bioihbjkbjnl/mcl2 huggingface dataset:
Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)
Condition: Mental Abuse of Adult; Emotional Abuse; Domestic Violence
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Women experience negative psychological outcomes long after the violent relationship has
      ended. Women suffer constant trauma and psychological distress being in emotional and
      mentally abusive relationship. Present study developed Culturally sensitive
      cognitive-behaviour therapy (CBT) to fit the client's cultural identity, context, and
      preferences.
    


Intervention name(s): CS-CBT; CBT
Intervention type(s): Other; Other
Intervention description(s): Culturally sensitive Cognitive Behavioural Therapy was delivered individually, focused on potential cultural beliefs and attitudes that might collide with core values of CBT.; CBT was delivered at an individual level, dealing with thoughts, feelings and behaviours in the present. Thoughts are identified and then challenged, to make them more objective and rational.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Holding, Stress, and Bonding During Therapeutic Hypothermia
Condition: Hypoxic-Ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Hypothermia
Study type: Interventional

Summary: 
      Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be
      enrolled in a new protocol that will allow mothers to hold their infants during the
      hypothermia treatment period. This is a safety study that will assess whether or not there is
      an increase in adverse event frequency in infants that are held during hypothermia. Parents
      and NICU nurses will be given a questionnaire after holding is complete investigating their
      feelings on maternal-infant bonding and safety of the holding protocol.
    


Intervention name(s): Holding during cooling
Intervention type(s): Other
Intervention description(s): An initial set of vital sings will be recorded before the infant is removed from the isolette. The mother will sit in a reclining chair next to the isolette and place a thermal barrier over her chest and abdomen. The infant will be transferred to the mother by placing the hands under the cooling blanket so as to move the infant and cooling blanket together as one unit. The mother will be allowed to hold for thirty minutes provided that the infant's temperature does not increase by greater than one degree centigrade and the oxygen saturation does not drop below 90%. After thirty minutes, the infant will be returned to the isolette.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The study will involve a 3-week (15 session) randomized double-blind clinical trial of two
      repetitive transcranial magnetic stimulation (rTMS) conditions in patients with treatment
      resistant depression. rTMS site selection will be localized from structural MRI scans.

      The patients will be randomized to one of two conditions

        1. rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,

        2. rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral
           prefrontal cortex targeted control).
    

Detailed description: 
      The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is
      administered at baseline and on a fortnightly basis. At study end response criteria is
      defined as a 50% reduction in total MADRS score and remission defined as a MADRS score of
      less than or equal to 10.

      Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale),
      CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global
      Impression Scale), GAF (Global Assessment of Functioning Scale). A cognitive battery is also
      administered.

      Inclusion Criteria:

        -  Moderate to severe depressive symptoms as indicated as MADRS >20

        -  Failure to respond to a minimum of two antidepressant medications

        -  No increase or initiation of new antidepressant therapy in the four weeks prior to
           entering the trial Exclusion Criteria

        -  Have an unstable medical condition, neurological disorder or any history of seizure
           disorder or are currently pregnant or lactating

        -  Previous brain injury or surgery, any metal clips, plates or other metal items in the
           head, cardiac pacemaker

        -  In the opinion of the investigator, are a sufficient suicide risk to require immediate
           electroconvulsive therapy

        -  Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of
           a personality disorder or another axis 1 disorder
    

Intervention name(s): Transcranial Magnetic Stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Educational/Counseling/Training
Keywords: Transcranial Magnetic Stimulation; Depression
A Study to Assess S-309309 in Healthy and Obese Participants
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of the study is to assess the safety and tolerability of S-309309 after oral
      administration in healthy adult or obese but otherwise healthy adult participants. The
      secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on
      ECG parameters after oral administration in healthy or obese but otherwise healthy
      participants.
    

Detailed description: 
      This study will consist of 2 Parts. Part 1 will include healthy participants who will be
      assigned to a dose group. Participants will then be randomized to receive a single oral
      administration of S-309309 or placebo in a fasted state. Administration will be initiated in
      the lowest dose group, and administration in the next dose group will not occur until a
      review of safety and tolerability has been completed for the preceding group.

      Part 2 will include 2 groups. Healthy participants and obese but otherwise healthy
      participants will receive multiple oral administrations of S-309309 or placebo in a fed
      state.
    

Intervention name(s): S-309309; Midazolam; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule administered orally; Syrup administered orally; Matching capsule to S-309309 administered orally
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      immunogenicity of FG-3019, a therapeutic antibody designed to block the pro-fibrotic activity
      of connective tissue growth factor (CTGF). CTGF triggers the production of collagen and
      fibronectin, which cause scarring and thickening of the lungs. Participants will be assigned
      sequentially to one of the 3 dose group: Low, medium, and high FG-3019.
    


Intervention name(s): FG-3019
Intervention type(s): Drug
Intervention description(s): FG-3019 will be administered per dose and schedule specified in the arm description.
Other intervention name(s): Recombinant human monoclonal antibody
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Idiopathic pulmonary fibrosis; IPF; Pulmonary fibrosis; Respiratory disease
Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome; Pain, Chronic
MeSH terms: Carpal Tunnel Syndrome; Syndrome; Chronic Pain
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to
      investigate if, and to what extent hydro-dissection hyalase and saline versus dexmedetomidine
      upon the median nerve could offer symptoms and clinical improvement
    

Detailed description: 
      Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities.
      Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general
      population, 3 and 7.8% in the working population. It occurs at any age, especially in
      individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of
      treatment modalities have been tried to improve the condition, starting from local anesthetic
      injection, steroid, and up to surgical decompression of the nerves.
    

Intervention name(s): Dexmedetomidine; Hyalase
Intervention type(s): Drug; Drug
Intervention description(s): injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydrodissection; injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells
      intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has
      not responded to conventional therapies. The goals of this study are to test the safety and
      tolerability of donor mesenchymal stromal cells in children with Inflammatory Bowel Disease.

      Mesenchymal stromal cells support the development of blood cells within the bone marrow. When
      isolated from a donor and infused into an animal or human, they have been demonstrated to
      travel to areas of inflammation, to alter immune responses, to decrease pro-inflammatory
      cytokines, and to promote tissue repair. Infusion of these cells does not lead to rejection.
      These properties lead investigators to hypothesize that that these may be they may be
      beneficial in treating inflammatory bowel disease.
    

Detailed description: 
      In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells
      intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has
      not responded to conventional therapies. Mesenchymal stromal cells support the development of
      blood cells within the bone marrow. They have also been demonstrated to travel to areas of
      inflammation, to alter immune responses, to decrease pro-inflammatory cytokines, and to
      promote tissue repair. Infusion of these cells does not lead to rejection. These properties
      lead investigators to hypothesize that that these may be they may be beneficial in treating
      inflammatory bowel disease.

      Investigators will culture donated bone marrow mesenchymal stromal cells in a unique
      automated system, and infuse the cells in a fresh, replicating stage of growth. This study is
      to test the safety and tolerability of donor mesenchymal stromal cells in children with
      Inflammatory Bowel Disease.
    

Intervention name(s): Allogeneic bone marrow-derived mesenchymal stromal cells
Intervention type(s): Biological
Intervention description(s): This study is a pilot phase 1 study of patients with moderately to severely active Crohn Disease (CD) and ulcerative colitis (UC) (≥ 18 years, Mayo score: ≥6 or CDAI: ˃ 220; <18 years, Pediatric Crohn's Disease Activity Index (PCDAI) :> 30) or Pediatric Ulcerative Colitis Activity Index (PUCAI) : >34). A fixed dose will be studied: 1 x 106 cells/kg administered intravenously (IV) weekly for 4 consecutive weeks, with the option of an additional 4 weeks of treatment, at the discretion of the principal investigator.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn disease; ulcerative colitis; mesenchymal stromal cells; inflammatory bowel diseases
Neramexane for Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      Tinnitus is commonly referred to as "ringing of the ears" - the perception of sounds in the
      absence of an external source of acoustic signals. Tinnitus may represent a severe disease
      and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing
      loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate
      and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous
      system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh
      receptor blocking activity. The purpose of this study is to assess the safety and efficacy of
      Neramexane compared with placebo in patients with subjective tinnitus.
    


Intervention name(s): Neramexane; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets, duration: 16 weeks; Oral tablets, duration: 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm
Condition: Spasticity of the Upper and Lower Limb Due to Cerebral Causes
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether injections with increasing doses (up to 800
      units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in
      treating patients with spasticity on one body side due to cerebral causes.
    

Detailed description: 
      A dose-titration approach will be used over three injection cycles, with a flexible
      observation period after injections of 12-16 weeks and a total duration of up to 48 weeks.
      Cycle 1 and 2: upper and/or lower limb to be treated; Cycle 3: upper and lower limb to be
      treated.
    

Intervention name(s): IncobotulinumtoxinA
Intervention type(s): Drug
Intervention description(s): Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.
For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection.
Intervention MeSH terms: incobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of FL058
      in healthy Chinese subjects.
    


Intervention name(s): FL058; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50mg、250mg、500mg、1000mg、1500mg、2000mg; empty bottle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
Condition: Severe Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      This is a proof-of-concept study designed to provide feasibility information on the clinical
      use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus.
      The study is expected to give preliminary efficacy and safety information.
    


Intervention name(s): vagus nerve stimulation (VNS)
Intervention type(s): Device
Intervention description(s): Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Emotion and Craving Regulation Among Individuals With Internet Gaming Disorders
Condition: Internet Gaming Disorder; Emotion Regulation
MeSH terms: Internet Addiction Disorder
Study type: Interventional

Summary: 
      To investigate the potential deficits in emotion and craving regulation capacities of
      drug-naïve young adults with Internet gaming disorder as compared with healthy controls.
    

Detailed description: 
      The purpose of this study is to examine the differences in young adults' capacities of
      utilizing cognitive appraisal versus mindfulness to regulate negative emotions and/or craving
      in response to negative affective stimuli or gaming cues, respectively. This project will be
      conducted in Beijing, China.
    

Intervention name(s): Emotion Regulation Task; Craving Regulation Task
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants are instructed to complete the emotion assessment after Look or Decrease the neutral or negative pictures. The "Decrease" asks the participants to use "cognitive reappraisal" or "mindfulness" strategies to decrease the intensity of emotion, whereas the "Look" asks the participants to look naturally at the picture. First, the "look" or "decrease" is displayed on the computer for 2 s. Then, a neutral or negative picture is presented on the screen for 7s. Finally, participants will rate the intensity of their emotion for 4s. Then, they have 1s-3s to relax before the next trial. In the meantime, Skin conductance activities will be recorded using a constant voltage with 1-cm 3 AgAg/Cl electrodes attached to the medial phalanx surfaces of the middle and index fingers of the nondominant hand.; Participants are instructed to complete the craving assessment after Look or Decrease the neutral or gaming pictures. The "Decrease" asks the participants to use "cognitive reappraisal" or "mindfulness" strategies to decrease the intensity of craving, whereas the "Look" asks the participants to look naturally at the picture. First, the "look" or "decrease" is displayed on the computer for 2 s. Second, a neutral or gaming picture is presented on the screen for 7s. Third, participants rate the intensity of their craving for 4s. Then, they have 1s-3s to relax before the next trial. In the meantime, Skin conductance activities will be recorded using a constant voltage with 1-cm 3 AgAg/Cl electrodes attached to the medial phalanx surfaces of the middle and index fingers of the nondominant hand.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Emotion and craving regulation
Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of multiple once
      daily ascending doses of AZD3199 in healthy men
    


Intervention name(s): AZD3199; Placebo; AZD3199; AZD3199
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Low dose
Dry powder for inhalation, o.d., 1+12 days; intermediate dose
Dry powder for inhalation, o.d., 1+12 days; high dose
Dry powder for inhalation, o.d., 1+12 days
Intervention MeSH terms: AZD-3199
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy male; tolerability; safety; inhalation
Clinical Performance Evaluation of 3D Ear Canal Scanning Technology
Condition: Ear Mold Impression Procedure
Study type: Observational

Summary: 
      Study participants will undergo ear canal impressions in a standard of care protocol
      utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning
      device, and conventional silicone impression material. The elapsed time of each procedure
      will be captured for each participant, and the average duration of the two methodologies will
      be compared.
    


Intervention name(s): 3D ear scanner; Conventional silicon ear impressions
Intervention type(s): Device; Other
Intervention description(s): A commercially-available ear scanning device used according to standard of care. A hand-held device is used and is considered less invasive than conventional earmold impressions.; A two part silicon impression material that is used to fill the ear and produce a physical cast of the ear canal. The procedure is standard of care.
Intervention MeSH terms: Silicon
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Adults with anatomically typical external auditory canals/meatus who have any degree, type,
        and configuration of hearing impairment.