Kornimate/medical-research-clean huggingface dataset:
treating nicotine dependence in schizophrenic individuals: effectiveness of bupropion - 1

Conditions: Tobacco Use Cessation; Tobacco Use Disorder; Schizophrenia

Summary: schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. the purpose of this study is to determine the effectiveness of bupropion sr (commonly known as zyban) in combination with a nicotine transdermal patch (ntp), in helping schizophrenic individuals quit smoking. in addition, this study will evaluate how the combination of bupropion sr and ntp affects psychiatric symptoms and medication side effects.

past research on the use of the ntp, atypical antipsychotics, and bupropion in schizophrenic individuals to aid in smoking cessation has been encouraging. the purpose of this study is to compare bupropion sr to a placebo to determine its effectiveness when used in combination with an ntp to help schizophrenic individuals quit smoking. participants in this double-blind, placebo-controlled study will be randomly assigned to receive either the ntp (21 mg/day) and placebo or the ntp and bupropion sr (300 mg/day). participants will begin taking one pill each day of bupropion sr (150 mg/day) or placebo at the start of the second week of the study. after three days, the dose of bupropion sr or placebo will increase to 2 pills each day. participants will continue this dosing regimen until the end of week 10. throughout the 10-week study, participants will receive weekly group therapy.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia or schizoaffective disorder and nicotine dependence * fagerstrom test for nicotine dependence (ftnd) score greater than 5 * smokes at least 20 cigarettes per day (1 pack per day) * expired breath co level \> 10 ppm and cotinine level \> 210 ng/ml at the baseline measurement * currently taking a stable dose of antipsychotic * complete remission from positive symptoms of psychosis as judged by a psychiatric evaluation exclusion criteria: * meets criteria for current abuse or dependence for any alcohol or illicit substance within the past month * history of hypersensitivity to bupropion or the nicotine transdermal patch (ntp) * current diagnosis of a serious documented medical disorder that would make bupropion treatment risky or results of psychiatric/medical screening that suggest a reason for concern (e.g., a history of severe heart, liver, or kidney disease or diabetes mellitus) * currently taking monoamine oxidase inhibitors or bupropion (zyban or wellbutrin) * currently taking diabetes mellitus medications, st. john's wort, appetite suppressants, ephedrine-containing medications, theophylline, clonidine, reserpine, methyldopa, or anti-anginal medications (e.g., beta-blockers, calcium channel blockers, nitroglycerin preparations) * history of schizoaffective disorder and not stabilized on a mood stabilizer (e.g., lithium, valproate, carbamazepine)

Keywords: nicotine dependence
the efficacy of thread embedding acupuncture on pain score, neck disability index, and pressure pain threshold for myofascial pain therapy in the upper trapezius muscle

Conditions: Myofascial Pain of Upper Trapezius Muscle

Summary: myofascial pain is characterized by myofascial trigger points, considered as a major cause of neck and shoulder pain in the working population. thread-embedding acupuncture is a new acupuncture modality that can provide long-term stimulation aimed at prolonging its therapeutic effect that is similar to conventional acupuncture, such as analgesic effects. the goal of this randomized controlled trial is to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. the primary aim of this study is to investigate whether thread-embedding acupuncture therapy gives better and last longer results for myofascial pain of the upper trapezius muscle than sham thread-embedding acupuncture.

this is a clinical trial study to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. the subjects are 44 males/female with myofascial pain in the upper trapezius muscle and will be randomly assigned to 2 groups: (1) thread-embedding acupuncture and (2) sham thread-embedding acupuncture. the subjects will receive a single treatment. the outcome will be assessed before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment. patients and the outcome assessors will be blinded to the group allocation.

Eligibility criteria:
inclusion criteria: * male or female aged 18-59 years. * subject with myofascial pain in the upper trapezius muscle. * vas score of 30-70 mm from 100 mm during activities (everyday activities or light exercise). * pain \> 3 months. * willing to participate in this research to completion and sign informed consent. exclusion criteria: * fibromyalgia. * have had cervical spine surgery. * have done dry needling therapy on the upper trapezius muscle in the last 9 days * have done thread acupuncture on the upper trapezius muscle in the last 6 months. * have performed pharmacopuncture on the upper trapezius muscle in the last 6 months. * vas score is more than 70 mm than 100 mm at resting. * history of anti-inflammatory drug treatment in the previous 2 weeks. * history of intra-articular steroid injections in the previous 3 months. * there is a tumor, wound, or skin infection at the needle insertion area. * fever (≥ 37.5 oc). * there is a hypersensitivity reaction in previous acupuncture therapy (metal allergy, severe atopy, keloids, or other skin hypersensitivity). * suffering from a blood disorder or taking blood thinners (anti-platelet or anti-coagulant drugs). * have a heart condition or uncontrolled diabetes. * blood glucose level (gds) ≥200 mg/dl is checked by capillary blood using a glucometer.
apollo-b: a study to evaluate patisiran in participants with transthyretin amyloidosis with cardiomyopathy (attr amyloidosis with cardiomyopathy)

Conditions: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Summary: the purpose of this study is to evaluate the efficacy and safety of patisiran in participants with attr amyloidosis with cardiomyopathy.


Eligibility criteria:
inclusion criteria: * documented diagnosis of attr amyloidosis with cardiomyopathy, classified as either hereditary attr amyloidosis with cardiomyopathy or wild-type attr amyloidosis with cardiomyopathy * medical history of heart failure with at least 1 prior hospitalization for heart failure, or current clinical evidence (signs and symptoms of heart failure) * clinically stable with no cardiovascular related hospitalizations within 6 weeks of study start * has never taken tafamidis before (tafamidis naïve) or currently on tafamidis for ≥6 months with evidence of disease progression while on tafamidis treatment * able to complete ≥150 m on the 6-minute walk test * screening n-terminal pro b-type natriuretic peptide (nt-probnp), a blood marker of heart failure severity, \>300 ng/l and \ 600 ng/l and \<8500 ng/l exclusion criteria: * known primary amyloidosis (al) or leptomeningeal amyloidosis. * received prior ttr lowering treatment * new york heart association heart failure classification of iii and at high risk * new york heart association heart failure classification of iv * neuropathy requiring cane or stick to walk, or is wheelchair bound * estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m\^2 * abnormal liver function * has hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection * has non-amyloid disease that significantly affects ability to walk (e.g., severe chronic obstructive pulmonary disease, severe arthritis, or peripheral vascular disease affecting ambulation) * prior or planned heart, liver, or other organ transplant * other cardiomyopathy not related to attr amyloidosis

Keywords: rnai therapeutic transthyretin ttr amyloidosis cardiomyopathy attr
inulin and acetate production and human substrate metabolism

Conditions: Obesity; Pre Diabetes

Summary: based on our hypothesis that orally administered resistant starch and inulin/beta glucan will be fermented into a scfa pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective: to investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.


Eligibility criteria:
inclusion criteria: * lean (bmi ≥ 20kg/m2 and ≤ 24.9kg/m2) * normoglycemic * aged 30 - 65 years or * overweight/obese (bmi ≥ 25kg/m2 and ≤ 34.9kg/m2) * pre-diabetes * aged between 30 - 65 years. exclusion criteria: * diabetes mellitus * gastroenterological diseases or major abdominal surgery (allowed i.e.: - appendectomy, cholecystectomy) * lactose intolerance and other digestive disorders * cardiovascular disease, cancer, liver or kidney malfunction (determined -based on alat and creatinine levels, respectively) * disease with a life expectancy shorter than 5 years * use of antibiotics 3 months prior inclusion * use of probiotics or prebiotics
study of symptoms linked to covid-19 in residents and professionals in ehpad, associated with a dual diagnostic approach by pcr and serology: a cohort in île-de-france.

Conditions: Symptoms Related to Covid-19

Summary: the main purpose is to study the prevalence of covid-19 in ehpad. the primary endpoint will be the combination of pcr results and symptomatology, making it possible to define positive cases in ehpad, in residents and professionals in contact with them. the prevalence obtained can be compared with the results of serology if these are performed.

this study is taking place in several nursing homes in ile-de-france, which will be recruited at the end of the diagnostic campaign. at the initiative of the ars ile-de-france, residents and professionals of selected ehpads will be subjected to systematic screening by rt-pcr for covid-19, then by serology after the first screening, regardless of whether either the result samples, by nasopharyngeal swab for rt-pcr, by capillary blood sampling or venipuncture according to the technique for serology, will be carried out according to the doctrines issued by the ars ile de france and the variations proposed by the appropriate departmental directorates in depending on local resources. the results will be brought to the attention of ehpads to adapt the care of residents and positive professionals. data will be collected daily from collection for the first test (rt-pcr), or retrospectively if the collection took place before the study. regarding the approach for collecting serologies: * all subjects included with a negative pcr will be offered the serological test, in accordance with the recommendations in force or the medical decisions of the establishments. * the qualitative results of the serologies of the subjects included in the study (residents and professionals) will be collected according to the same circuit as those of the rt-pcrs. * only the symptoms of residents with a positive serology will be collected, from the date of the sample and for a period of 14 days. * the symptoms of professionals with a positive serology can be collected, from the date of the sample and for a period of 14 days without mandatory character. * both techniques (elisa or trod) are accepted and the serology values will not be collected.

Eligibility criteria:
inclusion criteria: 1. / residents of nursing homes in île-de-france in which systematic covid-19 screening tests were carried out and agreeing to participate in the study. 2. / professionals in nursing homes in île-de-france in which systematic screening tests for covid-19 were carried out and agreeing to participate in the study: nursing assistants, nurses, coordinating doctors, hotel and service agents hygiene, etc. exclusion criteria: 1. / expression of opposition to the collection of symptoms by professionals, residents or their legal representatives. 2. / subjects who have not had a diagnostic test by rt-pcr.

Keywords: covid-19 serology reverse transcriptase pcr
extension study of iron chelation therapy with deferasirox in patients with transfusional iron overload

Conditions: Transfusional Iron Overload

Summary: a 1-year randomized phase iia core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload. the objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.


Eligibility criteria:
inclusion criteria: * patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox exclusion criteria: * pregnant or breast feeding patients * patients being considered by the investigator potentially unreliable and/or a history of non-compliance

Keywords: transfusional iron overload deferasirox
trigger- vs. substrate-ablation for paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to compare two strategies of catheter-based treatment of paroxysmal atrial fibrillation: pulmonary vein isolation either alone or combined with electrogram-guided substrate-ablation.

catheter ablation has evolved an accepted alternative in the curative treatment of atrial fibrillation (af). however, discussion about the best ablation strategy is still ongoing. in patients with paroxysmal af, it has been reproducibly demonstrated that curing rates of approximately 65-70% can be achieved with the electric isolation of pulmonary veins (pv) eliminating the initiating triggers of af episodes. recently, a new catheter ablation approach targeting in both atria fractionated, complex electrograms during ongoing af and modifying thus the substrate maintaining af has been described. the first describer of this technique reports curing rates of 92%. we want to compare in a randomized prospective study the treatment by pv isolation alone with a combined approach of pv isolation together with ablation of fractionated complex electrograms in patients with paroxysmal af. study endpoint is the achievement of stable sinus rhythm as assessed by 7 days holter ecg in the absence of antiarrhythmic drug treatment.

Eligibility criteria:
inclusion criteria: * age \> 18 and \<80 years * symptomatic paroxysmal atrial fibrillation * drug-refractory * anticoagulation exclusion criteria: * hyperthyreosis * moderate-to-severe mitral valve valvulopathy * lv-ejection fraction \<35% * prior ablation, pci or heart surgery \<3 months * left atrial thrombus
phase iii study to evaluate safety and efficacy of added exenatide versus placebo to titrated basal insulin glargine in inadequately controlled patients with type ii diabetes mellitus

Conditions: Diabetes Mellitus

Summary: study d5553c00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 3 study to compare the safety and efficacy of exenatide once weekly (eqw) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (t2dm). eligible patients will be randomized at visit 5 (day 1) to receive either eqw added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.


Eligibility criteria:
inclusion criteria: * has a diagnosis of type 2 diabetes mellitus (t2dm) * has hba1c of 7.5% to 12.0%, inclusive, at visit 1 (screening). * has fasting plasma glucose (fpg) concentration \<280 mg/dl (15.6 mmol/l) at visit 1 (screening) * treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to screening, in combination with diet and exercise alone or in combination with: 1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to visit 1 2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to visit 1 (screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the screening visit exclusion criteria: * serum calcitonin concentration ≥40 pg/ml (≥40 ng/l) at visit 1 (screening) * history of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dl (≥5.65 mmol/l) at visit 1 * positive serological test for hepatitis b or hepatitis c

Keywords: diabetes mellitus exenatide diabetes drug treatment efficacy placebo metabolism cardiovascilar metabolic
tailored internet-delivered cognitive behaviour therapy for symptoms of depression and comorbid problems

Conditions: Depression; Anxiety Disorders

Summary: the overall aim of this study is to develop and test a tailored internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.

internet-delivered cognitive behaviour therapy (cbt) has emerged as a promising way to administer evidence-based psychological treatments. mild to moderate major depression has previously been found to treatable via the internet, with the provision that minimal therapist guidance is given. however, previous research has not taken the issue of comorbidity into account. it is well known that major depression often is accompanied by anxiety and in addition the symptom profile in major depression may differ substantially. the idea behind the proposed research is to tailor the internet intervention according to the symptom profile. by used a large set of treatment modules (text-based) we aim to diagnose and then prescribe modules. in a randomized trial we want to compare this procedure (e.g., tailored cbt) with the standard internet-delivered cbt. we will also include a control group in the form of a supervised online discussion group who will later receive cbt.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of major depressive disorder * 15 or more on madrs-s exclusion criteria: * severe depression (more than 35 on madrs-s or based on interview) * severe psychiatric condition (e.g. psychosis or bipolar disorder) * changed medication during the last three months
mobile instruction for low back pain (mobil)

Conditions: Low Back Pain

Summary: the purpose of this project is to measure the impact of a short educational session on outcomes for patients consulting in primary care for low back pain. subjects will be patients consulting to their primary care provider for a primary complaint and new episode of low back pain. subjects will be randomized to receiving the educational tool versus usual care (information only without an educational component) in the clinic immediately prior to seeing their pcp. patients will be followed for a 6-month period, and outcome measures will be collected and compared across both groups.

patients that arrive for an initial evaluation for low back pain will be randomized to either receive the video education via an application (app) on a tablet computer, or usual care (which consists of information in the form of a handout but no further education prior to seeing the primary care provider - pcp). to control for exposure to the tablet computer, subjects in both groups will use the tablet computer to fill out the self-reported outcome measures. this will all take place while the patient is waiting to see their pcp, who will be blinded to the educational intervention that the patient received. after enrollment and completion of baseline outcome measures and surveys, the subject will be randomized to one of the 2 arms, receive the intervention, and then proceed to have their appointment with their pcp. the appointment with the pcp will proceed per usual care standards, with no additional research interventions. the subjects will be contacted for a follow-up at 1 and 6 months for assessment of self-reported outcomes measuring pain, function, and disability. the investigators will also abstract healthcare utilization from claims data and compare variables of healthcare use between both groups over the 6-month period following enrollment (radiographs, mris, prescription opioids, and specialty referrals).

Eligibility criteria:
inclusion criteria: 1. a tricare beneficiary with a primary complaint of low back pain consulting in a primary care clinic 2. between the age of 18 - 50 years 3. read and speak english well enough to interact with the mobile education technology, provide informed consent and follow study instructions exclusion criteria: 1. history of prior surgery to the lumbosacral spine 2. medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease 3. known current pregnancy or history of pregnancy in the last 6 months 4. already seen in primary care for an episode of low back pain within the last 3 months

Keywords: patient education low back pain technology
vetal laban intervention trial assessing bowel symptoms

Conditions: Irritable Bowel Syndrome

Summary: a two month intervention trial assessing the effect of vetal laban containing l. acidophilus on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (ibs).


Eligibility criteria:
inclusion criteria: * males and females aged 18 to 65 years * subjects fulfilling rome iii criteria for ibs * sufficient health and orientation for participating in the trial * obtained his/her informed consent after verbal and written information. * have a high probability for compliance with and completion of the study. * body mass index (bmi) between 19 and 35. exclusion criteria: * diagnosed or suspected organic gastrointestinal disease (i.e. colitis, crohn's disease, celiac disease, major bowel surgery, recurrent diverticulitis) or severely impaired general health including cancer and cancer therapy. * lactose intolerance * unwillingness to refrain from probiotic use during the trial * use of antibiotics within the 3 preceding months prior to recruitment * pregnant, planning pregnancy or lactating * expected major lifestyle changes related to nutrition, exercise, travelling etc. * participation in a clinical trial with an investigational product or drug within 3 months prior to screening. * substance abuse * subjects unable to read and understand the questionnaires

Keywords: ibs bowel function probiotic