bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
Condition: Oral Hygiene
Study type: Interventional

Summary: 
      This study will evaluate the effect of experimental sodium fluoride-silica dentifrice
      formulations, with and without zinc, on remineralization of enamel in situ. Following the
      remineralization phase, the acid resistance of the new mineral formed will be assessed.
      Fluoride uptake during the remineralization phase will also be measured.
    


Intervention name(s): Sodium fluoride (1426 ppm); Sodium fluoride (1150 ppm); Sodium fluoride (250 ppm); Sodium fluoride (1426 ppm) + zinc base A; Sodium fluoride (1426 ppm) + zinc base B; Fluoride (0 ppm)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base; Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base; Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base; Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base; Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base; Non-zinc, 0ppm fluoride in a silica gel base
Intervention MeSH terms: Zinc; Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Aquatic Exercise Program for Knee Osteoarthritis
Condition: Knee Osteoarthritis; Obesity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of PICO study is to design an aquatic exercise program specific for obese individuals
      with knee osteoarthritis which the main goals are OA symptoms management and the improvement
      of physical fitness. The author's opinion is that the musculoskeletal pain is the main
      constraint for any kind of mobility and its control should be considered as an important goal
      in the weight management's programs. Therefore the PICO project proposes an aquatic exercise
      program to controlling pain and other symptoms management, showing that it is possible to
      live with the disease, and motivating the change in lifestyle, thus preventing the
      installation or worsening of KOA. In this way, five hypotheses were formulated: H1. 3 months
      of aquatic exercise is enough to improve KOA symptoms and functionality in obese individuals;
      H2. The gait parameters of obese individuals with KOA can be improved by aquatic exercise;
      H3. Beyond the exercises skills, aquatic exercise group classes can work with an educational
      component, promoting lifestyles changes. H4: Pain reduction and a better psychological status
      can lead an increase of functionally, increasing amount of physical activity. H5: Even if the
      main goal is not weight management, the aquatic exercise program can lead a weight reduction
      or body composition change.
    

Detailed description: 
      The PICO program is an overall body fitness and mind intervention through aquatic exercise
      involving as well an education component, created specifically for individuals with KOA. Its
      a single-blinded, one center, and randomized controlled trial with 3 months duration.
      Participants will be randomized into one of two groups: aquatic exercise (AE) and control
      group (CG) which will participate in an educational program with the same hourly load.
    

Intervention name(s): Aquatic Exercise; Educational Program
Intervention type(s): Other; Behavioral
Intervention description(s): Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Aquatic exercise; Knee Osteoarthritis; Exercise; Pain; Obesity.
ICG-coated Endoscopic Clip for Tumor Localization
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The fluorescent clipping method involves endoscopic clipping a fluorescent clip into the
      colonic lesion site in advance of surgery, and observing the position of the fluorescence
      through the colonic wall by a light source of a certain wavelength band during surgery.

      The purpose of this study is to evaluate the efficacy of the localization of colonic lesions
      using ICG coated endoscopic clip in laparoscopic colon surgery.
    


Intervention name(s): ICG-coated clip
Intervention type(s): Device
Intervention description(s): Tumor localization using ICG-coated clip prior to surgery
Intervention model: Single Group Assignment
Intervention model description: Prospective single center open label early phase clinical trial
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Visceral Pleural Lumbar Lymphatic Drainage
Condition: Pulmonary Artery Stenosis
MeSH terms: Stenosis, Pulmonary Artery
Study type: Observational

Summary: 
      Anatomic variations of the pulmonary arterial tree can cause technical difficulties during
      pulmonary lobectomy in general and video-assisted thoracic surgery (VATS). Using CT
      angiography and 3D reconstruction, the investigators sought to identify anatomic variations
      of the pulmonary arterial tree and assess their respective frequencies.
    

Detailed description: 
      Purpose Anatomic variations of the pulmonary arterial tree can cause technical difficulties
      during pulmonary lobectomy in general and video-assisted thoracic surgery (VATS). Using CT
      angiography and 3D reconstruction, the investigators sought to identify anatomic variations
      of the pulmonary arterial tree and assess their respective frequencies. Methods the
      investigators retrospectively studied 88 pulmonary arterial trees in 44 patients having
      undergone VATS lobectomy for lung cancer over an 18-month period in Amiens University
      Hospital's Department of Thoracic Surgery. Each CT angiography with 3D reconstruction of the
      pulmonary arterial tree was performed by two experienced operators, according to a
      standardized procedure.
    

Intervention name(s): Pulmonary arterial tree
Intervention type(s): Other
Intervention description(s): The investigators performed 3D reconstruction of the pulmonary arterial tree on the CT angiography data set acquired during preoperative work-up.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The investigators studied patients having undergone VATS lobectomy for stage I-II lung
        cancer at the Amiens University Hospital's Department of Thoracic Surgery between October
        2012 and March 2014. We performed 3D reconstruction of the pulmonary arterial tree on the
        CT angiography data set acquired during preoperative work-up.
      
Keywords: Pulmonary artery; 3D reconstruction; Video-assisted thoracic surgery lobectomy; CT angiography; Anatomic variation
Body Weight Support in Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Body Weight; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effectiveness of body weight-supported
      treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord
      injury (SCI) in chronic stage
    

Detailed description: 
      The individuals who participated in this study were subjects with SCI with more than twelve
      months of evolution. All were classified as incomplete injury class C or D according to the
      American Spinal Injury Association (ASIA). Each received training on a BWST for six weeks.
      Two measures of stance balance were performed during the training protocol. The first measure
      was made before entering the training protocol; the final measure was implemented once the
      gait training on BWST protocol was completed. For instrumented stance balance testing, small
      wireless inertial motion sensors (OPAL sensors, APDM Inc., Portland, OR) were placed on the
      subjects' waist. Subjects performed instrumented stance with their eyes opened (iSway).
      Outcome measures were recorded and automatically generated using Mobility Lab software (APDM
      Inc., Portland, OR). Measures included the root mean square of sway and jerk (normalized to
      the range of acceleration amplitude).
    

Intervention name(s): BWST
Intervention type(s): Device
Intervention description(s): BWST (six weeks, 3 times/week)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore).
Condition: Neuro-surgery; Brain Tumor; Post-operative Complications; Neuro-ICU Stay
MeSH terms: Brain Neoplasms; Postoperative Complications
Study type: Observational [Patient Registry]

Summary: 
      Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but
      lifethreatening post-operative complications. There are currently no strong recommendations
      to help the clinician in an attempt to properly hospitalise these patients after their
      intervention (Neuro-ICU, ICU,surgical ward).

      Determining risk factors of post-operative complications could optimise resources. Therefore
      hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.
    

Detailed description: 
      Retrospective analysis of a prospective database to create a Risk Score. Post-operative
      neurosurgery complications recording (Hyponatremia < 135mmol/l,Insulin administration,
      Nausea-Vomiting, Glasgow Coma Score, Inhalation, Post-operative intra-cranial bleeding
      requiring neurosurgery, Intra-cranial hypertension, Use of osmotherapy, Status epilepticus,
      Brain death, Death).

      Collection of datas as Duration of mechanical ventilation, Length of ICU stay, Length of
      hospital stay.

      Validation of this score on an independent prospective cohort.
    

Intervention name(s): Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing neuro-surgery for a brain tumor
      
Keywords: Neuro-surgery; Post-operative complications; Neuro-ICU resources
Glucose Response in Persons With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This will be a randomized crossover design with oral nutrition supplement interventions.
    

Detailed description: 
      This will be a randomized crossover design with two oral nutrition supplement interventions.
      The subjects will be randomized to one of two interventions on two separate study days, one
      week apart.
    

Intervention name(s): Oral nutrition supplement - control; Oral nutrition supplement - test
Intervention type(s): Other; Other
Intervention description(s): Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.; Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a randomized crossover design. The subjects will be randomized to one of two interventions on two separate study days, one week apart.
Masking: Single (Participant)
Primary purpose: Supportive Care
The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Many adults in the United States regularly consumer energy drinks. Currently, the safety of
      energy drinks is still questionable and there are many reports associating energy drinks with
      adverse events including hospitalizations and deaths. Previous research shows that energy
      drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher
      volume (32 ounces) of energy drinks than those available in the market (24 ounces). The
      purpose of this study is to study if 24-ounce energy drinks can significantly affect heart
      rhythm and elevate blood pressure when compared to a placebo.
    

Detailed description: 
      The study is a randomized, double blind, controlled, crossover study comparing the effect of
      energy drinks and placebo on cardiovascular parameters including heart rhythm and blood
      pressure.

      Subjects who contact the PI for interest in study participation will be scheduled a time to
      study facility for initial evaluation on eligibility criteria. At initial evaluation,
      participants will be informed about the study details, presented with Informed Consent
      Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to
      participate. Once consented, participants will be asked a series of questions and screened
      for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient
      is eligible to enroll, they will be allocated a randomized identification number.

      Participants will be randomly assigned to consume either two-12 oz bottles of energy drink
      and two-12 oz bottles of control drink on 2 separate days. The study will occur over
      approximately 8 days with each session taking about 5 hours per day. Each session will have 6
      days between each other.

      Participants will be expected to refrain from any products containing caffeine or alcohol 48
      hours and fast 10 hours before each study visit. At the beginning of each study visit,
      baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to
      consuming study drinks. Repeat measurements will be obtained every 60 minutes after
      consumption over 4 hours.
    

Intervention name(s): Energy drink; Placebo drink
Intervention type(s): Other; Other
Intervention description(s): Two 12 oz bottles of commercially available energy drink; Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Energy drink; Heart rhythm; QT prolongation; Blood pressure
Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of a range of
      BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to
      moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study
      population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of
      BIIB037 after single-dose administration.
    

Detailed description: 
      BIIB037 is an investigational product being developed as a treatment for Alzheimer's disease
      (AD). BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibody that is
      selective for the fibrillar form of beta amyloid (Aß).
    

Intervention name(s): BIIB037; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg.; Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.
Other intervention name(s): Aducanumab; fully human IgG1 anti-Aβ mAb
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Utility of Amantadine Hydrochloride in the Treatment of Post-traumatic Irritability
Condition: Irritable Mood; Aggression; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Aggression
Study type: Interventional

Summary: 
      The purpose of this study is to determine if amantadine hydrochloride given 100 mg in the
      morning and at noon is safe and effective in the treatment of mood and behavior changes (i.e.
      irritability) after sustaining traumatic brain injury.
    

Detailed description: 
      Amantadine hydrochloride is a drug used commonly in clinical practice at the Carolinas
      Rehabilitation for the treatment of mood and behavior changes following traumatic brain
      injury. Clinical observation suggests that the use of amantadine improves caregiver report of
      "irritability" though there are no studies to validate this observation. This study
      investigates the efficacy and side effect profile of amantadine hydrochloride given in 2
      doses of 100 mgs each. Subjects are screened during regularly scheduled clinic appointments
      for the presence of irritability. If they are interested in possible participation in the
      study, they will be invited to meet with the research coordinator who will obtain informed
      consent. If the subject meets all the inclusion/exclusion requirements, they will leave
      clinic with study medication and begin taking the drug the next day. There will be a safety
      call between day 3 and 5 where the dose may be reduced to once per day. Follow-up assessment
      occurs at day 14 (by phone) and day 28 (in clinic). At study completion, the subject will
      have the opportunity to receive a prescription for amantadine as part of ongoing clinical
      care.
    

Intervention name(s): Amantadine
Intervention type(s): Drug
Intervention description(s): Amantadine 100 mg every morning and 12 noon
Other intervention name(s): Symmetrel
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritability; Aggression; Brain Injury; Amantadine; Irritability and Aggression Due to Traumatic Brain Injury
Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
Condition: Cholangitis, Secondary Biliary; Treatment Compliance; Antibodies Drug Specific
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Interventional
Phase: Phase 4

Summary: 
      Application of multi-center, prospective study on the severity of postoperative cholangitis
      biliary atresia classification, according to the degree of cholangitis targeted therapy, to
      improve the therapeutic effect of postoperative cholangitis biliary atresia, decrease the
      overuse of antibiotics related complications.
    

Detailed description: 
      Cholangitis patients post-kasai Portoenterostomy were grouped by cholangitis severity score,
      according to the severity was divided into mild, moderate, severe cholangitis, all levels of
      cholangitis patients were divided into subgroups by age and post-kasai Portoenterostomy
      jaundice matching design of experiment, then they were randomly divided into control group
      and experimental group, and all the control group unified antibiotic treatment, the
      experimental group was graded antibiotic treatment according to the severity cholangitis,
      after three days treatment，evaluate each treatment effect, average hospitalization days, the
      average hospitalization expenses, antimicrobial drug use strength to evaluate the therapeutic
      effect of postoperative cholangitis biliary atresia.
    

Intervention name(s): Sulperazon; Teicoplanin; Meropenem Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.; severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.; cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
Other intervention name(s): Tinidazole injection; Meropenem Injection; Tinidazole injection; Tinidazole injection
Intervention MeSH terms: Meropenem; Tinidazole; Teicoplanin; Sulperazone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cholangitis patients post-kasai Portoenterostomy were grouped by cholangitis severity score, according to the severity was divided into mild, moderate, severe cholangitis, all levels of cholangitis patients were divided into subgroups by age and post-kasai Portoenterostomy jaundice matching design of experiment, then they were randomly divided into control group and experimental group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholangitis; biliary atresia; kasai Portoenterostomy; antibiotics; treatment
Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
Condition: Tinea Cruris; Jock Itch
MeSH terms: Tinea; Tinea cruris
Study type: Interventional
Phase: Phase 3

Summary: 
      To see how well Naftin 1% cream works when applied once daily to the affected area. The
      results will be compared to those using a placebo cream, which is a cream with no active
      ingredient. Safety will also be measured.
    


Intervention name(s): Naftin 1% Cream; Placebo Cream
Intervention type(s): Drug; Drug
Intervention description(s): Topically applied once a day; Topically applied once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment