Kornimate/medical-research-clean huggingface dataset:
data acquisition study for a communication device for pediatric patients with cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of this study is to evaluate a touch screen application designed to help pediatric patients with cerebral palsy communicate. the study will test how well patients type on two different tools: one tool is already on the market , and the second tool is a newly developed app.


Eligibility criteria:
inclusion criteria: * patients between the ages of 7 years old - 21 years old * been diagnosed with spastic or dystonic diplegic or quadriplegic cerebral palsy. * are able to communicate through written words * are able to follow a 3- steps directions, and follow study directions and procedures. exclusion criteria: -
studying a quality of life questionnaire in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: collecting information about the quality of life of patients with colorectal cancer may help doctors learn more about the disease. purpose: this clinical trial is studying the european organization of research for the treatment of cancer (eortc) quality-of-life-questionnaire in patients with colorectal cancer.

objectives: * to test the reliability and clinical and psychometric validity of the european organization of research for the treatment of cancer (eortc) quality of life questionnaire (qlq-cr29) in an international sample of patients with colorectal cancer. outline: this is a multicenter study. patients are stratified into predetermined clinically distinct groups (colon cancer after surgery vs colon cancer undergoing adjuvant chemotherapy vs rectal cancer undergoing neoadjuvant radiotherapy vs rectal cancer after anterior resection with temporary stoma vs rectal cancer after abdominoperineal excision of rectum vs colorectal cancer undergoing palliative chemotherapy). quality-of-life data is collected alongside standard outcomes in patients undergoing treatment for colorectal cancer. patients complete the european organization of research for the treatment of cancer (eortc) quality of life questionnaire (qlq-c30), the revised colorectal cancer module (qlq-cr29), case report forms for clinical and sociodemographic data, and a debriefing questionnaire at different time points before, during, and after treatment. some patients complete more sets of the same questionnaire at later time points to assess sensitivity to change over time and test-retest reliability. reliability, and clinical and psychometric validity of the questionnaires are assessed by correlation analyses, exploration of known group comparisons, and responsiveness to clinical changes.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the colon or rectum * no brain metastases or intracranial tumor extension with cognitive impairment patient characteristics: * no limit on performance status * able to understand the language of the questionnaire * no psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * no other concurrent malignancies except basal cell carcinoma of the skin prior concurrent therapy: * no prior participation in this study (in a different subgroup) * no concurrent participation in other quality of life studies that might interfere with this study

Keywords: adenocarcinoma of the colon recurrent colon cancer stage i colon cancer stage ii colon cancer stage iii colon cancer stage iv colon cancer adenocarcinoma of the rectum recurrent rectal cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer stage iv rectal cancer
ion irradiation of sacrococcygeal chordoma

Conditions: Sacral Chordoma

Summary: the purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the raster scan technique.

the primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after r2 resection. the evaluation is therefore based on the proportion of treatments without grade 3-5 toxicity (ctcae, version 4.0) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint. local-progression free survival, overall survival and quality of life will be analyzed as secondary end points.

Eligibility criteria:
inclusion criteria: * histological confirmation of sacrococcygeal chordoma * karnofsky performance status ≥ 70% * patients age 18 - 80 years * macroscopic tumour (mri) * written informed consent exclusion criteria: * lack of macroscopic tumour * tumor extension in craniocaudal direction \>16cm * metal implants at the level of the tumor which could influence the treatment planning * inability of the patient to lie quiet for at least 20 minutes (eg due to pain) * prior radiotherapy of the pelvic region * simultaneous participation in another trial that could influence the results of the study * active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)

Keywords: sacral chordoma chordoma carbon ion therapy proton therapy hypofractionation
esophageal high resolution manometry and dysphagia

Conditions: Dysphagia

Summary: two to 15% of subjects present dysphagia. in case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. two different techniques are available: the conventional manometry and the high resolution manometry. the second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.


