bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
Condition: Hypopituitarism
MeSH terms: Hypopituitarism
Study type: Interventional

Summary: 
      In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine
      responses when hormones are injected. This is at least true for those with a complete
      insufficiency of the anterior pituitary. For example, administration of corticotropin
      releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore,
      "pure" hormone effects can be investigated.

      It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved
      in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was
      reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was
      therefore to study the effect of CRH on patients with hypopituitarism.

      To date, there is no information on sleep of patients with hypopituitarism. Secondary
      objective is therefore to compare sleep of patients with hypopituitarism with sleep of
      age-matched healthy controls.
    


Intervention name(s): corticotropin releasing hormone (CRH); Placebo; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): 50 µg injected at 2200, 2300, 0000, and 0100; injected at 2200, 2300, 0000, and 0100; injected at 2200, 2300, 0000, and 0100
Intervention MeSH terms: Hormones; Adrenocorticotropic Hormone; Corticotropin-Releasing Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Patients with hypopituitarism
CBT for Anxiety Disorder in Children With Co-morbid ASD
Condition: Randomized Treatment Study
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of the
      disorder. Up to half of the children with ASD are thought to suffer with anxiety in a way
      that interferes with their wellbeing and every day functioning. In this project the
      investigators will study the effect of the group program The Cool Kids Anxiety Program:
      Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific
      developed for children with ASD. The investigators expect a decrease in the overall anxiety
      level together with an increase in the ability of handling anxiety.
    

Detailed description: 
      The primary objective is to investigate the effect of a manualised Cognitive Behavioural
      Therapy (CBT) programme The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation
      (Cool Kids ASD) for anxiety disorder adapted to children with Autism Spectrum Disorder (ASD)
      in a waitlist controlled design.

      The investigators will investigate treatment effects on anxiety diagnosis and anxiety
      symptoms. Further, the investigators will investigate outcomes related to general
      functioning, co-morbid psychiatric disorders (Obsessive-Compulsive Disorder (OCD),
      hyperkinetic disorder and depression) and level of ASD symptoms (social and communicative
      skills).
    

Intervention name(s): CBT
Intervention type(s): Behavioral
Intervention description(s): The group based manualised CBT intervention consists of The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD).
Other intervention name(s): Cool Kids ASD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validity of Digital Models Obtained With iTero® and Lava Digital® in Comparison With Plaster Models.
Condition: Dentition/Teeth Measurement
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the validity, reliability and reproducibility of
      digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster
      models.
    

Detailed description: 
      The primary objective of this study is to evaluate the validity, reliability and
      reproducibility of the dental measurements obtained on the digital models with iTero® in
      comparison with those obtained on the plaster models (gold standard) and on the digital
      models with Lava Digital®.

      The secondary objective is to compare two different impression materials (i.e. alginate and
      polyvinylsiloxane (PVS)) and determine whether the impression material used affects the
      accuracy of the measurements.

      Statistical analysis:

        -  Intraclass correlation coefficient (ICC) will be used to evaluate the intra- and
           inter-operator reliability of the measurements for each method, i.e. the plaster models
           and the digital models.

        -  A paired t-test will be used to determine the validity of the digital measurements with
           iTero®, and to compare the impression materials (alginate and PVS).

        -  A Bland-Altman plot will also be used to compare the two digital methods (Lava Digital®
           et iTero®) with the plaster models.

        -  Dahlberg coefficient will be used to evaluate the technical error associated with the
           measurements that will be made.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients requiring an orthodontic treatment from the Orthodontics clinic of the University
        of Montreal
Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy
      children 15 months through 17 years of age
    


Intervention name(s): 20vPnC
Intervention type(s): Biological
Intervention description(s): 20-valent pneumococcal conjugate vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Non-steroid, Atopic Dermatitis Phase IIb 12-week Trial; Topical WBI-1001 Cream
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Welichem Biotech has developed a small molecule drug candidate, WBI-1001, that selectively
      targets the pathogenic features of inflammatory skin diseases, including atopic dermatitis (a
      form of eczema).The purpose of this clinical trial is to further test the safety and efficacy
      of WBI-1001 as a topically applied cream over an extended period of 12 weeks on patients with
      mild to moderate atopic dermatitis.
    

Detailed description: 
      A multi-centered, double-blinded Phase IIb study to evaluate the safety and efficacy of the
      non-steroid, anti-inflammatory WBI-1001 cream in the topical treatment of patients with mild
      to moderate atopic dermatitis, expressed as lesions up to 20% BSA. For the first 6 weeks
      patients will be randomized to one of three treatment groups simultaneously in a ratio of
      1:1:1.

      Group 1: vehicle cream (placebo), BID; Group 2: 0.5% WBI-1001 cream, BID; Group 3:1.0%
      WBI-1001 cream, BID. Patients randomized to treat all lesion areas.

      After the first 6 weeks all patients will be treated, non-placebo controlled, with WBI-1001
      cream. The Group 1 patients will enter a double-blinded phase for a further 6 weeks with half
      of them being treated BID with 0.5% and half with 1.0% WBI-1001 cream. Groups 2 and 3 will
      continue with their treatments unchanged for the remaining 6 weeks.

      During the treatment period, patients will apply the cream (BID) from the kit that they have
      been provided, and they will visit the study centre at prescribed times for assessment of
      efficacy, safety and tolerability. After completion of the 12-week treatment period patients
      will have a 2-week follow-up visit.

      Patients who withdraw from the study before Day 42 for reasons other than a treatment related
      AE will be replaced so that at least 40 patients per group will complete the
      placebo-controlled phase.
    

Intervention name(s): WBI-1001
Intervention type(s): Drug
Intervention description(s): A 12-week study to assess the efficacy, safety and tolerability of topically applied WBI-1001 creams. First 6 weeks will be double-blinded, placebo-controlled and the following 6 weeks will be double-blinded, non-placebo- controlled. After 6 weeks patients in Groups 2 and 3 will continue double-blinded treatment for a further 6 weeks, but patients in Group 1 will enter a 6-week double-blinded phase with one of the two active creams (half treated with 0.5% and half with 1.0% WBI-1001 cream). All patients treated twice daily (BID).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: non-steroid; anti-inflammatory; skin disease; topical cream; small molecule; atopic dermatitis; eczema
Effects of Installing Height-adjustable Workstations on Office Workers Workplace Sitting Time and Productivity
Condition: Workplace Inactivity
Study type: Interventional

Summary: 
      The purpose of this study was to look at the effects that height-adjustable workstations on
      occupational sitting time and workplace productivity in office workers. Participants
      workplace activity (sitting, standing and walking) and productivity was measured before the
      installation of the height-adjustable workstations. Workplace activity and productivity were
      then measured four weeks after the installation of height-adjustable workstations. The
      results were compared to a control group who received no intervention whilst the intervention
      had the height-adjustable workstations.
    

Detailed description: 
      Sedentary behaviour has been found to be ubiquitous within the workplace and due to the
      negative consequences of sedentary behaviour upon health, research has began to look at ways
      to reduce and interrupt sedentary behaviour.

      Interventions that have introduced height-adjustable workstations into the workplace have
      been found to reduce sedentary behaviour. Some employees and employers are concerned that
      using height-adjustable workstations and trying to reduce workplace sedentary behaviour can
      lead to a loss of workplace productivity.

      The present study looked at the effects of installing height-adjustable workstations on
      occupational sitting time and workplace productivity in desk-based workers. Workplace
      activity was measured objectively using ActivPal accelerometers and productivity was measured
      via self-report measures. Measurements took place at baseline and four weeks after receiving
      the height-adjustable workstation.
    

Intervention name(s): Height-adjustable workstation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash
Condition: Gingivitis; Dental Plaque
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      Myrrh-based mouthwash has the potential to be a suitable alternative to the gold standard
      chlorhexidine mouthwash for dental plaque and gingivitis reduction. To date, however, little
      research has been carried out to determine its true clinical significance on periodontal
      health. The purpose of this study is to evaluate and compare the efficacy of 1% myrrh
      mouthwash with commercially available 0.2% chlorhexidine mouthwash in terms of plaque and
      gingivitis reduction and inflammatory mediator (interleukin-1β) inhibition.
    

Detailed description: 
      This will be a single-center, triple-blinded, randomized, three-arm parallel, controlled
      trial in periodontally healthy adult volunteers (no clinical attachment loss and bleeding on
      probing < 10%). We will include all eligible patients seeking dental treatment at the center
      after gaining a written informed consent. After the initial dental screening and a session of
      professional teeth cleaning procedures, participants will be instructed to refrain from
      regular oral hygiene practices for 2 weeks to develop experimental gingivitis. Participants
      will then be randomly allocated to one of the three treatment groups [1:1:1] using a simple
      randomization method (i.e. computer-generated random numbers). They will be instructed to
      continue refrain from regular oral hygiene practices and use 10 ml of the assigned mouthwash
      twice daily for 1 minute. Treatment effect will be evaluated by comparing the baseline (day
      0) and post-intervention (day 14) values of all clinical parameters (modified gingival index,
      plaque index, proinflammatory interleukin-1β biomarker, and Gingival Bleeding Index).
    

Intervention name(s): Myrrh mouthwash; Chlorhexidine mouthwash; Normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.; 0.2% mouthwash solution of chlorhexidine gluconate.; 0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride)
Other intervention name(s): Commiphora myrrha mouthwash; Chlorhexidine gluconate mouthwash; Avalon Avohex mouthwash; Sodium Chloride solution
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingivitis; herbal; myrrh; myrrha; antigingivitis; antiplaque; IL-1; dental plaque
Effect of Ginseng in Type 2 Diabetes
Condition: Type II Diabetes Control
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in
      patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A
      total of 23 type 2 patients are enrolled in the study. Utilizing a double-blind, crossover
      design, the participants are randomized to receive either placebo or American ginseng extract
      (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes treatment.
      Following ≥4-week washout period the participants are crossed over to another 8-week
      treatment arm. Throughout the study period, all individuals maintain their original diabetes
      treatment and regular lifestyle. The primary endpoint is HbA1c, and secondary are fasting
      blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1. Safety
      parameters include liver, kidney and hemostatic functions.
    


Intervention name(s): CNT 2000 American ginseng extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Azathioprine in Recurrent Implantation Failure
Condition: Recurrent Implantation Failure; In Vitro Fertilization; Intracytoplsmic Sperm Injection
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Azathioprine increase pregnancy rate in patients with recurrent implantation failure
    


Intervention name(s): Azathioprine Pill; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Azathioprine increase pregnancy rate in cases with recurrent implantaion failure; Placebo tablets
Intervention MeSH terms: Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
Condition: Low Back Pain; Migraine; Diabetic Neuropathies; Osteoarthritis
MeSH terms: Osteoarthritis; Diabetic Neuropathies; Back Pain; Low Back Pain; Breakthrough Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl
      for the potential treatment of breakthrough pain episodes in patients who have chronic
      noncancer pain.
    


Intervention name(s): OraVescent Fentanyl
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Sudden Pain; Flares; noncancer; low back pain; neuropathic pain; osteoarthritis pain; migraine; chronic headache; diabetic peripheral neuropathy
US-guided Thoracic Spinal Epidural Anesthesia VS GA for Abdominal and Breast Surgeries
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Ultrasound-guided combined thoracic segmental spinal epidural anesthesia in comparison with
      general anesthesia in upper abdominal and breast surgery.
    

Detailed description: 
      The first group (S) will be given ultrasound-guided thoracic segmental spinal anesthesia at
      the level of T10 interlaminar space, patients will be in sitting position, a combined spinal
      epidural tray will be used. In this group, SonoSite C60x/5-2 MHz M-Turbo Convex Probe
      ultrasound Transducer to identify the T10 interlaminar space and after complete
      sterilization, the investigator will introduce the epidural needle in a Paramedian in plan
      approach till the epidural space. The spinal needle is then introduced through the epidural
      needle not more than 0.5 cm beyond the Dura matter. 2cc of heavy Marcaine plus 25 ug fentanyl
      are injected through the spinal needle. The epidural catheter is then threaded through the
      Touhy needle after withdrawal of the spinal needle to keep only 4cm up in the epidural space.
    

Intervention name(s): combined thoracic segmental spinal epidural anesthesia
Intervention type(s): Procedure
Intervention description(s): ultrasound guided thoracic segmental spinal anesthesia at the level of T10 interlaminar space , patients will be in sitting position, spinal needle is then introduced through the epidural needle not more than 0.5 cm beyond the Dura matter. 2cc of heavy Marcaine plus 25 ug fentanyl are injected through the spinal needle.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the best dosage of Capecitabine and Tarceva
      combination in the setting of radiation and to assess treatment effectiveness,
      progression-free survival and overall survival.
    

Detailed description: 
      Over the past several decades, 5-fluorouracil based chemoradiation has been the cornerstone
      for the treatment of locally advanced non-operable pancreatic cancer. However, the survival
      of these patients is disappointing. The majority of the patients suffer either local
      progression or metastatic disease. With the availability of Capecitabine, a few pilot studies
      showed the the drug is convenient, tolerable and safe in combination with radiation therapy.
      Capecitabine demonstrated its superior anti-tumor activity with 14 months of median survival.
      However, these are small Phase I studies and the survival benefit needs to be further
      validated with larger studies. Epidermal growth factor receptor (EGFR) has been implicated in
      tumor growth and angiogenesis. Inhibiting EGFR by Tarceva has demonstrated effective
      treatment in metastatic pancreatic cancer. Anti-epidermal growth factor therapy in
      combination with radiotherapy has been demonstrated efficacious in other solid tumors such as
      head and neck cancer. We hypothesize that the combination of Tarceva and Capecitabine has
      synergistic anti-tumor effect. Hence, improvement of median survival could be potentially
      achieved with this novel combination.
    

Intervention name(s): Capecitabine, Tarceva
Intervention type(s): Drug
Intervention description(s): Capecitabine is a self-administered (oral) medication & will be dose escalated and administered in four dose levels: Level I - 600 mg/m2 bid; Level II - 700 mg/m2 bid; Level III - 825 mg/m2 bid; Level IV - 925 mg/m2 bid. Tarceva will be self-administered(orally) in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single agent Tarceva 100 mg/day. Treatment of Capecitabine & Tarceva is continued daily until the completeness of the radiation or toxicity.
Other intervention name(s): Capecatine, Xeloda; Tarceva, Erlotinib, OSI-774
Intervention MeSH terms: Capecitabine; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiotherapy; Non-operable pancreatic cancer; locally advanced pancreatic cancer