bioihbjkbjnl/mcl2 huggingface dataset:
Pulsed Radiofrequency Treatment Of the Gasserian Ganglion for tRigeminal nEuralgia: a retroSpective Study
Condition: Trigeminal Neuralgia (TN)
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Observational

Summary: 
      With the Pulsed Radiofrequency treatment (PRF) Of the Gasserian ganglion for tRigeminal
      nEuralgia: a retroSpective Study (PROGRESS) the objective is to document the outcome of PRF
      (Pulsed Radiofrequency treatment) for patients with TN (Trigeminal Neuralgia), unresponsive
      to conservative treatment.
    

Detailed description: 
      Primary objective:

      To determine the proportion of patients in which PRF (pulsed radiofrequency) of the Gasserian
      ganglion for trigeminal neuralgia (TN) provides acute pain relief of at least 50% on the GPE
      (Global perceived effect) score (six weeks after treatment)

      Secondary objectives:

      - To determine the duration during which PRF of the Gasserian ganglion for trigeminal
      neuralgia provides a reduction of at least 50% on the GPE (Grade Point Equivalent) score.
    

Intervention name(s): PRF
Intervention type(s): Procedure
Intervention description(s): Pulsed Radiofrequency Current of the Gasserian Ganglion
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with trigeminal neuralgia who underwent their first PRF of the Gasserian ganglion
        between 01/09/2013 and 31/08/2021
Testing MST to Improve Adherence Among Youth With Chronic Poor Metabolic Control
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an
      intensive home-based family psychotherapy intervention, to a group of urban adolescents with
      poorly controlled Type 1 diabetes and their families.
    

Detailed description: 
      Substantial data exists to demonstrate that improving metabolic control in persons with Type
      1 diabetes mellitus (T1DM) can delay the onset of diabetes complications and reverse some
      existing complications as well. Unfortunately, those adolescents with T1DM who are at highest
      risk for diabetes complications are often the most resistant to hospital based care and
      traditional education/ supportive interventions. They are also faced with multiple barriers
      to improved metabolic control, which may include lack of knowledge about diabetes, family
      disorganization and disengagement, high levels of stress and an unhealthy lifestyle.
      Multisystemic Therapy (MST), a flexible and home-based therapeutic intervention originally
      designed for use with mental health populations, seems to be a promising approach to
      providing diabetic adolescents with the ability to engage in consistent and attentive illness
      management.

      The study recruited a sample of 127 adolescents in poor metabolic control and randomly
      assigned them to either the treatment intervention, MST plus standard medical care, or
      standard medical care alone. Families randomized to MST received intensive, home-based family
      therapy for approximately six months. Families completed data collection at baseline and then
      again at 7, 12 18 and 24 months after study entry.
    

Intervention name(s): Multisystemic Therapy
Intervention type(s): Behavioral
Intervention description(s): MST is an individualized approach that begins with a comprehensive, multi-informant assessment that allows for the development of treatment goals and interventions that are individually tailored for each family. Therapists draw upon a menu of evidenced-based interventions that include cognitive-behavioral therapy, parent training and behavioral family systems therapy.
Other intervention name(s): MST
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin Dependent Diabetes Mellitus; family therapy; adolescents
A Clinical Study Conducted in Multiple Centers Comparing Veliparib in Combination With Carboplatin and Paclitaxel Versus a Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer
Condition: Non-Small -Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin
      and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated
      Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC).
    

Detailed description: 
      Subjects will be randomized in a 2:1 ratio to one of the two treatment groups. The safety of
      each treatment group will be assessed by evaluating study drug exposure, adverse events,
      serious adverse events, all deaths, changes in laboratory determinations and vital sign
      parameters. Progression -Free Survival (PFS) using Response Evaluation Criteria in Solid
      Tumors (RECIST) (version 1.1) will be assessed as well as Overall Survival (OS) and the
      Objective Response Rate (ORR). Study visits will be conducted according to the protocol
      schedule. Study visits will include physical examination, laboratory blood sample collection,
      and assessment of vital signs, medical history and urinalysis. 12-lead Electrocardiogram
      (ECG) will be performed at protocol specified visits.
    

Intervention name(s): Veliparib; Carboplatin; paclitaxel; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): ABT-888
Intervention MeSH terms: Paclitaxel; Carboplatin; Veliparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; metastatic; ABT-888; paclitaxel; non-small cell lung cancer; PARP; veliparib; progression free survival; carboplatin
A Phase 1 Study of PPI-668 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) Genotype 1
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a
      potential treatment for hepatitis C virus infection. This study is being done to assess the
      safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of
      the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study
      will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of
      PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels)
      also will be assessed.
    


Intervention name(s): PPI-668; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules; capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: hepatitis C; NS5A inhibitor; Phase 1; genotype-1; genotype-2; genotype-3
An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
Condition: Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal
      Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to
      placebo.

      Secondary Objectives:

      To evaluate effect of dupilumab with regards to:

        -  symptoms of sinusitis,

        -  sinus computed tomography (CT) scan,

        -  NPS in the sub-group of participants with co-morbid asthma,

        -  Safety and tolerability.
    

Detailed description: 
      Screening period (4 weeks) + Randomized Treatment Period (16 weeks) + Post-Treatment Period
      (16 weeks) = 36 weeks.

      To ensure at least 28 participants with co-morbid asthma needed for subgroup analysis,
      recruitment of NP participants without co-morbid asthma would stop when approximately 28
      participants without asthma were randomized.
    

Intervention name(s): Placebo (for dupilumab); Dupilumab; Mometasone furoate nasal spray
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution for injection; Subcutaneous injection.; Solution for injection; Subcutaneous injection.; Nasal spray, 2 actuations in each nostril twice daily.
Other intervention name(s): SAR231893; REGN668; NASONEX®
Intervention MeSH terms: Mometasone Furoate; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis
Condition: Latent Tuberculosis; Latent Tuberculosis Bacteriology and Histology Unknown
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, dose-escalation study with three study groups. This study will
      be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection
      (LTBI) and 8 of whom will not have LTBI at study enrollment. The investigational product is
      AERAS-456 at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50
      ug of H56 antigen with IC31 500 nmol KLK (50/500). The vaccine is administered by
      intramuscular injection.
    

Detailed description: 
      This is a Phase I, open-label, dose-escalation study with three study groups. This study will
      be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection
      (LTBI) and 8 of whom will not have LTBI at study enrollment. The investigational product is
      H56:IC31 (AERAS-456) at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a
      dose of 50 ug of H56 antigen with IC31 500 nmol KLK (50/500). The vaccine is administered by
      intramuscular (IM) injection.

      Subjects will be assigned to a study group based on LTBI status at enrollment and time of
      completion of screening. Subjects without LTBI will be assigned to Group 1. Subjects with
      LTBI will be sequentially assigned to Groups 2 and 3 based on the order in which they
      complete screening. All subjects will receive a first dose of study vaccine on Study Day 0, a
      second dose of study vaccine on Study Day 56, and a third dose of study vaccine on Study Day
      112. Enrollment of subjects into Group 2 will begin only after a review of safety data from
      the 14-day period after initial vaccination of all subjects in Group 1. Likewise, enrollment
      of subjects into Group 3 will begin only after the corresponding review of safety data from
      Group 2.

      The total duration of study follow-up for all subjects is 210 days. Study groups 1-2 will
      enroll 8 subjects each and study group 3 will enroll 9 subjects. This study is planned at a
      single clinical site in South Africa. The sizes specified for each study group were selected
      because they are judged to be adequate for preliminary safety and immunogenicity evaluations
      for a Phase I study rather than for statistical reasons.
    

Intervention name(s): H56:IC31
Intervention type(s): Biological
Intervention description(s): H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant.
Other intervention name(s): AERAS 456
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Negative
Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products
Condition: Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the
      platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid
      metabolite between generic and reference clopidogrel products in Thai healthy volunteers
    

Detailed description: 
      Platelet aggregation (ex vivo) were measured by using Whole blood impedence aggregometry
      (Chrono-log®) and VerifyNow® P2Y12 assay. Plasma concentration of clopidogrel carboxylic acid
      metabolite were measured by High performance liquid chromatography (HPLC).
    

Intervention name(s): Generic clopidogrel product Apolets®; Original clopidogrel product Plavix®
Intervention type(s): Drug; Drug
Intervention description(s): Clopidogrel 75 mg once daily for 7 days
Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7; Clopidogrel 75 mg once daily for 7 days
Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
Other intervention name(s): Apolets®; Plavix®
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Clopidogrel; Platelet inhibition; Platelet aggregation
Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir
Condition: Hepatitis C, Chronic; Chronic Renal Failure
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal
      failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although
      no particular adverse event has been linked to this metabolite sofosbuvir is not recommended
      for patients with renal failure mainly because of lack of data. Nevertheless there are
      anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This
      study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir
      and daclatasvir in treating hepatitis C in 100 patients with renal failure.
    


