bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Transurethral resection of the prostate (TURP) represents the gold standard in the operative
      management of benign prostatic hyperplasia (BPH) and the transurethral resection of bladder
      tumor (TURBT) is the first-line surgical treatment for bladder tumors. One of the most
      important complications of urological endoscopic resections is intraoperative and
      postoperative bleeding requiring blood transfusion. Allogeneic blood transfusion is not free
      of risks, like infection transmission, hemolytic reactions, transfusion-related lung injury,
      fluid overload, increased costs and hospital length of stay.

      Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by
      blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA has been
      used to reduce blood loss and the need for allogeneic blood transfusion in cardiac surgery
      and orthopedic surgical procedures but few studies have assessed the efficacy of this
      antifibrinolytic agent in urological endoscopic procedures.

      The investigators designed this double-blind, placebo controlled study evaluate the safety
      and efficacy of the antifibrinolytic agent tranexamic acid in reducing blood transfusion in
      patients undergoing endoscopic surgery in urology.
    

Detailed description: 
      Participants will be randomized into one of two study groups: Group TXA: intravenous
      tranexamic acid: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1
      mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of
      saline. The study drug was prepared by an anesthesiologist not involved in the patient
      management and data collection. The anesthetic technique will be standardized. Serum
      hemoglobin was measured before and after surgery. The volume of the irrigation fluid,
      resected prostate weight and duration of resection were recorded.
    

Intervention name(s): Tranexamic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively; An equal volume of saline
Other intervention name(s): Exacyl; Saline
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: tranexamic acid; Transurethral Resection of the Prostate (TURP); Transurethral Resection of a Bladder Tumor (TURBT); Hemorrhage; Blood Transfusion
Long-term Evaluation of Single-piece ACrysof IOL Implantation on Development of Posterior Capsule Opacification
Condition: Posterior Capsule Opacification After Phacoemulsification and IOL Implantation
MeSH terms: Capsule Opacification
Study type: Observational

Summary: 
      Although contemporary cataract surgery has made tremendous strides in technological
      advancement, posterior capsular opacification (PCO) is still the most frequent long-term
      complication leading to decreased visual functions and thereby dissatisfying results. A great
      deal of effort has been made to develop new ways to prevent the formation of PCO. A key
      factor, widely discussed in literature, is the material and design of the intraocular lense
      (IOL) edge that can lead to PCO prevention. It is still not clear whether the sharp-edged IOL
      produces less PCO because of its optic geometry alone or whether the biomaterial contributes
      to the inhibition of PCO. With the clinical introduction of the single-piece acrylic
      hydrophobic IOLs with some optic and haptic design differences compared with three-piece
      acrylic hydrophobic IOLs, it has become possible to determine the influence of IOL material
      and design on PCO prevention. It is well established that the development of PCO is a dynamic
      process and that a longer follow-up time is correlated with a higher degree of PCO. So far,
      there have been prospective clinical studies on the clinical results of single and
      three-piece acrylic hydrophobic foldable IOLs. However, the question as to as to whether the
      PCO further increases or becomes stable or regresses on a long-term basis has not yet been
      answered. Since there is paucity of available literature that prospectively evaluates the
      development of PCO with the implantation of the single-piece SN60AT hydrophobic acrylic IOL
      on a long-term basis, the investigators decided to observe the degree of development of PCO
      at 5 years after cataract surgery.
    


Intervention name(s): Cataract surgery with IOL implantation
Intervention type(s): Procedure
Intervention description(s): Phacoemulsification with implantation of single piece Acrysof IOL
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing phacoemulsification for age-related uncomplicated phacoemulsification
Kinesio Taping Effects Applied With Different Directions and Tensions
Condition: MYOSITIS
MeSH terms: Myositis
Study type: Interventional
Phase: Phase 1

Summary: 
      The Kinesio Taping (KT ) method was developed more than thirty years ago in order to cause
      sensory effects through the epidermis and dermis, generating a variety of physiological
      effects in other systems. Clinical effects are well known levels in muscle, neurological
      system, injuries, inflammation, edema, among other physiological effects are thus largely in
      the theoretical framework. Objectives: The aim of this study is to evaluate the
      Electromyographic (EMG), Electroencephalographic (EEG), muscle temperature and flexibility
      effects with the Rectus Femoral muscle KT application. Methods: This is a pilot study with
      six subjects in which they were divided into two groups, A and B. Group A received the
      application of KT from muscle Origin to Insertion and group B Insertion to Origin, with both
      groups taped the non-dominant limb and the dominant limb was used as control group. The first
      application was conducted at 0% and the second with 75 to 100% tension. Evaluations were
      performed before the first application, immediately and 24 hours later. After this last
      evaluation, was withdrawn taping, evaluated without taping, reapplied 75 to 100 % of rated
      voltage and in sequence. The sixth last review was conducted 24 hours after this last
      application. Before every application a specific vibration was performed on the patellar
      tendon in order to trigger a neurophysiological imbalance rectus femoral.
    


Intervention name(s): Kinesio Taping
Intervention type(s): Device
Intervention description(s): Group A received the application of KT from muscle Origin to Insertion and group B Insertion to Origin, with both groups taped the nondominant limb and the dominant limb was used as control group. Diferent tensions will be applied with the tape to see its possible different affect in the outcomes.
Other intervention name(s): Kinesio Tex Tape FP (Finger Print)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Muscle
ARIES for Vasculogenic Erectile Dysfunction
Condition: Erectile Dysfunction; Sexual Dysfunction, Physiological
MeSH terms: Erectile Dysfunction; Sexual Dysfunction, Physiological
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the safety and efficacy of low-intensity extracorporeal shock
      wave therapy utilizing the Dornier Aries in the treatment of erectile dysfunction of
      vasculogenic origin.
    

Detailed description: 
      An increasing number of men are suffering from the effects of Erectile Dysfunction (ED) each
      year. The development of oral therapies (phosphodiesterase 5 inhibitors) has been successful
      for many with the disease. However, these drugs may be contraindicated in patients with
      cardiovascular risk factors (which are often predecessors to developing ED) and are often
      ineffective in patients with other comorbid conditions, such as diabetes mellitus. The main
      objective of this study is to determine the safety and efficacy of low-intensity
      extracorporeal shock wave therapy using the Dornier Aries in the treatment of erectile
      dysfunction of vasculogenic origin.

      This protocol allows for treatment of 23 men with 21-75 years of age with vasculogenic
      erectile dysfunction of at least 6 months' duration with low intensity extracorporeal shock
      wave therapy utilizing the Dornier Aries device.

      This protocol includes the application of 5000 shockwaves per session in 5 treatment areas
      with 1000 SW each at energy level 4-5 (energy flux density (0.051-0.062 mJ/mm²), while moving
      the applicator along the penile shaft within the treatment areas. The maximum energy applied
      during this treatment would be 23.35J.

      Conversely, the treatment protocol described within is designed to actually restore penile
      function as a disease-modifying therapy, and is not expected to require a maintenance regimen
      or continued treatments, as previous studies have demonstrated retained benefits at six
      months after the end of treatments.

      Dornier MedTech hired an independent party to monitor data and perform internal audits to
      ensure the precision, quality, and integrity of the data collected. The investigator(s)
      agrees to permit access to study records, source data, and source documents for this purpose.
    

Intervention name(s): ARIES (Extracorporal Shock Wave Application)
Intervention type(s): Device
Intervention description(s): The treatment protocol includes 1 treatment per week for 6 weeks and an application of 5000 shockwaves per session in 5 treatment areas with 1000 SW each at energy level 4-5 (energy flux density (0.051-0.062 mJ/mm²), while moving the applicator along the penile shaft within the treatment areas. The maximum energy applied during this treatment would be 23.35J.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shockwave; vascular ED; Organic ED
Diet Induced Intestinal Mucosal Adaptation
Condition: Healthy Conditions
Study type: Interventional

