Kornimate/medical-research-clean huggingface dataset:
a head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in sma (spinal muscular atrophy) patients

Conditions: SMA

Summary: a head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with sma. a single-center, randomized, single-blinded, comparative study of robotically assisted verticalization versus robotically assisted locomotion. the objective of research: the main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with sma depending on age and baseline functional status. the study consists of a head-to-head comparison of two rehabilitation models. 1. research period: 4 years 2. patients age: 0-21 y.o. 3. group size: 200 patients (100 patients in each group) 4. assignment of patients to study groups in a randomised manner


Eligibility criteria:
inclusion criteria: * signing of informed consent to participate in the experiment by the participant or the participant's parent/legal guardian * diagnosis of sma (spinal muscular atrophy 1-4) confirmed by genetic testing, symptomatic or pre-symptomatic * age between 0 and 21 years of age (will be determined on the day of starting participation in the project based on the date of birth) * treatment under a drug program for spinal muscular atrophy, provided that the patient has a diagnosis of spinal muscular atrophy at the date of eligibility. exclusion criteria: * cardio-respiratory disorders requiring invasive ventilation * advanced osteoporosis with multiple fractures prior to treatment * functional deterioration during the rehabilitation process in the range of scales appropriately selected for the sma type: prechtl, hine, chop-intend, hfms, rulm * lack of cooperation with the therapist * other functional indications preventing exercise

Keywords: sma robotically-assisted therapy robotically assisted locomotion robotically assisted verticalization
intestinal fatty acid-binding protein (i-fabp) levels in pediatric celiac patients

Conditions: Celiac Disease in Children

Summary: a prospective, longitudinal study meant to compare blood levels of i-fabp in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.

i-fabp is a reliable marker for intestinal damage and has been proved to respond more swiftly than traditional serology to enterocyte injury in celiac patients who do not a gluten free diet. in this study a pediatric population of celiac patients will be tested for i-fabp levels during initial endoscopic diagnosis and during one year of follow up. their levels will be compared to a control group of pediatric patients undergoing endoscopy for reasons other than suspicion of celiac disease. during the period of follow up, the test group will undergo repeat testing for i-fabp levels, as well as the traditional follow up testing for serology in celiac patients and a questionnaire regarding. the results will be analyzed in the hope of finding a way to use i-fabp as a more direct, accurate marker of disease activity, and of correlations between it's level and the patient's marsh score at diagnosis.

Eligibility criteria:
inclusion criteria: * children undergoing endoscopy for diagnosis of celiac disease, with elevated serology (ttg more than 3 times the norm), and whose histological marsh score is 2 or higher. exclusion criteria: * diseases known to cause elevation in i-fabp levels: bowel ischemia, inflammatory bowel disease, primary biliary cholangitis, liver failure, biliary duct obstruction, liver malignancy. * bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months * nsaid use in the last week. * intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy. * known genetic disorders (such as down's syndrome). * patients whose ttg was elevated but lower than 3 times the normal range.

Keywords: celiac disease children i-fabp
diagnostic equivalence of the skin prick test tape vs. conventional skin pricktest

Conditions: Allergic Rhinitis; Allergic Asthma; Allergic Conjunctivitis; Food Allergy

Summary: testing of a new ready-to-use tape in comparison to the currently used skin prick test for the diagnosis of allergies. assessment of clinical equivalence of the spt tape for representative common inhalant allergens to conventional spt in terms of wheal reaction positivity and overall safety. tests are performed in patients who have a medical history of relevant allergic rhinitis to any of the tested allergens.

an open-label, single site bridging study. subjects with a history of in-halation allergies will be tested in parallel with the spt tape and with the conventional spt procedure using one forearm each. in each patient, a panel of 8 allergens with the spt tape and with the conventional spt is applied on the two forearms one time only. the following soluprick® allergens and control solutions will be evaluated: positive control, negative control, phleum pratense, birch, dermatophagoides pteronyssinus, d. farinae, dog dander, cat dander, mugwort, alternaria sp. the allergens used for the spt and the spt tape are identical soluprick allergen solutions; allergens will be applied in the same location and order on both arms.

Eligibility criteria:
inclusion criteria: * subjects will be included only, if 1. they were informed about the nature, meaning, and scope of the study, and if they provided written consent to their participation 2. they are at least 18 years of age, 3. they have a history of allergic rhinitis due to grass and/or birch pollen, house dust mites, mugwort, cat and/or dog dander, and/or alternaria since 2 years or more exclusion criteria: * subjects may not be included, if 1. they are impaired in understanding nature, meaning, and the scope of the study, or are incapable of giving written informed consent, 2. they suffer from diseases, show other conditions, or take medications, which might impact the skin tests or might contradict the correct conduct and evaluation of the study. in particular this includes the following: 1. acute allergy, 2. history of systemic reactions or hypersensitivity to allergens, abuse of drugs or alcohol 3. severe diseases, 4. impaired reactivity of the skin (e.g. hyperkeratosis, ichthyosis, urticaria factitia) and acute chronic eczema in the skin test areas, skin infections, 5. pregnancy or nursing, 6. treatment with β-blockers, 7. treatment with antihistamines or systemic glucocorticoids during the last 4 weeks, with astemizol during the last 12 weeks, 8. treatment with tricyclic antidepressants benzodiazepines, and neuroleptic drugs which may have histamine-antagonistic effects during the last 2 weeks, 9. participation in any other medication study at the study time
naltrexone in the treatment of pyromania

Conditions: Pyromania

Summary: the proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.

the goal of the proposed study is to evaluate the efficacy and safety of naltrexone in pyromania. ten subjects with dsm-iv pyromania will receive 8 weeks of naltrexone or placebo. the hypothesis to be tested is that naltrexone will be effective in reducing the urges to set fires patients with pyromania. the proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility criteria:
inclusion criteria: 1. men and women age 16-75; 2. current dsm-iv pyromania exclusion criteria: 1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination; 2. history of seizures; 3. myocardial infarction within 6 months; 4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential; 5. clinically significant suicidality; 6. current or recent (past 3 months) dsm-iv substance abuse or dependence; 7. illegal substance within 2 weeks of study initiation; 8. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline; 9. initiation of a psychotropic medication within 2 months prior to study inclusion; 10. previous treatment with naltrexone; and 11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline

Keywords: pyromania fire setting compulsive fire setting
safety and efficacy of iqp-ak-102 in reducing appetite

Conditions: Weight Loss; Appetite Modulation (Focus of Study)

Summary: the individual ingredients in iqp-ak-102 have been widely used. backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation, aiming to reduce the appetite.


Eligibility criteria:
inclusion criteria: * age 18 to 65 years * 25≤bmi≤35 * expressed desire for weight loss * accustomed to 3 main meals/day * generally in good health * consistent and stable body weight 3 months prior to study enrolment * consistent regular physical activity * commitment to avoid the use of other weight loss products during study * commitment to adhere to diet and lifestyle recommended for the study exclusion criteria: * known sensitivity to the ingredients of the device * presence of any active gastrointestinal disease * malabsorption disorders * pancreatitis * stenosis in the gi tract * bariatric surgery * any other reason deemed suitable for exclusion, per investigator's judgement
preterm neonatal feeding protocol comparing feed administration time

Conditions: Feeding Intolerance

Summary: doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance. the purpose of this study is to test two different methods of feeding preterm babies in the hopes of identifying a method that will decrease some of the feeding intolerance that can occur when feeding premature babies.


Eligibility criteria:
inclusion criteria: * any infant born at ohsu or transferred in from another facility whose birthweight is greater than 500 grams and less than 1500 grams, and whose gestational age is less than 32 weeks. exclusion criteria: * any infant who has major anomalies including but not limited to \*gastroschisis * omphalocele * bowel obstruction or atresia * tracheo-esophageal fistula * hirschsprung's disease * congenital diaphragmatic hernia * congenital heart disease and other major syndromes * infants who have started enteral feeds prior to entering the study * any infant whose birth weight is greater than or equal to 1500 grams or less than 500 grams * any infant whose gestational age is greater than 32 weeks.

Keywords: feeding intolerance preterm bolus
a pharmacokinetic and safety study of paliperidone palmitate (jns010) in participants with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

this is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), parallel-group (each group of participants will be treated at the same time), comparison study to assess the pharmacokinetics and safety of paliperidone palmitate (study medication) in participants with schizophrenia. the study comprises a 64-day treatment period and a 155-day follow-up period. the participants will be randomly assigned to one of the four study groups. the study medication will be administered on days 1, 8, 36 and 64. pharmacokinetics of the study medication will be assessed as primary outcome. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria * participants who have been diagnosed with schizophrenia in accordance with the diagnostic criteria of diagnostic and statistical manual of mental disorders 4th edition (dsm-iv) * participants may be inpatients or outpatients * participants who have been taking an oral antipsychotic medication for at least 28 days before the date of informed consent * participants with a positive and negative syndrome scale (panss) score of less than or equal to 4 (moderate) at screening * participants who have taken risperidone by the start of investigational treatment and the record can be confirmed exclusion criteria * participants who have been diagnosed with a mental disease other than schizophrenia in accordance with the diagnostic criteria of diagnostic and statistical manual of mental disorders 4th edition (dsm-iv) * participants who have been diagnosed with substance-related disorders (except nicotine and caffeine dependence) * participants with complicated parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is muscle weakness, trembling and sweating) * participants with a complication of or with a history of convulsive disease such as epilepsy (seizure disorder) * participants with a complication of or with a history of cerebro-vascular accident (stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) or physical exhaustion associated with the state of dehydration (lose of water and minerals in the body) or malnutrition

Keywords: schizophrenia paliperidone palmitate jns010
cardiopulmonary effect of mechanical ventilation in children with right ventricular hypertrophy

Conditions: Heart-lung Interaction; Right Ventricular Hypertrophy; Postoperative Care; Congenital Heart Disease; Mechanical Ventilation

Summary: neurally adjusted ventilatory assist (nava) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort. the investigators hope to compare the hemodynamic and pulmonary effect in children after surgical repair of congenital heart disease with right ventricular hypertrophic ventilated with pressure control ventilation (pcv), pressure support ventilation (psv), and nava by a crossover study.

in the patients suffered from congenital heart disease with right ventricular hypertrophy, the preload of the heart will be influenced by the variation of the intrathoracic pressure. the cardiopulmonary interaction during mechanical ventilation will be an important influence factor on hemodynamics after surgical repair for these patients. as a new mode of mechanical ventilation, nava delivers ventilatory assist in proportion to patients' neural effort avoiding over ventilation. the investigators designed a crossover study to evaluate the cardiopulmonary effect in patients with congenital heart disease with right ventricular hypertrophy when ventilated with nava postoperatively, compared with the conventional mode of pressure control ventilation and pressure support ventilation. each patient will undergo three 60-min trials during the study period in randomized order. the cardiac output and volume status will be evaluated by a transpulmonary thermodilution device through a pulse contour cardiac output (picco) catheter at the last 10min of each trial. at the mean while an arterial blood gas and echocardiography will perform. data are expressed as mean ± standard deviation. datas from the three registrations will be compared using a repeated-measures anova. the comparison of each mode will be assessed by the snk methods post hoc test. a p value of less than 0.05 was considered significant.

Eligibility criteria:
inclusion criteria: 1. patients underwent surgical repair of right ventricular hypertrophic congenital heart disease 2. obtain informed consent signed by parents exclusion criteria: 1. significant residual shunt (more than 2mm), residual obstruction of right ventricular outflow tract (rvot) or a-v valve insufficiency. 2. hemodynamic instability (whose inotropic score more than 20); 3. significant bleed (whose chest drainage more than 5ml/kg/h); 4. failed to insert the picco catheter 5. dysfunction and abnormal of esophage; 6. inclusion in other research protocol
treatment of rumination: a randomized, parallel, controlled study

Conditions: Rumination Syndrome

Summary: background: rumination syndrome is defined as the involuntary return of ingested food from the stomach to the mouth due to an involuntary contraction of the abdominal muscles with concomitant opening of the esophageal sphincters. based on this, a biofeedback technique focusing on muscular activity has been developed and shown to be effective. however, these techniques are complex and not widely applicable. hypothesis: rumination can be effectively corrected using a simplified, non-instrumental biofeedback technique based on cognitive intervention. objective: to test the efficacy of a non-instrumental biofeedback technique using cognitive intervention to correct rumination. the methodology will follow previous studies but with a simplified biofeedback approach. methods: in parallel groups with balanced sex distribution, the response to biofeedback treatment versus a control treatment will be measured. over four weeks, three treatment sessions will be conducted: the biofeedback group will be trained to control abdominothoracic musculature using cognitive intervention (supported by original graphic material) before and after a standardized test meal. the control group will be given a placebo capsule before the test meal, and episodes of regurgitation will be recorded. after the first session, patients in the biofeedback group will perform daily exercises, while those in the control group will continue taking a placebo with each meal. treatment response will be assessed by comparing pre- and post-treatment measurements. patients from the control group will be offered biofeedback treatment after their immediate post-treatment evaluation. relevance: this project will help determine the effectiveness of a simplified mechanistic treatment for rumination. if proven effective, this approach could be implemented in other centers.


Eligibility criteria:
inclusion criteria: * rumination syndrome exclusion criteria: * relevant organic diseases
18f-dcfpyl pet-ct scan and prostate cancer

Conditions: Prostate Cancer Adenocarcinoma

Summary: primary objective: the primary objective of this study is to assess the efficacy of 18f-dcfpyl pet-ct for initial staging of prostate cancer in veterans compared to conventional imaging (99mtc-mdp bone scan and diagnostic ct or mri). the primary clinical endpoint of our study is the percent of veterans with prostate cancer in which the 18f-dcfpyl pet-ct identifies m1 disease at initial staging. secondary objectives: frequency of the change in primary treatment plan after initial staging.

this is a single arm phase ii clinical trial in veterans with prostate cancer, no prior local therapy, who are at risk of having metastatic disease (psa greater than 10, or gleason score greater than or equal to 4+3, or clinical stage greater than or equal to t2c). veterans who are planned to undergo or have recently undergone conventional, routine care initial staging scans for prostate cancer (99mtc-mdp or naf pet bone scan and diagnostic ct or mri of pelvis) will also receive a 18f-dcfpyl pet-ct scan. the primary endpoint is the percent of veterans with prostate cancer in which the 18f-dcfpyl pet-ct scan identifies evidence of m1 disease at initial staging.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and male. 2. ability to understand the study and the willingness to sign a written informed consent document. 3. histologically confirmed adenocarcinoma of the prostate. 4. psa greater than 10, or gleason ≥4+3, or clinical stage greater than or equal tot2c. 5. plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer. 6. eastern cooperative oncology group (ecog) performance score of 0 to 2. 7. no prior local therapy for prostate cancer (i.e., prostatectomy, radiotherapy, etc.). 8. willing to comply with the procedural requirements of this protocol. exclusion criteria: 1. serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection. 2. the subject has a condition or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study. 3. primary small cell carcinoma of the prostate. 4. participation in this study significantly delay the scheduled standard of care therapy. 5. weighs greater than 350 lbs., or unable to fit within the imaging gantry. 6. the subject undergone prior local therapy for prostate cancer (i.e. prostatectomy, radiotherapy, etc.). 7. currently receiving androgen deprivation therapy (adt) or anti-androgen? previous use of adt is allowed if the subject has been off adt or anti-androgen for 3 months or more.

Keywords: prostate cancer, pet ct scan, 18f-dcfpyl
prosthetic complications of screw retained restoration

Conditions: Edentulous Jaw; Edentulous Alveolar Ridge; Edentulous Mouth

Summary: on of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple encountered veneer material fracture and so there effect on patient satisfaction with multiple maintenance recalls.so, the investigators want to try a new technique of fabrication which was proposed for reducing the problems of lack of passivity which is the intraoral luting cement technique on titanium bases with reduced screw number but, with luting cement problems as de-cementation and cement biological effects on soft tissues and bone and there effect on number of patient recall visits and maintenance and so there effect on patient satisfaction


Eligibility criteria:
inclusion criteria: * - completely edentulous patients * patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture * completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created * completely edentulous patients (with the above mentioned criteria) who have no history of bruxism * completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (hba1c). (lesser than or equal to 6.4 percent ) exclusion criteria: * - patients having a medical condition that absolutely contraindicates implant placement. * patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (hba1c). (greater than to 6.4 percent ) * potentially uncooperative patients who are not willing to go through the proposed interventions. - moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day). * patients who are having complete lower denture * patients who have history of bruxism