bioihbjkbjnl/mcl2 huggingface dataset:
Single-dose Incremental Intravenous Injection of SY-007 in Healthy Subjects
Condition: Cerebral Apoplexy
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-dose incremental, randomized, double-blind, parallel,
      placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.
    

Detailed description: 
      Six dose-group trials are planned: 1 mg,4 mg,10 mg,20 mg,30 mg,and 45 mg.When the dose
      reaches 45mg, if the standard of increasing dose termination is still not reached, the
      researcher and the sponsor shall decide whether to continue the increasing dose after
      reviewing the previous study data, and each increasing dose shall not exceed 33.3% (e.g.,
      60mg) of the previous dose group. In the process of dose increasing, when the dose exceeds 20
      mg, if the dose level reaches the dose termination standard, an intermediate dose is set
      between this dose and the previous dose, and the study is returned to the intermediate dose
      group.In this study, a parallel design was adopted, in which each subject received only one
      dose of drug from one dose group, which ensured the safety of the subject to the greatest
      extent, and also avoided the interference of safety and PK results caused by possible
      insufficient elution or other factors.Among them, 1 mg dose group was the starting dose
      group, and 6 subjects were randomly assigned into sy-007 group for injection or placebo group
      at a ratio of 2:1. Only 2 subjects were given the drug for the first time. One day after the
      first two subjects were given the drug, after ensuring the safety of the first two subjects,
      the drug was given to the remaining 4 subjects.In other dose groups, sentry administration
      was also used. The first 2 subjects received sy-007 injection or placebo respectively. After
      3 days of hospitalization observation, the safety data of the first 2 cases were reviewed by
      the researcher and the sponsor, and the remaining subjects in this dose group were determined
      accordingly.Pharmacokinetic biological samples were collected from all dose groups and their
      safety was assessed.A total of 66~90 healthy subjects will be enrolled.
    

Intervention name(s): SY-007
Intervention type(s): Drug
Intervention description(s): A single dose of SY-007 or placebo injection(1mg-45mg)
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Parallel, Placebo control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine
Condition: Spinal Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate if a small amount of lignocaine added to
      bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can
      shorten the duration of the sensoric and the motoric blockade.
    


Intervention name(s): Lidocaine; bupivacaine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal anaesthesia; Bupivacaine; Lidocaine; Duration of blockade
Interval Versus Continuous Exercise During Pregnancy
Condition: Pregnancy Related; Glucose, Low Blood; Fetal Heart Rate or Rhythm Abnormality Affecting Fetus; Fetal Blood Flow
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      The objective of this randomized cross-over design was to investigate the fetal well-being
      and maternal glycemic response to an acute bout of aerobic high-intensity interval training
      (HIIT) and moderate-intensity continuous training (MICT) with pregnant individuals.
    


Intervention name(s): High intensity Interval Training; Moderate Intensity Continuous Training
Intervention type(s): Other; Other
Intervention description(s): HIIT protocol consisted of 10 one-minute intervals of high-intensity work (i.e., > 90% HRmax) interspersed with nine one-minute intervals of self-paced active recovery (19-minutes total).; The MICT protocol consisted of 30-minutes of moderate intensity cycling (i.e., 64 - 76% HRmax).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test
      formulation and insulin glulisine 100 Units/mL reference formulation after a single
      subcutaneous (SC) dose.

      Secondary Objectives:

        -  To assess the pharmacodynamic (PD) profiles and further pharmacokinetic (PK)
           characteristics of insulin glulisine U300 in comparison to insulin glulisine U100 after
           a single SC dose.

        -  To assess safety and tolerability of the test and the reference formulation of insulin
           glulisine.
    

Detailed description: 
      The study duration per patient will be 18 to 62 days and will consist of a 4 to 28 days of
      screening period, a treatment period of 2 days, a washout between dosing occasions of 5-18
      days, and follow up visit 7-14 days after last dosing.
    

Intervention name(s): Insulin glulisine (U300); Insulin glulisine; Insulin aspart; NPH insulin; Glucagon; Glucose; Heparin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: intravenous/subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: Powder and solvent for solution for injection
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: intravenous; Pharmaceutical form: solution
Route of administration: intravenous
Other intervention name(s): HMR1964 (U300); Apidra®; NovoRapid®; Insuman® Basal Solostar®; GlucaGen® HypoKit; Glucose 20%; Heparin-Natrium-5000
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin glulisine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef; Heparin; Calcium heparin; Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Postoperative Nausea and Vomiting and Acupuncture/Acupressure
Condition: Postoperative Vomiting; Nausea
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators
      practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would
      therefore be appropriate to consider the use of non-pharmacological methods in preventing
      PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV,
      and the adverse effects are minimal.

      Consequently, the investigators will investigate if acupuncture and acupressure can be
      implemented as a supplementary to the ordinary treatment in children undergoing surgery for
      tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for
      acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion
      decisions are conducted after the "intention-to-treat" principle. 126 patients are included,
      divided into two groups:

        1. Treatment Group - standard treatment and acupuncture performed after induction of
           anaesthesia, acupressure administered before awakening

        2. Control Group - standard treatment

      The primarily endpoints in this study are nausea, retching and vomiting. The effect of
      acupuncture/acupressure will be studied with regard to any association with possible factors
      of predisposition to PONV, as well as with other factors registered during the study. Adverse
      effects from the acupuncture site and wristband will be registered.
    


Intervention name(s): Acustimulation
Intervention type(s): Device
Intervention description(s): Acupressure in P6 bilaterally given after induction of anaesthesia for 20 minutes, followed by acupressure wrist bands applied on the same acupoints for 24 hours.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: POV tonsillectomy adenoidectomy acupuncture acupressure child; Effectiveness of acupuncture on
Mental Health Curriculum Study
Condition: Mental Health Issue
Study type: Observational

Summary: 
      The purpose of this study is to investigate the acceptability, appropriateness, feasibility,
      and preliminary effectiveness of a college course grounded in skills from dialectical
      behavior therapy (DBT) titled, "Wellness and Resilience for College and Beyond." The study
      takes place on 5 college campuses in Pennsylvania and West Virginia offering the Wellness
      Course during the 2020 calendar year (Spring and Fall 2020 semesters). The Wellness Course is
      an undergraduate college course that includes 14 two and a half hour long lessons, weekly
      homework assignments and tracking of skills use via a "diary card," and a cumulative final
      exam at the end of the semester. Students who choose to enroll in the wellness course are
      offered the opportunity to enroll in the study and a comparison sample of students not
      enrolled are recruited from each site.
    


Intervention name(s): Wellness and Resilience for College and Beyond (Undergraduate College Course)
Intervention type(s): Behavioral
Intervention description(s): The course, "Wellness and Resilience for College and Beyond" was originally developed by James Mazza, PhD and colleagues at the University of Washington as a 10-week course. The course developers adapted their course materials to fit the needs of a 16-week semester for the purpose of this study. The Wellness Course teaches students evidence-based skills for improving mental health from dialectical behavior therapy, acceptance and commitment therapy, and the field of positive psychology. Classes meet for 2.5 hours weekly with approximately half of class time spent on teaching new content (lecture) and the other half spent with students working in small groups on practice and discussion exercises.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is undergraduate college students recruited from five college campuses
        in Pennsylvania and West Virginia.
      
Keywords: Mental Health Education; Public Health; Dialectical Behavior Therapy; College Students
Effects of Gastric Bypass on Blood Levels of Duloxetine
Condition: Bariatric Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine
      between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control
      subjects matched for body mass index (BMI), age and gender.
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Single dose of 60 mg of duloxetine
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gastric Bypass; Duloxetine; Cymbalta; Pharmacokinetics
Vitamin A Therapy for Tuberculosis
Condition: Pulmonary Tuberculosis; HIV Infections
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will determine whether a daily vitamin and mineral supplement (a multivitamin
      including Vitamin A) will improve health when added to standard chemotherapy for
      tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected
      and HIV uninfected patients.
    

Detailed description: 
      By the year 2000, 13.8 % of individuals with HIV will be co-infected with tuberculosis (TB).
      Despite effective TB chemotherapy, mortality rates remain extremely high, and no simple,
      inexpensive intervention is available. Prior to the discovery of antibiotic treatment,
      cod-liver oil, a potent source of Vitamin A, was the standard treatment for TB. Vitamin A is
      essential for normal immune function, and Vitamin A supplementation is used in many countries
      to reduce mortality in children. Vitamin A deficiency in HIV infected people has been
      associated with increased mortality in the United States, Haiti, Malawi, and Uganda. This
      study will determine whether daily Vitamin A supplementation, given concurrently with TB
      chemotherapy, will reduce mortality in adults with HIV and TB.

      All study participants will receive standard TB chemotherapy (isoniazid, rifampicin,
      streptomycin, pyrazinamide) for the first 2 months, followed by isoniazid and ethambutol for
      the following 6 months. Participants will be randomized to receive either a daily vitamin and
      mineral supplement or placebo. Participants will be followed for 24 months after study
      enrollment.
    

Intervention name(s): multivitamin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Vitamin A
Galantamine Bioequivalence Study of Dr. Reddy's Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting
      condition.
    

Detailed description: 
      Comparative, Randomized, Single-Dose. 2-way Crossover Bioavailability Study of Dr.Reddy's
      laboratories, ltd. and Janssen Pharmaceutical Products. L.P. (Reminyte®)4 mg Galantamine HBr
      Tablets In Healthy Adult Male Volunteers under fasting Conditions
    

Intervention name(s): Reminyl
Intervention type(s): Drug
Intervention description(s): Galantamine Hydrobromide Tablets 4 mg
Other intervention name(s): Reminyl 4 mg
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional

Summary: 
      The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in
      diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial
      lung biopsy.
    

Detailed description: 
      Diagnostic procedures like transbronchial lung biopsy (TBLB), transbronchial needle
      aspiration (TBNA) and endobronchial biopsy (EBB) are routinely used to obtain pathological
      confirmation of pulmonary sarcoidosis. Real-time convex probe endobronchial ultrasound-guided
      TBNA (EBUS-TBNA) has shown immense potential, however it is costly, labor intensive and still
      has limited availability, especially in low and middle income countries. In the past, TBLB
      has been the bronchoscopic procedure of choice for diagnosis of sarcoidosis however currently
      its role is being debated with the advent of EBUS. We have observed that EBUS even though has
      high yield yet the optimal diagnosis is obtained only when combined with EBB and TBLB. The
      investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in
      diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial
      lung biopsy.

      The study compares the diagnostic yield of EBUS-TBNA (plus EBB and TBLB) vs. conventional
      TBNA (plus EBB and TBLB) for diagnosis of sarcoidosis.
    

Intervention name(s): EBUS-TBNA; Conventional TBNA; Endobronchial and transbronchial biopsy
Intervention type(s): Other; Other; Other
Intervention description(s): Mediastinal and hilar lymph node aspiration using endobronchial ultrasound; Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration; Endobronchial and transbronchial lung biopsy using flexible bronchoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
Condition: Central Nervous System Tumors; Brain Tumors
MeSH terms: Neoplasms; Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study was to determine if treating a limited volume of normal tissue
      surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar
      rates of disease control compared to standard radiation therapy. The study was also conducted
      to examine the effect of irradiation on neurological, endocrine and cognitive function.
    

Detailed description: 
      Radiation therapy is commonly used to treat a variety of brain tumors in children including
      ependymoma, craniopharyngioma and low- and high-grade glioma. The ability of the therapy to
      control brain tumors in children is known to depend on the tumor type, extent of resection
      and other clinical factors. Children who received radiation therapy on this study were
      evaluated for treatment failure at 12 months. In addition to the primary objective, the study
      was designed to explore the association between radiation dose and volume and a variety of
      neurological, endocrine and cognitive deficits up to 5 years after treatment.
    

Intervention name(s): Radiation Therapy; Radiation Therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.; External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain neoplasm; Brain cancer; Neoplasm intracranial
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and tolerability and immunogenicity of V114 when
      administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to
      Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response
      rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2
      serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior
      to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on
      anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean
      concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2
      serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.
    


Intervention name(s): Rotarix™; Infanrix™ hexa; V114; Prevenar 13™
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2); Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13); 15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration,; 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL intramuscular administration.
Other intervention name(s): VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Effect of Heliox on RSV Bronchiolitis
Condition: RSV Infection; Acute Bronchiolitis
MeSH terms: Bronchiolitis; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Helium is an inert gas with a density almost one-seventh of that of air. Based on its
      properties breathing a mixture of helium and oxygen (heliox) will lead to a reduction in
      resistance through narrowed airways and consequently decreases the work of breathing.
      Participating infants with RSV acute bronchiolitis will be supplied with heliox (ration of 21
      oxygen and 79 helium) delivered through a flow nasal cannula to evaluate heliox effect in
      improving their oxygenation. Heliox will act as an additive therapy to improve oxygenation in
      patients with lower respiratory tract infection caused by respiratory Syncytial Virus (RSV)
      and will decrease the need for more complicated therapies.
    


Intervention name(s): Heliox; Air
Intervention type(s): Drug; Drug
Intervention description(s): Heliox (21:79) via nasal cannula 2 litter per minutes; Air 21% via nasal cannula 2 litter per minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heliox