bioihbjkbjnl/mcl2 huggingface dataset:
Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess in a prospective multicentric study (Phase III) the
      introduction of a monoclonal antibody directed against B-cells associated with a standard
      therapy including chemotherapy and alpha-interferon in first line treatment of patients with
      a large tumor burden follicular lymphoma.
    

Detailed description: 
      Follicular lymphoma patients with a large tumor burden will be randomized for 18 months of
      treatment with either:

        -  Arm A: CHVP + alpha2a-interferon. Patients will receive 12 courses of CHVP
           (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and
           prednisolone 40 mg/m² for 5 days), one course every month for 6 months then one course
           every other month for 12 additional months associated with alpha2a-interferon 4.5
           millions units sub-cutaneously three times a week for 18 months.

        -  Arm B: CHVP + alpha2a-interferon + rituximab. Patients will receive 6 monthly courses of
           CHVP (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and
           prednisolone 40 mg/m² for 5 days) associated with 6 infusions of rituximab (375 mg/m2)
           associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week
           for 18 months.
    

Intervention name(s): rituximab
Intervention type(s): Drug
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lymphoma; follicular; B-cell; rituximab; interferon
Immunogenicity of ND1.1 by Delivery Directly to the Ileum
Condition: Avian Influenza
MeSH terms: Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted
      adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a
      radio controlled capsule. The secondary objective is to evaluate the immune response
      (cellular and humoral) of two doses of ND1.1 oral vaccine.
    


Intervention name(s): ND1.1
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Avian Influenza
NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema
Condition: Dyspnea; Peripheral Edema
MeSH terms: Dyspnea; Edema
Study type: Observational

Summary: 
      The objectives of this study are to:

        -  Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain
           natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure
           in patients with acute dyspnea and/or edema.

        -  Determine the exact biomarker cut-off point(s) for the differentiation of healthy
           persons, patients with heart failure and patients with dyspnea of other origin.

        -  Evaluate treatment costs in patients with dyspnea under special consideration of
           NT-proBNP measurement.
    

Detailed description: 
      Primary endpoint:

        -  Sensitivity and specificity of biomarker measurements for discrimination of heart
           failure from dyspnea of other origin.

      Secondary endpoints:

        -  Determination of Cut-off(s)

        -  Discrimination of cardiac and non-cardiac diseases causing to dyspnea or peripheral
           edema

        -  Determination of treatment costs of the initial hospital stay

        -  Evaluation of resource savings when implementing NT-proBNP for determination of
           diagnosis.

        -  Time to diagnosis.

        -  Hospitalization rate /Intensive care treatment rate between day 1 and 28

        -  Duration of initial hospital stay

        -  30-day re-hospitalization rate

        -  30 day mortality rate and adverse event rate

        -  1 and 5 year mortality rates

        -  1 and 5 year rehospitalization rates
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from dyspnea and peripheral edema
      
Biospecimen description: 
      Peripheral blood samples
    
Keywords: natruretic peptides; NT-proBNP; new biomarkers; congestive heart failure; atrial fibrillation; acute myocardial infarction; lung embolism
Double-blind Trial of Mannitol Cream to Block the Effect of Capsaicin Cream
Condition: Pain
Study type: Interventional

Summary: 
      Capsaicin is a TRPV1 (transient receptor potential vanilloid 1) agonist, causing pain upon
      application. The investigators wish to determine whether mannitol blocks the effect of
      capsaicin application. As both cream bases are identical and mannitol addition is the only
      difference between the creams, if the mannitol cream is more effective in blocking the effect
      of capsaicin on the TRPV1 (transient receptor potential vanilloid 1) receptor, the
      investigators will have established that mannitol down-regulates or blocks the TRPV1
      (transient receptor potential vanilloid 1) receptor.
    

Detailed description: 
      Capsaicin cream, which stimulates the TRPV1 (transient receptor potential vanilloid 1)
      receptor, causing a burning sensation, will be applied to both halves of the upper lip until
      a burning sensation with 8/10 intensity on an NRS (Visual Analog Scale) scale is experienced
      or five minutes have elapsed. Following this, the capsaicin cream will be wiped off and 30%
      mannitol in vehicle cream ( isopropyl palmitate, caprylic capric triglyceride, propylene
      glycol, ceteareth 20, cetearyl alcohol, glyceryl stearate, polyethylene glycol 100 stearate,
      dimethicone, octyldodecanol, lecithin, ethylhexyl glycerin and phenoxy ethanol) will be
      applied to one half of the upper lip, and vehicle cream alone will be applied to the other
      half. Cream assignment will be randomized and neither the subject nor the person applying the
      cream will know which half upper lip has which cream. Every minute for 10 minutes, the heat
      sensation felt in each half upper lip will be measured, using a visual scale from 0 to 10. A
      repeated measures analysis of variance will compare the NRS (Visual Analog Scale) scores from
      the 30% mannitol cream, to the NRS (Visual Analog Scale)scores from the vehicle cream.
      Significance will be accepted if P less than .05.
    

Intervention name(s): 30% Mannitol in vehicle cream; vehicle cream
Intervention type(s): Drug; Drug
Intervention description(s): applied to one half of the upper lip following removal of capsaicin cream.; application to the other half of the upper lip following capsaicin cream removal
Other intervention name(s): mannitol cream; Mannitol; mannite; manna sugar; C6H8(OH)6
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Mannitol; TRPV1 receptor; Pain; Burning pain; neuropathy; neuropathic pain
Physiotherapy Exercises in Patients With Sternal Instability After Cardiovascular Surgery
Condition: Mediastinitis; Coronary Artery Disease; Cardiovascular Infections
MeSH terms: Cardiovascular Infections; Mediastinitis; Coronary Artery Disease
Study type: Interventional

Summary: 
      Sternal instability caused by mediastinitis is one of the most feared complications for
      cardiac surgery team for generating large commitments and functional damages to patients.
      Biomechanically, the contraction of abdominal muscles such as transverse abdominal, produces
      forces that result in a "corset-like" action and anterior thoracic cage muscles too may
      assist in stabilizing the sternum. Thus, strengthening the abdominal muscles might contribute
      to the recovery of functional aspects. The aim was to evaluate whether contraction and
      strengthening the abdominal muscles could improve lung function and respiratory muscle
      strength in patients with sternal instability.
    

Detailed description: 
      Sternal instability was confirmed by physical examination and confirmed by chest tomography.
      The data were collected before and after the 3-week period of intervention.

      Sternal instability way assessed by the unstable sternal scale, graduated from zero to 4
      points.

      The respiratory muscle strength was measured through Manuvacuometry and the pulmonary
      function by the spirometry.

      Pain was recorded by using a Visual Analog Scale (0 -10); Discomfort Scale( 0-10) and
      Identification of Activities that cause pain and discomfort.

      Patients underwent abdominal exercise protocol for three weeks once a day, lasting about 15
      minutes followed by the physiotherapist.
    

Intervention name(s): physiotherapy exercises
Intervention type(s): Other
Intervention description(s): Consisted of trunk stabilization exercises.The exercises were undertaken for 15 minutes every day for tree weeks. Patients were the contract their abdominal muscles with an emphasis on the transverse abdominal. Patients were to contract their abdominal muscles in a supine,sitting and stand up position.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sternal instability; physical therapy; Respiratory muscle strength
Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine
      hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged
      6-17
    


Intervention name(s): SPD503 (Guanfacine hydrochloride) (2 mg); SPD503 (3 mg); SPD503 (4 mg); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation
Condition: Colonoscopy
Study type: Interventional

Summary: 
      The purpose of this study is to see whether patients controlling their own sedation during
      colonoscopy are less likely to need help breathing than when an anesthesiologist controls the
      medicine, and whether we can predict when the need for help will occur. The pump used in the
      study is approved for clinical use by the FDA, as are the medicines used in the pump.
    


Intervention name(s): patient control of pump; anesthesiologist controlled sedation
Intervention type(s): Other; Other
Intervention description(s): Patient controls sedation pump during colonoscopy.; Anesthesiologist will control the sedation pump during colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Conjunctivitis and Indentification of Risk Factors With and Without Prophylactic Antibiotic Treatment in Neonates
Condition: Ophthalmia Neonatorum
MeSH terms: Ophthalmia Neonatorum; Conjunctivitis
Study type: Observational

Summary: 
      The French guidelines for the use of Rifamycine eye drops in delivery room to prevent
      neonatal conjunctivitis have been actualized. Only newborns exposed to risk factors of
      conjunctivitis should be treated, compared to previous guidelines, treating all newborns.
      currently, there are no data describing risk factors for neonatal conjunctivitis. This study
      evaluated the incidence of conjunctivitis with or without Rifamycine eye drops treatment in
      the delivery room. Then risk factors for neonatal conjunctivitis where analyzed.
    


Intervention name(s): Rifamycine treatment; whithout Rifamycine treatment
Intervention type(s): Other; Other
Intervention description(s): Phone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment in delivery room.; Phone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines.
Intervention MeSH terms: Rifamycins; Rifamycin SV
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newborns
      
Keywords: neonate, infant; eyewash; delivery room; prophylaxis; risk factor's
Improved Discrimination Of Central And Obstructive Apnoeas In Infants
Condition: Central And Obstructive Apnoeas In Infants
MeSH terms: Apnea; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Referral of infants to the respiratory sleep disorders breathing team with apnoeas [pauses in
      their breathing] and apparent life-threatening episodes are frequent. While the majority of
      such episodes do not have a significant underlying problem a potentially life threatening
      condition accounts for a significant proportion of cases.

      In order to fully assess an infant, a full-scale overnight polysomnography study would be
      required. Unfortunately due to the complexity of such studies and because the equipment is
      generally fully booked for many weeks ahead it is extremely difficult to arrange timely
      assessment. Hence, currently, we are largely reliant on simple screening with pulse oximetry
      (measuring oxygen levels in the blood with a simple probe). This is able to identify
      potentially significant problems, but it is does not help to determine whether this is
      because the baby simply stops breathing for a period due to disturbance of its control of
      breathing, or whether it is experiencing obstructive episodes, for which there are a number
      of causes. This new equipment to be assessed would potentially provide a simple, robust means
      of undertaking definitive studies simply and effectively on the medical wards with assessment
      of chest and abdominal wall movement being linked to pulse oximetry.

      This is likely to provide a substantial and significant improvement on our current practice.
      The benefits will be that, for those with no significant underlying problems, we will be able
      to provide much greater reassurance for the parents, which is clearly very valuable, while in
      those with a problem we will be able to distinguish those with central or obstructive apnoea
      with a degree of certainty that will greatly streamline further assessments and treatment.
    


Intervention name(s): Volusense paediatric monitoring device
Intervention type(s): Device
Intervention description(s): Comparison of Volusense paediatric monitoring device to full cardiorespiratory polysomnography.
Other intervention name(s): Volusense
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung
      cancer. Relatives with family history of lung cancer are at increased risk of lung cancer
      compared to those without a family history in pooled analysis. A prospective trial using LDCT
      of lung to screen the relatives with family history of lung cancer is needed.
    

Detailed description: 
      Investigators invited participants with family history to join in this study under the
      criteria of (1) relatives of the lung cancer patients; (2) age older than 55 years old or age
      older than the age of onset of lung cancer proband if the family members were less than 55
      years old; (3) compulsory signing the consent agreement after understanding the purpose of
      study and the exposure of radiation. The participants with (1) proved lung cancer either with
      or without treatment, (2) presence of hemoptysis or history of remarkable lung fibrosis, (3)
      any other cancer history or (4) chest CT examination within one year would be excluded from
      the study.

      The study was planned to enroll 1000 participants from simplex families and 500 participants
      from multiplex families for lung LDCT screening. Multiplex family was defined as two or more
      family members with lung cancers, and simplex family as one family member with lung cancer.
    

Intervention name(s): low dose computed tomography
Intervention type(s): Device
Intervention description(s): Participants will receive 3 round of low dose computed tomography screening every year
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Low dose CT screening; Family history of lung cancer
Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Breast Pain
Condition: Cyclical Breast Pain
MeSH terms: Mastodynia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is being done to find out what effects Vitamin E or Evening Oil of Primrose has on
      cyclical breast pain.
    

Detailed description: 
      Cyclical mastalgia is a common complaint of women presenting to their primary care
      physicians. Cyclical breast pain is defined as prementstrual breast discomfort associated
      with hormonal fluctuations during the menstrual cycle. A clinical breast examination and
      sometimes additional imaging, such as sonography or mammography, is required as part of the
      evaluation to exclude malignancy. For most women, the symptoms are effectively managed with
      reassurance and conservative treatment measures such as the use of a supportive bra or over
      the counter pain medication such as acetaminophen or anti-inflammatories. However, a small
      number of women will require additional drug treatment with danazol after failing to respond
      to conservative measures. Unfortunately, danazol is associated with significant side effects.
      In the Mayo Breast Clinic, women with cyclical breast pain are managed with Vitamin E and
      Evening oil of primrose (EOP) either as single agents or in combination. These over the
      counter supplements are readily available, acceptable due to minial side effects and appear
      to lead to significant reduction in breast pain. We propose a randomized placebo controlled
      trial to determine if any vitamin E or EOP or the combination of both are effective in
      managing cyclical breast pain.
    

Intervention name(s): Vitamin E, Evening Oil of Primrose, and Placebo
Intervention type(s): Drug
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Novel Peptide Vaccination for Patients With Advanced Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and clinical efficacy of novel
      vaccination for advanced bladder cancer.
    

Detailed description: 
      DEP domain containing 1(DEPDC1) and M phase phosphoprotein 1(MPHOSPH1) have been identified
      using genome-wide expression profile analysis by the use of cDNA microarray in our previous
      studies. We have determined the HLA-A*2402 restricted epitope peptides derived from DEPDC1,
      DEPDC1-9-294, and MPHOSPH1, MPHOSPH1-9-278. These epitopes showed strong IFN-g production
      when stimulated with the appropriate targets expressed the appropriate protein and
      HLA-A*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after
      the vaccination. Therefore we focused on the safety and efficacy of novel vaccination for the
      advanced bladder cancer patients who already showed resistance to standard chemotherapies or
      radiotherapy.
    

Intervention name(s): MPHOSPH1 and DEPDC1
Intervention type(s): Biological
Intervention description(s): DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week for 3 months thereafter once two weeks. These peptides are determined to administer in accordance with the protein expression using immunohistochemical staining. These peptides are conjugated with Montanide ISA 51 as an adjuvant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epitope peptide; CTL; Advanced bladder cancer; Vaccination; advanced bladder cancer which showed resistance for standard treatments
Clinical Gene Therapy Protocol for the Treatment of Retinal Dystrophy Caused by Defects in RPE65
Condition: Leber Congenital Amaurosis
MeSH terms: Blindness; Retinal Dystrophies; Leber Congenital Amaurosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to assess the safety and efficacy of the active substance
      rAAV-2/4.hRPE65 in patients with Leber Congenital Amaurosis or Congenital severe early-onset
      retinal degeneration associated with RPE65 mutation.
    


Intervention name(s): rAAV2/4.hRPE65
Intervention type(s): Drug
Intervention description(s): One injection in on eye
Cohorte 1 : 3 patients will receive one injection of up to 400 microliters of the IMP
Cohorte 2 : 3 patients will receive one injection of up to 800 microliters of the IMP.
Cohorte 3 : 3 patients under age of eighteen will receive one injection up to 400 or 800 microliters of the IMP.
Intervention model: Single Group Assignment
Masking: None (Open Label)