bioihbjkbjnl/mcl2 huggingface dataset:
Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.
Condition: Vasoplegic Syndrome
MeSH terms: Vasoplegia
Study type: Interventional
Phase: Phase 3

Summary: 
      After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound
      hypotension associated with a decrease in systemic vascular resistance. The care of this
      disease is based on the intravenous administration of a vasopressor, usually norepinephrine.
      During the recovery phase, weaning of norepinephrine, is an important step in which any lack
      of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.
    


Intervention name(s): Norepinephrine; Norepinephrine
Intervention type(s): Drug; Drug
Intervention description(s): Administration and weaning of norepinephrine is based on dynamic arterial elastance; The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure, cardiac output), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate).
Other intervention name(s): Dynamic arterial elastance; Control
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The goal of this study is to apply cutting-edge imaging approaches, incorporating
      machine-learning for pattern recognition and multispectral analysis, to the development and
      validation of intermediate endpoint biomarkers in benign tissue that characterize the
      response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer
      among men with negative biopsies.
    


Intervention name(s): Dutasteride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg daily; Placebo Comparator
Intervention MeSH terms: Dutasteride
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Probability Sample
      
Biospecimen description: 
      Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial
    
Keywords: prostate cancer; dutasteride
Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
Condition: Infant Development
Study type: Interventional

Summary: 
      This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the
      growth, tolerance and compliance of healthy infants fed infant formulas with extensively
      hydrolyzed casein protein.
    


Intervention name(s): Experimental Infant Formula; Control Infant Formula
Intervention type(s): Other; Other
Intervention description(s): Feed Ad Libitum; Feed Ad Libitum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Assess the Efficacy of HH-120 Nasal Spray for Prevention of SARS-CoV-2 Infection in Adult Close Contacts of Individuals Infected With SARS-CoV-2
Condition: SARS-CoV-2 Infection
MeSH terms: Infections; COVID-19
Study type: Interventional

Summary: 
      An Investigator-initiated, Randomized, Single-Blind, Placebo-Controlled Trial to Evaluate the
      Efficacy of SARS-Cov-2 Post Exposure Prophylaxis and Safety of HH-120 nasal spray
    


Intervention name(s): HH-120 nasal spray 1; HH-120 nasal spray 2; Placebo Comparator 1; Placebo Comparator 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): HH-120 nasal spray 5 times daily for 3 consecutive days; HH-120 nasal spray 8 times daily for 3 consecutive days; Placebo nasal spray 5 times daily for 3 consecutive days; Placebo nasal spray 8 times daily for 3 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effect of Transcranial Direct Current Stimulation Associated With Aerobic Exercise Training for Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study consists of a randomized, double-blind, clinical trial with two months' duration
      of follow-up. The variable used was the VAS for pain, considering the values of any
      difference between the data before and after stimulation.
    

Detailed description: 
      The average between the analyzed values was 1.20, with a standard deviation of 0.84, taking
      into account a type I error of 5%, a type II error of 10% and a power of 80%. From the sample
      calculation was found an n = 10 for each group. The sample is amplified in order to avoid
      possible effects of dropout ending with a n = 15 in each group with a total N = 45.

      Randomization was performed by a blinded therapist using sealed envelopes for each
      individual. The subjects will be divided into three intervention groups: tDCS (tDCS - DC
      stimulator, Neurocom, Germany) / AE Group, in which will receive active intervention of
      aerobic exercise training and active tDCS intervention. AE group, which will receive active
      intervention of aerobic exercise and placebo tDCS. And tDCS group, which will receive placebo
      AE and active intervention for tDCS.

      Participants will be blinded to the intervention groups as well as therapists involved in the
      evaluation process.

      The evaluation methods were carried out one week before the beginning of the intervention
      (baseline) for all variables. After the first week of intervention (neuromodulatory period)
      was performed ratings for level of cortical excitability (T1), and after the end of the one
      month period of intervention for all variables (T2). Follow-up evaluations were conducted one
      month (T3) and two months (T4) after the end of the intervention period."
    

Intervention name(s): tDCS; active intervention of aerobic exercise; placebo tDCS; placebo AE
Intervention type(s): Device; Procedure; Device; Procedure
Intervention description(s): tDCS - DC stimulator, Neurocom, Germany; different types of aerobic exercise; only 30 seconds of cortical stimulaion , with the power turned off for the remaining time (tDCS - DC stimulator, Neurocom, Germany); the procedure was a training on the treadmill, but heart rate was maintained within 5% of the resting heart rate at the minimum speed on the treadmill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation; Exercise; Fibromyalgia
A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese
      girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable
      immune response to all human papillomavirus (HPV) strains contained in the vaccine. The
      success criterion for the primary analysis requires that point estimates for seroconversion
      rate be greater than 90% for all 9 HPV types.
    


Intervention name(s): V503
Intervention type(s): Biological
Intervention description(s): V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Papillomavirus vaccines; Uterine cervical cancer; Human Papilloma Virus infections
Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this long term extension study is to evaluate the long-term safety of
      ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).
    

Detailed description: 
      This is a multi-center, open-label, long-term safety extension study of ACTIMMUNE® in the
      treatment of FA in children and young adults. Participants who complete 26 weeks of treatment
      and the Week 28 Follow-Up Visit in HZNP-ACT-302 (NCT02593773) will be eligible to enter this
      long-term safety extension protocol. The Day 1 Visit of this study (HZNP-ACT-303) occurs on
      the same day as the Week 28 Follow-Up Visit for HZNP-ACT-302 (NCT02593773). Participants will
      be required to return for clinic visits at least every 6 months. The treatment duration is
      open-ended, and treatment will continue until ACTIMMUNE® is commercially available for the
      treatment of FA in the United States or until the Sponsor decides not to continue development
      for the treatment of FA.
    

Intervention name(s): interferon γ-1b
Intervention type(s): Drug
Intervention description(s): ACTIMMUNE® will be administered three times per week by subcutaneous injection. The initial dose will be individualized for each participant and will be determined by the investigator, provided that the initial dose does not exceed the maximum tolerated dose in HZNP-ACT-302 (NCT02593773). The investigator may subsequently adjust the dose for any participant if deemed clinically appropriate, provided that the dose does not exceed 100 μg/m².
Other intervention name(s): ACTIMMUNE®
Intervention MeSH terms: Interferons; Interferon-gamma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACTIMMUNE; interferon y-1b
Bioequivalence Study of Klaribact (Clarithromycin) 500 mg, Film Coated Tablet
Condition: Healthy Volunteers; Bioequivalence Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This is An Open Label, Randomized, Single Dose, Two Way Cross over, Two Period, Two
      Treatment, Two Sequence Bioequivalence Study to compare the rate and extent of absorption of
      Klaribact FC Tablet (Clarithromycin 500 mg) with Reference Product, Klaricid FC Tablet
      (Clarithromycin 500 mg) in healthy adult male subjects under fasting condition.
    

Detailed description: 
      The study will be conducted on 24 healthy adult male subjects in two Periods i.e. period I
      and II. The study subjects will stay at the clinical trial site for 35 hours, 11 hours before
      and 24 hours after the drug administration. All 24 subjects will be divided in two groups of
      12 subjects in each group. One group will be treated with the test drug (T) and the other one
      with reference drug (R) in Period I. After the wash-out period of 7 days, the volunteers in
      these groups will receive the alternate treatment sequence (RT) in Period II.

      Blood samples will be collected at 0 hr (before drug administration) 0.5, 1, 1.5, 2, 2.5, 3,
      3.5, 4, 5, 6, 8,10, 12, 16 and 24 hours after drug administration for quantification of
      Clarithromycin in plasma through LCMS/MS validated method.
    

Intervention name(s): Klaribact 500 mg Clarithromycin Tablet; Klaricid 500 mg Clarithromycin Tablet
Intervention type(s): Drug; Drug
Intervention description(s): A single dose consisting of one Tablet of either test drug (Klaribact 500 mg) or reference drug (Klaricid 500mg) administered to each of the subjects in fasting condition with 240 mL water in both Periods alternatively.; A single dose consisting of one Tablet of either test drug (Klaribact 500 mg) or reference drug (Klaricid 500mg) administered to each of the subjects in fasting condition with 240 mL water in both Periods alternatively.
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A single center, open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence Study; Clarithromycin Tablet
Three Dimensional Movement Analysis of Maxillary Impacted Canine: a Randomized Clincial Trial
Condition: Complicated Impacted Tooth
MeSH terms: Tooth, Impacted
Study type: Observational [Patient Registry]

Summary: 
      Maxillary canines are the second-most frequently impacted teeth in the dental arch after the
      third molars. The suspicion of a maxilary canine impaction raises with the absence of the
      permanent canine in the arch after the normal period of eruption, and has to be confirmed by
      a clinical evaluation of the patient and a radiographic assessment.

      The approaches to the management of impacted canines are many, but the preferred approach
      typically involves surgical exposure and guided orthodontic eruption.

      The initial mechanical eruption can be achieved in several ways, but an important distinction
      has to be done according to the anchorage method. The aim of this study is comparing
      Temporary Anchorage Devices (TADs), and cantilevers with a TMA sectional, using the
      quantification of canines and molars displacement as the main parameter.

      A TAD is a mini screw temporarily fixed to bone for the purpose of enhancing orthodontic
      anchorage either by supporting the reactive unit (the anchoring tooth) or by obviating the
      need for it at large, and is subsequently removed after use.

      The mini screw employed in this clinical trial will be an alloy type IV titanium screw with
      1.5mm diameter and 8-10 mm long, and under local anesthesia will be placed in an area between
      the first premolar and first molar, on the buccal or labial side according to the canine
      position and teeth position.

      For the evaluation of the canines and molar displacement, two CBCT will be required: the
      first one before the beginning of the traction (T0), the second one after three months (T1).
      Both the CBCT will be imported in the MIMICS image processing software (Materialize Group,
      Leuven, Belgium). Limiting the tissue density ranges and restricting the anatomical area of
      interest, a cropped colored mask will be obtained from each CBCT. Then the co-registration,
      through the identification of 5 at least landmark points, will allow the overlap of the two
      masks. At this point, calculating the 3D surface models, the tooth pre- and post-treatment
      positions will be evident and the measurement of the displacement possible.
    


Intervention name(s): miniscrew; TPA
Intervention type(s): Device; Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to the Orthodontic Department, Genoa University.
      
Keywords: impacted canine; miniscrew; cone beam
The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence
Condition: Alcoholism; Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Alcoholism; Alcohol Abstinence
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in
      improving the sleep in recovering alcohol dependent subjects.
    

Detailed description: 
      Sober alcohol dependent subjects frequently complain of difficulty falling asleep as well as
      staying asleep which may eventually lead to relapse. Novel antipsychotic medications such as
      quetiapine have shown some efficacy in treating alcoholism and have also shown some benefit
      in improving insomnia.

      The primary aim of this study is to determine the degree to which quetiapine improves sleep
      in veterans during the early phase of recovery from alcohol dependence. The sleep efficiency
      from an in-lab polysomnogram will be the primary outcome measure. Secondary measures of sleep
      will include the Pittsburgh Sleep Quality Index, Insomnia Severity Index, and actigraphy.
      Other additional aims will explore for alcohol use and cravings, change in psychiatric
      symptoms using the The Time Line Follow Back measure, Penn Alcohol Craving Scale (PACS), the
      Patient Health Questionnaire-9 item scale (PHQ-9), and the Beck's Anxiety Inventory (BAI)
      respectively.

      Twenty four subjects within the first year of sobriety will be enrolled. Participants will be
      undergo an extensive baseline screening procedure. After 2 consecutive in-laboratory
      polysomnograms they will be treated with either Quetiapine XR or matching placebo pills
      targetting a dose of 400 mg a night. The treatment duration will be 8 weeks and during the
      eight week of treatment they will undergo 2 more nights of in-laboratory polysomnogram. All
      subjects will also receive Medical Management therapy, a standardized psychosocial
      intervention which is medically-based and focusses on alcohol abstinence and medication
      compliance.
    

Intervention name(s): Quetiapine XR; Placebo.
Intervention type(s): Drug; Drug
Intervention description(s): Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder.; Inactive or inert pill which will be used as a comparator.
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcoholism; Insomnia; Quetiapine; Seroquel
Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A three (3) part study to evaluate the safety, tolerability and PK of RDN-929
    

Detailed description: 
      Part 1 (Randomized, Double Blind):

      Up to 6 single ascending doses of RDN-929 are planned to be tested in 6 cohorts of 8 healthy
      males (Cohort 1:1 to 1:6). Within each cohort subjects will be randomly assigned to receive
      either a single dose of RDN-929 (6 subjects) or matched placebo (2 subjects).

      Part 2 (Open):

      Part 2 will consist of 2 crossover treatment periods in one cohort of 12 healthy elderly
      subjects (at least 3 of each gender), aged 55-80 years. The treatments will be separated by a
      washout period of at least 7 days. The dose selected for this part of the study will be based
      on the results of Part 1.

      In Period 1, subjects will be randomized to receive a single dose of RDN-929 in either fasted
      or fed status. In Period 2, subjects will receive a single dose of RDN-929 under the
      alternate status.

      Part 3 (Randomized, Double Blind):

      Multiple ascending doses (MAD) of RDN-929 are planned to be tested in up to 4 cohorts of 8
      healthy elderly subjects (at least 3 of each gender per dose level cohort), aged 55-80 years.
      The doses will be selected by the safety review committee (SRC) based on all available
      safety, tolerability and PK data and after approval by the ethics committee.

      Within each cohort subjects will be randomly assigned to receive either, RDN-929 once daily
      (6 subjects) or matched placebo (2 subjects) once daily for 12 days. Escalation to the next
      higher dose level will be based upon a review of the safety and tolerability data.
    

Intervention name(s): RDN-929; Placebo oral capsule; RDN-929 TBD dose; RDN-929; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose from 2 mg to TBD; Matching placebo Single dose; Fed vs fast dose TBD based upon results of previous cohorts; Multiple dose based on results of previous cohorts; Matching placebo multiple dose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parts 1 and 3 are parallel designs with escalating doses within each part. Part 2 is a FE cross-over study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Degenerative Mitral Regurgitation in Intermediate Risk Patients
Condition: Mitral Valve Insufficiency; Mitral Regurgitation
MeSH terms: Mitral Valve Insufficiency
Study type: Observational

Summary: 
      The main objective of this project is to determine intermediate-term echocardiographic
      outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical
      risk who have undergone mitral valve surgery for degenerative mitral regurgitation.
    

Detailed description: 
      Severe mitral regurgitation is associated with significant morbidity and mortality. Mitral
      valve surgical repair has proven to be an effective and durable option in the treatment of
      symptomatic degenerative mitral regurgitation (MR).

      Echocardiography remains a cornerstone in the evaluation of patients with degenerative (Type
      II) mitral regurgitation allowing for assessment of mitral anatomy, quantification of
      regurgitant severity, assessment of biventricular function, non-invasive measurement of
      pulmonary artery systolic pressures and identifying the presence of other valvular disease.
      The AHA/ACC Valvular Heart Disease Guidelines recommend the use of exercise echocardiography
      in the setting of mitral regurgitation to determine the degree of mitral regurgitation and
      pulmonary artery systolic pressures pre and post exercise in addition to an objective
      determination of the symptoms and exercise capacity.

      Echocardiography (both resting and exercise modalities) is helpful in the post-mitral valve
      repair period in the assessment of the mitral valve gradient and recurrent mitral
      regurgitation. Symptomatic MR patients can have poor health-related quality of life (HRQOL)
      which improves and / or returns to comparable age-adjusted norms for reference populations
      after mitral valve repair or replacement.

      To date, there is limited assessment of the degree of mitral regurgitation, mitral stenosis,
      and exercise capacity following both surgical and percutaneous mitral valve intervention as
      measured by exercise echocardiography. We propose that this modality with the addition of
      novel imaging technologies will provide a robust avenue for the assessment of these patients
      longitudinally. Additionally, assessment of HRQOL, including both the physical and mental
      health domains, will provide important information with which to guide patient care after
      mitral valve surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a history of mitral valve surgery for Degenerative Mitral Regurgitation (Type
        II).
      
Keywords: degenerative mitral regurgitation