Kornimate/medical-research-clean huggingface dataset:
comparing multicomponent and aerobic training: impact on fitness, psychological and quality of life parameters in cancer survivors patients

Conditions: Cancer Survivors

Summary: the goal of this clinical trial is to evaluate if a multicomponent training program (mct), including aerobic and resistance exercises, or an aerobic training program (at) can improve physiological, physical fitness, mental well-being, and quality of life in cancer survivors currently stabilized. the main questions it aims to answer are: does mct or at improve physiological parameters, physical fitness, mental well-being, and overall quality of life compared to a waitlist control group (wlcg)? does mct provide superior physiological an psychological improvements compared to at? researchers will compare: mct (a combination of aerobic, mobility, and resistance training exercises) at (an aerobic-solo training) to see if these interventions improve fitness, health, psychological and quality of life outcomes compared to wlcg (participants not engaging in structured physical activity during the study), and if there will be significant differences between mct and at . participants will: complete assessments of anthropometric, physical fitness, and psychological parameters at baseline (t0) and after 24 weeks (t1). be randomly assigned to one of three groups (mct, at, or wlcg). engage in a 24-week structured training program (mct or imct) supervised by exercise professionals, including: warm-up sessions (10 minutes, low-intensity walking). main sessions (40 minutes): aerobic, mobility, resistance (mct), only-aerobic (at) exercises. cool-down sessions (10 minutes): breathing and stretching exercises. this study will provide insights into the efficacy of tailored physical activity interventions for stabilized cancer survivors.


Eligibility criteria:
inclusion criteria: * women/men; * age between 18 and 80 years at the time of initial treatment; * subjects in remission for at least 3 months; * no diagnosis of secondary cancer at baseline; * no physical impediment to physical activity (eastern cooperative oncology groups (ecog) performance status 0-1); * signature of a written informed consent form (or their legally recognized representatives must sign) indicating that the patient understood the purpose and procedures required for the study and is willing to participate in the study; * sedentary lifestyle (subjects who have not followed who guidelines for aerobic and resistance exercise in the past 3 months). * currently in treatment, as long as not hospitalized, in stabilized chronic condition, * positive medical specialist assessment of noncompetitive physical activity practice. exclusion criteria: * metastasis; * uncontrolled hypertension or untreated heart disease; * severe musculoskeletal or joint disorders with severe mobility limitations; * psychiatric disorders; * taking psychotropic drugs; * inability to engage in physical activity; * lack of fitness to practice sports. * expected absence of more than two weeks during the intervention period.

Keywords: cancer-related fatigue mental and physical well-being muscle function anxiety-depressive symptoms
an extension study to evaluate the long-term safety and tolerability of uttr1147a in participants with moderate to severe ulcerative colitis or crohn's disease

Conditions: Ulcerative Colitis; Crohn's Disease

Summary: this study will evaluate the long-term safety and tolerability of uttr1147a in participants with moderate to severe ulcerative colitis (uc) or crohn's disease (cd), enrolling up to 320 participants from the parent studies: phase ib study ga29469 (nct02749630) and phase ii study ga39925 (nct03558152).


Eligibility criteria:
inclusion criteria: inclusion criteria for study entry: * prior enrollment in study ga29469 or study ga39925 and meeting protocol defined entry criteria inclusion criteria for study entry and study re-entry: * ability to comply with requirements of the study, in the investigator's judgment * for women and men: use of highly effective contraception as defined by the protocol. exclusion criteria: exclusion criteria for study entry: * withdrawal of consent from parent study * discontinuation of study drug as required by the parent study protocol * discontinuation of study drug and withdrawal from study ga29469 prior to day 85 or from study ga39925 prior to week 8 * noncompliance in the parent study, specifically defined as missing scheduled visits or non-adherence with background medications and concomitant medications exclusion criteria for study entry and study re-entry: * pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of study drug or within 18 weeks after the final dose of study drug from ga39925, whichever is longer * any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms of infection judged by the investigator to be clinically significant since enrolling in the parent study * use of prohibited therapies as defined in the parent study * abnormal laboratory values, as defined in the protocol, recorded at the last visit in the parent study exclusion criterion for study re-entry: * use of prohibited concomitant therapy since enrolling in the extension study
transfer of feces in ulcerative colitis 2

Conditions: Ulcerative Colitis; Ulcerative Colitis Flare; Ulcerative Colitis Acute

Summary: the goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (fmt) compared to autologous fmt in patient with ulcerative colitis. participants will receive 4 treatments with frozen fmt via both upper and lower gastro-intestinal route (infusion via duodenal tube and enemas). donors are selected based on microbiota profile.


