Kornimate/medical-research-clean huggingface dataset:
using signos mhealth platform in adults for weight management

Conditions: Overweight and Obesity; Metabolic Syndrome; Weight Loss

Summary: metabolic syndrome and resulting downstream health effects remains a growing health concern. in published trials, the use of continuous glucose monitoring (cgm) assists behavioral changes efforts, leading to improved adherence and results from diet and exercise changes in individuals with obesity. mobile health (mhealth) platforms provide satisfactory, easy-to-use tools that help participants in the pursuit of weight change goals. the investigators hypothesize that the use of cgm data and targeted coaching and nutrition education will assist with weight optimization goals in the general (non-diabetic) population using the signos mhealth platform, with associated health benefits.

the scope of this study is to enroll participants into a study that utilizes a continuous glucose monitor (cgm) and mobile health application \[signos\] to optimize general wellness and body weight and composition. the signos users will be compared against a control arm.

Eligibility criteria:
inclusion criteria: to join our study, participant need to: * be at least 22 years old. * be overweight or obese, which we define as having a body mass index (bmi) between 25 and 40. * hba1c test result should be below 6.5% at the start of the study. * have and know how to use a smartphone that's compatible with the signos app. * be able to understand, speak, and read english well enough to participate fully in the study. exclusion criteria: participant can't join our study if participant has: * have type 1 or type 2 diabetes. * are already using a device to monitor glucose level. * have severe allergies to the sticky part of glucose monitors. * suffer from an eating disorder like anorexia or bulimia. * are currently taking certain medications for diabetes or weight loss. * have had or are planning to have weight loss surgery. * have major health issues like severe kidney disease, untreated thyroid problems, or skin conditions where the glucose monitor would be placed. * have been part of another clinical trial recently.
the role of 2-octyl cyanoacrylate in prevention of recurrent adhesions after circumcision

Conditions: Phimosis; Adhesions

Summary: the objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. the investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.

the objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. the investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive. secondary objective(s) to assess parent satisfaction and comfort level after circumcision with use of 2-octyl cyanoacrylate skin adhesive and compare to those undergoing circumcision without the use of 2-octyl cyanoacrylate skin adhesive.

Eligibility criteria:
inclusion criteria: * all patients undergoing circumcision * only male patients under the age of 7 years will be eligible exclusion criteria: * any patient over 7 years of age * previous circumcision * any parents who are not english language speaking

Keywords: circumcision 2 octyl cyanoacrylate phimosis
safety outcomes of lower immunosuppression versus traditional immunosuppression in heart transplant recipients

Conditions: Immunosuppression

Summary: this was a study to compare less intense immunosuppression with a more traditional approach. the hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.

this was a prospective, randomized, controlled (open-label) trial of 2 different strategies of immunosuppression in de novo post-heart transplant patients. the hypothesis was that immunosuppression with tacrolimus and mycophenolate mofetil, coupled with rapid steroid weaning would provide similar anti-rejection efficacy as tacrolimus with only a 2 week course of mycophenolate mofetil but including the same rapid steroid wean. the primary endpoint was the mean international society for heart and lung transplantation (ishlt) biopsy score over the first 6 months post-transplant. secondary endpoints included the incidence of adverse events over the first year post-transplant, as well as all-cause mortality, 12 month ishlt biopsy score (mean), along with the incidence of proven cytomegalovirus disease. in addition, the incidence of allograft vasculopathy as assessed by angiography or intravascular ultrasound was compared between groups.

Eligibility criteria:
inclusion criteria: * adult (at least 18 years old) * undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites * specifically included are patients on ventricular assist devices, and allosensitized recipients exclusion criteria: * age less than 18 * inability to provide proper informed consent * combined organ transplantation * re-transplantation

Keywords: immunosuppression steroid withdrawal rejection coronary disease cytomegalovirus infection
methamphetamine abuse treatment in patients with aids - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with aids.


Eligibility criteria:
please contact site for information.

Keywords: methamphetamine dependence
physical activity and sexuality after reduction mammaplasty

Conditions: Breast Hypertrophy

Summary: this prospective controlled trial was designed to determine whether breast reduction may influence physical activity and sexuality of breast hypertrophy women.

breast hypertrophy is a frequent condition among women; reduction mammaplasty is one of the most performed procedures in plastic surgery.previous studies have demonstrated that breast hypertrophy is associated to back pain, and patients often complain about physical limitations due to this condition, as well as sexual impairment. thus, this trial was designed to test the hypothesis that reduction mammaplasty may improve physical and sexual performance of breast hypertrophy patients,and patients'satisfaction with the results of the operation. three validated tools were used: the international physical activity questionnaire (ipaq), the female sexual quotient and the breast evaluation questionnaire.

Eligibility criteria:
inclusion criteria: * breast hypertrophy * candidate to reduction mammaplasty * body mass index under 30kg/m2 * women with sexual activity exclusion criteria: * pregnancy, delivery or breast feeding during the last 12 months * body mass index over 30kg/m2 * breast cancer history * previous breast surgery * smoking

Keywords: breast hypertrophy physical activity sexuality patient satisfaction
single and multiple ascending dose study of kn-002

Conditions: Asthma COPD

Summary: this is a phase 1, randomized, double-blinded, placebo controlled study. the study consists of 4 parts: part 1 is a single ascending dose (sad) study in healthy volunteers; part 2 is a multiple ascending dose (mad) study in subjects with stable, mild asthma; part 3 is a repeat dose in patients with moderate to severe asthma and part 4 is a repeat dose in patients with copd.


Eligibility criteria:
inclusion criteria: * male or female, 18 - 55 years old * willing and able to give informed consent and comply with the study * body mass index (bmi) 18 to 32 kg/m2 and weighs at least 50 kg * women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method * pre-bronchodilator fev1 ≥ 70 and ≥80% for part 1 and part 2 participants, respectively * pre-bronchodilator fev1 ≥50% predicted and ≤100% for part 3 * post bronchodilator fev1 ≥40 and ≤ 85% for part 4 exclusion criteria: * clinically significant laboratory test abnormalities * clinically significant abnormal blood pressure and/or pulse rate * resting ecg clinically significant abnormalities * respiratory tract infection within 6 weeks of screening * positive test for active covid-19 within 2 days prior to administration of imp
ct perfusion parameters predict vascular pattern in hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: distinct vascular patterns (ectc or non-ectc) of tumors plays an important role in tumor migration, metastasis and drug resistant in hepatocellular carcinoma (hcc). however, there is no non-invasive method to predict vascular pattern in clinical. in the present study, we prospectively assess ct perfusion parameters for evaluation of the vascular pattern in hcc.


Eligibility criteria:
inclusion criteria: 1. age over than 18 years old 2. tumor size of less than 5 cm 3. child-pugh a class liver function 4. an eastern cooperative oncology group performance status of 0 5. no previous treatment for hcc 6. pathological diagnosis of hepatocellular carcinoma 7. adequate organ function (white blood cell count ≥3.0 × 109/l, absolute neutrophil count ≥1.5 × 109/l, platelet count ≥75 × 109/l, aspartate transaminase and alanine transaminase≤5 × upper limit of the normal, creatinine clearance rate of ≤1.5 × upper limit of the normal, and left ventricular ejection ≥45%) exclusion criteria: 1. patients who received antitumor therapy before recurrence, including radiotherapy, transarterial chemoembolization, tyrosine kinase inhibitor, and immune checkpoint inhibitor 2. a known medical history of hiv infection 3. pregnancy or breastfeeding 4. portal vein tumor thrombosis or hepatic vein thrombosis detected by any routine imaging modality, including ultrasonography, dynamic contrast ct and mri 5. any evidence of tumor metastasis or prior recurrence 6. hepatic decompensation

Keywords: hepatocellular carcinoma ct perfusion parameters vascular pattern
aih risk stratification with multiparametric mri

Conditions: Autoimmune Hepatitis

Summary: the primary aim of this study is to investigate whether the baseline ct1 can predict those whose condition relapses following treatment withdrawal. the secondary aim is to investigate correlation of ct1 with histology to explore utility as a monitoring tool. a total of 97 patients with aih will be recruited and divided into 2 arms. 20 of which will be treatment naive and the other 77 will have been on treatment for the past 18-24 months and will be coming in for therapy cessation review.

patients with aih who have been undergoing immunosuppressive treatment for 18-24 months will be invited for a series of multiparametric mri (mpmri) scans to assess the utility of lms for monitoring characteristics of the disease. this will be a prospective, cross-sectional, observational study recruiting 97 participants (20 of which will be treatment naïve at recruitment) from those patients scheduled for a liver biopsy for therapy cessation review. they will be consented and invited for a livermultiscan. all patients whose treatment is ended based on histology results will be followed up over the subsequent 12 months, and those that experience a biochemical relapse or 'flare-up' will be invited for a second livermultiscan prior to their scheduled liver biopsy. all participants will attend their planned outpatient hepatology appointment with their doctor, who will document the intended treatment plan for each participant in line with their usual care pathway. their mri scan will then be scheduled for the same day as their outpatient appointment or within a 7-day window after their appointment with the consultant.

Eligibility criteria:
inclusion criteria: * patients undergoing management for aih being considered for treatment cessation * patients diagnosed with aih, are treatment naïve, and will be undergoing biopsy as per clinical pathway * diagnostic biopsy prior to cessation of treatment (where possible) * 18+ years of age. * ability to give informed consent exclusion criteria: * any contraindication to mri scanning * any clinically significant medical or psychiatric condition

Keywords: autoimmune hepatitis livermultiscan mri liver biopsy
a pilot randomized controlled trial for antibiotic exposure in neonatal sepsis using neutrophil cd64

Conditions: Neonatal Early-onset Sepsis; Neonatal Late-onset Sepsis

Summary: unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences including development of necrotizing enterocolitis (a serious, potentially life-threatening gastrointestinal illness in premature babies), late-onset infections, resistance to antibiotics, increased length of hospital stay, and death. starting and continuing antibiotic therapy for blood culture-negative infections in the neonatal intensive care unit (nicu) is fairly common with numbers of such patients varying from 20%-90% of infants undergoing a sepsis evaluation in the nicu. while blood culture results are the gold standard, there is usually a delay of up to 48-72h before the results are known. hence, initiation and continuation of antibiotic treatment are usually based on clinical evaluation and blood count criteria which do not possess high specificity or sensitivity, and may be unreliable in the first few hours after birth or in the early stages of infection. since the investigators found that neutrophil cd64 (a type of protein found on the surface of a type of white blood cell that can be detected quickly in a very small amount of blood sample) has high accuracy for early detection of blood culture-proven infections in newborn babies, with extremely high negative predictive value (can identify babies definitively with no infection), the investigators will use this test to decide whether to stop or continue antibiotics in the nicu. the investigators hypothesis is that neutrophil cd64 values can be safely used to discontinue antibiotics in newborns suspected of having infections. the investigators aims are to utilize sequential measurements of cd64 values to stop antibiotics early in neonates being investigated for both early and late-onset infections in the nicu. this is a prospective, randomized, controlled (rct) trial. the study population will be derived from the sub-set of all newborn infants who have undergone investigations for presence of infection in the nicu.


Eligibility criteria:
inclusion criteria: * infants undergoing a sepsis evaluation in the nicu exclusion criteria: * they have a major life-threatening congenital malformation * the attending neonatologist has objections to the infant participating in the study

Keywords: infant infection newborn antibiotics neutrophil cd64 blood culture
cognitive flexibility training for persistent pain: neuroimaging pilot (coflex-i)

Conditions: Chronic Pain; Knee Pain Chronic; Hip Pain Chronic; Back Pain

Summary: to determine whether a 5-week computer-based cognitive training intervention results in changes in resting-state functional connectivity (rsfc) within the brain networks.

this project is a single-center prospective pilot study to assess whether cognitive flexibility training through a lumosity®-based training module over the course a five week timeframe in patients with chronic hip, knee, and back pain results in detectable changes in resting-state functional connectivity (rsfc). the investigators will explore changes in rsfc particularly within the default mode (dmn), frontoparietal (fpn), and cingulo-opercular (con) brain networks.

Eligibility criteria:
inclusion criteria: * adults between 18 to 70 years old with chronic hip, knee or back pain for \>3 months * documented moderate to severe chronic pain * english fluency * access to a computer at home and an email account exclusion criteria: * lack of email/lack of basic computer skills * diagnosed alzheimer's or documented severe cognitive impairment * severely impaired vision or color blindness * unable to complete cognitive testing * an interventional pain procedure within one week prior to enrollment testing * scheduled to undergo a pain procedure during the five weeks of cognitive training * self-reported claustrophobia * contraindication to an mri scan (i.e. presence of metallic foreign body such as an artificial joint or aneurism clip, implanted pacemaker or spinal cord stimulator)
collect of cord blood from subjects at risk for sickle cell disease, for the purpose of laboratory research

Conditions: Sickle Cell Disease

Summary: the study consists in collecting umbilical cord blood cells from newborns at risk of sickle cell disease, to perform laboratory experiments aiming to characterize the cells with hbs/hbs mutation, to develop methods to prepare, to gene-modify and to preserve these cells.

pregnant individuals carrying at least one hbs allele will be included in the study to collect the umbilical cord blood of the child at birth. collected cells will be used anonymously for genetic and bioexperimental laboratory research, aiming to develop autologous gene therapy for sickle cell disease.

Eligibility criteria:
inclusion criteria: * pregnant women, giving birth at chsf and consenting to the collect and study of placental blood after delivery * age 18 to 45 years * biological testing of the participant includes hemoglobin electrophoresis and shows at least one hbs allele exclusion criteria: * lack of written consent * minors (not 18 years old) or under guardianship * diseases : hiv, hepatitis b, hepatitis c or htlv (human t leukemia virus).
to assess the level of adherence of subjects receiving saizen® via easypod™ in spain

Conditions: Growth Disorders

Summary: this is a spanish, multicentre, observational study to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter, longitudinal observational study. parents/subjects will provide their informed consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: - to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to identify adherence subject profiling * to asses the impact of adherence on insulin-like growth factor 1 (igf1) (i.e. above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to summary of product characteristics (smpc) * over the age of \>2 years * under \<18 years of age, or over 18 without fusion of growth plates * parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough (16 years old) to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country. exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the smpc * use of an investigational drug or participation in another interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
open label optimization study

Conditions: Major Depressive Disorder

Summary: the goal of this observational study is to demonstrate effectiveness in the treatment of major depressive disorder the primary objective is to assess the effectiveness in the treatment of major depressive disorder using the cgi-i at the end of the treatment participants will receive 10 treatments per day for 5 days (m-f) of saint®

this is a prospective, multi-center, open-label study. up to 1000 adult subjects, in a major depressive episode, who have failed to receive satisfactory improvement from a prior antidepressant medication in the current episode, are eligible to participate in this study if they are deemed to be appropriate candidates for tms. overall study duration is expected to be approximately 4 years. the study duration per subject is anticipated to be approximately 1 year. hypothesis: the saint® neuromodulation system will demonstrate effectiveness in the treatment of mdd as measured by cgi-i at the end of the treatment (cessation of stimulation).

Eligibility criteria:
inclusion criteria: 1. adult males or females, 18 and older, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. 2. confirmed primary clinical diagnosis of major depressive disorder (mdd) without psychotic features consistent with dsm-v criteria. 3. no medical conditions that would preclude the safe use of tms. 4. primary psychiatrist has determined tms to be an appropriate clinical option. 5. able to provide consent and comply with all study requirements. 6. negative pregnancy test at the intended time of saint™ 5-day acute course treatment and agreement to use effective birth control during saint® acute therapy. exclusion criteria: 1. have any contraindication to tms (section 2 user manual). 2. have any contraindication to receiving an mri 3. participants with an abnormal brain mri as determined by pi, study physician or designee. 4. deemed by the pi, study physician or designee to be a high risk of suicide or has made a suicide attempt within the last 6 months. 5. treatment dose with cortical depth adjustment is greater than 120% motor threshold and cannot be completed.

Keywords: major depressive disorder depression treatment resistant depression
stimulation of the anterior nucleus of the thalamus for epilepsy - recruitment stimulation of the anterior nucleus of the thalamus for epilepsy - recruitment rhythm

Conditions: Epilepsy

Summary: the primary objective is to demonstrate that a higher proportion of responders to deep brain stimulation (dbs) in the anterior nucleus (an) of the thalamus in refractory epilepsy patients in the sante study exhibit a recruitment rhythm relative to non-responders.


Eligibility criteria:
inclusion criteria: * enrolled in the santé study, have been implanted with a complete dbs system, and is currently receiving stimulation in the long-term follow-up phase (post month 13) of the study * patient or legal representative is able to understand and provide signed consent for participating in the study * willing and available to attend the visit as scheduled and to comply with the study protocol exclusion criteria: * patients unable to tolerate stimulation turned off during the testing period * are pregnant or suspected of being pregnant

Keywords: epilepsy recruitment rhythm dbs