bioihbjkbjnl/mcl2 huggingface dataset:
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
Condition: Whole Cell Pertussis; Haemophilus Influenzae Type b; Hepatitis B; Diphtheria; Tetanus; Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a
      booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15
      to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody
      persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity
      of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to
      subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
    

Detailed description: 
      This study will be conducted in two stages. In the DTP booster phase subjects will receive a
      booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24
      months in a single-blind manner so that the subjects' parents will not know which vaccine was
      administered to their child (this booster phase is no longer recruiting). In the Mencevax
      ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not
      boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open
      manner (this booster phase is not yet recruiting). Up to four blood samples will be taken:
      before and one month after the administration of the DTP booster dose and of Mencevax ACWY.
      To comply with the immunisation calender of Thailand, at 15-24 months all subjects will
      receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of
      varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will
      be offered.
    

Intervention name(s): Tritanrix-HepB/Hib-MenAC; Mencevax ACWY; Tritanrix-HepB/Hiberix; Meningitec
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine; GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine; Wyeth's MenC CRM197 conjugated vaccine, Meningitec
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Prophylaxis diphtheria; Hib & meningococcal serogroup A & C disease
a Randomized Multicenter Trial Comparing Vacuum Assisted Delivery With the New Device "iCUP" Versus the Reference Cup.
Condition: Vacuum Extraction, Obstetrical; Randomized Controlled Trials; Failures, Medical Device; Maternal Lesions; Neonatal Lesions
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis is that the new vacuum assisted delivery device iCup is more effective than
      the reference cup, in terms of maternal and newborn morbidities and functioning
    

Detailed description: 
      Currently, instrumental extractions are used in about 10% to 15% of the 860 000 annual
      deliveries in France and the use of vacuum extractors increases from year to year. In
      addition to sterilizable vacuum extractors several different types of vacuum extractor have
      been developed, in particular the single use Kiwi cup or the so-called 'soft' cup extractors.
      However, studies evaluating these new cups have not shown their superiority in comparison to
      the conventional metallic vacuum extractor.

      Accordingly, it is legitimate to assess the new vacuum extractor iCup, an innovative "mix" of
      metallic cup and 'soft' cups that should combine the advantages of both; and to compare the
      iCup vacuum extractor with the sterilizable metallic cup extractor, the most effective vacuum
      extractors available to date.
    

Intervention name(s): iCup; reference cup
Intervention type(s): Device; Device
Intervention description(s): new vacuum extractor: sterile disposable plastic cup; reference cup of the obstetrical ward: metallic cup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
Condition: Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI
      for the acute treatment of moderate to severe migraine headache.
    


Intervention name(s): Dronabinol MDI
Intervention type(s): Drug
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: efficacy & safety, migraine headache, placebo-controlled; migraine headache with or without aura
Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora
Condition: Intestinal Diseases; Helminthiasis
MeSH terms: Helminthiasis; Intestinal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy
      in the school children population. The aim of this study is to evaluate the efficacy of the
      albendazole one versus two and three doses, in school children infected with intestinal
      helminth.
    


Intervention name(s): albendazole; albendazole; albendazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet of 400 mg of albendazole per day for three consecutive days; single 1 tablet of 400 mg of albendazole; 1 tablet of 400 mg of albendazole per day for two consecutive days
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: albendazole; ascaris; trichiurus; hookworms
Visual Dysfunction in Mild Traumatic Brain Injury (MTBI): A Comparison Group Study
Condition: Post-Traumatic Stress Disorder
MeSH terms: Vision Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      In an on-going study of visual characteristics of personnel diagnosed with a mild traumatic
      brain injury (MTBI) related to their service in Iraq and Afghanistan we found a high rate of
      binocular vision problems (such as double/blurry vision, reading difficult, etc.). These
      individuals are also usually diagnosed with post traumatic stress disorder (PTSD). PTSD is
      known to cause some vision symptoms. We wish to conduct this study on individuals with PTSD
      (but not an MTBI) to see if they have symptoms similar to those in individuals who have MTBI.
      This will provide us with information useful in determining the specific cause of the visual
      symptoms in the MTBI population.
    

Detailed description: 
      We will recruit 75 patients diagnosed with PTSD, but with no history of mild traumatic brain
      injury (MTBI), from the population of the VAPAHCS PTSD Center and Clinics. These volunteers
      will be scheduled for an eye screening developed for a concurrent project to assess visual
      dysfunction (accommodation/vergence insufficiency, pursuit/saccade deficits, etc.) in
      patients diagnosed with MTBI and seen at the Palo Alto Polytrauma Network Site clinic. The
      MTBI patients have unexpectedly high rates of binocular dysfunction, although their visual
      acuities and visual fields are normal/near normal. The MTBI diagnosis is associated with a
      combat blast event in some 90% of cases. Th majority of this population has also been
      diagnosed with PTSD. PTSD is known to cause some visual symptoms, thus it is necessary for us
      to determine if the visual dysfunctions in the MTBI are related to their PTSD diagnosis or
      not. The volunteer participants will be scheduled for an eye screening and consented prior to
      the screening. Inclusion criteria include diagnosis of PTSD, aged 19 to 39, and willingness
      to participate. Exclusion criteria is primarily history of TBI. The visual screen includes
      assessments of visual acuity, visual field, self-reported visual function (i.e., light
      sensitivity, eye fatigue, reading difficulty), and measures of accommodative function,
      vergence, pursuit and saccades. The data collected will be compared to the data from the
      ongoing study of visual dysfunction in patients diagnosed with MTBI.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be drawn from the patient population of the VAPAHCS PTSD Center and
        Clinics.
Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag
Condition: Purpura, Thrombocytopaenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety profile and the photoirritant potential of
      eltrombopag in healthy subjects. The study is placebo- and positive controlled, randomized,
      parallel group with three treatment arms: eltrombopag (75 mg QD), placebo, and a positive
      control (ciprofloxacin, 500 mg BID). Eltrombopag will be administered in a double-blind
      fashion with respect to placebo and the positive control, ciprofloxacin, will be administered
      under observer-blinded conditions. Twelve to fifteen subjects will be recruited into each
      arm, to assure total enrollment of 36 evaluable subjects. The primary endpoint is the
      photosensitizing potential of eltrombopag as measured by photoirritant index (PI) and change
      in minimum erythemal dose (MED) in comparison with placebo.
    


Intervention name(s): Ciprofloxacin; Eltrombopag; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Given 500mg BID x 6 days; Given QD x 6 days; Given QD x 6 days
Other intervention name(s): Ciprofloxacin
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Photoirritant; Photosensitivity; Placebo control; Ciprofloxacin; Eltrombopag
Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
Condition: Obstetric Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Cesarean delivery is one of the most common surgical procedures, performed at an increasingly
      high rate. It is associated with intense postoperative pain that may hamper the
      rehabilitation process and interfere with patient satisfaction and care provided to the
      newborn. Therefore, control of perioperative pain with multimodal regimens using local
      anesthetic may be important in short- and long-term convalescence after surgery.

      Opioid-based regimens are the "gold standard" of cesarean delivery analgesia. However, spinal
      and epidural opioids have a ceiling effect.

      Wound infiltration with local anesthetics has been used widely in the multimodal approach of
      pain relief. Continuous wound infusion with local anesthetic through a multiorifice catheter
      increases the duration of action and efficacy of local surgical wound infiltration compared
      with a one-time wound injection of local anesthetic.

      After cesarean delivery, Local anesthetic continuous wound infusion would be associated with
      better reduction in pain scores when compared to intrathecal morphine . Therefore, an
      assessor and patient blinded, randomized study that aimed to compare the efficacy and side
      effects of these analgesia techniques was conducted.
    


Intervention name(s): wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain); Spinal Anesthesia; intrathecal morphine; Ropivacaine (Ropivacaina Molteni®); Normal saline
Intervention type(s): Device; Procedure; Drug; Drug; Drug
Intervention description(s): After peritoneum closure a 16cm multiorifice perforated catheter (Dosi-Pain® Kit, LEVENTON SAU, Spain) was inserted by the surgeon below the fascia used for normal saline continuous infusion in the Placebo group and for continuous ropivacaine infusion (Ropivacaina Molteni®, MOLTENI FARMACEUTICI, Italy) in the ropivacaine group.; Cesarean section was conducted under spinal anesthesia in both groups; Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group; A10ml bolus of ropivacaine 7.5mg/ml were administered in the wound catheter after skin closure then an infusion of ropivacaine 2mg/ml at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.; A10ml bolus of normal saline were administered in the wound catheter after skin closure then an infusion of normal saline at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.
Other intervention name(s): wound catheter; Placebo
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ropivacaine; wound infusion; analgesia; cesarean; intrathecal morphine; randomized controlled trial
A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia
Condition: Achondroplasia
MeSH terms: Achondroplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for
      the treatment of children with Achondroplasia.
    

Detailed description: 
      This is a Phase 3 randomized, placebo-controlled, double-blind multicenter study with
      approximately 110 subjects, aged 5 to < 18 years old. Subjects with documented Achondroplasia
      confirmed by genetic testing will have been enrolled in Study 111-901 for at least a 6-month
      period immediately before entering into the 111-301 study. Eligible subjects will be randomly
      assigned to one of two treatment groups: placebo or BMN 111 at 15 μg/kg. The route of
      administration is subcutaneous injection and the frequency is daily.
    

Intervention name(s): BMN 111; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection of 15 μg/kg of BMN 111 daily; Subcutaneous injection of 15 μg/kg of placebo daily
Other intervention name(s): Vosoritide; Modified recombinant human C-type natriuretic peptide
Intervention MeSH terms: Natriuretic Peptide, C-Type
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Achondroplasia; Dwarfism; Bone Diseases; Bone Diseases, Developmental; ACH; Natriuretic Peptide, C-Type; Musculoskeletal Diseases; Natriuretic Agents; Physiological Effects of Drugs; Skeletal Dysplasias; Genetic Diseases, Inborn; Osteochondrodysplasias
Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder (MDD) (DEPARRESTCLIN)
Condition: Major Depressive Disorder; Major Depressive Episode
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Predictive factors and biomarkers of response to antidepressants in major depressive disorder
      are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and
      desensitize serotonergic and dopaminergic receptors. The study hypothesis is that
      Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants
      in major depressive disorder. In a controlled prospective open naturalistic monocentric
      3-month study, 60 patients with a major depressive disorder requiring a treatment with
      venlafaxine will be included and assessed before treatment, 1 month and 3 months
      post-treatment. 20 controlled healthy subjects matched for age and gender will also be
      assessed. The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral
      Blood Mononuclear Cell measures and functional pathway. Antidepressant response will be
      assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.
    

