Kornimate/medical-research-clean huggingface dataset:
trial of the effect of low-molecular-weight heparin (lmwh) versus warfarin on mortality in the long-term treatment of proximal deep vein thrombosis (dvt) (main lite study)

Conditions: Thrombosis; Thromboembolism; Venous Thrombosis

Summary: the purpose of this study is to assess the long-term treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral warfarin sodium.

the accepted treatment for acute deep vein thrombosis (dvt) is initial continuous intravenous heparin followed by long-term oral anticoagulant therapy. improvements in the methods of clinical trials and the use of accurate objective tests to detect venous thromboembolism have made it possible to perform a series of randomized trials to evaluate various treatments of venous thromboembolism. the specific objectives of the main lite study are: * to determine if low-molecular-weight heparin, given subcutaneously once daily without laboratory monitoring, is more effective than adjusted oral warfarin sodium in the reduction of mortality rate. * to determine if such a low-molecular-weight heparin therapy is more cost-effective than present standard care methods. * to determine the incidence of factor v leiden and prothrombin 20210a mutant genetic abnormalities.

Eligibility criteria:
inclusion criteria: * patients having a first or recurrent episode of acute proximal vein thrombosis exclusion criteria: * presence of familial bleeding diathesis or presence of active bleeding contraindicating anticoagulant therapy * receiving therapeutic heparin or therapeutic low-molecular-weight heparin for more than 48 hours or have already been on warfarin for more than 2 days for the treatment of proximal deep vein thrombosis * receiving long-term warfarin treatment * females who are pregnant * known allergy to heparin, warfarin sodium, or bisulfites * history of heparin-associated thrombocytopenia * severe malignant hypertension * hepatic encephalopathy * severe renal failure * inability to attend follow-up due to geographic inaccessibility * inability or refusal to give informed consent * recent neurological or opthalmic surgery (within the previous 14 days) * pulmonary embolism requiring thrombolytic therapy, surgical thrombectomy, or vena cava interruption * life expectancy of less than 3 months * taking asa prior to randomization and unable to discontinue this medication during the 84 day study treatment period

Keywords: venous thromboembolism low-molecular-weight heparin
a study of concurrent stereotactic body radiotherapy with opdualag in metastatic uveal melanoma

Conditions: Uveal Melanoma

Summary: this is a phase 2 trial of concurrent stereotactic radiation therapy (sbrt) with immunotherapy with relatlimab and nivolumab for up to two years. sbrt will be given in three doses of 15gy each to 1-5 separate metastases. opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years

metastatic uveal melanoma has no standard therapy, but there is evidence that both radiation therapy and immunotherapy may be helpful and may be synergistic. this is a phase 2 trial of concurrent stereotactic radiation therapy (sbrt) with immunotherapy with opdualag (nivolumab 480mg and relatlimab 160mg) for up to two years. sbrt will be given in three doses of 15gy each to 1-5 separate metastases, limiting the total dosage to 700cc's of normal liver to \<15gy. opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years. objectives are to determine the safety and tolerability, and irecist will be used to determine responses.we will treat up to 50 patients.

Eligibility criteria:
inclusion criteria: * measurable metastatic uveal melanoma. * no concomitant therapy. * prior pd1 or tebendafesp allowed. * performance status 0-1. * no active hepatitis b. * no known hiv infection. * wbc\>2000, anc\>1500, hgb \>8. * creatinine \< 3 x uln. * ast \& alt \< 2.5 x uln bilirubin \< 2 x uln. * albumin \>2.9 exclusion criteria: * liver tumor volume \> 50%. * active cns metastases. * pregnancy. * prior therapy with opdualag or relatlimab * certain autoimmune diseases. * previous liver embolization or radiation. * use of systemic steroids

Keywords: metastatic
study evaluating 13-valent pneumococcal conjugate vaccine (13vpnc) in children with sickle cell disease

Conditions: Pneumococcal Conjugate Vaccine

Summary: this study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in children with sickle cell disease who have already been vaccinated with 23-valent polysaccharide vaccine. the study will measure the amount of antibodies (the proteins that fight off germs) produced by children with sickle cell disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. they will be given the vaccination twice, each vaccination separated by approximately 6 months.


Eligibility criteria:
inclusion criteria: * male or female subject between the ages of \>=6 to \<18 years. * diagnosis of scd * 23vps vaccination at least 6 months prior to enrollment. exclusion criteria: * previous vaccination with pneumococcal conjugate vaccine. * previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.
superior mesenteric artery dissection

Conditions: Vascular Diseases

Summary: this study investigate ct images of patients with spontaneous isolated superior mesenteric artery dissection (sismad). the investigators also further analyze the ct morphological differences between different options, aiming to determine "alarming ct character" during initial conservative treatment.

57 patients with sismad from oct 2011 to jan 2018 in investigator's hospital were included in this research. the investigators collected relevant clinical data and further investigated the cta characters of both true lumen and false lumen. sma angle, distance between entry site of dissection and sma root were also measured.

Eligibility criteria:
inclusion criteria: * sma dissection exclusion criteria: * sma dissection combined with aortic or other visceral arteries * trauma related sma dissection
sarcopenia and osteoporosis in the patients with hemophilia

Conditions: Sarcopenia; Hemophilia; Osteoporosis, Osteopenia; Hemophilic Arthropathy

Summary: hemophilia is a bleeding disorder and repeated joint bleeding leads to hemophilic arthropathy. among patients with hemophilia, vitamin d deficiency and hemophilic arthropathy have been associated with osteoporosis in several clinical studies.there is no data on the prevalence of osteoporosis in hemophilia patients in taiwan or asia. to the best of our knowledge, no previous studies have reported the prevalence of sarcopenia and correlation with osteoporosis in hemophilia adult patients. this study will investigate the prevalence and corelation of sarcopenia and low bmd in patients with hemophilia. patients in taiwan. the study will estimate the prevalence of sarcopenia and body composition in the hemophilia population and compared baseline demographic and clinical characteristics between the non-sarcopenia and sarcopenia individuals, with particular emphasis on the overlap with osteoporosis and hemophilic arthropathy.


Eligibility criteria:
inclusion criteria: * hemophilia patients exclusion criteria: * history of total hip arthroplasty * history of instrumentation in lumbar spine
pelvic floor muscle evaluation in women with stress urinary and urgency urinary incontinence

Conditions: Urinary Incontinence, Stress; Urge Incontinence

Summary: aims: to assess pelvic floor muscle (pfm) strength in women with stress urinary incontinence (sui) and urgency urinary incontinence (uui). methods: 51 women were prospectively divided into two groups, according to the symptoms as sui (g1 = 22) or uui (g2 = 29). demographic data, such as number of pads/ 24 hours, number of micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for which an urgent void could be voluntarily postponed), number of parity and vaginal deliveries were obtained using a clinical questionnaire. objective urine loss was evaluated by 60-min pad test. subjective \[urine stream interruption test (ust), visual survey of perineal contraction and transvaginal digital palpation\] and objective (vaginal manometry) evaluations of pfm were performed in all patients.


Eligibility criteria:
inclusion criteria: * presence of stress urinary or urgency incontinence exclusion criteria: * neurological diseases * previous pelvic surgeries * diabetes * cognitive difficulties * vaginal and urinary infection

Keywords: pelvic floor evaluation, women, stress urinary incontinence; urgency urinary incontinence.
clinical and cyto-histological evaluation of fractional co2 laser treatment on genito-urinary syndromes of menopause related to vaginal atrophy

Conditions: Genitourinary Syndrome of Menopause

Summary: estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms, since it is associated with an anatomical and functional cellular modification of the urogenital sphere. these changes result in urogenital atrophy responsible for vaginal dryness, painful intercourse (dyspareunia), discomfort, itching and burning sensations, dysuria, urgency and incontinence. these symptoms, which significantly affect quality of life, are found in more than 40% of menopausal women and are grouped under the term genitourinary syndrome of menopause (gsm). general or local estrogen-based treatments improve patients' symptoms, but remain contraindicated in women who have had breast cancer. non-estrogenic local treatments are less effective, remain restrictive and are therefore often abandoned. the co2 laser is currently part of the therapeutic arsenal for the management of patients with gsm. this device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age. this simple treatment, which lasts only a few minutes, is safe and painless and has no serious side effects. it restores the tone and elasticity of the tissues, with positive effects on the quality of life and the couple's relationship. the investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way (before, during and after the treatment), including the induced cytohistological changes, in patients with gsm who can benefit of this therapy.


Eligibility criteria:
inclusion criteria: * women over 40 years of age * patients with natural menopause or menopause secondary to cancer treatment (breast, pelvis or other) * patients with vaginal and/or urinary, non-vulvar gsm * patients for whom co2 laser therapy is proposed exclusion criteria: * vulvovaginal infections (vaginosis) * uninvestigated vaginal hemorrhage * herpes * pregnancy or breastfeeding * cervico-vaginal pathology (cervical and/or vaginal dysplasia) * suspected or diagnosed hpv * significant vaginal prolapse * patients on hormone replacement therapy
comparing general anesthesia, general anesthesia with esp block or tlip block in patients undergoing lumbar surgeries

Conditions: Lumbar Disc Herniation; Lumbar Discogenic Pain; Lumbar Spinal Stenosis; Failed Back Surgery Syndrome

Summary: the regional methods of anesthesia for the neurosurgical operations of the spine and spinal cord reducing the needs for opioids intra operatively and reducing pain in the postoperative period, decrease the numbers of failed back syndrome.


Eligibility criteria:
inclusion criteria: * back surgery exclusion criteria: * contraindications to the regional method of analgesia, * patient refusal, * patients with diabetes mellitus * mental illness * pregnancy
improved image quality for assessment of carotid artery stenosis by ultrafast ultrasound flow imaging

Conditions: Carotid Artery Stenosis

Summary: objective: to evaluate the technical performance of a novel cascaded wave imaging technique compared to plane wave imaging for blood flow imaging in patients with and without carotid artery stenosis. study design: observational, feasibility study in a total of 10 patients with and 10 patients without a hemodynamic significant carotid artery plaque. intervention (observational): all participants will undergo a carotid ultrasound measurement including conventional duplex ultrasound and ultrasound based flow imaging using plane waves and cascaded waves.


Eligibility criteria:
inclusion criteria: * capacitated adult male or female (≥18 years old); * informed consent form understood and signed; * recent conventional duplex measurement of the carotid artery confirming either the absence or presence of a plaque exclusion criteria: * hampered carotid blood flow imaging during conventional duplex/doppler measurements due to near to total carotid occlusion at the side of interest or a calcified plaque; * history of radiation at the head-neck area; * participating in another clinical study, interfering on outcomes.
the efficacy of mdi treatment with an optimization algorithm adjusting basal-bolus parameters in children and adolescents with type 1 diabetes at a diabetes camp

Conditions: Diabete Mellitus; Diabetes Mellitus, Type 1

Summary: our lab at mcgill university has developed an optimization algorithm for t1d mdi patients that estimates optimal basal-bolus parameters (basal injections and insulin-to-carbohydrate ratios) using glucose sensor data and insulin dosing data over several days. the algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal injections and icrs. the investigators hope that this algorithm will be able to optimize the patients' individual basal injections and icrs in order to improve glycemic control.

the objective of this project is to compare our basal-bolus optimization algorithm with physician adjusted basal-bolus parameters using a randomized parallel clinical trial in children and adolescents at a camp carowanis. the investigators hypothesize that using this optimization algorithm will be non-inferior to the physician-adjusted basal-bolus parameters regarding time spent in target glucose range (3.9 mmol/l - 10mmol/l). between 40 and 68 children and adolescent type 1 diabetes patients undergoing mdi treatment at camp carowanis will randomly undergo one of two interventions: 1. mdi with physician adjusted basal-bolus parameters: participants will be wearing the freestyle libre glucose sensor (abbott diabetes care). participants will undergo their conventional multiple daily injection (mdi) therapy. at breakfast, the research team will download the sensor data. camp physicians will review each participant's sensor and insulin data and make changes to their parameters based on their clinical judgement, as they would for all campers, regardless of study participation. these new parameters will be entered into the patient's camp file. 2. mdi with basal-bolus optimization algorithm adjusted basal-bolus parameters: participants will be wearing the freestyle libre glucose sensor (abbott diabetes care). at breakfast, the data from the glucose sensor and injection information will be entered into a computer and the optimization algorithm will be run. camp physicians will review the algorithm's recommendations before they are entered into the patient's camp file.

Eligibility criteria:
inclusion criteria: 1. males and females between 8 and 18 years old. 2. clinical diagnosis of type 1 diabetes for at least 12 months. the diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not needed. 3. undergoing multiple daily injection therapy. 4. hba1c ≤ 11%. exclusion criteria: 1. serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. 2. failure to comply with the study protocol or with team's recommendations. 3. injection of isophane insulin (nph) or any intermediate-acting insulin 4. more than one injection of slow-acting insulin per day.

Keywords: multiple daily injections type 1 diabetes pediatrics optimization algorithm
the "open wound bone augmentation concept" with amnion-chorion membrane

Conditions: Horizontal Ridge Deficiency

Summary: the purpose of this study is to compare two bone graft wound healing techniques; an open wound healing approach versus the standard closed wound healing approach.

open wound healing approach (experimental technique): the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta (the tissue sac that surrounds an embryo) and will be left partially open to heal. closed wound healing approach (standard technique): the wound where the graft was attached to the bone will be filled with collagen tissue (processed bone grafts from donors) and stitched closed while it heals. 20 patients needing more bone before placing a dental implant will be recruited for this trial. patients will be randomized to either the test (open wound healing approach) or control (closed wound healing approach) group.

Eligibility criteria:
inclusion criteria: * be at least 21 years of age * be missing 1 to 2 back teeth in the lower jaw for at least three months * need horizontal bone ridge augmentation (gain width of the bone) prior to implant placement, determined clinically and radiographically * have enough bone height at the site exclusion criteria: * currently smoke more than 10 cigarettes a day (self-reported) * have any medical conditions or jaw pathology that we decide might influence the outcome of the study * are pregnant or are lactating (self-reported) * have unstable periodontal disease or other dental infection * have poor oral hygiene * have any clinical conditions that make the subject unsuitable for bone graft surgery
decreased tongue strength is related to skeletal muscle mass in copd subjects

Conditions: Chronic Obstructive Pulmonary Disease

Summary: background: dysphagia is frequently observed in subjects with chronic obstructive pulmonary disease (copd). but tongue strength has not been investigated yet in copd subjects. the investigators hypothesized that tongue strength is weaker in copd subjects compared to normal subjects. methods: this was a single-centre, observational, and cross-sectional study. twenty-seven subjects with copd and twenty-four age-matched control subjects were enrolled in this study. isometric tongue strength was measured using a device fitted with a disposable oral balloon probe. the investigators also evaluated handgrip strength, gait speed, and appendicular skeletal muscle mass (asm) to define participants as having sarcopenia. asm, fat free mass index (ffmi), and skeletal muscle mass index (smi) were measured by bioelectrical impedance analysis. gait speed was measured using the 6-meter walking test. the eating assessment test-10 (eat-10) was used to diagnose dysphagia.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of stable copd. * age-matched control subjects who did not have any pulmonary disease. exclusion criteria: * participants with metallic implants. * history of stroke disease. * history of neuromuscular disease. * participants who did not have their front teeth.

Keywords: dysphagia
randomized esophyx versus sham / placebo controlled tif trial: the respect study

Conditions: Gastroesophageal Reflux Disease; Hiatal Hernia

Summary: the objective of the study is to evaluate the relative merits, safety and effectiveness of the esophyx transoral device in performing an advanced tif procedure in patients with "troublesome symptoms" as defined by the montreal consensus definition while on ppis compared with sham and placebo controls.

primary effectiveness endpoint: a clinically significant reduction in gerd symptoms, specifically "troublesome" regurgitation with or without heartburn assessed by the reflux disease questionnaire (rdq). troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity. secondary effectiveness endpoint: the normalization of esophageal acid exposure at 6 months and a clinically significant reduction in ppi usage at 12 months.

Eligibility criteria:
inclusion criteria: * age 18-80 years * dependent upon daily ppis for \> 6 months * troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of omeprazole or equivalent. troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity. * abnormal ambulatory ph study off ppi therapy for 7 days. * normal or near normal esophageal motility (by manometry) * hiatal hernia axial height is no larger than 2 cm and the transverse dimension should not exceed 2.5 cm * patient willing to cooperate with post-operative dietary recommendations and assessment tests * signed informed consent exclusion criteria: * bmi \> 35 * hiatal hernia \> 2 cm * esophagitis los angeles grade c or d * esophageal ulcer * esophageal stricture * esophageal motility disorder * pregnancy or plans for pregnancy in the next 12 months (in females) * immunosuppression * asa \> 2 * portal hypertension and/or varices * history of previous resective gastric or esophageal surgery, cervical spine fusion, zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis * active gastro-duodenal ulcer disease * gastric outlet obstruction or stenosis * severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment * coagulation disorders * interprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe device introduction.

Keywords: gerd esophagitis fundoplication anti-reflux surgery ppi dependent