Kornimate/medical-research-clean huggingface dataset:
a study of first-line ambrisentan and tadalafil combination therapy in subjects with pulmonary arterial hypertension (pah)

Conditions: Hypertension, Pulmonary

Summary: the purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with pulmonary arterial hypertension. this will be assessed by time to the first clinical failure event.


Eligibility criteria:
inclusion criteria: * subjects must have a diagnosis of pulmonary arterial hypertension (pah) due to the following: a. idiopathic or heritable pah b. pah associated with: i. connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease, systemic lupus erythematosus, or overlap syndrome) ii. drugs or toxins iii. human immunodeficiency virus (hiv) infection iv. congenital heart defects repaired greater than 1 year prior to screening (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) nb: subjects with portopulmonary hypertension and pulmonary veno-occlusive disease are not eligible for the study * subject must have a current diagnosis of being in world health organisation (who) functional class ii or iii. * subject must meet all of the following haemodynamic criteria by means of a right heart catheterization prior to screening: i. mpap of ≥25 mmhg ii. pvr ≥ 300 dynes/sec/cm5 iii. pcwp or lvedp of ≤12 mmhg if pvr ≥300 to \<500 dyne/sec/cm5 , or pcwp/lvedp ≤ 15 mmhg if pvr ≥500 dynes/sec/cm5 * subject must walk a distance of ≥125m and ≤500m at the screening visit exclusion criteria: * subject received previous pah therapy (phosphodiesterase type 5 inhibitor (pde5i), endothelin receptor antagonist (era), chronic prostanoid\*) within 4 weeks prior to the screening visit (\*chronic prostanoid use is considered \>7 days of treatment) * subject received era treatment (e.g., bosentan or sitaxentan) or pde5i treatment (e.g. sildenafil) at any time and discontinued due to tolerance issues other than those associated with liver function abnormalities * subjects who have previously discontinued ambrisentan or tadalafil in either another clinical study or commercial product (volibris/letairis or adcirca) for safety or tolerability reasons.

Keywords: pulmonary arterial hypertension ambrisentan sponsor rest of world: gsk tadalafil pah sponsor us: gilead
safety, efficacy, and pharmacokinetic study of intravenous ibuprofen in pediatric patients

Conditions: Fever

Summary: the primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.

the primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.

Eligibility criteria:
inclusion criteria: 1. have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures. 2. be between birth (28 weeks to \< 40 weeks gestational age) to ≤ 16 years of age. 3. have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºf (38.3 ºc). exclusion criteria: 1. have inadequate intravenous access. 2. have received antipyretic drug therapy within 2 hours before dosing. 3. have any history of allergy or hypersensitivity to nsaids or aspirin. 4. have received another investigational drug within the past 30 days. 5. be otherwise unsuitable for the study, in the opinion of the investigator. 6. have a fever due to hyperthermia. 7. pregnant or nursing.

Keywords: pediatric fever
a phase 3 study to evaluate the efficacy and safety of tnx-102 sl in participants with ptsd

Conditions: PTSD

Summary: this is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of tnx-102 sl 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.


Eligibility criteria:
inclusion criteria: * male and female subjects between the years of 18-75 with a diagnosis of ptsd (diagnosis can be made at screening) * index trauma must have occurred within 9 years of screening visit * must have occurred when the patient was ≥18 years of age exclusion criteria: * use of antidepressant medication within 2 months of baseline

Keywords: ptsd
a comprehensive oncology rehabilitation and exercise (core) program among breast cancer survivors

Conditions: Breast Cancer

Summary: the objective of this study is to demonstrate the feasibility and acceptability of the algorithm utilized within a cancer rehab program, named comprehensive oncology rehabilitation and exercise (core) program, among newly diagnosed stage i-iii breast cancer survivors, providers, and clinic staff. additionally, this study aims to generate preliminary estimates on the extent to which core, compared with standard of care (soc), elicits engagement in exercise and impacts changes in physical function and quality of life within this population.

enrollment: the study team will recruit 72 newly diagnosed stage i-iii breast cancer survivors to participate in a 24-week randomized controlled trial. participants will be randomized to core or soc in a 2:1 ratio, stratified by adherence to national physical activity guidelines. exercise intervention: participants randomized to standard of care will be instructed to continue their typical lifestyle activity. participants randomized to core will complete an in-clinic assessment consisting of the promis physical function and godin surveys to identify the appropriate pathway for triage. results from the questionnaires will be used to triage participants into one of three groups: 1. physical medicine \& rehabilitation (pm\&r): this rehab service is aimed at improving complex and acute functional deficits. participants with a t-score \< 40 on promis will be triaged to pm\&r, regardless of current exercise engagement. 2. personal optimism with exercise recovery (power): power is our institution's exercise oncology program. power is aimed at improving mild functional deficits and physical deconditioning. participants with a t-score of 40-50 on promis who are not meeting activity guidelines, will be triaged to power. participants with a t-score of ≥ 40 who are meeting activity guidelines, may choose to participate in power or be re-triaged to exercise self-management. 3. exercise self-management: this arm is aimed for participants who are fit and free of functional deficits and impaired physical conditioning. participants with a t-score of ≥ 51 on promis and currently meeting activity guidelines will be triaged to this group. they may choose to participate in power. assessments: five assessment methods will be collected over three time points: (1) post-diagnosis/pre-surgery, (2) post-surgery, and (3) 24-weeks post-surgery.

Eligibility criteria:
inclusion criteria: * newly diagnosed stage i-iii breast cancer survivors who have plans to undergo breast cancer surgery exclusion criteria: * stage i-iii breast cancer survivors who had received neoadjuvant chemotherapy

Keywords: survivors exercise
a study of maridebart cafraglutide in adult participants with type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: the main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years) * type 2 diabetes for ≥6 months according to the world health organization classification * hba1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory * treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening * body mass index of 23 to 50 kilograms per square meter exclusion criteria: * type 1 diabetes * use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening * estimated glomerular filtration rate (egfr) \<30 milliliters/minute/1.73 square meter, calculated by the chronic kidney disease-epidemiology equation. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy * history of acute or chronic pancreatitis * malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer * myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have new york heart association class iii or iv heart failure. * use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.

Keywords: obesity amg 133 t2dm hemoglobin a1c (hba1c)
psychological assessment of adults seeking orthodontic treatment

Conditions: Self-esteem; Personality; Quality of Life; Malocclusion; Orthodontics

Summary: is their a association between the objective and subjective severity of a malocclusion, quality of life and self-esteem/personality (as modifier between objective/subjective severity and quality of life (cfr study agou et al., 2008) ? a second goal is to compare motivation and expectations and the objective and subjective severity of the malocclusion on the other hand.


Eligibility criteria:
inclusion criteria: * good health, * thorough knowledge of the dutch language exclusion criteria: * language

Keywords: self-esteem personality quality of life malocclusion orthodontics
aortic valve replacement in elective patients from aortic valve multicenter registry

Conditions: Aortic Valve Stenosis

Summary: multicenter registry data analysis of aortic valve stenosis patients that underwent elective, isolated transcutaneous aortic valve implantation (tavi) or surgical aortic valve replacement between 2015 and 2019. in tavi group only transfemoral access was considered.

a retrospective analysis of the multicenter aortic valve registry patients operated between 2015 and 2019 in the three departments of cardiac surgery in poland: the medical university of silesia in katowice, medical university in gdańsk, and poznań, university of medical science. baseline clinical, procedural, and outcome data at follow-up were entered into prespecified electronic case report forms. follow-up status was validated by personal contact or access to polish national health fund. patients with planned concomitant intervention on coronary arteries (by bypass grafting or percutaneous intervention), other valvular interventions, arrhythmia ablation, or left atrial appendage occlusion were excluded too. in tavi group only femoral access was considered. for savr any tissue or mechanical valve implantation in an aortic position with sternotomy or minimal access was included.

Eligibility criteria:
inclusion criteria: * age \>18 years * elective procedure * aortic valve replacement with means of tavi or savr exclusion criteria: * concomitant procedures
treatment satisfaction in implantable cardioverter defibrillator recipients

Conditions: Improvement of Treatment Satisfaction

Summary: remote monitoring of implantable cardioverter defibrillators (icd) is a promising new development in icd therapy and has been shown to be technically feasible and safe.while data on safety and feasibility of remote monitoring are in favour of this technology, patients´ treatment satisfaction has not been sufficiently investigated. to date, there is only one small, non-randomised study investigating patients´ treatment satisfaction in highly selected and highly motivated patients at the time of implantation and 12 months thereafter7. therefore, the aim of the san remo trial is to investigate factors that are associated with patients´ willingness to accept the new method of follow-up on a broad basis of icd recipients and to determine their treatment satisfaction with icd therapy in a randomised, prospective trial.


Eligibility criteria:
inclusion criteria: * icd indication according to current national or international guidelines * patient available for follow-up during study period exclusion criteria: * clinically unstable medical conditions that require regular outpatient clinic follow-up

Keywords: icd home-monitoring quality of life
a trial of bed versus stirrups delivery in nulliparous women for prevention of perineal lacerations

Conditions: Perineal Lacerations

Summary: the investigators hypothesize that the rate of perineal lacerations in nulliparous women will be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery versus conventional delivery in obstetrical stirrups.

this is a randomized controlled trial of bed delivery in the supine position versus conventional delivery in obstetrical stirrups. it will include nulliparous women presenting in active labor to the l\&d east (low risk) unit at parkland hospital, \> 370/7 weeks gestation, with singleton fetuses in cephalic presentation. the primary outcome variable is any perineal laceration. secondary outcomes measures include (1) 3rd or 4th degree lacerations and (2) any lacerations in subgroup comparisons between study arms.

Eligibility criteria:
inclusion criteria: * nulliparous women presenting in active labor to parkland l\&d east unit * ≥ 370/7 weeks gestation * singleton fetus in cephalic presentation * ≥ 4 cm but ≤ 8 cm of cervical dilation * no medical or obstetrical complication exclusion criteria: * women with any obstetric or medical complication of pregnancy, such as pregnancy related hypertension, diabetes, labor induction * prior history of perineal trauma requiring surgical repair or known congenital perineal malformation * non-english or non-spanish speaking
the passy muir swallowing self training device

Conditions: Oropharyngeal Dysphagia

Summary: this is a device evaluation study to determine the optimal stimulation characteristics for using vibrotactile stimulation as a sensory triggering device for self retraining in patients with chronic moderate to severe dysphagia. stimulation characteristics to be tested are frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed or continuous).

participants were recruited who had chronic moderate to severe dysphagia following stroke or radiation treatment for head and neck cancer. their frequency of swallowing was transduced with an accelerometer placed on the skin over the thyroid cartilage and inductive plethysmography bands placed over the rib cage and abdomen. when laryngeal elevation coincided with respiratory apnea a swallow was marked. five different motor frequencies were evaluated to determine their effect on participants frequency of swallowing (swallows per minute). frequencies were 30, 70, 110, and 150 hz and a combination of 70 and 110 hz. for each vibratory frequency the number of swallows per minute occurring during stimulation was compared with sham when the participant was wearing the device but the motor was not turned on. the frequency fo swallowing during stimulation was compared with the frequency of swallowing between stimulations. visual analogue ratings of the urge to swallow and discomfort were also measured after each condition. other parameters were the pressure between the motor and the skin (0, 2, 4, and 6 kpa) and swallow initiation time when stimulation was on and when it was not. swallowing frequency with continuous versus pulsed stimulation was also compared.

Eligibility criteria:
inclusion criteria: * stroke or post radiation for the treatment of head and neck cancer * dysphagia with a score of 2 or greater on the penetration/aspiration scale or a mann assessment of swallowing ability ordinal risk rating of "probable" or "definite" exclusion criteria: * neck injury * epilepsy * neurological disorder other than stroke * psychiatric illness other than depression * uncontrolled gastroesophageal reflux disease * inability to communicate secondary to significant speech or language problems * inability to maintain alertness for 1 hour * significant health concerns that would put the participant at risk

Keywords: swallowing stroke sensory stimulation home based therapy head and neck cancer
rhythm and music to rehabilitate reading disorders

Conditions: Reading Disability

Summary: the purpose of this study is to determine whether music training is an effective treatment of reading disorders

introduction: children with dyslexia show deficits in temporal processing, both in language and in music. musical activity increases phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development, a compelling evidence for a role of music training in fostering brain plasticity. within this theoretical framework, we investigate the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia. methods: the study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test

Eligibility criteria:
inclusion criteria: * italian native language * reading performance (accuracy and/or speed) failed on at least two of three school grade standardized italian tests: text, words, pseudowords (cut-offs: z-score \<-1.8 standard deviations from the mean for speed scores, a score \<5th percentile in the accuracy scores). * hearing and neurological examination within normal range * normal or corrected-to-normal visual acuity * general iq \>85 at wechsler intelligence scale for children iii. exclusion criteria: * presence of comorbidity involving attentional deficit disorders with hyperactivity (adhd) * presence of comorbidity involving specific language impairment (sli) * presence of comorbidity involving oppositional defiant disorder (odd) * severe emotional-relational impairments * previous formal musical or painting education for more than one year, other on-going treatment. * presence of other diseases (i.e. diabetes , cystic fibrosis, asthma...) that could influence the performance in cognitive and executive functions.

Keywords: music training, rhythm
electroencephalography (eeg) predictors of transcranial direct current stimulation (tdcs) in obsessive-compulsive disorder (ocd)

Conditions: Obsessive-Compulsive Disorder

Summary: this study is designed to find electroencephalogram (eeg) biomarkers to predict transcranial direct current stimulation (tdcs) response in obsessive-compulsive disorder.

the purpose of this study is to explore resting state electroencephalography and transcranial magnetic stimulation and electroencephalography (tms-eeg) biomarkers that would predict transcranial direct current stimulation (tdcs) response in obsessive-compulsive disorder with cathode electrode targeting orbitofrontal cortex (ofc). 30 ocd patients will be recruited to this study and performed once a day, five times a week direct current stimulation treatment for two weeks. the investigators will assess symptom severity before and after two weeks of tdcs. through the study, yale-brown obsessive compulsive scale（y-bocs）, the obsessive compulsive inventory-revised (oci-r), the beck depression inventory(bdi), pittsburgh sleep quality index (psqi)and side-effect questionnaire will be obtained by a trained investigator. resting state electroencephalography and tms-eeg testing will be conducted before and after tdcs treatment.

Eligibility criteria:
inclusion criteria: * age: 18-50 years old; * dsm-5 criteria for ocd; * y-bocs total score \> or = 16 * \>or＝9 years education exclusion criteria: * any additional current psychiatric comorbidity * the inability to receive tdcs because of metallic implants, or history of seizures，history of head injury, or history of neurosurgery. * participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body. * any current significant medical condition. * serious suicide risk

Keywords: transcranial direct current stimulation
adherence enhancement for renal transplant patients

Conditions: Renal Failure; Medication Adherence; Hypertension

Summary: despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. medication nonadherence and clinical inertia are key contributors to graft loss. the purpose of the proposed rct feasibility study is to evaluate impact of a "bundled" wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. we propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility rct.


Eligibility criteria:
inclusion criteria: * persons \> 21 years of age * first time recipient of a solitary kidney transplant * prescribed at least 3 medications for immunosuppression and hypertension * previous history of non-adherence * functioning kidney transplant * ability to speak, hear and understand english * able to use medication delivery device and self administer medications * able to operate blood pressure monitor * comfortable using cell phone * no other diagnosis that might shorten lifespan * transplant physician's assent that the patient can participate exclusion criteria: * failure to meet all inclusion criteria

Keywords: renal failure medication adherence hypertension
prevalence of postpartum family planning and its association with spousal joint decision-making in family planning

Conditions: Postpartum Family Planning

Summary: this community-based cross-sectional study investigates the prevalence of postpartum family planning (ppfp) uptake and its association with joint spousal family planning decision-making among married women in rural sindh, pakistan. the study, conducted in thatta district with a population of approximately 0.98 million people, addresses sociodemographic challenges including high fertility rates, maternal and newborn mortality, and low contemporary contraception use. targeting married women aged 18-49 who gave birth within the past year, the research utilizes data from the global network's maternal and newborn health registry. data collection involves a pretested questionnaire administered by trained female data collectors. statistical analysis includes descriptive statistics and logistic regression using stata 17. the study aims to fill knowledge gaps regarding factors influencing ppfp uptake, particularly the role of joint decision-making in family planning. findings could inform targeted interventions to enhance maternal and child health, contribute to existing knowledge, and guide policymakers and healthcare providers in addressing the unmet need for family planning in rural pakistan.


Eligibility criteria:
inclusion criteria: * women who are married and gave birth a year ago * living within the maternal neonatal health registry catchment area for at least one year. * women who will give their consent. exclusion criteria: * pregnant women. * women who are critically ill and who face significant cognitive barriers that hinder their understanding and participation in the study.