Kornimate/medical-research-clean huggingface dataset:
consistency in individual differences in energy intake following acute exercise

Conditions: Obesity; Sedentary

Summary: the importance of exercise for weight control is well documented; however if exercise results in an increase in food intake, the beneficial effect of exercise may not be seen. this study addresses a gap in the current literature and examines why some people eat more after exercise and why some people eat less and also examines whether these responses are consistent over time. participants in this study will be asked to come to our center on 7 different occasions over a 3-4 month period. the first visit will be an assessment visit where body weight and body composition will be measured, questionnaires will be completed, and an exercise test will be performed. during the remaining 6 visits (3 pairs of sessions with visits in each pair separated by 48-96 hours) the procedures will be nearly identical. upon arrival at our center, participants will consume a meal replacement, complete a series of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be resting and 3 will be exercising). one hour following the exercise/resting session, individuals will be given access to a buffet of food, unaware that their food intake will be monitored. all food will be weighed and measured before and after the eating period and the amount of food consumed after each pair of exercise and resting conditions will be compared to one another. it is hypothesized that the difference in food intake will be consistent across pairs of testing sessions. findings from this study will help us to better understand the relationship between exercise and food intake and may ultimately lead to future studies that can address the clinically significant question of why some individuals gain weight and others lose weight when engaging in exercise training programs. findings from this study may also help to develop exercise programs that maximize the beneficial effect of exercise on body weight.


Eligibility criteria:
inclusion criteria: * age 18-45 years * bmi between 25.0 and \<35.0 kg/m2 * female * sedentary, defined as exercising at a moderate-intensity for less than 60 minutes/week over the past 6 months. exclusion criteria: * presence of any condition that would limit one's ability from exercising (i.e., orthopedic limitations) * recent weight gain or weight loss (± 10 pounds within the past 6 months) * currently enrolled in a weight loss program * history of heart disease or diabetes * currently taking any medication that would alter heart rate (e.g., beta blocker) or metabolism * women who are pregnant, planning on becoming pregnant in the next 2 months, or those pregnant within the past 6 months * uncontrolled hypertension (currently taking blood pressure medication or having a resting systolic blood pressure ≥140/90 mmhg * get an average of \<6 hours of sleep/night * does not currently eat breakfast regularly * known food allergies to test foods or states a disliking or unwillingness to eat more than 25% of the buffet foods.

Keywords: obesity exercise energy intake physical activity
the prelims feasibility trial

Conditions: Multiple Sclerosis

Summary: the prelims study is a mixed-methods feasibility randomised controlled trial of a point of diagnosis intervention programme which aims to provide emotional support for newly diagnosed people with multiple sclerosis (ms). this feasibility study will enable us to plan for a definitive trial to evaluate the clinical and cost-effectiveness of this point of diagnosis intervention programme. the aim is to assess the feasibility of the trial procedures and intervention, and to evaluate the key feasibility parameters before proceeding to a definitive trial. participants (n=60) will be randomised into three groups: (1) usual care; (2) usual care + support 1 (ms nurse support); (2) usual care + support 2 (ms nurse support plus peer support).

potential participants will be people who have been recently diagnosed with ms (or currently going through diagnosis process), and who are aged 18 years or over, recruited through ms clinics. participants, after consent, will complete baseline measures before being randomised into to one of three groups: (1) usual care; (2) usual care + support 1 (ms nurse support); (2) usual care + support 2 (ms nurse support plus peer support). group 1 (20 patients) will not receive any intervention. group 2 (20 patients) will receive support 1 which will include one face-to-face support session delivered by an ms nurse. group 3 (20 patients) will receive support 2 which includes ms nurse support (i.e., support 1) plus peer support. peer support will include a minimum of two peer support session delivered by peer support workers (i.e. patients with lived experiences). all groups will receive usual care. the outcome measures will be collected at 3 and 6 months after randomisation by all participants. feedback interviews with up to 21 participants (7 from each group) and up to 10 service providers (5 ms nurses who delivered the ms nurse support and 5 peer support workers who delivered the peer support) will be conducted to assess what parts of the intervention were helpful or unhelpful, the acceptability of randomisation and trial procedures, and the appropriateness of the measures used.

Eligibility criteria:
inclusion criteria: patients will be eligible to join the trial if they: * are 18 years or over * have recently received a diagnosis of ms (any type of ms) or currently going through ms diagnosis process) * can communicate in english * able and willing to give consent * not receiving psychological intervention exclusion criteria: patients will be excluded if they: * have a severe co-morbid psychiatric condition (e.g. dementia), as reported by patients or their carers or confirmed by the clinical team making the initial approach * are currently receiving psychological interventions or received this within the last three months (we will not exclude those on medication for their mood problems but will record this information). * do not have mental capacity to consent to take part in the trial * are unable to communicate in english

Keywords: diagnosis emotional support peer support
safety and tolerability study of inhaled carbon monoxide in kidney transplant patients

Conditions: Kidney Transplantation

Summary: the purpose of this study is to evaluate the safety and tolerability of two carbon monoxide doses when administered as an inhaled gas for 1 hour in patients receiving kidney transplants.

the mechanisms by which carbon monoxide exerts its effects in preventing damage of the graft appear to vary among the models and organs with the common theme of carbon monoxide acting as a potent anti-inflammatory molecule. carbon monoxide affects several intracellular signaling pathways. in addition, carbon monoxide generates increased levels of anti-inflammatory molecules. evaluate the safety and tolerability of three carbon monoxide dose levels consisting of a single 0.7 mg/kg dose and a single 2.0 mg/kg dose when administered post-operatively and a single 2.0 mg/kg dose, a single 3.0mg/kg dose and a 3.5 mg/kg dose when administered intra-operatively as an inhaled gas for 1 hour, by assessment of adverse events (aes), vital signs, laboratory variables, serum carboxyhemoglobin (cohb), oxygenation, electrocardiography (ecg), and neurocognitive status in patients receiving kidney transplants.

Eligibility criteria:
inclusion criteria: * male or female receiving a kidney transplant from any donor type * bmi between 16 and 36 inclusive * spontaneously breathing (non-intubated) with supplemental oxygen standardized at 2 liters via nasal cannula * hemodynamically stable with a systolic arterial pressure \> 90 mmhg and a heart rate \< 120 beats/min * acceptable transplantation candidate as judged by medical history, physical exam, ecg, vital signs, clinical chemistry, hematology, and urinalysis * given written and verbal information and had the opportunity to ask questions about the study * signed informed consent to participate in the study exclusion criteria: * exposure to any carbon monoxide source (e.g., fire, gas, or heavily polluted air) during the 48 hours prior to the study day * baseline blood level of cohb \>2% * baseline hemoglobin (hb) \<10.0 g/dl * patients with significant underlying lung disease such as moderate or severe asthma, copd, and interstitial lung disease * baseline oxygen saturation \<95% * pregnancy or breastfeeding * participation in other clinical trial within 2 months prior to study drug treatment

Keywords: kidney transplant, carbon monoxide
timolol option for ulcerated hemangiomas (touch trial)

Conditions: Infantile Hemangiomas

Summary: the purpose of this study is to determine whether timolol 0.5% gel forming solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.

ulceration is the most common complication associated with infantile hemangiomas. ulceration and the delay in wound healing places patients at risk for infection, bleeding, pain and permanent scarring. currently, the care of ulcerated hemangiomas is extremely difficult and patients are often subject to multiple treatment modalities. in the past two years, the leading advance in the treatment of hemangiomas has been the use of the non-selective, oral beta-blocker propranolol to arrest growth and promote involution of hemangiomas. recent literature also suggests beta-blockers may have a role in helping ulcerated wounds re-epithelialize. the use of a topical non-selective beta-blocker on isolated ulcerated hemangiomas may promote early healing and reduce the number of complications associated with ulceration. investigation is needed to explore the safety and tolerability of applying a topical beta-blocker on an ulcerated hemangioma and whether topical beta-blockade may be more efficacious than conservative care with topical antibiotics. in this study, infants will be randomized to either receive a topical antibiotic (topical mupirocin 2% ointment twice per day) or a topical beta-blocker (timolol 0.5% gel forming solution) according to a dose-escalation schedule. subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed. photographs and safety and efficacy measurements will be taken at each visit to assess response to therapy.

Eligibility criteria:
inclusion criteria: * infants weighing between 4-12kg * infants with corrected gestational age 44 weeks - 8 months of age * infant with an ulcerated hemangioma * informed consent exclusion criteria: * ulceration larger than 16cm2 * ulcerated hemangioma with active bleeding or infection at time of enrollment * disease threatening hemangioma meeting criteria for oral propranolol * previous treatment with topical/oral corticosteroid or propranolol * medical history of congenital heart disease with decreased cardiac output, stroke/cerebral vasculopathy, active reactive airway disease or metabolic disorder * history of an allergic reaction to mupirocin or timolol * currently taking medication that would interact with beta-blockers

Keywords: hemangioma infantile hemangioma ulcerated hemangioma timolol beta blocker vascular anomaly
project peer: understanding the lung cancer patient experience in the real-world setting

Conditions: Lung Cancer Patients; Caregivers

Summary: lungevity foundation, a non-profit lung cancer organization, wants to learn about living with lung cancer from the point of view of people with lung cancer and their family and friends who provide care. to do this, we have an online study designed to better understand how treatments people living with lung cancer receive impact their quality of life. participants will complete surveys once a month for 12 months. what does participation involve? 1. emailing the study team to learn more and get access to the study website. 2. once a month for 12 months you will receive a survey by email. 3. complete these surveys on a smartphone, tablet, or computer at your convenience and receive an e-gift card for your time.

peer is an international study, that is institutional review board (irb) approved and general data protection regulation (gdpr) compliant. the study objective is to collect longitudinal data to facilitate a rigorous understanding of the diagnostic and treatment experiences of people diagnosed with lung cancer and to identify determinants of treatment heterogeneity. study data will be used to understand the diagnostic and treatment pathways, explore patient-experience data in different domains (financial impact/quality of life/symptoms) and test the hypothesis that different classes of therapies (chemotherapy/ immunotherapy/ targeted therapy/ surgery/ radiation) impact patient experience (eg., physical function). study participants will consent and register for the study and complete an initial baseline survey. they will then be followed for 12 months and receive a monthly survey (11 surveys in total) via email. the development of the surveys was guided by input from patients, clinicians, fda experts, and incorporates questions from existing patient-reported outcomes (pro) measures. summarized study results will also be posted on lungevity's website. external researchers will be able to apply to have limited access to de-identified data.

Eligibility criteria:
inclusion criteria: * adults with self-reported lung cancer diagnosis or caregiver of someone with a self-reported lung cancer diagnosis (patient has to be alive) * ability to read and answer questions in english * access and ability to use a computer or other internet-connected device exclusion criteria: * younger than 18 * healthcare providers and healthcare professionals who provide care to lung cancer patients except for those who are themselves a patient or a caregiver to a loved one. * not able to provide informed consent

Keywords: lung cancer patient caregiver smoker non-smoker tobacco use tobacco exposure biomarker non-small cell lung cancer (nsclc) small cell lung cancer (sclc) quality of life treatment
prenatal steroids for treatment of congenital cystic adenomatoid malformations (ccam)

Conditions: Congenital Cystic Adenomatoid Malformation

Summary: congenital cystic adenomatoid malformations (ccams) are theorized to be growing immature lung tissue. administration of maternal steroids in the mid-trimester may stop the growth or decrease the size of the ccam, thus increasing normal lung tissue and improving survival in fetuses with large ccams. this is a prospective, blinded, randomized trial comparing administration of a single course of antenatal steroids (betamethasone) to control (i.e., placebo). the primary outcome variable will be incidence of hydrops. one month postnatal survival and relative size of the ccam as determined by ccam volume:head circumference ratio (cvr) between treatment/no treatment groups will be secondary outcome variables. change in size of ccam will be serially followed for both groups with individual growth curves being plotted prenatally and these will be compared with pathology weigh and volume to evaluate treatment effect. other prenatal data collected will include: incidence of polyhydramnios, incidence of premature rupture of membranes, incidence of material complications. we will also compare mode of delivery, postnatal respiratory compromise, need for resection in the first week of life, and occurrence of complications during newborn administration


Eligibility criteria:
inclusion criteria: * ga \< 26 weeks * maternal age \> 18 years of age * singleton pregnancy * normal chromosomes * ccam volume to head circumference ratio (cvr) \> 1.4 * no maternal medical/surgical contraindications * no evidence of hydrops * not previously randomization exclusion criteria: * maternal diabetes or use of insulin * preterm labor * multiple congenital anomalies with ccam * chromosomal anomaly with ccam * multiple gestation pregnancy with ccam * not willing to be randomized * unable or unwilling to return to ucsf for second dose of drug or placebo * cvr \< 1.4

Keywords: prenatal steroids hydrops congenital cystic adenomatoid malformation of the lung prenatal intervention betamethasone prenatal diagnosis
study of cerebral compliance in neurosurgical intensive care units (ec2)

Conditions: Cerebrospinal; Disorder

Summary: despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy. in treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box.

this study aims to analyse the shape of the different components of the intracranial pressure waves (p1, p2, and p3) when the patient is flattened to determine an index to define the level of cerebral compliance.

Eligibility criteria:
inclusion criteria: * continuous intracranial pressure monitoring * sedated patient on mechanical ventilation exclusion criteria: * craniectomy * major hemodynamic failure

Keywords: cerebrospinal compliance intracranial pressure. head injury pulse waveform
intravenous iron in patients with anemia of chronic kidney disease

Conditions: Kidney Failure, Chronic

Summary: the objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.

this is a randomized, open label, phase iv study in anemic predialysis patients (hb between 8 and 11.5 g/dl) who require iron supplementation. the duration of the study for each patient will be approximately 6 months. patients will be randomized to one of two treatment arms and admitted to the anemia correction phase (days 1-43). treatment will be intravenous iron sucrose alone versus iron sucrose plus rhepo. the main treatment evaluation will at the end of the correction phase: the primary end-point will be the change of hemoglobin during correction phase. secondary end-points will be the change of ferritin and transferrin saturation from baseline to day 43. safety assessments will include recording of adverse events, vital signs, physical examinations and clinical laboratory tests. incidence and severity of adverse events will be compared between the two different treatment arms.

Eligibility criteria:
inclusion criteria: chronic kidney disease anemia (hb 8 - 11.5 g/dl) age above 18 years signed informed consent exclusion criteria: rapid progression of kidney disease need for dialysis uncontrolled hypertension

Keywords: chronic kidney disease anemia intravenous iron recombinant human erythropoetin
clinical impact of bacteriuria on chronic inflammation in asymptomatic hemodialysis patients

Conditions: Inflammation on Dialysis; Bacteriuria in Hemodialysis Patients

Summary: when considering occult infections during the diagnostic workup of inflammation in hemodialysis (hd) patients, the urine-deprived bladder is frequently dismissed as potential site of infection. the urinary tract, even in end stage renal disease (esrd) patients on hemodialysis may represent a significant reservoir for infection. delayed diagnosis is a relevant issue because the urinary tract is often overlooked as a source of infection in dialysis patients, especially because of absence of urinary tract infection (uti) symptoms in hd patients. contributing factors to asymptomatic uti in hd patients include the presence of low urine volume, bladder stasis, and the fact that uti symptoms are mostly related to voiding, which is reduced or absent in these patients. persistence of asymptomatic bacteriuria and uti may be related to higher levels of inflammatory markers in hd population. in view of the association between cardiovascular disease and cardio-vascular and all-cause mortality with inflammation, as expressed by elevated crp and/or il-6 levels in hd patients, the investigators questioned whether presence of asymptomatic uti could contribute to elevated levels of inflammatory markers in patients with esrd on maintenance hd therapy. such a finding would provide a potential link between a treatable infection and a potential cardiovascular risk factor in this population.


Eligibility criteria:
inclusion criteria: 1. male or female, age \> 18 years, in chronic hemodialysis treatment at least 3 months 2. stable and adequate hemodialysis treatment three months prior to participation in study as defined by kt/v \> 1.2 and hemodialysis performed at least 3 times weekly 3. patients with native a-v fistula or graft 4. informed consent obtained before any trial-related activities exclusion criteria: 1. patients with an indwelling catheters 2. patients with periodontitis 3. patients with diabetic foot 4. patients with active malignant disease or liver cirrhosis 5. patients on chronic treatment with steroids on doses \> 10 mg/day prednisone (or equivalent) 6. patients treated with immunosuppressive agents 7. patients suffering from * acute vasculitis * severe systemic infections * heart failure (nyha class iii-iv)

Keywords: hemodialysis inflammation bacteriuria interleukin 6 c reactive protein
study to assess safety and tolerability in adults with growth hormone-deficiency (ghd)

Conditions: Growth Hormone Deficiency

Summary: this study assesses the safety and tolerability of weekly tv-1106 compared to daily rhgh in adults with ghd who have previously been treated with rhgh.


Eligibility criteria:
inclusion criteria: * males and females 18 years of age or over * diagnosis of adult ghd for at least 6 months, or patients who have hypopituitarism from surgical resection * treated with a stable dose of daily rhgh for at least 3 months prior to screening * stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening * other criteria apply, please contact the investigator for more information exclusion criteria: * patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator * presence of contraindications to rhgh treatment * patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening * patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year * patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening * presence of prader-willi syndrome, turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active cushing's syndrome in the past year. * patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (hba1c) ≥8% * patients using weight reducing agents or appetite suppressants * other criteria apply, please contact the investigator for more information