bioihbjkbjnl/mcl2 huggingface dataset:
Can Antioxidants Affect Pregnancy Rate in Patients With Expected Low Number of Egg Retrieval in IVF Cycles?
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to evaluate the effect of antioxidants on IVF outcome in infertile
      patients undergoing IVF who are expected to produce low number of eggs compared to a control
      group. The investigators assumed that the conception rate is higher in those patients taking
      some antioxidants supplementation. The patients will be given antioxidant drug one month
      before starting IVF trial once daily by mouth. Uniform protocol of stimulation will be done
      during the cycle by a type of short protocols known as the antagonist protocol. Egg retrieval
      will be done under anesthesia. pregnancy test will be done 2 weeks after embryo transfer. The
      investigators will also assess the number and quality of eggs on the day of egg pick up. In
      addition, the researchers will assess the number of first and second grade embryos that are
      put on the day of embryo transfer.
    

Detailed description: 
      The primary aim of this study is to assess the value of antioxidant intake on the pregnancy
      rate in IVF/ICSI (invitro-fertilization/intracytoplasmic sperm injection) cycles in poor
      responders. when the participants fulfill the eligibility criteria, informed consent will be
      taken. Block randomization will be done and the patients are allocated to one of two groups.
      The first group will take the antioxidant tablet daily orally for one month before the
      IVF/ICSI cycle. the other group will take placebo following the same regimen as the study
      group. Antagonist protocol will be done for all participants. Ovum pick up will be done under
      general anesthesia when one or more oocytes reaches 17 mm. The researchers will do embryo
      transfer on day 2 or 3 after ovum pickup. pregnancy test will be in blood after 2 weeks of
      embryo transfer.
    

Intervention name(s): Antioxidant Formula; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Antioxidant tablet will be taken by the patients; The placebo will be taken by the patients
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The first group will take antioxidant drug orally once daily for one month before IVF/ICSI cycle.
The second group will take placebo with a same regimen as the antioxidant group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infertility; IVF; ICSI; poor responders in IVF/ICSI cycles; antioxidant
Shiga Microalbuminuria Reduction Trial-2
Condition: Type 2 Diabetes Mellitus; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effects of a direct renin inhibitor (DRI),
      aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes
      under strict blood pressure control with angiotensin receptor blocker (ARB).
    


Intervention name(s): Aliskiren; any angiotensin receptor blockers
Intervention type(s): Drug; Drug
Intervention description(s): The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.; The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
Intervention MeSH terms: Angiotensin Receptor Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Albuminuria; Direct renin inhibitor; Angiotensin receptor blocker; Type 2 diabetes
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients
      with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3
      treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or
      c)placebo. The anticipated time on study treatment is <3 months, and the target sample size
      is <100 individuals.
    


Intervention name(s): Placebo; RG3421 120mg; RG3421 20mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): po daily; 120mg po daily; 20mg po daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
Condition: Blood Pressure
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the blood pressure lowering efficacy of a treatment
      regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II
      type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide
      diuretic combined with a beta-blocker.
    

Detailed description: 
      Primary objective:

      Sitting systolic blood pressure (average of three readings) will be the primary outcome
      variable.

      Secondary

        1. To compare the time interval between the two treatment groups, which after randomisation
           will be required, to reach and maintain the target defined as a blood pressure below 140
           mm Hg systolic and 90 mm Hg diastolic;

        2. To compare the duration of follow-up, during which a steady blood pressure control will
           be achieved;

        3. To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG
           changes in the two treatment groups;

        4. To assess the adherence to antihypertensive treatment as well as the rate of drop-outs
           in both treatment arms during a six-month period.
    

Intervention name(s): amlodipine 5/10 mg per day plus valsartan 160 mg/day; hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
Intervention type(s): Drug; Drug
Intervention description(s): Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning; hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning
Other intervention name(s): ExForge®; Lodoz®
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide; Bisoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood pressure; Hypertension; Blacks; Africa; Blood pressure control; Side-effects
Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers
Condition: Latent Tuberculosis Infection; Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI)
      when administered to healthy adult volunteers, compared to placebo; and determine its safe
      dosage range. An initial evaluation of immune responses to the vaccine compared to placebo
      will also be undertaken.

      In the present Phase I clinical trial, four increasing doses of RUTI will be tested, the
      groups composed by 6 volunteers each. (Total of 24 volunteers). The escalation to a new dose
      to test will be done after the safety of the previous dose has been ensured.

      For each dose of FCMtb to test, each volunteer will be inoculated twice (at day 0 and day 28)
      with RUTI (4 volunteers) or placebo (2 volunteers) and will be followed-up up to 25 weeks
      from the first inoculation. The global length of the study will be approximately 15 months.
    

Detailed description: 
      RUTI is a therapeutic vaccine made from virulent M.tuberculosis bacteria, grown in stressful
      conditions, fragmented, detoxified, heat inactivated (FCMtb) and liposomed. RUTI provides a
      strong humoral and cellular immune response against antigens from active growing and latent
      bacilli but also against structural antigens, as it has been proved in animal models of
      latent tuberculosis infection. The vaccine has been designed to be used against Latent
      Tuberculosis Infection as a therapeutic vaccine after 1-month of chemotheraputic treatment,
      instead the current treatment based on 6-9 months of chemotherapy.
    

Intervention name(s): RUTI; RUTI; RUTI; RUTI; placebo of the vaccine RUTI
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28; dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28; dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28; dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28; placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28
Other intervention name(s): FCMtb is the active compound of the vaccine RUTI; FCMtb is the active compound of the vaccine RUTI; FCMtb is the active compound of the vaccine RUTI; FCMtb is the active compound of the vaccine RUTI; placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LTBI (Latent tuberculosis infection); TB(Tuberculosis); Vaccine
Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      50-60% of patients with chronic hepatitis C are not cured by treatment with pegylated IFNα
      plus ribavirin.

      Retreatment of non-responders of previous (pegylated) IFNα plus ribavirin therapies with
      pegylated IFNα plus ribavirin results in a sustained response in less than 10% of the
      patients.

      Extensive analysis of IFNα signaling in cells expressing HCV proteins, in transgenic mice
      expressing HCV proteins, and in liver biopsies from patients with chronic hepatitis C point
      to STAT1 methylation as an important posttranslational modification targeted by HCV to
      inhibit IFNα signaling.

      STAT1 methylation can be increased and IFNα can be improved by adding AdoMet and betaine.

      The study is designed to test the hypothesis that a combination treatment with pegylated
      IFNα2b, ribavirin, AdoMet and betaine is superior to the current standard combination therapy
      with pegylated IFNα plus ribavirin.
    


Intervention name(s): S-adenosyl-L-methionine; betaine; pegylated interferon alpha2b; ribavirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Betaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Ivabradine on Residual Myocardial Ischemia After PCI
Condition: Angina Pectoris, Stable
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Angina Pectoris; Angina, Stable; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized pharmacological study evaluating the effects of ivabradine in patients
      with residual angina after PCI. The role of ivabradine in patients with angina, without
      systolic dysfunction, is not yet clear. The investigators performed in all patients an
      echostress to evaluate the effects of therapy with ivabradine after 30 days in terms of
      exercise tolerance and diastolic function.
    

Detailed description: 
      BACKGROUND. Residual angina after PCI is a frequently-occurring disease. Ivabradine improves
      symptoms but its role in patients without left-ventricular systolic dysfunction is still
      unclear. The aim was to quantify the effects of ivabradine in terms of MVO2 indicators and
      diastolic function.

      METHODS. 28 consecutive patients with residual angina after PCI were randomized to ivabradine
      5 mg twice/day(IG) or standard therapy(CG). All patients performed a stress echocardiography
      at the enrollment and after 30 days. Myocardial oxygen consumption was estimated from: double
      product(DP); triple product(TP) integrating DP with ejection-time(ET). Diastolic function was
      evaluated determining E and A waves, E' measurements and E/E' ratio both at rest and at the
      peak of exercise.
    

Intervention name(s): Ivabradine
Intervention type(s): Drug
Intervention description(s): Ivabradine 5 mg twice a day
Other intervention name(s): Procoralan; Corlentor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stable angina; coronary artery diseases; heart rate; exercise tolerability; diastolic function; ivabradine
Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample
Condition: Occupational-based Secondary Trauma
MeSH terms: Compassion Fatigue
Study type: Interventional

Summary: 
      This pilot study evaluates a somatic mindfulness training. Reductions in mental and physical
      health correlates of secondary trauma are assessed using a pretest-posttest design.
    


Intervention name(s): Somatic Mindfulness Training
Intervention type(s): Behavioral
Intervention description(s): Educational and experiential training to reduce occupational-based secondary trauma.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Phase 2 Safety and Efficacy Study of PRT060128, a Novel Intravenous and Oral P2Y12 Inhibitor, in Non-Urgent PCI
Condition: Percutaneous Coronary Intervention
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double-blind, triple-dummy, clopidogrel-controlled study
      of IV and oral PRT060128 compared to clopidogrel in patients undergoing non-urgent (including
      elective) PCI. After diagnostic angiography, patients scheduled for non-urgent PCI will be
      randomized to clopidogrel or to one of three dose levels of PRT060128.
    

Detailed description: 
      Each patient randomized in this trial will participate for approximately 12-24 weeks,
      including a Screening period of up to 2 weeks, the acute peri-procedural phase, and a 60-120
      day chronic treatment phase. The chronic phase includes daily in-hospital assessments until
      24 Hours or Discharge (whichever comes first), a telephone follow-up on Day 7-10
      post-Discharge, outpatient follow-up visits on Days 30 and 60-67, [Day 90 and Day 120 (if
      treated for 120 days)] and a telephone follow-up 7 days following the last dose of study
      drug.
    

Intervention name(s): clopidogrel; PRT060128
Intervention type(s): Drug; Drug
Intervention description(s): Loading dose of 300mg or 600mg, followed by once daily dosing of 75 mg; 80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg
Other intervention name(s): Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCI; percutaneous coronary intervention
Starting Pediatric Obesity Prevention in Pregnancy
Condition: Obesity; Pregnancy
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether we can use social networks to spread health
      information and health behaviors during pregnancy to prevent excessive gestational weight
      gain.
    

Detailed description: 
      The long-term goal of this research is to prevent obesity-related adverse health outcomes for
      future generations by applying information emerging from social network studies to the
      development of new population-based behavioral interventions. There are a number of critical
      periods during fetal development that appear to influence the later development of obesity.
      Interventions that prevent insult to these critical windows from occurring could improve
      children's life course trajectories. This project sets the groundwork for examining whether
      social networks could explicitly be utilized to support women in gaining weight during
      pregnancy within their clinically recommended weight gain target.
    

Intervention name(s): Social network building intervention; Home visit
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group support and 12 weekly health education/skills building sessions during pregnancy; Three home visits during pregnancy focused on providing education on infant injury prevention
Other intervention name(s): Madre Sana
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: gestational weight gain
A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to compare the pharmacokinetics (PK), safety, tolerability and
      immunogenicity of a single dose of 300 mg tralokinumab administered as a 1 × X mL
      subcutaneous (SC) injection with Device A and 2 × Y mL consecutive SC injections with Device
      B.
    

Detailed description: 
      This is a single center, randomized, open label, 2 period, 2 sequence cross over trial
      designed to compare the PK and to evaluate the safety, tolerability and immunogenicity of 300
      mg tralokinumab administered as a 1 × X mL SC injection with Device A (test treatment [T])
      and 2 × Y mL consecutive SC injections with Device B (reference treatment [R]) in healthy
      subjects. Additionally, the experience of tralokinumab being administered with Device A
      compared to Device B will be evaluated.

      After being informed about the study and the potential risks, all subjects giving written
      informed consent will be enrolled and randomized to 1 of 2 treatment sequences, Sequence TR
      or Sequence RT in a 1:1 ratio (i.e., subjects receive the 2 treatments in the specified
      order).
    

Intervention name(s): Tralokinumab administered as 1 × X mL with Device A; Tralokinumab administered as 2 × Y mL with Device B
Intervention type(s): Drug; Device
Intervention description(s): Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration; Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Exploratory PET-study of Deposition, Disposition and Brain Uptake of [11C]Nicotine After Inhalation of 2 Nicotine Formulations Via the myBluTM E-cigarette in Smokers
Condition: Healthy Volunteers
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      This is a single-center, exploratory positron emission tomography (PET) study of deposition,
      disposition and brain uptake [11C]nicotine when given to smokers as two different
      formulations via mybluTM e-cigarette system.
    


Intervention name(s): myBluTM Formulation 1; myBluTM Formulation 2
Intervention type(s): Other; Other
Intervention description(s): 1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 1, with inhalation of the vapour into the lungs; 1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Health Effects of Oats and Oat Bioactive in Human
Condition: Postprandial Glucose Regulation
Study type: Interventional

Summary: 
      Aim of the study is to investigate health effects of oats and oat derived components, in
      human intervention studies, with the purpose to build new knowledge for development of
      cardiometabolic protective foods.
    

Detailed description: 
      The overall goal is to increase the knowledge which can be used for the development of food
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices
      for people. More specifically the primary purpose of this project is to evaluate effects in
      healthy humans on cardiometabolic test markers of oat and oat based product. The new
      knowledge will form a base for the development of oat based food products with added health
      values.
    

Intervention name(s): Oat Beverage 1; Oat Beverage 2; Oat Beverage 3; Oat Beverage 4; Control product
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): Oat based beverage with added different concentration of extracted oat component.; Oat based beverage with added different concentration of extracted oat component.; Oat based beverage with added different concentration of extracted oat component.; Oat based beverage with added different concentration of extracted oat component.; Glucose based beverage without added test components is used as control product
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: a randomized blinded cross-over study
Masking: Single (Participant)
Primary purpose: Prevention
Relative Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability of fixed-dose combination tablet vs.

      mono-components of telmisartan and amlodipine
    


Intervention name(s): Telmisartan/amlodipine fixed-dose combination (FDC) tablet; Telmisartan; Amlodipine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment