Kornimate/medical-research-clean huggingface dataset:
pioglitazone therapy for chronic granulomatous disease

Conditions: Chronic Granulomatous Disease

Summary: the purpose of this proposed research is to investigate the efficacy and safety of the therapy with pioglitazone for chronic granulomatous disease (cgd) patients severe infection.

chronic granulomatous disease (cgd) is a rare genetic disease caused by defects in genes encoding the subunits of the nicotinamide adenine dinucleotide（nadph）phosphate oxidase complex. in normal phagocytes peroxisome proliferator-activated receptor gamma (pparγ) activation links nadph oxidase activity with enhanced mitochondrial reactive oxygen species (ros) production. there is deficient mitochondrial ros production in cgd，due to the lack of this upstream signaling by the nadph oxidase and pparγ. these patients are susceptible to bacterial and fungal infections, as well as extensive tissue granuloma formation. x-chromosome-linked cgd (x-cgd) is most frequently. and it generally produces a severe phenotype, with a mortality rate of 3% to 5% per year despite state-of-the-art prophylaxis and intensive multimodal treatment. at present the most curative treatment for patients with x-cgd is hematopoietic stem cell transplantion (hsct). but for many patients without an hla-matched donor and active infections/inflammatory complications still require novel approches. pparγ agonist such as pioglitazone, approved for type 2 diabetes, was reported to bypass the need for the nadph oxidase for enhanced mtros production and partially restored host defense in cgd. what's more, some animal models and several clinical cases have proved its efficacy. the investigators propose to study the efficacy and safety of the therapy with pioglitazone for children with severe infection of cgd, and its long-term effects. through this study the investigators hope to confirm the benefits of pioglitazone in the treatment of this rare disease especially for those patients without a prompt suitable matched donor or for whom the critical disease conditions force to postpone hsct.

Eligibility criteria:
inclusion criteria: 1. age：1 months to 18 years 2. chronic granulomatous disease 3. with severe infections exclusion criteria: 1. \> 18 years of age 2. infections are treatable by conventional therapy (antibiotics, antimycotics, allogeneic granulocytes)

Keywords: chronic granulomatous disease severe infection pparγ pioglitazone phagocytes
the health log: a randomized clinical trial

Conditions: Rheumatoid Arthritis

Summary: the goal of the present study is to determine if a health management tool improves self-efficacy, satisfaction with the doctor's visit, and agreement of the statement "how satisfied are you that your concerns were addressed during your clinic visit today" over time.

the patient-centered outcomes initiative (paco) was developed at brigham and women's hospital (bwh) to create a replicable model of patient-centered care that will improve treatment for patients with rheumatoid arthritis (ra) and lead to improved outcomes. this work began with focus groups of ra patients to determine which changes or programs they felt were needed. among the suggestions was a health management tool to improve doctor-patient communication. the patient advisory committee (pac), a part of paco which grew out of the focus groups, worked to develop the current health log. it consists of a permanent booklet and a refillable health log version that is filled out before each doctor's appointment. health management tools have also been developed for patients with other chronic conditions. dr. paul fortin of the university health network developed the lupus health passport, which helps patients keep track of their health and also has information about lupus as well as prevention of coronary artery disease (cad) and osteoporosis. however, although these health management tools have been well received, they have not been studied to see if they improve self-efficacy. we would like to determine if the use of the health log improves self-efficacy in ra patients over time. specifically we will be looking to: 1. determine if this health management tool improves self-efficacy over time with use, as measured by the self-efficacy other symptoms scale of the arthritis self-efficacy questionnaire. 2. determine if this health management tool improves satisfaction with the doctor's visit as measured by a vas scale 10-100. 3. determine if this health management tool improves agreement with the statement "how satisfied are you that your concerns were addressed during your clinic visit today", as measured by a vas scale 10-100.

Eligibility criteria:
inclusion criteria: * billing diagnosis of rheumatoid arthritis (714.0) or seronegative inflammatory arthritis and a member of the brass study at brigham and women's hospital exclusion criteria: * less than 18 years of age

Keywords: health management
the effects of two different home-exercise programmes on women suffering long term neck/shoulder muscle pain

Conditions: Neck Pain

Summary: the purpose of this study is to investigate the effects of specific neck/shoulder muscle exercises on pain, function, biochemistry and psychological factors in women suffering chronic neck/shoulder pain.


Eligibility criteria:
inclusion criteria: * female * 20-60 * long term neck/shoulder muscle pain * willing to exercise exclusion criteria: * widespread pain * pregnancy * major trauma in medical history * tendonitis in upper extremities * neurological causes of the pain * inflammatory and hormonal disorders

Keywords: chronic neck shoulder exercise
specified drug-use survey on vedolizumab for iv infusion 300 mg [crohn's disease]

Conditions: Crohn's Disease

Summary: the purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (iv) infusion 300 milligrams (mg) in crohn's disease (cd) patients in the routine clinical setting.

the drug being tested in this survey is called vedolizumab for iv infusion 300 mg. this drug is being tested to treat patients who have cd. this survey is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for iv infusion 300 mg in the routine clinical setting. the planned number of observed patients will be approximately 300. this multi-center observational trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: 1. have moderate or severe active cd 2. have inadequate response to existing therapies exclusion criteria: patients with any contraindication for vedolizumab
metabolic effects of atazanavir/ritonavir versus darunavir/ritonavir in combination with tenofovir/emtricitabine in naïve hiv-1 infected patients

Conditions: HIV-1

Summary: this is a prospective, open controlled trial in which naïve hiv-1 patients will be randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir / emtricitabine. they will be followed up during 96 weeks to determinate the cholesterol levels. randomization will be stratified according to the values of the ratio of total cholesterol/hdl cholesterol obtained during the screening visit (as they will be \<4.5 or ≥ 4.5).


Eligibility criteria:
inclusion criteria: 1. patients of both sexes aged 18 years or more. women of childbearing potential must commit to sexual abstinence or use barrier contraceptive methods during the study. 2. diagnosis of infection by hiv-1 (according to standard diagnostic criteria) 3. not previously treated with antiretroviral drugs 4. plasma viral load \> = 1000 copies / ml 5. clinically stable patients in the investigator's opinion at the time of inclusion 6. able to meet the schedule of study visits and other protocol requirements 7. written informed consent to participate in the study and undergo tests and examinations that entails exclusion criteria: 1. alt, ast levels greater than or equal to 5 times uln (upper limit of normal) 2. serum creatinine level greater than 2 times uln 3. diabetes mellitus (according to clinical and / or use of anti-diabetic agents) 4. obesity (bmi ≥ 30 kg/m2) 5. use of drugs that may affect lipid and / or glucose metabolism for at least 30 days prior to inclusion in the study. 6. active opportunistic infection requiring intravenous treatment 7. patients with known hypersensitivity to any of the products under study 8. use of drugs formally contraindicated in the product information for any of the drugs under study 9. contraindication to the use of any of the drugs under study 10. women pregnant or lactating at the time of study inclusion or anticipating pregnancy in the follow-up period provided by the test
reducing unnecessary computed tomography imaging for maxillofacial injury

Conditions: Maxillofacial Injuries; Image Interpretation, Computer-Assisted; Craniocerebral Trauma; Emergency Medicine

Summary: the aim is to prospectively assess the association between clinical parameters and the presence of maxillofacial fractures in trauma patients admitted to the emergency department. our hypothesis is that a clinical decision aid of critical parameters reduces unnecessary produced ct scans in maxillofacial trauma patients.

the reduction trial is a prospective multicentre cohort study conducted at the level i emergency departments of the university medical center groningen, isala hospital (zwolle, the netherlands) and the level ii trauma center nij smellinghe hospital (drachten, the netherlands). the increased availability of computed tomography (ct) in the emergency department is leading to an overuse for patients with suspected maxillofacial injury. the use of a clinical decision aid could lead to more expedient use of diagnostic imaging within this population of patients. therefore, all maxillofacial trauma patients admitted to the emergency department are included in this trial if the consultation is within 7 days after trauma. both maxillofacial trauma patients admitted to ct scan and patients without a radiological confirmed diagnosis are included. the research protocol was approved by the institutional review board of the university medical center groningen (groningen, the netherlands). informed consent was waived as patients are treated according to the standards of care. upon admission, each patient with maxillofacial injury will be allocated as a midfacial or mandibular trauma. during physical examination, either by the emergency physician or surgical resident, a pre-defined selection of clinical parameters will be assessed focussing on the assessment of potential presence of fractures in the maxillofacial region. the standardization of this examination will be ensured using a pocket map and easy accessible online instructional video's. the clinical parameters, fracture likelihood and physical examination findings will be structurally reported in electronic health record software using a smart tool dedicated for maxillofacial injury. data regarding patient demographics, mechanism of injury, concomitant injury, diagnostic outcome and radiation dose parameters will be derived from the medical records.

Eligibility criteria:
inclusion criteria: * consultation within 7 days of trauma exclusion criteria: * history of maxillofacial surgery

Keywords: multidetector computed tomography cone beam computed tomography maxillofacial fractures zygomaticomaxillary fractures
management of symptomatic post-operative lymphocele

Conditions: Lymphocele

Summary: symptomatic lymphocele (lc) can be a complication after pelvic and para-aortic lymphadenectomy performed for treatment or staging purposes in the management of some cancers. management procedures are: single or repeated puncture, prolonged drainage with drains or catheters, mostly followed by sclerotherapy, or surgery. a decision, which management option is most optimal, should be guided by two principles: first to control patient's symptoms, second to apply the least invasive but effective way to treat lc, taking into account that the patient has undergone major surgery recently, and often needs adjuvant treatment at the moment when symptomatic lc is diagnosed. the aim of this study is to validate feasibility, safety and efficacy of a minimally invasive management of a symptomatic lc - drainage with the usage of vascular catheter followed by sclerotherapy, as well as to evaluate patient's experience on the treatment. patients with symptomatic lc are evaluated with ultrasound. data about diameters, estimated volume of lc and other organs failure if appear is recorded. management options are discussed with patient, and if the method with catheter insertion and drainage is chosen than the patient is eligible for the study. after vascular catheter insertion into lc and fluid evacuation, patient is followed with active drainage. patients with drainage only are observed for a short period of time (up to 7 days), and if not efficient a sclerotherapy is considered. in case a patient does not agree to sclerotherapy, or there are contraindications, or it is doctor's decision that drainage alone is sufficient, than the prolonged drainage without sclerotherapy is the only procedure. the choice about the regimen used for sclerotherapy, it's volume, time intervals between repeated infusion depend on institution practice. data concerning feasibility, safety and efficacy are noted in designated templates. patients' experience on the treatment is evaluated with formal questionnaire facit-ts-g. the study is observational. primary outcome measure is to establish efficacy of the method. secondary outcome measures are safety and patient's experience on the treatment. investigators hope to establish step-by-step guidelines for optimal, minimally invasive management of symptomatic lymphocele.


Eligibility criteria:
inclusion criteria: * symptomatic lymphocele after abdominal lymphadenectomy for cancer, * age \> 18 years old, * informed consent signed, exclusion criteria: * asymptomatic lymphocele, * apparent infection of the skin or subcutaneus tissue over the lymphocele (in the place of potential catheter insertion), * significant coagulopathy

Keywords: lymphocele sclerotherapy drainage percutaneous
hemodynamic monitoring to prevent adverse events following cardiogenic shock trial

Conditions: Cardiogenic Shock; Heart Failure; Ambulatory Hemodynamic Monitoring

Summary: pilot prospective randomized unblinded pragmatic trial of pulmonary artery hemodynamic monitoring following hospitalization for cardiogenic shock


Eligibility criteria:
inclusion criteria: 1. subject or legal representative has signed informed consent form (icf) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator. 2. age ≥ 18 years 3. nyha class iii with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (lvef). 4. survive to discharge during a current hospital admission with cardiogenic shock (cs) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure \ 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmhg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output \ 2 mmol/l (5). hemodynamic criteria include cardiac index ≤ 1.8 l/min/m2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 l/min/m2 and pulmonary artery occlusion pressure ≥ 15 mmhg with vasoactive agents. 5. patients must have internet and phone access (to allow communication of the implanted device with the researchers). exclusion criteria: 1. technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator. 2. treatment with ongoing mechanical circulatory support (mcs) such as a durable left ventricular assist device (lvad) or recipient of a heart transplantation for the treatment of cardiogenic shock during the index hospitalization for cs. 3. if of childbearing potential with a positive pregnancy test. 4. transition to hospice care. 5. intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation. 6. presence of an active, uncontrolled infection. 7. any condition other than heart failure that could limit survival to less than 6 months 8. discharge to facility other than acute rehabilitation or to the ambulatory setting. 9. no access to internet or phone.
the effect of cipralex on quality of life, adrenal activity glucose metabolism, physical and mental health in pcos

Conditions: Polycystic Ovary Syndrome

Summary: objectives: to investigate the effect of cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(pcos). treatment: 2x20 women for 12 weeks. design: double blinded, randomized, placebo controlled.

we want to investigate the effect of cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(pcos). pcos is characterized by menstrual deregulation, high testosterone, mail hair growth and increased stress hormones from the adrenals. furthermore there are changes similar to those seen in diabetes. cipralex is known to decrease stress hormones. but no investigations are on the effect of cipralex on pcos, or how the increased stress hormones affect the pcos condition. we will examine 2x20 women with pcos. they will be randomized to cipralex or placebo. treatment duration is 12 weeks.

Eligibility criteria:
inclusion criteria: * bmi \>25 and \<50 * age \< 50 * pcos exclusion criteria: * epilepsia * use of metformin or oral anticonceptives * pregnancy/breastfeeding

Keywords: quality of life adrenal hyper activity glucose metabolism
treatment of recalcitrant hand and foot warts with intense pulsed light - a randomized controlled trial

Conditions: Warts

Summary: the purpose of the study is for recalcitrant hand and foot warts to compare the efficacy of treatment with intense pulsed light and paring versus paring alone.


Eligibility criteria:
inclusion criteria: * 18 years or older * recalcitrant warts * no previous ipl treatment of warts exclusion criteria: * immunosuppressive treatment * patients suffering from hiv, diabetes or other immunosuppressive diseases * pregnancy * previous ipl treatment * patients with a tendency to prodyce keloids or hypertrophic scars * mosaic and flat warts * lack of informed consent

Keywords: warts intense pulsed light rct recalcitrant hand and foot warts
pathological subtrochanteric fractures in 194 patients

Conditions: Subtrochanteric Femur Fractures

Summary: in this study, the investigators analyze a consecutive series of patients operated for pathological subtrochanteric femur fracture to describe survival and reoperation rates after surgery and to identify risk factors for death. moreover, the investigators include a cohort of patients with non-pathological subtrochanteric fractures for comparison.

the scandinavian sarcoma group (ssg) has initiated a skeletal metastasis register in 1999. the register is a quality-control database which prospectively collects individual-based information on patients operated for skeletal metastases in the long bones and pelvis. data on patient identity, age, sex, primary tumor, location of metastases, type of pathological fracture, and perioperative treatment were gathered. information concerning surgical procedures such as method of fixation, type of implant, and postoperative complications are registered. moreover, some clinical data such as pain levels (no, light, moderate, strong, or severe pain), pain medication use, mobility, and the karnofsky performance score are recorded. we will identify all patients surgically treated for pathological subtrochanteric femur fractures during 1999-2009. the stockholm hip fracture group provides data on the reference group. during 2003, a consecutive series of patients with acute non-pathological subtrochanteric femur fractures treated in stockholm were included in a prospective cohort study. the regional ethical review board located at the karolinska institutet approved the study (dnr 206/02). the aim of this study is to analyze survival and reoperation rates of patients operated for pathological subtrochanteric femur fracture. we want compare those findings with a cohort of patients with non-pathological subtrochanteric fractures.

Eligibility criteria:
inclusion criteria: * all patients with pathological subtrochanteric femur fractures register in the scandinavian sarcoma group register

Keywords: survival after surgery pathological subtrochanteric fractures
investigating the effectiveness of intradialytic massage on cramping in dialysis patients

Conditions: End Stage Renal Disease

Summary: primary aim. the primary aim is to determine the effectiveness of intradialytic massage on the frequency and severity of cramping among hemodialysis patients prone to lower extremity cramping during treatment. hypothesis: compared to control patients, intervention patients will be significantly less likely to have intradialytic cramping that requires staff intervention or treatment termination. this is a study involving 32 (16 intervention, 16 control) hemodialysis patients with frequent lower extremity cramps during treatment. frequent cramping during dialysis treatments is defined as 1 or more episodes of lower extremity cramps during or after dialysis over the previous 2 weeks. cramping frequency will be determined by chart notes. muscle cramping is defined as contraction of the large muscle group of the lower extremities sufficiently painful to require intervention by the dialysis staff for relief. the intervention group will receive a 20 minute massage of the lower extremities by a trained and licensed massage therapist during each treatment (3x per week) for 2 weeks. the control group will receive usual care by dialysis center staff.


Eligibility criteria:
inclusion criteria: * \>18 years of age and \<90 years of age. * on hemodialysis greater than 6 months. * a stable dry weight for the previous month. * frequent cramping during dialysis treatments defined as 1 or more episodes of lower extremity cramps during or after dialysis over the previous 2 weeks. * ability to give informed consent. exclusion criteria: * sores or wounds on feet or lower legs. * dermatitis of lower legs or feet. * edema greater than 2+. * known history of deep vein thrombosis. * vascular access (arteriovenous (a-v) graft, a-v fistula or catheter) for hemodialysis is located in the lower extremity. * evidence of open leg wounds, history of lower extremity amputation or documented history of peripheral vascular disease. * acute hemodynamic or clinical instability per the dialysis nurse or tech just prior to the intervention.