bioihbjkbjnl/mcl2 huggingface dataset:
Epidural Anesthesia for Gynecological Surgeries
Condition: Epidural Analgesics for Comparison
Study type: Interventional
Phase: Phase 4

Summary: 
      Regional anesthesia is the preferred mode of anesthesia for major abdominal surgeries in
      present times. Gynecological surgeries are often associated with severe pain requiring a
      well-planned analgesia regimen to ensure adequate patient-comfort, early mobilization, and to
      decrease stay time in the hospital/post-anesthesia care unit (PACU) enabling patients to
      return to their normal activities quicker. Dexmedetomidine has been approved by Food and Drug
      Administration (FDA) as a short-term sedative for mechanically ventilated intensive care unit
      (ICU) patients as it has a sedative effect without significant respiratory depression ,
      anxiolytic, analgesic, antihypertensive and sympatholytic properties. Epidural administration
      of preservative free midazolam induces antinociceptive effects in humans, when midazolam is
      added it acts through gamma amino-butyric acid (GABA) receptors and enhances the affinity of
      GABA receptors. Midazolam is involved in the release of endogenous opioids acting on spinal
      delta receptors so antinociceptive effects of morphine like substances are potentiated when
      epidural midazolam is added. Studies have revealed that use of epidural midazolam provides
      effective analgesia in adults. So, the present study will evaluate the additive analgesic
      effects of epidural midazolam in combination with bupivacaine in elective gynecologic
      surgeries and compare the results with the use of bupivacaine with dexmedetomidine and
      observe the quality of epidural anesthesia with occurrence of side effects.
    


Intervention name(s): Dexmedetomidine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): it has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia.; Midazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain.
Other intervention name(s): precedex
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if high-intensity resistance training can induce
      additional beneficial effects, for patients with moderate to severe long term pain in the low
      back, when added to a multidisciplinary treatment program.
    


Intervention name(s): High-intensity resistance training; General physical activity; Multidisciplinary rehabilitation program
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Exercise therapy; Resistance training; Multidisciplinary treatment
Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
Condition: Advanced Non CNS Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec
      administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct
      injection
    

Detailed description: 
      This is a phase 1, multicenter, open-label study of talimogene laherparepvec in pediatric
      subjects with advanced non-CNS tumors that are amenable to direct injection in the clinical
      setting. Approximately 18 - 24 pediatric subjects are expected to be enrolled and treated
      with at least 1 dose of talimogene laherparepvec into 2 cohorts stratified by age. DLT will
      be evaluated based on at least 9 DLT-evaluable subjects in cohort A1. The DLT evaluation
      period is 35 days from the initial administration of talimogene laherparepvec.
    

Intervention name(s): Talimogene Laherparepvec
Intervention type(s): Drug
Intervention description(s): Talimogene laherparepvec will be administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance. The first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL administered on day 1. The second injection, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered 21 (+3) days after the initial injection. All subsequent injections, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered every 14 (± 3) days. The treatment cycle interval may be increased due to toxicity.
Other intervention name(s): TVEC
Intervention MeSH terms: Talimogene laherparepvec
Intervention model: Single Group Assignment
Intervention model description: Approximately 18 to 24 treated pediatric subjects are expected to be enrolled into 2 cohorts stratified by age (permissible based on the incidence of DLTs, a minimum of 6 subjects/cohort and a minimum of 18 subjects total).
Cohort A1 (12 to ≤ 21 years of age)
Cohort B1 (2 to < 12 years of age) Initially, 3 subjects 12 to ≤ 21 years of age are to be enrolled and treated at 100% of the recommended adult dose regimen of talimogene laherparepvec (cohort A1). The dose level review team (DLRT) will review the safety data of the first 3 subjects in the older age cohort A1 to decide if the younger age cohort B1 can be opened for enrollment. If a DLT occurs in the first 3 DLT-evaluable subjects in the older age cohort (A1 or A2), the younger age cohort will not open until a DLT rate < 33% is observed with at least 6 DLT-evaluable subjects in the older age cohort (A1 or A2).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non CNS Tumor
A Study of LY3009104(Baricitinib) for Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple
      doses in Japanese healthy subjects.
    


Intervention name(s): LY3009104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): baricitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Women and Risk of Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This is a follow-up survey of women, 10-12 years after they were included in the
      population-based Stork Groruddalen study of pregnant women, primarily set up to study
      gestational diabetes and related health issues in pregnancy in a multiethnic population. The
      investigators will now update the information about the health status of these women to study
      the development of risk factors for type 2 diabetes and cardiovascular diseases.
    

Detailed description: 
      The STORK-Groruddalen is a cohort study of 823 pregnant women. Participation rate was high
      due to facilitation for ethnic minorities and data collection at the local Health Centres,
      set up to study ethnic differences in health to inform prevention strategies to reduce these
      differences. The investigators have published many papers from this well charatertized
      cohort, about gestational diabetes and related health issues in pregnancy. Participants have
      agreed to be contacted for subsequent follow-up surveys.

      The inivestigators are now planning a follow-up study of these woman during 2019-2022, to
      study trajectories for risk factors for type 2 diabetes and cardiovascular diseases such as
      BMI, blood pressure, lipids, behavioural factors, physical activity and mental health and
      other health issues. The investigators will collect selfreported information through
      questionnaires, perform clinical measurements and take blood samples and buccal swabs.
      Collecting updated information about a range of health outcomes for women in this cohort
      will, together with already collected data, enable us to study the development of risk
      factors for type 2 diabetes and cardiovascular diseases in a life course perspective.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Middle aged women, previous participants in the STORK G study still living in Norway
      
Biospecimen description: 
      Buccal swabs
    
Keywords: Prevention; Cardiovascular diseases; Physical activity; Ethnic differences in health; Risk factors
Attention and Visual Perception in Schizophrenia: A Functional Magnetic Resonance Imaging (fMRI) Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The main objective of the study is to contribute to a better understanding of the
      physiopathology of schizophrenia, by studying causal relationships between cognitive deficits
      and the neurobiological basis for these deficits. Processing visual information involves both
      automatic grouping processes and control processes. Automatic grouping processes allow the
      building of a global configuration from local contour information. It is necessary in order
      to recognize objects. Control processes allow tending to and prioritizing information parts.
      The paradigm the investigators use allows to dissociate these processes, and is used in order
      to characterize the impairments observed in patients with schizophrenia. It is adapted to
      fMRI in order to explore the neurobiological basis of the deficits. The investigators will
      examine whether functional disconnectivity between activated areas subtend the impairments
      observed in patients.
    


Intervention name(s): fMRI
Intervention type(s): Procedure
Intervention description(s): One 30 minute session
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic, residents of Strasbourg
      
Keywords: fMRI; Visual perception; Attention
Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations
Condition: Oral Cavity Disease
MeSH terms: Mouth Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers
      was performed to access pain of local anesthesia after using a topical anesthetic associated
      or not with prior application of microneedles to the palatal mucosa region
    

Detailed description: 
      A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers
      was performed by applying a microneedle patch and as a negative control the an identical
      patch but without microneedles sticking out and after the topical anesthetic was applied for
      in one session 2 minutes and the other session 5 minutes and the investigators evaluated the
      pain of needle introduction and the injection of the anesthetic.

      The application force of the microneedles was standardized to 10N by an applicator composed
      of a 5 mL syringe and a spring. Pain and discomfort associated to the procedure was evaluated
      with a Visual Analogue Scale (VAS), in these two different moments, introduction of the
      needle and injection of the anesthetic.
    

Intervention name(s): Topical Anesthetic; Local anesthetic
Intervention type(s): Drug; Drug
Intervention description(s): The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa; After the pre-treatment with microneedles and the use of topical anesthetic, the needle and injection of local anesthetic was inserted and pain was evaluated
Other intervention name(s): treatment; Lidocaine with epinephrine
Intervention MeSH terms: Lidocaine; Epinephrine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Microneedles; Oral Cavity; Transbuccal administration
Endoscopic Band Ligation Versus Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial
Condition: Gastric Antral Vascular Ectasia
MeSH terms: Gastric Antral Vascular Ectasia; Dilatation, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators goal is to compare the standard argon plasma coagulation (APC) treatment
      with endoscopic band ligation (EBL) in patients with Gastric Antral Vascular Ectasia.
    

Detailed description: 
      Gastric antral vascular ectasia (GAVE) is a vascular structural malformation in the stomach
      that can lead to active or chronic intermittent gastrointestinal bleeding or chronic
      iron-deficiency anemia.

      The current standard endoscopic treatment is with APC. There have been multiple reports and
      case series in the literature about successful treatment with EBL for GAVE, even in cases
      where APC was unsuccessful for treatment of GAVE. Our goal is to compare the standard APC
      treatment with EBL in patients with Gastric Antral Vascular Ectasia.
    

Intervention name(s): Endoscopic Band Ligation; Argon plasma Coagulation (APC) for GAVE
Intervention type(s): Device; Device
Intervention description(s): Endoscopic band ligation device: 6 Shooter Saeed Multi-Band Ligator (Cook Medical/Endoscopy); APC treatment for gastric antral vascular ectasia (GAVE) Argon plasma coagulation device: ERBE VIO 300D (Elektromedizin GmBH)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Antral Vascular Ectasia; Argon plasma Coagulation; Endoscopic Band Ligation; GAVE
The Objectives of This Study Are Comparative Assessment of the Tolerability, Safety and Immunogenicity of the Flu-M Vaccine vs. the Ultrix® Vaccine by Single Vaccination of Children Aged 6 to 17 Years.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparative assessment of the tolerability, safety and immunogenicity of the Flu-M vaccine
      vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years.
    

Detailed description: 
      At Stage I of the trial, it is planned to screen not more than 350 children aged 12 to 17
      years (12 years 0 months 0 days - 17 years 11 months 30 days), of which it is planned to
      include and randomize 300 children meeting the inclusion and non-inclusion criteria.

      Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs.
      the Ultrix® vaccine in the first 7 days after the vaccination of volunteers, during Phase I,
      an "Opinion on Tolerability and Safety Assessment for the Flu-M Vaccine vs. the Ultrix®
      Vaccine Involving Children Aged 12-17 Years (12 Years 0 Months 0 Days - 17 Years 11 Months 30
      Days) will be prepared/

      During Phase II , the trial for Phase I volunteers will continue in full in accordance with
      the Clinical Trial Regulations.

      During the trial, not more than 350 children aged between 6 - 11 years (6 years 0 months - 0
      days - 11 years 11 months 30 days) will be further screened, of which it is planned to
      include and randomize 300 children meeting the inclusion criteria and not falling under the
      non-inclusion criteria.
    

Intervention name(s): Flu-M [Inactivated split influenza vaccine]; Inactivated Split Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): solution for intramuscular injection, 0.5 ml; solution for intramuscular injection, 0.5 ml
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: influenza; flu; vaccine; Flu-M; FluM; Ultrix; SPbSRIVS
Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response
Condition: Healthy; PreDiabetes; Adult; Asian
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      This is a monocentric, randomized controlled, open-label, 2x2 cross-over study. The main
      objective of the study is to Evaluate the efficacy of Nestle YIYANG TangLv milk powder in
      lowering the Post Prandial Glucose Response (PPGR) of a high carbohydrate meal when consumed
      with the meal.
    

Detailed description: 
      This is an acute, monocentric, open label, randomized, 2-arm, cross-over, clinical trial in
      30 subjects of Chinese Han ethnicity. Subjects will receive the two different interventions
      in a randomized order. This study will assess the efficacy of the investigational product
      after a single consumption. Day before (V1 and V3) the intervention visits (V2 and V4) the
      subjects will be admitted at the investigational site for an overnight stay where they will
      consume a standardized dinner. V2 and V3 will be followed by a wash-out period of 3 days. The
      two arms are:

      Arm 1: skimmed milk (control) Arm 2: Nestle YIYANG TangLv milk powder
    

Intervention name(s): Blood collection
Intervention type(s): Biological
Intervention description(s): Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Nestle, postprandial glucose, incretins, insulin, healthy
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Condition: Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese
      subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24
      weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a
      6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268
      subjects.
    


Intervention name(s): BGS649; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules were taken weekly for a maximum of 24 weeks; Capsules were taken weekly for a maximum of 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypogonadotropic; hypogonadism; testosterone
ORWH:SCOR - Sex/Gender Factors Affecting Women's Health
Condition: Urinary Tract Infection
MeSH terms: Urinary Tract Infections
Study type: Observational

Summary: 
      This project is the clinical project of a Specialized Center of Research (SCOR) proposal
      which is designed to further our understanding of urinary tract infection (UTI) in women.
      Acute uncomplicated urinary tract infections (UTIs) occur in an estimated 7-11 million women
      each year, and the annual costs of caring for these women are thought to approach $1.6
      billion. Approximately 20-30% of women suffer from frequent recurrent infections. UTIs in
      young women result in substantial symptoms, time lost from work, and medical costs. An
      improved understanding of the mechanisms underlying UTIs could result in new approaches to
      their prevention and reduced numbers of women with infections and the amount of antibiotics
      use.

      In this project we seek a better understanding of the causes of UTI. Most experts believe
      that vaginal colonization with UTI-causing bacteria from the rectal flora precedes
      colonization of the urethra (the tube from the bladder for urination) and bladder and
      subsequent UTI, but the relationships between these events has not been established.
      Moreover, recent information from studies in mice strongly suggest that persistent bladder
      infection follows an initial bladder infection.

      In this project, we will prospectively follow a large group of women with recurrent UTI to
      determine: 1) the relationships in time between vaginal colonization with a UTI-causing
      bacteriuria, asymptomatic bacteriuria (bacteria in the bladder but without any UTI symptoms)
      and symptomatic UTI, and 2) the presence of persistent bacteria in the bladder following the
      symptomatic UTI at entry into the study and whether such bacteria are related to later UTIs
      that are caused by the same bacteria that caused the UTI at entry into the study. We will
      thus be able to determine the relative importance of vaginal colonization vs. persistent
      infection of the bladder as the origin of the bacteria causing recurrent UTI.

      UTI-causing bacteria cultured from women with symptomatic UTI and asymptomatic bacteriuria
      will undergo studies by Dr. Scott Hultgren's group at Washington University in Project 1 to
      identify unique genes that may help us understand why some bacteria cause symptoms and others
      do not. The effect of bacteria causing UTI in these women on host response will also be
      determined by studies by Dr. Jeff Gordon's laboratory at Washington University in Project 3.

      A better understanding of the molecular and epidemiologic basis of UTI is critical in
      developing the best possible prevention and management strategies.
    


Time perspective: Prospective
Keywords: Urinary tract infection
Effects of a Chewing Gum Containing POs-Ca and Fluoride on Enamel
Condition: Enamel Subsurface Lesion
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There were no differences in the degree of enamel remineralization of subsurface lesions
      among the chewing gums containing or not containing POs-Ca and fluoride.
    


Intervention name(s): chewing gum
Intervention type(s): Dietary Supplement
Intervention description(s): chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chewing-gum; enamel subsurface lesion; calcium additives; fluoride; in situ