bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of the Preparation of an Advanced Therapy Medicinal Product for Dental Pulp Regeneration
Condition: Dental Stem Cells; Dental Pulp Regeneration
Study type: Observational

Summary: 
      Current endodontic treatment are based essentially on the ouster of parenchyma in case of
      trauma or irreversible pulp inflammation. These situations typically affect immature teeth in
      subjects aged from 8 to 15 years. Consequently, loss of a functional pulp is leads to
      discontinuation of root development and apical closure. The challenge for the clinician in
      the management of such situations is then preserving a pulp vitality. But current practices
      consist in a filling of the endo-canal system with an inert or semi-inert material. In this
      case, no pulp vitality is present. New treatment methods are needed. The objective Pulp'R is
      the study the feasibility of preparing an autologous combined advanced therapy medicinal
      product (ATMP) for dental pulp regeneration in the patient with irreversible pulp
      inflammation or dental trauma.
    


Intervention name(s): teeth avulsion
Intervention type(s): Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male or Female aged from 8 to 15 years, with at least one tooth affected by a carious
        process, or a major trauma preventing the maintenance of the tooth in the arch, or
        requiring avulsion germs wisdom teeth.
      
Biospecimen description: 
      Dental Pulp stem cells
The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Adequate nutritional support is an essential element for achieving favourable outcomes in
      critically ill patients. Therefore, an accurate determination of patients' energy needs is
      required to optimize nutritional support and reduce the harmful effects of under- and
      over-feeding. Currently, indirect calorimetry is considered as a gold standard for measuring
      energy expenditure during critical illness.

      This randomized study aims to investigate the impact of indirect calorimetry guided nutrition
      therapy on clinical outcomes such as ICU. Mortality, hospital mortality, duration of
      mechanical ventilation, length of I.C.U./hospital stay and mascle wasting. The investigators
      hypothesis that nutrition therapy guided by IC will improve clinical outcomes in severely ill
      patients
    

Detailed description: 
      This is a single-blind randomized control study. Eligible participants are randomly assigned
      within 24 hrs of ICU. admission in two groups

        -  Intervention group: The calorie needs will be determined by indirect calorimetry.

        -  Control group: a routine standard weight-based equation (20-25kcal/kg ideal body
           weight/day) will be used to estimate the energy requirements of critically ill patients.

      Daily energy and protein data will be recorded for a maximum of 12 evaluable days
      (nutritional days) or until death or discharge from ICU.while outcome data will be collected
      for a maximum of 28 days.
    

Intervention name(s): Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)
Intervention type(s): Dietary Supplement
Intervention description(s): Enteral nutrition feeding formula is used in powder form and will be reconstituted by attending nurses, Continuous feeding is commonly used which will be prescribed by the attending clinicians, Energy and protein intake from EN will be estimated by multiplying the volume of feed given to energy (kcal) and protein (g) in 1 ml of standard dilution, and for Standard PN product, energy and protein intake will also be calculated based on the volume infused.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Indirect calorimetry, Energy expenditure, Critical illness
Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg Virus
Condition: Marburg Hemorrhagic Fever
MeSH terms: Hemorrhagic Fevers, Viral; Marburg Virus Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and pharmacology of single
      administrations of AVI-6003, a post-exposure prophylaxis candidate treatment for Marburg
      virus.
    

Detailed description: 
      Marburg hemorrhagic fever is a rare human disease caused by the Marburg virus, a filamentous,
      single-stranded, negative-sense RNA virus. In general, the mortality rate associated with
      Marburg virus outbreaks has ranged from 23% to 88%, with the highest death rates seen in more
      recent epidemics. No vaccine or effective therapy is available for Marburg hemorrhagic fever.
      AVI-6003 is an experimental combination of 2 phosphorodiamidate morpholino antisense
      oligomers with positive charges on selected subunits (PMOplus™). These oligomers specifically
      target viral messenger RNA encoding 2 Marburg virus proteins thought to be important in viral
      replication and host immune suppression. The present study is designed to characterize the
      safety, tolerability and pharmacokinetics of escalating single-administration doses of
      AVI-6003 in healthy human subjects.
    

Intervention name(s): AVI-6003; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intravenous administration; Single intravenous administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
Condition: Presbyopia; Refractive Error
MeSH terms: Presbyopia; Refractive Errors
Study type: Interventional

Summary: 
      The aim of this study is to assess visual performance of prototype soft contact lens designs
      compared to commercially available contact lenses over one-week of lens wear.
    

Detailed description: 
      Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where
      participants will wear prototype (test) and commercial (control) lenses bilaterally.
      Participants will be stratified based on their refractive error into either presbyopic or
      non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Up
      to 4 test lens designs will be assessed against the control/s in each parallel arm in a
      randomized cross over fashion, with a minimum 2 day washout period between the lens types.
      Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an
      evaluation visit.
    

Intervention name(s): Etafilcon A, Lotrafilcon B , Senofilcon A
Intervention type(s): Device
Other intervention name(s): Control lenses; Non-presbyopic group; Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist; Lens material: Lotrafilcon B , Etafilcon A; Presbyopic group; Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia; Lens material Lotrafilcon B, Senofilcon A; Test lens; Brand name: Iteration X; Lens material: Etafilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Presbyopia; Refractive Error; Contact Lenses
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
Condition: Fungemia; Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Fungemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the efficacy and safety between Mycamine and
      Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant
      blood diseases) or allogeneic hematopoietic stem cell transplant patients
    

Detailed description: 
      Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning
      regimen or within 48 hours after the transplant conditioning regimen, and administration time
      should be no longer than 42 days
    

Intervention name(s): micafungin (Mycamine); itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous; oral
Other intervention name(s): Mycamine; FK463; Sporanox
Intervention MeSH terms: Itraconazole; Micafungin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Antifungal; micafungin; itraconazole
EGFR Molecular Classification In Vivo
Condition: Molecular Imaging
Study type: Interventional

Summary: 
      The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and
      repeatable detecting EGFR-activating mutational status.
    

Detailed description: 
      The goal of investigators were to evaluate the use of 18F-IRS as a novel PET/CT radiotracer
      to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients.
      the investigators want to evaluated the use of 18F-IRS in lung cancer imaging in adult NSCLC
      patients with different EGFR mutational status of primary and metastatic cancers.
    

Intervention name(s): 18F-IRS
Intervention type(s): Radiation
Intervention description(s): According to experiment, 18F-IRS was non-toxic and stable in serum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Study to Compare Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this open-label, randomized, 2*2 crossover study is to compare the safety
      and Pharmacokinetics CG1801 and CGL1802 in Healthy Volunteers.
    

Detailed description: 
      Healthy volunteers are administrated single-dose over the period I and II (crossover) of
      CGL1802(Polmacoxib 2mg Tablet) and CG1801(Polmacoxib 2mg capsule) Every time before and after
      each medication, pharmacokinetic (PK) parameters and safety of CGL1802 and CG1801 is
      performed using a blood sample and conducting some tests (vital signs, physical exam, ECG,
      laboratory test, etc.) respectively.
    

Intervention name(s): CG1801; CGL1802
Intervention type(s): Drug; Drug
Intervention description(s): Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.; Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combined Behavioral and Pharmacologic Treatment of Polydrug Abuse
Condition: Opioid Dependence; Cocaine Abuse
MeSH terms: Opioid-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary goal of this study is to determine how contingency management can best be
      combined with standard or high doses of methadone to increase simultaneous abstinence from
      heroin and cocaine.
    

Detailed description: 
      A study of people pmaintained on Methadone using contingency management
    

Intervention name(s): Methadone; Contingency Management
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Vitamin D Supplementation Among Overweight Jordanian Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome; Hypovitaminosis D
MeSH terms: Polycystic Ovary Syndrome; Rickets; Overweight; Avitaminosis; Vitamin D Deficiency; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial
      designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on
      Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level, serum
      chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight Jordanian
      female patients diagnosed with PCOS and with hypovitaminosis D.
    

Detailed description: 
      This study is designed to assess the safety and efficacy of 50,000 IU vitamin D
      supplementation once weekly for 3 months on improvement in PCOS prognosis and improvement in
      serum 25(OH)D levels in 60 overweight Jordanian females (defined as having a BMI 25-30kg/m2),
      diagnosed with PCOS (based on Rotterdam criteria), and with hypovitaminosis D (defined as a
      serum 25(OH)D level < 20 ng/mL), compared with placebo.

      Evaluation of the safety and efficacy of the dosing regimen will be conducted over 6 study
      visits during which clinical and biochemical signs of PCOS as well as serum 25(OH)D level,
      serum chromium level, insulin resistance, and BMI will be evaluated.

      The measurements will be collected as follows : day (-7) during screening , Day (0) base line
      measurements , Day (30) , Day(60), Day (90), day (104).
    

Intervention name(s): 50,000 IU vitamin D3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU; Placebo film-coated tablet of Biodal 50,000 IU
Other intervention name(s): Biodal 50,000 IU; cholecalciferol 50,000 IU; Biodal 50,000IU
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D; deficiency; hypovitaminosis D; Biodal; 25 hydroxy Vitamin D; 25hydroxyvitamin D; 25(OH)D; PCOS; insulin resistance; BMI; chromium levels; vitamin D 3; cholecalciferol; 50,000 IU
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein
      cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of
      atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L)
      on atorvastatin 10 mg.

      Secondary Objectives:

        -  To evaluate the effects of alirocumab on other lipid levels in comparison with placebo,
           when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.

        -  To evaluate the efficacy of alirocumab when co-administered with a high dose of
           atorvastatin (80 mg) versus atorvastatin 10 mg.

        -  To evaluate the safety and tolerability of alirocumab when co-administered with 2
           different doses of atorvastatin.

        -  To evaluate the development of anti-alirocumab antibodies.

        -  To evaluate the pharmacokinetics of alirocumab.
    

Detailed description: 
      The duration of study participation depended on the status of the patient at screening:

        -  For participants receiving atorvastatin 10 mg at stable dose for at least 6 weeks prior
           to screening, the study participation was to be approximately 17 weeks including a
           screening period of 1 week, a double-blind treatment period of 8 weeks and a follow-up
           period of 8 weeks.

        -  For participants receiving a lipid lowering treatment other than atorvastatin/ or not at
           stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive
           participants, the study participation was to be approximately 23 weeks with a screening
           period of 1 week, a run-in treatment period with atorvastatin 10 mg of 6 weeks, a
           double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.
    

Intervention name(s): Alirocumab; Placebo (for alirocumab); Atorvastatin; Placebo (for atorvastatin)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One subcutaneous (SC) injection in the abdomen only.; One SC injection in the abdomen only.; Over-encapsulated tablet orally once daily in the evening with dinner.; One over-encapsulated tablet of placebo for atorvastatin orally once daily in the evening with dinner.
Other intervention name(s): SAR236553; REGN727
Intervention MeSH terms: Atorvastatin; Alirocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 10020603
Treatment Parameters for the Empower Neuromodulation System (ENS)
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The subject will be administered a treatment at a treatment location and then be asked if
      he/she believes it is the active treatment, sham treatment, or does not know. A
      clinical-grade nerve conduction assessment system will be used both to provide electrical
      stimulation at four locations to record peripheral responses. The subject will
      self-administer two treatment sessions at two active treatment sites.
    


Intervention name(s): TENS
Intervention type(s): Device
Intervention description(s): Transcutaneous electrical nerve stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AUD; TENS
Collection of Clinical and Instrumental Data in Adult Subjects Suffering From Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Atopic dermatitis represents a real challenge in public health as it affects a large
      percentage of children and adults. Affected individuals must cope with a significant
      psychosocial burden, in addition to dealing with the medical aspects of the disease.

      The purpose of this exploratory study is to collect clinical severity AD data, using
      PO-SCORAD (self-assessment by the subjects), SCORAD evolution, instrumental measurements and
      treatment follow up of subjects.

      The future objective is to develop a personalised prediction model of AD flares in order to
      improve management of AD by more accurate severity evaluations by the subject and the
      physician. Development of a method of early detection of flares will open new treatment
      pathways for AD management.
    

Detailed description: 
      This study will be conducted as a French monocentric exploratory study in adults with mild to
      moderate Atopic Dermatitis, and will be conducted on a maximum 25 included subjects.

      The clinical study will include 4 study visits, after inclusion visit, and the maximum
      duration of the study for each subject will be 3 months : Day 1, Day 29, Day 57, Day 85.

      In case of AD flare suspicion, the investigator may recommend a complementary visit. Any
      complementary visit will be confirmed by investigator according to the subject's information:
      photographs and PO-SCORAD sent by the subject. If visit is confirmed, it will be scheduled as
      soon as possible.

      The objectives are:

        -  to collect clinical AD severity data in order to evaluate natural AD evolution with
           clinical and subject's scales, during a three-month period.

        -  to collect non-invasive instrumental AD data on a target area and on adjacent area:
           cutaneous hydration, epidermal barrier conditions and colorimetric parameters on
           cutaneous erythema

        -  to examine clinical and instrumental AD data

        -  to collect illustrative photographs of AD lesions
    

Intervention name(s): Clinical evaluations; Non-invasive instrumental measurements; Subject's evaluations
Intervention type(s): Other; Other; Other
Intervention description(s): SCORAD and target SCORAD; TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index; PO-SCORAD, target PO-SCORAD and subject's questionnaire
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
Condition: Diastolic Dysfunction; Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to
      adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by
      transthoracic echocardiogram is difficult due to anatomical challenge, therefore the
      prevalence of this problem may be underestimated. The investigator would like to perform
      transesophageal echocardiogram in this group of patients after anesthesia induction to
      demonstrate the true prevalence of this syndrome.
    

Detailed description: 
      Morbidly obese patients are at risk for both respiratory and cardiovascular abnormalities.
      Many cardiac problems were previously reported including left ventricular hypertrophy, right
      and left ventricular systolic dysfunction etc. Diastolic cardiac dysfunction can be found in
      normal left ventricular systolic function and can lead to diastolic heart failure
      postoperatively.

      Preoperative screening by transthoracic echocardiogram is difficult due to anatomical
      challenge (thick chest wall, narrowing of inter-rib space), therefore the prevalence of this
      problem may be underestimated. Transesophageal echocardiogram provides better cardiac view,
      but requires sedation during procedure. So, it is not practical for out-patient setting. The
      investigator would like to perform transesophageal echocardiogram in this group of patients
      after anesthesia induction to demonstrate the true prevalence of this syndrome.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Criteria for patient enrolled to bariatric surgery in Siriraj hospital

          -  BMI more than 40 kg/m2

          -  BMI more than 35 kg/m2 with hypertension, type 2 diabetes, hyperlipidemia, obstructive
             sleep apnea, chronic arthritis

          -  age between 18 - 70 years old
      
Keywords: Diastolic dysfunction; Morbid Obesity; Bariatric surgery
Bioequivalence of TF3 and TF2 and Effect of Food on the PK of Tepotinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study was to demonstrate bioequivalence between the new tablet
      formulation (TF3, test treatment) and the tablet formulation used in clinical studies (TF2,
      reference treatment) and to investigate effect of food on pharmacokinetics (PK) of tepotinib.
    


Intervention name(s): Tepotinib TF2; Tepotinib TF3
Intervention type(s): Drug; Drug
Intervention description(s): Participants received a single oral dose of 500 mg Tepotinib TF2 under fasting or fed conditions in treatment period 1 or 2.; Participants received single oral dose of 500 mg (2 x 250 mg)Tepotinib TF3 under fasting or fed conditions in treatment period 1 or 2.
Intervention MeSH terms: Tepotinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Tepotinib; Pharmacokinetics; Bioequivalence