bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Laxity of Face and Neck
Condition: Laxity; Skin
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional
      skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects
      will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower
      lip, periocular and perioral areas, submandibular and middle neck, etc). The exact treatment
      area(s), choice of treatment density are left to the Investigator's discretion and subject's
      consent. Up to 3 treatments are allowed with a minimum of 30-day between the consecutive
      treatments.
    

Detailed description: 
      The study will enroll up to 50 subjects at 6-8 investigational sites. It will evaluating
      effectiveness of a micro-coring device for micro-excisional skin remodeling in subjects with
      moderate to severe wrinkles of face and neck who meet the Inclusion/Exclusion Criteria. The
      choice of treatment density is at the investigator's discretion with the subject's consent.
      Up to 3 treatments may be performed with a minimum of 30-day interval between the consecutive
      treatments. Subjects will undergo bilateral micro-coring of skin on the face and upper neck,
      including but not limited to upper and lower cheek, upper and lower lip, periocular and
      perioral areas, submandibular and upper neck. The exact area(s) of treatment are left to the
      Investigator's discretion and subject's consent.

      The subjects will be evaluated at each visit and following data will be collected:

        -  The incidence and severity of systemic and local adverse events.

        -  Wrinkle severity score assessed using the Lemperle Wrinkle Severity Scale.

        -  Changes in skin laxity assessed by Laxity Scale.

        -  Canfield Image Analyses.

        -  Needle and/or punch biopsy (in some subjects).

        -  Overall aesthetic improvement using the following scales:

        -  Subject and PI Global Aesthetic Improvement Scale (GAIS)

        -  Subject Satisfaction Scale

        -  Rhytides and Laxity Scale

        -  Lower face assessment

        -  Investigator evaluation of device usability and functionality. Data Analysis: Analyses
           will be conducted per measurement tools listed. Statistical analysis will include but
           will not be limited to T tests, univariate and multivariate analysis.
    

Intervention name(s): HighThroughput Micro Coring Device
Intervention type(s): Device
Intervention description(s): Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device
Other intervention name(s): skin micro-coring
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: facial wrinkles; skin laxity; sagging skin
Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery
Condition: Hydrocele; Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Study measures the difference in pain after hernia &/or hydrocele repair based on site of
      local anesthesia injection.
    

Detailed description: 
      This single-center, prospective, single blind, randomized study will enroll up to 50 subjects
      who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health
      System, post-operative pain management in children is managed either via oral/parenteral
      opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local
      anesthetics in the general area of incision), or via regional techniques (spinal, epidural,
      or peripheral nerve blocks). We have designed this study to determine if there is improved
      qualitative and quantitative post-operative pain control in patients receiving TAP block
      versus intraoperative peri-incisional, surgeon administered field block. Once informed
      consent has been given, each patient will be randomized (like flip of the coin) to either
      Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.
    

Intervention name(s): TAP block; Local Infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.; Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Postprandial Response to Different Jams
Condition: Postprandial; Hyperglycemia, Postprandial; Feeding Behaviors; Antioxidant; Lipid Profile
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of an acute intake of three different
      types of strawberry jam, differing in the carbohydrates and antioxidants content, on
      postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in
      healthy adults.
    

Detailed description: 
      Study Design: Randomized, postprandial, crossover, double-blind intervention with three arms.

      Subjects: Sixteen healthy adults

      Product studied: At each arm, participants consume 60g of strawberry jam:

        -  High-sugar jam (traditional; HS),

        -  Low-sugar jam (without added-sugar; LS),

        -  Low-sugar jam including antioxidant extract from strawberry pulp (LSA).
    

Intervention name(s): Strawberry Jam
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Antioxidant; glucose metabolism; jam; polyphenols; postprandial; strawberry
Safety Skills Training For Parents of Preschool Children
Condition: Behavior
Study type: Interventional

Summary: 
      As the leading cause of death and disability in children in America, unintentional injuries
      are a critical public health issue. Most injuries can be prevented by parents implementing
      effective child safety practices. This project produced an interactive multimedia (IMM)
      program delivered via Internet/Intranet that taught injury prevention skills to parents of
      children aged 2 through 5 years, with the ultimate goal of reducing mortality and disability
      from unintentional injury in this population.
    

Detailed description: 
      This project produced a comprehensive, interactive multimedia (IMM) program called Family
      Safety 123 to teach childhood injury prevention skills to parents of children 2 to 5 years of
      age. The program contained 40 high-quality video clips, each 2 to 5 minutes in length,
      depicting injury prevention strategies in 13 content areas: supervision, preventing airway
      obstructions, poison awareness, preventing burns, preventing falls, firearm safety, motor
      vehicle safety, pedestrian awareness, sports, playgrounds, water safety, bike safety, and
      other safety concerns. Each content area contained 1 to 6 videos comprised of short video
      presentations, modeling vignettes demonstrating desired behaviors, supportive testimonials,
      and suggestions for modifications to home and recreational environments. Family Safety 123
      video content is derived from The Injury Prevention Program (TIPP) sheets developed by the
      American Academy of Pediatrics, which recognizes injury prevention as a primary topic for
      parents.
    

Intervention name(s): Family Safety 123; AAP TIPP sheets
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Theoretically-based injury prevention videos for families; American Academy of Pediatrics The Injury Prevent Program materials converted to web-based materials.
Other intervention name(s): Family Safety 123 for Parents of Children 2-5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: child safety; injury; computer; prevention; internet
A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this 2-part drug interaction study are as follows:

        -  To evaluate the effect of gemfibrozil on the pharmacokinetics (i.e., amount in the
           blood) of selexipag and its metabolite ACT-333679 (Part I).

        -  To evaluate the effect of rifampicin on the pharmacokinetics of selexipag and its
           metabolite ACT-333679 (Part II).
    

Detailed description: 
      Because non-clinical studies have shown that selexipag and its active metabolite, ACT-333679,
      are substrates for cytochrome P450 2C8 (CYP2C8), the present clinical study aims at
      investigating the effect of a strong inhibitor (gemfibrozil) and a moderate inducer
      (rifampicin) of CYP2C8 on the pharmacokinetic of selexipag and ACT-333679 as recommended by
      the FDA's Guidance for Industry Drug Interaction Studies (FDA, 2012).
    

Intervention name(s): Selexipag; Gemfibrozil; Rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two selexipag film-coated tablets of 200 µg as single oral dose (total dose = 400 µg); Gemfibrozil film-coated tablet of 600 mg administered orally b.i.d. from Day 1 to Day 9; Rifampicin film-coated tablet of 600 mg administered orally o.d.from Day 1 to Day 9
Other intervention name(s): ACT-293987
Intervention MeSH terms: Rifampin; Selexipag; Gemfibrozil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics
The Clinical Applicability of the 'TIB' Olfactory Test Device
Condition: Anosmia; Hyposmia
MeSH terms: Anosmia
Study type: Observational

Summary: 
      The aim of this study was to evaluate the validity and test-retest reliability of the 'TIB'
      Olfactory Test Device, a new olfactory test tool developed by Top International Biotech,
      Taipei, and to determine its normative values. The olfactory function of 180 subjects was
      evaluated using both the traditional Chinese version of the University of Pennsylvania of
      Smell Identification Test (UPSIT-TC) and TIB. The subjects consisted of 60 healthy volunteers
      (normosmic group), 60 hyposmic patients, and 60 anosmic patients. The healthy volunteers were
      retested with the UPSIT-TC and TIB at an inter-test interval of at least 7 days. The cut-off
      scores of TIB among the different groups were determined by receiver operating characteristic
      curve.
    


Intervention name(s): 'TIB' Olfactory Test; Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): A new smell identification test, 'TIB' Olfactory Test Device (Top International Biotech, Taipei) has been developed in Taiwan. It consists of 16 tests with an odorant embedded in fragrant microcapsules positioned on a strip. The examinee scratches the strip to release the odorant. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors. This process is then repeated with the next odorant on the strip.; The University of Pennsylvania Smell Identification Test (UPSIT), which was developed at the University of Pennsylvania, is one of the most reliable and the most widely used olfactory test.The test consists of four 10-odorant booklets. Each odorant is embedded in 10 to 50 µm urea-formaldehyde polymer microencapsules fixed in a proprietary binder and positioned on a brown strip which is located at the bottom of each page of the test booklet.4 When the examinee takes the test, each of the 40 odorants is released by scratching the strip with a pencil tip. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normosmic group were from community. Hyposmic and anosmic patients were from out patient
        clinic department of Otorhinolaryngology.
CBT4CBT for Office Based Buprenorphine
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of
      CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased
      retention for buprenorphine maintenance patients in a larger and diverse population of
      individuals seeking buprenorphine treatment in primary care (N=100).
    

Detailed description: 
      In this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic
      (Central Medical Unit, CMU) will be randomized to either (1) standard buprenorphine
      maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance
      with CBT4CBT-Buprenorphine substituting for on-site counseling. This will be a 12-week trial.
    

Intervention name(s): CBT4CBT-Buprenorphine; Buprenorphine/naloxone
Intervention type(s): Behavioral; Drug
Intervention description(s): Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment; Standard outpatient buprenorphine maintenance
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
A Multi-Site Evaluation of the Pain Relief, Support, Fit and Comfort From Use of a Custom Knee or Ankle Brace in Persons Suffering From Chronic Ankle or Knee Pain and Instability
Condition: Joint Instability
MeSH terms: Joint Instability
Study type: Interventional

Summary: 
      This study will look to examine the overall performance of a custom fit knee or ankle brace
      as a means of providing ankle or knee joint support in subjects that have determined the need
      for bracing based upon chronic joint instability and/or joint swelling and pain following
      daily activity.
    


Intervention name(s): Dr. Scholl's Prototype Ankle Brace; Dr. Scholl's Prototype Knee Brace
Intervention type(s): Device; Device
Intervention description(s): Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.; Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Pain; Ankle; Knee; Brace
Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim of this clinical study is to establish a novel technique, the so called intraoperative
      fluorescence angiography, for kidney graft perfusion visualization during the transplant
      procedure.
    

Detailed description: 
      Additional to the common transplant procedure, measurements of the graft perfusion should be
      established in two ways. Firstly, each kidney should be measured by a common duplex
      ultrasound measurement to assess the resistance index (RI) in the three poles of the kidney
      (upper, middle, lower pole). Secondly, intraoperative fluorescence angiography is going to be
      performed. Therefore, the camera of the fluorescence angiography system (SPY Elite System,
      Novadaq, USA) is positioned over the organ, and the fluorescence dye (ICG) is applicated
      intravenously. The aim will be to correlate the fluorescence angiography findings with the
      RIs and therefore to establish valuable fluorescence parameters.
    

Intervention name(s): Indocyanine green
Intervention type(s): Drug
Intervention description(s): perioperative application of Indocyanine green (ICG)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of NPT189 in Healthy Subjects
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of single dose of NPT189
      in healthy volunteers. The study will also evaluate the pharmacokinetic characteristics of
      NPT189.
    

Detailed description: 
      This study is a Phase1, randomized, double-blind, placebo-controlled, single dose, dose
      escalation safety and tolerability study of NPT189 in health subjects. Six dose cohorts are
      planned each with a maximum of 8 participants per cohort. Participants will receive NPT189 by
      intravenous (IV) or a matching placebo by intravenous infusion. Safety, tolerability, and
      pharmacokinetics will be assessed.
    

Intervention name(s): NPT189; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IgG1 Fc-GAIM fusion protein, a recombinant fusion protein; Placebo
Other intervention name(s): IgG1 (Immunoglobulin G); Fusion Protein; GAIM (General Amyloid Interaction Motif)
Intervention MeSH terms: Immunoglobulins; Immunoglobulin G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury.
Condition: Spinal Cord Injury; Incomplete Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The objective of the study is to assess the efficacy of the Exo-H2 robotic exoskeleton for
      walking rehabilitation of people with incomplete spinal cord injury.
    

Detailed description: 
      The recovery of walking ability is a primary concern of rehabilitation programs for people
      who have suffered anincomplete spinal cord injury. Robotic therapy arises from the new
      concepts of neuroplasticity. One of the most novel contributions in this field is robotic
      exoskeletons. However, there is still not enough scientific evidence to support the clinical
      use of this technology.

      The aim of this proposal is to assess the efficacy of a new model of robotic exoskeleton (Exo
      H2) developed by the CSIC with HNP involvement in the context of HYPER project (Consolider
      2009 call) in gait rehabilitation for people with incomplete spinal cord injury. A
      multicenter study is proposed here, involving the National Hospital of Paraplegics and the
      Institut Guttmann. Two randomized groups of patients with subacute incomplete spinal cord
      injury will be defined. In one group, protocol gait rehabilitation based on the Exo H2 will
      be established and traditional gait therapy will be adapted for control group. Both groups of
      patients were assessed performing a physical exam including functional gait scales (10 MWT,
      6MWT, WISCI II score, SCIM) and a biomechanical gait analysis with kinetic and kinematic
      techniques. Functional assessment will be carried out before intervention, at the end of the
      intervention and a follow up six weeks later.
    

Intervention name(s): Walking therapy with Exo-H2 exoskeleton
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Incomplete spinal cord injury; Walking; Rehabilitation; Robotic exoskeleton
ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)
Condition: Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in
      adults with opioid-induced constipation (OIC) following repeat dose administration
    

Detailed description: 
      Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1
      safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore
      additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a
      6-week period.
    

Intervention name(s): RDC-1036 (ALKS 37); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules for oral administration; Capsules for oral administration
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid-induced constipation; RDC-1036; ALKS 37
Research Study to Investigate How a Study Medicine (NNC9204- 1177) Affects Blood Levels of Other Medicines in Healthy People
Condition: Healthy Volunteers; Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The study looks at how the study medicine (NNC9204-1177) affects other medicines in the body.
      Participants will get the study medicine and 5 other medicines which have all been approved
      by the authorities. Participants will get 1 injection of the study medicine each week for 11
      weeks. The study medicine is injected under the skin in the stomach area. All injections will
      be given by study staff. Participants will get 5 medicines as tablets, capsules or syrup to
      be taken with water at the beginning of the study and after 10 weeks of treatment with the
      study medicine. The study will last for about 4 months. Participants will have 14 visits to
      the clinic with the study staff and study doctor. Participants will have blood draws and 2
      different kinds of electrocardiograms taken during the study. They will be asked about your
      mental health. People who use any medication, including herbal products, cannot take part in
      the study. Women cannot take part if pregnant, breast-feeding or planning to become pregnant
      during the study period or if they use birth control pills or other hormonal birth control
      products.
    


Intervention name(s): NNC9204-1177; Cocktail of 5 already approved drugs
Intervention type(s): Drug; Drug
Intervention description(s): Increasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks; 5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-sequence, cross-over drug interaction trial
Masking: None (Open Label)
Primary purpose: Treatment