bioihbjkbjnl/mcl2 huggingface dataset:
Maintenance Bevacizumab Only or Bevacizumab Plus Metronomic Chemotherapy in Advanced Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study consist of 4-months induction first-line chemotherapy with the G.O.N.O. FOLFOXIRI
      regimen plus bevacizumab followed by maintenance with bevacizumab or bevacizumab plus
      metronomic chemotherapy (with capecitabine and cyclophosphamide) in mCRC patients.

      The main objective of this study is to preliminarily evaluate the potential effects of the
      combination of a metronomic chemotherapy with capecitabine and cyclophosphamide to
      maintenance bevacizumab on pharmacodynamic and clinical parameters among mCRC patients.
    


Intervention name(s): Maintenance:BEVACIZUMAB; Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:
BEVACIZUMAB 5 mg/kg over 30 minutes, day 1
IRINOTECAN 165 mg/sqm IV over 1-h, day 1
OXALIPLATIN 85 mg/sqm IV over 2-h, day 1
L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1
5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1
with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs):
- BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks); Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:
BEVACIZUMAB 5 mg/kg over 30 minutes, day 1
IRINOTECAN 165 mg/sqm IV over 1-h, day 1
OXALIPLATIN 85 mg/sqm IV over 2-h, day 1
L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1
5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1
with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs):
BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks),
CAPECITABINE 500 mg/tid orally, continuously,
CYCLOPHOSPHAMIDE 50 mg/day orally, continuously.
Intervention MeSH terms: Cyclophosphamide; Bevacizumab; Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic colorectal cancer; Ist line therapy; metronimic therapy; bevacizumab
The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
Condition: Oligozoospermia; Oligoasthenozoospermia; Oligoasthenoteratozoospermia
MeSH terms: Oligospermia
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare in Oligozoospermia Patient. The main questions
      it aims to answer are: 1. Electroacupuncture therapy and standard therapy can affect
      oligozoospermia. 2. Electroacupuncture therapy and standard therapy can affect semen and
      spermatozoa plasma SOD levels.

      Researchers will compare patient with standard therapy with patient with standard therapy
      with electroacupuncture.
    

Detailed description: 
      1. Male subjects aged more than 25 years and less than 45 years.

        2. Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million
           spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (<5 million
           spermatozoa/mL).

        3. Willing to take part in research and sign informed consent.
    

Intervention name(s): Electroacupuncture and Standard Therapy
Intervention type(s): Other
Intervention description(s): Acupuncture Needle Insertion with Electroacupuncture machine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered
      intravenously in the treatment of the patients with acute severe asthma not responding to
      conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted
      in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of
      intravenous MgSO4 administered is not common in clinical practice, because it's prone to have
      adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension,
      decreased tendon reflexes and so on with this treatment. The aerosolised route offers the
      advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle
      and lower incidence of side effects when compared to the intravenous route. At present, there
      are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma
      in children, and the conclusions are controversial.
    


Intervention name(s): Magnesium Sulfate; magnesium sulfate & albuterol; Albuterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg; 0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg; 0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg
Intervention MeSH terms: Magnesium Sulfate; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: magnesium sulfate; nebulized; lung function
Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study is conducted in the United States of America (USA). The aim of this study is to
      assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D),
      type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.
    


Intervention name(s): No treatment given
Intervention type(s): Other
Intervention description(s): The participants will not receive any treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with T1D, T2D and healthy subjects (HS) without personal or first degree family
        history of autoimmunity of diabetes. The HS will be mean age-matched with the T1D subjects.
      
Biospecimen description: 
      Monthly venous blood samples within the first half year and thereafter bi-monthly the rest of
      the year. A subgroup of the subjects will also be invited for a visit within a week after the
      former visit to assess the variation of the biomarkers within a week. The blood samples will
      be assayed for peripheral blood mononuclear cells (PBMC) specificity, phenotype and function
      as well as for islet autoantibodies (presence and precise titers), for autoantibody isotypes
      and diabetes risk parameters. Finally C-peptide levels and residual beta cell function will
      be measured three times during the study after a mix meal tolerance test (MMTT) in subjects
      with T1D.
Nutritional Therapy and Education With Multimedia Application in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of nutrition therapy in
      combination with education in diabetes using a multimedia application for improving
      indicators of metabolic control in patients with type 2 diabetes.
    

Detailed description: 
      Randomized clinical trial. Subjects with type 2 diabetes from three Family Medicine Units
      (primary care), with HbA1c >6.5% and <13.0%, without advanced macro or microvascular
      complications of diabetes.

      Two arms: the experimental group with nutrition therapy plus education in diabetes through a
      multimedia application. The application had seven modules: Introduction, nutrition, physical
      exercise in diabetes, myths and truths on diabetes, metabolic control parameters, knowing
      diabetes, complications of diabetes. The control group received only usual nutrition therapy.

      A monthly follow up during the first 7 months and then bimonthly, until 21 months of total
      follow up, with reinforcement in each visit of nutrition and other non-pharmacological
      therapy, with control on weight and blood pressure. Laboratory studies included HbA1c, lipids
      profile, creatinine and albuminuria, performed at 7, 14 and 21 months. Results were provided
      to both the patient and his family physician, so modification in drug treatment if needed,
      were performed.
    

Intervention name(s): Nutritional therapy and education; Nutritional therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes.
Education with multimedia application: Patients were exposed to the multimedia application previous to the nutritional counseling. Multimedia application comprises the following modules: 1) Introduction, 2) Nutrition, 3) Physical Exercise, 4) Diabetes myths 5) Metabolic control indicators 6) Knowing diabetes, 7) Diabetes complications including testimonials.; Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association Standards for medical care in diabetes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus; nutritional therapy; health education; self-management; multimedia
Comparison of Remimazolam With Flumazenil vs. Propofol During RFCA for Atrial Fibrillation
Condition: Recovery
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This prospective randomized trial aims to compare recovery time from discontinuation of
      remimazolam followed by flumazenil administration vs. propofol total intravenous anesthesia
      as the main general anesthetics during radiofrequency catheter ablation treatment of atrial
      fibrillation.
    

Detailed description: 
      Adult patients with atrial fibrillation undergoing radiofrequency catheter ablation under
      general anesthesia are randomized to receive either remimazolam with flumazenil or propofol
      total intravenous anesthesia as the main anesthetics. After completion of radiofrequency
      ablation, each anesthetic is discontinued. The primary outcome of the study is comparison of
      the time to the first eye opening responding to doctor's command from the discontinuation of
      each drug between the groups. Secondary outcomes includes the time to removal of supraglottic
      laryngeal mask airway device from discontinuation of each drug, incidence of three
      consecutive hypotension (systolic blood pressure under 80 mmHg) recordings at 2.5
      min-intervals, and intraprocedural vasoactive-inotropic score.
    

Intervention name(s): Remimazolam Besylate; Flumazenil; Propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Remimazolam Besylate is used as intervention drug for general anesthesia, which followed by flumazenil administration at the end of anesthesia, to be compared to propofol total intravenous anesthesia during radiofrequency catheter ablation of atrial fibrillation.; Flumazenil is used as additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.; Propofol is used as active comparator drug for general anesthesia until the end of anesthesia, to be compared to remimazolam besylate during radiofrequency catheter ablation of atrial fibrillation.
Intervention MeSH terms: Propofol; Flumazenil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: recovery; remimazolam; flumazenil; propofol; radiofrequency catheter ablation
DNA/RNA Analysis of Blood and Skeletal Muscle in Patients Undergoing Cardiac Resynchronization Therapy (CRT)
Condition: Cardiomyopathy (Ischemic or Non-Ischemic)
MeSH terms: Cardiomyopathies
Study type: Observational

Summary: 
      Genes expressing inflammatory cytokines (TNF- alpha, IL1 etc) and genes involved in apoptosis
      (Caspase 3, Bax, Bcl-2, Fas) are dysregulated in the skeletal muscles of the patients who
      have muscle wasting and decreased exercise capacity with CHF.

      Patients who show benefit from CRT may also show reversal of the inflammatory/apoptotic
      cascade that accompanies CHF and these patients may be the ones who benefit the most from CRT
    

Detailed description: 
      1. The general objective of this study is to:

        1. To identify the molecular pathways that may be altered in the blood and skeletal muscles
           of the patients undergoing CRT by using transcriptional analysis of the blood and
           skeletal muscle in these patients

        2. To identify objective measurable molecular signals, using gene expression profiling,
           that correlate with clinical improvement in patients undergoing CRT.

        3. To identify the molecular profile of patients who are most likely to benefit from CRT
           with improvement of exercise capacity and reversal of cardiac cachexia.

        4. To identify biochemical pathways involved in cardiac cachexia.

        5. To identify genes involved in positive remodeling and reversal of apoptotic cascade in
           the skeletal muscle.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are scheduled for a CRT-D device
      
Biospecimen description: 
      Serum TNF alpha, IL-1, IL6, CRP, uric acid, albumin, BNP, IGF-1 and growth hormone at
      baseline and at 6 months.

      50 ml of blood will be collected at baseline and at 6 months. It will be divided into
      aliquots as follows; 10 ml in Pax-gene tubes for mRNA extraction, 20 ml for various other
      biomarkers, 10 ml for proteomics and 10 ml will be stored for any future use.

      Approximately a 5x5 - 7x7mm muscle biopsy will be obtained from the mid thigh region of each
      subject at baseline and at six months
A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation
Condition: Sedation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A
      total of ICU patients undergoing mechanical ventilation are intended to be enrolled and
      randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.
    


Intervention name(s): HSK3486 0.1-0.2 /0.3 mg / kg group; Propofol 0.5-1.0/1.5 mg/kg group
Intervention type(s): Drug; Drug
Intervention description(s): Administered with HSK3486 at a loading dose of 0.1-0.2 mg/kg via intravenous pump. Then HSK3486 shall be administered immediately at an initial maintenance dose of 0.3 mg/kg/h respectively.; Administered with Propofol at a loading dose of 0.5-1.0mg/kg via intravenous pump. Then Propofol shall be administered immediately at an initial maintenance dose of 1.5 mg/kg/h respectively.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the product performance of a new silicone hydrogel
      soft contact lens when worn by current soft contact lens wearers on a daily wear basis.
    


Intervention name(s): Silicone Hydrogel Contact Lens
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Smartphone Intervention for Subthreshold Depression
Condition: Subthreshold Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The study aimed to examine the feasibility, usability, user satisfaction, safety, and
      preliminary efficacy of a smartphone application intervention for young adults with
      subthreshold depression.
    


Intervention name(s): Smartphone Application
Intervention type(s): Device
Intervention description(s): The participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Oral Apixaban (Eliquis) Versus Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy
Condition: Gynecologic Cancer; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the incidence of major bleeding (including clinically relevant
      non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with
      apixaban 2.5 mg twice a day (BID) compared to current standard of care, subcutaneous
      enoxaparin 40 mg once a day (QD) for 28 days post surgery.
    

Detailed description: 
      Apixaban (Eliquis) is an oral anticoagulant for the treatment and prevention of
      thromboembolic events. It is advantageous as there is no need to perform routine blood
      monitoring tests including, international normalized ratio (INR), partial thromboplastin time
      (PTT) and Factor Xa, to determine clotting in participants receiving treatment. Several
      studies have shown the efficacy of apixaban for the treatment and prevention of a venous
      thromboembolism (VTE).

      We anticipate that the same efficacy could be replicated in the prevention of VTE in women
      undergoing surgery for gynecologic cancer. An oral-anticoagulant for standard treatment for
      prevention of VTE outcomes following surgery could help improve the surgical mortalities
      associated with gynecologic oncology surgical patients, improve patient adherence for
      outpatient treatment, and reduce VTE surveillance and outcomes.
    

Intervention name(s): Oral apixaban; Subcutaneous enoxaparin
Intervention type(s): Drug; Drug
Intervention description(s): To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.; To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.
Other intervention name(s): Eliquis; Lovenox
Intervention MeSH terms: Enoxaparin; Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Maintenance and Tissues Conditions of Fixed Screw-Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures
Condition: Prosthesis and Implant Dentistry
Study type: Interventional

Summary: 
      The aim of this study was to compare the prosthetic maintenance requirements between
      implant-retained ball overdentures versus fixed screw- retained implant prosthesis. Clinical
      and radiographic changes in peri-implant tissue with using PGE2 as a PICF biomarker were also
      evaluated. Selected patients had been divided into two groups:

        1. Group (I): twenty seven patients had received implant-Supported ball over dentures.

        2. Group (II): twenty-seven patients had received screw retained restorations Interventions
           and study procedures

      Surgical and prosthetic procedures:

      Surgical Procedures A radiopaque radiographic stent was formed and was positioned in the
      patient's mouth during cone beam scanning. Four implants were planned with two virtual
      replicas, in the place of the lateral incisor and the second premolar.

      The stent was fabricated. After the healing period of four months finished, the patients were
      recalled and the super structure was fabricated according to the type of restoration
      Follow-up During the 12 months follow-up period, prosthodontic complications were recorded
      and calculated.

      Postoperative care Along with a conventional oral hygiene assessment and functional checkup,
      follow up visits were scheduled every 6 months and up to 12 months total follow up period.

      Clinical soft tissue measurements which include plaque index (PI), gingival index (GI), and
      PPD were measured at the mid-facial, mid-lingual, mid-mesial, and mid-distal aspects of each
      fixture using a graduated plastic probe to the nearest 0.5 mm. These clinical measurements
      were recorded after prosthesis delivery, 6 and 12 months postoperatively. The peri-implant
      marginal bone loss (MBL) was assessed radiographically after prosthesis delivery, 6 and 12
      months postoperatively.

      • Collection of peri-implant crevicular fluid (PICF) samples: PICF was collected.
    


Intervention name(s): Screw retained restoration; implant-retained ball overdentures
Intervention type(s): Procedure; Procedure
Intervention description(s): Hybrid prosthesis; Removable prosthesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity
Condition: Sleep
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion
      with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling
      asleep or falling back asleep after waking in the night, and grogginess upon waking. The
      study will be conducted as a virtual single-group trial in which all 35 participants will use
      the test product. This study will last 3 weeks, and participants will use the product daily
      (each night 30 minutes before bedtime for 20 nights). Participants will use a sleep tracker
      to monitor their sleep for a week at Baseline (before commencing the trial) and nightly
      throughout the trial. Participants will complete study-specific questionnaires at Baseline,
      and after first use, 3 days, 1 week, 2 weeks, and 3 weeks, in which they will also record the
      results from their sleep tracker.
    


Intervention name(s): Asutra's 'Dream the night away' nighttime lotion
Intervention type(s): Other
Intervention description(s): Product contains Water (Aqua), Magnesium Chloride, Dimethyl Sulfone (MSM), Prunus Amygdalus Dulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea Butter), Sodium Lactate, Cetearyl Alcohol, Glyceryl Stearate Citrate, Glycerin, Undecane, Cetyl Palmitate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Glyceryl Stearate, Magnesium Sulfate, Melatonin, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate, Xanthan Gum, Hydroxyacetophenone, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil, Citral, Geraniol, Linalool
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other