bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the
      treatment of acne vulgaris.
    

Detailed description: 
      Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the
      treatment of acne vulgaris for 84 days in male and female subjects age 12-40.
    

Intervention name(s): Dapsone 5.0% Gel (SEEGPharm); Placebo; Dapsone 5.0% Gel (Allergan)
Intervention type(s): Drug; Other; Drug
Intervention description(s): Topical Gel; Topical Gel; Topical Gel
Other intervention name(s): Experimental Arm; Placebo Comparator; Active Comparator
Intervention MeSH terms: Dapsone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH
Condition: Adenocarcinoma of the Gastroesophageal Junction; Esophageal Carcinoma
MeSH terms: Carcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the efficacy and safety of icotinib in treating advanced
      carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or
      positive FISH, the primary endpoint is objective response rates.
    

Detailed description: 
      Epidermal growth factor receptor (EGFR) signaling is critical for cancer cell proliferation,
      invasion, metastasis, and resistance to apoptosis.EGFR is overexpressed in many epithelial
      malignancies and therefore makes an attractive therapeutic target.This study is designed to
      evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the
      gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH,
      the primary endpoint is objective response rates. Secondary endpoints include progress-free
      survival, overall survival, safety and so on.
    

Intervention name(s): Icotinib
Intervention type(s): Drug
Intervention description(s): Icotinib: 250 mg is administered orally three times per day, until disease progression or untolerable toxicity.
Other intervention name(s): Conmana; BPI-2009
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility of Collateral Information Review and Its Impact on Clinical Decision-Making
Condition: Depressive Disorder; Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Observational

Summary: 
      This project will investigate how review of collateral information sources (CIS) may impact
      clinical decision-making across the lifespan.
    

Detailed description: 
      This study aims to explore how reviewing collateral information sources (CIS) may affect
      clinical decision-making for clinicians treating participants with varied mood disorders.
      Investigators will assess the types of collateral information used in the clinical setting
      and treatment decisions made after a clinical session. We will gather this information from
      interested clinicians who will provide this information after each patient visit over the
      course of one week.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        - Clinicians from McLean Hospital Outpatient Programs (geriatric, child and adult) and the
        McLean Behavioral Health Partial Program, which predominantly treat patients with mood
        disorders.
Controlled Acute Hypoxia Study - Abbreviated Sensor Line
Condition: Healthy; Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The primary objective of the study is to validate the proposed claims for the OxiCable
      device, for pulse rate and saturation accuracy in a diverse subject population over a
      specified saturation range.
    

Detailed description: 
      The general procedure of invasive controlled hypoxia clinical studies is to directly compare
      test pulse oximeter measurements to saturation measurements made by a multi-wavelength
      CO-oximeter taken from arterial blood samples from healthy human subjects. Following arterial
      cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject
      breathes while simultaneous measurements are recorded from the test pulse oximeters and
      arterial blood samples at targeted levels of saturation.
    

Observational model: Case-Only
Sampling method: Probability Sample
Study population: 
        Up to 20 subjects recruited from the Clinical Laboratory subject data base.
      
Keywords: Patient safety monitors
Effects of Connectivity-based rTMS and State-Dependency on Amygdala Activation
Condition: Amygdala Activation
Study type: Interventional

Summary: 
      Posttraumatic stress disorder (PTSD) is a highly debilitating disease with response rates to
      pharmacological treatment rarely exceeding 60%. Preliminary attempts have been made to use
      repetitive transcranial magnetic stimulation (rTMS) as a non-pharmacological treatment
      alternative, but thus far rTMS approaches have demonstrated only modest efficacy. A major
      factor contributing to these limited effects stems from the depth penetration of TMS, which
      is not sufficient to directly modulate deep subcortical structures, such as the amygdala,
      that are affected in PTSD. Moreover, while rTMS effects have been shown to be
      state-dependent, (i.e. vary substantially according to the neural state during stimulation),
      this important factor is rarely considered during the clinical application of rTMS. The
      current study addresses both of these limitations to improve the therapeutic efficacy of rTMS
      for PTSD. Here we will develop a protocol to test if connectivity-based rTMS is able to
      modulate amygdala activity through the functional connections with medial prefrontal cortex,
      taking advantage of state-dependency to enhance rTMS effects by actively engaging the
      amygdala through a fear perception task. BOLD activation in the amygdala and its connectivity
      with the frontal cortex will constitute the primary outcomes to test rTMS efficacy. Heart
      rate variability and skin galvanic responses, acquired during the presentation of fearful
      faces, will be used as continuous moderators of task engagement during rTMS. If successful,
      this study will pave the way for a large-scale study to investigate whether state-dependent,
      connectivity-based rTMS of the amygdala can improve rTMS efficacy as a clinical treatment for
      PTSD.
    


Intervention name(s): repetitive transcranial magnetic stimulation; Sham repetitive transcranial magnetic stimulation
Intervention type(s): Device; Device
Intervention description(s): excitatory 5Hz rTMS will be used; an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Quality of Life Measures in Patients With Retinal Degeneration
Condition: Retinal Degeneration
MeSH terms: Retinal Degeneration
Study type: Observational

Summary: 
      Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision
      cases in the UK and starts at an early age. The purpose of this observational study is to use
      the results of two questionnaires and a computerised test testing contrast sensitivity, to
      assess the impact of IRD on quality of life. This study will involve collecting data from
      patients with IRD, but also collecting data from normal controls.
    

Detailed description: 
      IRD presents a significant burden on the NHS as well as on the individual and families. IRDs
      are particularly difficult in a family situation due to guilt and other complex emotions
      related to inheritance patterns. Poorer mental health has been reported in patients with
      retinitis pigmentosa, manifesting in a range of ways including stress, depression and
      anxiety, particularly as the disease progresses. This is most probably caused by the
      uncertainty of the disease process and the progressive nature of the degeneration.

      Recent work has reported that quality of life significantly deteriorates with a drop in
      visual field diameter of 20 degrees or a drop in visual acuity lower then LogMAR 0.3
      (equivalent to 6/12). Contrast sensitivity is often used in conjunction with VA to assess
      visual capabilities. It is a measure of the ability to see reduced contrast and has a major
      impact on utility of vision. Relating contrast sensitivity function to quality of life will
      provide valuable information about whether this aspect of vision is a critical measure for
      patient health. This is especially important as novel treatments are being developed for the
      treatment of IRDs.
    

Intervention name(s): Questionnaire; Computerised contrast sensitivity function test
Intervention type(s): Other; Other
Intervention description(s): The participants will answer two questionnaires. These are the NEI VFQ-25 and the DLTV (daily living tasks of vision).; This test involves the patient identifying whether bars on a screen are horizontal or vertical. It is designed to measure contrast sensitivity.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        60 patients with inherited retinal degeneration will be recruited from the outpatient
        clinic in the Oxford Eye Hospital. 30 healthy controls will be recruited from advertising
        around the OUH hospitals and the University of Oxford.
      
Keywords: Retina; Retinal Degeneration; Quality of Life Measures
A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin IPV in China
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Observational

Summary: 
      In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion
      With Sabin IPV Schedules in China". At present, all the infants in the monitoring cohort were
      over 18 months old and at least one year had elapsed since the last dose of sIPV
      inoculation.Since there is no any data about the protection duration of two-dose Sabin IPV
      schedules, China CDC propose to follow up the study cohort to evaluate the proportion of
      seroprotection of antibody and measure neutralizing antibody titers against poliovirus at
      over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in
      Chinese children.
    

Detailed description: 
      In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion
      With Sabin IPV Schedules in China". This study offers evidence that two doses of sIPV
      administered at 4 and 8-11 months of age and three doses of sIPV administered at 2, 3, and 4
      months of age both provide serological protection against poliomyelitis. At present, all the
      infants in the monitoring cohort were over 18 months old and at least one year had elapsed
      since the last dose of sIPV inoculation.

      Since there is no any data about the protection duration of two-dose Sabin IPV schedules,
      China CDC propose to follow up the study cohort when all subjects are at least 18 months old
      to monitor persistence of antibody. So that, if the antibody levels are not high enough to
      protect children from the disease, remedial measures can be taken as soon as possible.So
      China CDC conduct this follow up study ,to

        1. Evaluate the proportion of seroprotection of antibody against poliovirus at over 18
           months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in
           Chinese children.

        2. Measure neutralizing antibody titers against poliovirus type I, II and III at over 18
           months of age infants after 2-dose Sabin IPV schedule, compared with 3-dose Sabin IPV
           schedule.
    

Intervention name(s): Sabin strain inactivated polio vaccine
Intervention type(s): Biological
Intervention description(s): Sabin IPVs have been given to participants in previously study, blood specimens will be collected once all the subjects reach the age of 18months.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children who had participated the previous Sabin IPV study in 6 counties in Shandong
        province.
      
Biospecimen description: 
      Serum
    
Keywords: Inactivated Poliovirus Vaccine; Sabin strain
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
Condition: Multiple Sclerosis, Acute Relapsing
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled,
      dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome
      will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
    


Intervention name(s): rHIgM22; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered via IV infusion
Other intervention name(s): M22
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy and safety of FE 999049 (follitropin delta) and its personalized
      dosing algorithm in controlled ovarian stimulation for in vitro fertilization
      (IVF)/intracytoplasmic sperm injection (ICSI) using a long gonadotropin-releasing hormone
      (GnRH) agonist protocol versus a short GnRH antagonist protocol.
    


Intervention name(s): FE 999049 + GnRH agonist (GONAPEPTYL); FE 999049 + GnRH antagonist (CETROTIDE)
Intervention type(s): Drug; Drug
Intervention description(s): Pre-filled injection pen; Powder and solvent for solution for injection
Intervention MeSH terms: Cetrorelix; Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Infections; Bacterial Infections; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine whether three manufacturing lots of V419 (PR5I) induce similar
      immune responses to all of the antigens contained in V419 when given concomitantly with
      Prevnar13™ and RotaTeq™.
    

Detailed description: 
      This study is partially Double-Blinded in that the participants' parents/guardians,
      investigator/study site personnel, and Sponsor's representatives will be blinded to the lot
      of V419 the participant is randomized to receive, but not to the participant's treatment
      group (V419 or control).
    

Intervention name(s): V419; PENTACEL™; Prevnar 13™; RotaTeq™; Recombivax HB vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age.; PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group; Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Whooping Cough (pertussis); Poliomyelitis; Hepatitis B infection; Haemophilus influenzae type b infection
Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this
      single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in
      healthy male subjects.
    

Detailed description: 
      Clinical pharmacology
    

Intervention name(s): Finerenone (BAY 94-8862) PEG solution; Finerenone (BAY 94-8862) immediate release tablet; Eplerenone (Inspra®); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862; 20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets; Single oral dose of 50 mg eplerenone; Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Healthy volunteers, proof-of-concept trial, PK and PD
Neural Correlates of an Olive Oil Essence
Condition: Neural Correlated of Different Foods
Study type: Interventional

Summary: 
      The aim of the current study was to investigate the effect of a low fat meal in comparison to
      a low fat meal dosed with the fatfree essence of olive oil.
    


Intervention name(s): low fat vs. essence yoghurt
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
a Predictive Scheme for Poor Responders in IVF Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      While practicing the different assisted reproductive techniques, the investigators are faced
      daily by the problem of poor responder females, and the debate about predicting its results
      based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for
      ovarian response, the need to re-assess its role was essential in our community, which led us
      to conduct this prospective multi-center IVF study.
    


Intervention name(s): transvaginal Ultrasound
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Poor responder females
A Food Effect Study in Healthy Volunteers With Belzutifan (PT2977, MK-6482) Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, single-dose study will be conducted in adult male and female subjects (N = 16)
      who are in general good health and selected for participation in the study according to the
      selection criteria. This study will assess the effect of food on the pharmacokinetics of
      belzutifan Tablets. The study will consist of two periods and will be conducted in a
      crossover fashion.
    

Detailed description: 
      Subjects will be randomized in equal numbers to two sequences of meal conditions (fasting and
      non-fasting). Serial blood samples will be collected after dose administration in each
      period. Subjects will be confined at the clinical research for a portion of each period.
    

Intervention name(s): Belzutifan
Intervention type(s): Drug
Intervention description(s): Belzutifan Tablets
Other intervention name(s): MK-6482,; PT2977
Intervention MeSH terms: Belzutifan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults
Condition: Vascular Stiffness; Insulin Sensitivity
MeSH terms: Insulin Resistance; Hyperglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators are studying the effects of Hyperglycemia on vascular function and insulin
      sensitivity on healthy adults
    

Detailed description: 
      The investigators will study 22 healthy subjects (18-35 yrs) four times as follows:

        1. Saline + Octreotide + euglycemia;

        2. Octreotide + hyperglycemia;

        3. Octreotide + hyperglycemia + insulin clamp and

        4. Octreotide + Euglycemia + insulin clamp.

      The sequence of admissions will be assigned randomly. The investigators will assess function
      in conduit (pulse wave velocity-PWV, augmentation index-AI and flow-mediated dilation-FMD),
      resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular
      (contrast enhanced ultrasound-CEU) vessels.

      This work will:

      a) identify whether vascular stiffness and indices of NO action are impaired throughout the
      arterial tree with hyperglycemia.
    

Intervention name(s): Octreotide; Insulin; Dextrose 20% solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): we are using it to block insulin secretion from the pancreas; we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp; We are using dextrose to maintain glycemia level
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject is studied 4 times in a randomized sequential order
Masking: None (Open Label)
Primary purpose: Basic Science