bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Pregabalin on Pain After Total Knee Arthroplasty
Condition: Primary Total Knee Arthroplasty
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Total knee arthroplasty can cause severe postoperative pain, and patients typically receive
      oral opioid analgesics for over 2 weeks. Side effects of pain management may impair
      participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems
      that pregabalin is very helpful to patients after total knee arthroplasty. However,
      pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses
      may not be effective, but use of high doses may increase the incidence and severity of side
      effects.The purpose of this study is to determine which dosage of pregabalin is the most
      effective at reducing pain after knee surgery.
    


Intervention name(s): Pregabalin 50mg; Pregabalin 100mg; Pregabalin 150mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.; Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.; Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.; Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Other intervention name(s): Lyrica; Lyrica; Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dried Purple Laver (Nori) as a Food Source of Vitamin B12 in Vegetarians
Condition: Vitamin B 12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      This is an intervention study aiming to understand the bioavailability of vitamin B12 from
      nori for vegetarians.
    

Detailed description: 
      Thirty vegetarian participants will be randomly assigned to one of three intervention arms:
      (1) 5g of nori (4 sheets, containing 2.4μg vitamin B12), (2) 8g nori (7 sheets, containing
      4μg vitamin B12), (3) control group (no nori). At baseline and end of 4 weeks, participants
      will be measured on serum vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine
      and folate.
    

Intervention name(s): Dried purple laver (Nori)
Intervention type(s): Other
Intervention description(s): Dried purple laver (Nori) that has been test to have bioactivity vitamin B12 will be given for intervention groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vitamin B12; Vegetarian diet; Purple laver (Porphyra sp.); Nori
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(3)
Condition: Hypertension and Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348(3)
    

Detailed description: 
      An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to
      evaluate the pharmacokinetics and tolerability of CKD-348(3) with coadministration of
      CKD-828, D097 and D337 in healthy adult volunteers
    

Intervention name(s): CKD-348(3); CKD-828, D097, D337
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Behavior of Cyclists in Response to Pain
Condition: Pain; Sport Injury; Athletic Injuries
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Observational

Summary: 
      A qualitative study, as a follow-up to an earlier study, that provides an opportunity to
      develop a deeper understanding of the injured cyclist's behavior related to seeking medical
      attention and endurance of pain. This study includes 10 club-level cyclists who have an
      injury and either have or have not sought medical attention.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Club-level cyclists, recruited from a local bike shop, who have an injury and either have
        or have not sought medical attention.
      
Keywords: Cycling; Endurance; Pain; Injury
A Midazolam Drug Interaction Study With PF-04171327
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on
      the blood levels (pharmacokinetics) of midazolam
    


Intervention name(s): PF-04171327 25 mg; Midazolam 2 mg
Intervention type(s): Drug; Drug
Intervention description(s): One 25 mg tablet administered once a day for 15 days; Midazolam oral syrup 2mg dose administered once on Day 1 and once on Day 15
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug interaction CYP3A4 glucocorticoids midazolam
Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Observational

Summary: 
      The purpose of this retrospective study is to assess corneal changes (keratometry,
      pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral
      crosslinking treatment compared to the untreated fellow eye. The corneal measurements
      obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating
      scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and
      ocular surgeries as potential factors involved in treatment outcome are also evaluated.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible keratoconus patients aged 18-50 years who underwent unilateral crosslinking
        treatment in our ophthalmology department and completed a postoperative follow-up of 2-14
        months
      
Keywords: crosslinking; keratoconus; keratometry; pachymetry; pentacam
Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block
Condition: ACL Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, randomized, single blinded trial involving human subjects. The goal of
      this study is to determine an optimal location (proximal or distal) for the nerve block and
      whether it will make a difference in how much opioid the patient will receive during and
      after surgery. Ultrasound will identify the adductor canal and the proximal end of the
      adductor canal/apex of the femoral triangle to determine the location of the blocks.

      Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB
      proximal to true AC with bupivacaine 0.5% 20cc
    


Intervention name(s): ACB within true AC with bupivacaine 0.5% 20cc; ACB proximal to true AC with bupivacaine 0.5% 20cc
Intervention type(s): Drug; Drug
Intervention description(s): The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.; Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
Other intervention name(s): bupivacaine; bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection
Condition: Subacromial Impingement Syndrome; Partial Thickness Rotator Cuff Tear
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The purpose of this investigator initiated study is to clinically evaluate the efficacy of a
      new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears.
      This treatment consists of a platelet rich plasma injection into and around the rotator cuff.
      It is thought that this treatment will dramatically improve outcomes for patients suffering
      from these two conditions.

