bioihbjkbjnl/mcl2 huggingface dataset:
Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to find out if Interferon-beta can recover its effectiveness in patients with
      Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.
    

Detailed description: 
      This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will
      receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12
      months.

      In the wash-out period prior to commencing treatment with AVONEX, patients will receive
      treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at
      monthly intervals.

      The patients will be examined clinically and laboratory tests will be performed at screening
      (month -1) and after 3, 9, and 15 months.

      Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein
      levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15
      months.
    

Intervention name(s): Interferon-beta-1a; methylprednisolone
Intervention type(s): Drug; Drug
Intervention description(s): dosage and frequency as per label; dosage and frequency as per Biogen Idec protocol
Other intervention name(s): Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Methylprednisolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; antibody; Neutralizing antibody; Binding antibody; MxA protein
An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis
Condition: ACTINIC KERATOSIS
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study was to evaluate the safety and therapeutic equivalence of generic
      ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic
      comparability of the two active products and the superiority of the two active products over
      the vehicle gel in the treatment of AK on the face and scalp.
    

Detailed description: 
      Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the
      Food and Drug Administration (FDA) in 2012 for the topical treatment of AKs on the face and
      scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). The FDA
      approved regimen for ingenol mebutate gel, 0.015% for the treatment of AKs on the face and
      scalp is once-daily application of one unit dose tube for three consecutive days applied to
      one contiguous skin area of approximately 25 cm2 (e.g., 5 cm x 5 cm).
    

Intervention name(s): Ingenol Mebutate (Picato®); Generic Ingenol Mebutate; Vehicle Foam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brand product; Generic formulated to have the same therapeutic effect of the brand; It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
Other intervention name(s): RLD; Test; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Condition: Postoperative Pain in Infants
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Infants handle ketorolac differently than adults. Study of handling of this pain medication
      given to infants following surgery. Detailed analysis of how the drug is eliminated from age
      2 months to 18 months. Compared morphine use in infants who received the drug to the group
      getting placebo. Safety testing for kidney and liver function, breathing measured by
      continuous oximetry, and any bleeding issues.
    

Detailed description: 
      Population kinetic analysis of ketorolac stereo-isomer concentrations after single dose given
      postoperatively in infants aged 2-18 months. Safety assessments of renal and hepatic function
      tests by blood tests before and after drug administration, urinalysis pre- and post-drug,
      continuous oximetry before and for 12 hours after drug. Morphine use between active drug
      groups and placebo group in the first 24 hours after surgery was assessed as a surrogate
      analgesic measure in these non-verbal infants. A modified infant pain scale was used to
      assure consistent pain management.
    

Intervention name(s): Ketorolac Tromethamine 1 mg/kg; Ketorolac Tromethamine 0.5 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.; Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.; Dextrose in water (D5W) infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.
Other intervention name(s): toradol; toradol; Dextrose in water (D5W)
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ketorolac pharmacokinetics; ketorolac stereo-isomers; infants; postoperative analgesia; safety
Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb
Condition: Induction of Labor
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Combined misoprostol and Foley bulb catheter has been shown to be an effective induction
      method. However, optimal route of administration for misoprostol has not been established.

      Therefore, the purpose of this study is to compare the effectiveness and safety of
      combination buccal miso-foley to combination vaginal miso-foley for third trimester cervical
      ripening and induction of labor.
    

Detailed description: 
      This randomized controlled trial of consenting women undergoing induction of labor with
      combined misoprostol and Foley catheter seeks to efficacy of vaginal versus buccal
      misoprostol route of administration.

      This project will include 216 women presenting at Christiana Care Health System. Women will
      be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact
      membranes and are undergoing an induction of labor using a Foley catheter combined with
      misoprostol. Following admission, women will be randomized into either vaginal or buccal
      misoprostol.

      Women will be randomized with equal probability to the intervention group using block
      randomization stratified by party.

      Patients will receive 25 micrograms of misoprostol along with the insertion of a16F Foley
      catheter. Misoprostol can be repeated up to five additional times for a maximum of 24 hours
      or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. The
      remainder of labor management will be at the discretion of each woman's obstetric provider.

      Prior to discharge from the hospital, baseline demographic and clinical data will be obtained
      via chart review
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): Women randomized to either vaginal or buccal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of vaginal or buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water.
vaginal or Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.
Other intervention name(s): cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Donanemab (LY3002813) in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of donanemab
      (LY3002813) when administered as single dose in healthy Chinese participants. The study will
      also assess how fast donanemab gets into the blood stream and how long it takes the body to
      remove it. The study is open to healthy participants. The study will last up to approximately
      85 days.
    


Intervention name(s): Donanemab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered IV.; Administered IV.
Other intervention name(s): LY3002813
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy
Condition: Pregnancy Complications
MeSH terms: Pregnancy Complications
Study type: Observational

Summary: 
      We hope to clarify how betamethasone affects glucose levels in the mother in the days after
      receiving the drug. This understanding will hopefully allow us to better anticipate the risk
      of maternal hyperglycemia and therefore establish more appropriate monitoring of maternal
      glucose to prevent maternal and neonatal complications of hyperglycemia.
    

Detailed description: 
      Pregnant patients who are undergoing inpatient betamethasone therapy as part of their
      clinical care will be eligible for the study. Once the clinical team and patients have agreed
      to pursue betamethasone therapy, the patients' treating physician or nurse will inquire if
      the patient is interested in participating in our study protocol. Those patients who are
      interested in participation will be consented by either a member of the treatment team or the
      study team. Prior to receiving the first betamethasone dose, a soft sensor for continuous
      glucose monitoring system (CGMS) will be inserted superficially under the skin. For those
      patients who will be receiving a scheduled course of betamethasone, the sensor may be
      inserted up to 24 hours prior to the betamethasone administration. The patient will be
      instructed on how to wear and care for the device. She will wear the CGMS for the duration of
      her hospitalization or for up to 7 days total, whichever time period is shorter. For those
      patients who are diabetic, they will receive normal finger stick blood glucose (FSBG)
      monitoring and insulin therapy as determined by their treating physicians. Those patients who
      are not diabetic will need to have 2 FSBG checks each day to correlate with the device.
      Abnormal values will be reported to the patients' treating physician and addressed by the
      treating physician. Prior to being discharged from the hospital, the patient will have the
      device removed. The patient will otherwise be treated routinely. We will record baseline
      demographic information and medical history from each of the women. We will also record
      information from the neonates' newborn medical records.
    

Intervention name(s): Dexcom Seven Plus Continuous Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women receiving betamethasone
A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Plaque, Atherosclerotic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic
      plaque in patients with coronary heart disease (CHD) including patients with other CHD risk
      factors. After a pre-randomisation period during which positron emission tomography computed
      tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either
      RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at
      intervals during the study. The anticipated time on study treatment is 2 years, and the
      target sample size is 100 individuals.
    


Intervention name(s): Dalcetrapib (RO4607381); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600mg po daily for 24 months; po daily for 24 months
Intervention MeSH terms: Dalcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes
Condition: Cartilage Injuries in the Human Knee
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain
      a repair and prevention of secondary osteoarthritis
    


Intervention name(s): Human allogenic chondrocytes
Intervention type(s): Procedure
Intervention description(s): Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Laughter Yoga Therapy on Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Laughter yoga sessions, stretches and stretches, songs, clapping and body It starts with
      light warm-up techniques that include movements. These are to break down all kinds of
      inhibitions and It is aimed at developing the feelings of childlike play. breathing exercises
      lungs they are ready to laugh and are combined with the following series of laughing
      exercises. LY In order to provide group dynamics in therapy, the group should consist of at
      least 5-12 people.

      provided. Real laughter is often experienced during laughter meditation; it's contagious and
      may trigger laughter in other people in the group, hence the group can establish greater
      connections with its members. Laughter yoga sessions are always held at the same time and in
      the same place to encourage the participation of individuals.

      has been done.
    

Detailed description: 
      Laughter yoga sessions, stretches and stretches, songs, clapping and body It starts with
      light warm-up techniques that include movements. These are to break down all kinds of
      inhibitions and It is aimed at developing the feelings of childlike play. breathing exercises
      lungs they are ready to laugh and are combined with the following series of laughing
      exercises. LY In order to provide group dynamics in therapy, the group should consist of at
      least 5-12 people.

      provided. Real laughter is often experienced during laughter meditation; it's contagious and
      may trigger laughter in other people in the group, hence the group can establish greater
      connections with its members. Laughter yoga sessions are always held at the same time and in
      the same place to encourage the participation of individuals.

      has been done. Therapy sessions are between 40-45 minutes. Sessions started on time and was
      completed on time. In the research, a total of 6 sessions of laughter, once a week, yoga was
      done. The experimental group was interviewed in an online meeting prepared by a certified LY
      trainer.

      She received LY exercises once a week (40 minutes per session) for 6 weeks (6 sessions). Each
      The meeting was organized with a maximum of 12 people.
    

Intervention name(s): Laughter yoga
Intervention type(s): Other
Intervention description(s): The experimental group was interviewed in an online meeting prepared by a certified LY trainer.
She received LY exercises once a week (40 minutes per session) for 6 weeks (6 sessions). Each The meeting was organized with a maximum of 12 people.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations
Condition: Menopause; Menopausal Vasomotor Symptoms
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes
      have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone
      replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and
      safety of different hormonal combinations will be evaluated and compared to placebo over the
      six month treatment period.
    


Intervention name(s): 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA); 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA); placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One tablet per day for 24 weeks; One tablet per day for 24 weeks; Placebo tablets for 24 weeks
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hot flashes
The Effect of Telerehabilitation on Clinical Stress Level and Stress Responses in Nursing Students
Condition: Stress
Study type: Interventional

Summary: 
      It was aimed to examine the effect of telerehabilitation on clinical stress level and stress
      responses in nursing students.
    

Detailed description: 
      It was aimed to examine the effect of telerehabilitation on clinical stress level and stress
      responses in nursing students.There is no study in the literature examining the relationship
      between telerehabilitation and clinical stress in nursing students. Since our study will be
      the first to investigate the subject, we foresee that it is scientifically important and will
      shed light on future studies. In addition, national or international publications are planned
      after the study is completed.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Muscle relaxing Technique
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel
      anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic
      asthma and the related increased sensitivity of the airways to other substances, as well as
      to investigate a possible anti-inflammatory effect of the drug in the airways.
    


Intervention name(s): Nebulized IVX-0142
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Allergic asthma; Allergen challenge; Bronchial hyperresponsiveness
Validation of a Nociception Monitor in Healthy Volunteers
Condition: Pain
Study type: Interventional

Summary: 
      Anesthesiology daily practice consists in management of sedation, immobility and analgesia.
      The monitoring of this last component remains largely based on indirect signs with poor
      sensitivity and specificity such as heart rate and blood pressure. Accordingly, there is an
      increased demand for more accurate analgesia monitors. Several parameters have been studied
      in the recent years such as spectral entropy, skin conductance, pupillometry or heart rate
      variability (HRV). The HRV is influenced by the balance of sympathetic and parasympathetic
      tones, and is therefore influenced by pain and analgesia.

      MDoloris Medical Systems SAS, located in Lille, France, had developed a monitor called
      PhysioDoloris (TM) that uses an analysis of the HRV to generate a clinically useable index,
      the Analgesia-Nociception Index (ANI). The ANI varies from 0 to 100, a lower number
      indicating less parasympathetic tone. It has been shown in previous studies under general
      anesthesia to decrease at the moment of surgical incision and pneumoperitoneum inflation and
      to increase with opioids administration.

      The purpose of this study is to show a correlation between the variation of the ANI with pain
      scores in awake healthy volunteers who are subjected to standardized painful stimuli of
      increasing intensity. The investigators hypothesize that an increasing pain score will
      correlate with decreasing ANI values.
    

Detailed description: 
      See above
    

Intervention name(s): Stimulation
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Analgesia; Monitoring; Analgesia Nociception Index; ANI; PhysioDoloris; Pain
Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This multi-center, open-label study is designed to examine the effects on long-term glucose
      control and safety of AC2993 in patients with type 2 diabetes treated with metformin,
      sulfonylurea, or metformin and sulfonylurea combination.
    


Intervention name(s): AC2993
Intervention type(s): Drug
Intervention description(s): Subjects will receive 5 μg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 μg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.
Other intervention name(s): synthetic exendin-4
Intervention MeSH terms: Exenatide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exenatide; exendin-4; diabetes; Amylin; Lilly