Kornimate/medical-research-clean huggingface dataset:
a non interventional study to asses the safety, effectiveness and tolerability of quinapril (acupil®) in an indian population

Conditions: Hypertension

Summary: this is a prospective, non-interventional, non comparative drug study. the efficacy of quinapril in asian population has been evaluated, but specifically in indian patients the data is sparse. data in a real world setting in a large population of indian patients would shed more light on the safety, tolerability and effectiveness of quinapril in the indian population.


Eligibility criteria:
inclusion criteria: * patients already on therapy with acupil® for a minimum period of 4 weeks, evidence of a personally signed and dated informed consent document exclusion criteria: * patients having a week 0 visit blood pressure reading of more than 180/110 mm of hg will not be eligible to participate in the study. * women of child bearing age, not willing to use contraceptives, will not be eligible for the study * women using oral contraceptives will also not be included in the study * patients who have received any drug other than acupil® as the first prescribed antihypertensive would not be eligible for enrollment into the trial * patients having any complication at week 0 visit which would require more thorough investigations or who required more than one anti-hypertensive drug at the time of initiation of their therapy will not be included in the study * patients having any contraindications as per the lpd of acupil®

Keywords: quinapril non-interventional/observational study safety
efficacy of impact in infant siblings of children with asd

Conditions: Autism Spectrum Disorder

Summary: over a 5 year period infant and baby siblings of children with autism spectrum disorders (asd) will be recruited to this study and will be randomized into 2 groups. parents of the intervention group will receive 12 weeks of coaching in how to implement this intervention. parents randomized to the control group will not receive intervention coaching. both groups will attend a series of clinic appointments for data collection that occur at 3 month intervals over a 9 month period.

this two-site randomized controlled trail (rct) will include a sample of 80 siblings of children with asd (sibs-asd) (11 months, 15 days to 18 months, 15 days) who are stratified on initial cumulative-risk status for communication disorder and then randomly assigned to ingersoll's improving parents as communication teachers (impact; ingersoll \& dvortcsak, 2010) treatment or to a business-as-usual (bau) control condition. the following hypotheses will be tested: 1. compared to the bau control, children assigned to the impact group will show (a) more growth on pivotal skills and language level, and (b) a lesser degree of asd symptomatology and language delay. 2. pretreatment, cumulative-risk level will statistically interact with (i.e., moderate) treatment assignment to predict children's (a) change in pivotal skills and language, and (b) severity of autism symptoms and language delay. 3. compared to the bau control, parents in impact will have more optimal parenting stress and parenting efficacy, at least in parents with average or below average depressive symptoms prior to treatment (i.e., depressive symptoms will moderate the effect of impact on parental stress and parenting efficacy). 4. the effect that impact has on growth of pivotal skills and language will be mediated by parents' frequency and fidelity of use of impact strategies at immediate post-treatment. 5. the effect of impact on degree of children's language delay and asd symptomatology at 6 months post-treatment will be mediated by their pivotal skill level at 3 months post-treatment.

Eligibility criteria:
inclusion criteria: younger sibling of a child with asd - 1. age: 11 months, 15 days to 18 months, 15 days 2. older biological sibling: must have a diagnosis of autism from uw or vu, which is confirmed via record review. if the older sibling was not diagnosed at uw or vu, then a diagnostic appointment must be made for the older sibling at the corresponding institution in order to confirm the diagnosis of asd. half-siblings are ok. 3. vision - wnl corrected 4. hearing - wnl corrected 5. motor: the child must be able to sit independently while picking up objects and giving them to another person. exclusions: no primary motor impairment. no feeding tubes. no other neurological or genetic conditions. primary language exposure: the primary parent speak to the child using english 50% of the time, and process.
a chronic disease self care management pilot study

Conditions: Chronic Disease

Summary: the intervention aims to activate patients' inherent resources and by this, facilitate empowerment, patient activation and self-care management of their chronic disease.

the intervention aims to activate patients' inherent resources and by this, facilitate empowerment, patient activation, and self-care management of their chronic disease. the participants will include people 18 years and older that have been diagnosed with a chronic disease. this pilot study will use a pre-post design. data will be collected initially and then at the seventh session. the intervention will be provided in seven sessions face-to-face for the first three sessions and then via video conferencing for the last four sessions. each session is facilitated by three researchers. once the sessions are finished the participants will be invited to a focus session so that qualitative data can be collected in week nine.

