bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the ability of a single dose of the live attenuated recombinant
      tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against
      infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005
      vaccine.
    

Detailed description: 
      Dengue infection ranging from mild illness to life-threatening disease is widespread in most
      tropical and subtropical regions of the world. Infection with any of the four serotypes of
      dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4) can cause dengue illness. TetraVax-DV-TV005
      (referred to as TV005) is a live attenuated recombinant tetravalent dengue virus vaccine
      developed to protect against all four dengue virus serotypes. This study will evaluate the
      ability of a single dose of TV005 to protect against infection with rDEN3Δ30, a naturally
      attenuated DENV-3, given 6 months following vaccination with TV005.

      This study will enroll healthy adults with no history of previous flavivirus infection. At
      Day 0 (study entry), participants will be randomly assigned to receive either the TV005
      vaccine or placebo. On Day 180, all participants will receive the rDEN3Δ30 virus. All
      participants will record their temperature 3 times a day for 16 days after each vaccination.
      Additional study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 184,
      186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Study visits will include physical
      examinations and blood collection.
    

Intervention name(s): TetraVax-DV-TV005; rDEN3Δ30; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): TetraVax-DV-TV005 contains 10^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10^4.3 PFU/mL of rDEN2/4Δ30(ME), 10^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10^3.3 PFU/mL of rDEN4Δ30. The vaccine is administered in 0.5 mL containing 10^3.0 PFU of each component with the exception of rDEN2/4Δ30 that is given at a dose of 10^4 PFU. TetraVax-DV-TV005 is administered by subcutaneous injection in the deltoid region of the upper arm.; Administered at a dose of 10^4 PFU by subcutaneous injection in the deltoid region of the upper arm.; Administered at a volume of 0.5 mL by subcutaneous injection in the deltoid region of the upper arm.
Other intervention name(s): TV005
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Vaccine
Exogenous Glucose Oxidation Breath Test
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in
      type 2 diabetic patients.
    

Detailed description: 
      Recruitment

      - Non diabetic participants will be recruited from within the National University of Ireland,
      Galway student and staff community. Diabetic patients will be recruited from University
      College Hospital, Galway in collaboration with their hospital consultant.

      Test- day

      - They will undergo two separate, identical and simultaneous Oral Glucose Tolerance test and
      13C-glucose breath tests on two separate occasions after an overnight fast of 12 hours
      starting at 8pm. On arrival their heart rate, blood pressure, height and weight will be
      recorded. Following a resting period of 10 minutes, samples will be obtained for fasting
      glucose and breath enrichment values (at t = -20 and -10mins). At t = 0 min, participants
      will consume a standard glucose solution. This glucose solution will consist of 150mg of
      13C-glucose, 74.85g of glucose and 200ml of water and 25ml of orange flavoring. Breath
      samples will be obtained immediately after consumption of test solution and repeated every 15
      min over a 4-h interval. Blood glucose concentrations will be taken every 15 min starting at
      t = 15 min, over a 2-h interval and every 30 min for another 2-h interval. Participants will
      remain at rest throughout the study.

      Sample size assessment

      - Target recruitment is 40 non-diabetics and 40 diabetic participants. This study will use a
      Student's t-test to determine difference, or otherwise, in glucose oxidation in breath 13CO2,
      in 2 different groups of individuals. With power arbitrarily set at 0.8, effect size of 1.21
      reduction in breath, and Alpha set at 0.01 a final number of 35 participants is required for
      each group. The n=40 for each group is set to allow a 5 participant drop out in each group
      Dillon et al (2009).
    

