bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth
Condition: White Spot Lesion
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the effectiveness of Casein phosphopeptide-amorphous
      calcium phosphate fluoride varnish (CPP-ACP FV) in comparison to fluoride varnish (FV) as a
      remineralizing agent for white spot lesions in primary teeth (WSLs).
    

Detailed description: 
      The study is a two parallel arms double blinded randomized controlled clinical trial. A total
      of 180 WSL in primary teeth in chikdren aged 2-5 y and satisfying the inclusion criteria were
      selected. Patients will be randomly allocated into 2 groups allocated to two varnishes: study
      group: CPP-ACP FV (MI varnish), Control group FV (Duraphat). Both fluoride varnishes
      applications are applied with identical intensive protocols every 2 weeks for 6 weeks. The
      application of each varnish will be according to manufacturer's instructions. The operator is
      not blinded to treatment type. Only the participants and statistician are blinded to
      treatment groups. The whole sample (N=180) will be followed up at 6 weeks and at 18 and 30
      weeks for Visio-tactile assessment and DIAGNOdent measurements
    

Intervention name(s): CPP-ACP; Duraphat
Intervention type(s): Drug; Drug
Intervention description(s): The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.; The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.
Other intervention name(s): MI varnish; Casein phosphopeptide-amorphous calcium phosphate fluoride varnish; Sodium Fluoride varnish
Intervention MeSH terms: Fluorides; Sodium Fluoride; Fluorides, Topical; Sodium fluoride topical preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a double blind randomized controlled clinical trial, with a 1:1 allocation ratio. Subjects are randomly assigned using a computer -generated list of random numbers to one of the two arms (MI varnish, Duraphat fluoride varnish).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fluoride varnish; Casein; MI varnish
A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior
      to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.
    


Intervention name(s): ITCA 650; ITCA placebo
Intervention type(s): Drug; Other
Intervention description(s): ITCA 650 is exenatide in DUROS; Formulation in DUROS (no exenatide)
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Effectiveness of Enteric Coated(E.C.) Anise-oil on Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but
      Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of
      Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and
      bloating.
    

Detailed description: 
      The purpose of this study is to assess the efficacy of Enteric-coated Anise-oil capsules
      comparing with placebo and Colpermin® for treatment of IBS patients. 120 patients with
      confirmed IBS with non-response criteria selected. In this double blind pilot study, the
      patients and researchers will be blinded about Receiving Drug, Placebo and Active allocation.
      Patients will be randomized into group A (Anise-oil EC Capsule 187 mg daily, for 4 weeks),
      group B (placebo Capsule once daily, for 4 weeks) and group B (Colpermin® Capsule once daily,
      for 4 weeks). At the end of therapy (4 weeks) and at baseline (first), 2 weeks after
      receiving drug, placebo and Colpermin® IBS load, will be evaluated and compared between
      groups.
    

Intervention name(s): Anise-oil EC Capsule; Placebo; Colpermin®
Intervention type(s): Drug; Other; Drug
Intervention description(s): Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks; One Placebo Capsule/Day for 4 Weeks; Colpermin® Capsule/Day for 4 Weeks
Other intervention name(s): Group A; Group B; Group C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pimpinella anisum L.; Peppermint oil; Irritable Bowel Syndrome
The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Anterior Wall Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The investigators applied G-CSF to patients 2 weeks after acute anterior MI and successful
      PCI to evaluate the efficacy and safety of G-CSF in improving myocardial function as cytokine
      which improve inflammation and mobilize stem cells from bone marrow for regeneration of
      myocardium.
    

Detailed description: 
      Ten patients in the treatment group and 10 patients in the control group were enrolled in
      this prospective, randomized, double blinded study. Two weeks after myocardial infarction
      that was accompanied by successful recanalization and stent implantation, the patients of the
      treatment group received 10 μg/kg body weight per day (divided BID) G-CSF subcutaneously for
      treatment duration of maximum 5.0 days. In both groups, ejection fraction was evaluated with
      echocardiography and cardiac scan (Gated SPECT method) 10 days after myocardial infarction
      and after 6 months. Tei index was measured by echocardiography.

