bioihbjkbjnl/mcl2 huggingface dataset:
To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers
Condition: Malaria,Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a proof-of-concept, first in human, Phase I, single center study designed to
      evaluate the safety, tolerability, immunogenicity and experimental efficacy of VLPM01 in
      healthy, malaria-naïve adult volunteers. The VLPM01 product will be adjuvanted with
      alhydrogel. The study design was based on the FDA's guidance "General Principles for the
      Development of Vaccines to protect Against Global Infectious Diseases" (2011).
    

Detailed description: 
      The study will have four (4) phases: Screening, Dose Escalation, Controlled Human Malaria
      Infection (CHMI) and Follow-Up. The study will be conducted at the Walter Reed Army Institute
      of Research in Silver Spring, Maryland (WRAIR), as this institute has extensive experience in
      conducting clinical studies of malaria vaccines with CHMI.

      A total of 36 participants will be enrolled in this study. Thirty (30) eligible participants
      will participate in the Dose Escalation Phase as vaccinees and 6 eligible participants will
      be added during the CHMI Phase to act as infectivity controls. Up to 6 additional eligible
      participants will serve as alternate vaccinees during the Dose Escalation Phase and up to 6
      eligible participants will as act as alternate infectivity controls during the CHMI Phase.
      Alternates are only enrolled if a designated vaccinee is not eligible on the day of first
      vaccination or if a designated infectivity control is not eligible on the Day of Challenge.
      Withdrawn participants will not be replaced.
    

Intervention name(s): 5 microgram VLPM01; 15 microgram VLPM01; 30 microgram VLPM01; Plasmodium falciparum challenge
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): VLPM01 is an alpha-VLP pre-erythrocytic malaria vaccine which targets circumsporozoite protein (CSP), adjuvanted with 0.75 mg alum.; VLPM01 is an alpha-VLP pre-erythrocytic malaria vaccine which targets circumsporozoite protein (CSP), adjuvanted with 0.75 mg alum.; VLPM01 is an alpha-VLP pre-erythrocytic malaria vaccine which targets circumsporozoite protein (CSP), adjuvanted with 0.75 mg alum.; Expose forearms to five (5) Plasmodium falciparum (strain NF54; clone 3D7) bites
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO
      80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis.
      LEO 80185 topical suspension has marketing approval in many countries under the brand names
      Taclonex Scalp® Topical Suspension and Xamiol® gel for the treatment of scalp psoriasis in
      adults. No studies have been performed in subjects younger than 18 years.
    


Intervention name(s): LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)
Intervention type(s): Drug
Intervention description(s): Topical suspension applied once daily for up to 8 weeks
Other intervention name(s): LEO 80185 topical suspension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions
Condition: Tibial Nonunions
Study type: Interventional

Summary: 
      This study is to evaluate the safety and effectiveness of the OP device for the treatment of
      nonunion bone fractures and to compare the healing rates of the OP Device to that of
      autograft.
    

Detailed description: 
      This study is to evaluate the safety and effectiveness of the OP device for the treatment of
      nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates)
      of the OP Device to that of traditional bone autografts to repair nonunions.
    

Intervention name(s): Surgical implantation of OP-1 device or autograft bone graft material
Intervention type(s): Device
Intervention description(s): Surgical implantation of OP-1 device or autograft bone graft material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.
Condition: Treatment Resistant Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      In this double blind, randomized placebo controlled trial we aim to determine the efficacy of
      simvastatin as an add-on treatment for treatment resistant depression. We will recruit 150
      people with treatment-resistant depression with the aim of determining whether the addition
      of simvastatin (20mg daily) to treatment as usual (TAU) for 12 weeks leads to an improvement
      in depressive symptom compared with placebo added to TAU.
    


Intervention name(s): Simvastatin 20 mg; Placebo Oral Tablet
Intervention type(s): Drug; Other
Intervention description(s): Simvastatin 20 mg added to TAU for 3 months.; Matched placebo added to TAU for 3 months
Other intervention name(s): Statins
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1-Simvastatin plus TAU, 2- Placebo plus TAU
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of RV1729
Condition: Asthma; Healthy Volunteers
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      RV1729 is a new medicine being developed for possible treatment of asthma and smoking related
      lung disease (also known as chronic obstructive pulmonary disease - COPD).

      The main purpose of this study is to investigate the safety, tolerability and
      pharmacokinetics of single and repeat doses of RV1729.
    


Intervention name(s): RV1729 single dose; RV1729 matching placebo single dose; RV1729: 14 day repeat dose; RV1729 matching placebo: 14 day repeat dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Safety and tolerability of single escalating doses; Safety and tolerability of single escalating doses; Safety and tolerability of repeat escalating doses; Safety and tolerability of repeat escalating doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption
Condition: Iron-deficiency; Ferritin Threshold; Iron Absorption; Stable Iron Isotopes
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The serum or plasma ferritin concentration (referred to hereafter as ferritin) is the most
      widely used indicator to detect iron deficiency and a low ferritin indicates depleted iron
      stores. However, the threshold ferritin that defines iron deficiency remains unclear and
      diagnostic ferritin cutoffs from expert groups vary widely.

      Our study aim is to define the ferritin in Kenyan young women at which the body senses iron
      depletion and begins to upregulate iron absorption from the diet; this approach could provide
      a functionally defined threshold of iron deficiency in Sub-Saharan African women.
    


Intervention name(s): Isotopically labelled iron sulfate 15mg
Intervention type(s): Other
Intervention description(s): test drink: water containing isotopic iron solution with vitamin C
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, open-label, follow-on study to gather additional information on the
      safety and tolerability of oral desensitization with CPNA in the subjects who participated in
      ARC001.
    

Detailed description: 
      This phase 2, open-label, follow-on, multicenter study was designed to gather additional
      information on the safety, tolerability, and efficacy of oral desensitization with AR101 in
      subjects who participated in study ARC001 (NCT01987817) as follows:

        -  Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001

        -  Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut
           protein (443 mg cumulative) in the DBPCFC at the end of study ARC001

      All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of
      Characterized Peanut Allergen (CPNA).

      Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may
      continue Extended Maintenance Phase until CPNA becomes commercially available or the study is
      terminated.
    

Intervention name(s): AR101 - Peanut protein capsule
Intervention type(s): Biological
Intervention description(s): Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Characterized Peanut Allergen; Peanut; OIT; Oral Desensitization; Peanut Allergen; Peanut-Allergic Children; Children; Peanut-Allergic Adults
Growing Up Milk (GUM) Intake and Nutrient Status of Toddlers
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the nutritional and cognitive effects of consuming
      Growing Up Milks (GUMs) and cow's milk.
    

Detailed description: 
      Single-site, double blind, partially randomized, controlled, 4-arm parallel group clinical
      trial. The purpose of this study is to determine if consuming nutrient enriched growing up
      milk improves the nutrition status and cognitive performance in healthy toddlers.
    

Intervention name(s): Test GUM; Standard GUM; Cows' milk
Intervention type(s): Other; Other; Other
Intervention description(s): Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.; Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.; Homogenized store-bought full fat cow's milk.
Other intervention name(s): Growing up milk; Growing up milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856
Condition: Cognition Disorder; Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognition Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the
      pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv)
      injection of a microdose of ACD856 in healthy subjects.
    


Intervention name(s): ACD856
Intervention type(s): Drug
Intervention description(s): IV injection 100 mcg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognition Disorder; Alzheimer's Disease
A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus; Healthy
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following
      single ascending intravenous (IV) dose administration in healthy participants and a single
      subcutaneous dose in healthy participants and multiple IV dose administrations in
      participants with mild to moderate Systemic Lupus Erythematosus (SLE).
    

Detailed description: 
      This is a Phase 1, randomized, placebo-controlled, multicenter study of JNJ-55920839. The
      study consists of Screening Period of 28 days. The healthy participants will have a
      6-day/5-night inpatient period. All Participants will receive study agent on Day 1 and SLE
      Participants will receive additional doses on Days 15, 29, 43, 57, and 71. The total duration
      of participation for each participant will be approximately 13 weeks for healthy
      participants, 22 weeks for participants with SLE. All eligible participants will be randomly
      assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part
      1, single ascending doses of JNJ55920839 or placebo will be administered to sequential
      cohorts of healthy participants as an IV infusion or as a subcutaneous injection. In Part 2,
      multiple doses of JNJ-55920839 or placebo will be administered as IV infusions to
      participants with SLE. Blood samples will be collected for assessment of pharmacokinetic and
      pharmacodynamics parameters in both part 1 and 2, along with assessment of safety and
      clinical outcomes. Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-55920839; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.; 0.9 percent (%) normal saline.
Other intervention name(s): CNTO 6358
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus; JNJ-55920839; Healthy Volunteers; CNTO 6358
Provigil (Modafinil) Study by Taiwan Biotech Co.
Condition: Narcolepsy; Cataplexy; Sleep Disorders; Hypersomnolence; Excessive Sleepiness
MeSH terms: Sleep Wake Disorders; Narcolepsy; Cataplexy; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional

Summary: 
      The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness
      associated with narcolepsy. Both of the subjective and objective sleepiness of the patients
      were assessed in the experiment by repeat measures.
    


Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of this dispensing study is to evaluate the clinical performance of existing wearers
      of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily
      wear.
    

Detailed description: 
      This is a 30-subject, prospective dispensing study comparing the clinical performance of the
      subjects' habitual Avaira sphere lenses following a refit with Clariti Elite sphere lenses.
      Subject's habitual Avaira sphere lenses will be evaluated at the first visit and then
      re-fitted with a pair of Clariti Elite sphere lenses for 4 weeks of daily wear. After the
      dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.
    

Intervention name(s): somofilcon A
Intervention type(s): Device
Intervention description(s): somofilcon A lens
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
Condition: THROMBOSED AV GRAFTS
Study type: Observational

Summary: 
      This pilot study will provide data to aid in the planning of a follow-up multi-center
      randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by
      formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm)
      was derived in consultation with the study PI and Co-PI who are experts in vascular surgery,
      and in particular, the field of hemodialysis access interventions. The results of this pilot
      study will provide the data that is necessary for generation of specific hypotheses that can
      then be formally tested in the follow-up RCT
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ESRD PATIENTS WITH THROMBOSED AV GRAFTS
      
Keywords: ESRD; CKD; AV GRAFTS; THROMBOSED AV GRAFTS
Clinical Trial for PB-119 in Healthy Subjects (Phase I)
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      GLP-1 analogues have been widely used because of their unique advantages (no risk of
      hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide
      in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with Exenatide
      as API).To improve the patients compliance and reduce potential adverse events associated
      with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be administered once
      weekly, was developed by PegBio Inc. In order to provide rational for dosage range to be
      studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic behavior of PB-119 in
      healthy subjects will be studied in this randomized, controlled dose escalating trial.
    


Intervention name(s): PB-119
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: safety,; pharmacokinetics,; Long acting GLP-1 analogue
Cognitive Behavioral Therapy for Nightmares in Children
Condition: Nightmare
Study type: Interventional

Summary: 
      Up to 50% of children experience nightmares annually. Nightmares interfere with sleep quality
      and quantity resulting in sleep deficiency, and are associated with negative mental health
      consequences. Previous research has shown efficacy of manualized CBT treatment for reducing
      trauma related nightmares in adults, and preliminary evidence has shown efficacy in children.
      This study is the first randomized clinical trial to evaluate the effectiveness of the
      treatment for idiopathic, as well as trauma related nightmares in children. The treatment in
      a manualized CBT protocol (5 sessions) that teaches sleep hygiene, relaxation strategies, and
      addresses nightmares therapeutically through exposure and rescripting.
    


Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): The manualized CBT protocol is five sessions that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blinded randomization into 2 groups: Treatment & Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after 6 week wait.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nightmares; Children; Trauma; CBT; Exposure; Relaxation; Rescripting; Cognitive; Behavioral; Therapy
Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery
Condition: Spine Surgery
Study type: Interventional

Summary: 
      The purpose of this study is determine if epidural anesthesia administered after surgery or
      lidocaine administered during surgery will decrease inflammation after spinal surgery and
      decrease the need for post operative pain medication compared to intravenous patient
      controlled analgesia. Participants undergoing spine surgery will be randomized into one of
      two groups;

      - A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV
      infusion.

      B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative
      Patient Controlled Analgesia.
    

Detailed description: 
      According to a survey of 1570 U.S neurosurgeons, in the United States about 527.000 spine
      surgeries were done in 1999. This represents close to 65% of the procedures performed by
      neurosurgeons. Furthermore, the number of hospitalizations related with spine surgery has
      significantly increased since 1970.

      IV PCA is considered the standard of care for postoperative pain control after surgery.
      Intravenous opioids have significant side effects such as respiratory depression,
      postoperative nausea and vomiting and sedation. Furthermore, they cause delayed return of
      bowel function and ileus.

      There is the possibility of surgically inserting a catheter into the epidural space at the
      end of surgery. In general epidural analgesia provides excellent pain relief after surgery
      and decreases opioid consumption significantly und thus opioid related postoperative
      complications. Furthermore epidural anesthesia affects the surgical stress response and might
      decrease inflammatory responses after surgery, thereby improving postoperative recovery and
      mobilization of the patients.

      Intravenous local anesthetics have potent anti-inflammatory properties. They also decrease
      postoperative opioid consumption. Clinical studies have shown that perioperative local
      anesthetic administration significantly reduces the incidence of thrombosis and postoperative
      pain, shortens postoperative ileus and decreases duration of hospitalization.
    

Intervention name(s): Lidocaine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours; perioperative placebo IV saline infusion of 2 mg/kg/h with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
Other intervention name(s): Liodocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spine Surgery; Intraocular pressure; Lidocaine; Epidural Anesthetic