Kornimate/medical-research-clean huggingface dataset:
effect of pioglitazone on hiv-1 related lipoatrophy: a randomized, double blind, placebo-controlled trial in 130 patients

Conditions: HIV-Associated Lipodystrophy Syndrome; HIV Infections

Summary: the aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in hiv 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.

lipodystrophy is one of the most frequent treatment side effect in hiv-1 infected patients. this complication can be stigmatizing in some affected patients and lead to reduced adherence to treatment, increased risk of cardiovascular complications and induce insulinoresistance. the pathophysiology of lipodystrophy remains poorly understood. some antiretroviral drugs could be involved. therefore, using ppar g as a therapeutic target with the objective to reverse drug induced lipoatrophy appeared as a promising objective thiazolidinediones are a new class of insulin sensitizing drugs for the treatment of type 2 diabetes. these pparg agonist which mainly promote the differentiation of adipocytes, decrease circulating plasma free fatty acids. in non-hiv infected patients this class of drugs decreases intraabdominal fat accumulation and increases subcutaneous fat depot. different previous studies were performed with that aim, most of them using rosiglitazone. we designed a prospective randomized, double blind placebo controlled multicentre study aiming to test the hypothesis that pioglitazone would improve lipoatrophy without deleterious effect on lipid profile in adult subjects receiving antiretroviral therapy.

Eligibility criteria:
inclusion criteria: * 18 years of ages and older * confirmed laboratory diagnosis of hiv-1-infection * karnofsky equal or over 70% * patients treated with stable antiretroviral therapy for at least 6 months * plasma viral load below 400 copies/ ml and cd4 count over 200/mm3 for at least 6 months * patients with a clinical peripheral lipoatrophy self reported by the patient and confirmed by physical examination exclusion criteria: * cachexia * cardiac failure class3 or 4 at nyha classification * acute opportunistic infection * pregnancy or breast-feeding * polynuclear neutrophils below 1000/mm3 * hemoglobin below 9 g/dl * platelets below 50 000/mm3 * creatinine level over 2 un * asat, alat over 2.5un * bilirubin, amylase, lipase level over 2 un * cd4 count below 200/mm3 * patients treated by any antidiabetic or lipid lowering drugs, anabolic or corticosteroid hormone

Keywords: hiv-associated lipodystrophy syndrome pioglitazone hiv infections treatment experienced
the effect of acipimox on glp (glucagon-like peptide)-1 secretion

Conditions: Diabetes Mellitus Type 2

Summary: glucagon like peptide 1 is produced in enteroendocrine l cells in the small intestine stimulated by peroral food intake. glp-1 induces insulin secretion, and analogues are used in the treatment of dm2 (type 2 diabetes mellitus). recently it was found, that levels of glp-1 are increased in response to acipimox. the hypothesis is that g protein coupled receptors on enteroendocrine l cells bind acipimox and thereby induce glp-1 secretion. in a controlled, open, randomized experiment, eight healthy, overweight men will be studied on an intervention day, where they receive acipimox, and on a control day. the study day includes an ogtt (oral glucose tolerance test), blood samples before and after the ogtt and a biopsy from adipose tissue.


Eligibility criteria:
inclusion criteria: * adult men * healthy * bmi 25-35 exclusion criteria: * known dm2 * receiving hypolipidemic drugs

Keywords: acipimox glp-1 insulin secretion
cyclophosphamide as graft-versus-host prophylaxis after allogeneic stem cell transplantation for multiple myeloma

Conditions: Multiple Myeloma

Summary: the present study is a multicenter, prospective phase ii-study to evaluate the chronic gvhd and progression-free survival at 2 years after after allogeneic stem cell transplantation for patients with multiple myeloma.

the present study is a multicenter, prospective phase ii-study to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients with multiple myeloma who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related/unrelated and haploidentical donor, and cyclophosphamide as post-transplant gvhd prophylaxis in comparision to a historical group. in this study will further determine toxicity and safety of cyclophosphamide as gvhd prophylaxis.

Eligibility criteria:
inclusion criteria: 1. multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after autologous stem cell transplantation 2. patients age: 18 - 65 years at time of inclusion (female and male) 3. performance status ecog \< 2 4. availability of haploidentical, matched or mismatched related or unrelated donor 5. patients understand and voluntarily sign an informed consent 6. the study population includes female of childbearing potential (focp). focp have to agree to comply with the applicable contraceptive requirements of the protocol as named below for the duration of the study and 6 months after end of study or having post-menopausal status or be permanently sterilized (at least 6 weeks post-sterilization). 7. men who are sexually active with focp must be instructed to use male contraception (condom) in order to avoid exposure of an existing embryo/fetus. contraception should be continued until 6 months after end of study. exclusion criteria: 1. severe active infection or other uncontrolled severe conditioning 2. severe renal, hepatic, pulmonary or cardiac disease, such as: * total bilirubin, sgpt or sgot \> 3 times upper the normal level * left ventricular ejection fraction \< 30 % * creatinine clearance \< 30 ml/min * dlco \< 35 % and/or receiving supplementary continuous oxygen 3. positive serology for hiv 4. pregnant or lactating women (positive serum pregnancy test) 5. women of child-bearing potential with unclear contraception 6. age \ 65 years. 7. uncontrolled invasive fungal infection at time of screening (baseline) 8. serious psychiatric or psychological disorders 9. participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment

Keywords: without detection of deletion 17p or translocation 4;14; post cyclophosphamide gvhd prophylaxis allogeneic sct
a mental health services engagement program for racial and ethnic minority young adults

Conditions: Psychosis; Bipolar and Related Disorders; Depressive Disorder

Summary: researchers aim to test a brief culturally-responsive young adult orientation program for community mental health services. they will conduct a 24-month randomized trial with 80 young adults from racial and ethnic minority groups in a community-based mental health clinic.

the study objective is to assess the feasibility and acceptability of three new culturally-responsive components added to the brief young adult engagement intervention called just do you. the new components incorporate techniques from the dsm-5 cultural formulation interview (cfi) and creative arts therapy to increase culturally-responsive content in just do you, which demonstrated evidence of keeping young adults connected to their treatment in a prior trial. components are designed to elicit relevant cultural characteristics, experiences, and perspectives of diverse young adults enrolled in psychiatric rehabilitation as part of the just do you orientation program. the investigators will examine whether the new culturally-responsive components improve engagement in mental health services and increase service utilization. a total of 80 young adults enrolled in an outpatient psychiatric rehabilitation program in new york will be recruited over 24 months to take part in a randomized full factorial pilot trial. participants will be given a baseline assessment and randomly assigned to one of eight combinations of intervention components. just do you will be delivered first to all participants, with the assigned combination of new components to follow. the intervention will be delivered at the psychiatric rehabilitation program and will last up to five weeks for each participant, depending on the experimental condition. outcome measures will be assessed at baseline, post-intervention, and 3-month follow up.

Eligibility criteria:
inclusion criteria: * aged 18-34 * from groups other than non-hispanic white * enrolled in services at the partnering clinic site exclusion criteria: * cognitive impairments (i.e., young adult cannot understand consent process) * unable to comprehend and speak english
healing touch & guided imagery for posttraumatic stress disorder symptoms

Conditions: Post-Traumatic Stress Disorder

Summary: this is a randomized controlled 2 year trial at camp pendleton, ca to determine whether a complementary medicine intervention (healing touch with guided imagery, ht+gi) reduces posttraumatic stress disorder (ptsd) symptoms as compared to treatment as usual (tau) in returning combat-exposed active duty military with significant ptsd symptoms. secondary aims will evaluate the effect of ht and gi on measures of depression, hostility, and general health status in this population.

the study enrolled 123 active duty subjects from the marine corps base camp pendleton in southern california with at least one or more symptoms of ptsd .

Eligibility criteria:
inclusion criteria: 1. female or male subjects 18 years or older 2. post-deployment from a combat zone 3. identified by post-deployment health re-assessment to have ptsd symptoms 4. referred by camp pendleton 5. subjects who are willing to sign a consent 6. subjects who are willing to participate for the length of the study exclusions: 1. female subjects who are now pregnant or nursing 2. subjects who are receiving healing touch or using guided imagery from other sources 3. subjects who have any major health condition that may interfere with participating in this study

Keywords: ptsd healing touch guided imagery military complementary medicine
rituximab treatment in sjogren's syndrome

Conditions: Sjogren's Syndrome

Summary: this study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary ss.

study design: phase ii trial study objective: evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary ss number of participating centres: 1 duration: follow-up 48 weeks study medication: 2 infusions on day 1 and day 15 rituximab infusions (1000 mg) or placebo infusions intravenous infusion of 100 mg of methylprednisolone before infusion of rituximab (or the placebo for rituximab), together with 60 mg per day of oral prednisone on days 2, 3, 16 and 17, 30 mg per day on days 4, 5, 18 and 19 and 15 mg per day on days 6 and 20 primary objective/endpoint: stimulated salivary gland function (stimulated submandibular/sublingual and parotid saliva) secondary objectives/endpoint: functional parameters laboratory parameters subjective parameters histological/molecular parameters number of subjects: 30 patients with primary ss (20 patients rituximab treatment, 10 patients placebo)

Eligibility criteria:
inclusion criteria: * stimulated whole saliva secretion ≥ 0,15 ml/min * male or female \> 18 years * primary ss according to the revised european - u.s. criteria(22) * positive autoantibodies (igm-rf \> 10 and ss-a and/or ss-b) * parotid gland biopsy (paraffine material and fresh frozen tissue) with characteristic features of ss performed at time of inclusion (no longer than 12 months ago) * use of reliable method of contraception during the study * written informed consent exclusion criteria: * the presence of any other connective tissue disease * preceding treatment with anti-tnf or other monoclonal antibodies * use of prednisone, hydroxychloroquine less than 1 month ago * use of mtx, cyclophosphamide, cyclosporin, azathioprine and other dmards less than 0,5 year ago * serum creatine \> 2.8 mg/dl (250 micromol/l) * asat or alat outside 1.5 x upper normal range of the laboratory * hb \< 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females * neutrophil granulocytes less than 0.5 x 109/l * platelet count less then 50 x 109/l * positive pregnancy test or breast-feeding * history of alcohol or drug abuse * serious infections * underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study * history of any malignancy with the exception of completely resected basal cell carcinoma of the skin
rc repair versus subacromial balloon spacer in older adults

Conditions: Rotator Cuff Tears

Summary: the purpose of this pilot study is to assess the feasibility of a full randomized trial design.

the feasibility objectives are: 1. recruitment 1. to establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent. 2. to establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears. 2. surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups. clinical objectives for observational purposes only are as follows: 1. patient reported and clinical outcomes. 2. number of "failures" in each group (defined as additional surgery and/or having \<12% improvement in sane score from baseline).

Eligibility criteria:
inclusion criteria: * 70 years of age or older * clinical and radiological diagnosis of a full thickness supraspinatus (or larger) rc tear \>2cm or more than 1 full tendon * ongoing symptoms after 3 months of physiotherapy * a tendon amenable to partial or complete repair (as determined by pre-operative mri) * absence glenohumeral arthritis (hamada \< 3) * absence of neoplastic diseases at treated site exclusion criteria: * previous surgery or pseudoparalysis on study shoulder * complete subscapularis deficiency * external rotation lag signs * avascular necrosis * post-infectious arthritis * proximal humerus fracture * inflammatory arithritis * axillary nerve palsy * concomitant tendon transfer * neuromuscular disorder * unable to speak/read english intra-operative exclusion: -tendon is not amenable to partial or complete repair

Keywords: rotator cuff repair subacromial spacer older adults
allogeneic cart-19 for elderly relapsed/refractory cd19+ all

Conditions: Leukemia

Summary: the purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (cd19)-directed chimeric antigen receptor modified t cells (cart-19) infusions in patients with relapsed / refractory b-cell acute lymphoblastic leukemia (b-all)

the relapsed and/or refractory b-all patients will receive infusions of allogeneic cart-19 within 1 week after chemotherapy. the re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (gvhd) prevention was conducted pre- and post- therapy.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years * patient with relapsed and/or refractory cd19 positive b-cell acute lymphoblastic leukemia (b-all) * estimated life expectancy ≥ 12 weeks (according to investigator's judgment) * eastern cooperative oncology group (ecog) performance status ≤ 2 exclusion criteria: * previous treatment with investigational gene or cell therapy medicine products * cd19 negative b-cell leukemia * any uncontrolled active medical disorder that would preclude participation as outlined

Keywords: cart all relapsed refractory cd19+
woodcasting versus thermoplast splint in cmc arthroplasty

Conditions: Carpometacarpal (CMC) Joint Arthritis

Summary: this study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty.

patients undergoing carpometacarpal arthroplasty will be randomized into the woodcast or thermoplast splint after their surgery to see which is preferred using compliance and surveys.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 years old. * intact medical decision making * eligible for surgical intervention * willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks exclusion criteria: * pregnant women * deemed unsuitable by principal investigator

Keywords: randomized hand and upper extremity
prompt human coronary collateral vasomotor function induced by dynamic physical exercise

Conditions: Coronary Artery Disease

Summary: the purpose of this study in humans with stable coronary artery disease (cad) treatable by pci (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to an instantaneous improvement of coronary collateral function.

the existence of coronary collateral vessels and their benefit against cardiac events have been recognized for many years, but their functional capacity in response to physical exercise has partially remained elusive. via endothelial shear stress, the fundamental stimulus for collateral development, exercise theoretically leads to collateral vasodilation and recruitment by an increase in heart rate and blood pressure during exercise. moreover, the phenomenon of "walking through angina" indicates that collateral function and physical activity are related and their interaction is of clinical relevance. the purpose of the present study in humans with stable coronary artery disease was to assess the instantaneous response of coronary collateral function to dynamic physical exercise.

Eligibility criteria:
inclusion criteria: * age more than or 18 years old * 1- to 3-vessel coronary artery disease (cad) * stable angina pectoris * at least 1 stenotic lesion suitable for pci * negative allen-test * written informed consent to participate in the study exclusion criteria: * patients admitted as emergencies * acute myocardial infarction * unstable cad * q-wave myocardial infarction in the area undergoing cfi measurement * cad treated best by cabg * severe valve disease * pregnancy

Keywords: cad prompt physical exercise collateral function
comparison between different sampling sites for detection of respiratory viruses

Conditions: Respiratory Tract Infection Viral

Summary: the goal of this observational study is to validate the use of less invasive samples (saliva, orobuccal or nasal swabs) than nasopharyngeal swab for testing common and clinically relevant respiratory viruses in children and adults presenting to an emergency departements with symptoms compatible with respiratory tract infection. the main question it aims to answer is: - is the precision of reverse transcription polymerase chain reaction (rt-pcr) for influenzavirus a or b, respiratory syncytial virus (rsv), and rhinovirus, on saliva, orobuccal swabs and nasal swabs comparable to the gold standard nasopharyngeal swab in a pediatric and adult population presenting with symptoms compatible with respiratory tract infection. among participants the following samples will be collected (nasopharyngeal swab is standard of care and not part of the study samples): * saliva * orobuccal swab * nasal swab


Eligibility criteria:
inclusion criteria: * patients presenting at the emergency departments or hospitalized at inselspital bern university hospital with any symptom compatible with an acute respiratory tract infection in whom a nasopharyngeal swab to test for respiratory viruses is performed (standard of care) * written informed consent from the trial subject has been obtained; for patients aged 0-13 years, or not able to provide informed consent, consent obtained from the legal representative; for patients between 14-18 years, written informed consent obtained from the respective patient as well as the legal representative. exclusion criteria: * patients unable to provide a saliva (e.g. patients with reduced level of consciousness). children too young to be instructed to provide saliva are not excluded, but saliva won't be collected. * patients with swallowing disturbances * patient's lack of accountability and inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly and legal representative not available.

Keywords: viral respiratory tract infection diagnostic test performance molecular diagnostic influenza rsv rhinovirus
motor learning in knee osteoarthritis

Conditions: Knee Osteoarthritis; Lower Extremity Biomechanics; Physiotherapy

Summary: non-surgical treatment options, like exercise therapy, show excellent short-term effects regarding pain reduction and improvement of knee function. however, mid- and long-term effects are missing so far. this might indicate that long-lasting changes in motor-skill performance (motor learning) have not occurred. motor learning is associated with permanent changes in the capability for skilled movement behavior avoiding unfavorable joint loads and inappropriate muscle activation patterns, leading to compensatory movement strategies. one-sided and high repetitive loads in the knee joint could be one reason for the progression of knee osteoarthritis. physiotherapeutic strategies should therefore be able to stimulate motor learning processes. in physiotherapy, motor learning can be optimized by using instructions and feedback, targeting an external focus of attention, when learning specific movement patterns. this study investigates the effects of a 12 week exercise therapy program, using an external focus of attention, on functional and biomechanical parameters in patients with knee osteoarthritis. to measure possible changes, functional measurements are taking place at baseline, after 6, 12 and 24 weeks. the biomechanical measurements (3d gait analysis) are taking place at baseline, after 12 and 24 weeks.


Eligibility criteria:
inclusion criteria: * kellgren-lawrence-score 1-3 * bmi \< 33 * free range of motion in the knee joint exclusion criteria: * activated knee osteoarthritis * lower extremity surgery in the past 6 weeks * intake or injection of corticosteroids in the past 3 month * long-term medication non-steroidal anti-inflammatory drugs * neurological diseases * drug or alcohol abuse

Keywords: physiotherapy external focus of attention knee adduction moment gait analysis osteoarthritis motor learning