bioihbjkbjnl/mcl2 huggingface dataset:
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended
      safety of TDF 300 mg per day among young women who are not HIV-infected.
    

Detailed description: 
      The protocol describes a randomized, fully-masked, parallel, placebo-controlled study of TDF
      for pre-exposure prophylaxis of HIV in high-risk women. TDF was selected for investigation as
      prophylaxis against HIV in high-risk women because of its unique pharmacological profile. In
      addition to the convenience of being a once daily single tablet, TDF's safety profile is
      comparable to placebo among HIV infected persons, it has striking anti-HIV potency, and it
      has low potential for selection of resistant viruses. TDF is cleared from the body by the
      kidneys and is not metabolized by the liver. Therefore, TDF has limited potential to have
      pharmacokinetic interactions with other hepatically metabolized drugs. Each of these
      properties is necessary given the realities of the intended target populations. Moreover,
      initial prevention studies in simian models have provided encouraging results. Finally, the
      drug's sponsor is supportive of investigating the potential use of TDF as a preventive, as
      well as a therapeutic agent.

      Participants' HIV status is monitored monthly. Participants are also monitored for safety
      using periodic physical examinations, serial laboratory tests and adverse event queries. Lab
      tests for kidney and liver function were to be conducted at screening, months 1, 3 and every
      3 months thereafter or at the final visit if early withdrawal. To minimize the risk of
      contracting HIV infection, participants are counseled monthly to use male condoms for each
      act of intercourse. Participants converting for antibodies to HIV are counseled and referred
      to medical services as appropriate for each country.
    

Intervention name(s): Tenofovir Disoproxil Fumarate
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonisation; IND Investigational New Drug Application; IRB Institutional Review Board; IU international units; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot; Human Immunodeficiency Virus
Fitness, Physical Activity and Movement Analysis in Obese Patients Undergoing Bariatric Surgery
Condition: Sleeve Gastrectomy
Study type: Interventional

Summary: 
      This study aims to describe the effects of sleeve gastrectomy, the most commonly performed
      bariatric procedure worldwide, on functional capacity, habitual physical activity, physical
      fitness (cardiorespiratory and muscular fitness) and gait parameters in severely obese
      subjects undergoing bariatric surgery. Functional capacity, physical activity, physical
      fitness and gait parameters will be objectively assessed and compared among candidates
      seeking sleeve gastrectomy and 6 months after sleeve gastrectomy.
    

Detailed description: 
      This study is a monocentric longitudinal study conducting in obese patients: candidates to
      sleeve gastrectomy and these same patients 6 months after.The primary aim of this study is to
      describe the effects of sleeve gastrectomy on habitual physical activity, physical fitness
      (cardiorespiratory and muscular fitness) and gait parameters in severely obese patients.
      Functional capacity will be assessed during a 6-min walk test, habitual physical activity
      with accelerometers during 7-day recordings in habitual life conditions (Actigraph GT3X® and
      activPAL®), cardiorespiratory fitness during a maximal exercise test on a cycle ergometer
      with a direct measure of peakVO2, muscle strength with an isokinetic dynamometer (Contrex®),
      muscle power and postural stability with force platforms (Kistler® and Satel®) and gait
      parameters with a gait analysis system (GaitRite®). Fatigue, quality of life and joint pain
      will be assessed with questionnaires (MFI-20, SF36 and WOMAC, respectively).
    

Intervention name(s): functional assessment
Intervention type(s): Other
Intervention description(s): assessment of functional capacity, habitual physical, cardiorespiratory fitness, muscle power and postural stability and gait parameters
Intervention model: Single Group Assignment
Intervention model description: Longitudinal study comparing data before bariatric surgery and one year after bariatric surgery
Masking: None (Open Label)
Primary purpose: Other
Keywords: Obesity; bariatric surgery; sleeve gastrectomy; physical activity; movement analysis
Drinking Effect of Electrolyzed Alkaline Reduced Water on Oxidative Stress and Fatigue After Intense Exercise
Condition: Oxidative Stress
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test the drinking effect of electolyzed alkaline
      reduced water (ARW) generated from alkaline ionizer (CGM MWPI-2101) on oxidative stress and
      fatigue after high-intensity exercise in healthy people. The main question[s] it aims to
      answer are:

        -  [question 1] Can pH 9.5 EARW reduce oxidative stress compared to purified water (PW)

        -  [question 2] Can pH 9.5 EARW decrease fatigue markers in blood

      Participants will drink water from the experimental device after high-intensity exercise.
      Blood sample will be collected before exercise, after highly intensive exercise, and after
      then 15 min. of drinking water.

      Researchers will compare EARW group and PW group to see the anti-oxidative and anti-fatigue
      effects.
    

Detailed description: 
      This study was designed as a randomized, controlled, crossover, double-blind clinical trial
      with a single intervention of ARW intake (pH 9.5, 10 mL/kg body weight) after highly intense
      exercise.

      The participants were divided into two groups, wherein they consumed either puriﬁed water (PW
      group) or EARW (EARW group). Blood samples were collected before exercise, immediately after
      exercise, and 15 min after drinking water.

      For the anti-oxidative effect, ROS, NO, GPx, and MDA levels were measured. For the
      anti-fatigue effect, latate, lactate dehydrogenase, phosphate and calcium were measured.
    

Intervention name(s): Electrolyzed alkaline reduced water generator
Intervention type(s): Device
Intervention description(s): Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise.
Other intervention name(s): Electrolyzed alkaline ionizer (CGM MWPI-2101
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The participants were randomly divided into two groups (n = 12) according to the sequence of random numbers obtained through an online number generator. After the first clinical trial, A wash-out period of one week was applied to prevent carry-over before crossing over, and the second clinical trial was performed.
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
Condition: Influenza Prophylaxis
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study was to evaluate if administration of a seasonal flu
      vaccine using a jet injector device is comparable to traditional needle and syringe delivery
      for eliciting an immune response. A secondary objective was to compare the safety of the two
      delivery methods.
    

Detailed description: 
      Needle-free jet injection devices create a fine stream of pressurized liquid that is able to
      deliver vaccines and other pharmaceutical products beneath the skin. Design aspects such as
      quality, pressure, orifice size, angle of injection relative to skin and injection stream
      coherence control the depth to which the product is delivered. This technology provides a
      safer delivery option for patients and healthcare staff by removing the need for needles for
      the administration of vaccines.

      In addition to improved safety, additional benefits of using jet injectors include more
      consistent and reliable dose volume delivery, reduced vaccine waste, diminished need to
      transport large quantities of sharps, reduced risk of needle sticks, syringe reuse, and costs
      associated with sharps waste. Jet injectors offer a needle-free procedure to those
      individuals who are adverse to needles.

      This study compared the efficacy of a disposable syringe jet injection device (Stratis) with
      traditional needle and syringe (NS) administration for the delivery of a trivalent
      inactivated influenza vaccine. Efficacy was evaluated by comparing measures of
      hemagglutination inhibition (HI); specifically GMTs, seroconversion and seroprotection.
      Safety of the two administration devices was evaluated by comparison of incidence of
      solicited local and systemic adverse events.
    

Intervention name(s): Stratis Jet Injector; Needle and Syringe; 2011-2012 Fluzone trivalent inactivated influenza vaccine
Intervention type(s): Device; Device; Biological
Intervention description(s): Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine; Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
Other intervention name(s): Jet Injector; Disposable Syringe Jet Injector; DSJI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Jet Injector; Stratis®; PharmaJet; Jet Injection
Effect of Knee Bracing on Improving Pain & Disability
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The overall purpose of the proposed pilot study is to establish the feasibility of conducting
      a clinical trial by evaluating the preliminary effects of 8 weeks of knee bracing on
      physiological measures of self-reported pain and disability, physical performance, physical
      activity, as well as femoral cartilage deformation in individuals with medial compartment
      knee osteoarthritis (OA). The investigators will recruit 36 symptomatic knee OA patients for
      the pilot study. The investigators will evaluate a class of braces (two different models will
      be used) designed to correct genu varum. The purpose of the study is to evaluate changes in
      these novel outcomes following the use of a class of braces used to reduce medial
      tibiofemoral compartment compression used for 8 weeks. This pilot study will inform a larger
      future trial to determine the efficacy of bracing on decreasing disability and disease
      progression in patients with knee osteoarthritis.
    


Intervention name(s): Medial Unloader Brace
Intervention type(s): Other
Intervention description(s): medial knee unloader braces use a three point bending system to increase space in the medial tibiofemoral compartment during weight bearing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
Condition: Seizures; Disorder of Fetus or Newborn
MeSH terms: Seizures; Fetal Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of
      Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.
    

Detailed description: 
      In adults, drug clearance is less than half of the glomerular filtration rate and the drug
      half-life is 6-8 hours. Renal function in infants at birth is characterized by immature
      glomerular filtration and is only 20% that of older children. The specific esterase
      responsible for levetiracetam hydrolysis has not been identified and its expression in
      newborn infants is unknown. Depending on its activity, the expected infant total
      levetiracetam clearance will likely be between 15-45% of older populations. However, due to
      immaturity in levetiracetam clearance in infants, accumulation with multiple dosing is
      possible. Therefore the maintenance dose is reduced compared to older children according to
      the anticipated impaired clearance.

      These anticipated differences in levetiracetam clearance and volume of distribution, will
      likely result in a prolonged drug half-life of 10-30 hours in infants. This prolonged
      elimination will require longer sampling to adequately characterize levetiracetam
      pharmacodynamics in this population.

      The primary intent of the data analysis is to determine levetiracetam pharmacokinetics in
      newborn infants and predict the dosage necessary to maintain concentrations similar to those
      seen with effective therapy in other populations. Graphs of serum concentration vs. time will
      be plotted for levetiracetam for each infant. Mean serum drug concentration vs. time curves
      will also be constructed. Summary statistics (i.e., n, mean, standard deviation, minimum,
      maximum, and coefficient of variation) will be calculated for serum concentrations for each
      time point and each dose level.
    

Intervention name(s): Low dose levetiracetam; High dose levetiracetam
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg/kg loading dose; 5 mg/kg daily for 7 days.; 40 mg/kg IV load; 10 mg/kg/day maintenance
Other intervention name(s): Keppra; Keppra
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neonatal seizures
Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers
Condition: Safety and Pharmacokinetics of Intravenous Baclofen
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine safety and characterize pharmacokinetics of
      higher doses of intravenous baclofen in healthy subjects.

      Thirty-six healthy adults received a single dose of PO baclofen (10mg, 15mg or 20mg) and a
      10-minute infusion of IV baclofen (7.5mg, 11.5mg or 15mg respectively) with a minimum 48-hour
      wash out period. Twelve subjects also received a 60-minute infusion of 15mg IV baclofen
      following an additional 48-hour wash out period.

      The pharmacokinetic and tolerability information gained from this study will support the
      development of further studies to assess the use of IV baclofen to prevent or treat baclofen
      withdrawal syndrome.
    

Detailed description: 
      This randomized, open-label, dose escalation, crossover study was conducted at a contract
      clinical research facility. Three single doses were evaluated using three cohorts (N=12 per
      cohort). Study doses were as follows: cohort 1 - 7.5mg IV and 10mg PO, cohort 2 - 11.5mg IV
      and 15mg PO, and cohort 3 - 15mg IV and 20mg PO. The IV baclofen doses for this trial were
      based on a 75% bioavailability observed in a previous low dose study.16 The oral formulation
      of the study drug used in this trial was 10mg baclofen tablet (Teva Pharmaceutical Industries
      Ltd.) and is commercially available. The intravenous formulation was 2mg/mL solution
      manufactured by Aptuit LLC. for this study. IV infusions were administered over 10 minutes.
      In addition, cohort 3 received 15mg over a 60-minute infusion. There was a minimum 48-hour
      washout period between doses. Initially, 3 subjects received study drug at a given dose,
      after assessing the safety and tolerance of baclofen the additional 9 subjects received study
      drug.
    

Intervention name(s): Intravenous baclofen
Intervention type(s): Drug
Intervention MeSH terms: Baclofen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: baclofen withdrawal; interruption; spasticity; pharmacokinetics; tolerability; intravenous
Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Multicentric retrospective study about the comparison of two different techniques of vaginal
      breach suturing after eradication surgery for deep infiltrating endometriosis and the
      surgical approaches (laparoscopic or vaginal) in terms of surgical, clinical and functional
      outcomes.
    

Detailed description: 
      Treatment of vaginal endometriosis can be successfully performed by vaginal or laparoscopic
      approach.

      The results of the surgical treatment confirm its validity with regard to the reduction of
      dyspareunia in the short to medium term but show less efficacy in the long follow-up. The
      long-term impact of surgery on sexual function may be influenced by multiple factors, such as
      recurrence of symptomatic or anatomical disease, preservation of autonomic nerve fibers
      responsible for the arousal and genital sensitivity and residual vaginal length. These
      factors are potentially dependent on the surgical approach performed to treat vaginal
      endometriosis.

      Particular importance as a surgical step assumes the closing phase of the vaginal defect that
      can be performed through a transverse or longitudinal suture. The longitudinal suture could
      guarantee, theoretically, a greater residual vaginal length and a better sexual function in
      the postoperative period than the vaginal closure by transversal suture, as demonstrated in
      previous studies about the suture techniques of vaginal cuff after hysterectomy.

      Up to date, there are no studies comparing surgical, clinical and functional outcomes of the
      vaginal suture neither the two surgical approaches (laparoscopic or vaginal) for vaginal
      endometriosis eradication.
    

Intervention name(s): longitudinal suture; transverse suture; Removal of vaginal endometriotic nodule
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, and closure of the vagina with a longitudinal suture; Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, and closure of the vagina with a transverse suture; Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, or vaginal technique, isolating the nodule through the vagina.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaginal endometriosis; Deep infiltrating endometriosis
Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Although the Atraumatic Restorative Treatment (ART) is well settled in the literature
      regarding occlusal-proximal cavities, the longevity of these restorations is still lower when
      compared to occlusal ones. This factor is often associated with low mechanical properties of
      glass ionomer cements (GIC). The objective of this randomized clinical trial is to evaluate
      the long-term cost-effectiveness of two different materials: an encapsulated GIC - Equia (GC
      Corp), compared with Giomer (Beautifill Bulk Restorative - Shofu) used as restoratives
      materials in occlusal-proximal ART restorations of primary molars. Children aged between 4
      and 8 years, will be selected in schools in the city of Cerquilho, São Paulo. All
      restorations will be held following the precepts of the ART and the manufacturer's
      instructions. The restorations will be evaluated after 3, 6, 12, 18 and 24 months according
      to Roeleveld et al. (2006) criteria. To verify the survival of the restorations will be used
      Kaplan-Meier survival analysis and log rank test. To evaluate the association between the
      clinical variables, Cox regression test will be applied. For the cost analysis will be used
      analysis of variance. The level of significance for all tests will be considered to 5%.
    


Intervention name(s): ART with Equia; ART with Giomer Beautifil-Bulk Restorative
Intervention type(s): Procedure; Procedure
Intervention description(s): Occlusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.; Occlusal-proximal ART restorations in primary molars using Giomer will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Giomer Beautifil-Bulk Restorative and occlusion will be checked.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atraumatic Restorative Treatment; glass ionomer cement; primary teeth; dental caries.
A Single and Multiple Ascending Dose Study of COR588
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, double-blind, placebo-controlled, single and multiple ascending
      dose study to assess the safety and tolerability of COR588 HCl in healthy male and female
      subjects.
    


Intervention name(s): COR588; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Increasing doses of COR588 will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.; Placebo will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment