bioihbjkbjnl/mcl2 huggingface dataset:
Impact of tDCS on Emotional Processing in Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Background: transcranial direct current stimulation (tDCS) is an innovative treatment for
      major depression. However, its mechanisms of action are still unclear. Major depression is
      characterized by impaired processing of emotional information, which returns back to normal
      after successful antidepressant treatment. In this randomized double-blind study, the
      investigators aim to assess the effect of tDCS on emotional processing in major depression.
    

Detailed description: 
      Methods: 40 subjects with major depression (20 active treatment and 20 placebo) will receive
      ten 30-minutes sessions of active two milliamps or sham tDCS (anode over left dorsolateral
      prefrontal cortex and cathode over right dorsolateral prefrontal cortex), twice a day for 5
      consecutive days. Psychometric assessment of depression (MADRS,Beck Depression Inventory ,
      CGI) and a neuropsychological assessment will be conducted before and after the treatment.

      A facial emotion recognition task and an attentional emotional task with measurement of
      eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before
      and after the first session, and after the last session.

      The investigators hypothesize that active tDCS will improve emotional processing in major
      depression, and that this will be observed after 1 and 10 sessions of tDCS.

      Conclusions: Studying the impact of transcranial direct current stimulation on emotional
      processing in major depression could allow to better understand its antidepressant mechanisms
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Subjects will receive 10 30-minutes sessions of two milliamps transcranial direct current stimulation , twice a day for 5 consecutive day.
Facial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; neuromodulation; depression; cognition
Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.
Condition: Smoking
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study's aim is to develop a clinical model that can be used to measure the nicotine
      delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that
      are marketed as a means to deliver nicotine to cigarette smokers. The study will compare the
      nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two
      devices currently marketed in the U.S.: Crown Seven and NJOY. Specifically, the effects of
      these devices will be compared with the effects of own brand cigarettes (positive control),
      and an abstinence condition (sham smoking; puffing from an unlit cigarette). The primary
      hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of
      electronic devices marketed as a means to deliver nicotine to smokers can be measured during
      a period of acute exposure.
    

Detailed description: 
      Potential reduced exposure products (PREPs) are being developed and marketed by the tobacco
      industry in an attempt to reduce some of the risks involved in tobacco use (see Breland et
      al., 2002b). Evaluating the effects of these products is crucial to public health, as past
      industry-sponsored efforts at harm reduction (e.g., so-called "light" and "ultra-light"
      cigarettes) were not evaluated and failed to reduce carbon monoxide (CO), nicotine, and
      carcinogen exposure in smokers; these efforts thus failed to reduce the harms of smoking
      (Stratton et al., 2001). This study is part of an on-going, NIH-funded program of research to
      develop a science-based model that uses outcome measures relevant to evaluating current
      tobacco industry-sponsored smoking harm reduction efforts systematically and efficiently.
    

Intervention name(s): OB; Sham smoking; CROWN SEVEN; NJOY
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval); 10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval); 10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval); 10 puffs from a so-called "electronic cigarette" named NJOY(16 mg cartridge; 30 second inter puff interval)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: tobacco; cigarette; nicotine
Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the long-term efficacy and safety of vortioxetine,
      once daily (QD), in adults with major depressive disorder.
    

Detailed description: 
      The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested
      to treat depression in people who have major depressive disorder (MDD). This study looked at
      MDD relief in people who took vortioxetine.

      The study enrolled 836 patients that had completed one of two other vortioxetine studies.
      Participants received 5 mg of vortioxetine for the first week of treatment. After completing
      the first week of treatment, the dose could be increased to 10 mg/day or decreased to 2.5
      mg/day based on participant's response as judged by the doctor.

      All participants were asked to take one encapsulated tablet at the same time each day
      throughout the study.

      This multi-center trial was conducted worldwide. The overall time to participate in this
      study was up to 56 weeks. Participants made 13 visits to the clinic, and were contacted by
      telephone 4 weeks after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Encapsulated vortioxetine immediate-release tablets
Other intervention name(s): Lu AA21004; Brintellix®
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Melancholia; Mood Disorder; Dysthymic Disorder; Drug Therapy
Assessment of Pelvic Floor Function in Elderly
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate the importance of functional assessment of the
      pelvic floor (AFA) in older women, as prognostic factor for Urinary Incontinence (UI).
    

Detailed description: 
      Incontinence elderly assessment
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        elderly women
      
Biospecimen description: 
      Women
    
Keywords: Urinary incontinence; pelvic floor; functional evaluation
Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients
Condition: Drug Metabolism During Pregnancy
Study type: Observational

Summary: 
      This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women
      to that of non-pregnant women; the placental transfer over time; and the subsequent
      metabolism of the transferred drug(s) in the neonate.
    

Detailed description: 
      Pregnant women who present to Labor and Delivery will be identified as potential participants
      based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin
      therapy. The additional group of 20 non-pregnant women will also be identified based on
      Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy.

      Once identified, interested candidates will be fully informed of the study procedures, have
      all questions answered, and informed consent obtained.

      Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4
      hrs until delivery; or Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24
      hrs. Dose times will be recorded.

      Non-pregnant participants will receive similar doses of either Ampicillin and/or Gentamicin,
      if not the same dose(s).

      Fingerstick blood collection will be drawn from both populations at the following timepoints:

        -  before the administration of Ampicillin, and/or

        -  before the administration of Gentamicin

        -  after the full initial dose of the antibiotic has infused, at 5 min, 15 min, 30 min,
           2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY (a 5 minute
           window for each timepoint will be permitted) If delivery occurs prior to the 3 or 6 hr
           timepoints, fingerstick blood collection should continue

      Samples will be obtained on filter paper via the Dry Blood Spot (DBS) method, which is
      clinically appropriate for the purposes of this study.

      Umbilical venous and arterial blood will also be drawn for sampling from the placenta after
      delivery, and cutting of the umbilical cord.
    

Intervention name(s): Ampicillin; Ampicillin and Gentamicin; Gentamicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery for Group B Strep prophylaxis; non-pregnant participants will receive Ampicillin for qualifying diagnosis; Pregnant participants will receive Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs for chorioamnionitis; non-pregnant participants will receive for qualifying diagnosis; Prescribed to non-pregnant participants
Intervention MeSH terms: Gentamicins; Ampicillin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women receiving ampicillin or gentamicin
      
Keywords: Pharmacokinetics (PK); Pharmacodynamics (PD)
The Impact of Steviol Glycosides on Human Gut Microflora Profile and Function
Condition: Healthy; Human Gut Microflora
Study type: Interventional

Summary: 
      Diet and dietary ingredients can have a profound effect on gut microflora, both positive and
      negative. The reported effects on low and non caloric sweeteners (LNCS) on human gut
      microflora are contradictory in some of the in vitro and rodent studies. More specifically,
      the latter studies, using doses above the acceptable daily intake (ADI), suggest that LNCS
      may have adverse effects on gut microflora whereas recent data from human RCTs, using doses
      at or below the ADI, show little to no effect. In this study we will compare the effects of a
      low energy beverage made with steviol glycosides vs. a beverage made with sucrose on human
      gut microflora profile and function in a double blind, randomized study. A sucrose beverage
      was chosen as a control as it represents a caloric sugar sweetened beverage which is commonly
      consumed.
    

Detailed description: 
      This is a double blind randomized parallel study with 2 treatments to understand the effects
      of a low energy steviol glycoside beverage vs. a sucrose sweetened beverage on gut microflora
      profile and function over 28 days.

      Participants will have a daily exposure to each test product for 28 days. (1) steviol
      glycosides (flavored water, steviol glycosides) and (2) sucrose (flavored water, sucrose).
      Individuals will be supplied with fecal collection kits to collect stool samples. The
      volunteers will be advised to collect a fecal sample before week 0(baseline), week 4(study
      end) and week 8(follow up period). Fecal microbial alpha diversity, beta diversity, and
      abundance of microbial taxa between the steviol glycoside and sucrose beverage consuming
      groups will be evaluated as well as fecal SCFA concentration, fasting serum insulin, glucose
      and lipids, weight, BMI, pulse and blood pressure at weeks 0(baseline),4(study end) and
      8(follow up).
    

Intervention name(s): Sucrose; Steviol Glycosides
Intervention type(s): Other; Other
Intervention description(s): Sucrose Beverage; Steviol Glycoside Beverage
Other intervention name(s): Sugar; Stevia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Steviol glycosides; gut microflora
Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol
Condition: Hypertension; Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are
      thought to be the possible mechanisms, inducing a generalized vasculopathy associated with
      microalbuminuria and vascular events in type II diabetic hypertensive patients
    


Intervention name(s): Irbesartan
Intervention type(s): Drug
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microalbuminaria in hypertensive patients with type II diabetes mellitus
Minus Anthracycline or Short-Term Versus Epirubicin and Cyclophosphamide Followed by Paclitaxel Regimen for Adjuvant Breast Cancer Therapy
Condition: Primary Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      We aimed to evaluate the noninferiority of short-term anthracycline-free chemotherapy (TC,
      six cycles of docetaxel and cyclophosphamide) or short-term anthracycline-based chemotherapy
      (CEF-T, three cycles of cyclophosphamide/epirubicin/fluorouracil followed by three cycles of
      docetaxel) to a standard anthracycline/taxane-containing chemotherapy (EC-P, epirubicin, and
      cyclophosphamide for four cycles followed by paclitaxel for twelve weeks) in HER2-negative
      operable breast cancer.
    

Detailed description: 
      It was initiated as an adjuvant chemotherapy trial to test noninferiority of an
      anthracycline-free short-term regimen (T75C600 x 6 [TC] once every 3 weeks) or a short-term
      regimen (C500E100F500 x 3 once every 3 weeks followed by T100 x 3 every 3 weeks [CEF-T])
      compared with a standard long-term anthracycline-containing regimen (E90C600 x 4 once every 3
      weeks followed by P80 x 12 once every week [EC-P]) in HER2-negative breast cancer. Patients
      were randomly assigned (1:1:1) to each arm after completing the surgical excision of the
      primary tumor.
    

Intervention name(s): Docetaxel Cyclophosphamide; Cyclophosphamide Fluorouracil Epirubicin Docetaxel; Epirubicin Cyclophosphamide Paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Docetaxel 75 mg/m² D1 Cyclophosphamide 600 mg/m² D1
1 cycle = 21 days
TC*6; 1st -3rd Cycle: Fluorouracil 500 mg/m² D1 Epirubicin 100 mg/m² D1 Cyclophosphamide 500 mg/m² D1
1 cycle = 21 days
4th-6th Cycle: Docetaxel 100mg/m² D1
1 cycle = 21 days CEF*3-T*3; 1st-4th Cycle: Epirubicin 90 mg/m² D1 Cyclophosphamide 600 mg/m² D1
1 cycle = 21 days
5th-8th Cycle: Paclitaxel 80mg/m² D1, 8, 15
1 cycle = 21 days EC*4-P*4
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Luminal A; Luminal B; TNBC; DFS; DDFS; OS
Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes
Condition: Anxiety Disorders; Child Developmental Disorders, Pervasive
MeSH terms: Down Syndrome; Anxiety Disorders; Developmental Disabilities; Autism Spectrum Disorder
Study type: Observational

Summary: 
      By testing physiological responses to anxiety in people with nervous system developmental
      disorders, this study will identify specific physiological characteristics associated with
      response to anxiety treatments.
    

Detailed description: 
      Anxiety is a common and significant problem for people suffering from disorders of nervous
      system development, including fragile X syndrome. There are few validated treatments for
      anxiety in people with these disorders, in part because the biological basis of anxiety in
      neurodevelopmental disorders has not been clearly described. This study will evaluate the
      physiological responses of people with fragile X syndrome, Down syndrome, and the fragile X
      premutation (a mild version of the genes that cause fragile X syndrome) to a variety of
      sensory, emotional, and social stimuli. By analyzing the data collected for this study,
      researchers aim to identify physiological characteristics linked to subgroups within the
      disorders, demonstrate links between physiological responses and behavioral or psychiatric
      symptoms, and measure physiological changes in people receiving treatment for their
      disorders.

      Participation in this study will include one testing session, which will take between 3 and
      3.5 hours. Participants who receive treatment for their anxiety may be asked to complete this
      testing a second time, after their treatment. During the testing session, sensors will be
      placed on participants' skin in several locations to measure heart rate, sweat response, and
      eye-blinks. Participants will then be asked to respond to multiple stimuli: sounds, lights,
      smells, pictures that elicit different types of emotions, an interaction with an unfamiliar
      person, and specialized toys. In addition, participants will undergo blood testing and have
      several samples of their saliva collected on the day of the testing session. Participants
      will also be asked to collect additional saliva samples at home three times a day on 4
      different days. Child participants and their parents may also be asked to complete
      questionnaires and interviews about behavioral and emotional problems.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals with fragile X syndrome, Down syndrome, the fragile X premutation, and normal
        development
      
Biospecimen description: 
      Saliva samples collected at four time periods
    
Keywords: Fragile X Premutation; Fragile X Syndrome; Down Syndrome
Efficacy of Whole Extract of Licorice in Neurological Improvement of Patients After Acute Ischemic Stroke
Condition: Acute Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Stroke is one of the most important causes of mortality and disability both in developed and
      developing countries. The only food and drug administration (FDA) approved therapy for acute
      stroke is recombinant tissue plasminogen activator (rtPA). But narrow therapeutic window has
      limited the usefulness of thrombolytic therapy. Therefore, finding effective neuroprotective
      drugs for the patients for whom thrombolysis is contraindicated or not feasible seemed to be
      mandatory in the world of cerebrovascular medicine.

      Licorice, extracted from root of a plant scientifically known as Glycyrrhiza glabra, is used
      in food industries. Certain medical properties has been contributed to licorice and
      specifically to its active chemical components such as flavonoids and glycyrrhizic acid (GA).
      GA has been revealed to assert its anti-inflammatory effect by suppression of NF-κB, a key
      component of lipopolysaccharide-induced inflammatory response. Neuroprotective
      characteristics of GA has been widely investigated in recent studies.

      In the present study, the investigators verified the efficacy and safety of oral
      administration of two different doses licorice extract in the patients with acute ischemic
      stroke, in a double-blind randomized controlled trial.
    


Intervention name(s): Licorice whole extract; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack:
Starch-filled capsules (as placebo)
450 mg whole licorice extract capsules
900 mg whole licorice extract capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Licorice; Glycyrrhizic acid; Ischemic Stroke; Acute
A Study of Apatinib in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor
      receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests.
      Phase I study has shown that the drug's toxicity is manageable and the maximum tolerable
      daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve
      progression free survival compared with placebo in patients with advanced non-squamous and
      non-small cell lung cancer who failed two lines of chemotherapy.
    


Intervention name(s): apatinib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Apatinib 750 mg p.o. once daily; placebo p.o. once daily
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSCLC; apatinib; phase II; lung; cancer
Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to
      determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen
    

Detailed description: 
      A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with
      histological stage IV colorectal cancer given irinotecan, leucovorin plus fluorouracil. The
      usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the
      disease-free survival rate (DFR), median survival time (MST), incidence and severity of
      adverse event.
    

Intervention name(s): irinotecan; leucovorin; fluorouracil
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irinotecan, leucovorin, fluorouracil, PhaseI/II, colorectal cancer,