bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Intralymphatic Immunotherapy
Condition: Allergy; Immune Tolerance; Injection Site Discomfort
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators want to investigate whether specific immunotherapy can be delivered
      directly into a lymph node. The investigators think that a direct introduction of allergen to
      the antigen presenting cells in the lymph node a give a strong immune response and that this
      can change the number of injections needed in allergen immunotherapy. The investigators do
      measurements of clinical effect and a variety of paraclinical test to see if the
      investigators can find af biomarker of successful specific immune therapy of grass allergy.
    

Detailed description: 
      Patients are injected with 3 or 4 doses of alk 225 Phleum Pratense 1000 standard quantity
      units/ml in a lymph node in the groin.

      The investigators monitor clinical response and use of medication during the grass pollen
      season. SMS (Symptom and Medication Score) will be used.

      The investigators count the number of immunoglobulin E grass producing plasma cells in blood
      one week after each injection. The investigators also do basophil activation tests, nasal
      provocation tests and titrated skin prick test to monitor effect.

      Adverse events will be recorded.
    

Intervention name(s): Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.; alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.; 0.1 ml Isoton saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4; 3 injection into a lymphnode; 4 injection into a lymphnode
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Allergen immunotherapy
The Leaky Lung Test
Condition: Asthma; Allergy; Reactive Airway Disease; Lung Diseases, Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a clinical trial designed to test the hypothesis that measuring the absorption and
      excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial
      permeability in asthma.
    

Detailed description: 
      A cohort of subjects with asthma and healthy controls will be exposed to inhaled mannitol
      according to FDA approved protocols for bronchoprovocation. Mannitol will be measured in the
      bloodstream and urine and used to determine an airway permeability index. This is a proof of
      concept study and not a trial of new therapeutics.
    

Intervention name(s): Mannitol
Intervention type(s): Drug
Intervention description(s): Subjects will be challenged with inhaled mannitol according to already approved protocols.
Other intervention name(s): Aridol for bronchoprovocation
Intervention MeSH terms: Mannitol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The primary goal of this study is to establish and evaluate an image-based biomarker for the
      impaired motor control and sensory information processing present in Cerebral palsy (CP)
      patients
    

Detailed description: 
      Cerebral palsy (CP) may lead to various motor deficits, which further influence the
      activities and participation. It would be ideal to characterize neural network and motor
      control model in patients with CP that underlies their clinical behavior by identifying
      altered neural network and motor control associated with behavioral improvement. The aim of
      this study is to investigate the brain image and motor control in patients with CP evaluated
      by multimodal imaging studies utilizing multi-modal techniques and kinematic analysis.

      This study includes a prospective longitudinal study of patients with CP over one-year. This
      study will be executed in 3 phases within 3 years: 1st phase (1st years): to establish the
      multimodal brain images and motor control, and clinical outcomes protocol with a prospective
      one-year follow-up study in healthy subjects; 2nd phase (2nd years): to establish the brain
      images and motor control, and clinical outcomes with a prospective one-year follow-up study
      in older patients with CP; and 3rd phase (3rd years): to establish the brain images and motor
      control, and clinical outcomes with a prospective one-year follow-up study in younger
      patients with CP. In a prospective longitudinal study, each participant received 3-times
      measurements: at the beginning, 6 months later, and one year after the first data collection
      point
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        CP and healthy children
      
Keywords: cerebral palsy; multi-modal brain techniques; MRI; Kinematic; motor control
Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine
Condition: Influenza; Virus Diseases
MeSH terms: Virus Diseases; Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were
      associated with significant morbidity and mortality. It is estimated that, in the United
      States alone, the next influenza pandemic could cause approximately 200,000 deaths and
      750,000 hospitalizations. Thus, the development of a vaccine against potential influenza
      strains has become a priority. The purpose of this study is to determine the safety and
      immune response to an H6N1 influenza vaccine candidate.
    

Detailed description: 
      H6 influenza viruses are of the low pathogenicity phenotype in poultry, and in the last
      decade, outbreaks of H6 influenza infection have been reported both in the United States and
      South Africa. The prevalence of H6 influenza viruses in a wide range of domestic and wild
      birds, and their propensity for reassortment has raised concerns regarding the pandemic
      potential of these viruses. This vaccine, therefore, is an important priority in the
      development of vaccines against potential pandemic influenza strains.

      This vaccine trial will be conducted in the Center for Immunization Research inpatient unit
      in the Mason F. Lord Building at the Johns Hopkins Bayview Medical Center (Baltimore, MD).
      The study will be initiated between April 1st and December 20th, 2008, when wild-type
      influenza is unlikely to be circulating in the Baltimore area.

      An individual's participation in the study will last approximately 90 days. All participants
      will receive two vaccinations approximately 4 - 8 weeks apart. After each vaccination,
      participants will remain in isolation at the study site for at least nine days or until
      rRT-PCR assays for influenza are negative for 2 consecutive days. A physical examination and
      nasal wash will occur each day during the isolation period. Blood collection will occur on
      the day of admission, the following day, and day 7 after vaccination. Follow-up outpatient
      visits are scheduled on Days 28 and 56 after the first vaccination and on Day 28 after the
      second vaccination. Follow-up visits will include serum collection, nasal wash, and interim
      medical history.
    

Intervention name(s): H6N1 Teal HK 97/AA ca recombinant vaccine
Intervention type(s): Biological
Intervention description(s): Approximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Influenza
Prevalence of Fetal Congenital Anomalies Among Pregnant Women Attending University Hospital
Condition: Fetal Anomaly
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      Congenital anomalies occur in 2-3% of births. They account for 20-30% of perinatal deaths.
      The aim is to assess the prevalence of fetal malformations in pregnant women attending
      University hospital
    

Detailed description: 
      This prospective cohort study of 20225 pregnant women attended Obstetrics Department of
      Beni-Suef University Hospital during period (January 2016 to January 2019). A full history
      taking was obtained according European surveillance of congenital anomalies EURO-CAT core
      data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit): ▪ Females
      presented early in first trimester were scheduled for routine first trimester scan in
      accordance with international society of ultrasound in obstetrics and gynecology guidelines.
      ▪ Females presented early in second trimester were scheduled for a routine second trimester
      scan. ▪ Females presented afterwards, had a routine ultrasound scan for fetal malformations.
    

Intervention name(s): Ultrasound scan
Intervention type(s): Device
Intervention description(s): A full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women attended Obstetrics and Gynecology Department of Beni-Suef University
        Hospital during the period (January 2016 to January 2019)
      
Keywords: Fetal anomalies
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional

Summary: 
      This is an open-label, randomized, parallel-group multicenter study designed to evaluate the
      efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual
      buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL
      BUP/NAL alone to change opioid use patterns in subjects with OUD.

      Approximately 400 subjects will be randomized. The study will include a screening visit and a
      randomization visit, followed by 24 weeks of study treatment. Subjects will be scheduled for
      evaluation visits, which will include a UDS and a self report of drug use, weekly during the
      first four weeks of treatment, then every other week from weeks 5 through 12, then monthly
      through week 25. Subjects will also return to the site for only a urine drug screen (UDS) and
      a self-report of drug use each week between the evaluation visits.

      The primary objective of the study is to determine whether the combination of sublingual (SL)
      buprenorphine/naloxone (BUP/NAL) standard of care (SOC) background therapy and the digital
      therapeutic OXD01 is superior to SL BUP/NAL alone to reduce opioid use.
    

Detailed description: 
      Medication-assisted treatment, the current standard for opioid addiction, is the use of
      medications in combination with counseling and behavioral therapies to provide a
      "whole-patient" approach to the treatment of opioid use disorder (OUD). However, patients may
      not have optimal access to faceto-face clinical behavioral health services. Digital
      therapeutics can help bridge the gap between accessible services and optimal treatment of
      OUD, the primary goal of which is to reduce the use of opioids. OXD01 is a device-based
      digital therapeutic, designed to offer individuals diagnosed with OUD quality psychotherapy
      intervention based on cognitive behavioral therapy and motivational interviewing. This study
      is being conducted to determine the value of OXD01 when combined with medication to change
      opioid use patterns in subjects with OUD.

      Note: No investigational product will be administered as part of this study.
    

Intervention name(s): OXD01 digital therapy; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): OXD01 digital therapy, 1-2 times per week 15-30 minutes each time.; sublingual buprenorphine/naloxone Medication-assisted treatment, the current standard for opioid addiction; the use of medications in combination with counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: digital therapy; cognitive behavioral therapy; CBT
The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This pilot trial compares two online interventions to improve adherence to anti-hormonal
      medication among women with the most common form of breast cancer (estrogen
      receptor-positive).
    


Intervention name(s): Education; Values
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.; An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Immunogenicity and Safety of Pandemic Influenza Vaccines in Adults Aged 18 - 49 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate
      vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.
    


Intervention name(s): GSK Biologicals' investigational vaccine GSK2590066A; GSK Biologicals' investigational vaccine GSK2592984A; GSK Biologicals' investigational vaccine GSK2340274A; GSK Biologicals' investigational vaccine GSK2340273A; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): Intramuscular injection, two doses; Intramuscular injection, two doses; Intramuscular injection, two doses; Intramuscular injection, two doses; Intramuscular injection, two doses
Other intervention name(s): Control
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: H5N1; Influenza; Pandemic
Pain Inhibitory Effects of a Single Painful Mechanical Stimulus Compared to Multiple and Multiple at Different Locations
Condition: Healthy
Study type: Interventional

Summary: 
      The objective is to estimate the effects on pain thresholds of a single painful mechanical
      stimulus compared to multiple and multiple stimuli at different locations.
    

Detailed description: 
      The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological
      responses within the peripheral and central nervous system responsible for pain inhibition.
      Almost all types of MT elicit a neurophysiological response that is associated with the
      descending pain modulation circuit. But it has not been demonstrated whether this inhibition
      occurs through a conditioned pain modulation mechanism induced by painful mechanical
      stimulation that is carried out with manual therapy techniques.
    

Intervention name(s): Mechanical Conditioning stimulus
Intervention type(s): Other
Intervention description(s): Painful mechanical stimulus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Conditioned Pain Modulation; Manual Therapy; Physiotherapy; Physical therapy
Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan
Condition: Systemic Sclerosis; Shortness of Breath; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Dyspnea; Hypertension; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the clinical characteristics and hemodynamic
      profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic
      sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects
      with exercise induced Pulmonary Arterial Hypertension (PAH) with scleroderma
    

Detailed description: 
      The current literature addresses therapies for patients with resting PAH only, diagnosed by
      right heart catheterization. However, the World Health Organization (WHO) also recognizes and
      defines exercise induced pulmonary arterial hypertension (ex-PAH), which may precede the
      development of resting PAH. The natural progression of PAH, especially during exercise, has
      not been well delineated. An exercise hemodynamic study previously showed that in normal
      healthy subjects the mean pulmonary pressure does not exceed 30mmHg even at maximal cardiac
      outputs. A prior study evaluated exercise Doppler echocardiography systemic sclerosis
      patients with normal resting echocardiograms, finding an abnormal response which was defined
      as an estimated right ventricular systolic pressure greater than 40 mmHg. In the same study,
      6.6% of the patients progressed to resting PAH over the followup period of 12 months. Limited
      data is available regarding the prevalence of ex-PAH in systemic sclerosis using right heart
      catheterization.
    

Intervention name(s): Ambrisentan
Intervention type(s): Drug
Intervention description(s): Ambrisentan 5mg or 10mg once daily
Other intervention name(s): Letairis
Intervention MeSH terms: Ambrisentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic Sclerosis; connective tissue disease; Shortness of breath; Pulmonary Hypertension
Perineural Steroids for Peripheral Nerve Blocks
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve
      blocks.
    

Detailed description: 
      The purpose of this randomized, double-blinded, placebo-controlled trial is to examine if
      dexamethasone given perineurally as an adjuvant to the nerve block will prolong the time to
      recovery from sensory nerve block from a saphenous (or adductor canal) nerve block. The
      primary outcome will be time to resolution of the nerve block as assessed by pinprick over
      the saphenous nerve distribution. If this primary end point is met, this study will also
      serve as an equivalency dosing study comparing 1 mg of perineural dexamethasone to 4 mg of
      perineural dexamethasone.
    

Intervention name(s): Dexamethasone; Bupivacaine; Epinephrine; Saphenous Peripheral Nerve Block
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): Used in nerve block mixture; Used in nerve block mixture; Used in nerve block mixture; Peripheral nerve block.
Other intervention name(s): Dexamethasone Sodium Phosphate Injection; Bupivacaine Hydrochloride; Adrenaline; Adductor Canal Peripheral Nerve Block
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Epinephrine; Bupivacaine; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthesia; Anesthesia, Conduction; Anesthesia, Local; Bupivacaine; Dexamethasone; Saphenous; Adductor Canal; Nerve Block; Analgesia; Preanesthetic Medication; Perioperative Period; Peripheral Nerve Block
This Study Contains an Active Drug Treatment Group With Mometasone Furoate Nasal Spray and a Placebo (Dummy) Treatment Group for Seasonal Allergic Rhinitis (SAR). (Study P05073)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works
      to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting.
      Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will
      evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how
      long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses,
      3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's
      opinion of the study drugs by asking different questions. This study is could last up to 53
      days for some subjects.
    


Intervention name(s): Mometasone Furoate Nasal Spray; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg); Placebo: 2 sprays in each nostril
Other intervention name(s): SCH 032088
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      To evaluate the response rate and the response duration of high dose chemotherapy with
      autologous bone marrow transplantation as intensification following induction chemotherapy in
      metastatic breast cancer and to evaluate prospectively the subdivision of patients with
      metastatic breast cancer according to prognostic groups.
    

Detailed description: 
      There are 2 phases to this study: 1) Induction- which consists of the administration of
      chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow
      will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses
      of chemotherapy followed by infusion of bone marrow cells
    

Intervention name(s): High-Dose Chemo with Autologous BMT
Intervention type(s): Procedure
Intervention description(s): Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Cancer Treatment; Breast Cancer Treatment