bioihbjkbjnl/mcl2 huggingface dataset:
DPNB for Prevention of CRDB
Condition: Indwelling Urinary Catheter; Male Patients; General Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is
      defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may
      cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve
      block (DPNB) was applied for penile surgery including circumcision and some anterior urethra
      surgery. The investigators hypothesize that DPNB relive CRBD for male patients with
      indwelling urinary catheter under general anesthesia.
    

Detailed description: 
      CRBD is not uncommon in the postoperative period, especially in male patients who have had
      urinary catheterization after anesthetic induction under general anesthesia, and this symptom
      complex may cause patient agitated and exacerbated postoperative pain. According to the
      previous study, i.v. tramadol 1.5 mg/kg administered 30 min before extubation results in
      reduction in the incidence and severity of CRBD. In clinical practice, tramadol is associated
      with side effects including nausea, vomiting, sedation, etc. Clinically, dorsal penile nerve
      block (DPNB) was applied in penile surgery, and got satisfactory pain relief effect
      postoperatively without side effects related to tramadol. Besides, we observed patients
      underwent urethra surgery with urinary catheter left in situ seldom complained of CRBD if
      DPNB and RB performed at the end of operation. We hypothesized that DPNB could relieve DPNB
      for male patient with indwelling urinary catheter insertion after induction of general
      anesthesia.

      In this study we compare the efficacy of dorsal penile nerve block (DPNB) with 0.33%
      ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the
      incidences of side effects postoperatively.
    

Intervention name(s): DPNB; Tramadol
Intervention type(s): Procedure; Drug
Intervention description(s): Patients receive DPNB 30min before extubation at the end of operation; Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Catheter Related Bladder Discomfort; Dorsal Penile Nerve Block
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Condition: Antiphospholipid Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and
      safe in reducing the risk of cardiovascular disease and blood clots in patients with
      antiphospholipid antibodies or Antiphospholipid Syndrome (APS).
    

Detailed description: 
      The primary objective of the study is to determine the effects of fluvastatin on
      pro-thrombotic and pro-inflammatory markers in aPL-positive lupus and non-lupus patients
      (primary endpoint) and to determine the safety of fluvastatin in aPL-positive lupus and
      non-lupus patients (secondary endpoint).

      All eligible patients will sign an IRB-approved consent form during the screening visit and
      give blood for baseline laboratory tests. Within a week of the screening visit, all patients
      will be started on Fluvastatin 40 mg daily for three months. At three months patients will be
      instructed to stop the study medication and they will be followed for another three months.
      Thus, the total duration of the study is six months: first three months is interventional and
      the last three months is observational.
    

Intervention name(s): Fluvastatin
Intervention type(s): Drug
Intervention description(s): Fluvastatin 40 mg daily for 3 months
Other intervention name(s): Lescol, Lescol XL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Persistently Antiphospholipid Antibody Positive Patients
Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases
Study type: Interventional

Summary: 
      The combination of ultrasound and muscular stretching may have positive effects on pain
      relief and on the balance of the masticatory muscles activity.
    

Detailed description: 
      This study aimed to evaluate the therapeutic response of ultrasound (US) and ultrasound
      associated with stretching of the masticatory muscles on the pressure pain threshold and the
      electrical activity of masseter and anterior temporal muscles in Temporomandibular Disorder
      (TMD) patients . The study included 18 women with TMD diagnosed by the instrument Research
      Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD). The pressure pain threshold,
      evaluated through algometry, and the electrical activity of the masticatory muscles were
      evaluated, by means of surface electromyography, before and immediately after the therapeutic
      procedures. The volunteers underwent three different interventions: ultrasound, ultrasound
      associated with stretching and ultrasound placebo, with a 1-week of minimum interval between
      them.
    

Intervention name(s): Ultrasound; Ultrasound associated with stretching; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): 3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles bilaterally; 3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles, bilaterally.
Active stretching of the masseter muscles with mouth opening and closed lips; Turned off ultrasound application on area of TMJ and masseter muscle, bilaterally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Temporomandibular Joint Disorders,; Ultrasonics,; Electromyography,; Pain Measurement,; Muscle Stretching Exercise
50 Human Subject Repeat Insult Patch Test
Condition: Erythema; Sensitisation
MeSH terms: Erythema
Study type: Interventional

Summary: 
      Consumer products or raw materials designed for consistent reapplication to areas of the skin
      may, under proper conditions, prove to be contact sensitizers or irritants in certain
      individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for
      evaluation of this irritation/sensitization potential if such exists.
    


Intervention name(s): CB-0002B
Intervention type(s): Other
Intervention description(s): CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: HRIPT; irritant
Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4
      dose regimens of CP-690,550, combined with methotrexate, for the treatment with active
      rheumatoid arthritis.
    


Intervention name(s): Placebo; CP-690,550; CP-690,550; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0 mg BID, 3 blinded tablets administered BID for 12 weeks; 10 mg BID, 3 blinded tablets administered BID for 12 weeks; 1 mg BID, 3 blinded tablets administered BID for 12 weeks; 3 mg BID, 3 blinded tablets administered BID for 12 weeks; 5 mg BID, 3 blinded tablets administered BID for 12 weeks
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase II MTX add-on study in Japan
Radioimmunotherapy With 90Y-ibritumomab Tiuxetan as Part of a Dose Reduced Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation for the Treatment of Non-Hodgkin Lymphoma
Condition: Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study evaluates the additional use of radioimmunotherapy with a 90-Yttrium labeled
      monoclonal antibody targeting lymphoma cells in two dose reduced conditioning regimens for
      allogeneic hematopoietic cell transplantation from human leukocyte antigen (HLA)-identical
      donors. Radioimmunotherapy should allow an increased anti-lymphoma effect of the conditioning
      while the allogeneic grafts may confer potent graft versus lymphoma effects and rescue from
      potential hematopoietic side effects of the radioimmunotherapy. The study evaluates the
      feasibility and toxicity of such approach and will also analyze disease response and survival
      of the patients treated.
    


Intervention name(s): Radioimmunotherapy; allogeneic hematopoietic cell transplantation
Intervention type(s): Drug; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NHL; low and high grade non-Hodgkin lymphoma
Implications for Treatment of the Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial
      to determine whether treatment with a statin improves muscle microvascular blood flow.
    

Detailed description: 
      To characterise features of the metabolic syndrome, including body fat, insulin sensitivity,
      and liver fat together with muscle micorvascular blood flow.

      To undertake a randomised controlled trial of atorvastatin 40 mg. o.d for 6 months to
      determine whether any of the above measures change with treatment.
    

Intervention name(s): atorvastatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 m.g. o.d. tablets for 6 months; Placebo
Other intervention name(s): Lipitor; Dummy
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: metabolic syndrome; Volunteers recruited from the community
Oral Versus Intravenous Tranexamic Acid
Condition: Blood Loss; Blood Transfusion
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this randomized clinical control trial is to determine whether oral TXA dosing in
      THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients
      undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are:

      Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing?

      Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing?

      Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g)
      on their day of surgery. Researchers will compare these groups to see if any differences
      emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).
    

Detailed description: 
      Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety
      of medical settings. The use of TXA in total hip arthroplasty (THA) and total knee
      arthroplasty (TKA) has resulted in dramatic decreases in operative blood loss and transfusion
      rates, revolutionizing the field of arthroplasty. The use of TXA, now common, has made
      autologous blood donation programs largely obsolete. Additionally, it has made perioperative
      blood transfusion uncommon.

      While AAOS guidelines suggest that all three available preparations of TXA (oral, IV,
      topical) are effective, preferred route of dosing varies by provider and institution. These
      preferences are based on habit, understanding of pharmacodynamics, and logistical issues
      regarding effective dosing. Oral TXA is the cheapest option, but some surgeons prefer IV
      dosing due to concerns regarding efficacy and controlled dosing.

      In this study, we seek to compare the efficacy of a single pre-op oral dose of TXA to a
      single pre-op IV dose of TXA.
    

Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Other intervention name(s): Lysteda
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Airway Inflammation, Symptoms and Lung Function in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation
Study type: Observational

Summary: 
      Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high
      prevalence worldwide and with relevant impact on patient-related quality of life, morbidity
      and mortality. There is evidence that airway inflammation correlates with the severity of the
      disease and that airway inflammation is further enhanced during exacerbation. However, it is
      unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by
      changes in airway inflammation.
    

Detailed description: 
      Patients will undergo a visit every 7 days during one month (5 visits in total). At each
      visit airway inflammation (exhaled NO, sputum inflammatory cell count) and lung function will
      be performed. At home patients will be asked to fill a daily diary for symptom assessment.
    

Intervention name(s): COPD treatment
Intervention type(s): Other
Intervention description(s): Patients, will be asked to continue their previous medication (GOLD guidelines) during the study. No interventional change in COPD treatment will be performed during the study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Moderate to severe COPD patients (according to GOLD guidelines) will be enrolled in the
        study
      
Biospecimen description: 
      Sputum cells.
    
Keywords: COPD; Airway inflammation; Symptoms; Lung function; Correlation
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
Condition: Healthy
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and immunogenicity of an investigational
      hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
    


Intervention name(s): HEPLISAV; Engerix-B
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24; Intramuscular injections at Week 0, Week 4, and Week 24
Other intervention name(s): Hepatitis B vaccine (recombinant), adjuvanted; HEPLISAV-B; Hepatitis B vaccine (recombinant)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HBV vaccine; HEPLISAV-B; Hepatitis B vaccine; Hepatitis B; Hepatitis; Hepatitis B virus (HBV); Prevention and Control; Healthy; Healthy volunteers
Effect of Follicular Flushing in Patients With Mono-follicular Growth Undergoing In Vitro Fertilization
Condition: Invitro Fertilization; Diminished Ovarian Reserve; Oocyte
MeSH terms: Flushing
Study type: Observational

Summary: 
      Retrieval of an oocyte from a follicle relies on the release of the cumulus-oocyte-complex
      (COC) from the follicular wall into the lumen, thereby allowing aspiration by a needle.
      Flushing the follicle with multiple aspirations from the same follicle is used as a means to
      increase the ratio of COC per aspirated follicle. Data showed that follicular flushing is not
      superior to direct aspiration either in normally responding patients or in poor responders
      undergoing in vitro fertilization (IVF). There is no data in the literature regarding the
      issue in patients with mono-follicular growth. Direct aspiration or repeatedly flushing the
      follicle for those with a single follicle will be investigated.
    

Detailed description: 
      Oocyte retrieval procedure This study aims to evaluate the effect of follicular flushing
      during oocyte retrieval procedure in patients with only one follicle. Double lumen needle
      will be used and direct follicular aspiration without flushing will be performed for all
      patients. If an oocyte will be obtained, the patient will be assigned to group A. If not, at
      least 1 course of follicular flushing will be used until retrieval of an oocyte and the
      patient will be assigned to group B.
    

Intervention name(s): direct follicular aspiration; follicular flushing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): direct follicular aspiration; follicular flushing
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women undergoing oocyte retrieval procedure due to primary infertility
      
Keywords: follicular flushing; double lumen needle
Influence of Resistant Starch Intake in Potatoes on Blood Glucose and Satiety Responses in Overweight Females
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Resistant starch (RS) is a type of fiber that has unique digestive properties that can impact
      overall health including glucose homeostasis and satiety. RS found in potatoes can be
      increased by using certain cooking methods and serving temperatures. The purpose of this
      trial will compare the acute glycemic and satiety responses after consuming potatoes
      differing in RS content that are 1) baked then chilled or 2) boiled and consumed hot in
      overweight females on two separate occasions.
    

Detailed description: 
      Potatoes are a low-cost, nutrient-dense dietary staple in the U.S. rich in complex
      carbohydrates, potassium, magnesium, and fiber, but low in fat and sodium. Starch is the main
      complex carbohydrate found in potatoes that yields glucose to contribute to overall energy
      needs. Another type of starch found in potatoes is resistant to amylase hydrolysis in the
      small intestine which is resistant starch (RS). Trials using RS as a functional ingredient
      (~15-30 g/day) in healthy and overweight adults resulted in improvements in postprandial
      glucose, insulin sensitivity, satiety hormone response, and subjective satiety. Limited data
      exists using RS naturally found in commonly consumed foods, such as potatoes. Altering the
      cooking methods and serving temperatures of potatoes can influence the amount of RS to impact
      glucose, satiety hormone response, and subjective satiety. Using a cross-sectional,
      cross-over design, the aim of this study will determine how potatoes 1) baked and chilled or
      2) boiled and consumed hot influence postprandial glycemic parameters, satiety hormones
      (glucagon-like peptide-1, peptide YY, and glucose-dependent insulinotropic polypeptide),
      subjective satiety, and subsequent energy intake in overweight females.
    

Intervention name(s): Potatoes
Intervention type(s): Other
Intervention description(s): Participants will follow the same protocol for each arm with a minimum of 1-week wash-out period between arms. For each arm, fasting blood will be collected then 200 g of potato will be consumed. Postprandial blood will be collected 15, 30, 60, and 120 minutes. Subjective satiety will be assessed using Visual Analogue Scale three times, as well as 48-hour subsequent dietary intake.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
Condition: Lupus Erythematosus, Discoid; Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, efficacy and tolerability of topical
      R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
      patients with active discoid lesions.
    

Detailed description: 
      This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to
      evaluate the preliminary efficacy, safety, tolerability, and pharmacokinetics of topical R333
      ointment formulated at 6% (60 mg/g) in DLE and SLE patients with active discoid lesions.
    

Intervention name(s): R932333; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): R393233 6% (60 mg/g), bid; Placebo, bid
Other intervention name(s): R333
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Discoid Lupus Erythematosus; Systemic Lupus Erythematosus
A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will characterize the effect of PF-04217329, alone and in combination with
      latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood
      samples will be collected to measure the amount of active metabolite of PF-04217329 in the
      plasma following dosing.
    


Intervention name(s): PF-04217329; latanoprost vehicle; PF-04217329; latanoprost
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical ocular solution, once-daily for 14 days; Topical ocular solution, once-daily for 14 days; Topical ocular solution, once-daily for 14 days; Topical ocular solution, once-daily for 14 days
Other intervention name(s): Xalatan
Intervention MeSH terms: Latanoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment