Kornimate/medical-research-clean huggingface dataset:
a phase 1 study of cnto 3157 in healthy volunteers and patients with asthma

Conditions: Asthma

Summary: this is a phase 1, safety study of cnto 3157 in healthy subjects and subjects with asthma.

a phase 1, randomized (study drug assigned by chance), double blind (neither physician nor patient knows if cnto 3157 or placebo has been assigned), placebo controlled, single, ascending-dose study of cnto 3157 in healthy volunteers and multiple dose study in patients with asthma. this study will compare the effects (both good and bad) of cnto 3157 to those of placebo. the purpose of this study is to evaluate the safety and potential side effects of cnto 3157 given to healthy volunteers and patients with asthma. in addition, the investigators will measure how much study drug is in the blood following a dose of cnto 3157, and determine if the body makes antibodies to it. (an antibody is a protein made by the body in response to a foreign substance). safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. there will be 2 parts to this study. the first part of this study will involve healthy volunteers, and the second part of the study will involve patients with asthma. about 56 healthy volunteers and 16 asthmatic patients will take part. volunteers will be required to stay at the research center after study agent administration for an inpatient portion of the study and then return for required out-patient visits. up to approximately 8 different dose levels will be studied. cnto 3157 will be administered by iv infusion. the duration of volunteer participation will be up to 21 weeks in part 1 and up to 24 weeks in part 2.

Eligibility criteria:
inclusion criteria: * healthy male or female between 18 and 55 years of age inclusive with no clinically significant abnormalities and have a body weight of 50 to 100 kg * patients with asthma must have been diagnosed at least 6 months prior to participation in the study exclusion criteria: * currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, immune deficiency state, respiratory disease (other than asthma for part 2), hepatic or gi disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease * have a positive pregnancy test at screening or prior to dose administration * have smoked tobacco or related products within 6 months prior to dosing * donated blood equal to or greater than ¿450 ml within 60 days prior to participation in the study * recent history (within previous 6 months) of alcohol or drug abuse

Keywords: cnto 3157 healthy volunteers asthma
a study of cabozantinib compared with placebo in subjects with radioiodine-refractory differentiated thyroid cancer who have progressed after prior vascular endothelial growth factor receptor (vegfr) -targeted therapy

Conditions: Differentiated Thyroid Cancer

Summary: the objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (pfs) and objective response rate (orr) in subjects with radioiodine-refractory differentiated thyroid cancer (dtc) who have progressed after prior vascular endothelial growth factor receptor (vegfr)-targeted therapy.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of differentiated thyroid cancer (dtc) 2. measurable disease according to response evaluation criteria in solid tumors (recist) 1.1 3. previously treated with or deemed ineligible for treatment with iodine- 131 for differentiated thyroid cancer (dtc) 4. previously treated with at least one of the following vascular endothelial growth factor receptor (vegfr)-targeting tyrosine kinase inhibitor (tki) agents for dtc: lenvatinib or sorafenib. note: up to two prior vegfr-targeting tki agents are allowed 5. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 exclusion criteria: 1. prior treatment with any of the following: cabozantinib; selective small-molecule v-raf murine sarcoma viral oncogene homolog b1 (braf) kinase inhibitor; more than 2 vegfr-targeting tki agents; more than 1 immune checkpoint inhibitor therapy; 1 systemic chemotherapy regimen (given as single agent or in combination with another chemotherapy agent) 2. receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before randomization 3. receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization 4. receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization. 5. known brain metastases or cranial epidural disease unless adequately treated

Keywords: thyroid cancer, papillary papillary thyroid carcinoma nonmedullary thyroid carcinoma cancer of the thyroid thyroid cancer follicular thyroid cancer thyroid cancer, follicular hürthle cell cancer
computer-based training (retraining) for people with gambling problems

Conditions: Gambling, Pathological

Summary: the study examines the efficacy and acceptance of a computer-based training program for individuals with problematic or pathological gambling behavior. the study intends to investigate the extent to which the computer-based training program leads to a significant reduction in pathological gambling (primary outcome) when compared to a control group. the study design is a randomized-controlled trial with one intervention group and one wait-list control group.

the study examines the efficacy of a computer-based training program for individuals with problematic and pathological gambling behavior. the main objective of the study is to investigate the extent to which the online program leads to a significant reduction in pathological gambling. the primary outcome is the pathological gambling adaptation of the yale-brown obsessive compulsory scale (pg-ybocs total score) as a measure of the severity of pathological gambling symptoms. secondary outcomes are further measures of gambling-related symptoms, such as the south oaks gambling screen (sogs), as well as rates of depression, measured with the patient health questionnaire - 9 items depression module (phq-9), and rates of impulsivity, measured with the impulsivity subscale of the eysenck's impulsivity inventory (i-7). the training is expected to lead to a significant reduction in problematic/pathological gambling behavior (pg-ybocs) and all secondary outcomes when compared to a control group. the study design is a randomized-controlled trial with one intervention group and one wait-list control group and two assessment times (pre and post). the intervention group receives the download link for the training program directly following the baseline survey and can use the training over a period of 8 weeks, whereas the wait-list control group receives access to the training after completion of the post-survey.

Eligibility criteria:
inclusion criteria: * informed consent * access to internet * sufficient command of the german language * willingness to participate in two short (25-30 minutes) online surveys * willingness to use the online program over a period of 8 weeks (participants who do not use the program are also included in the analysis) * willingness to leave an (anonymous) email-address * subjective need for treatment exclusion criteria: * presence of a lifetime diagnosis of schizophrenia or bipolar disorder * acute suicidal tendency (assessed with item 9 of the phq-9, ≥3)

Keywords: gambling, problematic gambling, pathological gambling
prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean section.

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. as a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. however, few studies had been indicated the ed50 (prevent postspinal hypotension in 50% of patients) and ed90 of prophylactic norepinephrine bolus and its potency compared to phenylephrine for postspinal anesthesia hypotension in patients undergoing caesarean section. the purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥37 weeks * american society of anesthesiologists physical status classification i to ii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension or baseline blood pressure ≥180 mmhg * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly

Keywords: norepinephrine phenylephrine postspinal anesthesia hypotension cesarean section
effect of snacks on appetite control

Conditions: Healthy Canadians; Appetite Control

Summary: this clinical trial is being conducted to study whether eating certain snacks will reduce your desire to eat and for a longer period of time compared to other snacks. the investigators are testing 2 different snacks. study #1 will involve eating 2 different seed-like snacks or water. study #2 will involve eating pita bread with jam, bread with jam or water. the test snack is higher in protein and/or fibre compared to the reference product.

healthy adults will be recruited to participate in a randomized, controlled, crossover study to investigate whether or not eating snacks made with buckwheat would increase satiety and reduce their energy intake when compared to a comparable snack. water was included as a non-caloric control. the study consisted of 3 visits and participants would receive a different treatment at each visit. visits were scheduled at least 7 days apart. visual analog scales will be used to assess appetite related sensations at 7 time points, fasting, 30 minutes after consuming the snack and then at 30 minute intervals for 180 minutes. participants will be provided with a lunch and the amount of food consumed will be weighed. i addition, participants will be asked to maintain a food record for the remainder of the day.

Eligibility criteria:
inclusion criteria: * body mass index 18-30kg/m2 * males and non-pregnant or non-lactating females exclusion criteria: * diagnosis of disease by a medical doctor that requires medical treatment during the study period. * daily tobacco use. * physical activity level \>1.8. * eat meals at irregular or unusual times. * food allergy, aversion or unwillingness to eat study foods. * use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite. * presence of a gastrointestinal disorder. * score \>65% on any 1 of the 3 categories of the three factor eating questionnaire-r18.

Keywords: satiety appetite snack
kiosk-model self-triage system in the pediatric emergency department

Conditions: Emergencies

Summary: an audio-assisted self-triage kiosk in the pediatric emergency department (ed) is expected to significantly reduce triage times, without any sacrifice of the quality of information that would be obtained by nurse-initiated triage.

with the rapid evolution of consumer based information technology patients have the opportunity to become collaborative partners in their care. in addition, by bridging information gaps and improving workflow efficiency, continuity of care is optimized and the potential risk for error is reduced. triage time for kiosk self-triage and nurse-initiated triage will be compared in terms of 1) triage time; 2) accuracy of medical history obtained; and 3) patient satisfaction.

Eligibility criteria:
inclusion criteria: * between 0 and 18 years of age * registered in the pediatric ed * accompanied by parent/guardian 18 years or older * version 3 emergency severity index (esi) of 3 to 5 * parent or guardian able to communicate in english or spanish exclusion criteria: * deemed medically unstable * esi score of 1 or 2 * incarcerated or in juvenile detention * parent/guardian unable to communicate in english or spanish

Keywords: triage automated admitting pediatric ed
a study evaluating the efficacy and tolerability of enstilar foam in patients with nail psoriasis

Conditions: Nail Psoriasis

Summary: the aim of the study is to evaluate the efficacy and safety of enstilar foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.

eligible subjects will be provided once daily enstilar foam (calcipotriene and betamethasone dipropionate). subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. the subject will be instructed to apply one application at night immediately before bed and not wash their hands before morning. all subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.

Eligibility criteria:
inclusion criteria: * must have a diagnosis of nail psoriasis in fingernail or toenails * history of plaque psoriasis or psoriatic arthritis * target nail will be koh negative for dermatophyte fungus * must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (phi) * between the ages of 18 and 85 years old * candidate for topical therapy in the opinion of the investigator exclusion criteria: * males and females unable to practice effective contraception throughout the study * unable to comply with the protocol * nursing mothers, pregnant women, and women planning to become pregnant while in this study * patients with erythrodermic or pustular psoriasis * sustained treatment to target fingernail within 6 months prior to screening * history of trauma or surgery to target fingernail * history of disease known to affect nails such as lichen planus, onychomycosis * history of systemic psoriasis therapy for less than 6 months

Keywords: enstilar foam
intracardiac flow remodeling in athletes

Conditions: Cardiac Remodeling, Ventricular

Summary: the uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. a better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are physiological or pathological. this prospective study proposes to assess in a trained-athlete population the cardiac remodeling in response to intensive exercise training. this study is observational, we do not interfere with athlete's training.


Eligibility criteria:
inclusion criteria: * age \> 18yrs old * ability to give written consent for participating in the study exclusion criteria: * age \< 18yrs old * cardiac diseases, arterial hypertension, cardiac devices, diabetes, renal, liver or pulmonary failure

Keywords: echocardiography intraventricular pressure gradients cardiac remodeling athletes
the effect of wearable technology-enhanced intervention on family caregivers

Conditions: Dementia

Summary: this study aimed to evaluate the effect of a smartwatch-supported intervention on the self-efficacy and quality of life of informal caregivers providing care to individuals with dementia. informal caregiving, especially in dementia, poses significant psychological and physical challenges. low self-efficacy among caregivers can negatively impact their coping skills, health behaviors, and overall quality of life. the intervention used commercially available smartwatches that provided real-time data on physical activity, sleep, and stress levels. these devices were used as part of a 8-week caregiver support program aimed at promoting better self efficacay and quality of life level of caregiver of dementia.

this study aimed to evaluate the effect of a smartwatch-supported intervention on the self-efficacy and quality of life of informal caregivers providing care to individuals with dementia. informal caregiving, especially in dementia, poses significant psychological and physical challenges. low self-efficacy among caregivers can negatively impact their coping skills, health behaviors, and overall quality of life. the intervention used commercially available smartwatches that provided real-time data on physical activity, sleep, and stress levels. these devices were used as part of a 8-week caregiver support program aimed at promoting self-care, stress awareness, and time management. this randomized controlled trial involved 44 participants, who were assigned to either the intervention group (smartwatch-supported care) or the control group (usual care). outcome measures included caregiver self-efficacy and quality of life, assessed both before and after the intervention using validated instruments. the study hypothesized that caregivers in the intervention group would demonstrate improved self-efficacy and better quality of life compared to those in the control group.

Eligibility criteria:
inclusion criteria: * a) able to speak and understand turkish, b) primarily responsible for the care of the pwd, c) provides at least 4 hours of care per day, d) owns a smartphone (for smartwatch integration), e) able to use both a mobile phone and a smartwatch (adherence tested through a descriptive characteristic form), f) willing to participate. exclusion criteria: * a)hospitalization of patient or caregiver due to acute condition, b) caregiver's visual or hearing impairment, c) new diagnosis affecting caregiver's mental health (e.g., depression).

Keywords: dementia caregivers telehealth wearable technology
a study of minirin melt in japanese patients with central diabetes insipidus (cdi).

Conditions: Central Diabetes Insipidus

Summary: this is an open-label dose-titration study in japanese central diabetes insipidus (cdi) patients designed to demonstrate the efficacy and safety of orally-disintegrating tablet of desmopressin.


Eligibility criteria:
inclusion criteria: * participants must be documented to have central diabetes insipidus (cdi) by at least two of the following four criteria (a-d): 1. failure to increase urine osmolality above 300 mosm/kg during a period of fluid deprivation sufficient to raise plasma osmolality and sodium above the upper limit of normal level for the reference laboratory (usually 295 mosm/kg and 148 meq/l, respectively) 2. complete and continuous control of the di by desmopressin therapy without "breakthrough" diuresis, hypernatremia, hyponatremia, or symptoms or signs of water intoxication. 3. a deficient plasma vasopressin response to osmotic or non-osmotic stimulation. 4. absence of the posterior pituitary bright spot on t-1 weighted midsagittal magnetic resonance imaging (mri) of the brain. * given written informed consent prior to any trial-related procedure is performed * 24 hour urine volume (ml), urine osmolality (mosm/kg), urine specific gravity, and serum sodium (meq/l) maintained at a normal level by desmopressin nasal administration * outpatient * the participant is, in the investigator's opinion, otherwise healthy * be willing and able to comply with the protocol requirements including restriction of water intake exclusion criteria: * presence or a history of nephrogenic diabetes insipidus or diabetes mellitus * presence of uncorrected hypothyroidism, hypoadrenalism or hypogonadism * abnormalities or disease of the oral cavity that might affect the release and absorption of drug * unable to be placed on water-intake restriction starting from two hours before bedtime * presence of a hypothalamus abnormality leading to thirst disorder * evidence of hepatic, renal, cardiac, or pulmonary dysfunction * uncontrolled hypertension * treatment with another investigational product within the past 3 months * concurrent treatment with diuretics, chlorpropamide, tricyclic antidepressants, indomethacin, carbamazepine * alcohol dependency or drug abuse * breastfeeding, pregnant, or likely to become pregnant * a mental condition, the lack of decision-making ability, dementia or a speech handicap * any other reason that the investigator believes inappropriate

Keywords: diabetes
understanding immunity to the flu vaccine in covid-19 patients

Conditions: Corona Virus Infection; Flu Vaccine; Immunity

Summary: the purpose of this study is to measure immunity to the flu vaccine over time in patients who have had covid-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term covid-19 symptoms. adults and children (age 13 to 64) who had been diagnosed with covid-19 as well as controls without covid-19 will be invited to participate in this study.


Eligibility criteria:
inclusion criteria: * age 13 through 64 years * diagnosed with covid-19 at least 2 months prior enrollment * patients with or without obesity, diabetes, chronic fatigue and/or long term covid-19 symptoms * patients without covid-19 diagnosis for controls exclusion criteria: * received the influenza vaccine less than 4 months ago * pregnant or lactating * patients with special risks attendant to venipuncture * use of immunomodulatory medications * immunodeficiency or autoimmune disease
effects of expiratory muscle training on cough efficacy in children and adolescents with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is an autosomal recessive genetic disease characterized by recurrent airway infections, affecting many systems including lung, pancreas and sweat glands. cough is an important defense mechanism for clearing the secretions that increase in respiratory diseases. there have been studies investigating the effect of expiratory muscle training on disease groups such as chronic obstructive pulmonary disease, multiple sclerosis, parkinson's disease, and the elderly and healthy individuals. studies that evaluating effects of expiratory muscle training in cystic fibrosis are limited in the literature. the aim of this study was to evaluate the effect of cough strength in children and adolescents with cf and the effect of expiratory muscle training program on cough strength, exercise capacity, respiratory muscle strength and quality of life.


Eligibility criteria:
inclusion criteria: * diagnosed with cystic fibrosis * 8-18 years * clinically stable during last six weeks exclusion criteria: * hemoptysis * low saturation (spo2\<90%) * acute lower respiratory tract infection * cardiac problems (heart failure, arrhythmia, cardiomyopathy, etc.) * cognitive problems * pneumothorax

Keywords: expiratory muscle training cough respiratory muscle strength exercise capacity