Kornimate/medical-research-clean huggingface dataset:
healthy start: exploring the fuel-mediated programming of neonatal growth

Conditions: Pregnancy; Obesity

Summary: the purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring.


Eligibility criteria:
inclusion criteria: * pregnant women and infants * prior to 23 completed weeks of gestation * live in colorado exclusion criteria: * multiple gestation * preexisting * cancer * psychiatric disease * steroid-dependent asthma, or * diabetes * previous premature delivery prior to 25 weeks gestation or fetal demise

Keywords: body composition body size
icf-based evaluation of the upper extremity in children with quadriparetic cerebral palsy

Conditions: Upper Extremity Spasticity; Quadriplegic Cerebral Palsy

Summary: cerebral palsy (cp) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills resulting from permanent, non-progressive damage to the developing brain before, during, or after birth. the worldwide prevalence of cp is 2-3 per 1000 live births. spastic cp accounts for approximately 85% of all cp cases. among the types of spastic cp, quadriparetic cp (qcp) is the most severe and accounts for 20% of spastic cp cases. individuals diagnosed with quadriparetic cerebral palsy (qcp) are restricted from participating in daily life activities due to inadequate upper extremity function (spasticity, muscle weakness, inability to perform isolated movements, and limitation of supination movements). in order to correctly evaluate children diagnosed with qcp and determine treatment priorities, it is very important to evaluate them based on the international classification of functioning, disability, and health (icf). in the literature, there is no study that evaluates the upper extremity of individuals with isolated qcp based on icf. the aim of this study is to examine the upper extremity functions of individuals with isolated qcp diagnosis within the framework of icf.

it is an observational study. purpose of the study: to examine the upper extremity functions of individuals with an isolated diagnosis of quadriparetic cerebral palsy (qcp) within the framework of icf. participants: children with quadriparetic cp between the ages of 0-17. questions: * what is the relationship between upper extremity spasticity and manual dexterity in children with qcp? * what is the relationship between manual skills and activities of daily living in children with qcp? the upper extremities of the patients with qcp will be evaluated within the framework of icf. body structure and functions will be evaluated with the modified ashworth scale (mas), activities with the manual ability classification system (macs), and participation with the functional independence measure for children (weefim). the evaluations will be made by physiotherapists experienced in children with cp.

Eligibility criteria:
inclusion criteria: * the age of the cases is between 0-17, * they have been diagnosed with quadriparetic cp, * the participants and parents want to participate in the study voluntarily. exclusion criteria: * having different types of cp such as dyskinetic, ataxic and mixed type, * having spastic diparetic or hemiparetic type cp, * having any history of surgery on the musculoskeletal system, * having received botulinum toxin injection within the last 6 months.

Keywords: icf body structure and function activity participation cerebral palsy upper extremity
an effectiveness study of the cool kids programme

Conditions: Anxiety Disorder

Summary: the aim of the present study is to investigate the effectiveness of the cool kids programme after implementation in two outpatient psychiatric clinics for children in southern jutland, denmark. the cool kids programme is a manualised cognitive behavioural treatment programme for children aged 6 to 12 years with anxiety disorders. previous efficacy studies have found that 60-80% of all children who complete the program show marked improvement. however, only one previous effectiveness study has ever been conducted. it is therefore relevant to examine whether the previously mentioned effect is maintained when the programme is implemented in a healthcare setting rather than a research setting.

the study was conducted at two outpatient psychiatric clinics for children in southern jutland, denmark. data was gathered from 55 patients who completed the cool kids programme as a treatment for anxiety disorder(s) from autumn 2013 to spring 2016. during the course of treatment both children and parents completed the child anxiety life interference scale (calis) at baseline, post-treatment and at a 3-months follow-up booster-session. this data was originally gathered for internal quality assessment at the clinics. as the data was utilized for the present study in 2017, it has not been possible to control for confounding factors or influence the data-collection process. all questionnaires were anonymised previous to being manually scored and keyed for secured electronic storage. participants were excluded from the data analysis if they had one or more incomplete or missing calis. all statistical analysis was carried out in ibm spss 24 statistical software and consists of linear mixed effect models and one-way repeated measures anovas.

Eligibility criteria:
inclusion criteria: * primary diagnose: anxiety or obsessive-compulsive disorder according to icd-10 criteria (f40-f42; f93) exclusion criteria: * comorbid diagnoses of: * autism spectrum disorder * conduct disorder * untreated or severe adhd * low intelligence quotient (iq)

Keywords: anxiety child cognitive behaviour therapy cbt effectiveness treatment cool kids
extension study to evaluate the long-term safety, tolerability, and efficacy of sbc-102 (sebelipase alfa) in adult subjects with lysosomal acid lipase deficiency

Conditions: Cholesterol Ester Storage Disease (CESD); Lysosomal Acid Lipase Deficiency; LAL-Deficiency

Summary: this was an extension study to study lal-cl01 (nct01307098). the primary objective of the study was to evaluate the long-term safety and tolerability of sebelipase alfa in participants with liver dysfunction due to lysosomal acid lipase (lal) deficiency.

participants who successfully received all 4 doses of sebelipase alfa in study lal-cl01 and opted to continue treatment in the extension study underwent screening assessments to determine study eligibility. eligible participants initiated treatment in the extension study at least 4 weeks after their last dose of sebelipase alfa in study lal-cl01. this extension study consisted of a treatment period of up to 5 years, and a follow-up period of approximately 30 days after the last dose of sebelipase alfa. cholesteryl ester storage disease (cesd) is the late onset phenotype for lal deficiency, a lysosomal storage disorder, which also has an early onset phenotype that primarily affects infants. cesd can present in childhood but often goes unrecognized until adulthood when the underlying pathology is advanced. many of the signs and symptoms are common to patients with other liver conditions. cesd is an autosomal recessive genetic condition and is characterized by hepatomegaly, persistently abnormal liver function tests (lfts) and type ii hyperlipidemia. splenomegaly and evidence of mild hypersplenism may affect some patients. untreated, cesd may lead to fibrosis, cirrhosis, liver failure and death.

Eligibility criteria:
inclusion criteria: * participant received all 4 scheduled doses of sebelipase alfa in study lal-cl01 with no life-threatening or unmanageable study drug toxicity. exclusion criteria: * clinically significant concurrent disease, serious inter-current illness, concomitant medications or other extenuating circumstances * clinically significant abnormal values on laboratory screening tests, other than lfts or lipid panel tests

Keywords: enzyme replacement therapy (ert) lysosomal storage disease late onset lysosomal acid lipase (lal) deficiency acid cholesteryl ester hydrolase deficiency, type 2 acid lipase disease cholesterol ester hydrolase deficiency lal deficiency lipa enzyme deficiency
safety and health intervention project

Conditions: Drug Overdose; Opioid Related Disorders

Summary: use of opioid medications for treatment of pain has increased greatly in the u.s., with the average quantity of prescribed opioids increasing 700% in a decade, from \~100 morphine milligram equivalents (mme) per person to \~700 mme per person from 1997 to 2007. there have been concurrent increases in opioid-related adverse outcomes, such as extramedical use, opioid use disorders, and overdose. as a result, there were more unintentional poisoning deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640). additionally, the number of americans seeking treatment for opioid use disorders has increased; in samhsa's treatment episode data set, prescription opioids were the primary substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530% increase. the specific aims of this project are to: (1) refine a motivational enhancement prevention intervention for prescription opioid overdose risk reduction and improved witnessed overdose response for at-risk patients in addictions treatment; (2) conduct a pilot randomized controlled trial comparing the prescription opioid overdose prevention intervention to a supportive educational control condition for patients in addictions treatment in order to: (a) obtain information about the feasibility of randomized controlled procedures; and (b) determine the distribution and variability of the primary (overdose risk behaviors) and mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk, knowledge of overdose risk factors and symptom recognition) outcomes; and (3) determine the distribution and variability in changes in hiv risk behaviors (e.g., reductions in injection of prescription opioids) over follow-up.


Eligibility criteria:
inclusion criteria: * patients 18 and older in treatment at cpi * able to provide informed consent. exclusion criteria: * acute suicidality * psychiatric condition that precludes participation in the intervention * inability to speak and understand english * inability to give informed, voluntary, written consent for any reason
phase i/ii hypofractionated radiotherapy for prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to examine the clinical feasibility of using intensity-modulated radiation therapy (imrt) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. progressively larger fraction sizes will be delivered in a phase i design based on both acute and long-term tolerances to the treatment. the dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. the delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. phase ii will commence with maximum tolerated dose (mtd) finding with up to 200 additional patients being enrolled during this phase of the study.


Eligibility criteria:
inclusion criteria: histologically proven adenocarcinoma of the prostate. * stage ≤ t2b disease, as defined by 1997 american joint committee on cancer (ajcc) classification * predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), or histologically negative pelvic nodes * gleason score ≤ 7 * no evidence of distant metastasis * age 18+ * informed consent signed in accordance with institutional protocol * pretreatment evaluations must be completed as specified in section 7.0. * ecog performance status 0-1 * no previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years * no prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * gonadotropin-releasing hormone agonist (gnrh-a) use permitted (maximum of 6 months duration). anti-androgen therapy permitted concurrently with gnrh-a. * no previous or concurrent cytotoxic chemotherapy * no radical surgery or cryosurgery for prostate cancer * the absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy * the absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol. * no current use of anticoagulation therapy, other than aspirin.
effects of probiotics on the gut microbiome and immune system in operable stage i-iii breast or lung cancer

Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Breast Adenocarcinoma; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8

Summary: this clinical trial evaluates whether engineering gut microbiome using probiotics will alter the body's immune system to react to stage i-iii breast or lung cancers that can be removed by surgery (operable). having diverse species of bacteria inside the bowel may help improve the immune system, particularly the ability of the immune system to recognize cancer. taking probiotics may change the diversity and make up of the bacteria in the bowels, and change how the immune system reacts to breast or lung cancer.

primary objectives: i. to conduct a pilot study of probiotics prior to surgery in operable breast and lung cancer patients. ii. to evaluate systemic and intratumoral immunomodulatory effects of probiotics in operable breast and lung cancer patients. outline: patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. patients receive probiotics orally (po) once on day 1, and then twice daily (bid) or three times daily (tid) for 2-4 weeks before standard of care surgery. patients also undergo collection of tissue samples during standard of care surgery.

Eligibility criteria:
inclusion criteria: * \>= 18 years of age * histologically confirmed adenocarcinoma of the breast operable stage i-iii or histologically confirmed carcinoma of the lung operable stage i-iii will be enrolled prior to their definitive surgery * patients must have adequate organ function * patients must be willing to provide tissue, blood and stool samples for the research study exclusion criteria: * patients must not receive systemic neoadjuvant therapy * patients must not have taken any probiotics in the past 30 days prior to the enrollment * patients with autoimmune disease, immune deficiency such as human immunodeficiency virus (hiv), irritable bowel, known diverticulosis, and other serious gastrointestinal (gi) conditions at treating physician's discretion will be excluded
mobile application support for women with breast cancer undergoing chemotherapy

Conditions: Breast Neoplasms

Summary: mobile phones have become an essential tool for everyday life. the convenience and easy accessibility of the data and information received through mobile phones have made mobile applications as the latest trend to provide education for patients in medical centers. in taiwan, breast cancer incidence has been the highest among all cancers and the fourth leading cause of cancer deaths in women. women with breast cancer who are undergoing chemotherapy suffer from a number of symptoms throughout the chemotherapy treatment that detrimentally affects their quality of life. thus, providing social support and nursing care aids for these vulnerable women is imperative to help them face their breast cancer challenges. this study will develop a mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers. this study will use a mixed-methods design to develop a mobile device application based on breast cancer literature and the clinical experiences of breast cancer patients to fulfill the needs women may experience during the chemotherapy treatment. women with breast cancer will be invited to help refine the mobile device application's content based on their experiences and feedback about the mobile application. upon completing the mobile application development, women with breast cancer patients will be recruited to participate in a randomized controlled trial to examine the effectiveness of the mobile application. the results of this study will provide a foundation to deliver a remote, personalized, and continuous health care model to improve the self-efficacy, social support, and quality of life of women with breast cancer, and ultimately enhancing the overall quality of care and patient satisfaction with the medical care participants receive.

this application has four modules: 1) a learning forum; 2) a ask-the-expert forum; 3) a website link forum; 4) a encouragement forum. the intervention group will receive routine care plus access to the "b with you" program during their six cycles of chemotherapy. self-efficacy, social support, and quality of life will be measured at baseline, then the 3rd and 6th cycles of chemotherapy.

Eligibility criteria:
inclusion criteria: * at least 20 years of age. * diagnosed with breast cancer for the first time. * treated with chemotherapy at the study sites. * able to access the internet with a mobile phone. * fluent in spoken and written chinese . exclusion criteria: * patients with cognitive dysfunction. * diagnosed mental health problems. * having with other cancers.

Keywords: breast cancer mobile applications self-efficacy social support quality of life
internet-based support for young people with adhd and autism - a controlled study

Conditions: ADHD; Autism Spectrum Disorders

Summary: young people between age 15 and 25 with adhd and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. parents complete an assessment scale for the next of kin. after treatment the young people are interviewed regarding the quality of the intervention. a comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual and is assessed at the same time points as the intervention group. the individuals are not randomized due to difficulties to recruit if the individuals do not know group assignment in advance.

young people between age 15 and 25 with adhd and/or autism spectrum disorders are consecutively included in the project and are offered coaching and support during eight weeks over the internet (chat and e-mail) twice a week. data is collected before and after the intervention as well as six months after end of treatment using self-report questionnaires (sense of coherence (soc), rosenberg self esteem scale, manchester short assessment of quality of life (mansa), montgomery asberg depression rating scale (madrs), and hospital anxiety and depression scale (had)). a parent or a partner completes an assessment scale for the next of kin. when treatment is completed, the young people are interviewed using a structured interview pertaining to the quality of the intervention. a comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual (tau) and is assessed at the same time points as the intervention group. the individuals are not randomized to the intervention and comparison groups due to difficulties to recruit if the individuals do not know group assignment in advance. in all, 24 individuals will be offered the intervention and 24 individuals will receive tau.

Eligibility criteria:
inclusion criteria: * adhd and/or autism spectrum disorder * age 15 to 30 exclusion criteria: * no current antisocial behaviour, psychotic symptoms and/or alcohol/substance abuse

Keywords: adhd autism spectrum disorders controlled internet based coaching
study evaluating the effect of high-fat meal on bioavailability and pharmacokinetics of single dose of moxidectin

Conditions: Infection

Summary: the primary objective of this study is to assess the effect of a high-fat meal (breakfast) on the concentrations of moxidectin measured in the blood after a single oral administration in healthy subjects.


Eligibility criteria:
inclusion criteria * men or women of non childbearing potential aged 18 to 50 years inclusive at screening. * body mass index (bmi) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg. exclusion criteria * any clinical important deviation from normal limits in physical examination findings, vital sign measurements, electrocardiograms or clinical laboratory test results. * presence or history of any disorder that may prevent the successful completion of the study.
a study to investigate the pharmacokinetics, safety and tolerability of chf 5993 pmdi in subjects with renal impairment.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of chf 5993 pressurised metered dose inhaler (pmdi) in subjects with different level of renal impairment in comparison with matching healthy volunteers. moreover, the safety and tolerability of the study drug will be also evaluated.


Eligibility criteria:
inclusion criteria: * healthy volunteers and * subjects with mild, moderate and severe renal impairment exclusion criteria: * pregnant or lactating women * positive hiv and hepatitis serology * history of drug abuse * history of hypersensitivity to the products used in the trial * smokers * respiratory disease such as asthma and copd * clinically relevant concomitant disease that may introduce a risk for the subjects'safety * presence of kidney stones * dialysis