bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is an open-label extension study, offering patients who participated and completed
      previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2
      additional years. The expectation is first to demonstrate that extended treatment with
      DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only
      patients who completed the previous 2-year study and still have beta-cell function above a
      threshold level will be eligible for this extension study.
    


Intervention name(s): DiaPep277
Intervention type(s): Drug
Intervention description(s): 1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; beta cells; immunomodulation; immunointervention
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus (SLE)
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic
      agent in the current treatment landscape where subjects with SLE have ongoing disease
      activity despite treatment with standard of care therapies.
    

Detailed description: 
      This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized,
      placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate
      response to SOC therapies including oral corticosteroids (OCS), immunosuppressants and
      immunomodulators. Previous biologic use is allowed with an adequate washout period.
    

Intervention name(s): Rozibafusp Alfa; Placebo for Rozibafusp Alfa
Intervention type(s): Drug; Drug
Intervention description(s): Rozibafusp Alfa will be presented in 5 mL glass vial; Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including OCS, immunosuppressants, and immunomodulators. Subjects will be randomized to receive placebo or 1 of 3 doses of Rozibafusp Alfa with the last dose at week 50. Treatment will be administered every 2 weeks (Q2W). All subjects will be required to complete a 16-week follow-up period after the 52-week treatment period.
The first interim analysis (IA) will be executed after the first 40 enrolled subjects have had the opportunity to complete the week 24 assessment. Additional IAs may be executed after approximately every 32 newly enrolled subjects have had the opportunity to complete the week 24 assessment. The last IA will occur when all subjects have had the opportunity to complete the week 24 assessment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Standard of Care therapies; Oral Corticosteroids; Inmunosuppressants; Immunomodulators; Systemic Lupus Erythematosus; B cell Activating Factor (BAFF); Inducible T cell costimulator ligand (ICOSL)
Micropulse Transscleral Diode Laser Cyclophotocoagulation (MP-TSCPC) as a Treatment Modality for Glaucoma Patients
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The study objective was to evaluate the efﬁcacy and safety of transscleral
      cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various
      types of glaucoma.
    

Detailed description: 
      Evaluation of the efﬁcacy and safety of a new form of transscleral cyclophotocoagulation
      (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.

      In this study, 810 nm infrared diode laser radiation in the micro- pulse mode was used in
      conjunction with a G probe (IRIDEX Medical Instruments, Mountain View, CA, USA).

      The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser set on micro-
      pulse mode, delivered over 100-200 seconds (envelope of micropulses) depending on severity of
      the case and other patient factors. With duty cycle 31.3% (This translates to 0.5 ms "on"
      time and 1.1 ms "off" time), which allows the tissue to cool down between laser shots, thus
      greatly reducing thermal damage.
    

Intervention name(s): Micropulse transscleral cyclophotocoagulation (MP-TSCPC)
Intervention type(s): Device
Intervention description(s): patients undergone micropulse laser transscleral cyclophotocoagulation. The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser radiation set on micro- pulse mode (Iris Medical Instruments, Mountain View, CA, USA), delivered over 100-200 s (envelope of micropulses) depending on severity of the case and other patient factors.
Follow-up was done at day 1, week 1, month 1, month 3, and month 6 postoperatively.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glaucoma; micropulse laser
Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring
Condition: Gastric Acid-related Diseases; Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH
      Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers
    


Intervention name(s): Calcium (13C)Carbonate
Intervention type(s): Drug
Intervention description(s): Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate
Intervention MeSH terms: Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Patients; Volunteers
The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the duration of application of halobetasol
      propionate 0.05% ointment to be used in a definitive study of bioequivalence of to
      formulations of this ointment.

      Part A: To validate vasoconstrictor assay precision.

      Part B: To evaluate the dose response vasoconstriction profile of Ultravate® 0.05% ointment
      at different dose durations over a short period of time (0.17 - 4 hrs).
    

Detailed description: 
      Study Type: Interventional Study Design: A single blind, single-exposure study on healthy
      adult male and female subjects.

      Official Title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction
      Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy
      Adult Subjects: Dose Ranging Study

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Vasoconstrictor Response
    

Intervention name(s): Ultravate® 0.05% ointment, single exposure
Intervention type(s): Drug
Intervention description(s): A: Experimental Subjects received Bristol-Myers Squibb Company formulated products
Other intervention name(s): Halobetasol
Intervention MeSH terms: Halobetasol
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Vasoconstriction; Halobetasol; Healthy adult subjects
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study explores how aromatase inhibitor therapy affects risk factors for heart disease in
      postmenopausal women with breast cancer.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breast cancer patients will be recruited via the Magee Breast Cancer Program of the Cancer
        Center at the University of Pittsburgh Medical Center. Healthy controls will be recruited
        via registries.
      
Biospecimen description: 
      Frozen serum samples. No further testing planned at the moment.
    
Keywords: Aromatase Inhibitor; Anastrazole; Arimidex; Heart disease; Lipids; Body composition; Breast cancer.
Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
Condition: Atrium; Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and
      Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation.

      The clinical study is intended to establish the efficacy and safety of the CardiacSense1
      wearable device intended to monitor and detect heart arrhythmia, specifically atrial
      fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf
      cleared Holter ECG device
    

Detailed description: 
      The clinical study is intended to establish the efficacy and safety of the CardiacSense1
      wearable device intended to monitor and detect heart arrhythmia, specifically atrial
      fibrillation (A-Fib). Study design as as follows:

      100 subjects, 50 (at least 30% of each gender) with A-fib and 50 without (at least 30% of
      each gender).

      All subjects will be measured during at least 24 hours. Primary endpoint - A-Fib detection
      Control: Holter device will be the reference

      For PPG analysis, each one hour will be considered as an event:

      If A-Fib is present for more than accumulated 5 minutes in that specific hour then it shall
      be considered an "A-Fib hour" If A-fib was present for less than accumulated 5 minutes then
      it shall be considered a "Non-A-Fib hour".

      For ECG analysis, each measurement of between 1-3 minutes will be considered an event.

      If A-Fib is present at that specific measurement, then it shall be considered an "A-Fib
      event" If A-fib was not present at that specific measurement, then it shall be considered a
      "Non-A-Fib hour".

      Sensitivity (true positive) is defined as the percentage of Holter defined "A-fib
      hours"/"A-Fib event" found by PPG/ECG.

      The asked sensitivity is 90%. Specificity (true negative) is defined as the percentage of
      Holter defined "Non-A-fib hours"/"A-Fib event" found by PPG/ECG. The required specificity is
      90%.
    

Intervention name(s): CS1 & heart monitor
Intervention type(s): Device
Intervention description(s): Daily activities while wearing the investigational device as well as the control device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Males and females, 50 of them diagnosed with atrial fibrillation (AF), and 50 healthy participants, at least 30% of each gender in each group.
Masking: None (Open Label)
Primary purpose: Screening
Ice-pick Intubation With Video Laryngoscopes in a Manikin With Restricted Access to the Airway
Condition: Tracheal Intubation
Study type: Observational

Summary: 
      To determine whether video laryngioscopes facilitate intubation in ice-pick position in a
      manikin with restricted access to the airway
    

Detailed description: 
      To determine whether video laryngioscopes facilitate intubation in ice-pick position (also
      called inverse intubation) in a manikin with restricted access to the airway
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        anaesthesiologists
      
Keywords: intubation; video laryngoscopes
Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine
Condition: Avian Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose
      between subjects previously vaccinated with LAIV H5N2 and naïve subjects
    

Detailed description: 
      It is a non-randomized, open label study to evaluate a licensed OrniFlu® inactivated vaccine
      (produced by Microgen Russia) which will be given to healthy adult volunteers who
      participated in a double blind placebo-controlled study Protocol No.: GPO AVIAN FLU
      Vaccine-V02-2 at Vaccine Trial Centre and Department of Clinical Tropical Medicine, Faculty
      of Tropical Medicine, Mahidol University in February to May 2013.

      A total of 60 subjects, of whom 40 received two doses of LAIV H5N2 (prime-boost group), and
      20 received placebo (control group) in the previous study will be asked to return to the
      clinic to receive a single dose of an inactivated H5 influenza vaccine.

      Total foloww up is 90 days.
    

Intervention name(s): OrniFlu® inactivated vaccine
Intervention type(s): Biological
Intervention description(s): All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H5N2 Vaccine
Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
Condition: Alcoholic Hepatitis (AH)
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of selonsertib
      (GS-4997) in combination with prednisolone versus prednisolone alone in participants with
      severe alcoholic hepatitis (AH).
    


Intervention name(s): Selonsertib; Prednisolone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 18 mg tablet administered orally once daily; 40 mg (4 x 10 mg tablets) administered orally once daily; Selonsertib placebo tablet administered orally once daily
Other intervention name(s): GS-4997
Intervention MeSH terms: Prednisolone; Selonsertib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cirrhosis; Prednisone; Jaundice
Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
Condition: Pain
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the ability of a single-dose of a novel ibuprofen formulation to
      relieve pain compared to placebo and standard ibuprofen in the treatment of episodic
      tension-type headache.
    


Intervention name(s): Novel Ibuprofen; Standard Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo; Single-dose of standard ibuprofen (400mg) plus placebo; Single-dose of placebo
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Headache
A Prospective Epidemiological Cohort Study Evaluating Occurrences of Influenza-like Illness.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      This Prospective epidemiological cohort study is being conducted in order to generate
      epidemiological data in support of Osivax's clinical development of a broad spectrum
      influenza vaccine based upon the internal influenza nucleoprotein (NP) as a target for immune
      response.
    

Detailed description: 
      The present study is being conducted in order to generate epidemiological data in support of
      Osivax's clinical development of a broad spectrum influenza vaccine based upon the internal
      influenza nucleoprotein (NP) as a target for immune response.
    

Intervention name(s): Blood samples
Intervention type(s): Other
Intervention description(s): Collection of blood samples and completion of an electronic Diary (eDiary)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects, men and women aged 18 to 55 years.
      
Biospecimen description: 
      Serum samples (total volume approximately 10 mL of whole blood per visit) obtained at study
      entry (before onset of the influenza season) and 6 months after, upon completion of the
      influenza season, will serve as alternative method for case confirmation and detection of
      unrecognized or asymptomatic infections.
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and
      safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an
      alternative dosing schedule as compared to the standard dosing schedule in young female
      subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with
      the FDA Amendment Act, Sep 2007.
    


Intervention name(s): Cervarix TM; Cervarix TM
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.; Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Other intervention name(s): HPV vaccine (GSK580299)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV; cervical cancer; papillomavirus; Human papillomavirus (HPV) vaccine
Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine whether a combination of ACP-103 (the study
      medication) with either haloperidol or risperidone will show antipsychotic efficacy and that
      it is safe and well tolerated. Further purposes of this study are to determine whether
      ACP-103, in combination with either haloperidol or risperidone, will enhance their
      antipsychotic effectiveness, demonstrate effectiveness against the negative symptoms, improve
      motoric tolerability, and is safe and well tolerated.

      This is a seven-week study (one week screening and six weeks of study medication) where a
      total of 400 patients who meet entrance criteria will randomly be assigned to receive one of
      five groups of study treatments of either low dose haloperidol plus ACP-103, low dose
      haloperidol plus placebo (a substance similar to a sugar pill), low dose risperidone plus
      ACP-103, low dose risperidone plus placebo, or high dose risperidone plus placebo. The study
      will begin with with a three to seven day drug-free period followed by six weeks of a stable
      daily dosage of study medication. Study subjects will be treated as hospital in-patients
      during screening and for the first 14 days of the study. Study subjects will be closely
      monitored throughout the study.
    


Intervention name(s): ACP-103
Intervention type(s): Drug
Intervention MeSH terms: Pimavanserin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; psychosis; delusions; hallucination
Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector
Condition: Contraceptive Usage; Bleeding Due to Intrauterine Contraceptive Device
Study type: Interventional
Phase: Phase 4

Summary: 
      The main side-effect of Implanon is the changes induces in bleeding patterns including
      amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without any
      previous symptom and it was characterized as "breakthrough bleeding" (BTB). BTB is the main
      causes of early discontinuations. Unfortunately, there is no indication to predict prior to
      insertion what sort of bleeding pattern any individual woman may have after insertion and the
      proposed treatments were disappointed. Nevertheless, previous studies with other
      progestin-only contraceptives (including Implanon) provide evidence that the provision of
      adequate and intensive counseling to potential users and new acceptors about bleeding changes
      can help to improve method continuation.

      The availability of Implanon in the public sector could help in the development of strategies
      to introduce the method in the public sector network and the training of medical residents.
    

Detailed description: 
      100 women were either allocated to received Implanon contraceptive implant, the LNG-IUS or
      TCu380A copper-IUD. The women were allocated according to their preference on each of the
      contraceptive methods.

      half of the women will receive the common counseling at the clinic and the other 50% will
      receive intense counselling about menstrual changes induced by these three contraceptive
      methods. The continuation rate up to one year will be evaluated through life-table analysis
    

Intervention name(s): copper-releasing intrauterine device; ENG-releasing implant; LNG-releasing intrauterine system; LNG-IUS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 100 women received a 380 mm2 of copper releasing intrauterine device; 60 mcg/day releasing etonogestrel implant; a LNG-IUS releasing 20 mcd/day of LNG; 100 women will receive an LNG-IUS
Other intervention name(s): Optima, Injeflex, Brazil; Implanion, MSD, Os, The Nedherland; Mirena, Bayer Oy, Turku, Finland; Mirena, Bayer Oy, Turku, Finland
Intervention MeSH terms: Copper; Levonorgestrel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment