Kornimate/medical-research-clean huggingface dataset:
integrated coronary multicenter imaging registry - extended

Conditions: Coronary Artery Disease

Summary: the coronary images of invasive angiography and optical coherence tomography (or coronary ct angiography) with ffr(fractional flow reserve) values of the intermediate lesions (50-70% stenosis) will be prospectively registered.


Eligibility criteria:
inclusion criteria: 1. patients who underwent coronary ct angiography because of chest pain 2. patients who need oct or ffr evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 50-70%) 3. age: 20-80 yrs 4. patients who consent and fully understand the protocol 5. patients who consent the clinical follow-up 6. patients who can be followed-up exclusion criteria: 1. patients who had contrast allergy 2. patients who had unstable blood pressure needing the vasopressors 3. patients who had severe left ventricular function (left ventricular ejection fraction\<30%) 4. chronic kidney disease who had cr level of greater than 2.0 mg/dl 5. patients whose expected survival is less than 12 months 6. patients who had a severe valvular disease
a study to evaluate the safety of long-term treatment with siltuximab in patients with multicentric castleman's disease

Conditions: Multicentric Castleman's Disease

Summary: the purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric castleman's disease (mcd).

this is an open-label (all people know the identity of the intervention), multicenter (study conducted in multiple sites), non-randomized (patients are not assigned by chance to treatment groups), phase 2b study. up to 75 patients with mcd will be eligible for the study, the majority of whom will be on active therapy with siltuximab at the time of enrollment. patients will be either siltuximab-naive or have not progressed on siltuximab in the opinion of the investigator. duration of disease control and survival will be assessed. data collection for patients who discontinue treatment will be limited to survival, occurrence of malignancies, and subsequent therapies for mcd, which will be assessed twice per year until the patient has been lost to follow up or has withdrawn consent for the study, whichever occurs first. an interim analysis will be conducted (no later than 2 years after the start of enrollment) to further evaluate the benefit and safety of long-term treatment with siltuximab in patients with mcd. a data will occur at 6 years after the start of enrollment and for those patients remaining on treatment after the data cutoff, data collection will be limited to pregnancies and serious adverse events (saes), including information on study agent administration and concomitant medications associated with an sae. safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study. the end of study is the date of the last assessment for the last patient.

Eligibility criteria:
inclusion criteria: * has multicentric castleman's disease * have previously been enrolled in study c0328t03 or cnto328mcd2001 (either treatment arm) * have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose * patients must not have had disease progression while receiving siltuximab. for those patients originally assigned to placebo in the cnto328mcd2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible * have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study exclusion criteria: * unmanageable toxicity, an adverse event, progression of disease, or withdrawal of consent as reason for discontinuing treatment from previous sponsor-initiated siltuximab study * vaccination with live, attenuated vaccines within 4 weeks of first dose of this study * known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies, to murine, chimeric, human proteins or their excipients

Keywords: multicentric castleman's disease multicentric castleman siltuximab long term safety
ha-wbrt vs srs in patients with multiple brain metastases

Conditions: Brain Metastases

Summary: this study compares the effectiveness and safety of two radiation treatment techniques for patients with multiple brain metastases.

for patients suffering from multiple brain metastases whole brain radiation therapy still constitutes a standard therapy. however, because of the risk of neurocognitive side effects as well as reduced local tumor control, employment of stereotactic radiosurgery (srs) is becoming more common. the disadvantage of srs alone may be poor intracranial tumor control because of frequent appearance of new distant brain metastases after therapy. in recent years hippocampal avoidance whole brain therapy has been shown to minimize treatment related side effects while reducing the rate of distant intracranial failure. in this study patients will be randomized to receive either hippocampal avoidance whole brain radiation therapy with integrated tumor boost (ha-wbrt+sib) or stereotactic radiosurgery. the investigators hypothesize that ha-wbrt+sib can improve intracranial tumor control compared to stereotactic radiosurgery, while avoiding additional neurocognitive side effects.

Eligibility criteria:
inclusion criteria: * at least 4 and not exceeding 15 brain metastases not exceeding a combined total volume of 25ml and not previously treated with radiotherapy * kpi ≥ 70, ecog ≤ 2 * age ≥ 18 years, male or female exclusion criteria: * neuroendocrine, sclc, germinoma or lymphoma histology * brain stem metastasis * life expectancy \< 3 months * suspicion of meningeosis carcinomatosa * previous wbrt * inability to participate in radiologic follow-up, contraindication to mr imaging (e.g. not mri compatible pacemaker, severe claustrophobia) * inability to participate in neurocognitive function testing, insufficient german language skills, aphasia, graphomotor impairment, insufficient vision, insufficient attention span * pregnancy, nursing or unwillingness to prevent pregnancy using effective methods of contraception during treatment * known abuse of medication, drugs or alcohol * known severe dementia (z-score \< 2) or major cognitive function disorder that is not caused by intracranial tumour * known clinical depression or psychotic disorder

Keywords: brain metastases hippocampal avoidance radiosurgery
the relationship between pre-pregnancy bmi and weight gain and outcomes in women with twin pregnancy

Conditions: Twin Pregnancy; Body Mass Index; Weight Gain; Pregnancy Outcome

Summary: prepregnancy body mass index (bmi) and gestational weight gain (gwg) have significant effects on the risk of pregnancy outcomes such as gestational hypertension disease and gestational diabetes mellitus in singleton pregnancies. this paper is to investigate the relationship between pre-pregnancy body mass index (bmi) and weight gain during pregnancy and pregnancy outcomes in women with twin pregnancy.


Eligibility criteria:
inclusion criteria: * age 18 \~ 41 years old; * the gestational age of the first diagnosed twin pregnancy is ≤10weeks; * double chorionic double amniotic sac pregnancy; exclusion criteria: * with heart disease, liver disease, kidney disease, complications (chronic hypertension, hyperthyroidism, diabetes and others ), genetic diseases, psychological and mental diseases; * with history of habitual abortion and cervical insufficiency;
trial to assess optimized dosage of lacosamide as add-on therapy in patients with partial onset seizure

Conditions: Partial Epilepsies

Summary: to evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy. explanation of acronym: self = safety efficacy lacosamide flexibility


Eligibility criteria:
inclusion criteria: * patient has a diagnosis of partial-onset epilepsy with or without secondary generalization * currently taking 1 to 3 concomitant marketed antiepileptic drugs * 18 years and older at study entry exclusion criteria: * previous use of lacosamide * hypersensitivity to any component of lacosamide * patients with partial onset seizures not clearly identifiable * history of generalized epilepsy * history of status epilepticus within last 12 months * uncountable seizures due to clustering within last 12 weeks * non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures * history of drug or alcohol abuse * history of suicide attempt * progressive cerebral disease * concomitant treatment of felbamate * prior or concomitant vigabatrin use * under legal protection

Keywords: epilepsy treatment. anti-epileptic drugs seizures
prospective evaluation of the prognostic impact of measurable residual disease (mrd) within a phase iii study comparing a fixed duration therapy versus continuous therapy with daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma requiring a first salvage treatment.

Conditions: Multiple Myeloma

Summary: we propose to conduct an ancillary prospective evaluation of the impact of dara-len-dex discontinuation after 2 years, on the persistence of mrd negativity in patients that were mrd negative at 2 years.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) who are included in the confirm phase iii trial (clinicaltrials.gov identifier: nct03836014). * subject that are still under therapy at 2 years (+/- 3 month) after randomization, either in the fixed duration therapy group or in the continuous therapy group of the confirm protocol * subject in complete response at 2 years (+/- 3 month) after randomization. * signed informed consent * affiliation to a social security system or equivalent exclusion criteria: * none

Keywords: multiple myeloma measurable residual disease daratumumab lenalidomide dexamethasone
beast: a pilot trial

Conditions: Anxiety Sensitivity; Functional Impairment

Summary: this pilot study trial will test the acceptability, feasibility, and usability of a brief enhanced anxiety sensitivity treatment to reduce anxiety sensitivity and functional impairment in veterans.

this study tests a treatment with two components: first, there is a single session face-to-face virtual intervention delivered by the counselor or therapist via va video connect software. second, a mobile app (mpro) is used for ema and to deliver emi components. veterans will be enrolled following informed consent. the research staff will read the measures to the veteran who will verbally provide their answers. veterans will next complete the baseline assessment. at the baseline assessment, veterans meet with the project coordinator by phone or virtually to complete a consenting process, guidance on the video software being used, and set-up and guidance on use of the mobile app. following the baseline assessment, participants will be scheduled to receive the face-to-face virtual intervention followed by two weeks of ema/emi via mpro. at the end of the two weeks, veterans will complete a post-intervention assessment appointment. the post-intervention assessment includes an exit interview for participants to provide additional feedback regarding acceptability of the intervention. follow-up assessment appointments will be completed at the 1-month and 3-month follow-ups.

Eligibility criteria:
inclusion criteria: * are english-speaking * score equal to or greater than 9 on the ssasi indicating elevated anxiety sensitivity * score equal to or greater than 5 on the whodas 2.0 exclusion criteria: * veterans with cognitive impairment as measured scoring equal to or greater than 11 on the blessed * orientation-memory-concentration test * veterans without access to a smartphone * veterans with significant medical or psychiatric conditions that may limit participation, including: * severe documented schizophrenia * an ongoing active psychotic or manic state * an imminent suicide crisis will be excluded from our study and provided the appropriate referral

Keywords: anxiety
hearing aid performance study for different spatial configurations

Conditions: Hearing Loss

Summary: this clinical investigation will extend the evaluation of perception of speech in different listening environments with hearing aids available on the market (from phonak). the clinical investigation is divided in three parts addressing different challenges met by hearing aid users.

hearing aids are designed to amplify and transmit sound to compensate for impaired hearing. the main objective of this medical device is to improve the perception of speech, which can be defined among many attributes by intelligibility or listening effort. evaluating the performance of the hearing aid or different features reasonably assumes that the talker location should be in front and close of the hearing aid user. however, listening situations in daily life might show much more variability regarding the spatial configuration of the talker, listener and noise sources. this investigation is designed to extend the evaluation of hearing aid features to different spatial configuration and also to evaluate the benefit of the investigational device. the investigational device is european conformity (ce) marked and will be used within its defined use and on the intended population. the investigation is divided into three independent parts: * beamformer (bf) benefit: the first part of the study will evaluate the effect of a wider beamformer on intelligibility and listening effort for a speech-in-noise condition when the talker is not in front of the listener in comparison to a narrower beamformer, * speech enhancer benefit: the second part of the study will evaluate the effect of the speech enhancer algorithm on distant speech in quiet and when speech in quiet is coming from an adjacent room with different measures such as listening effort, objective and subjective speech intelligibility, * hearing aid benefit: the third part of the study will evaluate the benefit provided by amplification with a speech-in-noise test where the talker is in front and close to the hearing aid user

Eligibility criteria:
inclusion criteria: * experienced (minimum use duration 6 months) * adult (minimum age: 18 years) hearing aid users, * written and spoken german, * ability to understand instruction, * ability to describe listening experiences, * ability to attend to the appointments, * healthy outer ear, * hearing loss within the fitting ranges of the investigational product, * informed consent as documented by signature. exclusion criteria: * clinical contraindications deformity of the ear (closed ear canal or absence of pinna), * known hypersensitivity or allergy, * not willing to wear the hearing aid, * fluctuating hearing that could influence the results.
the effect of motivational interviewing on diabetes self-management and severity of cyberchondria in individuals with diabetes

Conditions: Type 2 Diabetes; Motivation; Self-management

Summary: objective: the aim of this study was to determine the effects of diabetes education given to individuals with diabetes using motivational interviewing technique based on the health promotion model on diabetes self-management and cyberchondria severity. materials and method: the population of the study consisted of 1000 individuals. the sample consisted of 64 individuals, 32 experimental and 32 control, who met the research criteria. the research will be conducted between 15.02.2025-15.03.2025 in van regional training and research hospital diabetes outpatient clinic. data in the research; descriptive information form, diabetes self-management scale (dms), cyberchondria severity scale-short form (css-sf) scales will be applied. research experiment motivational interviewing intervention based on the health belief model will be conducted once a week for 1 month. at the end of 1 month, both scales will be administered again to individuals in both experimental and control groups.

objective: the aim of this study is to determine the effects of diabetes education given to individuals with diabetes using motivational interviewing technique based on the health promotion model on diabetes self-management and cyberchondria severity. material and method: the population of the study consisted of 1000 individuals. the sample consisted of 64 individuals, 32 experimental and 32 control, who met the research criteria. the research will be conducted in van regional training and research hospital diabetes outpatient clinic between 15.02.2025-15.03.2025. data in the study; descriptive information form, diabetes self-management scale (dmss), cyberchondria severity scale-short form (css-sf) scales will be applied. research experiment the motivational interviewing intervention based on the health belief model will be conducted once a week for 1 month. at the end of 1 month, both the scales will be administered again to the individuals in both the experimental group and the control group. descriptive statistical methods (number, percentage), chi-square test, independent t-test in groups and paired t-test will be used.

