Kornimate/medical-research-clean huggingface dataset:
do change in life style improve work ability?

Conditions: Obesity, Morbid; Sick-leave; Work Related Illnesses; Life Style

Summary: the main aim of this cohort trial is to get more information about how life style changes affect work participation for people with bmi above 30. the information can contribute to improving the quality of occupational rehabilitation programs in the specialized health care services and for others who work with weight loss programs and work related rehabilitation programs.

the goal of rehabilitation, in general, is to help people to reach and maintain their optimal function and copying capabilities and to promote independence and participation in society. for occupational rehabilitation is the goal also to increase function and work ability to prevent the individuals permanent to fall out of working life. people with high bmi needs beside work rehabilitation also focus on life style changes to reduce consequences of obesity. the central norway regional health authority (hmn rhf) has initiated action to reduce work absence and consequence of obesity by introducing a work related rehabilitation program for people with bmi above 30. this program combines work participation and life style changes and exists only in two institutions in norway. the goal of the program is to increase function and work ability and weight loss. the program is new, and few documents exist on the effect and the correlation between life style changes and work ability. there is also need to question whether obesity is the reason for work absence or is there other factors that affect work ability. this trial wants to follow-up a group of people who have been participating occupational rehabilitation at muritunet.

Eligibility criteria:
inclusion criteria: 1. people who are on sick leave or stands in danger of being sick because of problems related to obesity. 2. the participants must have a realistic opportunity to return to work. 3. body mass index above 30 4. age 18-67 years. exclusion criteria; 1. people with a severe eating disorder. 2. people without a capacity to consent. 3. people with severe alcohol and/or drug abuse. 4. people with a major mental illness. 5. being pregnant. 6. people with a health condition that contraindicates physical activity. 7. people who receive work assessment allowance. 8. people with or plan to apply for disability benefits. 9. people with permanently adapted work.

Keywords: obesity occupational rehabilitation sick leave life style treatment
validation of the neuropsychiatric fluctuations scale (efn-valid))

Conditions: Parkinson Disease; Fluctuating Mood Symptoms

Summary: neuropsychiatric fluctuations (nf) are among the most disabling non motor fluctuations in parkinson disease (pd). the investigators developed the nf-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in pd. the main goal of this project is to validate the nf-scale in french language in a multicenter approach.

anxiety, sadness, lack of energy and motivation, fatigue and pain are common during the off-medication condition, whereas euphoria, well-being, impulse control disorders, behavioral addictions, mania, and psychosis might occur during the on-medication condition. early diagnosis of npsyf is crucial for their holistic management. unfortunately, npsyf are often under-recognized by patients or misdiagnosed by physicians due to the lack of specific assessment tools. the nfs is composed of 20 items among which ten measure the "on neuropsychological state" and ten, the "off neuropsychological state". it provides two sub-scores (one on and one off) with a maximal total score of 30.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease * presence of motor fluctuations, requiring a levodopa test * french native speaker exclusion criteria: * dementia (moca \< 24) * parkinson syndrome other than idiopathic pd * people excluded according to french law (including pregnant women or nursing mothers, ...)
registry to collect health information about desmoplastic small round cell tumor

Conditions: Desmoplastic Small Round Cell Tumor

Summary: this study is a patient registry of people with desmoplastic small round cell tumor (dsrct). a patient registry is a collection of health information about a group of people, and it is usually focused on a specific diagnosis or disease. the purpose of this registry is to create a database- a collection of information-or better understanding dsrct. researchers will use the information from this database to learn more about dsrct and for current and future research on dsrct.


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of desmoplastic small round cell tumor * participants may be of any age as long as the appropriate consent and assent may be obtained * willing to provide historical and longitudinal clinical data exclusion criteria: * participant unwilling to provide consent or share historical and longitudinal clinical data

Keywords: patient registry 20-551
comparison of solostar with a syringe-administered glargine insulin in diabetic patients from the hospital

Conditions: Diabetes

Summary: in this study the investigators would like to test the hypothesis that in diabetic patients discharged from the hospital, solostar glargine insulin will be superior to syringe-injected glargine in terms of diabetes control, compliance, and patient satisfaction and preference. the investigators will test this hypothesis in a randomized, crossover trial.


Eligibility criteria:
inclusion criteria: * all patients with type 1 and 2 diabetes discharged from the hospital with recommendations to take glargine exclusion criteria: * patients unwilling to participate and patients incapable of complying with the study regimen, such as patients with alcohol and drug addiction problems and patients with severe mental illness

Keywords: diabetes
post-operative radiotherapy after neodjuvant chemo-immunotherapy and surgery in stage iii nsclc

Conditions: Non Small Cell Lung Cancer; Stage III Lung Cancer

Summary: this study investigates whether postoperative radiotherapy (port) improves outcomes for patients with stage iii non-small cell lung cancer (nsclc) who have residual disease after neoadjuvant chemo-immunotherapy and surgery. the primary objective is to compare event-free survival (efs) between patients receiving port targeting involved lymph node regions and those without port. secondary and tertiary endpoints include overall survival, locoregional and distant control, toxicity, and quality of life. the phase ii randomized trial will enroll 80 patients, stratifying by adjuvant immunotherapy use, with follow-up extending up to 5 years. statistical analysis aims to detect a 15% improvement in 3-year efs, with a total study duration of 8 years.


Eligibility criteria:
inclusion criteria: 1. participants must be ≥ 18 years old 2. ability to provide written informed consent 3. ecog performance status 0-2 4. histologically confirmed nsclc 5. absence of actionable driver mutation (egfr/alk/ros) 6. complete preoperative imaging staging, including: fdg-pet and brain imaging to exclude distant metastases will be mandatory. 7. baseline clinical or post-operative pathological stage iii including specifically stage t1-4n2-3 8. completion of 3-4 cycles of neoadjuvant chemo-io, regardless of the specific immunotherapy and chemotherapy used. 9. status post-complete (r0) surgical resection with mediastinal lymph node dissection. 10. residual nodal disease on final pathology specimen (i.e. absence of pathological complete response). 11. postoperative lung function examination: fev1 \> 1 l (or greater than 35% expected value) exclusion criteria: 1. pregnant individuals 2. previous chest radiotherapy 3. \>24 weeks after thoracic surgery 4. history of other non-cutaneous neoplasms within the last 24 months 5. active grade ≥ 2 pneumonitis. 6. presence of interstitial lung disease 7. recurrence or metastasis occurred 8. medical conditions that hinders the safe administration of radiotherapy or follow-up.

Keywords: post operative radiotherapy lung cancer non small cell lung cancer stage iii lung cancer neoadjuvant immunotherapy
znn bactiguard retrograde femoral nails pmcf study

Conditions: Femoral Fracture

Summary: post-market clinical follow-up (pmcf) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail zimmer natural nail (znn) bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.

the objective of this prospective pmcf study is to collect data to confirm safety, performance and clinical benefits of the zimmer natural nail (znn) bactiguard retrograde femoral nail (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures. the primary endpoint is the assessment of performance by analyzing fracture healing. the secondary endpoints are the assessment of safety, clinical benefit and post-op fracture related infection (fri). safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. relation of the events to implant, instrumentation and/or procedure should be specified. clinical benefit will be assessed by recording patient-reported outcome measures (proms). fris will be classified according to the updated diagnostic algorithm defined by the fri consensus group.

Eligibility criteria:
inclusion criteria: * patients must be 18 years or older. * patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. patients with delayed treatment (initial treatment by external fixation due to swelling / high energy trauma followed by definitive treatment by intramedullary nail) can also be included. * patient has been or is scheduled to be treated with the znn bactiguard system retrograde femoral nail. * patient must be able and willing to complete the protocol required follow-up. * patient must have a signed ec approved consent. * patients capable of understanding the surgeon's explanations and following his instructions. exclusion criteria: * skeletally immature patients * a medullary canal obliterated by a previous fracture or tumor * bone shaft having excessive bow or a deformity * lack of bone substance or bone quality, which makes stable seating of the implant impossible * all concomitant diseases that can impair the operation, functioning or the success of the implant * insufficient blood circulation * infection * patient is unwilling or unable to give consent. * patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol/drug addiction, known to be pregnant or breast feeding). * patient anticipated to be non-compliant and/or likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study). * not expected to survive the duration of the follow-up program

Keywords: bactiguard femur fracture intramedullary nailing infection control
bioequivalence study to compare sol-gel technologies' 5-fu cream with efudex® (5-fu) cream

Conditions: Actinic Keratosis (AK)

Summary: to compare the relative efficacy and safety and of 5-fu cream to the marketed formulation efudex® (5-fu) cream, and to demonstrate the superior efficacy of the two active formulations over that of the vehicle control cream, in the treatment of actinic keratosis.

to compare the safety and efficacy profiles of 5-fu cream with efudex® (5-fu) cream, and to demonstrate the superior efficacy of the two active formulations over that of the vehicle control cream, in the treatment of actinic keratosis.

Eligibility criteria:
inclusion criteria: 1. male and female 18 years of age and older. 2. subject is able to understand and willing to sign institutional review board (irb) approved written informed consent for this study. 3. subject must be generally healthy, based on medical records, and free from any clinically significant disease, other than ak, that in the opinion of the investigator might interfere with the study evaluations. 4. at least five (5) and no more than ten (10) clinically typical, visible or palpable, discrete ak lesions, each at least 4 mm in diameter on the face (excluding ears), forehead or bald scalp. exclusion criteria: 1. subject is pregnant, lactating, or is planning a pregnancy within the period of study participation. 2. subject suffers from excessive alcohol consumption, drug abuse or has a condition that could compromise the subject's ability to comply with study requirements. 3. presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma or other possible confounding skin conditions on the

Keywords: actinic keratosis ,ak
safety of everolimus and pemetrexed in lung cancer patients

Conditions: Non Small Cell Lung Cancer

Summary: this study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.


Eligibility criteria:
inclusion criteria: * lung cancer * only one prior regimen of chemotherapy for the treatment of non small cell lung cancer * adequate bone marrow function * adequate liver function * adequate renal function * negative serum pregnancy test exclusion criteria: * history of another primary malignancy in the last 5 years * having recently received an investigational drug * having recently received major surgery of wide field radiotherapy * chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators * severe or uncontrolled medical conditions other protocol-defined inclusion/exclusion criteria may apply

Keywords: lung cancer non small cell lung cancer nsclc rad001 everolimus afinitor pemetrexed
a study testing the effect and safety of casopitant (gw679769) while taking warfarin in healthy human volunteers

Conditions: Nausea and Vomiting, Chemotherapy-Induced

Summary: gw679769 may affect liver enzymes that metabolize warfarin. this study is designed to test the extent of the gw679769 affect on warfarin levels in humans.


Eligibility criteria:
inclusion criteria: * healthy subjects * non-smoking * females cannot be able to have children * must be able to swallow and retain oral medication * understand and sign the written consent * comply with the requirements and restrictions involved in an overnight 30 day confinement in a healthcare setting exclusion criteria: * cannot participate if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor. * blood donation in excess of 1 pint within 56 days before dosing of medication * iron deficiency * history of drug or alcohol abuse or dependency within the past 6 months * subjects cannot use any nicotine-containing products within the last 6 months * positive for hiv, hepatitis b or c * use of prescription or non-prescription drug(s), herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication * consumption of any food or drink containing grapefruit, seville oranges, kumquats, pomelos (or their juices) within 7 days of the first dose of study medication * history of bleeding disorders or excessive bleeding * female who has a positive pregnancy test * female who is lactating

Keywords: healthy human volunteer gw679769 warfarin casopitant
prevalence and impact on quality of life of lower urinary tract symptoms (luts) in night workers

Conditions: To Evaluate Lower Urinary Tract Symptoms (LUTS) and Their Impact on Quality of Life in Night Workers

Summary: the first large population-based study to evaluate lower urinary tract symptoms and their impact on quality of life in night workers.

the first large population-based study to evaluate lower urinary tract symptoms (luts) and their impact on quality of life in night workers. the study objective is to assess the prevalence and bother of luts in the population of night workers. this study will be conducted as a questionnaire survey with assessment of luts using a standardized protocol based on definitions by the international continence society (ics). the international prostate symptom score (ipss), the overactive bladder- validated 8-question screener (oab-v8), the patient health questionnaire-9 (phq-9), the athen insomnia scale, the work productivity and activity impairment questionnaire (wpai), the 12-item short form health survey (sf-12) questionnaires will be included. participants will be also asked to rate how often they experienced individual luts and the degree of associated bother.

Eligibility criteria:
inclusion criteria: night workers defined as any workers, who, during night time, work at least three hours of their daily working time as a normal course or who work at night at least 1/4 of their working time during the accounting period (definition by the polish labour code). exclusion criteria: non night workers urinary tract infection in the past 4 weeks
ventilator-associated pneumonia (vap) and humidification system

Conditions: Ventilator-associated Pneumonia

Summary: the purpose of this study is to determine which humidification system is more effective in preventing pneumonia in mechanically ventilated patients. the study will compare a heat and moisture exchanger versus heated humidification.


Eligibility criteria:
inclusion criteria: * patients expected to require mechanical ventilation for at least 48 hours exclusion criteria: * patients \< 18 yo and pregnant

Keywords: mechanical ventilation humidification system patients submitted to mechanical ventilation for at least 48 hours
survey of procedures and resources for initiating treatment of hiv in africa-south africa

Conditions: HIV; Antiretroviral Therapy

Summary: in its 2017 revision of the global guidelines for hiv care and treatment, the world health organization called for rapid or same-day initiation of antiretroviral treatment (art) for eligible patients testing positive for hiv. the south african national department of health adopted this recommendation in october 2017. neither organization provided detailed guidance, however, on how to implement the recommendation. in sub-saharan africa, where most hiv patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (arvs). among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for hiv is dispensed an initial supply of medications. there is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. the sprint (survey of procedures and resources for initiating treatment of hiv in africa) study will begin to develop this evidence base. sprint will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated art at the study sites. data will be collected from 12 clinics across 3 provinces in south africa (kwazulunatal province, gauteng province, and limpopo province). the survey will elicit detailed information about current procedures through structured interviews with clinic staff. the record review for a retrospective cohort of patients eligible for art will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. sprint is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.


Eligibility criteria:
inclusion criteria: * ≥18 years old * hiv-positive exclusion criteria: * pregnant
digestive endoscopy after out-of-hospital cardiac arrest

Conditions: Out-of-hospital Cardiac Arrest

Summary: post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. among the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest shock. the ischemic injury of the gastro-intestinal (gi) tractus is suggested by abnormalities in digestive biomarkers and by the frequent endotoxemia after ca. however, direct mucosal damage has not been clearly demonstrated after ohca. the real incidence of ischemic lesions of gi tract and their potential involvement in the post-ca shock is therefore unknown. we propose an original clinical research program aimed at rigorously determining the incidence of upper gi lesions after ohca and analyzing their contribution to the severity of post-ca shock through a prospective, interventional, multicentric study

the screening of the patients will be performed 2 to 4 days after their intensive care unit (icu) admission. procedure and exams at the day of inclusion (day 0): * collection of digestive symptoms * carrying out the œsophago-gastro-duodenoscopy and establishment of a formal report with the eventual lesions and their ischemic nature. * in the absence of contra-indication and upon final decision of the gastroscopist, systematic biopsies of fundic, antral and duodenal mucosa; contra-indication of biopsies are the presence of a vascular or haemorrhagic lesion and the coagulation disorders. * blood sample for h. pylori serology, and serum freezing. urinary sample for urine freezing procedure and exams from day 1 to hospital discharge: * daily collection of digestive symptoms and needs for vasopressor support * sepsis-related organ failure assessment (sofa) score at day 2 \& 5 * cerebral performance category (cpc) score determination at hospital discharge in case of digestive symptoms after day 0 and in accordance with good clinical practice, a second gastroscopy and/or an abdominal computed tomography scan(ct-scan) and/or a colonoscopy will be performed at the physician's discretion.

Eligibility criteria:
inclusion criteria: * adult patient hospitalized for less than 5 days in a participating intensive unit care following successfully resuscitated out-of-hospital cardiac arrest * patient still mechanically ventilated * hypothermia period over, corporal temperature \> 36°c. * written consent from a next of kin exclusion criteria: * in-hospital cardiac arrest * patients extubated before gastroscopy * contra-indication of gastroscopy: suspicion of digestive perforation, severe bleeding diathesis despite coagulation products transfusion, or suspicion of creutzfeldt-jacob disease * patients with cardiac valvular prosthesis or previous endocarditis * pregnancy, lactating women in case of severe coagulation disorders (platelet count \ 2) or heparin treatment or combined platelet inhibition treatment, the inclusion of the patient will be possible but digestive biopsies will not be allowed.