bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females
Condition: Human Papillomavirus; Cervical Intraepithelial Neoplasia; Persistent Infection
MeSH terms: Persistent Infection; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose
      immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle
      vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in
      adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6
      months) in young females aged 18 to 26 years.
    

Detailed description: 
      The study plans to enroll 600 adolescent females aged 9 to 14 years and 300 adult females
      aged 18 to 26 years. The adolescents will be divided into two cohorts, 300 each, receiving
      either a 2-dose (0, 6 months) immunization schedule or a 3-dose (0, 2, 6 months) immunization
      schedule. The adult female group will receive a 3-dose (0, 2, 6 months) immunization
      schedule.

      Each subject shall be administrated with the studied vaccine according to either 2-dose or
      3-dose schedule as above. Immediate reactions occurred during 30 minutes after each
      inoculation, all the local and systematic reactions occurred from 0 to 7 days after each
      inoculation will be recorded. All the adverse events (AEs) occurred from the first dose of
      administration to 1 month after the final dose of administration, as well as all the serious
      adverse events (SAEs) occurred from the first dose of administration to 6 months after the
      final dose of administration will be collected. Blood samples will be collected at day 0
      (prior to immunization) , month 6 (prior to the last injection) , month 7, month 12, month
      24, and month 36. All the blood samples will be tested HPV 16- and HPV 18-specific antibody
      titers.
    

Intervention name(s): HPV-16/18 vaccine
Intervention type(s): Biological
Intervention description(s): HPV 16 L1 virus like particles (VLP) 40μg; HPV 18 L1 VLP 20μg; Aluminium phosphate 225μg; NaCl 0.32M; Histidine buffer 10mM; Tween-80 0.01%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Development of a Telehealth Obesity Intervention for Patients With MS: Modifying Diet and Exercise in MS
Condition: Multiple Sclerosis; Obesity
MeSH terms: Multiple Sclerosis; Obesity
Study type: Interventional

Summary: 
      We will tailor a telehealth obesity intervention for obese patients with MS (figure 2). Half
      of the patients will be randomly assigned to 24 weekly hour-long group weight loss sessions
      and 6 monthly individual sessions; half will be assigned to a brief education/Treatment as
      Usual (TAU) control condition. Participants assigned to the control condition will also
      receive the active treatment 6 months following their enrollment. As such, we will have
      feasibility, acceptability, and outcome data for all patients who enroll and complete the
      intervention. During outpatient recruitment, clinicians will ask obese patients (WHtR >.57,
      BMI >29) if they would be willing to be contacted about a study investigating a weight loss
      intervention for patients with MS. Patients who express interest and respond to
      advertisements will be screened by telephone and via review of medical records. Patients who
      meet initial eligibility criteria will be invited for a baseline evaluation where they will
      be formally consented, complete questionnaires and behavioral tasks, and undergo a
      standardized physical exam. They will be monitored using actigraphy for 10 days. They will
      then be randomized to the group telehealth obesity intervention or TAU. At 6 months, all
      participants will undergo a second in-person follow-up assessment and TAU participants will
      begin the telehealth intervention. At 12 months, participants will undergo a third in-person
      assessment, providing treatment outcome data for all study participants and long-term weight
      maintenance data for patients initially assigned to the telehealth obesity intervention. At
      18 months, participants initially assigned to the TAU control condition will undergo a 4th
      assessment, providing weight maintenance data for all enrolled participants.
    


Intervention name(s): behavioral telehealth; Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will receive 24 weekly group phone counseling sessions. Each session will last approximately 60 minutes and begin with an open-ended check-in question, followed by review of weekly self-monitoring data, question and answer time, and end with a new didactic topic of the week addressing diet, physical activity, or behavior change topics. Participants will be instructed to follow a diet that is reduced to 1200-1500 kcal/day and includes ≥ 5 fruit and vegetable (FV) servings per day, <25% kcal from fat, and 20-30 g of fiber. Physical activity will be gradually increased through a guided home-based program. Throughout the intervention, self-monitoring will be emphasized as a key behavioral weight loss strategy.; Treatment as Usual
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Nuchal Ligament Calcification on Cervical Function in Patients With Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      Ossification of nuchal ligament often observed in patient with chronic neck pain, previous
      study showed ossification of nuchal ligament was associated with cervical spondylosis and
      radiculopathy. Patient with chronic neck pain was divided into two groups according to the
      presence of ossification of nuchal ligament on cervical radiographic images.

      This study is to evaluate and compare the neck function including range of motion, neck
      strength and pressure pain threshold, radiography characteristics and functional disability
      between two groups.
    


Intervention name(s): no intervention was used in this observational study
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        patient with chronic neck pain
      
Keywords: Ossification of nuchal ligament
Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Syndrome
Condition: Hepato-Renal Syndrome
MeSH terms: Hepatorenal Syndrome; Syndrome
Study type: Interventional

Summary: 
      Hepatorenal syndrome is a functional renal impairment occurring in cirrhotic patients . It
      develops secondary to splanchnic arterial vasodilatation which decreases the effective blood
      volume, activate the renin-angiotensin-aldosterone system, and stimulate of sympathetic
      nervous system.This study aims to compare the efficacy of nor-epinephrine versus midodrine/
      octreotide, together with intravenous albumin on renal functions of patients with hepatorenal
      acute kidney injury.
    


Intervention name(s): Midodrine/Octreotide; Nor-epinephrine
Intervention type(s): Drug; Drug
Intervention description(s): oral midodrine plus octreotide as subcutaneous injection; Intravenous infusion norepinephrine
Other intervention name(s): albumin at doses of 20 to 40 g/day; albumin at doses of 20 to 40 g/day
Intervention MeSH terms: Octreotide; Epinephrine; Midodrine; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis
Condition: Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of
      about 70 subjects with moderate to severe plaque psoriasis.
    

Detailed description: 
      Successfully screened subjects will be randomized in a ratio of 2:2:2:1 and stratified to
      previous biologics use for psoriasis.

      After a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment
      for 12 weeks.

      Clinical psoriasis area and severity index (PASI), Physician's Global Assessment (PGA),
      dermatological Quality of Life Index (DLQI), physical exams and Laboratory tests will be
      performed at baseline, the end of weeks 4, 8 and 12 respectively.
    

Intervention name(s): TLL018 tablets
Intervention type(s): Drug
Intervention description(s): Oral tablets administered at different doses BID daily for 12 weeks.
Other intervention name(s): TLL018 Placeboes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
Condition: Pediculosis
MeSH terms: Lice Infestations
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In a previous phase II study, the safety and efficacy of a novel formulation of malathion
      0.5% was evaluated in patients 2 years of age and older. Based on the results of that study,
      this formulation is currently in a phase III study for that population.

      The current study will use blood markers and clinical evaluations to determine the safety and
      tolerability of this formulation when used in children 6-24 months of age.
    


Intervention name(s): MALG (malathion) Treatment
Intervention type(s): Drug
Intervention description(s): MALG applied for 30 minutes
Other intervention name(s): Novel malathion formulation
Intervention MeSH terms: Malathion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head Lice
Single Ascending Dose Study of Two Liquidia Bupivacaine Formulations
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess and characterize the safety and tolerability profile of
      LIQ865A and LIQ865B formulations compared to diluent or aqueous bupivacaine hydrochloride
      when infiltrated into a defined area of the medial calf, and to characterize bupivacaine
      plasma pharmacokinetic (PK) and pharmacodynamic (PD) profiles after a single dose of LIQ865A
      or LIQ865B, and to determine the individual plasma concentration/time curves and mean PK
      parameters of each product.
    

Detailed description: 
      Infiltration of an aqueous local anesthetic, for example, bupivacaine, into surgical sites at
      closure provides temporary analgesia, typically lasting up to 6 hours, and is one aspect of
      the multimodal approach to postsurgical analgesia or fast-track surgery. However, the limited
      duration of action of local anesthetics, even longer acting agents such as bupivacaine,
      result in patients who are likely to experience end of duration breakthrough pain before they
      are able to take or tolerate oral analgesics, thus necessitating the use of strong parenteral
      analgesics in the immediate postsurgical period. LIQ865A and LIQ865B are two distinct
      formulations of bupivacaine manufactured via Liquidia Technologies PRINT (Particle
      Replication In Non-wetting Templates), which Liquidia intends to pursue for product approval.
      Both formulations being tested have the potential for producing long-lasting control of
      post-surgical incisional pain.
    

Intervention name(s): LIQ865A bupivacaine formulation; LIQ865B bupivacaine formulation; Diluent for LIQ865; 0.5% bupivacaine hydrochoride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single subcutaneous injection in medial calf; single subcutaneous injection in medial calf; Sterile diluent composed of 12.5mg/g sodium hyaluronate, 5.8mg/g sodium chloride, 1mg/g polysorbate 80, 6.1mg/g Tris base, in sterile water for injection - single subcutaneous injection; single subcutaneous injection
Other intervention name(s): Marcaine; Marcaine Spinal; Sensorcaine; Sensorcaine-MPF; Sensorcaine-MPF Spinal; Marcaine HCl; Exparel; Marcaine; Marcaine Spinal; Sensorcaine; Sensorcaine-MPF; Sensorcaine-MPF Spinal; Marcaine HCl; Exparel; Hyaluronic Acid; Marcaine; Marcaine Spinal; Sensorcaine; Sensorcaine-MPF; Sensorcaine-MPF Spinal; Marcaine HCl; Exparel
Intervention MeSH terms: Bupivacaine; Hyaluronic Acid
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Analytical, Diagnostic,Therapeutic Technique and Equipment; Anesthesia and Analgesia
A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacokinetics (PK) of SPR720,
      azithromycin, and ethambutol, administered separately and co-administered, in healthy adult
      participants.
    


Intervention name(s): SPR720; Azithromycin; Ethambutol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multiple oral doses of SPR720 capsules.; Multiple oral doses of azithromycin.; Multiple oral doses of ethambutol.
Intervention MeSH terms: Azithromycin; Ethambutol
Intervention model: Sequential Assignment
Intervention model description: It is anticipated that participants will enroll one after another in each arm of this study.
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Rising Oral Doses of BI 1060469 in Healthy Subjects and Mild Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      1060469 in healthy male and female subjects after oral administration of repeated rising
      doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and in
      asthmatic male and female patients after oral administration of repeated rising doses of 25
      mg and 150 mg qd of 1 day followed by 28 days.

      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose
      proportionality, dose linearity after single and multiple dose segments, pharmacodynamics
      (PD) of BI 1060469 and to describe the PK/PD relationship.
    


Intervention name(s): Placebo to BI 1060469; BI 1060469 Healthy; Placebo to BI 1060469 asthmatics; BI 1060469 asthmatics
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablet; tablet; tablet; tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
AttraX® Putty vs. Autograft in XLIF®
Condition: Degenerative Conditions of the Lumbar Spine
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the clinical success of AttraX Putty as a bone
      graft substitute for autograft in XLIF procedures.
    

Detailed description: 
      This is a single-center, prospective, randomized study. Subjects will be recruited from
      patients already under the Investigator's care who are indicated for XLIF with iliac crest
      bone graft (ICBG) autograft or AttraX Putty. To minimize bias, all consecutive patients at a
      given investigational site who meet eligibility requirements will be asked to consent to
      participate in the study whereby the biologic (ICBG autograft or AttraX Putty) will be
      randomly assigned. All subjects will be followed for 24 months following surgery to quantify
      the clinical and radiographic improvements of each biologic compared to baseline and in
      comparison with each other.
    

Intervention name(s): AttraX Putty; Iliac Crest Bone Graft (ICBG)
Intervention type(s): Biological; Other
Other intervention name(s): autograft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Degenerative disc disease; Lumbar spine
Safety/Tolerability and Pharmacokinetic Study of SID142
Condition: Arterial Occlusive Diseases
MeSH terms: Arterial Occlusive Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, oral multiple dosing, two-part, two-way crossover clinical trial to
      evaluate the safety/tolerability and pharmacokinetic profiles of SID142 in healthy volunteers
    


Intervention name(s): Renexin®; SID142
Intervention type(s): Drug; Drug
Intervention description(s): Cilostazol 100mg/ginko biloba leaf extract 80mg, Immediate release, bid; Cilostazol 200mg/ginko biloba leaf extract 160mg, Controlled release, qd
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Weight Loss Prior Mamma Reduction - A Pilot Study
Condition: Weight Loss; Hypertrophy
MeSH terms: Body Weight; Weight Loss; Hypertrophy
Study type: Interventional

Summary: 
      Due to a higher risk of complications, obese and overweight patients with macromastia are in
      Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI < 25 kg/m2.

      The study is a pilot study with a diet intervention group and no control group. The
      intervention is a 12 week low energy diet pre-operative weight loss program investigating if
      this will result in weight loss making the overweight and obese patients eligible for breast
      reduction surgery i.e. BMI < 25.
    


Intervention name(s): Low energy diet
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Men to Test the Influence of BI 1358894 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of
      rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and
      together with BI 1358894 (Test 1, Test 2) following oral administration.
    


Intervention name(s): Rosuvastatin; BI 1358894; Dabigatran etexilate
Intervention type(s): Drug; Drug; Device
Intervention description(s): Tablet; Tablet; Capsule
Intervention MeSH terms: Dabigatran; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
everlinQ Endovascular Access System Enhancements (EASE) Study
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Prospective, single-center study to evaluate the everlinQ System when used to create an
      endoAVF in hemodialysis patients.
    

Detailed description: 
      A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure
      using the everlinQ System. All subjects will be followed for up to 12 months post index
      procedure based on Investigator's discretion.
    

Intervention name(s): everlinQ endoAVF System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pregabalin for Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking
      and reducing drinking severity
    

Detailed description: 
      This is a two cell double blind placebo controlled randomized clinical trial of pregabalin
      for alcohol dependence
    

Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregabalin; patients; treatment
Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process
Condition: Ocular Physiology
Study type: Interventional

Summary: 
      This is a bilateral wear, dispensing, randomized, controlled, double-masked, 2-sequence ×
      2-period crossover study to evaluate ocular physiology following approximately one week of
      contact lens wear.
    


Intervention name(s): TEST LENS; CONTROL LENS
Intervention type(s): Device; Device
Intervention description(s): AO1DfA manufactured with PG hydration; AO1DfA manufactured with IPA hydration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 in Healthy Males
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study in healthy subjects to determine the effect of an 8-hour fast from food on the
      pharmacokinetics of [14C]-BGB-3111.
    

Detailed description: 
      This study will be an open-label, non-randomized study to evaluate the pharmacokinetics of
      [14C]-BGB-3111 when administered in healthy male subjects following at least an 8-hour fast
      from food (not including water).
    

Intervention name(s): [14C]-BGB-3111; BGB-3111
Intervention type(s): Drug; Drug
Intervention description(s): 20-mg capsule containing ~200 μCi of [14C]-BGB-3111,; Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111
Intervention MeSH terms: Zanubrutinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Pharmacokinetics; Safety
Foley Catheter Versus Double-balloon Catheter for Cervical Ripening
Condition: Cervical Ripening; Pregnancy, High-Risk
Study type: Observational

Summary: 
      The objective of this study is to compare pregnancy results which were used foley catheter or
      double-balloon catheter for cervical ripening among high-risk pregnant women.
    

Detailed description: 
      This is a prospective observational study. The planned sample size was calculated as 109
      patients per group with 80% power and 0.05 alpha error.

      The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation,
      bishop score <6, using a foley catheter or cook balloon for cervical ripening and high-risk
      pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational
      or gestational diabetes, hypertensive disorders).

      The exclusion criteria are being younger than 18 or over 40, communication problems, bishop
      score >6, being at active labor, multifetal pregnancy, non-vertex presentation, scarred
      uterus (cesarean or myomectomy), fetal structural or chromosomal anomaly, non-reassuring
      fetal cardiotocography before cervical ripening, regional anesthesia during the first stage.

      The primary outcomes are the rate of bishop score >6 after ripening, vaginal delivery rate
      and vaginal delivery within 24 hours of the initiation of ripening.
    

Intervention name(s): mechanical cervical ripening
Intervention type(s): Device
Intervention description(s): mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women with unfavorable cervices and need to deliver for maternal or fetal health
        condition.