bioihbjkbjnl/mcl2 huggingface dataset:
Adult Attention Deficit Hyperactivity Disorder
Condition: Adult Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder (ADHD).
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, parallel-group, multicenter, outpatient study
      evaluating the efficacy and safety of SEP 225289 in adults with ADHD using 2 oral dosages (4
      or 8 mg SEP 225289 once daily [QD]) versus placebo over a 4 week treatment period.
    

Intervention name(s): SEP-225289; SEP-225289; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SEP-225289 4mg once daily; SEP-225289 8mg once daily; Placebo once daily
Other intervention name(s): Dasotraline; Dasotraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Attention deficit hyperactivity disorder
Benefit of Prophylactic Embolization of the Splenic Salvage
Condition: Splenic Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The main objective is to show that splenic embolization improves salvage rate at one month in
      a population of hemostatically stable closed splenic trauma patients with a high risk of
      splenectomy
    


Intervention name(s): Embolization
Intervention type(s): Procedure
Intervention description(s): this arm of the study was interventional (splenic artery embolization)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: splenic rescue; splenectomy
A Study of Mirikizumab (LY3074828) Injection in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to compare how much mirikizumab, in two different formulations, is
      absorbed into the bloodstream and how long the body takes to get rid of it, when given as an
      injection under the skin or into the veins. Side effects of the injection will be collected.
      Each participant will be in the study for about 18 weeks, including screening.
    


Intervention name(s): Mirikizumab Test; Mirikizumab Test; Mirikizumab Reference
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered SC; Administered IV; Administered SC
Other intervention name(s): LY3074828; LY3074828; LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of PSAPs in Different Maskers
Condition: Auditory Perception
Study type: Interventional

Summary: 
      This study will measure the performance of three personal amplification devices when used by
      middle-aged adults. Speech understanding will be assessed with two different types of
      background noises at three different input levels.
    

Detailed description: 
      Speech understanding will be measured both unaided and aided with three different models of
      Personal Amplification devices (PSAPs). Sentences will be played to the participant from a
      loudspeaker located in front. Different types of background sounds (noise and other
      sentences) will be played from loudspeakers located to the right and left of the participant.
      Participants will be instructed to repeat back the sentence coming from the front. They also
      will rate subjective effort at the end of each block of trials.
    

Intervention name(s): Sound World Solutions CS50+; Tweak Focus; IQ Earbuds; Bose Hearphones
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Participants will be tested using the Sound World Solutions CS 50+ hearing devices.; Participants will be tested using the Tweak Focus hearing devices.; Participants will be tested using the IQ Earbuds hearing devices.; Participants will be tested using the Bose Hearphones hearing devices.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Each participant will be tested with one of the models of devices.
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.
Condition: Blood Flow Speed; Coronary Flow Velocity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if Ticagrelor increases the Adenosin induced
      coronary blood flow velocity.
    


Intervention name(s): AZD6140; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): P2Y12 receptor antagonist
Other intervention name(s): Ticagrelor
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ticagrelor; Healthy; Coronary flow velocity; Adenosine
Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing
Condition: Growth Hormone Deficiency
Study type: Interventional

Summary: 
      Specific Aim 1 Healthy male and female subjects and growth hormone (GH) deficient subjects
      display sexually dimorphic GH responses to GHRH administration

      Specific Aim 2 GH responses to GHRH in both healthy controls and in GH deficient patients
      correlate with expression and activity of the stimulatory G proteins, G alpha q and G alpha
      S. G protein levels correlate with gonadal steroid levels.

      Specific Aim 3 Sexually dimorphic GH responses to GHRH are enhanced in Tanner Stage V
      compared to Tanner Stage 1 individuals
    

Detailed description: 
      Growth hormone deficiency affects disproportionately more males than females. Although
      ascertainment bias plays a role in this sexual dimorphism, no plausible mechanism to fully
      explain this difference has been proposed.

      This investigator initiated study will provide currently unavailable data on sexual/age
      differences in response to GH stimulation testing. Data obtained from the study may provide a
      basis for developing appropriate normal ranges for adult GH testing, may provide a plausible
      mechanism for the enhanced hormone responsiveness observed in females, and may provide data
      on when the sexual differences to GH stimulation may develop.

      The objectives of this study are to:

        1. Confirm the sexual dimorphism in growth hormone responses for adult growth hormone
           testing in healthy male and female subjects

        2. Correlate peak Growth Hormone Releasing Hormone (GHRH)/arginine induced growth hormone
           responses with G protein levels in healthy subjects and in patients with a history of
           childhood GH deficiency

        3. Determine whether sexual dimorphism is acquired during puberty
    

Intervention name(s): GHRH/arginine stimulation testing
Intervention type(s): Procedure
Intervention description(s): GHRH(Geref) 1mcg/kg IVP followed by Arginine 10% solution 0.5mg/kg (maximum of 30 Gm) infused over 30 minutes. Labs drawn 6 times over 2 hours.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Growth hormone deficiency
A Comparison of 12 Month Daily Wear of Two Novel O2 Permeable Silicone Hydrogel CLs (HOP/SiH) and A Control, Standard O2 Lens
Condition: Contact Lenses, Extended-Wear
Study type: Interventional

Summary: 
      The purpose of this research is to compare the on-eye performance of 12 month daily wear
      versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable
      contact lenses by studying its effects on human eyes. Usual and customary care will be given
      in the form of eyeglasses and/or contact lenses.
    

Detailed description: 
      The purpose of this research is to compare the on-eye performance of 12 month daily wear
      versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable
      contact lenses on bacterial binding to corneal cells and central epithelial thickness. Usual
      and customary care will be given in the form of eyeglasses and contact lenses. To compare
      long-term Daily wear vs. immediate Overnight wear (Extended wear) of a new hyper-oxygen
      permeable silicone hydrogel contact lens on binding of Pseudomonas Aeruginosa to exfoliated
      human surface corneal cells collected from the eyes of human patients and on central corneal
      thickness, as follows: 1) a hyper Dk/t lens for 12 months of daily wear, 2) a hyper Dk/t lens
      for 12 months of de novo 6 night extended wear, and 3) a hyper Dk/t lens for 12 months of de
      novo 30 night extended wear.
    

Intervention name(s): Silicone Hydrogel Soft Contact Lenses
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Comparison of Daily wear versus Extended wear in bacterial binding and corneal epithelial thickness
Hypoalgesic Effects Neural Mobilization Techniques
Condition: Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of
      neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural
      stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.
    

Detailed description: 
      Asymptomatic subjects will be randomly allocated into three groups: the neural glide group;
      the neural stretch group; and the placebo group. Each subject will receive one treatment
      session. Outcome measures included bilateral pressure pain threshold measured at the
      trigeminal, cervical, and tibialis anterior points, which will assess pre-treatment and
      immediately post-treatment by a blinded assessor. Three-way repeated measures analysis of
      variance was used to evaluate changes in pressure pain threshold, with group (experimental or
      control) as the between-subjects variable and time (pre-, post-treatment) or side (dominant,
      nondominant) as the within-subjects variable.
    

Intervention name(s): Neural Glide; Neural stretching
Intervention type(s): Other; Other
Intervention description(s): This technique involves two movements, throughout several joints to glide the nerves. The subject sit on a couch with the right lower limb extended and the left lower limb flexed. The therapist will take the subject's head by putting his hands on the suboccipital and front region. In the initial movement, performe craniocervical flexion in the subject, while he helped with his right elbow to rectify the dorsal spine of the subject; at the same time, the subject performed dorsiflexion of the right ankle. In the final movement, the subject must increase thoracic kyphosis at the same time as performing plantarflexion in the right ankle; also, the therapist performed craniocervical extension in the subject; In the start position, the subject was supine on a couch, with knees bent with the right leg above the left, and supported with the popliteal zone. Both hands were crossed over the chest. The therapist was on the subject´s side, with his knee below the subject's head, bringing stability. One hand was placed on the occipital, and the other hand was placed over the crossed hands of the subject
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neural mobilization; Physical therapy; Asymptomatic subjects
Remifentanil Infusion Alone During the Closure Period for Early Emergence Following Craniotomy
Condition: Supratentorial Neoplasms
MeSH terms: Supratentorial Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for
      this purpose. The hemodynamic stability and at the same time early emergency are the main
      goals following neurosurgery. However there is no standard for discontinuation time for
      manually controlled systems today.

