bioihbjkbjnl/mcl2 huggingface dataset:
Double Blinded, Randomized, Placebo-controlled Clinical Study for Nelumbinis Semen
Condition: Stress
Study type: Interventional

Summary: 
      Nelumbinis Semen, has been widely used as treatment of post-menopause symptoms in women for
      hundreds of years in many Asian countries. This study examines whether PM011, standardized
      herbal medicine made from Nelumbinis Semen, treats stress in above 5 of BDI score of human
      subjects and discusses its potential as treatment for depressed patients.
    

Detailed description: 
      Nelumbinis Semen, has been widely used as treatment of post-menopause symptoms in women for
      hundreds of years in many Asian countries. This study examines whether PM011, standardized
      herbal medicine made from Nelumbinis Semen, treats stress in above 5 of BDI score of human
      subjects and discusses its potential as treatment for depressed patients. Subjects were
      divided into three groups, the placebo-treated group (n = 10), the PM011-2.4 g treated group
      (n = 11) and PM011-4.8 g treated group (n = 11) per day. Alpha/Beta ratio of
      electroencephalogram (EGG), Beck Depression Inventory (BDI) and Stress Response Inventory
      (SRI) were conducted in order to measure changes in stress before and after 2 weeks of PM011
      treatment.
    

Intervention name(s): PM011
Intervention type(s): Dietary Supplement
Intervention description(s): PM011 is a 400 mg hard gelatin capsule containing water extracts of Nelumbinis Semen. The sprayed-dry extract of the herbal medicine used was purchased from Sun Ten pharmaceutical company in Taiwan. Each participant received twelve capsules of PM011, which divided into 2.4 g treatment or 4.8 g treatment group or placebo daily for two weeks and was instructed to take six capsules after breakfast and six capsules after dinner. Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule.
Other intervention name(s): Nelumbinis Semen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, randomized, placebo-controlled clinical study for evaluating anti-stress effects of Nelumbinis Semen
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Coffee and In-vivo Oxidative Stress
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Food and beverage intake that leads to a decrease in the level of in vivo markers of
      oxidative stress indicates that such foods and beverages act as antioxidants (AOX) in humans.
      Coffee drinking at a high level (> 900 ml/day) for a short period of time (1 week) has been
      shown to reduce DNA oxidative damage-as indicated by a decrease in the level of percent tail
      DNA (%T)- in study populations comprised mainly of young adults aged < 30 years. It is not
      clear whether such findings remain present over a longer period of time, and to extend such
      findings across a population that is more representative of European adults who consume
      common daily intakes of coffee, which is a low-to-moderate daily intake level (< 750 ml/day).
      As such, the investigators propose to determine the effect of drinking 3 and 5 cups of coffee
      per day (equivalent to 450 and 750 ml per day, respectively) for 8-weeks on markers of in
      vivo oxidative stress relative to control in a population of healthy adults free of chronic
      diseases aged 35 to 65 years. To ensure that overall health is considered, the investigators
      will also evaluate the effect on markers of cardiovascular health, inflammation, and glycemic
      control.
    

Detailed description: 
      Objective: The main objective of the present study is to determine the short- and mid-term
      effects of a coffee, on oxidative stress parameters in humans.

      Study design: randomized, placebo-controlled, investigator-blinded, 3-arm parallel Study
      population: 168 apparently healthy volunteers: males and females aged >=35 and <= 65 years.

      Intervention: The treatments consist of daily consumption of either:

      Treatment 1: 0.45 L coffee (3 cups) and 0.30 L bottled water daily or; Treatment 2: 0.75 L
      coffee (5 cups) daily or; Treatment 3: 0.75 L water daily Duration of the treatment
      intervention is 8 weeks. Before the intervention period starts, a run-in period of five weeks
      where all subjects maintain their low antioxidant diet (Dutch average) is conducted by all
      subjects in order to standardize the antioxidant intake of the subjects.

      Main study parameters/endpoints: Mean level of %T as a measure of DNA oxidative damage at
      week 8. Secondary outcome is the mean level of 8-isoprostane in 24 hr urine.
    

Intervention name(s): Coffee consumption
Intervention type(s): Dietary Supplement
Intervention description(s): 3 or 5 cups of coffee daily for eight weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: oxidative stress; Comet assay; antioxidants
D-chiro-inositol Increases Androgens and Reduces Estrogens in Human Serum
Condition: Low Serum Testosterone Levels in Man
Study type: Interventional

Summary: 
      The aim of this pilot study is to test the effect of a 30 day-D-chiro-inositol oral treatment
      on a set of clinical parameters (mainly sex hormones) in a group of male volunteers selected
      by their age and BMI to investigate if D-chiro-inositol acts as an aromatase inhibitor.
    

Detailed description: 
      This is an open label clinical trial with a dietary supplement carried out in male volunteers
      selected by their age and BMI. The aim is to test the effect of oral daily treatment with 1 g
      D-chiro-inositol for 30 days on some clinical parameters, to see if D-chiro-inositol acts as
      an aromatase inhibitor. Testosterone, estradiol, Testosterone/Estradiol ratio,
      Dehydroepiandrosterone sulfate, Estrone, glycemia and insulinemia (with calculation of HOMA
      index), follicle-stimulating hormone, Luteinizing hormone, D-chiro-inositol and Myo-inositol
      serum concentrations have to be determined before and after D-chiro-inositol administration.

      We wish to evaluate if this treatment for one month is able to change the sexual hormone
      levels, increasing androgens and decreasing estrogens. Furthermore, we wish to control the
      safety profile of D-chiro-inositol, a well-known molecule, different from the classic
      aromatase inhibitors. We think that our pilot study can open up new perspectives of research
      and therapeutic applications for this many-sided molecule.
    

Intervention name(s): D-chiro-inositol
Intervention type(s): Dietary Supplement
Intervention description(s): as described previously
Intervention MeSH terms: Inositol
Intervention model: Single Group Assignment
Intervention model description: Ten male volunteers are treated daily with 1 g D-chiro-inositol for 30 days (2 capsules containing 500 mg each, twice a day). The serum levels of the detected parameters at the end of treatment are compared to the values found in the volunteers at the baseline, used as controls. Parameters under analysis: Testosterone/Estradiol ratio, Testosterone, dehydroepiandrosterone, estradiol, estrone, glycemia and insulinemia with Homeostatic Model Assessment for Insulin Resistance (HOMA) index, follicle stimulating hormone, luteinizing hormone, D-chiro-inositol and myo-inositol.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Testosterone; DHEAS; Estradiol; Estrone; HOMA index; D-chiro-inositol
Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)
Condition: Systemic Lupus Erythematosus; Atherosclerosis
MeSH terms: Atherosclerosis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 4

Summary: 
      Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis.
      Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow
      mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD
      in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug
      mycophenolate mofetil (MMF).
    


Intervention name(s): Mycophenolate mofetil; sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.; Arm 2 patients were given 2 sugar pills bd for 8 weeks
Other intervention name(s): Cellcept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SLE; Atherosclerosis; Endothelial function; Mycophenolate mofetil
Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses
Condition: Inflammation; Obesity
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the
      negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation
      responses. Half of the participants will receive a high polyunsaturated fat diet )50%
      carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty
      acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the
      other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50%
      carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated
      fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total
      energy will be saturated fatty acids.) for 7 days.
    

Detailed description: 
      Eating more saturated fats has been shown to decrease how many calories an individual burns
      and increase chronic disease risk by increasing inflammation, coagulation (blood clotting)
      potential, blood pressure, and cholesterol. Conversely, eating more poly-unsaturated fats has
      been linked to decreased risk of chronic diseases. The goal of this study is to determine
      whether or not eating a diet containing a lot of poly-unsaturated fats can compensate for the
      damaging effects of eating occasional high-fat meals that are high in saturated fats. Those
      damaging effects we are interested in studying include how much fat and calories a person's
      body burns, and measuring some markers of chronic disease risk in the blood (inflammation
      markers and blood clotting markers).
    

Intervention name(s): PUFA Diet; Control Diet
Intervention type(s): Other; Other
Intervention description(s): The 7-day diet will consist of 50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids.; The 7-day diet will consist of 50% carbohydrate, 35% fat, and 15% protein. Furthermore, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of a Couple-Focused mHealth Symptom Self-management Program
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      In this study, the investigators propose to test the efficacy of a couple-focused, web-based
      tailored prostate cancer symptom management program, Prostate Cancer Education and Resources
      for Couples (PERC) in a randomized clinical trial. A two-group (PERC versus National Cancer
      Institute (NCI) website plus treatment as usual) randomized controlled design will be used,
      and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 300
      patients completing initial treatment for localized prostate cancer and their intimate
      partners (i.e., 600 participants in total).
    

Detailed description: 
      This randomized clinical trial aims to test the efficacy of a couple-focused, web-based
      tailored prostate cancer symptom management program, Prostate Cancer Education and Resources
      for Couples (PERC). The study participants will include 300 patients completing initial
      treatment for localized prostate cancer and their intimate partners (i.e., 300 dyads and 600
      individuals). After informed consent, we will conduct baseline assessment (T1), randomly
      assign eligible participants to either PERC or the National Cancer Institute (NCI) website,
      and then collect data at 4 (T2), 8 (T3), and 12 months (T4) post-T1.
    

Intervention name(s): Prostate Cancer Education and Resources for Couples (PERC); usual care plus NCI website
Intervention type(s): Behavioral; Behavioral
Intervention description(s): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.; The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: symptom; family research; self-management; caregiving; social support; mHealth; healthy behavior; self-efficacy; quality of life; care transition
The EMERGE Project: Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Messages in Young Adults
Condition: Feasibility
Study type: Interventional

Summary: 
      As part of the development of the Engaging Microenterprise for Resource Generation and Health
      Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the
      feasibility of assessing economic and sexual risk behaviors using text messages. The team
      will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless,
      out-of-school, and un/under-employed. Participants will complete a text-messaged survey each
      week for 5 weeks. The study team will collect information about the number of participants
      who respond to the weekly survey, the number of questions to which they respond in each
      survey, and the number of hours from sending a survey to participants to receiving their
      response. As an exploratory aim, participants will also receive 3 informational text messages
      each week for 5 weeks on HIV prevention and economic empowerment. The study team will obtain
      qualitative feedback from participants regarding text messages they most and least liked. The
      survey is not designed to evaluate the effectiveness of the text message intervention.
    

Detailed description: 
      As part of the development of the Engaging Microenterprise for Resource Generation and Health
      Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the
      feasibility of assessing economic and sexual risk behaviors using text messages. The study
      team will enroll approximately 20 young adults, aged 18 to 24, who are African-American,
      homeless, out-of-school, and un/under-employed. Participants will complete a text-messaged
      survey each week for 5 weeks. The study team will collect information about the number of
      participants who respond to the weekly survey, the number of questions to which they respond
      in each survey, and the number of hours from sending a survey to participants to receiving
      their response. As an exploratory aim, participants will also receive 3 informational text
      messages each week for 5 weeks on HIV prevention and economic empowerment. The study team
      will obtain qualitative feedback from participants regarding text messages they most and
      least liked. The survey is not designed to evaluate the effectiveness of the text message
      intervention. The single-group study is anticipated to start in August 2017.
    

Intervention name(s): Text-message survey and informational text messages
Intervention type(s): Behavioral
Intervention description(s): Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this randomized, single-blind trial is to evaluate the effectiveness and
      tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation
      (rTMS) in patients with resistant bipolar depression. Patients will be assigned to receive
      either high or low frequency rTMS for 20 consecutive workdays (4 weeks). 10 Hz (high)
      frequency rTMS and 1 Hz (low) frequency rTMS will be given over the left or right
      dorsolateral prefrontal cortex (DLPFC), respectively. Patients will be assessed with several
      psychometric instruments at baseline, and at weeks 5 and 9.
    


Intervention name(s): Magstim Rapid2 Stimulator; Magstim Rapid2 Stimulator
Intervention type(s): Device; Device
Intervention description(s): 1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.; 10 Hz in 75 trains of 4-seconds duration, with 26-seconds intertrain intervals (3,000 pulses per session) at 120% of the rMT.
Other intervention name(s): 1 Hz rTMS; 10 Hz rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Repetitive transcranial magnetic stimulation; Bipolar depression; Randomized trial; rTMS; Neuromodulation
CP-690,550 Thorough QTc Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine
      whether intensive monitoring of QT interval in target patient populations is required during
      later stages of development. The current study is designed to ascertain whether CP-690,550 is
      associated with QTc prolongation.
    

Detailed description: 
      The current study is designed to ascertain whether CP-690,550 is associated with QTc
      prolongation
    

Intervention name(s): CP-690,550; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose 100 mg (5 x 20 mg tablets); Single dose placebo tablets (5 tablets); Single dose Avelox 400 mg tablet
Intervention MeSH terms: Moxifloxacin; Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: TQT study; CP-690; 550
Antidiabetic Effects of Adding a DPP-4 Inhibitor to Pre-Existing Treatment With an Incretin Mimetic in Patients With T2D
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Objectives: To quantify differences in control of glycemia (primary objective) and the
      secretion of endogenous incretin hormones (secondary objective) comparing sitagliptin or
      placebo added to pre-existing therapy with liraglutide and metformin
    

Detailed description: 
      This is a double blind, controlled, cross-over comparison of adding sitagliptin (or placebo)
      to pre-existing metformin+liraglutide therapy. Patients with type 2 diabetes mellitus (T2DM)
      on pre-existing treatment with metformin (≥ 1500 mg/d) monotherapy or metformin plus
      liraglutide (1.2 mg/d) will be studied. Patients on metformin monotherapy will, after
      screening and randomization, enter a run-in period of 2 weeks with the additional treatment
      of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week). At the end of
      this 2 weeks therapy, a mixed meal challenge will take place, with the assessment of glucose
      and hormone responses (insulin, C-peptide, glucagon, GLP-1 [glucagon-like peptide-1], GIP
      (gastric inhibitory peptide) and gastric emptying as measured by 13C (carbon 13)-octanoate
      breath tests. Prior to the meal tests, liraglutide will be administered at a dose of 1.2 mg
      per injection, which is the recommended dose for treatment. Sitagliptin will be used at a
      dose of 100 mg, which is recommended for clinical use.
    

Intervention name(s): Placebo; Mixed meal test; Liraglutide; Sitagliptin
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): Patients administered a single dose of placebo during a mixed meal challenge.; Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored; Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.; Patients administered a single dose of Sitagliptin during a mixed meal challenge.
Other intervention name(s): Victoza
Intervention MeSH terms: Sitagliptin Phosphate; Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Incretin, DPP-4 inhibitor