Kornimate/medical-research-clean huggingface dataset:
controlled study of upper and lower limb movements in patients patients with pathologies that have an impact on ambulation or motor function

Conditions: Neuromuscular Diseases

Summary: the main aim of the study is to validate the algorithms developed to analyze the signals from the various sensors contained in the magneto-inertial control units and reconstruct upper and lower limb movements under different normal and pathological conditions.


Eligibility criteria:
inclusion criteria: * subjects over 2 years old * male or female * control subjects with no pathologies that have an impact on ambulation or motor function. * signed informed consent and, in the case of minors, informed consent signed by the person with parental authority/guardian exclusion criteria: * any other previous or present pathology having an impact on current motor or balance function * recent surgery or trauma to upper or lower limbs, or major surgery or trauma within 6 months of inclusion. * for control subjects, athlete of at least national level. * pregnant or breast-feeding women
scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy

Conditions: Pain; Peripheral Neuropathy

Summary: this pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy

objectives: i. to record the types of patients that we treat, along with the reported efficacy and potential toxicity associated with scrambler therapy. ii. to get experience with patient reported outcome measurement tools that we use in this trial, including a report of analgesic use. outline: patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. treatment continues in the absence of unacceptable toxicity. after completion of study treatment, patients are followed up for 10 weeks. iii. to explore neurologic testing changes in patients receiving scrambler therapy.

Eligibility criteria:
inclusion criteria: * pain or symptoms of neuropathy or pain of \>= 1 month (30 days) duration for which the patient wants intervention * participants have to relate that tingling or pain was at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem and expected to have tingling or pain of at least 4/10 at the time of the first treatment * eastern cooperative oncology group (ecog) performance status (ps) = 0, 1, or 2 * life expectancy \>= 3 months (90 days) * case review by the study chair, or designate, as a case where treatment should be tried. * ability to complete questionnaire(s) by themselves or with assistance - ability to provide informed written consent exclusion criteria: * pregnant women * patients with implantable drug delivery systems, e.g. medtronic synchromed * patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices) * patients with a history of myocardial infarction or ischemic heart disease within the past six months * patients with history of epilepsy, brain damage, use of anti-convulsants for seizure prevention, concurrently using ketamine, symptomatic brain metastases; note: anti-convulsant use is allowed for neuropathy and heart failure (hf) if on a stable dose * skin conditions such as open sores that would prevent proper application of the electrodes * other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study * currently on gabapentin or pregabalin note: (because of data that support that patients don't do as well when on gabapentin or pregabalin, all patients on these medications will be weaned off of them prior to study initiation. the study team will provide instructions on how to do this).
glutenfree, gut microbiota and metabolic regulation

Conditions: Celiac Disease

Summary: high intake of dietary fiber provides health benefits and reduces the risk of developing cardio-metabolic diseases, such as type 2 diabetes (t2d) and cardiovascular disease (cvd). the intake of fiber is below the recommendations worldwide. in norway, bread and cereals represent a major source of fiber. a low fiber intake is evident for people with celiac disease due to the removal of wheat, rye and barley from the diet. we therefore need to increase our knowledge in relation to fiber-rich food that will be tolerated also by people with celiac disease. the aim of the study is to investigate the effect of fiber rich gluten free products on blood glucose levels compared to benchmark gluten free products.


Eligibility criteria:
inclusion criteria: * healthy individuals with celiac disease * bmi 18.5-27 * 18-65 years exclusion criteria: * chronic metabolic diseases, such as diabetes (type 1 and 2), cardiovascular diseases, cancer the last six months * gut diseases, including chron's disease, ulcerative colite * food allergies or intolerance, except for coliac disease * pregnant and/or lactating * smokers * bmi \ 27 * planned weight reduction and/or 5% weight change the last three months * blood donor the last two months and during the study period * not willing to stop using dietary supplements, including probiotic products, cod liver oil etc, four weeks before and throughout the study * use of antibiotics \< three months before study start and throughout the study period * alcohol consume \> 40 g/day * hormone treatment (except for contraceptives)
lactulose for the prevention of hepatic encephalopathy in cirrhotic patients with upper gastrointestinal hemorrhage

Conditions: Hepatocerebral Encephalopathy; Portal-Systemic Encephalopathy; Encephalopathy, Hepatic; Encephalopathy, Hepatocerebral

Summary: to evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (he) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients

variceal hemorrhage occurs in 25 to 35 % of patients with cirrhosis and accounts for 80 to 90% of bleeding episodes in these patients. around 25-30 percent of patients develop hepatic encephalopathy. development of hepatic encephalopathy in patients with gastrointestinal bleed can cause increase morbidity with higher hospital costs in these patients. to date no randomized trial has been done in terms of prevention of encephalopathy in gastrointestinal hemorrhage. one trial has compared lactulose in combination with antibiotic against mannite, showed equal efficacy in both groups. no study has been done evaluate the efficacy of lactulose in prevention of encephalopathy in these patients. we hypothesize that prophylactic use of lactulose decreases the risk of development of hepatic encephalopathy with upper gi bleed in cirrhotics.

Eligibility criteria:
inclusion criteria: * age \>18 years * all acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in er exclusion criteria: * increased α-fetoprotein level/ documented hepatoma * portal or hepatic vein thrombosis * large-volume or tense ascites requiring repeated therapeutic paracentesis * serious recurrent or ongoing co morbid illness (e.g., severe renal, cardiac, or respiratory failure; sepsis) * pregnancy * not willing to give consent to participate in the study * patients who are unable to read and write * er arrival time \> 12 hrs from index bleed
the efficacy of physical activity on improving health outcomes for renal transplant patients

Conditions: Chronic Kidney Diseases

Summary: the purpose of this study is to see whether a physical activity intervention improves fitness, strength and reduces sedentary behavior. the investigators are also interested in determining if changes will improve quality of life and outcomes associated with renal transplant waitlist.

over 30 million people have chronic kidney disease (ckd) and nearly 100,000 people are awaiting renal transplant for end stage renal disease (esrd). renal transplant, when compared to dialysis, improves quality of life, is more cost-effective, and reduces the risk of cardiovascular disease. however, many patients who are eligible for transplant become deconditioned while waiting for organ transplantation, and may be taken off the transplant waitlist for concerns the patient will not be able to tolerate surgery. moreover, poor physical functioning prior to transplant was associated with a 2.5-fold increased risk for delayed graft function and 2.30 fold higher risk of patient death after renal transplant. our team has also shown that functional limitations, such as slower gait speed and poorer grip strength, were associated with not being waitlisted for transplant and decreased survival in all transplant candidates undergoing evaluation. functional limitation may reduce the individuals' overall level of physical activity, which can increase further disability. while physical activity (pa) interventions have been shown to be effective in reducing morbidity and mortality in other chronic diseases, no study has tested the efficacy of a pa intervention in patients awaiting renal transplant. family caregivers are integral in the care of renal transplant candidates. decades of research has shown that family caregivers are at increased risk for cardiovascular disease (cvd) and mortality when compared to non-caregivers. investigators propose to include the family caregivers in the pa intervention to improve patient adherence to the intervention while reducing the caregivers' risk for cvd. the proposed study addresses several of the recommendations from consensus meeting on exercise in solid organ transplant which included testing a pa intervention in a large-scale trial with both standard and surrogate markers, using a novel technology-assisted delivery of the intervention, and focusing on mechanisms linking pa with health outcomes.

Eligibility criteria:
inclusion criteria * patient: * waitlisted for renal transplant * =\>21 years of age * caregiver: * primary caregiver for patient * =\>21 years of age exclusion criteria: * patient: * active suicidal ideation * thought disorder * delusions * hallucinations * recent myocardial infarction, heart attack, or stroke * planned elective surgeries for joint replacement * caregiver: * active suicidal ideation * thought disorder * delusions * hallucinations * recent myocardial infarction, heart attack, or stroke * planned elective surgeries for joint replacement

Keywords: exercise ckd graft survival transplant waitlist
a novel individualized connectome-guided approach for precision intermittent theta burst stimulation for depression

Conditions: Depression

Summary: the investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated itbs vs an anatomically-guided (beam f3) accelerated itbs. the study team will recruit both inpatients and outpatients who had been referred for tms for the treatment of depression.


Eligibility criteria:
inclusion criteria: 1. age ≥ 21 years. 2. dsm-5 diagnosis of current major depressive episode. 3. montgomery-asberg depression rating scale score of 20 or more. 4. inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication. 5. able to give informed consent. exclusion criteria: 1. dsm-5 psychotic disorder 2. drug or alcohol abuse or dependence (preceding 3 months). 3. rapid clinical response required, e.g., high suicide risk. 4. significant neurological disorder, which may pose increased risks with tms, e.g., epilepsy. 5. metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device. 6. pregnancy. 7. unsuitable for mri.

Keywords: neuronavigated itbs accelerated rct
study of efficacy and safety of omalizumab in refractory chronic spontaneous urticaria patients

Conditions: Chronic Spontaneous Uriticaria

Summary: this was a phase iii, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating h1 antihistamine treatment.


Eligibility criteria:
key inclusion criteria: * diagnosis of chronic spontaneous urticaria refractory to h1 antihistamine at the time of randomization * chronic spontaneous urticaria diagnosis for 6 months key exclusion criteria: * weight less than 20 kg * clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria * evidence of parasitic infection * any other skin diseases than chronic spontaneous urticaria with chronic itching * previous treatment with omalizumab * contraindications to diphenhydramine * history of anaphylactic shock * history or current diagnosis of ecg abnormalities indicating significant risk of safety for patients participating in the study * history of hypersensitivity to omalizumab or to drugs of similar chemical classes * pregnant or nursing (lactating) women

Keywords: chronic spontaneous uriticaria omalizumab
pembrolizumab plus neoadjuvant chemotherapy for locally advanced egj adenocarcinoma

Conditions: Adenocarcinoma of Esophagogastric Junction; Neoadjuvant Chemotherapy; Pembrolizumab

Summary: the purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-fu) followed surgery for locally advanced adenocarcinoma of esophagogastric junction

the neoadjuvant chemotherapy/chemoradiotherapy with surgery is the standard treatment in nccn guideline. but many patients refused or abandon radiotherapy because of the intolerable adverse effects. we designed a single-arm, open-label, phase ii trial of pembrolizumab plus cisplatin and 5-fluorouracil (5-fu) followed by radical surgery for locally advanced adenocarcinoma of esophagogastric junction. the purpose of this study is to observe and evaluate the efficacy and safety.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed aeg, siewert type i or ii; 2. potentially resectable ct3-4a, any n, m0 (ajcc 8 tnm classification); 3. have a performance status of 0 or 1 on the ecog performance scale; 4. age 18-75 years old, both men and women; 5. be willing and able to provide written informed consent/assent for the trial; 6. demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation; 7. female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; 8. be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on day 1. subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor. exclusion criteria: 1. prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for aeg; 2. ineligibility or contraindication for esophagectomy; 3. has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 4. has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); 5. has severe hypersensitivity and adverse events (≥grade 3) to nivolumab and/or any pd-1/pd-l1 inhibitors.
alzheimer's caregiver coping: mental and physical health

Conditions: Alzheimer Disease; Alzheimer Dementia; Alzheimer's Disease; Dementia

Summary: this study evaluates the effectiveness of behavioral activation (ba) therapy vs support and information for reducing risk for emotional and cardiovascular diseases in alzheimer's caregivers. half of participants will receive ba and the other half will receive support and information.

the burden of caring for a loved-one with alzheimer's disease is associated with adverse psychological and general health consequences for the caregiver. these consequences including risk for depression, cardiovascular disease, and earlier mortality. because preliminary work has demonstrated that an educational programs for caregivers reduce the negative affect associated with caregiving, the investigators wish to determine whether improving mood can also modify pathophysiological changes that have been linked to risk for developing cardiovascular disease. the investigators aims are to determine whether a 6-week behavioral activation (ba) intervention, followed by 3 booster sessions over a period of 6 months, compared to an information-support (is) intervention will be associated with significant improvement in indicators of vascular pathology, modification of psychobiological markers that have been associated with cardiovascular parameters, and to determine whether improvements in indicators of vascular parameters will be mediated by treatment related change in measures of distress and markers of cardiovascular disease risk.

Eligibility criteria:
inclusion criteria: * aged 55 years or older. * providing in-home care to a spouse with dementia. exclusion criteria: * taking coumarin anticoagulants. * taking nitrates or niacin. * taking non-selective β-blockers. * glucocorticoid use in the 2 weeks prior to enrollment. * taking aldomet or labetalol. * neither the caregiver nor alzheimer's patient can be diagnosed with a terminal illness with a life expectancy of less than 1 year * cognitive impairment * caregivers enrolled in another intervention study or receiving psychotherapy to improve well-being or reduce distress * blood pressure \>200/120 mm hg

Keywords: dementia caregiver cardiovascular disease stress depression anxiety heart disease carer care giver caregiving psychotherapy therapy behavioral activation education intervention cbt cognitive-behavior therapy
cp-675,206 in combination with short term androgen deprivation in patients with stage d0 prostate cancer

Conditions: Prostate Cancer

Summary: the current protocol will evaluate the safety of combining treatment with bicalutamide(casodex) and cp-675,206 (anti-ctla-4 monoclonal antibody) in patients with psa-recurrent non-metastatic (stage d0) prostate cancer. this is a dose escalation study with safety the primary endpoint. secondary endpoints will be to determine whether prostate associated immune responses are seen, and whether treatment is associated with an increase in psa doubling time and psa recurrence at one year, as markers of clinical activity. cohorts of six patients will be treated in each dose level. the investigators hypothesize that short-term androgen deprivation therapy will elicit prostate cancer-associated t-cell mediated tissue destruction that can be augmented with a monoclonal antibody blocking ctla-4, and that this will have therapeutic benefit in patients with recurrent prostate cancer.

this is an open label, single-center phase i study. all subjects will receive bicalutamide 150mg orally days 1-28. subjects will receive cp-675,206 iv over one hour on day 29. doses will range from 6 mg/kg to 15 mg/kg. this cycle will be repeated once at month 3. once the maximum tolerated dose has been determined, up to 6 additional subjects will be enrolled.

Eligibility criteria:
inclusion criteria: * at least 18 years of age \& histologic diagnosis of adenocarcinoma of the prostate * completed surgery or radiation at least 8 weeks prior to entry with removal of all visible disease * clinical stage d0 prostate cancer with rising psa and psa \>2ng/ml. * ecog performance of \<2 * normal hematologic, renal and liver function exclusion criteria: * cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy. * no prior treatment with an lhrh agonist or nonsteroidal antiandrogen such as casodex or flutamide * no evidence for metastatic disease per bone scan or ct scan of the abdomen and pelvis * no prior treatment with anti-ctla 4 monoclonal antibody * no history of known autoimmune disorder or hiv, hepatitis b or hepatitis c * no known brain metastases * no history of inflammatory bowel conditions including diverticulitis, ulcerative colitis, etc.

Keywords: stage d0 prostate cancer rising psa casodex tremelimumab
maintenance of physical condition and physical activity at one year after cardiac rehabilitation program

Conditions: Coronary Disease; Acute Coronary Syndrome

Summary: maintaining physical activity post-cardiac rehabilitation (cr) has a major role in disease progression and patient prognosis, especially given its potential impact on physical condition. unfortunately, during a nursing interview carried out 6 months after the cr at the center hospitalier de cholet, we find that 40% do not maintain regular physical activity. this observation is in line with the literature since it emerges respectively at 2 months and 1 year post-cr that between 47% and 59% of patients do not comply with the recommendations in terms of physical activity (guiraud et al, 2012). however, data suggest that during the post-cr follow-up phase at 6 months, there could be a maintenance of the physical condition assessed via the distance at the 6-minutes walk test (pavy et al, 2012; racodon et al, 2019). there is a lack of data on the maintenance of physical condition beyond 6 months since no study has evaluated the maintenance of physical condition at 1 year post-cr by 6-minutes walk test.

the objective of this study is to examine the maintenance of physical condition at one year after cardiac rehabilitation program by the 6-minutes walk test.

Eligibility criteria:
inclusion criteria : * patient participating in cardiac rehabilitation * patient who presented an acute coronary syndrome * patient having signed the written consent to participate * patient able to comply with the constraints of the protocol exclusion criteria : * patient with heart failure * patient reluctant or unable to comply with the protocol * pregnant, parturient and nursing mothers * persons deprived of their liberty or under guardianship

Keywords: physical condition physical activity cardiac rehabilitation