      The investigators aimed to study the effect of remifentanil infusion alone for early
      emergence and hemodynamic stability during the closure period in patients undergoing
      supratentorial craniotomy.
    

Detailed description: 
      Adult, American society of Anaesthesiologist score I-II, 80 patients who underwent elective
      supratentorial craniotomy for tumour resection were randomly assigned to group I or II. In
      group I; propofol was discontinued during the dural closure. After the propofol was
      discontinued, remifentanil dose was increased with the guidance of bispectral index spectrum
      and hemodynamic parameters. In group II; propofol discontinued before the end of the surgery.
      Time to awakening and extubation time, adverse events, total remifentanil and propofol
      consumptions and side effects were recorded. Heart rate and blood pressure were recorded
      during this period.
    

Intervention name(s): Remifentanil; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): 0.1-0.5 mcg/kg/min infusion; 75-200 mcg/kg/min infusion
Other intervention name(s): Ultiva
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The goal of this project is to explore the feasibility and the efficacy of a online
      mindfulness-based stress reduction intervention for people with chronic pain waiting for
      secondary or tertiary health care services
    


Intervention name(s): Mindfulness-based stress reduction
Intervention type(s): Behavioral
Intervention description(s): An online mindfulness-based stress reduction intervention will be administered in a group format of maximum 15 participants, once a week for 120 minutes for 8 weeks by an experienced therapist trained in MBSR. Sessions will include sitting and lying meditation, hatha yoga and a body scan where attention is sequentially focused on different parts of the body. Individual autonomous practice between 30-45 minutes, 6 times / week will also be recommended. To support individual autonomous practice, a daily diary and two guided videos (around 35 minutes/each) were created.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A two group parallel single blind pilot RCT
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: mindfulness-based stress reduction intervention
Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma
Condition: Manual Therapies; Respiratory Muscle Training; Exercise Therapy; Inspiratory Capacity; Asthma
MeSH terms: Asthma; Respiratory Aspiration
Study type: Interventional

Summary: 
      The aim of this study is to assess if an intervention of manual therapy and motor control
      exercises combined with an inspiratory muscle training program is more effective than an
      inspiratory muscle training program alone in increasing the maximum inspiratory pressure in
      patients with asthma. In addition, the study pretends to evaluate the changes caused by the
      intervention regarding possible postural changes and thoracic diameter.
    


Intervention name(s): Inspiratory Muscle training (IMT); IMT + Manual Therapy and Motor Control Exercise; Powerbreathe
Intervention type(s): Other; Other; Device
Intervention description(s): Inspiratory Muscle training This protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama); IMT + Manual Therapy and Motor Control Exercise The Inspiratory Muscle Training protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama). Manual Therapy and Motor Control Exercises will consist of joint mobilization/manipulation and exercises in the neck and thoracic regions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Inspiratory Muscle Training; Manual Therapies
Pharmacokinetics of Oral Desipramine With and Without Concomitant Administration of Crobenetine Infusion in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the steady state pharmacokinetics of Desipramine with/without concomitant
      administration of Crobenetine.
    


Intervention name(s): Desipramine tablet; Crobenetine infusion; Placebo infusion
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Investigation of Muscle Activity Pattern of Gluteus Medius and Tensor Fascia Lata in Patients With PFPS
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to investigate the muscle activity of gluteus medius and tensor
      fascia lata in health control group and patients with PFPS during submaximal isometric muscle
      contraction.The research question :Is there any difference of muscle activity of gluteus
      medius and tensor fascia lata between health control group and patients with PFPS during
      submaximal isometric muscle contraction ？Null hypothesis:There is no difference of muscle
      activity of gluteus medius and tensor fascia lata between health control group and patients
      with PFPS during submaximal isometric muscle contraction.
    

Detailed description: 
      Basic data

      - Name, age, sex, BW, BH, pain VAS scale（VAS-activity）, affected side, dominate leg, symptom
      duration, activity level

      Measurement

        -  Flexibility of iliotibial band：Ober test

        -  EMG data collection during 8s submaximal muscle contraction

        -  Muscle strength measurement of hip abductors
    

Observational model: Case-Control
Time perspective: Other
Keywords: patellofemoral pain syndrome; electromyography; gluteus medius; tensor fascia lata
A Dose Escalation Trial of SBRT After Induction Chemotherapy for Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose escalation trial to evaluate the safety of stereotactic body radiotherapy
      (SBRT) delivered in 3 fractions for patients with locally advanced pancreatic cancer (LAPC)
      who have received induction chemotherapy (FOLFIRINOX or gemcitabine and nab-paclitaxel).
    

Detailed description: 
      This is a phase I study, with an expansion cohort, of up to 34 patients to identify the
      maximum tolerated dose (MTD) of a 3-fraction regimen of stereotactic body radiotherapy (SBRT)
      for locally-advanced pancreatic cancer patients who have not developed distant progression
      following induction chemotherapy (FOLFIRINOX or gemcitabine and nab-paclitaxel) as per
      standard of care. After completion of induction chemotherapy, stereotactic body radiotherapy
      SBRT will be administered in 3 fractions, every other day, on an outpatient basis. Dose
      escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1 Gy per
      fraction at each dose level, dose level 2 will be 10 Gy x 3 fractions and dose level 3 will
      be 11 Gy x 3 fractions.
    

Intervention name(s): FOLFIRINOX or gemcitabine/abraxane; SBRT
Intervention type(s): Drug; Radiation
Intervention description(s): Patients will have received induction chemotherapy for 3+ months with either FOLFIRINOX or gemcitabine/abraxane with at least stable disease.; After completion of induction chemotherapy, stereotactic body radiation therapy (SBRT) will be administered in 3 fractions, every other day, on an outpatient basis. Dose escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1 Gy per fraction at each dose level, dose level 2 will be 10 Gy x 3 fractions and dose level 3 will be 11 Gy x 3 fractions.
Other intervention name(s): nab-paclitaxel
Intervention MeSH terms: Paclitaxel; Gemcitabine; Albumin-Bound Paclitaxel; Folfirinox
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1 Gy per fraction at each dose level, dose level 2 will be 10 Gy x 3 fractions and dose level 3 will be 11 Gy x 3 fractions.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Induction Chemotherapy; Stereotactic Body Radiotherapy (SBRT); Dose Escalation; Locally Advanced Pancreatic Cancer (LAPC); Maximum Tolerated Dose (MTD)
Physical Exercise Versus Rosiglitazone in CAD and Prediabetes
Condition: Impaired Glucose Tolerance
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to prospectively assess the relative benefits of either treatment
      with rosiglitazone or physical exercise on endothelial function in patients with impaired
      fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).
    


Intervention name(s): rosiglitazone; physical exercise; control
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): tablets 4 mg daily; stationary bike 5-6 times a week; control without intervention
Other intervention name(s): Avandia (GlaxoSmithKline)
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Celecoxib and Etoricoxib on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Tramadol is an opioid analgesic, which is widely used in the treatment of acute and
      neuropathic pain. After oral administration, tramadol is rapidly and almost completely
      absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed
      by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation
      is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral
      tramadol with selecoxib and etoricoxib. Selecoxib is known to inhibit CYP2D6. Twelve healthy
      male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of
      the ideal weight for height are taken into the study. Primary endpoints of the study are
      plasma concentrations of tramadol and its metabolites.
    


Intervention name(s): Placebo; Selecoxib; Etoricoxib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The subjects will be given orally placebo twice a day for 7 days prior to the study.; The subjects will be given orally selecoxib 200mg twice a day for 7 days prior to the study.; The subjects will be given orally etoricoxib 120mg once a day for 7 days prior to the study.
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics