Kornimate/medical-research-clean huggingface dataset:
cytidine and omega-3 fatty acids in bipolar disorder

Conditions: Bipolar Disorder

Summary: the goal of the proposed clinical trial is to assess the effect of oral cytidine and omega-3 fatty acids (o3fa) on bipolar disorder symptoms. this study is a 4-month, randomized, parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. during the 16 week period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids + cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo supplementation.

previous studies examining the effect of omega-3 fatty acids on bipolar depression have had mixed results. some studies have found that omega-3 fatty acids have a positive effect on bipolar depression symptoms, while other studies have found no difference between placebo and omega-3 fatty acid treatment. the variable effects noted with omega-3 fatty acids may be due in part to a real effect with limited potency. larger effects might be achieved by combining agents with synergistic effects. cytidine is necessary to form key intermediates in the biosynthesis of the phospholipids phosphatidylcholine and phosphatidylethanolamine, which are major components of eukaryotic cell membranes. recent human studies by our group have shown that cdp-choline (a compound composed of cytidine and choline) can modify brain phospholipid synthesis in healthy adults and may have antidepressant effects (babb et al., 1996; babb et al., 2002; carlezon et al., 2002; renshaw et al., 1999). the combination of omega-fatty acids and the related pyrimidine, uridine, was associated with enhanced antidepressant-like activity in rats (carlezon et al., 2005). thus, the combination of omega-3 fatty acid and cytidine, which is interconverted with uridine in the body, may provide a safe and powerful way to treat bipolar disorder, especially bipolar depression. this study is a 4-month, randomized, parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. during the 16 week period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids + cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo supplementation.

Eligibility criteria:
inclusion criteria: * bipolar disorder * mood episode within past year * stable medication regimen exclusion criteria: * primary psychiatric disorder other than bipolar disorder * significant suicide or homicide risk * unstable medical conditions * current or planned pregnancy * lactose intolerance * medications affecting lipid absorption or metabolism * clozapine treatment

Keywords: bipolar disorder bipolar depression bipolar mania manic depression depression mania hypomania
interest in the medium term of an infrared reflexotherapy on overweight or class i obese people

Conditions: Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People

Summary: the study aim is to assess the effect of an ir reflexotherapy on overweight and class i obese people.


Eligibility criteria:
inclusion criteria: * bmi between 27 and 35 kg/m2 (included), * aged 30 to 60 years old (included), * stable weight: no variation of 3 kg in the las 3 months, * signed the consent form, * able to follow the study, * health insured. exclusion criteria: * history of coronary disease (in the last 6 months), * progressive illness at the time of the study (cancer, neurodegenerative disease...), * diabetics (treated or not), * fasting blood total cholesterol equal or over 2.5 g/l (treated or not), * fasting blood triglycerides equal or over 2.0 g/l (treated or not), * fasting blood glucose equal or over 1.26 g/l, * peripheral neuropathy (polyneuritis, diabetic neuropathy) or central neuropathy (hemiplegia), * infectious cutaneous condition or allergies (to the contact point of the device), * history of stroke, * severe heart disease, * epilepsy, * reduced motility, * diagnosed eating disorder, * followed a diet in the last 90 days in order to lose weight, * took weight loss assistance drug (orlistat) in the last month or is likely to take one during the study, * psychiatric disorder incompatible with the study, * mental illness, * neurological disorder, * chronic somatic disease, * addiction or nicotine withdrawal, * under psychoactive drug , * alcool consumption over 3 glasses a day, * pregnant or breastfeeding women, * women that are likely to get pregnant during the study, * is unable to understand or follow the protocol * is deprived of liberty * is under judicial protection
efficacy and safety of vaccination against influenza h1n1 in patients with inflammatory bowel diseases (ibd) treated immunomodulators and biologics

Conditions: Influenza H1N1

Summary: the spread of influenza h1n1 has prompted the development of vaccines against this virus. ibd patients are at increased risk of developing complications of influenza h1n1. the efficacy and safety of h1n1 vaccination have not been evaluated in this population of patients. we would like to estimate the efficacy and safety of vaccination against influenza h1n1 in patients with ibd who treated with immunomodulatory drugs.

200 patients with ibd and 200 healthy subjects will participate in the study. all the subjects will be vaccinated with focetria (novartis) and will be evaluated the day of vaccination and 4 weeks later. the evaluation will include: efficacy of the vaccine: blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against a/california17/2009/h1n1 by hemagglutination inhibition test. safety of the vaccine: * records of adverse event * assessment of disease activity : cdai and mayo score

Eligibility criteria:
inclusion criteria: 1. patients suffering from ibd (inflammatory bowel disease): uc/ cd 2. able to firm an informed consent 3. aged - 18-65 4. candidates to receive vaccination against h1n1, according to the recommendation of the ministry of health 5. patients who treated with immunomodulators and biologics exclusion criteria: 1. allergy to eggs 2. known allergy to seasonal influenza vaccine 3. pregnant women 4. patients who inoculate another vaccine in the past 3 weeks (except vaccine fot seasonal influenza 5. patients without worsening in their disease condition (stable condition)

Keywords: vaccine
non-invasive blood test cross-validation study

Conditions: Reproducibility of Results; Safety Issues

Summary: the study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (nicmp), relative to the venipuncture method. the nicmp machine learned powered device utilizes a light sensor to capture readings from either palm. the study (n=90) proves an agreement and strong correlation with respect to the nicmp and venipuncture blood draw.


Eligibility criteria:
inclusion criteria: * undiagnosed population exclusion criteria: * diagnosed population, pregnant women, mental heath/disabled, prisoners, fetus or deceased
external validation of the apfel risk score and koivuranta score to predict postoperative nausea and vomiting in patients with liver cancer

Conditions: Postoperative Nausea and Vomiting; Hepatobiliary Surgery; Prediction Model

Summary: postoperative nausea and vomiting (ponv) is a common complication among surgical patients. the incidence ranging from 20% to 50% depends on different population studied. clinical practice guidelines recommend routine ponv screening before surgery using the apfel simplified risk score or koivuranta score. however, these two scores haven't been translated into chinese version and tested for psychometric qualities. therefore, this study aim to externally validate two ponv prediction models in the chinese hospital setting for ponv assessment.


Eligibility criteria:
inclusion criteria: * patients receiving hepatobiliary surgery exclusion criteria: * patients receiving chemothreapy；patients with cognitive disorders; patients unwilling to participate.

Keywords: postoperative nausea and vomiting hepatobiliary surgery assessment tool
decentralized dietary uc pilot trial

Conditions: Colitis, Ulcerative

Summary: this study is designed to assess differences in remote and on-site patient study participation in the state of massachusetts, as well as the significance of dietary interventions and their impact on uc. the study will activate one site with a principal investigator who will utilize each subject's local care system (local gastroenterologist) to collect study data, along with telemonitoring and video visits, to make key study assessments and decisions regarding subjects' progression in the study.


Eligibility criteria:
inclusion criteria: 1. males and females between the ages of 18 and 80, inclusive, who reside in the state of massachusetts. 2. ability and willingness to provide documented informed consent and to comply with the study procedures, including in-person visits for arm 1 and video visits for arm 2. 3. documented history of moderate to severe active uc 4. disease duration of ≥12 weeks at the time of screening (diagnosed according to american college of gastroenterology practice guidelines) 5. screening fecal calprotectin\>350 mg/g 6. diagnosis of moderately to severely active uc, including historical endoscopy sub score ≥2; a rectal bleeding sub score ≥1 and disease activity a minimum of 25 cm from the anal verge. 7. documented (via video or report) endoscopy performed within 2 years prior to randomization. 8. access to a computer or mobile device with internet connection and an active email address. exclusion criteria: 1. prior extensive colonic resection, subtotal or total colectomy or planned surgery for uc 2. past or present ileostomy or colostomy 3. short bowel syndrome 4. diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon 5. past or present fistula or abdominal abscess 6. history or current evidence of colonic mucosal dysplasia 7. use of tube feeding, defined formula diets or parenteral alimentation/nutrition which has not been discontinued ≥3 weeks prior to study enrollment 8. use of anticoagulants, herbal supplements and omega-3/fish oil supplements during the study 9. crohn's disease 10. significant uncontrolled co-morbidity, such as neurological, cardiac (e.g., moderate to severe heart failure nyha class iii/iv), pulmonary, renal, hepatic, endocrine or gastrointestinal disorders 11. history of alcohol, drug or chemical abuse within 6 months prior to screening 12. pregnant females, those intending to become pregnant, and those who are lactating 13. current participation in any other clinical trial

Keywords: telemedicine
axicabtagene ciloleucel:neurocognitive and patient-reported outcomes

Conditions: Diffuse Large B Cell Lymphoma; Transformed Lymphoma

Summary: the purpose of the study is to assess self-reported side effects and neurocognitive (brain, mood and thinking) functioning among patients treated with commercial axi-cel therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with diffuse large b-cell lymphoma, primary mediastinal b-cell lymphoma or transformed follicular lymphoma * scheduled to receive commercial axi-cel at moffitt cancer center * able to speak and read standard english * have no documented or observable psychiatric or neurological diagnoses that interfere with study participation (e.g., schizophrenia) * have no history of traumatic brain injury, stroke, or dementia * able to provide informed consent

Keywords: axi-cel therapy car-t
effects on lipoprotein metabolism from pcsk9 inhibition utilizing a monoclonal antibody

Conditions: Primary Hyperlipidemia and Mixed Dyslipidemia

Summary: this is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.


Eligibility criteria:
inclusion criteria: * fasting ldl-c at screening ≥ 100 mg/dl and ≤ 190 mg/dl * fasting triglycerides ≤ 150 mg/dl * body mass index (bmi) between 18.0 and 32.0 kg/m\^2 * framingham cardiac risk score 10% or less exclusion criteria: * treatment with a lipid-regulating drug or over the counter supplement in the last 3 months prior to screening * history of coronary heart disease (chd) or chd equivalent * uncontrolled hypertension * diabetes mellitus

Keywords: raised cholesterol cholesterol elevated cholesterol hyperlipidemias dyslipidemias lipid metabolism disorders metabolic diseases
evaluation of sestrin levels in patients with endometriosis

Conditions: Endometriosis

Summary: serum sestrin levels of endometriosis patients are compared with a group of healthy volunteers of the same age.

serum sestrin levels are compared with 45 endometriosis patients and 45 healthy volunteers of the same age. the energy metabolism of the endometriosis group and its possible relationship with the endometriosis stage will be compared since sestrin gives information about the energy metabolism of the people.

Eligibility criteria:
inclusion criteria: * diagnosed with endometriosis (surgery or ultrasound) * women without endometriosis exclusion criteria: * women without endometriosis * women who are only suspected endometriosis

Keywords: sestrin
evaluate the effect of atorvastatin on cerebrovascular reactivity in mild cognitive impairment (mci)

Conditions: Mild Cognitive Impairment

Summary: the purpose of this study is to evaluate the effect of atorvastatin on brain vessel reactivity and with it on blood flow in people with mild cognitive impairment.

participants are first being informed about potential benefits and risks of the study and are required to give written consent. after that participants will undergo detailed phone screen to determine eligibility for study entry. at week 0, participants who meet eligibility requirements will be prescribed atorvastatin (40 mg, once in the evening) in an open-label manner.

Eligibility criteria:
inclusion criteria are chosen to include participants with mci, enriched for vascular risk factors: * mci defined by clinical dementia rating (cdr) of 0.5 or 1.0. * memory, processing speed, executive function, language - cognitive scores \> 1.5 standard deviations below age-education norms. * not demented by history. * not taking statins currently or in the last 6 months. * cognitive/functional impairment not likely due to another neurological disease or delirium. exclusion criteria: * taking a statin currently or have taken a statin in the last 6 months. * contraindications to taking a statin. * transplant patient taking cyclosporine. * unable to undergo mri procedures (such as having an implanted pacemaker or defibrillator or stimulator or having non mri compatible metal). * diagnosis of dementia by history. * current diagnosis of substance abuse. * history of stroke or myocardial infarction in past 6 months. * history of hiv.

Keywords: cerebral vascular reactivity
nsaids with morphine-pca compared to epidural analgesia in thoracotomy pain

Conditions: Postoperative Pain

Summary: the investigators investigated whether a strictly controlled pain management with patients participating in a clinical study can attenuate persistence of post-thoracotomy pain. the investigators also wanted to find out whether nsaid + intravenous patient-controlled analgesia with morphine is an efficacious alternative to thoracic epidural analgesia.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective thoracotomy for lung surgery exclusion criteria: * contraindication to any of the study drugs or an epidural catheter, * significant liver, renal or cardiac disease * peptic ulcer * regular use of analgesics * re-thoracotomy, and the patient´s inability to understand the use of pca/patient controlled thoracic epidural analgesia (pcea).

Keywords: thoracotomy pain nsaid pca tea chronic
triple site ventricular stimulation for cardiac resynchronization therapy (crt) candidates

Conditions: Heart Failure

Summary: despite technological progresses the rate of non-responders to cardiac resynchronization therapy (crt) remains close to 30%. this inconsistent effect of crt might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during crt. one might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (lv) or right ventricular (rv) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. first studies have suggested that 1 rv + 2 lv pacing sites configurations increased significantly dp/dt, pulse pressure, lv end-diastolic pressure, and is associated with more lv remodeling and better responder rate compared with pacing a single lv site. first studies with 2 rv+lv pacing sites configuration demonstrated increased dp/dt and cardiac output and a decrease of the cardiac dyssynchrony. the present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (rv) and 1 left ventricular (lv) leads - main objective- and to assess its clinical benefit.


Eligibility criteria:
inclusion criteria: * signed informed consent * \> 18 years old * cardiac resynchronization indication : new york heart association (nyha) class iii/iv \& qrs width \> 120 ms milliseconds (ms) or nyha class ii \& qrs width \> 150 ms * sinus rhythm * first implant procedure exclusion criteria: * permanent ventricular tachycardia * permanent pacing indication for 3rd degree atrioventricular (av) block * diagnosed or suspected acute myocarditis * less than 1 year life expectancy related to a non-cardiovascular disease * impossibility to perform follow-up in the investigative center * pregnant woman * patient which may not cooperate to study procedures as evaluated by investigator * legally protected adult patient or patient unable to give an informed consent * patient enrolled in an other clinical trial * patient which does not benefit from a social protection system * renal insufficiency * patient registered on a heart transplant waiting list * disease and/or health condition which may interfere with study results

Keywords: heart failure cardiac resynchronization triple site ventricular pacing
cholangioscopy or conventional techniques for indeterminate biliary stenosis

Conditions: Malignant Biliary Stenosis

Summary: biliary stenosis not associated with a mass is difficult to diagnose with certainty. the diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. in the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting. the main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. the secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness. the primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).


Eligibility criteria:
inclusion criteria: * presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts * presence of clinical jaundice and / or biological cholestasis (ggt\> 3n) * absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal ct scan, mri with biliary sequences. * endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion. * no history of ercp in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion * collegial validation of the need for a formal diagnosis of indeterminate biliary stenosis in order to guide therapeutic management * patients aged 18 to 85 * patient who gave his consent to participate in the study * no contraindication to anesthesia (asa 1, 2,3) * patient affiliated to a social security scheme (beneficiary or beneficiary) * absence of pregnancy and current contraception in women of childbearing age exclusion criteria: * presence of a manifest tissue mass in relation to the biliary stenosis on ct and / or mri imaging. * very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity * history of ercp and / or percutaneous biliary drainage in the 6 months preceding inclusion * presence of a plastic or metal biliary prosthesis in place at the time of inclusion * history of cephalic duodeno-pancreatectomy or hepatico-jejunal anastomosis * non-passable stenosis of the main bile duct * severe coagulopathy, thrombocytopenia \<75,000 g / l, treatment with clopidogrel cannot be interrupted even temporarily * anesthetic contraindication (asa 4) * inability to obtain informed consent * person deprived of liberty

Keywords: biliary stenosis cholangioscopy cholangiocarcinoma ercp
stapled anopexy versus closed haemorrhoidectomy for haemorrhoids

Conditions: Hemorrhoids

Summary: the aim of this study is to determine the role of stapled anopexy in the treatment of haemorrhoids by comparing it to the current gold standard treatment, which is excisional haemorrhoidectomy.

the current gold standard treatment of haemorrhoids namely, excisional haemorrhoidectomy is associated with severe postoperative pain and prolonged recovery period. methods aiming at improving the outcome of excisional surgery included mainly modifications of the existing technique. alternative instruments other than scissors have been used for the actual excision of haemorrhoids with a view to reducing the postoperative pain. however, with the wound in the sensitive anoderm following excisional haemorrhoidectomy, pain continues to be a major problem irrespective of the method of excision or of the instrument employed. the new technique of stapled anopexy introduced in 1998 uses a radically different approach to treat haemorrhoids. the prolapsed anal cushion is repositioned and fixed without actually excising the haemorrhoidal pedicle thereby avoiding an external wound. this should result in reduction of the postoperative pain and subsequently should improve the recovery time. further potential advantages of the technique should include a more physiological approach to the treatment of the disease.

Eligibility criteria:
inclusion criteria: * adult human subjects (age \>=16 years) with symptomatic haemorrhoids (primary or recurrent) * symptomatic haemorrhoids (grades 2, 3, 4) needing surgical treatment exclusion criteria: * concurrent untreated or recurrent colorectal cancer * active inflammatory bowel disease * previous major anorectal surgery * on anticoagulant medications * non-consenting patients * unwilling for randomisation

Keywords: symptomatic haemorrhoids haemorrhoidectomy stapled anopexy