bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Techniques for Umbilical Reconstruction
Condition: Umbilicoplasty
Study type: Interventional

Summary: 
      The primary objective of the study will be to determine which of five traditionally used
      umbilical reconstructive techniques offers superior aesthetic results. Additionally,
      secondary objectives of post-operative complications such as hypertrophic scar formation will
      also be measured.
    

Detailed description: 
      This is a five arm, prospective, randomized, trial. Patients undergoing abdominoplasty or
      abdominally-based free tissue transfer (TRAM/DIEP flaps) at NYU Medical Center will be
      randomly assigned to receive one of five conventionally used umbilicoplasty techniques during
      the course of their surgery:

        1. Round procedure

        2. "Scarless" round procedure

        3. "Inverted u" procedure

        4. "Inverted v" procedure, and

        5. "Y deepithelialized" procedure

      As there has not yet been a superiority or inferiority comparison of these five methods, no
      patient will be receiving substandard care by randomization to one of the five procedures.
    

Intervention name(s): Round Procedure Umbilicoplasty; Scarless" round procedure; "Inverted U" Procedure; "Inverted V"Procedure; "Y deepithelialized" Procedure
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Umbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure"; Umbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure; Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure; Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure; Umbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to estimate the effect of anakinra, 100 mg once daily (QD), on
      the development of an anti-tetanus antibody response in subjects with RA after vaccination
      with a tetanus and diphtheria toxoids injection. In addition, this study will evaluate the
      general safety profile of therapy with anakinra, 100 mg QD, in subjects with RA after
      vaccination with a tetanus and diphtheria toxoids injection.
    


Intervention name(s): Anakinra (r-metHuIL-1ra)
Intervention type(s): Drug
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis, Inflammation; Interleukin-1 (IL-1), r-metHuIL-1ra; Autoimmune, Kineret®; Anakinra, Immunex; Amgen, Clinical Trials
Metabolic Adaptations to Chronic and Acute Exercise in Overweight Adults (ATX-Study)
Condition: Healthy
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The primary purpose of this study is to examine the effects of chronic exercise training and
      an acute session of exercise on key risk factors associated with Metabolic Syndrome (e.g.,
      glucose tolerance, blood lipid profile, and blood pressure) and alterations in subcutaneous
      adipose tissue structure and metabolic function in overweight adults.
    

Detailed description: 
      Subjects will be asked to complete the Substrate Metabolism Laboratory General Screening
      Questionnaire and American Heart Association Health/Fitness Questionnaire to determine if
      they are eligible to complete the preliminary testing procedures. If eligible, subjects will
      be asked to visit the Substrate Metabolism Laboratory to participate in the preliminary
      testing procedures (listed below) before participating in the experimental trial.

      PRELIMINARY TESTING PROCEDURES:

        -  Blood pressure, height and weight measurements

        -  Body Composition Assessment (~20 min)

        -  Exercise Fitness Test (~10 min)

        -  Resting Metabolic Rate (RMR) measurement (~30 min)

        -  3 hour Oral Glucose Tolerance Test (OGTT)

      EXPERIMENTAL TRIAL:

      The evening before the experimental trial, subjects will eat a standardized dinner meal and
      snack. The meal and snack must be eaten at specific times as indicated by the research staff.
      After eating the snack, subjects will need to fast (no food or beverages - besides water)
      overnight.

      Participants who exercise regularly will be instructed to exercise exactly 3 days before the
      experimental trial, and then abstain from their exercise training program until after the
      study is complete.

      In the morning, subjects will return to the Substrate Metabolism Laboratory. The research
      team will collect a blood sample from the subject's hand or forearm and a small sample of fat
      tissue in the subject's abdomen with a needle. Next, subjects will exercise on a treadmill at
      a moderate intensity for about 1 hour. Immediately after exercising the research team will
      collect a second blood sample. Subjects will remain in the laboratory for 1 hour after
      exercising, and then the research team will collect another blood and fat tissue sample. Upon
      completion of the experimental trial, subjects will be provided a snack before leaving the
      laboratory.
    

Intervention name(s): Exercise session
Intervention type(s): Other
Intervention description(s): A blood sample and fat biopsy will be obtained before and after the 60 minute moderate exercise session. There is no drug or device intervention in this study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Screening for Convergence Insufficiency in School-age Children
Condition: Convergence Insufficiency
MeSH terms: Ocular Motility Disorders
Study type: Observational

Summary: 
      The purpose of this study was to assess the ability of common tests of eye alignment,
      convergence, and accommodation to identify children with convergence insufficiency in a
      school screening setting.
    

Detailed description: 
      The purpose of the Screening for Convergence Insufficiency in School-age Children study was
      to assess the ability of common tests of eye alignment, convergence, and accommodation to
      identify children with convergence insufficiency in a school screening setting (where it may
      not be feasible to do more than one test).
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Of the 282 subjects included in the analysis, approximately 60% were female, 81.5%
        identified themselves as white, 11% as African American, 2.5% as other, and 5% did not
        report race. Two percent classified themselves as Hispanic or Latino, 76% reported not
        being Hispanic or Latino, and 22% did not report their ethnicity.
      
