Kornimate/medical-research-clean huggingface dataset:
nt-501 cntf implant for glaucoma: safety, neuroprotection and neuroenhancement

Conditions: Glaucoma, Primary Open Angle

Summary: ciliary neurotrophic factor (cntf) has been demonstrated in multiple pre-clinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like glaucoma. we hypothesize that cntf delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in glaucoma. patients in the trial will receive an nt-501 cntf implant (made by neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.


Eligibility criteria:
inclusion criteria: * must understand and sign the informed consent * must be medically able to undergo ophthalmic surgery for the nt-501 device insertion and possible removal, as well as the testing required. * diagnosis of glaucoma characterized by (a) clinical evidence of progressive rgc dysfunction and degeneration using both visual field and at least one structural modality; (b) residual visual field preservation including best-corrected visual acuity (bcva) better than 20/100; (c) failure to contain glaucomatous progression with maximally tolerated reduction of intraocular pressure (iop), or visual field defect affecting fixation, but not reducing bcva below 20/100. exclusion criteria: * other corneal, lens, optic nerve or retinal disease causing vision loss, * blind in one eye * requirement of acyclovir and/or related products during study * receiving systemic steroids or other immunosuppressive medications. * pregnant or lactating. * considered immunodeficient or has a known history of human immunodeficiency virus (hiv) * on chemotherapy, or a history of malignancy, unless it was treated successfully 2 years prior to inclusion in the trial.
effect of levocarnitine supplementation for the management of fatigue in levothyroxine-treated hypothyroid patients

Conditions: Patient Compliance

Summary: it has been observed that despite administration of apparently adequate thyroid hormone replacement in hypothyroid patients, many of them experience persistent fatigue and fatigue-related symptoms. carnitine transports long chain fatty acids into the mitochondria whereupon the high energy source (atp) becomes synthesized. levocarnitine administration reduced fatigue related symptoms in hypothyroid patients receiving thyroid hormone replacement. the present study deals with alleviation of fatigue in hypothyroid patients by carnitine supplementation.

it has been well-established now-a-days that, some chronic diseases impose generalized weakness, lethargy, lassitude amounting from degrees mild, moderate to a severe one to total incapacitation on the part of the patients. hypothyroid patients instate of receiving adequate thyroid hormone replacement, experience fatigue-related symptoms. carnitine is a non-essential amino acid synthesized endogenously from essential amino acids- lysine and methionine with in the body involved in long chain fatty acid transportation to the mitochondrial membrane. carnitine- transportation system is essential for production of energy at cellular level. thyroid hormone plays an important role in carnitine-dependent long chain fatty acid transport and oxidation. some available reports suggest that, levocarnitine supplementation produced potentially favourable effects on fatigue-related symptoms in hypothyroid patients although still awaits confirmation. the present study is an attempt to investigate into the effects of levocarnitine supplementation on fatigue in patients with hypothyroidism.

Eligibility criteria:
inclusion criteria: i. clinical diagnosis of primary hypothyroidism patients with fatigue symptoms ii. age : from 20 to 50 years iii. levothyroxine treatment: receiving for at least 6 months iv. serum free thyroxine level: 0.80-1.80 ng/dl v. serum thyroid-stimulating hormone level: 0.35-5.50 µiu/ml ( µiu = micro international unit) - exclusion criteria: i. patients with hypothyroidism 20 years and 50 years ii. acute or chronic liver diseases iii. anaemia iv. clinical diagnosis of diabetes mellitus. v. cardiovascular disease ( such as heart failure, arrhythmia and uncontrolled hypertension ) vi. patients with psychological disorders (such as depression, anxiety disorder, schizophrenia, alcoholism or fatigue disorder due to other systemic diseases) vii. patients having serious infections or terminal illness (such as tuberculosis, hiv or malignant tumor ) viii. autoimmune diseases ( such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis) ix. patients with impaired renal function x. pregnant or planned to be pregnant xi. nursing mothers -

