Kornimate/medical-research-clean huggingface dataset:
rifaximin for prevention of travellers' diarrhea

Conditions: Diarrhea

Summary: the purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Eligibility criteria:
inclusion criteria: 1. travelling to mexico within 72 hours of enrollment 2. read and understand english 3. in good health exclusion criteria: 1. acute diarrhea within previous 7 days 2. taken fqs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study. 3. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.

Keywords: td traveller's diarrhea campylobacter shigella salmonella e. coli diarrhea
bioavailability of bosutinib administered as capsule contents mixed with applesauce or yogurt relative to intact capsules under fed condition

Conditions: Healthy Participants

Summary: this study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy participants. the comparisons will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are cmax and auc. statistical analyses will be performed comparing these parameters calculated after administration of a single 500 mg dose with the intact capsule formulation (100 mg x 5) as the reference treatment and the capsule contents mixed with applesauce or yogurt (100 mg x 5) as the test treatments.


Eligibility criteria:
inclusion criteria: * female participants of non childbearing potential and/or male participants must be 18 to 54 years of age, inclusive, at the time of signing the informed consent document (icd). * capable of giving signed informed consent as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease. * any condition possibly affecting drug absorption. * participants with any of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: 1. estimated glomerular filtration rate (egfr) (chronic kidney disease epidemiology collaboration \[ckd-epi\]) \< 90 ml/min/1.73 m2; 2. aspartate aminotransferase (ast) or alanine aminotransferase (alt) level \> upper limit of normal (uln); 3. serum (total and direct) bilirubin level \> uln; participants with a history of gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<= uln; 4. amylase and lipase levels \> uln.

Keywords: bioavailability bosutinib maximum observed plasma concentration (cmax) area under the curve (auc)
continence care registry

Conditions: Neurogenic Bladder; Non-Neurogenic Bladder

Summary: this observational research study aims to build a multinational electronic patient-reported outcomes (epro) registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and other various aspects of using an intermittent catheter.

this observational research study aims to build a multinational epro registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. research resulting from data generated from an epro registry will factor in end user perspectives on intermittent catheterization habits and behaviors and intermittent catheter performance to inform and guide healthcare providers, end users, and caregivers in making the most informed healthcare decisions regarding intermittent catheterization. research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and various aspects of habits and behaviors, including health-related quality of life, of using an intermittent catheter.

Eligibility criteria:
inclusion criteria: 1. is at least 18 years of age; male or female. 2. is performing transurethral intermittent catheterization. 3. uses intermittent catheter(s) from any manufacturer as a form of management for urinary retention or incomplete bladder emptying. 4. must be able to provide informed consent and have no cognitive impairment that would hinder the ability to provide informed consent or self-reported data. 5. lives and has permanent residence in one of the countries that the study is being conducted at time of enrollment (usa, canada, uk, germany, france, the netherlands, or italy) 6. is willing and able to complete electronic questionnaires monthly for the first year of data collection and quarterly thereafter or appoint a caregiver proxy. 7. is able to read and respond to the questionnaires in the language options provided for a given country (e.g. french canadian or english for canada) exclusion criteria: 1. performs non transurethral catheterization, e.g., stoma. 2. participating in a clinical study involving transurethral intermittent self-catheterization at the time of enrollment. 3. employee of sponsor at the time of enrollment.

Keywords: intermittent self catheterization intermittent catheter urinary retention urinary incontinence urinary symptoms urinary tract infection (uti)
contrast echocardiography in non-st elevation myocardial infarction

Conditions: Non-ST-Elevation Myocardial Infarction

Summary: in patients with acute myocardial infarction, treatment logistics are primarily defined based upon st segment shift in the electrocardiogram. while patients with st elevation (stemi) are forwarded to immediate coronary angiography and percutaneous coronary intervention, patients without st elevation (nstemi) are initially medically treated and recommended coronary angiography within 48-72 hours. early invasive treatment has been found cost-effective in intermediate and high-risk nstemi patients and current guidelines recommend use of the thrombolysis in myocardial infarction (timi) risk score to identify patients who will benefit from early intervention due to high risk of new infraction and cardiovascular death. however, new research has suggested that timi risk score may not always identify patients with severe angiographic disease. the purpose of this study was to assess if contrast echocardiography could be used to identify nstemi patients with angiographically severe disease independent of their timi risk score.


Eligibility criteria:
inclusion criteria: * acute non-st elevation myocardial infarction exclusion criteria: * hemodynamic unstable * mechanical prosthetic heart valve * severly reduced pulmonary function
high plasma level of long pentraxin 3 is associated with insulin resistance in women with polycystic ovary syndrome (pcos)

Conditions: PCOS

Summary: in the present study, serum pentraxin 3 level and its relationship with insulin resistance were determined in patients with polycystic ovary syndrome (pcos. it was found that ptx3 level is increased in patients with pcos and it is positively correlated with homa-ir.


Eligibility criteria:
inclusion criteria: * absence of significant abnormalities on physical examination except hirsutism * no lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy * normal thyroid function and prolactin level * absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease exclusion criteria: * pregnant * possible ovarian tumors, * congenital adrenal hyperplasia or * bmi greater than 35 kg/m2

Keywords: pcos and ptx3 levels
daxibotulinumtoxina for injection for the management of plantar fasciitis

Conditions: Plantar Fasciitis

Summary: the specific aim of the study is to compare the safety and efficacy of a single administration of daxibotulinumtoxina for injection versus placebo for managing plantar fasciitis.


Eligibility criteria:
inclusion criteria: * written informed consent, including authorization to release health information * skeletally mature, male or female patients 18 to 65 years of age with diagnosis of plantar fasciitis * persistent heel pain for more than three months * women of child bearing potential must have a negative urine pregnancy test (upt) at screening visit and must use an effective method of birth control during the course of the study exclusion criteria: * previous surgery on the midfoot or hindfoot * neuromuscular disease * systemic muscle weakness * planning a pregnancy during the study * current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit
a psychosocial dyadic programme for patients with heart failure and their family caregivers

Conditions: Heart Failure

Summary: the overall aim of the study is to evaluate the effects of a psychosocial dyadic intervention on mutuality, psychological strengths (i.e., resilience and self-compassion), psychological distress (i.e., anxiety and depression), and qol outcomes of hf patients and caregivers. the hf patient-caregiver dyads will be randomly allocated to the intervention group to receive a 12-week relationship-focused psychosocial dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital.

heart failure (hf) is the terminal stage of various cardiovascular diseases. hf patient-caregiver dyads, who need to undertake the majority of hf care responsibility in the community, often experience a challenging adaptive process. there is a desperate need to develop and evaluate psychosocial dyadic interventions in hf patients and caregivers, as well as examine the working mechanism of such interventions. this sequential mixed-methods study consists of a single-blinded, two-arm randomized controlled trial (rct) and a qualitative study. the dyads will be randomly allocated in a 1:1 ratio to the intervention group to receive a 12-week relationship-focused psychosocial dyadic programme, or to the control group to receive the usual care provided by the clinical team in the hospital. besides, an empowerment-based approach will be employed in this programme to work together with patients and caregivers to set goals and develop an action plan to facilitate goal attainment. for the patients, mutuality scale, connor-davidson resilience scale, self-compassion scale short form, minnesota living with heart failure questionnaire, and hospital anxiety and depression scale will be administered at baseline, immediate and 3-month post-intervention. for the caregivers, the mutuality scale, connor-davidson resilience scale, self-compassion scale short form, family caregiver quality of life scale, and hospital anxiety and depression scale will be administered at baseline, immediate and 3-month post-intervention. a pilot study will be conducted to determine the feasibility, acceptability and preliminary effect of the intervention first. afterwards, a full-scale mixed-methods study will be conducted to evaluate the effects of the intervention and the mechanism underlying the intervention.

Eligibility criteria:
inclusion criteria: * patients and caregivers aged 18 years or older * patients diagnosed with heart failure * able to identify one family caregiver who provides unpaid daily caregiving≥3.5hr/ day to participate * patients and caregivers able to read simplified chinese and communicate in mandarin * have access to a telephone at home. exclusion criteria: * psychiatric problems requiring active treatment * other terminal illnesses, such as advanced cancer * with mechanical circulatory support, on the heart transplant list or with a history of heart transplant

Keywords: dyadic coping psychosocial intervention
mastectomy in ambulatory breast surgery

Conditions: Mastectomy

Summary: this is a prospective observational study, involving 550 mastectomies in lorraine institute of oncology, to assess care patients management of ambulatory surgical compared to standard surgery procedure.


Eligibility criteria:
inclusion criteria: * patient managed for breast cancer surgery * age \>18 years old * understand and comply with the requirements of the study * patient must be affiliated to a social security system exclusion criteria: * patient managed for a concomitant reconstructive surgery * bilateral breast surgery * patient already included in another clinical trial with an experimental molecule * men * patient deprived of liberty or under supervision * neoadjuvant therapy

Keywords: surgery breast cancer quality of life
safety and efficacy of g-pen compared to lilly glucagon for hypoglycemia rescue in adult type 1 diabetics

Conditions: Hypoglycemia; Diabetes Mellitus, Type 1

Summary: this is a blinded, randomized crossover study to compare the safety and efficacy of g-pen (glucagon injection) to lilly glucagon (glucagon for injection \[rdna origin\]) for hypoglycemia rescue of adult patients with type 1 diabetes.

this is a blinded, randomized, phase 3 comparative efficacy and safety study in adults with type 1 diabetes. patients will complete screening procedures up to 60 days before randomization to determine eligibility before enrollment to the treatment phase. the procedure for evaluating the efficacy of the g-pen (glucagon injection) consists of inducing hypoglycemia by intravenous administration of regular insulin diluted in normal saline. each participant will undergo two episodes of insulin-induced hypoglycemia, and in random order will receive 1 mg g-pen (glucagon injection) during one episode and 1 mg lilly glucagon during the other episode. there will be wash out period of 7-28 days between treatment visits. blood glucose levels will be monitored post-dosing, with a return of plasma glucose to a concentration \> 70 mg/dl within 30 minutes signifying successful hypoglycemia rescue. as a confirmation of efficacy, subjects will complete a questionnaire concerning changes in symptoms of hypoglycemia following treatment with glucagon. subjects will return for a follow-up safety visit 3-14 days following administration of the final dose of glucagon.

Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes mellitus for at least 24 months * usage of daily insulin treatment * random serum c-peptide concentration \< 0.5 ng/ml exclusion criteria: * pregnant or nursing * hba1c \>9.0% * renal insufficiency * hepatic synthetic insufficiency * aspartate or alanine aminotransferase \> 3 times the upper limit of normal * hematocrit less than or equal to 30% * use of \> 2.0 u/kg total insulin dose per day * inadequate bilateral venous access in both arms * congestive heart failure, new york heart association class ii, iii or iv * active malignancy within 5 years, except basal cell or squamous cell skin cancers * history of breast cancer or malignant melanoma * major surgical operation within 30 days * current seizure disorder. * current bleeding disorder, treatment with warfarin, or platelet count below 50,000 * history of pheochromocytoma or disorder with increased risk of pheochromocytoma * history of insulinoma * history of glycogen storage disease. * positive for hiv, hepatitis c virus or active hepatitis b virus infection * whole blood donation of 1 pint (500 ml) within 8 weeks * active substance or alcohol abuse * administration of glucagon within 28 days * participation in other studies involving an investigational drug or device within 30 days
inhaled iloprost (ventavis): efficacy, safety, and pharmacokinetics (pk) confirmation study

Conditions: Hypertension, Pulmonary

Summary: this study is to investigate the efficacy, safety, and pharmacokinetics (pk) of inhaled iloprost (ventavis) therapy in japanese pulmonary arterial hypertension (pah) patients in main treatment phase (12 weeks) and to investigate the safety, tolerability, and efficacy of longterm inhaled iloprost (ventavis) therapy in japanese pah patients in extension phase.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 to 75 years * symptomatic pulmonary artery hypertension (pah) classified (dana point classification 1) * new york heart association (nyha)/world health organization (who) functional class iii or iv * papmean at rest \> 25 mm hg, pulmonary capillary wedge pressure (pcwp) or left ventricular end-diastolic pressure \ /= 240 dyn.sec.cm-5 (\>/= 400 dyn.sec.cm-5 for patients treated with both endothelin receptor antagonist (era) and phosphodiesterase-5 inhibitor (pde5i) ) as measured by right heart catheter test * women of childbearing potential and men must agree to use adequate contraception when sexually active exclusion criteria: * baseline 6-minute walk distance of less than 100 meters or more than 500 meters * subjects with critical severe pah * forced expiratory volume in 1 second (fev1)/forced vital capacity (fvc) ratio \< 60% and/or total lung capacity (tlc) \< 70% predicted (especially at interstitial lung disease, tlc \< 60% predicted) * clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive pulmonary disease ) * more than mild patchy interstitial lung disease on high resolution computerized tomography (hrct) * history of left-sided heart disease * uncontrolled systemic hypertension as evidenced by systolic blood pressure \>/= 160 mm hg or diastolic blood pressure \>/= 100 mm hg on repeated measurement * systemic hypotension with systolic blood pressure \< 85 mm hg

Keywords: iloprost inhalation pulmonary hypertension pulmonary artery hypertension japanese patients
efficacy and safety of intravenous acetaminophen over 48 hrs for the treatment of post-op pain after gynecologic surgery

Conditions: Postoperative Pain; Hysterectomy

Summary: this study will be investigating the efficacy and safety administration of multiple doses of intravenous (iv) acetaminophen (ivapap) in the 48 hour period following gynecologic surgery.

the research hypothesis is that iv acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.

Eligibility criteria:
inclusion criteria: * undergo gynecologic surgery using standard abdominal approach such as midline or pfannenstiel incision * 18-75 years of age * body mass index (bmi) between 19-45 * american society of anesthesiologists (asa) risk class of i, ii, iii * not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery * moderate to severe pain at rest exclusion criteria: * requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization * procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or maylard incisions * has know hypersensitivity to opioids, acetaminophen, or the excipients of iv acetaminophen * known history of alcohol or drug abuse or misuse * has impaired liver function aspartate transaminase(ast), alanine aminotransferase(alt), bilirubin greater than or equal to 2 times upper limit of normal * has significant medical disease(s), or conditions that may contraindicate participation in the study * has participated in another clinical trial within 30 days of surgery

Keywords: pain gynecologic iv acetaminophen postoperative analgesic
expanded access program (eap) stimulan vg

Conditions: Stage IV Pressure Ulcer; Diabetic Foot Osteomyelitis

Summary: individual (single) patient expanded access may be considered.

patients facing serious or life-threatening illnesses who have exhausted currently available treatment options and are ineligible or unable to participate in a clinical trial may decide to explore therapeutic use of investigational drugs with their healthcare providers. under these circumstances, single-patient access can be requested from a licensed treating physician on behalf of the patient. please contact expandedaccess@biocomposites.com for more information.

Eligibility criteria:
inclusion criteria: - exclusion criteria: -
becoming traumatic brain injured patients at day 7 of their trauma

Conditions: Traumatic Brain Injury

Summary: to study the future of traumatic brain injured patients at day 7 of their trauma primary endpoint: fate, classified as survival with or without sequelae, death. use of the gos-e scale to classify survival with or without sequelae. the collection of this scale will be done by telephone contact, 7 days of admission to the emergency room. secondary judgment criteria: * compendium of the realization of the ct / time respected between the tcl and the ct / hospitalization / 2nd ct to realize at 24 hours in the patients treated by tac or aap * application of the recommendations of the french society of emergency medicine 2012: become 7 days of patients classified according to whether or not the recommendations, . * become tcl patients under aap or tac * number of reconsultation, rehospitalization, new imaging within 7 days after tcl


Eligibility criteria:
inclusion criteria: * patient of both sexes, at least 18 years old, * patient with mild head trauma, glasgow 13-15 * patient without tutorship or curatorship * affiliation to social security * no opposition of the patient or relatives to participation in the study. exclusion criteria: * patient already included in this study * refusal to participate in this search * patient undergoing enhanced protection (persons deprived of liberty by a judicial or administrative decision, adults under legal protection).
optimizing early enteral nutrition in severe stroke

Conditions: Severe Stroke; Acute Stroke; Dysphagia

Summary: the purpose of this academic lead study is to explore the ideal nutritional support strategy for patient with acute severe stroke.

of high mortality and morbidity, severe stroke is associated with devastating damages in neurologic, respiratory, circulatory and many other systems. the outcomes of patients with severe stroke depend largely on medical strategies on acute stage, especially on nutritional support management. unfortunately, clinical evidence are sparse and the ideal initial feeding strategy remains disputable. the if-stroke study aims to provide reliable data on the effects of modified full enteral feeding (target recruitment 200) and permissive underfeeding in patients with acute severe stroke (target recruitment 200) compared to full enteral feeding (target recruitment 200). patients presenting with acute (\<72h) severe stroke (gcs ≦ 12 or nihss ≧ 11) and dysphagia (defined by water swallowing test) will be randomly assigned to full enteral feeding, modified full enteral feeding, or permissive underfeeding treatment for 7 days.

Eligibility criteria:
inclusion criteria: * severe stroke occurred in 7 days. * gcs ≤12 or nihss≥11. * any cases of profiles #3 through 5 in water swallowing test or with disorder of consciousness. * plan to receive enteral feeding for at least 7 days. * informed consent. exclusion criteria: * gastrointestinal diseases before stroke, such as gastrointestinal resection, malabsorption,and irritable bowel syndrome. * brain death. * complicated with the disease which only have life expectancy \< 6 months in over 50% patients. * after cardiac arrest. * received parenteral nutrition support. * pregnant woman. * concurrent severe hepatic or renal dysfunction。 * unstable hemodynamics.

Keywords: severe stroke acute stroke enteral feeding mortality disability clinical trial