Kornimate/medical-research-clean huggingface dataset:
eustachian tube testing in a pressure chamber -- validation study

Conditions: Otitis

Summary: this study will compare eustachian tube function (etf) testing in adults with intact tympanic membranes (tm) using a pressure chamber to that obtained using standard methods requiring a non-intact tm.

the investigators propose to introduce new test methods and protocols to our laboratory for better clinical characterization of eustachian tube function in ears with intact tm's. these test will be done in a pressure-chamber and will use previously published and newly developed methods. participation will require a minimum of 5 visits to the ent research center, 1 for myringotomy (putting a small hole in the eardrum) and 4 for etf testing. hearing testing will be done at entry and exit; otoscopy (looking at the ears) and tympanometry (a test done with an earplug and varying pressures in the ear canal) are done at every visit.

Eligibility criteria:
inclusion criteria: * \>18 years old * normal middle-ear status exclusion criteria: * chronic illness including asthma, pulmonary, or cardiac problems * pregnancy * \>10 db hearing loss in any of the speech frequencies * past history of sensitivity or allergic reaction to lidocaine or related compounds

Keywords: otitis eustachian tube function normal middle ear status
serum vitamin d levels in critically ill patients undergoing regional citrate anticoagulation crrt

Conditions: Multi Organ Failure; Acute Kidney Injury

Summary: several studies point at a potential relationship between vitamin d deficiency and worse outcome in critically ill patients admitted to the intensive care unit. it is linked with the lack of vitamin d pleiotropic effects in the state of hypovitaminosis d. the pleiotropism of vitamin d is dependent on a specific feature of vitamin d receptor (vdr) namely polymorphism and its universal existence in the human body. vitamin d pleiotropism is linked with cancer cells inhibition, a modulation of the immune system, an influence on cardiovascular system and neuroprotection. in 35-65% critically ill patients hospitalized in the intensive care unit the acute kidney injury (aki) is diagnosed. acute kidney injury increases significantly the probability of death. the standard therapy of a severe aki in many intensive care units is the regional citrate anticoagulation continuous renal replacement therapy by means of continuous veno-venous hemodiafiltration (cvvhdf). the specificity of the regional citrate anticoagulation by means of precise ionized calcium and citrate dosing evokes questions regarding its influence on vitamin d and entire calcium-phosphate metabolism in the state of a severe aki treated with regional citrate anticoagulation continuous renal replacement therapy. the intention of that trial is to measure vitamin d plasma levels and other parameters (parathormone, ionized and total calcium, magnesium, phosphate, albumin, globulin) linked with calcium-phosphate metabolism in the human body. we would like to assess potential relationships between the regional citrate anticoagulation continuous renal replacement therapy and these parameters.


Eligibility criteria:
inclusion criteria: * respiratory, circulatory failure and acute kidney injury mechanically ventilated critically ill patients admitted to the critical care unit undergoing regional citrate anticoagulation continuous renal replacement therapy by means of continuous veno-venous hemodiafiltration (cvvhdf) exclusion criteria: * age less than 18 years * acute liver failure * hypercalcemia at admission (total calcium plasma level \> 10.6 mg/dl; total ionized calcium plasma level \> 1.35 mmol/l) * parathyroid glands disease at admission * serum vitamin d level \< 10 ng/ml at admission * end stage renal disease at admission * lack of relatives consent

Keywords: vitamin d continuous renal replacement therapy multi organ failure acute kidney injury critical care citrate anticoagulation
a long-term follow-up study in severe hemophilia a subjects who received bmn 270 in a prior biomarin clinical trial (270-401)

Conditions: Hemophilia A

Summary: the bmn 270 clinical development program consists of multiple interventional studies designed to assess the safety and efficacy of a single infusion of bmn 270 for at least 5 years post-infusion. this long-term follow-up study is needed to help further understand the long-term safety of bmn 270 beyond 5 years and to assess the durability of efficacy.

study 270-401 will collect additional follow-up data in a single study for approximately 10 years among all subjects who consent to participate and have completed their primary treatment study (ie, for any study in which they received bmn 270).

Eligibility criteria:
inclusion criteria: * participants must have completed their primary treatment study or be currently enrolled in the primary treatment study at the time of closure by the sponsor. participants may enroll in 270-401 even if they have restarted fviii prophylaxis or other hemophilia a treatment. * subjects must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. if the subject is unable to provide consent, a legally authorized representative may provide written informed consent. exclusion criteria: * participants who do not directly enroll in 270-401 at the time of the study completion visit in their primary treatment study should enroll in 270-401 within 4 months of the date of that study completion visit. if a participant wishes to enroll in 270-401 after 4 months, they must receive prior approval from the medical monitor. * participants must be overtly healthy and not have any condition that, in the opinion of the investigator or medical monitor, would prevent the participant from fully complying with the requirements of the study and/or would impact or interfere with evaluation and interpretation of the study data (including, if applicable, advanced hiv disease). * where applicable, per country regulation, the participant must not currently be committed to an institution by virtue of an order issued either by judicial or administrative authorities.

Keywords: gene therapy clotting disorders blood disorder blood coagulation disorders inherited blood coagulation disorders hematologic diseases coagulation protein disorders hemorrhagic disorders genetic diseases inborn factor viii coagulants
anti-obesity phentermine-topiramate extended release pharmacotherapy vs placebo among patients using a wearable activity tracker

Conditions: Obesity

Summary: researchers are assessing the effects of weight loss medication vs a placebo among participants provided with a wearable activity tracker, digital wellness devices and lifestyle recommendations.


Eligibility criteria:
inclusion criteria * adults with obesity (bmi \>30kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases. * age: 18-75 years. * gender: men or women. women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment. * women of childbearing potential must agree to use a method of effective contraception during study participation. * subject must have an apple iphone 6s or later with ios 13 or later and be willing to download the vitalcare (vitaltech affiliates llc) application from the apple app store. * able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures exclusion criteria * history of abdominal bariatric surgery * weight is greater than 450 lbs (204 kg) * recent use (within the last three months) of any antiobesity medication * recent weight change (gain or loss weight greater than 3% tbw in the last 3 months) * positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months. * significant untreated psychiatric dysfunction based upon screening with the hospital anxiety and depression inventory (had), and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). if such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. * hypersensitivity or contraindication to the study medication. * participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, vitalcare application, or unwilling to sign consent. * principal investigator discretion
memantine versus placebo in parkinson's disease dementia or dementia with lewy bodies

Conditions: Parkinson's Disease Dementia; Dementia With Lewy Bodies

Summary: the purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with parkinson's disease dementia or dementia with lewy bodies.

the objective of this exploratory study is to assess the benefits of memantine compared to placebo in out-patients with a diagnosis of parkinson's disease dementia or dementia with lewy bodies (mild to moderate severity) over a 6-month period. this is a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study with specific cognitive (attention, executive function, visual perception and memory), behavioural, functional and global measures.

Eligibility criteria:
inclusion criteria: * the study population will consist of male or female outpatients at least 50 years of age with mild to moderate disease severity (mmse 12 to 24 inclusive) according to ukpds and dsm iv tr criteria (for pdd patients) and the third report of the dlb consortium (for dlb patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study. exclusion criteria: * evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with acheis.

Keywords: memantine cognition parkinson's disease dementia dementia with lewy bodies
intermittent fasting in adults with type 1 diabetes

Conditions: Type 1 Diabetes; Obesity

Summary: the majority of adults with type 1 diabetes (t1dm) have either overweight or obesity. as such, dietary management has been recommended as an adjunct to insulin treatment to improve glycemic control and facilitate weight loss in patients with t1dm. daily calorie restriction (cr) is the main diet prescribed to patients with t1dm for weight loss. however, many patients find it difficult to adhere to cr because calorie intake must be vigilantly monitored every day. in light of these problems with cr, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. this diet is called "time restricted eating" (tre) and involves confining the period of food intake to 6-8 h per day. tre allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. the simplicity of tre, its accommodation of dietary preferences, and associated weight loss may translate to improved glycemic measures in patients with t1dm. the present study will be the first randomized controlled trial to compare the effect of tre versus cr for weight management and improved glycemic control in adults with obesity and t1dm.


Eligibility criteria:
inclusion criteria: * age between 18 to 75 years old * bmi between 25 and 50 kg/m2 * previously diagnosed with t1dm and currently using insulin * hba1c: 6.5-9.5% (regardless of medication use) * on either multiple daily doses of insulin (mdi) program or using an insulin pump (with or without closed loop feature) 11 * active prescription for glucagon exclusion criteria: * previously diagnosed with t2dm * have a history of eating disorders (anorexia, bulimia, or binge eating disorder) * are not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4 kg) * are not able to keep a food diary for 7 consecutive days during screening * are eating less than a 10-hour window at baseline * are pregnant, or trying to become pregnant * are night shift workers * history of severe hypoglycemia defined as requiring help from others, needed to use emergency glucagon administration in the past 6 months. * other significant medical history including heart failure, unstable coronary artery disease, chronic obstructive pulmonary disease requiring oxygen, cirrhosis, active cancer, history of stroke, end stage renal disease
neoadjuvant immunotherapy in early stage non-small-cell lung cancer presenting as synchronous ground-glass nodules

Conditions: Multiple Pulmonary Nodules

Summary: neoadjuvant immunotherapy in early stage non-small-cell lung cancer presenting as synchronous ground-glass nodules: a pilot study

in many cases, non-small-cell lung cancer(nsclc) manifested as synchronous ground-glass nodules(ggns) and makes complete surgical resection impossible. at the same time, there is no good solution for the remaining ggns after resection of the main lesion. theoretically, pre-operative anti-pd-1 therapy is optimal for promoting anti-tumor immune response on the basis of maximum tumor mutational burden (tmb). in addition, neoadjuvant immunotherapy should have long-term anti-tumor effect even after surgery, because tumor recurrence may cause memory cells activation and differentiation. this is a pilot study to analysis the pathological remission rate of neoadjuvant immunotherapy and adverse events related to the treatment

Eligibility criteria:
inclusion criteria: * not less than two ggns on chest ct * at least one lesion is diagnosed as nsclc from biopsy pathology * no contraindication for surgery * ecog score of 0 or 1 * no detectable evidence of distant metastasis exclusion criteria: * medical history of malignancy * pregnant or breeding period * severe organ failure (heart, liver, kidney, and lung) * high risk of cerebral-cardiovascular evens * infection out of control * received or receiving chemo- and radiotherapy * history of severe reaction due to allergy or hypersensitivity * severe mental disorder * currently been enrolled in other trials * autoimmune or chronic inflammatory disease

Keywords: immunotherapy multiple pulmonary nodules lung neoplasms
efficacy of metacognitive training for schizophrenia - a study protocol

Conditions: Schizophrenia

Summary: metacognitive training (mct) for schizophrenia has been used in several countries, but its efficacy remains unclear. mct is a program group that consists of changing the cognitive infrastructure of delusions. this study aims to evaluate the efficacy of the portuguese version of the metacognitive training programme and its effects on psychotic symptoms, insight to the disorder and functionality

a randomized controlled trial that will be realized in six psychiatric institutions of portugal. pilot study will be carried out initially. the sample will be constituted by individuals diagnosed with schizophrenia (experimental group (n=30) and control group (n=30). the evaluation instruments will be utilized are psyrats, bcis, psp and whodas 2.0 applied to both groups in three different moments. in experimental group the eight mct modules will be applied over four weeks. the objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the metacognitive training for schizophrenia. the hypothesis to be validated in this trial are: * the schizophrenic patients who integrate the experimental group and participate in the mct program will reduce the severity of psychotic symptoms and will present a better insight to disease and a better functioning on the final of the program than the control group; * in participants that participating in the mct program, the psychotic symptoms decrease at the end of the program and in the follow up (three months later) and the awareness for the disease and functioning improves.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years; * diagnosis of schizophrenia evaluated by psychiatrist assistant; * that didn't have any changes in neuroleptics medication four months before program. exclusion criteria: * substance dependence; * very severe psychotic symptoms that impedes understanding the objectives of the sessions; * had changes in neuroleptics medication four months before program.

Keywords: schizophrenia metacognitive training insight positive symptoms functioning
effect of certain breakfasts on appetite control

Conditions: Appetite; Post-prandial Glucose Response

Summary: this clinical trial is being conducted to study whether eating certain meals will reduce your desire to eat and for a longer period of time compared to others and to determine the post-meal glucose response associated with each of these breakfast foods.

the study is divided into 3 phases. each phase involves eating one of 3 different breakfasts every day for 1 month. the order of the breakfast products is random. during each phase participants will come to the research clinic for 4 visits (1 per week) for assessment of appetite-related sensations. gastric emptying will be assessed at 1 visit per phase and post prandial glucose response will be measured at 1 visit per phase (asper site only).

