Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of op2000 (deligoparin) in the treatment of active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study will evaluate the effectiveness and safety of the experimental compound op2000 (deligoparin) in patients with active ulcerative colitis. patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. op2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis.

this is a double-blind, placebo-controlled, research study to evaluate the effectiveness and safety of the experimental compound op2000 (deligoparin) in patients with active ulcerative colitis. patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. op2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis. patients will be randomized (assigned by chance like the toss of a coin) to receive 75 mg op2000, 125 mg op2000, or placebo once daily for 6 weeks. study drug will be administered by subcutaneous (under the skin) injection and patients will be taught how to self-administer these injections. following an initial screening visit, eligible patients will return to the clinic for initiation of study treatment and then again for follow-up visits after 1, 2, 4 and 6 weeks of treatment. a follow-up telephone call will be scheduled 2 months (and possibly also 4 and 6 months) after completing study treatment. study procedures will include a flexible sigmoidoscopy at the screening visit and at the week 6 visit.

Eligibility criteria:
inclusion criteria: * history of ulcerative colitis at least 3 months with biopsy and colonoscopy confirmation. * treatment with aminosalicylates at least 28 days, if tolerated. * duration of current flare-up at least 7 days. * must be able to self administer once-daily subcutaneous (under the skin) injections of study drug. exclusion criteria: * disease limited to the rectum. * toxic megacolon. * the use of anticoagulant drugs. * a history of any bleeding disorder. * a history of heparin-induced thrombocytopenia. * evidence of liver or kidney impairment. * women who are pregnant or breast feeding.
translating research into practice for postpartum depression

Conditions: Postpartum Depression

Summary: this is a study to assess the impact of introducing screening and planned follow up for postpartum depression. all women ages 18 to 45 who speak english or spanish who come to the enrolled community family medicine offices will either be given usual care or screened using the edinburgh postnatal depression screening tool. if the edps score is high the women will be given the phq-9 to more clearly identify the specific likelihood of being depressed. women who are determined to be depressed will be treated with medication or counseling based on the preference of the women and their physicians. women will be followed through nurse initiated phone calls and visits to the physicians office. outcomes include the level of depression symptoms, measure of comfort with parenting, and satisfaction with partner relationships comparing baseline levels with those at 6 and 12 months from the usual care and intervention sites. these data will be collected by questionnaire. in addition, with the women's permission, medical records will be reviewed.

a randomized controlled trial of screening and management of postpartum depression that includes a second phase assessing the maintenance of the intervention in the original intervention sites and a switch from usual care to intervention in the control sites. planned enrollment includes 29 family medicine practices and 3000 women over a period of four years. all follow up and management is initiated within the family medicine practices to improve generalizability and likelihood for dissemination. in addition to the patient centered outcomes, exploratory analyses will look at the uptake and degree of implementation and maintenance of the intervention based on characteristics of the practice including size, location, affiliation with larger group, type of practice and whether or not the practice is a community health center or residency practice.

Eligibility criteria:
inclusion criteria: * 5 to 12 weeks postpartum * able to speak and read english or spanish * 18 to 45 years of age exclusion criteria: * significant cognitive impairment and unable to answer screening questions

Keywords: depression postpartum dyad satisfaction parenting comfort screening management follow up primary care practice based research
mri/mrsi in risk assessment of prostate cancer patients

Conditions: Prostate Cancer

Summary: the purpose of this study is to see if magnetic resonance imaging (mri) and magnetic resonance spectroscopic imaging (mrsi) can tell which patients with prostate cancer are at a low risk for their cancer growing and spreading. magnetic resonance methods use magnets and radio waves to take pictures of body structure (mri) and to measure amounts of important chemicals within the body (mrsi). this study will look at the structural and chemical properties of prostates before undergoing treatment. hopefully, doctors will be able to use this method before making treatment decisions for patients with newly diagnosed cancer of the prostate. this study will continue our work to assess the value of mri/mrsi in addressing what is currently one of the greatest clinical challenges in the management of prostate cancer: the identification of low-risk organ-confined prostate cancer that can be managed expectantly with deferred treatment.

in this study, patients with low-risk, organ-confined prostate cancer identified in clinic or prior to their already scheduled standard of care mri in the department of radiology will be approached for the study. eligible patients will undergo a baseline emri/mrsi exam between 6 and 24 weeks following biopsy. patients will undergo definitive treatment (radical prostatectomy (rp) or radiation therapy (rt)) or will be placed on deferred therapy. predictor variables will be recorded for each patient after enrollment, before treatment and during treatment follow-up. patient outcome-disease progression will be determined by long term clinical follow-up

Eligibility criteria:
inclusion criteria: 1. gleason ≤6 (grade 3 + 3 or lower) biopsy proven prostate cancer 2. clinically low-risk localized disease as defined by nccn guidelines (clinical stage t1-t2a, maximum gleason score 2-6, peak serum psa level \< 10 ng/ml) 3. no evidence of disseminated disease (bone or lymph node metastases) 4. treatment-radical prostatectomy, radiation therapy, or deferred therapy-will be at mskcc 5. willingness to undergo serial surveillance trus-guided prostate biopsies and emri/mrsi examination at mskcc if placed on deferred therapy protocol 6. in the surgical cohort, rp (radical prostatectomy) is scheduled to occur within six months of emri/mrsi study exclusion criteria: 1. prior treatment (e.g. with hormonal therapy, radical prostatectomy, radiation therapy or cryosurgery) 2. inability to give informed consent because of age, general medical or psychiatric condition, or physiologic status 3. presence of known contraindication to emri 4. unwillingness or inability to undergo placement of endorectal mr coil or ultrasound probe. as is the case for a standard mr exam, the presence of a pacemaker or aneurysm clips could pose a risk to patients, making them unable to have an emri, and therefore unable to participate in this study.

Keywords: prostate cancer prostate
brain aging: muscle-to-brain axis modulates physio-cognitive decline

Conditions: Age-related Cognitive Decline; Age-related Physiology Decline

Summary: the primary goal is to develop a multidomain intervention program focused on preserving global or regional brain volume and functions while simultaneously improving physical mobility and cognitive functions in older individuals with mobility frailty. this initiative seeks to unravel the brain-muscle axis mechanisms contributing to the accelerated functional declines observed in older populations. moreover, our objective includes examining the relationships between the intervention and a broad spectrum of clinical characteristics, phenotypic traits, biochemical profiles, myokines, proteomics, metabolomics, brain imaging, and our previously identified discoveries involving exosomal mirna.

this study is a randomized controlled trial of 12-month multidomain intervention program among community-living older adults with early physical or cognitive impairments. inclusion criteria are: (1) community-dwelling adults aged ≥ 65 years, (2) slow gait speed (\<1 m/s in 6-meter walk test) or weakness (dominant handgrip strength \<28 kg in men, \<18 kg in women); subjects with the following conditions will be excluded: (1) established diagnosis of dementia, parkinsonism or other neurodegenerative disease (2) disable status: mobility-limiting conditions, (3) active, acute diseases receiving treatment, such as cancer, heart failure, copd and so on, (4) estimated life expectancy \<12 months, (5) current nursing home residents.

Eligibility criteria:
inclusion criteria: * aged ≥ 65 years * slow gait speed (\<1 m/s in 6-meter walk test) or weakness (dominant handgrip strength \<28 kg in men, \<18 kg in women) exclusion criteria: * established diagnosis of dementia, parkinsonism or other mobility-limiting, disable conditions * active, acute diseases receiving treatment, such as cancer, heart failure, copd and so on * estimated life expectancy \<12 months * current nursing home residents

Keywords: frailty cognitive impairment physio-cognitive decline syndrome dementia biomarkers skeletal muscle aging neuroimaging multidomain intervention
long-term open-label, safety study of sitaxentan sodium in japanese pulmonary arterial hypertension patients

Conditions: Hypertension, Pulmonary

Summary: the safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the stride clinical trial program. sitaxentan sodium was approved in the eu, canada and australia. in this study, the long-term safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in japanese pah patients.


Eligibility criteria:
inclusion criteria: * subject who completed the b1321052 study as planned. exclusion criteria: * has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \>160 mm hg or sitting diastolic blood pressure \>100 mm hg at screening. * has hypotension defined as systolic arterial pressure \<90 mm hg after sitting for 5 minutes at screening.

Keywords: sitaxentan sodium pulmonary hypertension
trial to assess the effects of vorapaxar (sch 530348; mk-5348) in preventing heart attack and stroke in particpants with acute coronary syndrome (tra•cer) (study p04736)

Conditions: Atherosclerosis; Myocardial Ischemia; Myocardial Infarction

Summary: the study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care in preventing heart attack and stroke. the study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.


Eligibility criteria:
inclusion criteria: men and women at least 18 years old with current clinical manifestation of non-st-segment-elevation myocardial infarction (heart attack) according to the following three criteria: * current symptoms of cardiac ischemia (chest pain leading to cardiac ischemia or heart attack) and * either of the following: * concurrent elevation of troponin i or t, or of creatine kinase - myocardial band (ck-mb) to a level above the upper limit of normal, or * concurrent appropriate electrocardiographic evidence and * any one (or more) of the following: * age \>= 55 years * documented history of prior heart attack or coronary revascularization (eg, angioplasty \[pci\], coronary artery replacement \[cabg\]) * diabetes (documented use of insulin or oral hypoglycemic\[s\]) * documented history of peripheral arterial disease exclusion criteria: * history of intracranial hemorrhage or of central nervous system (cns) surgery, tumor, or aneurysm * any bleeding disorder or abnormality * sustained severe hypertension or valvular heart disease * current or recent platelet count \<100,000 mm\^3 * planned or ongoing treatment with a blood thinning medication * pregnancy * any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study
comparison of length gain between square flap and z-plasty in post burn contracture release

Conditions: Burn Scar

Summary: the purpose of this study is to compare the gain in length after postburn contracture release using two different techniques, the more commonly practised z - plasty and relatively newer technique, square flap


Eligibility criteria:
inclusion criteria:- • both genders. * joints supple. * linear contracture bands. * age between 5years to 50 years. * surrounding non scarred skin. * contractures of axilla, cubital fossa, popliteal fossa and digits. exclusion criteria: * deep burns. * joint contractures. * surrounding skin scarred. * broad, irregular contracture. * neck, perineal, wrist or toe contractures
mat pilates versus general exercises for patients with nonspecific acute low back pain

Conditions: Low Back Pain

Summary: aim: to compare the effectiveness of mat pilates with general exercises in treating patients with nonspecific acute low back pain. novelty: pilates, typically performed with specific equipment, has shown clinically significant treatment effects in people with chronic low back pain. recent guidelines recommend patients remain active during episodes of low back pain; however, evidence regarding the type of exercise to perform is limited. mat pilates is a type of pilates exercise that does not require complex equipment. evaluating the effectiveness of two simple exercise methods (mat pilates and general exercises) can help expand intervention options for patients with acute low back pain, enabling them to choose an exercise they enjoy most.


Eligibility criteria:
inclusion criteria: * aged between 18 and 50 years old * acute nonspecific low back pain with at least 3 points on the visual analog scale (vas) * willing and able to provide informed consent * able to comply with the study protocol and attend all treatment sessions and follow-up assessments exclusion criteria: * presence of specific low back pain causes, such as lumbar radiculopathy, spinal stenosis, or spondylolisthesis * previous spinal surgery * contraindications to exercise, such as severe cardiovascular or respiratory conditions * currently pregnant or planning to become pregnant during the study period * participation in another clinical trial or receiving concurrent experimental treatment for low back pain
a pilot study of atazanavir/ritonavir/efavirenz as a nucleoside sparing regimen

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.


Eligibility criteria:
inclusion criteria: * provide written informed consent * hiv positive with plasma hiv rna viral load of ≥ 1000 copies/ml and cd4 cell count of ≥ 50 cells/mm3 * antiretroviral (arv) naive prior to enrollment * normal plasma triglycerides ≤ 200 mg/dl * women of child-bearing age must use effective barrier contraception exclusion criteria: * pregnancy or breast feeding * evidence of resistance to antiretroviral drugs * history of elevated blood cholesterol or triglycerides * history of diabetes * hypersensitivity to any component of the study drugs * any cholesterol or triglyceride lowering medications in the past six months * use of growth hormone, megestrol acetate, or anabolic steroids in the past six months * imprisonment or involuntary incarceration for medical treatment

Keywords: hiv/aids
ultrasound guided qlb versus laparoscopic superior hypogastric plexus block for postoperative analgesia after laparoscopic hysterectomy

Conditions: Post Hysterectomy Pain

Summary: pain following laparoscopic hysterectomy may interfere with early ambulation, discharge of patient from hospital and interfere with enhanced recovery with more opioid consumption. most of methods for postoperative pain depend on the use of high doses of opioids with more side effects such as nausea, vomiting, respiratory center depression, delay bowel motility and hemodynamics instability. to decrease of opioid consumption in postoperative pain management as well as related side effects, previous studies showed that quadratus lumborum block or superior hypogastric plexus block (shpb) had shown promising success in management of postoperative pain in patients undergoing laparoscopic hysterectomy. the present study will be conducted to compare of ultrasound guided ql block and laparoscopic superior hypogastric plexus block as a part of multimodal analgesia may allow adequate analgesia and decrease the overall use of opioids and allow patient enhanced recovery.

hypothesis: there is no difference between the analgesic effect of either ultrasound guided ql block or laparoscopic superior hypogastric plexus block on post laparoscopic hysterectomy pain. alternative hypothesis: there is difference between the analgesic effect of either ultrasound ql block or laparoscopic superior hypogastric plexus block on post laparoscopic hysterectomy pain. aim of the work better achievement of effective analgesia with less opioid consumption and related side effects for post laparoscopic hysterectomy pain. objectives to assess effect of both ultrasound quadratus lumborum block and laparoscopic superior hypogastric plexus block on analgesic outcome (visual analogue scale vas, duration of analgesia) after laparoscopic hysterectomy. to compare between ultrasound quadratus lumborum block and laparoscopic superior hypogastric plexus block regarding to total opioid for postoperative analgesia after laparoscopic hysterectomy and patient satisfaction. to record side effects related to regional block ( e.g., local anesthetic toxicity, vascular and neural injury) and opioids ( neasuea, vomiting, respiratory depression

Eligibility criteria:
inclusion criteria: 1. written informed consent from the patient. 2. bmi of less than or equal 30.0 kg m-2. 3. age 45-60 years old. 4. american society of anesthesiologists (asa) physical status classes i and ii.exclusion criteria: 1. allergy to local anesthetics. 2. infection at site of injection. 3. patients with coagulopathy. 4. patients with chronic pain syndromes. 5. physical and mental disease which could interfere with pain scores evaluation. 6. patients with distorted local anatomy.
value of ankle pressure index after maximal exercise tests

Conditions: Cardiovascular Diseases

Summary: estimate the response of ankle to brachial pressure index to incremental maximum exercise in subjects free from prior cardiovascular disease. estimate morbi-mortality of included patients over a 5 years follow up.


Eligibility criteria:
inclusion criteria: * 18 years old and more exclusion criteria: * patient with recent cardiovascular event

Keywords: ankle brachial index maximal exercise test
feasibility and effectiveness of a remote monitoring program for the treatment of diabetic foot ulcers

Conditions: Diabetic Foot; Diabetic Foot Ulcer; Wound; Foot; Wound Leg; Wound Heal; Diabetes Complications

Summary: this research is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. this will be a pilot non-blinded randomized controlled feasibility trial. the investigators will enroll 120 patients with an active diabetic foot ulcer (dfu) who present to the multidisciplinary diabetic foot clinic in baltimore, maryland. patients will be computer randomized 1:1 to receive wound care monitoring using remote dfu monitoring technology or standard in-person monitoring for 12 weeks.

the purpose of this research is to determine if a smartphone mobile application, also referred to as a mobile app or simply an app, designed to capture wound measurements and analyze wound tissue distribution in real-time, can be a practical patient-centered solution for regular wound management and assessment. the app will be compared to traditional in-person wound monitoring. one of the major limitations of most literature describing remote monitoring technologies is the lack of a control group. by randomizing half of the enrolled patients to remote monitoring via standard of care, the investigators will be able to compare patient and provider satisfaction with remote vs. in-person monitoring, as well as the wound healing outcomes.

Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years old * in treatment for lower extremity wound related to diabetic foot ulcer * able and willing to use a smartphone to assess the wound for the duration of the study * english language proficiency exclusion criteria: * patients with less than 1 dressing change per week * patients with wound size that cannot be covered with a single app scan (out of boundary conditions include wounds that wrap around patient's entire leg) * patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans
safe & easy for alzheimer's disease and related pathologies

Conditions: Cognitive Deterioration

Summary: all over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability. building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous information and communication technologies (ict) solutions which are not always easy to use in everyday life. the safee (safe easy environment) project aim is to improve the safety, autonomy and quality of life of older people at risk. the safee2 project develop non pharmacological therapeutic through diferent ict (stimulation aromatherapy automatic fragrance ...) . the goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

the non pharmacological therapeutic will be install at hospital room : * aromatherapy, * music therapy, * cognitive training in multimedia application offering cognitive games.

Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of alzheimer's disease according to nincds-adrda (mckhann, drachman et al. 1984) or typical or atypical alzheimer's disease (dubois b. et al. 2007). * score at mini mental test (mmse) ≥16. * subjects residing in nursing homes. * subjects beneficiaries of a social security scheme. * signature of free and informed consent. exclusion criteria: * failure to pass the neuropsychological tests because of a sensory or motor deficit. * sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions. * prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation; * persons deprived of liberty (administrative or judicial).