Kornimate/medical-research-clean huggingface dataset:
comparing a nucleoside-analogue-sparing regimen and a protease-inhibitor-sparing regimen in hiv infected patients

Conditions: HIV-Associated Lipodystrophy Syndrome

Summary: highly active antiretroviral therapy (haart) has improved the long time survival of hiv infected individuals. however an increasing number of hiv-patients have developed metabolic and morphological alterations including peripheral lipoatrophy. there is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (nrti)-sparing regimens. the hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an nrti-sparing regimen will have little risk of peripheral lipoatrophy. the researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing haart regimen or a protease-inhibitor sparing regimen. the main endpoint is changes in peripheral fat mass as determined by dual energy x-ray absortiometry (dexa)-scanning.


Eligibility criteria:
inclusion criteria: * antiretroviral naïve patients * hiv-1 infection as documented by a licensed hiv-1 antibody elisa. * fulfilling the criteria for starting antiretroviral therapy. * ability to understand and provide written informed consent. exclusion criteria: * women being pregnant or breast-feeding. * fertile women using no safe contraception. * patients with active intravenous drug use. * abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol. * ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz. * creatinine \> 200 mmol/l. * alt or ast \> 5 times upper normal value (200u/l).

Keywords: hiv lipoatrophy lipodystrophy treatment naive hiv infections hypercholesterolemia
establishing a descriptive cohort of patients cared for operation on the spine

Conditions: Quality of Life; Spinal Injuries; Spinal Diseases

Summary: this study aims to: 1. describe the monitoring of patients treated for spinal disorders. 2. create a comprehensive database of reliable and readily exploitable quickly to produce a library of cross publications between orthopedic surgery and neurosurgical services. this database will include clinical, functional , radiographic , educational, social and professional data. 3. obtain a cohort of patients in the comprehensive range of spinal pathologies. 4. standardize data collection in this cohort with similar national projects.


Eligibility criteria:
inclusion criteria: * the patient must be given free and informed consent and signed the consent * the patient must be affiliated or beneficiary of a health insurance plan * the patient is available for a 24-month follow-up * the patient is at least 18 years old * the patient has a symptomatic spinal pathology requiring surgical or orthopedic treatment exclusion criteria: * the patient is under judicial protection, guardianship or curatorship * the patient refuses to sign the consent * it is not possible to give informed information to the patient * the patient does not fluently read french. * the patient is not available for a 24-month follow-ip
evaluation the effect of exjade on oxidative stress in low risk myelodysplastic syndrome patients with iron over load

Conditions: Myelodysplastic Syndrome

Summary: certain percentage of mds patients develop iron overload. iron is known to participate in intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis, which was found to be increased in mds patients and consequently resulted in ineffective hematopoiesis. the aim of this study is to evaluate the antioxidant effect of the oral iron chelator deferasirox -exjade in low risk mds patients with iron over load by evaluating changes in several oxidative stress parameters certain percentage of mds patients develop iron overload.


Eligibility criteria:
inclusion criteria: * patients with myelodysplastic syndrome with an ipss score being intermediate-1 or low. * patients who already received ≥20 unit (100 ml/kg) of packed red blood cells and showing evidence of iron overload (serum ferritin \>1000 µg/l). * patients post stem cells transplantation with disease recurrence with mds ipss score low or intermediate 1. * patients who have given consent personally in writing exclusion criteria: * patients with myelodysplastic syndrome with an ipss score being intermediate-2 or high. * patients with serum creatinine \>2.0 x uln * patients with alt(sgpt) levels \> 5 x uln * significant proteinuria as indicated by a urinary protein/creatinine ratio \>0.5 mg/mg in a non-first void urine sample on two assessments during the screening period. * history of hiv positive test result. when there are any signs or symptoms indicative of the disease even if the diagnosis is not made, additional test should be conducted. * history of clinical or laboratory evidence of active hepatitis b or hepatitis c (hbsag in the absence of hbsab or hcv ab positive with hcv rna positive and alt above the normal range) * patients with systemic uncontrolled hypertension * patients with unstable cardiac disease not controlled by standard medical therapy * systemic disease (cardiovascular, renal, hepatic, etc.) which would prevent study treatment * pregnancy or breast feeding. female of child-bearing potential should conduct contraception during the clinical trial. * patients treated with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days * other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug * patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the study protocol * history of hypersensitivity to any of the study drug or excipients

Keywords: iron oxidative stress mds
practice and patient compliance on the ppi (proton pump inhibitors) treatment of gastroesophageal reflux in south korea

Conditions: Gastroesophageal Reflux

Summary: the purpose of this study is to examine the treatment profile of approximately 1,000 adult patients with gastroesophageal reflux who begin raberpazole sodium treatment for 4 months, and assess patients' adherence to the study drug.

this study is a multicenter, open-labeled, prospective, phase iv, observational study for patients visiting the gastroenterology department. the purpose of this study is to examine the treatment profile of approximately 1,000 adult patients with gastroesophageal reflux (gerd) who begin raberpazole sodium treatment for 4 months and assess patients' adherence to the study drug. the primary objective is to examine the treatment profile of gastroesophageal reflux in the secondary or tertiary clinical center. the secondary objective is to examine gerd patients' adherence to the study drug (rabeprazole sodium) during the treatment period. of the patients who visit the study centers and complain about gastroesophageal reflux symptoms during the study period, those who are deemed to need rabeprazole sodium administration at the investigator's discretion will be considered for this study. the main outcome measures are the patterns of gastroesophageal reflux management (eg. treatment duration of initial therapy etc) and the compliance of proton pump inhibitor treatment.the compliance data (number of tablets taken) will be calculated at the clinical visit by counting the number of dispensed tablets that are remaining. also, investigators will observe the gastroesophageal reflux symptom free rate at the end of initial therapy, gastrointestinal (gi) symptom relief and safety information at each visit. study period is up to 4 months. during the study, no standardized treatment is stipulated, and patients may receive any treatment considered by their physicians. rabeprazole sodium 10 mg - 20 mg tablet once daily for 4months.

Eligibility criteria:
inclusion criteria: * patients complaining about heartburn or acid regurgitation, the typical gerd symptoms, more than once a week * after a full explanation about the observational study, patients who fully understand it and sign a written consent form exclusion criteria: * patients who took rabeprazole sodium within the last four weeks * patients who are hypersensitive to the active ingredient of rabeprazole sodium or benzimidazole * patient with other digestive tract diseases other than gerd (gastrointestinal cancer, liver disease, pancreatic disease, peptic ulcer, inflammatory digestive tract diseases \[in case of ulcer, however, scars from healed ulcer may be included\]) * patients with other severe accompanying diseases including renal impairment, cerebrovascular disease, cardiovascular disease and severe respiratory disease * patients who must constantly take proton pump inhibitors other than rabeprazole sodium during study period * pregnant or lactating women

Keywords: rabeprazole sodium gastroesophageal reflux gerd observational
modulation of benzene metabolism by exposure to environment

Conditions: Lung Diseases; Cancer

Summary: the research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. to do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured.

the research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. to do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured. the exposures take place in the controlled environmental facility operated by the environmental and occupational health sciences institute (eohsi). this allows us to control the exact benzene air level and to use benzene containing 13c, a stable (non-radioactive) form of carbon, one of the atoms that make up benzene. isotopes are different forms of the same atom. using 13c will allow us to tell the difference between the benzene and the compounds it changes to in the body that come from our experiment compared to what is present in your body from other sources. in addition to just benzene exposure on some days the subject is also be exposed to methyl tertiary butyl ether (mtbe), another component of gasoline, to take an iron supplement pill and/or to take vitamins c and e pills. how benzene is metabolized or changed in the body will be compared for these differences to better understand how the body deals with benzene.

Eligibility criteria:

Keywords: benzene air pollution
nutritional therapy enriched with omega-3 in patients with lung resection

Conditions: Lung Cancer; Surgery

Summary: the aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.


Eligibility criteria:
inclusion criteria: * lung cancer diagnosis * elective surgery for lung resection schedule at least four days before surgery * signed informed consent. exclusion criteria: * acute or chronic organ failure as hepatic or renal insufficiency * patients with fish-allergy * history of any surgery within 3 months * immunocompromised patients

Keywords: lung cancer omega-3 prehabilitation nutrition perioperative nutrition infections inflammation response
the effect of labor dance on the labor pain, birth satisfaction and neonatal outcomes

Conditions: Labor Pain; Satisfaction; Infant Conditions

Summary: objective: this research was conducted to determine the effects of labor dance on perceived birth pain, birth satisfaction, and neonatal outcomes. design: this research was an experimental study with three groups. the data were collected during the active phase of labor as three groups; dance practitioner midwife group (dpmg-40 pregnant), dancing practitioner spouse / partner group (dpsg-40 pregnant) and control group (cg-80 pregnant). setting: this research was conducted at ministry of health izmir urla state hospital between april 1, 2017 and october 31, 2017. participants: the pregnant women in the dpmg danced with the midwives in charge of the delivery room and following the pregnancy, but those in the dpsg danced with their spouse/partners during the active phase of labor. labor pains were measured before the labor dance was begun (when the vaginal dilatation was 4 cm) and after the labor dance (when the vaginal dilatation was 9 cm) using a visual analogue scale (vas). in the postpartum period, the first, fifth, and tenth-minute apgar scores and oxygen saturation levels of the newborns were measured and recorded. the mackey childbirth satisfaction rating scale was applied to evaluate the women's birth satisfaction at the end of the first hour. in the control group, only routine practices were implemented in the hospital, and data were collected as indicated in the experimental groups.

during a labor dance, pregnant women's hands were wrapped around the neck of the partner (midwife or spouse), the pregnant woman put her head on her partner's shoulder, and they swung left to right accompanied by calming music. during the labor dance, the partner accompanied the pregnant woman's swinging movements and massaged the pregnant woman's sacral area at the same time. the study showed a positive effect of labor dancing on decreasing birth pain and improving satisfaction and neonatal outcomes whether the dance was performed with the spouse or the midwife during the intrapartum period.

Eligibility criteria:
inclusion criteria: those who were admitted to the ministry of health urla state hospital for labor * those whose cervical dilatation between 4 and 8 cm. * those who had received labor dance training by attending prenatal training with their spouses/partners in perinatal period. * those who met the inclusion criteria (volunteering, term pregnancy (37-41 gestational weeks), single foetus, not having any pregnancy complication (oligohydramniosis and polihydramniosis, placenta previa, pre-eclampsia, premature rupture of membrane, presentation anomalies, intrauterine growth retardation, intrauterine death, macrosomic baby, foetal distress etc.) exclusion criteria: when delivered by cesarean sectio, * labor was inducted * narcotic analgesics used
resistance exercise in rheumatic disease

Conditions: Rheumatoid Arthritis; Systemic Vasculitis

Summary: people with rheumatic disease often have decreased strength, muscle mass, and bone mineral density due to repeated bouts of inflammation, normal effects of aging, disuse, and inactivity. the medications used to quell the disease process, such as prednisone, can also have detrimental effects on body composition, strength, and functional capacity. the investigators propose to investigate the feasibility, safety, and effects of resistance exercise in older patients with rheumatoid arthritis (ra) and vasculitis. the unique resistance protocol the investigators propose involves performing movements in a slow and controlled fashion (i.e., no acceleration or use of momentum in the lifting and lowering of the resistance) to minimize force on the joints and connective tissues. this will be conducted in an individually-supervised environment with a new generation of exercise equipment that will accommodate their musculoskeletal capabilities and allow for reproducibility of the exercise protocol. the investigators intend to investigate the feasibility, safety, musculoskeletal, and psychological effects of this resistance exercise protocol in older patients with rheumatoid arthritis and vasculitis by testing their strength, body composition, functional ability, mood, and quality of life before and after this 16-week resistance exercise intervention.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis or systemic vasculitis (defined as granulomatosis with polyangiitis, churg-strauss, microscopic polyangiitis, anti-neutrophil cytoplasmic autoantibody (anca)-associated vasculitis, or giant cell arteritis) exclusion criteria: * non-english speaking * pregnancy * absolute cardiac or pulmonary contraindication to exercise * pacemaker
physical exercise for patients with head and neck cancer

Conditions: Head and Neck Cancer

Summary: the goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (rt), chemoradiation (crt) or bioradiation (brt), and healthcare related costs in patients with head and neck cancer (hnc) with and without a 10 week physical exercise intervention (pei) during rt, crt or brt ((c/b)rt). patients who were randomized in the pei group and accepted the invitation to undergo the experimental intervention receive a pei twice a week for 10 weeks. the pei will be executed 6 to 7 weeks during and 3 to 4 weeks after (c/b)rt. researchers will compare patients who undergo the pei with patients who did not undergo the pei to see if there is difference in physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of (c/b)rt , and healthcare related costs in patients with head and neck cancer (hnc) with and without a 10 week physical exercise intervention (pei) during (c/b)rt).


Eligibility criteria:
inclusion criteria: 1. patients with hnc who are scheduled for (c/b)rt, 2. ≥18 years of age, 3. sufficient dutch writing and reading skills, 4. a karnofsky performance status (kps) \>60, 5. able to walk ≥60m without a mobility aid, and 6. no contraindication for physical activity as measured with the physical activity readiness questionnaire (par-q). exclusion criteria: 1. recurrence of hnc and/or 2. secondary hnc.

Keywords: head and neck cancer chemo- or bioradiotherapy physical exercise intervention physical performance trial within cohorts twics
association of gut microbiome with neonatal complications and neurodevelopment in preterm infants

Conditions: Preterm Infants

Summary: a prospective cohort study investigating the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

the purpose of this study was to investigate the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

Eligibility criteria:
inclusion criteria: * preterm infants * born less than 28+0 weeks gestation exclusion criteria: * major congenital anomalies

Keywords: microbiome
hip arthroscopy versus conservative management of femoroacetabular impingement

Conditions: Femoroacetabular Impingement

Summary: the objective of this study is to determine if patients with femoroacetabular impingement (fai) who undergo arthroscopic hip surgery experience similar outcomes at 2 years post-operative with respect to physical function, pain, and health related quality of life, compared to similar patients who receive conservative management, including medication and physiotherapy.

arthroscopic surgery is now commonly used to treat patients with femoroacetabular impingement (fai) however there is a lack of scientific evidence to support its efficacy. two distinct types of fai have been defined: cam impingement and pincer impingement. cam impingement is described as an abnormally prominent anterolateral femoral head-neck junction that rubs against the acetabular rim during flexion resulting in impingement of the acetabular labrum. pincer impingement is described as an anatomical overcoverage of the femoral head by the acetabulum that impinges the labrum leading to proliferation, or an increase in the prominence of the acetabular rim, further exacerbating the impingement. previous studies investigating the efficacy of arthroscopic surgery of the knee and shoulder have shown no benefit compared to sham surgery and non-surgical management, therefore strong scientific evidence is needed to support its use in the treatment of hip pathology.

Eligibility criteria:
inclusion criteria: * patients with femoroacetabular impingement of the hip * 18 years of age or older * grade 1, 2 or 3 radiographic severity of osteoarthritis as defined by the tonnis classification scale. exclusion criteria: * identified isolated labral tear * inflammatory or post-infectious arthritis * previous arthroscopic treatment for hip osteoarthritis * previous major hip trauma * tönnis grade 4 osteoarthritis in two compartments in persons over 60 years of age. * patients with a major neurologic deficit, serious medical illness (life expectancy less than 2 years or high intraoperative risk) or those who are unable to provide informed consent or who are deemed unlikely to comply with follow-up.

Keywords: randomized controlled trial intention to treat
immersive virtual reality treatment for unilateral spatial neglect

Conditions: Stroke; Unilateral Spatial Neglect

Summary: unilateral spatial neglect (usn) is a relatively common neuropsychological syndrome following stroke. it is characterized by difficulties in detecting, orienting and identifying events located in the hemispace contralateral to a brain lesion, unrelated to a primary motor or sensory disorder. numerous methods have been developed for the rehabilitation of this syndrome. however, limitations in terms of efficacy are highlighted. these limitations may be linked to the fact that these methods are restricted to certain sensory modalities, thus failing to take into account the heterogeneity of the syndrome. moreover, some patients' adherence to rehabilitation programs can also be complicated by motivational difficulties. immersive virtual reality could help overcome these limitations. indeed, it enables the introduction of new sensory modalities, notably auditory, to support a better apprehension of space. the main objective of this study is to determine the efficacy of an immersive virtual reality rehabilitation protocol based on musical practice in patients suffering from usn. this study also aims to explore the benefits of this rehabilitation protocol on patients' daily lives, as well as to explore the influence of patients' mood and motivation on the benefits of the immersive virtual reality rehabilitation protocol. to achieve these goals, patients will benefit from immersive virtual reality rehabilitation based on music practice. this rehabilitation will be compared to conventional usn rehabilitation. to this end, patients will be divided into two groups: classical rehabilitation only or classical rehabilitation and immersive virtual reality in parallel. each patient will be randomly assigned to one of the two groups for a period of 2 weeks. pre- and post-rehabilitation assessments will be provided.


Eligibility criteria:
inclusion criteria: * men and women over 18 years * free and informed written consent * enrolled in the french social security system * cerebral lesion of vascular origin * unilateral spatial neglect syndrome exclusion criteria: * epilepsy or migraine * major vision problems * major hearing impairment * pre-existing cognitive impairment (mmse \< 20) * major disorders of verbal comprehension preventing the protocol * refusal to sign consent form

Keywords: rehabilitation unilateral spatial neglect immersive virtual reality music