bioihbjkbjnl/mcl2 huggingface dataset:
Dexmedetomidine as an Adjuvant for Femoral Nerve Block and Functional Recovery After Total Knee Arthroplasty
Condition: Elderly; Total Knee Arthroplasty; Femoral Nerve Block; Dexmedetomidine; Functional Outcome
Study type: Interventional
Phase: Phase 4

Summary: 
      Femoral nerve block (FNB) is a first-line analgesic technique for multimodal analgesia after
      total knee arthroplasty (TKA). Recent studies and meta-analysis indicate that dexmedetomidine
      combined with local anesthetics for FNB can prolong the analgesic duration, improve the
      analgesic efficacy, inhibit local inflammatory response, and reduce narcotic consumption. The
      investigators hypothesize that dexmedetomidine combined with ropivacaine for FNB can also
      improve functional recovery in aged patients after TKA.
    

Detailed description: 
      Many patients following total knee arthroplasty (TKA) complain moderate to severe
      postoperative pain. Multimodal analgesia, a combination of different techniques and analgesic
      agents, plays an increasingly important role to relieve pain after TKA. Femoral nerve block
      (FNB) is a first-line analgesic technique for multimodal analgesia after TKA. But local
      anesthetics alone often exert limited potency of analgesia and are insufficient to avoid
      supplemental opioid usage. Dexmedetomidine, a selective alpha 2-adrenergic receptor agonist,
      is widely used in clinical settings due to its properties of sedation, anxiolysis, analgesia,
      and sleep promotion. Recent studies and meta-analysis indicate that dexmedetomidine combined
      with local anesthetics for FNB can prolong the analgesic duration, improve the analgesic
      efficacy, inhibit local inflammatory response, and reduce narcotic consumption. The
      investigators hypothesize that dexmedetomidine combined with ropivacaine for FNB can also
      improve the functional recovery in aged patients after TKA.
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the dexmedetomidine group receive single-shot femoral nerve block preoperatively using a mixture of 0.375% ropivacaine and 1.0 μg/kg dexmedetomidine, in a total volume of 20 ml.; Patients in the control group receive single-shot femoral nerve block preoperatively using a mixture of 0.375% ropivacaine and normal saline, in a total volume of 20 ml.
Other intervention name(s): Dexmedetomidine hydrochloride; Normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Elderly; Total knee arthroplasty; Femoral nerve block; Dexmedetomidine; Functional outcome
Sleep Apnea and Visual Perceptual Skill Learning
Condition: Apnea
MeSH terms: Apnea
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether obstructive sleep apnea affects sleep
      dependent memory and learning. Subjects with apnea will be given a test of perceptual skill
      learning (the Visual Discrimination Task (VDT)) that has previously been shown to depend on
      sleep. Subjects will be tested on this task before and after sleep. The difference in
      performance after sleep compared to before sleep provides a measure of sleep dependent
      learning. Participants will be tested on one night when they have less apnea because they are
      using continuous positive airway pressure (CPAP) as prescribed by their physician, which is
      well known to reduce apnea; and on another night when they are in their native state and have
      a greater degree of apnea. Memory performance will be compared between the two nights to
      determine how apnea affects sleep dependent memory.
    


Intervention name(s): Subject using usual positive airway pressure therapy while sleeping for one night
Intervention type(s): Other
Intervention description(s): Participants use their usual positive airway pressure therapy while sleeping overnight
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Memory
Metabolic Effects of Enfuvirtide in Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The metabolic effects of T-20 are not completely known, since the drug is used in combination
      with other antiretroviral agents. A short-term study in healthy volunteers, with a
      double-blind crossover design vs. placebo will illustrate if there may be some direct
      metabolic effects without the influence of HIV infection and the concurrent use of other
      drugs.
    


Intervention name(s): Enfuvirtide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 90 mg/12h sc for 7 days; 0.9% saline solution/12h sc for 7 days
Intervention MeSH terms: Enfuvirtide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Randomized, controlled, double-blind clinical trial of three parallel branches to analyze the
      efficacy of a supplement extracted from the internal membrane of the egg shell on the joint
      pain of patients diagnosed with osteoarthritis.
    


Intervention name(s): nutraceutical
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will consume a capsule for eight weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine if repeated daily doses of T0903131 (INT131)
      Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes
      Mellitus.
    


Intervention name(s): T0903131 Besylate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily, oral; Once daily, oral
Other intervention name(s): INT131 Besylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was aimed to explore safety and immunogenicity of two formulations of a
      Meningococcal B Vaccine when administered to healthy infants.
    


Intervention name(s): rMenB; rMenB+OMV; DTaP-Hib-IPV; PC7; MenC-CRM; MenC-Hib; MMR
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.; One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.; Intramuscular (IM) injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2, 3 and 4 months in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.; IM injections of 3 doses of 0.5 mL each of PC7 supplied in prefilled syringe were administered at 2, 4 and 13 months of age in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.; MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized Men C component to be re-suspended with the saline solvent (aluminum hydroxide suspension) supplied. IM injection of 2 doses each of 0.5 mL were administered into the anterolateral area of the left thigh.; MenC-Hib was obtained by extemporaneous mixing of powder and solvent just before injection. One dose (0.5 mL) of MenC-Hib was administered at 12 months of age as an IM injection into the anterolateral area of the thigh.; IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months of age in the anterolateral area of the left thigh.
Other intervention name(s): Serogroup B meningococcal recombinant vaccine without OMV-NZ; Serogroup B meningococcal recombinant vaccine with OMV-NZ; Combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B; and inactivated polio vaccine; Pediacel; Heptavalent Streptoccus pneumonia vaccine; Prevenar; CRM197 conjugated meningococcal C vaccine; Menjugate; Combined meningococcal C and Haemophilus influenzae type B vaccine; Menitorix; Measles, mumps, and rubella vaccine; Priorix
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease; prevention; vaccination
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Condition: Exocrine Pancreatic Insufficiency
MeSH terms: Exocrine Pancreatic Insufficiency
Study type: Interventional

Summary: 
      Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that
      anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
      Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding
      in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.
    

Detailed description: 
      Protocol ALCT-0000497 consists of three distinct study periods as follows:

        1. In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.

        2. In Period B (11 days), subjects will be randomized to either Group A (active
           investigational then placebo control) or Group B (placebo control then active
           investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day
           washout period between Days 1 and 9, subjects will receive Peptamen 1.5.

        3. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with
           Impact Peptide 1.5.
    

Intervention name(s): RELiZORB; Placebo
Intervention type(s): Device; Device
Intervention description(s): Peptamen 1.5 received Period A and Period B (washout only). Impact Peptide 1.5 received Period B (Days 1 and 9 only) and Period C.; Sham device
Other intervention name(s): Peptamen 1.5; Impact Peptide 1.5
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Cycling Exercise With Virtual Reality Visual Stimulation for Rehabilitation in CVA Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Background: Hemiplegia is one of the main reasons why stroke survivors lose their walking and
      balancing ability. Many studies point out that cycling is an effective means for lower limb
      rehabilitation. However, during training, the unaffected limb may compensate for the affected
      one resulting in suboptimal rehabilitation. To address this issue, the investigators
      developed the virtual reality-cycling training system (VRCTS) which can acquire force and
      speed signals in real-time through a cycling module. The system then analyzes the acquired
      data and uses a 3D VR rehabilitation program to help patients to train their affected side.
      The aim of the study was to develop the VRCTS, verify its function and test system function
      on both normal subjects and stroke patients.

      Methods: In this system, the investigators designed a cycling device that is embedded with
      load cell and encoder sensors to detect cycling force and angle in real-time. A Cycling Graph
      User Interface Control and Data Recode System (Cycling CR System) was applied for signal
      analysis and feedback control. The investigators designed a 3D interactive VR rehabilitation
      program that can guide and train the users through visual feedback. Each user performed a
      pre-test to examine determine condition, left-right balance and other parameters, which
      allows the system to be customized.
    


Intervention name(s): virtual reality-cycling training system
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke,; rehabilitation,; leg cycling,; feedback,; virtual reality
A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET)
Condition: Canthal Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This double-blind study has two parts for each subject (same population):

      Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):

        -  To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of
           moderate to severe LCLs.

        -  To assess the subjects' level of satisfaction with the appearance of their LCLs compared
           to placebo.

      Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up
      to 1 year):

        -  To assess safety of Azzalure® following repeated administration in the improvement of
           moderate to severe LCLs.

        -  To assess the safety of Azzalure® when used concomitantly for improvement of moderate to
           severe LCLs and GLs.

        -  To assess the subjects' level of satisfaction with the appearance of their LCLs.
    


Intervention name(s): Botulinum Toxin Type A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Canthal lines
Lifestyle in Pregnancy and Offspring
Condition: Childhood Obesity; Adiposity; Body Composition; Metabolic Risk Factors
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Children born to obese women are at risk of increased adiposity and later adverse metabolic
      outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP
      study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant
      women were randomized to either lifestyle intervention or routine obstetric care. This
      present study follows the children until 3 years of age. We have the hypothesis, that the
      intervention during pregnancy results in a lower degree of adiposity and metabolic risk
      factors in the offspring. Clinical examination is taking place at age 2.5-3 years including
      anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring
      metabolic markers.
    


Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The primary objective of this trial is to investigate the effect of a symbiotic lozenge on
      dental caries in young children.
    

Detailed description: 
      The study is a multicentre, randomized, double-blind, placebo-controlled, parallel-group
      study in healthy children aged 5-8 years. The objective is to investigate the effect of a
      symbiotic lozenge on caries increment in primary molar teeth, primary canines and erupted
      occlusal surfaces at the first permanent molar teeth.The study will take place in Helsingør
      and Fredensborg municipality.

      The study consists of a baseline visit prior to a 12 months intervention period, followed by
      a visit after completion. During the intervention period, two to four months after the
      baseline visit, a saliva sample will be collected.

      All guardians to the subjects are encouraged to 1) brush their children's teeth twice daily
      with the fluoride toothpaste provided, 2) avoid the food provided in appendix D and 3) to
      continue the subject's dental appointments at local Public Dental Health Service (PDHS). No
      further specific oral hygiene or dietary instructions/restrictions are provided.

      Assuming a dropout rate of 12.5%, 175 children will be included in each treatment group.
    

Intervention name(s): 2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine.; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One lozenge once daily for 12 months; Placebo once daily for 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration
Condition: Non-Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, single arm study to study the safety, efficacy and tolerability of
      Pemigatinib when used on participants with squamous or nonsquamous NSCLC with a documented
      FGFR1-3 mutations or fusions/rearrangement who have progressed on prior therapies and have no
      available standard treatment options
    


Intervention name(s): Pemigatinib
Intervention type(s): Drug
Intervention description(s): 13.5 mg tablet
Other intervention name(s): INCB 54828
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants enrolled in this study will be assigned to 1 of 2 cohorts: Cohort A (squamous NSCLC) will enroll approximately 100 participants, and Cohort B (nonsquamous NSCLC) will enroll approximately 25 participants.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced Non-Small Cell Lung Cancer (NSCLC); fibroblast growth factor receptor (FGFR); FGFR1-3 mutations; FGFR1-3 fusions; FGFR1-3 rearrangements; squamous NSCLC; nonsquamous NSCLC; relapsed or refractory
The Comparison of 50% AS Versus PFAT+ 0.05 % COE in Severe Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study aimed to evaluate and compare the efficacy of a 1 month clinical trial of
      50% AS for the treatment of severe dry eye syndrom (DES) based on Schirmer's Test, tear
      break-up time (TBUT), fluorescein staining, and ocular surface disease index (OSDI) scores,
      as compared to conventional preservative-free artificial tears (PFAT) plus 0.05% COE
      treatment in patients with severe DES
    

Detailed description: 
      This is an retrospective comparative study. The designation of the patient whether to use AS
      8*1 or conventional PFAT 8*1 plus COE 2*1 was determined randomly. Student's paired samples
      t-test, independent samples Student's t-test, Wilcoxon signed-rank test and Mann-Whitney U
      test were used to compare data. All patients responded well to both treatments after the
      first 1-month treatment period, based on comparison of before and after treatment OSDI
      scores, Schirmer's test results, TBUT values, and OXFORD scale scores.
    

Intervention name(s): COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1; AS 50% eye drops 8*1
Intervention type(s): Drug; Biological
Intervention description(s): clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye; clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye
Other intervention name(s): Restasis+Refresh Single Dose; 50% autologous serum eye drops 8*1
Intervention MeSH terms: Cyclosporine; Ophthalmic Solutions; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The comparison of 50 % concentration autologous serum eye drops versus preservative free artificial eye drop plus 0.05 % cyclosporin ophthalmic emulsion in the treatment of severe dry eye syndrom
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dry eye; autologous serum; cyclosporine ophthalmic emulsion
Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence with Clinical Endpoints.
    

Detailed description: 
      Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence
      with Clinical Endpoints.
    

Intervention name(s): Adapalene/BP gel, 0.3%/2.5%; EPIDUO® FORTE; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Gel; Gel; Gel
Other intervention name(s): Adapalene, benzoyl peroxide; Adapalene, benzoyl peroxide; Vehicle
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment