bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Deep Dry Needling and Muscle Energy Technique on Chronic Non-specific Neck Pain Patients.
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare between applying deep dry needling and muscle
      energy technique in chronic non-specific neck pain patients. Researchers will compare between
      deep dry needling group, muscle energy technique group and control group to see if there are
      change in pain, range of motion or function.
    


Intervention name(s): Deep dry needling; Muscle energy technique; Neck stability exercise
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Method to decrease pain and improve function in musculoskeletal disorders.; Method to decrease pain and improve function in musculoskeletal disorders.; Method to decrease pain and improve function in musculoskeletal disorders.
Other intervention name(s): Post isometric relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia
Condition: Essential Hypertension; Type 2 Diabetes Mellitus
MeSH terms: Hypertension; Essential Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil
      (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.
    

Detailed description: 
      The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is
      being tested to treat people who have essential hypertension and type 2 diabetes mellitus
      (T2DM). This study will look at the blood pressure of people who take azilsartan medoxomil in
      addition to standard care for T2DM.

      The study will enroll approximately 380 patients. All participants will receive azilsartan
      medoxomil 40 mg tablets to be administered orally, once a day, for 12 weeks. If a
      participant's blood pressure (BP) has not reached BP goal of <140/85 mmHg at week 6,
      azilsartan medoxomil dose will be up-titrated to 80 mg daily.

      All participants will be asked to take one tablet at the same time each day throughout the
      study.

      This multi-center trial will be conducted in Asia. The overall time to participate in this
      study is 14 weeks. Participants will make multiple visits to the clinic, and will be
      contacted by 14 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Azilsartan Medoxomil
Intervention type(s): Drug
Intervention description(s): Azilsartan medoxomil tablets
Other intervention name(s): Edarbi®
Intervention MeSH terms: Azilsartan medoxomil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Training With Mobile Application in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Endocrine hormonal therapy (EHT) applied to avoid recurrence and metastasis of the breast
      cancer has also side effects which do not threaten life; however, it does negatively effects
      quality of life. The objective of this study was to determine the effects on quality of life
      of a mobile app-based (e-mobile) education for supportive care of patients with breast cancer
      receiving adjuvant endocrine hormonal therapy. The data were collected to with face to face
      and/or telephone interviews at 2 time points: prior to the initiation (T0) and after the
      completion (T1) of mobile app-based education. Patients were received education via mobile
      app for 12 weeks during which they were contacted in every 15 days; a mobile app-based
      (e-mobile) education was provided, including information about breast cancer definition,
      treatment process, symptoms management, adequate nutrition, regular physical activity and
      coping with stress. In this process, the control group patients were provided with standard
      care.
    

Detailed description: 
      Mobile devices have an increasing role for the patient care and its use in the field of
      oncology creates promising opportunities for supportive cancer care and patient education.
      Mobile applications were established for the supportive cancer care but their area of use is
      limited. Although there are many field specific medical mobile applications, there are few
      training programs for the benefit of patients. However, these are innovative tools and
      provide accessibility, individual training and consultancy in order for the patients to be
      able to cope with side effects of the treatment; thus, improving their quality of life,
      symptom management and distress.
    

Intervention name(s): receive mobile app-based education
Intervention type(s): Other
Intervention description(s): to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The data were collected to with face to face and/or telephone interviews at 2 time points: prior to the initiation (T0) and after the completion (T1) of mobile app-based education. Mobile application was including information about breast cancer definition, treatment process, symptoms management, adequate nutrition, regular physical activity and coping with stress. In this process, the control group patients were provided with standard care
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: breast cancer; quality of life; endocrine hormonal therapy; mobile phone; mobil app; education of patients; smartphone
Ameliorating the Obstacle of Pap Smear
Condition: Pain
Study type: Interventional

Summary: 
      To reduce the procedural pain of Pap smear, this study expects to apply the peak-end rule to
      Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix.
      This study aims to conduct a randomized controlled study at a tertiary center, National
      Taiwan University Hospital (NTUH). The investigators expect to compare the recalled pain
      intensity of the intervention and control groups.
    

Detailed description: 
      Purpose: In order to reduce the procedural pain, this study expects to apply the peak-end
      rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the
      cervix. Methods: This study aims to conduct a randomized controlled study at NTUH.
      Approximately 200 subjects are expected to be recruited. The investigators will utilize the
      peak-end rule by adding a non-painful step right after the most uncomfortable phase in the
      intervention group. All study subjects are requested to score on a numeric pain scale during
      the Pap test. All operators experienced in techniques for performing a Pap test should attend
      workshops for a standard operating procedure. A well-trained research assistant is also
      responsible for ensuring standardization of procedures to eliminate interoperator
      variability. The primary outcome was the recalled pain intensity at five minutes after the
      Pap smear test.
    

Intervention name(s): Modified Pap test
Intervention type(s): Procedure
Intervention description(s): Adding a non-painful step after the most uncomfortable phase of Pap smear
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are divided into two groups, one with traditional Pap smear and one with Pap smear adding a non-painful procedure at the end. The investigators will compare the real-time pain score and recalled pain to check whether the theory works.
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Cervical cancer screening; Pap smear; Procedural pain; Peak-end rule
Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this Phase 1, open-label, single-dose, parallel-group study is to evaluate the
      pharmacokinetics (PK) of a single 10-mg oral dose of baxdrostat in subjects with varying
      degrees of hepatic function. The main objectives are to:

        -  To assess the safety and tolerability of baxdrostat following administration of a single
           oral dose of baxdrostat to subjects with varying degrees of hepatic function; and

        -  To characterize the PK of baxdrostat following administration of a single oral dose of
           baxdrostat to subjects with varying degrees of hepatic function.

      Participants were administered a single 10-mg oral dose of baxdrostat in the fasted state the
      morning of Day 1. Plasma samples were drawn at various timepoints. Safety assessments
      included adverse events, vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory
      evaluations, and physical examinations.

      Twenty subjects in 2 groups based on the Child-Pugh classification in the protocol at
      screening: up to 10 subjects in the normal hepatic function group and up to 10 subjects in
      the moderate hepatic impairment group. Twenty subjects entered and completed the study.
    


Intervention name(s): baxdrostat
Intervention type(s): Drug
Intervention description(s): single oral dose of baxdrostat 10 mg
Other intervention name(s): CIN-107
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic impairment; PK; baxdrostat
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
Condition: Encephalopathy; Asphyxia Newborns
MeSH terms: Brain Injuries; Brain Diseases; Asphyxia
Study type: Observational

Summary: 
      The purpose of this study is early identification of asphyxiated newborns through eeg
      starting in the delivery room.
    

Detailed description: 
      There is a need for a reliable detector of birth asphyxia so that newborns with birth
      asphyxia can have timely and accurate diagnosis to receive therapeutic hypothermia within 6
      hrs of life, which has been shown to significantly reduce deaths and improve long term
      developmental outcomes.

      This study is designed to record EEG during birth transition through the first 10 minutes of
      life.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Term infants at delivery (37-44 weeks gestational age)
      
Keywords: Perinatal depression
New Approaches to Smoking Cessation in Heavy Drinkers
Condition: Nicotine Dependence; Cigarette Smoking; Alcohol Consumption; Heavy Drinking
MeSH terms: Tobacco Use Disorder; Alcoholic Intoxication; Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to develop and test an integrated cognitive-behavioral
      intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot
      phase will be used to refine this protocol for the subsequent randomized, controlled pilot
      phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a
      12-week treatment phase in which participants receive varenicline (Chantix) and weekly,
      personalized counseling.
    

Detailed description: 
      The purpose of the proposed project is to develop and test a 12-week integrated
      cognitive-behavioral therapy (CBT) intervention for smoking and alcohol (SA) + varenicline
      (Chantix) among heavy drinking smokers (i.e., CBT for SA). The project involves two phases.
      In Phase 1, an open-label pre-pilot study of CBT for SA will be conducted with 10 heavy
      drinking smokers. The primary results of this phase will be used to refine the CBT for SA
      protocol. In Phase 2, a randomized, controlled pilot study will be conducted with 40 heavy
      drinking smokers comparing CBT for SA with standard smoking counseling (SC). All participants
      in the randomized pilot study will also receive varenicline (Chantix).

      Primary and Study Completion dates were changed 6/2016 to reflect an additional year added
      year to the study.
    

Intervention name(s): Varenicline
Intervention type(s): Drug
Intervention description(s): 12-weeks of treatment. Dose will be titrated as follows:
Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quit smoking; Quit drinking
Laryngeal Mask Airway (LMA) Complication in Children
Condition: Laryngeal Mask Airway
Study type: Observational

Summary: 
      Desflurane is known to be the most pungent of the currently used volatile anesthetics. The
      investigators tried to find out if desflurane increases the incidence of perioperative upper
      airway complications in infants and children undergoing general anesthesia using supraglottic
      airways compared to sevoflurane.
    

Detailed description: 
      The investigators retrospectively reviewed and analyzed the electrical medical records of
      consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic
      airways using sevoflurane or desflurane as maintenance agents.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Other; Other
Intervention description(s): The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane as maintenance agents.; The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using desflurane as maintenance agents.
Intervention MeSH terms: Sevoflurane; Desflurane
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 1 to 15 years who underwent general anesthesia under supraglottic airways
        using sevoflurane or desflurane as maintenance agents in Seoul National University Bundang
        Hospital between June 2013 and June 2015.
Neurofeedback Therapy for Children Diagnosed With Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This project aims:

        -  to further explore the effectiveness of a novel sonified Neurofeedback management
           therapy for children diagnosed with Autism Spectrum Disorder (ASD)

        -  to determine if balance control is different before and after therapy
    

Detailed description: 
      Once the informed consent of a parent or guardian has been secured, each child will be asked
      to provide informed assent. If the child elects to participate in the research project,
      he/she is enrolled in the study and assign to one of two groups: Active Comparator or Sham
      Comparator. If possible, his/her ability to maintain balance is then assessed using a
      standard extended mCTSIB protocol (standing for 25 seconds on a hard surface/4" tall foam
      cushion with eyes open/closed and head neutral/turned right/left/flexed or extended) and
      his/her baseline qEEG are recorded. A series of questionnaires will be administered to the
      child and/or his/her parents/legal guardian/caretaker.

      Afterward the child will be instructed to wear the prescribed device (either the Active
      Comparator (Mente Autism™) or the Sham Comparator (a device externally identical to Mente
      Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats)) to use
      at home for 40 minutes a day for 12 weeks. At the end of the 12 weeks treatment period, the
      child will again be tested as at the beginning of the trial (posturography, qEEG, and
      questionnaires). At the end of the study, participants in the Sham Comparator group will be
      offered the option of receiving the full therapy.
    

Intervention name(s): Mente Autism™; Sham
Intervention type(s): Device; Device
Intervention description(s): A portable headband records EEG activity, and specialized algorithms convert the EEG activity into sonified binaural signals feeding them back to the user; a device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Neurofeedback; balance, postural; postural equilibrium; EEG
The Effect of the Inspiratory Muscle Training on Respiratory Parameters and Functional Capacity in Idiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis; Respiratory Aspiration
Study type: Interventional

Summary: 
      Scoliosis is the abnormality of the spine with direct effects on the shape and mechanics of
      the thoracic cage. Adolescent Idiopathic Scoliosis (AIS) is the most common 3-dimensional
      deformity of the spine which can potentially affect respiratory function, exercise capacity
      as well as the performance of inspiratory and expiratory muscles. During growth morphological
      changes of thoracic cage affects the pulmonary tissues and functions. Respiratory functions
      shows negative changes due to Cobb angle, curve localization, number of vertebra and onset
      age in patient with scoliosis.

      Exercise approaches include respiratory training program and aim to improve respiratory
      functions.It is reported that respiratory muscle weakness is a potent contributor to
      pulmonary impairment in mild, moderate, and severe forms of scoliosis. Studies showed that
      exercise training and respiratory exercises may improve respiratory function and exercise
      capacity in patients with AIS. Thus the aim of this study was to investigate the effect of
      inspiratory muscle training on respiratory muscle strength, respiratory function and
      functional capacity in adolescents with idiopathic scoliosis.
    


Intervention name(s): Home based exercise program; Inspiratory Muscle Training
Intervention type(s): Other; Other
Intervention description(s): Program will include deep diaphragmatic breathing exercises, local expansion exercise on the collapsed areas in scoliosis concave sides with elastic exercise bands, dynamic lumber stabilization exercises for core stabilisation, strengthening of interscapular muscles with elastic bands and stretching exercises for lumbar extensor, hip flexor and hamstring muscles. Exercises will be applied 2 sets of 10 repetitions and once a day.; Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure after assessment of respiratory muscle strength for each patient every week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent Idiopathic Scoliosis; Scoliosis; Inspiratory Muscle Training; Exercise Training; Respiratory Exercise Training; Pulmonary Function Test; 6-Minute Walk test; Respiratory Muscle Strength
Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects
Condition: Opiate Addiction
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol
      administered to opiate dependent subjects
    


Intervention name(s): 6β-Naltrexol escalating doses from 0.05-0.5 mg IV
Intervention type(s): Drug
Intervention description(s): Drug: Naloxone 0.1 mg IV/5 minutes to all subjects to determine tolerability to precipitated withdrawal during screening. Those that tolerate withdrawal proceed to Stage 1:
Drug: Lactulose 10 gm orally plus 3 IV infusions 30 minutes apart of Naloxone 0.1 mg IV and 2 placebo given randomly to all subjects. If tolerated, proceed to 5 additional medication dosing sessions with all subjects receiving oral Lactulose 10 GM plus IV escalating 6β-Naltrexol 0.05 mg, 0.15 mg, 0.5 mg with a randomized placebo.
Other intervention name(s): Naloxone; 6β-Naltrexol; Lactulose
Intervention MeSH terms: Naloxone; Lactulose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Naloxone; 6β-Naltrexol; Opioid-dependent; Pharmacokinetics; peripheral effects of withdrawal; central effects of withdrawal
Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study was to assess the efficacy and appropriate dose of iloprost for
      inhalation in the treatment of postoperative pulmonary hypertension in children with
      congenital heart defects.
    

Detailed description: 
      Pulmonary hypertension is a serious postoperative complication in children with congenital
      heart defects, which has a high incidence and mortality. Iloprost is a prostacyclin analogue.
      When applied by inhalation, it selectively dilates pulmonary vessels, without side affecting
      the systemic circulation. No randomized controlled trials (RCT) of iloprost have previously
      been performed in this indication. The investigators study is the first RCT of iloprost for
      inhalation after surgery of children's congenital heart diseases to be performed in this
      field.
    

Intervention name(s): iloprost nebuliser solution; iloprost nebuliser solution; distilled water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days; iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days; distilled water 2 ml per session
Other intervention name(s): Ventavis; Ventavis; Treeful
Intervention MeSH terms: Iloprost; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulmonary hypertension