Summary: 
      Human beings are 'omnivores' meaning that all principal components of food (i.e. the
      macronutrients: carbohydrates, fat, proteins) can be assimilated by the gastrointestinal
      tract. When the gut mucosa is exposed to dietary changes it adjusts its functional behaviour.
      For example, a fatty diet demands certain digestive mechanisms, whereas others are needed to
      take care of a carbohydrate rich diet. Such dietary induced changes in appearance and
      functionality of the small intestinal mucosa have been described in animals but only little
      is known about it in man. The present project aims at elucidating in man if a 2 weeks diet
      dominated by either fat or carbohydrates, but with similar energy content, is associated with
      changes in the small intestinal mucosal appearance and metabolic signalling capacity.
    


Intervention name(s): high fat diet (hfd); high carb diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sixty % of the energy content is based on fat.; Sixty % of the energy content is based on carbohydrates.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: intestinal; metabolic control; mucosa; human; diet
The Effect of Local Injectet GH on the Collagen Synthesis in the Ligamentum Patella
Condition: Growth Hormone; Elderly
Study type: Interventional

Summary: 
      Tendon and ligament injuries are a frequent problem among athletes but also in the general
      population. The healing process is a prolonged process, and complete recovery of tissue
      strength is nearly never reached. The purpose of this study is to examine the effect of local
      injection of human Growth Hormone on tendon collagen synthesis.
    

Detailed description: 
      Tendon and ligament injuries are a frequent problem among athletes but also in the general
      population. The healing process is a prolonged process, and complete recovery of tissue
      strength is nearly never reached. The purpose of this study is to examine the effect of local
      injection of human Growth Hormone on tendon collagen synthesis.

      in order to investigate the collagen synthesis potential and the influence of growth hormone,
      12 elderly males age > 50 year, is enrolled in this study.
    

Intervention name(s): Growth Hormone
Intervention type(s): Drug
Intervention description(s): infusion of Growth hormone in the patella tendon.
Other intervention name(s): infusion of Saline in the patella tendon.
Intervention MeSH terms: Hormones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases
Condition: Hypertension; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      A number of strategies have been evaluated to improve the prevention and control of the main
      cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized
      lifestyle educational programs were found to improve blood pressure (BP) control and
      adherence to healthy lifestyle. This study aims at evaluating for the first time the efficacy
      of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors among
      hypertensive adults.

      Participants will receive usual care and a guideline-based educational program on BP control
      and healthy lifestyle habits. Subjects in the NRP-e group will also receive weekly email
      alerts and phone calls from a nurse care manager for 6 months. Emails contain a reminder
      program on the compliance with a healthy lifestyle based upon current guidelines for CVD
      prevention. Follow-up visits will be scheduled at 1, 3 and 6 months after enrollment;
      randomization will be made centrally and blood samples will be evaluated into a single,
      accredited laboratory.
    


Intervention name(s): Nurse-led reminder through email.
Intervention type(s): Behavioral
Intervention description(s): Both groups will receive an educational program and usual care. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form.
Educational program and usual cardiovascular prevention. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
In-vivo Extraction of Pb, Cd andTSNA From Swedish Snus
Condition: Smoking Cessation; Smokeless Tobacco; Harm Reduction
Study type: Interventional
Phase: Phase 1

Summary: 
      In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users
      will be given repeated doses of four different types of portion snus: "General", "Catch",
      "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen
      (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific
      nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation
      of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco
      specific nitrosamines (TSNAs) respectively, will be done for each type of snus.
    

Detailed description: 
      Comparisons:

      A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

      B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per
      portion.

      C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine
      per portion.

      D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg
      nicotine per portion.

      Swedish portion snus will be administered once every hour (4 administrations/brand) and will
      be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.
    

