bioihbjkbjnl/mcl2 huggingface dataset:
Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After TKA: A Prospective RCT
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Total knee arthroplasty (TKA) may be associated with significant blood loss, and transfusion
      carries substantial risk of immunologic reaction and disease transmission. Several methods
      reportedly reduce postoperative blood loss and avoid homologous blood transfusion with
      traditional TKA approaches. Drain clamping was one of the widely used method and tranexamic
      acid administration was the recently adjuvant method to reduce blood loss in TKA. However,
      there were several regimens in either drain clamping or tranexamic acid administration
      reported in previous studies. Our objective was to compare the efficacy of our drain clamping
      protocol and/or tranexamic acid regimen for reducing blood loss and transfusion in TKA.
    


Intervention name(s): Tranexamic acid; Drain clamping; Drain clamping and tranexamic acid; No clamp and placebo
Intervention type(s): Drug; Procedure; Other; Other
Intervention description(s): the drain was not clamped and the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.; the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).; the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.; The drain was not clamped. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Evaluate the Effects of Food on the Pharmacokinetics of Fadanafil in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of high fat meal on the pharmacokinetics
      of single oral fadanafil tablet 100mg in healthy subjects.

      Fadanafil is a selective phosphodiesterase (PDE5) inhibitor. The proposed Phase 1b trial is a
      single center, randomized, open-label, two-period crossover study in approximately 14 Chinese
      healthy adult male subjects.
    


Intervention name(s): Fadanafil
Intervention type(s): Drug
Intervention description(s): Seven subjects in group A will receive treatment in the following order:
At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting->
At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal;Seven subjects in group B will receive treatment in the following order:
At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tretinoin With or Without Fenretinide in Treating Patients With Dysplastic Nevus Syndrome
Condition: Melanoma (Skin)
MeSH terms: Melanoma; Dysplastic Nevus Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of tretinoin and/or fenretinide may be an
      effective way to prevent the recurrence or further development of dysplastic nevus syndrome.

      PURPOSE: Randomized phase II trial to compare the effectiveness of tretinoin with or without
      fenretinide in treating patients with dysplastic nevus syndrome.
    

Detailed description: 
      OBJECTIVES: I. Compare the efficacy (clinical and histologic evidence of regression) of
      topical tretinoin with or without systemic fenretinide in patients with dysplastic nevi with
      personal or family history of cutaneous melanoma.

      OUTLINE: This is a randomized, double-blind study. Patients are stratified according to
      personal history of cutaneous melanoma vs family history of cutaneous melanoma in at least 2
      blood relatives. Patients are randomized to one of two treatment arms. Arm I: Patients
      receive topical tretinoin twice daily and oral fenretinide once a day for 6 months. Tretinoin
      is applied to one half of the back with the untreated side of the back serving as a matched
      control. Arm II: Patients receive topical tretinoin as in arm I twice daily and oral placebo
      once a day for 6 months. Treatment continues in both arms in the absence of disease
      progression or unacceptable toxicity. Patients are followed at 6 months.

      PROJECTED ACCRUAL: There will be 38 patients accrued for this study.
    

Intervention name(s): fenretinide; tretinoin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tretinoin; Fenretinide
Allocation: Randomized
Primary purpose: Prevention
Keywords: melanoma
Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach
Condition: Pain From Immunization
Study type: Interventional

Summary: 
      The aim of this study is to answer the following question: In healthy infants aged four to
      six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis,
      inactivated poliovirus and Haemophilus influenzae type B (DTaP-IPV-Hib) and pneumococcal
      conjugate vaccine (PCV) while receiving a combination of proven analgesic interventions
      (least painful injection technique, holding by parent, and oral sucrose solution) and
      non-procedural talk by the parent, does the addition of rubbing near the site of injection
      reduce pain as measured by the Modified Behavioral Pain Scale (MBPS) to a greater extent than
      no rubbing?
    

Detailed description: 
      Immunization is a significant source of pain and distress for infants. At present
      pain-relieving interventions are rarely employed to manage this pain.

      There are many non-pharmacological methods that can be used to reduce immunization pain.
      These include: sugar water, fast injection without aspiration, holding infants during the
      procedure, and non-procedural related parental behaviours such as distraction. At present,
      there are no studies of tactile stimulation during noxious procedures in infants and its
      effectiveness, therefore, is unclear. Light rubbing of the skin near the injection site that
      is administered by a parent immediately before, during and immediately after immunization is
      an easily learned, cost neutral intervention that could offer improved pain management.
    

Intervention name(s): Tactile stimulation added to Standard care; Standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent rubs the infant's skin near the injection site just before, during and after the injection.
Fast injection technique without aspiration.
Oral sucrose 2 minutes before first injection.
Parent holds infant close.; Fast injection technique without aspiration.
Oral sucrose 2 minutes before first injection.
Parent holds infant close.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: tactile stimulation; pain; immunization; infant
"MiniMed 640G System" User Evaluation With the Question of Reducing the Rate of Hypoglycemia
Condition: Type 1 Diabetes
MeSH terms: Hypoglycemia
Study type: Observational

Summary: 
      The Minimed®640G system (MM640G) consists of a combination of insulin and glucose sensor for
      continuous glucose monitoring (CGM). Here, the glucose sensor transmits not only the
      continuous glucose data on the display of insulin pump but, in the case of hypoglycemia also
      interrupt their insulin delivery of pump. In the currently available system Paradigm®VEO, the
      interruption takes place at a settled threshold level. In difference in the new system MM640G
      the shutdown algorithm can already be proactive and help avoid hypoglycemia completely. The
      so called PLGM algorithm (predictive low glucose management) should be tested in the user
      evaluation. The main objective is to answer the question of reducing the rate of hypoglycemia
      by application of the new PLGM algorithm.

      Included are a total of 24 patients, aged 1-21 years, in three pediatric diabetes centers.
    

Detailed description: 
      In the first phase of two weeks, the sensor-augmented pump therapy (SaP) is carried out
      without these interruption PLGM algorithm. In a second phase for 6 weeks, the PLGM function
      is set. Both phases are compared in terms of the rate of hypoglycemia, the time spent and the
      area under the curve (AUC) glucose range (values <70 mg / dl (3.9 mmol / l)).
    

Intervention name(s): Minimed®640G system
Intervention type(s): Device
Intervention description(s): Sensor augmented insulin therapy with and without use of Predictive low glucose management (PLGM)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  patients with type 1 diabetes

          -  CSII since 3 month at least
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Children With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of high doses of SPN 812 in children with
      ADHD
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group
      study, to assess the efficacy and safety of SPN-812 as monotherapy for the treatment of
      children 6-11 years old with ADHD.
    

Intervention name(s): Placebo; 200mg SPN-812; 400mg SPN-812
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo was administered once daily; 200mg SPN-812 was administered once daily and compared to placebo; 400mg SPN-812 was administered once daily and compared to placebo
Other intervention name(s): PBO; SPN-812; SPN-812
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients
Condition: Non-ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for
      Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.
    

Detailed description: 
      Some patients have a poor response to dual antiplatelet therapy (DAPT), and it can result in
      a poor prognosis after percutaneous coronary intervention (PCI). Devices like Ultegra Rapid
      Platelet Function Analyzer (VerifyNow®) enable us to quantify platelet reactivity quickly in
      the catheter laboratory. This means that the poor responders to DAPT can be identified, and
      the patients' outcomes can be improved by providing additional antiplatelet agents.
      Tirofiban, a GP IIb/IIIa inhibitor, is a potent antiplatelet agent which is recommended for
      Non-ST-Elevation acute coronary syndrome (NSTE-ACS) with high risk at presentation. However,
      its role is not clear for patients stabilized with standard medical treatment but with a poor
      responsiveness to DAPT.

      In this study, Investigators administered tirofiban on top of DAPT to patients with NSTE-ACS
      undergoing PCI who have a high platelet reactivity (HPR) identified by VerifyNow.

      To the best of our knowledge, there are few studies conducted with tirofiban for tailored
      antiplatelet therapy. Moreover, this is the first randomized study with NSTE-ACS patients for
      tailored use of tirofiban under the guidance of platelet reactivity.
    

Intervention name(s): Tirofiban
Intervention type(s): Drug
Other intervention name(s): Agrastat
Intervention MeSH terms: Tirofiban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Tirofiban; Resistance to antiplatelet agents
Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective:

      - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS)
      using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)

      Secondary objectives:

        -  to demonstrate that Sarilumab was effective on:

             -  assessment of higher level of response [ASAS 40% response criteria (ASAS40)]

             -  partial remission

             -  disease activity

             -  range of motion

             -  Magnetic Resonance Imaging (MRI) of the spine

        -  to assess the safety and tolerability of Sarilumab in participants with AS as well as
           the pharmacokinetic profile of Sarilumab in participants with AS
    

Detailed description: 
      The duration of participation in this study for each participant was approximately 22 weeks;
      including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks
      safety follow-up period.
    

Intervention name(s): Sarilumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Other intervention name(s): SAR153191; REGN88
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter
      study with an optional open-label extension (OLE) period. The purpose of this study is to
      evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This
      study includes 3 periods: induction, maintenance, and an optional OLE period.
    


Intervention name(s): BT-11 (440 mg); BT-11 (880 mg); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral, once daily tablet; Oral, once daily tablet; Oral, once daily tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate How Tamsulosin (at 1 Dose) and Solifenacin (at 2 Different Doses) Are Taken up From the Intestine, Distributed Through the Body and Eliminated From the Body When Administered in Combination as a Single Tablet (Called EC905)
Condition: EC905; Pharmacokinetics; Multiple Dose; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints
      related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the
      treatment of patients suffering from problems related to overactive bladder, such as needing
      to go to the toilet frequently and often having a sudden urgent need to go to the toilet.
      Certain patients with an enlarged prostate have complaints that may benefit from a
      combination of tamsulosin and solifenacin. EC905 is a single tablet containing both
      tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and
      solifenacin are taken up from the intestine, distributed through the body and eventually
      eliminated from the body when taken as a single EC905 tablet.
    

Detailed description: 
      In this study there are two sequence groups with 27 subjects in total. In Period 1, subjects
      are randomized to receive one of the two final combination tablet formulations of tamsulosin
      HCl and solifenacin succinate. In Period 1, 13 subjects receive one combination and 14
      subjects receive the other combination. In Period 2, the alternate treatment is provided.

      Screening takes place from Days -21 to -2 before the first admission day (Day -1). EC905 is
      administered from Day 1 to Day 12 (treatment period 1), and from Day 13 to Day 24 (treatment
      period 2). All treatments are administered with subjects in the fasted state.

      Blood samples for pharmacokinetic (PK) analysis of tamsulosin HCl and solifenacin free base
      are collected, and assessments of vital signs, safety electrocardiogram (ECG), safety
      laboratory, adverse events and concomitant medications are performed.

      Subjects are discharged on day 25 and an End of Study Visit takes place at least 10 days
      after the second treatment period, or after withdrawal.
    

Intervention name(s): EC905
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): tamsulosin HCl and solifenacin succinate
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Combination tablet EC905; Steady-state; Vesomni; VesiFlow; Urizia
Extracardiac Complications After Cardiac Surgery
Condition: Acute Lung Injury; Sepsis; Infections; Acute Kidney Injury
MeSH terms: Lung Injury; Acute Lung Injury; Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Hypothesis of the study is that patients undergoing major cardiac surgery can develop
      extracardiac complications correlated to cardiopulmonary by pass.
    

Detailed description: 
      To find out which are the main peri operative predictors of acute lung injury and other
      extracardiac complications, such as kidney injury, that prolonged Intensive Care Unit (ICU)
      length of stay after cardiac surgery. The main goal is to evaluate whether mechanical
      ventilation, in particular tidal volume, can be predictor of acute lung injure in this kind
      of patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing major cardiac surgery with cardiopulmonary by pass
Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the bioequivalence of new formula of aspirin relative to the established
      commercial effervescent aspirin when taken orally by healthy adult subjects
    


Intervention name(s): Acetylsalicylic Acid (Aspirin BAY1019036); Alka Seltzer Extra Strength; Aspirin Migraine; Aspirin Aspro
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One tablet of new formula Aspirin under fasting conditions; One effervescent tablet under fasting conditions; One effervescent tablet under fasting conditions; One effervescent tablet under fasting conditions
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aspirin; Acetylsalicylic Acid
Study of Hot Flashes and Night Sweats in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen
Condition: Vasomotor Symptoms; Endometrial Safety
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot study was designed to explore the effects of combined treatment with raloxifene
      HCl 60 mg and oral 17 beta-estradiol 1mg/day on the number of vasomotor episodes (hot flashes
      plus night sweats) in postmenopausal women discontinuing continuous combined hormone
      replacement therapy (ccHRT) compared to women treated with raloxifene HCl 60 mg alone.
    


Intervention name(s): Raloxifene; medroxyprogesterone acetate; estrogen; 17 beta estradiol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Raloxifene Hydrochloride; Medroxyprogesterone Acetate; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Estradiol; Polyestradiol phosphate; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention