Kornimate/medical-research-clean huggingface dataset:
effectiveness of bupropion for treating nicotine dependence in young people

Conditions: Tobacco Use Cessation; Tobacco Use Disorder

Summary: little is known about the best ways to help young people stop smoking. bupropion (a medication marketed as wellbutrin or zyban) has proved helpful in treating adult smokers. the purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. this study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. in addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.

cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the united states. most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. although behavioral treatments are available, they have not been very successful in past studies. depressed adults may have more difficulty quitting smoking than non depressed adults; this finding may also apply to depressed youth. the purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit, as compared to behavioral treatment alone. finally, the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion. participants in this double-blind study will be randomly assigned to receive either bupropion or placebo. both groups will receive behavioral treatment. the trial will last for 9 weeks, with weekly study visits. study visits will last 30 minutes to 1 hour and will include medication monitoring, self-reported and biological measures of smoking, and behavioral treatment. participants will have follow-up visits six months after completion of treatment.

Eligibility criteria:
inclusion criteria: * has smoked at least 10 cigarettes each day for 3 or more months * weighs at least 90 lbs * motivated to quit smoking and has had at least one previous failed attempt * speaks, reads, and writes english * either diagnosed as depressed or no history of a psychiatric disorder exclusion criteria: * history of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, autism, or non-nicotine substance use disorder in the 6 months prior to study entry * currently suicidal or with a history of a suicide attempt in the 6 months prior to study entry * psychotic symptoms * use of psychotropic medication(s) * serious medical condition * prior use of bupropion for smoking cessation * currently using other smoking cessation treatments

Keywords: adolescents, cigarettes, smoking, tobacco
evaluate health coaching support in technology-based interventions for meeting health goals

Conditions: Chronic Disease Prevention

Summary: this was a pilot evaluation conducted to test procedures for a possible future trial and provide preliminary insights regarding whether text messages sent to veterans could help support nutrition and/or physical activity health goals. for the purposes of the pilot, the goal was to enroll one participant.

the investigators prepared procedures for a one-group pilot intended to evaluate the delivery of automated text messages to veterans. completion of this pilot will provide preliminary insights regarding the delivering automated text messages focused on nutrition and/or physical activity health goals, and potential impacts on outcomes like self-efficacy, goal commitment, and health confidence.

Eligibility criteria:
inclusion criteria: * patient at designated va site * ownership of a cellular phone * over age 18 * pre-screened by their primary care physician for study inclusion for medical contraindication to physical activity and diet change exclusion criteria: * patient outside designated va site * non-ownership of a cellular phone * under age 18 * not pre-screened by their primary care physician for study inclusion for medical contraindication to physical activity and diet change or deemed ineligible to participate by primary care physician

Keywords: disease prevention digital health text messaging
a study to assess the pharmacokinetics of sb-742457 formulated as a capsule and a tablet in healthy elderly volunteers.

Conditions: Alzheimer's Disease

Summary: sb-742457 is a 5ht6 receptor antagonist that is in development for the symptomatic treatment of mild to moderate alzheimer's disease . to date, all clinical trials have been conducted using a capsule formulation of sb-742457. however, it is intended to conduct all futures studies with a tablet formulation. the aim of this study is to assess the pharmacokinetic profile of sb-742457 and its major metabolites following single doses of both the capsule and tablet formulations.


Eligibility criteria:
inclusion criteria: * men or surgically sterile or post-menopausal women * healthy as judged by a responsible physician. no clinically significant abnormality identified on the medical or lab evaluation. * bmi between 18.5 and 32.0 kg/m2 exclusion criteria: * a positive pre-study urine screen for drugs of abuse * abuse of alcohol * subjects who smoke more than 10 cigarettes or equivalent a day. * use of prescription drugs as well as herbal and dietary supplements within 7 days prior to the first dose of study medication, unless in the opinion of the investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety. * where participation in the study would result in donation of blood in excess of 500ml within a 56 day period. * has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. * the subject has received an investigational drug or participated in another research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication. * known or suspected history of seizures, including febrile seizures, unexplained recent loss of consciousness or history of significant head trauma with loss of consciousness.

Keywords: bio-availability, healthy elderly volunteers
inducing systemic immunity and regressions in metastatic melanoma

Conditions: Metastatic Malignant Melanoma

Summary: in patients with multiple metastatic nodules of melanoma, the investigators evaluated whether autologous cytokines injected into cutaneous metastases would induce a systemic immune response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that had never been injected. such immune responses were observed, and often the never-injected metastasis regressed completely. 20% of patients remained free of disease for greater than 5 years.

lymphocytic infiltrates were seen in never-injected nodules only after several weeks of injections elsewhere. no adverse events were seen. the tumor-infiltrating lymphocytes were able to kill autologous melanoma ex vivo. some patients who experienced complete regressions of all metastases lived without disease for over 10 years.

Eligibility criteria:
inclusion criteria: * multiple cutaneous or subcutaneous metastases of melanoma exclusion criteria: * visceral metastases on admission. * no current chemotherapy or immunotherapy. * note study performed between 1978 and 2002 before current therapies were available.
a longitudinal study to explore the impact of gut microbiome on brain health in alzheimer's disease

Conditions: Alzheimer Disease; Gut Microbiota; Metabonomics; Magnetic Resonance Imaging

Summary: gut microbiota dysfunction is associated with alzheimer's disease (ad). however, the potential modulatory mechanism remains unclear. previous studies have shown that gut-derived metabolites short-chain fatty acids (scfas) may be the key mediators between gut microbiota and brain, participating in the modulatory pathway "gut microbiota-scfas-brain networks". in this project, high-throughput targeted metabolomics technique will be used to explore the differences of scfas in the spectrum of ad, including cognitively normal individuals, subjective cognitive decline (scd), mild cognitive impairment (mci), and ad dementia. then, the gut microbiome and multi-modal mri techniques will be combined to elucidate potential interaction mechanisms of "gut microbiota-scfas-brain networks". finally, based on multi-omics features extracted from gut microbiome, metabolomics, and neuroimaging after five years, the diagnostic model of scd due to preclinical ad will be established using machine learning methods.


Eligibility criteria:
inclusion criteria: * cognitively normal group: 1. normal performance on standardized cognitive tests; 2. with no cognitive complaints or any concerns (worries). * scd group: 1. self-experienced persistent decline in memory, rather than other domains of cognition; 2. normal performance on standardized cognitive tests; 3. failure to meet the criteria for mci or dementia; 4. age at onset of scd ≥ 60 years old; 5. onset of scd within the last 5 years; 6. concerns (worries) associated with scd; 7. feeling of worse performance than others of the same age group. * mci group: 1. having impaired scores on both measures in at least one cognitive domain (memory, language, or speed/executive function); 2. having impaired scores in each of the three cognitive domains (memory, language, or speed/executive function); 3. the functional activities questionnaire (faq)≥9. * ad dementia group: 1. meet the criteria for dementia and have impaired daily functional activities; 2. episodic memory deficit; 3) clinical dementia rating (cdr) ≥ 1. exclusion criteria: * a history of stroke; * major depression and anxiety; * other central nervous system disorders that may cause cognitive impairment, such as parkinson's disease, tumors, encephalitis, and epilepsy; * cognitive impairment caused by traumatic brain injury; * systemic diseases, such as thyroid dysfunction, syphilis and hiv; * psychosis or congenital mental developmental delay; * a history of using antibiotics, probiotics, prebiotics, or synbiotics within 3 months; * the use of corticosteroid, immune stimulating medications, and immunosuppressive agents; * major gastrointestinal tract surgery in past 5 years; * severe gastrointestinal diseases, such as irritable bowel syndrome, infammatory bowel disease, severe gastritis, other dysfunction in digestion and absorption, which has been reported to infuence gut microbiota

Keywords: subjective cognitive decline multi-omics
efficacy of a long term, high intensity and long time stretch training program on viscoelasticity plantarflexors muscle in children with cerebral palsy (cp).

Conditions: Cerebral Palsy, Spastic; Children, Only

Summary: children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. in the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion.

this study assess efficacy of a long term stretching program of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. stretching program is characterized by 3 phases: baseline, intervention and follow-up.

Eligibility criteria:
inclusion criteria: * children aged 8 to 16 years * children diagnosed spastic cerebral palsy * children with decrease maximal dorsiflexion angle under +5° in the last four weeks * children who don't understand instructions exclusion criteria: * children who had damage orthopedics or surgical operation contraindicating realization of the experimental protocol * hospitalization incompatible with the progress of the protocol. * children who had botulinum injection, extensions casts or the implementation of new equipment (night or day orthosis) for less than three months or the progress of the protocol. * children having analgesic treatment in progress

Keywords: cerebral palsy stretching isokinetic dynamometer ultrasound ankle children
the curative effect of extended thymectomy performed through subxiphoid-right vats approach with elevation of sternum

Conditions: Thymoma; Myasthenia Gravis; Mediastinal Tumor

Summary: extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. video-assisted thoracic surgery(vats) plays an important role in the surgery of extended thymectomy. now, vats thymectomy through intercostal approach has been the commonly used minimally invasive surgical procedure for thymus surgery and is applied worldwide. but the intercostal approach may cause residue of thymus tissue and chronic pain. in 2013, doctor marcin zielin´ski form poland reported a new technique of minimally invasive extended thymectomy performed through the vats approach with double elevation of the sternum. and their early results proved this technique is probably the least invasive and the most complete technique of vats thymectomy with excellent cosmetic results. until now, doctor jiang fan form shanghai pulmonary hospital has performed 50 cases extended thymectomy through the subxiphoid approach with double elevation of the sternum by vats. this study is designed to compare the curative effect between this new method and traditional intercostal vats.

this study is a prospective multicentre cohort study.the main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy. by collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the subxiphoid-right vats approach with double elevation of the sternum is the least invasive and the most complete technique of vats thymectomy.

Eligibility criteria:
inclusion criteria: 1. mg with thymic hyperplasia, thymoma or other anterior mediastinum disease 2. masaoka stagingⅰ-ⅱ 3. patients with normal cardio-pulmonary function before operation, bmi\<30 exclusion criteria: 1. unable to tolerate surgery 2. masaoka staging ⅲ-ⅳ 3. patients who have undergone previous surgery or radiotherapy 4. myasthenia crisis 5. chronic pain or using opioid analgesics before surgery 6. preoperative mental disorders such as excessive anxiety 7. patients who underwent previous mediastinal surgery or cardiac surgery 8. patients with thoracic deformity

Keywords: thymoma thymectomy myasthenia gravis vats subxiphoid elevation of the sternum curative effect
chime: comparing health interventions for maternal equity

Conditions: Obesity and Overweight; Nutrition; Chronic Disease; Diabetes; Pregnancy

Summary: the goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum. the main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum. hypothesis (primary): both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group. hypothesis (secondary): the community-based intervention will have greater effectiveness than the self-management intervention. participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. general procedures include completion of: * questionnaires * dietary recalls * in-depth interviews * anthropometric measurements * collection of blood via finger stick or blood panel


Eligibility criteria:
inclusion criteria: * maternal age 18 years or older * maternal gestational age ≤ 20 weeks with viable singleton pregnancy documented on first trimester ultrasound with an intention to continue pregnancy to term * plans to continue receiving antenatal care at the recruitment site/network * maternal characteristics include at least one of the following: * self identifies as black/african american * self identifies as hispanic/latino/a/e/x * insured by medicaid * maternal ability to speak english or spanish * completion of baseline data collection (maternal survey data, weight, and height measurement prior to randomization) exclusion criteria: * age \< 18 years at baseline because of unique developmental differences of adolescents and regulations regarding age of consent * underweight (bmi \<18 kg/m2) at pre-pregnancy period * underlying disease/treatment that might impact weight status (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician) * unwillingness or inability to complete study visits or intervention components * unwillingness or inability to commit to intervention components for self or infant, including plans to move more than 100-mile radius from recruitment site * multiple gestations
intestinimonas for prevention of type 2 diabetes mellitus

Conditions: PreDiabetes

Summary: the study aims to assess the effects of a microbiota-based product containing intestinimonas in adults with pre-diabetes. the purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. in particular, the objective is to evaluate whether intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (ogtt) and whether it is able to modulate the microbiota composition in the study subjects.

the study aims to assess the effects of a microbiota-based product containing intestinimonas in adults with pre-diabetes. intestinimonas is an aerobic microorganism which produces butyrate and interacts with the local microbiota in small and large intestine. in preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by intestinimonas and similar microbiota. the purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. the study participants will be subjects who are overweight and are at risk of developing type 2 diabetes. the key objective of this randomized, placebo-controlled study is to evaluate whether intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral glucose tolerance test (ogtt) and whether it is able to modulate the microbiota composition in the study subjects. furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of intestinimonas will be compared with the low-dose tested in the initial double-blind randomised controlled trial (rct).

