Kornimate/medical-research-clean huggingface dataset:
effect of implantable contraception on type-2 dm and metabolic syndrome in women with history of gestational dm

Conditions: Diabetes Mellitus; Metabolic Syndrome

Summary: the purpose of this study is to determine the effect of implantable contraception on the incidence of diabetes mellitus in women with history of gestational diabetes mellitus comparing with those using nonhormonal contraceptives.

gestational diabetes mellitus (gdm) was defined as abnormal glucose tolerance detected for the first time in pregnancy. gdm is a well-known risk factor for developing overt diabetes later in life, especially type 2 diabetes. about 50-60% of woman with prior gdm will develop type 2 diabetes during their lifetime. recent studies show that women with previous gdm exhibit a markedly increased prevalence of the metabolic syndrome, even when glucose tolerance is normal. for both maternal and future offspring, women with prior gdm need safe, efficient, and acceptable choices for contraceptive methods that do not enhance their already substantial risk to develop either overt diabetes or metabolic syndrome and associated sequelae. the intrauterine device (iud) is a very effective and reversible contraceptive method without metabolic disturbances and therefore is an ideal contraceptive for women with prior gdm. progestins do not increase globulin production; thus, they do not increase coagulation factors or blood pressure. a nonrandomized open-label prospective trial of healthy obese, reproductive-age women in california were studied about the metabolic effects of progestin-only long-acting reversible contraception levonorgestrel-releasing intrauterine system (lng-ius) and etonogestrel implant (eng-i)\] comparing with nonhormonal contraception (nhc). the changes in fasting glucose and insulin sensitivity were seen among obese at 3 months.

Eligibility criteria:
inclusion criteria: * postpartum women with diagnosis of gestational diabetes mellitus * want to use implant contraception or nonhormonal contraceptions such as iud or tubal sterilization exclusion criteria: * age less than 18 years old * diagnosis of diabetes mellitus at post partum period * cardiovascular disease, liver disease, autoimmune disease * the women that reject to continue in the study.

Keywords: gdm implant diabetes mellitus metabolic syndrome
comparison of cardiac resynchronisation therapy (crt) response using high frequency (hf) - ecg or q-lv guided optimisation for left ventricular, pacing site.

Conditions: Heart Failure

Summary: the research aims to compare the response of cardiac resynchronisation therapy (crt) using hf ecg guided or the conventional method of q-lv measurement guided optimisation for left ventricular, pacing site.

the study aims to demonstrate that left ventricular (lv) pacing site optimisation using high frequency (hf) ecg improves lv reverse remodeling response to cardiac resynchronization therapy (crt), compared with q-lv (q-wave on the surface ecg to lv electrogram) measurement after 6 months of treatment. participants will be implanted with a cardiac resynchronisation therapy device with either pacemaker or defibrillator function. the study is a single-centre, randomized, prospective trial. one hundred and eighty participants will be assigned to either the treatment (hf-ecg guided lv pacing site optimisation) or control (q-lv guided lv pacing site optimisation) arm, employing a 1:1 randomization. the participants will be followed up for a period of 6 months.

Eligibility criteria:
inclusion criteria: * • eligible for implantation of a crt-d device according to published relevant esc and ccs guidelines; * in sinus rhythm; * nyha class ii, iii or iv * have reviewed, signed and dated an informed consent. * age 18 exclusion criteria: * previous implant with a pacemaker, an icd or a crt device. (except upgrade from single chamber icd with a fully functional defibrillation lead) not under recall or surveillance); * persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month; * ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (mi), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment; * incessant ventricular tachyarrhythmia; * unstable angina, or acute mi, coronary artery bypass-grafting (cabg), or percutaneous coronary intervention (pci) within the past 4 weeks; * correctable valvular disease that is the primary cause of heart failure; * indication for valve repair or replacement; * recent cerebro-vascular accident (cva) or transient ischemic attack (tia) (within the previous 3 months); * on transplant waiting list; * previous heart transplant; * already included in another clinical study that could confound the results of this study; * life expectancy less than 1 year; * inability to understand the purpose of the study; * unavailability for scheduled follow-up or refusal to cooperate; * age of less than 18 years; * pregnancy; * drug addiction or abuse; * under guardianship.
the effects of regular home use vs diabetic team- supported use of the medtronic carelink therapy management system.

Conditions: Type 1 Diabetes

Summary: randomized, two arms, controlled, open study comprised of two consecutive segments. at the first segment that will last during the first 4 months of the study, patients will be randomized to the care link treated group or non care link treated group. at this segment of the study the usage of the care link system will be accompanied by the diabetic team, through at least monthly contact via the internet initiated by the diabetic team. at the second segment of the study, during the following 4 months, both groups will use the care link system, home-use, without support initiated by the diabetic team.

a randomized, two arms, controlled, open study in order to compare the efficacy, short and long term effects of regular home-use vs diabetic team- supported use of the medtronic carelink therapy management system in patients with diabetes. primary objective: to assess the efficacy, short term (4 months) and long term (8 months) effects of using the medtronic carelink® therapy management system for diabetes on the following parameters: 1. metabolic control as expressed by hba1c. 2. hypoglycemic events- number and severity of episodes. 3. dka and ketosis events- number and severity of episodes. 4. patient's satisfaction and quality of life measured by treatment satisfaction and quality of life questionnaires. 5. 7 points glucose profile. secondary objective: to compare the efficacy of 4 months treatment using the carelink® therapy management system, accompanied with intensive contact (at least once a month) initiated by diabetic team via the internet/electronic mail vs home use treatment - without monthly contact initiated by the diabetic team study design: the study will be comprised of two consecutive segments. at the first segment that will last during the first 4 months of the study, patients will be randomized to the carelink treated group or non carelink treated group. at this segment of the study the usage of the carelink system will be accompanied by the diabetic team, through at least monthly contact via the internet initiated by the diabetic team. at the second segment of the study, during the following 4 months, both groups will use the carelink system, home-use, without support initiated by the diabetic team.

Eligibility criteria:
inclusion criteria: 1. type 1 diabetes diagnosed at least 6 months prior to study entry 2. current treatment with medtronic 722 /712 external insulin pump systems 3. treatment with insulin pump at least 3 month prior to study entry 4. an internet access from patient's home 5. age 0-35 years old 6. hba1c\>7.8 7. signing inform consent forms exclusion criteria: 1. any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study 2. patients participating in other device or drug studies

Keywords: medtronic carelink therapy management diabetes insulin pump blood glucose monitor
comparative effects of variable pressure support, nava and pav

Conditions: Respiratory Failure

Summary: experimental animal data suggest that increasing breathing pattern variability in mechanical ventilation could be beneficial. variable ventilation can be induced through the following modes: neurally adjust ventilatory assist (nava), proportional assist ventilation (pav) and variable-pressure support ventilation (v-psv). these modes have not yet been compared to each other. pilot observations in our department suggest a feasibility in patients. the objectives of the study are to compare the impact of psv, nava, pav and v-psv on the variability of the breathing pattern, patient-ventilator asynchrony, risk of lung overdistension, gas exchange, and repartition of ventilation.

cross-over, prospective, randomized controlled monocentric trial . patients on pressure support ventilation will be ventilated with psv, nava, pav, and v-psv (in a randomized sequence). in each mode the level of assistance will be set to achieve a similar tidal volume of 6-8 ml/kg. the following data will be measured and recorded: airway flow and pressure, electrical activity of the diaphragm (eadi), blood gases, electrical impedance tomography, end tidal partial pressure in carbon dioxide (petco2). will be calculated: the coefficient of variation (cv, standard deviation (sd)/mean) of the peak pressure (ppeak), eadi and of the main descriptors of the breathing pattern, the prevalence of the main patient-ventilator asynchronies, the prevalence of tidal volume (vt) \>10ml/kg, ventrodorsal repartition of ventilation and inhomogeneity index, dead space

Eligibility criteria:
inclusion criteria: * patient on mechanical ventilation for \>48 h * estimated duration of mechanical ventilation \>24h * hemodynamic stability exclusion criteria: * pregnancy * impossibility to insert an eadi catheter * neuromuscular disease, phrenic nerve lesions

Keywords: mechanical ventilation pressure support ventilation nava pav variable ventilation patient ventilator asynchrony
effectiveness of manual therapy and strengthening exercises in hemophilic arthropathy of the elbow joint

Conditions: Hemophilia; Arthritis

Summary: manual treatment involves techniques based on the principles of moving the joint faces and separating the joint gap, and soft tissues mobilization techniques. the use of manual therapy in hemophilia is gradually increasing although it previously described as a contraindication. the utility and use of strengthening exercises in hemophilia has been going on for a long time. in this study, the effect of manual therapy and strengthening exercises joint was investigated in hemophilic arthropathy of the elbow.

the aim of this study was to investigate the effects of strengthening exercises and manual therapy on bleeding frequency, pain, range of motion, muscle strength, arm circumference, joint health, functionality and quality of life in the physiotherapy and rehabilitation of hemophilic arthropathy of the elbow. seventeen adolescent and young adult hemophilic individuals aged 12-30 years with elbow arthropathy were included in the study. the individuals were divided into the two groups via simple randomisation as manuel therapy and exercise group (mteg) and home exercise group (heg). the individuals in heg were given strengthening exercises as a home program. those in the mteg were applied manual therapy by the physiotherapist and were given supervised strengthening exercises. all treatments were performed 3 times a week for 5 weeks totally 15 sessions. frequency of bleeding was evaluated with number of bleeding in the last 5 weeks. numerical pain scale was used for activity and resting pain. range of motion and muscle strength were measured with universal goniometer and digital dynamometer, respectively. the quick-dash questionnaire and oxford elbow score were used for the functionality of the upper extremity and quality of life, respectively. the joint health status was evaluated with hemophilia joint health score-elbow point and hospital for special surgery-elbow scoring system. evaluations were made by the same physiotherapist before and after treatment.

Eligibility criteria:
inclusion criteria: * having signs of hemophilic arthropathy in one or both elbow joints, being between the ages of 12-30 (adolescent and young adult), receiving prophylactic factor replacement therapy. exclusion criteria: * having undergone any surgical procedure for elbow arthropathy, having an orthopedic problem, such as a fracture, ligament or tendon injury, related to the upper limb in the past year, receiving physiotherapy and rehabilitation for the elbow joint in the last 6 months

Keywords: hemophilia arthropathy elbow joint manual therapy exercise
the bridges project: bridging resources to engage women in integrated hiv care and support services

Conditions: HIV/AIDS

Summary: the bridges project seeks to test a program intended to help women living with hiv who face specific barriers due to culture, gender, violence, trauma, adverse mental health, and substance use to be able to better access hiv care. this program was created and tried with women living with hiv, as previously studies have indicated that women with these experiences are less likely to have stable hiv care. the bridges project will use peer navigators, who are other women living with hiv who have had similar experiences and have been successful in accessing care, to help other women living with hiv to access hiv care and stay in hiv care. the bridges project will also provide support to women through group sessions co-facilitated by a licensed clinical therapist and peer navigator. through participation in bridges, women will: (1) build skills to cope with hiv care and treatment barriers (e.g., violence, trauma, adverse mental health, substance use); (2) be connected to hiv treatment and other support services (e.g., domestic violence, mental health, substance use); and (3) learn interpersonal skills to connect with support (e.g., service providers, peers, friends, family) when faced with new or ongoing barriers.

the bridges project intervention is culturally-tailored intervention for syndemic-affected cis- and transgender women living with hiv/aids (wlha) that aims to: 1) build skills to cope with syndemic-related affective distress, 2) facilitate linkages to both hiv treatment and relevant ancillary service providers (e.g., domestic violence, mental health, substance use), and 3) teach women interpersonal skills to activate social support networks (e.g., service providers, friends, family) when faced with new or ongoing barriers. participants in the the bridges project are estimated to demonstrate improvements in hiv care outcomes (i.e., linkage to hiv care, self-efficacy in art adherence, retention in hiv care) and syndemic-support outcomes (i.e., coping skills, activated social support networks, linkage to and receipt of ancillary support services) compared to hiv-infected women assigned to standard of care (self-guided access and use of ryan white case management).

Eligibility criteria:
inclusion criteria: * 18 years of age or older * identify as female, including cis-gender female or transgender female * living with hiv/aids * ability to speak and understand english * self-report one or more syndemic factor(s) \[lifetime history of or current: trauma, physical violence and/or sexual violence, ptsd symptoms, substance use, adverse mental health\] * identification as one of the following: out-of-care or unstable in care, newly diagnosed, never in care, or linked to care but have fallen out of care\]

Keywords: hiv care continuum ancillary support services
irm cardiaque en respiration libre pour des patients atteints de dystrophinopathie sévère

Conditions: Duchenne or Severe Becker Myopathy

Summary: clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis detection and quantification (and of function assessment) during mri without breath-holds in a population of adults and children with duchenne myopathy.


Eligibility criteria:
inclusion criteria: * dystophinopathy (duchenne or severe becker) * \>8yo * with social insurance * informed consent exclusion criteria: * arythmia * impossibility to undergo an mri (pacemaker, ....)

Keywords: mri free-breathing acquisitions myopathy fibrosis assessment function
autologous cord blood cells for prevention of bpd in preterm

Conditions: Safety Issues; BPD - Bronchopulmonary Dysplasia; Neonatal Death

Summary: to study the effect of autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates

we did a randomized, double-blind, placebo-controlled trial to assess effect of one intravenous dose of cord blood mncs compared with placebo in reducing incidence of bpd in very preterm neonates.we enrolled preterm neonates less than 32 weeks of ga at neonatal intensive care units (nicus) in guangdong women and children hospital within the first 24 postnatal hours. patients were randomly assigned by 1:1 to receive either (5×107cells/kg acbmnc or normal saline intravenously within 24 hours after birth according to a computer-generated schedule. the primary endpoint was efficacy at 36 ga or discharge home and all analyses were done by intention to prevent.mncs viability was also tested before transfusion

Eligibility criteria:
inclusion criteria: * born in the study hospital; * singleton birth; * less than 32 weeks ga * without congenital malformations or known chromosomal aberrations; * without clinical chorioamnionitis; * the mother was negative for hepatitis b (hbsag and/or hbeag) and c virus (anti-hcv), syphilis, hiv (anti-hiv-1 and -2) and igm against cytomegalovirus, rubella, toxoplasma and herpes simplex virus; * consents were obtained from their parents or guardians; * the umbilical cord blood cells after processing were available. exclusion criteria: * birth-weight was less than the third percentile for gestational age according to fenton curve, * if they had severe perinatal asphyxia (defined as an apgarscore of 0-3 for more than 5 minutes, a cord blood ph of less than 7.00, or both) and were expected to die shortly after birth.

Keywords: acbmnc very premature infants bpd
study to evaluate dietary supplementation with a version of anatabloc(r) in subjects with alzheimer's disease

Conditions: Alzheimer Disease

Summary: to explore whether dietary supplementation with a version of anatabloc(r) exerts an effect on blood levels of amyloid beta (aβ), or impacts global or functional measures of alzheimer's disease (ad) in subjects with mild to moderate ad.


Eligibility criteria:
inclusion criteria: * at least 65 years old. * have a diagnosis of probable ad or a concurrent diagnosis of probable ad and possible or probable vascular dementia. * score 16 or more on the mini-mental state examination (mmse). * otherwise stable medical history and general health. * weigh between 45 kg and 120 kg inclusive. exclusion criteria: * have contra-indications, allergy, or sensitivity to the study products or their components. * be currently taking any of the following medications: systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-cd20 antibody (e.g., rituximab); or anti-ctla-4 antibody (e.g., ipilimumab). * be a current smoker or smokeless tobacco user.

Keywords: randomized double-blind dietary supplements
study to evaluate the safety and efficacy of asc40 tablets in combination with bevacizumab in subjects with rgbm

Conditions: Recurrent Glioblastoma

Summary: this is a randomized, double-blind, controlled and multi-center phase iii clinical trial to evaluate the safety and efficacy of asc40 tablets combined with bevacizumab in the treatment of adult patients with recurrent glioblastoma. after standard radiotherapy and chemotherapy (temozolomide), the subject first experienced clinical recurrence or progression.


Eligibility criteria:
inclusion criteria: * 1. age ≥18 years old, both male and female; * 2. histologically confirmed glioblastoma; * 3. patients with glioblastoma who have failed standard treatment (surgery, stupp regimen), were diagnosed by mri and evaluated by rano standard to support the first recurrence. stupp regimen needs to complete at least 6 medication cycles. exclusion criteria: * 1. use low molecular weight heparin and warfarin within 35 days before randomization; * 2. arterial or venous thrombosis (such as cerebral infarction, myocardial infarction, venous thrombosis of lower limbs, arterial embolism of lower limbs, pulmonary embolism, etc.) occurred within 6 months before randomization

Keywords: asc40 recurrent glioblastoma
randomized double blind cross over study for nabilone in spasticity in spinal cord injury persons

Conditions: Spasticity in Spinal Cord Injured Persons

Summary: objectives: to determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (sci). methods: twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. they received either nabilone or placebo during the first four-week period (0.5mg od with option to increase to 0.5mg bid), then outcome measures were assessed. after a two-week washout, subjects were crossed-over to the opposite arm. the primary outcome was the ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. the secondary outcomes included spasm frequency scale, visual analog scale, wartenberg pendulum test, sum of the ashworth scale in eight muscle groups of each side of the body, and the clinician's and subject's global impression of change .


Eligibility criteria:
inclusion criteria: * patients with spinal cord injury were eligible for the study if they are 18-65 years old, have c5 (asia a-d) and below and the injury occurred greater than 1 year previously. they had to have stable neurological level of injury with moderate spasticity (ashworth \>/= 3) and no cognitive impairments. the spasticity medications needed to be unchanged for at least 30 days before inclusion, and no botulinum toxin injections for \> 4 months. exclusion criteria: they were excluded if they had: * heart disease as cannabinoids can reduce heart rate and blood pressure * history of psychotic disorders, schizophrenia or any active psychological disorder * previously documented sensitivity to marijuana or other cannabinoid agents * severe liver dysfunction * cognitive impairment * major illness in another body area * if they were pregnant or nursing mother * had history of drug dependency * used smoked cannabis \< 30 days before the onset of the study or were unwilling not to smoke during the study; or * if they fixed tendon contractures