bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating Effects of a Left Bundle Branch Block
Condition: Mechanical Dyssynchrony; Heart Failure; Bundle-Branch Block
MeSH terms: Bundle-Branch Block; Heart Block
Study type: Observational

Summary: 
      A left bundle branch block (LBBB) is related to abnormal cardiac conduction and mechanical
      asynchrony and is associated with hypertension and coronary artery disease. Improved
      evaluation of left ventricular (LV) mechanical asynchrony is needed, because of the
      increasing number of patients with a LBBB and heart failure. A variety of patterns of
      mechanical activation can be observed in LBBB patients.

      Novel imaging modalities such as tissue Doppler imaging, real-time 3D echocardiography and
      cardiovascular magnetic resonance imaging provide information about regional and global LV
      function in healthy subjects, patients without a LBBB with heart failure, patients with a
      LBBB without heart failure, and patients with a LBBB with heart failure.

      The investigators want to evaluate the different patient groups with the novel imaging
      modalities and they want to compare the novel imaging modalities with each other.

      The investigators hypothesized that, between the groups, differences concerning regional and
      global LV function are measurable.

      Each novel imaging technique has its own advantages and limitations but are comparable in
      measuring regional and global LV function.
    

Detailed description: 
      Within a time period of 3 years we evaluate different groups of patients and measure regional
      and global cardiac function.

      Therefore, we developed an echocardiography screening-protocol in which we use conventional
      2D echocardiography and conventional Doppler echocardiography, extended with tissue Doppler
      imaging and real-time 3D echo acquisitions.

      In a limited group of patients we perform a specially designed cardiovascular magnetic
      resonance imaging protocol which uses artificially induced grid-lines to evaluate regional
      and global cardiac function.

      Patients are referred to our hospital because of evaluation of their LBBB and or heart
      failure. We ask them if they would like to undergo the echocardiography and the
      cardiovascular magnetic resonance imaging.

      After a year we want to repeat the measurements in a small group of the patients to
      re-evaluate regional and global cardiac function.

      All patients should have a sinus rhythm and adequate acoustic windows. Patients should not
      have contraindications for cardiovascular magnetic resonance imaging.
    

Time perspective: Prospective
Keywords: Left Bundle Branch Block; Regional cardiac function; Global cardiac function; Mechanical asynchrony; Echocardiography; 2D echocardiography; Tissue Doppler Imaging; Real-time 3D echocardiography; Cardiovascular Magnetic Resonance Imaging-tagging
Novel Laboratory Methods in Nutrition Studies
Condition: Healthy
Study type: Interventional

Summary: 
      This prospective, nonrandomized, feasibility study will compare laboratory measures at the
      beginning and end of the study period in adults consuming a nutritional study product.
    


Intervention name(s): Nutrition Products
Intervention type(s): Other
Intervention description(s): a sachet containing AN777and amino acids; a carotenoid capsule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Novel laboratory methods
MIcrodoses of raNIbizumab in Diabetic MAcular Edema (MINIMA-2)
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to investigate if the drug ranibizumab administrated by
      microdose injection into the eye is safe and effective to treat diabetic macular edema.
    

Detailed description: 
      The MINIMA-2 Study is a multi-center clinical trial that initiated in order to investigate
      the effect of microdoses of ranibizumab in diabetic macular edema. The duration of the study
      is up to 13 months. Patients with diabetic macular edema will be randomized into 2 different
      groups. Consented subjects will receive monthly injections over a 6-month treatment period,
      and a 6 month follow-up and treatment period. Several eye examinations and procedures will be
      performed to evaluate response to the treatment. These include best corrected visual acuity
      testing (ETDRS), contrast sensitivity testing, ophthalmic examination, fluorescein
      angiography (FA)and macular thickness measurements based on optical coherence tomography
      (OCT). Serum chemistry, hematology and glycosylated hemoglobin HbA1c testing, urinalysis and
      pregnancy testing will be performed at screening visit (Days -14 to 0) and two more times
      during the study.

      Approximately 72 patients with a baseline central foveal thickness by OCT of at least 270
      will be included. The BCVA must be worst than 20/40 but better than or equal to 20/320 due
      diabetic macular edema.
    

Intervention name(s): Ranibizumab 0.05mg; Ranibizumab 0.5mg
Intervention type(s): Drug; Drug
Intervention description(s): Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria); Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetic macular edema; Ranibizumab
Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)
Condition: Mucopolysaccharidosis II
MeSH terms: Mucopolysaccharidosis II; Mucopolysaccharidoses
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether the administration of iduronate-2-sulfatase
      enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients
      with MPS II.
    

Detailed description: 
      MPS II is a rare, X-linked, lysosomal storage disorder caused by a deficiency in the enzyme
      iduronate-2-sulfatase. Because of this deficiency, glycosaminoglycans (GAG) accumulate in
      multiple tissues and organs, resulting in progressive cellular and organ system dysfunction.
      The purpose of this study is to determine if one year of therapy with iduronate-2-sulfatase
      enzyme replacement therapy, at a dose of 0.5mg/kg, weekly or every other week, is safe, and
      results in clinically meaningful improvement in multiple organ function, compared with a
      placebo group. Upon completion of the study, patients will be eligible to enroll in an
      open-label maintenance study.
    

Intervention name(s): Iduronate-2-sulfatase enzyme replacement therapy; iduronate-2-sulfatase enzyme replacement therapy; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Patients will receive weekly infusions of idursulfase at a dose of 0.5 mg/kg.; Patients will receive every other week infusions of idursulfase at a dose of 0.5 mg/kg.; Patients will receive weekly infusions of placebo.
Other intervention name(s): Elaprase; Elaprase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mucopolysaccharidosis II; MPS II; Hunter Syndrome; iduronate-2-sulfatase; I2S; Iduronate-2-sulfatase deficiency
Project CHOICES Efficacy Study
Condition: Risk for an Alcohol-Exposed Pregnancy; Hazardous Alcohol Use; Risk for Unintended Pregnancy
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      Project CHOICES Efficacy Study is a randomized controlled trial (RCT) designed to evaluate
      the clinical efficacy of a brief motivational intervention aimed at reducing alcohol-exposed
      pregnancies(AEP)in high-risk preconceptional women. The study is a multi-site collaborative
      study between the CDC and three universities. The hypothesis of the study is that a greater
      proportion of women will reduce thier risk of having an alcohol-exposed pregnancy after
      participating in the Information Plus Counseling (IPC) intervention than do those in the
      Information Only(IO) control group.
    

Detailed description: 
      Women at high risk for an AEP are define as sexually active, fertile women who are drinking
      more than 7 drinks per week and/or 5 or more drinks on any one day, and are noy using
      effective measures to prevent pregnancy. Participants will be recruited from community-based
      setting previously shown to have increased proportions of women at risk for AEP. Women in the
      intervention group (IPC) will receive 4 counselling sessions that include personal feedback
      on AEP risk behaviors drawn from baseline information,consequences of alcohol use in
      pregnancy, assessing readiness to change risk behaviors, pros and cons of risk drinking and
      unprotected intercourse, goal setting to reduce risk behaviors, and a consultation visit with
      a family planning provider to discuss appropriate choices for pregnancy prevention based on
      clinical assessment. Clients are counseled that there are two routes to reducing AEP risk,
      alcohol reduction or pregnancy prevention, with the ideal being both. Women in the control
      group (IO) will receive an informational brochure that addresses healthy lifestyle behaviors,
      including alcohol use, and a list of referral sources for health care treatment and alcohol
      abuse treatment. Both groups will be assessed at baseline using a full battery of measures
      that include alcohol and contraceptive use with follow-up measures at 3, 6, and 9 months
      after baseline.
    

Intervention name(s): Brief Motivational Counseling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Alcohol-Exposed Pregnancy; Binge drinking; Frequent drinking; Unintended pregnancy; Fetal Alcohol Syndrome
A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171
Condition: Respiratory Syncytial Virus Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of the study is to investigate the safety and tolerability of ALX-0171.

      The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the
      pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.
    