Detailed description: 
      Rationale: Predictive factors and biomarkers of response to antidepressants in major
      depressive disorder are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled
      Receptors and desensitize serotonergic and dopaminergic receptors.

      Hypothesis: The study hypothesis is that Beta-arrestins 1 and 2 are predictive factors and
      biomarkers of response to antidepressants in major depressive disorder.

      Method: In a controlled prospective open naturalistic monocentric 3-month study, 60 patients
      with a major depressive disorder requiring a treatment with venlafaxine will be included and
      assessed before treatment, 1 month and 3 months post-treatment. 20 controlled healthy
      subjects matched for age and gender will also be assessed.

      Assessments:

      The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral Blood
      Mononuclear Cell measures and functional pathway.

      Antidepressant response will be assessed using depression scales, olfaction and memory as
      surrogate markers of neurogenesis.
    

Intervention name(s): Venlafaxine extended release
Intervention type(s): Drug
Intervention description(s): antidepressant drug
Other intervention name(s): EFFEXOR
Intervention MeSH terms: Venlafaxine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depression; Antidepressant drug; Beta-arrestin; Biomarker; Predictive factor
A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants
Condition: Healthy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin
      complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters
      (bleeding duration and blood volume) following a punch biopsy, in addition to assessing their
      effects on the anticoagulant/pharmacodynamic (prothrombin time and endogenous thrombin
      potential) changes induced by rivaroxaban at steady state, to better understand their
      potential role in bleeding reversal.
    

Detailed description: 
      This is a 2 part, single center study to be conducted in healthy men and women. Part 1
      (open-label) consists of Screening Phase (within 28 days before admission into the study
      center on Day -1), followed by a 3 day treatment period and a follow-up visit on Day 8. A
      single oral 20 milligram (mg) dose of rivaroxaban will be administered on Day 1.
      Pharmacokinetic (PK), pharmacodynamics (PD), and punch biopsy parameters will be assessed.
      Part 2 (double-blind) consists of Screening Phase (within 28 days before admission into the
      study center on Day -1), followed by a 8 day treatment period (Day -1 to Day 7) and a
      follow-up visit on Day 11. Rivaroxaban (20 mg every 12 hrs) will be administered on Days 1
      through 3 and single 20 mg dose will be given on the morning of Day 4. A single dose of
      either 4-factor PCC, TXA or saline (Placebo) will be administered in a randomized, blinded
      fashion on Day 4. PK, PD, Exploratory Bio-markers and punch biopsy parameters will be
      assessed. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Rivaroxaban; Tranexamic acid; Kcentra, a 4-factor PCC; Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose of 20 milligram (mg) of rivaroxaban orally will be administered to participants on Day 1 in part 1 and through day 1 and 3 with a final 20 mg dose administered on the morning of Day 4 in part 2.; 1.0 g single dose of tranexamic acid (TXA), intravenously administered (over 10 mins) on Day 4.; Kcentra, a 4-factor PCC, 50 IU/kg, single dose, intravenously administered (maximum rate of 210 [international units] IU/min) on Day 4.; Saline [Kcentra saline control or TXA saline control] on Day 4.
Intervention MeSH terms: Rivaroxaban; Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; Rivaroxaban; XARELTO
Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical
      study is designed to test the hypothesis that lurasidone is more efficacious than placebo.
      The study will also evaluate the safety and tolerability of lurasidone as compared to
      placebo.
    


Intervention name(s): Lurasidone; Olanzapine; Placebo comparator; Lurasidone 40 mg tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 120mg/day; 15mg/day; Placebor Comparator; Lurasidone 40 mg tablets
Intervention MeSH terms: Olanzapine; Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Latuda; Lurasidone
GA YAZ ACNE in China Phase III
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg /
      ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne
      vulgaris over 6 treatment cycles.
    


Intervention name(s): EE20/Drospirenone (YAZ, BAY86-5300); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd; Inert tablet
Intervention MeSH terms: Drospirenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate Acne Vulgaris; Oral contraceptive; Female
Effect of Probiotic on Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      Constipation is a prevalent intestinal disorder. Lactobacillus casei strain Shirota (LcS)
      shows potential effect on alleviating constipation. This study evaluated the impact of
      fermented milk containing LcS on stool consistency and frequency. The stool short chain fatty
      acid and gut microbiota were also assessed.
    


Intervention name(s): Lactobacillus casei strain Shirota
Intervention type(s): Dietary Supplement
Intervention description(s): a bottle of 100 mililiter probiotic dairy beverage containing 10^8 CFU Lactobacillus casei strain Shirota every day after lunch.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment