Kornimate/medical-research-clean huggingface dataset:
optimizing the effectiveness of selective serotonin reuptake inhibitors (ssris) in treatment-resistant depression

Conditions: Depression

Summary: this study will determine the effectiveness of adding s-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.

some people with depression do not respond well to antidepressant treatment. s-adenosyl methionine (same) is a naturally occurring compound that may have antidepressant effects. same may also enhance the effectiveness of other antidepressants, such as selective serotonin reuptake inhibitors (ssris). this study will determine the effectiveness of oral same in enhancing the effects of ssris in patients currently not responding to ssri treatment. this study will last 6 weeks. no follow-up visits will occur. participants will be randomly assigned to add either oral same or placebo to their existing ssri regimen for 6 weeks. depression scales and self-report questionnaires regarding depressive symptoms will be used to assess participants at the end of the study.

Eligibility criteria:
inclusion criteria: * major depressive disorder * use of an ssri for at least 6 weeks prior to study entry with partial or no response exclusion criteria: * history of psychosis * allergy to same * alcohol or drug abuse in the past 3 months prior to study entry

Keywords: selective serotonin reuptake inhibitors s-adenosyl methionine ssri same
the effectiveness of atezolizumab in patients with locally-advanced or metastatic non-small cell lung cancer after prior chemotherapy

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: hyperion is a prospective, multicenter, non-interventional, two-cohort study collecting primary data in patients with locally advanced or metastatic nsclc of squamous or non-squamous histology after prior chemotherapy being treated with atezolizumab in routine clinical practice.


Eligibility criteria:
inclusion criteria: * diagnosis of locally advanced or metastatic nsclc (histologically or cytologically confirmed stage iiib/stage iv) and prior chemotherapy * decision to be treated with atezolizumab according to summary of product characteristics (smpc) by treating physician, independent of this non-interventional study * no contraindication to treatment with atezolizumab retrospective inclusion: * participants may be included retrospectively. retrospective inclusion and documentation is limited to up to 9 weeks after initial start of therapy with atezolizumab (corresponding to a maximum of 3 treatment cycles with drug administrations at 3-week intervals), corresponding to a maximum of 9 weeks prior to date of informed consent. quality of life for this population will be captured and assessed retrospectively with a modified questionnaire for the period immediately prior to treatment start until study inclusion. participants who started atezolizumab therapy more than 9 weeks prior to icf being obtained may not be included in the study. * participants who give consent to be retrospectively enrolled but have already discontinued atezolizumab for reasons such as loss of clinical benefit or toxicity may also take part in the study, given their first administration of atezolizumab is within 9 weeks of consenting to take part, and they meet all other eligibility criteria. exclusion criteria: patients not eligible for atezolizumab treatment according to smpc
rheumatoid arthritis dose ranging study (0663-086)(completed)

Conditions: Rheumatoid Arthritis

Summary: to assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * patient with diagnosed rheumatoid arthritis (ra) for at least 6 months prior who is otherwise judged to be in general good health and who is currently taking nonsteroidal anti-inflammatory drugs (nsaids) to treat his/her ra symptoms * patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time exclusion criteria: * patients with a disease or medical condition(s) that could worsen or interfere with the evaluation of the effectiveness of study medication are not allowed to participate

Keywords: arcoxia
esm versus om ：a randomized controlled trial

Conditions: Endoscopic Subcutaneous Mastectomy

Summary: the consideration of quality of life issues has led to the development of alternative surgeries for breast cancer patients, particularly in the case of localized disease. nipple-sparing subcutaneous mastectomy (sm), for example, was designed to preserve the nipple-areola complex which facilitates breast reconstruction. however, sm still leaves behind a conspicuous scar.there have already been some observation study show that endoscopic subcutaneous mastectomy(esm) can improve the cosmesis outcomes and at the same time as safe as the traditional sm.however there is no rct in this field.that is why the investigators design this study.


Eligibility criteria:
inclusion criteria: 1. diagnosis of stages i or ii ductal carcinoma 2. the distance from the tumor to the edge of the papilla is more than 3cm, the tumor volume is less than 3cm, the axillary lymph nodes have no obvious fusion and no adhesion with the axillary vein and brachial plexus 3. age from 18\~70 4. ecog scores 0\~2 5. normal function of liver, kidney and bone marrow exclusion criteria: 1. through physical examination and mri, it was confirmed that the tumor did not invade the skin, but was confined to the gland and did not invade the surface of the gland. 2. there are serious medical diseases 3. pregnant or lactating women women of childbearing age -
study of rotatory vestibular tests in major depression patients and healthy control subjects.

Conditions: Depression; Vestibular Disorder

Summary: this study evaluates the vestibular activity in major depression patients and healthy controls using the rotatory test and electronystagmography.

previous studies showed abnormal vestibular activity in major depression patients using caloric vestibular tests. the present study investigates the vestibular response to vestibular rotatory tests in major depression subjects and healthy controls.

Eligibility criteria:
inclusion criteria: * male and females adults (18 years or older) * met the diagnosing and statistical manual of mental disorders (dsm-iv-r, american psychiatric association, 2000) criterion. * had a score of 12 or more in the hamilton rating scale, 21 items for depression. * with or without actual pharmacological treatment, except benzodiazepines that were suspended 24 hours before the rotary test when corresponding. exclusion criteria: * pregnant women * neurologic disorders.

Keywords: depression vestibular disorder rotatory test electronystagmography
effects of preoperative immunonutrition in patients undergoing hepatectomy

Conditions: Bile Duct Cancer

Summary: the purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and th1/th2 differentiation in patients with major hepatectomy.

the investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after hepatectomy, and modulation of th1/th2 differentiation may play important roles in this effect. object of this study is to investigate the effects of preoperative immunonutrition on incidence of postoperative infectious complication, and th1/th2 balance after hepatectomy.

Eligibility criteria:
inclusion criteria: * hepatectomy exclusion criteria: * age younger than 18 years * ongoing infection * gastrointestinal obstruction * respiratory dysfunction * cardiac dysfunction * hepatic dysfunction * renal failure * history of recent immunosuppressive or immunological disease * preoperative evidence of widespread metastatic disease

Keywords: immunonutrition hepatectomy th1 th2
magnesium as adjuvant for sciatic block

Conditions: Hallux Valgus

Summary: the aim of the study is to evaluate if magnesium added to ropivacaine can reduce onset time and can enhance offset time.

patients are randomly divided into two groups: group "m" (ropivacaina 7,5 mg/ml with mg 4 mg/kg)and group"c" (without mg). standard monitoring is applied to each patient in perioperative period. an indipendent observer collect data: time to perform block, sensitivity onset,motor onset, pain during surgery and complication. in the post-operative period till 24 hours for each patient is evaluated off-set time, pain and analgesic consumption.

Eligibility criteria:
inclusion criteria: * given consent * allux valgus correction surgery exclusion criteria: * allergy to local anesthetic * infection in the site of puncture

Keywords: local anesthetic adjuvant, magnesium solfatus, sciatic block
hepatitis b virus mutants and the therapeutic effect of peginterferon alfa-2a in hbeag-positive chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: in order to clarify the association between hbv mutations appearing before and during interferon therapy and the therapeutic effects, serial serum samples from 100 hbeag-positive chb patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the mutations of pres/s gene and bcp-prec/c region, particularly for the deletion mutations. furthermore, real-time pcr will be performed to measure the ratios of wild-type hbv and deletion mutant hbv before and at the end of peginterferon alfa-2a therapy. finally, statistical analysis will be done to elucidate whether the mutations of pres/s gene and bcp-prec/c region have any relation with the therapeutic effect of peginterferon alfa-2a.

hepatitis b virus (hbv) infection is a serious worldwide health issue. approximately 400 million people worldwide are chronic hepatitis b (chb) patients. currently, two therapeutic methods can be used to treat chb. one is the nucleos(t)ide analogues, the other is the interferon alfa. interferon alfa acts mainly by enhancing the immune system and directly inhibits the virus to a limited extent. it is known that mutations at pres, s, basal core promoter, precore and core gene are associated with an increased risk of hcc. however, it remains to be clarified as to the relation between hbv mutations and the therapeutic responses to interferon treatment. in order to clarify the association between hbv mutations appearing before and during interferon therapy and the therapeutic effects, serial serum samples from 100 hbeag-positive chb patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the mutations of pres/s gene and bcp-prec/c region, particularly for the deletion mutations. furthermore, real-time pcr will be performed to measure the ratios of wild-type hbv and deletion mutant hbv before and at the end of peginterferon alfa-2a therapy. finally, statistical analysis will be done to elucidate whether the mutations of pres/s gene and bcp-prec/c region have any relation with the therapeutic effect of peginterferon alfa-2a.

Eligibility criteria:
inclusion criteria: hbeag-positive chronic hepatitis b patients on peginterferon therapy exclusion criteria: hbeag-negative chronic hepatitis b patients hbeag-positive chronic hepatitis b patients on other kinds of therapy

Keywords: chronic hepatitis b peginterferon alfa-2a
a long-term follow-up study of botulinum toxin type a in patients with overactive bladder as a result of spinal injury or multiple sclerosis

Conditions: Overactive Bladder

Summary: the purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type a on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. this is a follow-up study to two allergan sponsored studies (nct00311376 and nct00461292).

botulinum toxin type a 300u has been discontinued from the study. patients remaining in the arm containing botulinum toxin type a 300u will receive botulinum toxin type a 200u moving forward. also, the masking of the study is now open-label.

Eligibility criteria:
inclusion criteria: * patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled: * patient completed at least 52 weeks in the preceding study. * no longer than 6 months has elapsed since completion of the preceding study * patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study. exclusion criteria: * history or evidence of pelvic or urologic abnormality. * previous or current diagnosis of bladder or prostate cancer.
extended-release naltrexone for opioid relapse prevention following release from jail

Conditions: Opiate Dependence

Summary: this pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with xr-ntx pre-release vs. controls not receiving xr-ntx.

this protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (xr-ntx), a full opioid antagonist that prevents the activity of heroin and other opioids. investigators at nyusom and nyc dohmh will recruit heroin dependent persons from nyc jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. all n=40 participants receive a two-session, individual psychosocial intervention, motivational interviewing. half (n=20) will be randomized to pre-release treatment with xr-ntx. immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at bellevue hospital, including a second xr-ntx dose among xr-ntx arm participants. the primary outcome is relapse to sustained opioid use during the first 30 days post-release. we hypothesize an xr-ntx arm will report significantly lower rates of sustained opioid relapse following release.

Eligibility criteria:
inclusion criteria: * adults incarcerated in nyc jails with known release date * dsm-iv criteria for current opioid dependence * no current agonist (methadone, buprenorphine) treatment * currently opioid free by history ('detoxed') and with a negative urine for all opioids * general good health as determined by complete medical interview and physical examination * age 18-60 years. exclusion criteria: * history of liver failure, cirrhosis, or recent liver function test levels greater than three times normal * pregnancy, lactation, or planning conception * active medical illness that might make participation hazardous * untreated psychiatric disorder * history of allergic reaction to naltrexone, plg (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent. * current chronic pain condition treated with opioids.

Keywords: extended-release naltrexone prisoners opioid addiction prevention medication treatment alternatives prevention of relapse to opioid addiction
tiotropium bromide in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: to date, there have been no formal clinical studies completed using tiotropium in cf patients. while there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with chronic obstructive pulmonary disease (copd), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. therefore, boehringer ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult cf. the phase iii trial (205.438) is a part of the approved paediatric investigation plan (pip) agreed for spiriva® respimat® in cystic fibrosis.


Eligibility criteria:
inclusion criteria: 1. patients with a documented diagnosis of cystic fibrosis (cf) (positive sweat chloride \>=60 meq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations. 2. male or female patients (children less than 12 years and adolescents \>12 years). 3. patients \>=5 years of age must be able to perform acceptable spirometric maneuvers, according to the american thoracic society (ats) standards. 4. pre-bronchodilator forced expiratory volume in one second (fev1) \>25% of predicted values. 5. pre-bronchodilator fev1 at visit 2 must be within 15% of fev1 at visit 1. 6. no evidence of respiratory tract infection and no pulmonary exacerbation requiring use of intravenous/oral/inhaled antibiotics, or oral corticosteroids within 2 weeks of screening. 7. the patient or the patient's legally acceptable representative must be able to give informed consent. 8. patients who are on a cycling tobi® regimen must have completed at least 2 cycles every other month tobi® administration prior to the screening visit. 9. patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks prior to visit 1 (screening). 10. patients having previously participated in study 205.339 can also be selected. exclusion criteria: 1. patients with a known hypersensitivity to study drug 2. patients who have participated in another study with an investigational drug within one month preceding the screening visit. 3. patients who are currently participating in another trial. observational studies are allowed. permission should be obtained from sponsor of other study. 4. patients with known relevant substance abuse, including alcohol or drug abuse. 5. adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening. 6. female patients of child bearing potential who are not using a medically approved form of contraception. 7. clinically significant disease or medical condition other than cf or cf-related conditions that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. patients with diabetes may participate if their disease is under good control prior to screening.
blended depression therapy: cognitive behaviour therapy face-to-face and via internet

Conditions: Major Depressive Disorders

Summary: to asses the clinical effectiveness of blended cognitive behavior therapy (cbt): face-to-face and internet-based treatment for adults with major depressive disorder (mdd) in primary care compared to treatment as usual.

the study is part of a eu-project. participants are recruited via regular routes from primary care settings. following the mini international neuropsychiatric interview (m.i.n.i.) participants will be randomly allocated to either blended treatment for 10 sessions/weeks or to treatment as usual. we will include 150 participants in total.

Eligibility criteria:
inclusion criteria: * depressive symptoms according to dsm-iv * have access to a computer with internet connection * have good knowledge of the swedish language exclusion criteria: * recent (during last 6 weeks) change in psychiatric medication * presently in any other psychological treatment * severe depression * suicidal ideation

Keywords: major depressive disorder (mdd) blended treatment cognitive behavior therapy (cbt) face-to-face internet-based treatment
montelukast and inhaled nasal steroid tx in adult obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: in children with mild apnea combined therapy with an inhaled nasal steroid and a medication that decreased nasal congestion (montelukast) was shown to be effective. we are testing to see if this combination works in adults with mild apnea as well.

40 adults with mild osa (\< 5 apneas/hypopneas per hour of sleep) will receive either a combination of two medicines that decrease nasal congestion-montelukast and nasal budesonide-or a placebo pill and nasal spray. after 3 months of therapy, a repeat sleep study will be done to determine the differences, if any, in the frequency of sleep disordered breathing in the two groups.

Eligibility criteria:
inclusion criteria: * age 18 - 100 years * rdi between 5 - 15 * all races * both sexes exclusion criteria: * craniofacial, syndromic, neurological abnormalities * current or previous use of singular, rhinocort within last 6 months * acute upper respiratory infections * recent nasal trauma, nasal surgery, nasal septum perforation * known immunodeficiency or under going immunosuppressant therapy * current therapy with drugs that interact with montelukast or budesonide

Keywords: osa medical treatment
symbicort in asthmatic children - seedling

Conditions: Asthma

Summary: the purpose of this study is to compare symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years


Eligibility criteria:
inclusion criteria: * baseline lung function tests results as determined by the protocol * required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol exclusion criteria: * has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers * has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months * has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study

Keywords: asthma symbicort budesonide/formoterol budesonide formoterol children
biomarkers of angiogenesis and disease in patients with unresectable malignant mesothelioma treated on clinical trial calgb-30107

Conditions: Malignant Mesothelioma

Summary: rationale: collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer. purpose: this laboratory study is looking at biomarkers of angiogenesis and disease in patients with unresectable malignant mesothelioma treated on clinical trial calgb-30107.

objectives: * determine if elevated levels of thrombospondin i serum levels, vascular endothelial growth factor receptor i, fibroblast growth factor, transforming growth factor, and mesothelin portend a poor prognosis in patients with unresectable malignant mesothelioma treated with vatalanib on protocol calgb-30107. * determine if elevated levels of thrombospondin i serum levels, vascular endothelial growth factor receptor i, fibroblast growth factor, transforming growth factor, and mesothelin correlate with response or stable disease in these patients. outline: serum samples previously obtained from patients on protocol calgb-30107 are tested for levels of thrombospondin i serum, vascular endothelial growth factor receptor i, fibroblast growth factor, transforming growth factor, and mesothelin using enzyme-linked immunosorbent assays (elisa). projected accrual: a total of 47 specimens will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of malignant mesothelioma * unresectable disease * must have received treatment with vatalanib on protocol calgb-30107 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: advanced malignant mesothelioma recurrent malignant mesothelioma epithelial mesothelioma sarcomatous mesothelioma