bioihbjkbjnl/mcl2 huggingface dataset:
Follow-up Study on the Antibody Response to Hepatitis B, Acellular Pertussis Toxin and Inactivated Poliovirus Antigens 1 Month After the 4th Hexavac® Vaccination in Healthy Children, Who Participated in NeisVac-C Study 216
Condition: Meningococcal Meninigitis, Serogroup C
MeSH terms: Hepatitis B
Study type: Observational

Summary: 
      The primary aim of the study is to show that the antibody response to hepatitis B, acellular
      pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with Hexavac®
      is not influenced by the concomitant administration of NeisVac-C.
    


Keywords: Meningococcal Vaccine; Meningococcal Meningitis, Serogroup C; Neisseria Meningitidis
A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the single-dose plasma PK of mobocertinib and
      its active metabolites (AP32960 and AP32914) in participants with moderate and/or severe HI
      compared to matched-healthy participants with normal hepatic function.
    

Detailed description: 
      29-Apr-2020 Enrollment of new participants into this study was paused due to the COVID-19
      situation. The duration of this pause was dependent on the leveling and control of the
      COVID-19 pandemic.

      The drug being tested in this study is called mobocertinib. The study will assess the PK of
      single dose mobocertinib and its active metabolites (AP32960 and AP32914) in participants
      with moderate and/or severe HI compared to matched-healthy participants with normal hepatic
      function.

      The study will enroll approximately 24 participants. Participants will be assigned to 1 of
      the following 3 treatment groups in a staggered manner based on their degree of hepatic
      impairment which will be determined based on Child-Pugh Score as follow:

        -  Moderate HI (Child-Pugh B): Mobocertinib 40 mg

        -  Severe HI (Child-Pugh C): Mobocertinib 40 mg

        -  Normal Hepatic Function: Mobocertinib 40 mg

      Healthy participants with normal hepatic function will be recruited to match both moderate
      and severe HI by age (mean plus or minus [+-] 10 years), gender (+-2 participants per
      gender), and body mass index (BMI, mean +-10 percent [%]).

      All participants will be asked to take single dose of mobocertinib on Day 1. The dose level
      for severe HI may be modified based on the previous results of approximately 3 moderate HI
      and healthy participants who completed up to Day 10 study procedures.

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 51 days. Participants will be contacted by
      telephone 30 days after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): Mobocertinib
Intervention type(s): Drug
Intervention description(s): Mobocertinib capsule.
Other intervention name(s): AP32788; TAK-788
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
AZD5672 Bioavailability Study in Healthy Male and Female Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to compare the blood levels achieved with a new formulation of
      AZD5672 to an existing formulation of AZD5672 used in previous studies
    


Intervention name(s): AZD5672; AZD5672; AZD5672; AZD5672
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 40 mg tablet (Test formulation); 40 mg tablet (Reference formulation); 100 mg tablet (Test formulation); 100 mg (2 x 50 mg tablet (Reference Formulation)
Intervention MeSH terms: N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: AZD5672; relative bioavailability; rheumatoid arthritis (RA)
Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy
Condition: Osteoporosis
MeSH terms: Osteoporosis; Spinal Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effect of subject knowledge of their disease status on persistence in
      subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment
      of GIO.
    


Intervention name(s): Actonel
Intervention type(s): Drug
Intervention description(s): Actonel 5 mg orally once daily (OD), calcium 500 mg + vitamin D 200 units twice daily (BID)
Other intervention name(s): Risedronate Sodium
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Regional Changes in Upper Limb Perfusion Following Brachial Plexus Block: A Pilot Study
Condition: Anesthesia, Conduction; Nerve Block; Sympathectomy; Regional Blood Flow
Study type: Observational

Summary: 
      Ultrasound-guided regional anesthesia is increasingly being used in the modern surgical
      environment to provide specific intraoperative anesthesia and postoperative analgesia.
      Infiltration of local anesthesics around peripheral nerves firs blocks sympathetic, then
      sensory, then motor nerve function. Sympathectomy-induced vasodilation following brachial
      plexus block results in increased skin temperature and arterial flow within minutes.

      Although it has not been shown to reliably increase diameter or cross-sectional area of
      distal arteries, brachial plexus block does change the pattern and quantity of blood flow to
      the hand. Given that the magnitude of change of flow cannot be attributed to vessel radius,
      the investigators suspect that the more laminar fluid dynamics are due to vascular tone.

      The investigators study aims to quantify alterations in physiology and peripheral vasodilator
      response. The investigators anticipate that axially block will significantly improve regional
      blood flow.
    


Intervention name(s): Monitoring
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals coming for elective upper extremity surgery who would already be having a
        brachial plexus block for their anesthesia.
Effects of FT011 in Systemic Sclerosis
Condition: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis, Systemic
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This
      study is being conducted to see what the body does to the drug (pharmacokinetics), and what
      the drug does to the body (pharmacodynamics).
    


Intervention name(s): FT011; FT011; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two x 100mg capsules once daily for 12 weeks; Two x 200mg capsules once daily for 12 weeks; Two placebo capsules once daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty
Condition: Anesthesia
MeSH terms: Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication
      on the emergence agitation after rhinoplasty.
    

Detailed description: 
      Emergence agitation (EA) is a clinical condition characterized by agitation, confusion,
      disorientation, and aggressive behavior in the early phase of recovery from general
      anesthesia (incidence about 21.3%). This may lead to various injuries, self-extubation,
      bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and
      myocardial oxygen consumption. Premedication with dexmedetomidine and gabapentin are
      promising options for EA.
    

Intervention name(s): Dexmedetomidine; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward.; The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward
Intervention MeSH terms: Dexmedetomidine; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Condition: Clavicle Fracture; Fractures
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      This is a multicentre randomized clinical trial prospectively comparing operative treatment
      versus conservative (nonoperative) care in the management of displaced distal (Type II)
      clavicle fractures.
    


Intervention name(s): Non-operative Treatment; Operative Treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard protocol for conservative treatment will consist of the implementation of a sling, for clavicular support and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon.; The operating surgeon will determine the positioning of the patient for surgery. ORIF of the distal clavicle fracture will be carried out as follows:
Anatomic reduction of the fracture Definitive fixation with a contoured clavicle plate and screws; a AO hook plate; a 3.5 LCDC, reconstruction, or compression plate is acceptable; a 1/3 tubular plate is not acceptable Use of bone graft is optional (iliac crest bone autograft)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clavicle; fractures; distal
Parallel Arm Trial of AD109 and AD504 In Patients With OSA
Condition: OSA - Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study
      to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in
      Obstructive Sleep Apnea.
    


Intervention name(s): AD109; AD504; Atomoxetine Hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration at bedtime; Oral administration at bedtime; Oral administration at bedtime; Oral administration at bedtime
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Position Differences and Physical Performance Among Female Team Handball Players
Condition: Handball Players; Position Differences; Physical Performance
Study type: Observational

Summary: 
      Our study was conducted to compare the physical performances of the upper extremity and lower
      extremity of handball players according to the positions they played.

      In this cross-sectional study, a total of 39 elite female handball players with at least of 5
      years playing experience were tested.Maximal voluntary isometric (MVIC) knee flexion and
      extension strength were measured using a handheld dynamometer (HDD) (Lafayette Instrument
      Company, Lafayette, IN). Lower extremity vertical power was identified through the use of the
      VertiMetric (Lafayette Instrument Company, Lafayette, IN) according to protocols suggested by
      Ambegaonkar et al. Trunk extension endurance was measured using the Biering-Sorensen test as
      previously described.The Davies test (DT) was used to assess upper body agility and
      stabilization.The Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) was utilized
      to assess shoulder performance function and stability according to protocol suggested by
      Goldbeck and Davies.The Shark Skill Test (SST) was developed in order to assess lower
      extremity agility and neuromuscular control.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In this cross-sectional study, a total of 39 elite female handball players with at least of
        5 years playing experience were tested. Player positions were identified for each athlete
        by their coaches or by self-report as: goalkeepers, centres, pivots, or wing players. All
        of them were playing in the premier Turkish professional handball league.
Influence of Manual Diaphragm Release on Pulmonary Functions in Women With COVID-19
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Manual noninvasive respiratory techniques gained interest to treat respiratory pathologies
      related to COVID 19. This study designed to determine the combined effect of manual
      diaphragmatic release technique with the effect of conventional breathing exercises and prone
      positioning on pulmonary function parameters (FVC, FEV1, PEF, FEV1/FVC, FEF25, FEF50, FEF75,
      FEF25/75).
    

Detailed description: 
      Forty females were randomly assigned to two groups. Group A received manual diaphragm release
      with conventional breathing exercises and prone positioning. Group B received conventional
      breathing exercises and prone positioning. Both groups took their prescribed medications.
      Their ages ranged from 35 to 45 years and with moderate COVID-19 illness. Any cases with mild
      and severe COVID-19 illness, ICU admission, and chest diseases were excluded.

      Main measures: pulmonary function parameters (FVC, FEV1, PEF, FEV1/FVC, FEF25, FEF50, FEF75,
      FEF25/75).
    

Intervention name(s): manual therapy; breathing exercise and prone position alone
Intervention type(s): Other; Other
Intervention description(s): manual diaphragmatic release technique combined with breathing exercise; deep breathing exercise and prone position
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty females were randomly assigned to two groups. Group A received manual diaphragm release with conventional breathing exercises and prone positioning. Group B received conventional breathing exercises and prone positioning. Both groups took their prescribed medications. Their ages ranged from 35 to 45 years and with moderate COVID-19 illness. Any cases with mild and severe COVID-19 illness, ICU admission, and chest diseases were excluded.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Breathing Exercise; COVID-19; manual diaphragmatic release; Pulmonary function parameters
Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effectiveness and safety of long-acting
      risperidone given as a once monthly injection to adult patients with schizophrenia or
      schizoaffective disorder.
    

Detailed description: 
      Risperidone, taken by mouth on a daily basis, has been an effective treatment for
      schizophrenia and schizoaffective disorder. Risperidone is also available in a long-acting
      injectable form so that patients can take their medicine by bi-weekly injections. This study
      will assess the effectiveness and safety of long-acting risperidone injection given once a
      month instead of every two weeks (based on previous studies with dosing every 2 weeks).
      During the four-week lead-in phase, patients will receive one 50-milligram injection every
      two weeks for two doses. Patients continue to take their prescribed dose of risperidone
      tablets (from 2 to 6 milligrams per day) for the first 14 days. After the first month,
      patients will receive one 50-milligram injection once a month for 48 weeks. This dose can be
      increased to 75 milligrams if patient meets relapse criteria, and is willing to stay in the
      trial. Patients will be asked questions to help determine how well the monthly injections are
      working. Laboratory tests (including drug levels), physical examinations and adverse event
      reporting will be performed to determine the safety of the monthly injections. Risperidone
      oral tablets, 2 to 6 milligrams per day, for first 2 weeks; long-acting risperidone
      intramuscular injections, 50 mg in 2 milliliters of liquid, every 2 weeks for 1 month, then
      injections once a month for 48 weeks. Monthly injection dose may be increased to 75 mg in
      2-mL if needed.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorder; long-acting risperidone; intramuscular injection
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects
Condition: Healthy Volunteers; Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat
      bacterial infections, including those due to multi-drug resistant bacteria.
    

Detailed description: 
      The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly
      members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of
      hospital acquired infections. In particular, the recent dissemination of a serine
      carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable
      threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

      Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2003 or biapenem)
      plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine
      beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and
      pharmacokinetics of biapenem, administered alone, in healthy adult subjects.
    

Intervention name(s): RPX2003 (Biapenem); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation.
Single dose followed by multiple dose, three times a day.; Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation.
Single dose followed by multiple dose, three times a day.
Intervention MeSH terms: Biapenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949);
      MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the
      long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and
      migraine recurrence.
    


Intervention name(s): Rizatriptan 5 mg; Rizatriptan 10 mg; Standard Care
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s); Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s); Active standard care
Other intervention name(s): MK-0462, Maxalt; MK-0462, Maxalt
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Migraine headache
Empagliflozin and Sympathetic Nerve Traffic
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the effects of the Inhibition of the Sodium-Glucose Linked Transporter 2 in the
      kidney with empagliflozin compared to hydrochlorothiazide on blood pressure and on central
      sympathic nervous activity will be examined.
    

Detailed description: 
      The drug empagliflozin is a selective oral inhibitor of the sodium-glucose co-transporter 2
      (SGLT-2) in the kidney.On the market empagliflozin is approved for the treatment of type 2
      Diabetes. The mechanism of action can be described as follows: SGLT-2 is responsible for 90%
      of the reabsorption of Glucose in the kidney. If this Transport System is inhibited the
      secretion of glucose via the urine is increased. Therefore the blood glucose concentration
      will be lowered.

      It has been noted that the SGLT-2 drugs are lowering the blood pressure as well, but the
      specific characteristics of the durg leading to this effect have not been examined in
      adequate clinical trial up to now.

      To evaluate the central sympathic nervous activity a microneurography will be performed in
      this study; this examination will provide Information if empagliflozin dose decrease the
      sympathic nervous activity. If this is the case new effects of empagliflozin have to be
      discussed, Otherwise it can be assumed that the blood pressure decrease is a result of an
      increase of urine volume. In this case the sympathic activity should be increased.

      This study will be performed in parallel groups who will receive a double-blind, randomised
      treatment, either empagliflozin or hydrochlorothiazide. The hypothesis that empagliflozin -
      in contrast to hydrochlorthiazide - does not increase the sympathic nervous activity in
      obese, hypertensive subjects with type 2 Diabetes treated with metformin will be tested.
    

Intervention name(s): Empagliflozin; Hydrochlorothiazide 25 mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet; 1 tablet
Other intervention name(s): Jardiance; HCT
Intervention MeSH terms: Empagliflozin; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment