Kornimate/medical-research-clean huggingface dataset:
efficiency clinical study of novatex medical compression garments in patients with ehlers-danlos syndrome

Conditions: Ehlers-Danlos Syndrome

Summary: objective of this study is to assess the efficiency of novatex medical compression garments in patients with an ehlers-danlos syndrome (eds). to answer this objectif a comparison before/after use of compression garments will be performed for all patients.

inclusion period: 1 year follow-up period: 26 months study period : 38 months patient visits will be organized as follow: * v0: first visit at inclusion, clinical evaluation * v1: 4 months after inclusion, clinical evaluation without compression garments and presure garments prescription * v2: 8 months after inclusion, clinical evaluation with compression garments * v3: 14 months after inclusion, clinical evaluation with compression garments * v4: 20 months after inclusion, clinical evaluation with compression garments * v5: 26 months after inclusion, clinical evaluation with compression garments only the first two visits are specific to the study to be able to compare before and after the use of compression garments. next visits are the usual visits (every 6 months) for the use of compression garments in patients with an eds.

Eligibility criteria:
inclusion criteria: * patient between 15 and 60 years old * ehlers-danlos syndrome type: " classical ", " classical-like ", " hypermobile ", " arthrochalasia ", " kyphoscoliotic ", " musculocontractural " ou " myopathic ", as defined in the new international eds classification 2017 * patient who have never used compression garments * patient for whom compression garments will be prescribed at 4 months * patient who have dated and signed a consent form * patient who have understood the study * patient who are affiliated to french social health insurance system and/or in compliance with the recommendations of the national law in force relating to biomedical research exclusion criteria: * patient under guardianship or enabled to complete questionnaires * pregnant or breastfeeding woman * patient who presents allergy to one of compression garments components * patient with a current medical history who promotes postural disorders * patient with an asymptomatic "hypermobile sprectrum disorder" type of eds as defined in the new international eds classification 2017 * patient with a current or recent (\<3months) participation in another investigational study
subscapularis repair augmentation for total shoulder arthroplasty

Conditions: Shoulder Injuries

Summary: the primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a biobrace. the secondary purpose is to determine if there are any clinical differences.

the investigators would like to learn if subscapularis repair augmentation with the biobrace in total shoulder arthroplasty (reverse and anatomic) will result in sonographic and/or clinical improvements. this will allow for improvements in technique and better outcomes for patients going forward.

Eligibility criteria:
inclusion criteria: * total shoulder arthroplasty exclusion criteria: * vulnerable population
12 fractions carbon ion radiotherapy for localized prostate cancer

Conditions: Radiotherapy; Prostate Cancer

Summary: the arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.

the radiation dose of 51.6gye in 12 fractions is currently widely used in japan, and clinical studies of 51.6gye/12fx have also been carried out for sbrt. there are some differences in equipment and carbon ion treatment planning system used between japan and our center. therefore, we designed this phase i clinical study to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer.

Eligibility criteria:
inclusion criteria: * pathologically confirmed adenocarcinoma of prostate * stage ct1-3n0m0 localized prostate cancer * no lymph nodes or distant metastasis * age ≥ 45 and \< 85 years of age * karnofsky performance score ≥70 * no previous pelvic radiation therapy (rt) * no previous prostatectomy * no previous invasive cancer (within 5 years before the prostate cancer diagnosis) * ability to understand character and individual consequences of the clinical trial * willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial exclusion criteria: * no pathologically confirmed adenocarcinoma of the prostate * pelvic lymph node metastasis (n1) * distant metastasis (m1) * previous pelvic radiotherapy * previous prostatectomy

Keywords: localized prostate cancer carbon ion radiotherapy
investigation of the role of human papilloma virus (hpv) in the prognosis of head and neck cancer

Conditions: Head and Neck Cancer

Summary: human papilloma virus (hpv) is a recognised cause of some head and neck cancers. important questions remain however, regarding the role of specific types of hpv, their effect on prognosis and different subtypes of oral, pharyngeal and laryngeal cancer, interaction with other risk factors (such as smoking and alcohol), and potential geographical differences in the effect of hpv. via the alcohol-related cancers and genetic susceptibility in europe (arcage) study, which is an international collaboartive case-control study conducted in 15 centres in 11 european countries, and pooling our results with the hpv-ahead consortium, we will conduct a systematic analysis of hpv subtypes known or suspected to be involved in head and neck cancer. this will involve investigation of hpv risk by tumour site (oral, oropharynx, hypopharynx, larynx), tumour stage, country, sex and age, and whether risk is modified by exposure to other known or suspected carcinogens including tobacco, alcohol and medical history. it is intended that this work will contribute to the development of evidence that may feed into treatment protocols for these cancers as well as evaluations of the feasibility for extending hpv vaccine programs.


Eligibility criteria:
inclusion criteria: * consent to follow-up and use of tissue samples exclusion criteria: * no existing consent

Keywords: cancer epidemiology head and neck hpv
trial for harm reduction with incentives & vaping e-cigarettes

Conditions: Obesity; Smoking Cessation

Summary: the purpose of this study is to provide preliminary information on the effect of electronic nicotine delivery systems (ends) provisions and contingent incentives (ci) on smoking in individuals with overweight/obesity who smoke cigarettes (swo). all participants will be provided information on the comparative risk of ends relative to cigarette smoking, and a randomized group of participants will be provided ends provisions for 6 weeks. all participants will complete breath samples for 28 days to measure their exhaled carbon monoxide and will either receive fixed incentives for sample completion or receive varying incentives contingent on their carbon monoxide levels. researchers will compare groups to understand the effect of each condition on smoking-related behavior.

individuals with overweight/obesity who smoke cigarettes (swo) have greatly increased risks of metabolic, cardiac, and pulmonary diseases due to the synergistic effects of tobacco and obesity. switching to electronic nicotine delivery systems (ends) may decrease the risk of negative health outcomes and be a promising approach for swo. the purpose of this study is to provide preliminary information on the effect of electronic nicotine delivery systems (ends) provisions and contingent incentives (ci) on individuals with overweight/obesity who smoke cigarettes (swo). the primary aim of this study is to examine the effect of ends provision on smoking and the effect of the provision of ci provision on smoking. the secondary aims are to assess the effects of ends and ci provision on exhaled carbon monoxide (co), cigarette dependence, intention to quit smoking, and quitting self-efficacy, and to determine whether any changes in weight occurred secondary to the use of ends. evidence of the efficacy of switching to ends and the use of ci could be utilized in healthcare settings to reduce the risk of morbidity and mortality among smokers with obesity.

Eligibility criteria:
inclusion criteria: * bmi ≥ 25 kg/m2 * smoked ≥ 5 cigarettes/day during the past year * 21 or older * exhaled co of \> 6 ppm at baseline * willing to use ends for 6 weeks * daily access to a bluetooth-enabled smartphone/tablet exclusion criteria: * planning to set a smoking quit date in the next 30 days * receiving smoking cessation treatment of any kind in the past 30 days * currently using ends \> 4 day per month * hospitalized for mental illness in past 30 days * heart-related event (e.g., heart attack, severe angina) in past 30 days * resides with another person enrolled in the study * pregnant, nursing, or planning to become pregnant in the next 6 months.

Keywords: obesity overweight electronic nicotine delivery systems contingent incentives harm reduction
topiramate for binge eating disorder among adolescents

Conditions: Eating Disorders; Bulimia Nervosa

Summary: this is a study of topiramate to see whether topiramate decreases binge eating behavior among adolescents and young adults. the investigators did also checked whether topiramate affected cognitive function or not.


Eligibility criteria:
inclusion criteria: subjects (aged 12 to 23) were included if they * met the criteria of bulimia nervosa or eating disorder nos with binge-eating behavior in dsm-iv-tr, * had weight \> or = 100th % of expected body weight for their age, * engaged in binge eating at least once a week for 9 out of the 12 weeks prior to the study entry, and * were judged by a clinician to be stable enough to be treated for their psychiatric condition as an outpatient (i.e, no acute suicidality, hallucination, unstable vital signs or persistently abnormal laboratory results due to eating disorder). exclusion criteria: * subjects whose psychotropic medications had been changed within 4 weeks prior to the entry or who had started psychotherapy within 3 months prior to the entry were excluded. * subjects were also excluded if they were taking carbonic anhydrase inhibitors, carbamazepine, phenytoin, phenobarbital, valproic acid, evening primrose oil or oral contraceptives. * other exclusion criteria were: history of substance use disorders within the 6 months prior to study, iq \< or = 70, medical conditions causing weight loss (i.e., hyperthyroidism, diabetes mellitus type 1, malignancy) or that contra indicate treatment with topiramate (nephrolithiasis or glaucoma), history of non response or poor tolerance to topiramate in the past and history of non-adherence to medication treatment.

Keywords: binge eating behavior adolescents
the availability of the enhanced liver fibrosis (elf) test affects the rate of diagnosis of nonalcoholic steatohepatitis (nash) with fibrosis in patients referred to hepatology

Conditions: Fatty Liver; NAFLD

Summary: background: during the hepatology evaluation, vibration-controlled transient elastography (vcte) is often used as a clinical decision aid to target high-risk patients for liver biopsy. the enhanced liver fibrosis (elf) test is expected to be approved in the us. we tested the hypothesis that making the elf results available to the treating hepatologist will result in more appropriate and targeted use of liver biopsy in patients with elevated liver enzymes or fatty liver, and will result in more cases of advanced fibrosis/cirrhosis being diagnosed. methods: during the hepatology evaluation for elevated liver enzymes or fatty liver at the university of kansas medical center, the hepatologists (8 total) make a clinical decision on whether patients shall receive vcte. at the end of the clinic visit, patients were enrolled and randomized to receiving an elf test. patients with liver biopsy within the last five years or decompensated cirrhosis were excluded. the primary outcome is the rate of a diagnosis of f3-4 fibrosis based on liver biopsy or clinical diagnosis of cirrhosis with the initiation of hepatocellular carcinoma surveillance. four hundred fifty patients are to be enrolled over two years.


Eligibility criteria:
inclusion criteria: * patients from hepatology clinic undergoing new evaluation for nafld. exclusion criteria: * patients with liver biopsy within the last five years or decompensated cirrhosis were excluded. patients known to have other liver diseases were also excluded. patients consuming \> 14 drinks in the past 6 months were excluded. patients may be subsequently found to have positive viral or autoimmune serologies after enrollment because the serology result is typically not available at the time of enrollment. these patients will be excluded from the analysis.
comparison of antipsychotic combination treatment of olanzapine and amisulpride to monotherapy

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: a study to examine whether an antipsychotic combination treatment of olanzapine and amisulpride is more effective than olanzapine and amisulpride alone.

polypharmacy in antipsychotic therapy is an important issue when treating patients with schizophrenia. it is not well confirmed that a combination of two antipsychotic drugs lead to therapeutic benefit in contrast to monotherapy. however there is a highly frequent practice of combining atypical non-clozapine treatment that could be due to potential benefits when seeking alternatives to a high rate of non-response in acute phase. therefore there is a need for further trials of sufficient power to address efficacy and safety issues of this regimen. combining two selected atypical drugs in a complementary way may minimize side-effects and enhance efficacy. in order to specify these advantages it is intend to examine approaches to combination treatment: amisulpride and olanzapine show complementing receptor binding profiles and have shown to have efficacy and good tolerability when administered in combination in retrospective studies. the object of this trial is to study whether acutely ill patients with combination of amisulpride and olanzapine are more frequently in symptomatic remission after 8 weeks than those with olanzapine or amisulpride monotherapy.

Eligibility criteria:
inclusion criteria: * patients with schizophrenia and schizoaffective disorder according to international classification of diseases (icd-10); * age 18-65; * positive and negative symptom scale total-score ≥ 70 and two items of the positive symptom subscale ≥4. * voluntary treatment after written informed consent * legal capacity * exclusion of pregnancy by laboratory test (beta hcg) exclusion criteria: * participation in other interventional studies with drugs or medical devices * first episode patients * physical disease that might have effects on the conduct or evaluation of the trial * contraindications to medication according to experts information * oversensitivity to active substance or other component of the drugs used * known clozapine resistance * suicidal ideation * pregnancy or lactation * which of pregnancy or absence save contraception * dependency to sponsor or investigator * institutionalization through judicial or regulatory order * oversensitivity to placebo (mannite/aerosil)

Keywords: schizophrenia amisulpride olanzapine polypharmacy
effectiveness of oral nutritional supplements (ons) in a meals-on-wheels population

Conditions: Elderly; Malnutrition

Summary: researchers will measure weight, height, hand grip strength and quality of life information of meals on wheels (mow) clients who are considered to have nutrition problems. participants will randomly be put into a group that receives either typical meals from meals on wheels or ensure plus supplements with their meals. three months later the same data will be collected again. the objective of this study is to demonstrate the effectiveness of providing oral nutritional supplements (ons) to mow clients with or at risk of malnutrition on nutritional status over a 3-month period.

while it is well known that older adults are at increased nutritional risk and that nutrition intervention, such as oral nutritional supplementation (ons) is beneficial in this population, there is limited research on the effect of oral nutritional supplements (ons) in the meals on wheels population. this prospective randomized controlled trial will determine the effectiveness of oral nutritional supplements (ons) in addition to daily meals from meals on wheels on weight status, hand grip strength, quality of life, and malnutrition screening scores in mow clients with or at-risk of malnutrition over a 3-month study period.

Eligibility criteria:
inclusion criteria: * participant is meals on wheels inc. of tarrant county client. * participant is 60 years of age or older. * participant is identified as medium or high risk of malnutrition as defined by the mst (medium risk mst score =2-3 or high risk mst score =4-5). * participant is willing and/or able to consume oral nutritional supplements (ons). * participant provides written informed consent to participate in the study. * participant provides authorization to use and/or disclose personal and/or health data. exclusion criteria: * patient cannot safely consume an oral nutritional supplement (ons). * example patient has active gastrointestinal disease (e.g., intestinal obstruction, inflammatory bowel disease, ischemic colitis, diverticulitis, irritable bowel disease, pancreatitis). * patient has diabetes mellitus.

Keywords: elderly malnutrition oral nutrition supplement meals on wheels
determine mtd, evaluate efficacy and safety of genexol®-pm plus carboplatin with advanced ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose of genexol®-pm plus carboplatin and evaluate the efficacy and safety of genexol®-pm plus carboplatin regimen in subjects with advanced ovarian cancer.

this is a phase i trial to determine the maximum tolerated dose and recommended phase ii dose of the combination therapy with genexol®-pm and carboplatin and to evaluate the efficacy and safety of genexol®-pm when administered with carboplatin in subjects with advanced ovarian cancer after debulking surgery.

Eligibility criteria:
inclusion criteria: * women ≥ 18 years old. * signed informed consent before inclusion. * subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(figo iiib-iv) * subjects who have measurable disease by recist after debulking surgery. * ecog performance status of 0, 1, or 2. * estimated life expectancy of more than 6 months * subjects who have the clinically acceptable function of blood, kidney and liver at screening visit * hb ≥ 10g/dl * anc ≥ 1.5×10\^9/l * platelet count ≥ 100×10\^9/l * serum total bilirubin ≤ 1.5×uln * serum ast and alt ≤ 2.5×uln * serum alp ≤ 2.5×uln * serum creatinine ≤ 1.5×uln exclusion criteria: * subjects who have received chemotherapy for ovarian cancer other than debulking surgery. * subjects who have a history of radiotherapy to pelvis or abdominal cavity * subjects who receive immunotherapy or hormonal therapy for ovarian cancer * subjects who have other malignancies within the past 5 years * subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit * subjects who have a history of metastasis or currently have a metastasis to the central nervous system(cns) * subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on nci ctcae v3.0 * subjects who have serious medical condition * uncontrolled or severe cardiovascular disease(ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure) * uncontrollable infection * previous allergic reactions in connection with paclitaxel and carboplatin * subjects who participate another clinical trial within the last 4 weeks before inclusion
psychosomatic intervention in fibromyalgia.

Conditions: Fibromyalgia

Summary: fibromyalgia is a widespread musculoskeletal pain syndrome. it is characterized by physical manifestations which are also the expression of a psychological distress as well as specific illness attitudes and behaviors. indeed, it is considered a psychosomatic disorder. in this framework, we hypothesize the clinical utility of a psychosomatic assessment guided by rheumatologists and clinical psychologists (study 1) and the utility of an integrated multidisciplinary psychosomatic intervention based on cognitive restructuring/psychoeducation followed by museum therapy (study 2). for study 1 a cross-sectional observation study will be implemented, for study 2 a randomized controlled trial will be applied.

fibromyalgia (fm) is a widespread musculoskeletal pain syndrome characterized by chronic widespread pain, unrefreshing sleep, physical exhaustion, and cognitive difficulties. it occurs in all populations throughout the world, with prevalence between 2% and 4% in general populations. definition, pathogenesis, diagnosis, and treatment of fm remain points of contention. there is no specific diagnostic laboratory test or biomarker to support the diagnostic process and the diagnosis is clinical. for this reason, rheumatologists and clinical psychologists are strongly involved in the diagnostic process and might benefit from tools for comprehensive psychosomatic assessment. also the treatment of fm remains a challenge, because pharmacological interventions don't consider psychological and social problems and non-pharmacological treatments have shown poor efficacy and are often tested via non-rigorous methods. a multidisciplinary approach which include biological aspects and psychological one, under comprehensive psychosomatic principles, seem to be the best choice for fm. the primary aim of the present study is to evaluate the psychological status of fm subjects, focusing on a psychosomatic assessment and then testing the efficacy of a multidisciplinary psychosomatic intervention based on cognitive restructuring followed by museum therapy vs a control condition followed by museum therapy.

Eligibility criteria:
inclusion criteria: 1. able and interested in participating to the research, as proved by signed informed consent; 2. a diagnosis of fm according to the italian society for rheumatology clinical practice guidelines (ariani et al., 2021) 3. age higher than 18 years exclusion criteria: 1. co-occurrence of psychiatric disorder(s) according to the diagnostic and statistical manual of mental disorders, 5th edition (american psychiatric association, 2013) as diagnosed via the mini-international neuropsychiatric interview; 2. currently under psychotherapy; 3. pharmacological modifications during the period of the trial; 4. undergoing non pharmacological interventions during the period of the trial

Keywords: fibromyalgia psychosomatic intervention cognitive restructuring museum therapy