Keywords: Normal
Novel Dose Adjustment Schedule for Late Injection in SCIT in AR
Condition: Allergic Rhinitis; Immunotherapy
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Allergen specific immunotherapy is currently the only curative intervention for allergic
      rhinitis (AR). Subcutaneous immunotherapy (SCIT) need to be reinstituted with an interruption
      of more than 16 weeks in maintenance period, leading to increased time and economic cost
      burden and difficulties for continuing further treatment for patients. The aim of present
      study was to develop a novel dose adjustment schedule for such situation and to compare the
      clinical efficacy and adverse reactions between novel and conventional schedules for dust
      mite (DM) SCIT of AR subjects.
    


Intervention name(s): Novel dose adjustment of Alutard SQ; conventional dose adjustment of Alutard SQ; Routine continuous cluster of Alutard SQ
Intervention type(s): Biological; Biological; Biological
Intervention description(s): novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ; conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ; Patient receiving continuous cluster SCIT for DM during the same period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
Condition: Deep Vein Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the risk of recurrent venous thromboembolism
      (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked
      proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of
      therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.
    


Intervention name(s): Discontinue anticoagulant therapy (Negative d-dimer); Continue on anticoagulant therapy (positive d-dimer)
Intervention type(s): Other; Other
Intervention description(s): Patients with negative d-dimer discontinue long-term anticoagulant therapy.; Patients with positive d-dimer continue or re-start on anticoagulant therapy
Intervention MeSH terms: Anticoagulants; Fibrin fragment D
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unprovoked deep vein thrombosis; unprovoked pulmonary embolism; anticoagulant therapy
Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis; Xerostomia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy
      induced oral mucositis and xerostomia and improving quality of life in head and neck cancer
      patients. This is a randomized, double-blind, placebo controlled trial conducted in head and
      neck cancer patients. Mixed-block randomization is used to divide eligible patients into two
      groups: melatonin 40 mg or matched placebo. The patients are required to take the studied
      drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the
      first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5
      fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to
      standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale
      and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H&N), pain (VAS 0-10) and
      adverse event frequency.
    


Intervention name(s): Melatonin; Matched Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Melatonin 20 mg/ 10 ml melatonin suspension gargle for 2 minutes before radiation 15 minutes and 20 mg melatonin gelatin capsule taken orally after 21:00 hours each night throughout the study; Drug: Melatonin 20 mg/ 10 ml placebo suspension gargle for 2 minutes before radiation 15 minutes and 20 mg placebo gelatin capsule taken orally after 21:00 hours each night throughout the study
Other intervention name(s): 20 mg/10 ml melatonin suspensions; 20 mg melatonin gelatin capsule; 20 mg/10 ml placebo suspensions; 20 mg placebo gelatin capsule
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain
Condition: Temporomandibular Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Myalgia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of using topical cream of Ping On
      Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and
      masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both
      Ping On Ointment and Vaseline are considered intervention.
    

Detailed description: 
      Aims: To compare the effectiveness of using topical cream of Ping On Ointment and using
      Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain,
      in order to establish the true efficacy of Ping On Ointment. Methods: In this randomized,
      double-blinded, placebo-controlled trial, 55 subjects with TMJ and/or masticatory pain (Group
      1 patients according to the Research Diagnostic Criteria for Temporomandibular Disorder
      (RDC/TMD) received Ping On Ointment for 4 weeks; or placebo for 4 weeks. Subjects were
      evaluated with standard measures of efficacy: pain intensity measured by visual analogue
      scale and maximal comfortable mandibular opening, at baseline and again after 4 weeks of
      treatment.
    

Intervention name(s): Ping On Ointment; Vaseline
Intervention type(s): Drug; Drug
Intervention description(s): Ping On Ointment; Placebo
Other intervention name(s): TCM topical analgesic
Intervention MeSH terms: Analgesics; Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Continuous Multiple Dose PB-119 Injection in Health Volunteers
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, multiple dose study, pharmacokinetic and pharmacodynamics studies will
      be performed at the same time with tolerability study. Three dose arms are designed, 12
      subjects will be enrolled in each arm, will equal number of males and females.
    

Detailed description: 
      Pharmacokinetic and pharmacodynamics studies were performed in parallel with PB-119
      25μg、50μg、and 100μg dose escalation tolerability study, plasma samples were collected to
      determine drug concentration and pharmacodynamics parameters. The study duration of each arm
      was 8 weeks, study medication was given about 8:00 a.m. on day 1 of each week, totally 6
      times, and subject was followed until 15 days after last dose (50 days of study) and then
      study can be completed.
    

Intervention name(s): PB-119 injection
Intervention type(s): Biological
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cupping in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this exploratory randomised trial is to study the effect of pulsatile cupping
      in osteoarthritis of the knee compared to waiting list control.
    

Detailed description: 
      Cupping is a traditional therapy in many cultures of the world and is used to treat
      osteoarthritis of the knee. In this randomised trial we want to study the effect of pulsatile
      cupping in osteoarthritis of the knee compared to waiting list control. Pulsatile cupping is
      administered by a special cupping machine (HeVaTec) with silicone cupping glasses to the knee
      joint. Pulsatile pressure is generated by a pump that generates vacuum.
    

Intervention name(s): Pulsatile cupping
Intervention type(s): Device
Intervention description(s): 8 sessions cupping in 4 weeks, administered by a cupping machine. Cupping is administered in each session for 15 minutes with silicon cupping glasses to the knee (osteoarthritis) and the lower back.
Other intervention name(s): Cupping machine: Puls Reguliertes Vakuum PRV 02; HeVaTec ; registered and certified in Germany [MPG] DIMDI Identifizierungscode DE/0000042259)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis
Active Ingredients & Efficacy of Aquatic Therapy for Autistic Children
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Accidental drowning is the number one cause of death in children with autism spectrum
      disorders (ASD) and highlights the critical need for swim lessons and water safety training
      for this population. Our team has developed and tested an innovative, occupational therapy
      (OT) based aquatic program - AquOTic - that provides preliminary support for the use of an
      individualized swim skills training intervention in children with ASD. The AquOTic program
      uses a combination of sensory, motor learning, and behavioral approaches to improve water
      safety and swim skills. In this study, we will use a randomized control trial design to
      identify the efficacy of the AquOTic intervention to improve swim performance in children
      with ASD.
    

Detailed description: 
      Once enrolled, children will be randomized to one of three groups. Group A will receive the
      intervention right away. Group B will use a waitlist control for 10 weeks, then will receive
      the intervention. Group C will be a control group, and will be offered the intervention at
      the end of the control period. Each group will have 12 participants.

      AquOTic a group based aquatic occupational therapy intervention that uses evidence-based
      therapeutic teaching techniques including therapeutic relationship, grading of activities,
      shaping, positive reinforcement and individualized goals to direct the intervention.

      We will also develop a fidelity measure to operationalize the therapeutic strategies and
      quantify the active ingredients of the AquOTic program. Our long-term goal is to create
      evidence for an OT-based swim intervention for children with ASD that has the potential to
      decrease the drowning risk in this population.
    

Intervention name(s): AquOTic
Intervention type(s): Behavioral
Intervention description(s): group-based aquatic occupational therapy sessions with 1:1 support
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study uses a waitlist control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
An Explorative Study on the Pharmacokinetics and Pharmacodynamics of Sunitinib in Healthy Volunteers
Condition: Blood Pressure
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is conducted:

        -  to investigate the influence of sunitinib (study drug) on the plasma biomarkers VEGF-A,
           VEGF-C, soluble VEGFR-2, and soluble VEGFR-3 (vessel endothelial growth factors) and on
           the blood pressure;

        -  to generate a pharmacokinetic/pharmacodynamic model for sunitinib using biomarkers.
    


Intervention name(s): sunitinib (Sutent)
Intervention type(s): Drug
Intervention description(s): 50 mg capsule Sutent, one application a day for five days
Intervention MeSH terms: Sunitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetic/pharmacodynamic modeling; biomarkers (growth factors) as a possible tool of drug effect
AM-101 in the Treatment of Post-Acute Tinnitus 2
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to test the safety and local tolerance of repeated
      treatment with AM-101.
    

Detailed description: 
      This open-label extension study is assessing the safety and local tolerance of repeated
      treatment with AM-101 in subjects previously treated in the scope of the TACTT3 study.
    

Intervention name(s): AM-101
Intervention type(s): Drug
Intervention description(s): AM-101 gel for intratympanic injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
Condition: Partial Epilepsy
MeSH terms: Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089
      as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking
      phenytoin or phenobarbital will be enrolled followed by additional subjects taking
      anti-epileptic drugs other than phenytoin and phenobarbital to further investigate long-term
      safety.
    

Detailed description: 
      see above
    

Intervention name(s): YKP3089
Intervention type(s): Drug
Intervention description(s): see above
Other intervention name(s): other AEDs
Intervention MeSH terms: Cenobamate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of CoolTXT for Non-Invasive Fat Reduction
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      This study is being performed to reduce unwanted fat, in various body areas, using a new
      applicator and control unit for Zeltiq.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and feasibility of a new product under
      development for non-invasive fat reduction. The new product delivers controlled cooling via a
      conformable surface applicator, rather than the existing vacuum applicator. A range of
      treatment parameters will be investigated. At the investigator's discretion, each treatment
      area may receive up to 3 treatments, spaced 2 - 8 weeks apart. The subjects will return for
      follow-up at 2 months and 4 months after final treatment. Therefore, the entire study period
      may last up to 8 months.
    

Intervention name(s): The Zeltiq System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lipolysis; Cryolipolysis; Fat Reduction