred to as treatment groups). participants who are treatment-naive or prior relapsers to ifn-based therapy will receive 12 weeks of treatment with tmc435 (100 mg) once daily with pegifn alfa-2b and ribavirin (pr) followed by an additional 12 or 24 weeks of treatment with pr. participants who are non-responders to ifn-based therapy will receive 12 weeks of treatment with tmc435 (100 mg) once daily with pr followed by an additional 36 weeks of treatment with pr. tmc435 is a 100-mg capsule and will be taken orally by mouth. the soc treatment will consist of pegylated interferon (pegifn alpha-2b) (1.5 mcg/kg) injected with a syringe subcutaneously (under the skin) once weekly and ribavirin 200-mg capsules (daily dose: 600-1000 mg based on body weight) taken orally by mouth 2 times a day after meals for 24 or 48 weeks.

Eligibility criteria:
inclusion criteria: * patient must have chronic genotype 1 hcv infection with hcv rna level \>= 5.0 log10 iu/ml * patient has never received treatment for hcv (treatment-naive), relapsed after previous ifn-based therapy (prior relapser) or failed to respond to previous ifn-based therapy (non-responder) * patient must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication. exclusion criteria: * co-infection with any other hcv genotype or co-infection with the human immunodeficiency virus (hiv) * diagnosed with hepatic cirrhosis or hepatic failure * a medical condition which is a contraindication to peg-ifn or ribavirin therapy * history of, or any current medical condition, which could impact the safety of the patient in the study

Keywords: hepatitis c, chronic tmc435 hepatitis c hepatitis c virus interferon alfa-2b ribavirin viral ribonucleic acid
fetoscopic tracheal balloon occlusion in left diaphragmatic hernia

Conditions: Diaphragmatic Hernia

Summary: left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. in severe cases, extracorporeal membrane oxygenation (ecmo) is used as a life-saving intensive care means to enable survival of severely affected infants. clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. therefore, the purpose of this randomized clinical trial in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. primary outcome measure is the need for postnatal ecmo therapy.


Eligibility criteria:
inclusion criteria: * pregnant women from european countries carrying fetuses with left diaphragmatic hernia. * normal karyotype, no further severe anomalies on prenatal ultrasound study. * fetal liver herniation into the chest; gestational age-related lung volume between 20-25% of normal as determined by magnetic resonance imaging between 30+0 - 34+0 weeks+days of gestation. exclusion criteria: * any maternal disease or condition that would result in an increased risk to her health from the experimental procedure. * abnormal fetal karyotype, further severe fetal anomalies on prenatal ultrasound.

Keywords: congenital diaphragmatic hernia tracheal occlusion fetus fetal surgery fetoscopy ecmo
tryptophan for impaired ahr signaling in celiac disease

Conditions: Tryptophan Metabolism Alterations; Celiac Disease

Summary: this is a prospective, randomized, double-blind, placebo-controlled exploratory trial to evaluate the effect of l-tryptophan supplementation on celiac-related symptoms in individuals who have biopsy-confirmed celiac disease (ced) and symptoms non-responsive to a gluten-free diet (gfd). fifty participants, aged 18 to 75 years, who self-report persistent ced-related symptoms despite taking a gfd for more than 1 year and who score \> 40 on the celiac symptom index (csi) will be randomized to receive l-tryptophan or placebo for 3 weeks.

at visit 1, consented participants will receive study instructions and be randomized 1:1 to l-tryptophan or placebo (simplecap). a dietitian will counsel all 50 participants on how to maintain a low tryptophan, gluten-free diet. this diet provides an adequate intake of protein (50 g/day) and energy (1800 kcal/day) while limiting the consumption of high tryptophan-containing foods. study participants will receive all their intervention capsules at visit 1 to be taken for 3 weeks, starting the day after visit 2. at visits 2 and 3, just before and after the intervention, participants will complete dietary and symptom questionnaires, provide blood, stool, and urine samples, and undergo upper endoscopy to obtain aspirates from the second part of the duodenum, using a sterile catheter followed by six duodenal biopsies, 2 from the first part (bulb) and 4 from the second part of the duodenum. dietary compliance will be assessed 3-day recalls which will further be analysed by using esha food processor, a nutritional analysis software.

Eligibility criteria:
inclusion criteria: * 18 and 75 years of age * celiac disease (ced) diagnosis: individuals with histological and serological evidence of ced serology (positive biopsy and anti-ttg iga) * persistent ced related symptoms (\>40 on the celiac symptom index) despite \>1 year of a gluten free diet (gfd) exclusion criteria: * acid anti-secretory and antacid medications * antibiotics, antibacterial agents or probiotics, currently, or within the last 8 weeks * current organic gastrointestinal or other autoimmune diseases, such as inflammatory bowel disease or diabetes mellitus (type 1) * lactose and/or fructose intolerance * history of bariatric surgery, fundoplication or gastrectomy (partial or complete) * connective tissue disease * concurrent organic gi pathology other than benign polyps, haemorrhoids, lipomas, helicobacter pylori infection, diverticulosis and melanosis coli * chronic treatment with high dose opioids * alcohol or drug abuse * concurrent systemic disease and/or laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection * allergy or sensitivity to any component of the study medication or placebo * use of lithium and monoamine oxidase inhibitors (maois) * participation in another dietary treatment study within the last 4 weeks

Keywords: tryptophan celiac disease aryl hydrocarbon receptor
bundling gentle body massage along with regular position change under phototherapy

Conditions: Hyperbilirubinemia, Neonatal

Summary: this study aimed to investigate the effect of bundling gentle body massage along with regular position change on bilirubin level and clinical outcomes among full-term neonates with hyperbilirubinemia under phototherapy. hypothesis full-term neonates with hyperbilirubinemia who receive gentle body massage along with regular position change exhibit less bilirubin level and better clinical outcomes than those who don't.

a quasi-experimental study was carried out in the nicu of xx. sixty full-term neonates were randomly assigned to two equal groups. the control group received the conventional nicu care of infants undergoing phototherapy. phototherapy was given by single blue leds emitting light in a narrow spectrum (450-470 nm). initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. the neonates were positioned supine under the phototherapy. the treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. the neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. they were also observed for signs of dehydration. the intervention group received all basic routine care in addition to regular position change from supine to laterals under the phototherapy every two hours. they also received gentle body massage

Eligibility criteria:
inclusion criteria: * full-term * receive enteral feeding (breast, bottle, or mixed feeding, gavage) * newly admitted exclusion criteria: * required exchange transfusion * required mechanical ventilation * has acute phase of circulatory insufficiency * hemolytic disease * neurological disorders * congenital anomalies * neonatal sepsis diarrhea

Keywords: hyperbilirubinemia neonatal massage therapy bilirubin stool frequency length of hospital stay
the development and efficacy of a recovery group for people with mental illness

Conditions: Mental Illness

Summary: recovery-oriented approach has been promoted in psychiatric rehabilitation in recent years. this approach emphasizes that people with mental illness can live a hopeful life even though the symptoms still exist. however, few recovery-oriented programs are available in taiwan. this study aimed to develop of a recovery-oriented program for people with mental illness and investigate its feasibility.

the study participants with mental illness were from a community mental health center in the south of taiwan. the recovery-oriented program was conducted by a group leader, a senior occupational therapist, with one supervisor and one observer. the program was designed based on pathways to recovery, a self-help book published by university of kansas. participants attended a 1-hour class per week. the teaching methods included didactic presentation, peer exchange, group discussion, and practice. the group leader, supervisor, and observer reviewed the content and participants' performance after each class and made content adjustments if needed.

Eligibility criteria:
inclusion criteria: * diagnosis of mental illness exclusion criteria: -
reverse t-stenting and minimal protrusion with external minicrush for treatment of complex coronary bifurcation

Conditions: Coronary Artery Disease; Coronary Stenosis; Coronary Disease

Summary: the reverse t-stenting and minimal protrusion (reverse tap) is an up-front 2-stent technique that treats complex coronary bifurcation. compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting. nowadays, no studies compare the reverse-tap and the external minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

according to definition criteria, pci of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularisation (tvr) than provisional stenting. the double-kissing crush stenting (dk-crush) has been tested with the culotte and the classic crush techniques in the unprotected left main disease (ulmd) and in no-ulmd setting, respectively, showing better clinical outcomes. however, due to its technical complexity and simultaneous improvement of the classic crush technique in the external minicrush, the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation. the dk-crush technique has never been tested with the external minicrush, leaving the operators to choose one or the other according to their experience and preferences. the reverse t-stenting, and minimal protrusion (reverse tap) is an up-front 2-stent technique that treats complex coronary bifurcation. compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting. nowadays, studies need to compare the reverse-tap and the external minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

Eligibility criteria:
inclusion criteria: * patients \>18 years old; * patients with an indication of pci, including chronic coronary syndrome (ccs) and acute coronary syndrome (acs), according to current guidelines recommendations; according to medina and definition criteria, patients with at least true and complex coronary lesions involved in coronary bifurcation. exclusion criteria: * patients that refused informed consent; * patients without valid vascular access that could make unsafe pci; * patients with an expected life of less than one year; * patients with scheduled major surgery that required prolonged dapt interruption; * pregnant patients; * patients with dapt contraindications.

Keywords: reverse tap external minicrush coronary bifurcation lesion
effect of shortening the etching time on the clinical performance of resin composite restorations in primary teeth

Conditions: Dental Caries

Summary: the aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. this randomized clinical trial will include subjects (5-10 year-old children) selected at pediatric clinic of federal university of santa maria. the sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. the sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (adper single bond 2; 3m espe): recommend by manufacturers (15 seconds) and half-reduced etching time (7 seconds). the restorations will be clinically followed every 6 months for up to 18-month using the fdi criteria for clinical evaluation. survival estimates for restoration longevity will be evaluated using the kaplan-meier method.

the aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. this randomized clinical trial will include subjects (5-10 year-old children) selected at pediatric clinic of federal university of santa maria. the sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. the sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (adper single bond 2; 3m espe): applying of 35% phosphoric acid by 15 s - recommend by manufacturers and half-reduced etching time (7 s). the restorations will be clinically followed every 6 months for up to 18-month using the fdi criteria for clinical evaluation. survival estimates for restoration longevity will be evaluated using the kaplan-meier method.

Eligibility criteria:
inclusion criteria: \*active carious lesion in middle dentin limited to the occlusal surfaces of primary molars. exclusion criteria: * children who refuse or fail to cooperate with the completion of clinical procedure; * teeth without antagonist; * carious lesions in inner half of dentin; * presence of painful symptoms or signs of pulpal changes.
imaging template for reporting anal fistula

Conditions: Anal Fistula

Summary: magnetic resonance imaging (mri) is the most used diagnostic tool for pre-operative assessment of anal fistula. however, there is lack of standardization in reporting this investigation. moreover, reports may miss a number of key information for surgical planning. the aim of this study is to assess the effectiveness, reproducibility, and acceptability of a new template for reporting anal fistula, which may favor standardization in clinical practice and inform surgical decision making.


Eligibility criteria:
inclusion criteria: * adults with primary anal fistula (cryptoglandular or crohn-related) undergoing mri exclusion criteria: * active cancer of the anorectum * recto-vaginal fistula
erectile dysfunction/prostate/rt/androgen

Conditions: Prostatic Neoplasms

Summary: the optimal duration of hormonal therapy is yet to be determined in the treatment of locally advanced carcinoma of the prostate. the rtog performed a trial of 4 months of neoadjuvant and concurrent hormones(consisting of goserelin and flutamide) compared to radiation alone, and found that there was an improvement in local control and progression-free survival, but no improvement in overall survival. the eortc performed a similar trial, but used goserelin alone for a period of 3 years. this trial showed an improvement in local control, disease-free survival, and in contrast to the rtog trial, an improvement in overall survival. the rate of erectile dysfunction in men who receive a prolonged period of gosereline (i.e. 2 yrs) is not known, but suspected according to expert opinion, to be significantly higher than a shorter course of hormonal ablation. therefore the price of of a survival advantage in locally advanced prostate cancer maybe at a cost of increased rates of erectile dysfunction.


Eligibility criteria:
inclusion criteria: * patients with clinical stage t1-t4 carcinoma of the prostate * must have undergone radical radiation and at least 2 years of pharmacological androgen ablation.pharmacological androgen ablation may include: lhrh-agonists with or without non-steroidal androgen ablation, steroidal anti-androgens, progestational agents, and cypoterone (androcur). * must be currently 6 months or more after their last injection of lhrh-agonists if it was being given every 3 months or 4 months or more after their last injection, if it was being given monthly. if the patient was on oral androgen ablation agent, they must be off this medication for a period of at least 4 months. * currently off hormonal therapy * able to sign the consent form and fill out questionnaire used in the study. exclusion criteria: * no patients who have been treated, or are currently being treated with bicalutamide * no previous orchidectomy.
post-marketing re-evaluation of wangbi granules for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the group used a randomized controlled trial to conduct a post-marketing re-evaluation study of wangbi granules. the study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of chinese and western medicine treatment with wangbi granules. the study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years. 2. meeting the 1987 acr or 2010 acr/eular diagnostic criteria. 3. meeting the diagnostic criteria of chinese medicine for kidney deficiency and dampness and stasis blocking channels in chinese medicine. 4. rheumatoid arthritis disease activity score das28 of 2.6 to 3.2. 5. regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks. 6. voluntary participation and signed written informed consent. exclusion criteria: 1. patients taking immunosuppressive drugs other than traditional dmards for rheumatoid arthritis within 3 months prior to enrollment (traditional dmards include hydroxychloroquine sulfate, methotrexate, salazosulfapyridine tablets, and raglan polysaccharide tablets, among others). 2. organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (alt/ast \> 3 times the normal upper limit), kidney (ccr \<60ml/min) and other important organ function impairment or hematological system diseases. 3. psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, tia, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome. 4. women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within one month of the last dose or within one month of the last dose are unwilling to use contraception. 5. persons with a bmi greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials. 6. other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.).
mind body intervention for long covid-19

Conditions: Long COVID; Post-Acute Sequelae of COVID-19; COVID Long-Haul

Summary: the goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with long covid. the study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from long covid in participants as compared to usual care and an active control (second mind body intervention). the investigators will secondarily investigate whether the intervention alleviates individual somatic complaints and improves daily functioning, relative to usual care and the active control


Eligibility criteria:
inclusion criteria: 1. adult (≥ 18 years of age) 2. infection with sars-cov2 (i. e., positive antibody, antigen, or pcr testing) 3. symptoms attributed only to covid-19 and not to known comorbid disease (e.g., other infections, cancer, etc) 4. a somatic symptom score ≥ 10 on the sss-8 questionnaire with involvement of at least 3 domains 5. symptoms present at least 3 day a week for a minimum of 3 months 6. willingness to engage in a mind-body intervention exclusion criteria: 1. clear diagnosis of physical disease (e.g. lung fibrosis, myocarditis) not inclusive of non-specific findings such as mild arthritis 2. hospitalization in an intensive care unit for acute covid-19 infections 3. age greater than 65 years 4. diagnosis of dementia or similar cognitive impairment 5. active addiction disorder (e.g. cocaine) that would interfere with study participation 6. major psychiatric comorbidity (e.g., schizophrenia). mild to moderate anxiety and depression are not considered in this category