      Results: No severe side effects of G-CSF treatment were observed. Ejection fraction
      determined by cardiac scan increased in the treatment group from 0.428 to 0.462 and from
      0.470 to 0.496 in the control group but there was no significant improvement of left
      ventricular ejection fraction when the G-CSF treated group was compared to the controls
      (p=0.821 for cardiac scan and p=0.705 for echocardiography). Changes in Tei index was not
      significant in the treatment group (p=0.815) however it reached significant level in the
      control group (p=0.005), respectively.
    

Intervention name(s): G-CSF; placebo infusion of normal saline
Intervention type(s): Drug; Drug
Intervention description(s): after 2 week post MI an d PCI G-CSF was infused for 5 days at dose of 10 microgram/Kg; 2 week post MI and PCI normal saline was infused
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: G-CSF; Myocardial infarction
Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response
Condition: Dystonia, Focal
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      Botulinum neurotoxin (BoNT) is injected into muscles for treatment of dystonia. BoNTs are
      zinc proteases, and their enzymatic effect is reduced in the setting of low zinc. The study
      hypothesis is that a large enough fraction of unselected dystonia patients receiving BoNT
      injection have suboptimal zinc concentration in their tissues, and will experience improved
      response to BoNT if the injection is preceded by oral zinc supplementation (OZS). OZS
      consists of 50 mg of zinc acetate oral tablet each day for 7 days before injection. This is a
      double blind placebo controlled cross-over study, randomized order placebo and OZS, in
      patients at a neurology clinic on stable dose of BoNT.
    


Intervention name(s): Zinc Acetate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 50 mg tablet; Zinc Acetate matched placebo tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single site randomized placebo controlled trial, cross-over
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Combined Effects of Simultaneous Variety and Portion Size on Meal Intake of Women
Condition: Eating Behavior
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the combined effects of simultaneous meal
      variety and portion size on food intake at a meal. Additionally, other individual
      characteristics will be examined for their influence on the effects of simultaneous variety
      and portion size on meal intake.
    


Intervention name(s): Simultaneous Variety; Single-Food; Small Portion; Large Portion
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 3 different foods served; 1 food served; Small meal portion size; Large meal portion size
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      -  to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate
           85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine

        -  to demonstrate the superiority of Trexima versus the individual components (sumatriptan
           as the succinate 85 mg and naproxen sodium 500 mg), and

        -  to evaluate the safety of the Trexima.
    


Intervention name(s): sumatriptan; naproxen sodium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: TREXIMA; MIGRAINE HEADACHES; Subjects may be enrolled if they are 18-65 years of age, have a demonstrated history of migraine headaches
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
Condition: Systemic Lupus Erythematosus; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 single and multiple dose escalation study to evaluate the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with
      seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This
      study will include two parts: Part A and Part B. Part A will consist of single ascending dose
      cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of
      approximately 112 subjects at approximately 10 sites.
    


Intervention name(s): PF-06835375; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.; Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
Condition: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; Fatigue; Pain
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic; Myalgia; Syndrome; Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to analyze income variables in Chronic Fatigue Syndrome/Myalgic
      Encephalomyelitis, and to analyze the effect of short vs. long Cognitive Behaviour Therapy.
    


Intervention name(s): CBT; CBT; Control group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Individual Cognitive Behavior Therapy during 16 weeks; Individual Cognitive Behavior Therapy during 8 weeks; Waiting 16 weeks and receiving 8 weeks individual CBT after waiting period.
Other intervention name(s): Grades excercise therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CBT; Fukuda criteria; Mental functioning; Physical functioning
BPO vs Hibiclens Soap for Surgical Preparation
Condition: Propionibacterium Acnes
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical
      preparation. The objective is to determine whether benzoyl peroxide soap, commonly available
      in drug stores for over-the-counter acne treatment, is as or more effective than the standard
      surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of
      Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty
      (joint replacement).
    


Intervention name(s): Benzoyl Peroxide 10% Bar; Chlorhexidine Gluconate
Intervention type(s): Drug; Drug
Intervention description(s): Patients will wash with Benzoyl Peroxide 10% Bar; Patients will wash with Chlorhexidine Gluconate
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
Condition: Paediatric Outpatient Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale:

      The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug
      premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so
      coordination between departments and operating room, exposed to the risks of side effects and
      failure and this variability action. Alternative means were evaluated, such as the presence
      of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games.

      Electronic tabs are small devices; light, easy to use with age-specific and interactive
      programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety
      and distract children compare to preoperative medication.

      Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10
      years old programmed for a short term and low level of pain outpatient surgery. My pass score
      will be measured when arriving at the hospital, at the time of the separation with the
      parents, at the time of the anaesthetic mask induction and after the surgery.

      118 patients will be randomized as follows :

        -  Arm 1 : Hypnovel® (midazolam)

        -  Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon
           area.
    


Intervention name(s): electronic tab; Midazolam oral intake
Intervention type(s): Procedure; Drug
Intervention description(s): classic use of an electronic tab with age specific games
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: outpatient surgery; anaesthesia; midazolam; electronic tab
A Study of RC48-ADC in Subjects With Advanced Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection
      in subjects with advanced breast cancer with HER2 positive or HER2 low expression
    


Intervention name(s): RC48-ADC 1.5 mg/kg (HER2 Positive); RC48-ADC 2.0 mg/kg (HER2 Positive); RC48-ADC 2.5 mg/kg (HER2 Positive); RC48-ADC 2.0 mg/kg (HER2 Low Expression)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 1.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.; 15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.0mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.; 15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.; 45 advanced breast cancer participants with HER2 Low Expression will be treated with RC48-ADC at a dose of 2.0 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives
Condition: Oral Contraceptives
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine whether the treatment with AZD1981 will
      affect the metabolism of hormones included in oral contraceptives.
    


Intervention name(s): AZD1981; Neovletta 21/28; Placebo AZD1981
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4X100 mg per oral, twice daily for 28 days; Once daily with (21) or without (28) pause for bleeding.; 4X100 mg per oral, twice daily for 28 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase I; Drug-drug interaction; Oral contraceptives; AZD 1981
Lung Ultrasonography After Major Cardiac Surgery
Condition: Pneumonia; Cardio/Pulm: Respiratory Failure; Cardiopulmonary Bypass
MeSH terms: Pneumonia; Respiratory Insufficiency
Study type: Observational

Summary: 
      Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac
      surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia,
      but its usefulness and reliability was never evaluated after cardiac surgery. This study
      investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.
    


Intervention name(s): Lung Ultrasound
Intervention type(s): Diagnostic Test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute respiratory failure after cardiac surgery and hospitalized in the
        surgical Intensive Care Unit of ICU of Cardiology Institute, Pitié Salpêtrière University
        Hospital, Paris, France
To Compare Cemented Versus Screw-retained Implant-supported Single Crowns With Customized Zirconia Abutments
Condition: Implant-supported Single Crowns
Study type: Interventional

Summary: 
      The aim of this study is to test whether or not the use of screw-retained implant crowns on
      customized zirconia abutments results in biological, technical and esthetic outcomes similar
      to those obtained with cemented all-ceramic crowns on customized zirconia abutments, both
      made with a computer-aided design and manufacturing procedure (CAD/CAM).

      The null-hypotheses is that marginal bone level change is equal at screw-retained and
      cemented crowns
    


Intervention name(s): Cemented crowns; Screw-retained crowns
Intervention type(s): Procedure; Procedure
Intervention description(s): The final lithium disilicate crowns will be cemented with an adhesive cement after tightening the abutments with the torque indicated by the manufacturer and closing the screw access hole with white guttapercha. The abutment will be cleaned with ethanol. A retraction cord will be placed for cementation if indicated. The crown will be etched with hydrofluoric acid and subsequently silanized. A sufficient amount of cement will be filled in the crown without creating major excesses. When the crown is seated correctly, the cement will be light-cured for a few seconds to facilitate the removal of the now hard excess cement.
- Excess cement will be meticulously removed with a carbon scaler. The removal of all excess cement will be checked with an X-ray and by visual and tactile inspection.; The screw-retained crowns will be inserted and tightened with the torque indicated by the manufacturer. The screw access hole will to be closed with white guttapercha and a composite filling (Filtek, 3M ESPE).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care