bioihbjkbjnl/mcl2 huggingface dataset:
Naturalistic Monitoring and Treatment of Chronic Insomnia
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      90 individuals with chronic insomniacs and 30 healthy normal sleepers will have their sleep
      monitored by the SleepScore Max for 10 weeks. Individuals with chronic insomnia will be
      randomized into one of three groups (30 subjects in each): a test intervention group, a
      passive control group, and an active control group. The purpose of the study is to examine if
      the SleepScore max provides a accurate measurement of sleep relative to a validated,
      wrist-worn sleep monitor and if a integrated coaching feature within the SleepScore Max
      facilitates improvement in sleep relative to other gold standard treatment methods.
    

Detailed description: 
      90 chronic insomniacs, carefully screened using the criteria of Chronic Insomnia Disorder
      according to the International Classification of Sleep Disorders 3 (ICSD-3), will be studied.
      Additionally, 30 healthy normal sleepers will be included as controls. The duration of study
      participation will be 10 weeks. All subjects will wear an actigraph during week 1 to record
      baseline sleep patterns, followed by 8 weeks of recording with the SleepScore Max. During
      week 10, the subjects will wear the actigraph again to measure post intervention sleep. The
      healthy subjects will be used as a control to test if the SleepScore Max can track sleep well
      as compared to actigraphy. The subjects with chronic insomnia will be randomized into one of
      three groups (30 subjects in each). One of these groups is the test intervention group, in
      which subjects will track their sleep with the SleepScore Max device and will receive
      feedback and coaching from the Smartphone app associated with the device. The other two
      groups will serve as passive and active controls. The passive control group will track their
      sleep using the SleepScore Max device, but without any feedback or coaching. The active
      control group will also be tracking their sleep with the device, without feedback or
      coaching, but they will also undergo online CBTi which is a user guided program to track
      sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep
      scheduling and sleep hygiene to help improve sleep.
    

Intervention name(s): SleepScore Max coaching feature; Online CBTi
Intervention type(s): Device; Behavioral
Intervention description(s): The SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep.; Online Cognitive Behavioral Therapy for insomnia is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continous Positive Airway Pressure (CPAP) Compliance Study
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Does an internet based text or email interaction and education improve CPAP compliance for
      patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.
    


Intervention name(s): additional educational material; Standard of care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The internet-based intervention group would receive a weekly text or an email (based on the subject's preference). The content of the message asks about their approximate compliance over the past week. Based on their response, they will be directed to one of two internet web pages.; participants will receive education from staff nurses as needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
Condition: Influenza
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety
      and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be
      screened within 28 days of randomization (Day 1).
    

Detailed description: 
      This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety
      and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be
      screened within 28 days of randomization (Day 1). Approximately 60 subjects who meet all
      inclusion and no exclusion criteria and provide written informed consent will be enrolled
      into 3 sequential cohorts of 20 subjects each defined by the viral particle dose (1×10(9th),
      1×10(10th), and 1×10(11th) vp). Within each cohort and its sentinel group, subjects will be
      randomized in a 3:1 ratio to receive 1 intranasal dose of NasoVAX or placebo (Day 1). A
      sentinel group of 5 subjects from each cohort will be dosed and followed through Day 8.
      Dosing of the remainder of each cohort may proceed if no events meeting stopping criteria
      have occurred. The SRC, consisting of the Investigator, the Medical Monitor, and a Sponsor
      Representative, will review AE, reactogenicity, and laboratory data through Day 8 for all
      subjects in each cohort before subjects are randomized to the next higher dose. If any event
      meeting stopping criteria occur, the SRC will review all available safety information before
      additional patients are dosed.
    

Intervention name(s): NasoVAX
Intervention type(s): Biological
Intervention description(s): Single ascending dose study
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese
Condition: Healthy Participants
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy male and female participants of non-childbearing potential who are
      overweight or obese.
    

Detailed description: 
      The study will comprise of:

        -  A Screening Period of maximum 28 days.

        -  A Treatment Period during which participants will be resident at the Clinical Unit from
           three days before (Day -3 ) Investigational Medicinal Product (IMP) administration (Day
           1) until at least 4 days (96 hours) after IMP administration, participants will then be
           discharged on the morning of Day 5.

        -  Weekly outpatient visits on Days 8, 15, 22, 29, and 36 for blood sample collection,
           Electrocardiogram (ECGs), and adverse events (AE) recording.

        -  A Follow-up Visit 6 weeks (Day 43) after the last IMP dose.

      Furthermore, 3 dose levels of AZD6234 for Subcutaneous (SC) administration (Cohorts 1 to 3)
      and one dose level for Intravenous (IV) administration (Cohort 4) are planned to be
      investigated in healthy participants who are overweight or obese. The IV cohort (Cohort 4)
      can begin in parallel or after Cohort 3. One dose level for SC administration is planned to
      be investigated in Japanese participants only (Cohort 5), and up to 3 additional dose levels
      for SC administration are planned to be investigated in healthy participants (Cohort 6 to 8).
      Depending on the findings, additional (optional) dose level cohorts may be added at the
      discretion of the Sponsor.
    

Intervention name(s): AZD6234; Placebo; Acetaminophen
Intervention type(s): Drug; Drug; Combination Product
Intervention description(s): Participants will receive a single dose of AZD6234 as a solution via SC or IV injection; Participants will receive matching volumes of the placebo as a solution via SC or IV injection; Participants will receive a single dose of acetaminophen as part of a meal
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Overweight; Obese; Non-childbearing
Pedometer Assisted Physical Activity in Individuals With COPD. A Multicenter Randomized Controlled Trial.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Home based and tele-rehabilitation programs may be potentially useful to deliver and to
      maintain the benefits in difficult-to-reach areas. Tele-health technologies allow for
      distribution of healthcare services and exchange of information between healthcare providers
      and patients in different geographical locations and provide an important tool to reach
      people living in rural communities. In a previous single center study, we had shown that a
      home pedometer assisted program to enhance physical activity was as effective as and cheaper
      than a standard outpatient supervised exercise training program.13 We wondered whether the
      results of that study 13 might be confirmed in a larger multicenter randomized controlled
      trial (RCT). Therefore the aim of this multicenter RCT was to evaluate the benefits and costs
      of a program of pedometer assisted physical activity as compared to standard hospital
      outpatient supervised exercise training program.
    

Detailed description: 
      A multicenter RCT was conducted in Moewardi (Surakarta, Central Jawa, Indonesia) and Mohammad
      Rabain (Muara Enim, South Sumatra, Indonesia) hospitals from February the 1st, 2019 to
      February the 29th 2020. The study was performed according to the Helsinki Declaration,
      approved by the Committee of Moewardi Hospital, Surakarta, Central Jawa, Indonesia (Number
      713/IX/HREC/2018, September 26th, 2018 and Indonesian Ministry of Health).Participants with
      COPD as defined by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD)
      guidelines and eligible for this study were allocated into two groups using a randomly
      generated sequence. Before and after the program, the following outcome measures; 6MWT, BODE,
      physical activity, MRC and CAT Score.
    

Intervention name(s): pedometer home based rehabilitation; Exercise training
Intervention type(s): Device; Other
Intervention description(s): Home based pulmonary rehabilitation for 6 weeks using pedometer Omron HJ 321 pedometer (Omron Healthcare Co Ltd, Kyoto, Japan); Hospital based exercise training for 6 weeks
Other intervention name(s): pedometer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary rehabilitation; Tele-medicine; Exercise capacity; Dyspnoea; Quality of life
A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomised, double-blind, active comparator controlled, three-period
      cross-over, single dose trial in subjects with type 1 diabetes mellitus.
    

Detailed description: 
      This is a single center, randomised, double-blind, active comparator controlled, three-period
      cross-over, single dose trial in subjects with type 1 diabetes mellitus.

      Each subject will be randomly allocated to a sequence of three treatments:(i) simultaneous
      administrations of BioChaperone® pramlintide human insulin (BC Pram Ins) and placebo, (ii)
      simultaneous injections of pramlintide (Symlin®) and human insulin (Humulin®) and (iii)
      simultaneous injections of insulin lispro (Humalog®) and placebo.

      Subjects will come in a fasted state to the clinical trial centre in the morning, meal test
      procedures will be performed and subjects will stay at the clinical trial centre until the
      post-dose follow-up period has been terminated.
    

Intervention name(s): BC Pram Ins; Symlin® and Humulin®; Humalog®; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Injection of BC Pram Ins; Injection of pramlintide and human insulin; Injection of lispro; Injection of 0.9% NaCl
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Argentina
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is an Argentinian, Multicentre, Observational Study to evaluate Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth
      hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via
      easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects
      will provide their Informed Consent/assent to upload their data for population-based analyses
      and, ultimately, clinical outcomes. Adherence data will be primarily derived from the
      easypod™ device combined with physician data entry of outcome measures. Data will be
      collected both retrospectively and prospectively. This will allow the establishment of
      adherence profiles and explore the hypothesis that patient adherence support programs improve
      adherence and subsequent clinical outcomes. Collected data will be also analyzed in a
      multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling

        -  To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
Other intervention name(s): Somatropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and
      maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by
      healthy women in the United States.
    


