Kornimate/medical-research-clean huggingface dataset:
opsens optowire for fractional flow reserve - the o2 pilot study

Conditions: Stable Angina; Unstable Angina Pectoris; Chest Pain; Ischemia

Summary: the purpose of this study is to assess the usability and safety of the opsens optowire and optomonitor in measuring fractional flow reserve (ffr) in patients with coronary artery disease who are undergoing a coronary angiogram.

fractional flow reserve (ffr) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. an ffr of 1.0 is widely accepted as normal. an ffr value lower than 0.75 - 0.80 is generally considered to be associated with myocardial ischemia (mi). ffr is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. this ratio represents the potential decrease in coronary flow distal to the coronary stenosis. over the past decade, ffr measurement has been increasingly used in cardiac catheterization laboratories. it provides a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization. opsens, inc. has developed a new pressure wire for use in determining ffr in coronary arteries; the optowire. the optowire is an instrumented guide wire with a fiber optic pressure sensor mounted 3.5 cm proximal to the tip. the optowire measures blood pressure during diagnostic and/or interventional procedures when used in combination with the optomonitor. the o2 study is a pilot study which aims to provide preliminary experience in human patients with coronary artery disease. the study data will also be used as part of design validation. the o2 study is a prospective single arm study designed to assess the usability, functionality, and safety of the optowire and optomonitor in patients.

Eligibility criteria:
inclusion criteria: * patients with * stable angina or, * unstable angina pectoris or, * atypical chest pain or no chest pain but with suspected ischemia * at least one moderate lesion in native coronary artery thought to produce ischemia * operator and patient agree for procedures * patient (\> 18 years) has signed a written informed consent prior to procedure exclusion criteria: * lesions with angiographic 'haziness' or suspected to contain thrombus * post-coronary artery bypass grafting * total occlusion * if use of atherectomy device is indicated

Keywords: angiography angioplasty coronary artery disease diagnostic fractional flow reserve
iron and the breast-fed infant: iron status and two regimens of iron supplementation

Conditions: Iron Deficiency

Summary: normal breastfed infants can develop iron deficiency by 6 months of age. this trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. this was a prospective randomized trial involving breastfed infants. to be eligible, infants had to be predominantly breastfed (\<200 ml/day of formula) at 4 months of age. at 4 months infants were randomly assigned to one of two interventions or to control. the interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (medicinal iron group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (cereal group). the control group received complementary foods chosen by he parents but no source of iron provided by the investigators. the interventions took place from 4 to 9 months. all infants were subsequently followed to 2 years of age.


Eligibility criteria:
inclusion criteria: * predominantly breastfed (at 4 months) term infants exclusion criteria: * not predominantly breastfed at 4 months * premature infants

Keywords: iron, breastfed infant
arabic translation and validation of the (overactive bladder symptom score) oabss

Conditions: Overactive Bladder

Summary: the english version of the overactive bladder symptom score (oabss) questionnaire was translated to arabic language. the questionnaire was validated by comparing the response to the questionnaire in a patient with overactive bladder (oab) before and after providing treatment with antimuscarinics.


Eligibility criteria:
inclusion criteria: * more than 20 years * had three months history of overactive bladder symptoms (urgency with or without incontinence and associated with frequency and nocturia). exclusion criteria: * active urinary tract infection. * predominant symptoms of urinary stress incontinence; * diabetes mellitus; * previous abdominal and pelvic (urological or gynecological gastrointestinal) surgery; * previous neurological disease.
rapid immunization study of the japanese encephalitis vaccine ic51

Conditions: Japanese Encephalitis

Summary: the study investigates a rapid immunization regime of the japanese encephalitis vaccine ic51 (je-piv) in healthy subjects aged \> or = 18 years

this is a multicenter, observer blinded, controlled, randomized phase 3 study. the study population consists of healthy male and female volunteers, aged at least 18 years. approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * written informed consent obtained prior to study entry exclusion criteria: * history of clinical manifestation of any flavivirus infection * history of vaccination against japanese encephalitis (je), yellow fever and dengue fever (an anti-jev neutralizing antibody titer \>= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis) * use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine * immunodeficiency including post-organ-transplantation or immunosuppressive therapy * a family history of congenital or hereditary immunodeficiency * history of autoimmune disease * any acute infections within 4 weeks prior to enrollment * infection with hiv, hepatitis b or hepatitis c * pregnancy, lactation or unreliable contraception in female subjects
pregnancy after stem cell transplantation in premature ovarian failure

Conditions: Premature Ovarian Failure

Summary: out of 112 high risk patients for premature ovarian failure (pof), diagnosis was established in 10 cases. ess cut off point for menstruation and pregnancy was 6.

out of 112 high risk patients for pof, diagnosis was established in 10 cases. endometrial fractional biopsy was taken, stained with h\&e stain and by immubohistchemical (ih) staining by stem cell marker oct4. ih expression of stem cell marker oct4 was evaluated before and after transplantation according to edessy stem cell score (ess). after laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (fsh, lh and e2), clinical (resuming menstruation), us (folliculometry), histopathological (hp), and ih expression of stem cell (stem cell positivity and scoring according to ess). these cases were of ess 5 and 6.

Eligibility criteria:
inclusion criteria: * post-menarche female less than 40 years old. * normal karyotyping female. * primary ovarian failure females * follicle-stimulating hormone (fsh) more than or equal to 20 iu/l. * agree to sign the designed consent for the study. exclusion criteria: * autoimmune diseases. * breast cancer, ovarian cancer. * hypersensitivity to any gonadotropin-releasing hormone (gnrh) analogs. * those with major medical problems such as malignancy, hepatitis, etc.

Keywords: pof ess stem cell
comparison of two types of biopsy forceps for obtaining cold biopsy polypectomy for small sessile colorectal polyps less than 6 mm in diameter

Conditions: Colorectal Polyps

Summary: the purpose of this study is to evaluate the efficacy of the new rj4 compare with the standard rj3 biopsy forceps for performing polypectomy for small colorectal polyps.


Eligibility criteria:
inclusion criteria: * colon polyps less than 6 mm exclusion criteria: * no colon polyps

Keywords: evaluate the effectiveness of one bite polypectomy with the rj3 biopsy forcep versus the rj4 biopsy forcep
magnesium sulfate and postoperative hypercoagulability in laparoscopic gynecological surgeries

Conditions: Magnesium Sulfate; Thromboelastometry

Summary: this will be a prospective randomized, double-blind study, aiming at investigating the effects of magnesium sulfate on postoperative hypercoagulability in patients undergoing laparoscopic gynecological surgeries under general anesthesia

this randomized, double-blind, controlled study investigates the effects of magnesium sulfate on postoperative hypercoagulability in patients undergoing laparoscopic gynecological surgeries under general anesthesia. using thromboelastometry, the study aims to assess the impact of magnesium sulfate on blood coagulation parameters. patients are divided into two groups, with one group receiving magnesium sulfate and the other receiving normal saline. both patients and investigators are blinded to the treatment allocation. the study will analyze clotting time, clot formation, and coagulation markers to evaluate the therapeutic potential of magnesium sulfate in reducing postoperative hypercoagulability.

Eligibility criteria:
inclusion criteria: * asa i and ii patients * laparoscopic gynecological surgeries * age \>18 years * patients receiving prophylactic anticoagulant therapy 12 hours before surgery based on the caprini score * patients receiving prophylactic anticoagulant therapy 12 hours postoperatively based on the caprini score. exclusion criteria: * asa ≥ iii * age \<18 years * bmi \>40 kg/m² * pregnancy * known hematologic disorders * liver/kidney/cardiovascular disease * severe anemia (6,5- 7,9 g/dl) * inability or refusal to provide informed consent
prognostic role of minimal residual disease in acute myeloid leukemia

Conditions: Acute Myeloid Leukemia; Minimal Residual Disease; Wilms Tumor

Summary: study purpose is to assess the prognostic role of minimal residual disease (defined as medullary expression of wt1 gene), performed at baseline and during treatment according to clinical practice. mrd results will be relate to treatment outcome and survival analysis variables (overall survival, disease free survival, cumulative incidence of relapse)


Eligibility criteria:
inclusion criteria: * diagnosis of acute myeloid leukemia * age \> 18 years * intensive chemotherapy as first line curative treatment * observation period: march 2004 - september 2014 * bone marrow wt1 expression and immunophenotyping by multi-parametric flow cytometry performed at baseline * written informed consent exclusion criteria: * diagnosis of acute promyelocytic leukemia * bone marrow wt1 expression and immunophenotyping by multi-parametric flow cytometry not performed at baseline * patient ineligible to intensive chemotherapy

Keywords: acute myeloid leukemia minimal residual disease wilms tumor
treatment of major depressive disorder with psychotic features.

Conditions: Major Depression With Psychotic Features

Summary: the purpose of this study is to determine the safety and efficacy of risperidone monotherapy in the treatment of psychotic depression. we hypothesize that risperidone is as equally as effective as haloperidol plus sertraline for depression with psychotic features

risperidone is a novel antipsychotic that is usually not associated with the adverse effects of neuroleptics. in addition, preliminary evidence suggests that it has additional mood stabilizing properties as compared with neuroleptics. we are examining the effect of risperidone alone for the treatment of psychotic depression. after providing written informed consent, subjects with major depression and psychosis will undergo a routine medical and neurological evaluation. if subjects qualify they will undergo a 3 to 7 day washout. subjects will be randomly assigned under double-blind conditions to risperidone plus placebo; risperidone plus sertraline; or haloperidol (hpdl) plus sertraline in a prospective parallel design for a 6 week trial. outcome measures include the hamilton rating depression scale, the positive and negative symptom scale and the clinician administered ratings scale for mania and simpson angus scale. rating will be conducted on a weekly basis throughout the study.

Eligibility criteria:
inclusion criteria: * subjects will be men and women 18 to 70 years of age with major depression and psychosis that is either an initial episode or a recurrent episode (unipolar or bipolar). * subjects with an anxiety disorder or an additional mood disorder such as dysthymia are eligible. * baseline hdrs score of greater than 21. * a baseline panss score of greater than 4 on at least one of the 5 psychosis items exclusion criteria: * pregnant women women of child-bearing age who refuse a urine pregnancy test or who refuse to use a contraceptive technique when sexually active. * persons with other psychotic disorders; a mood disorder due to a general medical condition or substance-induced; a current substance dependence disorder; or a dementing disorder are excluded. * persons with serious, unstable medical illnesses.

Keywords: depression
evaluate the efficacy and safety of tgr-1202 in participants with chronic lymphocytic leukemia who are intolerant to prior therapy

Conditions: Chronic Lymphocytic Leukemia

Summary: the main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior btk (bruton tyrosine kinase) inhibitors (ibrutinib, acp-196, other) or prior pi3k-delta inhibitors (idelalisib, duvelisib, other).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of chronic lymphocytic leukemia (cll) * discontinuation on prior btk inhibitor or pi3k delta inhibitor due to adverse events within prior 9 months * presence of measurable disease exclusion criteria: * progression on prior btk or pi3k delta inhibitor * prior treatment with tgr-1202 * richter's transformation or cll transformation to aggressive lymphoma

Keywords: cll
safety, tolerability, pharmacokinetics and measurement of whole blood activity (wba) of pnu-100480 after multiple oral doses in healthy adult volunteers

Conditions: Tuberculosis

Summary: the purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of pnu-100480 given for 14 or 28 days. killing activity against the bacterium that causes tuberculosis (tb) will also be measured. the effect of adding an additional tuberculosis (tb) agent (given for 2 days) in addition to pnu-100480 will be evaluated. linezolid open label to determine activity in whole blood assay (wba).

evaluate safety, tolerability, pharmacokinetics and whole blood activity (wba) of pnu-100480 given for 14 or 28 days; evaluate wba of pnu with pyrazinamide; evaluate wba of linezolid

Eligibility criteria:
inclusion criteria: * healthy adult volunteers willing and able to be confined to the clinical research unit and comply with study schedule. * women of non-childbearing potential only. exclusion criteria: * history of hypersensitivity to, or intolerance of, linezolid. * antibiotic treatment within 14 days prior to dosing, or any previous antibiotic use at the discretion of the investigator. * previous history of irritable bowel syndrome (ibs) or inflammatory bowel disease (ibd).

Keywords: safety tolerability pharmacokinetics (pk) pharmacodynamics whole blood activity (wba) pnu-100480 linezolid pyrazinamide multiple dose
efficacy of bupivacain local infiltration for the management of pain during cesarean section

Conditions: Pain, Postoperative

Summary: this study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (vas) and assessing the need for rescue analgesia after surgery.


Eligibility criteria:
inclusion criteria: * gestational age ≥ 36 weeks * elective cesarean section * transverse segmental caesarean section pfannenstiel type * spinal anesthesia * maternal age 18 to 45 years * any gravaparity * patient asa i or ii exclusion criteria: * any patient who does not meet the inclusion criteria. * emergency cesarean section * history of chronic or neuropathic pain * patient with cardiopulmonary disease * known allergies to the drugs used in the study * patient who does not wish to participate in the study

Keywords: cesarean section postoperative pain bupivacain
thirst-guided subject-controlled rehydration in healthy volunteers

Conditions: Dehydration Hypertonic

Summary: water is largest single component to the human body and is requisite for numerous essential metabolic processes. dehydration refers to deficient body water content and is prevalent in healthcare. it has been repeatedly shown that dehydration is associated with increased mortality and morbidity. despite its prevalence and deleterious sequelae, there is substantial deficiency in the knowledge, assessment and management of this pathological state: there is no internationally-recognised definition, clinical signs can be subtle and unreliable, and there is no objective marker with everyday clinical utility. as a consequence, diagnosis of dehydration and prompt rehydration strategies are often poorly delivered in healthcare environments. thirst plays an integral part in body water homeostasis. plasma osmolality will increase with uncompensated water loss and is considered the most reliable surrogate objective marker of dehydration. increased osmolality is sensed by hypothalamic osmoreceptors stimulating thirst and pituitary secretion of antidiuretic hormone (adh). thirst has been shown to be sensitive to small changes in plasma osmolality and shows little intra-individual variation. in view of this, it is rational to propose tendering control of intravenous rehydration to patients, enabling them to use the finely-honed intrinsic thirst mechanism to guide their own fluid therapy. a recent pilot study demonstrated that healthy subjects, when allowed to regulate their own intravenous fluid therapy in response to thirst intensity, rehydrated themselves more efficiently than subjects receiving a guideline-based, clinician-delivered fluid regimen. what is unclear is the extent of the reliability of thirst in guiding intravenous fluid rehydration therapy. the investigators propose a double-blinded, repeated measures study in which healthy volunteers are dehydrated using exercise-heat stress in a climatic chamber. once dehydrated by 3-5% of their body weight, subjects will receive intravenous fluid rehydration which they can demand in response to their sensation of thirst. in one arm of the study they will receive low volume fluid bolus on demand, and in the other arm they will receive a higher volume fluid bolus. thirst scores and surrogate markers of dehydration will be measured throughout this process. the investigators can then assess whether the demand for additional fluid in response to thirst reduces in frequency in proportion to the degree of correction of fluid deficit.


Eligibility criteria:
inclusion criteria: * healthy physically active male volunteers aged 18-65 years. * participants must be normotensive (systolic pressure between 90 and 150 mmhg, diastolic pressure between 60 and 90 mmhg). * participants greater than 29 years of age will be required to have a 12 lead ecg evaluated by an appropriate imo prior to participating. exclusion criteria: * known cardiovascular disease * known renal disease * known hepatic disease * taking medications which might affect sense of thirst or salt/water handling * history of heat intolerance
benefit of adding stretching to standard intervention for patients with nonspecific mechanical neck pain

Conditions: Neck Pain

Summary: the purpose of this study is to assess the benefit of adding stretching exercises to cervical mobilization and cervical range of motion exercises on cervical range of motion, pain, pain threshold, level of disability and patient satisfaction for patient with non-specific mechanical neck pain

all recruited participants will sign a statement of informed consent. subjects were randomly divided into two groups (combined intervention group and standard intervention group). the following questionnaires were completed in the following order: neck disability index (ndi), numeric pain rating scale (nprs), and global rating of change scale (groc). next, cervical range of motion (rom) and pain threshold were measured for both groups. the combined intervention group received the cervical passive mobilization, stretching, and home program (stretching and rom exercise). the standard intervention group received cervical mobilization and home program (rom exercises).

Eligibility criteria:
inclusion criteria: * the participant will be eligible to participate in the study if he or she is between 18 and 60 years of age, had non-specific neck pain for at least 2 weeks exclusion criteria: * participants will be excluded from the study if they had one or more of the following conditions: had previous surgery in cervical spine area, chronic disease such as diabetes, vertigo, dizziness, fracture of the cervical vertebra or scapula, multiple sclerosis, osteoporosis, rheumatoid arthritis or osteoarthritis as approximately 60% of people who aged between 50-60 years will have osteoarthritis.
mirtazapine for acute and chronic post mastectomy pain

Conditions: Breast Cancer

Summary: our aim in this study will be to investigate the effect of mirtazapine on acute post-mastectomy pain manifested by total morphine consumption in first 24 hours and vas score at rest and movement (primary outcomes). chronic neuropathic pain using lanss pain scale (leeds assessment of neuropathic signs and symptoms) and to evaluate the quality of recovery using the quality of recovery-40scoring system(qor-40) (secondary outcomes) following modified radical mastectomy for breast cancer.


Eligibility criteria:
inclusion criteria: female patients aged 20-70 years scheduled for modified radical mastectomy with axillary dissection for breast carcinoma exclusion criteria: * known allergy to the study drugs significant organ dysfunction drug or alcohol abuse epilepsy patients with chronic pain or regularly receiving analgesics any psychiatric illness that would interfere with the perception and the assessment of pain
use of probiotic yogurt in the treatment of acute diarrhea in children

Conditions: Acute Diarrhea; Acute Gastroenteritis

Summary: the purpose of this study is to determine the effect of probiotic yogurt in acute watery diarrhea in children. the investigators will compare the effect of two different probiotics products.

background: acute gastroenteritis is one of the most and frequent disease in the childhood, considering the advances in treatment, lactobacillus rahmnosus has being well described as a probiotic who reduces the number of days of hospitalization and also de the severity. objectives: to evaluate the effect of the probiotic yogurt in the treatment of children who are between 10 months and 3 years old with acute non-dysenteric diarrhea. methods: a randomized clinical trial, controlled, double-blind. the investigators will have two groups of patients : one group will receive lactobacillus rahmnosus in a yogurt presentation and the other one will receive sacharomyces boulardii in a lyophilized form ; the parameters of evaluation are going to be the number of diarrhea stools by day, number of vomiting episodes, hours with fever, nutritional and immunization state.

Eligibility criteria:
inclusion criteria: * all acute diarrhea exclusion criteria: * severe malnourishment * severe dehydration * systemic infections

Keywords: acute diarrhea probiotics children