bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Vitamins Among Children of HIV-infected Women
Condition: HIV Infections; Pregnancy Complications
MeSH terms: Pregnancy Complications
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the effects of multivitamin (B, C, E) supplementation
      on reducing the risk of morbidity and mortality outcomes among children born to HIV positive
      mothers, compared to placebo supplementation.
    

Detailed description: 
      An increasing body of evidence supports the efficacy of single and, more recently, multiple
      micronutrient supplementation in reducing morbidity and mortality in susceptible populations.
      For example, we recently completed a multiple micronutrient supplementation trial in
      HIV-positive Tanzanian women that showed a significant reduction in pre-term birth, fetal
      loss, and low birthweight. In children, we and others have also demonstrated the beneficial
      effects of vitamin A supplementation in reducing diarrheal disease and mortality. Our next
      priority is to evaluate the efficacy of multiple micronutrient supplementation in susceptible
      children. Children born to HIV-infected women are at risk of multiple micronutrient
      deficiencies due to poor dietary intake, malabsorption, and increased metabolic needs. In
      addition, these children, if HIV-infected themselves, are at significantly higher risk of
      death due to infectious illnesses compared to their non-infected peers. In this study, we
      propose to study the efficacy of micronutrient supplementation in reducing the risk of
      morbidity and mortality outcomes among children born to HIV positive mothers, compared to
      placebo supplementation.
    

Intervention name(s): Multivitamins - vitamins B complex, C and E; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Age-appropriate dosages of vitamin C, vitamin E, thiamine, riboflavin, niacin, vitamin B6, folate, and vitamin B12 administered orally to children aged 6 weeks to 6 months, and two capsules per day for children aged older than 6 months for at least 12 months; Placebo capsules administered orally once day orally to children aged 6 weeks to 6 months, and twice per day for children aged older than 6 months
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Birth Outcomes; Nutrition; HIV; AIDS; Vitamins; Multivitamins; Maternal and child health outcomes; Tanzania; Africa
A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a 24 week study evaluating the effects of botulinum toxin Type A on semen quality in
      patients with signs and symptoms of Benign Prostatic Hyperplasia (BPH).
    


Intervention name(s): Botulinum Toxin Type A; Placebo (saline)
Intervention type(s): Biological; Drug
Intervention description(s): OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.; Saline injected into the prostate on Day 1.
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Home-HIT and Type 1 Diabetes
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study aimed to use a multi-disciplinary approach to evaluate a 6-week home-based
      high-intensity interval training (Home-HIT) intervention in people with type 1 diabetes.
    

Detailed description: 
      This study aimed to use a multi-disciplinary approach to evaluate a home-based high-intensity
      interval training (Home-HIT) intervention in people with type 1 diabetes.

      Eleven individuals with type 1 diabetes (4 men/7 women; age 30±3 years; BMI 27.1±1.2 kg·m-2;
      V ̇O2peak 32.4±2.1 ml∙kg∙min-1; duration of type 1 diabetes 10±2 years) completed six weeks
      of Home-HIT. The effect of Home-HIT on V ̇O2peak, blood pressure, insulin dose and glycaemic
      profile was assessed pre and post-training. Adherence and ability to meet target heart rate
      (HR) thresholds (compliance) were monitored using a HR monitor and mobile phone application.
      Change in glycaemia was measured pre, post and 1h post exercise sessions throughout the
      six-week period. A qualitative online survey was completed post-training.

      This is the first study to combine physiological outcomes with a qualitative evaluation of a
      training intervention in people with type 1 diabetes. Home-HIT resulted in high adherence
      alongside increased V ̇O2peak and decreased insulin dose. Because Home-HIT is time-efficient
      and removes barriers to exercise including fear of hypoglycaemia, it may represent an
      effective strategy to increase exercise participation in people with type 1 diabetes.
    

Intervention name(s): Home-HIT
Intervention type(s): Behavioral
Intervention description(s): Participants completed 6 weeks of home-based high-intensity interval training 3 times per week
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)
      doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be
      evaluated.
    

Detailed description: 
      The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)
      doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be
      evaluated.Eligible subjects will be assigned to a sequential treatment cohort and randomized
      to each treatment group (active/placebo ). Subject enrollment will continue into the next
      cohort after review of the dose safety from the previous dose cohort.
    

Intervention name(s): QLM3003; QLM3003 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g）; 1%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g）(matching corresponding study medication)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immune response of two-doses of GSK
      Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      The study has five core arms and the stratification is based on site and age. In addition,
      there are 4 possible contingent groups of which 2 will be studied based on an analysis
      concerning immunogenicity performance at Day 42 in core groups above.
    

Intervention name(s): Pumarix™; Pandemrix ™
Intervention type(s): Biological; Biological
Intervention description(s): Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.; Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza; GSK 1557484A vaccine
Clinical Evaluation of "Snow-plow"Technique Versus Bulk Fill Technique in Restorations of Class II Cavities
Condition: Class II Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of the study is to assess the performance of " snow-plow" technique as compared to
      Bulk Fill technique in restoration of class II cavities.
    

Detailed description: 
      1. With limited evidence-based information about the clinical performance of resin
           composite in class II cavities. it is beneficial to compare the newly introduced
           "snow-plow' technique using a randomized clinical trial to test the null hypothesis that
           this new technique has the same clinical performance.

        2. The comparator will be the bulk fill technique as an alternative to the conventional
           layering technique. This is because it has shown lower polymerization shrinkage when
           comparing it to the conventional composite. Bulk fill has reduced the chair time for the
           patient. It is done by the application of 4mm increment and cured at once.

        3. Patients are selected according to the eligibility criteria discussed in the following
           section.

        4. local anesthesia will be administered and the operative field will be isolated before
           starting the restorative procedure. A standard class II cavity will be prepared at the
           two-surface cavities.

        5. The preparation will be performed using rotary instrumentation for cavity preparation by
           a water-cooled high-speed hand-piece by the same operator.

        6. The teeth are then restored using one of the two techniques according to their
           allocation with the same steps discussed in the different arms.

        7. The restorations are assessed using the modified USPHS criteria at the time intervals
           stated in the outcome measures.
    

Intervention name(s): "Snow-plow" technique; Bulk fill technique
Intervention type(s): Procedure; Procedure
Intervention description(s): In class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds.; In class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Impact of HPV on a Cohort of Southern Italian Women: Epidemiological, Clinical, Morphological and Microbiological Features
Condition: Cervix Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      HPV is known to be the causal agent in the majority of cervical cancers. However, the role of
      the cervical bacterial microbiome in cervical cancer is not clear
    


Intervention name(s): Cervical biopsy
Intervention type(s): Diagnostic Test
Intervention description(s): in office Cervical biopsy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: hpv; cervical cancer; microbiome
Effects of Oral PEG 3350 on Electrolyte Balance
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to evaluate the influence of three different doses of PEG 3350 with or without
      electrolytes on the electrolyte balance in patient volunteers with confirmed chronic
      constipation.
    


Intervention name(s): PEG 3350 plus electrolytes; PEG 3350 without electrolytes
Intervention type(s): Drug; Drug
Intervention description(s): Each patient was treated with PEG 3350 with electrolytes for 10 days at a dose of either one, two or three sachets per day.; Each patient was treated with PEG 3350 for 10 days at a dose of either one, two or three sachets per day.
Intervention MeSH terms: Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Posttraumatic Stress Symptoms Among Rescuers at Risk
Condition: Trauma; PTSD; Self Efficacy; Coping Skills; Suicidal Ideation
MeSH terms: Suicidal Ideation
Study type: Observational

Summary: 
      This cross-sectional, anonymous online survey aims to examine how salient variables influence
      PTSS, well-being, and suicidal ideation across the following professions of rescue workers:
      firefighters, ambulance personnel, police officers, and emergency and psychiatric nurses.
      PTSS, coping strategies, well-being, suicidal ideation, previously experienced and
      work-related trauma, and self-efficacy were measured and analyzed using multiple regression
      and structural equation modeling.
    

Detailed description: 
      Employees of rescue and emergency services are at a risk of posttraumatic stress symptoms
      (PTSS) due to exposure to trauma and work-related stressors. Salient predictors for the
      development of PTSS among rescue workers have been identified; however, little is known about
      how predictors (e.g. coping strategies) differ among professions requiring repeated
      engagement in emergencies. The present survey examines how these variables influence PTSS,
      well-being, and suicidal ideation across different professions of rescue Workers using
      multiple regression and structural equation modeling.
    

Intervention name(s): No Intervention: anonymous online survey
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Employees of rescue and emergency services in the canton Bern, Switzerland: - Firefighters
        of the canton Bern

          -  Ambulance personnel of the canton Bern

          -  Police officers of the canton Bern

          -  Emergency nurses of the University Hospital of Bern

          -  Psychiatric nurses of University Hospital of Psychiatry, Bern
      
Keywords: PTSD; Trauma; Coping; Self Efficacy
Safety and Efficacy Study of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult Subjects
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the study are to demonstrate the effectiveness, safety and tolerability of
      multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults
      experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus.
    


Intervention name(s): PUR003; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Twice-daily (BID) doses of PUR003 will be delivered via inhalation using a commercially available nebulizer for a total of 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: influenza; healthy subject; virus inoculation; symptom scores; viral shedding; bioaerosol output
Immediate Effects of TENS and HVPS on Subacromial Pain and Shoulder Movements
Condition: Shoulder Pain Chronic
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      This study was performed to investigate the immediate effects of transcutaneous electrical
      nerve stimulation (TENS) and high voltage pulsed stimulation (HVPS) on resting pain and
      pain-free range of shoulder motion (pfROM) in patients with subacromial pain syndrome (SAPS).
    

Detailed description: 
      Transcutaneous electrical stimulation (TENS) and high voltage pulsed current/stimulation
      (HVPS) are both electrotherapeutic agents which can be used for pain relief in
      musculoskeletal conditions. Standard TENS devices usually deliver biphasic pulsed currents
      with a pulse duration between 50 μs and 1000 μs and pulse frequencies between 1 and 250 pps.
      HVPS devices are TENS-like devices which deliver direct current with twin monophasic spiked
      pulses of 10-500 V (500-ohm load) with a short pulse duration (microseconds). In both
      conventional TENS technique and HVPS for pain relief, the aim is to activate spinal gating
      mechanism by selectively stimulating large diameter Aβ fibers. Theoretically, high-frequency
      (~10-250 pps), low-intensity (nonpainful) currents are most efficient in selectively
      activating Aβ fibers, which is practically recognized by the user reporting 'strong but
      comfortable' nonpainful electrical paresthesia beneath the electrodes. There is no available
      evidence for the efficacy of TENS in patients with subacromial pain. Also, there has been
      little experimental work on the effects of HVPS on pain relief in the literature, as well as
      no known study for its efficacy in SAPS.
    

Intervention name(s): Electrical stimulation
Intervention type(s): Device
Intervention description(s): Two kinds of electrical stimulation (TENS and HVPS) and placebo intervention
Other intervention name(s): TENS; HVPS; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subacromial pain; Joint range of motion; Electrotherapy; Physiotherapy; Impingement
Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetics of a human
      monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate the safety and pharmacokinetics of a human monoclonal antibody
      (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.

      Participants will be randomly assigned to one of two groups. Participants in Group 1 will
      receive 10 mg/kg of VRC07-523LS at Weeks 0, 16, and 32. Participants in Group 2 will receive
      30 mg/kg of VRC07-523LS at Weeks 0, 16, and 32.

      Study visits will occur at Weeks 0, 2, 16, 18, 32, 34, and 48. Visits may include physical
      examinations; blood and urine collection; rectal, cervicovaginal, and seminal secretion
      collection; cervical, rectal, and vaginal biopsy collection; HIV testing; risk reduction
      counseling; and questionnaires. Study staff will contact participants at Week 50 for
      follow-up safety monitoring.
    

Intervention name(s): VRC07-523LS
Intervention type(s): Biological
Intervention description(s): Administered by intravenous (IV) infusion
Other intervention name(s): VRC-HIVMAB075-00-AB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomized, placebo-controlled study, consisting of a single
      ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will
      participate in only one cohort during the study.
    


Intervention name(s): WCK 4873; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets); Visually matching placebo
Intervention MeSH terms: Nafithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Olanzapine Treated Adolescents With Schizophrenia or Bipolar I Disorder
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterize olanzapine pharmacokinetics: the inter- and
      intra- subject variabilities of olanzapine pharmacokinetics; and the potential influence of
      patient factors such as age, weight, gender, origin, and smoking status on olanzapine
      pharmacokinetics in adolescents with schizophrenia or bipolar I disorder. This study will
      also assess the safety of olanzapine delivered orally.
    


Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Efficacy of OneTouch® Verio™IQ Meter
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      Diabetes mellitus is one of the most prevalent disease in the western world. The control of
      glucose levels has a big impact in the prevention of diabetes complications. The measure of
      glucose levels in capillary blood with glucometers is the gold standard to measure and
      control the glucose levels. Nowadays the glucometers become to more precise and sophisticated
      devices. One of the most notables advance is the inclusion of software that cam predicts
      glucose trends. This software has not be tested in routine clinical practice.
    


Intervention name(s): Verio Pattern Alert® activated; Verio Pattern Alert® deactivated
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Aripiprazole and Effexor XR Drug Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to learn whether aripiprazole has effect on
      the steady-state pharmacokinetics of venlafaxine in healthy subjects. The safety and
      tolerability of aripiprazole and venlafaxine co-administration will also be studied.
    


Intervention name(s): Venlafaxine on Day -4 to day 14, Aripiprazole dosed starting on Day 1: 3 days at 10 mg, 4 days at 1 mg and 7 days at 20 mg.
Intervention type(s): Drug
Intervention description(s): Tablets, Oral, Venlafaxine: 75 mg; Aripiprazole: 10, 15, 20 mg once daily, 14 days.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole; Venlafaxine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy Subjects