Eligibility criteria:
inclusion criteria: 1. healthy males and females (not pregnant or lactating) aged 19 to 60 years. 2. body mass index: 18.5-30 kg/m2. exclusion criteria: 1. a change in medication (dose or type) or medical event requiring hospitalization within the past month. 2. daily tobacco use. 3. physical activity level \>1.8. 4. eat meals at irregular or unusual times. 5. food allergy, aversion or unwillingness to eat study foods. 6. use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite or blood sugar. 7. presence of a gastrointestinal disorder. 8. taking drugs that affect gastric emptying. 9. score \>65% on any 1 of the 3 categories of the three factor eating questionnaire-r18.

Keywords: breakfast satiety fibre glucose gastric emptying
prophylactic entecavir for hbv reactivation in past hbv infected patients with hematopoietic stem cell transplantation

Conditions: Hepatitis B Reactivation; Hematopoietic Stem Cell Transplantation; Antiviral Drug; HBV

Summary: this study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for hbv reactivation in past hbv infected patients (hbsag-, hbcigg+) with hematopoietic stem cell transplantation.

this study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for hbv reactivation in past hbv infected patients (hbsag-, hbcigg+) with hematopoietic stem cell transplantation. in this study, patients are randomized into treatment group or delayed treatment group. \* stratified randomization (block randomization within strata) according to the presence of hbsab at baseline was used in this study. 1. experimental: treatment group (n=82) the intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. the intervention group visit clinic every month and examined liver function test, hbsag/ab. hbv dna level is examined at every 3 months. \* oral administration of entecavir is planned to start within 7 days after hematopoietic stem cell transplantation. 2. no intervention: delayed treatment group (n=82) the delayed treatment group visit clinic every month and examined liver function test, hbsag/ab. hbv dna level is examined at every 3 months. if the patient in the delayed treatment group shows hbv reactivation (positive hbsag or hbv dna ≥10 iu/ml), entecavir treatment is started.

Eligibility criteria:
inclusion criteria: 1. age: 19 - 70 2. patients receiving hematopoietic stem cell transplantation 3. hbv serologic test: hbsag (-), anti-hbc igg (+) 4. ecog performence: 0-2 5. patients with informed consent exclusion criteria: 1. hbv dna (+, ≥10 iu/ml) at the time of screening 2. receiving hematopoietic stem cell transplantation from donor with hbsag+ 3. combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis c etc.) 4. hiv (+) 5. previous antiviral therapy history for chronic hepatitis b 6. other concomitant malignancy 7. combined autoimmune disease (rheumatic arthritis, sle etc) 8. ctp class b, c 9. decompensated complications (ascites, hepatic encephalopathy etc.) 10. active tuberculosis

Keywords: hepatitis b reactivation hematopoietic stem cell transplantation prophylatic antiviral agents past hbv infection
guided self-help for parents of children with externalizing problem behavior

Conditions: Oppositional Defiant Disorder; Attention Deficit Hyperactivity Disorders; Attention Deficit and Disruptive Behavior Disorders

Summary: the efficacy of cognitive-behavioral based guided self-help for parents of children with externalizing problem behavior is tested in a randomized clinical trial. parents work through cognitive-behavioral self-help booklets and additionally receive counseling telephone calls every two weeks. in the control condition parents are provided non-directive self-help booklets and additionally receive counseling telephone calls. it is hypothesized that the cognitive-behavioral treatment is superior.


Eligibility criteria:
inclusion criteria: * child diagnosis of odd and/or adhd based on dcl-odd and dcl-adhd respectively exclusion criteria: * child iq is below 80 * child has diagnosis of pervasive developmental disorder (pdd) * indication for inpatient/intensive treatment for child * parent training while intervention period * planed start, change or discontinuation of psychopharmacological treatment for child while intervention period * no parental adherence or willingness for randomisation process * language or reading difficulties of participating parent

Keywords: controlled clinical trials, randomized