bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study of SHEN26 Capsule in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, and placebo-controlled phase I clinical trial. It is
      designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of SHEN26
      capsules after single and multiple ascending dosing in healthy Chinese adult participants,
      and the food effect on the PK profile of SHEN26 capsules.
    

Detailed description: 
      This phase of the study includes three parts: single ascending dose (SAD), food effect (FE),
      and multiple ascending dose (MAD) in healthy participants.

        -  SAD Part: There are dose groups of 50 mg, 200 mg, 400 mg, 800 mg, and 1200 mg for the
           SAD part of the trial.

        -  FE Part: This part of the study is tentatively assigned to the 400 mg dose group of the
           SAD part. After the participants complete the SAD part and pass their safety check on
           Day 4, they enter the second cycle. Participants are required to fast for more than 10
           hours on the night of Day 4, and they will be dosed again on Day 5, 30 min after the
           start of the high-fat meal (the meal had to be completed within 30 min).

        -  MAD Part: Based on the safety, tolerability, and PK data from the SAD part, if
           available, the appropriate dose will be selected for the MAD study. Three dose groups of
           200 mg, 400 mg, and 600 mg are planned for this part of the study.
    

Intervention name(s): SHEN26 capsule; SHEN26 capsule; SHEN26 placebo; SHEN26 placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Specification: 50mg/capsule and 200mg/capsule. Participants will receive SHEN26 capsule(s) orally for a single dose.
The specification of 50mg/capsule will only be used for the 50mg dose group in the SAD part. For the other dose groups and other parts of the study, 200mg/capsule will be used.; Specification: 200mg/capsule. Participants will receive SHEN26 capsules orally for Q12h X 5.5 days.; Placebo matching the SHEN26 capsule. Specification: 50mg/capsule and 200mg/capsule.
Participants will receive SHEN26 placebo orally for a single dose.; Placebo matching the SHEN26 capsule. Specification: 200mg/capsule.
Participants will receive SHEN26 placebo orally for Q12h X 5.5 days.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare PK of single dose of vedolizumab SC 108 milligram
      (mg) administered as PFS vs investigational device.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab SC. The study will assess the PK,
      and variability of a vedolizumab SC in a PFS vs investigational device.

      This study will include 2 different device delivery presentations in 2 treatment groups.
      Participants in each treatment group will be randomized to one of the three administration
      sites: Abdomen, thigh, or arm. The study will enroll approximately 24 participants, including
      4 participants allocated to each administration site within each treatment group.
      Participants will be randomly assigned (by chance, like flipping a coin) to one of the two
      treatment groups:

        -  Group A: Vedolizumab SC PFS

        -  Group B: Vedolizumab SC Investigational Device

      All participants will receive a single dose of study drug on Day 1.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 196 days. Participants will be contacted by
      telephone on Day 168 after their last dose of study drug for a follow-up assessment which
      will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey.
    

Intervention name(s): Vedolizumab SC
Intervention type(s): Drug
Intervention description(s): Vedolizumab SC liquid.
Other intervention name(s): ENTYVIO, KYNTELES, MLN0002
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers
Condition: Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

Summary: 
      Background: The medical and economic burden of upper respiratory tract infections (URTIs) is
      extremely high, while prevention and treatment options are limited. Therefore, there is a
      constant need for new methods in order to significantly decrease such morbidity. Extensive
      evidence shows that vitamin D is associated with respiratory health, including in the
      prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and
      can serve as a model for research in this field.

      The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D
      levels will reduce the frequency, length, and severity of URTIs and their accompanying
      functional impairment, while improving cellular immune function and physical function.

      Methods: After screening 100 competitive adolescent swimmers to obtain ~60 with low serum
      levels of vitamin D, this study group will be randomized to receive either vitamin D
      supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months.
      Participants will fill a daily questionnaire regarding frequency, length and severity of
      URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin
      D status (25(OH)D) and immune function among study participants at the beginning of the study
      and after supplementation. Physical function on land and in water will also be assessed.

      Expected results: Increase in serum 25(OH)D levels following supplementation will
      significantly decrease the frequency, length and severity of URTI's and their functional
      impairment, while enhancing the cellular immune system function and physical capacity.
    


Intervention name(s): vitamin D; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2000 IU/day of vitamin D3 as a once-daily dose; sweetened water
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: infections; immune system; vitamin D; sport; children
Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis
Condition: Psoriasis; Arthritic Psoriasis
MeSH terms: Arthritis, Psoriatic; Psoriasis
Study type: Interventional

Summary: 
      Body composition analysis and especially body fat distribution in regions of interest
      (android and in particular intra-abdominal region) provides some information on the risk of
      cardiovascular disease. There is little data available on the body composition analysis in
      psoriasis and psoriatic arthritis (diseases with higher risk of cardiovascular disease), in
      particular data on fat distribution in regions of interest regarding the risk of
      cardiovascular disease.

      Adipokines, secreted by the adipose tissue, have pro or anti-inflammatory and metabolic
      properties that are interesting to explore in pathologies with a higher risk of
      cardiovascular disease like psoriasis or psoriatic arthritis.

      Adipokines have been investigated in psoriasis but fat tissue and in particular its
      distribution (android/visceral or intra-abdominal) has not been studied in parallel.
      Moreover, relation between adipokines and psoriasis area or severity has been studied but the
      relation between adipokines and cardiovascular risk factors has not yet been investigated.

      The aim of this study is to investigate relations between the body fat distribution,
      adipokines rates and the risk of cardiovascular disease of these patients.
    


Intervention name(s): bone densitometry; questionnaires; biological analyses
Intervention type(s): Other; Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity, Abdominal; Adipokines; Risk of cardiovascular diseases
Music Therapy as an Adjunct in CIED Lead Extraction Procedures
Condition: C.Surgical Procedure; Stress; Pain, Procedural; Anxiety
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The study will investigate possible effects of music therapy as an adjunct in an invasive
      cardiac procedure where infected or broken pacemaker leads, or leads from implantable
      cardioverter-defibrillators are removed from inside the heart through the vein. The procedure
      is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are
      given at the start of the procedure, and repeated if needed. In spite of the drugs, most
      patients will experience som degree of pain and/or anxiety and increased stress during the
      procedure. The music therapy intervention contains individually facilitated music listening
      and coping techniques, aiming to regulate stress responses. The music listening and guidance
      is provided by a certified music therapist before, during and after the invasive procedure.
    

Detailed description: 
      See study protocol
    

Intervention name(s): Facilitated Music Listening
Intervention type(s): Behavioral
Intervention description(s): The patient gets a preparatory session with the music therapist one day before the invasive procedure, where individual assessment is made based on a biopsychosocial approach. Sequences of facilitated Music listening is provided during the pre-, peri and postoperative phase, and a closing dialog performed postoperatively. Patient-preferred music is chosen from a limited set of playlists provided on the app The Music Star.
Other intervention name(s): Music therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Jaw Clenching on Anaerobic Ability and Ventilatory Flows
Condition: Mouth Breathing
MeSH terms: Mouth Breathing
Study type: Interventional

Summary: 
      The latest findings on the ergogenic effects of a dentistry-design, bite-aligning mouthpiece
      require additional research to assess its impact on anaerobic ability and ventilatory
      parameters. This study was aimed at determining the ergogenic acute effects of wearing a
      custom-made mouthpiece on oral airflow dynamics, Wingate Test performance parameters.
    

Detailed description: 
      The objectives of this study are to investigate the acute effects of a customized,
      bite-aligning mouthpiece on the different parameters assessed during a Wingate Test, as
      compared to clenching the jaw without a mouthpiece, in a physically-active, male population.
      The study also investigate the influence of wearing a mouthpiece on non-forced and forced
      airflow dynamics, as compared to open mouth and a jaw clenching without mouthpiece.
      Mouthpieces are made using a new scanning method that simplified the fitting process and
      lowered its cost.

      A nonrandomized study was designed to compare the effect of the occlusion condition on the
      anaerobic power and airflow dynamics. Conditions of wearing or not wearing mouthguard (MOUTHG
      and NO-MOUTHG, respectively) are randomly distributed in all tests. Each subject participate
      in three sessions. The first session is used to obtain informed consent assess anthropometric
      measurements and to scan the subject's mouth structure. In the second session, subjects are
      familiarized with the test protocols via a learning session that included demonstration of
      Wingate Test and the airflow dynamics measurements. Subjects also perform the airflow tests
      and the first Wingate Test trial. In the third session, subjects perform the second Wingate
      Test trial. Conditions are randomly distributed in all tests. Wingate Test trials were
      separated by three days and subjects were not allowed to perform intensive training
      workloads.
    

Intervention name(s): Mouthguard; No mouthguard
Intervention type(s): Device; Device
Intervention description(s): Condition of wearing mouthguard; Condition without mouthguard
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: mouthguard; ventilation; anaerobic power; ergogenic effects
EEG Changes of type1 Diabetes During Sleep -Insulin Induced Hypoglycemia
Condition: Sleep EEG
MeSH terms: Hypoglycemia
Study type: Observational

Summary: 
      Hypoglycaemia is associated with characteristic changes in the EEG with the appearance of
      slow frequency waves. In a recent study the investigators have shown that these changes can
      be recorded from subcutaneous electrodes and processed by an automated mathematical algorithm
      based on non-linear spectral analysis, and that changes are present before the occurrence of
      severe hypoglycaemia in type 1 diabetes patients. An alarm device based on real-time analysis
      of continuous EEG-recordings may thus be possible. For many diabetes patients nocturnal
      hypoglycaemia is a feared complication which may thus be preventable.
    

Detailed description: 
      The different sleep stages are associated with specific EEG-changes of high complexity with
      the occurrence of slow frequency waves during stages of deep sleep.

      The aim of this study is to assess EEG changes during insulin-induced hypoglycaemia in type 1
      diabetes patients in the different stages of sleep. The core questions will be:

      (i) Will the pathological hypoglycaemia-related EEG-changes dominate over the physiological
      sleep-related changes when hypoglycaemia occurs during sleep? (ii) Is it possible to refine
      the mathematical algorithm to an extend, where EEG-changes during hypoglycaemia can be
      distinguished from sleep-related EEG-changes in all sleep stages.

      (iii) If so, at what blood-glucose level will hypoglycaemia associated EEG-changes be
      detectable and (iv) Will patients be able to react adequately by ingestion of carbohydrates
      if an alarm can is given at the time of hypoglycaemia associates EEG-changes.

      Twelve patients with type 1 diabetes will be studied. EEG will be recorded during graded
      hypoglycaemia achieved by insulin infusion and frequent glucose measurements. EEG will be
      analysed by the automated algorithm and by visual analysis to address the questions (i), (ii)
      and (iii). To address question (iv) real-time EEG-analysis with a predefined threshold
      defining hypoglycaemia will be performed and an alarm will aim to warn the patients of
      impeding hypoglycaemia. Patients will be asked to consume carbohydrates at alarm.

      During the experiments the patients will be under continuous observation.
    

Intervention name(s): Hypo device
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 diabetes
      
Keywords: EEG; Sleep; device; diabetes; hypoglycemia
OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA
Condition: Duration of Hospitalization; Clinical Manifestation of COVID-19
Study type: Observational

Summary: 
      In order to compare the effectiveness between Remdesivir and Favipiravir, an observational
      analytic study using a retrospective cohort design. Eighty-eight medical records of COVID-19
      patients from January to August 2021
    

Detailed description: 
      Coronavirus Disease 2019 (COVID-19) is an infectious disease caused by Severe Acute
      Respiratory Syndrome Coronavirus 2 (SARS CoV-2). Antiviral therapies are considered to be one
      of the COVID-19 treatments. Remdesivir and favipiravir are the antivirals recommended by
      Indonesia's 3rd COVID-19 Management Guidelines. They have a similar mechanism to inhibit
      virus replication, specifically by inhibiting RNA-dependent RNA polymerase (RdRp) of the
      virus. Several studies reported that patients who received these antivirals had a lower
      duration of hospitalization. However, the effectiveness comparison of remdesivir and
      favipiravir remains unknown.

      An observational analytic study using a retrospective cohort design. Eighty-eight medical
      records of COVID-19 patients from January to August 2021 are collected by consecutive
      sampling technique, and this research was carried out at Gotong Royong Hospital Surabaya.
    

Intervention name(s): Remdesivir
Intervention type(s): Drug
Intervention description(s): The patients, based on their clinical condition, got remdesivir OR favipiravir at least five days of treatment. The WHO ordinal scale was used to assess patients' clinical progress in the first and second weeks.
Other intervention name(s): Favipiravir
Intervention MeSH terms: Remdesivir; Favipiravir
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients' medical records from Gotong Royong Surabaya Hospital were obtained from January
        2021 to March 2021 and June 2021 to August 2021, since remdesivir was rarely used from
        April 2021 to May 2021.
Dose-Exposure-Response in Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type I
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after
      single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic
      clamp technique using the Biostator (TM).
    


Intervention name(s): Insulin glulisine
Intervention type(s): Drug
Intervention MeSH terms: Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Insulin glulisine; Euglycaemic clamp; Diabetes mellitus Type 1
Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis
Condition: Carpal Tunnel Syndrome; Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Carpal Tunnel Syndrome; Syndrome
Study type: Observational

Summary: 
      This study aimed to investigate median nerve hypervasculatitation in psoriatic arthritis
      (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people.
    

Detailed description: 
      Carpal tunnel syndrome(CTS), a type of median nerve neuropathies, is the most common
      peripheral nerve entrapment syndrome. Most cases are idiopathic but CTS can be associated
      with rheumatologic disorders. There isn't any gold standard technique in diagnosis of CTS.
      Electrodiagnostic studies (EDS) are usually performed to confirm diagnose, to differentiate
      other diseases or to detect severity. But EDS have some disadvantages such as EDS are time
      consuming, uncomfortable, may require interventional procedures, can not directly assess the
      anatomy of the median nerve and its surrounding structures. For these reasons, the use of
      ultrasonography (US) in the diagnosis of carpal tunnel syndrome has been investigated for a
      long time. Most of them focused on the cross-sectional area(CSA) of median nerve. Fewer
      studies have investigated the vascularity of the median nerve. But there is conflict results
      because conventional Doppler techniques may fail to show small vessels or slow blood flow.
      Superb microvascular imaging (SMI) is a new ultrasound technology that can diferentiate blood
      flow signals from artifacts by using a new algorithm. In carpal tunnel syndrome
      hypervasularitation of median nerve has showed by SMI. To our best knowledge, there isn't any
      study assessing median nerve hypervascularity by using SMI in PsA. So we aimed to investigate
      median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without
      CTS by using SMI, then compare them with normal people.
    

Intervention name(s): Superb Microvascular Imaging
Intervention type(s): Diagnostic Test
Intervention description(s): Superb microvascular imaging (SMI) is a new ultrasound technology that can diferen-tiate blood flow signals from artifacts by using a new algorithm.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        PsA patients according to the CASPAR criteria who consecutively applied to the FTR
        outpatient clinic for PsA follow-up and healthy volunteers who applied to the FTR
        outpatient clinic enrolled in the study.
      
Keywords: Carpal Tunnel Syndrome; Psoriatic Arthritis; Superb Microvascular Imaging
Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers
Condition: Endodontically Treated Teeth
MeSH terms: Tooth, Nonvital
Study type: Interventional

Summary: 
      The clinical use of a flowable premixed calcium-silicate bioceramic sealer used in
      association with warm carrier-based/single-cone technique will be compared with epoxy
      resin-based sealer with carrier-based technique.
    

Detailed description: 
      Healthy consecutive patients (n= 109) requiring 141 root canal treatments were enrolled in
      this study and divided in 3 groups (Group 1: Ceraseal + single cone cold technique n=47.
      Group 2: Ceraseal + Carrier-based technique n=47. Group 3 AH Plus + Carrier based technique
      n=47).

      Periapical X-rays were taken preoperatively, after root canal filling and after 6, 12 and 24
      months. Two evaluators blindly assessed the Periapical Index (PAI) and sealer extrusion in
      the 3 groups (k =0.90). Healing rate and survival rate were also analysed.

      Chi square tests was used to analyse significant differences among the groups. Multilevel
      analysis was performed to analyse the factors associated to healing status and survival
      status.
    

Intervention name(s): root canal filling with Ceraseal sealer
Intervention type(s): Other
Intervention description(s): root canal filling with Ceraseal sealer
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: root canal treatment; healing rate; warm obturation technique; bioceramic sealer