bioihbjkbjnl/mcl2 huggingface dataset:
Hydrogel Endovascular Aneurysm Treatment Trial
Condition: Cerebral Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      This research study is being done to test the effectiveness of a new generation FDA approved
      device for treating aneurysms compared to the current standard device for endovascular
      aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of
      minimally invasive surgery, which is performed on blood vessels. The technique involves the
      introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the
      skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery found
      near the groin. The catheter is then maneuvered through the body to the location of the
      aneurysm in the brain using image guidance. Coils are delivered into the aneurysm through the
      catheters. Once the coils are delivered in the aneurysm, they are detached from the catheter.
      This is repeated until enough coils fill the aneurysm, blocking the blood flow to the
      aneurysm. The body responds by forming blood clots around the coil(s), which helps block the
      flow of blood into the aneurysm and keeps the vessel from rupturing or leaking. This study
      will compare the study device to the standard bare platinum coil to see which is better at
      preventing future rupturing or leaking. The study device is called the HydroCoil Embolization
      System and this study is a post-market clinical trial.

      About 600 subjects from multiple institutions will take part in this study.
    

Detailed description: 
      Your part in this study will last up to 24 months and will involve 6 visits (1 baseline visit
      before your surgery, the surgical procedure and 4 follow-up visits). These visits will occur
      at the same time as the visits you would receive as standard of care after your surgery.

      If you are in this study, you will be placed in one of two study groups by chance using a
      process similar to the flip of a coin. This process is called randomization. Neither you nor
      the study staff will select the group you will be in. One group, the control group, will have
      their aneurysm treated by the bare platinum coils during their endovascular procedure. The
      other group, the study group will receive coils from the HydroCoil Embolization System. Both
      groups will receive the same standard of care and follow-up, but during the surgery different
      types of coils will be used.
    

Intervention name(s): HydroCoil Embolic System; Control (bare platinum coils)
Intervention type(s): Device; Device
Intervention description(s): HydroCoil Embolic System; bare platinum coils
Other intervention name(s): MicroVention, Inc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment trial; cerebral aneurysm; randomized; coils; endovascular; HEAT; bare platinum; Hydrogel; Hydrocoil
Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange
Condition: Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Interval (missed) cancers and lower than expected mortality reduction of proximal colon
      cancers in the United States and elsewhere after screening colonoscopy drew attention to
      quality indicators. Missed adenomas which are more likely to be in the proximal colon may be
      contributing factors. An independent predictor of the risk of interval cancers is adenoma
      detection rate. In pilot observations, the investigators showed that water exchange enhanced
      adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized
      controlled trial will compare water exchange with water immersion and traditional air
      insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that
      compared with air insufflation and water immersion, water exchange produces a significantly
      higher adenoma detection rate in the right colon.
    

Detailed description: 
      All of the procedures will be recorded and stored as digital files.
    

Intervention name(s): Air insufflation; water immersion; Water exchange
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Insufflation during colonoscopy including insertion phase; Water will infused during insertion phase and removed during withdrawal phase of colonoscopy; Water will infused and removed during insertion phase of colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: adenoma detection rate; colonoscopy; water exchange
ANAVEX2-73 for Treatment of Early Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function
      after 48 weeks of daily treatment. Additional outcome measures include refined measures of
      sleep, behavioral and psychological symptoms typically observed in AD, changes in daily
      functioning of participants and changes in caregiver burden, as well as changes in quality of
      life measures of both, patients and caregivers during treatment with ANAVEX2-73.
    

Detailed description: 
      This is a Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and
      function after 48 weeks of daily treatment. Additional outcome measures include refined
      measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in
      daily functioning of participants and changes in caregiver burden, as well as changes in
      quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73.
      In addition, safety assessments, pharmacokinetic (PK) assessments and collections of CSF and
      blood markers of AD pathophysiology before and after treatment will be performed.
    

Intervention name(s): High dose ANAVEX2-73; Mid dose ANAVEX2-73; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral capsule; Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized 1:1:1 to two different ANAVEX2-73 doses or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
Condition: Healthy
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine
      and immediate reactions within the first 30 minutes after injection.
    

Detailed description: 
      This trial was an open-label study, no randomization, and no placebo or control group. Total
      30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24
      hours, 48 hours, 72 hours, and 28 days after injection.
    

Intervention name(s): DPT/HepatitisB/Hib vaccine
Intervention type(s): Biological
Intervention description(s): DPT/HepatitisB/Hib vaccine (Bio Farma)
Other intervention name(s): Pentavalent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: DTB/HB/Hib vaccine; Infants; Phase I
Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Rectal Neoplasms; Colonic Neoplasms
Study type: Interventional

Summary: 
      A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling
      through the colon in low risk subjects.
    

Detailed description: 
      Asymptomatic adults between the ages of 18 and 70 will undergo screening of the colon using
      the aer-o-scope, under fluoroscopy, following by screening of the colon using a standard
      approved colonoscopy for determination of safety.
    

Intervention name(s): Aer-O-Scope Colonoscopy
Intervention type(s): Device
Intervention description(s): Screening Colonoscopy
Other intervention name(s): Aer-O-Scope
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: polyp
3D -Printed Single Implant Overdentures
Condition: Edentulous Mouth
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      A randomized clinical trial (RCT) was designed. The participants were randomly allocated into
      either of the two groups intervention or control group each of 14 participants. Participants
      in control group (Group-A) received conventional manufactured implant overdenture while
      participants in intervention group (Group-B) received CAD-CAM manufactured implant
      overdenture.
    

Detailed description: 
      Introduction: Mandibular single implant overdenture is a well-established treatment modality
      that address limited financial resources of patients and simultaneously enabled the
      management of conventional complete denture problems. CAD/CAM technology helped to mitigate
      the problems encountered with conventional fabrication techniques, which results in improved
      dentures fit and retention. Therefore, the aim of the current trial study was to evaluate
      whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient
      satisfaction, denture retention, implant survival rate and decreased post-insertion
      maintenance or not compared to overdentures manufactured using conventional techniques.

      Methods: A randomized clinical trial (RCT) was designed. The participants were randomly
      allocated into either of the two groups intervention or control group each of seven
      participants. Participants in control group (Group-A) received conventional manufactured
      implant overdenture while participants in intervention group (Group-B) received CAD-CAM
      manufactured implant overdenture.
    

Intervention name(s): conventional single implant overdenture; 3d printed single implant overdenture
Intervention type(s): Other; Other
Intervention description(s): conventional manufactured implant overdenture; CAD-CAM manufactured implant overdenture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Condition: Mixed Gliomas
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for adults with recurrent or refractory mixed gliomas provide
      very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy
      suggest that it may prove beneficial in the treatment of adults with recurrent or refractory
      mixed gliomas.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in adults with recurrent or
           refractory mixed gliomas as measured by an objective response to therapy (complete
           response, partial response or stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in adults with recurrent
           or refractory mixed gliomas.

      OVERVIEW: This is a single arm, open-label study in which adults with recurrent or refractory
      mixed gliomas receive gradually escalating doses of intravenous Antineoplaston therapy
      (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for
      at least 12 months in the absence of disease progression or unacceptable toxicity. After 12
      months, patients with a complete or partial response or with stable disease may continue
      treatment.

      To determine objective response, tumor size is measured utilizing MRI scans, which are
      performed every 8 weeks for the first two years, every 3 months for the third and fourth
      years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study
    

Intervention name(s): Atengenal; Astugenal
Intervention type(s): Drug; Drug
Intervention description(s): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).; Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Other intervention name(s): A10; AS2-1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult mixed glioma; refractoy adult mixed glioma
Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults
Condition: Pneumococcal Infection; Influenza
MeSH terms: Influenza, Human; Pneumococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children
      and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs),
      meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in
      China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children
      and adults. The main objective of this study is to show that both vaccines can safely be
      administered together without affecting the immune response of protecting against disease.
    


Intervention name(s): 23-valent pneumococcal polysaccharide vaccine; trivalent influenza vaccine; 23vPPV+TIV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM); Single 0.5ml trivalent influenza vaccine was administered IM; Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; vaccine; pneumococcal; influenza
Efficacy of Enhanced External Counterpulsation on Ventricular Function
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy of Enhanced External
      Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart
      disease
    

Detailed description: 
      Patients with coronary heart disease will be randomized into two groups:

      standard medical treatment and standard medical treatment plus EECP intervention. Ventricular
      structure and function will be measured and compared.
    

Intervention name(s): Experimental: Enhanced External Counterpulsation; Standard medical therapy
Intervention type(s): Device; Drug
Intervention description(s): Enhanced External Counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy has been approved by the United States Food and Drug Administration (FDA) for the treatment of refractory angina and heart failure. Administration of 35-36 hours EECP therapy over a 7 week period, one hour session every working day.; Guideline- driven standard medical treatment for 7 weeks
Other intervention name(s): EECP; Guideline- driven standard medical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary Heart Disease; Ventricular Function; Vascular Endothelium; Counterpulsation, External
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the use of a robotic device that is remotely controlled to maneuver
      a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation
      procedures.
    

Detailed description: 
      Key to the success of an electrophysiology procedure is the ability to accurately map, sense
      and pace the heart. Electrophysiology mapping catheters are available in a variety of shapes
      and electrode configurations. The majority of these catheters are manipulated manually by the
      physician. The Vdrive simplifies these manipulations by allowing an operator to mechanically
      advance, retract, rotate, deflect and maneuver a circular mapping catheter. The circular
      mapping catheter is not altered in structure, function or indication in the same manner as
      the predicate device (Cardiodrive Catheter Advancement System).

      This is a prospective, randomized, non-blinded, controlled study comparing manual navigation
      of a circular mapping catheter with mechanical navigation by the Vdrive. A total of 120
      patients are expected to complete the study: 80 patients in the Vdrive navigation arm and 40
      patients in the manual navigation arm. Patients will be enrolled at a minimum of one site in
      the European Union where the product is currently marketed and the United States, where the
      Vdrive is considered to be investigational.
    

Intervention name(s): Vdrive Lasso navigation; Manual Lasso navigation
Intervention type(s): Device; Procedure
Intervention description(s): Remote robotic Lasso navigation; Manually maneuver a Lasso catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: magnetic navigation; robotic control; RMT ThermoCool catheter
A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the local tolerability associated with the SC
      administration of TV-46046, and inform next steps of the TV-46046 development program.
    

Detailed description: 
      Eligible participants will be enrolled and receive 1 of each of the 4 SC study injections in
      each abdominal quadrant approximately 1 hour apart: 120 milligrams (mg)/0.3 milliliter (mL)
      of TV-46046, 60 mg/0.3 mL of 1:1 saline diluted TV-46046, 0.3 mL of TV-46046 Placebo and 104
      mg/0.65 mL Depo-subQ 104 per the assigned sequence.
    

Intervention name(s): TV-46046; Depo-subQ 104; TV-46046 Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TV-46046 will be administered per dose and schedule specified in the arm.; Depo-subQ 104 will be administered per dose and schedule specified in the arm.; TV-46046 Placebo will be administered per schedule specified in the arm.
Other intervention name(s): Medroxyprogesterone acetate injectable suspension; Depo-subQ Provera 104®
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Lidocaine Gel 2% and Muscle Traction Pain During Squint Surgery in Pediatrics
Condition: Squint
MeSH terms: Strabismus
Study type: Interventional

Summary: 
      Assessing the efficacy of lidocaine gel 2% application 10 minutes before surgery on post
      operative pain and the use of analgesics postoperatively
    

Detailed description: 
      After inhalational induction of anesthesia and applying the pulse oximeter to the patient's
      finger but and before cannulating or managing the patient's airway lidocaine gel 2% is
      efficiently applied to the surgical eye (to give more time for the gel to act without
      delaying the surgery) then cannulation and laryngeal mask inserted to maintain ventilation
      properly.

      Applying lidocaine gel 2% should be filling the upper and lower 10 minute fornices before
      disinfecting the eye and starting the surgery

      The primary outcome is assessing postoperative pain and need for postoperative systemic
      analgesia The secondary outcome is to monitor the oculocardiac reflex intraoperatively and
      the need for intraoperative atropine.
    

Intervention name(s): lidocaine gel 2%; control group
Intervention type(s): Drug; Other
Intervention description(s): assessing its efficacy in decreasing muscle traction pain,In the operation room, we started inhalational induction of anesthesia with sevoflurane till the patient is deeply anesthetized. In the experimental group, we applied lidocaine gel 2% abundantly below both eyelids of the surgical eye for at least 3 minutes before the surgical incision, while nothing was applied to patients in the control group.; In the operation room, we started inhalational induction of anesthesia with sevoflurane till the patient is deeply anesthetized. In control group, we didn't apply lidocaine gel 2% to the operative eye .
Other intervention name(s): xylocaine gel, topical anesthesia
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 group control and xylocaine gel 2% group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: squint; muscle traction; pain