bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Condition: Hyperinsulinism
MeSH terms: Hyperinsulinism
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I
      in children with hyperinsulinism.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study.

      Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or
      placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are
      crossed over to the other regimen for an additional 4 weeks.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): insulin-like growth factor I
Intervention type(s): Drug
Intervention MeSH terms: Mitogens
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: endocrine disorders; hyperinsulinism; rare disease
Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single center, open prospective study to evaluate the effectiveness of quetiapine
      monotherapy in the maintenance treatment of adolescent patients with a bipolar spectrum
      disorder (bipolar I and bipolar II disorders, cyclothymia, and bipolar disorder not otherwise
      specified [bipolar NOS]) for a minimum of 48 weeks. Patients will be screened (enrolment
      phase) either when already stabilized or during an acute episode of mania/hypomania or
      depression.
    


Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quetiapine; bipolar spectrum disorders
Hydrocortisone Use After Etomidate in Intensive Care
Condition: Patient Admitted in Reanimation
Study type: Interventional
Phase: Phase 3

Summary: 
      the objective of the study is to assess the value of substitution with 200mg/24h of
      hydrocortisone for 48 hours for patients in intensive care who have received a single
      injection of etomidate
    

Detailed description: 
      Etomidate is a hypnotic widely used for patients in intensive care who require rapid
      induction, because of its short duration of action, its excellent cardiovascular tolerance
      and maintenance of cerebral perfusion pressure.

      For this reason etomidate remains the hypnotic of choice for induction of unstable patients.
      Other hypnotics currently in existence do not provide adequate safety with a sufficiently
      predictable and stable effect in this situation. However, it may induce acute adrenal
      insufficiency by inhibition of 11-b-hydroxylase necessary for the synthesis of cortisol from
      compound S. An observational study conducted at the Grenoble University hospital in 2006
      showed that the duration of this blockage can reach up to 48 hours. Acute adrenal
      insufficiency in intensive care patients is associated with a poor prognosis. The main
      objective of this study is to assess the value of substitution with 200mg/24h of
      hydrocortisone for 48 hours for patients in intensive care who have received a single
      injection of etomidate.

      This is an interventional, prospective, randomized, placebo-controlled, double-blind,
      analytical study with a cohort of 100 patients between 18 and 80 years, of both sexes, who
      have had tracheal intubation in a pre-hospital or shock treatment setting with the
      administration of a single injection of etomidate.
    

Intervention name(s): Hydrocortisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment; NaCl 0.9%
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: shock; Tracheal Intubation; reanimation; suprarenal insufficiency; Etomidate; Adrenocorticotropic Hormone; hydrocortisone
Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.
Condition: Asthma,; Pharmacokinetics,; Cmax,; Tmax,; λz,; AUC,; Ketoconazole,; Metabolite
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic profile
      when administered with ketoconazole. Subjects will be treated first with AZD5069 only
      followed by a washout period before starting with the combined treatment (both ketoconazole
      and AZD5069).
    

Detailed description: 
      An open-label, fixed-sequence, single-centre phase I study to assess the effect of
      ketoconazole on the pharmacokinetics of AZD5069 after oral administration of a single dose
      AZD5069 to healthy male volunteers
    

Intervention name(s): AZD5069; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): AZD5069 15 mg (3x5 mg capsules) single administration; Ketoconazole 400 mg (2x200 mg tablets)
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I,; healthy volunteers,; fixed-sequence,; open-label,; ketoconazole,; combination,; safety
Methorexate and Knee Osteoarthritis
Condition: Pain Reduction; Physical Function Improvement
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable
      pain and functional disability amongst older adults in particular.Synovial inflammation and
      proliferation has emerged as a key component of OA and as a potential predictor of worsening
      disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic
      diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate
      (MTX) in decreasing pain and inflammation in symptomatic knee OA.

      128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited.
      Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either
      25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the
      dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and
      secondary outcome measures is improvement in physical function scores.

      Keywords:

      methotrexate knee osteoarthritis inflammation pain reduction physical funtion
    


Intervention name(s): 25 mg/week oral methotrexate tablets; 25mg/week oral placebo tablets
Intervention type(s): Drug; Drug
Other intervention name(s): interventional drug
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: methotrxate, knee osteoarthritis, inflammation, pain, function
Pharmacokinetics of AZD7295 Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.
    


Intervention name(s): AZD7295; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): Up to 650mg AZD7295 capsules per dose. To be given 2 or 3 times daily for 5 days.; Placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Pharmacokinetic Study of Intranasal 2-DG in Healthy Volunteers
Condition: Acute Nasopharyngitis
MeSH terms: Nasopharyngitis; Common Cold
Study type: Interventional
Phase: Phase 1

Summary: 
      2-DG-01 is a randomized, double-blind, placebo-controlled, single and multiple ascending dose
      phase 1 study assessing safety, tolerability and pharmacokinetics of 2-DG in normal healthy
      volunteers (NHV). The safety and pharmacokinetics of 2-DG are assessed after single or
      multiple intranasal administrations.
    

Detailed description: 
      2-DG-01 is a randomized, placebo-controlled, double- blind single and multiple ascending dose
      phase 1 study in normal healthy male and female volunteers aged 18 years or older.

      The primary objective of this study is to assess the clinical safety and tolerability of
      intranasal 2-DG in NHVs.

      The secondary objective of this study is to assess the human pharmacokinetics of 2-DG.

      The study is divided in two sub-parts: Part A, a single ascending dose (SAD) study of 2-DG
      and Part B, a multiple ascending dose (MAD) study.

      Part A consists of 3 cohorts: Cohorts 1 and 2 with a randomization ratio for 2-DG to placebo
      of 4:1 and Cohort 3 with a randomization ratio for 2-DG to placebo of 8:2.

      Part B consists of 3 cohorts: Cohort 4 with a a randomization ratio for 2-DG to placebo of
      4:1 and Cohorts 5 and 6 with a randomization ratio for 2-DG to placebo of 8:2.

      Cohorts 1, 2 and 4 will also be controlled by randomized intranasal application of placebo
      into the opposite nostril to obtain an intra-individual estimate for local tolerability.
      Other cohorts will receive either 2-DG or placebo into both nostrils.

      Interim safety reviews are performed by a Data Monitoring Committee.
    

Intervention name(s): 2-Deoxyglucose; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intranasal administration; Intranasal administration
Other intervention name(s): 2-DG; 2-Deoxy-D-glucose
Intervention MeSH terms: Deoxyglucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Virus disease; Respiratory infection; Common cold virus; Rhinovirus
Comparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery
Condition: Cardiovascular
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      To evaluate the effect of oxycodone and sufentanil in preventing cardiovascular responses to
      tracheal intubation in the patients with coronary heart disease (CHD).
    

Detailed description: 
      Laryngoscopy and tracheal intubation can provoke an increase of blood pressure (BP) and/or HR
      [1.2]. This hemodynamic stress may lead to an imbalance between myocardial oxygen consumption
      and supply and therefore induce myocardial ischemia, which may be endurable in the patients
      with normal cardiovascular condition but is potential harmful to the patients with coronary
      heart disease. Thus it is critical to attenuate the cardiovascular stress induced by
      laryngoscopy and endotracheal intubation in the high risk patients.
    

Intervention name(s): Oxycodone 10mg; Sufentanil
Intervention type(s): Drug; Drug
Intervention description(s): induction with 0.3mg/kg of oxycodone in general anesthesia; induction with 0.3 µg/kg of Sufentanil in general anesthesia
Intervention MeSH terms: Sufentanil; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Oxycodone; Sufentanil; tracheal intubation
Sleep Disturbances and Pulmonary Artery/Aorta Diameter in Scleroderma Patient
Condition: Scleroderma; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Dyssomnias; Parasomnias; Hypertension; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Observational

Summary: 
      To determine sleep disturbance, pulmonary function test, 6 minute walk, echocardiogram
      abnormality, arterial blood gas, ventilation/perfusion scan of the chest in Scleroderma
      patient with Pulmonary Hypertension.
    

Detailed description: 
      As above
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Males, Females and Minorities

        Age range of subjects 18-75 years old
      
Keywords: Scleroderma; Pulmonary Hypertension
Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      To compare economic factors and the rate of adverse events between two types of
      instrumentation used for total knee replacement: Single-use Efficiency Instruments with
      Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical
      Technique
    


Intervention name(s): Customized patient instruments; Traditional Metal Instruments
Intervention type(s): Device; Device
Intervention description(s): Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.; Traditional metal instrument will be used to make bone cuts and size the components in this control group.
Other intervention name(s): Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®); Traditional Metal Instruments with Conventional Surgical Technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Knee Replacement
Urinary Concentration and Diluting Ability in Patients With Chronic Renal Disease and/ or Hypertension
Condition: Renal Insufficiency, Chronic; Hypertension
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hypertension
Study type: Observational

Summary: 
      The investigators want to test the hypothesis that patients with chronic renal disease have a
      poorer ability to preserve water after being thirsty and a poorer ability to excrete water
      after a load of fluid. They presume that these abilities become poorer when renal
      insufficiency progresses. The investigators further hypothesize that patients with
      hypertension also have a decreased ability to concentrate and dilute urine.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy participants were recruited by advertisements in public and private institutions
        Patients with primary hypertension or chronic renal failure were recruited from the
        Out-patients' Clinic, Department of Medicine, Section of Nephrology, Holstebro Hospital
      
Keywords: Urine concentration ability; chronic renal insufficiency; hypertension; aquaporin2; Patients with chronic renal insufficiency; Patients with hypertension; Healthy volunteers
Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to compare TRV130 to placebo and morphine to learn about its effects
      on pain relief and side effects.
    

Detailed description: 
      This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability
      of TRV130.
    

Intervention name(s): TRV130 1.5 mg; TRV130 3 mg; TRV130 4.5 mg; Morphine 10 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): TRV130 1.5 mg IV x 1 dose; TRV130 3 mg IV x 1 dose; TRV130 4.5 mg IV x 1 dose; Morphine 10 mg IV x 1 dose; Dextrose 5% in water IV x 1 dose
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry
Swedish Age Assessment Study
Condition: Age Determination by Skeleton
Study type: Interventional

Summary: 
      It is important that asylum seekers should have as accurate age assessment as possible and
      that children's fundamental rights are met by choosing methods based on best available
      knowledge. The aim is to provide, on the basis of best available knowledge, suggestions for
      methods of medical age assessment of whether a person is over or under 18 years of age.

      The primary issue is to investigate whether five selected growth zones in knee joint, ankle
      and wrist individually or in combination can better determine the 18-year limit compared with
      previous research.
    

Detailed description: 
      Swedish Age Assessment study is conducted with the aim of

        -  Deepening the knowledge of age-assessment methodology with magnetic camera examinations
           among born and registered in Sweden aged 14.0 through 21.5 years

        -  With a magnetic camera, investigate whether five selected growth zones in the knee joint
           and ankle joint (distal femur, proximal tibia, distal tibia and calcaneus) and distal
           radius (wrist) individually or in combination can better determine the 18-year limit
           compared with previous research

        -  To investigate how gender and growing environment can affect the end of growth zones
    

Intervention name(s): MRI scan of knee, ankle and wrist
Intervention type(s): Diagnostic Test
Intervention description(s): At the day of the intervention, the subject is informed about the study by a nurse and provides written informed consent.
Girls must leave urine tests to rule out pregnancy. The questionnaire for the study is answered by the subject and weight and length are measured. The subject is asked to self-assess his/her puberty.
After detailed information on how a magnetic camera examination is carried out, an examination of five selected growth zones (knee joint, ankle joint including heel leg and wrist) is performed using 1.5 Tesla magnetic camera with dedicated cartilage sequence.
Other intervention name(s): Self assessment of puberty by Tanner scale; Questionnaire on socioeconomics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Medical age assessment
The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates.
Condition: Delayed Cord Clamping; Umbilical Cord Milking; Preterm Neonates
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm
      neonates. A randomized controlled trial
    

Detailed description: 
      Placental transfusion either by deferred cord clamping or umbilical cord milking became
      standard care and recommended management especially in preterm deliveries.1 In average, about
      80 ml of blood was found to be transferred to the neoborn by one minute after birth.2 This
      additional blood can afford extra iron and blood volume giving the benefit of less iron
      deficiency anemia during the first year of life, less need for blood transfusion, less need
      for vasopressors and less intraventricular hemorrhage (IVH) by 50%.3 Placental transfusion
      with different techniques proved safety with no significant risks regarding postpartum
      hemorrhage, polycythemia, jaundice, Apgar score or admission rates.4 Our study aims to
      compare delayed cord clamping with umbilical cord milking as the best way for placental
      transfusion for preterm neonates.
    

Intervention name(s): delayed cord clamping; cord milking
Intervention type(s): Procedure; Procedure
Intervention description(s): delay of cord clamping for 60 seconds; active cord milking 5 times
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Clinical Study to Assess the Efficacy and Safety of DA-3002
Condition: Turner's Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.
    


Intervention name(s): DA-3002; Genotropin®
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Turner's Syndrome; Short Stature; Dwarfism
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Condition: Infectious Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective and subjective musculoskeletal evaluations will be performed to determine
      differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we
      can tell what the natural occurrence of such musculoskeletal conditions is in the general
      pediatric population.
    

Detailed description: 
      This study is classified as "interventional" due to study-specific medical examinations and
      interventions. Regarding the study drug intake, routine administration is observed only,
      there is no intervention in study drug administration.
    

Intervention name(s): Ciprofloxacin; Non-quinolone antibiotic
Intervention type(s): Drug; Drug
Intervention description(s): Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label; Common used dose and route
Intervention MeSH terms: Anti-Bacterial Agents; Ciprofloxacin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatrics; Safety; Musculoskeletal System; Neurologic Manifestations; Joint Diseases; Joint Deformities, Acquired
A Long-term Evaluation of a Novel Intravaginal Device
Condition: Pelvic Floor Disorders; Sexual Dysfunction; Stress Incontinence
MeSH terms: Urinary Incontinence, Stress; Pelvic Floor Disorders
Study type: Interventional

Summary: 
      An open-label long-term evaluation of a novel intravaginal device in female patients
      experiencing sexual and bladder function issues.
    

Detailed description: 
      To determine the long-term clinical efficacy of the vSculpt therapy on treating the pelvic
      floor area and vaginal tissue for females who experience bladder and sexual dysfunction.
    

Intervention name(s): vSculpt
Intervention type(s): Device
Intervention description(s): Pelvic Floor Toning and Vaginal Rejuvenation Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment