Kornimate/medical-research-clean huggingface dataset:
saroglitazar magnesium 4 mg in the treatment of nafld in women with pcos (evidences vii)

Conditions: Non-alcoholic Fatty Liver Disease in Women With PCOS

Summary: this is a multicenter, phase 2a, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of saroglitazar magnesium in women with well characterized pcos.

this is a multicenter, phase 2a, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of saroglitazar magnesium in women with well characterized pcos. \\ the study will be conducted over a period of up to 34 weeks and will include screening (days -28 to -7) phase, a 24-week treatment phase following randomization on day 1. the primary endpoint of the study is change in hepatic fat content from baseline following 24 weeks of treatment as measured by mri-pdff.

Eligibility criteria:
inclusion criteria: * females, 18 to 45 years of age. * previously confirmed diagnosis of pcos: 1. oligo-and/or anovulation; 2. hyperandrogenism (clinical and/or biochemical); 3. polycystic ovary morphology on ultrasonography * evidence of nafld within 6 months prior to the screening visit (visit 1). * alanine transaminase ≥ 38 u/l at visit 1. visit 2 alt must not increase \>30% from visit 1. * hepatic fat fraction ≥10% by mri-pdff. * willingness to participate in the study. * ability to understand and give informed consent for participation. * woman who agrees to use the contraceptive methods. exclusion criteria: * presence of other chronic liver diseases (hepatitis b or c, autoimmune hepatitis, cholestatic liver disease, wilsons disease, hemochromatosis, etc.). * average alcohol consumption ≥ 7 drinks per week for women in the 6 months prior to enrollment. * clinical, imaging, or histological evidence of cirrhosis. * patients who have used medications known to cause hepatic steatosis for more than 2 weeks in the past year. * prior bariatric surgery. * weight loss of more than 5% in the 3 months preceding screening. * severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness). * known allergy, sensitivity or intolerance to saroglitazar magnesium, comparator or formulation ingredients. * use of antidiabetic and lipid lowering medications if the dose is not stable for at least the 3 months preceding screening. * intake of vitamin e (\>100 iu/day) or multivitamins containing vitamin e (\>100 iu/day) 3 months before enrollment. * use of drugs with potential effect on nafld/nash in the 3 months prior to screening. * illicit substance abuse within the past 12 months. * pregnant or breast feeding females. * women with known cushing syndrome or hyperprolactinemia. * refusal or inability to comply with the requirements of the protocol, for any reason, including scheduled clinic visits and laboratory tests. * history of myopathies or evidence of active muscle diseases. * history or current significant cardiovascular disease. * history of malignancy. * history of bladder disease.

Keywords: nafld pcos saroglitazar magnesium
virtual reality for the management of pain and anxiety for outpatient interventional radiology procedures

Conditions: Pain; Anxiety

Summary: this study explores the use of virtual reality (vr) to reduce pain and anxiety during thyroid biopsies and picc line insertions under local anesthesia. one group experienced the procedure with vr, while the other group did not. participants completed questionnaires before and after the surgery to measure pain and anxiety levels. the main goal is to observe if vr can significantly decrease pain and anxiety during these procedures.

this prospective, randomized, controlled study investigates the efficacy of virtual reality (vr) as a means to alleviate pain and anxiety in individuals receiving thyroid biopsies and picc placements with local anesthesia. this study was conducted at temple university hospital between june 2021 and august 2022. a total of 107 patients were randomized into treatment and control groups. the vr experience involved wearing a headset with an immersive 3d visual display and accompanying music, simulating a calming environment. patients completed visual analog scales for pain and anxiety both before and after the intervention, reflecting their pain and anxiety levels prior to and during the procedure. the primary endpoints were to observe the effect of vr on pain and anxiety in both groups.

Eligibility criteria:
inclusion criteria: * age over 18 * scheduled to receive fine-needle aspiration (fna) thyroid biopsy * scheduled to receive peripherally inserted central catheters (picc) exclusion criteria: * declining to participate * inability to provide consent * emergency procedures * administration of general anesthesia/moderate sedation * visual or hearing deficits * pregnancy * current prisoner status * nerve or sensory deficits over area of procedure * covid-19 positive status

Keywords: interventional radiology thyroid biopsy peripherally inserted central catheter virtual reality pain anxiety visual analog scale
study of molecular and genetic abnormalities in patients with myeloid neoplasms

Conditions: Acute Myeloid Leukemia; Myeloproliferative Neoplasms; Myelodysplastic Syndromes; Myeloproliferative/Myelodysplastic Neoplasm

Summary: the objective of this study is to describe the prevalence and prognostic impact of the most common genetic abnormalities in patients with myeloid neoplasms, including acute myeloid leukemia (aml), myeloproliferative neoplasms (mpn), myelodysplastic syndromes (mds) and myeloproliferative/myelodysplastic neoplasms. patients will have samples of blood and/or bone marrow collected and sent to hospital israelita albert einstein for analysis and storage. patients with a diagnosis of acute myeloid leukemia will be treated according to an uniform protocol.


Eligibility criteria:
acute myeloid leukemia-intensive chemotherapy inclusion criteria: * diagnosis of aml according to who criteria * age greater than 18 years * performance status (ecog) between 0-2 * adequate liver and kidney function * signed informed consent form * no prior therapy for aml, except use of hydroxyurea for control of elevated white blood cell counts * adequate contraception for fertile men and women * eligible for intensive chemotherapy (as judged by the treating physician) exclusion criteria: * acute myeloid leukemia with retinoic acid receptor alpha (rara) translocations (apl, acute promyelocytic leukemia) * pregnant women * hiv-positivity * new york heart association class iii and iv congestive heart failure * patient refuses to use adequate contraception * history of hypersensibility to any of the used chemotherapy drugs * patient refuses to sign informed consent form acute myeloid leukemia-non-intensive chemotherapy inclusion criteria: * diagnosis of aml according to who criteria * age greater than 18 years * signed informed consent form * no prior therapy for aml, except use of hydroxyurea for control of elevated white blood cell counts * adequate contraception for fertile men and women * non-eligible for intensive chemotherapy (as judged by the treating physician) exclusion criteria: * acute myeloid leukemia with rara translocations (apl, acute promyelocytic leukemia) * pregnant women * hiv-positivity * patient refuses to use adequate contraception * history of hypersensibility to any of the used chemotherapy drugs * patient refuses to sign informed consent form chronic myeloid disorders: inclusion criteria: * diagnosis of myeloproliferative neoplasm or myelodysplastic syndrome or myeloproliferative/myelodysplastic neoplasm according to who criteria * age greater than 18 years * signed informed consent form exclusion criteria: * patient refuses to sign informed consent form

Keywords: acute myeloid leukemia myeloproliferative neoplasms myelodysplastic syndromes myeloproliferative/myelodysplastic neoplasm leukemia mds mpn aml chronic myelomonocytic leukemia (cmml) polycythemia vera (pv) essential thrombocythemia (et) myelofibrosis (mf)
study to evaluate the safety and effectiveness of gp0116

Conditions: Skin Manifestations

Summary: this is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the u.s. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (nlfs).


Eligibility criteria:
inclusion criteria: * men and non-pregnant, non-breastfeeding women aged 22 years or older. * wsrs grade of 3 or 4 (moderate to severe folds) on each nlf as assessed by the blinded evaluator. the wsrs for each nlf does not need to be equal. * intent to undergo treatment for correction of both left and right nlf. exclusion criteria: * known/previous allergy or hypersensitivity to any injectable hyaluronic acid (ha) gel * known/previous allergy or hypersensitivity to local anesthetics * previous or present severe or multiple allergies manifested by severe reactions * previous facial surgery near the treatment area
non-inferiority evaluation of multicenter, randomized, single-blind, parallel-controlled clinical trials on the safety and efficacy of full-suture anchors for rotator cuff injury and/or shoulder instability surgery

Conditions: Shoulder Instability Rotator Cuff Injury

Summary: multicenter, randomized, single-blind, parallel-controlled non-inferiority assessment for safety and efficacy of rotator cuff injury and/or shoulder instability surgery

this clinical trial compares the clinical effects of rotator cuff injury and/or shoulder instability surgery with the full suture anchor made by hangzhou ruijian mastine medical equipment co., ltd. and the polyether ether ketone bone anchor system made by arthrex, inc., usa, and evaluates the safety and effectiveness of the experimental device in clinical application

Eligibility criteria:
inclusion criteria: 1. the age of the patients ranged from 18 to 75 years (including 18 and 75 years), with no gender limitation 2. patients with rotator cuff injury and/or instability of the shoulder joint are eligible for surgical indications of suture anchor 3. subjects were willing and able to sign informed consent exclusion criteria: 1. patients with severe osteoporosis； 2. a variety of conditions, such as previous infection, suspected infection, current infection, that may or may lead to insufficient implant support or impaired rehabilitation； 3. those with severe allergic constitution (e.g. severe allergic purpura, asthma, rhinitis, shock, etc.)； 4. patients with abnormal liver and kidney function \[sgpt (alt) or sgot (ast) or creatinine (cr)\] were 1.5 times higher than the upper limit of normal value; patients with coagulation dysfunction (such as prothrombin time (pt) prolonged or shortened \> 3 s, activated partial thromboplastin time (aptt) prolonged or shortened \> 10 s, platelet count (plt) \< 50 \*109/l)； 5. those with severe cardiopulmonary disease and uncontrolled epilepsy within half a year are limited to participate in the study； 6. cervical spinal cord disease, brachial plexus nerve injury, poor compliance, psychosis, mental disorders, difficult to cooperate with； 7. pregnancy test positive, pregnant or lactating women, recent family planning; during the trial can not take feasible contraceptive measure； 8. surgical site peripheral nerve injury； 9. subjects who had participated in clinical studies of other drugs, biological agents or medical devices before enrollment did not reach the primary endpoint 10. high blood pressure control is still not suitable for surgery； 11. malignant tumor patients； 12. researchers believe that there are other circumstances that are not suitable for this clinical trial.

Keywords: shoulder instability rotator cuff injury
does a follow-up appointment help parents of children on picu?

Conditions: Post Traumatic Stress Disorder

Summary: the aim of our study is to determine the feasibility of carrying out a randomized controlled trial (rct) to investigate whether screening parents of children admitted to pediatric intensive care unit (picu) so as to target follow-up at those most at risk of developing posttraumatic stress disorder (ptsd), is effective at reducing adverse psychological sequelae.

the study will assess the feasibility of offering a follow up clinic to parents identified to be vulnerable for future psychological difficulties after their child's admission to the paediatric intensive care unit (picu) at bristol children's hospital. both mothers and fathers of children admitted to picy for a duration of at least 12 hours will be invited to participate in this study. screening measures will be used to identify vulnerability to future post-traumatic stress disorder (ptsd) and depression. where one or both of the parents has been scored as high risk they will be randomised to receive the intervention or the control arm of the study (ratio 1:1). the intervention involves a follow-up clinic two months pots admission, staffed by the unit clinical psychologist, a picu doctor and picu nurse. in the control arm no follow-up clinic will be offered (i.e. current standard care). objectives: i) to investigate the recruitment rates, clinic attendance and follow-up rates in order to perform an accurate sample size calculation for a larger study. ii) to carry out initial statistical analysis to estimate the odds ratio and 95% confidence interval of developing ptsd, anxiety and depression after being offered the follow-up intervention as opposed to not being offered it. iii) to assess the acceptability of providing targeted follow-up both to those who receive it and those who are excluded due to low risk. the study is of importance to the public because not only does ptsd negatively affect quality of life, it is also associated with increased use of health care services and resources.

Eligibility criteria:
inclusion criteria: * all parents of children admitted to paediatric intensive care for over 12 hours. exclusion criteria: * parents deemed unsuitable for the study by the responsible consultant. this will include families where a child's condition is suspected to result from non-accidental injury or where withdrawal of care is being discussed due to a child's critical condition. families will be excluded if their child died during or after admission, as these families are already followed up routinely.

Keywords: picu follow up ptsd
mirs 04 : interpectoral nerve block with ropivacaine versus placebo before breast cancer surgery

Conditions: Malignant Neoplasm of Breast

Summary: compare the effect of ropivacaine versus placebo pectoral nerve block (pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery.

before surgery, the 3rd interpectoral space will be identified. after aspiration, half of the solution of ropivacaine 5 mg/ml not exceeding 3 mg/kg of maximal dose and 30 ml of maximal volume or saline (not exceeding 30 ml of maximal volume) will be injected into the interpectoral space underneath the pectoralis major muscle for the pecs 1 block. the other half of the solution will be injected above the serratus anterior muscle at the third rib. evaluation of the percentage of patients treated with step 2 or 3 analgesics during the three postoperative hours.

Eligibility criteria:
inclusion criteria: 1. women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by breast-conserving surgery (tumorectomy) with sentinel node technique on one day surgery. 2. age between 18 and 85 years. 3. asa class 1, 2 or 3 4. signed informed consent form. exclusion criteria: 1. ongoing neoplasm or history of neoplasm other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial. 2. axillary dissection planned during surgery planning 3. all bilateral surgery the day of pecs administration 4. metastatic breast carcinoma at diagnosis (m1). 5. allergy to local anesthetics and morphine. 6. use of analgesics during the 12 hours preceding the surgical procedure. 7. history of ipsilateral surgery during the previous 6 months. 8. history of substance abuse. 9. pregnant woman or breastfeeding. 10. subjects deprived of their liberty or under guardianship (including temporary guardianship). 11. subjects no covered by social security scheme 12. experiencing any psychiatric condition or major cognitive impairment that may hamper completion of self-reported questionnaires. there is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period

Keywords: surgery conservative nerve block
competitive accuracy of radiological imaging compared to liver biopsy in patients with liver fibrosis

Conditions: Liver Fibroses; Liver Cirrhosis

Summary: the study "competitive accuracy of radiological imaging compared to liver biopsy in patients with liver fibrosis" is designed to test the accuracy of non-interventional radiological imaging and compare its results with the "gold standard" liver biopsy. this is prospective non-randomized single patient group study.


Eligibility criteria:
inclusion criteria: * chronic liver disease * signed informed consent * liver biopsy indicated by treating gastroenterologist/infectologist exclusion criteria: * non-corrected blood coagulation tests * acute liver disease * age below 18 years or above 80 years * disagreement to participate in the study * pregnancy

Keywords: liver fibrosis liver cirrhosis liver biopsy shear wave imaging dynamic liver scintigraphy
internet-based program to improve asthma management in children

Conditions: Asthma

Summary: asthma is a respiratory condition that affects millions of children. it can be controlled, however, with the proper medications and treatment. asthmanet, an internet-based asthma management system, aims to improve the asthma care of children by providing their parents and doctors with appropriate tools and feedback related to asthma management. the purpose of this study is to evaluate the effectiveness of asthmanet at improving quality of care and controlling asthma symptoms in children.

in the united states, almost 9 million children have been diagnosed with asthma. it is a leading cause of hospitalization, chronic disease, and school absenteeism. with the proper treatment, most children with asthma are able to lead a normal life. however, if asthma is not adequately controlled, it can be a life-threatening disease. it is important for parents to work with their child's doctor to develop a comprehensive treatment plan that minimizes asthma symptoms. asthmanet, an interactive web-based system, aims to improve the quality of care for children with asthma by enhancing parents' asthma care skills and encouraging parents to discuss their child's asthma care with their doctor. asthmanet provides evidence-based guidelines, asthma management tools, and individually tailored feedback to both parents and physicians to improve communication and enhance asthma management skills and behaviors. the goal of this study is to evaluate the effectiveness of asthmanet at increasing medication and treatment adherence in children with asthma. this 1-year study will enroll young children with asthma. participants will be randomly assigned to either use the asthmanet web site or not use the web site. the web site will provide parents of children in the asthmanet group with individualized clinical information regarding their child's asthma care and with decision-making aids that they can share with their child's doctor. the web site will also prompt parents to make additional doctor appointments, as needed, to discuss their child's condition. all children will attend regularly scheduled doctor's appointments for asthma and receive their usual care; there are no additional study visits specifically for this study. study researchers will review medical records to analyze medication usage and asthma symptoms. participants in the asthmanet group will complete questionnaires on a monthly basis to assess asthma status; the control group will complete questionnaires at month 6 and year 1.

Eligibility criteria:
inclusion criteria: * asthma * receives asthma care at a clinic in western washington * has access to the internet at home exclusion criteria: * does not speak or read english
diabetes group visits

Conditions: Diabetes

Summary: this pilot study aims to increase access to diabetes education by delivering it in a culturally-appropriate community setting and by involving different members of the diabetes care team including physicians, diabetes educators, and health promoters/community health workers. diabetes medical group visits will be held at the grady north dekalb satellite clinic the third thursday of the month starting in october 2009. there will be two cohorts of patients- english speaking patients and spanish speaking patients. each group will be scheduled for 4 2-hour group visits throughout a period of 9 months. these visits will be every 8 weeks for each group. during the visit, the patient will be seen by a physician, attend a diabetes education session, re-fill their diabetes medications and receive lab orders.

patients who participate in the diabetes group visits should achieve improvement in clinical outcomes - better a1c levels, reduced blood pressure, reduced cholesterol levels ; adherence to evidence-based medicine - keeping appointments and scheduling eye exams, foot-checks, and/or taking medication as prescribed; behavioral outcomes- goal setting, achievement of goals, problem solving; access - attendance at educational sessions; ability to obtain affordable medications and devices; and satisfaction among patients and health professionals.

Eligibility criteria:
inclusion criteria: * primary care at the grady north dekalb health center * valid grady card * age 18-80 * hba1c\>=8.0% - 11.0% * must speak english or spanish exclusion criteria: * -primary care provider excludes patient from study * patient is reluctant to participate in a group visit * reduced life expectancy as determined by any of the following: * end-stage renal disease on dialysis * active congestive heart failure ii and iv * lung disease requiring supplemental oxygen * current malignancy with any evidence of disease or currently undergoing chemotherapy or radiation therapy * cirrhosis of the liver * aids * mayor mental health disorders
a multicomponent intervention for prevention and treatment of sleep disturbances in a psychiatric intensive care unit

Conditions: Dyssomnias

Summary: hospitalized adult patients suffer from sleep deprivation, which has been associated with multiple negative consequences, both in short and in the long term. many factors have been attributed to poor sleep quality, including excessive noise, inappropriate lighting, interactions with the healthcare team, administration of drugs, patients' symptoms, among others. there is scarce evidence reporting multicomponent interventions aimed at ensuring and improving sleep quality in hospitalized patients. the following before-after, randomized controlled trial will evaluate and determine the feasibility, acceptability and effectivity of a multicomponent intervention in improving sleep quality and reducing the consequences of poor sleep in a psychiatric intensive care unit (picu). the intervention is comprised of changes in health personnel habits, improvements in the picu environment, patient's psychoeducation and continuous sleep and activity monitoring through a validated wearable device.


Eligibility criteria:
inclusion criteria: * hospitalized in the last 72 hours. * capacity to consent * approval by treating physician exclusion criteria: * active psychosis * active eating disorder * delirium * major cognitive disorder

Keywords: sleep psychiatric intensive care unit multicomponent intervention wearable activity tracker behavioral intervention psychoeducation environmental interventions