Kornimate/medical-research-clean huggingface dataset:
visible abdominal distension

Conditions: Irritable Bowel Syndrome; Dyspepsia; Functional Bloating

Summary: background. abdominal distention is produced by an abnormal somatic postural tone. the authors developed an original biofeedback technique. in a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. however, the technique is technically complex and unpractical. aim. to prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers. selection criteria. episodes of visible abdominal distension. intervention. patients will be randomized into biofeedback and placebo groups. three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period. biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. in each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. placebo: sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.


Eligibility criteria:
inclusion criteria: * episodes of visible abdominal distension triggered by meal ingestion exclusion criteria: * organic cause detected by clinical work-up * constipation * abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation
the influence of mcimt (modified constrained induced movement therapy), bilateral intensive treatment, and ndt approach on the ul function in children with hemiplegic cerebral palsy

Conditions: Hemiplegic Cerebral Palsy

Summary: the purpose of this pilot study was to compare unimanual training (cimt) and bimanual training (habit) protocols aimed to improve ability of the involved hand in children with hemiplegia. both protocols were conducted in an educational setting for 2 hours a day for 2 months, one-hour group session and one-hour individual therapy session conducted by occupational therapists or assistants. the children in the cimt group practiced various tasks using their involved hand with the contralateral hand constrained with a mitt. the children at the habit group practiced various bimanual tasks without constraint. twelve children (2 - 6.5 yrs.) participated in this study. the inclusion criterion included minimal extension movement of the involved wrist, and for the cimt group, the ability to of tolerates the mitt. the children were matched in relation to cognitive level and macs score and randomly divided into the two intervention groups. each child's assessment included the quality of upper extremity skills test (quest), the assisting hand assessment (aha), and the blocks and box for children above age 5 yrs old. range of motion (rom) was assessed using an electronic gonimeter, and muscle tone was recorded using surface emg and the tardiue scale. the child health questioner (chq) was completed by the parents before, and 6 months after, the intervention. children were assessed starting two month before, and two month after, the intervention.


Eligibility criteria:
inclusion criteria: * children with hemiplegia exclusion criteria: * no ability for a minimal extension movement in the wrist

Keywords: improving the assisting hand function in children with hemiplegic cerebral palsy
miglustat in niemann-pick type c disease

Conditions: Niemann-Pick Type C Disease

Summary: this is a phase ii randomized controlled study of miglustat in adult and juvenile patients with niemann-pick type c disease. up to 42 patients will be randomised in a 2:1 ratio to either treatment with miglustat or to a non-treatment group. both groups will follow an identical visit schedule.


Eligibility criteria:
inclusion criteria: 1. patients with niemann-pick type c disease confirmed by abnormal cholesterol esterification and abnormal filipin staining. 2. patients who can ingest a capsule. 3. patients who are above the age of four (4) years of age. exclusion criteria: 1. patients younger than 18 years who are unable to give informed assent and/or whose legal guardian is unable to provide informed consent. 2. patients aged 18 and over who cannot provide informed consent and/or whose legal guardian is unable to provide witnessed informed consent. 3. sexually active and fertile patients who do not agree to use adequate contraception throughout the study and for three months after cessation of ogt 918 treatment. 4. patients who cannot tolerate the study procedures or who are unable to travel to the study center as required by this protocol. 5. patients currently undergoing therapy with other investigational agents or patients taking drugs or food supplements which may interfere with gastrointestinal absorption or motility. 6. patients suffering from clinically significant diarrhea (\>3 liquid stools per day for \>7 days) without definable cause within 3 months of screening visit, or who have a history of significant gastrointestinal disorders. 7. patients with an intercurrent medical condition that would render them unsuitable for the study e.g. hiv, hepatitis infection. 8. patients who in the opinion of the investigator (for whatever reason) are thought to be unsuitable for the study. 9. patients with an adjusted creatinine clearance of less than 70 ml/min/1.73m2 (crcl \<70). 10. patients younger than four (4) years of age.

Keywords: zavesca miglustat niemann-pick type c actelion
tissue collection study for patients with non-small cell lung cancer with resectable disease

Conditions: Non-Small Cell Lung Cancer

Summary: a 15-gene lung signature was created to identify predictive and prognostic biomarkers for non-small cell lung cancer (nsclc) patients. the 15-gene signature was validated using a microarray platform with fresh frozen tumor tissue to place nsclc patients into high risk and low risk cohorts with significantly different survivals. using fresh frozen tissue can be challenging, so this study attempts simplify the process by migrating the 15-gene signature from fresh frozen to two alternative tissue formats: formalin fixed paraffin embedded (ffpe) and rnalater. the gene expressions of the different tissue formats will be compared to see if the fresh frozen tissue results are similar to the alternative tissue formats.

patients with early stage nsclc will be consented prior to surgery so that any excess tissue collected during surgery can be collected in one of the three tissue formats (fresh frozen, ffpe, rnalater) and sent to the sponsor for testing.

Eligibility criteria:
inclusion criteria: * new diagnosis of stage i or ii non-small cell lung cancer (nsclc) * must have resectable disease and complete surgical resection planned * histologically or cytologically confirmed adenocarcinoma, squamous or large cell carcinoma nsclc * no prior chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer * tumor specimen samples must be collected within 1 hour of surgery * patient must be at least 18 years of age * patient must sign and date an approved study consent form exclusion criteria: * patients with psychiatric or addictive disorders that would preclude obtaining study consent * informed consent obtained the same day as surgery * absence of histological diagnosis of lung cancer * known infectious disease * history of chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer or any prior cancer or any other non-cancer diseases or illnesses, i.e. rheumatoid arthritis

Keywords: tissue collection lung cancer non-small cell lung cancer early stage lung cancer
immunohistochemical algorithm for the diagnosis and classification of hepatocellular carcinomas with tert, tp53 and ctnnb1 mutation

Conditions: Hepatic Cancer; Hepatic Resection

Summary: the presence of certain mutations in hcc, such as tert and tp53, have a suspected or proven prognostic role in resected patients, but lack a morphological or immunophenotypic counterpart, which would allow us to define which tumours are rationally candidate for molecular biology analysis. the identification of a histological and immunohistochemical algorithm to determine which hccs to take to ngs for prognostic purposes will save time and economic costs in the laboratory by rationalising available resources. in the future, the application of the immunohistochemical and molecular algorithm on biopsy could allow better prognosis and predictivity even before surgery/therapy.

the primary aim is the identification of possible associations between the biomarkers p53 and beta-catenin and the presence of the genetic mutations tert, tp53 and ctnnb1 identified by clinical practice, in patients undergoing hepatic resection of hcc. the secondary objective is the identification of possible associations between the presence of biomarkers glutamin synthetase, glypican-3 and hsp70 and genetic mutations identified by clinical practice, in patients undergoing hepatic resection of hcc. study design: exploratory study. it is planned to recruit approximately 100 patients, who underwent liver resection for hcc and already underwent ngs analysis (for which the mutational profile is already known). all clinical and histological data will be collected, immunohistochemistry investigations will be performed on formalin-fixed and paraffin-embedded material corresponding to that used for molecular analysis. study population: the study envisages the enrolment of 100 patients, already undergoing liver resection for hcc at the irccs aou of bologna, in the period 2020-2022, who will be retrospectively re-evaluated.

Eligibility criteria:
inclusion criteria: * age ≥18 years * patients resected for hcc * availability of ngs data * availability of paraffin material for immunohistochemistry investigations exclusion criteria: * none

Keywords: molecular diagnostics immunohistochemistry
safety and efficacy of remote ischemic conditioning in patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: he purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.

in this study, 912 cases of ischemic stroke in 48 hours were included in 5 centers in china according to the principle of random, double-blind and parallel control .the experimental group receive basic treatment and remote ischemic conditioning for 200mmhg, 2 times per day for 7 consecutive days .the control group receive basic treatment and remote ischemic conditioning control for 60mmhg, 2 times per day, 7 days in a row . two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning therapy.

Eligibility criteria:
inclusion criteria: * 1）age≥18 years, \< 80 years, regardless of sex； * 2）patients with clinically definite diagnosis of acute ischemic stroke and able to commence ric treatment within 12 hours of stroke onset * 3）baseline nihss score\>5, and≤25 ； * 4）gcs score ≥8； * 5）signed and dated informed consent is obtained exclusion criteria: * 1) patients with suspected posterior circulation infarction； * 2) patients who undergo thrombolytic therapy or endovascular treatment； * 3) mrs≥2 score before the onset of the disease； * 4) double upper limbs or lower limbs paralysis was found in this case； * 5）active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on； * 6) other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain； * 7) treated blood pressure ≤90mmhg/60mmhg or≥180mmhg/100mmhg； * 8) severe organ dysfunction or failure； * 9) persons suffering from severe hematological diseases or severe coagulation disorder dysfunction； * 10) those who had a history of severe trauma or had major surgery within 6 months prior to admission； * 11) the patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb；acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc； * 12) pregnant or lactating women； * 13) previous remote ischemic conditioning therapy or similar treatment； * 14) patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons； * 15) severe hepatic and renal dysfunction * 16) unwilling to be followed up or treated for poor compliance； * 17) he/she is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission； * 18) other conditions that the researchers think are not suitable for the group.
augmenting cognitive behavioral therapy with inhibitory control training

Conditions: Binge-Eating Disorder; Bulimia Nervosa

Summary: the primary aim of this study is to determine whether a computerized inhibitory control training (ict) will improve cbt treatment outcomes for bulimia nervosa and binge eating disorder.

this study involves a brief phone screen and baseline assessment to determine eligibility. participants who are eligible for the study will receive 12 sessions of cbt treatment and will be randomly assigned to an ict or ict sham condition which will consist of completing ict computer tasks on a daily basis during the first four weeks of treatment and booster sessions following treatment. participants will also complete research assessments at mid-treatment, post-treatment, and 3-month follow-up intervals. research assessments include a battery of questionnaires, computerized tasks, interviews, and behavioral tasks.

Eligibility criteria:
inclusion criteria: * age 18-55 * meet dsm-5 criteria for bulimia nervosa (i.e., at least one episode of binge eating and compensatory behavior per week on average for the past 3 months) or binge eating disorder (i.e., at least one episode of binge eating per week on average for the past 3 months). * be stable on psychiatric medications for at least 3 months exclusion criteria: * have a diagnosis of anorexia nervosa or a bmi \< 18.5 * have extreme malnutrition or other medical complications that require acute hospitalization * are at acute suicide risk * are currently experiencing other severe psychopathology that would require a more intensive or specialized treatment program than the current study provides (e.g. severe depression, active psychotic disorder) * have previously completed a trial of cbt for bulimia nervosa or binge eating disorder * have a diagnosis of an intellectual disability or autism spectrum disorder * currently taking stimulant medications * score of 95% or higher on 550ms block of go/no-go assessment task, indicating high inhibitory control at baseline
visual and tactile scanning training in patients with neglect after stroke

Conditions: Hemispatial Neglect

Summary: the purpose of this study is to evaluate whether 20 sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation will be feasible and provide better results compared to 20 sessions of 30 minutes of a standard visual scanning programme.

in patients with stroke, unilateral neglect is a predictor for poor independency and quality of life. current therapies are lacking a progression of intensity based on clear criteria. in addition, therapies include rather analytical exercises and the transfer of the achieved functions to activities of daily living remains difficult. therefore, the investigators developed a criterion based system, in which the investigators are matching interventions to specific neglect related deficits and behaviour. the investigators plan a randomised controlled trial (stage 2 "development of concept trial") to evaluate whether an experimental group with 20 sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation or a control group with 20 sessions of 30 minutes of a standard visual scanning programme results in larger improvements on the neglect behaviour during activities of daily life (catherine bergego scale). sixteen stroke patients with left side neglect (i.e. right brain lesions) will be recruited in an inpatient rehabilitations setting.

Eligibility criteria:
inclusion criteria: * first or second time right hemispheric stroke (haemorrhagic or ischaemic, diagnosed with computer tomography or magnetic resonance imaging) * time after last stroke: less than 8 weeks * hemispatial neglect with at least seven points on the catherine bergego scale * right handed exclusion criteria: * reduced vision after rectification (i.e. corrected vision sufficient to read newspaper-sized print) * mini-mental state evaluation score below 11 * not fluently speaking and understanding french or german language in order to understand the tasks and the assessments, as assessed and judged by the medical doctor and the staff.
efficacy and safety of yw17 (laronidase-cinnagen) compared to aldurazyme® in mps i patients

Conditions: Mucopolysaccharidosis Type 1

Summary: the purpose of this phase iii study is to assess the efficacy and safety of yw17 produced by cinnagen company compared to aldurazyme® in mucopolysaccharidosis type i (mps i) patients. all patients receive aldurazyme® for 12 weeks, followed by yw17 for another 12 weeks. the primary outcome is the assessment of the maintenance of the mean ugag levels at the end of each medication administration. the secondary outcomes are the assessment of 6-minute walking test (6mwt), predicted forced vital capacity (fvc), enzyme activity assay, and adverse events (aes).

this is a phase iii, single-sequence, cross-over study to assess the efficacy and safety of yw17 produced by cinnagen company in comparison with aldurazyme® in mps i patients. all patients receive 0.58 mg/kg of aldurazyme® for 12 weeks and then receive 0.58 mg/kg of yw17 for another 12 weeks. premedication with antipyretics and/or antihistamines is administered for all patients one hour before the infusion. the primary outcome is to compare the mean ugag levels at weeks 8, 10, and 12 (related to aldurazyme®) with the mean ugag levels at weeks 20, 22, and 24 (related to yw17). the secondary outcomes, including 6mwt and fvc are assessed at the beginning and the end of each medication administration. enzyme activity is assessed at the end of each medication administration. safety assessments are performed during the study.

Eligibility criteria:
inclusion criteria: * age 5-18 * diagnosed with mps i * signing informed consent form exclusion criteria: * prior bone marrow transplantation or being a candidate for receiving haematopoietic stem cell transplantation (hsct) * prior tracheotomy * being naïve to laronidase * acute hydrocephalus * abnormal renal function determined by measuring serum creatinine and blood urea nitrogen (bun) levels * any severe organic disease that is not associated with mps i * known hypersensitivity to laronidase or components of the laronidase solution * presence of any medical condition or other circumstances that could significantly interfere with study compliance * pregnancy and lactation * administration of any investigational drug within 30 days before study enrollment

Keywords: urinary glycosaminoglycans laronidase mucopolysaccharidosis type i aldurazyme®
kinesiophobia in prostate cancer

Conditions: Prostate Cancer; Kinesiophobia; Physical Inactivity

Summary: this study aimed to investigate the effects of prostate cancer on patients' physical activity, kinesiophobia, fatigue and functionality. this research is a prospective study to be conducted on volunteer individuals between the ages of 40-75. people diagnosed with prostate cancer (study group) and healthy adults who have not been diagnosed with prostate cancer before (control group) will be included in the study. the demographic characteristics, physical activity levels and quality of life of all individuals participating in the study will be evaluated with an online form. in demographic data, physical, sociodemographic data such as age (years), height (cm), body weight (kg), body mass index (kg/m2) and disease-specific information will be recorded. physical activity level will be measured with the international physical activity survey short form (ufaa), fatigue with the functional evaluation of chronic disease treatment-fatigue questionnaire, fear of movement with the causes of fear of movement questionnaire, and quality of life with the functional evaluation of cancer treatment-prostate version questionnaire (khtfd-y).


Eligibility criteria:
inclusion criteria: * (for prostate cancer-study group) * being between the ages of 40-75 * want to participate in the study * being able to read and write * being diagnosed with prostate cancer by a specialist physician, * being able to provide their mobility independently, * (for healthy controls - control group) * being between the ages of 40-75 * not having any previous cancer history and not having undergone cancer surgery * volunteering to participate in the study exclusion criteria: * those with a previously known or accompanying diagnosis of dementia * not wanting to participate in the study * the individual has a disease that may prevent him or her from understanding and completing the survey. * illiterates * those who do not want to participate in the research voluntarily * having active metastasis * having undergone chemotherapy and radiotherapy in the last 6 months