bioihbjkbjnl/mcl2 huggingface dataset:
Fluid Lavage of Open Wounds
Condition: Open Fracture Wounds
MeSH terms: Wounds and Injuries; Fractures, Open
Study type: Interventional

Summary: 
      Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a
      common complication. There is currently little evidence as to which is the most effective way
      to wash out these wounds. This study is a multi-center, prospective, randomized study. The
      infection rates will be compared between irrigation using high pressure versus low pressure
      versus gravity flow, and also saline versus a soap solution as the irrigation solution. The
      results from this study will help to determine the best method of washing out open fractures
      wounds. In this study, all open wounds will be washed out using methods commonly used by
      orthopaedic surgeons
    


Intervention name(s): Saline Solution; Soap solution; Gravity Flow Irrigation; Low Pressure Irrigation; High Pressure
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Irrigation with Saline; Irrigation with Castile Soap Solution (80 ml per 3L bag of saline); Gravity flow irrigation will be standardized across participating centers as 3L bags of normal saline (alone or with soap solution) suspended 6-8 feet above floor level using an I.V. pole. Irrigation tubing (measuring 1/4 - 3/8 inch inner diameter) will be connected to the 3L bag and secured with a stopcock (or compressive device) until ready for use.; Irrigation with the Stryker SurgiLav System. At the low pressure setting delivers 5.9 p.s.i. pressure. The high-flow irrigator tip will be held perpendicular to and 5cm above the wound.
Irrigation with the Zimmer PulsaVac. For low pressure delivery, the shower tip will be used at the low pressure setting which delivers a pressure of 5.8 p.s.i.; Irrigation with the Stryker SurgiLav System. For the high pressure delivery, the multi-orifice tip will be used at the high setting which delivers a pressure of 30 p.s.i.
Irrigation with the Zimmer PulsaVac System: For the high pressure delivery the shower tip will be used at the high pressure setting which delivers a pressure of 23 p.s.i.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Single-Dose Relative Bioavailability Study of SST-6006, a Topical Sildenafil Cream Versus Oral Sildenafil in Healthy Male Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how a single dose of sildenafil cream (SST-6006) is
      absorbed and eliminated by the body, with and without the use of a condom, compared to a
      single oral sildenafil dose and to evaluate the safety of sildenafil cream.
    


Intervention name(s): 5% Sildenafil Cream (SST-6006); Oral Sildenafil 50 mg
Intervention type(s): Drug; Drug
Intervention description(s): 5 % Sildenafil Cream; Oral Sildenafil 50 mg
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic Characterization
Plasma Protein Levels and Very Preterm Birth
Condition: Very Preterm Infants
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The primary aim of this study is to investigate the relationship between early plasma protein
      levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims
      are the following: i) to evaluate maternal and neonatal factors affecting plasma protein
      level at birth; ii) to evaluate the relationship between plasma protein level and albumin
      level on the first day of life; iii) to evaluate the association between early
      hypoproteinemia and neonatal mortality and morbidity in very preterm infants.
    


Intervention name(s): Evaluation of the relationship plasma protein levels - neonatal hemodynamics
Intervention type(s): Other
Intervention description(s): Patient inclusion at birth
Total plasma protein values measurement on cord blood sample at birth
Hemodynamic evaluation at 6 hours after birth with colour doppler echocardiography and organ blood flow colour doppler
Total plasma protein and albumin values measurement on plasma sample at 12 hours after birth
Blood pressure, heart rate, O2 saturation, capillary refill time, rSO2 [regional (cerebral and somatic) tissue oxygenation by NIRS - near infrared spectroscopy] will be monitored over 24 hours after birth.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Very preterm infants with birth at less than 32 weeks of gestational age
      
Keywords: Preterm baby; Total plasma protein; Albumin; Hemodynamic disturbances; Perfusion; Near Infra Red Spectroscopy (NIRS); Ultrasound
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1

Summary: 
      1. purpose: To conduct the relative bioavailability study of a single dose and multiple
           doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus
           Glivec (Novartis Pharma Stein AG).

        2. Experimental Design： Two-period crossover design

        3. Test drug: imatinib mesylate capsule Reference drug: Glivec

        4. Sample size：20
    

Detailed description: 
      To conduct the relative bioavailability study of a single dose and multiple doses of imatinib
      mesylate capsule(Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma
      Stein AG) and compare the bioequivalence and pharmacokinetics of the two products in 20
      patients with chronic myeloid leukemia.
    

Intervention name(s): mesylate imatinib capsule; Glivec
Intervention type(s): Drug; Drug
Intervention description(s): Single and multiple oral mesylate imatinib capsule 400mg qd; Single and multiple oral Glivec 400mg qd
Other intervention name(s): 111201; Mesylate Imatinib tablet
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Ascending Dose Study of TRN-157 in Healthy Subjects
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This single ascending dose study is to determine and evaluate the safety and tolerability of
      TRN-157 in approximately 40 healthy subjects.
    


Intervention name(s): TRN-157; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine
Condition: Acne Scars
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital
      Lidocaine when acne scars are treated
    


Intervention name(s): Restylane Vital Lidocaine
Intervention type(s): Device
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Testing the Effectiveness and Safety of a New Prototype of a Passive Industrial Exoskeleton for Back Support
Condition: Prevention of Diseases of the Musculoskeletal System
Study type: Interventional

Summary: 
      This research will provide data on evaluation of the effectiveness and safety of using a
      passive exoskeleton designed to reduce the negative impact of static and dynamic loads
      associated with body tilts, lifting and holding weights on the musculoskeletal system of
      workers. To evaluate a passive industrial exoskeleton for back support, a protocol was
      developed in which individual production operations will be modeled.

      This research will recruit 9 valunteers. During a 4-hour laboratory visit, each subject will
      perform three identical experimental tests: one test without an exoskeleton and two tests
      using two different modifications of the exoskeleton prototype. To avoid sequence bias, the
      test order will be randomized (balanced). Two types of labor operations will be simulated.
      One operation will consist in lifting the load, which is 20% of the volunteer's body weight,
      from a height of 14 cm to a surface with a height of 70 cm, the frequency of lifting is 1
      time in 30 seconds. The second operation is holding a cargo weighing 5 kg in a forced working
      position (tilt of the body more than 30 °) for 1 minute, after which rest will follow for 1
      minute, and then the work will be repeated. Both types of work will be performed for 105
      minutes, then a break of 15 minutes, then 105 minutes of work. Heart rate, blood pressure,
      ECG (Custo) will be monitored. An ergospirometric device (Metamax) will be used to collect
      muscle activity data (Trust-M, Myoton), inertial sensors (Trust-M) will be used to evaluate
      the biomechanics of movements. In addition, questionnaires will be filled out for a
      subjective assessment of the use of exoskeleton prototypes (local discomfort scale,
      exoskeleton properties assessment questionnaire).
    


Intervention name(s): Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back; protocol will be performed without exoskeleton
Intervention type(s): Device; Other
Intervention description(s): Both exoskeleton types are passive exoskeletons for supporting the back. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions; protocol will be performed without exoskeleton
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized counterbalanced cross-over design
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: industrial exoskeleton; exoskeleton; passive industrial exoskeleton
The Effect of Vitamin K2 on Bone Turnover
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with
      osteoporosis. One month of menatetrenone therapy enhanced the secretion and
      gamma-carboxylation of osteocalcin. Moderate increases of bone resorption and formation
      markers were observed after 6 months. These changes may contribute to fracture prevention in
      patients with osteoporosis.
    


Intervention name(s): Menatetrenone (Vitamin K2)
Intervention type(s): Drug
Intervention MeSH terms: Vitamin K; Vitamin K 2; Menatetrenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Proof of Concept Study of OC000459 in Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a randomised, double blind, placebo controlled, parallel group evaluation of the
      effect of OC000459 given orally for eight weeks on active eosinophilic esophagitis.
    


Intervention name(s): OC000459; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): OC000459 100mg, twice daily, tablet; Placebo tablets to match OC000459 tablets, twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: EoE
Bioavailability of Variably Aged MK-0974 Tablets (MK-0974-038)(COMPLETED)
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the comparative bioavailability of three capsule formulations of
      MK-0974.
    


Intervention name(s): telcagepant potassium; MK-0974 5Mo5C; MK-0974 12Mo5C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): [INTERVENTION NAME: MK-0974 12MoRT] Single dose MK-0974 12MoRT (12 month aged MK-0974 capsules, stored at room temperature) 300 mg in one of three treatment periods; Single dose MK-0974 5Mo5C (5 month aged MK-0974 capsules, stored at 5 Â°C) 300 mg in one of three treatment periods; Single dose MK-0974 12Mo5C (12 month aged MK-0974 capsules, stored at 5 Â°C) 300 mg in one of three treatment periods
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aging, Aged Garlic, Vascular Function and Muscle Oxygenation
Condition: Aging; Hypertension; Dyslipidemias; Abdominal Obesity
MeSH terms: Dyslipidemias; Obesity, Abdominal
Study type: Interventional

Summary: 
      The number of elderly individuals affected by cardiovascular diseases has been increasing in
      our country. Garlic (Allium sativum) has been associated with decrease of reactive species of
      oxygen, hypertension, high cholesterol, platelet aggregation, blood coagulation and
      especially cardiovascular diseases. The present study evaluated the effects of a garlic
      supplementation on vascular function and blood pressure in the elderly at cardiometabolic
      risk. Twenty-eight elderly individuals were submitted to an ingestion of four capsules of an
      aged garlic extract (KYOLIC® Aged Garlic Extract™). Muscle oxygenation and function were
      measured 180 min after interventions. Urinary thiosulfate, blood nitrate, nitrite, systolic
      blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at
      baseline and 180 min after interventions.
    


Intervention name(s): Aged Garlic Extract; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic); 800 mg of maltodextrin (four capsules)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Aging; Aged Garlic; Functional Food; Vascular Function; Muscle oxygenation; Exercise performance
Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots
Condition: Pulp Necrosis; Regeneration
MeSH terms: Dental Pulp Necrosis; Necrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center exploratory clinical trial is a randomized trial designed to test whether a
      regenerative endodontic procedure using tissue engineering principles (REGENDO), or a
      revascularization (REVASC) endodontic procedure, in comparison to standard apexification
      treatment using a mineral trioxide aggregate barrier (apexification; APEX), produces a
      significantly better composite clinical outcome for the treatment of immature permanent teeth
      with pulpal necrosis.
    

Detailed description: 
      This is a multi-center randomized clinical trial designed to test whether a regenerative
      endodontic procedure using tissue engineering principles (REGENDO), or a revascularization
      (REVASC) endodontic procedure, when compared to the standard apexification treatment using
      mineral trioxide aggregate barrier-MTA apexification (APEX), produces a significantly better
      composite clinical outcome for the treatment of immature permanent teeth with pulpal
      necrosis. This study will use an antibiotic mixture called Triple Antibiotic Paste (TAP),
      consisting of ciprofloxacin, metronidazole and minocycline, in the tooth for disinfection of
      the root canal in study arms REGENDO and REVASC. The FDA has issued an Investigational New
      Drug (IND) number allowing use of the triple antibiotic mixture in this trial. Other dental
      materials used in this study have already been FDA approved for use in humans to provide a
      matrix for the promotion of tissue growth in the root canal space. The study will also
      attempt to identify the type of bacteria within the root canal space and surrounding tissues
      by analyzing a small sample collected on a cotton-tip applicator. This clinical trial hopes
      to determine which of the three treatment methods helps the tooth to grow stronger and
      survive for at least two years after treatment.
    

Intervention name(s): Triple Antibiotic Paste; Standard Treatment
Intervention type(s): Drug; Other
Intervention description(s): USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency; Standard Treatment no use of study drug
Other intervention name(s): Ciprofloxacin, Metronidazole, & Minocycline; No use of study drug
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole; Ciprofloxacin; Minocycline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Necrotic tooth pulp; Immature permanent teeth; Regeneration
Platelet Count Trends in Pre-eclamptic Parturients
Condition: Obstetric Labor Complications; Preeclampsia; Thrombocytopenia
MeSH terms: Pre-Eclampsia; Obstetric Labor Complications; Thrombocytopenia
Study type: Observational

Summary: 
      Thrombocytopenia (platelet count < 100,000/mL) occurs in approximately 15% of women with
      preeclampsia. Neuraxial analgesia is contraindicated in parturients with a coagulopathy;
      therefore, the platelet count(PC) is routinely checked prior to the initiation of neuraxial
      analgesia in women with preeclampsia/eclampsia. Catheter removal is also contraindicated in
      the presence of a coagulopathy. Some women have an acceptable PC at the initiation of
      neuraxial analgesia, but may become significantly more thrombocytopenic during labor and
      delivery. In a study of severely preeclamptic parturients, some with HELLP (H=hemolysis of
      red blood cells, EL=elevated liver enzymes, LP=low platelet count) syndrome, the admission PC
      correlated with the PC nadir. However, the natural progression of the PC has not been studied
      in women with mild preeclampsia. We hypothesize that women with mild preeclampsia or severe
      preeclampsia without HELLP syndrome, and whose admission PC is greater than 150,000/mL, will
      have a stable PC during the course of labor and delivery and do not require another PC check
      prior to initiation of neuraxial analgesia or removal of the epidural catheter. The purpose
      of this study is to determine the positive predictive value of an initial PC greater than
      150,000/mL for maintaining a PC greater than 80,000/mL during labor and delivery.
    

Detailed description: 
      All women who delivered from 1/2000 through 12/2002, with the discharge diagnosis of mild
      preeclampsia, severe preeclampsia (including HELLP and eclampsia), and preeclampsia
      superimposed on chronic hypertension were identified through the Perinatal Database. Platelet
      counts (PC) for each patient, from one month prior to the delivery admission, until hospital
      discharge, were analyzed. The number of PC determinations per parturient was determined. For
      each diagnosis, the positive predictive value (PPV) of an initial PC > 150,000/mL for
      maintaining subsequent PC > 80,000/mL, as well as the PPV of the PC prior to initiation of
      neuraxial analgesia was calculated. The median time interval from the closest PC
      determination to initiation of neuraxial analgesia was calculated.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant Women
      
Keywords: Platelets; Labor; Preeclampsia
Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770
      alone and in combination in healthy subjects.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-dose study of
      orally administered VX-809 and VX-770 in healthy subjects. This study will evaluate safety
      and tolerability of VX-809 and VX-770 alone and in combination.

      Subjects will be randomized to receive study drug or placebo during three 14-day treatment
      periods separated by 14-day washout periods. In Treatment Period 1, subjects randomized to
      study drug will receive VX-809 every 24 hours. In Treatment Period 2, subjects randomized to
      study drug will receive VX-770 every 12 hours. In Treatment Period 3, subjects will receive
      VX-809 every 24 hours and VX-770 every 12 hours. Subjects randomized to placebo will receive
      placebo during all treatment periods.

      Enrollment is planned at 1 clinical site (Lenexa, Kansas). Up to 72 subjects will be
      enrolled. The study will be separated into 3 dose escalation cohorts. Cohort 1 and Cohort 2
      will enroll 24 subjects. Cohort 3 is optional and may be conducted after a review of safety
      and pharmacokinetic data by Vertex.
    

Intervention name(s): VX-809; VX-770; VX-809 placebo; VX-770 placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): capsule, taken once daily; tablet, taken once every 12 hours; capsule, taken once daily; tablet, taken once every 12 hours
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment