bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, multicenter, prospective with a clinical benefit, open-label and
      randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide
      Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an
      Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly
      Diagnosed Multiple Myeloma.

      Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4
      consecutive 21 day cycles of an induction treatment with either VTD or VCD.
    

Detailed description: 
      The patient population will consist of adult men and women who have a confirmed diagnosis of
      Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the
      patients consulting in an investigating centre's haematology service for newly diagnosed,
      symptomatic, untreated multiple myeloma.

      in each treatment arm there will be :

        1. Induction therapy : 4 cycles of VTD (21 days)or VCD

        2. Systematic stem cell harvest after cycle 3
    

Intervention name(s): Thalidomide®; Cyclophosphamide; Velcade®; Dexaméthasone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Thalidomide; Dexamethasone; Cyclophosphamide; Bortezomib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple myeloma; Newly Diagnosed
A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse
Condition: Substance Misuse; Suicide
MeSH terms: Suicide; Suicide Prevention
Study type: Interventional

Summary: 
      The primary aim of this study is to design and develop a digital game that models the process
      of a safety planning intervention. To do so, the investigators will explore and better
      understand peer or student perceptions around potential warning signs, coping strategies, and
      seeking help among youth who may be at greater risk of suicide due to misuse of substances.
      Focus groups/interviews with adolescents, young adults, adults, and school-based behavioral
      health providers will be conducted. Findings will inform the development of a digital
      intervention to reduce the risk of suicide among adolescents who misuse substances. Once a
      prototype of the game is developed, play-test focus groups with adolescents, college-aged
      youth, and school-based mental health providers will be conducted to finalize the
      intervention. Once finalized, the investigators will conduct a pilot study with 60
      adolescents aged 13-19 to assess user experience, acceptability and feasibility of the
      digital game.
    

Detailed description: 
      Formative Work: In year 1, the aim is to design and develop a digital game that models the
      process of a safety planning intervention. To do so, the investigators will explore and
      better understand peer or student perceptions around potential warning signs, coping
      strategies, and seeking help among youth who may be at greater risk of suicide due to misuse
      of substances. Focus groups with adolescents, college-aged youth, and school-based mental
      health providers will be conducted. Findings will inform the development of a digital
      intervention to reduce the risk of suicide among adolescents who misuse substances. Once a
      prototype of the game is developed, the investigators will conduct play-test focus groups
      with adolescents and school-based mental health providers to finalize the digital game.

      The focus of this clinical trial is the Pilot RCT: In year 2, the investigators will assess
      user experience, acceptability, and feasibility of the game as well as explore the following
      proximal outcomes such as but not limited to adolescent well-being, intentions to use a
      safety planning intervention, coping strategies, substance misuse in last 30 days, and
      associated risk factors related to suicidal risk (e.g., hopelessness, impulsivity, etc.).
    

Intervention name(s): supportED; Control
Intervention type(s): Other; Other
Intervention description(s): suicide prevention videogame; non-health related videogame
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible individuals will be assigned to either the 1) supportED group (n=30) or 2) control group (n=30).
Masking: None (Open Label)
Primary purpose: Prevention
Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      Allergic rhinitis (AR) is defined as inflammation of the nasal mucosa after exposition to an
      allergen in sensitized patients. AR causes not only nasal symptoms such as sneezing, itchy
      nose, rhinorrhea and nasal obstruction, but also has a significant impact on quality of life.
      Symptom control and overall satisfaction in patients undergoing subcutaneous immunotherapy
      (SCIT) or sublingual immunotherapy (SLIT) on the long term has not yet been investigated so
      far.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who started immunotherapy
A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache
Condition: Migraine
MeSH terms: Headache Disorders; Headache
Study type: Interventional

Summary: 
      Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for
      your chronic daily headache (CDH). GONB has been used for many years in the treatment of
      headaches. The nerve block is done by injecting a liquid drug through the skin of the back of
      the head to the area of the greater occipital nerve. The nerve runs superficially in this
      area, therefore the drugs are injected just under the skin. The injected drugs block
      electrical transmission through the nerve, resulting in reduced head pain. There are
      treatment options for patients receiving a GONB, however, some clinicians use local
      anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local
      steroid injection. The purpose of this study is to evaluate whether or not there is an
      observed difference between these two treatment approaches for GONB. We expect to enroll 60
      patients into this research study at Thomas Jefferson University only.
    


Intervention name(s): lidocaine, bupivicaine and saline; lidocaine plus bupivicaine plus triamcinolone (steroid)
Intervention type(s): Drug; Drug
Intervention description(s): lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.; lidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.
Other intervention name(s): Kenalog
Intervention MeSH terms: Triamcinolone; Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
SURPASS Retrospective Study
Condition: Breast Cancer; Breast MRI; Neoadjuvant Systemic Therapy; Sentinel Lymph Node
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study aimed to determine whether sentinel lymph node biopsy (SLNB) could be a reliable
      option for evaluating nodal status in patients who had responded well to neoadjuvant systemic
      therapy (NAST), even if they had initially presented with a high nodal burden. The study
      investigated the outcomes of SLNB followed by axillary lymph node dissection (ALND) in this
      patient population, taking into account the response to NAST and the breast cancer subtype.
    

