Kornimate/medical-research-clean huggingface dataset:
the ihealth study in college students

Conditions: Alcohol Abuse; Alcohol Dependence; Unhealthy Alcohol Use; Risky Alcohol Consumption Amounts; Hazardous Alcohol Use

Summary: the objective of this project was to test the feasibility of electronic mail recruitment and web screening for hazardous drinking, to compare different approaches to encouraging screening, and to estimate the effects of minimal and more extensive feedback in preparation for a future alcohol web-based brief intervention study

this pilot study aims to test the feasibility of electronic mail recruitment and web screening for alcohol problems, to compare different approaches to encouraging screening, and to estimate the effects of minimal and more extensive feedback in preparation for a future alcohol web-based brief intervention study. to do so, 4300 freshman adult college students will be randomized to receive an electronic mail request to complete a web alcohol screening test using an alcohol-specific or a general wellness approach. the primary outcome is the proportion of respondents who complete alcohol screening. additional outcomes include readiness to change drinking, help-seeking, alcohol consumption and consequences. the results of this pilot study will provide information useful to 1) colleges deciding how best to implement universal screening for hazardous alcohol use, and 2) in the preparation of a larger study of web-based screening and brief intervention for hazardous drinking in college students.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * full time student * college freshman exclusion criteria: -

Keywords: alcohol alcohol abuse alcohol dependence alcohol consumption unhealthy alcohol use screening brief intervention effectiveness electronic intervention web-based intervention college students
a prospective, non-interventional, multinational, observational study with isatuximab in patients with relapsed and/or refractory multiple myeloma (rrmm)

Conditions: Plasma Cell Myeloma

Summary: primary objective: to assess the effectiveness, in terms of overall response rate (orr) of isatuximab patients with rrmm in routine clinical practice, within 12 months to assess other effectiveness parameters such as progression free survival (pfs), pfs rate (pfsr), duration of response (dor), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (cr) or better of isatuximab patients with rrmm in routine clinical practice to assess the profile of patients (demographic, disease characteristics, comorbidities and prior mm treatment history) who are treated with isatuximab in routine clinical practice to describe safety of isatuximab in routine clinical practice (based on adverse event \[ae\] reporting) to assess quality of life (qol) using the european organization for research and treatment of cancer (eortc) 30 item core questionnaire (qlq c30) and the accompanying 20 item myeloma questionnaire module (qlq my20) secondary objective: not applicable

duration per participant is 2.5 years

Eligibility criteria:
age ≥18 years * patients with rrmm who have at least one prior line of therapy * patients for whom the treating physician has made the decision to initiate isatuximab per routine practice and independently of the purpose of the study; for retrospectively enrolled patients, exposure to isatuximab treatment for a maximum of three months prior to study enrollment * able to understand and complete the study-related questionnaires * patient must have given signed informed consent prior to study start. for retrospectively enrolled patients who are deceased at the date of enrollment into the study, a waiver of consent will be required; patients who have started and stopped treatment up to three months before icf are eligible . most important exclusion criteria for potential participants: patients who are receiving isatuximab for an indication other than rrmm * patients who have received any other investigational drug or prohibited therapy for this study within 28 days or five half-lives from randomization, whichever is longer * patients having contraindication to the isatuximab summary of product characteristics (smpc) or package insert (pi) * patients having contraindications as noted in the drug-specific local isatuximab smpc/pi of combination drugs * any country-related specific regulation that would prevent the patient from entering the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effects of tdcs in elderly with pain due to knee osteoarthritis

Conditions: Osteoarthritis, Knee; Chronic Pain

Summary: the purpose of this study is to evaluate if anodal tdcs stimulation over m1 may decrease chronic knee oa pain in elderly subjects with defective cpm. in addition, this trial will help to investigate the role of central sensitization in knee oa and evaluate how tdcs stimulation may affect it.


Eligibility criteria:
inclusion criteria: * individuals \> 60 years old, of both genders. * diagnosis of primary knee osteoarthritis with chronic pain self-reported. * be able to sign the informed consent to participate in the study. * chronic pain (over the past 6 months) of at least 4 on a 0-10 vas scale on average. * reduction on vas (visual analogic scale) during cpm (conditioned pain modulation) \< 10% exclusion criteria: * contraindications to transcranial brain stimulation, i.e. implanted brain medical devices or implanted brain metallic devices. * severe acute or chronic decompensated disease. * cognitive and behavioral impairment. * epilepsy. * history of fractures in the lower limbs and/or spine in the last 6 months. * use of carbamazepine within the past 6 months as self-reported. * severe depression (with a score of \>30 in the beck depression inventory) * history of syncope. * traumatic brain injury with residual neurological deficits. * history of alcohol abuse within the past 6 months as self-reported.

Keywords: osteoarthritis elderly musculoskeletal pain transcranial direct current stimulation
uncpm 22322 - adaption of the transition of care model for post-discharge hiv-ncd care in lilongwe, malawi - mlatho

Conditions: HIV; Noncommunicable Diseases

Summary: this is an implementation research study that will adapt and pilot test the transitional of care model (tcm), originally conceived and developed in the usa, for targeted use as a post-discharge intervention for adults hospitalized with comorbid hiv and ncds in malawi using a mixed methods approach.

this study will enroll 75 consecutive adults hospitalized with comorbid hiv and at least have one common cardiometabolic condition (e.g., hypertensive urgency, heart failure, stroke, or diabetes) and provide them with the adapted tcm according to the sop developed in the prior phase. it is expected that 15-20% will also have comorbid opportunistic infections. the study will evaluate the acceptability and feasibility of the adapted intervention. using mixed methods, including surveys and interviews, the study will evaluate the acceptability and feasibility of providing the inpatient and post-discharge components of the adapted tcm. the study will also describe key 3-month post-discharge clinical outcomes (mortality, readmission) and indicators that may mediate clinical outcomes (linkages/retention in care, adherence to antiretroviral therapy/non-communicable disease (art/ ncds) medications, dual control of hiv and ncds, social demographic variables). clinical outcomes and indicators in the pilot participants will be compared with a comparable historical control group of patients who had routine care at kch in the recent past.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * living with hiv * admitted to internal medicine * has at least a cardiometabolic nco as the primary or secondary reason for admission based on the hiv inpatient consultation exclusion criteria: * patients living beyond lilongwe urban
use of interferential current (ifc) therapy after total knee arthroplasty

Conditions: Osteo Arthritis Knee

Summary: interferential current therapy (ifc) is a form of electrical therapy that utilizes two simultaneous low frequency electrical stimulation which when they cross interfere with one another resulting in an interference or beat frequency. this beat frequency provides a therapeutic area of relief by blocking painful stimuli at the area of interest. ifc is different from the other electrical treatment modalities used because the cancellation effect allows for establishment of the treatment area to be in the deeper tissues of the body, whereas other electrical modalities can only be used to treat superficial body parts that lie just under the skin. the main objective of this proposed study is to assess the post-operative short term outcomes of the patients who receive ifc treatment during their post-total knee arthroplasty (tka) surgery hospital stay. the implications of the study would be improved patient outcome which could result in shorter hospital stay, reduced use of opioid medication, decreased need for manipulation under anesthesia and reduced re-admission rate.


Eligibility criteria:
inclusion criteria:adult patients with knee osteoarthritis who have failed conservative therapy and undergoing elected tka. - exclusion criteria: i. \<18 years old ii. any patient with pacemaker or any electrical stimulator device iii. patients without capacity to consent for the study iv. patients not able to have local nerve block or spinal anesthesia v. patients with prior chronic opioid use vi. patients who are categorized to have 'severe' fear and anxiety responses to pain, according to the pain catastrophizing scale (pcs) survey.
study of tomography of nephrolithiasis evaluation

Conditions: Urolithiasis

Summary: this is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared to computed tomography (ct) for the initial emergency room evaluation of patients with suspected renal colic. the investigators will compare several measures of effectiveness including morbidity related to the patient's underlying disease, or complications related to delayed diagnosis, patient status regarding pain/missed days of work, and utilization of health care resources based on one of three study arms: ultrasound in the emergency department, ultrasound in radiology or ct.

this is a multi-center, randomized controlled trial of ultrasonography compared with computed tomography (ct) for the evaluation of patients with suspected urolithiasis. the study will be conducted at 15 large urban emergency departments (eds), reflecting geographic, socioeconomic, racial and ethnic diversity, and include academic medical centers as well as safety net hospitals. the patients will be randomized to one of three arms: 1) ultrasound in the emergency department (ed), 2) ultrasound in radiology or 3) ct in radiology. the investigators will then collect precise and unbiased data on a comprehensive range of outcomes that will allow assessment of effectiveness, safety, accuracy and cost between patients randomized to one the three groups. taken together, these measures are intended to provide the basis for a valid comparison of imaging of patients with suspected urolithiasis seen in the ed. the results of this trial could lead to a change in clinical practice that is associated with both improved patient outcomes and reduced cost. broad stakeholder involvement from within radiology, emergency medicine and several subspecialty communities has been sought to ensure the strategic completion of study aims and to help rapidly disseminate the results of the study into clinical practice. this will create a collaborative network of eds willing to act as a laboratory for studying the comparative effectiveness of diagnostic testing. as a result, the proposed trial will demonstrate the feasibility of conducting randomized control trials (rcts) of imaging that incorporates measurements of outcomes that can be expanded to additional imaging tests in the future.

Eligibility criteria:
inclusion criteria: * men or women = or \>18 but \<76 years of age presenting with acute renal colic * emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones. exclusion criteria: * children \< 18 years old * elderly patients \> or = 76 years old * pregnancy or planning pregnancy * morbid obesity (\>285 pounds in men, \>250 pounds in women) * patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected). * history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)

Keywords: kidney stone urolithiasis urinary tract infection ultrasound computed tomography safety cost accuracy
all-case surveillance of prizbind®

Conditions: Hemorrhage

Summary: to evaluate safety and effectiveness of prizbind® for intravenous solution 2.5 g under japanese clinical condition.


Eligibility criteria:
inclusion criteria: patients who are prescribed with prizbind® for intravenous solution 2.5 g by the discretion of investigators exclusion criteria: none
a 12-week randomized study to evaluate oral istradefylline in subjects with moderate to severe parkinson's disease

Conditions: Idiopathic Parkinson's Disease

Summary: this is a study to assess the efficacy and safety of oral istradefylline (kw-6002) in patients with moderate to severe parkinson's disease. while on this study, participants will continue to take their usual, prescribed, stable regimen of levodopa/carbidopa or levodopa/benserazide therapy plus adjunct parkinson's medications. patients will be randomized 1:1:1 to receive either istradefylline 20 mg per day, or istradefylline 40 mg per day or an equivalent placebo. patients will be treated for a 12 week period to demonstrate the effectiveness of istradefylline in improving parkinson's disease symptoms (referred to as improvement in patient off time) and that istradefylline has an acceptable safety profile in this group.


Eligibility criteria:
inclusion criteria: * 30 years of age or older. * uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd * pd stages 2-4 in the on state for modified hoehn and yahr scale. * on levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit * taking at least 400mg levodopa combination daily and on stable regimen of any other anti-parkinsonian drugs (mao-b, comt, da) for at least 2 weeks prior to randomization * stable dopaminergic regimen for at least 4 weeks immediately prior to randomization * documented end-of-dose wearing-off and levodopa-induced dyskinesia * have an average of two hours of off time per day exclusion criteria: * subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion. * subject who have had neurosurgical operation for pd * subjects taking a2a antagonist, potent cyp3a4 inhibitors, potent cyp34a inducers * subjects who smoke \> 5 cigarettes/day

Keywords: parkinson's disease moderate to severe parkinson's disease
aldosterone blockade to prevent myocardial remodeling in patients with controlled essential hypertension

Conditions: Myocardial Remodeling

Summary: the goal of this project is to investigate the effects that the addition of aldosterone blockade with eplerenone will have on the progression of diastolic dysfunction in patients with controlled essential hypertension.

the purpose of this project is to determine if eplerenone, an aldosterone blocker, prevents remodelling of the heart in patients with controlled essential hypertension, defined as having a blood pressure of equal to or less than 130/80 in diabetics and equal to or less than 140/90 in non-diabetics. this study will investigate if the addition of 25 milligrams of eplerenone daily to a subject's hypertension medication regimen will prevent the progression or development of diastolic dysfunction. echocardiography will be used to measure the changes in heart structure of subjects receiving eplerenone versus subjects receiving placebo (a drug that may resemble the study drug but contains no active ingredient). approximately 30 subjects will take part in this study.

Eligibility criteria:
inclusion criteria: * treated and controlled hypertension * less than 140/90 in non-diabetics * less than 130/80 in diabetics exclusion criteria: * currently receiving an aldosterone blocker * clinical evidence of congestive heart failure * prior myocardial infarction * renal dysfunction with a creatinine clearance of less than 40ml/min * serum potassium \> 5.5meq/l at initiation * concomitant use of a medication that inhibits the cyp3a4 enzyme (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir)

Keywords: aldosterone blockade aldosterone receptor blockers cardiac chamber size wall thickness left ventricular ejection fraction left atrial volumes diastolic function
influence of physical treatments of human milk on the kinetics of gastric lipolysis in preterm newborns

Conditions: Premature Birth

Summary: the optimization of newborns nutrition is a challenge especially for preterm newborns for whom nutrition plays a crucial part in cerebral and global development. human milk is considered as the best food for newborns. several short and long-term beneficial health effects were attributed to breastfeeding and have induced the increase of human milk in preterm newborns nutrition. whereas the chemical composition of infant formula has been optimized to mimic human milk, there is still a major difference between the structure of human milk and commercial infant formulas. it is well known in adult nutrition that the structure of emulsions influences their susceptibility to hydrolysis, such results have been obtained either on in vitro or in vivo studies. human milk is a natural emulsion (oil in water). lipids droplets are dispersed under the form of entities called milk fat globules (average diameter 4 µm, span 0.1-20 μm). the globules are stabilized by a trilayered membrane composed mainly of polar lipids (phospholipids, sphingolipids and gangliosides), of proteins, neutral lipids and other minor compounds. the physical treatments apply to human milk or more generally to bovine milk to pasteurize or stabilize the milk modify the structure of the natural emulsion. heat treatment for instance induces whey proteins denaturation and the adsorption of protein aggregates on the surface of the milk fat globules. heat treatment also leads to the denaturation of bile salt stimulated lipase. these effects limit intragastric lipolysis in preterm newborns. conversely, reduction of milk globules size, by homogenisation of milk, increases the specific surface available for lipase adsorption and limits the lost of fat during enteral administration of milk. such treatment could thus enhance gastric lipolysis and improve fat absorption of preterm newborns. the objective of this trial is to evaluate the effects of physical treatments (pasteurization and homogenisation by ultrasonication) applied to human milk on gastric lipolysis and milk destructuration. this trial is conducted, in vivo, on preterm newborns.


Eligibility criteria:
inclusion criteria: * premature neonates born before 32 weeks of gestation * newborn dwelled near rennes * volume of enteral nutrition \> 120 ml/kg/j (day 0) * written-informed parental consent for the study exclusion criteria: * digestive congenital anomalies * antecedent of enterocolitis * patient included in other study * abdominal distension on day 0 * treatment by morphine or catecholamine on day 0

Keywords: preterm newborns gastric lipolysis physical treatments human milk
comparison of the continous suprainguinal fascia iliaca compartment block and continous epidural

Conditions: Pain, Postoperative

Summary: this study evaluates the effectiveness of postoperative analgesia quality, interleukin-6, hemodynamic stability and qor-40 of continuous suprainguinal fascia iliaca compartment block (s-ficb) compared with continuous epidural in patients undergoing cephalomedullary nailing surgery. half of participants will receive continuous s-ficb with patient control regional analgesia using ropivacaine 0.2% continue 2ml/hr and demand dose 5ml as needed, while the other half will receive continuous epidural with patient control epidural analgesia using same regimen.

the continuous suprainguinal fascia iliaca compartment block (s-ficb) and continuous epidural are regional anaesthesia that can be used to relieve postoperative pain of femur surgery. but there are few studies have been done to compare both techniques. the s-ficb is an alternate peripheral nerve block technique using local anaesthetic administered into the fascia iliaca compartment at the inguinal region which targets the femoral, obturator and lateral femoral cutaneous nerves. the epidural is well known and proven to have an adequate analgesia effect using local anaesthetic in the epidural region targeted for femur surgery. based on previous studies, the effectiveness of the s-ficb single shot was no longer than 18 hours. then we choose to continue s-ficb to find out how adequate it is. the s-ficb with ropivacaine has a proven anti-inflammatory effect for the first 24 hours postoperative.

Eligibility criteria:
inclusion criteria: 1. patients is planned for cephalomedullary nailing surgery 2. patients with bmi 18 - 30 kg/m2 3. patients with asa physical status i - iii exclusion criteria: 1. patients with contraindications to regional anesthesia 2. patients with mental disorders or psychiatric disorders 3. patients have a history of allergy to the local anesthetic drug 4. patients or family refused to participate in the study

Keywords: pain postoperative
moderate-dose cyclophosphamide for childhood acquired aplastic anemia

Conditions: Aplastic Anemia

Summary: severe aplastic anemia (saa)is characterized by the depletion of hematopoietic precursors associated with life-threatening complications. high-dose cyclophosphamide has been found to yield a complete response (cr) in adults and children with saa.however, the optimal dosage of cyclophosphamide for patients in childhood remains unclear. so we explore the ideal dosage of cyclophosphamide for the treatment of children with saa.

tisdale et al. (2000,2002) attempted to compare immunosuppression using atg/csa with high-dose cyclophosphamide (50 mg/kg/d for 4 consecutive days) plus csa in a randomized trial of newly diagnosed adults with saa. both groups received csa as part of the treatment regimen. however, the trial was terminated prematurely due to excessive morbidity among the patients treated in the cyclophosphamide arm. they documented that invasive fungal infections were severe among the cyclophosphamide group. between january 2008 through may 2009, in our department, nine pediatric patients with a diagnosis of saa were enrolled a study with lower dose of cyclophosphamide with 30mg/kg/day for 4 consecutive days and combination with csa, this study shows promise for children with severe aplastic anemia.now we want explore the dosage of cyclophosphamide.

Eligibility criteria:
inclusion criteria: * acquired childhood severe aplastic anemia (saa) exclusion criteria: * not childhood and acquired severe aplastic anemia

Keywords: aplastic anemia; cyclophosphamide; immunosuppressive therapy; cyclosporine a