Kornimate/medical-research-clean huggingface dataset:
open-label, long-term safety study of lp352 in subjects with developmental and epileptic encephalopathy

Conditions: Developmental and Epileptic Encephalopathy; Dravet Syndrome; Lennox-Gastaut Syndrome

Summary: the objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of lp352 in subjects with developmental and epileptic encephalopathies who completed participation in study lp352-201.

this phase 2, multicenter, open-label, multiple-dose extension clinical study is designed to evaluate long-term safety of lp352 in subjects with developmental and epileptic encephalopathy who completed study lp352-201. the study consists of a screening period (day -1) and a 50-week open-label treatment period that includes a 15-day up-titration period (during which time subjects will titrate up to their highest tolerated doses) and an open-label maintenance period (48 weeks). the treatment period will be followed by a down-titration/taper period (up to 15 days) and follow-up period (14 days after completion of down-titration). the starting dose of up-titration will be 6 mg tid. the target final maintenance doses are 6 mg tid, 9 mg tid, and 12 mg tid after a 15-day up-titration period, if tolerated.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study lp352-201 2. diagnosis of dravet syndrome, lennox-gastaut syndrome, or other developmental and epileptic encephalopathy 3. the patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed exclusion criteria: 1. had an sae in study lp352-201 that was definitely, probably, or possibly related to exposure to study drug 2. current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure 3. has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject 4. current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior 5. currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss 6. positive test result on the drug screen, except tetrahydrocannabinol (thc) for patients taking prescribed cannabidiol

Keywords: cdkl5 deficiency disorder developmental and epileptic encephalopathy dravet syndrome epilepsy lennox-gastaut syndrome treatment resistant epilepsy tuberous sclerosis complex
impact of marking surgical incision on patient's abdomen

Conditions: Surgical Procedure

Summary: this is a study looking at patient's satisfaction with incision site and location after undergoing minimally invasive gynecologic surgery. (laparoscopy) the study group will have the anticipated incision marked with a washable marker on their abdomen. the control group will have preoperative counselling as usual. after surgery, will assess patient's satisfaction with the incision scar.

this study is a prospective, randomized controlled trial examining the impact of marking the patient abdomen at the time of the preoperative visit on patient's satisfaction with scar appearance and symptoms, and pain at the incision site after undergoing minimally invasive gynecologic surgery for benign conditions. we hypothesize that preoperative marking and instruction about incision expectations will improve patient's postoperative satisfaction with scar appearance and symptoms as well as decrease incision site pain compared to traditional preoperative counseling. patients that will undergo laparoscopic surgical intervention will be identified. the patient will be randomized into two groups: preoperative marking the abdomen versus conventional preoperative counseling. if the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit. if she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen. after completed the surgery, information regarding type of surgery, reason for the procedure, estimated blood loss, surgical length, complications, location and size of abdominal incisions made on the patient's abdomen will be collected. then at the 6 weeks post op visit, patient's satisfaction with the incision scar will be evaluated with a validated patient scar assessment questionnaire form and by one 5 point likert scale question used in previous studies. the pain at rest at the incision site will be evaluated by a visual analog pain scale (vas). patients will also be asked to evaluate their generalized pain using a modified mcgill present pain intensity scale.

Eligibility criteria:
inclusion criteria: 1. age 18 - 89 2. diagnosed with a benign surgical pathology 3. patient scheduled for elective minimally invasive gynecologic surgery exclusion criteria: 1. have a diagnosis of gynecologic cancer 2. history of prior laparoscopic surgery 3. emergency surgery 4. inability to provide informed consent 5. unable to follow up in the office for post operative visits 6. skin hypersensitivity or allergy to marker dye 7. positive pregnancy test

Keywords: surgical incision laparoscopy pain
assessing patient response to therapeutic exercise based on clinical prediction rule (cpr) for spinal manipulation

Conditions: Low Back Pain

Summary: the purpose of this study is to determine whether patients who meet the criteria of the clinical prediction rule for spinal manipulation may respond more favorably to repeated exercises according to a direction of preference (what makes the symptoms decrease). the investigators do not know which of these two commonly-used treatments (manipulation or specific exercise) is better to treat low back pain.

with the trends in health care focusing on treatment effectiveness, it is important for physical therapists to select the most appropriate intervention according to patient classification. physical therapy interventions for management of lbp include therapeutic exercises and spinal manipulation. the purpose of this study is to determine whether patients who fit the clinical prediction rule (cpr) for spinal manipulation may respond instead to exercise according to repeated lumbar movements in the direction of preference. the subjects for this study will be comprised of individuals referred for treatment of low back pain and data will be collected by physical therapists with certification in mdt who had experience treating patients through the use of spinal manipulation. patient functional questionnaires and impairment measures will be used to analyze the patient's perceived level of function and outcome. following the completion of an informed consent, subjects will undergo a physical therapy examination by a licensed physical therapist. patients will be included in the study if they meet the cpr for spinal manipulation as describe in earlier research 6,11. following the examination, all qualified subjects will be randomly assigned to either the (1) spinal manipulation group or (2) the mckenzie (mdt) group and will receive treatment in accordance with their assigned group. the assessment tools administered at the initial examination will be readministered for follow-up analysis.

Eligibility criteria:
inclusion criteria: * people who meet the clinical prediction rule for spinal manipulation exclusion criteria: * people receiving worker's compensation * those who have had spinal surgery

Keywords: mckenzie thrust manipulation clinical prediction rule
iparent2parent program for parents of children with juvenile idiopathic arthritis

Conditions: JIA

Summary: the iparent2parent program matches parents of children living with arthritis with a trained parent mentor who will provide parents of children newly diagnosed with arthritis: practical coping advice and social support through shared lived experiences. this study will compare two groups of parents: those who are in the iparent2parent program and those in the control group (no mentor).

parents/primary caregiver of children with jia are an often overlooked but essential member of their child's health care team. they are responsible for managing their child's treatment program, and act as advocates for their child to support positive adaptation to jia and to learn self-management skills for the disease. this is in the context of managing the financial, logistical, emotional, and social demands of parenting in general. within pediatric tertiary care centres, peer-support programs for parents of children with jia are often limited or difficult to access. the iparent2parent program aims to fill this gap in services by offering a program of trained parent peer mentors who can provide practical coping advice, foster adaptive problem solving, and provide social support via shared lived experience.

Eligibility criteria:
inclusion criteria: * english speaking caregiver of a child diagnosed with jia according to ilar criteria prior to their 18th birthday * access to computer capable of using free skype software exclusion criteria: * significant cognitive impairment or major co-morbid illness of parent that impeded ability to engage in program (e.g.; psychosis, active suicidal ideation, cognitive delays that would impact ability to participate and complete questionnaires.)
impact of promoting community initiated kangaroo mother care (kmc) for low birth weight infants

Conditions: Low-Birth-Weight

Summary: this study is being conducted to assess the impact of promoting community initiated kangaroo mother care (cikmc) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age. this large individually randomized controlled trial will enroll 10500 low birth weight babies. the secondary objectives are examining the impact of the intervention on exclusive breast feeding and growth at 1 and 3 months, infections and hospitalizations in the neonatal period and from 1 to 5 months of age, recognition of illnesses and early care seeking from appropriate sources, motor and mental development in a subsample. newborns weighing \>=1500 to \<=2250gm are being enrolled into the study within 3 days of birth. eligible babies are randomized to intervention or control arms. mothers in the intervention arm are supported for kmc and breastfeeding by study anm (auxiliary nurse midwife) and study asha (accredited social health activist) like workers . routine home visits are conducted in both intervention and control arms by government workers according to the existing government program. survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months. the data safety and monitoring committee (dsmc) conducted two interim analyses, first in september 2017 when about half of the infants had been enrolled, and second in june 2018, when almost three quarters of the enrolled babies had been followed till 28 days of age. following the second interim analysis, the dsmc concluded that a sufficient number of infants would be enrolled by the end to september 2018 to clearly answer the study question concerning the impact of cikmc on both neonatal and early infant mortality. the dsmc recommended that data collection be completed by the end of october 2018.


Eligibility criteria:
inclusion criteria: low birth weight babies (≥1500 to ≤2250 g) screened within 3 days and their mothers. * born at home * singleton or twins or triplets * infants born in hospital, discharged and kmc not initiated in the hospital exclusion criteria: * infant unable to feed * infant has breathing problem * infant is less active than normal * gross congenital malformations * mother does not intend to stay in the study area for the next 6 months

Keywords: kangaroo mother care in community mortality
efficacy and safety study of reslizumab to treat eosinophilic esophagitis in subjects aged 5 to 18 years

Conditions: Eosinophilic Esophagitis

Summary: this trial will study three doses of reslizumab versus placebo in children with eosinophilic esophagitis (ee). the objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety profile compared to placebo.


Eligibility criteria:
inclusion criteria: * written informed consent obtained * male or female patients aged 5 to 18 years at time of screening * of non-childbearing potential, of childbearing potential and willing to use specific barrier methods outlined in the protocol * confirmed active ee (at screening or within six weeks prior to baseline visit) as defined by esophageal mucosal eosinophils greater than or equal to 24 per high power field (hpf; 400x magnification) * within the week prior to dosing, patient has one of the following symptoms of moderate (or worse) severity: vomiting, regurgitation (acid taste or feeling material movement upward), abdominal, chest pain/heartburn (burning or pain behind the sternum), or difficulty swallowing * been on a therapeutic dose of proton pump inhibitors (ppis; with or without histamine h2 receptor antagonists)for at least four weeks without resolution of symptoms, or by negative ph probe (with or without having failed a course of ppis) exclusion criteria: * another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome \[hes\],churg strauss vasculitis, eosinophilic gastroenteritis \[eg\], or a parasitic infection) * history of abnormal gastric or duodenal biopsy or documented gastrointestinal \[gi\] disorders (e.g., celiac disease, crohn's disease or helicobacter pylori infection) * history of the following gi surgeries: fundoplication, gastric surgery or surgery for intestinal atresia * use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin e \[ige\] monoclinal antibody \[mab\], methotrexate, cyclosporin, interferon alpha \[α\], or anti tumor necrosis factor \[tnf\] mab) within six months prior to study entry * received attenuated live attenuated vaccines (e.g., measles, mumps, rubella \[mmr\], bacillus calmette-guerin \[bcg\], varicella, flumist or polio) within three months prior to study entry * use of swallowed inhaled corticosteroids for the treatment of ee within one month prior to study entry. note: inhaled and nasal corticosteroids for the treatment of asthma and allergies, respectively, are permitted provided that the dose remains the same during the study * a stricture on endoscopy that prevents passage of the endoscope * participation in any investigational drug or device study within 30 days prior to study entry * female subjects who are pregnant or nursing * concurrent infection or disease that may preclude assessment of ee * concurrent immunodeficiency (human immunodeficiency \[hiv\], or acquired immunodeficiency syndrome \[aids\] or congenital immunodeficiency)

Keywords: eosinophilic esophagitis gerd ee reslizumab il-5 interleukin-5 cinquil
bromhexine and spironolactone for coronаvirus infection requiring hospitalization

Conditions: COVID 19

Summary: patients with mild and severe covid 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. patients will get investigated therapy for ten days. change in clinical assessment score covid 19 (cas covid 19) between baseline and 12th day will be evaluated as a primary endpoint. forty-five-day risk of death or mechanical ventilation will also be assessed.


Eligibility criteria:
inclusion criteria: signed inform consent covid 19 with the mild and severe course. the diagnosis could be made with positive polymerase chain reaction (pcr) (international statistical classification (icd-10) code - u07.1) and/or virus pneumonia in computer tomography (icd 10 code - u07.2) 5. lung exposure on ct more than 25% 6. sp02 without supportive oxygen ≤ 93% 7. c-reactive protein \> 60 mg/l or elevation of c reactive protein 3 times in 8-14 days after first symptoms exclusion criteria: * pregnancy and breastfeeding * hypersensitivity to spironolactone * hypersensitivity to bromhexine * known liver failure * glomerular filtration rate \<20 ml/ min * physician judgment that the patient will need mechanical ventilation in 24 hours * other indications for spironolactone * active cancer

Keywords: covid 19 bromhexine spironolactone
socially assistive robots to enhance magnification device use for reading

Conditions: Low Vision

Summary: the aims of this exploratory research project are to customize, deploy and evaluate the preliminary efficacy of a socially assistive robot as a novel approach to motivate and encourage optimal, long-term use of new magnification devices for reading in individuals with vision loss. the goals are to promote patient acceptance, adherence and skills reinforcement to achieve proficiency in the use of the magnifier, in order to attempt to reduce visual disability while performing important daily activities, such as reading tasks. this is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, all of which motivate the development of this complementary approach for the provision of additional support at home by the socially assistive robot.


Eligibility criteria:
inclusion criteria: * individuals with any level of vision loss due to any ocular disease, * age 18 and older, * received a magnification device(s) (i.e., hand-held optical magnifiers, portable electronic video magnifiers, some stand magnifiers and cctvs) from the ucla vision rehabilitation center. exclusion criteria: * schedules not permitting participation in planned study sessions or visits (including planning to move or take extended vacation during study period), * inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment as per tics), * substance abuse, * significant hearing loss (unable to hear communication by phone or from robot), * significant medical condition likely to limit participation or lifespan, * their magnifier device has features that would not work in conjunction with the beacon sensors: (1) hands-free and do not have a place where the patient's hand is holding the device during use (therefore, they would not register a significant change in temperature), and/or (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device.

Keywords: robot
strategies to increase adherence to physical activity in a phase iii cardiac rehabilitation program

Conditions: Ischaemic Heart Diseases

Summary: this study consists of a randomised clinical trial of two parallel groups conducted in patients with ischaemic heart disease after completing phase ii of cardiac rehabilitation (rhbc) at the centro de especialidades mislata (cem),hospital manises. the objective is to assess adherence to structured and unstructured physical activity in the long term (6 and 12 months). in addition to the usual recommendations in the control group (cg), a motivational programme will be added to the intervention group (ig), which will consist of establishing an individualised exercise plan reviewed monthly, in addition to maintaining continuous contact with the physiotherapist.

regular physical activity is an important measure in the prevention of cardiovascular diseases. in the phase ii cardiac rehabilitation programme, the acquisition of healthy lifestyle habits is taught and encouraged, with physical exercise as a fundamental pillar of the programme. physical exercise should be maintained throughout life (rhbc phase iii) in order to continue to produce cardiovascular benefits. however, few studies focus on strategies to increase adherence to physical activity, despite its benefits in disease control. motivation is one of the main barriers described by patients as well as the lack of contact with healthcare staff once the acute disease process is over. therefore, we propose a simple, practical and economical intervention to increase adherence to physical activity, through a motivational programme, based on the establishment of objectives for each patient, carrying out an individualised physical exercise programme according to their preferences and needs, also establishing continuous contact with the physiotherapist to review and establish new objectives.

Eligibility criteria:
inclusion criteria: * patients with ischaemic heart disease who have completed phase ii of cardiac rehabilitation in cem. * patients of both sexes. * patients classified as low, medium and high risk * age between 18 and 70 years at the time of the cardiac event. exclusion criteria: * older 70 years old
pre-emptive us guided superior hypogastric plexus block in pelvic cancer surgeries : a randomized double-blinded study

Conditions: Analgesia

Summary: the superior hypogastric plexus (shp) is a retroperitoneal structure with a predominance of afferent sympathetic nerve fibers. the perception of central pelvic pain is thought mainly to involve transmission through this plexus. therefore, blocking or of shp has been used to treat pelvic pain.

ultrasound guided superior hypogastric plexus block there is 2 equal groups: group s (shpb group 18 patients) ultrasound guided shpb is done after induction of balanced general anesthesia (fentanyl, propofol and rocuronium) using 20 ml bupivacaine 0.5% before skin incision, group c (control group 18 patients) in which same technique will be done but using normal saline 0.9% instead of bupivacaine. patients of both groups will receive patient controlled analgesia using morphine with continous background infusion of morphine 1.5 mg/h with adding granisterone 2mg/60 ml and ability to give bolus of 0.5 mg morphine on demand. • dosing and administration; group s (shpb group 18 ultrasound guided shpb ) using 20 ml bupivacaine 0.5% before skin incision. group c (control group 18 patients) in which same technique will be done but using normal saline 0.9%

Eligibility criteria:
inclusion criteria: * asa ii,iii. * patients undergoing pelvic surgeries. exclusion criteria: * patients refusal, * coagulopathy, * infection.
study evaluating combination of levonorgestrel (lng) and ethinyl estradiol (ee) in premenstrual dysphoric disorder

Conditions: Menstruation Disturbances; Premenstrual Syndrome

Summary: the purpose of this study is to determine whether levonorgestrel (lng)/ethinyl estradiol (ee) is effective in treating the symptoms of severe premenstrual syndrome (pms).


Eligibility criteria:
inclusion criteria: * generally healthy, women aged 18 to 49 years. * history of severe pms symptoms over the last year, as determined by the investigator. * regular 21 to 35 day menstrual cycle for 2 months prior to first study visit. exclusion criteria: * major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years. * contraindication to combination oral contraceptives. * use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study. other exclusions apply.

Keywords: premenstrual syndrome (pms) hormone therapy