Intervention name(s): Buccal Administration of nicotine; Buccal Administration of nicotine; Buccal Administration of nicotine; Buccal Administration of nicotine
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Oral pouch 1g, single dose. One pouch administered over 30 minutes.; Oral pouch 1g, single dose. One pouch administered over 30 minutes.; Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.; Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
Other intervention name(s): Smokeless tobacco; ST; Potential Exposure Reduced Product; PREP; Smokeless tobacco; ST; Potential Exposure Reduced Product; PREP; Smokeless tobacco; ST; Potential Exposure Reduced Product; PREP; Smokeless tobacco; ST; Potential Exposure Reduced Product; PREP
Intervention MeSH terms: Lobeline; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: smokeless tobacco; Nicotine; Cadmium; lead; Tobacco Specific Nitrosamines
A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a
      varenicline patch applied to the skin.
    


Intervention name(s): varenicline free base patch
Intervention type(s): Drug
Intervention description(s): varenicline transdermal delivery system (6.0 mg payload [drug amount loaded in each patch]) will be applied to the upper back over a single 24 hour period
Intervention MeSH terms: Varenicline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: varenicline percutaneous transcutaneous topical transdermal transdermal delivery system patch
A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir
      (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI
      fixed-dose combination tablet) in healthy Japanese adult participants.
    


Intervention name(s): Darunavir/Cobicistat
Intervention type(s): Drug
Intervention description(s): Participants will receive a FDC tablet of darunavir 800 mg and cobicistat 150 mg orally in the morning of Day 1.
Other intervention name(s): TMC114/JNJ-48763364-AAA
Intervention MeSH terms: Darunavir; Cobicistat; Cobicistat mixture with darunavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Volumetric Analysis of Resorption Types on CBCT
Condition: Endodontic Disease; Tooth Resorption
MeSH terms: Dental Pulp Diseases; Tooth Resorption
Study type: Observational

Summary: 
      More accurate management of resorption can be achieved thanks to the three-dimensions
      volumetric and linear analysis, and the axial classification presented in this study.
    

Detailed description: 
      The aim of this study was to investigate the volumetric and linear analysis, and to present
      the axial classification of root resorptions using cone beam computed tomography (CBCT).

      A total of 43 teeth of external cervical resorption (ECR) (n=27), external replacement
      resorption (ERR) (n=4) and internal root resorption (IRR) (n=12) were identified from 34
      patients. The volume of resorption and total tooth, the widest lengths of these resorptions,
      and the amount of thinnest dentin thickness around them were measured and compared according
      to age and sex. Additionally, the eight regional axial classification was performed and the
      percentages in these regions were evaluated. Significance was set at p=0.05 for statistical
      analysis.

      More accurate management of resorption can be achieved thanks to the three-dimensions
      volumetric and linear analysis, and the axial classification presented in this study.
    

Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Cases of resorption that had CBCT images were included in the study. Radiographic features
        of resorption were defined in the images of 34 patients in accordance with these criteria.
        A total of 43 teeth with ECR (n=27), ERR (n=4), and IRR (n=12) were identified from 34
        patients.
      
Keywords: cone beam computed tomography; endodontics; tooth Resorption
Palpation and ACCURO for Placing Spinal in C-section
Condition: Anesthesia,Obstetrical
Study type: Interventional

Summary: 
      The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to
      create pictures of the spine in three dimensions. This may allow the physician to view the
      spine in more detail for procedures such as spinal anesthesia and other diagnostic
      procedures.

      We aim to assess the benefit of using both the Accuro and traditional landmark palpation
      technique to determine accurate spinal level in women who undergo cesarean section. This
      study will also assess provider preference for use of both Accuro and palpation compared with
      palpation alone or use of Accuro alone.

      Anesthesia Providers will first identify the L4/L5 space using the traditional technique of
      palpating the iliac crests to estimate spinal level, which will be marked with a single dot
      from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5
      interspace.

      Results will be compared to results obtained in IRB 18070 "Handheld 3D lumbar spine
      navigation: A clinical validation study RM002" where subjects who were undergoing a C-section
      were randomized to either palpation or Accuro alone.
    


Intervention name(s): Palpation and Accuro
Intervention type(s): Device
Intervention description(s): Identify placement for spinal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research