Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of apremilast in subjects with moderate to severe atopic dermatitis

Conditions: Dermatitis, Atopic Dermatitis

Summary: a study to evaluate the efficacy and safety of apremilast (cc-10004) in subjects with moderate to severe atopic dermatitis


Eligibility criteria:
inclusion criteria: 1. males or females, aged ≥ 18 years (≥ 20 for japanese subjects) at the time of consent. 2. have a diagnosis of atopic dermatitis for ≥ 12 months. 3. have moderate to severe atopic dermatitis which is considered inappropriate for topical therapy or which cannot be adequately controlled by topical therapy. 4. meet the laboratory criteria as defined per protocol 5. females of childbearing potential (fcbp) must have a negative pregnancy test at screening and baseline. sexually active fcbp must use one of the approved contraceptive options required per protocol while on and for at least 28 days after the last dose of study medication 6. male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception while on and for at least 28 days after the last dose of study medication. exclusion criteria: 1. active tuberculosis (tb) or a history of inadequately treated tuberculosis. 2. positive for hepatitis b surface antigen or hepatitis c antibody 3. pregnant or breast feeding 4. history of allergy to any component of the study medication. 5. active skin infection requiring systemic antimicrobials at baseline.

Keywords: atopic dermatitis atopic eczema
neutrophil, lymphocyte and platelet as a predictor for aki and mortality

Conditions: Acute Kidney Injury

Summary: cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. the authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.

acute kidney injury (aki) after cardiovascular surgery remains a serious complication associated with increased mortality for up to 10 years. the incidence of aki after cardiovascular surgery is as high as 55% and the incidence of renal replacement therapy (rrt) to be up to 8 %. cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. the authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.

Eligibility criteria:
inclusion criteria: * adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (cpb), including valve replacement and surgery on the thoracic aorta at the seoul national university hospital between 2007 and 2015 exclusion criteria: * missing preoperative serum creatinine (scr) values * missing preoperative platelet, neutrophil and lymphocyte counts * patients who underwent preoperative hemodialysis

Keywords: acute kidney injury cardiovascular surgery mortality
trial of homeopathy on management of menorrhagia

Conditions: Menorrhagia

Summary: the purpose of this study is to compare outcomes and quality-of-life issues in the treatment of menorrhagia, this randomized double blind controlled trial compared homeopathy and placebo. clinical criteria were confirmed the diagnosis, and subjective assessment of the condition was performed during one pre-treatment and three treatment cycles. outcome measures were bleeding days, intensity. average pads used during menstrual cycle, abdominal \& back pain, general health and overall satisfaction.


Eligibility criteria:
inclusion criteria: * age between 35-49 years with regular heavy menstrual bleeding * menstrual loss requiring more than 5 pads/tampons per day * menstrual cycle longer than 6 days exclusion criteria: * organic causes of menorrhagia * history of renal or hepatic impairment, * endocrine disorder including diabetes, thyroidism * thromboembolic disease, * inflammatory bowel disease, * peptic or intestinal ulceration, or coagulation or fibrinolytic disorders and --malignancy.
study of two titration algorithms with insulin glargine 300 units/ml in type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: the primary objective of this study is to obtain efficacy and safety descriptive data on 2 different titration algorithms: the insight titration algorithm (self-titration of 1 unit/day) and the edition trial algorithm with insulin glargine 300 units/ml when given as basal insulin in uncontrolled type 2 diabetes mellitus (t2dm) patients on basal insulin with or without non-insulin anti-hyperglycemic agent (niaha) or in insulin naïve patients. secondary objective: the secondary objective is to gain additional efficacy and safety data (glycated hemoglobin \[a1c\], fasting plasma glucose \[fpg\], 7-point self-measure plasma glucose \[smpg\], insulin dose and weight) and determine patient related outcome and health care professional satisfaction as it pertains to each titration regimen.

the total study duration is approximately 14 weeks (2 weeks screening and 12 weeks treatment) with a 2-day safety follow-up and a study extension of 12 weeks for eligible patients.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus. * patients who are ≥18 years of age. * treated for diabetes for at least 6 months. * if on basal insulin, stable for at least 3 months prior to screening visit on their basal insulin treatment(s) (±20% total insulin dose) * if on niaha, stable for at least 8 weeks prior to screening visit on their niaha(s) (no change in dose or initiation of new niahas). * patients on uncontrolled basal insulin (insulin glargine, normal protamine hagedorn \[nph\], detemir) +/ niahas with an a1c \>7.0% and ≤10% or uncontrolled on niahas (insulin naïve patients) with an a1c \>7.0% and ≤11%. * signed informed consent form. exclusion criteria: * patients with type 1 diabetes mellitus (t1dm). * nightshift worker. * female patients who are pregnant or lactating. * treatment with an insulin other than basal insulin (premixes, rapid insulin, fast acting insulin analogues) within the previous 3 months. * patients with less than 1 year history of diabetes. * patients unwilling to inject insulin or perform self-monitoring blood glucose. * current alcohol or drug abuse. * patients unlikely to comply with the protocol and complete the study eg, uncooperative attitude, inability to return for follow-up visits. * patients with active cancer or any other diseases or conditions which in the opinion of the investigator would make the patient unsuitable for participation in the study. * any clinically significant laboratory findings that in the judgment of the investigator would preclude safe completion of the study. * known allergies to study drugs. * participation in another clinical study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
french-german cohort study to determine factors associated with weight loss in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a neurodegenerative disease. studies have shown the importance of weight loss at the time of diagnosis and during the progression of the disease. however, the pathophysiological mechanisms behind weight loss remain unknown. identifying these mechanisms could make it possible to propose an effective therapeutic strategy against weight loss for als patients, which could improve their survival and quality of life. in this context, the investigators are proposing an innovative multidisciplinary project aimed at structuring a large franco-german cohort to identify the markers associated with weight loss in als. participants will undergo high quality standard care for als patients. in addition, participants will be asked to respond different questionnaires and blood samples will be taken for analysis to identify biological markers.

als is the most frequent adult onset motor neuron disease and is highly variable in terms of clinical features, genetics, and neuropathology. a large body of evidence has demonstrated the importance of weight loss at the time of diagnosis and during disease progression. weight loss affects between one and two-thirds of patients and is adversely associated with survival. high caloric nutrition was able to slow weight loss and prolong survival in fast progressing als patients. pathophysiological mechanisms underlying weight loss remain unknown because high-quality cohort data collecting clinical features, genetics, omics, and imaging related to the metabolic and disease status of patients are lacking. the investigators hypothesize that weight loss in als patients is biologically driven through specific pathways. the investigators propose an innovative and ambitious multidisciplinary project to structure a large french-german cohort to identify markers associated with weight loss. the investigators aim at identifying the biological correlates of weight loss to disentangle the mechanistic basis of this critical symptom and to determine clinical and biological profiles along with their impact on disease progression and survival.

Eligibility criteria:
inclusion criteria: * incident cases included at the time of diagnosis with a definite, probable, probable laboratory-supported, or possible als according to el escorial revised criteria and gold coast criteria for early diagnosis. * incident als cases identified and followed-up in the participant als \& other motor neuron diseases referral centres: seven in france and two in germany. * patients who signed the informed consent form. * adults aged \>18 years old exclusion criteria: * inability to understand the requirements of the protocol. * cognitive inability to sign and comprehend the informed consent form. * patients who will not accept riluzole therapy during their follow-up.

Keywords: amyotrophic lateral sclerosis weight loss genetics nutrition prognosis metabolomics inflammation
leber hereditary optic neuropathy (lhon) historical case record survey

Conditions: Leber Hereditary Optic Neuropathy (LHON)

Summary: the objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of leber hereditary optic neuropathy (lhon). visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed. the survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of lhon. no exclusion criteria apply. patients are not required to attend the clinic for the survey. data will be collected in a completely anonymous manner. ethical approvals and data release agreements will be obtained as required by local regulations.


Eligibility criteria:
inclusion criteria: * patients with genetically confirmed diagnosis of lhon
a titration of fractional inspired oxygen using oxygen reserve index in child

Conditions: Hyperoxemia

Summary: the purpose of this prospective randomized controlled trial is to determine whether using the oxygen reserve index can prevent hyperoxemia in pediatric patients receiving single-lung ventilation. participants will have their fio2 adjusted in a prescribed manner based on the arm to which they are assigned. the researchers will compare whether blood oxygen levels were lower in the ori group.


Eligibility criteria:
inclusion criteria: * children under 7 years of age undergoing surgery under unilateral pulmonary ventilation * children with american society of anesthesiology physical status i, ii, iii exclusion criteria: * patient who have chronic respiratory failure * patient who have a history of bronchopulmonary dysplasia, respiratory distress syndrome of neonate, laryngomalacia, tracheomalacia or tracheal stenosis * patient whose initial oxygen reserve index value is zero * patient who need supplementary oxygen before surgery
stress ball during lumbar puncture the effect of the application on anxiety level

Conditions: Neurologic Disorder

Summary: individuals who come to the neurology clinic to undergo lumbar puncture, and meet the inclusion criteria, and agree to participate in the study will be given a stress ball during the procedure and will be asked to squeeze this ball.

before starting the research, the purpose of the research will be explained to patients who meet the inclusion and exclusion criteria, and their verbal and written consent will be obtained. the declaration of helsinki will be adhered to throughout the research. data will be obtained by administering face-to-face surveys. the population of the study will be individuals who meet the inclusion criteria at the neurology clinic of istanbul university - istanbul faculty of medicine, and the individuals who agree to participate in the study will constitute the sample. to determine the number of samples, a comparison of two groups was made using the "g-power 3.1.7" program. the minimum sample size that would provide type i margin of error (α): 0.05 and power of the test (1-β): 0.80 was determined as 47 people in total. taking into account sample loss, it was aimed to reach a total of 50 people. then, the form questioning socio-demographic information and the stai xt state-trait anxiety scale will be applied. before the lp begins, the patient's free hand will be given an elastic ball that is large enough to hold in the palm of the hand and squeeze easily. he/she will be asked to squeeze this ball slowly throughout the process. at the end of the procedure, the ball will be removed from his hand and the patient will be relieved. after the patient is relaxed, the stai xt state-trait anxiety scale will be administered again. the state anxiety scale is a sensitive scale for evaluating sudden changes in emotional reactions. the trait anxiety scale aims to measure the continuity of anxiety that a person generally tends to experience. since this study aims to evaluate the anxiety levels of patients regarding their current situations, the state anxiety scale will be used.

Eligibility criteria:
inclusion criteria: * -being over 18 years old * volunteering to participate in the study * being able to read and write * no problems in verbal communication * lumbar puncture procedure will be performed exclusion criteria: * - do not come to the neurology clinic for any procedure other than lumbar puncture.
urinary retention after removing urinary catheter at 24 hour versus 48 hour in patients with vaginal surgery

Conditions: Urinary Retention; Pelvic Organ Prolapse

Summary: comparison incident of urinary retention in patients with vaginal surgery of pelvic organ prolapse, who removed urinary catheter at 24 hours versus 48 hours after surgery

vaginal surgery of pelvic organ prolapse needs to insert urinary catheter for monitoring post-operative complication, hemodynamic status, and prevention post-operative urinary retention. urinary retention occur 2.4 - 43% after pelvic organ prolapse surgery, whereas retaining urinary catheter is common cause of urinary tract infection, often hospital-acquired infection. at rajavithi hospital always remove urinary catheter at 48 hour after surgery. accordingly, appropriated time for removing urinary catheter in patients with vaginal surgery of pelvic organ prolapse is unclear. this study aims to reduce timing for removing urinary catheter after vaginal surgery, not increase urinary retention and re-catheterization and reduce urinary tract infection and day of hospital stay.

Eligibility criteria:
inclusion criteria: * woman with pelvic organ prolapse, who undergoing vaginal surgery and agrees to participate in this study * able to understand and communicate thai language exclusion criteria: * woman with diabetes mellitus with hba1c \> 10.9% * woman with stroke * woman with urinary tract infection before surgery * woman with urinary retention before surgery * woman, who experienced surgery for urinary incontinence * woman, with operative complication including of hemorrhagic shock (blood pressure \ 120 beats per minute, intra-operative blood loss \> or = 750 ml), urinary tract injury, bowel injury

Keywords: urinary retention pelvic organ prolapse vaginal surgery urinary catheter
hcv/hiv coinfection: antiviral therapy and fibrosis

Conditions: HIV Infection; Hepatitis C

Summary: the chief purpose of this research is to understand how antiretroviral therapy (art) affects progression of liver disease in persons co-infected with hiv and hepatitis c virus (hcv). the investigators study liver disease progression in a cohort of dually infected persons according to the success of art.

enrolled subjects will complete questionnaires concerning health status, lifestyle, and alcohol/drug use. participants will undergo liver elastography every 6-12 months.

Eligibility criteria:
inclusion criteria: co-infected arm 1. subject must be an hiv/hcv co-infected adult with hiv infection diagnosed by antibody testing and chronic hcv infection diagnosed by reactive hcv antibody and detectable plasma hcv rna. 2. subject must receive medical care at the jhu hiv clinic or through the viral hepatitis center. 3. subjects previously enrolled in the study cohort, but not currently receiving care in the moore clinic, may continue in the study. 4. females of childbearing potential must be willing to undergo a urine or serum pregnancy test. 5. subject must be able to provide informed written consent. control arm 1. subject must have or be at risk of having medical conditions that increase the risk of liver disease. these include, but are not limited to, hiv mono-infection, hcv mono-infection, hepatitis b infection, alcohol addiction, and/or non-alcoholic steatohepatitis. 2. females of childbearing potential must be willing to undergo a urine or serum pregnancy test. 3. subject must be able to provide informed written consent. exclusion criteria: 1. to avoid risks associated with ionizing radiation, female subjects may not be pregnant or breast feeding at the time of dexa scanning. to avoid unknown risks to the fetus, female subjects may not be pregnant at the time of liver biopsy or fibroscan. 2. to avoid interference with the dexa scan, the subject may not have undergone a nuclear medicine exam with the past week and/or may not have undergone an x-ray procedure with contrast solution within the past 72 hours. 3. to avoid unknown risks, subjects with an implanted cardiac device such as a defibrillator or pacemaker may not undergo fibroscan.

Keywords: hiv human immunodeficiency virus acquired immune deficiency syndrome virus aids virus immunodeficiency virus, human virus, human immunodeficiency hepatitis c hepatitis c, chronic hepatitis c virus hepatitis c antibodies hepatitis c antigens
a smartphone intervention for wic mothers to improve nutrition and weight gain during pregnancy

Conditions: Weight Gain During Pregnancy

Summary: the study will test the effectiveness of a smartphone-based behavior modification program adapted for use in women, infants, and children program in a state-wide, randomized controlled trial in 432 low-income women enrolled in the louisiana women, infants, and children program.

the study is a multi-site randomized controlled trial, testing the effectiveness of the smartphone-based behavior modification program in pregnant women within the louisiana women, infants, and children program. equal number of participants will be randomized to either the intervention or the control. although the intervention itself lasts 24 weeks (only during pregnancy), women will be enrolled in this study for approximately 18 months, from the 10-16th week of pregnancy until 12 month postpartum follow-up. study outcomes will be assessed at three visits during pregnancy (early, mid, and late,) and three visits postpartum (1, 6, and 12 months).

Eligibility criteria:
inclusion criteria: * less than 16 weeks gestational age at screening visit * have a bmi of 18.5 to 40 kg/m2 * expecting a singleton pregnancy * certified to receive women, infants, and children services during current pregnancy * has smartphone with internet access * willing to be identifiable to other study participants in this study program exclusion criteria: * smoking * drug or alcohol use * non-pregnancy related illness * hypertension at screening visit * current mental health issue or eating disorder * inability to complete a behavioral run-in task * plans to move out of the state in the next 18 months
tesetaxel in chemotherapy-naive patients with progressive, castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.


Eligibility criteria:
key inclusion criteria: * at least 18 years of age * histologically confirmed prostate cancer, currently with progressive disease * evidence of metastatic disease * castrate level of testosterone (\< 50 ng/dl) * eastern cooperative oncology group performance status 0 or 1 * chemotherapy-naïve * adequate bone marrow, hepatic, and renal function * ability to swallow an oral solid-dosage form of medication key exclusion criteria: * history or presence of brain metastasis or leptomeningeal disease * operable cancer * uncontrolled diarrhea * uncontrolled nausea or vomiting * known malabsorptive disorder * currently active second malignancy other than non-melanoma skin cancers * human immunodeficiency virus (hiv) infection based on history of positive serology * significant medical disease other than cancer * presence of neuropathy \> grade 2 (national cancer institute common toxicity criteria \[nci ctc\]; v4.0) * need for other anticancer treatment * need to continue any regularly-taken medication that is a potent inhibitor or inducer of the cyp3a pathway or p-glycoprotein activity * less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the cyp3a pathway or p-glycoprotein activity * less than 4 weeks since use of another investigational agent

Keywords: castration-resistant prostate cancer tesetaxel taxanes chemotherapy-naive chemotherapy-exposed progressive, metastatic castration-resistant prostate cancer