bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study of Single Dose IL-6R mAb Injection in RA Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose,multi-center, randomized, double-blind, positive-controlled and
      parallel group clinical study that aims to evaluate the safety,tolerability,PK/PD
      characteristics and Preliminary Efficacy of Recombinant Humanized IL-6R Monoclonal Antibody
      Injection in Patients With Active Moderate-to-Severe Rheumatoid Arthritis.
    

Detailed description: 
      This study is aim to evaluate the safety, tolerability, PK/PD characteristics, immunogenicity
      parameters and Preliminary Efficacy of Recombinant Humanized IL-6R Monoclonal Antibody
      Injection in Patients With Active Moderate-to-Severe Rheumatoid Arthritis. There are 4 dose
      groups and each group enrolls 10 patients: 4mg/kg(IL-6R mAb); 6mg/kg(IL-6R mAb); 8mg/kg(IL-6R
      mAb) and 8mg/kg(tocilizumab ).each patient receives a single intravenous(i.v.) dose. The
      infusion time is from 60 to 90 minutes (the speed can be adjusted appropriately if there are
      injection reactions).
    

Intervention name(s): IL-6R Monoclonal Antibody Injection 4mg/kg; IL-6R Monoclonal Antibody Injection 6mg/kg; IL-6R Monoclonal Antibody Injection 8mg/kg; Tocilizumab Injection 8mg/kg
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): IL-6R Monoclonal Antibody Injection 4mg/kg i.v.,single use; IL-6R Monoclonal Antibody Injection 6mg/kg i.v. , single use; IL-6R Monoclonal Antibody Injection 8mg/kg i.v. , single use; Tocilizumab Injection 8mg/kg i.v., single use
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Chiropractic Plus Nutritional Supplement in Patients With Chronic Pain and Inflammation.
Condition: Chronic Pain; Inflammatory Response
MeSH terms: Inflammation; Chronic Pain
Study type: Interventional

Summary: 
      Evaluating the effect of a combined therapy of chiropractic sessions plus nutritional
      supplement containing hemp, omega-3 fatty acids, and broccoli extract oil in patients
      experiencing chronic pain and inflammation.
    


Intervention name(s): Nutritional Supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Nutritional Supplement + Chiropract sessions; Placebo + Chiropractic sessions
Other intervention name(s): Chiropract sessions; Chiropract sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Safety Study of PPI-1019 in Subjects With Mild-Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single-center, double-blind, inpatient study followed by an outpatient,
      placebo-controlled, multiple-IV injection evaluation of the safety and tolerability of
      PPI-1019 in subjects with mild-moderate Alzheimer's disease (AD). The primary objective of
      the study is to assess the safety of multiple IV injections of PPI-1019 in subjects with
      mild-moderate Alzheimer's disease.
    


Intervention name(s): PPI-1019 (APAN)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alzheimer's Disease
US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the
      Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help
      maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).
    


Intervention name(s): HGNS Treatment
Intervention type(s): Device
Intervention description(s): The Apnex Hypoglossal Nerve Stimulation System (HGNS) is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping and off when the patient is awake.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; OSA; Hypoglossal nerve stimulation; Sleep apnea
Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms
Condition: Prodromal Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The Recognition and Prevention (RAP) Program is conducting a research study comparing an
      antidepressant, sertraline, alone versus in combination with a second-generation
      antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts,
      suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention
      and social skills in adolescents.
    

Detailed description: 
      Eligible patients are enrolled in a 16-week trial consisting of symptom and side effects
      ratings (10 visits), monthly blood and urine tests, and neuropsychological testing at the
      first and last visits. At the initial appointment, all patients are assigned to sertraline
      and are randomly assigned to an adjunctive risperidone or placebo group. The treating
      physician is also blind to the medication assignment, which allows both the doctor and the
      patient to assess side effects and symptom improvement, unbiased by expectation. All patients
      receive an active medication.
    

Intervention name(s): risperidone; sertraline-primary
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: clinical high risk; attenuated positive symptoms; attenuated negative symptoms; cognition; functional status; prodromal psychosis
Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome
Condition: Tourette Syndrome; Chronic Tic Disorder
MeSH terms: Tourette Syndrome; Tics; Tic Disorders; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility of a trial on an oral orthotic for
      reducing tic severity in children ages 7-25 years with Tourette syndrome (TS) or Chronic Tic
      Disorder (CTD).
    

Detailed description: 
      The study is a 2 group, 2 week randomized controlled feasibility trial of an active vs sham
      oral orthotic to reduce tic severity in children and adolescents ages 7-25 years. Responders
      to acute phase treatment will be followed for 10 additional week (12 weeks total) to assess
      intervention durability, safety and acceptability. Non-responders to the sham orthotic will
      be provided active treatment at the end of the 2 week acute phase. We aim to assess and
      enroll 24 participants; twelve participants will receive an orthotic adjusted to the
      appropriate therapeutic height, and twelve participants will receive an identical sham
      orthotic, but not adjusted to the recommended height for the given participant.
    

Intervention name(s): Active Oral Orthotic Treatment; Placebo Oral Orthotic Treatment
Intervention type(s): Device; Device
Intervention description(s): Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study.; After two weeks, this treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study.
Other intervention name(s): Occlusal Splint; Oral Orthotic; Dental Orthotic; Dental Appliance
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourette's; Tic Disorder; Dental Appliance; Oral Orthotic; Mouthguard
Effect of Action Observation Physical Training on Quality of Upper Limb and Functional Independence in Children With Hemiplegia
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy; Hemiplegia
Study type: Interventional

Summary: 
      30 children with a diagnosis of hemiplegic cerebral palsy
    

Detailed description: 
      children aged 6-9 years were randomized into 2 groups, control group and study group
    

Intervention name(s): action observation physical training; Traditional physical therapy training
Intervention type(s): Other; Other
Intervention description(s): Action observation training 3 sessions per week for 3 successive months; Traditional physical therapy training 3 sessions per week for 3 successive months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: HCP
Nitrites, Exercise, and Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high
      nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised
      exercise training at the limb ischemic threshold (SET) will produce a greater clinical
      benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic
      threshold (PET).
    


Intervention name(s): Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training; Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
Intervention type(s): Drug; Other
Intervention description(s): The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training.; The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.
Other intervention name(s): James White Drinks; James White Drinks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Exercise; Functional Capacity
Applying Speed of Processing Training to Individuals With Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      This pilot study will document the efficacy of a behavioral intervention for Processing Speed
      (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been
      successful used in the aging population in several studies. This study will (1) apply a
      treatment protocol for PS impairments, well-validated in aging, to persons with TBI with
      impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess
      the effectiveness of the intervention utilizing global measures of daily life, including an
      objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in
      that it will be the first to evaluate the efficacy of a highly-manualized structured
      behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal
      methodology for carrying out such studies, a randomized clinical trial. Given the prevalence
      of PS deficits in the TBI population and the significant impact such deficits have on
      everyday functioning, public safety, and overall quality of life, the identification of an
      effective intervention for PS deficits in TBI could have a profound impact on the population
      and society as a whole.
    


Intervention name(s): Speed of Process Training
Intervention type(s): Behavioral
Intervention description(s): SPT involves trainer-guided practice of computer-based exercises, including Target Detection (indicating presence or absence of targets, identifying targets, etc.) and Discrimination and Localization (performing same/ different discriminations of targets presented very quickly and followed by a masking pattern) 10, 19, 84. Display speed, ranging from 17 to 500 ms, is the primary manipulation during training, which increases task demands and thus demands on PS itself. These training tasks are tailored to each individual's ability by the trainer.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Processing Speed; Intervention; Traumatic Brain Injury; Cognition
BI 10773 Administered as Oral Solution to Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the pharmacokinetics of BI 10773 and total radioactivity including
      excretion mass balance, excretion pathways and metabolism following the oral administration
      of [14C] BI 10773
    


Intervention name(s): [14C]-BI 10773 - oral solution
Intervention type(s): Drug
Intervention MeSH terms: Empagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular Access in Hematological Patients - PICC Versus CVC
Condition: Vascular Access Complication
Study type: Interventional

Summary: 
      The use of peripherally inserted central catheters (PICCs) represents a major advance for
      hematological patients, enabling the effective delivery of chemotherapy and/or blood products
      particularly for prolonged infusions or in situation of difficult venous access. In modern
      medical practice their use has increased rapidly for several reasons, including ease of
      insertion, many uses (e.g., drug administration and venous access), perceived safety, and
      cost-effectiveness compared with centrally inserted central catheters (CICCs).
    

Detailed description: 
      The use of peripherally inserted central catheters (PICCs) represents a major advance for
      hematological patients, enabling the effective delivery of chemotherapy and/or blood products
      particularly for prolonged infusions or in situation of difficult venous access. In modern
      medical practice their use has increased rapidly for several reasons, including ease of
      insertion, many uses (e.g., drug administration and venous access), perceived safety, and
      costeffectiveness compared with centrally inserted central catheters (CICCs). Despite these
      benefits, PICCs are associated with deep vein thrombosis of the arm and pulmonary embolism.
      These complications, which are often called venous thromboembolism, are important because
      they not only complicate and interrupt treatment, but also increase cost, morbidity and
      mortality. Despite this effect, the burden and risk of PICC-related venous thromboembolism is
      uncertain and clinicians have scarce evidence on which to base choice of vascular access.
      Evidence to choose one vascular access over the other is lacking in literature, in particular
      for patients affected by haematological malignancies, in which chemotherapy is more likely to
      cause myelosuppression, with a major risk of bloodstream infections. Furthermore, the precise
      incidence and the risk of PICC-related venous thromboembolism relative to that of other CICCs
      is unknown. An understanding of this risk in the context of growing PICC use is an important
      cost and patients safety questions. Up to now, no systematic review has been done to
      investigate these questions.
    

Intervention name(s): Centrally inserted central catheters (CICCs); Peripherally inserted central catheters (PICCs)
Intervention type(s): Device; Device
Intervention description(s): Randomization between two well established clinical routine vascular access devices; Randomization between two well established clinical routine vascular access devices
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: PICC; BLOODSTREAM INFECTIONS; VASCULAR ACCESS; DEEP VEIN THROMBOSIS; CICC
Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer for Young Healthy Adults in South Korea
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      The human cornea is affected by the magnitude and velocity of both internal and external
      forces because the cornea has both static and dynamic resistance components. Considering
      these natures of the human cornea, many investigators have tried to demonstrate corneal
      biomechanical properties to understand these characteristics of the cornea. Corneal
      biomechanical properties are known to influence the accuracy of measurements in intraocular
      pressure (IOP) and are recognized as important factor to explain the susceptibility of
      development of glaucomatous damage. Until recently, the only instrument which enabled the in
      vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA,
      Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the
      biomechanical properties of the cornea according to the dynamic bidirectional applanation
      process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis
      ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful
      instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer
      captures the dynamic process of corneal deformation caused by an air puff using an
      ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now,
      well-organized analysis on the normative data of the corneal biomechanical profiles measured
      with the dynamic Scheimpflug analyzer for young healthy adults has not been reported yet.
      Hence, in the present study, we aim to conduct normative data analysis for the corneal
      biomechanical properties with the dynamic Scheimpflug analyzer in a cohort of young healthy
      adults in South Korea.
    


Intervention name(s): Dynamic Scheimpflug Analyzer
Intervention type(s): Device
Intervention description(s): Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young myopic patients
Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine ABA of TAK-906 following single oral (capsule)
      administration of 50 milligram (mg) of TAK-906 and single intravenous (IV) microtracer dose
      administration of 100 microgram (μg) (approximately 1 microcurie [μCi]) of [14C]-TAK-906 in
      Period 1 (ABA), and to determine the mass balance of TAK-906 in urine and feces following a
      single oral (solution) administration of 50 mg (approximately 100 μCi) of [14C]-TAK-906 in
      Period 2 (absorption, distribution, metabolism, and elimination [ADME]).
    

Detailed description: 
      The drug being tested in this study is called TAK-906. The study will determine ABA in Period
      1, and ADME, and mass balance of TAK-906 after single oral administration in Period 2 in
      healthy adult male participants. Plasma and urine samples will be collected for PK
      determination; plasma, whole blood, urine, and feces samples will be collected for total
      radioactivity (TRA) determination; and plasma, urine, and feces samples will be collected to
      characterize the metabolite profiles of TAK-906.

      The study will enroll approximately 6 participants. The study is designed to consist of 2
      periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1 (ABA study
      period), all participants will receive single unlabeled oral 50 mg dose of TAK-906 as capsule
      followed by microdose of 100 μg (approximately 1 μCi) [14C]-TAK-906 as intravenous infusion
      followed by a washout period of at least 7 days before the dose in Period 2. In Period 2
      (ADME study period), all participants will receive a single dose of 50 mg (approximately 100
      μCi) [14C]-TAK-906 as an oral solution.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 65 days including screening period. Participants
      will be contacted approximately 30 days after the last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): TAK-906 Oral Capsule; [14C]-TAK-906 Intravenous Infusion; [14C]-TAK-906 Oral Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-906 capsule.; [14C]-TAK-906 intravenous infusion.; [14C]-TAK-906 oral solution.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Understanding The Effect Of A Strong CYP3A4 Inducer On Glasdegib Pharmacokinetics
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study also aims to determine the effect of a strong enzyme (CYP3A4) inducer-rifampin- on
      drug exposure of Glasdegib. This study will be conducted in healthy subjects given a single
      dose of glasdegib in each period.
    


Intervention name(s): Glasdegib; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Subjects receive a 100mg oral dose of glasdegib under fasted conditions with washout, then single 100mg oral dose of glasdegib under fasted following dosing to steady state with rifampin; Subjects receive rifampin 600 mg oral dose daily [Day -6 to day 4]
Intervention MeSH terms: Rifampin
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glasdegib; PF-04449913; Drug-drug interaction; CYP3A4 inducer; Pharmacokinetics