Kornimate/medical-research-clean huggingface dataset:
short- and long term growth in children with asthma

Conditions: Asthma

Summary: the purpose of this study is to assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma

when children with asthma are treated with inhaled corticosteroids there is a risk of systemic adverse events such as growth suppression. it has been reported that treatment with budesonide 200 microgram per day does not affect short term growth in children with asthma. the aim of the present study is to assess if an unaffected short term growth means that also long term growth will be unaffected. short and long term growth in asthmatic children treated with budesonide will be compared with the growth in asthmatic children treated with montelukast.

Eligibility criteria:
inclusion criteria: * age 6-11, * prepubertal, * asthma, * normal weight and height, * informed consent exclusion criteria: * treatment with systemic/inhaled/intranasal corticosteroids within the last week, * major surgery within 4 weeks, * usage of drugs that significantly inhibit cyp3a4
circulating tumor dna as an early marker of recurrence and treatment efficacy in ovarian carcinoma

Conditions: Ovarian Carcinoma

Summary: prospective multicentre assay to assess ctdna value for ovarian cancer monitoring and disease recurrence after front-line treatment.

the main objective is to explore the capacity of ctdna to be an early marker of ovarian carcinoma recurrence after front-line treatments, i.e. to show significant modifications before clinical diagnosis of disease relapse. prospective multicentre open-label study during visits in the frame of management of the disease, blood samples will be collected at diagnosis, after each cycle of eventual neoadjuvant chemotherapy, every 6 months during the following 2 years, and every year during the remainin time of follow-up. tumor samples will be collected at surgery or through a biopsy. patients will then have a standard care follow-up for a period of 5 years.

Eligibility criteria:
inclusion criteria: 1. patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy. 2. indication of preoperative and/or adjuvant chemotherapy. 3. age ≥ 18 years old. 4. patient affiliated to the ''national security'' regimen or beneficiary of this regimen 5. signed written informed consent prior to any screening procedures being performed non inclusion criteria: 1. contraindication to surgical assessment. 2. pathological diagnosis of mucinous carcinoma. 3. history of concurrent malignancy or malignancy within 5 years before study enrollment, (with the exceptions of adequately treated non melanomatous skin cancer or curatively re-sected noninvasive cervical cancer). 4. assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol. 5. patient in urgency situation, adult under legal protection, or unable to give his consent. exclusion criteria after histological exam: any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.
using infrared spectroscopy for diagnosis severity of nonalcoholic fatty liver disease

Conditions: Fatty Liver; Non-alcoholic Fatty Liver Disease

Summary: the main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from nash


Eligibility criteria:
inclusion criteria: * patients who have undergone a liver biopsy for simple fatty liver or nash and for which a serum sample is serum bank * men or women * aged of 18 years or more * after giving their consent to participate in research exclusion criteria: * known cancer * refusal of consent * inflammatory disease
supporting women with breast cancer to practice dibh at home before radiation therapy

Conditions: Health Literacy; Distress, Emotional; Preparedness; Mobile Application

Summary: to examine the effect of a preparatory digital tool including a new instruction for deep inspiration breath hold (dibh), before start of radiation therapy in women diagnosed with left sided breast cancer, compared with usual care.

the following questions will be posted: * are there any differences in levels of distress (primary outcome) between the control and intervention group at baseline and over time? * are there any differences in preparedness for rt (secondary outcomes) between the control and intervention group at baseline and over time? * are there any correlations between health literacy (hl) levels (secondary outcome) and levels of distress (primary outcome) in the control and intervention group? * are there any differences in objective clinical variables (chest mobility and respiratory movements and planned absorbed dose to the heart) between the control and intervention group before and after the intervention (baseline and at planning ct)? * which patterns of practice and use of the application (when, how, how often and for how long) can be discerned from the intervention group? * are there any correlations between different levels of practice and use of the digital tool and primary and secondary outcomes? * how do patients in the different groups (control and intervention group) describe their experience of care and information process during rt with dibh? * are there differences regarding health economic variables in terms of costs and health care usage (e.g., estimated time for planning and conducting computed tomography (ct), number of scheduled ct examinations) and patient effects (e.g. co-morbidities (heart related), sick leave, and quality-adjusted life year (qalys) between patients in control- or interventions group? * are there any differences regarding effects on environmental aspects and costs in the different groups (control and intervention)?

Eligibility criteria:
inclusion criteria: inclusion criteria for the study: * patients \> 18 years of age * with a left-sided breast cancer diagnosis or dcis * who are to receive rt with dibh technology * with curative intention * preparatory ct visit minimum 7 days to a maximum of 4 weeks * able to speak and understand good enough swedish to be able to assimilate content in the mobile app and answer surveys and interview questions * have access to a smart mobile phone. exclusion criteria: * patients receiving palliative rt or neoadjuvant chemotherap * planning ct starting \< 7 days * people with some form of orthopedic, rheumatological or neurological injury or disease that limits the possibility of carrying out the intervention.

Keywords: dibh rct radiotherapy mobile application distress
addition of januvia (sitagliptin) improves glycemic control in patients inadequately controlled by metformin (mk0431-078)

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: to compare the efficacy of three strategies of lifestyle changes associated with januvia (sitagliptin) 100 mg/day in patients with type 2 diabetes mellitus (t2dm) inadequately controlled by metformin (hemoglobin a1c \[hba1c\] 6.5-9%). a difference between the three strategies of lifestyle changes was expected.


Eligibility criteria:
inclusion criteria: * man or woman aged \>/= 18 years,with t2dm and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (hba1c 6.5-9%) exclusion criteria: * daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months. * hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis * known hypersensitivity or contraindication to metformin
vibrotactile coordinated reset for the treatment of advanced parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of our study is to evaluate vibrotactile coordinated reset stimulation (vcr) and its effects on advanced stage parkinson's symptoms. vcr will be administered with a device called the stanford cr glove. vcr is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. patients will be followed for two years.

this study involves gentle vibrations delivered to the finger-tips which have been shown in pilot studies to be effective in reducing motor symptoms associated with parkinson's disease.

Eligibility criteria:
inclusion criteria: 1. age at the time of enrollment: 18 years of age or older 2. idiopathic parkinson's symptoms between hoehn and yahr stages 2 to 4 3. fluent in english 4. if patient is on medication that affects brain function or alters eeg activity, the patient must feel comfortable going off this medication prior to eeg recording 5. appropriate social support if required during an off state. 6. comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes. 7. feels comfortable going off pd related medication during in person study visits. 8. lives in the united states exclusion criteria: 1. any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies 2. any current drug or alcohol abuse. 3. participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. any other trial participation should be approved by the principal investigators. 4. pregnancy, breast-feeding or wanting to become pregnant 5. physical limitations unrelated to pd that would affect motor ratings 6. craniotomy 7. brain surgery 8. patient is unable to communicate properly with staff (i.e., severe speech problems) 9. excessive drooling 10. a type of hair style that would impede the use of an eeg cap 11. sensory abnormalities of the fingertips 12. patient is taking a medication that may cause significant withdrawal effects

Keywords: non-invasive
exercise-based cardiac rehabilitation after thoracoscopic ablation in patients with persisent atrial fibrillation

Conditions: Atrial Fibrillation, Persistent; Cardiac Rehabilitation; Cardiopulmonary Fitness

Summary: thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. however, the postoperative rehabilitation is very important to prevent early recurrence of atrial arrhythmia. the purpose of this study is to evaluate the efficacy of professional cardiac rehabilitation in patients after thoracoscopic ablation.


Eligibility criteria:
inclusion criteria: * patients who underwent thoracoscopic ablation due to persisent atrial fibrillation exclusion criteria: * below 18 years * over 80 years old * malignancy * pregnancy
development of a predictive index for probable depression among secondary school students

Conditions: Depression; Stress; Youth

Summary: the present study aims to develop a new predictive index to predict future depression of adolescents by using factors including individual, interpersonal and environmental. the index can be used to predict likelihood of students who are non-probable depression cases convert into probable depression cases. in addition, the investigators also test the factors of depression remission. it can hence be used in school setting to identify high-risk students, and provide them with secondary interventions that are designed by considering modifiable significant variables identified in this unique, large-scale, longitudinal study.

a 12-month longitudinal study will be conducted in secondary school settings. the investigators will investigate incidence of probable depression (i.e., from non-depression, cesd\<16, at baseline to probable depression, cesd≥16, at month 12) and remission of probable depression. the investigators will investigate factors that can prospectively predict new cases/remission of probable depression, including both well-documented risk/protective factors and some under-examined but potentially important local factors (e.g. school/academic stress, psychological resilience). the relative importance of the risk/protective factors at different socio-ecological levels will be compared and their combined effect will be identified. based on the selected factors, the investigators will derive a new prediction index called the adolescent depression prediction index (adpi) in a model building sample and test its performance in predicting incidence of depression in a validation sample among secondary school students in hong kong.

Eligibility criteria:
inclusion criteria: * secondary 1 (seventh year of formal education) to secondary 4 chinese students, who are studying local mainstream schools in hong kong. * able to read chinese and speak either cantonese or mandarin. exclusion criteria: * eligible students whose parents refuse to give consent to take part in the study.

Keywords: adolescent depression stress resilience
adult growth hormone deficiency and cardiovascular risk

Conditions: Growth Hormone Deficiency

Summary: this protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. we will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, mri and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. we hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.

subjects will first be tested for possible growth hormone deficiency. this will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. once we have the results on enough subjects we will split the cohort into those subjects who are growth hormone deficient and those who have normal growth hormone. the two groups will each undergo various tests all designed to assess some component of cardiovascular risk. ultimately we will compare the results of each test to see if those who are growth hormone deficient have an increased risk for cardiovascular disease.

Eligibility criteria:
inclusion criteria: * adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma exclusion criteria: * currently taking growth hormone, radiation therapy in the past 5 years, changes in dose of other pituitary hormone replacement therapy in past 3 months, taking hydrocortisone (or its equivalent) at a dose of \> 30 mg/day, pregnant or nursing women

Keywords: growth hormone
macra part b in côte d'ivoire

Conditions: Malaria

Summary: this study aims to evaluate the effectiveness of monthly malaria rapid diagnostic test (rdt) validation meetings at district level on reducing the proportion of rdt results recorded as positive in health facility registers in cote d'ivoire.

pmi insights supported a multi-country evaluation of the accuracy of the recording and reporting of rapid diagnostic test (rdt) results at health facilities in benin, côte d'ivoire, nigeria, and uganda (macra part a). the evaluation found a high degree of agreement between rdt results recorded in health facilities and an objective panel reading of the same rdts. however, the changes in test positivity rate (tpr) after the start of the study suggest that some of this agreement may have been a result of the hawthorne effect: in all countries except benin, tpr declined after the start of the evaluation in facilities where evaluation staff were present, compared with control facilities. this suggests that the presence of evaluation staff caused health care workers to change their behavior with respect to reporting positive rdt results. the study evaluated the durability of rdt results and found that 95% of rdt cassettes retained their original reading over a one-month period. this provides evidence that stored rdt cassettes may be compared to health facility registers at monthly validation meetings, as long as a certain margin of error is used to account for the proportion of tests that may change. the results from the first phase of the study were used to identify potential interventions to improve rdt reporting and recording accuracy in health facilities. the second phase of the study aims to evaluate the effectiveness of monthly district-level rdt result validation meetings on reducing the proportion of rdt results recorded as positive in health facility registers and reported to the national health management information system. this is a two-arm cluster-randomized controlled effectiveness evaluation. districts will serve as the clusters and will be assigned using restricted randomization to the intervention or control arm. in the intervention arm, the ministry of health will lead monthly district-level rdt validation meetings facilitated by a digital phone-based app which uses ai to record rdt results (healthpulse, audere, johannesburg, south africa). there will be no study activities in the control facilities. monthly rdt validation meetings will take place over a four-month period (april to july 2025), after which a cross-sectional survey and in- depth interviews will be conducted.

Eligibility criteria:
inclusion criteria: * healthcare workers responsible for testing or interpreting malaria rdts in the selected study facilities * district and regional health teams involved in the monthly rdt validation meetings from districts selected for the study.
safety and efficacy of rgh-188 (cariprazine) in bipolar depression

Conditions: Bipolar Depression

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.


Eligibility criteria:
inclusion criteria: * men and women, 18-65 years old * currently meet the dsm-iv-tr criteria for bipolar i or ii disorder without psychotic features, with a current depressive episode * a verified previous manic, hypomanic, or mixed episode * score of 20 or higher on the hamd-17 * score of 2 or higher on item 1 of the hamd exclusion criteria: * score greater than 12 on the young mania rating scale * eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to visit 1 * principal dsm-iv-tr-based diagnosis of an axis i disorder other than bipolar disorder (a secondary diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or specific phobias is acceptable)

Keywords: bipolar depression
bioequivalence of 5 tablets of 100 mg versus 2 tablets of 250 mg tf3 of tepotinib

Conditions: Healthy

Summary: this study investigated the bioequivalence of the 100 milligrams (mg) and 250 mg dose strengths of tepotinib tablet formulation 3 (tf3) when administered at the same dose under fasted condition.


Eligibility criteria:
inclusion criteria: * healthy participants of non-child bearing potential * body weight between 50 to 100 kilogram (kg) * body mass index (bmi) between 18.5 and 29.9 kilogram per meter square (kg/m\^2) * other protocol defined inclusion criteria could apply exclusion criteria: * participation in a clinical study within 60 days prior to first drug administration * whole blood donation or loss of greater than 450 milliliter (ml) within 60 days prior to first drug administration * any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation * other protocol defined exclusion criteria could apply

Keywords: tepotinib bioequivalence pharmacokinetics
fulvestrant (faslodex™) as a treatment in postmenopausal women with estrogen receptor positive breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.


Eligibility criteria:
inclusion criteria: * postmenopausal women defined as women who have stopped having menstrual periods * written informed consent to participate in the trial * biopsy confirmation of invasive breast cancer * evidence of hormone sensitivity * willingness to undergo biopsies exclusion criteria: * any previous treatment for breast cancer * unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop. * any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus * the presence of more than one primary tumor * history of hypersensitivity to castor oil * history of known bleeding disorders

Keywords: early breast cancer neoadjuvant therapy hormonal treatment newly diagnosed breast cancer estrogen receptor positive breast cancer treatment naïve neoadjuvant treatment neoadjuvant setting invasive breast cancer
timing of postpartum depot medroxyprogesterone acetate administration on breastfeeding, contraceptive continuation, and depression

Conditions: Contraception; Postpartum Depression; Lactation

Summary: the investigators plan to enroll 184 women who are planning to breastfeed and use dmpa after delivery to find out whether the timing of postpartum administration of dmpa (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.

in the united states, depot medroxyprogesterone acetate (dmpa) is given to women after delivery and before hospital discharge with the belief that women who delay starting dmpa may be more likely to become pregnant when they are not yet ready to be pregnant and that giving dmpa before discharge has little to no negative effect on breastfeeding. administering dmpa to breastfeeding women has not been widely questioned because the limited existing studies do not show any adverse impact of dmpa on breastfeeding. however, these studies used inappropriate control groups and did not control for prior lactation experience. the investigators plan to enroll 184 women who are planning to breastfeed and use dmpa after delivery to find out whether the timing of postpartum administration of dmpa (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants. the investigators will also look at rates of use of highly effective contraception (defined as dmpa, intrauterine device, implant, sterilization, or lactational amenorrhea) and postpartum depression.

Eligibility criteria:
inclusion criteria: * age \> 18 years old and \> 24 0/7 weeks pregnant at time of enrollment * planning to deliver at magee-womens hospital and to breastfeed * plans to use dmpa for postpartum contraception for at least 6 months * willing and able to provide informed consent in english and to comply with study protocol exclusion criteria: * intolerance of irregular vaginal bleeding * severe coagulation disorder * severe liver disease (lfts \>2x upper limits of normal at time of randomization) * contraindications to breastfeeding: maternal hiv infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia * history of breast cancer, reduction or augmentation surgery * history of severe clinical depression * multiple gestation

Keywords: postpartum contraception contraceptive continuation breastfeeding postpartum depression progestins