Kornimate/medical-research-clean huggingface dataset:
a study to determine the effectiveness of a self-regulation program to treat pediatric obesity

Conditions: Obesity

Summary: the objective of this study is to pilot test, evaluate and compare the effects of cue reactivity and sensitivity training (crst) and children's appetite awareness training (caat) in 48 children aged 8-12 years old. the central hypothesis is that crst and caat will reduce eating in the absence of hunger in overweight children immediately following treatment and 6-months post treatment. the primary aim of this proposed study is to evaluate the efficacy and compare the effectiveness of cue responsivity and sensitivity training (crst) or children's appetite awareness training (caat) in decreasing eating in the absence of hunger (eah) in overweight children. following this first intervention, a second intervention to determine the efficacy of a combination program (combined caat \& crst) will be implemented. the secondary aim of this study is to evaluate change in the following related measures for both children and adults who participated in crst, caat, and the combination program: bmi for age, food intake, perceptions of control over eating, and self-efficacy in managing high-risk food situations.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) greater than the 85%-ile * child consumes 10%+ of daily caloric need during eating in the absence of hunger (eah) assessment * child between the age of 8-12 at the time of the first data collection visit exclusion criteria: * non-english speaking * history of eating disorder * food allergies * unavailable on days of intervention meetings * current participation in a weight loss or maintenance program * presence of any medical condition affecting weight or growth * presence of any physical, emotional, or behavioral disability that would prevent participant from taking part in the weekly study visits or the three data collection visits.

Keywords: obesity pediatric childhood overweight
study of the prevalence of iron deficiency in patients with scheduled major surgery (carenfer pbm)

Conditions: Diagnostic

Summary: many patients who are candidates for scheduled major surgery have a pre-operative iron deficiency which is poorly diagnosed. the management of per-operative iron deficiency is a part of the concept of the "patient blood management", which is a concept recommended by health regulatory agencies in many countries. the objective of this study is to obtain updated data on the prevalence of iron deficiency in france in patients undergoing a scheduled major surgery, applying the french recommendations (determination of ferritinemia and transferrin saturation factor).


Eligibility criteria:
inclusion criteria: * patient, male or female, over 18 years of age * patient with scheduled major surgery * patient with signed consent exclusion criteria: * protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision * pregnant or breastfeeding woman
focal cryoballoon ablation for malignant dysphagia

Conditions: Dysphagia; Esophageal Cancer; Cryotherapy

Summary: rationale: dysphagia is commonly encountered in patients with esophageal carcinoma who are no candidates for treatment with curative intent. it often has a considerable impact on quality of life and can cause malnourishment. current palliative treatments mainly include esophageal stenting and radiotherapy, but these can be associated with substantial drawbacks such as a high rate of adverse events, fatigue or an untimely/ temporary symptom improvement. recent studies showed promising results for the use of spray cryotherapy as palliation for dysphagia. moreover, there are suggestions that cryotherapy has a positive effect on the host's anti-tumor response. however, no data exists on the feasibility, efficacy and safety for cryoballoon therapy in the esophagus. secondly, cryo-immunologic data in patients with ec is lacking. objective: 1. to evaluate the feasibility of cryoballoon ablation in patients with esophageal carcinoma and symptoms of dysphagia. additionally, efficacy and safety will be assessed. 2. to evaluate the effect of cryoballoon ablation on host's anti-tumor response. study design: pilot study, multi-center prospective uncontrolled intervention study study population: adult patients (≥18 years) with dysphagia due to incurable esophageal carcinoma intervention (if applicable): focal cryoballoon ablation of visible tumor during an upper endoscopy. cryoballoon ablation will be performed for two cycles of 12 seconds. in total, patients will undergo 3 treatment sessions (range 1-3) with an interval of 1-3 weeks based onthe severity of symptoms reported by the patient. main study parameters/endpoints: * - feasibility of cryoballoon ablation defined as technical success of the procedure * safety based on incidence of procedure-related serious adverse events * efficacy defined as success rates two weeks after the last cryoablation treatment based on patient reported symptom improvement, and objective evaluation of the esophageal lumen that is free from tumor * host's anti-tumor response after cryoballoon ablation based on sequential esophageal tumor biopsies and peripheral blood samples


Eligibility criteria:
inclusion criteria: * age \&gt;18 years at time of consent * histopathologically-confirmed esophageal / gastroesophageal cancer * patients in the palliative setting (with or without (future) systemic chemotherapy) * dysphagia defined as a score of ≥2 (able to swallow only semi-solids) * signed written informed consent exclusion criteria: * alternative etiology for dysphagia * inability to pass the ultraslim endoscope * severe medical comorbidities precluding endoscopy * uncorrected coagulopathy * prior distal esophagectomy * previous esophageal varices * expected survival \&lt;6 weeks * prior radiotherapy for esophageal cancer * t4b esophageal cancer * incapacitated subjects * pregnant or breastfeeding

Keywords: cryoballoon ablation
vaniprevir administered with pegylated-interferon and ribavirin in japanese treatment-naïve chronic hepatitis c participants (mk-7009-043)

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-ifn) and ribavirin (rbv) versus treatment with peg-ifn and rbv alone in japanese treatment-naïve participants with chronic hepatitis c (chc) genotype (gt)1. the primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (svr24) in at least one of the vaniprevir arms is superior to the percentage of participants achieving svr24 in the control arm.


Eligibility criteria:
inclusion criteria: * japanese participant diagnosed with compensated chc gt 1 * absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease. * ifn treatment naive * no evidence of cirrhosis exclusion criteria: * co-infection with human immunodeficiency virus (hiv) * positive hepatitis b surface antigen or other evidence of active hepatitis b infection * any other condition that is contraindicated or for which caution is required for treatment with peg-ifn or rbv * any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-ifn and rbv, to the participant.
clinical assessment of new treatment regimen for adult fulminant myocarditis

Conditions: Fulminant Myocarditis

Summary: this is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using "life-support based comprehensive treatment regimen" and conventional therapy. in the present study, participants receive various treatment as part of routine medical care without any assignment of specific interventions to them. the process of treatment during hospitalization were recorded in medical chart and was reviewed by independent research personnel.


Eligibility criteria:
inclusion criteria: * 16 years of age or older; * diagnosed as fulminant myocarditis: * evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (tni and ck-mb and bnp or nt-pro-bnp); * acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope; * image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (lvef) \< 45%; * cardiogenic shock, e.g., systolic blood pressure ≤90 mmhg or mean arterial pressure \ 40 mm hg, which is associated with the signs of hypofusion: cyanosis, cold extremities, oliguria, and/or changes in mental status. exclusion criteria: * also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from fulminant myocarditis; * myocardial injury caused by sepsis, chemotherapeutical agents, or poisons; * unstable hemodynamics or shock caused by hypovolemia.

Keywords: fulminant myocarditis retrospective cohort study
multinational glanzmann study

Conditions: Glanzmann Thrombasthenia

Summary: glanzmann thrombasthenia is a rare autosomal recessive platelet disorder characterized by a lack of functional integrins alfaiib or beta3 (glycoproteins iib/iiia). the prevalence is variously reported to be between 1:200,000 to 1:1,000,000, with substantial geographic variation. the clinical phenotype is dominated by an increased mucocutaneous bleeding tendency. in absence of a primary bleeding prophylaxis, the current treatment of glanzmann thrombasthenia is mainly focused on prevention or management of bleeding. however, as potential new therapies emerge, clinicians require unbiased, long-term safety and efficacy data for both current treatment and new therapies. we have designed this study to investigate genetic phenotype (itga2b and itgb3 genes) and the prevalence of antibodies against human leucocyte antigen (hla) and human platelet antigen (hpa), the latter two being a potential consequence of the current golden standard treatment: platelet transfusion. the results of this study will be merged with a longitudinal registry with retrospective and prospective data collection of clinical phenotype, haemorrhagic burden and bleeding management. analysis of the data from the glanzmann-nhs+ study and the registry will help us to get a better understanding of the clinical variation among participants with glanzmann thrombasthenia. the ultimate goal is to accelerate improvement in the care of patients with glanzmann thrombasthenia.


Eligibility criteria:
inclusion criteria: * adult patients (≥16 years); * biochemically or genetically diagnosed glanzmann thrombasthenia. * willing and able to give written informed consent. exclusion criteria: * patients with acquired thrombasthenic states caused by auto-immune disorders or drugs.
effects of daily taurine intake for 6 months on biological age and body metabolism indicators as well as physical fitness in 55-75-year-old women and men

Conditions: Taurine; Aging, Biological; Physical Activity; Metabolic Health; Anti-Aging; Longevity; Dietary Supplement; DNA Methylation; Sport

Summary: the goal of this clinical trial is to investigate the effect of taking 4 grams of taurine by older adults on aging processes over a period of 6 months. it will also check for effects of taurine on participant's physical fitness, metabolic and cognitive functions. the main question it aims to answer is: • does a supplementation with 4 g of taurine daily over a period of 6 months slow down biological aging in humans? researchers will compare supplementation with taurine to a placebo (a look-alike substance that contains no drug) to reliably determine whether taurine has an effect. participants will: * take 4g of taurine or a placebo every day for 6 months * visit the study site 4 times for checkups and tests: for a screening visit, at the beginning of the intervention, after 8 and 24 weeks

measurements performed during study visits: * biological age estimate via proteome analysis * organ age estimates (proteomics) * dna methylation * inflammatory biomarkers (crp, cytokines) * metabolic variables: fasting blood glucose, insulin, homa-ir, hba1c, lipids, bmi * physical fitness (hand grip strength, leg extensor strength, pwc130) * resting energy expenditure * cognitive function via questionnaire * quality of life * heart rate variability * physical activity, nutrition

Eligibility criteria:
inclusion criteria: * women or men * age 55 - 75 * bmi 22 - 30 kg/m² * written consent exclusion criteria: * acute or chronic inflammation (e.g. flu infection) * severe chronic illness (e.g., type 1 or type 2 diabetes mellitus, copd, renal insufficiency) * myocardial infarction or stroke in the previous 6 months * psychiatric disorder, including depression or dementia * weight change of ≥ 5 kg in the last 6 months

Keywords: taurine biological aging metabolic health anti-aging epigenetic clock aging physical activity cognition cellular senescence hallmarks of aging humans dietary supplements longevity taurine deficiency taurine level aging metabolism longevity physiology drug effects dna-methylation aging ptoeomics dna methylation taurine microbiome taurine gut micorbiota taurine cognition taurine sport taurine dna methylation nutritional medicine sport biology taurine physical fitness taurine physical acitvity taurine sport biology taurine muscle strength taurine pwc 130 taurine homa ir taurine mental health taurine human aging taurine cardiometabolic risk taurine cardiometabolic health taurine blood pressure taurine fasting glucose taurine inflammation taurine biological aging
pupillometry and pain thresholds patients substituted by methadone and buprenorphine

Conditions: Opiate Dependent; Previous Illicit Drug Use

Summary: the purpose is to study the relation between pupillary diameter measured under scotopic conditions, and the pain thresholds measured at the time of peak and residual effect of methadone/buprenorphine in opiate-dependent patients following a substitution program.

patients substituted since at least 3 months shall be included during a regular control visit. each session shall consist in * check for toxics in urine sample; * measurement of pupil diameter; * measurement of mechanical punctuate pain threshold; * measurement of mechanical bone pain threshold. a first session shall be done at time of residual effect of the opiate. a second session shall be done at time of peak effect of the opiate.

Eligibility criteria:
inclusion criteria: * substitution treatment stable since at least 3 months * capacity to understand the protocol * likely to come to visits * covered by french welfare exclusion criteria: * chronic pain * concomitant acute pain * pregnancy or breast feeding * relevant mental disease * peripheral neuropathy * diabetes * regular intake of ketamine * neuroleptic concomitant treatment

Keywords: analgesics, opioids opiate substitution treatment methadone buprenorphine hyperalgesia pupil pain psychophysics previous illicit drug intake, under a substitution program
post operative pain control of poem procedure

Conditions: Achalasia

Summary: peroral endoscopic myotomy (poem) is a minimally invasive treatment for esophageal achalasia with a natural orifice transluminal endoscopic procedure and far less invasive than the standard surgical or laparoscopic heller myotomy (lhm). less is known about the postoperative pain after poem and the minor surgery trauma, short length of stay may lead to underestimation of postoperative pain control. we tend to observe the pain status after the poem surgery under the empirical treatment in our center, and find a proper intra-operative way of pain control to solve the post-operative pain and seek the possible influence factors of postoperative pain.


Eligibility criteria:
inclusion criteria: * achalasia patients undergoing elective poem surgery * age 18-80 * bmi 18-30 kg/m2 exclusion criteria: * patient refusal * asa≥ 3 * abnormality of liver and kidney function in patients * patients with mental disorder, language disorder, and other patients who can not cooperate with and complete the follow-up and questionnaire pre- and post- operatively * patients (including propanotamo, propofol, lidocaine, and other drugs) against drug taboos in the anesthetic scheme * patients with chronic pain before operation with analgesic drugs

Keywords: achalasia peroral endoscopic myotomy post-operative pain
sahlgrenska cardiomyopathy project

Conditions: Dilated Cardiomyopathies; Hypertrophic Cardiomyopathy; Restrictive Cardiomyopathy; Arrhythmogenic Right Ventricular Cardiomyopathy; Myocarditis; Sarcoidosis With Myocarditis; Giant Cell Myocarditis; Amyloidosis; Heart (Manifestation)

Summary: this is a joint project by sahlgrenska university hospital: sahlgrenska, östra and mölndal. our objective is to diagnose and map patients with well phenotyped cardiomyopathies (cmp) including in depth clinical and molecular phenotyping to enable earlier and specific treatment. the project will serve as: 1. resource for diagnostic and therapeutic trials 2. common biomaterial bank 3. resource for detailed molecular analyses on patients' biomaterials and patient specific symptoms and examination results


Eligibility criteria:
inclusion criteria: * patients with primary cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, left ventricular non-compaction cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, myocarditis, giant cell myocarditis, sarcoidosis and amyloidosis engaging the heart exclusion criteria: * patient with other preexisting cardiac diseases such as significant valvular, ischemic or pericardial disease before they receive a cardiomyopathy diagnose * patients \< 18 years
impact of total thyroidectomy on voice and swallowing

Conditions: Thyroidectomy; Voice Alteration; Swallowing Alteration

Summary: purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function.

voice and swallowing alterations are frequently reported after thyroidectomy, even in the absence of nerve injury. these impair quality of life. purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function. patients will be assessed using the greek- version of voice handicap index (vhi) and a questionnaire developed by the authors regarding swallowing symptoms. furthermore they will undergo flexible laryngoscopy for evaluation of laryngeal mobility.