Intervention name(s): Oral glucose breath test
Intervention type(s): Other
Intervention description(s): Simultaneous oral glucose tolerance test and exogenous 13C-glucose breath test following a 12hr overnight fast. Fasting samples were obtained for plasma glucose, insulin, c-peptide, leptin, adiponectin, resistin, HbA1c and two breath 13CO2 abundance values (at t = -15 and -5min). At t = 0min, each subject drank a 75g glucose solution (Thornton & Ross, UK) containing 0.15g of 1-13C glucose. Further breath samples (every 15 min over a 240min interval) and further plasma blood glucose, insulin and c-peptide samples (90,120,180min) were also taken.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: 13CO2; Breath test; Glucose oxidation; Diabetes mellitus
Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study compared the effectiveness of pain neurophysiology education and neck/shoulder
      exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).
    

Detailed description: 
      Forty three adolescents with chronic idiopathic neck pain were randomly allocated to receive
      pain neurophysiology education and shoulder/neck exercises (n=21) or no intervention (n=22).
      Data on pain intensity (Visual Analogue Scale), pain disability, neck flexor and extensor
      muscles endurance, scapulae stabilizers endurance, pain catastrophizing (Pain catastrophizing
      Scale), trait and state anxiety (State-Trait Anxiety Inventory) and knowledge of pain
      neurophysiology (Neurophysiology of Pain Questionnaire) were collected. Measurements were
      taken before and after the intervention.

      Statistical analysis were performed using a mixed-methods ANOVA.
    

Intervention name(s): neurophysiology of pain education and exercises
Intervention type(s): Other
Intervention description(s): Pain neurophysiology education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. It was delivered in small groups (4 to 7 participants). A total of 4 sessions were delivered over 4 weeks (1 session per week). Each session took between 45 minutes and 1 hour.
Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular muscles delivered over 3 sessions (the first session covered pain neurophysiology education only). Each exercise was performed in 3 series of 10 repetitions. The number of exercises targeting the same group of muscles increased from one in the 2nd session to 2/3 in the 4th session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
Condition: Adult Idiopathic Generalized Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to evaluate antiresorptive therapy with denosumab
      (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal
      women with idiopathic osteoporosis.

      Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial,
      "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in
      Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a
      36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6
      months).

      The goals of the study are to estimate the effects of denosumab on central and peripheral, as
      well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data
      to inform the design of a future randomized study. This study presents the first opportunity
      to study the effects of denosumab after TPTD in this unique and severely affected group of
      young women.

      Funding Source: FDA Office of Orphan Products Development (OOPD).
    

Detailed description: 
      Osteoporosis in premenopausal women with normal menstrual function and no specific cause is
      termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of
      <200,000 affected premenopausal women in the United States.

      Denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous
      gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not
      retained in the skeleton, and may thus be preferable for use in young women who may be
      contemplating future pregnancies. The investigators hypothesize that denosumab, initiated
      after completion of two years of TPTD, will maintain or improve central and peripheral areal
      and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.
    

Intervention name(s): Denosumab
Intervention type(s): Drug
Intervention description(s): Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Other intervention name(s): Prolia; Xgeva
Intervention MeSH terms: Denosumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: osteoporosis; premenopausal; denosumab; idiopathic; Idiopathic Osteoporosis in Premenopausal Women
Foam Tape Allergy a Sticky Situation
Condition: Medical Adhesive Allergy; Dermatologic Conditions; Dermatologic Lesions
MeSH terms: Skin Diseases; Hypersensitivity
Study type: Interventional

Summary: 
      Foam tape is commonly used in the emergency department as a dressing over chest tubes owing
      to its occlusive and compressible properties. There is a paucity of data regarding the
      incidence of significant cutaneous reactions to this material. We conducted a prospective
      trial to evaluate the incidence of dermatitis following application of foam tape to the upper
      arm of a cohort of healthy volunteers.
    

Detailed description: 
      This was a prospective, interventional trial. We enrolled a cohort of consenting, healthy
      physicians, nurses, and ancillary staff at a teaching facility who did not have known
      hypersensitivity to foam tape. Study investigators applied a 2x2 inch piece of 3M microfoam
      adhesive to the medial aspect of each subject's upper arm. The contralateral arm served as a
      reference for comparison. The adhesive remained in place for 48 hours and the study authors
      assessed patients utilizing the previously validated Cutaneous Irritancy Scoring System
      (CISS). Categorical variables analyzed by chi-square, continuous variables with t-tests.
    

Intervention name(s): 2x2 inch piece of 3M microfoam adhesive
Intervention type(s): Other
Intervention description(s): A 2x2 inch piece of 3M microfoam adhesive will be applied to the medial aspect of the subject's upper arm.
The adhesive will remain in place for 48 hours at which time an investigator will remove the adhesive and assess the study area. A numerical value will be assigned based on the Cutaneous Irritancy Scoring System (CISS). The study site will be compared to the contra-lateral upper extremity at the end of the 48 hour period.
Intervention model: Single Group Assignment
Intervention model description: A cohort of consenting, healthy physicians, nurses, and ancillary staff at a teaching facility who did not have known hypersensitivity to foam tape were enrolled. Study investigators applied a 2x2 inch piece of 3M micro-foam adhesive to the medial aspect of each subject's upper arm. The contralateral arm served as a reference for comparison. The adhesive remained in place for 48 hours and the study authors assessed patients utilizing the previously validated Cutaneous Irritancy Scoring System (CISS).
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dermatology; Contact Dermatitis
Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with
      persistent asthma.
    


Intervention name(s): IMA-638; IMA-638; placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): SC Injection, 12 weeks; SC Injection, 12 weeks; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination
      with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or
      GT2 or GT3 chronic hepatitis C (CHC) infection.
    


Intervention name(s): AL-335; Odalasvir (ODV); Simeprevir (SMV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).; ODV capsules will be administered in a dose range of 25 to 50 mg.; SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).
Other intervention name(s): ACH-3102
Intervention MeSH terms: Simeprevir; Odalasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electrical Currents on Hypoalgesia
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study is to compare the hypoalgesic effects of TENS, Interferential
      current and Aussie current in pressure pain threshold and sensory discomfort in healthy
      subjects.
    


Intervention name(s): Interferential current; Aussie Current; TENS
Intervention type(s): Device; Device; Device
Intervention description(s): Interferential current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kilohertz (kHz) and modulated frequency will be set at 100 Hz.; Aussie current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kHz and modulated frequency will be set at 100 Hz.; TENS will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Pulse duration will be set at 125 microseconds and frequency will be set at 100 Hz.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: volunteers; 18 to 65 years; Males and Females
A Study Evaluating ABT-199 in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy
Condition: Relapsed/Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to assess the safety profile, characterize
      pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and
      the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed
      /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard
      therapy.
    


Intervention name(s): ABT-199; bortezomib; dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABT-199 at cohort-defined dosing schedules and dose levels. ABT-199 at defined dose and schedule for Safety Expansion cohort; Bortezomib at cohort-defined dosing schedules and dose levels. Bortezomib at defined dose and schedule for Safety Expansion cohort; Dexamethasone at cohort-defined dosing schedules and dose levels. Dexamethasone at defined dose and schedule for Safety Expansion cohort.
Intervention MeSH terms: Dexamethasone; Bortezomib; Venetoclax
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: relapsed/refractory multiple myeloma; relapsed multiple myeloma; refractory multiple myeloma; multiple myeloma
The Effects of Serum Vitamin D and IVF Outcome
Condition: Vitamin D Deficiency; Vitamin D Insufficiency; Infertility
MeSH terms: Infertility; Vitamin D Deficiency
Study type: Observational

Summary: 
      The purpose of this study is to investigate whether an association exists between serum
      vitamin D levels and IVF treatment outcome
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing IVF, ICSI and FET treatment cycles at the Birmingham Womens
        Fertility Centre
      
Keywords: Vitamin D; Infertility; IVF; ART
Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears
Condition: Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Injuries
MeSH terms: Rupture; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Although the success of physical therapy following surgery has been well-documented and
      validated in patients undergoing Anterior Cruciate Ligament Reconstruction (ACLR) procedures,
      more recent studies have demonstrated that patient outcomes are the most favorable when
      surgery is delayed approximately 4 weeks until after the patient has completed a preoperative
      physical therapy program, or "pre-habilitation." The ultimate goal of pre-habilitation is to
      regain full range of motion in the knee and reach approximately 80% of pre-injury quadricep
      strength. However, extra physical therapy can stress both time and resources. Thus, we
      propose a home-based, self-guided pre-habilitation program. We hypothesize that patients
      participating in self-guided pre-habilitation will experience the same benefits as patients
      in a traditional office-based physical therapy program.
    


Intervention name(s): Self-guided pre-habilitation exercise program; Traditional pre-habilitation
Intervention type(s): Other; Other
Intervention description(s): A set of self-guided exercises developed by an athletic trainer to perform at home in order to optimize the knee for ACL repair surgery; Pre-habilitation exercise sessions under the direct supervision of a physical therapist.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
YAZ Premenstrual Dysphoric Disorder (PMDD) in China
Condition: Premenstrual Dysphoric Disorder ( PMDD)
MeSH terms: Premenstrual Dysphoric Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo
      in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).
    


Intervention name(s): EE20/DRSP(YAZ, BAY86-5300); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd; Inert tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Premenstrual Dysphoric Disorder ( PMDD); Oral contraceptive
Effects of Daily Supplementation of 5-HTP on Body Composition
Condition: Body Composition
Study type: Interventional

Summary: 
      The purpose of this investigation was to compare supplementation with 5-HTP to placebo on
      indices of body composition. A randomized trial compared a sample of 48 resistance-trained
      individuals taking either 100 mg of 5-hydroxytryptophan supplementation or a placebo.

      The investigators tested anthropometric measurements using a multi-frequency bioelectrical
      impedance device (InBody® 270). The primary outcome (i.e., changes in anthropometric
      measurements) was assessed at the first visit (pre-test-) and post-test (8 weeks). Secondary
      outcomes include resting heart rate, blood pressure, and dietary intake.
    


Intervention name(s): 5-HTP; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.; Maltodextrin capsule
Other intervention name(s): CLEANMOOD™; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study followed a placebo (PLA)-controlled, double-blind and parallel-group design.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Body Composition; 5-HTP
Effects of Fish Oil on Platelet Function and Coagulation
Condition: Platelet Aggregation, Spontaneous; Atherosclerosis; Surgery
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      Many patients undergoing surgery use naturopathic drugs, including fish oil. Fish oil has
      been reported to increase bleeding in patients through inhibiting platelet aggregation and
      prolonging of clot formation time. The Swedish Medical Products Agency recommends that
      patients stop taking the naturopathic medicines including fish oil two weeks prior planed
      surgery. The aim of this study is to examine the effects of fish oil given to healthy
      volunteers using point of care coagulation assessment and flow dependent Cellix instrument
      before and after intake of fish oil.
    

Detailed description: 
      Healthy volunteers will be given maximum dose of fish oil for 7 days. Blood samples will be
      collected before and immediately after the 7 days of intake and analysed using point of care
      coagulation assessment instruments and flow dependent platelet aggregation using a microfluid
      flow controlled system (Cellix). For point of care coagulation assessment the multiple
      electrode platelet aggregometer Multiplate, the viscoelastic rotational thromboelastometers
      ROTEM and Sonoclot will be used. Flow cytometry may also be utilized.
    

Intervention name(s): Fish oil
Intervention type(s): Drug
Intervention description(s): Blood samples before and after 10 day intake of maximum dose fish oil
Intervention model: Single Group Assignment
Intervention model description: Before and after
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Thrombocyte aggregation; Fish oil; Alternative medicine; Point of care testing; Coagulation monitoring