Kornimate/medical-research-clean huggingface dataset:
change 4 better (c4b)

Conditions: Problem Gambling

Summary: the purpose of this research study is to determine the effectiveness of the change4better (c4b) mobile app at reducing the severity of problem gambling as compared to standard treatment as usual (tau).

this study is a 6-month randomized clinical trial for individuals with a gambling disorder enrolled in or seeking treatment for problem gambling at an outpatient treatment facilities affiliated with the bettor choice gambling treatment programs in connecticut. the purpose is to evaluate the feasibility and efficacy of a cognitive behavioral therapy-based mobile app (change4better; c4b), as an adjunct to treatment as usual (tau) in community-based outpatient treatment programs. eligible participants will be randomly assigned to receive either: (1) standard treatment as usual (tau) or (2) tau plus access to the change4better (c4b) mobile app. tau will consist of standard services provided at outpatient clinics within the bettor choice programs. clinicians providing tau within the bettor choice program will not be participants in the research trial, and they will not be asked to perform any additional duties outside of their typical services. participants assigned to c4b will receive tau plus access to the c4b mobile app, which they can access as often as desired using their own device. the c4b mobile app will be managed by the yale research team.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older; 2. able to speak, read and write in english; 3. report gambling in the past month (28 days); 4. meet dsm-5 criteria for gambling disorder within past 12 months as determined by the structured clinical interview for pathological gambling - dsm-5 version (sci-pg-dsm); 5. at least mild gambling severity as measured by gsas (total \>8) 6. seeking or currently enrolled in treatment for gambling; if seeking treatment, must be deemed appropriate for outpatient level of care by treatment facility clinical team 7. own a smartphone with internet access. exclusion criteria: 1. unwilling or unable to provide informed consent due to severe cognitive impairment or inability to read; 2. deemed to have current untreated psychosis or mania; 3. active suicidal ideation; 4. physical dependence on opioids and/or alcohol requiring medical detoxification.

Keywords: problem gambling mobile app
cnv in amd analyzed by oct angiography under intravitreal eylea (coctaeyl)

Conditions: AMD; Exudative Macular Degeneration

Summary: the main objective of this study is to analyze a new noninvasive imaging examination, oct angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet amd undergoing treatment on octa and to correlate octa findings with sd-oct findings.


Eligibility criteria:
inclusion criteria: * naïve patients * type 1 or type 2 choroidal neovascularization (cnv) * age ≥ 55 years * presence of subfoveal cnv secondary to age-related macular degeneration (amd) * at the time of inclusion, multimodal imaging should reveal exudative features * exudative amd diagnosis established between 1 and 7 days before inclusion * monitored monthly * loading phase then bimonthly retreatment. * signed informed consent. * patient covered by the french health insurance exclusion criteria: * polypoidal choroidal vasculopathy * type 3 neovascularization * choroidal neovascularization attributable to causes other than amd * macular hematoma * pigment epithelial detachment higher than 150µm * fibrosis \> 50% lesion on fundus color photography, fibroglial scar * media opacity annoying acquisition * retinal vascular occlusion * diabetic retinopathy * adult-onset foveomacular vitelliform dystrophy and other pattern dystrophies, * refractive error \>-6d * active intraocular inflammation in the study eye * patient who does not meet the local indication criteria for eylea® treatment. contraindications listed in the smpcs must be taken into account * patient taking part in an interventional study at the time of enrolment. * any history of allergy to the antiseptic used during preparation of the eye for the ivt injection in the investigational site (e.g. povidone iodine or chlorhexidine). * pregnant and lactating women * stroke and/or myocardial infarction 3 months before inclusion
assessment of insulin glargine in type 2 patients for good glycemic control

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: * to observe the efficacy of the forced titration to reach good glycemic control in lantus treated patients secondary objectives: * to assess the forced titration on physician and patient satisfaction * to evaluate the impact of training tools by means of patient profile


Eligibility criteria:
inclusion criteria: * t2 insulin naïve patients * patients whom their physician is considering initiation of lantus treatment * poor glycemic control 7,5 %10 % * t2 treatment with oads more than 3 months * bmi\<40 kg/m2 exclusion criteria: * impaired renal function (cr\>2mg/dl or current renal dialysis) * acute or chronic metabolic acidosis * active liver disease or serum alt or ast \>2,5 than normal * history of hypoglycemia unawareness * diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry * pregnancy, breast feeding the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
thoracoscopy versus fibrinolysis in children with empyema

Conditions: Empyema

Summary: the null hypothesis is that patients receiving either thoracoscopy or fibrinolysis for empyema recover in the same amount of time. therefore, we will test this by randomizing the next 40 patients who consent to the study to one treatment or the other.

this will be a single institution, prospective, randomized clinical trial involving patients who are found to have at least a single septation within a pleural effusion as diagnosed by ultrasound or computed tomography. additionally, patients with a pleural effusion wherein a pleural tap reveals pus as defined by many (\> 10,000/mm3 ) white blood cells or positive cultures will be considered. this is intended to be a definitive study. power calculations based on the known 4.8 post intervention hospital days after vats and the estimated 7 post intervention days after fibrinolysis with α = 0.05 and power of 0.8 show the need for 18 patients in each arm. we will intend to recruit 40. this sample size was constructed in consultation with dr. steve simon, and the range of hospital stay in our retrospective experience was utilized. therefore, this number should represent an adequate power in spite of the known varied level of illness. one group will undergo thoracoscopy to clean the pleural space and leave a chest tube postoperatively to drainage. the other group will undergo chest tube placement with subsequent infusion of fibrinolytics to dissolve the thick purulent material allowing drainage. both groups will have the same antibiotic regimen with the same management algorithm.

Eligibility criteria:
inclusion criteria: * patients less than 18 years of age requiring an intervention for empyema by one of the following: 1. septation or loculation seen on ultrasound or computed tomography 2. many white blood cells, bacteria present, or thick viscid purulence identified on pleural tap exclusion criteria: 1. immunodeficiency process 2. secondary diagnosis or condition that will keep them in the hospital beyond the empyema 3. existing contraindications to vats or chest tube.

Keywords: thoracoscopy fibrinolysis empyema children
development of new techniques for functional magnetic resonance imaging of the brain

Conditions: Diagnosis, Psychiatric

Summary: this protocol is intended to facilitate development and testing of new techniques for functional mri by uc davis research faculty, as well as to facilitate the evaluation of new techniques provided by the system manufacturers (ge and siemens).

new techniques covering a wide range of clinical and scientific applications will be developed, tested and evaluated. these include 1. investigation of sensory stimulus processing and cognitive processing, both in normal subjects and patients with psychiatric disorders, 2. early detection of stroke and other ischemic injury, and 3. characterization of tumor distribution and activity. the new techniques will routinely need to be tested with respect to the following: 1. sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms, 2. signal-to-noise and contrast-to-noise ratio, 3. spatial and temporal resolution, 4. distribution and severity of image artifacts, and 5. duty cycle limitations. most clinical applications will require coverage of the entire brain and consequently high duty cycle operation, which needs to be traded off with spatial and temporal resolution, as well as contrast mechanisms. the work will also involve the testing of different experimental paradigms (time sequence of stimuli or cognitive tasks) to identify that which provides the highest signal change associated with the specific brain activity of interest. although 3t provides twice the signal of 1.5t systems, for some research applications this image quality advantage of 3t may be outweighed by other effects of higher field on the signal. consequently, most new techniques will be evaluated on both the 1.5t and 3t systems, and a decision will be made based upon the overall image quality, regarding which system is to be used. the protocol does not involve injection of any contrast agent or drug, or other minimally-invasive or invasive procedure. it is intended specifically for those studies in which the subject is required, in addition to trying to relax and lie still, only to experience and respond to various non-harmful sensory stimuli, or to perform common cognitive (e.g. math calculations) and or motor (e.g. finger tapping) tasks.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * ability to give informed, written consent * not pregnant or breastfeeding exclusion criteria: * electrically, magnetically, or mechanically activated implants (for example, cardiac-pacemakers) * ferromagnetic implant, such as an aneurysm clip, surgical clip, or prosthesis * history of uncontrolled claustrophobia

Keywords: brain functional mri
cubii for exercise in people with ms

Conditions: Multiple Sclerosis; Fatigue; Activity, Motor; Quality of Life

Summary: the goals of this observational study are to evaluate (1) the feasibility, usability, and satisfaction with the cubii elliptical and (2) the preliminary efficacy of the cubii elliptical for increasing activity (primary outcome), physical function, and quality of life, and decreasing physical and psychological symptom (e.g., pain, fatigue, depression) severity in people with ms. the main question it aims to answer is how usable and feasible is the cubii as a mode of exercise for people with ms? participants will use the cubii as they choose and keep a written log of this use. they will answer questions about their demographics, ms disease-related variables (e.g., pain, fatigue, falls), activity, exercise, quality of life, and biopsychosocial symptom variables) and provide additional data regarding the feasibility, usability, and satisfaction with use of the cubii.

data indicates people with ms are less active than their peers in the general population. exercise interventions are important non-pharmacologic approach to maximize function and quality of life for people living with ms. based on current evidence and expert opinion, the national multiple sclerosis society (nmss) recommends that healthcare providers promote the benefits of exercise and lifestyle physical activity for every person with ms. individuals with at least moderate impairments (approximately 50% of ms population) often require adaptive exercise due to mobility and balance impairments. these individuals are likely to present with neurologic impairments that impact their gait and/or coordination and may experience limitations in walking distance and necessitate precautions for falls, as well as the use of assistive devices or compensatory strategies. the cubii product line is well-placed for this subset of the ms population because it allows for safe, seated exercise that can still meet the recommendations for aerobic and resistance training. this study will capitalize on a representative, heterogeneous sample of ms patients who are seeking to change their coping behaviors around ms, including by exercising more, and an existing exercise unit that can be utilized by people with a range of mobility.

Eligibility criteria:
inclusion criteria: * clinician-confirmed ms * 18 years of age or older * walks with the aid of an assistive device (e.g., cane, walker, forearm crutches) * able to read and speak english * lives in the greater seattle metropolitan area * all genders * has an iphone or android phone that can download apps exclusion criteria: - people unable to exercise for health reasons
safety and efficacy of cd19/cd22 dual targeted car-t cell therapy in r/r b-cell acute lymphoblastic leukemia

Conditions: CD19+ and CD 22+ B-ALL

Summary: this is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti cd19 and cd22 car-t cell in the treatment of r/r b-all.

cd19-directed car-t cell therapy has shown promising results in the treatment of relapsed/refractory b-cell acute lymphoblastic leukemia. cd19 and cd22 are proteins usually expressed on the surface of the b leukemia cells. the dual-cars enables the t-cells to recognize and kill the tumor cell through recognition of cd19 and cd22.

Eligibility criteria:
inclusion criteria: 1. sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2. a definite diagnosis of b-cell lymphocyte leukemia, which meets any of the following criteria: relapsed : a) relapsed within 12 months after first remission;refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter cr for 2 or more times; c) the first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation; 3. ecog scores: 0\~2 4. cd19 positive and cd22 positive were detected by immunohistochemistry or flow cytometry; 5. estimated survival time\>3 months; 6. peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment. 7. for patients with only extramedullary recurrence of b-all, there must be at least one assessable lesion. exclusion criteria: 1. serious cardiac insufficiency； 2. has a history of severe pulmonary function damaging; 3. presence of other malignant tumors. 4. presence of active fungal, bacterial, viral, or other infection requiring iv antibiotics for management. 5. presence of other severe autoimmune diseases or immunodeficiency disease; 6. patients with active hepatitis b or hepatitis c(\[hbvdna+\]or \[hcvrna+\]); 7. known positive serology for human immunodeficiency virus (hiv) or syphilis。 8. has a history of serious allergies on biological products (including antibiotics); 9. female patients who are under pregnancy and/or lactation, or planing on pregnancy for the next 12 months. 10. any other situations that the researchers believe will affect the results of the study.

Keywords: cd19 cd22 b-all car-t
gait and rem sleep behavior disorder

Conditions: Parkinson's Disease; REM Sleep Behavior Disorder

Summary: many people with idiopathic rapid eye movement (rem) sleep behavior disorder (rbd) have an underlying synucleinopathy, the most common of which are parkinson's disease (pd) and lewy body disease. identifying additional abnormal clinical features may help in identifying those at greater risk of evolving to a more severe syndrome. because gait disorders are common in the synucleinopathies, early abnormalities in gait in those with rbd could help in identifying those at increased risk of developing overt parkinsonism and/or cognitive impairment. the investigators aim to identify subtle gait abnormalities in idiopathic rbd and to identify sensitive and early biomarkers: 1. to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and 2. to track their evolution in the parallel with the disease progression. main objective: in comparison with age and gender matched-controls, to identify in patients with rbd a larger reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task). secondary objective: 1. in comparison with age and gender matched-pd patients, to identify in patients with rbd a smaller reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task). 2. in patients with rbd to identify correlations between the spatio-temporal characteristics modifications of gait between a single (gait) and a dual-task (gait+cognitive task) and the percentage of rem without atonia - the dopamine transporter (dat) density using fp-cit single-photon emission computed tomography; the reduction of the olfactory discrimination and thresholds. 3. in patients with rbd to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)


Eligibility criteria:
inclusion criteria: * specific inclusion criteria for rbd patients - to reach the diagnosis criteria of rbd (international classification of sleep disorders 2) * specific inclusion criteria for pd patients - to reach the diagnosis criteria of idiopathic pd (queen square brain bank) - hoehn yahr score ≤ 2 exclusion criteria: * specific exclusion criteria for rbd patients - diagnosis of pd - other pathology associated to rbd diagnosis - presence of antiparkinsonism medication * specific exclusion criteria for pd patients - clinical signs of parkinsonian syndrome- mini mental state examination \< 24/30- gait disorder clinically observable * specific exclusion criteria for controls - neurological disease- gait disorder

Keywords: gait rem sleep behavior disorder parkinson's disease follow-up
improving driving in young people with autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: this study will examine the effects of treatment with the anti-anxiety medicine buspirone on driving performance (eye tracking) in individuals with high-functioning autism spectrum disorder (hf-asd). the study consists of an assessment visit at massachusetts general hospital (mgh), as well as two driving simulation visits that will take place at massachusetts institute of technology (mit). subjects will be given buspirone and asked to take the medication for the two days preceding the driving simulation visit.


Eligibility criteria:
inclusion criteria: * males and females, ages 18-24, with a diagnosis of dsm-v autism spectrum disorder * has a valid driver's license exclusion criteria: * major sensorimotor handicaps (e.g. deafness, blindness) * individuals who have never held a valid driver's license * intellectual deficiency (verbal comprehension index \< 80) * inadequate command of the english language * subjects with any clinically meaningful medical or psychiatric condition as determined by the investigator * individuals who are currently taking a monoamine oxidase inhibitor (maoi) for any reason * pregnant

Keywords: autism spectrum disorder asd anxiety
beetroot juice intake in postmenopausal hypertensive women

Conditions: Hypertension; Menopause

Summary: the goal of this clinical trial is to verify the hemodynamic and biomarker responses of beetroot juice intake in postmenopausal women with hypertension. the main questions it aims to answer are: is beetroot juice dose related to better hemodynamic responses in hypertensive postmenopausal women? is beetroot juice dose related to better oxidative stress profile responses in hypertensive postmenopausal women? the investigators will conduct a parallel clinical study with 10 days of intervention, in which 48 women will be randomized into 3 groups: 1) two shots of beetroot juice intake per day (800mg of no3-); 2) one shot of beetroot juice intake per day (400mg of no3-); 3) placebo intake (beetroot juice without no3-).

the entire intervention will take place at the physical education campus of university, in the cardiorespiratory and metabolic physiology laboratory (laficam). the recruitment and approach of the volunteers will occur through media dissemination, such as radio announcements, television programs, and social media through digital media. after the dissemination, volunteers will make contact via phone, email, or social media, and a preliminary registration will take place. after this registration, the researchers will verify which volunteers meet the inclusion criteria, and only then will the recruitment take place. the volunteers will be invited to come to laficam to be informed about the intervention program and then sign the informed consent form. before starting the intervention program, all volunteers must present a medical certificate clearing them to participate in a physical exercise training program; once the certificate is submitted, initial tests and general evaluations will be conducted. the initial evaluations will consist of a questionnaire, anthropometric and body composition assessment, and evaluation of the physical activity level. after the questionnaires are administered, a familiarization with the sensory perceptions of beetroot juice will be conducted. this familiarization is important to verify if the volunteers are fit to carry out the intervention. the volunteers will be randomized into three groups: group 1: the volunteers will ingest two shots containing 70 ml of beetroot juice with 400 mg of nitrate per day, one shot in the mornig and one shot at night, for 10 days; group 2: this group will intake 70 ml of beetroot juice with 400 mg of nitrate every morning. group 3: this group will intake 70 ml of beetroot juice without nitrate for 10 days.

Eligibility criteria:
inclusion criteria: * amenorrhea for at least 12 months * controlled hypertension exclusion criteria: * decompensated hypertension in stages 2 and 3 * having a history of stroke or acute myocardial infarction * smoker * having a diagnosis of diabetes mellitus * using hormone therapy.

Keywords: beetroot juice hypertension postmenopausal blood pressure
cerebellar loops and attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the aim of this study is to investigate the integrity of connectivity between the neocortex and the cerebellum in the attention deficit hyperactivity disorder (adhd). fibers integrity will be measured using magnetic resonance imaging techniques.

adhd is a neurodevelopmental trouble characterized by attentional deficits, impulsivity and motor hyperactivity. morphological neuroimaging studies in adhd children have revealed cerebellar abnormalities, however data in adults regarding cerebellum alterations are scarce. in this study we will analyse the conectivity of the cerebellum of adults adhd patients. we will use diffusion tensor imaging (dti) technique, and morphological data will be compared with the neuropsychological status.

Eligibility criteria:
inclusion criteria: patient with adhd : * diagnosis of adhd * 18 - 35 years old healthy volunteer : * 18 - 35 years old * no adhd diagnosed exclusion criteria: * associated neurological or psychiatric pathologies * pregnant woman * mri counter indication

Keywords: attention deficit disorder hyperactivity cerebellum alteration fronto-cerebello-frontal loops