bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Korean Version of PEERS Social Skills Training for Young Adults (PEERS-YA-K) With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      Despite the psychosocial difficulties common among young adults with autism spectrum
      disorders(ASD), little to no evidence-based social skills interventions exist for this
      population. Using a randomized controlled trial(RCT) design, the current study tested the
      effectiveness of an evidence-based, caregiver-assisted social skills intervention known as
      PEERS for Young Adults with high-functioning young adults with ASD using self- and
      caregiver-report measures.
    

Detailed description: 
      1. Both the case and the control of this study shall be a high-functioning group consisting
           of young adults aged 18 to 35 years with ASD and an IQ of 70 or over. A total of 48
           young adults will be recruited and divided into two groups. One will be the case group
           and the other will be the waitlist control group. And the study will be going on 3
           institutions. Again, the case will be divided into two sub-groups of ten and carry out
           this new developed program for both parents and young adult. That is, the program will
           be carried out two times in each of both groups. The waitlist control group will be
           allowed to receive personal outpatient treatment and general therapeutic intervention
           from community while waiting.

        2. Effects of the program will be measured both at the case and the control by using a
           scale which measures social interaction, quality of peer relationship, disposition of
           autism and social anxiety. Equal assessments for both the case and the control will be
           conducted right before the beginning of the program and right after the completion of
           the program and four months after the completion of the program.
    

Intervention name(s): Parent-assisted social skills training program for young adult with ASD
Intervention type(s): Behavioral
Intervention description(s): The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
Other intervention name(s): PEERS
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Social skill training; PEERS
The Effect of Amiloride and Spironolactone in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators wish to investigate the potential effects of potassium. In this study we
      will examine patients with hypertension and increase their potassium-levels using Amiloride
      and Spironolactone.

      The investigators will examine the changes in the cardiovascular system using a
      Sphygmocor-scanner.
    

Detailed description: 
      Purpose of the study is to examine the effect of amilorid and spironolacton on

        1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),

        2. Pulsewavevelocity, augmentation index and centralt bloodpressure,

        3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and

        4. Ambulatory blood pressure
    

Intervention name(s): Spironolactone; Amiloride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg twice a day; 5 mg twice a day; twice a day
Intervention MeSH terms: Amiloride; Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Potassium; Blood-pressure
mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms
Condition: Traumatic Brain Injury With Brief Loss of Consciousness; Post-Concussion Syndrome
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Unconsciousness
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy
      for persistent post-concussive symptoms after mild tramatic brain injury
    

Detailed description: 
      Active duty military personnel and Veterans received for 60-minute daily chamber sessions in
      which they received HBO2, 1.5 atmospheres absolute (ATA), or sham intervention (1.2 ATA, room
      air) for post concussion syndrome (PCS).

      The study is to provide a rationale for the selection of outcome assessments to serve as
      primary and secondary endpoints for a pivotal randomized clinical trial of hyperbaric oxygen
      for the treatment of PCS. The participants will undergo a comprehensive battery of symptom
      and quality of life assessments. The distribution of response, change in response over time,
      homogeneity of variance across subgroups, and relationships between outcome measures will be
      compared by treatment assignment with a cohort from a study of similar design among a normal
      study population.
    

Intervention name(s): Hyperbaric oxygen (HBO2) at 1.5 atms; Sham control 1.2 atms
Intervention type(s): Drug; Drug
Intervention description(s): The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.; The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).
Other intervention name(s): 1.5 atms; 1.2 atms (shame)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: HBO2; HBOT; mTBI; Brain injury; PCS; PTSD; hyperbaric oxygen
Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple
      ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to
      investigate whether CORT125236 ameliorates the effects of prednisone on various
      pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially
      provided that this is justified by the pharmacokinetic (PK) and safety data obtained from
      completed cohorts. The first MAD cohort will not start until data are available from at least
      3 SAD levels to allow MAD administration to proceed. The decision on whether to start Part 3
      can be made at any point after completion of 3 SAD levels, and will be based on achieving
      sufficiently high plasma CORT125236 exposure in Part 1 of the study.
    


Intervention name(s): CORT125236; Placebo matching CORT125236; Prednisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration; Placebo matching CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration; Prednisone tablet 25 mg (20 mg + 5 mg tablets) for oral administration
Intervention MeSH terms: Prednisone; Cortisone
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Epidural Analgesia and Delivery of Second Twin
Condition: Epidural; Analgesia; Labor Pain
MeSH terms: Labor Pain
Study type: Observational [Patient Registry]

Summary: 
      Over an 8-year period, 124 twin pregnancies at gestational age ≥32 weeks with both twins
      presenting as a vertex and eligible for vaginal delivery were reviewed. Excluded were
      patients with the following intrapartum factors which may affect mode of delivery of second
      twin: 1. Presentation of the 2nd twin: breech or other than vertex; 2. Monochorionic twins;
      3. Induction of labour; 4. difference in foetal weight between twin B and twin A ≥25%. The
      chi-square statistic was used to compare differences in the incidence of retained second twin
      between the groups.
    

Detailed description: 
      The investigators conducted this prospective study in women with twins pregnancy planned for
      trial of vaginal delivery and gave birth between January 2014 and December 2019, in the
      Department of obstetrics and Gynaecology of the Sabah Maternity Hospital, Sabah Specialized
      Area, Kuwait. The Sabah Maternity Hospital is a tertiary care hospital for the country of
      Kuwait with approximately 12500 deliveries per year. The study protocol was approved by the
      Ethics Committee.
    

Intervention name(s): Bupivacaine-fentanyl
Intervention type(s): Drug
Intervention description(s): Initial epidural bolus of 10 ml Bupivacaine 0.125% plus 50 mcg Fentanyl, followed by continuous infusion pf Bupivacaine 0.0625%™ plus 1mcg/dl Fentanyl
Other intervention name(s): Epidural Catheter insertion
Intervention MeSH terms: Fentanyl; Bupivacaine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with twins pregnancy planned for trial of vaginal delivery and gave birth
      
Keywords: Epidural; Analgesia; Labour
Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
Condition: Hemorrhoids; Anal Fistula
MeSH terms: Hemorrhoids; Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after
      anal surgery.
    

Detailed description: 
      Hemorrhoidectomy and fistulotomy these two types of anal surgery are common surgeries in
      colon and rectal surgery division in Shuang Ho hospital. For these patients underwent
      surgical treatment, some surgeons used gauze with Bosmin for hemostasis and analgesia after
      surgery, and other surgeons used Gelfoam. These choices were often determined by surgeon's
      personal preference according to their experiences. Shuang Ho hospital has top three quantity
      of hemorrhoidectomy in Taiwan. So, a randomized controlled trial is conducted to evaluate the
      difference between hemostatic agents use after anal surgery.
    

Intervention name(s): Gelfoam; Bosmin gauze
Intervention type(s): Device; Other
Intervention description(s): Use Gelfoam as a hemostatic agent after anal surgery.; Use bosmin gauze as a hemostatic agent after anal surgery.
Intervention MeSH terms: Gelatin Sponge, Absorbable
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label randomized single dose two-way crossover study to compare the
      bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with
      120 ml of chocolate pudding relative to the same dose given as two intact capsules.
    

Detailed description: 
      Prior studies have shown that intact quinine sulfate capsules can be taken without regard for
      food. This is an open label randomized single dose two-way crossover study to compare the
      bioavailability of a single oral dose of quinine sulfate 648mg(2 x 324 mg capsules) when
      opened and mixed with 120 ml of chocolate pudding relative to the same dose given as two
      intact capsules. Eighteen healthy adult subjects will be enrolled. Following a fast of at
      least 10 hours subjects will be randomized to receive either 648 mg of quinine sulfate as the
      intact capsules or opened mixed in 120ml of chocolate pudding. Following a washout period of
      at least 7 days all subjects will be given the alternate dose under similar conditions.
      Following each dose, blood samples will be collected at times sufficient to determine the
      difference in bioavailability (if any) between the two methods of drug administration. In
      addition patients will be monitored for any adverse events including Electrocardiogram (EKG)
      changes (at baseline and 4 hours after each dose).
    

Intervention name(s): quinine sulfate; quinine sulfate
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 324 mg capsules (648 mg); 2 x 324 mg capsules (648 mg)
Other intervention name(s): Qualaquin; Qualaquin
Intervention MeSH terms: Quinine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy; Bioequivalence; Pharmacokinetics
Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity
Condition: IDV Associated Nephrotoxicity
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who
      have chronic indinavir (IDV) associated nephrotoxicity.
    

Detailed description: 
      Primary objective:

      To determine whether a switch to a SQV can cause improvements in renal function in patients
      with chronic IDV associated nephrotoxicity without improvement after IDV dose reduction.

      Secondary objective:

        1. To describe the pathophysiology of chronic IDV associated renal impairment through renal
           biopsies at baseline and week 48

        2. To describe the pathophysiology of chronic IDV associated renal impairment through renal
           tubular function at baseline and week 48

        3. To determine whether a switch to an SQV can cause improvements in renal pathophysiology
           in patients with chronic IDV associated nephrotoxicity through renal biopsies performed
           at baseline and at weeks 48

        4. To determine whether a switch to an SQV results in improvements in hypertension, lipid
           profiles and cutaneous side effects
    

Intervention name(s): Saquinavir
Intervention type(s): Drug
Intervention description(s): SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI
Intervention MeSH terms: Saquinavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IDV nephrotoxicity
Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury
Condition: Liver Disease; Impaired Liver Function; Parenteral Nutrition Associated Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      This study is being done to determine if an investigational study drug called Omegaven can
      help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN
      is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are
      unable to drink fluid or eat food by mouth.
    

Detailed description: 
      PAtients with direct bilirubin >2gm/dL and short bowel syndrome are eligible for enrollment.
      Omegaven at 1gm/kg/day will be administered via central venous line instead of standard lipid
      preparations.
    

Intervention name(s): Omegaven
Intervention type(s): Drug
Intervention description(s): Omegaven will be used in place of soy oil Intralipid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: TPN; Liver Function; parenteral nutritional fat emulsions
A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China
Condition: Thrombelastography,Acute on Chronic Liver Failure, Platelet
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Observational

Summary: 
      Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease
      (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin
      production and provides a global assessment of coagulation incorporating the cumulative
      effect of the interactions at various levels between plasma components and cellular component
      of coagulation. And through the platelet mapping, it can help provide a picture of patients'
      function of platelet. This study aims to explore the predictive role of platelet mapping in
      ACLF prognosis, organ failure developments and short term mortality.
    


Intervention name(s): standard treatment
Intervention type(s): Other
Intervention description(s): standard medical treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with HBV-related chronic liver disease, International Normalized Ratio (INR)≥1.5
        and total bilirubin≥85μmol/L
      
Keywords: Thrombelastography,acute on chronic liver failure, platelet
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
Condition: NASH - Nonalcoholic Steatohepatitis; Healthy
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open label, randomized, 3 treatment arms, with and without food
      dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK)
      and Pharmacodynamics (PD) of Farnesoid X Receptor (FXR) agonist/modulator EYP001a in healthy
      volunteers and Nonalcoholic Steatohepatitis (NASH) patients.
    

Detailed description: 
      In total 16 participants (4 healthy volunteers and 12 NASH patients) will be enrolled and
      randomly assigned to one of the 3 treatment arms:

        -  Treatment Arm 1: Dose A once daily morning dose (n=4 NASH patients, n=4 healthy
           volunteers)

        -  Treatment Arm 2: Dose B once daily morning dose (n=4 NASH patients)

        -  Treatment Arm 3: Dose C twice daily - first morning dose and second dose 3 hours post
           first dose (n=4 NASH patients).

      Subsequently, all the enrolled participants (both healthy volunteers and NASH patients) will
      be randomly assigned to one of the 2 parallel study Groups:

        -  Group A (n=8, 2 healthy volunteers and 6 NASH patients): This group will include 2 NASH
           patients from Treatment Arms 1, 2 and 3 and 2 healthy volunteers from Treatment Arm 1.
           Participants in Group A will be dosed in a fasted state on Days 2, 3, 4 and 5 followed
           by dosing in fed state on Days 6, 7, 8 and 9.

        -  Group B (n=8, 2 healthy volunteers and 6 NASH patients): This group will include 2 NASH
           patients from Treatment Arms 1, 2 and 3 and 2 healthy volunteers from Treatment Arm 1.
           Participants in Group B will be dosed in a fed state on Days 2, 3, 4 and 5 followed by
           dosing in fasted state on Days 6, 7, 8 and 9.

      The maximum total engagement duration for eligible participants in this study is up to 76
      days: 60 days screening, 1-day admission visit and 8 days dosing period (in-patient in
      clinical trial unit) and 7 days follow-up.

      The participants who are eligible for enrolment will be admitted to the Clinical Trial Unit
      on Day 1. The participants will receive EYP001a at the study site by trained personnel per
      the schedule of dosing for the study from Day 2 to Day 9 in fed/fasted state depending upon
      the study group. Participants will be discharged on the morning (8:00 AM) of Day 10 after
      collection of last PK and PD blood samples. Participants will return to the Clinical Trial
      Unit on Day 16 for the follow-up visit.
    

Intervention name(s): EYP001a
Intervention type(s): Drug
Intervention description(s): Oral tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Safety, Tolerability and Efficacy of KP-413 in Subjects With Atopic Dermatitis(AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability and efficacy of KP-413
      topical ointment compared with vehicle ointment in treating adult subjects with atopic
      dermatitis (AD).
    


Intervention name(s): KP-413 Ointment
Intervention type(s): Drug
Intervention description(s): Study drug ointment to be applied topically to the selected treatment areas on the head/neck and torso/limbs twice a day for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis
Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg
      extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release
      tablet under fed conditions using a single-dose, randomized, 2 treatment, 2-period,
      2-sequence crossover design.
    


Intervention name(s): Lithium
Intervention type(s): Drug
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
Condition: Hepatitis C Infection; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and
      dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b)
      hepatitis C virus (HCV).
    


Intervention name(s): ombitasvir/paritaprevir/ritonavir; dasabuvir
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; Tablet
Other intervention name(s): ABT-267/ABT-450/r; ombitasvir also known as ABT-267; paritaprevir also known as ABT-450; ABT-333
Intervention MeSH terms: Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Virus; Interferon-Free; Ribavirin-Free; Hepatitis C; Hepatitis C Genotype 1b
Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
Condition: Laceration; Anxiety
MeSH terms: Lacerations
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this research study is to show superiority of intranasal dexmedetomidine to
      intranasal midazolam as anxiolysis prior to pediatric laceration repairs.
    


Intervention name(s): Dexmedetomidine; Midazolam
Intervention type(s): Drug; Drug
Other intervention name(s): Precedex; Versed
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dexmedetomidine; Midazolam