Kornimate/medical-research-clean huggingface dataset:
an examination of brown adipose tissue and energy expenditure in infants

Conditions: Cold Induced Thermogenesis

Summary: excess fetal adipose tissue growth during intrauterine development increases future obesity risk. development of brown adipose tissue, a highly thermogenic organ in utero, may affect postnatal energy expenditure, thus influencing obesity risk. this pilot research study is designed to understand the developmental origins of energy balance by examining maternal and neonatal factors that influence neonatal brown adipose tissue and to quantify its physiological relevance to energy expenditure in human neonates.

the developmental origins of obesity begin in utero with growth and differentiation of adipose tissue. fetal white adipose tissue accretion is highly variable and dependent on the maternal intrauterine environment. unlike white adipose tissue, brown adipose tissue has a high capacity for thermogenesis. brown adipose tissue is present at birth and it is believed to support the critical function of thermoregulation in early postnatal life. therefore, brown adipose tissue may also influence the development of neonatal energy balance. similar to white adipose tissue, it is hypothesized that development of brown adipose tissue in utero is also influenced by maternal factors such as prepregnancy body mass index and gestational weight gain. the research aims of this study to 1) identify maternal and neonatal factors that contribute to neonatal brown adipose tissue and 2) to identify changes in neonatal brown adipose tissue and to energy expenditure in response to a mild cold exposure. to achieve these aims, we will conduct a pilot and feasibility study that is cross-sectional, observational study in up to 60 infants 0-3 weeks of age. using state-of-the-art methodology, we will assess brown adipose tissue, body composition, and resting metabolic rate under thermoneutral and mild-cold stimulated conditions.

Eligibility criteria:
inclusion criteria: * aged 0 weeks to less than 3 weeks at visit 1 * be willing to complete mri procedures exclusion criteria: * unable to complete two clinic visits within 14 days * born with health conditions that would render the procedures unsafe * born earlier than 36 and 0 days gestation * taken a steroid drug since birth * implanted metal or electronic objects that render mri unsafe

Keywords: infant energy expenditure indirect calorimetry brown fat neonatal magnetic resonance imaging
transcutaneous electrical acupoint stimulation on blood pressure

Conditions: Hypertension

Summary: this study will be conducted in patients with high-normal blood pressure and grade 1 hypertension and will be divided into two phases. in phase one, a small group of patients will undergo transcutaneous electrical acupoint stimulation treatment for three consecutive days. blood pressure changes will be observed before and after each stimulation session, as well as 1 hour, 3 hours, and 5 hours after stimulation, during the night of the treatment day, and the next morning. phase two will be a single-center, single-blind, parallel randomized controlled trial. after screening, patients will be randomly assigned to either the "stimulation" experimental group or the "sham stimulation" control group. for three consecutive days, both groups will receive their respective interventions at the same time each day, and their blood pressure changes will be recorded.


Eligibility criteria:
inclusion criteria: * office systolic blood pressure between 130-150 mmhg and/or diastolic blood pressure between 80-95 mmhg * age between 18 and 75 years * not currently receiving antihypertensive medication or having discontinued antihypertensive medication for more than two weeks * able to undergo and complete the transcutaneous electrical acupoint stimulation treatment * agree to participate and sign the informed consent form exclusion criteria: * pregnant or breastfeeding women * severe heart conditions, including coronary heart disease, myocardial infarction, arrhythmia, heart failure, or having an implanted cardiac pacemaker * skin conditions, including eczema, allergic dermatitis, or seborrheic dermatitis * neuromuscular diseases, mental disorders, epilepsy, or cognitive impairment * lower limb deep vein thrombosis or thrombophlebitis * wounds, surgical scars, or malignant tumors at the stimulation areas * inability to tolerate the transcutaneous electrical acupoint stimulation treatment or allergic to electrical stimulation * currently participating in other clinical trials
palonosetron vs. ondansetron for postoperative nausea and vomiting in bariatric surgery

Conditions: Nausea, Postoperative; Vomiting, Postoperative; Patient Reported Outcomes; Pain, Postoperative; Antiemetics

Summary: evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.

postoperative nausea and vomiting (ponv) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. in recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-ht3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of ponv in bariatric surgery. in this study, the effects of ondansetron and palonosetron on ponv in patients who undergo sleeve gastrectomy will be compared.

Eligibility criteria:
inclusion criteria: * all morbidity obese patients underwent laparoscopic sleeve gastrectomy exclusion criteria: drug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-ht3 antagonists, emergency surgeries and chemotherapy within.
a second-generation ai based therapeutic regimen in patients with gaucher disease treated with enzyme replacement therapy.

Conditions: Gaucher Disease Type 1

Summary: an open-labeled, prospective, single-center proof-of-concept study. patients with gaucher disease aged 18-75 who received intravenous enzyme replacement therapy once every two weeks were enrolled. the study utilized the altus care™ cellular phone-based application, which integrated an algorithm-based approach to provide random dosing regimens within a pre-defined range determined by the physician. the app allowed personalized therapeutic regimens with variations in dosages and administration times.

patients diagnosed with gd and intravenously treated at home with a regular dose of enzyme replacement therapy once every two weeks for 6 months (30- 60 u/kg per mouth) were included in the study. we installed altus care™- this is a cellular phone-based application that allows easy digitization of treatment plans or research protocols and remote implementation. in coordination with the patient's treating physician and the home treating nurse, an individualized treatment plan was prepared for each patient within a pre-defined range of minimal and maximal once in two weeks ert dosages and timing frames for its administration. per protocol, the patient's monthly dose was not changed, but each dose and the timing of administration was changed randomly using the app. during the follow-up period, the research coordinator made a regular weekly checkup by phone, questioning the patient's clinical well-being and adherence to the treatment plan. a physical examination, cbc, and lyso-gb1 assessed response to therapy were done approximately every two months (twice during the study and once again at the end of the follow-up). the patients filled out sf-36 questionnaires at the beginning and the end of the follow-up.

Eligibility criteria:
inclusion criteria: * adult \>18 years old * non-pregnant * diagnosed with gaucher disease * treated with ert for a minimum of 3 years * an unchanged dose in the past 6/12 months exclusion criteria: * pregnant * patients with evidence of severe infectious, malignant, autoimmune, or other disabling systemic diseases * patients unable to provide written informed consent * patients that do not possess a smartphone * patients who cant adhere to the visit schedule and protocol.
ibis megastudy of interventions to encourage hiv retesting

Conditions: HIV

Summary: in this study, the investigators will test the effectiveness of multiple low-cost behavioral interventions, designed with end-user input, to promote hiv retesting among adults in rural kenya and uganda who have higher risk of hiv exposure.

hiv re-testing is crucial in ensuring early identification of disease to promote well-being of an individual as well as preventing onward spread of infection. the ibis megastudy of interventions to encourage hiv retesting aims to test up to 12 different strategies aimed at encouraging repeat testing of hiv among individuals \>/= 15 years old who are at increased risk of hiv infection. the different strategies are aimed at modifying individual behavior to enhance hiv testing. the study aims to enroll 30,000-40,000 individuals from 8 hiv testing sites in south west uganda and western kenya. the study will then evaluate the effectiveness of the interventions by comparing hiv retesting rates 3-6 months later in the different study arms. the data collected during the study will further be used to understand which of the interventions offered worked best and for whom.

Eligibility criteria:
inclusion criteria: * at least 15 years of age * accessing hiv testing services at study-associated hospitals or clinics * at increased risk of hiv infection (defined by national (kenya or uganda) moh criteria) * documented negative hiv antibody test at time of enrollment * no intent to migrate out of community in next 3 months * daily access to a mobile phone (required since some of the interventions will be delivered by phone) exclusion criteria: * hiv-positive at time of enrollment

Keywords: behavioral economics &#34;nudge&#34; interventions megastudy uganda kenya hiv retesting
study of bms-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the purpose of this study is to evaluate bms-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (scchn), nonsmall cell lung cancer (nsclc), or renal cell cancer (rcc) with measurable disease per recist 1.1 * participants expected to have received standard of care therapies including an available pd-(l)1 inhibitor * eastern cooperative oncology group performance status of 0 or 1 * women of childbearing potential must agree to follow methods of contraception exclusion criteria: * participants with active, known or suspected autoimmune disease * participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications * uncontrolled or significant cardiovascular disease * history of or with active interstitial lung disease or pulmonary fibrosis * prior participation in anti-natural killer cell receptor (anti-nkg2a) clinical study * history of allergy or hypersensitivity to study drug components other protocol-defined inclusion/exclusion criteria apply

Keywords: nsclc (non-small cell lung cancer) rcc (renal cell carcinoma) scchn (squamous cell carcinoma of the head and neck)
a study to investigate the safety and efficacy of once-weekly peg-somatropin (gensci004) in children with growth hormone deficiency

Conditions: GHD

Summary: the purpose of this phase 3 study is to evaluate the safety and efficacy of once-weekly gensci004 over 108 weeks in children with ghd aged from 6 months to 17 years old, inclusive.

the purpose of this phase 3 study is to evaluate the safety and efficacy of once-weekly gensci004 over 108 weeks in children with ghd aged from 6 months to 17 years old, inclusive.

Eligibility criteria:
inclusion criteria: 1. investigator-determined diagnosis of ghd prior to the historical initiation of daily rhgh trerapy 2. participant must be 6 months to 17 years old 3. tanner stage \<5 at visit 1 4. open epiphyses 5. normal fundoscopy at screening 6. written, signed, informed consent of the participant's parent(s)/lar(s) and written assent of the participant exclusion criteria: 1. history or presence of malignant disease 2. children with diabetes mellitus 3. major medical conditions and/or presence of contraindications to gh treatment 4. pregnancy 5. participation in any other study of an investigational agent within three months prior to visit 1 6. prior exposure to investigational drug or any other long-acting growth hormone 7. any other reason per investigator's discretion

Keywords: ghd growth hormone deficiency
interactive voice-based administration of the phq-9

Conditions: Major Depressive Disorder

Summary: this study investigates a new delivery method for the patient health questionnaire - 9 (phq-9), a clinically accepted tool for diagnosing major depressive disorder. the new tool records auditory responses to the assesment and the study will examine if the instrument is effective at capturing participant depression levels. if proven effective, future studies may investigate if the new format can be used to improve at home clinical care.

this study is an investigation of a new delivery system of the patient health questionnaire - 9 (phq-9), a clinically accepted tool for diagnosing major depressive disorder. the purpose of the study is to examine if the new delivery system of the phq-9 is effective at capturing participant depression levels. the new version uses a mirror device, which is similar to a smart television with a mirror interface. the device records auditory responses to the phq-9 through amazon alexa. we will be comparing the responses from the mirror device to those given on the clinically established paper format. if proven effective at capturing depression levels of patients, future studies may investigate if the new format can be used to improve at home clinical care.

Eligibility criteria:
inclusion criteria: * newly admitted patients to the oklahoma state university behavioral medicine clinic exclusion criteria: * vulnerable populations, such as children (i.e., minors or individuals under the legal age of consent) and individuals who are incarcerated (i.e., prisoners), will be excluded. * individuals who are not their own guardian (i.e., those suffering from severe disabilities) will also be excluded.
daily light exposure for sleep disturbance, fatigue, and functional outcomes in acute brain injury

Conditions: Stroke; Traumatic Brain Injury; Non-traumatic Brain Injury

Summary: the purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.in a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms.


Eligibility criteria:
inclusion criteria: 1. inpatient admission to st. luke's rehabilitation institute for stroke, traumatic brain injury, or non-traumatic brain injury 2. male or female, 18 to 85 years of age (to match limits of assessment instruments) 3. able to provide written informed consent or have a legally authorized representative that can provide written informed consent 4. stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms 5. normal vision or corrected to normal vision (if glasses or contacts are tinted, willing to remove during light exposure) 6. normal hearing or corrected to normal hearing 7. willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment exclusion criteria: 1. history of epileptic or other seizure disorder 2. cataract surgery in the past 12 months 3. significant visual impairment affecting light reaching the retina/performance of the retina: cataracts, macular degeneration, diabetic retinopathy, congenital blindness, total blindness, glaucoma, or retinal detachment 4. endorsement of suicidal ideation on the phq-9 depression screen (standard of care admission assessment at st. luke's) 5. pre-injury diagnosis of a sleep disorder, including: sleep apnea, insomnia, narcolepsy or periodic limb movement syndrome 6. neurological disorders other than those attributed to the primary diagnosis, including multiple sclerosis, parkinson's disease, huntington's disease, alzheimer's disease or other dementias, amyotrophic lateral sclerosis) 7. bipolar diagnosis 8. females who are pregnant as determined from subject's medical records or who are breastfeeding 9. in active withdrawal from alcohol or street drugs 10. unwillingness to refrain from wearing tinted glasses or contact lenses during light exposure
patellar tendinopathy - the effect of load magnitude in exercise-based treatment

Conditions: Patellar Tendinopathy; Jumper's Knee

Summary: the purpose of this project is to investigate if the magnitude of a loading based 12 weeks rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon structure and function. the investigators hypothesize that a greater magnitude (90% of 1rm) of loading will yield a more positive clinical outcome, tendon structure and function in patients with patellar tendinopathy compared to a lower magnitude of loading (55% of 1 rm) when total exercise volume is equal in both groups.

randomized controlled intervention study with one year follow-up

Eligibility criteria:
inclusion criteria: * uni- or bilateral patellar tendinopathy * symptoms \> 3 months * ultrasonographical tendon swelling * ultrasonographical hypo-echoic area with doppler * bmi 18.5-30 exclusion criteria: * patellar tendinopathy \> 12 month * previous knee surgery * confounding diagnosis to the knee joint * diabetes or arthritis * previous corticosteroid injection for patellar tendinopathy * smoking * being elite volleyball players
a phase iii study of esg401 for locally advanced or metastatic hr+/her2- breast cancer

Conditions: Metastatic Breast Cancer

Summary: the aim of this study is to evaluate the efficacy and safety of esg401 in patients with unresectable locally advanced or metastatic hr+/her2- breast cancer.

this is a open-label, randomized, multicenter phase 3 study to evaluate esg401 versus treatment of physician's choice (tpc) in subjects with unresectable locally advanced or metastatic hr+/her2- breast cancer who had failed at least one line of systemic chemotherapy.

Eligibility criteria:
inclusion criteria: * individuals able to understand and give written informed consent. * males or females aged ≥ 18 years ; * histologically and/or cytologically confirmed hr+/her2- breast cancer who had failed at least one line of systemic chemotherapy in metastatic settings; * patients who are eligible for a chemotherapy regimen in the control group; * patients with at least one measurable lesion per recist 1.1 criteria; * eastern cooperative oncology group (ecog) performance status score of 0 to 1; * expected survival ≥ 12 weeks; * patients with adequate organ and bone marrow function; * female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 180 days after the last dose. exclusion criteria: * received chemotherapy, targeted therapy, immunotherapy, interventional therapy or other systemic anti-cancer therapie within 4 weeks before the first investigational product administration; * toxicities from prior anti-tumor therapy not recovering to ≤ grade 1; * received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ; * prior topoisomerase i inhibitor therapy, including antibody-drugconjugate(adc) therapy, or prior trop2 targeted therapy, or use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration; * new thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months; * uncontrolled systemic bacterial, viral or fungal infections; * subjects with symptomatic or untreated cns metastases, or those requiring ongoing treatment for cns metastases; * patients with primary cns malignancy；or patients with other malignancies within 3 years prior to the first dose; * patients with uncontrollable systemic diseases; * patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea; * subjects with clinically significant cardiovascular disease; * human immunodeficiency virus (hiv) infection; * active hepatitis b or hepatitis c; * known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to any investigational drug or excipient ingredient; * pregnant or lactating women.
phase i study of sequential cord blood transplants

Conditions: Lymphoma; Leukemia; Multiple Myeloma; Myelodysplastic Syndrome

Summary: the purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.

eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. gvhd prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil starting on day 0. sequential cord blood units will be infused on day 0.

Eligibility criteria:
inclusion criteria: * disease status: nhl, hd, or mm refractory to chemotherapy or relapsed; cll rai stage iii/iv, or lymphocyte doubling time of 6 months, or stage i/ii resistant to 2 chemotherapy regimens; aml or all in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder * estimated disease-free survival of less than one year * ecog performance status of 0, 1, 2 * lack of 6/6 or 5/6 hla matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant * 4/6 or greater hla a, b, crb1 cord blood units with a combined nucleated cell dose from of \> 3.7 x 10(7) nc/kg exclusion criteria: * cardiac disease: symptomatic congestive hearth failure or rvg or echocardiogram determined left ventricular ejection fraction of \< 45%, active angina pectoris, or uncontrolled hypertension * pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected dlco of \< 50% * renal disease: serum creatinine \> 2.0 mg/dl * hepatic disease: serum bilirubin \> 2.0 mg/dl (except in the case of gilbert's syndrome), sgpt or sgot \> 3 x normal * neurologic disease: symptomatic leukoencephalopathy, active dns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation * hiv antibody or hepatitis b surface antigen positivity * uncontrolled infection * pregnancy or breast-feeding mother