Eligibility criteria:
inclusion criteria: * male or female older than 18 years * patient with unexplained dysphagia * patient without cause of dysphagia on eso-gastro-duodenal endoscopy * patient referred for esophageal manometry * patient with health insurance * informed consent signed exclusion criteria: * patient younger than 18 years * allergy to one component of manometry catheter * drug intake which can modify the esophageal motricity within 12 hours preceding the realization of the manometry * patient unable to give his consent or legally incompetent * patient non qualified according to the investigator * patient refusal or absence of informed consent signed * concomitant participation to another study

Keywords: dysphagia conventional manometry high resolution manometry
fabry's disease and pregnancy (prefab)

Conditions: Fabry's Disease; Pregnancy

Summary: fabry's disease is a progressive systemic disease x-linked which combines neurological (fabry's pain crises), dermatologic (angiokeratomas), renal (renal failure), cardiovascular (hypertrophic cardiomyopathy, valvular disease, conduction disorder, coronary heart disease) and cerebral vascular (stroke) symptoms . it is a glycosphingolipid metabolism disorder due to deficient or absent activity of the alpha-galactosidase a, causing accumulation of globotriaosylceramide in the lysosomes. the incidence is estimated being 1/40 000. some patients suffering from fabry's disease today are of childbearing age and their multidisciplinary care (by neurologists, obstetricians and anesthetists) raises several questions. about the anesthetic, the question of epidural block is debated in patients with neurological diseases and recommendations are not unequivocal. indeed one of the problems of the management in those conditions is the potential worsening of the disease because of the anesthetic procedure. in addition, the possibility of an antiplatelet and / or an anticoagulant treatment in these patients may also contre-indicate an epidural block. the rate of epidural block achieved in patients with fabry's disease is not currently known. moreover, only sparse data on pregnancy outcomes in these patients are reported.


Eligibility criteria:
inclusion criteria: * fabry's disease patients, aged 18 years or more, having had at least one childbirth exclusion criteria: * patient under a legal protection procedure * patient denying to participate to the study * lack of affiliation to a social security system
study evaluating safety of gsi 136 in young and elderly japanese males

Conditions: Alzheimer Disease; Healthy

Summary: this is a first-in-human study of gsi-136, a gamma-secretase inhibitor being developed for the treatment of alzheimer disease. this study will take place in japan only and will provide an initial assessment of the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of gsi-136 after administration of ascending single oral doses to healthy japanese male subjects and healthy japanese elderly male subjects.


Eligibility criteria:
inclusion criteria . 1. men aged 20 to 45 years, or greater than 65 years, inclusive, at screening and who agree to use a medically acceptable form of contraception during the study and to continue its use for 12 weeks after test article administration. 2. healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory tests, vital sign measurements and 12-lead electrocardiogram (ecg). exclusion criteria 1. presence or history of any disorder that may prevent the successful completion of the study. 2. any history or presence of chronic respiratory disorder or disease including but not limited to asthma, sleep apnea, or chronic obstructive pulmonary disease (copd).

Keywords: alzheimer disease
implementation of a sexual health intervention for young men who have sex with men (msm) in two vietnamese cities

Conditions: HIV; Chlamydia; Gonorrhea; Syphilis; Hepatitis C

Summary: this study seeks to implement a sexual health promotion intervention for male sex workers in hanoi and ho chi minh city, vietnam. the study hypothesis is that this intervention will increase testing, treatment and vaccination for sexually transmitted infections, including intentions of participants to engage in these services beyond the conclusion of the intervention. at the community level, the study hypothesis is that male sex workers will be more aware of sexual health care and more likely to access these services in the future.

the intervention is administered in community and clinic settings. the full intervention consists of seven core modules: sexual health, sexual diversity, hiv/sti transmission, behavioral risk and risk reduction, alcohol and drugs, stigma, and hiv/sti and health seeking practices. in the community, outreach is conducted by health educators to deliver the intervention modules that young men express and interest in, as well as to provide risk reduction materials including condoms and lubricant. study interviewers conduct a cross-sectional interview of young male sex workers in community venues (the interviewers and health educators are never present in a venue at the same time), and a random sample of interviewees are invited to a local clinic, where they receive a more detailed interview, the full intervention (delivered one on one by a health educator and including all seven modules), a clinical exam, testing for hiv and other stis (hbv, hcv, gonorrhea, syphilis, chlamydia), onsite treatment, vaccination and referral, and a post-intevention assessment.

Eligibility criteria:
inclusion criteria: * born biologically male; age 16-29; exchanged sex for money or other material goods with another man in the past 90 days exclusion criteria: * inability to provide informed consent
effects of yogurt with probiotics in adults with type 2 diabetes mellitus

Conditions: Type2 Diabetes

Summary: the purpose of the study is to analyze the effects of the consumption of yogurt with concentrated and lyophilized probiotic cultures on the parameters associated with glucose homeostasis, inflammation and oxidative stress in patients with type 2 diabetes mellitus (t2dm).

after being informed about the study and the potential risks, all patients who gave their written informed consent underwent a screening period of 1 week to determine their eligibility to participate in the study. at week 0, patients who met the eligibility requirements were randomized in a double-blind manner (participant and investigator) to the american diabetes association (ada) diet + yogurt with premium probiotics (300 g/d) or ada diet + conventional yogurt (300 g/d) or ada diet without fermented dairy.

Eligibility criteria:
inclusion criteria: * patients with t2dm diagnosed at least one year ago. * that they are outpatients. * between 25 and 65 years old. exclusion criteria: * smoking patients. * lactose intolerance. * pregnancy or breastfeeding. * presence of kidney, liver, immunodeficiency, inflammatory bowel disease or thyroid disorder. * use of insulin, estrogen, progesterone or diuretic injections. * consumption of probiotic supplements two months before the start of the study

Keywords: probiotics glucose homeostasis
study to determine how bcx4161 is metabolized and eliminated by the body

Conditions: Hereditary Angioedema

Summary: the purpose of the study is to assess the extent that radioactive dose of bcx4161 taken by mouth ends up in the urine, feces and expired air. if there are metabolites of bcx4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.


Eligibility criteria:
inclusion criteria: 1. healthy males 2. age 30 to 65 years of age (inclusive) 3. body mass index of 18.0 to 32.0 kg/m2 4. must be willing and able to communicate and participate in the whole study 5. must provide written informed consent 6. a history of regular bowel movements 7. must agree to use an adequate method of contraception key exclusion criteria: 1. participation in a clinical research study within the previous 3 months 2. current or history of any drug or alcohol abuse in the past 2 years or positive drugs of abuse screen 3. current smokers 4. radiation exposure, including that from the present study, exceeding 5 msv in the last 12 months or 10 msv in the last 5 years 5. clinically significant medical history, current medical or psychiatric condition, ecg finding, or laboratory/urinalysis abnormality 6. activated partial thromboplastin time or pt outside of normal laboratory limits

Keywords: bcx4161 biocryst hereditary angioedema mass balance kallikrein inhibitor adme
use of a mobile health app in managing pediatric atopic dermatitis

Conditions: Atopic Dermatitis

Summary: a randomized controlled study in children with ad, divided into three groups: a control group without access to the app, an experimental observational group with the app, and an experimental interventional group with potential investigator supervision. outcome measures included the scorad and the poem scores.

three study groups: a control group that did not use the mobile health atopic app, an experimental observational group provided with the mobile app without supervision by the investigators and experimental interventional group provided with the mobile app with potential supervision by the investigators. upon study enrollment, participants receive recommended treatment plans and instructions for contacting the doctor via messenger for any questions during treatment. virtual oversight disclosed to participant of the intervention arm, including registration status and regularity of use of the app. outcome endpoints are objective severity assessment using the scorad scale, and subjective assessment of effectiveness using the poem scale.

Eligibility criteria:
inclusion criteria: * children with ad and their parents that provided an informed consent to participate in the study exclusion criteria: * previous experience with the atopic app * participation in affiliated online atopic school program * presence of concomitant skin disease or pathological conditions that may affect the assessment of effectiveness (severe somatic diseases, mental disorders, oncologic or acute infectious diseases, etc.) * avoidance from registration during consecutive 5 days following the screening visit (for participants in groups 2 or 3,)
a open-label, drug-drug interaction with maraviroc (ddi)

Conditions: Infection, Human Immunodeficiency Virus

Summary: this is a phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. for the effect of maraviroc on the pharmacokinetics (pk) of bms-626529 (the active moiety of bms-663068), there is no formal hypothesis to be statistically tested. the purpose of this assessment is to estimate the effect of maraviroc on the pk of bms-626529 when coadministered in healthy subjects. for the effect of bms-663068 on the pk of maraviroc, the hypothesis to be statistically tested is that bms-663068 will not have a clinically significant effect on the pk of maraviroc when coadministered in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive * women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion exclusion criteria: * any condition possibly affecting drug absorption * pre-existing liver dysfunction * any significant acute or chronic medical illness * orthostatic intolerance * other protocol specified exclusion criteria could apply
effect of perioperative glucocorticoid replacement on prognosis of surgical patients with sellar lesions

Conditions: Pituitary Neoplasms; Craniopharyngiomas

Summary: the purpose of this four-arm randomized controlled study is to determine whether eliminating glucocorticoids (gc) replacement in perioperative period in surgical patients with sellar lesion could result in similar or better outcomes comparing to traditional replacement therapy, regarding postoperative recovery of pituitary function and other postoperative complications (infection, pain, quality of life, recurrence). surgical patients of our center with mri-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (itt) will be performed for assessment of the pituitary function at enrollment. patients with normal pituitary function will be randomized into non-gc replacement group (group a) and low-dose gc replacement group (group b), while patients with impaired pituitary function will be randomized into low-dose gc replacement group (group c) and high-dose gc replacement group (group d). the primary outcome is the hypothalamic-pituitary-adrenal (hpa) -axis function of the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (acth) levels. the secondary outcomes include the hypothalamic-pituitary-thyroid (hpt) axis function (tsh, thyroid-stimulating hormone, free t3, free t4), postoperative water-electrolyte balance, infection, recurrence and health-related quality of life.


Eligibility criteria:
inclusion criteria: * age \>= 18 * surgical patients with mri-confirmed diagnosis of sellar lesions (non-functioning pituitary adenoma or craniopharyngioma) exclusion criteria: * patients with pre-existing hyperthyroidism or cushing's syndrome * patients with long-term glucocorticoids replacement history * patients with other co-morbidities that pose known influence upon the hpa-axis function (cardiovascular or cerebrovascular disease, metabolic disease or epilepsy) * patients with severe panhypopituitarism * patients with history of radiotherapy of the pituitary gland

Keywords: hydrocortisone pituitary adenomas replacement therapy
venous thrombo-embolism imaging database (vte-id)

Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

Summary: the purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (vte), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked vte. to do so, the investigators will create a retrospective imaging database including multiple imaging modalities, performed at diagnosis of the vte.

using a large imaging data in vte (including ultrasound, ct-scan and ventilation/perfusion lung scan), the investigators will search for association between imaging data and vte phenotypes, mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked vte. then, using a radiomic approach, the investigators will try to identify new imaging biomarkers able to provide an individual phenotyping in these patients. these imaging biomarkers will be validated using an internal cross validation technique.

Eligibility criteria:
inclusion criteria: * 18 years or older. * confirmed vte diagnosis (deep vein thrombosis or pulmonary embolism). * inclusion in the edith (etude des déterminants et interaction de la thrombose veineuse) between november 2009 and november 2019. * no opposition to be included in the present study. exclusion criteria: * patients under 18 years old. * patients under judicial protection. * patient physically or cognitively unable to give consent. * refusal to participate.

Keywords: venous thromboembolism image processing radiomics
an exercise intervention to improve overall brain health

Conditions: Brain Care Score; Exercise; Hypertension; BMI

Summary: the goal of this clinical trial is to test the effects of 10 weeks of exercise on overall brain health, reduction in blood pressure, and the number of blood vessels in the back of the eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. the main question\[s\] it aims to answer are: * to test the effect of moderate vs intensive exercise on brain care score outcomes. * to ascertain the differential impact of moderate vs high intensity exercise in reducing hypertension and its downstream effects.


Eligibility criteria:
inclusion criteria: * diagnosed with hypertension * have a body mass index ≥ 25 kg/m2 * are between the ages of 35-65 years old * access to a smart phone that allows installation of 2 two applications that record your workouts * pass a fitness evaluation. exclusion criteria: * do not have hypertension * weight over 300 lbs * unable to pass the fitness evaluation * bmi less than 25kg/m2

Keywords: brain health brain care score exercise hypertension overweight obesity bmi