Kornimate/medical-research-clean huggingface dataset:
environmental and acceptance-based innovations for weight loss maintenance

Conditions: Obesity; Overweight; Weight Loss

Summary: the major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. the project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training.


Eligibility criteria:
inclusion criteria: * have a bmi between 27 and 45 kg/m2 * have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest) * successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits exclusion criteria: * have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss * are pregnant or plan to become pregnant in next 2 years * report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain * are participating in or plan to participate in another weight loss program in the next 2 years

Keywords: obesity overweight weight loss
a study to investigate the efficacy, safety and tolerability of peg in patients with genital herpes

Conditions: Genital Herpes

Summary: the aim of this study is therefore to investigate the efficacy of the peg-formulation to reduce the frequency and duration of genital herpes recurrences, to assess its safety and tolerability and to investigate its effect on shedding.


Eligibility criteria:
inclusion criteria: * informed consent * 18 - 65 years * positive for hsv-1 and/or -2 (as determined by serology testing in course of study) * initial infection \> 1 year ago * ≥ 6 recurrences in the last year (or in the year prior to a recent prophylactic therapy) * ≥ 2 recurrences during the six-month baseline period exclusion criteria: * known or suspected allergy or intolerability to peg * prophylactic antiviral drugs, virostatic agents, cytostatics, immunomodulatory drugs and steroids within less than 14 days prior to baseline period, or plan to take such drugs during the trial * pregnancy and/or breast-feeding * history of malignant diseases (described in chapter 7.2) * known or suspected non-compliance to study protocol * participation in another investigational drug study in the last 30 days prior to baseline period
using ultromics echogo hfpef algorithm to identify and treat high heart failure risk in patients with type 2 diabetes

Conditions: Heart Failure; Diabetes

Summary: a pragmatic electronic health record (ehr) based randomized controlled trial to evaluate the utility of providing ultromics echogo analysis results and recommendations for hf risk prevention therapies using an ehr embedded clinical decision support tool.

historic echocardiograms will be analyzed using the ultromics echogo algorithm. for patients that have a positive echogo result i.e. hfpef detected, the provider will get an clinical decision support alert flagging high risk of hfpef based on randomized assignment. experimental: alert group provider will receive a computer-based alert notifying the provider that the patient has subclinical hfpef as determined by the ultromics echogo algorithm and associated guideline recommendations for the management of these patients. the alert will include guideline-based and standard-of-care recommendations for the use of sglt-2 inhibitors and/or glp-1 ra (if obesity is present). the purpose of the alert is to inform the providers about the risk of heart failure and provide them guidance regarding the guideline-recommended standard of care. the providers can choose to provide care as deemed fit based on the information provided. the investigators will assess the practice patterns of providers in response to the ehr-based alert over the study period (6-month follow-up). the investigators will also assess the downstream hospitalization events for hf within 12 months of the initial alert. no intervention: control group providers in the control group will not receive risk information, the computer program will not issue an on-screen alert. the investigators will monitor the practice pattern in this group as well over the study period. follow up. adherence to sglt-2i and glp-1 ra medications will be assessed by evaluating the electronic health record and documenting if the patient had a follow-up with a healthcare provider at 6 months and medication listed in the active prescription medication list.

Eligibility criteria:
clinical cohort inclusion exclusion critria: inclusion criteria : * patients with diagnosis of type 2 diabetes and high watch dm score. * echocardiogram available in last 6-months. exclusion criteria: * history of hf * active sglt2-inhibitor use. * active glp1-ra use. * no echocardiogram within 6-months. corresponding providers to patients identified by the above inclusion exclusion criteria will be included in the clinical trial of the decision support tool.
intraoperative floppy iris syndrome in korean patients taking α1-adrenergic receptor antagonists

Conditions: Intraoperative Floppy Iris Syndrome

Summary: intraoperative floppy iris syndrome (ifis) is a recently described condition observed during cataract surgery. it has been hypothesized that irreversible atrophy of the iris dilator muscle associated with α1-adrenergic receptor antagonists (α1-ara) is responsible for ifis. however the prevalence of ifis in korean population is not reported. the purpose of this study is to evaluate the prevalence and clinical manifestations of ifis in relation to iris anatomical change in korean patients taking α1-ara.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cataract * korean patients exclusion criteria: * history of iridocyclitis, iris neovascularization, or prior iris surgery * traumatic cataracts, zonular dialysis, or cataracts associated with ocular disease (e.g., uveitis)

Keywords: occurrence of
observational study of oral atogepant to evaluate real-world effectiveness in adult participants with migraine

Conditions: Migraine

Summary: migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. this study will evaluate the effectiveness of atogepant in treating adult participants with migraine in a real-world setting. atogepant is an approved drug for preventive treatment of migraine in adults. approximately 1000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study across the world. participants will receive atogepant oral tablets as prescribed per standard clinical practice and will be followed for 2 years. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * at least 1-year history of migraine with or without aura consistent with a diagnosis according to the international classification of headache disorders (ichd)-3, 2018. * prescribed atogepant according to the relevant approved local label. * for participants who initiate atogepant at the prescribing physician or treating health care provider (hcp) discretion as part of their routine clinical care, the decision to administer atogepant must be made prior to and independent of recruitment into the study. * willing and able to comply with the requirements of the study. * not on concomitant preventive medication for migraine or have been on a stable preventive medication for migraine for at least 3 months prior to enrollment in the study. if on a stable preventive medication, the prescribing physician or treating hcp and participant must confirm that there is no plan to change concomitant preventive medication during the first 12 weeks of the study. exclusion criteria: * previously exposed to atogepant as routine therapy or from clinical trials experience prior to entry. * contraindications to atogepant as per local labeling. * pregnant or planning to be pregnant or women of childbearing potential not using contraception. * enrolled in any interventional studies that may include investigational compounds for migraine, or non-abbvie observational studies. * in the opinion of the prescribing physician or treating hcp, the participant has a history or current evidence of any condition that might interfere with patient's ability to comply with the study requirements.

Keywords: migraine atogepant qulipta aquipta
levetiracetam treatment of children with subclinical sleep-activated epileptiform activity (ssea)

Conditions: Subclinical Sleep-Activated Epileptiform Activity; CSWS

Summary: in clinical practice at the national centre for epilepsy (sse) in norway we see many children who have subclinical epileptiform activity in eeg that increases substantially during slow wave sleep (ssea; subclinical sleep-activated epileptiform activity). they may or may not have seizures. hence, according to the definition some children with ssea do not suffer from epilepsy because they do not experience seizures. many of these children have symptoms such as: attention deficit hyperactivity disorders (ad/hd), dyslectic problems, sleep problems, tantrums or autistic symptoms . we hypothesize that this subclinical epileptiform activity during slow sleep may act negatively on cognitive functions, language and behaviour in some children; even when the spike-wave discharges are less frequent than in csws (continuous spike-waves during slow sleep).


Eligibility criteria:
inclusion criteria: * children 5-10 years * iq \> 50

Keywords: csws, interiktal epileptiform activity
open trial of telehealth group for improving peer relationships (peers) in nf1

Conditions: Neurofibromatosis 1; Social Skills

Summary: this is an open trial of the ucla peers protocol delivered via telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.


Eligibility criteria:
inclusion criteria: * physician diagnosis of neurofibromatosis type 1 * age 12-17 * main language spoken in the home is english * reliable internet access * current functional impairment in peer relationships * teen is interested and motivated to participate exclusion criteria: * main language spoken in the home is not english * cognitive or developmental delays that affect reading comprehension or understanding of treatment material * significant behavioral concerns * other comorbid medical conditions * major surgery in past 6 months * prior social skills group treatment within past 6 months * prior participation in peers
effects of respiratory rehabilitation by gender in copd patients

Conditions: COPD; Pulmonary Rehabilitation

Summary: without calling into question the effectiveness of pulmonary rehabilitation in women, the difference in outcome by gender was not established due to insufficient evidence . studies demonstrating the effectiveness of pulmonary rehabilitation include a majority of men, which no longer corresponds to the sex ratio of the disease. the impact of gender on pulmonary rehabilitation outcomes was not established due to insufficient evidence.


Eligibility criteria:
inclusion criteria: * patient \> 18 years old * no opposition filed * patient with copd * completed participation in respiratory rehabilitation program exclusion criteria: * refusal of participation * patient under tutorship or curatorship * no final assessment * patients with sex changes in marital status

Keywords: copd pulmonary rehabilitation dyspnea quality of life
lubiprostone for functional constipation in the under 18 years patients

Conditions: Clinical Efficacy; Treatment Efficacy; Drug Side Effect

Summary: the investigators will enroll subjects 8 - \< 18 years of age, fulfilling rome iv criteria for functional constipation. participants will be randomly assigned to either lubiprostone treatment (study group), or the control group (will receive either lactulose or bisacodyl tablets). safety and efficacy will be assessed.

the investigators will enroll 274 subjects who will be randomly divided equally into interventional and control groups. participants and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid. the control group will receive lactulose 1 ml/kg, once or twice daily (maximum 60 ml/day or bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \ 12 years. both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16). participants (and their guardians) will be instructed to regularly document the number of spontaneous bowel motions/week and to define their bristol chart category for every bowel motion. in addition, the participants will be encouraged to contact the trial team if any adverse events appeared. this is in addition to regular visits at 0, 2, 8, 12 weeks for assessment of safety (efficacy will be assessed at weeks 8, 12, and 16).

Eligibility criteria:
inclusion criteria: * patients 8 - \< 18 years of age who have a confirmed diagnosis of pediatric functional constipation according to the rome iv criteria, who give written informed consent personally or from their legal guardians. * discontinuation of any medication affecting gastrointestinal (gi) motility at least 2 weeks before starting the treatment allocation. * patient's daily diary that indicates an average of \< 3 weekly spontaneous bowel movements (sbms), with ≥ 25% of sbms involving at least some straining and/or a 5-point modified bristol stool form scale type 1 or 2. * patients who completed the study protocol. exclusion criteria: 1. if the patient's constipation is attributed to any of the following: physical, mental, or cognitive illness, inflammatory bowel disease, medication, anatomical, neurological, endocrine, or metabolic factors. 2. if the patient is a candidate for or underwent abdominal surgery, or has any condition other than constipation that could affect gastrointestinal motility or defecation. 3. patients suffering from hirschsprung's disease. 4. patients experiencing any alarming signs e.g. unexplained significant weight loss. 5. untreated fecal impaction at the time of enrollment.

Keywords: lubiprostone functional constipation adolescent children spontaneous bowel motions drug safety
thiol disulfide balance and oxidative stress change in endometrial polyp patients

Conditions: Endometrial Polyp; Oxidative Stress

Summary: changes in thiol disulfide balance and oxidative stress mechanisms in patients with endometrial polyps


Eligibility criteria:
inclusion criteria: for participants in the control group: • to be without endometrial polyp for the polyp group, they were as follows: * individuals experiencing menometrorrhagia * a body mass index (bmi) of 25 or more * hypertension * endometrial polyps detected via saline infusion ultrasonography exclusion criteria: * pregnancy * diabetes mellitus * pelvic mass * malignancy * the use of tamoxifen, hormonal contraceptives, or hormone replacement therapy.
standard follow-up program (sfp) for breast cancer patients

Conditions: Breast Cancer

Summary: motive: in order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients. goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. a standard database of patiënts receiving photon treatment will be created. these data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment. to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. a standard database of patients receiving photon treatment will be created. these data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.


Eligibility criteria:
inclusion criteria: * patients with breast cancer patients receiving a radiotherapy dose exclusion criteria: * failure to comply with any of the inclusion criteria

Keywords: acute toxicity late toxicity prediction models
cigarette smoking in smokers with and without schizophrenia

Conditions: Tobacco Dependence; Schizophrenia

Summary: higher rates and severity of tobacco dependence in people with schizophrenia, as compared with the general population, contribute to the lower life expectancy seen in this population. dependent tobacco smoking is controlled by how different aspects of cigarette smoking are perceived. there is evidence suggesting that people with schizophrenia differ in how they perceive cigarette smoking, which, if confirmed, would have implications for tailoring treatment interventions for smoking cessation in schizophrenia.

the aim of the present study is to determine whether tobacco smoking in people with schizophrenia is governed by different aspects and effects of cigarette consumption. smokers participating in this study either have no psychiatric diagnosis, or a diagnosis of schizophrenia or schizoaffective disorder. over four study visits, participants will sample and compare different research cigarettes, complete questionnaires and concentration tasks, and smoke one type of research cigarette for eight hours while wearing a nicotine patch. by shaping our understanding of tobacco dependence in schizophrenia, the present project may redirect treatment development toward strategies tailored to the specific vulnerabilities of this population, which is among the most severely affected by its detrimental impact on health and life.

Eligibility criteria:
inclusion criteria: * regular smoker of at least 10 cigarettes or cigarillos/day for at least 2 years * for participants with schizophrenia: dsm-5 diagnosis of schizophrenia or schizoaffective disorder * for participants with schizophrenia: able to give informed consent * for smokers with schizophrenia: no change in psychiatric medication or dosage in the last 4 weeks exclusion criteria: * uncontrolled hypertension (resting systolic bp above 150 or diastolic above 95 mm hg) * cardiovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, severe arrhythmias, or ekg abnormalities * severe asthma * chronic obstructive pulmonary disease * neurological illness, such as stroke, seizure disorder, neurodegenerative disease, or organic brain syndrome * mental retardation * alcohol or substance use disorder except nicotine within the last year * use of benztropine (cogentin), varenicline (chantix), bupropion (wellbutrin, zyban), or any type of nicotine replacement * pregnant or lactating * for healthy control smokers: dsm-5 diagnosis of depression, bipolar disorder, adhd, autism spectrum disorder, anorexia, bulimia nervosa, or any schizophrenia-spectrum disorder * for healthy control smokers: immediate family history of psychosis
study to compare (copd) assessment test in copd stage iii and iv in a prophylactic treatment

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study will assess the treatment of patients with chronic obstructive pulmonary disease (copd) stage iii and iv who will self administer the alphacore stimulation three times a day over a course of 2 months. patients will either receive an active alphacore device or a sham device during these two months while not knowing which device they have been provided. at the end of the two months, all patients will be asked to continue in the study for another 2 months to self administer with the active alphacore device. subjects will complete diaries at home on their breathing and quality of life and will return to the clinic monthly for assessment by the investigator.

performance and safety variables: the primary efficacy endpoint for this study is the total chronic obstructive pulmonary disease (copd) assessment test (cat) score change from baseline to the 8 week follow-up period comparing the two device groups. secondary efficacy endpoints will be the mean difference from baseline to the 8 week follow-up for the following assessments: medical research council (mrc) dyspnoea scale, 6 minutes walking test and forced expiratory volume in one second (fev1) safety variables: each subject will be assessed throughout the study for adverse events and at the last visit (4 months) subjects will undergo another physical examination including vital signs and blood pressure.

Eligibility criteria:
inclusion criteria: * age 40-75 years * diagnosed chronic obstructive pulmonary disease(copd) stage iii and iv according to global initiative for chronic obstructive lung disease (gold) guideline * forced expiratory volume in one second (fev 1) \< 50% * forced expiratory volume in one second (fev1/forced expiratory vital capacity (fvc) \< 70% * signed informed consent form exclusion criteria: * participation in other clinical trials (drug or medical device) 30 days prior to start of this study * subject is unable to comply with the procedures if the protocol for the study or any other reason judged by the investigator that could interfere with the study assessment or follow-up * has an abscess or other infection or lesion (including lymphadenopathy) at the alphacore® treatment site. * is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. * has a history of carotid endarterectomy or vascular neck surgery on the right side. * right side or bilateral vagotomy * has a recent or repeated history of syncope. * has a recent or repeated history of seizures. * pregnant or breast feeding women

Keywords: copd vagus nerve stimulation vagal nerve stimulation nvns vns non invasive gammacore
phase ll study of imatinib mesylate for the neoadjuvant treatment of patients with gastrointestinal stromal tumors (gist)

Conditions: Gastrointestinal Stromal Tumors

Summary: this study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with gist. it will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.


Eligibility criteria:
inclusion criteria: * patients with age between 18 and 80 years * diagnosis of gist not previously treated * patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other gi function) exclusion criteria: * presence of metastatic disease * use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: gastrointestinal, stromal, neoadjuvant, imatinib, mesylate, pre-operatory