bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For rhTSH In Post-thyroidectomized Patients
Condition: Differentiated Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For
      Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
    

Detailed description: 
      This phase I/II study of rhTSH, To observe the safety and tolerability characteristics of
      different doses of rhTSH In Post-thyroidectomized Patients, and to observe the dose-limiting
      toxicity (DLT) and maximum tolerated dose (MTD).
    

Intervention name(s): Recombinant Human Thyroid Stimulating Hormone for Injection
Intervention type(s): Drug
Intervention description(s): rhTSH was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH.
Other intervention name(s): rhTSH
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe
      to administer to subjects with severe Hemophilia A or B with or without inhibitors and will
      demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in
      hemophilic animal models.
    


Intervention name(s): PF-05280602; PF-05280602; PF-05280602; PF-05280602; PF-05280602
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 micrograms per kilogram of PF-05280602, IV infusion, single dose; 4.5 micrograms per kilogram of PF-05280602, IV infusion, single dose; 9.0 micrograms per kilogram of PF-05280602, IV infusion, single dose; 18.0 micrograms per kilogram of PF-05280602, IV infusion, single dose; 30.0 micrograms per kilogram of PF-05280602, IV infusion, single dose
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The was an ascending dose trial with one open label treatment, intervention model was sequential dose escalation.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Safety; Pharmacokinetic; Pharmacodynamic
A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants
Condition: Adalimumab
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF)
      compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC)
      injection, as assessed principally by area under the serum concentration-time curve (AUC)
      from time 0 extrapolated to infinity (AUCinf) and maximum observed serum concentration (Cmax)
      in healthy adult participants.
    


Intervention name(s): ABP 501-HCF; ABP 501-LCF
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single-dose SC injection of ABP 501-HCF.; Participants will receive a single-dose SC injection of ABP 501-LCF
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Tumor necrosis factor; monoclonal antibody
Motion Coaching Technology for Physical Therapy in Low Back Pain.
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      In this study, we will compare exercise execution between two groups of patients: (1)
      individuals who undergo instruction session by a PT and then perform exercises with a written
      handout at home and (2) individuals who use the mHealth motion coach at home. Participants
      will perform the same 4 exercises. Both groups will be instructed to exercise at home,
      supported either by the handouts or the Motion Coach technology and then return after 1 week
      for assessment.

      For the assessment, standardized videos will be used to capture pose during exercise
      execution. Group 1 will perform the exercises with the written handout; group 2 will perform
      the exercises with the motion coach. Rating will be performed by a panel of PT professionals
      on the overall assessment of each exercises and on the three segments mentioned below that
      are exercise specific. The first group with PT instruction and written handout portion will
      be compared to the second group with the motion coach.
    


Intervention name(s): Kaia Back Pain App; Physiotherapist Exercise Instructions and written handouts
Intervention type(s): Other; Other
Intervention description(s): The Kaia Back Pain App provides instructions on exercise execution to participants for one week; Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer
Condition: Cancer of Head and Neck
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      The investigator will seek to determine the feasibility of wearable biometric sensors to
      acquire high resolution biometric data, including heart rate and activity level (i.e. steps)
      for patients undergoing radiation therapy and surgery, with or without postoperative
      radiotherapy.
    

Detailed description: 
      Active cancer treatment such as surgery, chemotherapy or radiotherapy can cause side effects
      or toxicities, which, if untreated, can lead to poorer quality of life, decreased patient
      well-being, and worse clinical outcomes. Routine monitoring of patients while under active
      treatment can entail the routine practice of clinic visits at regular intervals with the
      acquisition of vital signs, routine laboratory testing, patient-reported outcome surveys, and
      face-to-face interaction with their physician.

      In recent years, the availability of commercially-available wearable fitness sensors has
      allowed end-users to monitor their fitness progress and activity levels. These devices depend
      on small sensors that can collect minute-to-minute data on heart rate and activity level that
      may be transmitted to a smartphone or computer. Through this system, users can easily track
      and monitor their fitness progress.

      In this trial, the investigator will seek to determine the feasibility of wearable biometric
      sensors to acquire high resolution biometric data, including heart rate and activity level
      (i.e. steps) for patients undergoing radiation therapy and surgery, with or without
      postoperative radiotherapy. The investigator believe that changes in heart rate may predict
      for increasing pain, dehydration, and stress in general. Moreover, changes in daily step
      count are a surrogate for performance status on treatment, and the investigator will perform
      a series of preliminary analyses to assess whether there is validity to this hypothesis. The
      investigator hope to use biometric monitoring to identify patients at risk for adverse
      outcomes, with the ultimate goal of intervening before these outcomes occur.
    

Intervention name(s): wearable sensor
Intervention type(s): Device
Intervention description(s): A commercially-available wearable fitness sensor
Other intervention name(s): FITBIT
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Rifampin Capsules
Condition: Anesthesia; Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-center, open-label, randomized,two-way crossover,
      propofol-controlled, two-stage study evaluating the safety and
      pharmacokinetics/pharmacodynamics of IV maintenance dose and IV single loade dose plus
      maintenance dose of HSK3486 emulsion for injection in healthy subjects.
    


Intervention name(s): HSK3486; rifampin , HSK3486
Intervention type(s): Drug; Drug
Intervention description(s): Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.; Sequence 2: Orally take 600 mg rifampin once a day for 8 consecutive days in the morning on an empty stomach, followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later.
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility and Preliminary Efficacy of a Web-Based Self-Help Program for College Students
Condition: Repetitive Negative Thinking
Study type: Interventional

Summary: 
      The goal of this pilot study is to test the feasibility and preliminary efficacy of the
      repetitive negative thinking (RNT) focused web-based self-help program in college students.
      The main questions it aims to answer are:

        -  Does the program work without any help of a clinician?

        -  Does the program have any reducing effect on the participants' RNT, depression, anxiety,
           stress and cognitive fusion scores? - Does the program help participants to improve
           their psychological flexibility and committed actions? Participants will be administered
           a set of questionnaires before and after completing the 10-day long web-based self-help
           program, provided on a daily basis. Researchers will compare the intervention group with
           a waitlist control group to assess for any potential placebo effect.
    

Detailed description: 
      After obtaining informed consent, all participants will receive a set of questionnaires for
      baseline measurement. Participants will be randomized into two groups using block
      randomization: one as the intervention group and the other as the control group (waitlist
      condition). This method helps ensure an equal distribution of participants with similar
      characteristics in both groups, minimizing potential biases and increasing the validity of
      the study.
    

Intervention name(s): RNT Focused Web- Based Self-Help Program
Intervention type(s): Behavioral
Intervention description(s): This 10 day long intervention contains psychoeducational contents, experimental exercises, monitoring behavior and committed action strategies. Each step of the intervention aims to develop a specific psychological flexibility skill like cognitive defusion etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group vs waitlist group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acceptance and Commitment Therapy; Rumination
The Diagnostic Performance of Tilt Test in Athletes
Condition: Syncope
MeSH terms: Syncope
Study type: Interventional

Summary: 
      In the present study the investigators evaluate the sensitivity and specificity of passive
      tilt test in athletes, as well as their haemodynamic responses and autonomic nervous system
      activity during head-up tilt. Moreover, the investigators try to apply a novel algorithm for
      the improvement of diagnostic yield of tilt test in athletes.
    

Detailed description: 
      We examine athletes with a history of reflex syncope and athletes without history of reflex
      syncope.All subjects undergo a tilt test, for the evaluation of haemodynamics, heart rate
      variability (HRV) and baroreflex sensitivity.
    

Intervention name(s): Passive tilt test
Intervention type(s): Other
Intervention description(s): Passive tilt test (without pharmacological provocation). After a horizontal supine rest period of 5 min, the tilt table was inclined at 60° head-up position for 30 min. A positive response was defined according to the European Society of Cardiology guidelines for the diagnosis and management of syncope
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of single and multiple day
      dose of JNJ-67670187 compared to placebo.
    

Detailed description: 
      This study will be a Phase 1 randomized double-blind, placebo controlled multi dose study in
      up to 144 adult healthy volunteers. The safety, tolerability and impact on the microbiome
      following intake of oral dose of JNJ-67670187 for up to 14 days will be evaluated.
    

Intervention name(s): JNJ-67670187; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.; Participants will receive matching placebo in all cohorts.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Laryngeal Mask Airway as a Bridge for Intubation of Obese Patients for Sleeve Gastrectomy
Condition: Bariatric Surgery Candidate
Study type: Interventional

Summary: 
      Ventilation, as well as intubation of a morbidly obese patient, is challenging and require
      special preparations and skilful hands, in this study laryngeal mask airway insertion is used
      as a bridge for intubation to facilitate ventilation as give enough time to anaesthetics and
      muscle relaxants to work on.
    

Detailed description: 
      The ordinary pathway of intubating a morbidly obese patient for sleeve gastrectomy is
      bordered by the risk of difficult ventilation and intubation with the subsequent events of
      hypoxia and hypoventilation. When the patient is easy ventilated, it gives some sort of
      confidence and pleasure for the anaesthetist that the way of intubation will not be so hard.

      One problem here is the difficulty of ventilating a morbidly obese patient, in this study the
      investigators used laryngeal mask airway as a bridge before inserting the endotracheal tube
    

Intervention name(s): Laryngeal mask airway; face mask
Intervention type(s): Device; Device
Intervention description(s): Insertion of laryngeal mask airway before intubation of a morbidly obese patient; use of face mask before intubation of a morbidly obese patient
Other intervention name(s): LMA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Kahn Study; Investigation Of The Efficacy Of Ziprasidone Versus Olanzapine In The Management Of Recent-Onset Psychosis; A Flexible-Dose, Parallel Group, Double-Blind Study
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study intends to compare novel antipsychotics ziprasidone and olanzapine, to confirm the
      findings of an open study -where stable patients receiving olanzapine switched to
      ziprasidone- which showed maintenance of clinical effect with improvements in all domains of
      cognitive function at 6 weeks (Daniel, 1999). Direct comparison of the two agents in a
      well-controlled double-blind fashion will allow an evaluation of the effect on cognitive
      function in the short and long-term management of patients with recent-onset schizophrenia,
      schizoaffective and schizophreniform disorder.
    


Intervention name(s): olanzapine; ziprasidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effect of Non-Surgical Periodontal Treatment on Bone Metabolism in Type 2 Diabetes and Systemically Healthy Individuals
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      In this study, it was concluded that sclerostin and irisin may be alternative markers for
      evaluating the effectiveness of periodontal treatment and healing of periodontal tissues by
      affecting bone metabolism.
    

Detailed description: 
      Background: Diabetes and periodontitis are chronic inflammatory diseases with similar
      pathogenesis and clinical and immunological interrelationships. The aim of this study is to
      determine periodontal clinical parameters and sclerostin, irisin, Receptor Activator of
      Nuclear Factor κB Ligand (RANKL)/Osteoprotegerin (OPG), interleukin-6 (IL-6) and tumor
      necrosis factor-α (TNF-α) levels in gingival crevicular fluid (GCF) in individuals with type
      2 diabetes and systemically healthy periodontitis and to evaluate the effect of non-surgical
      periodontal therapy on these clinical parameters and biomarkers.

      Method: Within the scope of this study, applying to Necmettin Erbakan University Faculty of
      Dentistry Periodontology Clinic; A total of 50 individuals, including 25 patients with type 2
      diabetes and periodontitis (DMP group) and 25 patients with systemically healthy and
      periodontitis (SSP group), were included in the study. After recording the clinical
      periodontal parameters (gingival index (GI), plaque index (PI), probing pocket depth (PPD),
      clinical attachment level (CAL)) of each individual included in the study, GCF samples were
      obtained and non-surgical periodontal therapy were completed. The individuals were invited to
      the controls 3 months later and the procedures for clinical periodontal measurements and DOS
      samples collection were repeated. Levels of biomarkers in DOS samples were determined by
      ELISA (Enzyme Linked Immunosorbent Assay) method.
    

Intervention name(s): ELISA
Intervention type(s): Diagnostic Test
Intervention description(s): ELISA(enzyme-linked immunosorbent assay)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gingival Crevicular Fluid; Irisin; Periodontitis; Sclerostin
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and tolerability of an
      investigational drug for the treatment of manic episodes of bipolar disorder. The
      investigational drug will be given as additional therapy to one of the five following
      medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These
      medications are already FDA (Food and Drug Administration)-approved treatments for mania.
    


Intervention name(s): Licarbazepine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bipolar disorder; manic episode; treatment; licarbazepine
A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and immunogenicity of different combinations of influenza
      vaccine in healthy young children.
    


Intervention name(s): Adjuvanted and un-adjuvanted influenza vaccines
Intervention type(s): Biological
Intervention description(s): 16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; Flu; Vaccine; Adjuvant
An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary aim of this study is to assess whether naltrexone as a monotherapy is effective
      in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that
      increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a kappa
      opioid receptor antagonist, it increases dopamine in the brain.

      We predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults
      with ADHD.
    


Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention description(s): Adults with ADHD
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Naltrexone; Adults
3D Printed Personalized Extendable Prosthesis
Condition: Osteosarcoma in Children
MeSH terms: Osteosarcoma
Study type: Observational

Summary: 
      The goal of this type of observational study is to investigate the preliminary effect of 3D
      printed personalized extendable prosthesis replacement on limb salvage in children with
      osteosarcoma. The main question it aims to answer is:

      Is 3D printed personalized extendable prosthesis replacement has a good outcome in limb
      salvage pediatric osteosarcoma？
    

Detailed description: 
      Osteosarcoma is one of the most common primary malignant bone tumors in children and
      adolescents. In this study, the investigators try to investigate the preliminary effect of 3D
      printed personalized extendable prosthesis replacement on limb salvage in children with
      osteosarcoma.
    

Intervention name(s): 3D printed personalized extendable prosthesis
Intervention type(s): Device
Intervention description(s): 3D printed personalized extendable prosthesis replacement for limb preservation in children
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        children with osteosarcoma undergoing prosthesis replacement or limb amputation were
        admitted to our hospital
PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, exploratory, single dose, randomized, double-blind, two-way cross over,
      pilot, glucose clamp study to assess pharmacokinetic and pharmacodynamic effects of Gan &
      Lee's insulin glargine injection in comparison to the marketed Lantus (US) in subjects with
      type 1 diabetes mellitus (T1DM).
    


Intervention name(s): Gan & Lee insulin glargine followed by Lantus; Lantus followed by Gan & Lee insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): 0.4 IU/kg Gan & Lee insulin glargine injection SC, Lantus 0.4 IU/kg injection SC; Lantus 0.4 IU/kg injection SC, 0.4 IU/kg Gan & Lee insulin glargine injection SC,
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science