Eligibility criteria:
inclusion criteria: * increased bmi \> 25, * fasting plasma glucose (fpg) 100-125 mg/dl or glucose \> 140 after ogtt, or hba1c 5.7% - 6.4% exclusion criteria: * type 2 diabetes

Keywords: prediabetic state metabolic syndrome
macromolecular imaging of white and gray matter pathology in multiple sclerosis

Conditions: Multiple Sclerosis; MS

Summary: the overall purpose of this research is to determine whether new macromolecular measures optimized for whole brain (gray matter and white matter) magnetic resonance imaging (mri), predict neuro-cognitive impairment in multiple sclerosis (ms) patients.

mri is a vital component of a ms work-up, providing noninvasive evidence of ms lesions, detecting active inflammatory lesions, and measuring brain atrophy to assess neurodegeneration. recent years of mri research have generated strong evidence of gray matter (gm) involvement in ms, resulting in the reclassification of ms as a whole-brain disease. similar to white matter (wm), a primary target of ms pathology in gm is myelin, the protective sheath insulating the penetrating axons within gm and extending brain connectivity all the way to the neuronal bodies. this aim of this research is to examine if the associations between imaging measures of gm disease and cognitive performance can establish gm-based imaging correlates predicting the disease course and accurately assessing treatment results. this observational research will enroll adults diagnosed with ms both with and without cognitive impairment. subjects will be asked to complete a single research visit that includes the administration of a mri scan and a neuro-cognitive testing session.

Eligibility criteria:
inclusion criteria: * clinically definite ms * adult age 18 to 60 exclusion criteria: * contraindication to mri * changes in ms therapy in the last 6 months * less than 6 weeks after relapse or corticosteroid use * currently taking medication that may affect cognition (e.g. donepezil, rivastigmine, adderall) * history of significant alcohol or drug abuse * current or recent significant migraines * confounding neurological or cognitive disorders or deficits (stroke, parkinson's disease, alzheimer's disease, epilepsy) * sensory or physical impairments that might interfere significantly with cognitive testing * history of developmental or learning disability or attention-deficit/hyperactivity disorder.\\ exclusion criteria for healthy controls: * history of alcohol/drug abuse * history of migraines * developmental or learning disability/attention-deficit/hyperactivity disorder * currently pregnant/breastfeeding

Keywords: magnetic resonance imaging
study comparing radio frequency ablation plus chemotherapy and chemotherapy alone in patients with unresectable crlm

Conditions: Colorectal Cancer Liver Metastasis

Summary: to date no prospective trials have been completed that demonstrated whether rfa is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in overall survival compared with chemotherapy (target therapy) alone. the primary objective of this trial is to determine overall survival for patients with colorectal cancer liver metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.


Eligibility criteria:
inclusion criteria: all patients must meet the following criteria: patients must have incurable crlm patients must have no more than 10 liver metastases (lms) remaining after surgical resection, with diameter less than 5cm patients is medically eligible to receive rfa, as determined by the mdt (multidisciplinary team) eastern cooperative oncology group (ecog) performance status 0 or 1 age \> 18 years subject life expectancy \> 3 months platelets \> 100×103/mm3 total bilirubin \<1.5mg/dl creatinine level \< 2.0 mg/dl all patients must sign an informed consent form exclusion criteria: the crlm is amenable to curative surgical therapy uncorrectable coagulopathy subject is pregnant, nursing, or wishes to become pregnant during the study other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival current or planned treatment with any experimental chemotherapy or target drugs

Keywords: colorectal cancer liver metastasis radiofrequency ablation chemotherapy target therapy