Kornimate/medical-research-clean huggingface dataset:
down syndrome clinical trials - study of alzheimer's disease in down syndrome

Conditions: Alzheimer's Disease in Down Syndrome

Summary: the primary objective is to characterize trajectories of change on the primary outcome measures in this study population through longitudinal collection of measures of cognition, function, behavior, and health status.

the ds-ctn will engage in rigorous, high quality research to better understand ad-ds and the medical needs of this population. the life-dsr study will utilize the ds-ctn network to achieve these goals through evidence-based research and a combination of proven and novel methodologies. the network will initially recruit and employ experts and clinical trial sites who have access to adults with ds and whose focus is on ad-ds. this trial also aims to develop sensitive and well-validated assessment instruments of cognition, behavior and function appropriate for future clinical trials directed at ad-ds in adults with ds ages 25 and older. in addition, this life-dsr study will serve as a parent protocol that includes one or more sub-studies, each of which has its own protocol and consent form. these sub-studies will recruit from eligible participants enrolled in this life-dsr protocol.

Eligibility criteria:
inclusion criteria: 1. age 25 years or older 2. diagnosis of ds, typically supported by karyotype analysis documenting full trisomy for chromosome 21 or complete unbalanced translocation of chromosome 21. karyotype analysis is not required for study entry 3. participants, or legal authorized representative, and their study partner if applicable, in the opinion of the investigator, are able to understand and willing to sign written informed consent. 4. participants must have a study partner who has frequent interaction with the participant on a regular basis, will agree to participate in annual clinic visits, can provide accurate responses to questions about the participant, and facilitate participation in the study visits, in the opinion of site pi or study coordinator. 5. participant and study partner must be capable of reliably completing study assessments. exclusion criteria participants and study partners who, in the opinion of the site pi, are not able to complete trial procedures or adhere to the schedule of study assessments will be excluded from study participation.

Keywords: down syndrome alzheimer's disease
efficacy study of escitalopram for depression in patients with diabetes

Conditions: Major Depression; Diabetes Mellitus

Summary: patients with diabetes and major depression treated with escitalopram might experience significant improvement in depression and anxiety scores; functional ability; diabetes-related self-care; and pain symptoms

major depression is common in patients diabetes (point prevalence about 15-20%). it has been shown that patients with diabetic and major depression experience more severe diabetes symptoms, greater disability, more frequent medical complications, greater healthcare utilization costs, poorer glycemic control, and greater difficulties with diabetes self-care activities, compared with patients with diabetes without depression. few specific features of escitalopram, a selective serotonin reuptake inhibitor (ssri), make it a promising medication for use in diabetes. these include a benign side effect profile; high tolerance in elderly patients; rapid action with efficacy often demonstrated in as little 1-2 weeks, which in turn could help improve compliance; its efficacy for treatment of generalized anxiety disorder, which may also be relatively common in patients with diabetes, and co-occurs frequently with depression. this study is designed to test the efficacy of escitalopram for the treatment of major depression in patients with diabetes mellitus.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * diagnosis of type-1 or type-2 diabetes mellitus (excluding gestational diabetes) by a specialist at least 6 months prior to the study. * current diagnosis of major depression based on dsm-iv criteria . * hamilton depression rating scale (hamd) baseline score \> 17 * available for 14-weeks of treatment and all evaluations. * able to understand study rules and procedures and willing to sign written informed consent for study participation. exclusion criteria: * competence: not competent to understand and sign informed consent forms and/or to understand and answer the evaluations. * psychiatric exclusions: one or more of the following: alcohol or substance abuse or dependence in past 6 months; psychotic symptoms or history of psychosis; bipolar disorder; organic brain syndrome; significant suicide risk; homicidal thoughts. * medical exclusions: known intolerance or hypersensitivity to escitalopram or other ssri; pregnancy; breastfeeding; women of childbearing potential not using adequate contraception; significant renal or hepatic dysfunction (such that demands medical workup and/or regular follow up); resting heart rate less than 40/minute (or 50/minute if symptomatic); uncontrolled hypertension (systolic blood pressure \>180 mm hg or diastolic blood pressure \>100 mm hg); any acute or unstable medical condition that might interfere with the safe conduct of the study. * concomitant medication(s) exclusion: current use (within 2 weeks of enrollment) of one or more of the following: antidepressants; regular benzodiazepine; neuroleptics; anticonvulsants; reserpine; guanethidine; clonidine; methyldopa.

Keywords: efficacy antidepressant escitalopram major depression diabetes mellitus self care
characterizing the intestinal hormonal secretion in non-obese, obese and non-obese patients after bariatric surgery

Conditions: Obesity

Summary: the enteroendocrine system is composed from different cells along the different parts of the gastrointestinal tract, secreting diverse hormones and bariatric surgery alters intestinal hormone secretion, affecting glycemic control and weight. the aim of the study is to characterize the composition and secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post bariatric surgery.

obesity and diabetes mellitus (dm) impose a significant burden of morbidity on many individuals around the world. in recent years, the enteroendocrine cells system with its diverse hormones (glucagon, glp-1, gip and others) was increasingly recognized as a key player in obesity and dm homeostasis. bariatric surgery induces weight loss as well as an improvement in glycemic control often leading to diabetes reversal and occasionally to postprandial hypoglycemic events. the aim of the study is to characterize the composition and secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post bariatric surgery.

Eligibility criteria:
inclusion criteria: * \>18 years * bmi\>= 35 or bmi\<=25 or 6-12 months after rygb surgery exclusion criteria: * known hiv infection * any nsaid's usage in the last 3 months * known celiac disease * concomitant disease with potential small bowel or colonic involvement (tb, sarcoidosis, ibd, microscopic colitis etc') * pregnancy * participation in another clinical trial * any use of medications known to modulate glucagon levels such as glp1 analogs, dpp4 inhibitors and/or sglt2 inhibitors. * insulin-treated patients. * declined to sign an informed consent

Keywords: obesity
ultrasound accelerated thrombolysis of pulmonary embolism

Conditions: Submassive Pulmonary Embolism

Summary: the ultima study is intended to prove that in patients with pulmonary embolism and a right ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1 (rv/lv ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-pa) as compared to unfractionated heparin anticoagulation. specifically, at 24 hours the rv/lv ratio will be significantly reduced in the treatment arm compared to the control arm.


Eligibility criteria:
inclusion criteria: * patients with acute pe symptoms \< 14 days. * filling defect by contrast-enhanced chest ct in at least one main or proximal lower lobe pulmonary artery * right ventricular dysfunction confirmed by echocardiography where the rv/lv end diastolic diameter ratio is ≥ 1.0. exclusion criteria: * age less than 18 years or greater than 80 years * index pe symptom duration \> 14 days * insufficient echocardiographic image quality in the apical or subcostal four-chamber view that prohibits the measurement of the right and left ventricular end-diastolic dimensions * known significant bleeding risk * administration of thrombolytic agents, e.g., tissue plasminogen activator, streptokinase, or urokinase, within the previous 4 days * active bleeding * known bleeding diathesis * known coagulation disorder, platelet count \ 2.5 * history of any intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleed * intracranial neoplasm, arteriovenous malformation, or aneurysm * recent (\< 3 months) gi bleeding. * recent (\< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, cpr, obstetrical delivery, or other invasive procedure. * allergy, hypersensitivity, or thrombocytopenia from heparin, rt-pa, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used. * estimated glomerular filtration rate (egfr) \< 50 ml/min as calculated by the cockroft formula. * hemodynamic collapse at presentation defined as: need for cardiopulmonary resuscitation; or systolic blood pressure \ 90 mm hg. * severe hypertension on repeated readings (systolic \> 180 mmhg or diastolic \> 105 mmhg). * pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested). * participating in any other investigational drug or device study. * life expectancy \< 90 days. * inability to comply with study assessments (e.g. due to geographic distance). * previous enrollment in this study * any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated. * known right-to-left shunt, for example from large patent foramen ovale or atrial septal defect * large (\>10 mm) right atrial or right ventricular thrombus

Keywords: pulmonary embolism pulmonary thromboembolism anticoagulation thrombolysis ultrasound accelerated thrombolysis
predicting caries risk in underserved toddlers in primary healthcare settings

Conditions: Dental Caries

Summary: the study aims to develop a questionnaire that can be used to help uncover a child's risk of developing dental caries (also known as tooth decay or a cavity). the aim is to develop a practical and easily-scored risk tool that a primary medical care provider can use to help find young children with the highest risk for developing cavities.

the duration of expected time to participate is 3 years (which includes 3 dental examinations).

Eligibility criteria:
inclusion criteria: adults * if primary caregiver is the parent/legal guardian: the parent/legal guardian must provide written informed consent for the child and her/himself (if s/he is the primary caregiver) prior to participation. * if primary caregiver is not the parent/legal guardian: if another individual is the primary caregiver, then this individual must provide written informed consent for her/himself prior to participation. * the parent/legal guardian and the participating primary caregiver must each be at least 18 years old or an emancipated minor * the parent/legal guardian must consent and allow examination of the oral cavity of her/his child. the primary caregiver must complete the caries risk assessment questionnaire. * the primary caregiver must be willing to participate, anticipate being the child's primary caregiver during the study period, and anticipate being available for all examinations (baseline, 18 month follow up, and 36 month follow up), in addition to intermediate contacts in between examinations. children * child must be 9-15 months of age at the time of the baseline study visit. * child must be generally healthy (i.e., no current medical condition that makes it difficult for her/him to receive a dental examination). * child must allow examination of the oral cavity. exclusion criteria: adults * a participant pair (adult-child) who demonstrates an inability to comply with study protocol requirements will be excluded - this determination will be at the site primary investigator's discretion. * non-english, non-spanish reading/speaking individuals will be excluded, as they will not be able to comprehend the consent document or complete the risk questionnaire. children * children who are in foster care at study initiation will be excluded, due to the likelihood that their primary caregiver will change multiple times during the length of the study. * need for antibiotic and/or sedative premedication prior to dental exam. * uncontrolled epilepsy. * active cancer treatment. * unrepaired congenital heart defects that would require premedication prior to dental exam.

Keywords: dental caries high risk dental cavities children dental care
insufficient cellular oxygen in icu patients with anaemia

Conditions: Critical Care; Anemia; Erythrocyte Transfusion; Oxygen; Mitochondria

Summary: the purpose of this study is whether the mitochondrial oxygenation tension (mitopo2) is a feasible and reliable tool in icu patients with anaemia undergoing red cell transfusion to ultimately personalize blood transfusion decisions in the icu.

evidence is increasing that in some cases a hb trigger of 7-8g/dl may be too low and te question arises whether an individualized red cell transfusion strategy may benefit critically ill patients. new studies have shown the potential of protoporphyrin ix-triple state lifetime technique to measure mitochondrial oxygenation tension (mitopo2) in vivo, which possibly is an early indicator of oxygen disturbance in the cell and therefore a physiological trigger for red cell transfusion. the goals are: 1. determining the feasibility of using mitopo2 and the variability of mitopo2 measurements in critically ill intensive care unit (icu) patients before and after receiving a red cell transfusion 2. describing the effects of red cell transfusion and the associated change in \[hb\] on mitopo2 and on other physiologic measures of tissue oxygenation and oxygen balance 3. describing the association between mitopo2 and vital organ functions. included patients will undergo red cell transfusion as planned. however, red cell transfusion will be delayed by 2 hours. at multiple predefined moments data collection including blood samples and measurements of mitopo2 will take place. the results of this study cannot be immediately translated to clinical practice. using these results, the investigators will design a phase 2 diagnostic study, most probably a randomized clinical trial that will yield applied knowledge with respect to personalizing red cell transfusion. application will be in icu patients with anaemia who might or might not profit from red cell transfusions. it will lead to a reduction of both over- and under- transfusion.

Eligibility criteria:
inclusion criteria: * adult patient admitted to the icu * hb below 6.3 mmol/l (10 g/dl) * central venous catheter in situ * red cell transfusion planned exclusion criteria: * adults without a legal representative to ask for informed consent * patients less than 18 years old * pregnant or breast feeding women * patients in need of emergency red cell transfusion e.g. bleeding * not having a central venous catheter in situ * porphyria and or known photodermatosis * patients with an expected icu stay \<24 hours * patients with hypersensitivity to the active substance or to the plaster material of ala
feasibility of systematic handgrip strength (hgs) testing and short-term changes in muscle strength in digestive cancer patients treated by chemotherapy

Conditions: Handgrip Strength Test; Sarcopenia; Digestive Cancer; Muscle Strength; Chemotherapy

Summary: sarcopenia is defined as a loss in skeletal muscle mass and function (strength and/or performance). there is a high prevalence in elderly and in patients with cancer. several mechanisms are known to explain sarcopenia (inflammation, neurodegenerative process, hormonal disorders, lack of exercise, malnutrition). the consequences were analysed in several studies where sarcopenia appeared to be an independent factor of mortality, and associated with cancer-related fatigue, nosocomial infections, cardio-vascular diseases, and chemotherapy toxicities. diagnosis is based on the measure of the muscle mass performing an abdominal computed-tomography (ct) scan, and on the measure of the muscle strength using the handgrip test with a "jamar®" hydraulic hand dynamometer. ct scan is more invasive and less easy to reach than handgrip test. this test is used to be performing in elderly but not in cancer patients having chemotherapy. present prospective study explored the feasibility of systematic handgrip strength testing and short-term changes in muscle strength in digestive cancer patients treated by chemotherapy.


Eligibility criteria:
inclusion criteria: * patients with digestive cancer having a chemotherapy and/or biotherapy in the department of reims * \> 18 years old * after patient agreement * linked to social security system exclusion criteria: * legal guardianship * \< 18 years old * neuro-muscular issue
hydrogen peroxide and nitrite reduction in exhaled breath condensate of copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of the study is to investigate the effect of inhaled apocynin on ros (reactive oxygen species) and nos (reactive nitrogen species) synthesis in 13 copd patients. effects of nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (ebc) after 30, 60 and 120 minutes.

apocynin reduced hydrogen peroxide concentration in exhaled breath condensate 60 and 120 minutes after apocynin nebulization comparing to placebo (0.43 μm vs. 0.59 μm and 0.41 μm vs. 0.58 μm respectively, p\ 0.05). no influence of apocynin on safety parameters, and no adverse effects has been observed.

Eligibility criteria:
inclusion criteria: * patients suffering from bronchial copd (ii and iii stage) * patients free of any medication few days before research * patients had not suffered from any infectious diseases including upper respiratory tract infections for at least 3 months prior to the study exclusion criteria: * patients suffering from gold i stage * patients taking medications few days before the study * infectious diseases that had occurred 3 months or less before the study

Keywords: apocynin copd
tms in treatment of schizophrenia negative symptoms

Conditions: Schizophrenia

Summary: primary objective: to examine the efficacy and safety of high frequency repetitive transcranial magnetic stimulation (hf rtms) with h7-coil applied once daily during the twenty days, augmentative to the standard antipsychotic pharmacotherapy and other treatment of negative symptoms in schizophrenia. targeted population: patients diagnosed with schizophrenia, 18-55 years old with predominant negative symptoms, stable condition for \>3 months and unchanged antipsychotic therapy for \>1 months and no treatment with antidepressants. study design: industry independent, multicenter, prospective randomized sham-controlled, two-arms, triple-blind superiority clinical trial with concealed allocation and masked independent outcome assessment. primary outcome: adjusted median of differences in total sans score. adjustment for age, gender, baseline total sans score, duration of the disorder, and antipsychotic therapy.


Eligibility criteria:
inclusion criteria: 1. confirmation diagnosis of schizophrenia (icd-10 f20) using the mini-international neuropsychiatric interview (mini) (lecrubier et al., 1997; sheehan et al., 1998), 2. age 18-55 years, 3. both genders, 4. panss negative symptoms subscale score \>24, 5. panss positive symptoms subscale score \<20, 6. stable condition (no acute psychosis exacerbation, no psychiatric hospitalization because of relapse or worsening of symptoms) during at least three months, 7. stable antipsychotic therapy with no change of drugs or doses during the one months before the enrollment. exclusion criteria: 1. antipsychotics dose change or change of antipsychotic drug, 2. hospitalization for somatic illness in another institution, 3. termination of treatment in a psychiatric hospital "sveti ivan", 4. pregnancy, 5. missed more than three consecutive interventions, 6. withdrawal of consent to participate for the sake of intolerance of tms or for other reasons.
reversal of obesity cardiomyopathy

Conditions: Cardiomyopathy

Summary: the overall purpose of this study is to determine if weight loss is beneficial for obese patients with diastolic heart failure.


Eligibility criteria:
inclusion criteria: * all subjects will have obesity and have a bmi \> 35kg/m2. * subjects must be between the ages of 35 and 65 years, in order to limit the confounding affect of age on our endpoints. to determine if potential subjects meet these criteria, they will: 1. be interviewed, 2. their clinical charts reviewed, by the research study coordinator and/or the pi, and 3. undergo a history and physical by a physician (study day 2). subjects who are to undergo gastric bypass surgery will be in the intervention arm. they will be matched with control subjects. we will attempt to have no more than one control subject for each gastric surgery subject. exclusion criteria: * subjects who have a condition that may masquerade as diastolic heart failure will be excluded (see research and design). * subjects who are \ 65 years, \> 400lbs (the weight limit of the mri table) not obese, unstable, not able to lie flat for the imaging studies, not ambulatory, unable to give informed consent, pregnant, lactating, with atrial flutter or fibrillation, current smokers, or who will undergo a different type of bariatric surgery (not roux-en-y gastric bypass) will be excluded from participation. * those who have evidence of other major systemic diseases (e.g., cancer, significant lung disease, creatinine \> 2.0mg/dl, hemoglobin \< 10g/dl, and liver function tests twice the normal range) will be excluded. * subjects who have \> class i hypertension will be excluded. the investigators will exclude patients with an lv ejection fraction \ 55mmhg).