Kornimate/medical-research-clean huggingface dataset:
glycocalyx monitoring in major abdominal surgery

Conditions: Major Abdominal Surgery

Summary: the study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. it would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters.

this monitoring is possible in real time and real conditions by micro-camera glycocheck™ (microvascular health solutions inc., salt lake city, utah, usa), a non-invasive monitoring allowing the study of sublingual microcirculation and glycocalyx.

Eligibility criteria:
inclusion criteria: for the hipec group : * adult patients * age \< 75 years * receiving hipec for primary or secondary peritoneal carcinosis for the cdp group : * adult patient * age \< 75 years * receiving cdp for pancreatic neoplasia * patient who has read and understood the information letter and does not object to taking part in the study * patient affiliated to a social security scheme exclusion criteria: * secondary distant peritoneal metastases * chronic heart failure * chronic liver failure at stage c of the child-pugh score * stage iv or v chronic renal failure * inflammation of the sublingual buccal mucosa or injury that may locally influence sublingual microcirculation * patient refusal * person deprived of liberty by an administrative or judicial decision or person placed under court protection or guardianship

Keywords: glycocalyx microcirculation cephalic duodenopancreatectomy hyperthermic intraperitoneal chemotherapy
bone mineral density (bmd) in adolescents with growth hormone deficiency (ghd)

Conditions: Dwarfism, Pituitary; Turner Syndrome

Summary: this study is a multicenter, open-label, postmarketing surveillance study. the substudy will collect information on bmd in adolescents and young adults with ghd or turner syndrome who are completing gh treatment for statural indications.


Eligibility criteria:
inclusion criteria: * bone age of at least 15 years for girls or at least 16 years for boys within 6 months of obtaining the dxa scan * previous enrollment in the ncgs core study, 85-036 * tanner stage 4 or greater * either spontaneous or induced puberty * subjects who plan on terminating gh treatment for statural purposes for one or more of the following reasons: epiphyseal fusion, slowing growth rate indicates that near adult height has been reached, or satisfied with current height exclusion criteria: * current therapy with a non genentech gh product * pregnancy (to avoid exposure to low levels of radiation from dxa scanners) * bilateral hip replacement * weight \>130 kg (286 lb.)

Keywords: growth hormone deficiency
reducing hospital readmissions in patients with depressive symptoms

Conditions: Depression

Summary: project re-engineered discharge (project red) has previously demonstrated that patients who received the red were 30% less likely than patients receiving usual care to access inpatient or emergency services within 30 days of discharge. in this project, the investigators add a new dimension to red by integrating screening, referral and treatment for depression into the original red intervention and determining if this enhanced intervention increases the effectiveness of red in preventing readmissions and controlling costs in the 180 days after discharge for patients with signs of depression.


Eligibility criteria:
inclusion criteria: * over 18 years of age * admitted to any boston medical center inpatient service or for observation * screen positive for depressive symptoms (patient health questionnaire - 2 \>/= 3) * speaks english with health care providers * has access to a telephone * live in the boston area and don't plan on leaving the boston area for more than 2 weeks in the next 6 months * screen positive for depressive symptoms (phq -9 \>/= 10) exclusion criteria: * has plans for inpatient rehabilitation, nursing home, or other institutional settings after discharge. * suicidal precautions * sickle cell crisis (scc) * alcohol and/or drug dependence * diagnosis of bipolar disorder, schizophrenia or other psychotic disorder * in police custody

Keywords: rehospitalization reutilization depressive symptoms pharmacotherapy cognitive therapy self-help complementary therapies
dietary magnesium in preventing low blood magnesium levels in patients with ovarian cancer receiving carboplatin chemotherapy

Conditions: Ovarian Carcinoma

Summary: this trial studies how well a diet high in magnesium works in preventing low blood magnesium levels (hypomagnesemia) in patients with ovarian cancer receiving carboplatin chemotherapy. hypomagnesemia is a common side effect of carboplatin-containing chemotherapy. a magnesium rich diet may increase the levels of magnesium in the blood and help prevent hypomagnesemia resulting from carboplatin chemotherapy.

