bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen
      (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for
      hypoglycemia rescue of adult patients with type 1 diabetes.
    

Detailed description: 
      This is a blinded, randomized, Phase 3 comparative efficacy and safety study in adults with
      type 1 diabetes. Patients will complete screening procedures up to 60 days before
      randomization to determine eligibility before enrollment to the treatment phase.

      The procedure for evaluating the efficacy of the G-Pen (glucagon injection) consists of
      inducing hypoglycemia by intravenous administration of regular insulin diluted in normal
      saline. Each participant will undergo two episodes of insulin-induced hypoglycemia, and in
      random order will receive 1 mg G-Pen (glucagon injection) during one episode and 1 mg Lilly
      Glucagon during the other episode. There will be wash out period of 7-28 days between
      treatment visits.

      Blood glucose levels will be monitored post-dosing, with a return of plasma glucose to a
      concentration > 70 mg/dL within 30 minutes signifying successful hypoglycemia rescue. As a
      confirmation of efficacy, subjects will complete a questionnaire concerning changes in
      symptoms of hypoglycemia following treatment with glucagon.

      Subjects will return for a follow-up safety visit 3-14 days following administration of the
      final dose of glucagon.
    

Intervention name(s): G-Pen (glucagon injection); Lilly Glucagon (glucagon injection [rDNA origin])
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector; 1 mg of Lilly glucagon reconstituted from lyophilized powder
Other intervention name(s): glucagon; glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of
      dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran
      etexilate as capsule following oral administration. To evaluate acceptability and
      palatability of Pellets sprinkled on food and Oral Liquid Formulation
    


Intervention name(s): Dabigatran etexilate; Dabigatran etexilate; Dabigatran etexilate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pellets (multiple dose of dabigatran); Granules resolved in reconstitution solution (multiple dose of dabigatran); Hard capsule (multiple dose of dabigatran)
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Microbiome Analysis of Constipated Versus Non-constipation Patients
Condition: Rome IV Functional Constipation
MeSH terms: Constipation
Study type: Observational

Summary: 
      This study intends to evaluate the microbiome of chronically constipated patients as compared
      to those with a non-constipated gastrointestinal system.
    

Detailed description: 
      Biogeographically accurate microbiome sampling using the HyGIeaCare platform and an
      evolutionary biology informed learning platform will allow an improved discovery of
      bacterially derived novel molecular entities with therapeutic potential for chronic
      constipation. This approach intends to enhance our ability to understand the gut microbiome
      and use it towards developing therapeutic solutions, in comparison to traditional collection
      methods and taxonomic-based data analysis approaches.
    

Intervention name(s): No change in procedure except for specimen collection throughout procedure
Intervention type(s): Other
Intervention description(s): Stool specimens will be taken before and during the HyGIeaCare procedure. Microbiome comparisons will be made across all specimens
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers and chronically constipated patients
      
Biospecimen description: 
      Overall, we expect to enroll 20 subjects. Each volunteer or patient will provide a
      traditional stool sample ("spot sample"), collected in their home. During the HyGIeaCare
      prep, we will collect up to 3 samples from each patient (unless we will need an "initial" one
      from the constipated population).
Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to
      placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe
      chronic obstructive pulmonary disease (COPD).
    


Intervention name(s): Inhaled PT005; Inhaled PT005; Inhaled PT005; Inhaled placebo; Formoterol Fumarate 12 mcg (Foradil Aerolizer)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose, inhaled; single dose, inhaled; single dose, inhaled; single dose, inhaled; single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer
Other intervention name(s): Foradil Aerolizer
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Health Evaluation of Abilify Long-term Therapy
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a post-market surveillance, and the treatment to patients will be depended upon the
      decision based on physician's clinical judgment. The health profiles during the switching
      period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will
      be recorded and evaluated.
    

Detailed description: 
      Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Oral Contraceptive Pill for Premenstrual Worsening of Depression
Condition: Premenstrual Syndrome; Depression
MeSH terms: Premenstrual Syndrome; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      To determine if augmentation with the oral-contraceptive pill containing drospirenone and
      ethinyl estradiol is more effective than placebo in the treatment of premenstrual
      breakthrough of depression.
    


Intervention name(s): Drospirenone and ethinyl estradiol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily by mouth; Once daily by mouth
Other intervention name(s): Yaz
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Women; PMS; Depression
Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      What is the best medication for hormonal stimulation in cycles with high intra-uterine
      insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days)
      or daily injections with Human Menopausal Gonadotropin (Menopur)?
    


Intervention name(s): Clomifen, Ethinyl Estradiol; Menotropins
Intervention type(s): Drug; Drug
Intervention description(s): starting on day 2 or 3 of the cycle: 1 tablet of Clomifen each day, for 5 days in a row. Dose 50mg or in subsequent cycles, 25 mg or 100 mg or 150 mg. After the 5 days of Clomifen, one tablet of Ethinyl Estradiol 50 mg per day, for 5 days in a row or until beta hCG is injected; Starting on day 2 or 3 of the cycle, a daily subcutaneous injection of 37.5 IU or 75.0 IU
Intervention MeSH terms: Ethinyl Estradiol; Clomiphene; Menotropins; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biochemical and Genetic Markers of Hypertension in Women
Condition: Cardiovascular Diseases; Hypertension; Heart Diseases; Inflammation
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases; Inflammation
Study type: Observational

Summary: 
      To investigate biochemical and genetic markers of inflammation and endothelial dysfunction as
      determinants of hypertension.
    

Detailed description: 
      BACKGROUND:

      Hypertension affects up to 50 million Americans, and is a major risk factor for
      cardiovascular disease and other health outcomes. Among Black women, hypertension is more
      prevalent, less well controlled by treatment, and has more damaging health outcomes versus
      Whites for reasons still unclear. While several lifestyle and dietary factors are associated
      with hypertension, relevant biochemical and genetic markers remain less well studied

      DESIGN NARRATIVE:

      This is a nested case-control study of incident hypertension in 800 case-control pairs (400
      each of white and black women, totaling 1,600 women). Data will be used from the Women's
      Health Initiative Observational Study (WHI-OS), a cohort of 93,676 ethnically diverse
      postmenopausal women aged 50 to 79 years with extensive clinical and questionnaire data.
      Three hypotheses will be tested. First, the investigators will assess whether markers of
      inflammation - C reactive protein (CRP), interleukin-6 (IL-6), IL-1-8, tumor necrosis factor
      (TNF) receptor 2, soluble intercellular adhesion molecule-1 (slCAM-1), and
      metalloproteinase-9 (MMP-9) - are associated with the risk of hypertension in White and Black
      women. Second, they will examine six novel polymorphisms linked to the above inflammatory
      biomarkers - the CRP, IL-6, IL-1-beta, TNF-a, slCAM-1, and MMP-9 genes- and two other
      polymorphisms related to inflammation and the metabolic syndrome- the adiponectin and PPAR-y2
      genes - for their potentially important associations with the risk of hypertension. Third,
      they will comprehensively evaluate important single-nucleotide polymorphisms in the above
      genes and examine associations between common haplotypes and hypertension risk in White and
      Black women, using state-of-the art genotyping technology and statistical methods. Power is
      excellent; for each biochemical marker, they have 80% power to detect a trend across
      quintiles for a relative risk (RR) of hypertension, comparing the fifth versus first
      quintiles, of 1.49 for analyses of 800 case-control pairs and 1.74 for analyses of 400
      case-control pairs. For each genetic marker, they have 80% power to detect an additive effect
      of an allele for a RR of hypertension of 1.36 for 800 case-control pairs and 1.57 for 400
      case-control pairs.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women's Health Initiative Observational Study (WHI OS)
The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      It is postulated that high frequency repetitive transcranial magnetic stimulation (rTMS) can
      decrease the corticospinal inhibition and enhance the motor recovery. This study is aimed to
      investigate the effect of high frequency rTMS on lower extremity motor recovery and gait
      parameters in patients with chronic motor incomplete traumatic spinal cord injury (SCI).
    

Detailed description: 
      A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1
      year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS
      group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the
      motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS
      sessions, patients underwent a rehabilitation program including exercises for strengthening,
      walking and balance. Lower extremity motor score (LEMS), the temporal-spatial gait parameters
      measured by 3D gait analysis, Walking Index for SCI-II (WISCI-II) scale and 10 meters walking
      test were assessed at baseline, 3 weeks (after the treatment sessions) and 5 weeks
      (follow-up).
    

Intervention name(s): repetitive transcranial magnetic stimulation therapy
Intervention type(s): Device
Intervention description(s): A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance.
Other intervention name(s): rehabilitation program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: r TMS; spinal cord injury; motor recovery,; gait
The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder
Condition: Depression
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study evaluated the effectiveness and safety of improving depressive symptoms by
      applying tDCS for 6 weeks to patients with mild to moderate depression.
    

Detailed description: 
      Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over
      the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5~7 times a week
      and they were evaluated every 2weeks through questionnaires.
    

Intervention name(s): Mind STIM
Intervention type(s): Device
Intervention description(s): transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 4

Summary: 
      The trial is designed to evaluate the efficacy and tolerability of carbamazepine in
      neuropathic pain in diabetic patients
    


Intervention name(s): Carbamazepine
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuropathic Pain; Brief Pain Inventory; DN4 questionnaire; ElectroCardioGram
Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
Condition: Upper Gastrointestinal Surgery; Post-operative Analgesia; Wound Infusion Catheter; Upper Midline Incision
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Comparison of efficacy in management of pain in abdominal surgery between epidural versus
      wound infusion catheter {catheter placed within the incision site}
    


Intervention name(s): Wound catheter infusion; Epidural infusion
Intervention type(s): Other; Other
Intervention description(s): Wound catheter has multiple holes spread around 360 degrees throughout its active length. It is placed in the musculofascial plane during closure of the wound. Local anaesthetic infusion will be delivered through the catheter.; Epidural catheter will be placed in the level T7-T9 , and local anaesthetic infusion will be given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Testing a New App for Children With Glue Ear
Condition: Hearing Loss, Conductive
MeSH terms: Hearing Loss; Hearing Loss, Conductive; Otitis Media with Effusion
Study type: Interventional

Summary: 
      To assess whether children with glue ear ( and some normal hearing controls) and their
      families find the Hear Glue Ear application acceptable and easy to use. Whether the hearing
      screening section on the app is comparable to the hearing test data obtained from formal
      audiology hearing tests.
    

Detailed description: 
      The Hear Glue Ear application aims to provide up-to-date information for families as well as
      audiobooks, songs and games for children with hearing loss secondary to glue ear, to be able
      to aid with their developmental skills (particularly speech, language, auditory processing,
      auditory memory and listening skills) during the period of time when they have glue ear.

      Outcome measures include acceptability of the application by the family (provided by
      questionnaires to the child and an adult parent/ carer), usability of the app (a member of
      the research team will observe the child using the app and how much difficulty they have such
      as how many times the researcher has to help/ intervene) and comparison of the hearing screen
      on the app with formal audiology hearing test result.
    

Intervention name(s): Hear Glue ear application
Intervention type(s): Device
Intervention description(s): Hear Glue ear is an application used on phones, ipads, tablets or computers which provides free information, songs, audiobooks, games and a home hearing screening game.
Other intervention name(s): headphones used with the hearing screening game on the application
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Teal of an app
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: glue ear
Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Problems with diabetes management in adolescents with type 1 diabetes are common - occurring
      at rates as high as 93% - and have serious health consequences, including poor blood sugar
      control and risk for later complications. Therefore, the investigators proposed to test a
      positive psychology intervention for adolescents with type 1 diabetes aimed at increasing
      motivation for diabetes management; specifically, to increase the frequency of blood glucose
      monitoring. This intervention will boost positive mood in adolescents (age 13-17) through
      tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a
      way to improve motivation for diabetes management. In addition, this study will explore the
      use of technology, by comparing telephone-administered vs. automated text-messaging versions
      of the intervention, to determine which mode of delivery is more appealing, convenient, and
      beneficial for adolescents in managing their diabetes.

      Participants and parents will complete questionnaires on mood and diabetes management during
      a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes
      management will be collected from participants' electronic medical records.
    


Intervention name(s): Positive Affect; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Positive psychology intervention to improve motivation for diabetes management.; Educational materials on diabetes management
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were assigned to Positive Affect - Phone, Positive Affect - Text, or Education groups for the duration of the study.
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms; Gastrointestinal Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients
      undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and
      investigated Prevention of gastrointestinal bleeding.
    

Detailed description: 
      This study is a Multicenter, Randomized, Parallel and Prospective study to compare Ulcer
      healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic
      Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and to investigate
      Prevention of gastrointestinal bleeding.

      Participants are defined as persons who underwent a Endoscopic Submucosal Dissection for
      Gastric Adenoma or Early Gastric Cancer. For 8 weeks, Participants treated as Ilaprazole 20mg
      or Rabeprazole 20mg once a day. After treatment, The ulcer healing rate was evaluated by
      Endoscopy at 4, 8 weeks.
    

Intervention name(s): Ilaprazole; Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast; Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast
Other intervention name(s): Ilaprazole(Noltec®); Pariet®
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ilaprazole; Gastric Adenoma; Early Gastric Cancer; Endoscopic Submucosal Dissection