bioihbjkbjnl/mcl2 huggingface dataset:
Transfer of Skills From VR-Trainer to Operation Room
Condition: Clinical Competence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose is to determine if skills obtained by training in the laparoscopic virtual
      reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as
      improved score in a technical skills assessment.
    

Detailed description: 
      The purpose is to determine if skills obtained by training in the laparoscopic virtual
      reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as
      improved score in a technical skills assessment. Design: prospective randomized double
      blinded intervention study.

      Subjects:Younger gynaecologists (Postgraduate year 2-8) Half are having conventional training
      the other half is undergoing virtual reality simulator training before performing their first
      laparoscopic salpingectomy.

      Outcome is measured by blinded video evaluation with criteria. The criteria is defined in the
      previous validated scoring system Objective Structured Assessment of Technical Skills (OSATS)
    

Intervention name(s): LapSimGyn training until expert proficiency level is reached; Traditional clinical education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Two consecutive simulations reaching predefined expert level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Keywords: training; teaching; curriculum
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
Condition: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T
      vaccine has immunological and safety profiles that are comparable to those of the control
      vaccine that is already marketed (Infanrix®Hexa)

      Primary Objective:

      To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune
      response that is at least as good as the response following Infanrix®Hexa in terms of
      seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months)

      Secondary Objectives:

        -  To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep
           B-PRP~T and Infanrix®Hexa) one month after the third dose of the primary series.

        -  To assess the overall safety in each group one month after each dose of the primary
           series and through the entire study.
    

Detailed description: 
      The present trial will involve two-month old Peruvian infants, randomly assigned to receive
      three doses of either the investigational or the control vaccine at 2, 4, and 6 months of
      age.
    

Intervention name(s): DTaP IPV HB PRP~T vaccine; DTaP-HB-IPV and Haemophilus influenzae type b
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Infanrix® Hexa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; whooping cough; Haemophilus influenzae type b; Hepatitis B; Poliomyelitis
A Research Study Looking at the Effect of Food Intake on How the Medicine NN0385-0434 Behaves in the Body of Healthy Participants
Condition: Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk; Elevated Cholesterol; Healthy Volunteers
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study participants will receive NNC0385-0434. NNC0385-0434 is being developed for the
      treatment of hypercholesterolemia, a fat metabolism disorder characterized by high levels of
      cholesterol in the blood. The dose to be tested in this study is 40 mg NNC0385-0434.

      NNC0385-0434 is a new potential medicine that is currently being tested for intake as a
      tablet. It is not yet approved and cannot be prescribed yet. Besides 40 mg of NNC0385-0434,
      each tablet also contains 500 mg of the absorption enhancing agent SNAC, which helps to move
      NNC0385-0434 from the stomach into the blood.

      The aim of this study is to investigate the effect of food intake on the amount of
      NNC0385-0434 in the blood after multiple tablet intake. For this purpose, NNC0385-0434 is
      given either after a high-fat breakfast or on an empty stomach. After dosing, participants
      must either fast for another 4 hours or receive a meal 30 minutes after dosing, depending on
      the group participants are assigned to. After taking the NNC0385-0434 tablets, the amount of
      NNC0385-0434 (and of SNAC) in the blood will be measured. The effect of food intake on the
      uptake of NNC0385-0434 into the body will be investigated so that correct and safe intake
      recommendations and medicine labels can be given.

      The study can last for up to approximately 14 weeks for each participant, with a total of 7
      clinic visits. This includes a screening period (up to 4 weeks) and one in-house treatment
      period (together a total of 13 consecutive days). It also includes a follow-up period with 5
      ambulatory visits at the clinic (for approximately 7 weeks [total of 50 days] after the last
      dosing). participants will have blood tests at every clinic visit. Participants must be
      healthy and have a body mass index (BMI) between 20.0 and 34.9 kg/m2 (both inclusive). Only
      men can participate in this clinical study.
    


Intervention name(s): NNC0385-0434
Intervention type(s): Drug
Intervention description(s): All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF40 Cream
Condition: Sunburn
MeSH terms: Sunburn
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the penetration of micronized and pigmentary TiO2 in Formulas 283419 2 and
      760.001 into the stratum corneum of Compromised (Induced Sunburn) human skin via skin
      stripping of human subjects.
    


Intervention name(s): Titanium dioxide
Intervention type(s): Drug
Intervention description(s): Topical cream
Intervention MeSH terms: Titanium dioxide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Sun Protection
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
Condition: Stress
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The proposed research has the following objectives:

      Based off findings from the "Development of a Resiliency Program for Siblings of Children
      with Autism Spectrum Disorder" qualitative focus group study (protocol 2019P002284), the aim
      is to determine the feasibility and acceptability, of an 8-session Relaxation Response
      Resiliency (SibChat) program for siblings of children with ASD.

      We primarily aim to test the preliminary effectiveness of a pilot waitlist controlled trial
      on improving resiliency and stress coping, This will be assessed by comparing Baseline-3 mo.
      scores on primary and secondary outcome measures between the Immediate and Waitlist control
      groups.

      Among participants randomized to both conditions, we secondarily aim to investigate the
      extent of pre-post changes in primary and secondary outcomes. Among immediate condition group
      only, we also aim to assess whether end-of-treatment (3 mo. post enrollment) improvements
      will be sustained at 6-mo. post enrollment.
    

Detailed description: 
      This intervention will be a modified version of Dr. Elyse Park's evidence-based 8-week
      multimodal treatment which is designed to promote adaptation to stress and promotion of
      resiliency. The program is an 8 session, 1 hour a week multi modal intervention that
      incorporates relaxation techniques, stress awareness discussion, and adaptive strategies for
      coping with stress. This study will refine an 8-session group virtual-delivered resiliency
      treatment program consisting of 8 virtual group 1-1 ½ hour sessions. The goal of this study
      would be to advance our ultimate objective to implement a national sibling resiliency
      program.
    

Intervention name(s): Relaxation Response Resiliency Program for Siblings of Children with ASD
Intervention type(s): Behavioral
Intervention description(s): Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resiliency Training; Autism Spectrum Disorder; Family Relationships
Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy
      adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination
      trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the
      two drug products will be evaluated separately in the fed and fasted state.
    


Intervention name(s): Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets); Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
Intervention type(s): Drug; Drug
Other intervention name(s): Contrave
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Obesity; Overweight; Contrave; Antiobesity agents; Antiobesity drugs; Weight loss drug; Bioequivalence; Pharmacokinetic
Absolute Bioavailability of BMS-791325
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of
      BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.
    

Detailed description: 
      Primary Purpose: Other: Protocol is designed to assess the absolute bioavailability of 150 mg
      (2x75 mg tablets) BMS-791325 administered orally
    

Intervention name(s): BMS-791325; [13C]-BMS-791325
Intervention type(s): Drug; Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Pudendal Nerve Block for Post-Episiotomy Pain Relief
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized
      Clinical Trial
    


Intervention name(s): Pudendal Nerve Block
Intervention type(s): Procedure
Intervention description(s): Pudendal Nerve Block
Other intervention name(s): Bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Bupivacaine
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This will be a 5-visit, randomized, partially single-masked, bilateral wear, dispensing,
      2-treatment × 2-period crossover study with spectacle-wear washout and wash-in periods.
    


Intervention name(s): ACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism; ACUVUE Oasys 1-Day with HydraLuxe Technology
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Studying of Natural Constituents' Treatment of Plantar Warts
Condition: Plantar Wart
MeSH terms: Warts; Foot Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Moringa banana nigella and Banna coat extract were prepared and formulated in the form of bi
      gel for transdermal delivery of these plant extracts. The formulation was prepared and
      charterized for organoleptic charters, morphology, and penetration efficacy. The optimised
      formulation was assessed clinically on patients suffering from plantar warts. The clinical
      study was phase 1 and interventional randomised allocation.
    


Intervention name(s): Banaba Leaf Extract
Intervention type(s): Drug
Intervention description(s): a herbal extract in the form of Bigel
Other intervention name(s): moringa banna nigella
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC
      in patients with moderate plaque-type psoriasis.
    

Detailed description: 
      Approximately 30 subjects will be enrolled in this double-blind, placebo-controlled study.
      The randomization will be stratified 2:1 into the LYC-30937-EC cohort (2) or the placebo
      cohort (1). The active cohort will receive LYC-30937-EC 25 mg once daily, which demonstrated
      safety and tolerability in Phase I trials.

      The study is designed for patients with previously diagnosed moderate chronic plaque-type
      psoriasis and consists of the following:

        -  Screening period (initials assessment and eligibility scoring)

        -  Day 1: confirm eligibility, baseline efficacy assessments (PASI, IGA), randomize and
           initiate dosing

        -  Week 2: safety assessments including vital signs, body temperature, physical exam,
           clinical labs will be performed

        -  Week 4: efficacy (PASI, IGA) and safety assessments including vital signs, body
           temperature, physical exam, and clinical labs will be performed

        -  Week 8: efficacy (PASI, IGA) and safety assessments including vital signs, body
           temperature, physical exam, and clinical labs will be performed

        -  Week 12: final efficacy assessments (PASI, IGA), safety assessments including vital
           signs, body temperature, physical exam, ECG, and clinical labs will be performed

        -  Week 14: final safety assessments including vital signs, body temperature, and clinical
           labs
    

Intervention name(s): Drug: LYC-30937-EC; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment
      for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major
      and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA
      delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and
      depression as in-person BA treatment for depression.
    


Intervention name(s): Behavioral Activation
Intervention type(s): Behavioral
Intervention description(s): Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
Other intervention name(s): BA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Behavioral Activation; Tele-medicine
Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate
Condition: BPH With Large Prostate
MeSH terms: Prostatic Hyperplasia; Hypertrophy
Study type: Interventional

Summary: 
      The goal of this study is to compare the perioperative and postoperative characters of
      plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients
      with large prostate.
    

Detailed description: 
      Despite the availability of numerous minimally invasive alternatives, monopolar transurethral
      resection of the prostate (TURP) remains the most frequently performed operation for benign
      prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for
      large prostates is associated with various complications and unsatisfactory long-term
      results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes
      than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to
      compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients
      with large prostate. Moreover, we evaluate the long-term results of both approaches.
    

Intervention name(s): PkEP; B-TURP
Intervention type(s): Procedure; Procedure
Intervention description(s): Plasmakinetic enucleation of the prostate; Bipolar transurethral resection of the prostate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: benign prostatic hypertrophy; bipolar transurethral resection of the prostate; plasmakinetic enucleation of the prostate
A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to validate the clinical performance of a new contact lens
      design when worn over a period 1 week compared to nelfilcon A (control).
    

Detailed description: 
      The purpose of this study is to validate the clinical performance of a new contact lens
      design when worn over a period of 1 week compared to nelfilcon A (control). The primary
      outcomes of interest is lens fit acceptance.
    

Intervention name(s): Test Contact Lens; Nelfilcon A
Intervention type(s): Device; Device
Intervention description(s): Daily disposable contact lens; Focus Dailies All Day Comfort contact lens (nelfilcon A)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Caudal Block With Tramadol and Levobupivacaine or Bupivacaine
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational [Patient Registry]

Summary: 
      Caudal block is the regional anesthetic technique that is used most frequently in pediatric
      surgery. Opioid drugs have been added to local anesthetic solutions to prolong duration of
      analgesia but ideal combination were not found that has minimal adverse effect. The aim of
      this study was to compare the postoperative analgesic efficacy of equal concentrations of
      bupivacaine plus tramadol or levobupivacaine plus tramadol in pediatric patients undergoing
      minor urological surgery.
    

Detailed description: 
      Sixty-eight children aged 2 to 7 years who were undergoing inguinal herniorrhaphy or
      orchidopexy received bupivacaine 0.25% plus tramadol 2 mg/kg (BT group) or levobupivacaine
      0.25% plus tramadol 2 mg/kg (LT group) by the caudal route after laryngeal mask anesthesia.
      The primary outcome of the study was to compare the duration and quality of postoperative
      analgesia. The postoperative pain relief was evaluated by the Children and Infants
      Postoperative Pain Scale (CHIPPS) at 2, 4, 6, 12, and 24 h postoperatively. In addition, the
      time of first analgesic requirement was noted.
    

Intervention name(s): Levobupivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): in the levobupivacaine-tramadol (LT) group received a caudal injection of levobupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg levobupivacaine plus 35 mg tramadol), resulting in a total volume of 1 ml/kg at maximum volume of 15 ml; in the bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg bupivacaine plus 35 mg tramadol)
Other intervention name(s): Chirocaine, Abbott Lab, Nycomed Pharma, Norway; Marcaine, Astra Zeneca, UK
Intervention MeSH terms: Bupivacaine; Levobupivacaine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA status I children aged 2 to 7 years who were scheduled for elective inguinal
        herniorrhaphy or orchidopexy were enrolled.
MASCOT : Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV
Condition: Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian
      patients
    


Intervention name(s): oxaliplatin
Intervention type(s): Drug
Intervention MeSH terms: Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment