bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries
Condition: Adhesions
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to investigate and determine the difference between the extent and severity of
      intra-abdominal adhesions in patients where SurgiWrap film was placed compared to patients
      with no adhesion barrier inserted.

      Hypothesis: Due to the preclinical safety data and clinical case reports in various
      indications it is anticipated that the surgical sites where the resorbable anti-adhesion
      barrier SurgiWrap was placed, there will be a reduction of adhesions compared to the control
      group with no treatment.
    


Intervention name(s): Polylactic Acid Sheet
Intervention type(s): Device
Intervention description(s): SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.
Other intervention name(s): SurgiWrapTM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Surgery; Colectomy; Proctocolectomy; Adhesions
Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy
Condition: Adhesive Capsulitis of Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      Breast cancer surgeries particularly mastectomy results in limited shoulder movement which
      can lead to arm, shoulder pain and stiffness. Females who underwent mastectomy have reported
      a significantly higher incidence of shoulder morbidity
    

Detailed description: 
      Exercise therapy might help in reduction of pain and restoration of the range, coordination
      and control of movement in patients with adhesive capsulitis. Graded resistance exercises are
      effective in decreasing fatigue levels, enhancing functional capacity and muscle strength.
      Rehabilitation exercises which strengthen the scapular stability can be extremely beneficial
      in rehabilitation treatment of patients with shoulder pain and problems
    

Intervention name(s): Exercise; Thera band
Intervention type(s): Other; Other
Intervention description(s): Hot packs, active range of motion exercises, pendular exercises, wall climb exercises, mobilization exercises, and shoulder capsular stretching; graded Thera band exercises for shoulder flexion, abduction, internal, and external rotation
Other intervention name(s): conventional physical therapy program; graded Thera band exercises and scapular stabilization exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK598809 is being developed as an innovative treatment for substance dependence and
      potentially other compulsive behavioral disorders. This study will asses the effects of a
      single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male
      volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or
      GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of
      at least seven days between each session.
    


Intervention name(s): GSK598809
Intervention type(s): Drug
Intervention description(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacodynamics,; pharmacokinetics,; tolerability,; Safety,; single dose,; placebo,; Nicotine reward; GSK598809
Real-world Daptomycin Use in Chinese ICUs
Condition: Daptomycin; Real-world Study; Intensive Care Unit
Study type: Observational [Patient Registry]

Summary: 
      Analyze the effectiveness and safety of Daptomycin(Jiangsu Hengrui Medicine Co., Ltd) in
      Gram-positive infections in Chinese Intensive Care Units by using the real-world data
      platform, https://rws.scccmqc.com. Patients who received at least one dose of Daptomycin
      between 2016 to 2021 are eligible.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patient who are suspected of Gram-positive infection in the Intensive Care Units.
Platelet-Rich Plasma Therapy for Patellar Tendinopathy
Condition: Patellar Tendinitis
MeSH terms: Tendinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall goal of this research is to find an effective treatment for patellar tendinopathy
      (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to
      investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function
      scores) and bio-mechanical (knee strength) measures will be correlated with disease
      modification changes assessed using conventional and novel quantitative magnetic resonance
      imaging (MRI) and ultrasound (US) techniques.
    

Detailed description: 
      Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1
      (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the
      patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the
      patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided
      dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar
      tendon. The efficacy of the different treatment options will be assessed by pain- and
      function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P)
      quality of life scores, activity level scores, knee strength measurements, and conventional
      and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.
    

Intervention name(s): PRP; Dry Needling; Dry Needling - Sham
Intervention type(s): Biological; Procedure; Procedure
Intervention description(s): Injection of autologous platelet rich plasma (PRP); This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.; This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemotherapy uses different ways to stop cancer cells from dividing so they stop
      growing or die.

      PURPOSE: Phase II trial to study the effectiveness of gallium nitrate in treating patients
      with AIDS-related non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate and duration of response in patients with
      AIDS-related non-Hodgkin's lymphoma treated with gallium nitrate after failure on first-line
      chemotherapy regimen. II. Determine the qualitative and quantitative toxic effects of this
      regimen in these patients. III. Determine the pharmacokinetic parameters of this regimen in
      these patients, and determine if there is a correlation between those parameters and
      response.

      OUTLINE: Patients receive gallium nitrate IV continuously on days 1-7. Courses repeat every 4
      weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve
      complete remission (CR) receive 2 additional courses past CR. Patients who relapse after
      achieving CR may be retreated in the absence of disease progression. Treatment for relapse
      after a second CR is at the discretion of the principal investigator. Patients with
      leptomeningeal disease at study entry must receive intrathecal (IT) methotrexate with IV
      leucovorin calcium or IT cytarabine. Patients who develop leptomeningeal disease while on
      study may continue treatment with gallium nitrate but must also receive IT methotrexate and
      leucovorin calcium (with or without radiotherapy) or IT cytarabine. Patients are followed for
      survival.

      PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 2 years.
    

Intervention name(s): cytarabine; gallium nitrate; leucovorin calcium; methotrexate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Cytarabine; Methotrexate; Gallium nitrate; Calcium; Levoleucovorin
Primary purpose: Treatment
Keywords: AIDS-related peripheral/systemic lymphoma; AIDS-related diffuse large cell lymphoma; AIDS-related immunoblastic large cell lymphoma; AIDS-related small noncleaved cell lymphoma; AIDS-related diffuse mixed cell lymphoma; AIDS-related diffuse small cleaved cell lymphoma; AIDS-related lymphoblastic lymphoma
Orbital Artery Doppler Ultrasound in Brain Death
Condition: Brain Death
MeSH terms: Brain Death; Death
Study type: Interventional

Summary: 
      Brain death is the irreversible loss of all activity in the brain, brainstem, and cerebellum,
      the part of the central nervous system that remains inside the skull.

      The clinical diagnosis of brain death should be supported by ancillary tests that provide
      information about cerebral blood flow or electrical activity in the brain. Some of the
      ancillary tests that evaluate cerebral blood flow include transcranial Doppler
      ultrasonography (TDUS), computed tomography (CT) angiography (CTA), and catheter-based
      cerebral angiography.

      This study hypothesized that Orbital Doppler ultrasonography (ODUS) alone is more effective
      than TDUS in detecting intracranial blood flow in diagnosing brain death. To this end, the
      investigators examined the results of ODUS in patients diagnosed as brain dead who underwent
      CT angiography.
    


Intervention name(s): Orbital Doppler ultrasonography; Transcranial Doppler ultrasonography; Computed Tomography Angiography
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): During measurement, Doppler settings were adjusted to detect low flow and the smallest available Doppler gate was used for all ODUS examinations. The imaging probe position for ODUS was used transversely and axially, and mean values were recorded. ODUS 10-18 MHz linear probe was used.; During the measurement, Doppler settings were adjusted to detect low flow, and the minor available Doppler gate was used for all TDUS examinations. For TDUS, a temporal window was used approximately 1 cm above the midpoint of the line joining the lateral palpebral fissure and the external auditory meatus.
Transcranial Doppler ultrasonography ( TDUS) 3-5 MHz convex array probe was used.; Cranial Computed Tomography Angiography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Early Hydration in Acute Myocardial Infarction
Condition: Contrast Induced Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether hydration with sodium bicarbonate is more
      effective than hydration with sodium chloride to prevent contrast nephropathy in patients
      undergoing primary coronary intervention for acute ST elevation myocardial infarction.
    


Intervention name(s): sodium bicarbonate solution; Isotonic saline
Intervention type(s): Drug; Drug
Other intervention name(s): 154 mEq/L in dextrose and H2O; 0.9% sodium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Contrast-induced nephropathy; Contrast media; Angiography; Coronary percutaneous intervention
Assessment of Change in CYP3A Activity by Route of Administration Using Metabolic Markers in Healthy Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study objective is to evaluate and validate of endogenous markers for the assessment of
      change in CYP3A activity by route of administration in Korean healthy subjects using
      metabolomics. In addition, we aim to screen novel endogenous marker, which could determine
      the total or intestinal CYP activity.
    

Detailed description: 
      This study is an open-label, one-sequence, three-period study. A total of 16 healthy male
      subjects will be enrolled. In period 1, subjects will be administered midazolam IV 1 mg, and
      co-administration of midazolam IV 1mg and grapefruit juice 500 mL. In period 2, subjects will
      be administered midazolam PO 5 mg, and co-administration of midazolam PO 5mg and grapefruit
      juice 500 mL. In period 3, subjects will be administered clarithromycin 500 mg for 3-days in
      b.i.d regimen prior to admission. Subjects will be administered midazolam IV 1mg and PO 5mg
      after admission.
    

Intervention name(s): Midazolam; Clarithromycin; Grapefruit juice
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): Midazolam 5 mg PO, Midazolam 1 mg IV; Clarithromycin 500 mg bid; Grapefruit juice 500 mL
Intervention MeSH terms: Clarithromycin; Midazolam
Intervention model: Single Group Assignment
Intervention model description: An open-label, one-sequence, three-period study
Masking: None (Open Label)
Primary purpose: Basic Science
Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-center, randomized, three-period, two-sequence crossover study
      in healthy adult subjects to occur at one site in the United States. This study will evaluate
      the relative Bioavailability (BA) of an enasidenib sprinkle formulation, compared to the
      reference tablet formulation, when taken in the fasted state. This study will also evaluate
      the Pharmacokinetics (PK) of the enasidenib sprinkle formulation after a single oral dose in
      the fed state to assess the food effect. The study will consist of a Screening phase, a
      Treatment phase, and a Follow-up phone call. Approximately 28 healthy adult subjects (males
      or non-pregnant females) will be enrolled.
    


Intervention name(s): Enasidenib
Intervention type(s): Drug
Intervention description(s): Enasidenib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enasidenib; CC-90007; pharmacokinetics; Healthy Adults
Safety,Effectiveness and Acceptability of Sino-implant II in DR
Condition: Contraception
Study type: Interventional

Summary: 
      A study to assess the contraceptive effectiveness of Sino-implant (II).
    

Detailed description: 
      Randomized trial to assess the contraceptive effectiveness of Sino-implant (II) and to
      compare levonorgestrel concentrations, safety and acceptability of Sino-implant (II) and
      Jadelle.
    

Intervention name(s): Jadelle; Sino-implant (II)
Intervention type(s): Drug; Drug
Intervention description(s): LNG containing subdermal contraceptive implant; LNG containing subdermal contraceptive implant
Other intervention name(s): Zarin, Femplant, Trust, Simplant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonization; IND Investigational New Drug Application; IRB Institutional Review Board; IU International units; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot
Intraosseous Morphine in Primary TKA
Condition: Knee Disease; Arthritis Knee; Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The research team wants to investigate if an intraosseous injection (directly into the bone
      marrow) of morphine during primary total knee replacement helps with post-operative pain
      following primary total knee replacement surgery. For this study patients will either be
      randomized into one of two groups: Group 1: Receives an intraosseous injection of morphine
      (mixed with standard antibiotics) during their primary total knee replacement or Group 2:
      Serves as the control group and only receives an intraosseous injection of antibioitics
      during their total knee replacement. The research team will have patients fill out a symptom
      journal for two weeks following their surgery to measure pain levels and pain medication
      consumed throughout the day as well as nausea and other symptoms. Additionally, the research
      team will take blood samples both intraoperatively and post-operatively (10 hours post-op) to
      measure the level of inflammatory markers as well as morphine.
    


Intervention name(s): Morphine
Intervention type(s): Drug
Intervention description(s): 10mg of Morphine delivered Intraosseously
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: Receives an intraosseous injection of morphine (mixed with standard antibiotics) during their primary total knee replacement or Group 2: Serves as the control group and only receives an intraosseous injection of antibioitics during their total knee replacement.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Intraosseous; Total knee arthroplasty; Morphine
Retention of Maxillary Complete Dentures Modified With Titanium Dioxide Nanoparticles: A Randomized Crossover Clinical Trial.
Condition: Denture Retention; Complete Dentures
Study type: Interventional

Summary: 
      This study investigates the effect of the addition of titanium dioxide nanoparticles to
      denture base materials on their retention compared to that of the unmodified denture base
      materials.
    

Detailed description: 
      All patients will be randomly allocated to two equal groups either with the protocol I or II
      (5 in each group) with an allocation ratio of 1:1 through a computer-generated sequence by a
      spreadsheet (Excel, Microsoft Office 2010; Microsoft Corp). The group with the protocol I
      will use the modified dentures with titanium dioxide nanoparticles (TiO2NP) during the first
      month, followed by no use of the first denture and the use of their old relined dentures
      instead for 1 month (washout), and then the use of the unmodified dentures for 1 month; the
      group with the protocol II will use the unmodified dentures during the first month, followed
      by no use of the first denture and the use of their old relined dentures instead for 1 month
      (washout), and then the use of the modified dentures TiO2NP for 1 month. Assessment of
      retention will be done immediately and 1 month after denture insertion.
    

Intervention name(s): Complete denture base modified by Titanium dioxide nanoparticles.
Intervention type(s): Other
Intervention description(s): Titanium dioxide nanoparticles will be mixed with resin powder of the denture base before mixing the powder and liquid of the heat cure denture base material.
Intervention MeSH terms: Titanium dioxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influence of Beta-glucan Enriched Barley Flour in Bread on Glycemic Response
Condition: Glycemic Index
Study type: Interventional

Summary: 
      Objective of the study is to investigate the influence of beta-glucan enriched barley flour
      as constituent of bread on glycaemic response (GR) in healthy human volunteers. Glycaemic
      response will be measured as AUC of blood glucose after consumption of barley bread, and
      compared with white bread.
    

Detailed description: 
      Objective of the study is to investigate the influence of beta-glucan enriched barley flour
      as constituent of bread on glycaemic response (GR) in healthy human volunteers. Glycaemic
      response will be measured as the area under the curve (AUC) of blood glucose after
      consumption of barley bread(s), and compared with AUC for white bread. Measurements will be
      done in line with recommendations. In line with recommendations ten healthy human volunteers
      will be tested to obtain a sufficient statistical power. GR measurement will be based on
      available carbohydrates. Amount of bread will be standardised to contain 50 g of available
      carbohydrates. Subjects will consume bread sample with 250 mL of water, within 10-15 minutes.
      Blood sampling times will be at 0 min (baseline sample), followed by 15, 30, 45, 60, 90 and
      120 min after starting to eat the test meal. Glucose levels will be measured in capillary
      blood. For reference and test meals, the investigators will do at least 2 AUC measurements
      per subject. AUC calculation will be based on incremental AUC, ignoring area under the
      baseline. Comparison will be done as the mean of the individual ratios.

      The differences between the different products ingested will be analyzed with the statistical
      test of analysis of variance. In case of failure to find homogeneity in the variances the
      nonparametric ANOVA, the Kruskal-Wallis test, will be used. The results will be expressed as
      mean ± standard deviation for each with a significance level of 0.05 for all the statistical
      tests.
    

Intervention name(s): REFERENCE: white bread; TEST: b-glucan enriched bread
Intervention type(s): Other; Other
Intervention description(s): Determination of glycemic response after consumption of white bread:
Capillary glucose will be taken at 0 min (baseline sample), followed by 15, 30, 45, 60, 90 and 120 min after starting to eat the meal to calculate the area under the curve (AUC).; Determination of glycemic response after consumption of bread enriched with barley beta-glucans (Test A) :
Capillary glucose will be taken at 0 min (baseline sample), followed by 15, 30, 45, 60, 90 and 120 min after starting to eat the meal to calculate the area under the curve (AUC).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Glycemic Index; glycemic response