bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold
Condition: Nasolabial Fold
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of the study medical device,
      Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction
      of nasolabial folds
    

Detailed description: 
      This study is a multi-center, double blind, intra-individual controlled, active-controlled
      clinical trial.

      Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after
      Injecting medical device.
    

Intervention name(s): Neuramis® Deep Lidocaine; Restylane® PERLANE-L
Intervention type(s): Device; Device
Intervention description(s): HA filler; HA filler
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wrinkle Severity Rating Scale; Global Aesthetic Improvement Scale; Hyaluronic acid filler; filler; Nasolabial Fold
Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft
Condition: Genovarum
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in
      patients with genovarum deformity using iliac crest allograft compared to the results when
      using iliac crest autograft.
    


Intervention name(s): Iliac crest allograft; Iliac crest autograft
Intervention type(s): Procedure; Procedure
Intervention description(s): Opening wedge osteotomy of proximal tibia with allograft from iliac crest; open wedge osteotomy of proximal tibia using autogenous iliac bone graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Genovarum; Medial opening-wedge high tibial osteotomy; allograft
A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to explore the pharmacokinetic profile and safety after biweekly
      (every 2-week) intramuscular (IM) injections (6 injections) of risperidone long acting
      injectable 25, 37.5, or 50 mg/dose in schizophrenic patients. The efficacy of the study
      medication will also be assessed.
    

Detailed description: 
      This is an open-label, multicenter, randomized, 3-arm trial to compare the pharmacokinetic
      profile and the safety profile between 3 dose groups. There are 2 periods in this study: a
      10-week treatment period and an 8-week follow-up period. Patients will receive 6 injections
      of long acting injectable risperidone at one of the dose levels (25, 37.5 and 50 mg) every 2
      weeks according to their randomly assigned treatment. Blood samples will be collected
      throughout the 10-week treatment and 8-week follow-up period to determine the changes in
      study drug concentration in the plasma. Safety will be assessed by monitoring of adverse
      events, subjective symptoms/objective findings, laboratory tests, physical examinations,
      electrocardiograms, injection site reactions, and the Drug-Induced Extrapyramidal Symptoms
      Scale (DIEPSS). Efficacy of the study drug will be assessed based on the Positive and
      Negative Syndrome Scale (PANSS) and the Clinical Global Impression - Severity (CGI-S) and
      Clinical Global Impression - Change (CGI-C) scales. The patients will receive injections of
      long acting injectable risperidone (either 25, 37.5, or 50 mg) in their muscle every 2 weeks
      for 10 weeks for a total of 6 injections.
    

Intervention name(s): Risperidone long acting injectable
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Risperidone; Intramuscular injection; Pharmacokinetics
Early Diagnosis of Asthma in Young Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The overall aim of the study is an early asthma diagnosis in young children by the use of
      non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early
      lung function measurements
    


Intervention name(s): beclomethasondipropionate
Intervention type(s): Drug
Intervention description(s): 2 x 100 ug dd for two months, via aerochamber
Other intervention name(s): Qvar Extra Fijn
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: asthma; transient wheezing; early diagnosis; exhaled air; nitrogen monoxide; airway resistance
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
Condition: Choroidal Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 3

Summary: 
      To report preliminary results on safety and tolerability of intravitreal injection of
      Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green
      (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.
    


Intervention name(s): Ranibizumab injection and TTT - ICG based
Intervention type(s): Drug
Intervention description(s): Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Other intervention name(s): Lucentis injection
Intervention MeSH terms: Ranibizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Choroidal melanoma; Lucentis; TTT-ICG
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the
      safety, tolerability, PK and PD properties of single ascending intravenous (IV) and
      subcutaneous (SC) doses of KPL-404 in healthy subjects
    

Detailed description: 
      This study includes 2 single ascending dose (SAD) parts; (Part A) IV SAD (up to 5 planned
      dose level cohorts) and Part B SC SAD (up to 3 planned dose level cohorts).

      Safety assessments will include adverse events (AEs), concomitant medications, clinical
      laboratory, vital signs, 12-lead electrocardiogram, and physical examination. Serial blood
      samples for PK, PD, and anti-drug antibodies will be performed during each part of the study
      during the Treatment and Safety Evaluation Period.
    

Intervention name(s): KPL-404; Matching Placebo
Intervention type(s): Drug; Other
Intervention description(s): humanized IgG4 monoclonal antibody; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Clinical Trial to Evaluate the Efficacy and Safety of DWKH
Condition: Respiratory Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, Double-blind, Parellel, Multicenter, Active-controlled
    


Intervention name(s): DWKH; DWKH-R; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of DWKH three times daily; Administration of DWKH-R three times daily; Administration of Placebo three times daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this pilot study is to evaluate the validity and feasibility of an educational
      approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely
      changes in therapy, when needed.
    


Intervention name(s): SMBG plus intensive education
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Self monitoring blood glucose
Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery
Condition: Heart Valve Diseases
MeSH terms: Lung Injury; Heart Valve Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the
      postoperative course of the patients. The investigators hypothesized that RIPCcom, combined
      intervention of remote ischemic preconditioning and remote ischemic postconditioning, would
      confer beneficial influence on inflammatory response and resultant postoperative pulmonary
      dysfunction after CPB in patients undergoing complex valvular heart surgery who are at
      increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate
      the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients
      undergoing complex valvular heart surgery.
    


Intervention name(s): remote ischemic pre and postconditioning (RIPC)
Intervention type(s): Procedure
Intervention description(s): RIPCcom group: combined intervention of remote ischemic pre- and postconditioning consisted of three 10-minute cycles of right lower limb ischemia, which was induced with an automated cuff-inflator placed on the right upper leg and inflated to 250 mmHg, with an intervening 10 minute of reperfusion during which the cuff was deflated. This intervention were performed at 10 minutes after induction of anesthesia and then 10 min after weaning from CPB.
Other intervention name(s): combined intervention of remote ischemic preconditioning and remote ischemic postconditioning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction
Condition: Heart Failure; Diastolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Diastolic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether high intensity interval training (HIIT) is
      superior to moderate continuous training in increasing cardiopulmonary capacity in heart
      failure with preserved ejection fraction patients.
    

Detailed description: 
      High intensity interval training (HIIT) has been proved to increase oxygen consumption,
      having superior cardiovascular effect when compared to moderate continuous training (MCT) in
      post-infarction patients (Wisloff et al.) Aerobic training also had shown positive effect on
      oxygen consumption and diastolic function in subjects with HFPEF when compared to usual care
      (Edelmann et al).

      However, the comparison of HIIT and MCT on improving functional capacity and diastolic
      function in HFPEF patients has not yet been study.
    

Intervention name(s): High Intensity Interval Training; Moderate Continuous Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The HIIT group will warm up for 10 minutes at 60% to 70% of peak heart rate(50% to 60% of V̇O2peak) before walking four 4-minute intervals at 85% to 95% of peak heart rate. Each interval will be separated by 3-minute active pauses, walking at 60% to 70% of peak heart rate. The training session will be terminated by a 3-minute cool-down at 60% to 70% of peak heart rate. Total exercise time will be 38 minutes for the HIIT group. Patients will perform 3 training sessions per week for 12 consecutive weeks.; The moderate continuous training (MCT) group will undergo treadmill walking continuously at 60% to 70% of peak heart rate for 47 minutes each session to make sure the training protocols will be isocaloric. Patients will perform 3 training sessions per week for 12 consecutive weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a new intervention (CARES: Cognitive Adaptations to
      Reduce Emotional Stress Associated with Type 1 Diabetes) designed to reduce caregiver
      depressive symptoms in families of children with T1D. This is a pilot in which all enrolled
      parents/caregivers will be placed in the intervention group to assess initial pre- to
      post-treatment impact of the intervention on parent/caregiver depression, distress, and
      diabetes-related outcomes (e.g., glycemic control).
    


Intervention name(s): CARES Intervention
Intervention type(s): Behavioral
Intervention description(s): A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea
Condition: Erythematotelangiectatic Rosacea; Papulopustular Rosacea
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      A single center prospective, randomized, controlled split face study comparing a 532nm KTP
      laser with a 595nm PDL for the treatment of Erythematotelangiectatic Rosacea and
      Papulopustular Rosacea.

      Subjects will receive laser treatments and will be followed at 6 weeks post-final laser
      treatment.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of the 532nm KTP laser
      within the Cutera® Excel V system for the treatment of Erythematotelangiectatic Rosacea and
      Papulopustular Rosacea as compared to a 595nm Pulse Dye Laser.

      The objectives of this study are:

      1) To evaluate and compare the safety and efficacy of the laser treatments for
      Erythematotelangiectatic Rosacea and Papulopustular Rosacea at 6 weeks post final laser
      treatment.
    

Intervention name(s): 532nm KTP Laser vs 595nm Pulse Dye Laser
Intervention type(s): Device
Intervention description(s): Intervention for the Cutera Excel V system is to cease treatment to any subject that is experiencing any adverse reaction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 532nm; Excel V; Cutera; Laser; Laser Light; PDL; 595nm; Flash Lamp
A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac
      Disease
    

Detailed description: 
      A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation,
      Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and
      Subjects With Well-Controlled Celiac Disease
    

Intervention name(s): 4 dose levels of ALV003
Intervention type(s): Drug
Intervention description(s): 4 dose levels of ALV003 vs placebo
Other intervention name(s): ALV003 and ALV003 placebo equivalent
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Celiac Disease
Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock)
Condition: Hemorrhagic Shock
MeSH terms: Shock; Shock, Hemorrhagic
Study type: Interventional
Phase: Phase 2

Summary: 
      Based on encouraging results from animal studies, the investigators hypothesize that early
      administration of IV Premarin® in patients with hemorrhagic shock will safely reduce
      secondary injury, and improve survival.
    

Detailed description: 
      Annually in the United States, approximately 30 million people require treatment for
      traumatic injuries in emergency departments. Two million of these patients require
      hospitalization, with several hundred thousand ultimately dying, often due to extreme blood
      loss. Importantly, these traumatic injuries are the leading cause of death and disability for
      children and young adults under the age of 44, with the total cost of trauma in the U.S.
      approaching $260 billion each year.

      Despite advances in pre-hospital care, early resuscitation, surgical interventions and
      intensive care monitoring aimed at the primary traumatic injury, many survivors never
      recover. A significant cause of this mortality and morbidity is thought due to potentially
      preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in
      the first few hours after the severe traumatic event.

      In spite of the current bleak outlook for many of these patients, a series of animal
      investigations have uncovered a promising solution to the problem of the secondary injury
      seen in hemorrhagic shock and other similar processes, namely the early administration of
      estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound.

      Based on encouraging results from animal studies, the investigators hypothesize that early
      administration of IV Premarin® in patients with hemorrhagic shock will safely reduce
      secondary injury, and improve survival.
    

Intervention name(s): Premarin IV; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One time dose of Premarin IV; One time dose of placebo.
Other intervention name(s): Estrogen IV; Infuvite Multivitamin
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads
      to changes in ventricular re-polarization. This in turn can result in changes of heart
      rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor
      antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed
      in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this
      study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular
      adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg
      position.
    

Detailed description: 
      Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads
      to changes in ventricular re-polarization. This in turn can result in changes of heart
      rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor
      antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed
      in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this
      study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular
      adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg
      position. Fifty-six patients, aged more than 19 years, undergoing robot-assisted laparoscopic
      prostatectomy will be divided into ramosetron group (n=28) and control group (n=28). Randomly
      selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In
      contrast, patients in the control group are given the same volume of normal saline after
      induction and given a 0.3 mg of ramosetron after measurement of QTc interval. The primary
      endpoint is the difference in maximal change of QTc interval between groups.
    

Intervention name(s): Ramosetron; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.; In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention