bioihbjkbjnl/mcl2 huggingface dataset:
Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy
Condition: Gastric Cancer; Complication of Surgical Procedure
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Laparoscopic gastrectomy has fewer infectious complications compared to open surgery.
      Recently, the incidence of postoperative infectious complications was greatly reduced due to
      the development of surgical techniques and improvement of prevention and control of surgical
      infection. Previous multicenter, phase II study (KSWEET-01) revealed that the incidence of
      infectious complications of laparoscopic gastrectomy without prophylactic antibiotics was not
      significantly higher than previously reported data.

      Therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy
      without prophylactic antibiotics, specially reference to the postoperative infectious
      complications.
    

Detailed description: 
      The purpose of this study was to investigate the non-inferiority of incidence of infectious
      complications in the experimental group that did not use prophylactic antibiotics compared to
      the control group using prophylactic antibiotics.

      The primary endpoint is the incidence of surgical site infections within 30 days after
      surgery and the difference limit of the non-inferiority of the experimental group is assumed
      to be - 0.05 (5%). Assuming that the incidence of postoperative infectious complications in
      the control group is 5% and the incidence of infectious complications in the experimental
      group is assumed to be about 8%. It is assumed that the significant level is 5% and the power
      is at least 80%.

      According to the above method, a total of 260 patients (130 patients in each group) are
      needed when 117 patients are needed in each group and about 10% of drop rates and protocol
      violence are considered.
    

Intervention name(s): No use of antimicrobial prophylaxis; Use of antimicrobial prophylaxis
Intervention type(s): Procedure; Procedure
Intervention description(s): Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer; Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
Other intervention name(s): No AMP; AMP
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric cancer; Laparoscopic gastrectomy; Prophylactic antibiotics; Infectious complications
Hemodynamic Instability Following Carotid Artery Stenting
Condition: Carotid Stenting
Study type: Interventional

Summary: 
      Hemodynamic instability was controlled in 27 patient during carotid stenting and it was
      showed that hemodynamic instability can be predicted by Valsalva maneuver before stenting and
      hemodynamic instability have no prognostic effect on result of carotid stenting.
    

Detailed description: 
      One of the important complications of Carotid Artery Stenting (CAS) is post procedural
      hypotension and bradycardia referred to as Hemodynamic Instability (HI). However its
      incidence and contribution to short-term prognosis of patients have been of a large debate.
      In this study we aim to assess the incidence and predictive factors of HI and its role in
      mortality and morbidity of patients in short-term follow-up.

      Materials and Methods: 27 patients were selected based on NASCET criteria and underwent CAS
      between September 2008 and September 2009. Continuous EKG monitoring & supine blood pressure
      (BP) was obtained before and after stent deployment and on the following day to detect HI
      defined as systolic BP≤90mmHg or heart rate≤60 beats per minute. Patients were asked to
      perform Valsalva maneuver before and after stent deployment. Valsalva ratio along with other
      demographic and procedural data was documented and compared between patients with and without
      incidence of HI.

      Results: 17 patients (63%) developed HI after CAS. The degree of stenosis was found to have a
      significant correlation with occurrence of HI with P value<0.006. No other risk factor or
      demographic data showed any correlation with HI. Valsalva Ratio (VR) were significantly lower
      in HI group compared with non-HI group indicating a significant autonomic dysfunction
      (P<0.003). In the follow-up one (4.3%) patient had developed major stroke and others were
      symptom free.

      Conclusion: HI occurs frequently following CAS but seems to be a benign phenomenon and
      doesn't increase the risk of mortality or morbidity after the procedure in short-term. VR at
      rest (VR≤1.10) baseline autonomic dysfunction and degree of carotid artery stenosis can be
      used as measures for prediction of HI after CAS.
    

Intervention name(s): valsalva maneuver; valsalva maneuver
Intervention type(s): Procedure; Procedure
Intervention description(s): valsalva maneuver after carotid stenting; valsalva maneuver after carotid stenting
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Carotid artery stenting; Hemodynamic Instability; Valsalva Ratio
Circulating Oxidative Stress and Gestational Hypertension. Study of the Evolution of Free-radical Markers of Oxidative Stress From Before to After Childbirth in Two Groups of Women: Normal Pregnancy and Pre-eclampsia.
Condition: Pregnancy Complicated by Pre-eclampsia.; Normal Pregnancy
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Interventional

Summary: 
      The aim of this study is to explore a mechanism that could potentially explain why women with
      a pregnancy complicated by pre-eclampsia are described as having an increased risk of
      cardiovascular disease later in life.

      If the hypothesis of this study turns out to be true, that is to say that women with
      pre-eclampsia have a higher level of oxidative stress than women with a normal pregnancy and
      that this difference persists after the delivery (6 months), a controlled randomized
      interventional study aiming to evaluate either therapeutic supplementation with antioxidant
      vitamins (Vit C and E) or modifications in diet could be envisaged.
    


Intervention name(s): blood sample
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity and Preference - Pilot
Condition: Impairment of Oral Perception
Study type: Interventional

Summary: 
      The goal of this study is to test the hypothesis that repeated consumption of artificial
      sweetener reduces sweet taste intensity.
    

Detailed description: 
      Significant controversy surrounds the possibility that consumption of artificial sweeteners
      (AFS) leads to weight gain. Some studies have found correlations between AFS use and weight
      gain and/or diabetes [1-4] while others have indicated that AFSs may aid in weight loss [5]
      or have no effects on body mass index (BMI) [6]. In rats, exposure to AFS leads to reduced
      chow intake following a sweet preload [7, 8], higher body weight [9, 10] and increased
      glucose responses and decreased GLP1 release following an oral glucose tolerance test [11]
      compared to exposure to caloric sweeteners. Given that the five FDA approved AFSs are found
      in thousands of foods [12] this marks a clear and significant gap in knowledge. Our
      preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following
      consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data
      provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste
      intensity, most likely by down-regulation of the sweet taste receptor. Therefore, it is
      imperative that we gain a greater understanding of the consequences of AFS use, since
      alterations in sweet taste perception that occur in response to AFS exposure may promote
      weight gain.
    

Intervention name(s): Sucralose; Sucrose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 packets per 12 fl oz; equisweet to sucralose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
Condition: Covid19; Long COVID-19; Post-COVID-19 Syndrome
MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with
      post-COVID-19 syndrome.
    

Detailed description: 
      This interventional pilot study will assess the use of low dose naltrexone (LDN) and NAD+ for
      the treatment of patients with post-COVID-19 syndrome (long-COVID-19).

      Patients with a positive test for SARS-CoV-2 1-4 months before enrollment will be included.
      Subjects should have self diagnosed post-COVID19 syndrome and experiencing persistent fatigue
      since positive test. Patients will be screened using the fatigue survey and cases with a
      moderate to severe score will be included.

      Patients will receive LDN and NAD+ treatment for 12 weeks. In this study, fatigue and quality
      of life will be assessed using validated surveys. Surveys will be conducted at baseline (at
      the time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. The improvement of
      scores from baseline levels will be assessed.
    

Intervention name(s): Naltrexone; NAD+
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Naltrexone at 4.5 mg/day; NAD+ will be applied using iontophoresis patches. The patches will be provided by ready-made NAD+ solutions (400 mg) to be applied to the positive electrode of the patch and saline to the negative electrode. The patch is powered by a self-contained battery, producing an electric current to facilitate NAD+ absorption through the skin into the blood. Patches are worn for 4-6 hours once a week.
Other intervention name(s): Low dose Naltrexone (LDN); Nicotinamide adenine dinucleotide
Intervention MeSH terms: Niacinamide; Naltrexone
Intervention model: Single Group Assignment
Intervention model description: Patients will receive LDN and NAD+ treatment for 12 weeks. The researchers will assess fatigue and quality of life using validated surveys. Surveys will be conducted at baseline (at time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. Improvement of scores from baseline levels will be determined.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Long COVID-19; Post-COVID-19 syndrome; naltrexone; NAD; Nicotinamide adenine dinucleotide; low dose naltrexone; LDN
Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler
Condition: Trapeziometacarpal Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      1. Introduction:

           Investigators think that surgery with preservation of healthy joints (hemitrapeziectomy)
           in trapeziometacarpal osteoarthritis without affecting sapho-trapezo-trapezoid joints,
           is better for scaphoid stability by preventing its collapse and thus preserving the
           stability of the carpus.

        2. Objectives and Hypothesis:

           Ligamentoplasty with partial trapeziectomy in grades II-III Eaton presents better
           results in the pollicis-lateral pinch (key pinch) strength than ligamentoplasty with
           total trapeziectomy.

           Main Objective:

           To demonstrate using the dynamometer that the postoperative key pinch strength higher
           using ligamentoplasty with partial trapeziectomy in grades II-III Eaton.

           Secondary objectives:

           To measure the collapse of the first column of thumb using calibrated radiographic
           analysis. Pain (E.V.A Scale). Range of motion (measured with goniometer). Quality of
           life (DISABILITIES OF THE ARM, SHOULDER AND HAND questionnaire).

        3. Methodology:

      It is a single-center randomized trial, parallel-group, in which two types of surgical
      techniques (TT - TP) will be compared. Patients will be randomized in this two techniques
      will be followed for one year, in routine clinical practice.
    


Intervention name(s): Ligamentoplasty with partial trapeziectomy; Ligamentoplasty with total trapeziectomy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total Trapeziectomy; Partial Trapeziectomy; Ligamentoplasty
The Effects of Intake of Protein From Cod Fillet and Cod Residual Material on Lipid Regulation, Glucose Regulation and Inflammation in Overweight or Obese Adults.
Condition: Overweight and Obesity; Healthy
MeSH terms: Overweight; Inflammation
Study type: Interventional

Summary: 
      A high intake of fish is associated with positive health effects, including prevention and
      treatment of chronic non-communicable diseases, such as cardiovascular diseases (CVDs) and
      type 2 diabetes. These health effects have traditionally been attributed to the omega-3 fatty
      acids in fatty fish, but recent studies have suggested that also fish proteins may improve
      biomarkers of metabolic disease. Intake of cod fillet have previously shown beneficial
      effects on blood lipids, glucose regulation and body composition in adults with overweight or
      obesity. Health effect of cod residual material from fillet production (i.e., head, backbone,
      skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish
      species have shown promising effects on glucose regulation in rats. The main aim of the
      current study is to investigate the effects of protein from cod fillet and cod residuals on
      serum lipids, glucose regulation and inflammatory markers in healthy overweight or obese
      adults.
    


Intervention name(s): Intact cod protein from fillet; Intact cod protein from residual material; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Intact cod protein from fillet 8 g protein daily for 8 weeks; Intact cod protein from residual material, 8 g protein daily for 8 weeks; Control group receive tablet containing fillers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, non-randomized, open-label, fixed sequence study to investigate the
      effect of multiple oral dosing of LEO 32731 (up-titrated), on CYP3A activity in healthy male
      subjects using midazolam as a probe CYP3A substrate.

      The study will be conducted in two seamless parts:

      Part I - Maximal Tolerated Dose (MTD) Part II - Drug-Drug Interaction with midazolam
    


Intervention name(s): LEO 32731; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): LEO 32731 is being developed by LEO Pharma.; Benzodiazepine
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-383.
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-383.
    

Detailed description: 
      A phase 1 clinical trial to evaluate pharmacokinetics and safety in healthy adult after oral
      administration of CKD-383 and co-administration of CKD-501, D745, D150.
    

Intervention name(s): CKD-501, D745, D150; CKD-383
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
Condition: Erosive Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With
      acute and chronic gastritis.
    


Intervention name(s): Placebo; SK-MS10; SK-MS10
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosage; Dosage; Dosage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
Condition: Turner's Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis
Study type: Interventional
Phase: Phase 3

Summary: 
      Children with growth failure due to inadequate secretion of growth hormone or growth
      retardation due to Turner's syndrome are individually dosed and treated for 12 weeks
    

Detailed description: 
      Ferring Pharmaceuticals A/S has developed a new ZOMACTON 10 mg formulation. The formulation
      provides a higher concentration and thereby a smaller volume to be administered. ZomaJet
      Vision X is a needle-free injection system. It sends a thin jet of ZOMACTON through the skin
      and into the subcutaneous tissue without the use of a needle. The mode of administration is
      referred to as "transjection". By use of ZomaJet Vision X, both transjection and
      reconstitution of ZOMACTON 10 mg can be done without using a needle. The rationale of the
      study is to describe the local tolerability of the new ZOMACTON 10 mg administered by ZomaJet
      Vision X.
    

Intervention name(s): ZOMACTON
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus
Condition: Allergy
Study type: Interventional
Phase: Phase 2

Summary: 
      Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic
      and non-allergenic components. Many factors such as the biovariability, differences in
      extraction process and subsequent handling of allergens can affect the final composition,
      potency, and stability of allergen preparations. Genetic diversity of affected people adds
      another level of complexity. In order to control variability and to achieve consistency and
      reproducibility for optimal safety and sensitivity/specificity, it is essential to
      standardize the amount of allergen used in prick tests. Therefore, the system for biological
      standardization mainly used in Europe still is the biological calibration of in-House
      Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines
      as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT)
      value. The aim of this procedure is to estimate the biological activity of allergen extracts.
      The activity of an allergen extract is defined as 10,000 Diagnostic Biological Units (DBU)
      per ml (1 SPT per ml), when the extract provokes a specific skin reaction with a wheal of the
      same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when
      both solutions are administrated using the same technique (prick testing) on at least 20
      individuals who are clinically allergic and cutaneously reactive to the allergen concerned.

      The present study aims to standardize the allergen extracts of Betula pendula, Phleum
      pratense and Dermatophagoides pteronyssinus by using this method.

        -  Trial with medicinal product
    


Intervention name(s): Extracts of allergens
Intervention type(s): Other
Intervention description(s): Skin prick test of extracts of allergens in 4 tenfold dilutions. Assessment wheal size after 15 minutes
Intervention model: Single Group Assignment
Intervention model description: Skin prick test of extracts of allergens in 4 tenfold dilutions.
Masking: None (Open Label)
Primary purpose: Diagnostic
Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders
Condition: Voice Disorders
MeSH terms: Voice Disorders
Study type: Interventional

Summary: 
      The study compares two different approaches of voice therapy. Vocal Functional Exercises
      (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II -
      Tecnisystem do Brasil TSI 1210).
    

Detailed description: 
      Both approaches combined with Vocal Hygiene Program (Behlau, 2007).The target population are
      female teachers because they have the highest risk for developing voice problems. For this
      study the investigators are primarily interested in seeing if Vocal Functional Exercises and
      Voice Amplification are equally effective at improving vocal functioning in teachers with
      voice disorders. The Fiberoptic endoscopic evaluation will be done before randomization. All
      the participants will complete before and after a 6-week treatment phase (a) Voice Activity
      and Participation Profile (PPAV), an instrument designed to appraise the self-perceived
      psychosocial consequences of voice disorders to assess the impact of voice disorders on daily
      activities (b) Audio voice recording for later acoustic analysis, through the Kay Elemetrics
      Multi Dimensional Voice Program (c) Audio recording for later perceptual analysis through
      Consensus Auditory-Perceptual Evaluation of Voice (CAPE_V). It is believed that the search
      for evidence in clinical studies like this can contribute to awareness programs and vocal
      training for teachers.
    

Intervention name(s): Voice Amplification; Function Voice Exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral: Voice Amplification. Patients use VA over a course of 6 weeks Control group. No treatment over a course of 6 weeks.; Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Voice disorders; Voice