bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative
      nausea and vomiting following Laparoscopic gynecological surgeries.
    


Intervention name(s): Intravenous Dexamethasone; Intraperitoneal Dexamesathone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Postoperative Management for Degenerative Spinal Conditions
Condition: Spinal Degenerative Disorder
Study type: Interventional

Summary: 
      The overall objective of this study is to conduct a two-group randomized control trial (RCT)
      to compare which of two treatments provided by telephone - a cognitive-behavioral based
      physical therapy (CBPT) program focusing on self-management strategies or an education
      program about postoperative recovery - are more effective for improving patient-centered
      outcomes in older adults recovering from lumbar spine surgery for degenerative conditions.
      Our central hypothesis is that the CBPT intervention focusing on self-management will
      decrease pain and disability and improve general health, physical activity and physical
      function in community-dwelling adults undergoing spine surgery, through reductions in fear of
      movement and increases in pain self-efficacy.
    


Intervention name(s): CBPT; Education
Intervention type(s): Behavioral; Other
Intervention description(s): Changing Behavior through Physical Therapy (CBPT) is a cognitive-behavioral based self-management program.; Patient education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Binaural Beat Technology and Rhythmical Photic Stimulation
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Background Many nurses must shoulder heavy workloads and often develop depressive emotions
      due to work stress. Previous studies pointed out that binaural beat technology (BBT) and
      rhythmical photic stimulation can effectively improve negative emotions but there are very
      few related empirical studies.

      Objectives This study examined the effectiveness of BBT combined with rhythmical photic
      stimulation in improving depressive symptoms in nurses.

      Methods This is a randomized controlled trial and nurses in central Taiwan were recruited as
      participants. These participants were randomized into three groups: BBT combined with
      rhythmical photic stimulation group, BBT group, and relaxing music group. The intervention
      period was 2 weeks, with 30 minutes per session. The Beck Depression Inventory (BDI),
      Pittsburgh Sleep Quality Index (PSQI), vitality and mental health scale (VT&MH from SF-36),
      and heart rate variability (HRV) were used as parameters for pre- and posttest evaluation in
      this study. The Wilcoxon signed-rank test was used to test if there are significant
      differences in various parameters in the three groups before and after intervention. The
      Krusal-Wallis test was used to test for significant differences in parameter changes between
      the three groups.
    


Intervention name(s): Sound and light therapy (BBT and FL group); Sound therapy group (BBT); Relaxing music group
Intervention type(s): Other; Other; Other
Intervention description(s): During intervention, the participants close their eyes and wear an eye mask and stereo earphones. They then listen to 30 minutes of 10 Hz BBT music (intercalated with relaxing music) through their mobile phone. The intervention music was first embedded in the participant's mobile phone and the BBT music application was purchased from the mobile phone app (Brainwave Studio software, Dalcoms Inc). When listening to music, 10 Hz light stimulation was added to the BBT and FL group (using a mobile phone). Table 1 shows the intervention status. The rhythmical photic stimulation program was a commercially available mobile phone app (Strobe Therapy software released by FuwhatSoft).; Participants in the sound therapy group (BBT) listened to 30 minutes of 10 Hz BBT music (intercalated with relaxing music) through their mobile phones. Except for rhythmical photic stimulation, the other steps were the same as the BBT and FL group.; Participants listened to 30 minutes of relaxing music (the same as that of the experimental groups) through their mobile phone. Except for rhythmical photic stimulation and 10 Hz BBT, the other steps were the same as the experimental groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Diagnosing Respiratory Disease in Children Using Cough Sounds
Condition: Pneumonia; Bronchiolitis; Asthma; Croup; Upper Respiratory Tract Infection; Lower Respiratory Tract Infection; Reactive Airway Disease
MeSH terms: Infections; Communicable Diseases; Bronchiolitis; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders
Study type: Observational

Summary: 
      The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software
      application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis,
      asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in
      infants and children. Patient's cough sounds will be recorded using a smartphone and analysed
      using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis
      and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or
      patient.
    


Intervention name(s): Recording of Infants and Children's Cough Sounds
Intervention type(s): Other
Intervention description(s): Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with signs or symptoms of respiratory disease presenting to participating
        Emergency Departments, Urgent Care Clinics, Primary Care Clinics
Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Energy Deficit
Condition: Whole-body Protein Balance; Muscle Protein Synthesis
Study type: Interventional

Summary: 
      The optimal EAA-containing protein format necessary to maximally stimulate muscle protein
      synthesis and optimize whole-body net protein balance during caloric deprivation has not been
      determined. This study will address that gap in knowledge by examining post, whole-body
      exercise muscle and whole-body protein kinetic responses to ingesting varying EAA-containing
      protein formats after a 5 day period of negative energy balance. This study will provide the
      initial evidence to support the development of a recovery-based food product for military
      combat rations.
    

Detailed description: 
      Ten resistance-trained adults will complete this ~55-d randomized, cross-over study.
      Participants will participate in three, non-consecutive 5-d controlled energy deficit
      periods, each separated by a 14-d washout period (i.e., sufficient time to restore nitrogen
      and metabolic homeostasis after moderate weight loss). Post-exercise (whole-body exercise
      model) muscle protein synthesis (MPS) and whole-body protein turnover responses to varying
      EAA-containing protein formats will be determined the morning after completing the 5-d energy
      deficit.
    

Intervention name(s): Essential Amino Acid Enriched Whey Protein; Whey Protein; Military Ration Entree
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): protein powder formulation that includes whey and free-form essential amino acids; commercially available whey protein isolate; chili and beans entree; current meal component of the meals ready to eat rations
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, partially-blind, cross-over controlled trial
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of
      ABT-712, compared to placebo, administered over a 4-week period in participants with moderate
      to severe mechanical chronic low back pain (CLBP).
    

Detailed description: 
      The study used a randomized withdrawal design with an open label (OL) period prior to a
      double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712
      during the OL period were randomized into the DB period. Study drug was given for a total of
      8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper.
      During the OL period, all participants took increasing doses of ABT-712 until they were
      taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2
      ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group
      took 2 placebo tablets twice daily.
    

Intervention name(s): ABT-712; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ABT-712 extended-release tablet; Placebo tablet
Other intervention name(s): Hydrocodone and acetaminophen extended-release; Hydrocodone bitartrate and acetaminophen extended-release
Intervention MeSH terms: Acetaminophen; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Effect on sleep interference by pain
Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness and safety of vortioxetine, once
      daily (QD), in patients with Major Depressive Disorder.
    

Detailed description: 
      The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested
      to treat depression in adults who have major depressive disorder (MDD). This study looked at
      MDD relief in people who took varying dosages of vortioxetine.

      The study enrolled 560 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the four treatment groups-which remained undisclosed to the
      patient and study doctor during the study (unless there was an urgent medical need):

        -  Vortioxetine 1 mg

        -  Vortioxetine 5 mg

        -  Vortioxetine 10 mg

        -  Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but
           had no active ingredient.

      All participants were asked to take one capsule at the same time each day throughout the
      study.

      This multi-centre trial was conducted in Europe, Asia, Australia, and South Africa. The
      overall time to participate in this study was up to 14 weeks. Participants made 7 visits to
      the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a
      follow-up assessment.
    

Intervention name(s): Vortioxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Encapsulated immediate-release vortioxetine tablets; Vortioxetine placebo-matching capsules
Other intervention name(s): Lu AA21004; Brintellix®
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Depressive Disorder; Mood Disorder; Mental Disorder; Melancholia, Involutional; Paraphrenia, Involutional; Drug Therapy
Comprehensive Functional Assessments for NOCAD
Condition: Coronary Artery Disease; Myocardial Ischemia; Coronary Microvascular Dysfunction
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
Study type: Observational [Patient Registry]

Summary: 
      To validate and investigate the efficacy of comprehensive functional assessments for the
      diagnostic and prognostic value in NOCAD.
    


Intervention name(s): coronary physiological indices
Intervention type(s): Device
Intervention description(s): coronary physiological indices
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population enrolled from Zhongshan Hospital, Fudan University (Shanghai,
        China)，with coronary angiography and available cadmium zinc telluride - single photon
        emission computed tomography imaging (CZT-SPECT).
A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an
      allosteric integrin activator, in healthy male subjects
    

Detailed description: 
      This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation
      study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following
      single and multiple oral dose administration to healthy male subjects, with a separate,
      open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be
      carried out in 3 parts.

      Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential,
      single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of
      7HP349 following administration of single oral doses in healthy male subjects, and to define
      the OPD of 7HP349.

      Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential,
      multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK
      of 7HP349 following up to 5 once daily oral doses in healthy male subjects.

      Part C: This is a randomized, open label, two-treatment, three-period, crossover study to
      evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
    

Intervention name(s): 7HP349 Single Ascending Dose; 7HP349 Multiple Ascending Dose; Placebo Single Ascending Dose; Placebo Multiple Ascending Dose; 7HP349 Food Effect
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Part A: 7HP349 Capsules, Single Ascending Dose (SAD); Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD); Part A: Placebo Capsules, Single Ascending Dose (SAD); Part B: Placebo Capsules, Multiple Ascending Dose (MAD); Part C: 7HP349 Capsules, Food Effect
Other intervention name(s): 7HP349 SAD; 7HP349 MAD; Placebo SAD; Placebo MAD; 7HP349 FE
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study consists of three parts, Part A, Part B and Part C, which will be undertaken sequentially. Part A is a SAD study to determine the safety, tolerability and PK of 7HP349 in healthy male subjects, and to define the OPD. Part B is a MAD study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects. Part C is a crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the impact of different warm-up times of
      risankizumab autoinjector (AI) on the participant injection site pain experience in healthy
      adult volunteers.
    


Intervention name(s): Risankizumab
Intervention type(s): Drug
Intervention description(s): Subcutaneous autoinjector
Other intervention name(s): SKYRIZI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Risankizumab
Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Interventional
Phase: Phase 4

Summary: 
      Intranasal Ketorolac tromethamine has a potential role as a short term pain management tool
      for Interstitial Cystitis without the risk and undesirable effects of narcotics.
    


Intervention name(s): Ketorolac Tromethamine
Intervention type(s): Drug
Other intervention name(s): SPRIX
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease
      central blood pressure in subjects with hypertension.
    

Detailed description: 
      Participants with hypertension who were treated with antihypertensive agents were randomly
      assigned to an active (KRG 2 g/day) or a placebo treatment group in a double-blind cross over
      manner.

      Participants were not allowed to change their antihypertensive medications except safety
      issue. Brachial systolic BP (SBP), diastolic BP (DBP), Central SBP and DBP will measured at
      baseline,at 2 and 4 months.

      Efficacy and safety data will be monitored by Daegu Catholic University Medical Center
      Institutional Review Board and reported to the Korean Ginseng Society.
    

Intervention name(s): Korean Red Ginseng Capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week; Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
Other intervention name(s): Korean Red Ginseng (KRG) Capsule was manufactured; from roots of a 6-year-old Panax ginseng Meyer.; Placebo of Kerea Red Ginseng(KRG) Capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: blood pressure, ginseng
Closing the Loop for 36 Hours in Adolescents With Type 1 Diabetes: Evaluation of Reduced Meal Bolusing
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The main focus of our research is the development of a closed-loop system for glucose control
      in people with type 1 diabetes. After having demonstrated the safety and efficacy of
      overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to the
      daytime. Meal-related insulin dosing can be challenging and prandial insulin overdosing can
      be associated with the occurrence of postprandial hypoglycaemia, thus representing a
      confounding factor of hypoglycaemia free glucose control during the day. A further
      investigation is needed to evaluate alternative strategies for prandial insulin dosing. We
      will study eight adolescents with type 1 diabetes during closed-loop insulin delivery
      combined with either standard or reduced insulin doses with the meals, in a randomised
      crossover design. Stable glucose isotopes will be administered to collect data for modelling
      of glucose turnover around the meals, during daily activities and overnight.

      The information provided by the use of glucose isotopes would be very helpful to increase our
      understanding of the physiology of glucose turnover and to facilitate the development of an
      improved control algorithm. Ultimately this study will help with the development of a
      closed-loop system to match insulin infusions to change in glucose levels in real life
      conditions.
    


Intervention name(s): Closed-loop insulin delivery
Intervention type(s): Device
Intervention description(s): Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. Standard or reduced meal insulin dosing will be performed in a randomised design.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closed-loop insulin delivery; Post-prandial hypoglycaemia; Meal insulin dosing
The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases
      pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will
      be a useful adjunct to opioid treatment in chronic neuropathic pain.
    

Detailed description: 
      This is an open-label study to evaluate the safety and efficacy of N-acetyl-L-cysteine in
      patients with Chronic neuropathic pain.
    

Intervention name(s): N-acetyl-l-cysteine
Intervention type(s): Drug
Intervention description(s): 1200 mg BID x 4 weeks
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uncontrolled; neuropathic pain