Kornimate/medical-research-clean huggingface dataset:
family-based outcome results

Conditions: Obesity

Summary: many obesity related risk factors are strikingly apparent in minority populations. mexican-american children have the highest rates of overweight. the goals of this study are to: 1) test the acceptability of a 14-week family-based intervention with 3-5 year old children and their parents; 2) estimate the effectiveness of a 14-week family-based intervention designed to show smaller changes, on average, in bmi appropriate for growth; 3) estimate the effectiveness of a 14-week family-based intervention designed to produce changes in television viewing, physical activity, fat, fiber, and fruit and vegetable intake in 3-5 year old latino children and their parents at post-intervention and year 1 follow-up.


Eligibility criteria:
inclusion criteria: * have received an annual physical * parent or guardian willing to give consent * parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child exclusion criteria: * requires a specialized diet outside of that served by the chicago public schools * has a chronic physical or behavioral disorder that requyires participant to be under close emdical psychologicagl supervision and routinely absent from the study

Keywords: childhood obesity minorities diet physical activity parents
a pilot clinical study of the efficacy and safety of a disposable intravaginal device for stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: this pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (sui).


Eligibility criteria:
inclusion criteria: * have a ≥ 3 month history of experiencing stress urinary incontinence * be willing to use the pessary investigational device to control stress incontinence exclusion criteria: * pregnant, lactating or planning to become pregnant during the study * within 3 months post partum * intrauterine device (iud) placement of less than 6 months * a history of toxic shock syndrome (tss) or symptoms consistent with tss * experience difficulty inserting or wearing an intra-vaginal device, including a tampon * vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months * has any screening laboratory value outside the laboratory reference range considered clinically significant by the investigator * for any reason, the investigator decides that the subject should not participate in the study

Keywords: stress urinary incontinence sui
neurobehavioral moderators of post-traumatic disease trajectories

Conditions: PTSD; Trauma

Summary: the research goal is to uncover the neurocognitive moderators of ptsd trajectories, by documenting clinical symptoms, cognitive functioning, and brain structure and function, one-, six- and fourteen months following a traumatic event, in a large population of survivors at initial high risk for ptsd.


Eligibility criteria:
inclusion criteria: * age 18 - 65 years * able to read and comprehend hebrew * arrived in the er because of one of the following: car accidents, terrorist attacks, work accidents, home accidents, burns, physical assault, large-scale disaster. exclusion criteria: * individuals with known claustrophobia * individuals with history of substance abuse * individuals with current or past psychotic or bipolar i disorder * individuals with chronic ptsd at the time of the current trauma * individuals on psychotropic medication or recreational drugs in the week that precedes the mri * individuals with hearing problems * individuals with head trauma with coma exceeding 30 minutes * individuals which can't perform mri due to safety reasons (e.g. irremovable metals in their body)
efficacy and safety of hrs9531 tablet in obese subjects

Conditions: Chronic Management of Body Weight

Summary: to evaluate the efficacy of hrs9531 tablet compared with placebo in reducing body weight in obese subjects after 26 weeks of treatment.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent; 2. male or female subjects, 18-65 years of age at the time of signing informed consent; 3. at screening visit, 28.0 ≤bmi≤ 40.0 kg/m2; 4. diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months; 5. non-pregnant or lactating women. fertile male and female (including partners) agree to use highly effective contraceptive methods. exclusion criteria: 1. uncontrollable hypertension; 2. presence of - clinically significant lab or ecg results that may affect the evaluation of the efficacy or safety of the study drug at screening visit; 3. phq-9 score ≥15; 4. medical history or illness that affects body weight; 5. history of diabetes; 6. acute infection, acute trauma, or medium to large surgery within 1 month prior to screening; 7. history of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening; 8. any organ-system malignancies developed within 5 years; 9. confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness; 10. history of alcohol and/or substance abuse or drug abuse; 11. use of any medication or treatment that may have caused significant weight change within 3 months; 12. history of bariatric surgery; 13. known or suspected hypersensitivity to trial product(s) or related products; 14. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 15. surgery is planned during the trial; 16. mentally incapacitated or speech-impaired; 17. acute or chronic hepatitis; 18. the investigators determined that other conditions were inappropriate for participation in this clinical trial.
safety, tolerability, pharmacokinetics, and pharmacodynamics of nbi-74788 (crinecerfont) in pediatric participants with congenital adrenal hyperplasia

Conditions: CAH - Congenital Adrenal Hyperplasia

Summary: this is a phase 2, open-label, multiple-dose, study to assess the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of nbi-74788 (crinecerfont) in pediatric participants (14 to 17 years of age) with a documented medical diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (cah).


Eligibility criteria:
inclusion criteria: 1. be in good general health. 2. have a medically confirmed diagnosis of classic 21-hydroxylase deficiency cah. 3. be on a stable regimen of steroidal treatment for cah that is expected to remain stable throughout the study. 4. participants of childbearing potential must be instructed on the proper use of barrier methods of contraception and agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently from screening until the final study visit or a prespecified window after the last dose of study drug, whichever is longer. 5. participants of childbearing potential must have a negative pregnancy test at screening and negative urine pregnancy test at baseline. 6. have a negative urine drug (for illegal drugs) and alcohol breath test at screening and baseline. 7. be willing and able to adhere to the study regimen and study procedures described in the protocol and informed consent/assent form, including all requirements at the study center and return for the follow-up visit. exclusion criteria: 1. have a clinically significant unstable medical condition or chronic disease, or malignancy. 2. had a medically significant illness within 30 days of screening. 3. have a known or suspected differential diagnosis of any of the other known forms of classic cah. 4. have a history that includes bilateral adrenalectomy, hypopituitarism, or other condition requiring daily therapy with orally administered glucocorticoids. 5. are pregnant or lactating females. 6. have a history of epilepsy or serious head injury. 7. have a known history of long qt syndrome or cardiac tachy-arrhythmia. 8. have hypersensitivity to any corticotropin releasing hormone antagonists. 9. test positive at screening for hepatitis b, hepatitis c, or human immunodeficiency virus (hiv), or have a history of a positive result. 10. have a recent history of alcohol or drug abuse, or current evidence of substance dependence or abuse criteria. 11. used any anticoagulants or antiplatelet therapies within 30 days before screening. 12. have an active bleeding disorder. 13. used any other investigational drug within 30 days before initial screening, or plans to use an investigational drug (other than the study drug) during the study. 14. have a blood loss ≥250 ml or donated blood within 56 days or donated plasma within 7 days before baseline.
to assess immunogenicity, reactogenicity & safety of 2 formulations of gsk's hrv vaccine as 2-dose vaccination (infants)

Conditions: Infections, Rotavirus

Summary: this trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of gsk biologicals' hrv vaccine compared to the lyophilized formulation of gsk biologicals' hrv vaccine


Eligibility criteria:
inclusion criteria: * healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks. * written informed consent obtained from the parent or guardian of the subject. exclusion criteria: * se of any investigational or non-registered product (drug or vaccine) other than the hrv vaccine within 30 days preceding the first dose of hrv vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * planned administration/ administration of a vaccines not foreseen by the study protocol except for dtpw, hbv/hib and opv vaccines within 14 days before each dose of hrv vaccine and ending 14 days after. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * household contact with an immunosuppressed individual or pregnant women. * previous confirmed occurrence of rv ge.

Keywords: prophylaxis against gastroenteritis caused by rotavirus
prp in 2ry spontaneous pneumothorax

Conditions: Pneumothorax Spontaneous Secondary

Summary: secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive prp with different doses and schedules


Eligibility criteria:
inclusion criteria: * copd patients developed spontanous pneumothorax and was managed with intercostal tube insertion exclusion criteria: * refusal of participation
abundance of a natural odour in human cerebrospinal fluid after olfactory exposure

Conditions: Overweight and Obesity

Summary: the goal of this clinical trial is to investigate the abundance of a natural odour in human cerebrospinal fluid in obese and lean participants after inhalation thereof. participants will undergo blood sample collection and inhalation of either a natural odour or placebo through an inhaler in addition to a liquor puncture prescribed in standard of care context.


Eligibility criteria:
inclusion criteria obese participants: * age 18-60 years * written informed consent * scheduled for routine liquor puncture * bmi ≥ 30 kg/m2 * no proven diagnose of diabetes inclusion criteria lean participants: * age 18-60 years * written informed consent * scheduled for routine liquor puncture * bmi 18-25 kg/m2 exclusion criteria: * known allergy to the natural odour * acute upper respiratory tract infection, acute or chronic sinusitis * present or past surgical intervention of the nasal cavity, the paranasal sinus, the pituitary or the frontal brain * pregnancy/lactation * any kind of severe chronic disease (e.g. severe heart failure, active cancer disease, severe renal impairment with an estimated glomerular filtration rate \<30 ml/min/m2) * inability to understand the study procedure and to sign the study consent

Keywords: natural odour inhalation rct placebo controlled cerebrospinal fluid
study on the reapplication of chloraprep after lower extremity surgery and prior to dressing application

Conditions: Lower Extremity Surgery; Surgical Site Infection; Bacterial Colonization; Surgical Antiseptic

Summary: the purpose of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. decreasing the extent of bacterial colonization of the skin surrounding the surgical site during the initial healing phases would theoretically decrease the rate of infection in high-risk persons.


Eligibility criteria:
inclusion criteria: * male and female * adults (18+) * both elective and non-elective procedures * lower extremity surgery performed below the knee and requiring post-operative splint immobilization for 2-3 weeks * able to understand and read the english language * signed informed consent exclusion criteria: * pregnant (to be assessed the day of surgery per standard of care surgical protocol) * known allergies to chlorhexidine gluconate or isopropyl alcohol * multiple planned lower extremity surgeries * local skin disease * pre-existing or known infection at surgical site * open wounds or local abrasions * unable to or unwilling to follow through with study requirements

Keywords: infection chloraprep chlorhexidine lower extremity surgery antiseptic bacterial colonization
efficacy of prabotulinum and onabotulinum toxin-a for facial wrinkles

Conditions: Face; Skin Fold; Rejuvenation

Summary: the appearance of facial wrinkles, lines, or folds is a natural phenomenon during aging. different scales help classify wrinkles objectively, such as the facial wrinkle scale. others help classify patients' subjective perspectives, like the face-q questionnaire. the application of botulinum toxin is the most performed non-surgical aesthetic procedure in the world to treat facial expression lines. the present study aims to compare the efficacy of onabotulinum toxin-a (botox®) and prabotulinum toxin-a (nabota®) to treat expression lines in the upper third of the face, based on objective and subjective follow-up, using the fws scale and face-q questionnaire, respectively.

this is an experimental, comparative, longitudinal, open-label, prospective study at the instituto de oftalmología fundación conde de valenciana i.a.p, mexico city, mexico. the investigators used a proportion formula to calculate the sample size, with an alpha value of 0.05, and a precision of 3%. the difference in the effect between the two toxins is 20%, considering a 20% loss, with a total of 18 patients. a nonprobabilistic sampling of consecutive cases was performed. once patients were selected and included in the study, they were randomly assigned to a group. after inclusion, simple randomization was performed in the onabotulinum and prabotulinum groups. each group received intramuscular administration of onabotulinum toxin-a and prabotulinum toxin-a in the upper facial third. the investigators used descriptive statistics to analyze the demographic variables and employed the mann-whitney u test to assess differences in the quantitative and ordinal outcome variables between the groups before and at the end of the study. additionally, the investigators employed the chi-square test to compare the intergroup results before and at the end of the study for nominal variables. to compare intragroup results over time, the investigators conducted a repeated measures anova test for continuous variables, friedman test for ordinal variables, and cochran's q test for nominal variables. we used spss version 20 (chicago, il, usa) for analysis and considered a value of p\<0.05 as statistically significant.

Eligibility criteria:
inclusion criteria: * 25 and 40 years of age * diagnosis of expression lines in the upper facial third of any degree * wished to improve their aesthetic appearance exclusion criteria: * known allergy to milk protein or albumin * pregnancy and lactation * cardiovascular or neuromuscular disease * recent history of infections in the facial region * concomitant intake of aminoglycosides or cyclosporine a

Keywords: botulinum toxin onabotulinum prabotulinum upper third facial wrinkles botulinum toxin comparison aesthetic
3d phase sensitive inversion recuperation mri to detect and characterize multiple sclerosis spinal cord lesions

Conditions: Multiple Sclerosis

Summary: this study aims to assess the interest of 3d phase sensitive inversion recuperation (psir)sequence in the mri detection of spinal cord lesion. it will compare the sensitivity of this mri sequence compared to the t1 and t2 sequences recommended in the assessment of neuraxis inflammatory diseases.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patients scheduled for spinal cord mri exploration for the assessment of neuraxis inflammatory diseases exclusion criteria: * contraindication to mri * allergy to contrast media * patient under legal protection * no health insurance coverage * patient's refusal to participate in the study
headache inducing effect of levcromakalim in migraine with aura patients

Conditions: Headache; Migraine; Aura

Summary: to investigate the role of katp channels in migraine with aura patients.


Eligibility criteria:
inclusion criteria: * migraine with aura patients of both sexes. * 18-60 years. * 50-100 kg. exclusion criteria: * headache less than 48 hours before the tests start * daily consumption of drugs of any kind other than oral contraceptives * pregnant or nursing women. * cardiovascular disease of any kind, including cerebrovascular diseases.

Keywords: levcromakalim
comparison of prophylactic acyclovir and placebo in prevention of eczema herpeticum in pediatric burns

Conditions: Herpes Virus Infection

Summary: introduction: early detection is important in treating patients with eczema herpeticum (eh), which may arise in paediatric burn patients. as soon as a clinical diagnosis is confirmed, antiviral medications should be started to ensure an early resolution of the disease. several studies have indicated that acyclovir is the best treatment for eh lesions in the majority of individuals. objective: compare efficacy of the prophylactic acyclovir and placebo in preventing eczema herpeticum in paediatric burn patients

materials and methods study design: randomised control trial. setting: pediatric burn unit mayo hospital lahore duration: 1st october 2019 to 30th september 2020. data collection procedure: all the patients were managed with intravenous fluids, antibiotics, antipyretics and hydrocolloid dressing as per ward routine management protocol along with prophylactic acyclovir and placebo. on the zero day of admission, after parents provided informed consent, patients were randomly assigned to one of two groups using a computer-generated table. group a patients were given intra venous acyclovir divided into three doses for 7 to 14 days during their stay. group b patients were given 15% intravenous hypertonic sodium chloride divided into three doses as placebo for 7 to 14 days, so that parents could be blinded to group allocation. patients were observed for developing signs of eczema herpeticum and tzanck smear was done every 10th day and first follow up at outpatient department after 7days of discharge.

Eligibility criteria:
* age 1 month to ≤ 13 years .10 to 60 percent total body surface area (tbsa) burn. * 2nd and 3rd degree burn exclusion criteria * patients having previous history of skin disease. * patients having any comorbidity e.g. psoriasis, asthma, atopic dermatitis and conjunctivitis. * immunocompromised patients. * patients on steroids or chemotherapy. * patients already having eczema herpeticum and positive baseline tzanck smear

Keywords: eczema herpeticum pediatric burns acyclovir prophylaxis
phase 2 study of akcea-angptl3-lrx (isis 703802) in participants with familial chylomicronemia syndrome (fcs)

Conditions: Familial Chylomicronemia Syndrome; Lipoprotein Lipase Deficiency; Hyperlipoproteinemia Type 1

Summary: this is a single center, open-label study to evaluate the efficacy of akcea-angptl3-lrx for reduction of triglyceride (tg) levels in participants with fcs.


Eligibility criteria:
key inclusion criteria: * genetically confirmed chylomicronemia syndrome. * fasting triglycerides greater than or equal to (\>=) 750 milligrams per deciliter (mg/dl) \[8.4 millimoles per liter (mmol/l)\] at screening. key exclusion criteria: * diabetes mellitus if newly diagnosed or if glycated hemoglobin (hba1c) \>= 9.0%. * active pancreatitis within 2 weeks of screening. * acute coronary syndrome within 6 months of screening. * major surgery within 3 months of screening. * treatment with glybera therapy within 2 years of screening. * previous treatment with akcea-angptl3-lrx. * have any other conditions in the opinion of the investigator which could interfere with the patient participating in or completing the study.

Keywords: familial lipoprotein lipase deficiency hyperlipoproteinemias familial hyperlipoproteinemia type 1 hyperlipoproteinemia type i hyperchylomicronemia, familial lipoprotein lipase deficiency, familial hyperlipidemias dyslipidemias lipid metabolism disorders lipid metabolism, inborn errors metabolic diseases metabolism, inborn errors genetic diseases, inborn
diazepam trial in gad65 associated epilepsy

Conditions: GAD 65 Antibody-associated Epilepsy

Summary: the purpose of this study is to determine whether diazepam reduces the frequency of seizures in gad65 antibody associated epilepsy.

gad65 is an intracellular enzyme that plays a key role in the conversion of glutamate to gamma-aminobutyric acid (gaba), the primary inhibitory neurotransmitter in the cns. benzodiazepines augment the sensitivity of the gaba-a receptor to gaba, prolonging its inhibitory effect, perhaps enhancing the potential for neural inhibition in conditions in which gaba is depleted. gad65 antibodies have been identified in a subset of patients with drug resistant focal epilepsy and limbic encephalitis. while it has not been definitively determined that these antibodies cause gad65 inhibition and gaba depletion directly, diazepam, a common benzodiazepine, has been established as a mainstay of therapy for stiffperson's syndrome, a condition that is commonly associated with gad65 antibody positivity. given these observations, diazepam has been used by the investigators in a small number of patients with intractable epilepsy in the setting of gad65 antibody positivity, with some encouraging anecdotal results with one patient being rendered seizure free for three years. the purpose of this study is to generate prospective data on use of diazepam in patients with epilepsy related to high-titer gad65 antibody positivity.

Eligibility criteria:
inclusion criteria: * high-titer serum gad65 positivity \> 20 nmol/l high-titer serum gad65 igg seropositivity titer \>20 nmol/l and/or csf gad65 seropositivity titer \> 0.02 nmol/l. * drug-resistant focal epilepsy, having failed 2 previous anti-seizure medications. * stable treatment for the 1 month prior to enrollment. * patients must be able to give informed consent or have an appropriate representative available to do. exclusion criteria: * alternative etiology for epilepsy. * already on another benzodiazepine. * on a regularly scheduled opiate. * co-existing antibodies associated with seizures. * pregnancy or breast feeding.