Kornimate/medical-research-clean huggingface dataset:
tolerance evaluation of a nighttime moisturizing balm on babies and adults with eczema

Conditions: Atopic Dermatitis (AD)

Summary: the purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

at least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed subjects. the tolerability of this formulation will be monitored in a small group of ten adult subjects with mild to moderate eczema prior to testing in babies. in group a, adults will be asked to give their informed consent and an evaluation of inclusion/exclusion criteria will be performed at the site. after screening, all subjects will be asked not to use any skin treatments until the next clinic visit. subjects will use the investigational product as indicated at least twice per day on the face - cheeks only, arms, legs and torso for 14 days. for both adults and babies, only the baseline measurements are collected at 5-10 minutes after first application, but not at day 1, day 7 and day 14 visits. babies from 6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will follow a similar testing directions in group b of the study.

Eligibility criteria:
inclusion criteria: 1. male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years and above. 2. adult subjects only - male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partners use of a highly effective form of birth control for 3 months. 3. diagnosed as having eczema. 4. willing to stop the use of any non- assigned moisturizers and/or creams for the entire duration of the study. 5. willing to not introduce any new fragrances (e.g. cleansers, lotions, perfumes, etc.), or in the household environment (e.g. room fresheners, cleansing agents, laundry detergents, etc.) for the duration of the study. 6. willing to avoid excessive (more than 30 minutes) sun exposure without the use of their regular brand of sunscreen and protective clothing. 7. willing to not enter/use hot tub or whirlpool bath for the duration of the study. 8. willing to avoid the beach during the course of the study, and willing to document any activities at or in a swimming pool in the daily diary. exclusion criteria: 1. use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema. 2. adults females who are pregnant (self-reported) or breastfeeding. 3. participation in any clinical study within 30 days of visit 1. 4. atopic dermatitis requiring systemic, super-potent (class i) or potent (class ii or iii) topical corticosteroids. 5. requires greater than 2.0 mg/day inhaled or intranasal corticosteroids. 6. subjects who exhibit clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections. 7. subjects who are currently on phototherapy.

Keywords: eczema skin irritation
gastrostomy tube placed after gastropexy versus gastrostomy tube placed using the traditional push/pull techniques

Conditions: Gastrostomy, Methods

Summary: endoscopic placement of a percutaneous gastrostomy tube is a safe, efficient and well standardized technique. two variants of this maneuver - the pull and the push techniques - are widespread worldwide. more recently different techniques, that allow the direct insertion of a gastrostomy tube has been described. the common characteristic shared by all these technique is the fact that the gastrostomy tube is inserted directly into the stomach (without passing through the pharynx), after the gastric and abdominal wall have been securely fasten together (gastropexy). advantage of direct techniques are the followings: 1. the tube can placed also in the case of an oesophageal stenosis 2. studies suggest that the peristomal wound infection are less frequent using direct techniques 3. in some variants of these techniques, a balloon type gastrostomy tube or a button can be placed also in the case of first positioning. both the balloon type tube and the button are easy to be changed also at the bed-side. drawbacks of the direct techniques are: 1. these technique are easy, but a little more cumbersome than classic push or pull maneuvers 2. operators are often not familiar with direct insertion 3. kits suited for direct insertion are generally more costly than available kits for push or pull placement of gastrostomy tube. the kit manufactured by the kimberly-clark (mic introducer kit) allows direct insertion of a balloon type gastrostomy tube or of a button and it is interesting, because it makes simple to perform the gastropexy. the study aim is to confirm that the use of the kit introducer mic, may allow safe placement of a gastrostomy tube and may reduce the incidence of peristomal wound infection. furthermore if a balloon type gastrostomy tube or a button are positioned, they may be changed at the bed-side, without referral of the patient to the endoscopic unit or to an other sanitary facility.


Eligibility criteria:
inclusion criteria: * all consecutive patients, candidates to percutaneous endoscopic gastrostomy placement for any common clinical indication, in the centres participating to the study. exclusion criteria: * age \< 18 * age \> 85 years old * pregnancy * coagulation deficit or anti-coagulant oral therapy * total gastrectomy * absence of trans-illumination, verified during esophagogastroduodenoscopy * pharyngeal or esophageal stenosis, not allowing the passage of a standard scope; * ascitis * active gastric ulcer * the patient or his tutor do not consent to the study * documented allergy to penicillin * asa v.

Keywords: enteral nutrition gastrostomy, adverse effects gastrostomy, nursing endoscopy,gastrointestinal surgical wound infection
outcomes of three corner fusion without triquetrum excision versus conventional four corner fusion in snac wrist

Conditions: Scaphoid Fracture

Summary: the investigator compare two types of limited wrist arthrodesis used for management of cases with scaphoid non union advanced collapse (snac) as regard the outcome to provide the most suitable technique

there is a controversy regarding the suitable limited wrist arthrodesis technique for snac wrist grade ii and iii . for several decades , scaphoid excision and four corner fusion (between lunate , capitate , hamate and triquetrum) was the gold standard with good functional outcomes . later on , a more limited fusion technique was described , three corner fusion ( between lunate , capitate and hamate) with scaphoid and triquetrum excision to improve ulnar deviation range . on the other hand , biomechanical studies mentioned that the triquetrum had a certain proprioceptive function that could be affected when it was included in the fusion process .furthermore , if the triquetrum was excised the radiolunate contact pressure would increase with higher risk of development of arthritis. the aim of the study to compare the conventional four corner fusion with three corner fusion with triquetrum excision

Eligibility criteria:
inclusion criteria: * snac wrist g ii , iii exclusion criteria: * cases with radiolunate arthritis * scapholunate advanced collapse * grade 1 scaphoid non union advanced collapse * kienbock disease * skeletally immature patients

Keywords: snac wrist four-corner fusion three corner fusion
only mesh fixation with glue of ventral/incisional laparoscopic hernia repair

Conditions: Ventral Incisional Hernia

Summary: this multicenter randomized controlled non-inferiority trial of only mesh fixation with a glue applicator is a trial to evaluate the outcomes between atraumatic laparoscopic mesh fixation with glutack-glubran2® and conventional traumatic fixation, so the primary endpoint of the study is to analyze the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.

patients older than 18 years undergoing an elective ventral/incisional hernia laparoscopic repair with a hernia defect between 4-10cm of transversal defect the patients included are adults with a bmi lesser than 35 kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (w2 ehs) on anterior or lateral location (m1-m5 up to 10 cm of length or l1-3) for the interventional procedure, three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. a dynamesh ipom previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. after this maneuver, mesh fixation is performed depending on the randomized arm (125 per arm): either traumatic fixation with the conventional procedure and device or with glutack-glubran®2. after two years of follow-up, the recurrence will be analyzed.

Eligibility criteria:
inclusion criteria: * all adults with a bmi lesser than 35 kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (w2 ehs) on anterior or lateral location (m1-m5 up to 10 cm of length or l1-3) * asa grade from i-ii * informed consent signed exclusion criteria: * patients less than 18 years and over 80 years of age. * fascial transverse defect less than 4 cm and more than 8 cm. * recurrent ventral or incisional hernia in the same place * emergency surgery * procedure involving concomitant surgeries (e.g. gastrointestinal, biliary or genitourinary surgery) * bmi greater than 35 kg/m2 * asa iii-iv * pregnancy * tobacco

Keywords: ventral hernia incisional hernia mesh glue tackers ipom plus
building social networks to enhance postpartum weight loss and appropriate infant feeding practices

Conditions: Obesity

Summary: the purpose of this study is to examine whether we can use social networks to spread health information and health behaviors that 1) support women in returning to their pre-pregnancy weight after delivery; and 2) promote healthy infant feeding practices.

the long-term goal of this research is to prevent obesity-related adverse health outcomes for future generations by applying information emerging from social network studies to the development of new population-based behavioral interventions. there are a number of critical periods during fetal and infant development that appear to influence the later development of obesity. interventions that prevent insult to these critical windows from occurring could improve children's life course trajectories. this project sets the groundwork for examining whether social networks could explicitly be utilized to prevent obesity from developing by transmitting health information and health behaviors that 1) prevent postpartum weight retention in first time mothers and 2) promote appropriate infant feeding practices. the secondary aim is to assess which individual-level network-related characteristics best predict postpartum body composition and infant feeding practices.

Eligibility criteria:
inclusion criteria: * latina (self-defined, or born in central or south america) * spanish-speaking and/or english-speaking, * 18 years of age or older * less than 24 weeks pregnant * did or did not have a termination of a previous pregnancy before 20 weeks * has not carried a pregnancy to term * normal, overweight or obese (pre-pregnancy bmi \>18.5 and \<39) exclusion criteria: * non-latina, * non-spanish-speaking or non-english speaking * less than 18 years of age * more than 24 weeks pregnant * had a termination of a previous pregnancy after 20 weeks * multiparous * underweight (pre-pregnancy bmi \< 18.5) * morbidly obese (pre-pregnancy bmi ≥ 39) * currently enrolled in another program that targets weight, physical activity, or nutrition

Keywords: gestational weight gain postpartum weight loss breastfeeding overfeeding
characterization of the microbiome in peritoneum, jejunum, rectum and stool

Conditions: Obesity; Diabetes Mellitus; Fatty Liver, Nonalcoholic; Leaky Gut Syndrome; Chronic Pancreatitis

Summary: characterization of the human microbiome in the jejunum and comparison to the microbiome in the rectum and stool in order to see how the microbial communities change within the intestines.

subjects to undergo surgery with opening of the jejunum will be sampled with sterile swabs from peritoneum and the inside of the jejunum. a swab will also be taken from the rectum. the peritoneum is regarded as a sterile place until today. we try to either verify this, we also could find a scientific base for theories like leaky gut or other forms of bacterial migration through the intestinal wall. many of these patients undergo bariatric surgery. many of them do have a dramatic change in glucose metabolism immediate after surgery. therefore stool swabs will be taken before and 5 days after surgery.

Eligibility criteria:
inclusion criteria: * abdominal surgery containing opening of jejunum * singing of consent exclusion criteria: * inflammative condition (appendicitis, pancreatitis, crohn, colitis ulcerous, cholecystitis and similar)

Keywords: microbiome obesity chronic liver disease
one versus two unit transfusions in oncology patients - the ottop trial: a randomized open-label pragmatic controlled trial

Conditions: Anemia; Oncology

Summary: the aim of this trial is to determine if the transfusion of one unit of red blood cells to anemic oncology patients results in comparable numbers of transfusion episodes when compared to transfusion of two units of red blood cells.

the aim of this trial is to determine if administration of one unit of red blood cells to anemic oncology patients is non-inferior to the administration of two units of red blood cells in terms of the number of annual transfusion episodes. if demonstrated, our findings will cut the total transfusion episode time in half and avoid exposure to an additional unit of red blood cells while freeing up scarce hospital resources.

Eligibility criteria:
inclusion criteria: * adults over 18 years of age with solid tumour (non-hematologic) malignancy undergoing chemotherapy * requiring a red blood cell transfusion as determined by their treating oncologist exclusion criteria: * active bleeding (who grade 3 and 4) * known history active hemolysis * inpatient admission * refusal to receive red blood cell transfusion * unwilling or unable to provide informed consent
a pk/pd genetic variation treatment algorithm versus treatment as usual for adolescent management of depression

Conditions: Depression

Summary: the overall goal of this investigator-initiated trial is to evaluate the impact of platform algorithm products designed to rapidly identify pharmacokinetic (pk) and/or pharmacodynamic (pd) genomic variation on treatment outcome of depression in adolescents. this new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence

treatment seeking adolescent patients with a moderate to severe major depressive episode defined as a 40 or greater on childhood depression rating scale-revised (cdrs-r) will be invited to participate in this study evaluating the genesight® platform. this new technology can rapidly assess pk and pd genetic variation that can potentially impact antidepressant, anti-psychotic, and stimulant treatment selection. these patients will have genesight® testing and will be randomized to one of two groups. in group 1 (n=138), genesight® testing results will be available to the patient's treating clinician prior to treatment selection. in group 2 (n=138), testing results will not be available to the patient's research treating clinician. however, all testing results will be made available to all participants and clinicians after the 8-week trial (upon completion of blinded assessments at week 8). the patients and the clinical raters will be blinded to group assignment.

Eligibility criteria:
inclusion criteria: * age 13-18, male or female, any race/ethnicity * treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan. * major depressive episode diagnosis or bipolar disorder based on ksads-pl semi-structured psychiatric interview with a severity criteria-40 or greater on childhood depression rating scale-revised (cdrs-r) * ability to provide informed consent exclusion criteria: * inability to speak english * inability or lack of willingness to provide informed consent and assent. * axis i diagnoses: autism spectrum disorder, anorexia nervosa, schizophreniform, and schizophrenia. * psychotropic medication change (including dosage) between screening \& randomization visits. * patients who meet dsm 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. must have at least early, partial or full, remission x 3 months * serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator. * significant unstable medical condition. * anticipated inability to attend scheduled study visits. * patients who in the judgment of the investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol. * cytochrome (cyp) \& serotonin transporter genomic testing within 5 years.

Keywords: depression genotyping pharmacokinetic pharmacodynamic
pulsed electromagnetic field versus pulsed high intensity laser in the of osteoprosis

Conditions: Osteopenia or Osteoporosis

Summary: osteoporosis is the most prevalent metabolic bone disease. although osteoporosis is widely considered to be much more prevalent in women approximately 39% of new osteoporotic fractures estimated to have occurred worldwide in 2000 were in men. a number of studies investigate the effect of physical therapy modalities in treatment of osteoporosis. the use of pulsed electromagnetic field (pemf) represents an attractive alternative for osteoporosis. previous studies suggested that pulsed electromagnetic field could be beneficial for increase bone mineral density in osteoporotic patients, but there is a lack of knowledge about the comparison with pulsed high laser therapy.

objectives: this randomized controlled study aims to investigate theeffect of full-body pulsed electromagnetic field versus pulsed high intensity laser therapy in the treatment of men with osteopenia or osteoporosis methods: ninty male patients with osteopenia or osteoporosis will participate in this study, their age ranges between 30-60 years. they have bmd t-scores ≤ - 1.5. all patients will be randomized into one of three groups. group one received pemf and exercise (pemf+ex), group two received hilt and exercise (hilt+ex) and group three will be treated by exercise alone (ex). the exercise training program will include treadmill and aerobic exercises for hip and upper limb will be performed for 50 minutes.pemf was administered to the whole body for pemf groups using a 1.8×0.6m mat 30 minutes/day, 3 times/week for 3 months. dual-energy x-ray absorptiometry (dexa) will assess bone mineral density bmd (g/cm2), bone mineral content (bmc), t-score and z-score at the lumbar spine, proximal femur and forearm region, bone markers (25-hydroxy vit d , total, undercarboxylated ostocalcin, parathyroid hormone, total and ionized calcium and alkaline phosphatase (alp), also will be measured. the assessment will be done at baseline, after treatment (12 weeks) and after 6 months as follow up. the data will be analyzed using repeated measures analysis of variance (anova) for comparison between pre-treatment and post treatment measurement intervals. one-way anova is used to compare between each treatment interval in treatment groups at pre-test and post treatment measurement intervals. the level of significance is set at 0.05 for all tests.

Eligibility criteria:
inclusion criteria: * patients with a t-scores of ≤ #1.5, all patients received the same medical treatment for osteoporosis and the same average blood glucose level, sufficient ability to understand the nature and potential risks of the study. exclusion criteria: * diabetes mellitus, ischemic heart disease, arrhythmia, uncontrolled thyroid disease, cardiac pacemaker, tuberculosis, neuropsychiatric disorders (dementia, cerebrovascular disease, alcohol abuse, severe depression, panic disorder, bipolar disorder, or psychosis), and malignancy.

Keywords: t-scores of ≤1.5
comparison of an ultra-low strut thickness everolimus-eluting biodegradable polymer stent versus durable polymer everolimus-eluting stents in patients treated with percutaneous coronary intervention

Conditions: Ischemia, Myocardial; Coronary Artery Disease; Percutaneous Coronary Intervention (PCI)

Summary: the objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer evermine50 stent to the everolimus-eluting family stents (durable polymer everolimus-eluting xience or promus stents) in a population-based setting with coronary artery stenosis treated with percutaneous coronary intervention


Eligibility criteria:
inclusion criteria: * all patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents exclusion criteria: * age \< 18 years * not able to consent to study participating (eg. intubated patients) * unstable circuit or in cardiogenic shock and therefore not able to understand the information and purpose of the study * do not speak danish * already included in the sort out xii study * life expectancy \<1 year * allergic to study related treatment

Keywords: drug-eluting stent outcome
a home-based breathing training on menopausal symptoms

Conditions: Menopause; Menopause Related Conditions

Summary: this is a prospective, triple-blinded and randomized controlled trial examining the effects of a home-based breathing training assisted with biofeedback on menopausal symptoms and autonomic functions among community menopausal women. we also examines whether the changes in autonomic functions would be mediators between slow breathing and menopausal symptoms. this study will include menopausal women, aged from 45 to 64, who experienced menopausal symptoms. participants will be randomly assigned to either an intervention group (n = 80) or a waiting-list control group (n = 80). the intervention group will undergo the home-based breathing training 20 minutes twice daily and participants in the control condition will participate the same breathing training after a four-week waiting list period. the primary outcome measures are menopausal symptoms measured by symptom diaries of menopausal symptoms and the greene climacteric scale (gcs). secondary outcome measures are autonomic functions expressed by blood pressure (bp), heart rate (hr) and heart rate variability (hrv). measurements will be taken at baseline, week 4, and week 8.

ditto

Eligibility criteria:
inclusion criteria: * aged from 45 to 64, reporting cessation of menstrual cycles with natural causes ≧ 12 consecutive months * the greene climacteric scale (gcs) chinese version scores ≧ 1 exclusion criteria: * clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis or mental deficiency * received hormone replacement therapy prescribed by gynecological physicians * took cardiac medications which may affect the autonomic functions, ex., β-blockers, etc.