primary objective: i. evaluate intervention feasibility. secondary objective: i. evaluate occurrence of hypomagnesemia and the need for a pharmacy regimen including oral and intravenous magnesium dosage. exploratory objective: i. explore changes in other electrolytes, weight, and occurrence of chemotherapy delay or discontinuation and hospitalization which can be related to dietary intervention and program completion. outline: patients receive a dietary magnesium intervention consisting of a food reference list and phone calls or video interviews from a registered dietitian, integrative medicine physician, or a mid-level provider over 10-20 minutes once a week for up to the 6th cycle of chemotherapy (average 15 weeks).

Eligibility criteria:
inclusion criteria: * patients with previously untreated ovarian cancer. * receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles. * able to tolerate an oral diet. exclusion criteria: * prior platinum-based chemotherapy. * serum creatinine level \> 1.4 mg/dl prior to treatment. * artificial nutrition (e.g. ensure or boost) accounts for \> 50% of total calorie intake.
diabetes in-charge: trial of diabetes intervention in the community to help achieve reduced glucose elevation

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to test whether providing personalized diabetes self-management recommendations and feedback improves blood sugar control more than providing generalized diabetes educational material alone.

diabetes mellitus (dm) is a common chronic disease that is rapidly rising in prevalence, affecting upwards of 35,000 adults in the hamilton, ontario region (population 400,000). the magnitude and growth of the problem and its serious health consequences suggest that: 1. diabetes is now a major public health problem; and 2. interventions at the community level are needed to mitigate its health impact. during the last 5 years, diabetes hamilton was successfully piloted as a free community-based program available to anyone with diabetes. it promotes diabetes self-management, self-efficacy and awareness through the provision of generalized diabetes information (e.g. newsletters, workshops, forums, resource directories) to consumers, local physicians and other health professionals. this trial will determine if supplementing diabetes hamilton with an automated tailored feedback system that: 1. provides information; 2. generates and communicates specific evidence-based recommendations to users from a self-administered questionnaire; 3. copies this communication to the patient's designated physician; 4. facilitates access to community resources; and 5. provides a simple way for the patient to track changes in indicators of health can improve a1c and other diabetes care indicators more than diabetes hamilton alone.

Eligibility criteria:
inclusion criteria: * type 2 diabetes of 1 or more years duration * health insurance coverage within ontario * ages 40 or older * registered in, or willing to register in diabetes hamilton * able to read and understand english and provide informed consent in english * have home access to either mail, e-mail or the internet * have a baseline a1c \>= 7% exclusion criteria: * current pregnancy * residence in an institution that provides diabetes care * cohabiting with study participant * residence outside the city of hamilton * inability to read or understand english * inability/unwillingness to sign the informed consent or comply with protocol

Keywords: diabetes community intervention self-management prevention
pilot study on cytokine filtration in covid-19 ards

Conditions: Coronavirus Infection; Acute Respiratory Distress Syndrome; COVID

Summary: background: there are no proven therapies for covid-19 infection. covid-19 infects the respiratory epithelium of the lower airways, causing widespread damage via cytopathic effects, resulting in severe inflammation and pneumonitis. high local and circulating levels of cytokines, or cytokine storm, can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ards). methods: this is a pilot randomized, controlled, uni-center study testing safety and efficacy of cytokine filtration on patients with severe ards. eligible patients will be randomized to 72 hours filtration or no filtration on top of the standard treatment for ards. indications for randomization are patients with moderate or severe ards with need of ventilation support (either invasive or non-invasive), with inflammatory markers. the primary outcome will be days on mechanical ventilation (mv) support. secondary outcomes are 30-day mortality, icu days, need for extracorporeal membrane oxygenation (ecmo) support, duration of renal replacement therapy (rrt) and catecholamine therapies, hospital length of stay, multi-organ failure. all analysis will be done according to the intention to treat principle.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. positive revere transcription polymerase chain reaction (rt-pcr) for covid-19 in a respiratory track sample 3. acute (less than 36 hours) onset of moderate to severe ards, as defined by berlin criteria: * having pneumonia or worsening respiratory symptoms * bilateral pulmonary infiltrates on chest imaging (x-ray of ct scan) * pulmonary wedge pressure \<18 mmhg or no clinical signs of left heart failure * hypoxemia: arterial oxygen pressure/fraction of inspired oxygen (pao2/fio2 ratio) \ 30bpm 4. rise of inflammatory biomarkers: c-reactive protein (crp) \>10 mg/l exclusion criteria: 1. patients with a known contraindication for anticoagulation 2. pregnancy or breast feeding 3. patient already included in another research study 4. decision by a physician that involvement in the study is not in the patient's best interest 5. failure to have patient's authorization. in case of a mechanical intubated patient, lack of authorization from a first line family member 6. multi-organ failure 7. patients treated with tocilizumab at the time of start filtration

Keywords: covid ards coronavirus
improving post-discharge antimicrobial use

Conditions: Infections

Summary: one in five hospitalized patients is prescribed an antimicrobial at the time of discharge, and a large proportion of these post-discharge antimicrobials are unnecessary. the investigators will evaluate a novel method for reviewing post-discharge antimicrobial prescriptions in real-time with the goal of improving antimicrobial selection and duration.

antimicrobial stewardship programs (asps) work to improve antibiotic prescribing within hospitals. asps often restrict their activities to inpatient antimicrobial-prescribing. however, at least 40% of all antimicrobial exposure associated with an acute-care hospital stay is prescribed at the time of hospital discharge (i.e., post-discharge). post-discharge antimicrobials mediate clinical outcomes after discharge and may facilitate the spread of antimicrobial resistance. several studies have shown that post-discharge antimicrobial use is often inappropriate. for example, using national va data, the investigators found that 61% of fluoroquinolone treatment days were prescribed at hospital discharge; manual chart reviews at 9 hospitals found that 40% of these post-discharge fluoroquinolone prescriptions were either unnecessary or sub-optimal. other studies have found that 53-79% of all post-discharge antimicrobials are either unnecessary or sub-optimal. post-discharge antimicrobials are an important target for antimicrobial stewardship. however, inpatient stewardship metrics do not capture post-discharge antimicrobials and asps frequently do not evaluate these prescriptions. a 2016 va survey found that less than 50% of hospitals routinely reviewed targeted antimicrobials at discharge. according to a 2016 survey in michigan, only 17% of 48 hospitals had a process for reviewing outpatient antimicrobial orders at discharge. it is unclear how inpatient stewardship resources can be effectively leveraged to improve post-discharge antimicrobial use. if the goal is to improve post-discharge antimicrobial use, a potentially effective strategy may be an audit-and-feedback process focused solely on prescriptions for patients who will soon be discharged. in this trial, the investigators will evaluate the feasibility and effectiveness of such a process.

Eligibility criteria:
inclusion criteria: --the local stewardship team agrees to implement the discharge stewardship intervention on at least one inpatient service or ward. exclusion criteria: --the hospital already has an audit-and-feedback process in place that focuses on antimicrobial prescribing at hospital discharge.

Keywords: antibiotic prescriptions hospital discharge antibiotic stewardship
a double-blind, randomized, placebo-controlled, parallel-group study to assess the safety and efficacy of td-1211 in subjects with opioid-induced constipation

Conditions: Opioid Induced Constipation

Summary: a double-blind, randomized, placebo-controlled, parallel-group study to assess the safety and efficacy of td-1211 in subjects with opioid-induced constipation


Eligibility criteria:
inclusion criteria: * history of constipation with onset after initiation of opioid therapy * self-reported oic of approximately 3 spontaneous bowel movements (sbms) per week or less for each week over at least the previous two week period * have used chronic opioids with a total daily dose ≥30 mg of morphine equivalent units (meu, appendix 7) for the 12 weeks preceding the screening visit. subjects should have used a stable daily regimen of opioids for at least the 2 weeks preceding the screening visit * willing to stop all laxatives and other bowel regimens with the exception of bisacodyl/enema treatment allowed per protocol throughout the oic confirmation, treatment, and follow-up periods exclusion criteria: * have participated in a clinical trial of an investigational drug or medical device within 30 days prior to screening * have any condition that may affect drug absorption, (e.g., previous gi surgery) * any other condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety or tolerability of the investigational drug, or prevent compliance with the study protocol

Keywords: opioid induced constipation oic constipation opioid side effects morphine induced constipation opioid therapy
tadalafil in subjects with mild to moderate hypertension

Conditions: Hypertension

Summary: purpose: the primary objective of this study is to evaluate the efficacy and safety of tadalafil when administered once daily at doses of 5 and 20 mg to adult subjects for 8 weeks with mild to moderate hypertension.


Eligibility criteria:
inclusion criteria: * have a documented medical history of hypertension. * have cuff seated diastolic blood pressure values greater than or equal to 95 and less than or equal to 104 mm at study entry * have a negative serum pregnancy test at the time of enrollment and agree to use two medically reliable methods of contraception until study completion, if female is of child-bearing potential, between menarche and 1 year post menopause and not surgically sterilized. * are able to comply with study procedures and visits exclusion criteria: * have resistant hypertension or systolic hypertension. * are obese, defined as having body mass index (bmi) greater than or equal to 35. * are females who are pregnant or breast feeding. * have a history of severe renal insufficiency or significant thyroid, renal or hepatic disease. * have a glycosylated hemoglobin a1c (hba1c) greater than or equal to 10% during the screening period. * have significant anemia. * have a significant or unstable cardiac history such as history of heart attack, unstable angina, or stroke within 6 months of study entry, history of angina that was treated with long- or short-acting nitrates within 90 days of study entry, history of coronary artery bypass graft surgery or cardiac angioplasty within 90 days of study entry, history of abnormal heart rhythms such as sick sinus syndrome or 2nd- or 3rd-degree av block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, a history of recurrent ventricular tachycardia, or symptomatic bradycardia, a history of sudden cardiac arrest. * have symptomatic heart failure requiring treatment, or significant disease of the heart valves. * have been treated for severe asthma, bronchospasm, or copd within 3 months of study entry. * have severe peripheral vascular disease. * have a documented diagnosis of sleep apnea.

Keywords: high blood pressure
optimizing quality of life by improved patient expectation following atrial fibrillation catheter ablation

Conditions: Atrial Fibrillation

Summary: the aim is to investigate whether optimizing patients' expectations towards the interventional treatment of atrial fibrillation (catheter ablation) leads to a lower disease-related impairment of the patients compared to the control group in the first three months after ablation (the so-called blanking period).


Eligibility criteria:
inclusion criteria: * symptomatic atrial fibrillation * indication for pulmonary vein isolation * sufficient command of the german language exclusion criteria: * age \<18 years * permanent atrial fibrillation * presence of psychiatric disorders which impair the study participitatin * presence of another medical condiction which influences quality of life stronger than the cardiac condition * atrial fibrillation induced by intoxication, medicamentation or infection * inability to grap the course of the study
investigation of kinesiophobia in volleyball players by gender

Conditions: Volleyball Player

Summary: kinesiophobia is a form of behavior that includes fear and anxiety in which the person tends to stay away from the movement. . in the future, this may lead to a decrease in muscle strength and condition, leading to loss or decrease in physical adequacy, avoidance of exercise and, accordingly, psychological problems. kinesiophobia also negatively affects the success of the treatment process in athletes or normal patients.

in athletes, this situation affects the sports activity that they place at the center of their lives, causing loss of performance and, accordingly, the emergence of psychological problems. athletes are faced with the deterioration of bone integrity during training or matches according to their branches, or they are injured by structures such as muscles, tendons and ligaments. one of the important criteria in pain, kinesiophobia and exercise is sleep quality. results such as sleep quality or increased stress level in insomnia and inattention may have an effect on pain or kinesiophobia. the deterioration in sleep quality leads to a decrease in the performance ability of the person, affecting the daily activity, decreasing the energy level and being in a daytime sleepy state.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-30 * taking part in amateur volleyball clubs exclusion criteria: * individuals under the age of 18 * individuals who have had a surgical procedure in the last six months * use of nsaids and similar disease-modifying drugs (diaserein, glucosamine, etc.) in the last month.

Keywords: kinesiophobia
study comparing daclatasvir (bms-790052) with telaprevir combined with peginterferon alfa-2a and ribavirin in patients with chronic hepatitis c virus infection

Conditions: Hepatitis C

Summary: the purpose of this study is to compare the effectiveness of bms-790052 (daclatasvir) and telaprevir when given in combination with peginterferon alfa-2a and ribavirin in genotype 1b patients

allocation: randomized stratified

Eligibility criteria:
key inclusion criteria: * participants chronically infected with hepatitis c virus (hcv) genotype 1a or 1b * hcv rna viral load ≥10,000 iu/ml * no prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals * no history of cirrhosis liver biopsy within 3 years or fibroscan® within 1 year * body mass index of 18 to 35 kg/m\^2 * negative for hiv and hepatitis b virus key exclusion criteria: * evidence of decompensated liver disease * evidence of medical condition other than hcv contributing to chronic liver disease

Keywords: hepatitis c virus
prospective, longitudinal natural history study in dystrophic epidermolysis bullosa

Conditions: Dystrophic Epidermolysis Bullosa

Summary: the objective of this study is to characterize the extent and severity of disease in subjects with deb and the progression of disease over a timeframe relevant to interventional studies. the data from this study will be used to inform the study design and address statistical considerations of future treatment protocols.

this is a prospective, multicenter, multinational, longitudinal assessment of disease severity in subjects with deb. subjects with either dominant or recessive deb (dominant dystrophic epidermolysis bullosa (ddeb) and recessive dystrophic epidermolysis bullosa (rdeb), respectively) will be assessed four times over a one year period: upon enrollment, and at 1 to 2 weeks and 6 and 12 months after enrollment. all subjects with either ddeb or rdeb that meet the study entry criteria will be offered participation in the study, provided they can be accommodated within the anticipated study timeline. in addition to their usual clinic assessment, subjects will have a quantitative evaluation of skin involvement and will be asked to fill out questionnaires that measure among other things disease severity, qol, pain, pruritus, and medical and family histories.

Eligibility criteria:
eligibility criteria * subjects of any age (newborns included) may participate * subjects over 18 years of age and parent(s)/legal guardian(s) of subjects \<18 years of age must provide written informed consent prior to participating in the study and informed assent will be obtained from minors at least 7 years of age * subjects must have a documented diagnosis of deb based on clinical presentation and either skin biopsy results showing an absence or reduction in c7 or anchoring fibrils or genetic analysis showing a mutation in collagen, type vii, alpha 1 (col7a1); alternatively, subjects must have a clinical diagnosis of deb and a documented diagnosis of deb (as above) in a first degree relative * no experimental systemic therapy for deb including, but not limited to, bone marrow transplantation, systemic immune suppression, or experimental therapies that involve live cells which have the potential for systemic spread such as gene transfer, stem cell infusions or other cell type injections

Keywords: dystrophic epidermolysis bullosa type vii collagen qol evaluation in epidermolysis bullosa instrument for scoring clinical outcomes for research of epidermolysis bullosa birmingham epidermolysis bullosa severity score