bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase
      alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to
      treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV)
      infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12
      months. At the end of the 12-month treatment period eligible subjects will be offered
      enrollment in an open-label extension study if taliglucerase alfa is not commercially
      available.
    


Intervention name(s): Taliglucerase alfa
Intervention type(s): Drug
Intervention description(s): Taliglucerase alfa for infusion every two weeks for 12 months
Other intervention name(s): prGCD, plant cell expressed glucocerebrosidase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gaucher disease; pediatric
Influence of Naloxone on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris on Concomitant Treatment With Morphine
Condition: Unstable Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Unstable
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate differences in the pharmacokinetics and
      pharmacodynamics of ticagrelor and its active metabolite between patients who received
      ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and
      morphine alone for unstable angina pectoris.
    

Detailed description: 
      According to contemporary guidelines, ticagrelor is a recommended antiplatelet agent in acute
      coronary syndromes, including unstable angina pectoris. Quick platelet inhibition plays
      pivotal role in the treatment of acute coronary syndromes. As evidenced in the IMPRESSION
      study, analgesia with morphine delays platelet inhibition in patients with acute myocardial
      infarction. On the other hand, the results of the MOJITO study prove that administration of
      crushed ticagrelor tablets leads to quicker platelet blockage.

      Taking the above into consideration, we created a pharmacokinetic/pharmacodynamic study
      aiming to evaluate differences between patients who received crushed ticagrelor orally
      followed by either 1) a combination of intravenous morphine and orally administered naloxone
      or 2) intravenous morphine alone.

      The primary study outcome is time needed for ticagrelor and its active metabolite to reach
      their maximum plasma concentration in each study arm. Secondary outcomes include ticagrelor
      and AR-C124900XX maximum concentration and the area under the plasma concentration curve for
      both agents.

      Platelet reactivity will be assessed with the Multiplate Analyzer in all study participants
      at nine predefined time points.
    

Intervention name(s): Crushed ticagrelor followed by morphine; Crushed ticagrelor, morphine,naloxone
Intervention type(s): Drug; Drug
Intervention description(s): Crushed ticagrelor (180 mg) followed by morphine 5 mg intravenously; Crushed ticagrelor (180 mg) orally followed by morphine 5 mg intravenously and naloxone 1 mg orally
Other intervention name(s): Brilique; Brilique
Intervention MeSH terms: Morphine; Naloxone; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Koa Family: California's Obesity Prevention Project
Condition: Weight Loss; Diet Habit; Physical Activity; Overweight and Obesity
MeSH terms: Obesity; Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to learn if a new whole-person lifestyle program improves the
      health of low-income mothers.
    

Detailed description: 
      This study will employ a randomized controlled trial (RCT) design to test a newly developed
      obesity reduction program, Koa Family, among overweight or obese mothers. An exploratory,
      uncontrolled study will assess its acceptance among normal-weight mothers.

      Koa Family consists of a 6-month whole-person lifestyle program (WPLP) combined with text
      messaging and social media support and the opportunity to take part in a neighborhood tree
      planting campaign. This multi-pronged program is intended to reduce weight in the short-term
      while building self-empowerment and connections to community resources so that participants
      can sustain long-term weight loss.

      Koa Family will be implemented in select communities in Yolo and Sacramento counties,
      California. Overweight or obese study participants will be randomized to either an
      intervention or control group; all normal-weight participants will be assigned to the
      intervention. All participants will complete a survey and have their height and weight
      measured at baseline and 3-, 6-, 9- and 12-month follow-up. Intervention participants will
      also take part in a focus group at the 3-month midpoint of the intervention.
    

Intervention name(s): Koa Family
Intervention type(s): Behavioral
Intervention description(s): Koa Family is a 6-month program consisting of a whole-person lifestyle program (WPLP) combined with text messaging and social media support and a neighborhood tree planting campaign. The WPLP will bring groups of 8 to 10 mothers living in the same community together for 22 weekly 90-minute support sessions. Each session will cover a topic on whole-person living, including healthy eating, physical activity, stress reduction, coping, and well-being. Participants will receive brief text messages on their cell phones to encourage healthy lifestyle choices. Participants also will be invited to join a "secret" Facebook group where they can support one another in healthy lifestyle change. Finally, participants will have an opportunity to take part in a neighborhood tree planting campaign.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutrition
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants
      with herpes simplex virus infection limited to skin, eyes, and mouth.

      II. Determine the neurologic outcome in these patients when treated with this regimen.

      III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain
      reaction (PCR) result when all other CSF parameters remain normal in these patients.

      IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with
      clinical neurological assessment in these patients when treated with this regimen.

      V. Determine whether the continuous administration of this drug suppresses recurrent skin
      lesions in these patients.

      VI. Determine the safety of this regimen in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE:

      This is a randomized, double blind, placebo controlled, multicenter study.

      All patients undergo a lumbar puncture and then receive acyclovir IV every 8 hours on Days
      1-14. On Day 12, patients may undergo a lumbar puncture (at discretion of investigator).
      Whole blood is obtained for herpes simplex virus PCR analysis. Upon completion of intravenous
      therapy, patients with a negative CSF PCR are randomized to one of two treatment arms.

      Arm I: Patients receive oral acyclovir three times daily for 6 months.

      Arm II: Patients receive placebo three times daily for 6 months.

      In case of cutaneous recurrence during the first 12 months of the study, patients receive
      open label oral acyclovir (if CSF PCR is negative) or acyclovir IV (if CSF PCR is positive)
      for 5 days. Patients may or may not continue on study drug following this treatment.

      Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.
    

Intervention name(s): acyclovir
Intervention type(s): Drug
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: herpes simplex virus infection; herpesvirus infection; immunologic disorders and infectious disorders; rare disease; viral infection
Effects of Blood Letting in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Metabolic syndrome (MS) has an increasing prevalence worldwide and there is an urgent need
      for improvement of medical treatment. In traditional medicine phlebotomy (blood letting) is a
      recommended treatment for subjects with obesity and vascular disease. Recent studies showed
      that blood letting with iron depletion may improve insulin sensitivity in patients with
      diabetes mellitus. The investigators aimed to test if traditional blood letting has
      beneficial effects in patients with MS. A randomized trial with a sample size of 64
      self-referred MS patients was conducted. Patients in the blood letting group were allocated
      to blood letting intervention and the control group was offered a later treatment (waiting
      list). In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after
      4 weeks. Primary outcomes were the change of systolic blood pressure and of insulin
      sensitivity as measured by HOMA-Index.
    


Intervention name(s): blood letting
Intervention type(s): Procedure
Intervention description(s): blood letting twice within 4 weeks. First blood removal baseline with 400ml of venous blood and second blood removal with 300-400ml according to serum ferritin levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metabolic syndrome; Phlebotomy; blood letting; hypertension; insulin sensitivity
Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy
Condition: Colon Neoplasm; Pain
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      In minimally sedated Asian patients in a community setting the investigators showed that a
      limited volume of water infusion instead of air insufflation in either the rectal sigmoid
      colon or the whole colon significantly reduced pain score during colonoscopy. Cecal
      intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in
      our previous studies.1, 2 In contrast, several US reports described the successful use larger
      volumes of water infused throughout the entire colon in patients undergoing colonoscopy which
      result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review
      suggested that the cause of the difference might lies in the timing of water removal.6
      Specifically, the investigators group removed the infused water predominantly during
      withdrawal phase (water immersion) and the U.S. group removed water during insertion phase
      (water exchange).

      This prospective, randomized controlled trial compared water exchange or water immersion with
      traditional air insufflation in patients undergoing minimally sedated colonoscopy. The
      investigators test the hypothesis that water exchange can reduce more pain than water
      immersion in the investigators clinical setting.
    

Detailed description: 
      All procedures will be recorded and stored as digital files.
    

Intervention name(s): air insufflation; water immersion; water exchange
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): insufflate air during the insertion of colonoscopy; infuse water during insertion, aspirate water during withdrawal; infuse and remove water during insertion phase of colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: colonoscopy
Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
Condition: Major Depressive Disorder Without Psychotic Features
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing
      antidepressant treatment in patients with major depression who have not had a complete
      therapeutic response to treatment with the antidepressant alone.

      The investigators hypothesize that added asenapine will produce greater reductions in
      depression than will added placebo.
    

Detailed description: 
      The investigators will undertake a 6-week, double-blind, randomized, parallel-group,
      placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis
      who have had an incomplete therapeutic response to treatment with an antidepressant
      medication alone.
    

Intervention name(s): Asenapine 5-20 mg daily; Placebo 1-4 tablets daily
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID; One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Other intervention name(s): SAPHRIS; Placebo
Intervention MeSH terms: Asenapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Antidepressant; Antipsychotic
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Condition: Ocular Hypertension; Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil
      (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active
      comparator Timolol Maleate Ophthalmic Solution, 0.5%.
    


Intervention name(s): AR-13324 Ophthalmic Solution 0.02%; AR-13324 Ophthalmic Solution 0.02% BID; Timolol maleate Ophthalmic Solution 0.5% BID; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 1 drop once daily (QD), PM, OU; 1 drop BID, AM/PM, OU; 1 drop BID, AM/PM, OU; 1 drop QD, AM, OU
Other intervention name(s): Netarsudil; Netarsudil
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ocular hypertension.; Glaucoma
Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal
      polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is
      to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent
      pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.
    

Detailed description: 
      This study is a randomized, double-blind phase Ⅳ clinical trial in subjects aged 40-65 years
      to evaluate the lot-to-lot consistency,immunogenicity and safety of 23-valent pneumococcal
      polysaccharide vaccine of commercial scale.The experimental vaccine was manufactured by
      Sinovac Biotech Co., Ltd.A total of 1800 subjects will be enrolled.The subjects will be
      randomly divided into three groups in a ratio of 1:1:1 to received one dose of vaccine on day
      0.
    

Intervention name(s): Experimental 23-valent Pneumococcal
Intervention type(s): Biological
Intervention description(s): The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B,17F,18C, 19A, 19F, 20, 22F, 23F, and 33F in 0.5 mL of sodium chloride mixture per injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the
      duration of action of insulin lispro due to a facilitation of the absorption of the insulin
      after subcutaneous injection.

      The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in
      subjects with Type 1 diabetes under a dose of 0.2 U/Kg.

      This trial is a single-center, randomised, double-blinded, two-treatment, two-period
      cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus.
      Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2
      U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.
    


Intervention name(s): BioChaperone insulin lispro; Humalog®
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin); Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
Condition: Pregnancy Related
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomized controlled trial is to compare the effectiveness of epidural
      clonidine, dexmedetomidine, or fentanyl adjuncts for labor analgesia.
    

Detailed description: 
      Adjuncts for epidural labor analgesia have remained unchanged for decades, whereas changes in
      patient population and the opioid epidemic have created an increased demand for non-opioid
      alternative adjuncts to limit peripartum opioid exposure. This study aims to identify
      effective alternative and non-opioid adjunctive agents for epidural labor analgesia.

      The opioid crisis in the United States has translated to an increasing number of pregnant
      women requiring care for labor and delivery. These trends have resulted in new questions
      about alternative epidural analgesia adjuncts besides lipophilic opioids (e.g., fentanyl and
      sufentanil) because: 1) many people with opioid or substance use disorder desire to avoid
      opioids in all formulations and routes of administration; and 2) epidural fentanyl or
      sufentanil administration for labor can potentially interfere with the accuracy of urine drug
      screening in the postpartum period, which has implications for postpartum social services
      considerations.

      Some existing literature suggests that dexmedetomidine and clonidine are viable adjuncts to
      local anesthetics that offer a faster onset and a better quality of analgesia for patients
      requiring labor analgesia. However, the relative effectiveness of these adjunctive agents for
      labor analgesia have not been compared head-to-head. Better data on how these adjuncts
      compare with each other for labor analgesia efficacy, can result in more informed clinical
      care strategies.
    

Intervention name(s): Clonidine; Dexmedetomidine; Fentanyl; Ropivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Clonidine belongs to the drug classification of antihypertensives; Dexmedetomidine belongs to the drug classification of sedatives; Fentanyl belongs to the drug classification of analgesic opioid agonists and is used as the standard of care; Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care
Intervention MeSH terms: Clonidine; Fentanyl; Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is designed as a randomized, quadruple blinded, parallel arm, controlled, non-inferiority trial in 3 groups allocated in a 1:1:1 ratio
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnancy; Vaginal Delivery; Epidural Labor Analgesia
Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
Condition: Paraplegia; Spinal Cord Injuries (SCI)
MeSH terms: Spinal Cord Injuries; Paraplegia
Study type: Interventional

Summary: 
      ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower
      limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be
      used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple
      sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.
    


Intervention name(s): ReWalk - a motorized exoskeleton suit
Intervention type(s): Device
Intervention description(s): The subject will wear the ReWalk suit and have training sessions for walking with the device
Other intervention name(s): Exoskeleton suit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ReWalk; Paraplegia; Spinal Cord Injuries (SCI)