Eligibility criteria:
inclusion criteria: * having diabetes for at least 6 months * being over 18 years old * to have sufficient communication skills to answer verbal and written questions and fulfill instructions * being literate * no physical, cognitive or mental impairment in answering the questions * willingness to participate in research. exclusion criteria: * being under 18 years of age * being hospitalized in inpatient treatment institutions due to dm or dm complications during the research process * the emergence of any health problem that prevents the person from continuing the research * do not leave the study voluntarily.

Keywords: cyberchondria violence health belief model self-management type 2 diabetes motivational interview
a low glycemic load diet during pregnancy in overweight women

Conditions: Overweight; Pregnancy

Summary: this study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.


Eligibility criteria:
inclusion criteria: * pregnant women with prepregnant or first trimester bmi equal to or greater than 25 kg/m2 and less than 45 kg/m2 * singleton pregnancy * willing to consume the diets for duration of pregnancy * participant to be at week 28 or less of pregnancy at baseline visit exclusion criteria: * smoking during pregnancy * major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease) * patients taking prescription medication known to affect body weight * alcohol consumption during pregnancy * patients who declare their intention to deliver infants in the environment outside of beth israel deaconess medical center, boston * high level of physical activity

Keywords: glycemic index glycemic load low fat impaired glucose tolerance large for gestational age infant excessive body weight
balance: a pragmatic trial of a digital health intervention to prevent weight gain in primary care

Conditions: Obesity; Overweight; Overnutrition; Nutrition Disorders; Signs and Symptoms

Summary: up to 50% of obese patients are not interested in, or ready for, weight loss. clinical practice guidelines clearly recommend that these patients avoid gaining weight. however, despite this clinical guideline, weight gain prevention interventions are not available in primary care practice. balance is a pragmatic, randomized controlled effectiveness trial for weight gain prevention for patients within rural community health centers, using a digital health platform.

clinical practice guidelines emphasize recommend weight gain prevention, but evidence-based treatments are not available in primary care. balance, a pragmatic effectiveness trial, will test a scalable treatment approach for medically-vulnerable adults, those who suffer disproportionately from obesity and its adverse health effects. balance builds on the design and findings of the shape study (nct00938535) to test a pragmatic intervention within rural community health centers. balance will randomize overweight adults and adults with obesity who are patients a local community health center network (piedmont health services) to either: 1) a 12-month weight gain prevention intervention or 2) usual care. intervention group components include tailored behavior change goals; mhealth self-monitoring and feedback; skills training videos; and stepped responsive coaching from clinic registered dietitians. the usual care group will receive standard primary care offered by their providers and automated text messages and health information about maintaining a healthy weight. all intervention components and materials will be provided in spanish or english.

Eligibility criteria:
inclusion criteria: * patients of piedmont health services' community health centers in central north carolina only * bmi between 25 and 40 kg/m2 and weighs less than 380 lbs * speaks english or spanish * had a non-urgent outpatient visit at a participating community health center clinic at piedmont health services within the last 2 weeks * has a cell phone * willing to receive 3-12 study-related text messages per week exclusion criteria: * current piedmont health services employee * has past bariatric surgery or planned bariatric surgery (within next 2 years) * diagnosed with cancer in the last 6 months and is in active treatment * has a history of cardiovascular event (stroke/mi) in the last 12 months * was hospitalized for a mental health issue in the last 12 months * diagnosis of end stage renal disease * currently participating in a weight loss program/research study * plans to move out of area and not receive care within community health center network (within the next 2 years) * currently or recently pregnant (within the last 6 months) - females only * currently or recently lactating (with the last 2 months)- females only * plans to get pregnant in the next 12 months - females only

Keywords: mhealth digital health primary care pragmatic clinical trial behavior change weight management
to evaluate the therapeutic equivalence and safety of azelaic acid 15% topical gel

Conditions: Rosacea

Summary: a multi-center, double-blind, randomized, placebo controlled, parallel-group study

a multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing azelaic acid topical gel 15% to finacea® and both active treatments to a placebo control in the treatment of moderate of facial rosacea.

Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea; * subjects had to have a definite clinical diagnosis of facial rosacea severity grade 3 as per the ige exclusion criteria: * female subjects who were pregnant, nursing, or planning to become pregnant during study participation;