bioihbjkbjnl/mcl2 huggingface dataset:
TELICAST : Telithromycin in Acute Exacerbations of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

        -  The primary objective is to evaluate the clinical efficacy of telithromycin versus
           placebo as a supplement to the usual standard of care during an acute exacerbation of
           asthma. Efficacy will be assessed by:

             -  Changes in the diary card summary symptom score assessed daily for 6 weeks, and

             -  Changes in the domiciliary morning Peak Expiratory Flow Rate (PEFR) following oral
                telithromycin treatment

      Secondary Objectives:

      The secondary objectives of the study are:

        -  To evaluate the microbial activity of telithromycin during an exacerbation of asthma by:

             -  Assessment of the patient's clinical improvement relative to initial C. pneumoniae
                or M. pneumoniae status, and

             -  Analysis of the quantitative changes from baseline in C. pneumonia or M. pneumoniae
                by culture and quantitative Polymerase Chain Reaction (PCR).

        -  To evaluate the safety of 10 days of oral telithromycin as a supplement to the standard
           of care for patients with acute exacerbations of asthma

        -  To assess additional efficacy endpoints and health outcome evaluations following 10 days
           of treatment with either oral telithromycin or placebo, with either treatment used as a
           supplement to the standard of care for patients with acute exacerbations of asthma:

             -  Changes and daily variability in the PEFR during the 6 weeks of study treatment,

             -  Health status at follow-up (6 weeks)

             -  Pulmonary function tests:

                  -  Forced Expiratory Volume in 1 second (FEV1)

                  -  Forced Vital Capacity (FVC)

                  -  Forced Expiratory Flow Rate (FEF25-75%)

             -  Need for additional medications (e.g., inhaled corticosteroids, oral
                corticosteroids, bronchodilator use),

             -  Time to next acute exacerbation of asthma.
    


Intervention name(s): Telithromycin
Intervention type(s): Drug
Intervention MeSH terms: Telithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effect of Diet on Learning Abilities for Children in Kindergarden
Condition: Cognitive Performance
Study type: Interventional

Summary: 
      The main aim of this intervention study is to test the effect of diet on improvement in
      cognitive performanc in kindergarden children aged 4-6 years. Children will be randomly
      allocated into two groups, one consuming prepared meals with herring or mackerel for four
      months, and one group consuming meals containing meat as a control group.
    

Detailed description: 
      Positive effects of n-3 long chain polyunsaturated fatty acids (PUFAs), as provided by fatty
      fish intake, on cognitive functions are widely accepted, but so far there is no clear
      evidence from randomized intervention studies in children and young adults, although fish
      intake has been positively associated with cognitive functions in observational studies. The
      main aim of this study is to test the effect of diet on improvement in cognitive performance
      in kindergarden children aged 4-6 years. In the intervention study, children will be randomly
      allocated into two groups, one consuming prepared meals with herring or mackerel for four
      months, and one group consuming meals containing meat as a control group. The children
      (n=200) will consume the prepared meals three times a week. Cognitive performance of the
      children will be tested at study start and end using the the Wechsler Preschool and Primary
      Scale of Intelligence (WPPSI_III) and nine hole peg test. Children will be screened for
      mental health problems in the Strengths and Difficulties Questionnaire (SDQ), which is a
      global measure of children's mental health. Compliance will be monitored by documentation of
      study fish intake and measuring fatty acid status. For a more detailed investigation of
      effects of increased herring and mackerel intake, before and after intervention blood and
      urine will be collected for lipidomic analysis (metabolites), vitamin D and iodine
      determination and genotyping (fatty acid metabolism and inflammation).
    

Intervention name(s): Seafood; Non-seafood
Intervention type(s): Other; Other
Intervention description(s): The aim is to investigate the effect of meals consisting of mackrel and herring on learning abilities by using a two-armed individually randomized non-blinded intervention trial.; The aim is to investigate the effect of meals consisting of meat on learning abilities by using a two-armed individually randomized non-blinded intervention trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diet; Vitamin-D; Meat; Fatty fish; Iodine; fatty acid; Intervention study; Wechsler Preschool and Primary Scale of Intelligence; Strengths and Difficulties Questionnaire; Nine hole peg test
A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors
Condition: Solid Tumors; Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate MEDI1191 administered intratumorally in sequential and concurrent combination
      with intravenous durvalumab in patients with solid tumors.
    

Detailed description: 
      This is a multicenter, open-label study to evaluate MEDI1191 delivered by intratumoral
      injection in sequential and concurrent combination with intravenous durvalumab to subjects
      with solid tumors. The study has a dose escalation design using mTPI-2 to evaluate a range of
      doses.
    

Intervention name(s): MEDI1191; Durvalumab
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will receive MEDI1191 (at least twice); Subject will receive durvalumab every 4 weeks
Intervention MeSH terms: Durvalumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MEDI1191; Durvalumab; MEDI4736; Imfinzi
The Effect of PACAP27 on the Extra- and Intracerebral Arteries Assessed by Magnetic Resonance Angiography (MRA) on Healthy Volunteers
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      Studying Pituitary adenylate cyclase-activating peptide 27 (PACAP27) effects on extra- and
      intracerebral arteries assessed by MRA on healthy volunteers.
    

Detailed description: 
      PACAP neuropeptide, which belongs to the vasoactive intestinal polypeptide
      (VIP)/glucagon/secretin family. PACAP exists in two forms: Studying Pituitary adenylate
      cyclase-activating peptide 38 (PACAP38), which consists of 38 amino acids and PACAP27 which
      contains 27 amino acids at its N-terminus. PACAP38 is implicated in migraine pathophysiology
      however PACAP27 is not studied well. Therefore, the investigators will study PACAP27's effect
      on extra- and intracerebral arteries assessed by MRA on healthy volunteers.
    

Intervention name(s): PACAP27; Placebo
Intervention type(s): Other; Other
Intervention description(s): PACAP27 is vasodilator of cerebral vessels; Saline
Intervention MeSH terms: Pituitary Adenylate Cyclase-Activating Polypeptide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 18 healthy volunteers will receive PACAP27 or placebo. All Data will also be analyses blinded.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide
Condition: Self-Injurious Behavior; Suicidal Ideation; Suicide, Attempted; Borderline Personality Disorder; Emergency Services, Psychiatric
MeSH terms: Emergencies; Suicide; Personality Disorders; Suicidal Ideation; Borderline Personality Disorder; Self-Injurious Behavior; Suicide, Attempted
Study type: Interventional

Summary: 
      The purpose of the study is to test a standardized version of brief admission (BA) through
      randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a
      crisis management model for individuals with recurrent self-harm, including suicide attempts
      and at least three symptoms of Borderline Personality disorder. Participants will be
      allocated to BA + Treatment as Usual (TAU) or TAU.
    

Detailed description: 
      When individuals with recurrent self-harm and suicidal behaviour seek acute admission to
      hospital due to a crisis and associated increased suicidal ideation, recommendations for
      clinical care are still conflicting. The risk for iatrogenic effects of inpatient care are
      considerable, and long hospital admissions without a clear treatment structure may predict
      decompensation in functioning. This has resulted in a clinical practice of avoiding admission
      for individuals diagnosed with Borderline Personality Disorder (BPD).

      Brief admission (BA) as an intervention has a longstanding history in the delivery of mental
      health services in the Netherlands. The core elements of brief admission were determined
      through consultation with Dutch researchers, interviews with individuals with experience,
      Dutch clinicians familiar with Brief Admission, and local guidelines from hospitals familiar
      with implementing this crisis management intervention. Core elements of the intervention were
      standardized into a protocol, and an educational manual was developed to train clinicians
      involved in the trial. An objectively rated fidelity measure was developed in order to ensure
      adherence.
    

Intervention name(s): Brief Admission
Intervention type(s): Other
Intervention description(s): Participants randomised to Brief admission (BA) will participate in a negotiation together with their out-patient clinician and a representative from the ward. The aim of the negotiation is to form an individualised contract defining how BA will work for them. After signing the contract, will have the possibility to admit themselves to hospital according to the procedure stated in the contract.
Other intervention name(s): Brukarstyrd Inläggning (Swedish)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brief admission; admission; deliberate self-harm; self-harm
Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and
      Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.
    


Intervention name(s): Apetrol ES
Intervention type(s): Drug
Intervention description(s): sequences of administered drugs
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bupivacaine With Epidural Volume Extension
Condition: Spinal Anesthesia; Epidural; Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study the investigator will address the efficacy of using low dose bupivacaine spinal
      anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing
      short obstetric procedures.
    

Detailed description: 
      Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or
      combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical
      procedures. However, one downside to neuraxial anesthesia is the increased time patients have
      to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial
      block. In this study, the investigators will address the efficacy of using low dose
      bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for
      patients undergoing short obstetric procedures. This will be accomplished by performing a CSE
      with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into
      the epidural space to help increase the spread of the local anesthesia in the spinal space.
      The idea is that physicians will be able to use less local anesthetic due to getting a
      greater spread of medication. This lower amount of local anesthetic will lead to a decreased
      duration of the spinal block; therefore, it will significantly decrease PACU length of stay.
      This technique will be compared to our traditional dose of spinal anesthetic without EVE in
      the CSE. Both groups will have an epidural catheter in place to allow us to give any
      additional local anesthetic to keep the patient comfortable throughout the procedure if the
      spinal anesthesia begins to wear off. The aim of this study is to determine if low dose
      spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short
      obstetric procedures while still providing an adequate surgical block.
    

Intervention name(s): 10 mg Bupivacaine; 5 mg Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space; 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.
Other intervention name(s): Marcaine and Sensorcaine; Marcaine and Sensorcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neuraxial epidural techniques; Combined spinal epidural; Epidural volume extension; Transient Neurologic Symptoms (TNS)
Rapid Diagnostic Test for Septic Arthritis
Condition: Juvenile Idiopathic Arthritis; Arthritis, Septic; Arthritis, Unspecified
MeSH terms: Arthritis, Infectious; Arthritis; Arthritis, Juvenile
Study type: Observational

Summary: 
      Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass
      Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age
    

Detailed description: 
      Arthritis is an inflammation of the joints that can have many causes. In children, septic
      arthritis (SA) is the most common cause of acute arthritis (around 45% of cases). Juvenile
      Idiopathic Arthritis (JIA) is a disease characterized the presence of arthritis in one or
      more of unknown origin in children under 16 years of age, lasting more than 6 weeks. It is
      the most common pediatric rheumatological disease with a prevalence of 16 to 150 cases per
      100,000 children. Finally, in approximately 40% of children the origin of acute arthritis
      remains undetermined (ND arthritis). In this group, all the examinations performed are not in
      favor of a bacterial origin and the evolution of arthritis do not allow the diagnosis of JIA
      to be retained and no other disease is found.

      During the first few days of arthritis, differentiation between AS and non-septic arthritis
      is difficult. The available clinical and biological parameters do not allow for easy and
      rapid differentiation between AS and non-septic arthritis.

      This project aims to develop a new diagnostic technique based on molecular analysis of the
      proteome in the joint puncture fluid.
    

Intervention name(s): Mass spectrometry
Intervention type(s): Diagnostic Test
Intervention description(s): Proteomic analysis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute arthritis
      
Biospecimen description: 
      synovial fluid blood sample stool sample nasal swab
Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery
Condition: Macular Holes; Retinal Detachment
MeSH terms: Retinal Detachment; Retinal Perforations
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a structured exercise program on
      musculoskeletal pain of patients in face-down posture after retinal surgery.
    

Detailed description: 
      After being informed about the study, patients who are planning to get vitrectomy for macular
      hole or retinal detachment are going to be randomly assigned into two groups; exercise group
      and control group. All patients are going be admitted to the hospital prior to the surgery.
      After the surgery is done, the patients are going to maintain a face-down position in the
      ward until postoperative day 3. After returning to the ward after surgery and completed the
      pain scoring forms, exercise training is going to be conducted for patients assigned to the
      exercise group by a physical therapist. Three times of daily self-exercise sessions are going
      to be performed according to the training provided to the patients. Pain score will be
      measured on the first, second and the third postoperative days. Patients will be discharged
      on the third postoperative days.
    

Intervention name(s): A structured exercise
Intervention type(s): Behavioral
Intervention description(s): Exercise training will be conducted by a physical therapist which will take about 10 to 15 minutes. Patient education will include how to keep face down in various postures, and how to actively exercise the related muscles and joints while maintaining face-down posture through video clip and brochure. Patients will go through three times of self-exercise sessions everyday according to the training provided to the patients. Active exercise for the FDP patients will include exercise in a hands and knees position, limb exercise in an FDP, and exercise in a standing position. The exercises were performed within the range of individual muscle strength and fitness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: face-down posture; musculoskeletal pain; vitrectomy
A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels
Condition: Cardiovascular Disease; Cerebrovascular Accident; Coronary Heart Disease
MeSH terms: Stroke; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine the degree of additional reduction in
      cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently
      accepted minimum target level for patients with pre-existing CHD. Secondary objectives
      include the safety profile of this treatment strategy, its cost-effectiveness, effect on
      other atherosclerotic-related events and procedures, and total mortality.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Major cardiovascular event; Major Coronary event; Revascularization
Transcriptomic Study of ER 4017 Topical Application in Elderly Subject
Condition: Aging
Study type: Interventional

Summary: 
      The stratum corneum (SC) is the superficial layer of the epidermis situated at the interface
      between the body and its outside environment. Its strategic position confers it a crucial
      role of protection against aggressions. After disruption, the kinetic of cutaneous barrier is
      slower in elderly comparatively to young subjects.

      The purpose of this study is to investigate, by characterizing molecular events, the
      effectiveness of ER4017 (Hydroxypropyltetrahydropyrantriol) to restore kinetic barrier
      function after acute disruption of stratum corneum in ederly subjects.

      10 male volunteers aged from 60 to 75 years are randomized to receive topical application of
      ER4017 versus placebo on skin inner forearms twice a day during 3 months. After sequential
      selloptape strips, epidermal samples of treated and control skin are removed under local
      anesthesia, using a dermatome. Differential gene expression analysis is performed using micro
      array techniques and quantitative RT-PCR.

      treatment, randomized on the location, double blind, placebo control, internal control
      subject, prospective study.
    

Detailed description: 
      Structural modifications of the superficial dermis during the aging process associated to
      alterations in the GAG- and PG profile appear to impact the quality of the dermal epidermal
      junction (DEJ). Previous biological and clinical evaluations of ER4017, a C-glycoside
      biomimetic of xylose, showed its capacity to stimulate GAG- and PG synthesis and to improve
      morphogenesis of the whole DEJ.

      The aim of the study is to investigate the gene expression in human epidermis treated with
      ER4017 following sequential sellotapes strips after a 3 months ER4017 topical application.
      For this purpose, the modulation of gene expression is determined using a cDNA microarray
      technology. Stratum corneum disruption is performed following 3 months topical application on
      skin inner forearms. All the experiments are performed in 10 elderly healthy men. Volunteers
      are clinically and biophysically evaluated at baseline and then at monthly intervals or at 3
      months respectively.
    

Intervention name(s): ER4017 (hydroxypropyltetrahydropyrantriol); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cream, 10%, each day during 3 months
Other intervention name(s): ER4017
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: aging; barrier function; transcriptomic
Long-Term Outcome in Congenital Undescended Testis After Surgical Treatment by Orchidopexy
Condition: Undescended Testis
MeSH terms: Cryptorchidism
Study type: Observational

Summary: 
      The purpose of this study is to determine the long-term outcome in congenital undescended
      testis after surgical treatment by orchidopexy and to what extent orchidopexy is the
      treatment for congenital undescended testis.
    


Time perspective: Retrospective
Keywords: orchidopexy, long-term outcome, congenital