Kornimate/medical-research-clean huggingface dataset:
mindfulness-enhanced pivotal response group treatment on parenting stress

Conditions: Autism Spectrum Disorder

Summary: this project tests the feasibility and preliminary proof of concept for a mindfulness-enhanced adaptation of pivotal response treatment on parenting stress and child communication, using a randomized controlled design.

one of the core features of autism spectrum disorder (asd), social communication impairment, presents in a variety of ways, including reduced functional language use and social initiations, which often warrant intensive intervention services. additionally, parents of children with asd demonstrate increased levels of parenting stress when compared to parents of typically developing children and children with developmental delays. elevated parenting stress has been shown to diminish positive treatment outcomes, which lends support to develop methodologies to concomitantly target child and parent behaviors. the current randomized control trial (rct) uses a dual-pronged approach to directly target both child communication deficits and parenting stress within a group format. this rct combined an empirically supported behavioral therapy, pivotal response treatment (prt), with components from acceptance and commitment therapy and mindful parenting for reducing parenting stress. caregivers and their minimally or pre-verbal child with diagnosed or suspected asd were randomly assigned to one of the following supplemental conditions: mindfulness-enhanced prt (mprt) or psychoeducation-enhanced prt (pprt) as an active control condition. the current study assessed feasibility and acceptability in addition to demonstrating proof of concept in regard to additive effects of mprt compared to pprt.

Eligibility criteria:
inclusion criteria: * for children: minimally verbal or nonverbal, 1.5 to 6 years old, current or suspected autism spectrum disorder diagnosis, demonstrated ability to make meaningful vocalizations * for parents: willingness to attend group treatment sessions, record weekly videos, and share videos in a group setting exclusion criteria: * for children, no active medical problems (e.g., unstable seizure disorders) * for parents, no severe mental health problems (e.g., suicidal intent, psychosis)
establishing safe drainage limits for pleural chest tube removal.

Conditions: Thoracic Surgery; Thoracic Trauma

Summary: the purpose of the study is to evaluate a safe threshold for when to remove chest tubes in patients based on the amount of drainage present.

measurement of pleural fluid drainage in chest tubes of trauma patients.

Eligibility criteria:
inclusion criteria: * presence of at least one chest tube * no air leak present * fluid is not infected * pleural drainage of fluid was an indication for placement of the chest tube * patient is post-thoracic surgery * patient is post-thoracic trauma * informed consent obtained exclusion criteria: * presence of air leak * infected pleural fluid * active intra-thoracic bleeding * thoracic empyema * non-removal of chest tube (i.e.: expired) * pregnancy * less than 18 years of age * unable to obtain informed consent
safety of adu-1604 in adults with metastatic melanoma

Conditions: Metastatic Melanoma

Summary: this study is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, pk, and pd of adu-1604 and explore initial clinical activity in adults with metastatic melanoma.

adu-cl-17 is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, pharmacokinetics (pk), and pharmacodynamics (pd) of adu-1604, an anti-ctla-4 monoclonal antibody, and explore initial clinical activity in adults with metastatic melanoma. the primary objective of the study is to determine the recommended phase 2 dose (rp2d) of adu-1604 administered by iv infusion once every 3 weeks for 4 doses. the study will be conducted in two parts: dose escalation followed by dose confirmation.

Eligibility criteria:
inclusion criteria: 1. male or female aged ≥18 years 2. histologically-confirmed metastatic or unresectable melanoma 3. progression of disease following at least one prior therapy, and is not a candidate for, or is intolerant to, established therapy known to provide clinical benefit (i.e. available treatment options have been exhausted). subjects must have braf mutation status confirmed; if a subject is braf v600e/k positive, they must have received a braf- targeted regimen prior to entering the study, unless the patient was deemed ineligible for such treatment 4. measurable disease according to recist (v1.1) \[not required during dose escalation\] 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: 1. prior diagnosis of uveal or mucosal melanoma 2. prior treatment with ctla-4-directed therapy in the metastatic setting. use of ctla- 4-directed treatment in the adjuvant or neoadjuvant setting is acceptable provided the last dose was \>6 months before the first dose of adu-1604 and there was no discontinuation of treatment due to a treatment-related toxicity.
a randomized trial of oral misoprostol alone versus oral misoprostol followed by oxytocin for labour induction

Conditions: Induction of Labor

Summary: the primary objective of the trial is to assess the following: in women who have undergone cervical preparation with oral misoprostol as part of labour induction for hypertensive disease in india, is augmentation using oral misoprostol superior to the standard protocol of intravenous oxytocin?

every year approximately 30 000 women die from hypertensive disease in pregnancy. magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. low dose oral misoprostol, a prostaglandin e1 analogue, is a highly effective method for labour induction. usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion. however, some studies have shown that oral misoprostol can be continued into active labour. in the cochrane review on labour induction, those whose augmentation was continued with misoprostol (m/m protocol) had 42% less css than those who changed to oxytocin (m/ox protocol; 15% vs 26%). this misoprostol-only protocol would be simpler and probably more acceptable to women. however, these two protocols have never been directly compared. we propose a pragmatic, open-label, randomised trial to compare an m/m labour induction protocol with the standard m/ox protocol.

Eligibility criteria:
inclusion criteria: * • ongoing pregnancies with a live fetus who require induction because of preeclampsia or hypertensionwomen will be included irrespective of whether an intrapartum caesarean birth on fetal grounds would be considered or not * women age ≥18 years * signed informed consent form * undergone cervical ripening with misoprostol if cervix initially unfavourable * decision to augment labour for inadequate uterine contractions despite ruptured membranes (either artificial or spontaneous as part of the induction process)s exclusion criteria: * women with previous caesarean births * those unable to give informed consent * cervical ripening with agents other than misoprostol (e.g. foley catheter, prostaglandins) * multiple pregnancy * history of allergy to misoprostol * adequate uterine activity * pre- induction ruptured amniotic membranes * frank chorioamnionitis (systemic illness with purulent vaginal discharge and uterine tenderness)

Keywords: preeclampsia misoprostol oxytocin
a randomized, comparative study of daily dapsone and daily atovaquone for prophylaxis against pcp in hiv-infected patients who are intolerant of trimethoprim and/or sulfonamides

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable pneumocystis carinii pneumonia in hiv-infected patients with cd4 counts \<= 200 cells/mm3 or \<= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides. trimethoprim/sulfamethoxazole (tmp/smx), which is effective for secondary pcp prophylaxis, is associated with allergic manifestations and side effects that limit its use. patients who are intolerant of tmp/smx require an effective alternative. dapsone and atovaquone have both shown promise as pcp prophylactic agents.

trimethoprim/sulfamethoxazole (tmp/smx), which is effective for secondary pcp prophylaxis, is associated with allergic manifestations and side effects that limit its use. patients who are intolerant of tmp/smx require an effective alternative. dapsone and atovaquone have both shown promise as pcp prophylactic agents. patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.

Eligibility criteria:
inclusion criteria concurrent medication: strongly recommended: * pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone who have cd4 count \< 100 cells/mm3 and are toxoplasmosis seropositive. patients must have: * working diagnosis of hiv infection. * cd4 count \<= 200 cells/mm3 or \<= 15 percent of total lymphocyte count at any time in the past or a history of pcp. * history of intolerance of trimethoprim and/or sulfonamides that required permanent discontinuation. note: * pregnant patients are eligible at the clinician's discretion. prior medication: allowed: * prior pcp prophylaxis. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * active pneumocystosis. concurrent medication: excluded: * pcp prophylaxis (other than study drug) or any medication with potential anti-pcp activity. patients with the following prior conditions are excluded: * known treatment-limiting reaction to dapsone or atovaquone.

Keywords: pneumonia, pneumocystis carinii dapsone antifungal agents acquired immunodeficiency syndrome atovaquone
procalcitonin level and kinetics in children with bacterial infections

Conditions: Bacterial Infections; Bacteremia; Meningitis; Urinary Tract Infection; Mastoiditis; Lobar Pneumonia; Septic Arthritis; Cellulitis; Osteomyelitis

Summary: the purposes of this study are: 1. to determine whether procalcitonin level at admission of pediatric patients with bacterial infections can be used as a marker for prediction of defervescence and hospitalization length 2. to examine the kinetics of procalcitonin in pediatric patients with bacterial infections and persistent fever


Eligibility criteria:
inclusion criteria: * positive blood, urine, synovial, bone, pleural effusion, abscess or csf culture * cellulitis, lobar pneumonia, osteomyelitis,

Keywords: uti
humoral and cellular responses to vaccination against coronavirus disease 2019 (covid-19) in the very elderly living in geriatric institutions

Conditions: Elderly People Institutionalized in Long-term Care Services

Summary: the main objective of this study is to describe the humoral and cellular response to bnt162b2 vaccination in people over age 75 institutionalized in the long-term care units of the paris public hospitals (aphp)

this is an interventional study with minimal risk and constraints, multicenter with biological collection. two populations are studied: patients and members of care staff. the following data will be collected: * for patients and staff: age, gender, existence of coronavirus disease 2019 (covid-19) infection and whether or not it is symptomatic and date of first positive rt-pcr test, medical history * for patients: nutritional status (loss of appetite, weight loss, body mass index, albuminemia) vaccination antibodies are measured using 3 blood sample: the first carried out before the anti-coronavirus disease 2019 (covid-19) vaccination; the second on d21 (shortly before the vaccination booster injection) and the third on d50-54. in addition, during the first sample, assays will be carried out informing us of your nutritional and inflammatory status.

Eligibility criteria:
inclusion criteria for patients: * person aged 75 and over, * hospitalized in a long-term care unit participating in the study, * having agreed to be vaccinated with the bnt162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities, * not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study, * having given their written consent to participate in the study, or having not expressed their opposition to participating and whose legal guardian has given their consent. inclusion criteria for younger adults (priority care staff): * staff who have agreed to be vaccinated with the bnt162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities, * not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study, * having given their written consent to participate in the study.

Keywords: mrna bnt162b2 vaccine coronavirus desease 2019 (covid-19) anti-rbd igg vaccine antibodies blood sample
phase 2 study of human umbilical cord derived mesenchymal stem cell for the treatment of lupus nephritis

Conditions: Lupus Nephritis

Summary: the efficacy measure of huc-msc in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.

inclusion criteria: 1. male or non-pregnant females age 16 to 65 years inclusive. 2. written informed consent obtained from patient or parents/guardian. 3. patients with sle fulfilling american rheumatism association criteria and sledai score\>8 or bilag score a/b. 4. patients with newly diagnosed world health organization (who) class iii or iv lupus nephritis.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant females age 16 to 65 years inclusive. 2. written informed consent obtained from patient or parents/guardian. 3. patients with sle fulfilling american rheumatism association criteria and sledai score\>8 or bilag score a/b. 4. patients with newly diagnosed world health organization (who) class iii or iv lupus nephritis exclusion criteria: patients with any of the following are not eligible for enrollment into the study: 1. pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test. 2. participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study. 3. those persons directly involved in the conduct of the study. 4. serum creatinine more than 250 µmol/l. 5. white blood cell (wbc) count of less than 3.5 x 109/l. 6. active peptic ulcer disease. 7. active systemic infection. 8. history of alcohol or substance abuse. 9. history of malignancy within previous 5 years. 10. any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.

Keywords: msc for the treatment of lupus nephritis
substrate oxidation in children in response to high and low dairy intake

Conditions: Childhood Obesity

Summary: the investigators propose a randomized trial comparing higher levels of dairy intake compared to lower levels of dairy intake. participants will be 20 boys and girls, age 10-13, overweight (\>85%) who are currently consuming 1 or fewer servings of dairy per day. each participant will be randomized to either higher or lower levels of dairy intake. a baseline calorimeter stay will determine 24-hour energy needs. participants will then receive the diet they have been randomized to receive for 6 days and will then have a second calorimeter stay. during this 2nd stay, each participant will continue to receive the diet they were randomized to receive and will achieve a 300 kcal energy deficit through physical activity. the investigators hypothesize that children who receive a 300 kcal energy deficit from the energy expenditure of exercise and receive 3 to 4 servings of dairy products will show greater increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of exercise and receive 1 or fewer servings of dairy products.

the study objective was to conduct a randomized clinical trial comparing enhanced levels of dairy consumption to lower levels of dairy consumption during an energy deficit resulting from 300 kcal of exercise. participants were 24 sedentary and overweight boys, 13-15 years of age and girls, 12 to 14 years of age, and consuming 1 or fewer servings of dairy and less than 600 mg calcium per day at baseline. participants were randomly assigned to either higher or lower dairy for 6 days and then crossed over to the opposite treatment subsequent to 2 weeks of wash out. the investigators provided all meals and snacks for the participants during the higher and lower dairy conditions. during the wash out period, participants were instructed to consume their normal diet as assessed at baseline which consisted of 1 or fewer servings of dairy and less than 600 mg calcium. participants stayed in the calorimeter at baseline, day 7, and day 28 (end of study), after crossover. the calorimeter measured substrate oxidation under the condition of a 300 kcal energy deficit due to exercise.

Eligibility criteria:
inclusion criteria: * must be overweight * and 10-13 years old * currently consuming 1 or fewer servings of dairy * less than 600 mg calcium per day exclusion criteria: * not meeting the above criteria * must be present for duration of the study

Keywords: dairy obesity
pedometers for gestational diabetes

Conditions: Gestational Diabetes

Summary: ten to 50% of women with gestational diabetes (gdm), or glucose intolerance first recognized during pregnancy, develop diabetes within 5 years after delivery. although intensive interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is unknown if such strategies would be effective in women with gdm. women with recent gdm, even though no longer pregnant, face significant barriers to lifestyle modification, including caregiving responsibilities and low perception of risk. web-based programs can reinforce physical activity through visual feedback of pedometer output, tailored messaging, education, and on-line communities. such a program is currently available for adults with chronic disease and is led by dr. richardson, a co-pi on this application. using data from focus group and survey work conducted by dr. kim, the other co-pi, this program can be modified to women with recent gdm. for specific aim 1, we propose to adapt a chronic disease web-based pedometer program to women with recent gdm. for specific aim 2, we propose to conduct a pilot and feasibility study of the program. the intervention will last 12 weeks.


Eligibility criteria:
inclusion criteria: * gestational diabetes diagnosis within past three years * access to computer with internet, usb port and windows xp or vista * regular email user (weekly or more) * can walk a block on her own * sedentary (less than 150 minutes purposeful physical activity per week) exclusion criteria: * pregnancy * unable to consent legally

Keywords: gdm gestational diabetes pregnancy diabetes walking exercise pedometer online
sit less program for patients with type 2 diabetes

Conditions: Type 2 Diabetes; Sedentary Behavior; Sedentary Time; Physical Activity

Summary: this randomized controlled trial aims to evaluate an 8-week intervention designed to reduce sedentary behavior (sb) in patients with type 2 diabetes (t2d) using wearable technology. the intervention involves the use of fitbit devices to prompt standing/walking breaks, a smart water bottle to encourage hydration-related movement, and tailored text messages for behavior reinforcement. participants will be assessed at baseline and post-intervention for changes in sb, light physical activity, cardiometabolic markers, and patient-centered outcomes. the study seeks to determine the intervention's acceptability and preliminary efficacy in reducing sb and improving health outcomes in t2d patients.

the investigators propose to develop and conduct a pilot randomized controlled trial to test a wearable technology-based sedentary behavior (sb) reduction intervention in type 2 diabetes (t2d) patients. the study will recruit 80 participants who will be randomized to either the control group or the intervention group. the 8-week intervention aims to reduce daily sb by at least 120 minutes through the use of fitbit devices, a smart water bottle, and tailored text messages. participants will set personalized sb reduction goals and receive prompts to stand or walk, along with hydration reminders from the smart water bottle to encourage movement. specifically, the study aims to: determine the acceptability of the sb reduction intervention in t2d patients by evaluating satisfaction and compliance; evaluate the preliminary efficacy of the intervention on reducing total sb time and numbers of prolonged sb bouts; and explore preliminary effects on light physical activity, cardiometabolic markers (24-hour glycemic control, bmi, waist circumference, blood pressure), and patient-centered outcomes (confidence in reducing sb, habit strength for sb, and quality of life). outcomes will be measured at baseline and post-intervention using biometric assessments, questionnaires, and continuous glucose monitoring. the study seeks to provide insights into the feasibility and potential health benefits of a technology-driven sb reduction program for t2d patients.

Eligibility criteria:
inclusion criteria: * ages 18 and above * diagnosed with type 2 diabetes * self-reported hba1c\<13 * self-report of sitting ≥ 8hr/day * ability to stand and walk * ownership of a smartphone. exclusion criteria: * currently using an activity tracker * currently participating in exercise or other research programs. * random blood glucose \> 300 mg/dl. * non-english speaking. * patients classified as unstable (e.g., heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake. * any conditions that prevent standing or walking due to physical or cognitive limitations, such as cognitive impairment, severe pain, problems with lower limbs, or a history of surgeries that limit movement. * participation in sit less program v1 (irb #221566). * currently pregnant.
comparing ivf/icsi cycle outcomes of post ovulation ovarian stimulation protocol with elonva without gnrh antagonist to follicular phase day 2 stimulation fixed day 5 antagonist protocol

Conditions: Stimulation in the Ovary; IVF Outcome

Summary: there are several approaches to the timing of antagonist administration in ivf/icsi cycles. the primary goal is indeed to prevent premature ovulation, which could jeopardize the success of the cycle there is an emerging concept that suggests that the progesterone produced by the corpus luteum (formed after ovulation) might be sufficient to prevent further ovulation, obviating the need for antagonist or exogenous progesterone administration. this hypothesis relies on the natural regulatory mechanisms of the menstrual cycle to maintain a progesterone-dominated environment post-ovulation. we hypothesized that this approach would minimize treatment costs /burden without having an impact on the outcome.


Eligibility criteria:
inclusion criteria: * age 18 to 38 years old. * normal menstrual cycle of 25-35 days. * body weight 60to90 kg * amh\>1.3 - \ 5 on menstrual cycle days 2-3, exclusion criteria: * history of premature ovulation * azoospermia * pcos * endometriosis afs ¾ * endometrioma * known chromosomal abnormalities

Keywords: progesterone premature ovulation ovarian stimulation luteal stimulation