Kornimate/medical-research-clean huggingface dataset:
genetic testing and phenotypic characterization of severely obese pediatric and adult volunteers

Conditions: Pro-opiomelanocortin (POMC), Proprotein Convertase Subtilisin/Kexin Type 1 (PCSK1) and Leptin Receptor (LepR) Gene Mutations

Summary: the purpose of this screening study is to identify people who have a rare genetic cause of obesity - specifically three genetic variants (a change in the dna structure) of the pomc, pcsk1 and lepr genes that are currently known to result in obesity. this screening study will not include any investigational drugs. you will be asked to provide a dna sample and answer some questions about your medical history and hunger.


Eligibility criteria:
individuals who meet any of the following inclusion criteria may be eligible: 1. participant aged 2 or older. 2. study participant and/or parent or guardian is able to communicate well with the investigator, to understand and comply with the requirements of the study, and be able to understand and sign the written informed consent/assent. 3. ≥40kg/m2 (age 18 and older) or 1.4x 95th percentile of bmi for age (ages 2-17) - with evidence of hunger or hyperphagia by screening surveys, indicated by a patient or observer score at or greater than midpoint of scale. o individuals with clinical evidence of rgdo (per appendix 4) but do not meet the bmi criteria may be included if the investigators estimation and proband demonstrates a bmi z-score difference of \>1 between proband and any other sibling; and/or the proband demonstrates a bmi difference \>10 kg/m2 between proband and parents. 4. ≥50 kg/m2 (age 18 and older) or 1.5x 95th percentile of bmi for age (ages 2-17). cohorts included under this criteria include ≥50-60 kg/m2 (age 18 and older) or 1.5x 95th percentile of bmi for age (ages 2-17) and ≥60 kg/m2 (age 18 and older) or 1.6x 95th percentile of bmi for age (ages 2-17). 5. ≥ 40 kg/m2 (pre-operative) or 1.4x 95th percentile of bmi for age (ages 12-17) with history of bariatric surgery or planned surgery within 3 months (prior to or following screening). individuals who meet any of the following exclusion criteria will not be eligible: 1. prior craniopharyngioma or other hypothalamic brain region surgery or surgeries/procedures for brain tumor, i.e., ventriculoperitoneal shunt and radiation therapy 2. diagnosis of prader-willi syndrome

Keywords: pomc pcsk1 pro-opiomelanocortin
nebulized bacteriophage therapy in cystic fibrosis patients with chronic pseudomonas aeruginosa pulmonary infection

Conditions: Chronic Pseudomonas Aeruginosa Infection; Cystic Fibrosis

Summary: this is a phase 1b/2a study with the primary objective to determine if bx004-a is safe and tolerable. exploratory objectives include whether bx004-a reduces sputum pseudomonas aeruginosa (psa) bacterial load in cf subjects with chronic psa pulmonary infection.

this is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and tolerability of bx004-a in cf subjects with chronic psa pulmonary infection. the study is divided into two parts, a single-ascending and multiple-dose phase (part 1) and a multiple dose phase (part 2). subjects in both parts will be included in a 6-month safety follow-up. a data safety monitoring board will monitor safety in both parts. the purpose of the study is to evaluate safety and tolerability of bx004-a, and whether bx004-a reduces the psa burden in the sputum of cf subjects with chronic psa pulmonary infection. clinically stable cf subjects with a confirmed diagnosis of cf and chronic psa pulmonary infection will be enrolled.

Eligibility criteria:
key inclusion criteria: * cystic fibrosis patients with chronic pseudomonas aeruginosa pulmonary infection receiving standard of care cf medications * age ≥ 18 years * fev1 ≥ 40% predicted * clinically stable lung disease * willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits. key exclusion criteria: * known hypersensitivity to bacteriophages or excipients in the formulation. * receipt of prior bacteriophage therapy within the 6 months prior to screening * recovery of burkholderia species from respiratory tract within 1 year prior to screening * currently receiving treatment for allergic bronchopulmonary aspergillosis * currently receiving treatment for active infection with non-tuberculous mycobacteria * history of severe neutropenia * history of lung transplant * history of solid organ transplant * acquired or primary immunodeficiency syndrome * initiation or change in cf modulator therapy less than 3 months prior to screening * pregnant or breastfeeding female
the effect of a multi-modal program on fear of cancer recurrence in breast cancer patients

Conditions: Breast Cancer

Summary: the goal of this clinical trial is to learn if mmp intervention can alleviate fcr , breast cancer symptoms and social support among breast cancer patients. he main questions it aims to answer are: * null hypotheses (h0): there is no significant difference in fcr, breast cancer symptoms, and social support between the mmp intervention group and the control group. * alternative hypotheses (h1): there are significant differences in fcr, breast cancer symptoms, and social support between the mmp intervention group and the control group researchers will compare mmp to a routine care to see if mmp works to alleviate fcr, breast cancer symptoms and social support. participants will: * receive interventions once per chemotherapy cycle for 8 weeks. * the fcri-sf, msas-sf-sc, and ssrs scales will be utilized to assess fcr levels, breast cancer symptoms and social support in both the experimental and control groups, with measurements conducted at baseline (t1), 8 weeks post-intervention (t2), and 12 weeks post-intervention (t3).


Eligibility criteria:
inclusion criteria: * diagnosis meets the criteria outlined in the breast cancer diagnosis and treatment guidelines, with a pathological diagnosis of breast cancer and currently undergoing chemotherapy * age ≥ 18 years * clear consciousness and the ability to communicate independently * aware of the diagnosis and has signed the informed consent form exclusion criteria: * presence of mental illness or cognitive impairment * hearing or speech impairmen * distant metastasis of cance * severe physical illness or other malignant tumors requiring treatment

Keywords: fear of cancer recurrence symptoms social support
combined endoscopic epicardial and percutaneous endocardial ablation versus repeated catheter ablation in persistent and longstanding persistent atrial fibrillation

Conditions: Atrial Fibrillation; Persistent and Longstanding Persistent Atrial Fibrillation

Summary: this is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of persistent and longstanding persistent af referred for radiofrequency (rf) ablation.the study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of af in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.


Eligibility criteria:
inclusion criteria: 1. patient has a history of symptomatic persistent af and a left atrium (la) \> 4cm or long standing persistent af as defined by the hrs/ehra/ecas expert consensus statement 2. patient is refractory to or intolerant of at least one antiarrhythmic drug (class i or iii) 3. patient is mentally able and willing to give informed consent exclusion criteria: 1. patient has longstanding persistent af \> 10 years 2. patient presenting with paroxysmal af 3. patient with persistent af and a la-diameter ≤ 4cm 4. af is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause 5. patient underwent previous ablation procedure or heart surgery 6. patient needs other cardiac surgery procedures besides af treatment (valve, coronary, others) 7. contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, previous cardiac tamponade, pleural adhesions, prior thoracotomy) 8. body mass index \> 35 9. la diameter \> 6 cm 10. left ventricular ejection fraction \< 30 % 11. severe mitral regurgitation (\>ii) 12. patient unable to undergo transesophageal echocardiogram (tee) 13. presence of la thrombus by tee, ct scan, mri or angiography 14. history of cerebrovascular disease, including stroke or transient ischemic attack (tia) within 6 months prior to enrollment 15. active infection or sepsis 16. other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis) 17. contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy 18. pregnancy, planned pregnancy or breastfeeding 19. life expectancy is less than 12 months 20. patient is involved in another study involving an investigational drug or device

Keywords: atrial fibrillation persistent and longstanding persistent af hybrid procedure catheter ablation
early detection of lung cancer with machine learning based on routine clinical investigations

Conditions: Adenocarcinoma of Lung; Bronchial Neoplasms; Early Detection of Cancer; Machine Learning

Summary: this observational, cross-sectional study in lung cancer patients and lung cancer-free controls aims to develop a machine learning model for early detection of lc based on routine, widely accessible and minimally invasive clinical investigations. the model with adequate predictive performance could later be used in clinical practice as an aid in defining the optimal population and timing for lung cancer screening program.


Eligibility criteria:
all patients: * age ≥ 50 years and \< 80 years at the index date of diagnosis (for cases) or pseudodiagnosis (for controls). * presence of at least one extended blood analysis, spirometry and dlco report within the 6 months before the index date. * chest ct scan performed in a non-urgent setting (electively) within the 6 months before the index date (= index ct). * active smokers at the index date or former smokers that ceased smoking within 15 years before the index date. * smoking history ≥ 20 pack-years. additional for cases only: confirmed histological diagnosis of bronchogenic lung cancer in the time period ≥ 2010 and ≤ 2020. additional for controls only: * absence of lung cancer at all times ≤ 2020, confirmed by chest ct scan at the index date. * documented to live without diagnosis of lung cancer for at least 3 years after the index date. extended criteria for the lung cancer prediction subgroup: in addition to the above stated inclusion criteria, patients in this subgroup have at least one extended blood analysis, spirometry and dlco report available in the time interval between 3-5 years before the index date.
the reality study - a real-life long-term analysis of xolair therapy

Conditions: Allergic Asthma

Summary: the primary objective is to assess the clinical effectiveness of long-term omalizumab therapy in 240 patients treated over an 8 year period in a real-life clinical setting and to compare the pre- and post-treatment clinical characteristics to identify and better understand the markers of response to omalizumab. to date, there are no established criteria for identifying 'response' to omalizumab therapy. currently, the commonly accepted clinical criterion for omalizumab treatment response is the physician's overall assessment, gete (global evaluation of treatment effectiveness). most clinical trials have evaluated the efficacy of omalizumab treatment after a 16 week treatment period and lack the impact of long-term omalizumab therapy. investigators propose multiple approach modules to better assess and identify 'response' and to define 'responders' to omalizumab and evaluate the long-term impact in a real-world clinical practice. besides evaluating individual outcome variables, it is important to attempt the 'clustering of variables' to further investigate if any baseline clinical phenotypes are predictive of better response enabling us to refine the patient population who will gain most benefit from therapy.

medical records from 240 omalizumab-treated patients will be evaluated. comprehensive data will be collected for any asthma-related event (see evaluation criteria below), omalizumab dose, asthma-medications, spirometry, asthma control test (act) and any respiratory infection and/or antibiotic use since last visit. data will be analyzed to compare the clinical phenotypes and outcome among patients to identify, characterize and define 'responders' and 'non-responders' to omalizumab. periodic assessments for demonstrated level of response and need for continued therapy will be evaluated quarterly. also, real-life patient adherence data to long-term omalizumab therapy will be analyzed and the factors for withdrawal and non-adherence will be identified. reduction in annualized rate of asthma exacerbation, steroid bursts and oral steroid dosage, er/unscheduled doctor's visits, hospitalization and improvement in spirometry and act score and review of asthma medications will be evaluated quarterly. 'cluster analysis' will be performed by grouping variables (such as age, asthma duration and severity, dosage, therapy duration, sensitization profile, ige levels etc.) in effort to identify groups of responders.

Eligibility criteria:
inclusion criteria: 1. moderate-to-severe persistent allergic asthmatic patients with inadequate asthma control 2. received omalizumab therapy per steps 5 \& 6 of the nhlbi guidelines 3. positive skin test or in-vitro specific ige to perennial allergens 4. measured baseline total serum ige level (within 1 year from first dose) 5. patient followed at aaiast/aarc (from february 2004 to december 2011) exclusion criteria: * n/a; retrospective study

Keywords: allergic asthma omalizumab therapy ige profile
patient perception of visual distortions

Conditions: Cataract; Astigmatism

Summary: the purpose of this study is to evaluate visual distortions reported by pseudophakic patients.


Eligibility criteria:
inclusion criteria: * corneal astigmatism of at least 0.75 diopters * bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes * at least one month postoperative from second-eye surgery * ability to understand, read and write english to give consent and complete study questionnaire * availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits * sign informed consent and health insurance portability and accountability act (hipaa) authorization * other protocol-defined inclusion criteria may apply exclusion criteria: * any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms * patient is pregnant or is lactating * participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial * other protocol-defined exclusion criteria may apply
cardiovascular disease population risk tool

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to develop, evaluate, and apply a predictive algorithm for assessing cvd risk in the community setting: the cardiovascular disease population risk tool (cvdport).

this observational study will use the ontario sample of the canadian community health survey (2001, 2003, 2005; 77,251 respondents) to assess risk factors - focusing on health behaviours (physical activity, diet, smoking, and alcohol use). incident cvd outcomes will be assessed through linkage to administrative healthcare databases (619,886 person-years of follow-up until 31 december 2011). socio-demographic factors (age, sex, immigrant status, education) and mediating factors such as presence of diabetes and hypertension will be included as predictors. risk prediction models will be developed using competing risks survival analysis. the analysis plan adheres to published recommendations for the development of valid risk prediction models to limit the risk of over-fitting and improve the quality of predictions. key considerations are fully pre-specifying the predictor variables; appropriate handling of missing data; use of flexible functions for continuous predictors; and avoiding data-driven variable selection procedures that increase the risk of type i error. the 2007 and 2009 surveys (approximately 50,000 respondents) will be used for validation. calibration will be assessed overall and in predefined subgroups of importance to clinicians and policymakers.

Eligibility criteria:
inclusion criteria: * respondents to the canadian community health surveys exclusion criteria: * not eligible for ontario's universal health insurance program * pregnant * prior history of heart disease or stroke * younger than age 20

Keywords: cardiovascular diseases clinical prediction rule population projection risk stratification health behavior
restore motor function through robotic arm exoskeleton and brain computer interface

Conditions: Amyotrophic Lateral Sclerosis

Summary: the current project will aid patients with motor impairment to reduce the need for homecare. specifically the aim is to develop and implement a robotic exoskeleton and brain computer interface to assist and eventually perform arm and hand movement in patients with the progressive neurodegenerative disease als. this proposal brings together state-of-the-art robotic technology, eeg-based brain computer interface (bci) know-how, clinical expertise, patient perspective and industrial partners to develop and implement a robotic arm/hand device that will adapt, with increasing brain-computer control, based on the need of the patient. in short the bci will measure electroencephalography (eeg) from the surface of the scalp and recognize signature eeg as the patient intents to move. as the patient loses muscle power the bci robotic-device will gradually take over and support motor activity, even when the patient is totally paralyzed. as the device supports hand/arm function only, the investigators aim to address adls associated to hand function, specifically eating activities.


Eligibility criteria:
inclusion criteria: * als according to the latest revision of el escorial criteria (ludorph et al. 2015) * loss of muscle force or fine motor skills in a hand exclusion criteria: * other severe neurological or psychiatric disease * drug or alcohol dependency * pregnancy * severe cognitive disturbances found to impede with study completion

Keywords: brain computer interface
effective mechanisms of wu-chu-yu tang on gastroesophageal disorder

Conditions: Wu-Chu-Yu Tang; Gastroesophageal Reflux Disorder; 24 Hours Esophageal PH and Multichannel Intraluminal Impedance Testing

Summary: gastroesophageal reflux disorder (gerd) is due to gastric content reflux to esophagus cause symptom and complication including intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. because the changes of dietary habit, and improvement of examination skill and data analysis, the prevalence of gerd increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence is 25% in taiwan community. the etiology of gerd is multi-effect, such as transient lower esophageal sphincter relaxation and abnormal pressure of lower esophageal sphincter, which may induced the esophageal mucosal injury by gastric acid, bile or pancreases enzyme. wu-chu-yu tang consists of evodia fargesii dode (evodia fruit), panax ginseng c. (ginseng), ziziphus jujube mill (chinses date), zingiber officinale rosee (fresh ginger).according to "i-fang-chi-chieh" and "shanghonzobinglun" recordings that wu-chu-yu tang can treat vomiting, and also can relax gastric tonicity and can enhance peristalsis of stomach. according to randomized, double blind, placebo control trial to evaluate the efficacy of wu-chu-yu tang on gastroesophageal reflux disease, we know the wu-chu-yu tang have the equivalent effect proton pump inhibitor omeprazole. but, the mechanism of wu-chu-yu tang is still unknown.


Eligibility criteria:
inclusion criteria: 1. gender：male or female. 2. age：from 20 years old (inclusive) to 75 years old (inclusive). 3. diagnosis of gastroesophageal reflux disease. 4. there is a heartburn or acid regurgitation phenomenon. 5. after detailed description of the entire research purpose or process, voluntarily participate in the study and sign the consent form. exclusion criteria: 1. exclude peptic ulcers, gallstones (including intrahepatic and common bile ducts) and major diseases such as: cancer, congestive hear failured nyha class\>ii, copd attack. 2. barrett's esophagus, narrow esophagus or caustic injury of upper gastrointestinal tract. 3. history of esophagus and gastroduodenal surgery. 4. tarry stool suspected gastrointestinal bleeding. 5. history of alcohol or drug abuse. 6. patients with a history of allergies to the test drug. 7. can not cooperate with mental illness. 8. pregnant women or women who are breastfeeding. 9. liver function sgot and sgpt are more than twice the normal value. 10. renal function test bun, creatinine is greater than the normal value.
how to cope with anxiety and depression. a randomized controlled trial.

Conditions: Depression; Anxiety; Self Efficacy

Summary: the purpose of this study is to investigate whether citizens experiencing symptoms of anxiety and depression will benefit from a self-management training program with respect to: 1) self-efficacy, and 2) symptoms of anxiety and depression, and 3) self reported measures of health related quality of life (hrqol)

* the intervention is a danish adaption of the chronic disease self-management program developed by the stanford patient education research center, the expert patient program community interest company (eppcic), and the english national health service (nhs). * the danish adaptation has been performed by the danish committee for health education.

Eligibility criteria:
inclusion criteria: * \>= 18 years of age * suffering from anxiety and/or depressive symptoms * voluntary participation exclusion criteria: * potential suicidal behavior * potential aggressive behavior * significant cognitive impairment

Keywords: depression anxiety randomized controlled trial self care intervention studies health education
effect of computer-based cognitive training on attention and executive functions in patients with parkinson's disease

Conditions: Parkinson Disease; Executive Dysfunction

Summary: the current study adresses the effect of two different computer-based cognitive trianing programmes on attention and executive functions in patients with parkinson's disease.

the current study adresses the effect of two different computer-based cognitive training programmes (brain+ evolution and scientific brain training pro) on attention and executive functions in patients with parkinson's disease. the patients are assigned to one of three groups. two training groups with each their programme, and a control group. the training groups will train at home for 8 weeks with follow-ups every second week. the control group will not train at home, but will also receive a follow-up with computer-based stimuli (computerized card game) every second week, to minimize the possibility that a possible effect is due to the follow-up's with a professional, and not due to the computer training at home.

Eligibility criteria:
inclusion criteria: * patients with parkinson's disease and * montreal cognitive assesment (moca)-score between 22-28 * motorically cabable of using an ipad * not receiving antipsychotic medicine * no comorbid diseases which might influence the level of executive functioning, for an example adhd or acquired brain damage exclusion criteria: * people without parkinson's disease * parkinson's patients not included in the above inclusion criteria

Keywords: parkinson executive dysfunction attention computer-based cognitive training