Kornimate/medical-research-clean huggingface dataset:
behavioral/drug therapy for alcohol-nicotine dependence (naltrexone/nicotine patch)

Conditions: Alcoholism; Smoking

Summary: this study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. the study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol and nicotine dependence. * individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours. * smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day. * motivated to quit smoking. * willing and able to participate in the 12 week outpatient treatment. * acceptable health. * able to provide a collateral informant. * willing to be followed for 6 months after treatment ends. * willing and able to provide the names of three family members or friends to aid in locating participants for follow-up. exclusion criteria: * current diagnosis of dependence on other substances except nicotine and alcohol. * having moderately severe or severe alcohol withdrawal symptoms. * recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males). * history of opioid abuse. * recent use of cocaine. * not desiring to quit smoking. * recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems. * history of psychosis. * current suicidality, homicidally or psychiatric symptoms requiring other medications. * presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy. * current treatment with psychotropic medications. * pregnancy or nursing for female patients. inability or unwillingness to participate in the 12-week outpatient treatment.
efficacy and safety of dov 21,947 in the treatment of major depressive disorder

Conditions: Major Depressive Disorder

Summary: the primary objectives of this placebo-controlled trial are to evaluate effectiveness and safety of dov 21,947 at two oral dose levels.

dov 21,947 is an investigational drug that is being developed for the treatment of depression. the purpose of this study is to evaluate the safety and effectiveness of a flexible dosing schedule of dov 21,947 (25 mg twice daily for two weeks, then 50 mg twice daily for four weeks as compared to placebo) in the treatment of major depressive disorder. information about any side effects that may occur will also be collected. the efficacy evaluation will be based on the change in the total madrs and hamd-17 scores from randomization to week 9 .the secondary objective is to determine if dov 21,947 improves the quality of life for patients with mdd as compared to placebo

Eligibility criteria:
inclusion criteria: 1. males or females between 18 and 65 years of age (inclusive). 2. either outpatients or inpatients diagnosed with major depressive disorder (mdd) according to diagnostic and statistical manual of mental disorders (dsm-iv-tr, see appendix 3) and mini international neuropsychiatric interview (mini). 3. patients with recurrent depressive episode of at least 2 months in duration. patients must have previously responded (significant clinical improvement judged by the principal investigator) to at least one antidepressant treatment. 4. hamd-17 total score \* 22 with a severity score of at least 2 on item 1 at the placebo run-in visit and the baseline/day 1 visit. 5. hamd-17 score reduction ≤ 15% between the placebo run-in visit and the baseline/day 1 visit. 6. ham-a total score \< 17 at the screening visit. exclusion criteria: 1. patients with a hamd-17 total score reduction of more than 15% between the placebo run-in visit and the baseline/day 1 visit (placebo responders). 2. patients with a medical history of mdd that consistently did not respond significantly to an adequate treatment regimen of a monoamine oxidase (mao) inhibitor. 3. patients who are known to be antidepressant treatment-resistant. patients are defined as treatment-resistant if in the past they have failed adequate antidepressant treatments (dose level approved in the product labeling and was administered for at least 4 weeks) from two or more different pharmacological classes (e.g., tca, ssri, snri, mao-i, etc). failure to respond to an adequate antidepressant treatment is defined as the absence of at least a 50% improvement in symptoms by patient report or documented history, or lack of significant clinical improvement at the principal investigator's discretion. 4. patients with a medical history of mdd who consistently did not respond significantly to electroconvulsive shock therapy (ect) or had ect within a year prior to the screening visit regardless of outcome. 5. patients with psychotic depression
development of the drive curriculum to address childhood obesity risk factors

Conditions: Pediatric Obesity

Summary: the purpose of this study is to help overweight or obese children to maintain or reduce their body mass index (bmi) through the home-based parent training program the investigators developed called drive. the investigators hypothesize that children from families that receive the drive program will show greater maintenance or improvement in their bmis than families who do not receive drive.

the drive program (developing relationships that include values of eating and exercise) is a home-based parent training program with 15 sessions focused on improve family nutrition and physical activity and promoting positive parent-child interactions. the aim of this study is to pilot-test the development of a childhood obesity program that includes parenting and health information. participants in this study will be recruited through community organizations based upon their obesity health risk. only families whose children's bmi percentile is greater than or equal to 75 will be eligible to participate in this study these participants will be randomly assigned to either the control group, in which participants will receive health information via mail only, or the experimental group that will participate in 15 drive sessions focusing on parent-child interactions, health and nutrition, and physical activity. both groups will complete a baseline assessment, mid-point assessment, and post assessment in their home, which will measure parent and child height, weight, and waist circumference; parent attitudes towards health and nutrition; and parent and child food consumption and physical activity levels. results from this study will provide information regarding the feasibility of implementing the drive curriculum as well as its impact on parent and child body mass indexes, and parents' knowledge, and attitudes related to nutrition.

Eligibility criteria:
inclusion criteria: * child age 2-6 years old with a bmi percentile greater than or equal to 75 * fluent in english * parent has primary custody of the primary child participant in the study exclusion criteria: * pregnant or currently breastfeeding (parent) * planning to get pregnant while enrolled in the study (parent) * have bmi greater than 45 (parent) * chronic disease that affects body weight, appetite, or metabolism (for example, diabetes- type i or type ii) (child) * have hiv or aids (child) * use prescription or over-the-counter medications or herbal products that affect appetite, body weight, or metabolism (child) * plan to move out of the atlanta/baton rouge area for the duration of enrollment (approximately 5 months) (family) * plan to be out of the atlanta/baton rouge area for more than 2 weeks for the duration of enrollment (approximately 5 months) (family)

Keywords: children pediatric obesity parent training home-based nutrition physical activity parent-child interaction parenting
induced and controlled dietary ketosis as a regulator of obesity and metabolic syndrome pathologies

Conditions: Metabolic Syndrome; Diabetes Mellitus, Type 2; Pre Diabetes

Summary: original research article entitled induced and controlled dietary ketosis as a regulator of obesity and metabolic syndrome by madeline gibas for consideration for publication in a clinical journal. this research manuscript builds on previous landmark studies that report that major weight and fat mass loss in type ii (t2d) patients who were fed a very low carbohydrate, ketogenic diet. in this manuscript, the investigators outline our research study that showed statistically significant (p \< 0.05) changes over time in hemoglobin a1c, weight, bmi, body fat percentage and ketones for patients with metabolic syndrome who were fed a very low carbohydrate diet, ketogenic diet.

purpose -assessment of prolonged, physiological, dietary ketosis on pathological processes induced by metabolic syndrome (mets) including a reduction in fasting triglycerides, bmi and body fat mass, a significant decrease and/or normalization of hga1c and an increase in resting metabolic rate. design - qualitative setting - bristlecone health, inc., maple grove, minnesota subjects - 30 adults previously diagnosed with mets randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes. intervention - 10-week diet with controlled glycemic indices provided for ketogenic group; other groups maintained normal diet. baseline triglyceride, hga1c, vo2 max, body mass index (bmi), resting metabolic rate (rmr), blood ketone levels and body fat mass measurements were assessed for all three groups at week 0 and week 3, 6 and 10. measures - anova followed by tests pairwise differences using tukey's hsd correction. analysis - five of the seven variables for the ketogenic group showed a statistically significant difference between week 0 and 10 data points.

Eligibility criteria:
inclusion criteria: * previously diagnosed with metabolic syndrome exclusion criteria: * no diagnosis of metabolic syndrome * \< 18 years old
using xenograft combined with barrier membrane to improve the formation of deep periodontal pockets

Conditions: Periodontal Pocket; Periodontal Bone Loss; Impacted Third Molar Tooth

Summary: to evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars.

the mandibular third molar is the last tooth to erupt in the dentition, and due to the insufficient eruption position, it can lead to different degrees of impact. during the eruption of impacted tooth, the crown may be partially or completely covered by the gingival flap. a deep blind pocket is formed between the gingival flap and the tooth crown, and food and bacteria are easily impinged in the blind pocket. under the influence of oral environment and dental plaque, the presence of blind pockets can lead to the loss of periodontal attachment and the absorption of alveolar bone, thus affecting the distal periodontal status of adjacent molars. organic bone xenograft material composed of absorbable organic bovine hydroxyapatite is one of the commonly used transplantation materials for repairing bone defects. the application effect of allogeneic bone materials in periodontal therapy has been recognized by many experts and scholars. guided bone regeneration (gbr), as a conventional periodontal bone graft, has achieved good results in periodontal tissue regeneration. aljuboori et al. found that when the third molar was removed and gbr was performed at the same time, the depth of distal periodontal pocket probing of the adjacent second molar was significantly reduced in the re-examination 6 months after surgery. hence, this study intends to use xenograft combined with barrier membrane to improve the formation of distal periodontal pocket of the second molars after third molars extraction.

Eligibility criteria:
inclusion criteria: * 26-45 years old * completely or partially impacted mandibular third molar * no evidence of acute inflammation * in good physical status and oral health * regular attendance at control visits exclusion criteria: * pregnancy or lactation * aggregate systemic pathologies such as diabetes, thyroid disorders, bone metabolism diseases, among others * patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with bone metabolism * patients with uncontrolled periodontal conditions, endodontic conditions and other oral disorders * heavy smoke (10 cigarettes/day or more) * the second molar has no contact with the third molar, or the third molar crown has alveolar bone
qol and sarcopenia in patients with ascites

Conditions: Ascites Hepatic; Ascites, Malignant

Summary: clinical data regarding quality of life in patients with refractory ascites is limited and preceded the development of newer questionnaires that may be more robust. one primary objective of this study is to study changes in quality in life in a prospective fashion using newer general and ascites-specific quality of life survey instruments specific to benign and malignant etiologies. sarcopenia is a condition that is prevalent in cancer and cirrhosis. current data is retrospective and associative, evaluating heterogeneous patient populations at different stages within the timeline of refractory ascites. the other primary objective of this study is to study sarcopenia in a prospective fashion and to understand its kinetics once a patient develops refractory ascites. prospectively-obtained measures of deterioration in patient-reported outcomes and in muscle mass will form the basis for the next stage of investigation of interventions to mitigate these declines.

patients with refractory ascites defined as requiring \>1 paracentesis within a 6 week period will be prospectively enrolled. the patient-reported outcomes measurement information system (promis-10) and ascites-specific (ascites q and edmonton symptom assessment system: ascites modification) quality of life questionnaires will be obtained at baseline, then at 1-, 2-, 4- and 6 months. sarcopenia will be assessed by muscle area measurement from a single ct image at the l4 level at baseline, 2- and 6 months.

Eligibility criteria:
inclusion criteria: 1. age \>/=18 2. eastern cooperative oncology group (ecog) performance score \< 3 3. refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment. 4. capable of giving informed consent exclusion criteria: 1. life expectancy less than 3 months 2. unable to participate in neuropsychological tests/questionnaires 3. pregnant or nursing women. .

Keywords: ascites sarcopenia
micellar curcumin and metabolic syndrome biomarkers

Conditions: Metabolic Syndrome, Protection Against

Summary: the purpose of this study is to investigate the effect of micellar curcumin on inflammation and lipid metabolism markers in subjects at risk for the metabolic syndrome.


Eligibility criteria:
inclusion criteria: * total cholesterol \> 5.2 mmol/l * ldl cholesterol \> 3.4 mmol/l * triglyceride \> 2.26 mmol/l * crp \> 2 mg/l exclusion criteria: * intake of drugs or dietary supplements * pregnant women and breastfeeding mothers * smokers * previous illnesses such as heart attack, cancer or dementia * addiction
a study to assess the efficacy and safety of rel-1017 as adjunctive treatment for major depressive disorder (mdd)

Conditions: Major Depressive Disorder; Depression

Summary: this is an outpatient, 2-arm, phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of rel-1017 once daily (qd) as an adjunctive treatment of major depressive disorder. study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.0 and 35.0 kg/m2. * diagnosed with major depressive disorder (mdd) based on structured clinical interview for dsm-5 (scid-5) for mdd. * current major depressive episode (mde). * treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with a depressant medication in the current mde. exclusion criteria: * any current and primary psychiatric disorder other than major depressive disorder. * severe alcohol or substance use disorder. * history of bipolar i and ii disorder, psychosis, and/or mania. * poorly controlled diabetes as defined by hba1c \> 7.5%, despite standard care. subjects with hba1c \>7.5% may continue in the study if approved by the relmada medical monitor. * having received ketamine or esketamine within 60 days prior to screening.

Keywords: rel-1017 relmada nmda receptor antagonist esmethadone adjunctive antidepressant reliance depression
adenosine receptors influence ischemia-reperfusion injury

Conditions: Ischemia-Reperfusion Injury

Summary: ischemic preconditioning is defined as the development of tolerance to ischemia-reperfusion injury by a previous short bout of ischemia resulting in a marked reduction in infarct size. this mechanism can be mimicked by several pharmacological substances such as acetylcholine and adenosine. to detect ischemia-reperfusion injury in humans in vivo kharbanda et al. developed a method in which endothelial dysfunction represents the effects of ischemic preconditioning. this method, however, uses acetylcholine to measure endothelial function before and after forearm ischemia. we, the investigators at radboud university, hypothesize that the use of acetylcholine in this model reduces ischemia-reperfusion injury. therefore, we will compare this protocol with a protocol in which endothelial function is only measured after ischemia. we expect an increase in ischemia-reperfusion injury when endothelial function is only measured after the forearm ischemia. after determining the optimal method to measure ischemia-reperfusion injury of the vascular endothelium we will determine the effect of acute and chronic caffeine, an adenosine receptor antagonist, on ischemic preconditioning. with this study we expect to find that adenosine mimics ischemic preconditioning of the vascular endothelium. moreover, we expect to find that acute caffeine intake reduces ischemia-reperfusion injury whereas chronic caffeine intake does not. this study will increase our knowledge about the mechanism of ischemic preconditioning and may also provide leads to exploit this endogenous protective mechanism in a clinical setting.


Eligibility criteria:
inclusion criteria: * healthy volunteers

Keywords: acetylcholine adenosine caffeine ischemic preconditioning
use of inertial sensors to characterize the fatigability of post-stroke hemiplegic patients

Conditions: Hemiplegic Gait; Fatigue

Summary: this is an experimental, observational, prospective study designed to develop medical knowledge. the main objective of the study was to identify clinically significant, easily interpretable, quantitative indices of fatigue-related gait pattern changes in post-stroke hemiplegic patients. this study is part of a usual framework of management of post-stroke hemiplegic patients with additional data collection, via the use of inertial measurement units, considered here as non-interventional. to achieve this identification, 2 6-minute walk tests will be performed for each patient at the beginning and end of the same day. patient-perceived fatigue will be recorded by the borg scale every minute during the 6-minute test. the level of activity during the rehabilitation day is also part of the data collected (number of hours of physical and non-physical activity). at the end of the second 6-minute test, the patient's participation in the study ends. in addition to the inertial measurement, two scores will be collected to assess the correlation between fatigability and the level of anxiety/depression and stroke severity : * national institutes of health stroke scale (nihss) * hospital anxiety and depression scale (had)


Eligibility criteria:
inclusion criteria: * patient affiliated or entitled to a social security plan * patient who has received informed information about the study and who has given his/her consent * post-stroke patients (subacute or chronic) * 1 single unilateral ischemic or hemorrhagic stroke (supratentorial or subtentorial) confirmed by ct or irm with consecutive hemiparesis * no lower extremity surgery * ability to walk for 6 minutes without human assistance * ability to understand instructions in french non inclusion criteria: * patients with cognitive problems that prevent them from understanding instructions * patent under guardianship or curatorship * post-stroke hemiplegic patient (acute = \< 6 months) * cardiorespiratory pathology incompatible with ct6 * chronic decompensated pathology * neurological pathology * orthopedic pathology of the lower limbs or rheumatic conditions that may affect the ability to walk
spa therapy in knee osteoarthritis (oa): nancy-thermal

Conditions: Knee Osteoarthritis

Summary: non-pharmacological treatments are recommended for the management of knee osteoarthritis (eular or oarsi recommendations) and some thermal modalities may be effective for relieving symptoms in knee osteoarthritis. however supporting evidence is limited and nothing is known about the advantage of one modality of thermal therapy over another. the main objective of the study is to compare the number of patients achieving a composite response criteria associating the minimal clinically important improvement at 6 months, defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised western ontario and mcmaster universities osteoarthritis index function score and no knee surgery in 2 spa therapy protocols (a "usual protocol" and an "active protocol") in knee osteoarthritis. the secondary objectives are: 1. to compare the efficacy of the 2 protocols at 3 months. 2. to determine the evolution of quality of life and medical care consumption 3. to describe postural abnormalities 4. to determine predictive factors to a favourable response at 3 and 6 months

this is a monocentric randomised non inferiority trial comparing 2 spa therapy protocols in symptomatic knee oa. in the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. in the second group, the same 4 treatments are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week. data will be collected at inclusion, 3 and 6 weeks and 3 and 6 months.

Eligibility criteria:
inclusion criteria are: * both gender * uni or bilateral symptomatic knee oa * pain vas \> 3 on a 0-10 scale) * fulfilling acr criteria for knee oa * kellgren and lawrence stage 2 or over on standard radiograph non inclusion criteria are: * severe comorbidity * isolated femoro-patellar knee oa * total knee replacement surgery expected during the next year * other joint disease * a contraindication or intolerance to any aspect of spa treatment (immune deficiency, evolving cardiovascular conditions, cancer, infection), * spa treatment within the previous 12 months * knee injection within the past month for corticosteroids and within the past 3 months for hyaluronic acids * osteoarthritis (sysadoa) change in the past 3 months * massages, physiotherapy or acupuncture in the past month * patients will not be allowed to modify their non-steroidal antiinflammatory drug (nsaid) or their analgesic drug within the past 5 days and in the previous 12 h respectively.

Keywords: knee osteoarthritis spa therapy spa modalities