      Subjects will be randomized by choosing a slip of paper from an envelope. This process will
      randomize 25 patients to the experimental group, and 25 patients to the control. The
      experimental group will undergo a blood draw, allowing for an injection of platelet rich
      plasma around the rotator cuff. The control group will undergo a corticosteroid injection
      into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be
      followed for three months for pain, and will fill out questionnaires at six weeks and three
      months post injection, which will give insight into functionality and pain changes that the
      rotator cuff is experiencing due to treatment.

      Subjects will be outpatients. Subjects may include employees, students, minorities, and
      elderly, although no subsets of these will be formed.

      Subjects will be between 18 and 89 years of age.

      In total, subject participation will last approximately 3 months.
    


Intervention name(s): platelet rich plasma injection; corticosteroid injection
Intervention type(s): Biological; Drug
Intervention description(s): 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions.; Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.
Other intervention name(s): platelet rich plasma - PRP; naropin; xylocaine; triamcinalone; naropin; xylocaine
Intervention MeSH terms: Lidocaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: subacromial impingement; partial thickness rotator cuff; PRP; platelet rich plasma
Roll for Intervention - TBI Group Treatment
Condition: Communication Disorder, Social
MeSH terms: Communication Disorders; Social Communication Disorder
Study type: Observational

Summary: 
      Communication group intervention for individuals with Traumatic Brain Injury based on INSIGHT
      protocol (Keegan et al, 2020) with roll playing game focus
    

Detailed description: 
      Individuals with TBI recruited to participate in a study about applying INSIGHT protocol to a
      virtual roll playing game environment. The game 'monsters of the week' will be used to
      administer the cognitive-communication ingredients outlined by INSIGHT (Keegan et al 2020)
      and progress towards social communication goals will be documented throughout the course of
      participating in the roll playing campaign (7-8 weeks - meeting 2 hours each week). The
      individuals without neurological disorders will follow the same protocol.
    

Intervention name(s): INSIGHT
Intervention type(s): Behavioral
Intervention description(s): See Keegan et al., 2020
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group 1: individuals who have received a brain injury at least 1 year prior to enrollment.

        Group 2: age, education and gender matched individuals who have no history of neurological
        difficulties
Effect of Intratracheal Dexmedetomidine Administration on Recovery From General Anesthesia in Pediatrics Undergoing Lower Abdominal Surgery:
Condition: Intratracheal; Dexmedetomidine
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The incidence of intratracheal tube-induced laryngeal irritation, including coughing,
      bucking, and cardiovascular stimulation, on emergence from general anesthesia has been
      reported to occur in 38% and 96% of cases. This may cause agitation and unstable hemodynamics
      during anesthesia recovery, and can lead to complications, such as laryngeal edema, sore
      throat, increased intra-abdominal pressure, and anastomotic bleeding. Accordingly, many
      anesthesiologists have been seeking methods through which such laryngeal irritation can be
      attenuated, thus allowing for a smoother extubation. Furthermore, it has contributed to the
      aggravation of cough reflexes.
    

Detailed description: 
      Several strategies have been reported to facilitate smoother extubation, such as intravenous
      lidocaine, remifentanil, and dexmedetomidine. Dexmedetomidine is a potent, alpha-2-selective
      adrenoceptor agonist that causes sympatholytic, sedation and analgesia without respiratory
      compromise. The sedative properties of dexmedetomidine are largely due to effects on the
      locus ceruleus, producing a level of consciousness mimicking natural sleep Delivering
      dexmedetomidine intravenously to attenuate airway and circulatory reflexes during extubation
      has been extensively evaluated in clinical studies. Recent studies have also indicated that
      the intranasal application of dexmedetomidine is significantly useful and effective in the
      achievement of improved sedation and analgesia) and offers a safety profile similar to
      traditional sedatives ( ketamine and midazolam). Additionally, intratracheal local anesthetic
      instillation has been reported to be effective in preventing laryngeal reflexes. However,
      both the efficacy and safety profile of intratracheal dexmedetomidine applications are
      largely unknown and the technique has not been specifically investigated.
    

Intervention name(s): Intratracheal dexmedetomidine; Saline Solution
Intervention type(s): Drug; Drug
Intervention description(s): Thirty minutes before the end of the surgery, Dex (0.5μg/kg diluted and mixed in 1ml saline in a medical spray bottle) will be sprayed down the intratracheal tube; Thirty minutes before the end of the surgery, 1ml saline in a medical spray bottle will be sprayed down the intratracheal tube
Other intervention name(s): precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine what the study drug does to the body, what the body
      does to the study drug, and if the study drug is safe and well tolerated when given to adult
      healthy volunteers.
    


Intervention name(s): PF-05230907; Placebo for PF-05230907; PF-05230907; Placebo for PF-05230907; PF-05230907; Placebo for PF-05230907; PF-05230907; Placebo for PF-05230907; PF-05230907; Placebo for PF-05230907; PF-05230907; Placebo for PF-05230907
Intervention type(s): Biological; Drug; Biological; Drug; Biological; Drug; Biological; Drug; Biological; Drug; Biological; Drug
Intervention description(s): 0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose; 0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose; 0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose; 0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose; 1 micrograms per kilogram of PF-05230907, IV bolus, single dose; 1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose; 2 micrograms per kilogram of PF-05230907, IV bolus, single dose; 2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose; 3 micrograms per kilogram of PF-05230907, IV bolus, single dose; 3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose; 5 micrograms per kilogram of PF-05230907, IV bolus, single dose; 5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer. It may also help doctors predict which patients will respond to treatment.

      PURPOSE: This laboratory study is looking at prognostic factors in patients receiving
      tegafur-uracil for stage II colon cancer that was completely removed by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Identify the prognostic factors in patients with curatively resected stage II colon
           cancer receiving adjuvant chemotherapy with tegafur-uracil.

        -  Identify predictive factors of chemosensitivity to this regimen in these patients.

      OUTLINE: Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR
      for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite
      instability and genomic deletions on chromosome arm 18q; and pathologically for tumor
      budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and
      fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for
      correlation with disease-free survival, relapse-free survival, and overall survival of
      patients.
    

Intervention name(s): UFT adjuvant chemotherapy
Intervention type(s): Drug
Intervention description(s): UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.
Other intervention name(s): Adjuvant chemotherapy with tegafur-uracil
Intervention MeSH terms: Tegafur
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with curatively resected stage II colon cancer in Japan.
      
Biospecimen description: 
      Tumor tissue samples
    
Keywords: stage II colon cancer; stage II rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum
Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC
Condition: High-flow Nasal Cannula; Exercise Capacity; Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is to compare the exercise capacity (6-min walking distance) under
      the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the
      minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2.
      FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2
      value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value
      that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min
    

Detailed description: 
      In the pervious study, the investigators demonstrated that 4 weeks of training using both
      high FIO2 and high flow through an HFNC significantly improved the 6MWD compared with
      training using a 6 L/min nasal cannula. However, it was unclear whether the effects of
      pulmonary rehabilitation under HFNC were due to high FIO2, high flow rate, or a synergistic
      effect. It is also unknown whether there are differences in the effects of pulmonary
      rehabilitation under HFNC for each underlying disease.
    

Intervention name(s): High-flow nasal cannula
Intervention type(s): Device
Intervention description(s): The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: HFNC; 6MWD
A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease
Condition: Coronary Disease; Coronary Arteriosclerosis; Hyperlipidemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

      To look at ultrasound images taken in the blood vessels of the heart and to look at various
      lipids in the blood of people with known coronary heart disease
    

Detailed description: 
      For additional information please call: 1-800-718-1021
    

Intervention name(s): torcetrapib/atorvastatin; atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Torcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effects of Alpha-1 Antitrypsin (AAT) on the Progression of Type 1 Diabetes
Condition: Diabetes; Type 1 Diabetes
MeSH terms: Alpha 1-Antitrypsin Deficiency; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the drug Alpha-1 Antitrypsin (AAT, Aralast NP)
      will preserve beta-cell function and help slow the progression of type 1 diabetes.
    


Intervention name(s): Alpha 1-Antitrypsin (AAT, Aralast NP)
Intervention type(s): Drug
Intervention description(s): Eligible subjects will be treated once a week for 8 weeks (8 total treatments).
Other intervention name(s): Alpha-1 Antitrypsin; AAT; Aralast NP
Intervention MeSH terms: Alpha 1-Antitrypsin; Protein C Inhibitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; type 1 diabetes; AAT; Alpha-1 Antitrypsin