Kornimate/medical-research-clean huggingface dataset:
telmisartan as an adjunctive treatment for metabolic problems in patients with schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this is a 12-week, randomized, double-blinded, placebo-controlled trial of telmisartan 80 mg/day as an adjunctive to clozapine or olanzapine therapy, in 70 schizophrenia subjects to examine telmisartan's effect on glucose metabolism, weight, food intake, resting energy expenditure, and body composition. in addition, the study will examine insulin's effects on psychopathology and cognition. potential subjects will be identified by their clinicians at the freedom trail clinic, or massachusetts general hospital. approximately 70 subjects will be enrolled.

the specific aims include: primary aims: 1. examine the efficacy of telmisartan added to regular doses of clozapine or olanzapine in improving insulin resistance. 2. examine the efficacy of telmisartan in reducing fasting triglycerides. secondary aims: 1. examine the effects of telmisartan on negative symptoms, positive symptoms, and cognitive function. 2. examine telmisartan's effects on lipids, body composition, and waist/hip ratio. 3. examine telmisartan's effects on inflammatory biomarkers including c-reactive protein (crp) and interleukin 6 (il-6).

Eligibility criteria:
inclusion criteria: 1. age 18-65 years 2. diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype 3. treatment with clozapine or olanzapine for at least 6 months 4. stable dose of antipsychotic agent for at least one month 5. well establish compliance with out-patient medications 6. females subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study. exclusion criteria: 1. inability to provide informed consent 2. current substance abuse 3. psychiatrically unstable 4. significant medical illness including severe cardiovascular, hepatic, renal disease 5. current insulin treatment of diabetes 6. history of immunosuppression 7. current or recent radiation or chemotherapy treatment for cancer 8. chronic use of steroids 9. pregnancy or breast feeding 10. use of diuretics, digoxin, warfarin because the possible drug-drug interaction of telmisartan

Keywords: schizophrenia cognition metabolism antipsychotics psychopathology
the effects of a combined exercise training program on vascular health and metabolic profile in obese adolescent girls.

Conditions: Obesity, Adolescent

Summary: the purpose of this study was to examine the impact of 12 weeks of combined exercise training (cet) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance, and body composition in obese adolescent girls. thirty obese adolescent girls participated in this study. the girls were randomly divided into cet group (n=15) and control group (n=15). the cet group performed concurrent resistance training followed by aerobic training at 40-70% of the heart rate reserves (hrr) 3 days/week for 12 weeks. plasma nitric oxide, endothelin-1, c-reactive protein, arterial stiffness, homeostasis model assessment of insulin resistance (homa-ir), glucose, insulin, and the adiponectin/leptin ratio were measured before and after the 12-weeks study.


Eligibility criteria:
inclusion criteria: * obese with hyperinsulinemia * abdominal obesity * sedentary (no regular exercise training or physical activity) * no weight loss diet during last 6 months. exclusion criteria: * hypertension * pregnancy * chronic disease
lyon pji retrospective cohort study

Conditions: Bone and Joint Infection

Summary: bone and joint infections (bji), although infrequent (prevalence of 70 per 100,000 in france), have a significant economic and clinical impact. between 2008 and 2013, the prevalence of bji increased and infections involving joint prosthesis (pji) represent a third of bji in france. they are most often post-operative and more expensive than native ioas. this study aims to describe pji and understand the failure mechanisms of pji in order to improve their management.


Eligibility criteria:
inclusion criteria: * patients having had a pji between 2018 and 2020 exclusion criteria: -

Keywords: prosthesis joint infection relapse
mcmaster catheterization for thoracoscopic surgery study

Conditions: Non-Small Cell Lung Cancer; Lung Neoplasms; Metastatic Lung Cancer; Urinary Retention; Urinary Tract Infections

Summary: it is common practice to insert a foley catheter into the bladder to drain urine during and after a lung resection. recently, there has been increasing interest in the potential risks associated with this catheterization, particularly with regard to infection. as thoracic surgery adopts minimally invasive surgical techniques, the need for urinary catheterization during surgery is being questioned since these less invasive surgeries are known to result in less post-operative acute pain, shorter length of stay, and other outcomes that tend to decrease overall anesthetic needs for this patient population. thus, there is a need to investigate whether patients who have had a minimally invasive lung resection truly need the foley catheter at all. this will be achieved by assigning patients to either an experimental no-catheter group or the standard of care routine urinary catheter group to determine if patients with no catheter experience different rates of complications. this pilot study will primarily determine if there is a difference in post operative urinary complications between the groups. it is hoped that this study will definitively determine whether a foley urine catheter is a necessary procedure in the course of a minimally invasive lung resection.

urinary catheterization is standard practice during and shortly after lung resections. the standard practice is being questioned in an era where unnecessary interventions are being re-considered, particularly since urinary catheterization is not without a risk of adverse events. the study is being done to establish an evidence base to support widespread discontinuation or continuation of this standard practice. consenting patients will be randomized to either the catheterized or non-catheterized arms. patient urinary management will be managed as per an a priori-defined protocol that follows st. joseph's healthcare hamilton (sjhh) institutional standards.

Eligibility criteria:
inclusion criteria: * must undergo minimally invasive video-assisted thoracoscopic thoracic surgery (vats) or robotic-assisted thoracoscopic thoracic surgery (rts) anatomic pulmonary resection surgery (lobectomy, segmentectomy) * must be diagnosed with primary or secondary lung cancer eligible for resection exclusion criteria: * patients who are unwilling to comply with study procedures * patients who are unable to complete questionnaires with assistance * non-vats/rts pulmonary resection patients * non-anatomic pulmonary resection * patients with benign disease * patients requiring chronic urinary catheterization * patients with contraindications to placement of urinary catheter

Keywords: urinary catheterization randomized controlled trial thoracic surgery, video-assisted quality improvement evidence-based practice post-operative complications
a study for patients with secondary progressive multiple sclerosis

Conditions: Secondary Progressive Multiple Sclerosis

Summary: the purpose of this study is to determine whether mbp8298 is effective and safe in the treatment secondary progressive multiple sclerosis. dirucotide is generic name for mbp8298.


Eligibility criteria:
inclusion criteria: * documented history of spms * absence of relapse in the 3mos prior to baseline * edss of 3.5 - 6.5 * pyramidal or cerebellar fss greater than or equal to 3 * a cohort of 100 hla dr2/4 negative patients is required. once enrollment to this cohort is complete, all further patients are required to be hla dr2/4 positive. * informed consent * subject reliability and compliance exclusion criteria: * diagnosis of primary progressive ms * subjects have previously received mbp8298 * recent history of malignancy, with the exclusion on basal cell carcinoma. * steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental ms treatment * therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or acth for relapse treatment. * initiation or discontinuation of therapy with 4-ap or 3,4-dap at any time during the study period. * history of anaphylactic/anaphlactoid reactions to glatiramer acetate * abnormal lab values at the screening visit deemed by the investigator to be clinically significant * known allergy to gadolinium-dtpa * treatment at any time with cladribine, total lymphoid irradiation, monoclonal antibody treatment * treatment at any time wtih an altered peptide ligand * any conditions that could interfere with the performance of study specific procedures e.g.mri * previous randomization to this study * known positivity for hiv, hepatitis b, or hepatitis c * participation in any other non-ms clinical trial within 30 days prior to performance of the first study specific test or any investigational therapy in the past 6 mos. * females who are breast feeding, pregnant or not using a medically approved method of contraception regularly * known or suspected current or past alcohol or drug abuse (within the last year) * any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements * any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study
dragonboat activity for breast cancer

Conditions: Breast Cancer

Summary: the goal of this study is to determine how a structured and supervised physical activity program linked to dragon boat practice can improve motivation to participate in physical activity sessions. it is also the purpose of this study to evaluate the improvement in body composition, body image perception and physical function. for this purpose, a group of women operated on for breast cancer was recruited and divided into two experimental groups: one group participated in a structured program of dragon boat while the other followed a home-based program of exercises independently in the home environment. anthropometric measures (weight, height, bmi) and arm circumference, data on lifestyle and psychological well-being were evaluated by means of questionnaires. tests were also performed to assess shoulder strength, aerobic capacity and mobility. the results of this study will (a) identify the strategies used that make dragon boat activity effective in ensuring quality participation in physical activity, (b) define the physiological effects of dragon boat activity on physical functionality and (c) correlating objective measures with subjective perceptions thanks to the integration of new body composition analysis techniques (regional bia) and validated questionnaires on the perception of body image.


Eligibility criteria:
inclusion criteria: * age 45-70 years * body mass index: \<18 and \<30 kg / m2 * diagnosis and treatment for breast cancer exclusion criteria: * other corneal diseases (cardiovascular, hepatic, respiratory) * participation in other structured exercise programs
hypothalamic-pituitary-adrenal (hpa) axis study in adult and adolescent subjects with perennial allergic rhinitis (par)

Conditions: Perennial Allergic Rhinitis

Summary: the purpose of the study is to evaluate the effects of bdp hfa nasal aerosol on hpa-axis function.


Eligibility criteria:
inclusion criteria: * informed consent * male or female subjects 12-45 years of age * documented history of perennial allergic rhinitis * general good health * other criteria apply exclusion criteria: * history of physical findings of nasal pathology (within 60 days prior to screening visit 1) * participation in any investigational drug study 30 days preceding screening visit 1 * history of respiratory infection/disorder with 14 days preceding screening visit 1 * use of any prohibited concomitant medications
manually assisted cough technique and incomplete cervical spine injury

Conditions: Spinal Cord Injuries

Summary: to determine the effectiveness of manually assisted cough technique on peak cough flow and pulmonary functions in patients with incomplete cervical spine injury. previous studies were designed to target only a small sample. level and american spinal cord injury association (asia) scale were not specified so this study covers this aspect.

the previous studies show that the partial control of the muscle necessary for cough, which varies with motor level, proportionately improves the patient's ability to cough volitionally. spinal cord injury also affects mucus clearance, the peak flow meter was used to assist the ability of cough and they also measure the peak cough flow (pfc).in the literature for the airway clearance, the following techniques were used, incentive spirometer, balloon, and blowing exercise, manually assisted cough technique active cycle of breathing exercise, postural drainage, autogenic drainage, positive expiratory pressure. there is increasing interest in strategies such as interval training that may provide a tolerable training load while maintaining an effective stimulus for adaptation. manually assisted cough technique is used to enhance the cough strength, to help with mucus secretion it can be carried out in lying, side-lying, or sitting positions.it is important that clear secretion in order to maintain clear and healthy lungs, the risk of repeated chest infection and complication can be reduced which improve the quality of life. manually assisted cough is a technique using strong arms to assist cough. this may be providing help in neuromuscular disease or spinal cord injury with weak respiratory and abdominal muscle.

Eligibility criteria:
inclusion criteria: * the patient with incomplete cervical spine injury at c4, c5, * bronchitis, * shortness of breath having peak cough flow (pcf) less than 50% and * asia impairment scale c \&d exclusion criteria: * the patient with upper cervical, * thoracic, and * lumbar spine injury, * diagnosed with tb, * degenerative diseases, * surgical conditions, and * complete spinal cord injury.

Keywords: manually assisted cough technique peak cough flow pulmonary function spinal cord injury
use of a treated, devitalized and sterile meniscus segment (menisc-t) in the treatment of scaphotrapeziotrapezoid osteoarthritis

Conditions: Osteoarthritis Hand

Summary: the purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus implant placed in joint interposition in the treatment of stt osteoarthritis.


Eligibility criteria:
inclusion criteria: * male or female; age between 18 and 75 years. * patient with symptomatic stt oa. * patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention. * patient with a quickdash score \> 33 points (converted to 50%). * patient with wrist pain (vas) in front of the stt joint at rest \> 4/10. * patient who received the study information and provided consent. * member or beneficiary of a national health insurance plan. exclusion criteria: * pregnant or breastfeeding woman; woman without effective contraception. * patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically. * patient with signs of neuropathy with functional disorders such as hyperesthesia. * patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia. * person confined by a judicial or administrative decision. * adult subjected to legal protection measures or unable to provide his/her consent.

Keywords: scaphotrapeziotrapezoid osteoarthritis (stt oa)
a multicenter, prospective, observational study with primatrix for the treatment of neuropathic diabetic foot ulcers

Conditions: Foot Ulcers, Diabetic

Summary: to evaluate the effectiveness of primatrix in the treatment of dfus in subjects without significantly compromised arterial circulation.


Eligibility criteria:
inclusion criteria: * type i or type ii diabetes with investigator-confirmed reasonable metabolic control * peripheral neuropathy * a full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area * an ulcer which has been in existence for a minimum of 30 days, prior to the day of screening exclusion criteria: * suspected or confirmed signs/symptoms of wound infection * wounds with exposed bone or tendon * hypersensitivity to bovine collagen
comparing of the pharmacokinetic, pharmacodynamic, safety and immunogenicity of mw032 and xgeva® in healthy adults

Conditions: Bone Tumor

Summary: a randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of mw032 and xgeva® in healthy adults.

this is a phase i, single center, randomized, double-blind and parallel group clinical trial. the primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of mw032 and xgeva® in healthy volunteers. the secondary objective are to assess the clinical safety and immunogenicity similarity of single and subcutaneous injections of mw032 and xgeva® in healthy volunteers. at the same time, preliminary evaluate the pharmacodynamic similarity between mw032 and xgeva®. subjects would receive a single 120mg（1.7ml）of mw032 or xgeva® through subcutaneous injection.

Eligibility criteria:
inclusion criteria: * age: 18-65 years old (including 18 and 65 years old), healthy male subjects. * body mass index (bmi) within the range 19-28kg/m2. * history, physical examination, laboratory tests and test related items of inspection were normal or mildly abnormal clinically insignificant. * volunteered to participate in this clinical trial, capable of giving written informed consentan. * the subject (including the subject's partner) takes effective contraceptive measures. exclusion criteria: * nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the results of the study. * occurred or suffering from osteomyelitis or onj (mandibular necrosis) previously. * clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease). * subject has viral hepatitis (including hepatitis b and hepatitis c), aids antibodies, and treponema pallidum antibodies. * those who have used the following drugs within 1 month or 5 half-lives (whichever is longer) before participating in this study, including but not limited to: estrogen-containing contraceptives, bisphosphonates, fluoride, hormone replacement treatment (ie tibolone, estrogen, estrogen-like compounds, such as raloxifene), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin d supplements (\>1000 iu/day), corticosteroids (inhaled or topical corticosteroids can be used 2 weeks before enrollment), anabolic hormone drugs, calcitriol, diuretics.

Keywords: denosumab biosimilar
cardiac substructure radiation dose and early clinical monitoring of stage n2-3 non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: calculating which cardiac substructure accepting with the highest radiation dose by conventional radiotherapy, then to investigate the relationship between the changes of global longitudinal strain or cardiac magnetic resonance imaging and cardiac biomarkers and the certain cardiac substructure for stage n2-3 non-small cell lung cancer

all patients receive intensity-modulated radiotherapy (imrt). the prescription dose of ptv is 60-70gy，troponin i, troponin t, hypersensitive troponin, brain natriuretic peptide and nt-probnp are detected before radiotherapy, at the end of radiotherapy (day 15), at the end of radiotherapy and at 1 month after radiotherapy. echocardiography was performed before radiotherapy, in the middle of radiotherapy (day 15) and at the end of radiotherapy to obtain global longitudinal strain value. cardiac magnetic resonance imaging is used to measure the blood flow of the anterior descending coronary artery before and at the end of radiotherapy.

Eligibility criteria:
inclusion criteria: 1. patients at tnm stage n2-n3 nsclc confirmed by histopathology or cytology using iaslc international tnm staging standard (8th edition) 2. kps score \>80; aged 18 to 75 year-old 3. no contraindications to radiotherapy 4. no history of heart disease before treatment 5. patients receiving intensity modulated radiation therapy (imrt) 6. patients receiving ptv at a prescription dose of 60-70gy by imrt 7. patients receiving radiotherapy alone and concurrent chemoradiotherapy exclusion criteria: 1. patients with pleural effusion 2. patients with serious medical illness or infection 3. patients with acute myocardial infarction within 6 months 4. in patients with nyha grade 3-4, baseline lvef before radiotherapy is below 59% 5. patients with congenital heart diseases, valvular diseases and arrhythmia 6. patients with pericardial effusion 7. patients receiving immunotherapy and drug targeted therapy 8. patients with a history of anthracycline use