bioihbjkbjnl/mcl2 huggingface dataset:
Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,
      insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required
      insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would
      regulate glucose levels through the infusion of two hormone: insulin and glucagon.

      The main objective of this project is to compare the efficacy of single-hormone closed-loop
      strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose
      levels in children with type 1 diabetes in a diabetes camp.

      The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent
      in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop
      strategy, which in turn is more effective than the conventional pump therapy to reduce time
      spent in hypoglycemia
    

Detailed description: 
      Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,
      insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required
      insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would
      regulate glucose levels through the infusion of two hormone: insulin and glucagon.

      The investigators aim to conduct a randomized three-way cross-over trial comparing single
      hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump
      therapy. The investigators aim to compare the three interventions for 3 consecutive nights in
      children with type 1 diabetes in a diabetes camp.
    

Intervention name(s): Single-hormone closed-loop strategy; Dual-hormone closed-loop strategy; Insulin pump therapy
Intervention type(s): Device; Device; Device
Intervention description(s): Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.; Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.; Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Hypoglycemia; Insulin; Glucagon; Closed-loop system; Artificial pancreas
A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Study type: Interventional
Phase: Phase 1

Summary: 
      In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group
      study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately
      11 centres in the USA, Canada and Australia.

      The primary objective of the study is to assess the patient response to three W0027 regimens
      in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability
      and skin and nail pharmacokinetics to the three Albaconazole regimens.
    


Intervention name(s): W0027; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics of Carnosine
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the
      healthy adults.
    


Intervention name(s): pure carnosine; Beef; Chicken; Chicken broth
Intervention type(s): Dietary Supplement; Other; Other; Other
Intervention description(s): one time dose of pure carnosine (450 mg); one time dose, 150 g of beef; One time dose, 150g of chicken breast; one time dose of chicken broth obtained from 150g of chicken breast
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: histidine dipeptides; carnosine; anserine
A Clinical Study of Light Therapy on Depressive Episodes of Bipolar Disorder
Condition: Depressive Episodes of Bipolar Disorder
MeSH terms: Bipolar Disorder; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy and safety of light-emitting
      diode(LED) light therapy on Chinese patients with Depressive Episodes of Bipolar Disorder and
      to gather prime research data and application parameters of LED light source which is not
      currently available in China.
    


Intervention name(s): Bright Light therapy; dim Red Light therapy
Intervention type(s): Device; Device
Intervention description(s): In this group, participants will be exposed to the LED treatment device (lightbox) which delivers bright light and meanwhile medicated with just one particular antipsychotics drug(a mood stabilizer or an atypical antipsychotic drug)except of antidepressants.; In this group, participants will be exposed to the same LED treatment device (light box) which delivers dim red light,which is considered to be biologically inactive, and meanwhile medicated with just one particular antipsychotics drug(a mood stabilizer or an atypical antipsychotic drug)except of antidepressants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Biologic Joint Replacement Strategy for Knee Trauma and Post-Traumatic Osteoarthritis
Condition: Knee Osteoarthritis; Post-traumatic Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Participants will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts
      of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of
      the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped
      allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and
      treatment-specific postoperative rehabilitation.
    

Detailed description: 
      With IRB approval, patients will be enrolled in a prospective clinical trial to assess
      outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic
      OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci),
      anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated
      donor bone, and treatment-specific postoperative rehabilitation. Demographic and operative
      data will be collected. Outcome assessments will include VAS pain, IKDC, SANE, Tegner and
      PROMIS Mobility for knee at 6 months and yearly after surgery. In addition, serial limb
      alignment measurements, ultrasonographic assessments of meniscal location and integrity,
      quantitative MRIs for cartilage composition, and serum and urine biomarkers for treatment
      monitoring will be performed. All complications and re-operations will be recorded. OCA
      survival will be determined based on maintenance of acceptable levels of pain and function
      and/or need for revision surgery or total knee arthroplasty.
    

Intervention name(s): Unicompartmental Biologic Arthroplasty; Extensive Biologic Arthroplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Unicompartmental Biologic Arthroplasty surgery.; Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee Pain
The Effect of NN1250 in Subjects With Type 2 Diabetes of Different Race and/or Ethnic Origin
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of
      NN1250 (insulin degludec, IDeg) in subjects with type 2 diabetes of different race and/or
      ethnicity.
    


Intervention name(s): insulin degludec; insulin detemir
Intervention type(s): Drug; Drug
Intervention description(s): 0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days; 0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MP-3 Biofeedback Training and Central Vision Loss
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      The objectives of this investigation are:

        -  evaluate the results of rehabilitation treatment using photostimulation with a
           structured stimulus in two different samples of low vision subjects with central vision
           loss who will be subjected to biofeedback at the MP3 microperimeter with different
           timing;

        -  compare the effectiveness of the rehabilitation treatments in the two groups to provide
           useful indications for proposing standardisation of the rehabilitation pathway focusing
           on photostimulation in subjects with central vision loss.
    


Intervention name(s): MP-3 microperimeter; MP-3 microperimeter
Intervention type(s): Device; Device
Intervention description(s): Biofeedback stimulation two days a week; Biofeedback stimulation three days a week
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Flixonase Safety in Patients With Allergic Rhinitis (AR)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Observational

Summary: 
      This is an inception cohort study that analyses data from an administrative medical records
      database. The two inception cohorts are: 1) patients initiated on intranasal FP and 2)
      patients initiated on another INS (not FP). The candidates for the inception cohorts did not
      use any intranasal steroid in the year prior to initiation.
    


Intervention name(s): Intermittent, sub-chronic and chronic Flixonase use; Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase
Intervention type(s): Drug; Drug
Intervention description(s): Intermittent exposure episode is a series of fewer than four sequential prescriptions for Flixonase with gaps of no more than 60 days between any two. Sub-chronic use episode is a series of at least four and not more than eight sequential prescriptions for Flixonase with gaps of no more than 60 days between any two. Chronic use episode is a series of at least nine sequential prescriptions for Flixonase and gaps of no more than 60 days between any two. A span of at least 180 days must occur between the first and last prescription.; Intermittent exposure episode is a series of fewer than four sequential prescriptions for an intranasal steroid other than Flixonase with gaps of no more than 60 days between any two. Sub-chronic use episode is a series of at least four and not more than eight sequential prescriptions for an intranasal steroid other than Flixonase with gaps of no more than 60 days between any two. Chronic use episode is a series of at least nine sequential prescriptions for an intranasal steroid other than Flixonase and gaps of no more than 60 days between any two. A span of at least 180 days must occur between the first and last prescription.
Intervention MeSH terms: Fluticasone; Xhance
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The General Practice Research Database (GPRD). Patient records dated between January 1990 -
        January 2002 were used to develop the overall study cohort.
      
Keywords: Intranasal steroids; beclometasone diproprionate; steroid-related outcomes
Oxytocin And Uterotonic Agent Use For Cesarean Delivery
Condition: Uterine Atony; Hypotension
MeSH terms: Uterine Inertia; Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      The central objective of this study will be to evaluate a standardized, evidence-based
      regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean
      delivery

      The investigators primary hypothesis is that the proposed uterotonic drug regimen, when
      compared to conventional dosing regimen, during elective cesarean delivery will:

      1. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain
      satisfactory uterine tone.

      Secondary outcomes to be evaluated will be:

        1. Reduce the side effects associated with uterotonic drug use

        2. Reduce the time to establishment and maintenance of adequate uterine tone
    

Detailed description: 
      The current guidelines for the administration of oxytocin during cesarean delivery are
      diverse, empiric, and vague. A stepwise, standardized, checklist driven algorithm for the use
      of oxytocin and other uterotonic agents during cesarean delivery is needed to guide
      practitioners in a clear and concise manner. This algorithm should encompass laboring and
      non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other
      uterotonic agents.

      More specifically, the investigators believe that the following points should be incorporated
      into a protocol: 1) oxytocin should be used in initial doses of less than 5 IU; 2) oxytocin
      should not be administered as a rapid IV bolus; 3) an initial rapid infusion of oxytocin
      should be followed by a maintenance infusion; 4) higher initial and infusion doses of
      oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin
      is not producing effective uterine contractions, other uterotonic drugs acting via different
      pathways should be considered in a standardized way.
    

Intervention name(s): Oxytocin Infusion; Oxytocin Bolus
Intervention type(s): Drug; Drug
Intervention description(s): 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.; 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
Other intervention name(s): methylergonovine maleate (methergine) 0.2 mg IM; carboprost tromethamine (hemabate) 0.25 mg IM; misoprostol 600 mcg buccally; methylergonovine maleate (methergine) 0.2 mg IM; carboprost tromethamine (hemabate) 0.25 mg IM; misoprostol 600 mcg buccally
Intervention MeSH terms: Misoprostol; Oxytocin; Methylergonovine; Carboprost; Carboprost tromethamine; Maleic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uterine Atony; Hypotension; Cesarean Delivery; Hemorrhage; Phenylephrine; Ephedrine
Rebif New Formulation (RNF) Quality of Life (QOL) Study
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and
      injection site redness Rebif treated subjects with relapsing forms of MS who transition to a
      new formulation of Rebif (RNF).
    


Intervention name(s): Rebif New Formulation Non Titrated; Rebif New Formulation Titrated
Intervention type(s): Drug; Drug
Intervention description(s): human interferon beta 1a - Rebif New Formulation; Human interferon beta 1a Rebif New Formulation
Intervention MeSH terms: Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.
Condition: Surgical Acute Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in
      the treatment of surgical acute wounds.
    


Intervention name(s): Urgotul: Low-adherent dressing; TulleGras M.S.: Vaseline gauze
Intervention type(s): Device; Device
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: non-inferiority; randomized; TulleGras; Urgotul; healing; surgical acute wounds; pain
Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Determine the response, disease-free survival, and overall survival of
      patients with primary light chain amyloidosis treated with high-dose melphalan and autologous
      stem cell transplantation.

      II. Determine the toxicity of this regimen in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients may receive induction chemotherapy before study entry. Patients
      then receive filgrastim (G-CSF) or another growth factor for 4-6 days as peripheral blood
      stem cell (PBSC) mobilization. PBSC (or bone marrow) is harvested over 2-3 days.

      Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1. PBSC
      and/or bone marrow is reinfused on day 0. Patients receive G-CSF beginning on day 0 and
      continuing until blood counts recover. This course may be repeated 4-12 weeks later.

      Patients are followed every 3 months for 1 year and then annually for 5 years.
    

Intervention name(s): Melphalan; Autologous Stem Cell Transplantation
Intervention type(s): Drug; Procedure
Intervention description(s): 100 mg/m2 twice a day from Days -2 and -1 as induction therapy; Bone marrow and peripheral blood stem cells harvested
Intervention MeSH terms: Melphalan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amyloidosis; arthritis & connective tissue diseases; genetic diseases and dysmorphic syndromes; hematopoietic/lymphoid cancer; oncologic disorders; plasma cell neoplasm; primary systemic amyloidosis; rare disease
Probiotic Bacteria to Infants With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The objective of the study is to examine whether 8 weeks intervention with probiotics
      influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence
      of the immunologic status and the intestinal microflora, inflammation and permeability will
      be investigated.
    

Detailed description: 
      The aim of the study is to investigate whether two different probiotics influence the
      clinical and subjective symptoms in infants with Atopic Dermatitis (AD). The influence on the
      immunologic status and the intestinal microflora, inflammation and permeability will also be
      investigated.

      Sixty two infants (6 to 24 months of age) suffering from AD will be randomised in 3 groups
      receiving either Lactobacillus acidophilus NCFM (1x10^10 Colony forming units),
      Bifidobacterium lactis Bi-07(1x10^10 Colony forming units) or placebo every day for 8 weeks.

      At the beginning and at the end of the study the following analyses will be made:

        1. SCORing Atopic Dermatitis (SCORAD) index to describe the extent and severity of the
           eczema, and to describe the subjective symptoms.

        2. Blood samples will be drawn to examine:

             -  Immunoglobulin E (IgE), total and specific for egg and milk.

             -  Eosinophil Cation Protein (ECP)

             -  Interleukin-10 (Il-10), Interleukin-12 (Il-12) and Interferon-gamma (IFN-gamma)

        3. Fecal samples will be collected to examine:

             -  Calprotectin (intestinal inflammation)

             -  Bacterial Deoxyribonucleic acid (DNA) will be extracted in order to perform
                Polymerase chain reaction (PCR) analysis.
    

Intervention name(s): Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
Intervention type(s): Behavioral
Intervention description(s): 10^10 colony forming units pr day of probiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Infants; Atopic Dermatitis; SCORAD; IgE; Eosinophil Cation Protein; Calprotectin; Intestinal microflora
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double-blind placebo controlled study of efficacy and
      safety of characterized peanut oral immunotherapy in peanut allergic individuals.
    

Detailed description: 
      This is a multicenter, randomized, double-blind placebo controlled study of efficacy and
      safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will
      receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized
      1:1 to peanut OIT or placebo.
    

Intervention name(s): AR101 powder provided in capsules; Placebo powder provided in capsules
Intervention type(s): Biological; Biological
Intervention description(s): Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol; Study product formulated to contain only inactive ingredients for use as defined in the protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Characterized Peanut Allergen; Peanut; OIT; Oral Desensitization; Peanut Allergen; Allergy; Peanut Allergy; Peanut-Allergic Children; Children; Peanut-Allergic Adults