Eligibility criteria:
inclusion criteria: * all patients submitted to total thyroidectomy during the study period exclusion criteria: * previous thyroid/ neck surgery * documented voice disorders

Keywords: total thyroidectomy voice handicap index swallowing disorders thyroid surgery voice disorders
a study of ixekizumab (ly2439821) in participants in japan with generalized pustular psoriasis and erythrodermic psoriasis

Conditions: Generalized Pustular Psoriasis; Erythrodermic Psoriasis

Summary: the reason for this study is to see if the study drug ixekizumab is safe and effective in participants with generalized pustular psoriasis and erythrodermic psoriasis.


Eligibility criteria:
inclusion criteria: * present with gpp or ep based on an investigator-confirmed diagnosis and meet the associated criteria * gpp: meet the criteria for gpp set by ministry of health, labour and welfare (mhlw) at screening and baseline regardless of il-36 mutation status. * ep: diagnosed to have bsa ≥80% involvement (with inflammatory erythema) at screening and baseline. * candidates for phototherapy and/or systemic therapy * men must agree to use a reliable method of birth control during the study * women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment exclusion criteria: * history of drug-induced psoriasis * concurrent or recent use of any biologic agent * cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study * have previously received ixekizumab * serious disorder or illness other than psoriasis * serious infection within the last 12 weeks * breastfeeding or nursing (lactating) women

Keywords: generalized pustular psoriasis (gpp) erythrodermic psoriasis (ep) japan
remote evaluation in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study aimed to demonstrate the remote reliability of the 30-second sit-to-stand test in patients with multiple sclerosis.

the population of the research will be participants with multiple sclerosis. the 30-second sit-to-stand test will be performed in the participant's home environment. . patients will be instructed to cross their arms over their chest and complete as many standing cycles as possible in 30 seconds, standing until fully upright and then sitting until the hips touch the chair without the assistance of the hands. inter-rater reliability will be assessed by two different raters in the same video interview. in contrast, intra-rater reliability will be evaluated by analyzing the number of repetitions recorded by the same rater in two different video interviews conducted 24-28 hours apart.

Eligibility criteria:
inclusion criteria: * having been diagnosed with ms according to the mcdonald criteria by a neurologist * having and being able to use a device with internet access (e.g. smartphone, computer or tablet) * having edss between 1.5 and 6.5, * being between the ages of 18-65. exclusion criteria: * patients who have had a recurrence of the disease in the last 30 days, * have an additional health problem (orthopedic, neurological, internal or cardiorespiratory) that prevents standing/walking, * do not agree to participate in the study.

Keywords: 30 seconds sit and stand test remote reliability
safety and tolerability of vildagliptin versus placebo in patients with type 2 diabetes and moderate or severe renal insufficiency

Conditions: Diabetes Mellitus, Type 2

Summary: this clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (t2dm) and moderate or severe renal insufficiency.


Eligibility criteria:
inclusion criteria: * history t2dm * moderate or severe renal impairment exclusion criteria: * glucose \> 270 mg/dl (\>15 mmol/l) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: type 2 diabetes, vildagliptin
comparative study of navigation-assisted orthopilot® elite and robotic-assisted mako® total knee arthroplasty

Conditions: Osteoarthritis, Knee; Joint Diseases; Rheumatoid Arthritis of Knee; Posttraumatic Arthropathy

Summary: randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted orthopilot elite and robotic-assisted mako total knee arthroplasty (tka). the aim of the study is the comparison of the clinical outcome between navigated and robotic-assisted tka. the hypothesis of the study is that both treatments achieve similar results regarding functional and clinical aspects.


Eligibility criteria:
inclusion criteria: * indication for a tka with a fixed-bearing total knee endoprosthesis * written informed consent for participating in the clinical study exclusion criteria: * patient age \ 90 years * patient not willing to participate at the follow-up * pregnancy * retropatellar arthrosis requiring patella resurfacing * american society of anaesthesiologists (asa) classification \>3

Keywords: computer assisted orthopedic surgery robotic assisted orthopedic surgery orthopedic navigation total knee arthroplasty total knee replacement