Intervention name(s): Dapivirine Vaginal Ring; Maraviroc Vaginal Ring; Placebo Vaginal Ring; Dapivirine-Maraviroc Vaginal Ring
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): dosage form: dapivirine vaginal ring dosage:25 mg frequency:continuous use duration:28 days; dosage form: maraviroc vaginal ring dosage:100 mg frequency:continuous use duration:28 days; dosage form: placebo vaginal ring dosage:N/A frequency:continuous use duration:28 days; dosage form: combination vaginal ring dosage:25 mg dapivirine + 100 mg maraviroc frequency:continuous use duration:28 days
Intervention MeSH terms: Maraviroc; Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV infections; Anti-HIV agents; HIV-1
Telerehabilitation for Post COVID-19 Condition
Condition: Long COVID; Chronic Fatigue Syndrome
MeSH terms: Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic; Fatigue
Study type: Interventional

Summary: 
      Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of
      patients with COVID-19 report persistent symptoms up to 8 months after the infection. There
      are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to
      test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate
      the acceptability and the potential impact of the program on treating patients with
      functional limitations and persistent fatigue symptoms. It's a pre and post-study without a
      control group.
    

Detailed description: 
      Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of
      patients with COVID-19 report persistent symptoms up to 8 months after the infection. There
      are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to
      test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate
      the acceptability and the potential impact of the program on treating patients with
      functional limitations and persistent fatigue symptoms. It's a pre and post-study without a
      control group. The intervention will be based on cardiopulmonary rehabilitation principles
      and will be administered for 12 weeks. Fatigue, post-exertional malaise, and
      functional/exercise capacities will be evaluated.
    

Intervention name(s): Telerehabilitation program based on cardiorespiratory principles
Intervention type(s): Other
Intervention description(s): The intervention consists of a hybrid program. The participant will receive rehabilitation sessions in presence (aerobic component of the intervention based on maximal oxygen uptake measured before intervention by means on a ergospirometric test) and at home via a telerehabilitation platform. The length of the intervention is 12 weeks. For the in-presence sessions, they are going to be 75 minutes, 2x/week. For the at-distance sessions, they are going to be 45 minutes, 1x/week in groups of 3 to 4 participants. The intervention will consist of a warm-up, endurance, postural, and strengthening exercises, cool down and respiratory exercises. An exercise book with final recommendations is provided to the participants at the end of the intervention.
Intervention model: Single Group Assignment
Intervention model description: The study design is a pre-post without a control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiorespiratory; exercise; virtual rehabilitation; post COVID-19 syndrome; fatigue; physiotherapy; post-COVID affection; post-COVID condition
Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases
Condition: Hypertension; Diabetes Mellitus
MeSH terms: Hypertension
Study type: Observational

Summary: 
      This is an observational clinical study, patients with systemic diseases will be enrolled
      according to the inclusion and exclusion criteria. Patients will received the examination of
      sublingual microcirculation by using incident dark field video microscope (Cytocam，Braedius
      Battery Powered Transilluminator). The microcirculation data includes total small vessel
      density, perfused small vessel density, microvascular flow index, and heterogeneity index.
      The patients will be divided into right groups according to their systemic diseases as
      follows: group 1 hypertension (60 patients), group 2 diabetes mellitus (60), group 3
      hypertension and diabetes mellitus (60), group 4 end stage renal disease with hemodialysis
      (60), group 5 kidney transplant recipients (60), group 6 coronary artery disease (60), and
      group 7 peripheral arterial occlusive disease (60).
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with systemic diseases
Erector Spinae Muscle Block Versus Caudal Block by Sonar in Pediatrics Undergoing Lower Abdominal Surgery
Condition: Postoperative Analgesia
Study type: Interventional

Summary: 
      this prospective randomized double blind controlled study was conducted on 60 child scheduled
      for lower abdominal surgery under general anesthesia. the patients were randomly allocated
      into 3 parallel groups.group (ESB) patients received ultrasound-guided erector spinae block
      in a dose of 0.4mg/ml of 0.25%bupivacaine between the 10th transverse process and erector
      spinae muscles.group(CB) patients received ultrasound-guided caudal block in a dose of
      2.5mg/kg of 0.25%bupivacaine. group(CO) did,t received any block
    

Detailed description: 
      on arrival of the patients to the operative theatre and after placement of the standard
      monitoring general inhalational anesthesia was induced by face mask with sevoflurane (4-8%)
      in oxygen after IV cannula was secured patients received 1mic/kg fentanyl and intubation was
      facilitated by 0.5mg/kg atracurium. isoflurane 1-2% with oxygen was used for maintenance of
      anesthesia. after stabilization of the patient's hemodynamics and before skin incision
      erector spinae block or caudal block was performed with the patient in lateral position.
      after the block patients were flipped back to their normal supine position, surgery took
      place 10 min after injection of local anesthetic. after termination of surgery reversal of
      the atracurium was done by giving neostigmine in a dose of 0.04mg/kg and atropine 0.02mg/kg
      and awake extubation was done
    

Intervention name(s): erector spinae block - caudal block
Intervention type(s): Procedure
Intervention description(s): the child placed in lateral position identification of spinous process of 10th thoracic vertebral then the transducer was moved 2.5 cm laterally to visualize the transverse process and a total of 0.4mg/kg of 0.25%bupivacaine was adminstered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment