Kornimate/medical-research-clean huggingface dataset:
methylphenidate for the treatment of acute mania

Conditions: Mania

Summary: this study aims at evaluating the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.

mania can be regarded as an autoregulatory mechanism to enhance unstable vigilance. there is increasing evidence that psychostimulants that increase vigilance may be effective in treating mania. however, controlled studies are lacking. this is a two-arm, randomised, placebo-controlled, double-blind, parallel, multi-centre phase iiib exploratory study to evaluate the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.

Eligibility criteria:
inclusion criteria: 1. inpatients 2. written informed consent by patients who are competent to consent to study participation. 3. diagnosis: manic episode according to the international classification of diseases 10th revision (icd-10): f30.0, f30.1, f31.0 or f31.1 4. male or female of at least 18 years of age 5. ymrs total score ≥ 20 and ≤ 45 points 6. body mass index (bmi) \> 17 7. patients must be able to swallow tablets (study drug). exclusion criteria: 1. any other current major psychiatric icd-10 disorder is an exclusion criterion except for the following f90, f17.1, f17.2, f40-f59, f60-f69 2. contraindications for treatment with methylphenidate except as noted otherwise 3. serious non-psychiatric disease, that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator 4. oral administration of monoaminooxidase (mao)-inhibitors within two weeks, fluoxetine within 6 weeks and of any other antidepressant or primarily psychotropic substance except for those specified below within one week before study entry. 5. stable treatment with mood stabilisers including lithium, anticonvulsants (e.g. valproate, carbamazepine) or antipsychotics (e.g. risperidone, olanzapine) or benzodiazepines is not an exclusion criterion and will be continued; however, patients receiving more than 2 of these substances are not eligible for inclusion 6. medical history of other disorders of cns including tics or dyskinesia 7. medical history of cardiovascular diseases, severe hypertension, glaucoma, hyperfunction of the thyroid 8. patients with congenital or acquired long qt syndrome, or with a familiy history of qt prolongation, sudden cardiac death or other significant inherited cardiac disorders (e.g. family history of hypertrophic cardiomyopathy). 9. history of electroconvulsive therapy within the last 3 month 10. known alcohol and drug addiction or abuse, except for patients with abstinence \> 3 month. patients with sporadic abuse of cannabis (products) will not be excluded from the study. that is even true with a positive tetrahydrocannabinol (thc) screen in urine. 11. pregnant or nursing woman 12. concomitant participation in other clinical trials or participation during the 30 days prior to screening 13. prior participation in this study 14. suicidality
aspirin trial belgium

Conditions: Colon Cancer

Summary: the purpose of this study is to determine whether acetylsalicylic acid is effective on the recurrence and survival of colon cancer patients.

the purpose of this study is to determine the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (os) for stage ii and iii colon cancer patients of 45 years of age and older. preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. it is a phase iii double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. patients will be stratified at randomization by centre, age (\<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

Eligibility criteria:
inclusion criteria: * patients 45 years and older with histologically confirmed adenocarcinoma of the colon * patients must have tnm stage that is one of the following: pt3-4; n0-2 and m0, or pt1-2 and n1-2 (union for international cancer control (uicc) stage ii and iii) (in case of \>1 tumour: more advanced tumour is stage ii or iii) * patients must have completed surgical resection (r0) (both laparoscopic and open surgery) within 12 weeks of randomization exclusion criteria: * patients with rectal cancer (defined as tumour within 15 cm from the anal verge) * patients currently taking oral anti-coagulants or use of lmwh or use of doacs * patients currently taking (low-dose) acetylsalicylic acid or other anti-aggregantia for any reason * patients with a history of bleeding disorders or active gastric or duodenal ulcers * patients currently taking high dose systemic glucocorticoids (≥ 30 mg predniso(lo)n or equivalent) * patients with (suspected) (non-) polyposis syndrome (fap/afap, map, lynch syndrome) * patients with \>100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member * allergy or intolerance to salicylates * patients with local or distant recurrent disease * previous malignancies other than cin or scc with a disease free survival less than 5 years * presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Keywords: colonic neoplasms colorectal neoplasms intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms neoplasms by site neoplasms colonic diseases aspirin recurrence digestive system diseases intestinal diseases disease attributes pathologic processes
turkish adaptation, validity and reliability of pound satisfaction scale in patients with stroke after stroke rehabilitation

Conditions: Stroke

Summary: the aim of this study is to adapt the pound satisfaction scale (pss) to turkish society in stroke patients and to make its validity and reliability in turkish. the pss scale developed by pound et al evaluates the patient's satisfaction with the received rehabilitation program and services received in stroke patients. the pss scale will be filled in face-to-face with volunteer participants who have received a stroke rehabilitation program and meet the inclusion criteria. 130 participants will be included in the study. in order to assess the concurrent validity of the pss, the sf-36 (short form) which evaluates the quality of life, and the patient satisfaction scale in physiotherapy (pssp) which evaluates patient satisfaction will be used. scales will be repeated after 15 days to assess test-retest reliability.

the reliability and validity of the scale will begin with language equivalence and cultural adaptation. the scale will be translated from english to turkish by two people who are fluent in turkish and english. a single turkish translation will be obtained from these two turkish translations with a common opinion. the scale, which has been translated into turkish, will be translated into english by two other people who are fluent in turkish and english. the scale translated into english will be compared with the original. if the developer of the scale approves the translation of the scale, participants will be recruited for the study. in the pre-trial phase, a preassessment will be conducted with 15 participants to test the intelligibility of the scale. based on the results of the pre-test phase, the final version of pss will be able to be modified. the pss scale will be filled in face-to-face with volunteer participants who have received a stroke rehabilitation program and meet the inclusion criteria. 130 participants will be included in the study. in order to assess the concurrent validity of the pss, the sf-36 (short form) which evaluates the quality of life, and the patient satisfaction scale in physiotherapy (pssp) which evaluates patient satisfaction will be used. scales will be repeated after 15 days to assess test-retest reliability.

Eligibility criteria:
inclusion criteria: * to benefit from physiotherapy and rehabilitation services, * mini mental state examination (mmse) score\> 24 * patients with stroke * native language being turkish exclusion criteria: * native language not being turkish * patients with motor sequelae from other diseases and insufficient cognitive or educational level to complete the scale * mini mental state examination (mmse) score \< 24

Keywords: stroke patient satisfaction rehabilitation
comparison of 25-hydroxy vitamin d level in caucasian women receiving vitamin d supplementation and not receiving supplementation: a randomized controlled trial.

Conditions: Vitamin D Deficiency

Summary: the objective of this study is to assess whether vitamin d supplements are sufficient to increase females who are deficient or borderline deficient in vitamin d levels to normal levels.


Eligibility criteria:
inclusion criteria: * premenopausal caucasian women, ages 18-47 * subjects in good health * tanning bed group: regular tanning bed user at least once a week for previous 10 weeks exclusion criteria: * pregnancy and lactation * subjects with liver disease, renal disease, multiple myeloma, parathyroid disease, irritable bowel disease, celiac disease, cystic fibrosis and pancreatic disease * subjects with hypocholesterolemia and primary hyperparathyroidism * subjects taking the following medications: * steroids * orlistat * lipid lowering medication: cholestyramine, statins * antiepileptic drugs: phenobarbital and phenytoin * currently on vitamin d supplements or using any medication contain vitamin d i.e. cod liver oil, topical calcipotriol or history of use within 1 month * rifampicin, isoniazid * ketoconazole * subjects currently on uv therapy
diagnostic value of 18f-fluorodeoxyglucose positron emission tomography/computed tomography in prosthetic valve endocarditis

Conditions: Prosthetic Valve Endocarditis (PVE)

Summary: the diagnosis of prosthetic valve endocarditis (pve) remains challenging. in pve cases, initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a decreased diagnostic accuracy for the modified duke criteria. aims: the investigators sought to determine the value of 18f-fluorodeoxyglucose positron emission tomography/computed tomography (18f-fdg pet/ct) for diagnosing pve. methods: in two referral french centers (timone hospial, marseille and georges pompidou european hospital, paris), the investigators plan to include consecutive patients suspected of having pve. all of the patients will be subjected to clinical, microbiological, and echocardiographic evaluation. cardiac pet/ct will be performed at admission and the data analysis will be based on visual interpretation and quantitative measurement of fdg uptake (suvmax). the final diagnosis will be defined according to the clinical and/or pathological modified duke criteria determined during a 3-month follow-up (gold standard).


Eligibility criteria:
inclusion criteria: * unexplained persistent or recurrent fever \>38°c; * and/or unexplained increased serum c-reactive protein (crp) level \>10 mg/l; and/or positive blood cultures, independent of the echocardiographic analysis results; * and/or positive serological testing for coxiella burnetii, bartonella spp., mycoplasma pneumoniae, legionella pneumophila, aspergillus spp., or tropheryma whipplei; * and/or a mass or a new partial prosthetic valve dehiscence observed using echocardiography. exclusion criteria: * pregnancy, * an inability to lie flat, * a need for urgent cardiac surgery, * hemodynamic instability, * cardiac surgery \<1 month ago, * and a blood glucose level \>1.8 g/l. patients with a poor pet/ct image quality
bio-behavioral lung cancer prevention program

Conditions: Smoking Cessation

Summary: the overall goal of this research is to increase our understanding of the role of individual genetic differences in response to bupropion treatment and the psychobiological mechanisms by which genetic and treatment factors interact in the smoking cessation process. the ultimate objective is to provide information necessary to match bupropion vs. behavioral counseling cessation treatment to those smokers with the greatest need and likelihood of benefit. this study is a double-blind randomized placebo-controlled clinical trial of bupropion hcl (brand name zyban) in adult male and female smokers. the factorial design includes one treatment factor (bupropion 300 mg/day + counseling vs. placebo + counseling) and several subject factors (e.g. genotype, personality). smoking history, psychological status will be assessed at baseline and blood will be drawn for genotyping. bupropion or placebo will be delivered over a 10-week treatment period and subjects will be instructed to quit smoking after two weeks of medication (week 3 of treatment). all subjects will also receive a 7-week group behavioral smoking cessation treatment (over an 11 week period). this study may yield information that will help clinicians identify the most effective smoking cessation treatment for a particular patient, based on his/her background.


Eligibility criteria:
inclusion criteria: eligible smokers will be those currently smoking at least 10 cigarettes a day. exclusion criteria: exclusionary criteria are: planning a pregnancy, pregnancy, lactating, seizure disorder, history of head trauma or prior seizure, family history of a seizure disorder, brain (or cns) tumor, history of or currently diagnosed with bulimia or anorexia nervosa, diabetes treated with oral hypoglycemics or insulin, excessive use of alcohol or alcoholism, current addiction to opiates, cocaine, or stimulants, use of other drugs containing bupropion (e.g., wellbutrin, wellbutrin sr), allergy to bupropion, currently taking particular medications (e.g., monoamine oxidase inhibitor, antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants and anorectics), recently taken a maoi (less than 14 days) or a recent discontinuation of a benzodiazepine.
safety, tolerability, and sustained weight loss of endoscopic sleeve gastroplasty with diet modification and exercise

Conditions: Obesity

Summary: the purpose of this study is to compare the effect of endoscopic sleeve gastroplasty (esg) with diet and exercise, to diet and exercise alone, to see which is better in weight loss reduction. investigators will also compare the effects of esg to diet and exercise comorbidities such as diabetes, sleep apnea and high cholesterol as well as the various obesity related hormones.

this is a single center, prospective randomized case control study with an additional non randomized case arm. this study includes two research interventional groups. groups a: esg with diet and exercise modules. group b: diet and exercise modules only. investigators propose to compare esg to behavioral modification including diet and exercise for patients who have a bmi greater than or equal to 40 kg/m2 or greater than or equal to 30 kg/m2 with 1 or more obesity related co-morbidity and who cannot undergo conventional bariatric surgery(or decline the surgical option). investigators will also compare the effects of esg to diet and exercise on comorbidities such as diabetes, sleep apnea and high cholesterol as well as the various obesity related hormones.

Eligibility criteria:
inclusion criteria: * bmi greater than or equal to 40 kg/m2, greater than or equal to to 30 kg/m2 with 1 more obesity related co-morbidity, or or greater than or equal to 35 kg/m2 without co-morbidity co-morbidities include: 1. sleep apnea (stop-bang questionnaire and polysomnography) 2. bp \>130/80 or on hypertension meds. 3. a1c \> or = to 5.7, fasting \>100 or random \>126, exclude 6.5 and above 4. waist circumference \>102, or 40 inches if male or \>80 cm 35 inches if female 5. metabolic syndrome (3 criteria, blood pressure, waist circumference, triglycerides \> 150 or hdl \< 50/40) * failure to respond to non-invasive weight loss management for at least 6 months. * valid health insurance to cover the cost of procedure and standard of care pre-and post-procedure management/workup. exclusion criteria: * untreated endocrine diseases (diabetes, thyroid disorder, pituitary disorder, and sex gland disorder). * diabetes or a1c \>6.5 * heart disease, for example, arrhythmia, heart failure, myocardial infarction. * kidney disease with serum creatinine greater than 2.5 mg/dl. * cerebrovascular disease, for example, stroke or otherwise unable to exercise. * any pregnant or lactating women or who have had childbirth within 6 months. * any patients on retinoid therapy or undergoing retinoid therapy that will not last throughout the length of the trial. * patients with significant psychiatric disorder. * any other chronic condition deemed unsuitable to undergo either arm of the trial.
effect of stress on heroin-related memory retrieval

Conditions: Heroin Dependence; Learning and Memory

Summary: the purpose of this study is to determine whether cortisol and propranolol are effective in the modulation of stress induced heroin-related retrieval enhancement.


Eligibility criteria:
inclusion criteria: * participants had to have met dsm-iv criteria for heroin dependence prior to abstinence. exclusion criteria: * current use of any medications; current dsm-iv diagnosis of any affective, anxiety, or psychotic disorder; current dependence on any substance besides heroin and nicotine (based on dsm-iv criteria); or risk factors for untoward side effects from propranolol and cortisol (i.e., irregular heartbeats, history of cardiogenic shock, history of severe heart failure, asthma, fungal infections, hyperlipidemia, history of hypertension, or abnormal ecg or other laboratory findings).
kidney function and anorexia nervosa

Conditions: Anorexia Nervosa; Kidney Injury

Summary: anorexia nervosa (an) is an eating disorder that can lead to severe medical complications. kidney injuries are unknown in patients with extremely malnourished an (bmi \<13). the primary objective of the study is to evaluate the frequency and to determine the profiles of patients who may develop kidney injuries. the secondary objective is to evaluate the evolution of kidney injuries after a phase of refeeding. guidelines for medical treatments and dietary intakes will be recommended to avoid severe or irreversible renal disease.

anorexia nervosa is an eating disorder that can lead to undernutrition and severe somatic complications. the clinical nutrition unit in paul brousse hospital provide care to adult patients with a severe forms of an. kidney complications are poorly known and little explored. indeed, patients suffering from an have a higher prevalence of kidney failure due to the absence of a reference methods. kidney injuries come from multiple origin like chronic ionic disorders, dehydration and hyperprotein diet. the aim of this study will be to evaluate kidney injuries and to follow its evolution during refeeding. blood and urine simple of cystatine c will be add to routine analyses. this will allow us to know if, there is a concordance between the reference technique (measurement of glomerular filtration rate by isotopic method 99mtc-dtpa) and the measurement of cystatin c. thus, guidelines of dietary intake and medical treatments can be achieved in order to prevent severe forms requiring dialysis and kidney transplantation.

Eligibility criteria:
inclusion criteria: * patient with undernutrition (bmi \< 18,5); * patient with an according to dsm-5 criteria, validated by eating disorder diagnostic scale and edds-questionnaire; * patient informed and signed a consent form; * patient affiliated to a social security plan. exclusion criteria: * patient no-reponding to all criteria of dsm-5; * patient with a renal comorbidity no-related to an; * patient under ame scheme; * pregnancy or breastfeeding; * participation to another interventional study.

Keywords: anorexia nervosa renal function undernutrition eating disorder glomerular filtration rate (gfr) cystatin c
study of oxidized albumin in liver transplant patients

Conditions: Liver Failure; Liver Cirrhosis; Liver Transplant Disorder

Summary: the overall goal is to describe the oxidation state of albumin before, during and after liver transplantation. this is a pilot observational study in which the oxidative state in 10 patients undergoing liver transplantation will be described. samples for analysing the oxidation state of albumin, general oxidative damage and anti-oxidant state, the activation of the complement system and factors involved in coagulation will be obtained before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.


Eligibility criteria:
inclusion criteria: * patients on waiting list for liver transplantation exclusion criteria: * none

Keywords: oxidised albumin complement coagulation
treatment patterns in castrate resistant prostate cancer patients with bone metastases in a medicare population

Conditions: Prostate Cancer

Summary: the goal of the study is to provide a detailed description of treatments for crpc (castrate resistant prostate cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.


Eligibility criteria:
inclusion criteria: * first diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period * members age ≥ 55 to 89 years at index * medicare members with medical and pharmacy coverage; and * continuously enrolled during the pre- and post-index periods. exclusion criteria: * member with diagnosis of any other cancer (excluding melanoma (icd-9 172.x) and other metastases (icd-9 198.x)) before the index date; and * members age ≥ 89 years of age at index date

Keywords: castrated resistant prostate cancer patients with bone metastases