Keywords: fatigue, levocarnitine,
safety and efficacy of acarbose+saxagliptin compared with metformin+saxagliptin in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: to investigate the safety and efficacy of acarbose+saxagliptin compared with metformin+saxagliptin in patients with type 2 diabetes,100 patients with t2dm will be enrolled in this study.they will randomly be assigned to acarbose+saxagliptin or metformin+saxagliptin group.hba1c，fasting and postprandial c-peptide will be observed before and after the interventions.

participants coming on study will be assigned to two groups：acarbose+saxagliptin and metformin+saxagliptin. it may take 1 weeks to be stabilize to a standardized dose, and then the investigators will follow-up the patients for 3 months.during the period,patients will be asked to come back to the investigators center to receive the related examination every month. the investigators will detect hba1c，fasting and postprandial c-peptide before and after the interventions.

Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes mellitus（course of disease less than one year） who has not receive drug treatment. * t2dm patients who has not receive drug treatment for three months at least. * hba1c for 7.5-10%. exclusion criteria: * new or worsening signs or symptoms of coronary heart disease * medical history of active liver disease and kidney disease * poorly controlled hypertension（systolic blood pressure\>160mmhg or diastolic blood pressure\>95mmhg） * a clinically important hematological disorder * a history of intolerance or hypersensitivity or any contraindication to study medications (including saxagliptin, metformin, acarbose) * is pregnant or breast feeding or is expecting to conceive or donate eggs * a medical history of drug abuse * can not be followed -up on time * endocrinological diseases（eg： hyperthyroidism、hypothyroidisn and cushing syndrom） * gastrointestinal diseases * mental disorser * hypoxic disease
cognitive behavioral therapy for insomnia (cbti) in gerd patients with insomnia

Conditions: Gastroesophageal Reflux Disease

Summary: this study will enroll patients with persistent reflux symptoms despite proton-pump inhibitor therapy and chronic insomnia. participants that are eligible for the study and agree to participate will receive cognitive behavioral therapy for insomnia (cbti) delivered by a web-based approach. the goal of the treatment is to improve the participants insomnia and reflux symptoms. in addition to the cognitive behavioral therapy, participants will be asked to keep a daily diary and periodically complete questionnaires to assess their symptoms.


Eligibility criteria:
inclusion criteria: * patients with persistent reflux symptoms (gerdq \>8) despite proton-pump inhibitor (ppi) therapy. * patients screened positive for chronic insomnia (insomnia severity index \[isi\] ≥15). exclusion criteria: * patients with major esophageal motility disorder, prior foregut surgeries, severe cardiopulmonary diseases, or major psychological comorbidities. * patients who report being in "poor" or "very poor" physical or mental health. * patients with sleep apnea (based on stop-bang questionnaire \>4) * patients with audit score \>15, indicating alcohol dependence * patients regularly taking medications for sleep \>2 times per week who cannot stop the sleep aid at least 4 weeks prior to and during the study trial. * patients who have previously undergone cbt for insomnia (in person or online).

Keywords: cognitive behavioral therapy gerd
morton's neuroma: manipulation versus steroid injection

Conditions: Morton Neuroma

Summary: this study compares manipulative therapy to steroid injection in the treatment of morton's neuroma.

the aim of this study is to establish whether manipulative therapy is an effective treatment for morton's neuroma, a nerve entrapment in the foot. steroid injection is the current gold standard conservative treatment for this condition. therefore, a subject group shall be compared to a steroid injection intervention group. outcomes will be compared using visual analogue pain scales -vas, foot function index questionnaires and algometric pressure threshold testing. an improvement in the manipulation group vas of 20mm above the injection group shall be considered as the minimum worthwhile change as this has been identified as the minimum clinically important difference in pain between treatment groups in visual analogue pain scales.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of morton's neuroma * over 18 years of age * presenting vas score \> 30mm exclusion criteria: * diabetes, * rheumatoid arthritis * fibromyalgia. * those currently taking statins or analgesics * previous neuroma surgery

Keywords: manipulation plantar digital neuritis morton's neuroma nerve entrapment foot
study of five different methods of delivering a lifestyle modification program for weight loss

Conditions: Obesity

Summary: the aim of the study was to compare 5 methods of delivering a weight loss lifestyle modification program to obese patients on a background of sibutramine. the methods differed in the type and frequency of counseling utilized to deliver dietary, physical activity and behavioral recommendations for weight loss.


Eligibility criteria:
inclusion criteria: * 1- body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and \<40 kg/m2. * 2- eligibility to be prescribed sibutramine, following the eligibility requirements listed in the us package insert * 3- willingness and ability to comply with study related procedures * 4- access to internet and email exclusion criteria: * uncontrolled blood pressure (defined as ≥140/90 mmhg), diabetes, coronary heart disease, chronic congestive heart failure, stroke, significant metabolic, hepatic or renal disease, current malignancy, gastric bypass surgery or had a weight loss ≥10%, participated in a structured weight loss program, or had taken weight loss agents during the past 6 months. women were excluded if pregnant or breastfeeding; women of childbearing potential had to use adequate contraception.
treatment of sleep apnea syndrome with ncpap versus oral appliance

Conditions: Sleep Apnea Syndrome

Summary: this prospective randomized cross over study aims to compare ncpap with mandibular advancement device for the treatment of sleep apnea syndrome.the effectiveness of ncpap and oral appliance on apnea-hypopnea index, daytime sleepiness and quality of life will be compared in 60 patients.


Eligibility criteria:
inclusion criteria: 18 to 70 years old bmi \< 35 kg/m2 apnea-hypopnea index between 10 and 60 events/h complaint of snoring and sleepiness dental status adequate for treatment with oral appliance informed consent exclusion criteria: psychiatric disease professional driver other cause of sleepiness
a virtual ward to reduce readmissions after hospital discharge

Conditions: Acute Disease

Summary: the purpose of this study is to see whether a virtual ward reduces readmissions after hospital discharge.

we will conduct a pragmatic, randomized controlled trial to evaluate a new model of care for high-risk medical patients after discharge from hospital. this new model of care has two key elements. first, we will use the lace index (see citation below for details) to identify patients who are at high risk of readmission or death after hospital discharge. these patients will be randomized to either the virtual ward or usual care on the day of discharge. although patients being cared for in the virtual ward will reside at home, they will benefit from a hospital-like interdisciplinary team, a shared set of notes, a single point of contact, round-the-clock physician availability and increased co-ordination of specialist, primary and home-based community care for several weeks after hospital discharge.

Eligibility criteria:
inclusion criteria: * discharge from medical service * lace score greater than or equal to 10 * age greater than or equal or 18 * resident in toronto central local health integration network catchment area * patient or designate able to speak english well enough for follow up telephone calls exclusion criteria: * previously enrolled in study * discharged to a rehabilitation or complex continuing care facility
cardiac metabolic profiling in the fed state

Conditions: Heart Failure

Summary: this is a non-randomized interventional prospective study, aiming to provide insight into cardiac substrate utilization in the fed state. patients will participate during an elective pvi procedure which would have taken place regardless of the current study. during this study, study subjects will receive peripheral parenteral nutrition (ppn) through an intravenous (iv) line. during the procedure, blood samples will be drawn from the catheters which will be in situ for the purpose of the elective pvi procedure. cardiac arteriovenous (a-v) gradients of metabolites will be measured, reflecting cardiac uptake and release of metabolites in the fed state.

the heart requires tremendous amounts of energy to sustain its continuous mechanical work. the heart can utilize various metabolic substrates to generate energy, including carbohydrates, lipids, amino acids and ketone bodies. however, most research on cardiac fuel use has been done in rodents and surprisingly little is known about cardiac fuel use in patients with heart disease. prior experimental studies showed that carbohydrates are important fuels for cardiac energy production. in contrast, a recent study in patients with heart disease showed that the heart only utilizes little amounts of carbohydrates. this study was however, performed in fasting subjects, which could have an important effect on substrate preference. the primary aim of this non-randomized interventional prospective study is to provide insight into cardiac substrate utilization in the fed state. patients will participate during an elective pvi procedure which would have taken place regardless of the current study. during this study they will receive peripheral parenteral nutrition (ppn) through an intravenous (iv) line. blood samples will be drawn with the catheters which will already be in situ for the purpose of the elective pvi procedure. cardiac arteriovenous (a-v) gradients of metabolites will be measured, reflecting cardiac uptake and release of metabolites in the fed state.

Eligibility criteria:
inclusion criteria: * undergoing elective pvi procedure * adult age (≥ 18 years) * have given verbal and written informed consent exclusion criteria: * chronic renal disease with an estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2 * chronic liver disease and/or severe liver dysfunction with asat and/or alat \> 3x the upper limit of normal (uln) * pregnancy or breastfeeding * insulin dependent diabetics * congenital metabolic disease * weight below 40 kg * inability to understand and read dutch or english * known allergy or hypersensitivity to any of the non-investigational products in the study protocol * any other clinical condition that would jeopardize patient's safety while participating in this trial or may prevent the patient from adhering to the trial protocol.

Keywords: cardiac metabolism arteriovenous gradient metabolites fed state heart failure
acute subcutaneous defibrillation

Conditions: Ventricular Arrhythmias

Summary: to assess the defibrillation efficacy of a subcutaneous defibrillation system.


Eligibility criteria:
inclusion criteria: * subject must be undergoing implant of a commercially approved icd system * subject must be willing to provide informed consent * subject must be \> 18 years old exclusion criteria: * subject with impaired kidney function as measured by a glomerular filtration rate (egfr) estimate \< 29 mls/min/1.73m2 (recorded in the last six months) * subject has high risk of infection * subject has ef \< 15% * subject at high risk of stroke * having a device replacement * subject with an implanted active non-icd device, cardiac or non-cardiac (e.g., neuro stimulator, pacemaker) * subject is indicated for crt * subject is pacemaker dependent * subject enrolled in a concurrent study that may confound the results of this study * subject has medical conditions that would limit study participation * subject is pregnant * subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
morbimortality amelioration in preeclamptic primiparas study. moma pre prim study

Conditions: Pregnancy; Primiparity; Hypertension; Preeclampsia; Intrauterine Growth Retardation

Summary: the purpose of this study is to determine whether close monitoring of patients with a high sflt1 plasma level between 25 and 28 weeks of gestation (i.e. at high risk of subsequent preeclampsia) improves maternal and fetal outcomes. the investigator hypothesize that 1/ early screening for preeclampsia by plasmatic sflt1 will reduce maternal and fetal mortality and morbidity and 2/ a simple urinary plgf screening will be effective.

we will measure plasmatic sflt-1 level between 25 and 28 weeks of gestation and flow velocity of uterine arteries by doppler (22 - 26 weeks of gestation) in primipara. patients will be stratified according to the results of the uterine artery doppler measurement, and then randomized in two groups a and b. in group a, sflt-1 concentration will be communicated to the obstetrician (+ or -): the threshold of abnormally high plasmatic concentration of sflt-1 is 957 ng/ml. in patients with a high plasmatic concentration of sflt-1 (+), the pregnancy will be closely monitored including repeated clinical, biological, and ultrasound examinations. patients with sflt-1 plasmatic concentration below 957 ng/ml (-) will be routinely followed-up.in group b, the result of sflt-1 measurement will not be communicated and the pregnancy will be routinely monitored.abnormal doppler recordings in either group will result in a close monitoring as per our usual local practice. urinary plgf (expressed as a ratio plgf/creatininemia) will also be measured and the results will be analyzed at the end of the study. beside sflt-1, we will store the plasmatic samples to measure other biomarkers that could be relevant in the future (no dna analysis will be done without a new patient consent).

Eligibility criteria:
inclusion criteria: * pregnant womenage ≥ 18 years * followed in our center before the 28th week of gestation * under social security coverage * signed informed consent exclusion criteria: * age \< 18 years * followed in our center after the 28th week of gestation * no social security coverage * refusal to be included

Keywords: preeclampsia hypertension intra uterine growth retardation antiangiogenic factor prevention
effectiveness of dasatinib in adult patients with chronic myeloid leukemia in china: a multicenter, registry study

Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Summary: the primary objective is to describe the effectiveness of dasatinib (sprycel®) in cml patients in china in the real-world clinical practice setting.

breakpoint cluster region (bcr) abelson murine leukemia viral oncogene homolog 1 (c-abl) chronic myeloid leukemia (cml)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: because this is a product registry study, it will include adult cml patients in any phase treated with dasatinib in china if they meet the following criteria: * willing and able to provide written informed consent * ≥18 years of age * confirmed diagnosis of cml patients by attending physician * naive to dasatinib before enrollment in study treatment or have received \<3 months of dasatinib treatment * plan to or are receiving dasatinib therapy based on physician's clinical judgment * administered dasatinib after imatinib-resistance or intolerance exclusion criteria: - patients participating in clinical trials for cml that explicitly prohibit recruitment in additional studies
evaluation of efficacy and safety of somatostatin used as inflow modulator in liver transplantation.

Conditions: Liver Transplant With Clinically Significant Portal Hypertension

Summary: this study is a 5 day, single-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of somatostatin used as inflow modulator in liver transplantation. patient systemic and hepatic dynamics will be collected and recorded at predefined time-points. to evaluate the ischemia-reperfusion injury, it is planned to perform liver biopsies at two different time-points to compare the liver structure and proteomic variations.


Eligibility criteria:
inclusion criteria: * ability and willingness to provide written informed consent * cirrhotic patients with established clinically significant portal hypertension (csph) defined as an increase in hepatic venous pressure gradient \>= 10 mmhg * recipients who are 18-70 years of age receiving a primary liver transplant from a brain dead donor or living donor * whole liver grafts and partial liver grafts can be included exclusion criteria: * patients who are recipients of multiple solid organ transplants, or have previously received an organ or tissue transplant that may not be completely resolved by thrombectomy * hiv positive patients * patients with known history of portal thrombosis or diagnosed at the time of transplantation that may not be completely resolved by thrombectomy. * patients included in the preoperative assessment without a csph at the time of the first intraoperative measurement of portal pressure * patients with low portal perfusion (=\< 90 ml/min\*100 g of lv) measured at the time of operation. portal flows above this limit can be excluded in the eventuality that, after infusion, the portal perfusion falls below this limit * patients with porto-pulmonary hypertension * patients with known cardiac arrhythmias * recipients of cardiac-dead donors * fulminant hepatic failure patients

Keywords: liver transplant portal hypertension
pleural cryobiopsies during semirigid thoracoscopy: a new technique

Conditions: Pleural Effusion; Pleural Diseases

Summary: the purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. the secondary aim is to evaluate safety with focus on bleeding intensity.

the primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. we will assess size, morphological features, immunohistochemistry and diagnostic yield as measures of the quality of the samples. the secondary aim is to evaluate safety with focus on bleeding intensity.

Eligibility criteria:
inclusion criteria: * 18 or more years old * unilateral pleural effusion of unknown origin * pleural irregularities suspicious for pleural malignancy * referral for thoracoscopy after less invasive means of diagnosis had failed exclusion criteria: * uncontrolled bleeding tendency * unstable cardiovascular status * severe heart failure * ecog performance status 4 * persistent hypoxemia after evacuation of pleural fluid * pleural symphisis, fibrothorax

Keywords: flex-rigid pleuroscopy cryobiopsy pleural biopsy pleural effusion safety thoracoscopy