Intervention name(s): ALX-0171; Placebo
Intervention type(s): Biological; Other
Intervention MeSH terms: Gontivimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability of BI 1356 With and Without Co-administration of Pioglitazone and the Bioavailability of Pioglitazone With and Without Coadministration of BI 1356 in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the bioavailability of BI 1356 with and without co-administration of
      pioglitazone and the bioavailability of pioglitazone with and without coadministration of BI
      1356
    


Intervention name(s): BI 1356; BI 1356 + Pioglitazone; Pioglitazone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pioglitazone; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ibuprofen in Migraine Patients
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators planned to compare the effectiveness of an intravenous
      ibuprofen against an intravenous dexketoprofen among patients (18-65 years) who were admitted
      to the emergency department (ED) with acute migraine-related headaches and diagnosed migraine
      without aura.

      In this study, patients who presented with migraine-related headache to emergency departments
      will be included in this study. Two different therapy option are created; first, 400mg
      intravenous ibuprofen with 10mg intravenous metoclopramide Hcl , second, 50 mg intravenous
      dexketoprofen with 10mg intravenous metoclopramide Hcl.

      Patients's headache scores will be measured with visual analog score (VAS) at the
      pretreatment and post-treatment periods (0. minutes, 30. minutes, and 60. minutes.) 60
      minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose
      headache score does not decrease by more than 50% from pretreatment-VAS score.
    


Intervention name(s): Ibuprofen 400 mg; Dexketoprofen
Intervention type(s): Drug; Drug
Intervention description(s): 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.; 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Intervention MeSH terms: Ibuprofen; Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine without migraine; intravenous ibuprofen; intravenous dexketoprofen
The Effect of Beverages Varying in Protein Quantity on Appetite and Energy Intake
Condition: Obesity
Study type: Interventional

Summary: 
      Over the last decades, changes in the diet and lifestyle have led to overall energy imbalance
      becoming commonplace and the emergence of an obesity epidemic with more than 1.6 billion
      adults being overweight.

      Consumption of foods that can affect appetite by increasing satiety could regulate the total
      energy intake and thus body weight. There is data suggesting that the macronutrient
      composition of the foods and especially protein content may have a potent role on satiety.
      However, it is difficult to pinpoint the optimum quantity needed to observe significant
      effects of protein on satiety.

      The research project is dedicated to identify which food components [proteins, carbohydrates
      (CHO), fats] and the optimized protein quantity needed to accelerate satiation, suppress
      appetite and extend satiety until hunger appears again.

      It is hypothesized that the consumption of protein-enriched meals will induce a reduction in
      hunger through the impact on gut hormones and peptides that are closely related to the
      short-term regulation of food intake.
    


Intervention name(s): Beverages varying in macronutrient content on appetite
Intervention type(s): Dietary Supplement
Intervention description(s): In this randomized, within-subject study, subjects are asked to consume 7 iso-energetic and iso-volumetric beverages as breakfast (20% of estimated energy requirements) with varying distribution of macronutrients. The objective is to identify the optimal protein quantity or macronutrient distribution on suppressing appetite.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Appetite; Satiety hormones; Dietary Protein
A Trial Comparing Qam With Qpm Dosing in Assisted Reproductive Technologies (ART)
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI
      when taking their gonadotropin dosage in the morning (am) or evening (pm).
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infertile women between 21 and 44 years old
      
Keywords: IVF; ICSI; gonadotropin; am dose; pm dose; pregnancy; implantation; live birth
Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids
Condition: Levels of Fatty Acids in the Blood Cells of Infants
Study type: Observational

Summary: 
      To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming
      infant formulas containing differing levels of fatty acids
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infants 12-25 days of age
Epidemiology of Hearing Loss in Diabetic and Non-Diabetic Veterans
Condition: Diabetes; Tinnitus; Hearing Loss
MeSH terms: Hearing Loss; Deafness; Tinnitus
Study type: Observational

Summary: 
      The purpose of this study is to determine if individuals with diabetes are at increased risk
      of hearing impairment or tinnitus (the perception of ringing or noises in the ears or head).
      An important goal of this research is also to obtain a better understanding of possible
      interactions between hearing disorders and other chronic conditions, such as diabetes.
      Participation in this research will be for a few hours only, to be scheduled at the
      participant's convenience and according to the testing schedules of the different clinics
      involved.
Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in
      the treatment of subjective tinnitus in comparison to placebo.
    


Intervention name(s): Neramexane mesylate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.; Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigating the Effect of Single-session Sauna Use on Body Temperature
Condition: Core Body Temperature 101.3 F
Study type: Interventional

Summary: 
      Whole-body hyperthermia (WBH) to an internal temperature of 38.5 C (101.3 F) using an
      infrared heating device has been associated with significant reductions in clinical
      depression. This prior work utilized a WBH medical device that is manufactured in Germany, is
      not FDA approved, and is not widely available. The goal of this initial pilot project is to
      ascertain whether an infrared sauna, the Curve Sauna Dome, which is readily accessible (i.e.,
      can be purchased by consumers in the US) can be used to conduct WBH that achieves an internal
      body temperature of of 101.3 F in healthy volunteers.
    

Detailed description: 
      Prior work has demonstrated that whole body hyperthermia (WBH) to an internal temperature of
      38.5 C (101.3 F) using an infrared heating device is associated with significant reductions
      in clinical depression. This prior work utilized a Heckel WBH device, a medical device
      manufactured in Germany that is not FDA-approved and that is not widely available. The goal
      of this pilot project is to ascertain whether the Curve Sauna Dome, an infrared sauna that is
      readily accessible (i.e., can be purchased by consumers in the US) can be used to conduct WBH
      that achieves an internal body temperature of of 38.5 C (101.3 F) in healthy volunteers.
    

Intervention name(s): Curve Sauna Dome
Intervention type(s): Device
Intervention description(s): All participants receive WBH for 80-110 minutes in an infrared sauna. Participants lay supine in the sauna during this time, and their head is external to the sauna.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, three-period, fixed-sequence study to evaluate the drug-drug
      interaction, pharmacokinetics and safety of dutasteride and tamsulosin when administered
      alone and in-combination in Chinese healthy male volunteers.
    

Detailed description: 
      This will be an open-label, three-period, fixed-sequence study to evaluate the drug-drug
      interaction, pharmacokinetics and safety of dutasteride and tamsulosin when administered
      alone and in-combination in Chinese healthy male volunteers. The study will last
      approximately eleven weeks. Blood samples for pharmacokinetic analysis will be taken at
      pre-specified times. Safety will be assessed by measurement of concurrent medication,changes
      in clinical laboratory values, ECG, vital signs, and collection of adverse
      events.Approximately 24 healthy adult males will be enrolled such that approximately 18
      subjects complete dosing and critical assessments.This will be an open label, single
      sequence, three-period study. Approximately 24 healthy male volunteers will be enrolled. At
      the first study period, the subjects will receive 0.5mg of dutasteride (Dut) as a single dose
      (SD) under fed conditions. Serum sampling will take place pre-dose and over the next 72 hours
      post dose (Per. A). After a 28-30 days washout, the subjects will be brought in and be given
      0.2mg tamsulosin as Harnal D tablet for 7 days with the morning meal. Serum sampling for
      pharmacokinetics of tamsulosin will take place at day 1, day 2 and day 3 pre-dose and at days
      4 for 24 hours (Per. B). On the next day (Day 5), the subjects will be given both 0.2mg
      tamsulosin Harnal D tablet and 0.5mg of dutasteride. Serum sampling will take place at Day 5
      pre-dose and followed for 72 hours (Per. C) for both dutasteride and tamsulosin. Subjects
      will participate in a follow-up visit approximately 2 weeks after the last dose of study
      drug.
    

Intervention name(s): Dutasteride and Tamsulosin
Intervention type(s): Drug
Intervention description(s): 0.5mg dutasteride once a day on Day 1 Period A , and Day 5 Period C,0.2mg Tamsulosin once a day on Day 1 to Day 7 in Period B and Period C
Intervention MeSH terms: Tamsulosin; Dutasteride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics, Chinese; Avodart, Duodart, dutasteride, tamsulosin, drug-drug interaction,