Kornimate/medical-research-clean huggingface dataset:
evaluation of anti-xa levels in surgery patients receiving weight-based heparin

Conditions: Deep Vein Thrombosis; Pulmonary Embolism; Venous Thromboembolism

Summary: the purpose of this study is to determine if weight-based heparin infusions at a rate of 10 units/kg/hour are sufficient to maintain a target anti-xa of 0.1-0.35 iu/ml for vte prophylaxis in patients undergoing microvascular surgery. additionally, a pilot protocol has been developed to titrate these heparin infusions to ensure patients have sufficient vte prophylaxis. all patients will be enrolled in the observational arm of the study and receive anti-xa level monitoring. patients with out-of-range anti-xa levels will cross over to the interventional arm of the study and receive real time heparin infusion dose adjustments per the pilot protocol. the primary outcome measured will be the percentage of patients with anti-xa levels in the target range of 0.1-0.35 iu/ml while on a heparin infusion at 10 units/kg/hour.


Eligibility criteria:
inclusion criteria: * patients undergoing surgical procedures * initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively exclusion criteria: * age \<18 years old * pregnant * incarcerated * mentally disabled
a study of an infectivity enhanced suicide gene expressing adenovirus for ovarian cancer in patients with recurrent ovarian and other selected gynecologic cancers

Conditions: Ovarian Cancer

Summary: in spite of surgical and chemotherapeutic advances, long term survival for advanced and recurrent gynecologic cancers remains dismal and no curative treatment for recurrent disease exists. novel treatment strategies are needed. this is a study to determine the maximally tolerated dose of and toxicities associated with intraperitoneal delivery of an infectivity enhanced adenovirus that expresses a suicide gene and an gene that allows imaging of gene transfer. this vector will be given in combination with intravenous ganciclovir in patients with recurrent ovarian and other gynecological cancers.


Eligibility criteria:
inclusion criteria: * patients must have histologically documented invasive epithelial ovarian, extraovarian, fallopian tube or endometrial carcinoma. * patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional therapy. * patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable. * patients must have a gog performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months. * patients must have adequate hematologic, renal, and hepatic function defined as: * wbc \> 3,000 ul * granulocytes \> 1,500 ul * platelets \> 100,000 * creatinine clearance \> 80 mg/dl or serum creatinine \> 2.0 * serum transaminases \< 2.5 x upper limits of normal * normal serum bilirubin * pt/ptt/inr \< 1.5 x institutional uln * o2 saturation \> or = 92 % * patients must be 19 years or older and must have signed informed consent exclusion criteria: * patients with epithelial tumors of low malignant potential, stromal tumors and germ cell tumors of the ovary are ineligible to participate in the study. * patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study. * patients who are pregnant or lactating are ineligible to participate in the study. * patients with a gog performance status of 3 or 4 are ineligible to participate in the study. * patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or ef \< 55%, pulmonary hyper- tension, active or chronic debilitating pulmonary disease(i.e., active pneumonia, severe copd, pulmonary edema, o2 saturation \< 92%), or coagulation disorders (i.e. bleeding disorders, or on therapeutic anti- coagulants)

Keywords: ovarian cancer recurrent ovarian cancer and other gynecologic cancers
dairy products and metabolic syndrome

Conditions: Blood Pressure; Metabolic Syndrome X

Summary: the purpose of this trial is to investigate the effect of dairy products on the so called metabolic syndrome. metabolic syndrome is a cluster of risk factors, such as high blood pressure and high cholesterol, for the development of diabetes and heart disease. participants will be randomly assigned to either eat a portion of a norwegian traditional cheese which is high in protein and low in fat (group 1), or eat a slightly higher than normal intake of regular gouda-type cheese (group 2), or to limit their intake of cheese (group 3). dairy products are a significant source of bioactive peptides, small pieces of protein which may have an effect on our health. these effects may be antimicrobial, antioxidative, or blood pressure lowering. the traditional norwegian cheese, gamalost, which is naturally high in protein (50%) and low in fat (\<1%), has been found to be particularly high in these bioactive peptides. specifically, the cheese was found to have a very high ace-inhibitory activity, meaning it has the potential to lower blood pressure without the use of pharmaceuticals. a pilot study was performed in may 2012. no intervention was given in this trial, but participants answered an extensive questionnaire about dietary habits and lifestyle. this trial found that the people who ate the most gamalost had a slightly lower blood pressure than those that did not eat the cheese. since that was just a point-in-time study with no intervention or control, the investigators are not able to say anything certain about cause and effect, which is why the investigators want to perform this larger controlled study. in total, the investigators aim to recruit 300 people to participate in this trial, i.e. 100 in each group. the participants will be randomly placed in one of the groups and they will have to do the intervention for eight weeks. at inclusion, the investigators measure blood pressure, fasting blood glucose, weight, height, waist circumference, and the investigators draw a fasting blood sample to measure cholesterol. the same measurements will be repeated at the end of the eight weeks. at inclusion they will also fill out an extensive questionnaire about their diet and lifestyle. a shorter version of the same questionnaire will also be given at the end of the trial period. the overall goal of the study is to assess the effect of dairy products on the metabolic syndrome, but the main hypothesis is to assess whether a high intake of gamalost can reduce blood pressure in a group of people.


Eligibility criteria:
inclusion criteria: * healthy adults * must be able to eat cheese evey day exclusion criteria: * pregnant women * taking blood pressure lowering medication * not able to read norwegian
china peace million persons project

Conditions: Cardiovascular Disease

Summary: china peace millions persons project is a national screening project for cardiovascular disease in china. this project was approved by national health and family planning commission (nhfpc), china and founded by ministry of finance, china in 2014. the specific objectives of the project are to: 1. identify subjects at high-risk of cvd and provide counseling for medication and lifestyle improvements 2. evaluate the feasibility of such screening methods for subjects at high risk of cvd, and to assess the effect of health counseling on cvd incidence rates and risk factors control 3. inform future intervention and long-term follow up efforts for primary and secondary cvd prevention in china.


Eligibility criteria:
inclusion criteria: 1. 35 - 75 years old 2. registered in the hukou of the selected region 3. sign the consent form exclusion criteria: -

Keywords: screening counseling follow-up cardiovascular disease population-based project china
beta 3 agonists in treatment of non-neurogenic voiding dysfunction in children

Conditions: Voiding Disorders; Overactive Bladder

Summary: a randomized clinical study to evaluate the safety and efficacy of using the beta 3 agonist drug (mirabegron) combined with standard behavioral therapy in comparison to using the anticholinergic drug (solifenacin) combined with behavioral therapy, for children with non-neurogenic voiding dysfunction refractory to behavioral therapy alone, using improvement of dysfunctional voiding symptom score as a primary measurement of efficacy.

the study aims to evaluate the beta 3 agonist drug (mirabegron) as regard its safety and efficacy when used in children with non neurogenic voiding dysfunction, including children suffering from frequency, urgency, urgency incontinence and hesitancy who do not have neurological disease explaining these symptoms and who failed behavioral urotherapy. the patients will be randomly allocated into two groups, one will receive standard behavioral therapy plus mirabegron, the other will receive standard behavioral therapy plus the anticholinergic drug solifenacin for three months. patients will be assessed initially and after three months using: * medical and voiding history (bladder voiding diary, dysfunctional voiding symptom score (dvss) , bristol stool scale) * dysfunctional voiding symptom score (dvss) , bristol stool scale * urine analysis and mid-stream urine culture. * uroflowmetry. * pelvic us and post-void residual urine (pvr).

Eligibility criteria:
inclusion criteria: * children with non-neurogenic voiding dysfunction predominantly filling phase dysfunctions or oab, refractory to behavioral therapy as a primary monotherapy, with dysfunctional voiding symptom score of ≥6 for females and ≥9 for males, between the age of 5 \& 18 years old. exclusion criteria: * neurogenic or anatomical bladder problems. * patients with contraindications to beta 3 agonists or anticholinergic drugs.
bg9928 in subjects with hepatic impairment

Conditions: Hepatic Impairment

Summary: the primary objective of the study is to evaluate the effect of hepatic function on the pharmacokinetics of a single oral dose of bg9928 in subjects with mild and moderate hepatic impairment and in subjects with normal hepatic function.


Eligibility criteria:
inclusion criteria: * must be between the ages of 18 and 75, inclusive. * must have a body mass index (bmi) between 19 kg/m2 and 36 kg/m2, inclusive. the following criteria apply only to subjects enrolled into groups 1 and 2 (mild or moderate hepatic impairment): * must have stable hepatic disease (i.e., no change in disease status within the last 2 months as determined by the enrolling investigator) with laboratory and clinical findings that support the diagnosis of hepatic impairment. * must have a total child-pugh score (section 22, appendix i) of 5-6 (mild), or 7-9 (moderate). * must be otherwise healthy as determined by the investigator on the basis of pre-study physical examination, medical history, 12-lead ecg, vital signs, and clinical laboratory parameters. subjects with controlled hypertension and those problems directly associated with the primary diagnosis of hepatic impairment may be included. subjects with stable, mild, chronic concurrent diseases, such as degenerative joint disease, may be included. exclusion criteria: * history of an allergic reaction to any methylxanthine-containing compound. * history of seizure within the past 10 years, or use of any medication for the suppression of seizures within the past 5 years. * history of brain surgery, meningitis/encephalitis, penetrating head trauma, stroke, or transient ischemic attack within the past 6 months. * history of active (within 6 months) drug or alcohol abuse, a positive drug screen (without a medically indicated rationale), or a positive alcohol breath test at screening or on day -2. * history of human immunodeficiency virus (hiv) antibody. * serious systemic infection (e.g., septicemia) within the 30 days prior to day 1. * fever, with body temperature \>38oc, within the 48 hours prior to day 1. * active bacterial or viral infection.

Keywords: pharmacokinetics
platelet-dependent thrombosis: a placebo-controlled trial of antiplatelet therapy (clopidogrel)

Conditions: Type 2 Diabetes Mellitus; Coronary Artery Disease

Summary: patients with diabetes are more likely to develop furring of their coronary arteries and present with angina and heart attacks. furthermore, after such an event, they have poorer outcomes (higher rates of death) and survivors are more likely to have recurring symptoms. using a novel "clotting chamber" the investigators have shown that patients with diabetes are more likely to develop blood clots. this study will look at the role of different blood thinning medications in patients with diabetes. if successful, the investigators will provide evidence to conduct large clinical studies to look at the role of additional blood thinning medication in reducing heart attacks and strokes in patients with diabetes.

the objective of this study is to compare the effect of clopidogrel on platelet dependent thrombosis in patients with t2dm and cad with placebo. the badimon chamber, an ex vivo arterial injury model is used for this purpose. this model simulates the in vivo situation of high shear arterial wall damage and helps to quantify thrombus which is the sum endpoint of all haemostatic abnormalities seen in vitro.

Eligibility criteria:
inclusion criteria: * patients with t2dm and cas as defined below: * clinical definitions * t2dm: diagnosed according to the who criteria \[53\]. * cad:presence of any one of the following: angina plus positive exercise tolerance test, enzyme and/or q wave positive myocardial infarction, angiographic evidence ( \>50% stenosis of one vessel), percutaneous or surgical coronary revascularisation. * aged between 18 and 75 * provided written consent for participation in the trial prior to any study-specific procedures or requirements. exclusion criteria: * contraindication to clopidogrel * smoking (current smokers and patients who quit smoking less than six months) * malignancy(diagnosed or under investigation) * haematological disorders (anaemia, malignancy, bleeding disorders) * women of child-bearing potential * use of corticosteroids/other antithrombotic agents(warfarin) * chronic liver disease (cirrhosis, malignancy and patients with more than twice the upper limit of liver function tests) * unable to consent. * use of other investigational study drugs within 1 year prior to study entry * previous participation in this study

Keywords: type 2 diabetes mellitus coronary artery disease platelet dependent thrombogenicity aspirin clopidogrel badimon chamber
transcranial temporal interference stimulation in severely brain injured patients with disorders of consciousness

Conditions: Disorders of Consciousness; Severe Brain Injury; Unresponsive Wakefulness Syndrome; Minimally Conscious State

Summary: the purpose of this academic lead study is to explore the effect of noninvasive neuromodulation of the cm-pf via ttis for patients with disorders of consciousness.


Eligibility criteria:
inclusion criteria: * traumatic and nontraumatic etiology of vs/uws or mcs according to published diagnostic criteria. exclusion criteria: * patients in coma, with less than 1 week after acute brain insult, with fluctuating diagnosis on baseline assessment, and with a metallic cerebral implant or pacemaker, and with epilepsy.
to evaluate the effectiveness of a virtual and telephone intervention for the prevention of postpartum depression in women at risk

Conditions: Depression, Postpartum

Summary: women's perinatal mental health problems can create a cascade of short- and long-term negative influences for the mother, child, and the family as a whole. to prevent these impacts, preventive online and telephone interventions exist, but need to be tested and improved to develop this type of support to women in quebec. the parents \& babies program, which is a distance learning course, followed during pregnancy and accompanied by telephone follow-up, aims to improve the mental health of future parents.the investigators seek to evaluate the effect of the intervention of the parents \& babies program offered with telephone support compared to the course offered without telephone follow-up.

the parents \& babies intervention to be evaluated is an adaptation of the existing, evidence-based mothers \& babies program which has shown efficacy in four clinical trials for the prevention of postpartum depression through in-person (group or individual) counseling the parents \& babies program was adapted to be virtual and include: 1) specific modules for the mother-partner dyad; 2) third-wave cognitive behavioral therapy (cbt) strategies targeting well-being, relaxation, mindfulness, self-compassion, and gratitude; 3) confinement and social distancing related material. participants follow the program online or with a paper workbook and are called weekly by a member of the intervention team. participants will fill out three questionnaires (online or by telephone) at 12-25 weeks' gestation, 3 months' postpartum and 6-months postpartum to assess baseline values and trial outcomes, respectively.

Eligibility criteria:
inclusion criteria: * pregnant women (12-25 weeks' gestation) * subclinical and clinical levels of depression (edinburgh postnatal depression scale (epds) scores 8-16) * ability to read and understand french. exclusion criteria: * epds score in the clinical range (≥ 17) or no symptoms (epds \< 8) * positive screening of psychotic symptoms using the psychosis screening questionnaire (psq) * self-reported substance abuse problems.
electrochemistry measurement of skin hydration parameters

Conditions: Atopic Dermatitis; Acne; Skin Electrochemistry

Summary: to date measuring the effect of dermocosmetic products on the main identified factors of aging and alteration of the skin barrier is based on invasive and expensive experiments. electrochemistry enables to measure a specific signal for a substance of interest e.g. vitamin c using an surface contact with an electrode. therefore, this study will evaluate the reliability and feasibility of measurements of skin's hydration parameters such as nmf and squalene using electrochemistry. these study will be made on three groups of individuals with different skin types: dry skin i.e. atopic dermatitis patients, oily skin i.e. acne skin and a control group of individual without facial dermatosis. collects of parameters of interest will be made by using patch using electrochemistry (contact with an electrode and potentiostat to detect an electric signal) . it is a simple method that relies on a sensor / electrode pair that allows a study of the surface molecules of the skin. application in the measurement of vitamin c in food products has already been validated. on a second hand, a collect by chromatography of the parameters of interest will be carried out in order to compare the new method with the reference method. this procedure has been developed via a procedure including collecting surface parameters using a patch an developping special electrodes and miniaturized detecting signal tool (potentiostat)


Eligibility criteria:
inclusion criteria: * 18 ≤ age ≤ 70 * subjects with past history or follow-up for acne or rosacea stage i ou ii, atopic dermatitis mild to moderate without immunosuppressive treatment * subjects enabling to perform a one day visit at the hospital * written consent according to local regulatory requirements * affiliated to a social security scheme exclusion criteria: * pregnant women or breastfeeding * patient under guardianship or curatorship, legal protection or protection of justice * participation in other interventional research on skin moisturizer

Keywords: electrochemistry squalene nmf skin
creon after pancreatic surgery

Conditions: Pancreatic Insufficiency

Summary: this study will provide efficacy data for creon 25000 mms in ps patients as well as long-term safety data. during the long-term treatment with creon 25000 nutritional parameters will be assessed and correlated with cfa


Eligibility criteria:
inclusion criteria pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria: * direct or indirect pancreatic function test (except stool fat excretion) and * steatorrhoea: stool fat \> 15 g/day (using van de kamer method) * proven chronic pancreatitis * females of child-bearing potential must agree to continue using a medically acceptable method of birth control exclusion criteria * subjects in an unstable situation (catabolic) after pancreatic surgery * ileus or acute abdomen * current excessive intake of alcohol or drug abuse * hypersensitivity vs porcine proteins / pancreatin * subjects taking digestive enzyme preparations have to stop them before start of the run-in period

Keywords: pancreatic exocrine insufficiency after pancreatic surgery
a rollover study of arry-371797 in patients with lmna-related dilated cardiomyopathy

Conditions: LMNA-Related Dilated Cardiomyopathy

Summary: this is a rollover study designed to investigate the safety and effectiveness of investigational study drug arry-371797 in patients who previously received arry-371797 in a study for patients with lmna-related dilated cardiomyopathy sponsored by array biopharma and may, in the investigator's opinion, derive benefit from continued treatment.


Eligibility criteria:
key inclusion criteria: * received arry-371797 as treatment for a genetic dilated cardiomyopathy secondary to lmna mutations in a clinical study sponsored by array biopharma. * may, in the opinion of the investigator, benefit from continued arry-371797 treatment. * additional criteria exist. key exclusion criteria: * discontinued treatment in the parent study for any reason other than study completion or sponsor termination of the study. * additional criteria exist.

Keywords: laminopathy arry-797
pilot brief communal coping intervention for adults with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: we plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. to that end, we will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has t1d

we will recruit 66 couples in which one person has type 1 diabetes. power is based on effect sizes from previous couple intervention studies and meta-analyses on primary outcomes. couples will be randomly assigned to either a communal coping intervention or an attention (diabetes education) control group. all couples will come to the laboratory or meet via zoom, complete a baseline questionnaire assessment (primary and secondary outcomes, mediators) and have a videotaped conversation about how they cope with diabetes. the intervention group will receive the communal coping intervention. couples in the intervention group will identify 5 collaborative implementation intentions, whereas controls will identify 5 individual implementation intentions. after the in-person session, couples will individually complete a daily diary at the end of the day for 14 consecutive days which focuses on daily communication, mood, and patient self-care. during the first 7 days, the intervention group will receive two text messages per day (morning focus on shared appraisal, evening focus on one of collaborative implementation intentions identified during in-person session). an in-person follow-up interview will take place 6 weeks after the initial session, during which primary outcomes, secondary outcomes, and mediators will be assessed and the videotaped conversation repeated.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes for at least one year * married or living with someone for at least one year who is willing to participate in the study as the study partner * age 18 and over * reliable access to the internet at home exclusion criteria: * non-english speakers * patient has a major chronic illness that affects daily life more than diabetes (e.g., currently undergoing treatment for cancer) * partner does not consent to participate in study * partner has diabetes