bioihbjkbjnl/mcl2 huggingface dataset:
Lipopeptide Immunisation With GTU-multiHIV Trial
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      The combination of GTU-MultiHIV B DNA and LIPO-5 vaccines in a prime-boost strategy is
      expected to induce strong and diverse HIV-specific immune responses in HIV-infected patients.
      The investigators will carry out the clinical therapeutic immunization "proof of concept"
      trial in HIV infected patients. The investigators propose a multi-center double blind
      randomized versus placebo phase II clinical trial in patients who are chronic asymptomatic
      HIV-infected patients, with undetectable viral load while treated with a potent combination
      of antiviral drugs. Patients will continue antiviral therapy combined with either therapeutic
      vaccination or placebo vaccination. Patients will undergo the procedure which includes a
      prime with the GTU-MultiHIV B DNA vaccine or placebo administered by IM injections via
      Biojector (a needle-free injection system) followed by a boost of LIPO-5 vaccine or placebo
      also given IM.

      In total, 105 HIV-1 patients will be enrolled: 35 in the placebo arm and 70 in the vaccine
      arm. Patients will receive antiretroviral treatments and 3 administrations of DNA vaccine or
      its placebo at weeks 0, 4 and 12 (corresponding to prime vaccinations). They also receive 2
      doses of LIPO-5 vaccines or its placebo at week 20 and 24 (corresponding to boost
      vaccinations). At week 36 antiretroviral treatments will be interrupted until week 48.
      Patients will be intensely monitored during the treatment interruption period. After start of
      cART treatment (at the latest in W48), a data collection from clinical car will be carried
      out. A blood sample with W74 will allow to study the persistence ot the immunizing responses,
      1 year after the injection of the last vaccine/placebo.

      The primary efficacy endpoint is a plasma HIV-1 RNA level at week 48 (e.g. 12 weeks after
      stopping all antiviral treatment).

      The main hypothesis for conducting a phase II randomized trial is that immune responses in
      vaccinated patients may be associated with a better control of viral replication following
      c-ART interruption as compared to placebo-vaccinated patients.
    


Intervention name(s): Placebos of GTU-multiHIV B and LIPO-5 vaccines; GTU-multHIV B vaccine and LIPO-5 vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Placebos corresponds respectively to 1X PBS pH = 7.2 and glucose 5%; Vaccines are respectively an HIV-DNA plasmid and a mixture of 5 HIV-lipopeptides.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      After surgery on his penis, your child will probably have some pain. The investigators will
      give you a prescription for acetaminophen (Tylenol) with codeine, given by mouth (orally),
      for pain. In this study, the investigators want to see if a local anesthetic cream applied to
      the base of the shaft of the penis can reduce the need for oral medicine .
    

Detailed description: 
      Your child will receive a general anesthetic for the surgery. After your child is asleep, he
      will receive a local anesthetic injection in the area of the tailbone (normal procedure for
      this surgery). At the end of the operation your child will go to the recovery room. At the
      time of discharge from the hospital, we will be give you the prescription for acetaminophen
      with codeine (standard medication given for children undergoing surgery on the penis), and a
      tube of cream. The tube will contain either a local anesthetic cream (LMX-4)® or a cream with
      no active medicine (a placebo). We want you to apply the cream to the base of your son's
      penis every six hours. Which kind of tube you get will be picked randomly (similar to drawing
      numbers out of a hat) by a computer. Thirty minutes after applying the study cream, or sooner
      if needed, if you think your child needs pain medication, you may give the oral pain medicine
      (Tylenol with codeine as prescribed on the bottle). You may continue to apply the cream and
      give oral medicine every six hours as long as you think your child needs pain medicine for a
      maximum of 7 days. The cream can also be re-applied when changing diapers to facilitate the
      continued use of the cream even if it is sooner than the suggested 6 hours.
    

Intervention name(s): LMX4; LMX4 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One inch every six hours; One inch every six hours
Other intervention name(s): Placebo cream
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device
Condition: Bad Molar Teeth Arrangement Requiring Orthodontic Device
Study type: Interventional

Summary: 
      Thus study consists of evaluating the effect of low level therapy on pain induced by
      insertion of an orthodontic device (the "quadhelix"). Each day during the first seven days
      post procedure, the level of pain will be reported on an analogic visual scale.

      As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will
      also be daily registered.
    

Detailed description: 
      Patient will be randomized into one of the 3 following arms :

        -  arm 1 (experimental) : administration of Low Level Laser Therapy just after insertion of
           the quadhelix.

        -  arm 2 (sham procedure) : material necessary to perform Low Level Laser Therapy will be
           installed but the laser will not be activated.

        -  arm 3 (no intervention): material necessary to perform Low Level Laser Therapy will NOT
           be installed
    

Intervention name(s): Low level laser therapy; sham procedure
Intervention type(s): Device; Procedure
Other intervention name(s): low level laser therapy (970nm) (SIROLaser advance material of SIRONA dental systems laboratory); Same intervention than experimental arm except that the laser is not activated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee
Condition: Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This study consists of a randomized, double-blind, placebo-controlled crossover trial with
      open label extension evaluating a topical natural health cream containing ß-caryophyllene
      alone and in combination with 0.025% capsicum oleoresin against placebo. At the end of the
      randomized controlled phase of the trial all participants will be given open-label
      combination cream to be administered over the subsequent 3 weeks.

      Primary Endpoint: Evaluation of improvement in pain interference as measured by the BPI in
      individuals who are experiencing pain due to osteoarthritis of the knee.

      Secondary Endpoints: Secondary endpoints are: Confirmation of safety of the topical cream
      when used daily over 10 weeks.

      Further evaluation will include overall patient satisfaction with the products tested.
    


Intervention name(s): BetaC + Capsaicin Topical Cream; BetaC Topical Cream; Placebo Topical Cream
Intervention type(s): Other; Other; Other
Intervention description(s): BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.; BetaC Topical Cream Cream applied to painful knee area 3 times per day.; Placebo Cream applied to painful knee area 3 times per day.
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relative Bioavailability Study in Healthy Subjects Comparing 2 Dry Powder Oral Suspensions of Rivaroxaban Under Fasting and 20 mg of an Oral Suspension of Rivaroxaban Under Fed Conditions to 10 mg of an Immediate Release Tablet Under Fasting Conditions
Condition: Pharmacokinetics
MeSH terms: Malnutrition; Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Rivaroxaban is a substance developed for use in the treatment of blood coagulation
      disorders.Thrombosis (blood clots) can occur as a result of excessive coagulation activity in
      the blood vessels. Excessive coagulation activity can occur in children as well, and
      rivaroxaban is therefore being developed for the treatment of thromboembolic events in
      children and adolescents. As small children are often unable to swallow tablets, an oral
      suspension (mixture of a liquid containing finely distributed solids) has been developed
      which allows dosing according to body weight.The objective of this trial is to compare the
      bioavailability (proportion of a substance that remains available unchanged in the blood
      circulation) of a new oral suspension of rivaroxaban with a previously used oral suspension
      and with a rivaroxaban tablet approved for treatment. In order to evaluate the potential
      influence of food, the new oral suspension containing 20 mg rivaroxaban will be taken after
      consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown
      products (metabolites) in blood), safety and tolerability will be assessed.
    


Intervention name(s): Rivaroxaban (Xarelto, BAY59-7939); Rivaroxaban (Xarelto, BAY59-7939); Rivaroxaban (Xarelto, BAY59-7939); Rivaroxaban (Xarelto, BAY59-7939)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 10 mg oral suspension (dry powder) in fasted conditions.; Single dose of 20 mg oral suspension (dry powder) in fed conditions.; Single dose of 10 mg oral suspension in fasted conditions.; Single dose of 10 mg tablet in fasted conditions.
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Biological Availability; Relative Bioavailability Trial
Immunogenicity of Hepatitis B Vaccination Among Drug Users
Condition: Hepatitis B Vaccination
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Uptake, adherence, and completion of vaccination among drug users were low, and their immune
      function and immune response to hepatitis B vaccination were also suboptimal, indicating that
      the current practice of hepatitis B vaccination can't protect drug users from HBV infection.

      This is a randomized, open-label, blank-controlled trial, conducted among drug users with
      drug rehabilitation. This study will compare the immunogenicity and safety of three
      intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug
      users
    

Detailed description: 
      Comparison of 2 vaccination strategy against Hepatitis B in Drug Users

      Intervention:

      Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at
      months 0, 1 and 6;

      Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at
      months 0, 1 and 6;

      Arm 3 : Receive no vaccination during the study period.
    

Intervention name(s): 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hepatitis B vaccination; Immunogenicity; Randomized controlled trial; Drug abuse
Pulmonary Recruitment Maneuver With 15 and 30 cmH2O Pressure to Reduce the Postoperative Shoulder Pain
Condition: Surgery
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Pulmonary recruitment maneuver (PRM) has been shown to reduce postoperative shoulder pain by
      removing excessive intraabdominal gas following laparoscopic surgery(LS). A recent study
      demonstrated that compared to PRM in the supine position, PRM at semi-fowler position
      provides better evacuation of the remaining intraabdominal gas following gynecologic LS.

      This study aimed to compare the impact of PRM with 15 cm H2O and PRM with 30 cm H2O on
      postoperative shoulder pain in patients undergoing gynecologic LS.
    

Detailed description: 
      Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each
      positive pressure inflation was done for 5 s at a maximum pressure of 30-40 cm H2O in the
      neutral position. When used after laparoscopic surgery and just before the extubation, PRM
      has been shown to facilitate the removal of intraabdominal gas and thus reduce the
      postoperative shoulder pain which is associated with the volume of the gas accumulating under
      the diaphragm. A recent study demonstrated that compared to PRM in the supine position, PRM
      at semi-fowler position provides better evacuation of the remaining intraabdominal gas and
      less postoperative shoulder pain following gynecologic LS. However, whether a PRM with lower
      pressure is also effective in reducing postoperative intraabdominal gas and postoperative
      shoulder pain is of question. This study aimed to compare the impact of PRM with two
      pressures (15 cm H2O or 30 cm H2O) in addition to the semi-fowler position on postoperative
      shoulder pain in patients undergoing gynecologic LS.
    

Intervention name(s): Pulmonary recruitment maneuver (PRM)- 30 cm H2O; Pulmonary recruitment maneuver (PRM)- 15 cm H2O
Intervention type(s): Other; Other
Intervention description(s): Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation will be performed for 5 s at a maximum pressure of 30 cm H2O in the semi-fowler position (30° head-of-bed elevation ). PRM is performed after LS when the main umbilical port is remaining and aims to remove the remaining gas following LS.; Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation will be performed for 5 s at a maximum pressure of 15 cm H2O in the semi-fowler position (30° head-of-bed elevation ). PRM is performed after LS when the main umbilical port is remaining and aims to remove the remaining gas following LS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: gynecologic laparoscopic surgery; post-laparoscopic shoulder pain; pulmonary recruitment manoeuvre
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by
      the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of
      AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive
      the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen,
      will be allowed if a need for additional painkillers would arise. A number of patients will
      receive Naproxen as control.
    


Intervention name(s): AZD1940; Naproxen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 800ug oral administration; 500mg oral administration; Placebo given pre-surgery
Other intervention name(s): Naprosyn
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Analgesic effect; Molar extraction
Effect of Creatine and L-Arginine on Endothelial Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The study is a double blind 2x2 factorial study. Patients with coronary disease will be
      randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary
      supplement. The function of the endothelium will be tested using ultrasound before and after
      each treatment. These studies will help us understand why the endothelium is abnormal in
      patients with coronary artery disease and how L-arginine is acting on endothelial function.
    


Intervention name(s): Creatine; L-arginine and creatine; l-arginine; placebo, double
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Creatine 21 g daily; L-arginine; l-arginine 9 g daily; placebo
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: In recent years, probiotics have shown promise in treating a variety of diseases.
      Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri
      NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.

      Objective: The purpose of the study is to determine the lipid lowering efficacy of a
      One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12
      weeks in subjects with hypercholesterolemia.

      Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm,
      multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in period
      and a 12-week intervention period.
    


Intervention name(s): One-a-Day L. reuteri NCIMB 30242 supplement capsule; One-a-Day placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Once per day, 12 weeks; Once per day, 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.
Condition: Urinary Tract Infection
MeSH terms: Infections; Urinary Tract Infections; Vesico-Ureteral Reflux
Study type: Interventional

Summary: 
      Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial
      prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).
    

Detailed description: 
      A voiding cystourethrogram was performed for each child less than 3 years old with a first
      urinary tract infection. In case of vesico-ureteral reflux, a randomization was done between
      continuous antimicrobial prophylaxis with low dose of trimethoprim-sulfamethoxazole and no
      antibioprophylaxis. Duration of follow up was 18 months.
    

Intervention name(s): Antimicrobial prophylaxis
Intervention type(s): Procedure
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary tract infection; Vesico-renal reflux; Child; Antimicrobial prophylaxis; Recurrence of urinary tract infection
the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)
Condition: Fetus Fetus; Pregnancy Complications
MeSH terms: Pregnancy Complications
Study type: Interventional

Summary: 
      the effects of fetal EFT on fetal cardiac function and fetal and maternal outcomes were
      investigated in obese pregnant women compared with normal-weight pregnant women.
    

Detailed description: 
      All pregnant women underwent a comprehensive fetal anomaly screening. One obstetrician (S.D.)
      assessed all of the measurements. Every measurement was performed using a convex 2-5 MHz
      Voluson E8 probe (GE Healthcare, Milwaukee, WI). Fetal biometry, UA, MCA Doppler,
      cerebroplacental ratio (CPR), modified MPI (mod-MPI), and EFT were assessed in accordance
      with the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) guidelines
    

Intervention name(s): Doppler ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): Doppler study was performed in all cases. perinatal outcomes were evaluated.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: case control
Masking: Single (Participant)
Primary purpose: Screening
Keywords: obesity,; fetal epicardial thickness; myocardial performance index; perinatal outcome
Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Our overall goal is to evaluate the safety and efficacy of consumption of two algae
      formulations compared to a placebo on: degree of severity of skin lesions, plasma lipid
      levels, as well as other health-related markers, in individuals with clinically diagnosed
      psoriasis.
    


Intervention name(s): Corn starch; Unique Marine Algae Concentrate (UMAC); Golden brown algae
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 90mg/d; 90mg/d; 90mg/d
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Algae; Psoriasis; Lipid metabolism; Inflammation; Oxidative stress