bioihbjkbjnl/mcl2 huggingface dataset:
Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Each subject will be randomly allocated to a sequence of two treatments applied at two
      separate dosing visits. At each dosing visit subjects will be injected with individualised
      doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a
      standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at
      both dosing visits of one individual and will be administered subcutaneously in the abdominal
      region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home
      in the evening before each dosing visit. Subjects will attend the clinical site in a fasted
      state in the morning of each dosing day and stay at the clinical trial centre until 10-hour
      after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing
      visits will be separated by a wash-out period of 5-15 days.
    


Intervention name(s): Biochaperone® Combo; Humalog® Mix25
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection of an individualized dose; Subcutaneous injection of an individualized dose
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Vestibular Rehabilitation on Static Posturography Results
Condition: Unilateral Vestibular Dysfunction Disease
Study type: Interventional

Summary: 
      Thirty subjects with unilateral vestibular hypofunction diagnosed by videonystagmography
      (VNG) were voluntarily included in the study. In addition to Static Posturography test, head
      thrust test, Unterberger test, bucket test, eyes open/closed tandem stance test, eyes
      open/closed semitandem stance test, Romberg test, one leg standing on foam floor with eyes
      open/closed and before vestibular rehabilitation treatment In the initial evaluations, the
      Visual Analogue Scale (VAS) and the Dizziness Disability Inventory (DHI) were applied to
      assess the severity of standing on one leg with eyes open/closed, dynamic visual acuity,
      vertigo, and fatigue. As a result of the study, it was concluded that vestibular
      rehabilitation is beneficial in patients with unilateral vestibular hypofunction and its
      effectiveness can be monitored with Static Posturography.
    

Detailed description: 
      Patients were re-evaluated after 8 weeks of vestibular rehabilitation and the results were
      compared. The vestibular rehabilitation program was changed every two weeks. During the
      eight-week period, the patients performed the exercise program 3 times a day with 10
      repetitions of each exercise. According to the evaluation results after the treatment, there
      was a statistically significant improvement in static posturography, especially in the
      modified-CTSIB test. There was a statistically significant improvement in dynamic visual
      acuity, head thrust test, bucket test, standing on one leg on firm and foam ground with eyes
      open/closed, tandem stance test with eyes closed, and Unterberger test. Statistically
      significant scores were obtained in VAS and DHI results.
    

Intervention name(s): Vestibular Rehabilitation
Intervention type(s): Other
Intervention description(s): The patients received vestibular rehabilitation treatment in 4 sessions at 15-day intervals and applied the given exercise programs as home exercise in the form of 10 repetitions, 3 times a day. The exercises were performed sitting, standing and walking, respectively. Balance exercises were developed by changing the support area, support surface and arm positions. When they come to each session, the exercise programs are according to the patient's condition; alternating standing and walking forward, backward, tandem and semitandem positions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unilateral vestibular hypofunction; balance; static posturography; vestibular rehabilitation
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.
Condition: Benign Breast Neoplasm
MeSH terms: Neoplasms; Breast Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for
      breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer
      localization.

      In this study, our hypothesis are as following:

        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure
           better outcome.

        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of
           the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.
    

Detailed description: 
      Indocyanine green, ICG (ICG-fluorescence)

        -  ICG is the most commonly used fluorophore which approve by FDA.

        -  NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in
           breast cancer and localization of liver metastasis, especially superficial lesion

        -  Contains sodium iodide, patients who have history of allergy to iodides should be used
           as caution.

      Nonpalpable benign brest lesion localization

        -  New method for the localization and resection of non-palpable breast lesions.

        -  The breast lesion was correctly localized, and the area of ICG corresponded well to the
           site of the lesions.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer.
      
Keywords: Near-infrared fluorescence; Indocyanine green, ICG; Radio-guided surgery; breast cancer
A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the long-term safety and efficacy of repeating treatment with
      MabThera, in combination with methotrexate and steroids, in patients who were previously
      randomized into MabThera study WA17042. The anticipated time on study treatment is until
      Mabthera is available on the local market and the target sample size is 100-500 individuals.
    


Intervention name(s): methotrexate; rituximab [MabThera/Rituxan]
Intervention type(s): Drug; Drug
Intervention description(s): a 10-25 mg stable dose given orally or parenterally throughout study; 1 g given by intravenous infusion on Days 1 and 15 of each treatment course
Other intervention name(s): MabThera/Rituxan
Intervention MeSH terms: Rituximab; Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting
      conditions.
    


Intervention name(s): Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA); Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on
      cardiac repolarisation in healthy male subjects
    


Intervention name(s): SNAC; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration; Oral administration; Oral administration
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Real-world Experience of ICIs Plus Chemotherapy With or Without Radiotherapy for Advanced ESCC.
Condition: Metastatic Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Observational

Summary: 
      This study is a multi-center, non-interventional study. Clinicopathologic, treatment ,
      outcome and efficacy data will be collected from medical records in metastatic esophageal
      squamous cell carcinoma (ESCC) patients.
    

Detailed description: 
      This study is a multi-center, non-interventional study. Patients' background, treatment
      pattern, treatment outcome, efficacy will be collected in metastatic esophageal squamous cell
      carcinoma (ESCC) patients who were treated with chemotherapy combined with immunotherapy as
      1st line treatment at approximately 5 institutions. The patients should have received at
      least 1 cycle of immunotherapy and chemotherapy with or without radiotherapy. Based on these
      data, overall survival (OS), progression free survival (PFS) from start of 1st line treatment
      and the role and efficacy of radiotherapy for these patients will be assessed.
    

Intervention name(s): Chemotherapy combined with immunotherapy; radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): chemotherapy：paclitaxel+platinum-based anticancer drugs immunotherapy：anti-PD-1 Immune checkpoint inhibitors; Intensity-modulated radiation therapy
Intervention MeSH terms: Immunomodulating Agents
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1. The clinical stage is IVb stage, that is, non-regional lymph node metastasis and
             distant organ metastasis (AJCC8th) of esophageal carcinoma.

          2. Patients who had received at least one cycle of first-line chemotherapy combined with
             immunotherapy, received or did not receive radiotherapy;

          3. Pathologically diagnosed as esophageal squamous cell carcinoma;
Women's Health Project for Women Wanting to Lose Weight
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The prevalence of obesity has steadily increased in the United States. This can lead to the
      worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and
      osteoarthritis. The medical management of obesity involves dietary counseling and education,
      behavioral counseling with goal setting, and exercise. Patients with short sleep periods in
      the range of 5 to 7 hours per night are often heavier than normal sleepers even after
      controlling for other factors. We hypothesize that the addition of focused counseling on
      healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help
      women lose weight.
    

Detailed description: 
      None needed
    

Intervention name(s): Diet and exercise counseling; Diet, exercise, sleep hygiene counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Not needed; None needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; weight loss; sleep hygiene; diet; exercise
Improving Childhood Immunization
Condition: Improve Childhood Immunization Rates
Study type: Interventional

Summary: 
      Specific Aim: To improve childhood immunization rates by utilizing automated Electronic
      Health Record-derived provider-specific performance feedback reports, coupled with automated
      Electronic Health Record-derived trigger alerts.

      Hypothesis: The automated Electronic Health Record-derived provider-specific performance
      feedback reports will result in a 50% decrease in unimmunized children ages 0-13 years of
      age, when coupled with automated Electronic Health Record-derived trigger alerts, compared
      with trigger alerts alone.
    


Intervention name(s): Provider bulletins; Trigger alerts
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for
      drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is
      co-administered with abiraterone acetate in healthy adult men.
    

Detailed description: 
      This is a non-randomized (individuals will not be assigned by chance to study treatments),
      open-label (individuals will know the identity of study treatments), 2-period,
      sequential-design, drug-drug interaction study of abiraterone acetate and ketoconazole in
      approximately 20 healthy adult men. This study will consist of a screening period followed by
      an open-label treatment phase consisting of 2 treatment periods. Successive drug
      administration will be separated by a washout period of at least 10 days. All individuals
      will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a
      single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to
      17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and
      administration of a single dose of 1000 mg abiraterone acetate on Day 14. Serial
      pharmacokinetic (study of what the body does to a drug) samples will be collected at each
      treatment period as detailed in the protocol. Safety will be monitored continuously from the
      time of informed consent signing until the end of the study.
    

Intervention name(s): Period 1: Abiraterone; Period 2: Abiraterone/Ketoconazole; Period 2: Abiraterone/Ketoconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1000 mg abiraterone acetate tablet administered orally on Day 1; 400 mg ketoconazole tablets administered orally on Days 11 to 16; 1000 mg abiraterone acetate tablet administered orally on Day 14
Intervention MeSH terms: Ketoconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Pharmacology; Pharmacokinetics; Pharmacodynamics; Drug-drug interactions; CYP3A4; Abiraterone acetate; JNJ-589485; JNJ-212082; Ketoconazole
Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis
Condition: Acute Exacerbation of Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the
      Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With
      acute and acute exacerbation of chronic bronchitis for 7 days.
    


Intervention name(s): Combination of Broussonetia spp and Lonicera spp
Intervention type(s): Drug
Intervention description(s): 600 mg/ day or 1200 mg/ day for 7 days
Other intervention name(s): N02RS1
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Testosterone Administration and ACL Reconstruction in Men
Condition: Muscle Atrophy; ACL Reconstruction; Trauma; Osteoarthritis
MeSH terms: Muscular Atrophy; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being done to test whether taking testosterone can prevent loss of muscle mass
      and strength due to anterior cruciate ligament (ACL) reconstructive surgery. Testosterone is
      the principal male sex hormone and an anabolic (muscle promoting) steroid. It is essential
      for the development of male reproductive tissues and promotes increased muscle, bone mass,
      and the growth of body hair.

      The investigators hope to learn whether testosterone given before and after ACL
      reconstructive surgery will increase muscle mass and strength and potentially improve
      recovery time following surgery.
    

Detailed description: 
      Overall Objective: The overall objective of this study is to determine if 8 weeks of
      testosterone first administered 2 weeks prior to surgery, can improve the outcome of anterior
      cruciate ligament (ACL) reconstruction.

      Overall Hypothesis: Standard-of-care rehabilitation with the addition of testosterone
      administration will augment muscle mass, strength, and physical function following ACL
      reconstructive surgery compared to standard rehabilitation alone.

      Significance: Muscle mass and strength are greatly reduced following ACL surgery. The
      investigators hypothesize that administration of testosterone will minimize these reductions
      or potentially increase muscle mass and strength. In doing so, testosterone may hasten a
      patient's return to physical activity. If testosterone improves recovery after ACL surgery,
      the same treatment may be used for other injuries that involve trauma and muscle atrophy.
      Furthermore, this study will examine the effect of trauma with or without testosterone on
      myogenic regulators in muscle tissue taken during ACL surgery-providing possible mechanistic
      insights for the clinical outcomes.
    

Intervention name(s): Testosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8 weeks of testosterone administration beginning 2 weeks before ACL surgery; 8 weeks of saline administration beginning 2 weeks before ACL surgery
Other intervention name(s): testosterone enanthate; saline
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Testosterone; ACL Reconstruction; Clinical outcomes; Lean mass; Strength; Muscle atrophy
Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.
    


Intervention name(s): Dapagliflozin
Intervention type(s): Drug
Intervention description(s): Tablet and IV solution, Oral and IV, 10 mg po and 100 µg IV, Single oral dose followed by a single IV dose (IV dose administered at 1h after oral dose), 1 day
Intervention MeSH terms: Dapagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enteral Glutamine in Neurologically-injured Patients
Condition: Neurologic Injury; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Nutrition is an important part of the recovery process after having a head injury so that
      subjects can gain strength and fight off infection. Liquid nutrition formulas are often given
      to patients through a tube that has been placed into the intestines for feeding when they are
      unable to eat on their own. Some reports suggest that nutrition with extra amounts of the
      amino acid called glutamine may decrease infections and hospital stay in severely injured
      patients.The purpose of this study is to evaluate if giving extra amounts of an amino acid
      called glutamine with liquid nutrition formulas will decrease the risk of infection and
      length of stay in the intensive care unit after having a head injury.
    


Intervention name(s): Enteral glutamine powder; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): nutritional supplement; placebo control
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparative Study of Menstrual Blood and Systemic Blood
Condition: Retention; Menstruation
Study type: Observational

Summary: 
      The purpose is to investigate how menstrual blood differs from systemic blood to evaluate if
      menstrual blood could be utilized as a natural and non-invasive access to blood for regular
      health monitoring and early diagnostics.
    


Intervention name(s): Comparative blood analysis
Intervention type(s): Other
Intervention description(s): Collection of menstrual blood and systemic blood
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy menstruating women.
      
Biospecimen description: 
      Menstrual Blood and Systemic Blood
NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the usefulness of two transdermal gels to be used
      in the future development for a male contraceptive.
    

Detailed description: 
      The success of hormonal male contraception depends on the near complete suppression of
      spermatogenesis without producing any untoward effects on libido or other androgen-dependent
      functions or any other adverse events. The treatment with androgen alone has geen shown to be
      highly effective in Asian men but less effective in non-Asian men in clinical trials. To
      increase the efficacy of androgen alone treatment on spermatogenesis, combined regimens of a
      progestin and an androgen have shown promising results. The steady-state delivery of a
      progestin and an androgen by transdermal gel application would be a user-friendly delivery
      method as compared to injectable or implant approaches. Nestorone (NES) is a synthetic
      progestin that does not have any androgenic and estrogenic activity and is not expected to
      have some of the undesirable side effects of other drugs.

      We propose to evaluate whether NES gel alone or in combination with T gel applied
      transdermally will result in more effective suppression of gonadotropins than NES or T gel
      applied alone in healthy men. Fifty healthy male subjects, age 18-50 will be enrolled at each
      center (2 sites).
    

Intervention name(s): Nestorone gel; Testosterone Gel
Intervention type(s): Drug; Drug
Intervention description(s): 2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment; 100 mg Testosterone gel daily for 3 weeks
Other intervention name(s): Testim
Intervention MeSH terms: ST 1435; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Male contraception; Androgen; Progestin; Spermatogenesis; Gonadotropin suppression; Testosterone; Nestorone