bioihbjkbjnl/mcl2 huggingface dataset:
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
Condition: Respiratory Tract Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the
      efficacy and safety of maternal immunization with RSVpreF against medically attended lower
      respiratory tract illness (MA-LRTI) in infants.
    

Detailed description: 
      This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to
      assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 randomization) in
      infants born to healthy women vaccinated during pregnancy, as well as the safety and
      immunogenicity in the pregnant women. This will be a global study which will span multiple
      RSV seasons.
    

Intervention name(s): RSVpreF; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): RSV vaccine (RSVpreF); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory Tract infection; RSV; Vaccine; Maternal
Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy
Condition: Severe Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This is a multi-country, multicentre, observational cross-sectional one-visit study of
      patients suffering from severe asthma in primary and secondary care settings in Europe
    

Detailed description: 
      This study aims to generate real-world data on the characteristics of patients considered to
      have severe asthma in primary and secondary care settings that should be referred for
      assessment for biologics. It is anticipated that these data from European countries, will
      help to estimate the unmet need for better treatments in severe asthma patients and will
      provide supporting evidence on the current shortcomings in referrals to asthma specialist or
      secondary care clinics. This information could also support the development of better severe
      asthma care pathways across Europe.

      Approximately 1,500 other patients like you will take part in the RECOGNISE study.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients aged ≥ 18 years treated in primary or secondary care settings with
        diagnosed asthma defined as severe according American Thoracic Society/European Respiratory
        Society (ATS/ERS) guidelines (iii).
A Study of GSK573719 in Healthy Japanese Male Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, randomized, double blind, placebo controlled, single and repeat dose
      study to investigate the safety, tolerability, and pharmacokinetics of inhaled dose of
      GSK573719 with lactose and containing magnesium stearate by a novel dry powder device in
      healthy Japanese male subjects.
    


Intervention name(s): GSK573719 250 μg; GSK573719 500 μg; GSK573719 1000 μg; GSK573719 matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Strip 1 of the dry powder inhaler will contain GSK573719 250 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.; Strip 1 of the dry powder inhaler will contain GSK573719 500 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.; Strips 1 and 2 of the dry powder inhaler will contain 500 μg each of GSK573719 micronized drug with lactose along with magnesium stearate. It will be available as dry off white powder for inhalation.; Strip 1 and 2 of the dry powder inhaler will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Lavender Aromatherapy Spine Procedure Study
Condition: Spine Injuries and Disorders; Pain, Back
MeSH terms: Back Pain; Spinal Injuries
Study type: Interventional

Summary: 
      Patient anxiety prior to invasive procedures poses a significant barrier to successful
      treatment if not well-managed. The purpose of this study is to evaluate lavender
      aromatherapy, a non-sedating alternative, to reduce anxiety prior to interventional spinal
      procedures.
    


Intervention name(s): Activated Lavender Elequil aromatabs® (#372); Unactivated Lavender Elequil aromatabs® (#372)
Intervention type(s): Other; Other
Intervention description(s): Activated Lavender aromatherapy tablets wrapped in tape; Unactivated Lavender aromatherapy tablets wrapped in tape
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: aromatherapy; lavender; anxiety; spine intervention
Evaluation of Meningococcal C Vaccine Programmes in Canadian Children
Condition: Meningococcal Sero-type C Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to see which of the three current provincial Meningococcal C
      Conjugate vaccine schedules in Canada provide the longest lasting protection against
      Meningococcal C disease and to see if a booster vaccination is needed.
    

Detailed description: 
      In 2002-2005, Canada introduced universal MenC programmes consisting of 1,2 or 3 infant
      doses. Most are one (12 mth) dose. High rates of serogroupC disease in 2000 and 2001 prompted
      some provinces to launch universal MenC vaccination programmes in 2002. The goal was to
      provide protection in infancy and early childhood (the time of most risk) with the hope that
      the protection would extend throughout adolescence (the second highest risk). It is unclear
      if early multi-dosing or 1 dose programmes would offer better protection (lack of data). Each
      province in Canada has chosen different Meningococcal C Conjugate vaccine provision schedules
      for the primary vaccinations.

      This study will look at short term protection after the differing provincial series of
      vaccinations has been given and compare those who do not get primary vaccination under 1 year
      of age (NS) with two schedules of primary immunization (BC at 2 and 4 mths and Alberta at 2
      months). A blood sample will be collected at 12-13 mths for this comparison. A booster
      vaccination of the current provincial Men C vaccine will be provided at 12 months. Another
      blood sample will be collected 1 mth later to look at the difference in responses between the
      groups (different provincial primary vaccination schedule). 2 years and 4 years later (at age
      3 and age 5), another blood sample will be collected to look at the difference in long term
      protection of the groups where the primary schedule was different.
    

Intervention name(s): NeisVac C vaccine (12mth)
Intervention type(s): Biological
Intervention description(s): NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age
Other intervention name(s): NeisVac C vaccine (Baxter); Meningococcal C congugate vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Meningococcal C vaccine; Meningitis study; Canadian vaccine schedule; Prevention of Meningococcal C disease
PMS Promotes the Recovery of Patients After Heart Valve Replacement
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Study type: Interventional

Summary: 
      Acute gastrointestinal injury (AGI) is related to poor outcomes in patients after heart valve
      replacement. The purpose of this study is to evaluate the effect of the probiotic mixture
      supplementation (PMS) in patients after heart valve replacement by preventing acute
      gastrointestinal injury (AGI).
    

Detailed description: 
      Patients with heart valve diseases often have chronic cardiac insufficiency. Accumulating
      evidence supports a relationship between the complexity and diversity of the gut microbiota
      and heart failure. Bacterial colonization and translocation of their toxins to the
      bloodstream due to altered intestinal permeability are directly correlated with systemic
      inflammation. The activation of pro-inflammatory pathways and chronic inflammation was
      hypothesized as a major contributing factor in the pathogenicity and progression of heart
      failure (HF) Patients undergoing heart valve replacement with cardiopulmonary bypass (CPB)
      are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually
      leads to AGI. AGI is related to poor outcomes of critically ill patients through many
      underlying mechanisms. It can leads to infectious complications, multiple organ dysfunction
      syndromes (MODS), and even death. On the other hand, the supply of probiotics, the good
      bacteria, is beneficial, despite still having a few controversial results. Therefore, it is
      important to carefully assess the efficacy of probiotics in the prevention of AGI and other
      complications in patients undergoing heart valve replacement surgery with CPB, as well as to
      evaluate the safety of its use.
    

Intervention name(s): Probiotic mixture
Intervention type(s): Dietary Supplement
Intervention description(s): orally take .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart valve diseases; Probiotics; microbiomes; cardiac surgery
Alternative Treatments of Vitamin D Deficiency
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in
      treatment of vitamin D deficiency.
    

Detailed description: 
      Patients with vitamin D deficiency were recruited and randomized into two groups, one exposed
      to UVB and the other receiving oral treatment with vitamin D supplementation.
    

Intervention name(s): Narrowband UVB; Vitamin D and calcium
Intervention type(s): Radiation; Dietary Supplement
Intervention description(s): UVB 3 times a week; 1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium
Other intervention name(s): NB-UVB; Vitamin D supplementation
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Vitamin D; UVB; Vitamin D supplementation
Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy
Condition: Cesarean Section Complications
Study type: Interventional

Summary: 
      The present study aims to investigate whether there is a difference in short- and long-term
      complications in patients undergoing cesarean myomectomy (endometrial or serosal myomectomy)
      during cesarean section.
    

Detailed description: 
      Myomectomy is frequently performed during cesarean section. Infertility, myoma recurrence,
      adhesions , uterine rupture (complete/incomplete), impaired uterine healing (partial or
      complete dehiscence/poor/good), placental abnormalities, and perinatal complications in
      subsequent pregnancy are may be associated with cesarean myomectomy. In this study, patients
      who underwent cesarean myomectomy during cesarean section in our institute were analyzed in a
      retrospective manner. Patients were divided into three groups as those receiving serosal
      myomectomy, endometrial myomectomy and those who only underwent cesarean section. The groups
      were compared with respect to the presence of adhesion formation, time to achieve pregnancy
      (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental
      abnormalities.
    

Intervention name(s): Cesarean section with cesarean myomectomy (serosal); Cesarean section without myomectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Serosal or endometrial myomectomy performed during cesarean section; Cesarean delivery without performing myoemctomy
Other intervention name(s): Cesarean section with cesarean myomectomy (endometrial)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cesarean section; Cesarean myomectomy
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
Condition: Preoperative Sedation of Children
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine
      hydrochloride nasal spray for preoperative sedation in children.
    


Intervention name(s): Dexmedetomidine Hydrochloride Nasal Spray; Dexmedetomidine hydrochloride nasal spray blank preparation
Intervention type(s): Drug; Drug
Intervention description(s): In the low weight group, the subjects will receive a low dose of dexmedetomidine nasal spray.
In the high weight group, the subjects will receive a high dose of dexmedetomidine nasal spray.; In the low weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
In the high weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dexmedetomidine hydrochloride nasal spray compared with placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg
      ER Tablets under fasting conditions.
    


Intervention name(s): Eplerenone 50 mg Tablets Sandoz Inc., USA; Inspra 50 mg Tablets GD Searle LLC, USA
Intervention type(s): Drug; Drug
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma
Condition: Urothelial Carcinoma
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single
      agent as first-line and second-line treatment for advanced urothelial carcinoma. The response
      rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is
      one the most active chemotherapeutic agents in urothelial cancer, frequently used as
      combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate,
      vinblastine, adriamycin, and cisplatin).

      Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung
      cancer with highly favorable toxicity profile.

      This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced
      urothelial carcinoma.
    


Intervention name(s): Pemetrexed; Cisplatin; Dexamethasone; Vitamins
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pemetrexed 500 mg/m2 IV over 10 minutes on D1 every 3 weeks; Cisplatin 70 mg/m2 IV over 60 minutes on D1 every 21 days; Dexamethasone 4 mg bid PO from D-1 to D2 every 3 weeks; Folic acid 350 ug - 600 ug daily from D-7 daily vitamin B12 1,000 ug every 9 weeks from D-7
Other intervention name(s): Alimta; cisplan; Dexa
Intervention MeSH terms: Dexamethasone; Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced urothelial carcinoma
A Phase I Study of ICP-022 in Healthy Subjects
Condition: Systemic Lupus Erythematosus; Rheumatoid Arthritis
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, double-blind, placebo-controlled, dose escalation study
      in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ICP-022 following oral single and multiple escalating dose
      administration.
    

Detailed description: 
      This is a single center, randomized, double-blind, dose escalation, placebo-controlled,
      first-in-humans phase 1 study to investigate the safety and tolerability of single and
      multiple escalating doses of ICP-022 in healthy volunteers. 40 healthy male participants
      (aged between 18 and 55 years of age inclusive) will be enrolled into Part 1 (single
      escalating dose administration) of this study, and additional 24 male subjects will be
      enrolled in Part 2 (multiple escalating dose administration). Part 1a consists of 5 cohorts
      of 8 participants each, while Part 2 includes 3 cohorts of 8 participants each.

      Part 1a consists a treatment period with single oral dosing, and a safety follow-up to 7 days
      after dosing. Cohort 4 of Part 1a will return on Day 8 to repeat the study under fed
      condition in Part 1b.

      Part 2 consists a treatment period with multiple dosing (once per day for 14 consecutive
      days), and a safety follow-up until 28 days after dosing. All subjects will receive either
      ICP-022 or placebo.
    

Intervention name(s): ICP-022; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): The drug product is a white, round, uncoated tablet.; The placebo is a white, round, uncoated tablet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
Condition: Osteoarthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single
      Center.
    


Intervention name(s): Ozone gas; Steroid injection
Intervention type(s): Device; Drug
Intervention description(s): Injection of ozone gas intra articularly; Injection of steroids (diprospan) intra articularly
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: A sequential series of patients receiving steroid injections was compared to a sequential series of patients receiving ozone injections
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adavosertib Plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation
MeSH terms: Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Adavosertib in combination with carboplatin, paclitaxel, gemcitabine, or PLD.
    

Detailed description: 
      This is an open-label, four-arm lead-in safety and efficacy study in which adavosertib will
      be combined in four separate treatment arms as follows: adavosertib plus gemcitabine (Arm A);
      adavosertib plus weekly paclitaxel (Arm B); adavosertib plus carboplatin (Arm C); and
      adavosertib plus PLD (Arm D). A subset of patients will be evaluated for the safety
      assessment of each treatment arm.

      The adavosertib plus paclitaxel arm (Arm B) will enrol approximately 30 additional patients
      at selected sites as part of a further efficacy evaluation based on emerging data that
      suggests clinical activity.

      In addition, the adavosertib plus carboplatin arm (Arm C) will enrol approximately 23
      patients overall at selected sites as part of a further efficacy evaluation based on emerging
      data that suggests clinical activity.

      To further optimise the dosing schedule of adavosertib in Arm C, a safety expansion arm
      (referred to as Arm C2) of approximately 12 additional patients will be enrolled at selected
      sites to explore emerging pre-clinical and clinical data that suggest that prolonged
      adavosertib exposure may increase the clinical activity.
    

Intervention name(s): Adavosertib; Paclitaxel; Carboplatin; Gemcitabine; PLD
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Adavosertib will be taken as oral capsules with water, approx. 2 hours before or 2 hours after food.; Paclitaxel will be administered as a 1-hour IV infusion (± 10 minutes) at a dose of 80 mg/m2 according to institutional standards on Days 1, 8, and 15 of each 28 Day cycle.
Patients should be pre-medicated with corticosteroids, diphenhydramine and/or H2 antagonists according to institutional standards.; Carboplatin, at a dose calculated to produce an AUC of 5 will be administered by intravenous infusion according to institutional standards on Day 1 of each 21 Day cycle. The carboplatin dose will be calculated using the Calvert Formula based on the patient's glomerular filtration rate (GFR) which is estimated by using the creatinine clearance.; Gemcitabine 800 mg/m² will be administered IV on Days 1, 8, and 15 of each 28-Day cycle.; PLD (pegylated liposomal doxorubicin) 40 mg/m² IV will be given on Day 1 of each 28-Day cycle.
Other intervention name(s): MK1775; Taxol; Paraplatin
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine; Adavosertib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian, Fallopian Tube, or Primary Peritoneal Cancer