Eligibility criteria:
inclusion criteria: * age ≥18 and \<70 * ability to give informed consent * established ulcerative colitis with known involvement of the left colon according to the lennard-jones criteria * partial mayo score of ≥ 3 and calprotectin \> 250 * full mayo score 5-9 * endoscopic mayo score of ≥2 in either the rectum or sigmoid upon screening sigmoidoscopy * stable dose of thiopurines or , 5-asa, or budesonide in preceding 8 weeks. * stable dose of budesonide in preceding 2 weeks. * prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week starting from week 4. * women need to use reliable contraceptives during participation in the study * alkaline phosphatase \> 1.5 x uln in the subgroup of psc/uc patients. exclusion criteria: * condition leading to profound immunosuppression * for example: hiv, infectious diseases leading to immunosuppression, bone marrow malignancies * use of systemic chemotherapy * child-pugh b liver cirrhosis * anti-tnfα treatment in preceding 2 months * vedolizumab treatment in preceding 2 months * tofacitinib treatment in preceding 2 months * ustekinumab treatment in preceding 2 months * cyclosporine treatment in preceding 4 weeks * use of methotrexate in preceding 2 months * prednisolone dose \> 15 mg/day in preceding 2 weeks * use of topical therapy in preceding 2 weeks * life expectancy \< 12 months * difficulty with swallowing * use of systemic antibiotics in preceding 4 weeks * use of probiotic treatment in preceding 4 weeks * positive stool cultures for common enteric pathogens (salmonella, shigella, yersinia, campylobacter, enteropathogenic e coli) * positive c. difficile stool test * positive dual faeces test for pathogenic parasites e.g. dientamoeba histolytica, giardia lamblia, dientamoeba fragilis, blastocystis hominis only if microscopically many or very many blastocysts are seen. * positive serological test for hiv * history of surgery: * presence of a pouch * presence of stoma * known intra-abdominal fistula * pregnancy or women who give breastfeeding * vasopressive medication, icu stay * signs of ileus, diminished passage * allergy to macrogol or substituents, eg peanuts, shellfish * known allergy to iv gadolinium in the subgroup of patients who would be scheduled for mri liver * crohn's disease * subject who has any conditions that in the opinion of the investigator, would compromise the safety of the subject or the quality of the data and is an unsuitable candidate for the study
clinical trial to evaluate the immunogenicity and safety of an adjuvanted a(h1n1)v influenza vaccine and a non-adjuvanted a(h1n1)v influenza vaccine in hiv-infected patients (anrs 151 hifluvac)

Conditions: HIV Infections

Summary: a 1-year multicenter, randomized, single-blinded, phase ii trial, stratified on haart. the purpose of this trial is to evaluate the immunogenicity and safety of a a(h1n1)french national agency for research on aids and viral hepatitis influenza vaccine, administered with or without adjuvant, in hiv-infected patients after one or two injections.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * able to give written consent * covered by french social security * hiv-infected (infection attested by the patient's chart) * patients treated by haart for at least 6 months, with a viral load inferior to 50 copies/ml on at least 2 last visits * patients without any treatment for hiv for at least 6 months and without any indication to start a treatment in the following 3 months * patients followed for their hiv-infection in an anrs center and whose home is close to the center in case of influenza-like illness, consultation and hospitalization in the center where he is followed if necessary * for women with childbearing potential, using an effective method of contraception, and willing to undergo urine pregnancy tests prior to each vaccination. exclusion criteria: * pregnancy * receipt of chemotherapy, immunotherapy (il2, il7, iv ig), or corticosteroids within 3 months prior to enrolment * thrombopenia inferior to 20 000/mm3 * febrile episode (at least 38°c rectal or if at least 37,5°c measured orally) within one week prior to vaccination * opportunistic infection (treated for less than 1 month) * co-infection with hcv and treated with ifna * influenza (clinically or virologically documented) in the last 6 months * history of documented auto-immune disease (lupus, systemic inflammatory disease, ...) * child c cirrhosis * solid organ transplant recipient * intolerance to 1 component of the vaccine * other immunization received within 3 weeks prior to inclusion or planned until after the last vaccine injection.

Keywords: hiv infection adjuvanted and non-adjuvanted a(h1n1)v influenza vaccine immunogenicity safety
involvement of the sodium pump and endogenous digitalis-like compounds in bipolar disorder

Conditions: BIPOLAR DISORDER

Summary: this study deals with the possible molecular mechanisms that underlie the etiology of bipolar disorders (bd). previous studies have implicated na+, k+-atpase and endogenous digitalis-like compounds (dlc) in the depressive state of this disease. the possibility, however, that they are also involved in the manic phase of the disease was never addressed. the results of this study may have significant implications for the treatment of bd by dlc derivatives.

depressive symptoms are the hallmark major depressive disorder, dysthymia and bipolar depression within the context of bipolar disorder (bd). they share clinical characteristics including depressed mood, anhedonia, and low energy and require medical treatment. the na+, k+-atpase is a major transporter in the plasma membrane which has an important role in regulating cell volume, cytoplasmic ph and ca++ levels. digitalis-like compounds (dlc); steroids identified as normal constituents of human brain, plasma and other tissues, exclusively interact with the na+, k+-atpase and induce numerous biological effects. we raised the hypothesis that na+, k+-atpase/dlc system is involved in bd based on studies from ours and other laboratories, which tested the involvement of this system in the depressive state of bd. the possibility that the interaction of dlc with the na+, k+-atpase is involved in the manic state of bd was scarcely investigated. to address this issue we intend to determine circulating dlc levels in patients with bd at different states of the disease;

Eligibility criteria:
inclusion criteria: * bipolar disorder patients exclusion criteria: * none

Keywords: bipolar mania depression
family experience of home opioid use after pediatric surgery

Conditions: Pain Management

Summary: a systematic review examining outpatient opioid use identified only three pediatric studies published between 2015 and 2016. of these three, two studies had a short-term follow up with patients at three days after discharge; moreover, these three studies were limited by focusing on one surgical population, restriction of data to 0-12 yr old participants, and the other being a brief report. as a result, there are no pediatric studies that have examined opioid use amongst 0-18 yr olds, across multiple surgery types, and beyond 3 days after discharge.

this study is being done to learn how long children (0-18 yrs) needed to use the prescribed opioid medication for and how families can be better prepared to provide adequate and safe pain management at home. follow up will take place 28 days after discharge from the hospital.

Eligibility criteria:
inclusion criteria: * families are filling a prescription for opioid medications at shoppers drug mart at the hospital for sick children * parent has strong command of the english language (i.e., no interpreter required) exclusion criteria: * child has used opioid medication at home within 6 months before the date of their surgical procedure * child has history of chronic pain * child is being discharged to a rehabilitation facility anticipated
reducing delay of vaccination in children study

Conditions: Communicable Diseases

Summary: this trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination.

this intervention is based on the concept of "message tailoring," whereby each mother is provided with individually customized vaccine- related information that addresses their unique concerns, values, questions and logistical barriers. message tailoring is an evidence-based health messaging strategy that has been shown to improve compliance with a wide variety of preventive health care behaviors among diverse patient populations. in this three-armed trial the investigator will examine how providing mothers with multiple "doses" of a tailored versus untailored version of our intervention compares with "usual care" for the impact on infant under-vaccination. secondary outcomes will include maternal vaccine-related attitudes (including level of vaccine hesitancy), alignment of maternal values with provider recommendations, and self-efficacy for overcoming logistical barriers to vaccination.

Eligibility criteria:
inclusion criteria: * enrolled at kaiser permanente colorado, pregnant in the 3rd trimester, and plan to use kaiser permanente colorado for the child's medical care received. exclusion criteria: * less then 18 years of age, non-english speaking and an inability to consent
laparoscopic vs abdominal radical hysterectomy in patients with early cervical cancer

Conditions: Cervical Cancer; Postoperative Pain

Summary: the purpose of this study is to determine whether laparoscopic radical hysterectomy for early cervical cancer will has decreased postoperative pain intensity compared to abdominal radical hysterectomy with similar postoperative complications and survival rates.

background: radical hysterectomy with pelvic lymphadenectomy is one of the figo (international federation of gynecology and obstetrics) recommended treatments for early cervical cancer. the objective of this study was to compare radical hysterectomy by laparoscopic approach and open radical hysterectomy in a single center randomized clinical trial. nevertheless, there are no finished randomized controlled trials comparing laparoscopic radical hysterectomy and abdominal radical hysterectomy although there is an ongoing trial. methods: were enrolled 30 ia2 with lymph vascular space invasion and ib cervical cancer patients. postoperative pain intensity was defined as primary endpoint and pain intensity was measured by a 10-point numeric rating scale. secondary outcomes were: intraoperative and other postoperative outcomes, histopathological outcomes and 5-year follow-up. data analysis is being done at this moment

Eligibility criteria:
inclusion criteria: * women of 18 years or older referred to our service with histologically confirmed primary squamous, adenocarcinoma or adenosquamous cervical cancer diagnosed by biopsy or cervical conization, clinically figo (international federation of gynecologic and obstetrics) staged ia2 with lymph vascular invasion, ib and ii a. exclusion criteria: * patients with clinically advanced disease (iib-iv), previous pelvic or abdominal radiotherapy, pregnancy, clinical diseases that would preclude one or both surgical approaches.

Keywords: cervical cancer radical hysterectomy, laparoscopic overall survival disease-free five-years survival
a study on efficacy and safety of topiramate in the treatment of patients with obesity

Conditions: Obesity

Summary: the purpose of this study is to compare the safety and effectiveness of topiramate (64mg, 96mg, 192mg, and 384mg daily) with placebo in the treatment of obesity.

topiramate is not approved for the treatment of obesity. this is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and effectiveness of topiramate in treatment of obese patients. patients will receive 24 weeks of treatment by topiramate or placebo, followed by 2 week taper and a safety follow-up. effectiveness will be determined by changes from baseline to week 24 in body weight, body mass index (bmi), anthropometric measurements (waist circumference, hip circumference, waist/hip ration), fasting lipid profiles, fasting plasma glucose, hba1c (shows average blood sugar level over months), fasting uric acid, fasting insulin, and blood pressures. safety evaluations (incidence of adverse events, physical examinations, 12 lead ecgs, vital signs, computerized neuropsychological test battery) will be performed throughout the study. the study hypothesis is that topiramate will be effective in achieving and maintaining weight reduction in obese patients and is well tolerated. the patients will be randomized to receive either topiramate (64, 96, 192, or 384 mg daily) or placebo daily by mouth for 24 weeks.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \>=30 and \<50 * bmi \>= 27 and \< 50 if patient has controlled hypertension or abnormal blood lipids * stable weight * female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test) exclusion criteria: * known contraindication, or hypersensitivity to topiramate * exposure to any other experimental drug or device within last 30 days * a diagnosis of diabetes * history or evidence of clinically significant liver disease, cardiovascular disease, uncontrolled hypertension or high thyroid levels * history of obesity with known cause * history or family history of kidney stones * history of weight loss surgery * history of malignancy within last 5 years

Keywords: obesity hypertension hyperlipidemia body mass index
impact of an online behavioral weight loss program

Conditions: Overweight; Obesity

Summary: this study was designed to test the impact of a 12-week online behavioral modification program for weight loss, with or without a fortified beverage. subjects are randomized to four conditions: 1) online basic lifestyle counseling (obli); 2) online lifestyle counseling (olc); 3) obli plus a beverage (bev); 4) olc + bev. the three hypotheses were: 1)after 12 weeks, individuals in the olc condition would lose more weight than those in obli; 2) after 12 weeks, the olc + bev condition would lose more weight than the olc condition; and 3) after 12 weeks, the obli + bev condition would lose more weight than the obli condition.

this study tests the impact of an innovative combination of a fortified beverage (a diet cola containing green tea extract, soluble dextrin fiber, and caffeine) and an online support weight loss program in a multi-center randomized clinical trial. the study compares the impact of all combinations of the beverage and the online behavioral modification treatment program over 12 weeks at three treatment center in the us and eu.

Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) of 25 to 40; 2. age 18 to 65 years; 3. blood pressure less than 140 mmhg systolic and 90 mmhg diastolic; 4. caffeine intake 100-400 mg/d; and 5. ability to participate in physical activity for a minimum of 150 min/week. exclusion criteria: 1. pregnancy, lactation or actively trying to become pregnant; 2. medical illnesses or medications that could affect body weight; 3. cigarette smokers; 4. weight loss of 10 or more pounds in the last 3 months; 5. fasting blood glucose greater than 126mg/dl; 6. participation in a clinical research study that would conflict with the purpose of the current trial; and 7. other factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.

Keywords: overweight obesity
genicular nerve block in rheuamtoid arthritis

Conditions: Pain; Joint Function Disorder; Inflammation

Summary: n=64 ra patients either early or established disease diagnosed after acr/eular criteria 2010 with unilateral persistent knee arthritis. they were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. both groups were examined by solar scoring system, visual analogue scale (vas) and lysholm score at 0, 2 and 12 weeks. a semi-quantitative score was used to assess tenderness and swelling at the same intervals.


Eligibility criteria:
inclusion criteria: * ra patients * age \> 18 * unilateral persistent knee arthritis exclusion criteria: * participants with severe knee osteoarthritis * peripheral neuropathy * psoriatic arthritis * skin infection * or those who have allergy for bupivacaine