Kornimate/medical-research-clean huggingface dataset:
forced-dose titration of spd489 in adults with binge eating disorder

Conditions: Binge Eating Disorder

Summary: to evaluate the efficacy of spd489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week


Eligibility criteria:
inclusion * subject meets the following diagnostic and statistical manual of mental disorders fourth edition - text revision (dsm-iv-tr) criteria for a diagnosis of binge eating disorder (bed). * binge eating disorder is of at least moderate severity in which subjects report at least 3 binge eating days per week. * subject has a body mass index (bmi) of \>24 and \<46. exclusion * subject has concurrent symptoms of bulimia nervosa or anorexia nervosa. * subject is considered a suicide risk or risk to harm others.
correlation between sacral angle and lumbar range of motion in women with genu valgum

Conditions: Genu Valgum

Summary: many patients with genu valgum present with postural changes, such as: internal rotation of the tibial and femoral axes, anteversion of the iliac bones, increased lumbar lordosis, thoracic hyperkyphosis and cervical hyperlordosis. such pathomechanical changes may interfere with lumbar range of motion. investigators of this study try to answer the following question: is there a relationship between sacral angle and lumbar range of motion in women with bilateral genu valgum. the results of this study will help professionals to plan a proper treatment program for patients with genu valgum.

sixty four female participants were under the following procedures: * screening for genu valgum via postural assessment from frontal view, then measuring the q angle bilaterally. * patients with q-angle \>20 degress were under the following procedures: a. full-length ap standing x-ray,then the investigators measured the hip-knee angle (the angle between the mechanical axis of the femur and the tibia). it will be obtained by connecting the center of the femoral head to the midpoint of the tibial eminential spine in a line tangential to the femoral condyles, and another line from here to the centre of the trochlea tali. b-lumbo-sacral x-ray lateral view was done at the time and the sacral angle was the measured by ferguson´s technique in degrees using a protractor and this was the sacral angle. c- during the same session, trunk range of motion was measured by modified schober test d- collected data were taken for statistical analysis.

Eligibility criteria:
inclusion criteria: 1. female with bilateral genu valgum (q angle\> 20 degrees. 2. age ranges from 18-25 years old. 3. bmi ≥ 30 (kg/m2) exclusion criteria: 1. previous lumbar surgery 2. lumbar spine fracture 3. spondylolisthesis 4. foraminal or extra foraminal lumbar disc herniation 5. spinal tumors, and bone metabolic diseases 6 - knee surgeries
the effect of restrictive fluid and vasopressin during surgery of burn patients

Conditions: Burn Surgery

Summary: this is a randomized double-blinded study to investigate in which the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loos during burn surgery.

this is a randomized double-blinded study to investigate the effect of fluid restriction and vasopressin on blood loss during surgery of the burn patients. the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loss during the surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * burn patients undergoing surgery (tbsa \> 20%) exclusion criteria: * age \< 18 years old * history of renal disorder * history of cardiac disorder
health-related quality of life and fatigue in adult patients with primary immune thrombocytopenic purpura (pitp)

Conditions: Immune Thrombocytopenic Purpura

Summary: symptoms of primary immune thrombocytopenic purpura (pitp), such as spontaneous bruising, menorrhagia, mucosal bleeding and other symptoms might significantly affect the hrqol of pitp patients. however, very little evidence exists on hrqol outcomes in patients diagnosed with pitp. the investigators project will aim at providing scientific community solid evidence based data on the extent to which hrqol is compromised and in which specific area. the purpose of this study is thus to compare generic health-related quality of life (hrqol) profiles of adult patients with primary immune thrombocytopenic purpura (pitp) with that of a matched italian population control group.

objectives: the primary objective is to compare hrqol of patients with pitp with that of a matched italian population control group. secondary objectives include evaluation of: * patient-reported fatigue amongst the three different pitp groups. * social support and psychological wellbeing as a possible determinant of hrqol. * possible association between socio-demographic (e.g., age, living arrangements, education and employment status) and clinical variables (e.g., time from diagnosis, and current treatment if any) with patient reported health outcomes (e.g., hrqol, fatigue, and social support). * to assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics and to compare patient's stated preferences for involvement in treatment decision with the perceptions of their treating physicians (only for newly diagnosed pitp).

Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of pitp in any phase of the disease; * patients aged at least 18 years; * informed consent provided exclusion criteria: * participating in other hrqol investigations that might interfere with this study * having any psychiatric condition or major cognitive impairment hampering self-reported hrqol evaluation.

Keywords: health-related quality of life fatigue pito primary immune thrombocytopenic purpura
absorption and systematic pharmacokinetics of idp-123 lotion in comparison with tazorac cream

Conditions: Acne

Summary: the absorption and systematic pharmacokinetics of idp-123 lotion in comparison with tazorac cream.

randomized study evaluating the absorption and systematic pharmacokinetics of idp-123 lotion in comparison with tazorac cream in subjects with moderate to severe acne vulgaris under maximal use conditions.

Eligibility criteria:
key inclusion criteria: * male or female, at least 9 years of age (at least 12 years of age for tazorac cream). * verbal and written informed consent must be obtained. subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if the subject reaches age of consent during the study they should be re-consented at the next study visit). * subject must have a score of 3 (moderate) or 4 (severe) on the evaluator's global severity assessment at the screening and baseline visit. * subjects with facial acne inflammatory lesion count no less than 20 but no more than 40. * subjects with facial acne non-inflammatory lesions count no less than 20 but no more than 100. key exclusion criteria: * use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study. * any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema. * any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. * subjects with a facial beard or mustache that could interfere with the study assessments. * subjects with more than 2 facial nodules.
study to evaluate efficacy & safety of tralokinumab in subjects with asthma inadequately controlled on corticosteroids

Conditions: Asthma

Summary: a multicentre, randomized, double-blind, parallel group, placebo controlled, 12-week, phase 2 study to evaluate the effect of tralokinumab on airway inflammation in adults with asthma inadequately controlled on inhaled corticosteroid.

this is a multicentre, randomized, double-blind, parallel group, placebo-controlled, phase 2 study to designed evaluate the effect of a 300 mg dose of tralokinumab administered subcutaneously every 2 weeks on airway inflammation in adults with asthma inadequately controlled on inhaled corticosteroids (ics) with or without other controllers. approximately 80 subjects will be randomized. subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 12 week treatment period.

Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years 2. documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1) 3. documented treatment with an asthma controller regimen requiring treatment with ics (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1) 4. additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1. 5. at enrolment (v1) the subject must have a predicted normal value (pnv) for the pre-bronchodilator (bd) fev1\>50% and more than 1l. 6. post-bd reversibility in fev1 of ≥12% and ≥200 ml at enrolment (v1). exclusion criteria: 1. history of interstitial lung disease, chronic obstructive pulmonary disease (copd), or other clinically significant lung disease other than asthma. 2. history of anaphylaxis following any biologic therapy. 3. hepatitis b, c or hiv 4. pregnant or breastfeeding 5. history of cancer 6. current tobacco smoking or a history of tobacco smoking for \>10 pack-years. 7. previous receipt of tralokinumab

Keywords: asthma reactive airways respiratory tract disease obstructive tract disease lung diseases
efficacy of urinary follicle-stimulating hormone (fsh) among poor responders

Conditions: Infertility

Summary: we proposed to compare outcomes in women with dor undergoing art with rec-fsh + u-hmh with those with u-fsh only in gnrh antagonist protocols.


Eligibility criteria:
inclusion criteria: * at least one trial with adequate ovarian stimulation resulted by 4 or less oocytes retrieval. exclusion criteria: * high responder patients

Keywords: art poor responder gnrh antagonist gonadotropins
the 3dknee™ system: a post-market study

Conditions: Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis; Varus Deformity; Avascular Necrosis

Summary: the purpose of this study is to evaluate the survivorship and efficacy of the encore 3dknee™ system in a group of patients who will receive the 3dknee™ as a primary (first) orthopedic implant in the knee. each knee will be designated as a separate subject and followed for a period of 2 years.


Eligibility criteria:
inclusion criteria: * this must be a primary knee replacement on this knee. * have knee joint disease related to one or more of the following * degenerative joint disease, including osteoarthritis or traumatic arthritis * avascular necrosis of the femoral condyles * post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy * moderate valgus, varus, or flexion deformities * rheumatoid arthritis * patient is likely to be available for evaluation for the duration of the study * able and willing to sign the informed consent and follow study procedures * patient is not pregnant * patient must be over 18 years of age exclusion criteria: * if there has been a total knee replacement on this knee in the past (no revisions allowed in study) * infection, or history of infection, acute or chronic, local or systemic * alcoholism or other addictions * muscular, neurological or vascular deficiencies which compromise the affected extremity * obesity * insufficient bone quality * loss of ligamentous structures * high levels of physical activity * materials sensitivity * prisoner * mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements * patient is pregnant * is younger than 18 years of age
training in exercise activities and motion for growth (team 4 growth) rct

Conditions: Congenital Heart Disease

Summary: this is a phase iii randomized controlled trial of a passive rom exercise program that will be performed in infants with hlhs and other single right ventricle anomalies following the norwood procedure at phn and auxiliary centers.

growth is often impaired in infants with congenital heart disease (chd). nutritional interventions, drug therapy and surgical palliation have had varying degrees of success in enhancing growth. passive rom has improved somatic growth in preterm infants and has been demonstrated in a previous pediatric heart network (phn) to be safe and feasible in neonate's post-norwood procedure. improved growth may also favorably impact neurodevelopment, behavioral state, and time to hospital discharge. this study's objectives are to evaluate growth in infants with hypoplastic left heart syndrome (hlhs) or other single right ventricle (rv) anomalies after the norwood procedure who are randomized to a passive range of motion (rom) exercise program vs. standard of care.

Eligibility criteria:
inclusion criteria: * hospitalized infants with hlhs or other single rv anomalies * \>=37 weeks gestation * \<=35 days of age * planned norwood procedure (or hybrid leading to norwood within 35 days) * parent or guardian willing to comply with protocol and provide written informed consent exclusion criteria: * birthweight \<3rd percentile for gestational age * chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example trisomy, noonan, or turner syndromes) * non-cardiac diagnosis associated with growth failures * listed for cardiac transplant * anticipated discharge within 14 days of screening

Keywords: norwood hypoplastic left heart syndrome single right ventricle passive range-of-motion
laparoscopic vs. open prostatectomy outcomes

Conditions: Prostate Cancer Surgery

Summary: this study is aimed at discovering the differences in outcomes, regarding quality of life issues(continence, impotence) of patients who have had either laparoscopic or open surgical technique for prostate cancer.

this study is a post surgical, data collection effort in order to gather definitive, quality of life(continence, impotence) information regarding the outcomes of patients who have undergone either laparoscopic vs. prostatectomy surgeries for prostate cancer. as part of the study, 200 subject's medical records will be retrospectively reviewed and 100 current subjects will be prospectively contacted. the information collected may benefit patients who undergo a prostatectomy

Eligibility criteria:
inclusion criteria: * subjects who have undergone a prostatectomy exclusion criteria: * none

Keywords: prostate cancer surgery laparoscopic surgery for prostate cancer prostatectomy urologic surgical procedures
telehealth for pain and unhealthy drinking among plwh

Conditions: HIV; Chronic Pain; Unhealthy Alcohol Use

Summary: this randomized controlled trial is a between-groups design to compare the motivational and cognitive behavioral management for alcohol and pain (mcbmap) intervention to a brief advice and information control condition. two-hundred and fifty participants who have hiv with moderate or greater chronic pain will be randomized for the trial. recruitment will take place through digital media. a unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. consent and baseline assessment will be completed remotely. following baseline assessment, participants will complete two weeks of ecological momentary assessment (ema) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. participants will complete outcome assessment measures at 3- and 6-months post-baseline. following the 3-month outcome assessment, participants will complete another two weeks of ema.


Eligibility criteria:
inclusion criteria: * able to confirm hiv diagnosis, via visual evidence of antiretroviral (art) medication bottle or medical record presented to study staff over zoom. * engaged in unhealthy drinking, defined as: * \>7 drinks for women / \> 14 drinks for men per week. * or ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month. * experiencing moderate or greater chronic pain (4 or greater on the numerical pain rating scale) for at least 3 months. * own a smart phone. * lives in the usa. * has a us mailing address. exclusion criteria: * history of bipolar, schizoaffective disorder or schizophrenia per self report. * unstable dose of psychoactive medication for pain or alcohol/substance use \[i.e., if on medication, participant has not been on same dose for least 2 months\] * history of withdrawal-related seizures or delirium tremens * current non-pharmacological treatment for alcohol use disorder or chronic pain * acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months. * current cancer-related pain * unable to provide one or more individuals for follow-up contact * individual who is unwilling to provide their sex at birth * limited or non-readers

Keywords: pain management telehealth unhealthy drinking ecological momentary assessment
the effects of oxiris in cardiogenic shock requiring va-ecmo

Conditions: Cardiogenic Shock

Summary: cardiogenic shock (cs) defines a state of systemic hypo-perfusion leading to end-organ dysfunction related to cardiac pump failure and with mortality rates in the range of 27-50% according to recent reviews. patients with cs often received mechanical circulatory support, and venoarterial extracorporeal membrane oxygenator (v-a ecmo) is an effective tool to support refractory cs while ensuring continuous organ perfusion. patients with cs present clinical signs of systemic inflammation and elevated plasma levels of prototypical inflammatory and vasoactive mediators, including c-reactive protein (crp), interleukin-6 (il-6) and tumor necrosis factor alpha (tnfα). as data is scarce in this field, we decided to perform a prospective randomized controlled pilot study to investigate the efficacy of extracorporeal cytokine and lipopolysaccharide adsorption using oxiris on humoral inflammation parameters, hemodynamics, and clinical outcomes in patients with cs requiring va ecmo.


Eligibility criteria:
inclusion criteria: 1. patients with more than 18 years old 2. cs is defined as the presence of the following: 2-1) systolic blood pressure is less than 90 mmhg for more than 30 minutes despite the fluid therapy, or the use of pressure boosting agents to maintain the systolic blood pressure more than 90 mmhg. 2-2) peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema. 2-3) causes of cs include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during percutaneous coronary intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism. 3. patients receiving va ecmo owing related to the causes listed in 2-1, 2-2, 2-3. 4. written informed consent from patient or legal surrogates exclusion criteria: 1. other causes except for cs: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure. 2. shock with unwitnessed cardiac arrest outside the hospital 3. severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure) 4. suspicious of brain death 5. those who refused active treatment 6. body weight under 30 kg 7. heparin allergy 8. pregnancy

Keywords: cardiogenic shock venoarterial extracorporeal membrane oxygenation endotoxin cytokine oxiris
offset of ticagrelor's effect on endothelial function as assessed with peripheral arterial tonometry (endopat assay)

Conditions: Coronary Artery Disease; Endothelial Function

Summary: ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (cv) events when directly compared to clopidogrel in the plato trial, implicating possible pleiotropic actions for the drug. it has been shown that ticagrelor increases adenosine concentration, by interfering with its red blood cells' uptake and by inducing the release of atp which is then converted to adenosine. recent studies in healthy volunteers and patients with coronary artery disease (cad) have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration. ticagrelor administration, in comparison with other p2y12 inhibitors, may influence the endothelial function, as assessed by the peripheral arterial tonometry method (endopat 2000 system (itamar medical, caesarea, israel), which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation (fmd). this is a prospective, observational study, which will be conducted in patients with coronary artery disease subjected to percutaneous coronary intervention (pci) under ticagrelor maintenance dose (md) 90mg x 2, who are about to stop treatment, due to completion of 1 year antiplatelet therapy. eligible patients will be subjected to peripheral arterial tonometry at day 0 (immediately after receiving the last pill of ticagrelor) and at day 2 and day 5 post study drug discontinuation. peripheral blood sample will be taken from the patients at day 0 for genotype analysis.


Eligibility criteria:
inclusion criteria: 1. age above 18-80 years old 2. patients with coronary artery disease receiving ticagrelor maintenance dose (md) 90mg x 2 and are about to discontinue the treatment due to the completion of 1 year of dual antiplatelet therapy. 3. patients giving written informed consent. exclusion criteria: 1. acute coronary syndrome 2. foreseeable need for anticoagulant treatment within the next 5 days 3. severe non-regulated with theophylline/aminophylline administration chronic obstructive pulmonary disease 4. creatinine clearance \<30ml/min/1.73mm2 5. hba1c \> 10mg/dl

Keywords: ticagrelor endothelial function peripheral arterial tonometry