Eligibility criteria:
inclusion criteria: * 18 years of age * undergoing treatment for chronic illness * cognitive capacity to participate in group formats * able to answer questions from questionnaires * able to read and speak english. * score greater than 18 on the moca cognitive test exclusion criteria: * major reduction in cognitive capacity (i.e. major strokes, dementia, or other related conditions). * serious mental illness that impacts the ability to give consent or limits effective participation within a group discussion as assessed by the pi and ra in consultation following routine study protocols used in the study setting (patients may suffer from mild cognitive impairment but must be able to understand and complete questionnaires and engage in intervention groups). * patients in palliative phases of cancer. * patients in an acute medical crisis or in need of intensive care. -patients who attend similar interventions in the same period or within the past 3 months. -
fih ph 1 study of trpc5 channel inhibitor gfb-887 in healthy subjects

Conditions: Healthy Volunteers

Summary: the study will comprise primarily a single-ascending dose (sad) escalation component.

double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.

Eligibility criteria:
healthy participant cohorts - key inclusion criteria: 1. males or females, of any race, between 18 and 55 years of age, inclusive, at screening. 2. body mass index between 18.0 and 32.0 kg/m\^2, inclusive, at screening. 3. systolic blood pressure of between 90 and 140 mmhg, diastolic blood pressure between 60 and 90 mmhg, and heart rate between 40 and 100 bpm at screening. 4. female participants will be post-menopausal or surgically sterile (as confirmed by medical history). 5. male participants will agree to use contraception while on study drug and for at least 90 days after the final follow-up visit. 6. able to comprehend and willing to sign an informed consent form (icf) and to abide by the study restrictions. 7. participants must be in good health. healthy participant cohorts - key exclusion criteria: 1. females of childbearing potential. 2. significant history or clinically significant manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). 3. history of alcoholism or drug/chemical abuse within 2 years prior to (first) check-in. 4. use of tobacco or nicotine-containing products within 60 days prior to (first) dosing, or positive cotinine at screening or check-in.

Keywords: glomerulosclerosis proteinuria nephrotic syndrome nephrosis focal segmental glomerulosclerosis kidney diseases urologic diseases glomerulonephritis nephritis diabetic kidney disease diabetic nephropathies endocrine system diseases diabetes complications
a study of tarceva (erlotinib) and standard of care chemotherapy in patients with advanced, recurrent, or metastatic non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: this 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic nsclc experiencing disease progression after failure of platinum-based chemotherapy.eligible patients will be randomized to receive either tarceva 150mg po daily, or comparator (either alimta 500mg/m2 every 3 weeks, or taxotere 75mg/m2 every 3 weeks). the anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * histologically documented, locally advanced or recurrent or metastatic nsclc; * measurable disease; * disease progression during 1-4 cycles of platinum-based chemotherapy. exclusion criteria: * any other malignancies within the last 5 years; * unstable systemic disease.
parents helping infants study: educational intervention to change the knowledge, attitudes and behaviour of new parents about early infant crying

Conditions: Shaken Baby Syndrome

Summary: this research project seeks to implement an early intervention program that can be effective in the prevention of shaken baby syndrome (sbs) and infant abuse. the investigators' hypothesis is that the period of purple crying intervention program can be effective in reducing the shaking and abuse of infants through changes in knowledge, attitudes and behaviours about early infant crying, especially inconsolable crying.

the period of purple crying phrase refers to the educational information and the action steps that caregivers need to know about the properties of early crying in normally developing infants that are uniformly frustrating to caregivers. the study will be implemented and evaluated in 1000 new mothers, by public health nurses during newborn home care visits in the vancouver coastal and fraser health authorities. there are two treatment arms in the study. the first half of all subjects (n=500) will receive the purple intervention materials (a video and a pamphlet) about infant crying. the second arm will receive comparable materials on infant safety and sids. specific goals of the research program are: 1. to change the understanding (i.e knowledge and attitudes) and reduce the frustration of parents of new infants about the normality of the frustrating properties of crying; 2. to change the behaviour of parents to increase care giving contact in response to crying but to 'walk away' if frustrated or angry; 3. to provide parents with the ability to educate other caregivers (relatives, baby sitters) to reduce frustration induced by inconsolable crying and obtain help if needed; 4. to provide parents with the knowledge to protect their infants from occasional caregivers who could harm their infants because of the frustrating nature of early crying; 5. to provide effective knowledge, skills and teaching materials to regional health care providers in direct contact with parents concerning crying, shaking and abuse.

Eligibility criteria:
inclusion criteria: * new mothers of healthy infants born at \> 34 weeks gestation with access to a video or dvd player. exclusion criteria: * mothers of: infants born at \< 34 weeks gestation; multiple infants (twins, triplets, etc.); or infants who have serious medical conditions. * mothers who don't speak and read english.

Keywords: prevention randomized controlled trial community education shaken baby syndrome crying colic
intravitreal ranibizumab in retinal pigment epithelial detachments

Conditions: Pigment Epithelial Detachment

Summary: the purpose of this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (amd).

pigment epithelial detachments (ped) secondary to age-related macular degeneration (amd) have been excluded from practically all study populations of ranibizumab studies so far. ped represents a special entity in amd. as yet, no standard treatment has been established for this disease.the stimuli that induce ped are not very well known, but there is evidence suggesting that angiogenic factors such as vascular endothelial growth factor (vegf) also play a role in the pathogenesis. ranibizumab is an anti-vegf antibody fragment that blocks vegf activity in patients with neovascular amd.

Eligibility criteria:
inclusion criteria: * patients with age-related macular degeneration and serous pigment epithelial detachment as determined by fluorescein and indocyanine green angiography and optical coherence tomography (oct) * patients who have a best-corrected visual acuity (bcva) score between 73 and 24 etdrs letters * patients with pigment epithelial detachment (ped) ≥ 200 µm as determined by oct * male or female patients 50 years of age or greater * patients willing and able to comply with all study procedures exclusion criteria: * patients with best-corrected visual acuity (bcva) \ 73 letters in the study eye * patients previously treated by intravitreal injections of steroids or anti-vegf agents, or patients previously treated by verteporfin photodynamic therapy or focal laser photocoagulation * history of uncontrolled glaucoma in the study eye
trial of vitamin d3 supplementation in paediatric asthma

Conditions: Asthma

Summary: epidemiological and observational studies have linked vitamin d deficiency with increased asthma/allergy incidence . vitamin d insufficiency (\<75nmol/l) has been associated with increased incidence of severe childhood asthma. further, high 25(oh)d levels were associated with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower airway hyper-responsiveness in childhood asthmatics. the association between vitamin d and allergy and asthma appears to be stronger in children than adults, with some even suggesting that childhood asthma may may be caused by vdd.

asthmatic children will be recruited in winter. after baseline testing, children will be randomized to take 2,000iu vitamin d or placebo daily for 15 weeks. after the 15 weeks, testing will be repeated. tests involve blood draws, questionnaires and breathing tests.

Eligibility criteria:
inclusion criteria: * previous clinical diagnosis of asthma * ability to perform pulmonary function tests * established on anti-asthmatic pharmacotherapy with no expected change exclusion criteria: * use of medications that influence vitamin d metabolism or absorption * chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease
improving opioid safety in veterans using collaborative care and decision support

Conditions: Chronic Pain

Summary: the investigators propose to develop a novel intervention that targets the system (collaborative care), pcp (computerized decision support for opioid therapy) and veteran (cm-delivered mi) to reduce problematic prescription opioid use and encourage non-opioid pain management alternatives.

the investigators will develop and test the acceptability, feasibility, and preliminary efficacy of a collaborative care intervention in which one of two care managers delivering both interventions will assist primary care providers (pcps) by using motivational interviewing to communicate computer-based athena-ot (opioid therapy) decision support guidelines to veterans with chronic pain. specifically, after honing the intervention, the investigators will conduct a pilot randomized controlled trial of collaborative care/motivational interviewing in 100 veterans (ages 18 and older) with chronic pain in primary care who are prescribed opioid pain medications and exhibit at least one "high-risk" opioid use behavior (e.g. obtaining early opioid refills, etc.). using athena-ot decision support, pcps will make guideline-concordant recommendations to all enrolled study patients and initiate a pain care plan. veterans randomized to collaborative care, will have one mi session with their assigned study care manager followed by 3 care manager-delivered telephone mi/monitoring sessions; patients randomized to the attention control arm will have one brief session with their assigned care manager, followed by 3 care manager-delivered neutral telephone sessions

Eligibility criteria:
inclusion criteria: * current male or female patient at san francisco va medical center or affiliated va clinics * must be older than 18 years * chronic musculoskeletal pain of at least 6 months duration and * prescribed one or more opioid pain medication for more than three months and * evidence of being a high-risk opioid user as determined by pi, electronic medical record, and study measures exclusion criteria: * non-english speakers * plans to relocate within 6 months; not able to come to san francisco va medical center for three in-person visits * cancer or other terminal illness involving palliative care with opioid medications * serious or untreated mental illness

Keywords: opioids chronic pain collaborative care
uterine microbiome in recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss, Not Pregnant; Vaginal Microbiome

Summary: the female genital tract microbiome may reflect female reproductive health and may be related to pregnancy outcomes. disturbances in this microbiome may be associated with adverse reproductive outcomes. the investigators hypothesize that the endometrial and vaginal microbiome composition in women with a history of recurrent pregnancy loss are different, compared with those in normal fertile women.

the investigators want to describe the endometrial microbiome composition in normal fertile women and women with a history of recurrent pregnancy loss by analyzing mid-luteal phase vaginal swab and endometrial biopsy samples using 16s rrna sequencing.

Eligibility criteria:
1. recurrent pregnancy loss patients inclusion criteria: * 18-38 years old * having a regular menstrual cycle, from 25 to 35 days * having ≥ 2 recurrent pregnancy loss and * couples with normal karyotype results * having no condition causing pregnancy loss such as antiphospholipid syndrome, abnormal thyroid function. * agree to participate in the study exclusion criteria: * irregular menstrual cycle * having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid) * using intrauterine device within the last 3 months * using antibiotic/vaginal pessary/contraceptive pills within 2 weeks * having sexual intercourse within 48 hours 2. healthy control patients inclusion criteria: * 18-38 years old * having a regular menstrual cycle, from 25 to 35 days * no history of pregnancy loss * having 1 or more live birth, with the youngest child ≥ 6 months old * agree to participate in the study exclusion criteria: * irregular menstrual cycle * having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid) * using intrauterine device within the last 3 months * using antibiotic/vaginal pessary/contraceptive pills within 2 weeks * having sexual intercourse within 48 hours

Keywords: microbiome recurrent pregnancy loss
patient and care partner experiences living with multiple myeloma (pace-mm)

Conditions: Multiple Myeloma

Summary: this research study is explore the impact over time of multiple myeloma and its associated treatments on the physical and cognitive function and quality of life of patients and their care partners and how these impacts affect the overall illness experience.

this study aims to identify the factors, for example, age, race, sex, education, household income, clinical or other geriatric conditions such as depression, anxiety, or lack of social support that can predict those most likely to experience changes in physical and cognitive function and quality of life. furthermore, patients and care partners experienced challenges, because of multiple myeloma and its associated treatments, will be studied using semi-structured interviews. patients will complete baseline geriatric assessments and a 30-45-minute cognitive test, and both will be reassessed in 3 months intervals. the geriatric assessment is primarily patient-reported surveys and involves a multi-domain evaluation of a patient's functional status (i.e., their ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medications, and nutritional status. care partners will be asked to complete baseline surveys that will also assess their well-being and ability to function at home. to provide a more comprehensive understanding of the myeloma-related experiences a subset of patients and their care partners will be asked to participate in a baseline interview repeated over time to understand how the disease and its treatments shape the experiences. duration of subject participation: 6 months

Eligibility criteria:
inclusion criteria: patients must meet the following inclusion criteria to participate in this study: 1. aged ≥55 2. new myeloma diagnosis as defined by the international myeloma working group, does not have another non-myeloma plasma cell disorder such as poems (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes) or amyloidosis. 3. starting systemic treatment. 4. able to understand and speak in english. 5. able to provide informed consent to participate. care partners must meet the following inclusion criteria to participate in this study 1. aged ≥18. 2. able to understand and speak in english. 3. able to provide informed consent to participate. 4. be a care partner for a patient with multiple myeloma and is also enrolled in the assessment portion of this study. 5. willing and able to participate in semi-structured interviews. exclusion criteria: 1. all participants meeting any of the following exclusion criteria at enrollment will be excluded from the study: inability to read and speak english. 2. dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Keywords: newly diagnosed multiple myeloma physical function cognitive function quality of life geriatric assessments care partners