Detailed description: 
      To determine the feasibility of sentinel lymph node biopsy (SLNB) in this study, the
      investigators evaluated the false-negative rate (FNR) of SLNB. The FNR was calculated as the
      number of patients with negative SLNs who had a residual disease in the rest of the axillary
      lymph nodes (ALNs) divided by the total number of patients with residual disease in either
      the SLNs, the rest of the ALNs, or both: FN/true-positive + FN. The investigators compared
      the FNR of the SLNB according to the radiologic response measured using breast MRI in each
      subtype. The investigators further evaluated the FNR in subgroups stratified by clinical
      nodal stage. Additionally, the investigators assessed additional metastatic ALNs in cases
      with 1-2 metastatic SLNs through the completion of ALN dissection.
    

Intervention name(s): Sentinel lymph node biopsy followed by axillary lymph node dissection
Intervention type(s): Procedure
Intervention description(s): This is a retrospective study to determine the feasibility of sentinel lymph node biopsy (SLNB) after neoadjuvant systemic therapy (NAST) according to response to NAST and breast cancer subtypes. All patients received SLNB followed by axillary lymph node dissection after NAST.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study included patients diagnosed with breast cancer who received neoadjuvant systemic
        therapy (NAST) followed by curative surgery between January 2013 and December 2018. All
        patients were cN1-3 breast cancer at initial presentation In addition, all patients
        underwent sentinely lymph node biopsy (SLNB) followed by axillary lymph node dissection.
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect on the exposure of BI 1815368
      in plasma when given as oral single dose together with multiple oral doses of itraconazole
      (Test, T) as compared to when given alone as oral single dose (Reference, R).
    


Intervention name(s): BI 1815368; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): BI 1815368; Itraconazole
Other intervention name(s): Sempera®
Intervention MeSH terms: Itraconazole
Intervention model: Crossover Assignment
Intervention model description: Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
Masking: None (Open Label)
Primary purpose: Treatment
Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias
Condition: Spinocerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
Study type: Interventional

Summary: 
      Exergame training might offer a novel treatment approach even in largely nonambulatory
      subjects with multisystemic degenerative spinocerebellar ataxia.
    

Detailed description: 
      Effective treatments for patients with degenerative spinocerebellar ataxia are scarce. It has
      recently been shown that intensive coordinative training based on either physiotherapy or
      exergames (= whole-body controlled videogames; might improve degenerative ataxia, but its
      effectiveness is still disputed. This situation is even more complicated for degenerative
      ataxia subjects in advanced disease stages and with high multisystemic disease load. Here,
      underlying neurodegeneration has progressed to many irreversible states and includes many
      additional extra-cerebellar systems, making functional plasticity and therapeutic success
      much less likely. Moreover, intervention outcome assessment in subjects unable to walk freely
      is more delicate. Correspondingly, nonambulatory ataxia subjects in advanced disease stages
      are currently often excluded from treatment trials, thus leaving them without prospects of
      access to novel treatments.

      The investigators here hypothesized that exergame training might offer a novel treatment
      approach even in largely nonambulatory subjects with multisystemic degenerative
      spinocerebellar ataxia. Using a rater-blinded, intraindividual control study design, the
      investigators show that an individualized exergame training strategy, tailored to
      individuals' disease stage, improves postural control and ataxia-specific control functions
      even in advanced disease.
    

Intervention name(s): General training
Intervention type(s): Other
Intervention description(s): Advanced spinocerebellar disease receive 12 weeks of coordinative training based on commercially available videogames (Product names: Nintendo Wii ®, Microsoft XBOX Kinect®).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exergaming; Neurodegenerative diseases; Rare disease; Motor exercises; Training; Spinocerebellar ataxia
The Effects of Using Virtual Reality Glasses During the Non-Stress Test
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      The aim of this study to determine the effect of virtual reality glasses use on anxiety,
      stress and fetal well-being during the non-stress test. Personal information form was used as
      data collection form, Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) was
      used to assess distress, State-Trait Anxiety Inventory (STAI) was used to assessanxiety.
    

Detailed description: 
      Material and Method

      This research was conducted between between October 2021 and February 2022 in Fethi Sekin
      City Hospital. When power analysis was performed, the sample size was calculated to be at
      least 71 women for each group (71 experiments, 71 controls). During the NST procedures, VR
      glasses were given to the participants in the experimental group by the researcher for the
      intervention. Data collection form for experimental and control groups before the NST
      procedures; Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) and State-Trait
      Anxiety Inventory (STAI) were applied two times before and after NST procedure. After the NST
      procedures, both groups were re-administered. Descriptive statistics and independent t-test
      were used for data analysis.
    

Intervention name(s): Virtual Reality (VR) glasses
Intervention type(s): Other
Intervention description(s): During the Non Stress Test (NST), the pregnant women in the experimental group watched a video of nature scenery with Virtual Reality (VR) glasses for 10 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study was designed as a randomized controlled trial conducted with experimental and control groups (71 experimental group, 71 control group).
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Anxiety; non-stress test; stress; virtual glasses
Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Condition: Ovarian Cancer; Peritoneal Cavity Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel
      works in treating patients with relapsed or refractory ovarian epithelial or peritoneal
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate in patients with platinum-sensitive or -resistant relapsed
           or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine
           and docetaxel.

      Secondary

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the overall survival of patients treated with this regimen.

        -  Determine the time to treatment failure and progression-free survival of patients
           treated with this regimen.

      OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
      treatment with a platinum-containing regimen (platinum-resistant disease vs
      platinum-sensitive disease).

      Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1
      and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable
      toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR
      (≥ 6 total courses of treatment).

      PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I [platinum-resistant
      disease] and 17-33 for stratum II [platinum-sensitive disease]) will be accrued for this
      study.
    

Intervention name(s): Docetaxel; Gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days; 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
Other intervention name(s): Taxotere®; Gemzar ®
Intervention MeSH terms: Gemcitabine; Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; peritoneal cavity cancer
Human Lung Responses to Respiratory Pathogens
Condition: Respiratory Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      For most individuals, the lung has a remarkable ability to deal with exposure to a variety of
      inhaled bacteria. Some individuals, however, do have recurrent bacterial infections, usually
      in the form of acute or chronic bronchitis and, in some instances, pneumonia. The reasons for
      this variability in bacterial infections between otherwise healthy subjects, between types of
      lung disease, and within the same type of lung disease are poorly understood.

      Variability in susceptibility to bacterial infections is partially explained by differences
      in exposure to infectious agents, genetic susceptibility and innate (or early) immune
      responses. It is of interest that the incidence and severity of bacterial infections is
      greatest during the winter months. Other than viral infections, there are few variables that
      change with season. Vitamin D is one known immune modulator with a seasonal periodicity. The
      hypothesis of this study is that levels of vitamin D are an important determinant of the
      innate defense of the lung against inhaled bacteria. The investigators further postulate that
      vitamin D has effects on the innate immune function of both alveolar macrophages and lung
      epithelial cells.
    


Intervention name(s): Vitamin D3 (cholecalciferol); Placebo Sugar Pill
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Vitamin D; Respiratory infection; Innate immunity
Ninth Dorsal Osteopathic Visceral Manipulation D9
Condition: Osteopathia; Manipulation
MeSH terms: Bone Diseases
Study type: Interventional

Summary: 
      The aims of this study is to verify that the vertebral manipulation of dorsal level D9
      influences the pancreas biochemical and endocrinology blood values.
    

Detailed description: 
      A longitudinal experimental study was conducted in which the osteopathic thrust maneuver was
      applied. In this research, 87 healthy subjects participated, of which 56.3% (n = 49) are men
      and 43.7% (n = 38) are women aged 19-29 who study at the Catholic University of Murcia.The
      blood analytical values of insulin and glycemia have been measured in 4 different times: at
      baseline, after 2,5 and 10 minutes of the technique application with the purpose to verify
      any possible change.
    

Intervention name(s): Manipulation
Intervention type(s): Other
Intervention description(s): Thrust technique application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thrust technique; Blood levels; Pancreas; Ninth vertebra; Manipulation
CT Coronary Angiography After Arterial Switch Operation
Condition: CT Coronary Angiography; Arterial Switch Operation
Study type: Interventional

Summary: 
      The purpose of this study is to find a non-invasive alternative (with using ECG gated
      64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in
      patients who had undergone arterial switch operation for transposition of the great arteries
    

Detailed description: 
      Objectives To find a non-invasive alternative (with using ECG-gated 64-slice CT angiography)
      to invasive coronary angiography for detecting coronary lesions in children who had undergone
      arterial switch operation for transposition of the great arteries.

      Background Assessment of the integrity of reimplanted coronary arteries is crucial for
      long-term outcome after arterial switch operation for transposition of the great arteries.
      Non-invasive tests have limited accuracy for detecting coronary lesions, and invasive
      coronary angiography is usually required in this setting.

      Materials and methods Patients (age 4 to 30 years old) who undergone arterial switch
      operation in neonate period are potentially eligible. They will be prospectively included in
      the study. They will have both examinations, their routine invasive coronary angiography and
      ECG-gated 64-slice CT angiography. The ability of CT to detect lesions of the ostia and
      proximal segments of the reimplanted coronary arteries was analyzed by blinded comparison to
      invasive coronary angiogram.

      Expected results and clinical implications We expect to demonstrate that ECG-gated 64-slice
      CT angiography is safe and accurate for the detection of coronary lesions with a high
      sensitivity (expected sensitivity>95%) as compared to invasive angiography. In that
      condition, ECG-gated 64-slice CT angiography could replace the invasive coronary angiography
      for the follow-up of patients with reimplanted coronary arteries after arterial switch
      operation for transposition of the great arteries.
    

Intervention name(s): 64-slice CT angiography
Intervention type(s): Procedure
Intervention description(s): the sensitivity and specificity of 64-slice CT angiography for the detection of lesions at the ostia and proximal segments of the reimplanted coronary arteries
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Arterial switch operation; Transposition of the great arteries; Congenital heart diseases; CT coronary angiography