Kornimate/medical-research-clean huggingface dataset:
communicating risk information for obesity

Conditions: Obesity

Summary: this study will examine the impact of providing genetic risk information for obesity on people's attitudes and beliefs about obesity, health behaviors and weight outcomes. specifically, this study will examine the feasibility of using genetic information to motivate efforts to reduce obesity among individuals recruited to the coriell personalized medicine collaborative (cpmc), see below for description of cpmc.

the investigators will conduct a randomized controlled feasibility trial to examine the short-term impact of personalized risk feedback for obesity. this study is uniquely situated to provide important data on how individuals interpret various sources of risk information and how they arrive at an overall perception of risk for a condition. taken altogether, study findings will be used to serve as an overall model for future intervention efforts to effectively communicate obesity risk information with the goal of improving weight management and overall population health. cpmc-the cpmc is an ongoing evidence-based longitudinal research study designed to determine the utility of using personal genome information in health management and clinical decision-making. they collect saliva samples, perform genetic analysis and provide genetic risk feedback for several disease conditions including coronary artery disease and type 2 diabetes. the present study will build upon the existing genetic testing and web feedback infrastructure at coriell to conduct behavioral science research to address critical public health questions.

Eligibility criteria:
inclusion criteria: must be age 18 or older, active enrollees in the cpmc trial, and able to read and write in english. exclusion criteria: individuals that do not meet the inclusion criteria.

Keywords: obesity genetics risk assessment health behaviors randomized controlled trial
procedure for duodenal-ileal diversion for patients with weight regain following sleeve gastrectomy

Conditions: Obesity, Morbid

Summary: study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.

single-center, open-label pilot study to evaluate the safety and effectiveness of the gi windows single neodymium magnet anastomosis procedure when used to create a duodenal-ileal diversion for subjects with inadequate weight loss or weight regain following sleeve gastrectomy.

Eligibility criteria:
inclusion criteria: * age 22-65 years at screening * body mass index (bmi) ≥35 and ≤50 * patient is ≥12 months but ≤ 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain. * weight stable over 3-month period * negative h. pylori breath test * agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years * if female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period * able to understand and sign informed consent documents. exclusion criteria: * known or suspected allergy to nickel or titanium or nitinol * contraindication to general anesthesia * previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper gi series * any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon. * clinically significant findings during screening endoscopy at target region for compression anastomosis * uncontrolled hypertension * pre-existing severe comorbid cardio-respiratory disease * history of type 1 diabetes or poorly controlled type 2 diabetes * abnormal liver biochemistry * history of chronic gastrointestinal disease * specific genetic or hormonal cause of obesity * recent tobacco/nicotine product cessation (within 3 months prior)
multi-level supermarket discount study

Conditions: Obesity

Summary: the study team's objective is to test the effect of supermarket discount levels on fruit and vegetable (f\&v) and non-caloric beverage purchasing and consumption, as well as health outcomes. the study team will implement this economic intervention in a local supermarket chain to assess the effects of a 32-week intervention of fruit and vegetable (f\&v) and non-caloric beverage discounts of 30%, 15%, and 0% (control group) on purchasing, dietary intake, and health outcomes, including body weight and composition, blood pressure, and biochemical markers of cardiovascular disease risk. the 32-week intervention will be preceded by an 8-week baseline and will have a follow-up period of 16 weeks. there will be no discounts in effect during the baseline and follow-up periods.

the objective is to test the effect of supermarket discount levels on fruit and vegetable (f\&v) and non-caloric beverage purchasing and consumption, as well as health outcomes. the study team will implement this economic intervention in a local supermarket chain to assess the effects of a 32-week intervention of fruit and vegetable (f\&v) and non-caloric beverage discounts of 30%, 15%, and 0% (control group) on purchasing, dietary intake, and health outcomes, including body weight and composition, blood pressure, and biochemical markers of cardiovascular disease risk. the prediction is that the impact will increase with the level of discount. the 32-week intervention will be preceded by an 8-week baseline and will have a follow-up period of 16 weeks. there will be no discounts in effect during the baseline and follow-up periods. the prediction is that some of the interventional effects will carry over to the follow-up period.

Eligibility criteria:
inclusion criteria: * bmi: 24.5 - 50 * weight stable (±5% body weight in last 3 mo) * accessible by telephone * living in nyc and not planning move * primary household food shopper * ≥50% of food shopping at foodtown/brooklyn harvest and agrees to 100% shopping at store during study * consumption of \>50% of food shopping * eat out or take out ≤5 times weekly exclusion criteria: * pregnant or contemplating pregnancy * enrolled in related studies * active weight loss program * presence of serious medical (e.g. cancer, diabetes) or psychiatric disease (e.g. bipolar) * changes in medications or smoking in past 3 mo * excessive alcohol use (≥4 drinks/day) or illicit drug use * planning a vacation ≥ 4 consecutive weeks or 6 total weeks during study * receiving snap benefits

Keywords: nutrition
master framework for relapse or refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia Refractory

Summary: this is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites

treatment outcome for acute myeloid leukemia (aml) has improved over the last few decades. with intensive multidrug induction regimens, a complete remission is expected. despite such advances, therapy resistance or relapse remains the main causes of death in adult patients and in children. relapsed or refractory (r/r) aml is a hard-to-treat disease, with a 5-year overall survival (os) estimate below 20% in adults and 30%-35% in children, and no standard of care exists. hsct (allogeneic hematopoietic stem cell transplantation) remains the only curative strategy for r/r aml patients, including pediatric and elderly ones. some new personalized therapies have recently been integrated into the treatment options of r/r aml. however, there is a need to collect consistent data on the efficacy of these new strategies in real-world settings. lack of data from clinical trials can be a barrier in most countries, limiting patient accessibility to some very effective drugs. the stream study is part of the horizon europe mission cancer 2022 impact-aml project, that proposes to create an inclusive master framework for relapsed or refractory acute myeloid leukemia. in stream we will collect data and monitor outcomes of patients with r/r aml across europe. in close collaboration with the european reference network on rare hematological diseases (ern-eurobloodnet, ga101157011), stream is developed under ern-eurobloodnet central registry, the european rare blood disorders platform (enrol), incorporating eu standards for interoperability and the gpdr-compliant spider pseudonymization tool offered by the eu-rd platform in the context of rare disease registries will be implemented, to allow cross-hospital and cross-country participation. the stream study will allow to collect high-quality data from patients at any stage of the disease, for any cancer subtype, in any age group, including pediatric and elderly population, unfit patients, patients with rare mutations, patients with high-impact end-organ damage, patients from rural regions, post-transplant relapse. data collected in stream will foster the production of novel knowledge on rare populations in a pragmatic setting and will form the basis for building international trials to be conducted worldwide.

Eligibility criteria:
inclusion criteria: * patients with aml diagnosis according to who2022 or icc2022 * treatment failure (i.e. relapse, refractory or progression, including mrd) according to eln2022 criteria * participant or his/her legal representative is willing and able to give informed consent for participation in the study exclusion criteria: * patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.

Keywords: relapsed refractory acute myeloid leukemia framework
osteonecrosis in children with acute lymphoblastic leukemia

Conditions: Osteonecrosis; Acute Lymphoblastic Leukemia

Summary: acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. the hips, shoulders, knees and ankles may be affected. pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. long-term effects including arthritis and progressive joint difficulties will not be known for decades. this study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. the study will be the basis for future intervention and prevention trials.


Eligibility criteria:
inclusion criteria: * enrollment in the stopp-cis study * informed consent of patient or care givers * \>5 years of age at mri assessment exclusion criteria: * individuals with a history of claustrophobia precluding mri assessment

Keywords: bone health osteonecrosis acute lymphoblastic leukemia
performance study of the invendo c20 colonoscope system in colorectal cancer screening

Conditions: Colorectal Cancer Screening

Summary: the purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the invendo c20 colonoscopy system


Eligibility criteria:
inclusion criteria: 1. screenees, i.e. asymptomatic persons willing to undergo screening colonoscopy, at average risk for colorectal cancer 2. age between 50-75 years 3. signed informed consent exclusion criteria: 1. family or personal history of colorectal neoplasia including familial adenomatous polyposis (fap) or hereditary non-polyposis colorectal cancer 2. prior colonoscopy within preceding 10 years 3. a suspected diagnosis of inflammatory bowel disease, bowel obstruction, acute diverticulitis, known severe diverticulosis or any known large bowel disease 4. clinically significant cardiovascular or pulmonary diseases 5. gastrointestinal-tract related symptoms, complaints or diseases suggesting performance of colonoscopy (no screening cases) 6. cancer or other life threatening diseases or significant chronic conditions 7. blood clotting disorders and /or anti-coagulant therapy including aspirin within the last 7 days 8. known pregnancy or positive screening pregnancy tests 9. previous abdominal surgery except for uncomplicated cholecystectomy, appendectomy or minor pelvic surgery (e.g. hernia repair, oophorectomy) 10. morbid obesity (bmi \> 40) 11. clinically significant abnormal screening laboratory findings 12. clinically significant abnormal screening ecg findings 13. drug abuse or alcoholism 14. inability of the screenee to adequately communicate 15. screenees under custodial care 16. participation in a clinical study within the last 30 days
weight distribution asymmetry in relation to speed during gait in children with spastic cerebral palsy.

Conditions: Gait, Spastic

Summary: background: improving walking ability is one of the major concerns in therapeutic interventions for children with cerebral palsy. aim: determine the relation between the weight distributed on both lower limb and speed during walking.

sixty children with spastic diplegia (group a) and forty-five with hemiparesis ( group b) with age ranged from ten to twelve, they had spasticity grade 1 and 1+ according to modified ashworth scale and they were able to walk with assistance (level ii on gross motor classification system).evaluation was held by the biodex gait trainer for measuring weight distribution on both lower limbs and speed during gait to determine if there was a relation between weight distribution asymmetry and the speed of gait of those children

Eligibility criteria:
inclusion criteria: the selection criteria to the diplegic group were as follows: 1. children diagnosed as spastic diplegia or hemiplegia; 2. the ability to stand independently without support for not less than 30 seconds; 3. the ability to walk independently; a classification of level ii in the gross motor function classification system (gmfcs); 4. and capability to understand simple verbal commands. exclusion criteria: 1. participants were excluded if they were treated for lower limbs orthopedic surgical or with botulinum toxin injection within the last 6 months 2. or if they had fixed lower limb deformity.

Keywords: assymetry-gait-speed-cerebral palsy
chronic effects of tendon vibrations on the neuromechanical muscular properties.

Conditions: Healthy

Summary: it is a randomized, controlled clinical trial, in healthy volunteers. they are in two groups : the test one will perform the vibration training (1h of vibrasens 3 times a week, 24 sessions) whereas the control group will not be training. the primary outcome is the maximal voluntary strength.

these last 10 years, a new idea born: vibrations could have potential effects on muscular reconditioning. researchers have previously demonstrated the effects on plantar ankle flexion, with the increase of the strength, on healthy volunteers. nowadays physicians would like to demonstrate the effects on another muscular group: ankle's dorsal flexors. 24 sessions are programmed on 8 weeks. moreover, the last results showed a modification of the nervous capacities of the cortical voluntary activation. transcranial magnetic stimulation (tms) is a great tool to explore the neuromuscular function, at the cortical stage. the use of this tool will allow the characterization the effects of the vibration training on the cortical activation state.

Eligibility criteria:
inclusion criteria: * between 18 and 50 years old * both gender * occasional sportsman (\<4h/week) * affiliated to a social security scheme * having freely given their written consent exclusion criteria: * taking neuro-active substances able to modify cortico-spinal excitability from day 10 to the end of the study * contraindication to magnetic field application * previous pathologies susceptible to modify the process of the tests (particularly stakeholders presenting knee or ankle pathologies) * participation during the same time in another interventional experimentation
mechanisms of chiropractic spinal manipulation for chronic low back pain

Conditions: Chronic Low-back Pain

Summary: this is a mechanistic randomized controlled trial on the effects of chiropractic spinal manipulative therapy on patients with chronic low back pain. it is designed as a mechanistic trial, in which the main objective is to identify which variables related to central sensitization can help predict the response to spinal manipulation, and the evolution of which of these variables can help explain clinical changes in chronic low back pain patients receiving spinal manipulative therapy.

the study is a mechanistic randomized controlled trials on the effects of chiropractic spinal manipulative therapy on patients with chronic low back pain. 100 chronic low back pain patients will be randomly allocated to receive 12 sessions over 4 weeks of spinal manipulative therapy or placebo spinal manipulation. the main objective is to identify variables related to a central sensitization or nociplastic pain phenotype can help predict the response to spinal manipulation. additionally, changes in these variables during the treatment period will be used to identify potential pain mechanisms involved in pain relief by spinal manipulation. an additional group of 50 healthy volunteers will be used to measure the same variables and their evolution during 4 weeks in a healthy control population. response to treatment will be measured according to changes in pain intensity and disability.

Eligibility criteria:
healthy volunteers will be accepted for that specific comparison group. those volunteers must demonstrate no evidence of any systemic pathology, inflammatory, psychiatric, neurological or pain condition. inclusion criteria: * diagnosis of primary chronic low back pain (performed in the initial evaluation or previously received by a healthcare professional), with or without leg pain * minimum of three months of duration exclusion criteria: * diagnosis of neuropathic pain in the lower extremity * evidence of specific pathology affecting the lumbar spine * diagnosis of psychiatric disorder or pain disorder affecting the hand/thumb or in the vicinity of the lumbar area * intake corticosteroids, opioids or anticytokine medications * pregnancy * having been treated with spinal manipulation in the previous 12 months

Keywords: chronic low back pain spinal manipulation central sensitization pressure pain thresholds cytokines chiropractic
safety and pharmacokinetics of nnc 0129-0000-1003 in subjects with haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this trial is conducted globally. the aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of nnc 0129-0000-1003 in previously treated subjects with severe haemophilia a.


Eligibility criteria:
inclusion criteria: * haemophilia a * body mass index (bmi) below 35 kg/m2 * history of a minimum 150 exposure days (eds) to fviii products (prophylaxis/prevention/surgery/on-demand) exclusion criteria: * any history of fviii inhibitors * surgery planned to occur during the trial * platelet count less than 50,000 platelets/microlitre (assessed by laboratory) * congenital or acquired coagulation disorders other than haemophilia a
impact of therapeutic patient education on the toxicity of immune checkpoint inhibitors in oncology

Conditions: Therapeutic Patient Education; Immune Checkpoint Inhibitors; Melanoma; Advanced Non-small Cell Lung Cancer; Renal Cell Carcinoma; Head and Neck Cancer; Immune-related Adverse Event

Summary: the aim of this therapeutic education program is to reduce the apparition of immune-related adverse event with patients treated with ici

this study aims to highlight the impact of patient therapeutic education (tpe) in oncology. tpe is an integral part of the care pathway for patients with a chronic pathology such as diabetes, asthma, chronic obstructive pulmonary disease, cardiovascular diseases requiring anticoagulants, haemophilia, renal failure, hiv infection, autoimmune diseases etc.... front of therapeutic progress, many cancers are now taken for a chronic disease. in oncology, tpe starts to grow. indeed, tpe makes the patient more autonomous, which could reduce the occurrence and / or aggravation of some toxicities, improve the quality of life, the effectiveness of treatment and optimize health costs. therefore, it is important to develop programme of therapeutic education in oncology. the toxicity of ici is unusual and sometimes lethal. this toxicity must be recognized and managed quickly to maintain a satisfactory dose-intensity. tpe finds its place by raising awareness among patient to the occurrence of these toxicities. this randomized tpe versus standard care study project will assess the contribution of education in the management of severe toxicities. the investigators believe that changes in patient behaviour will reduce the number of toxicities ≥3 in the tpe arm.

Eligibility criteria:
inclusion criteria: * patient with melanoma, non-small cell bronchial cancer, renal cell carcinoma, ca carcinomas of the upper airways to be treated with ici * patient who has never received treatment by ici * informed patient who signed his consent * age \> or = 18 years * social insurance exclusion criteria: * patient receiving corticosteroid or immunosuppressant 14 days before inclusion * immunocompromised patient * uncontrolled brain metastases * refusal to participate, patient protected by guardianship * patient unable to understand the study or unable to follow the education sessions
tissue study of bv8/pk-2 inhibition in human cancer

Conditions: Cancer

Summary: study hypothesis is that inhibition of bv8 production in bone marrow cells of a mice wil reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice and transform their bone marrow cells into non-bv8 producing cells. than we will implant primary human tumor tissue (taken from surgical specimens after informed consent)in those mice and follow-up on the mice.

1-10 grams of human cancer tissue will be taken from surgical specimen without interference to the pathological data gathering process. those tissues will be implanted in nude mice that will either be treated with anti-bv8 antibodies or will be transplanted with bone marrow in which bv8 expression is silenced.

Eligibility criteria:
inclusion criteria: * ages 18-85 years * pathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma undergoing surgical pancreaticoduodenectomy exclusion criteria: * refuse to take part * preoperative chemotherapy

Keywords: bv8/pk-2 mdsc myeloid derived suppressor cells bmdc bone marrow derived cells angiogenesis pancreatic cancer