Intervention name(s): Sofosbuvir 400 mg and daclatasvir 60 mg
Intervention type(s): Drug
Intervention description(s): Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness < 12 KPa) or 24 weeks if cirrhotic
Other intervention name(s): Sovodak
Intervention MeSH terms: Sofosbuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C; renal failure; sofosbuvir; daclatasvir
Protective Ventilation Based on Alveolar Ventilation in Children
Condition: Anesthesia; Peroperative Complication
MeSH terms: Intraoperative Complications
Study type: Observational

Summary: 
      Protective ventilation decreased morbidity and mortality in adults' patients and is now a
      standard of care in intensive care unit and in anesthesiology. In children, there is no
      evidence in the literature to recommend protective ventilation during anaesthesia. Moreover
      the ratio of instrumental dead space to tidal volume is higher in children than in adults.
      Therefore, it is difficult to propose an "optimal" tidal volume for all children. The
      objective of this study is to evaluate the use of alveolar ventilation (estimated by the
      volumetric capnography) in children under anesthesia. The hypothesis is that in children,
      alveolar ventilation reported to ideal body weight is a constant to maintain normocarbia,
      unlike the tidal volume.
    


Intervention name(s): Alveolar ventilation monitoring estimated by the capnographic ventilation
Intervention type(s): Other
Intervention description(s): Children are monitored using end-tidal CO2, Transcutaneous CO2 and volumetric capnographic. Respiratory rate is set using textbooks and guidelines (pediatric advanced life support). The physician in charge adapts the volume to target a CO2 between 38 and 42 mmHg. Data are recorded after a stabilization period of at least 5 minutes.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children under general anaesthesia
EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA
Condition: Lung Adenocarcinoma Metastatic
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Study type: Observational

Summary: 
      First-line treatment with afatinib prolongs overall survival in patients with metastatic
      non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely,
      somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In
      this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19
      and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).
    

Detailed description: 
      First-line treatment with afatinib prolongs overall survival in patients with metastatic
      non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely,
      somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid
      availability of these biomarker results is mandatory to prevent delayed or inferior
      treatments.

      Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is
      well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via
      targeted resequencing allows simultaneous interrogation for multiple mutations, but has its
      limitations based on the amount of tumor tissue required and assay times. RT-PCR using
      Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations
      in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is
      feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to
      compare results with results obtained via standard NGS mutation analyses.
    

Intervention name(s): LC-RT-PCR and NGS
Intervention type(s): Genetic
Intervention description(s): highly sensitive PCR vs. multiplex targeted-resequencing
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with suspected lung cancer on the chest CT-scan images receiving EBUS-TBNA
        (endobronchial ultrasound-guided transbronchial needle aspiration) for clinical
        pre-treatment workup of mediastinal and hilar lymph nodes
      
Biospecimen description: 
      EBUS-TBNA specimen of lymph nodes and primary tumor
Bioavailability of Soft Gelatin Capsule Formulation of BI 201335 NA Compared to the Solution Formulation in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to establish the relative bioavailability of a new soft
      gelatin capsule (SGC) formulation of BI 201335 NA compared to the current solution
      formulation (powder in bottle, PIB) for two doses (40 mg, 240 mg) in a parallel, two-way
      cross-over study design.
    


Intervention name(s): low dose BI 201335 NA soft gelatine capsule (SGC); high dose BI 201335 NA soft gelatine capsule (SGC); low dose BI 201335 NA powder in bottle (PIB); high dose BI 201335 NA powder in bottle (PIB)
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Magnetic Stimulation in Alcohol Use Disorder
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex may
      affect neuro-adaptations associated with alcohol use disorder (AUD), potentially influencing
      craving and alcohol intake.

      Investigators investigated alcohol intake and dopamine transporter (DAT) availability by
      Single Photon Emission Computed Tomography (SPECT) in the striatum of AUD patients before and
      after deep rTMS.
    

Detailed description: 
      The study included AUD patients. Patients were enrolled by the alcohol addiction unit of the
      Internal Medicine, Gastroenterology and Hepatology Department of the Catholic University in
      Rome, Italy, according to the inclusion criteria. Screening collection of medical history,
      physical, neurological and psychiatric examinations as well as laboratory tests were
      performed. Moreover, patients were underwent to baseline SPECT assessment of striatal DAT
      availability using 123I-N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-iodophenyl) nortropane
      (123I-FP-CIT) as the radiotracer. Subsequently, patients were randomized in two groups
      (matched for gender and age) by a computer program for the REAL deep rTMS or SHAM. After
      weekly sessions of deep rTMS for four weeks, patients were underwent to the same clinical
      assessment as in the screening phase and second SPECT .

      Moreover, the alcohol intake during both the four weeks prior to the enrollment and the 4
      weeks of rTMS sessions were assessed through the Timeline Followback (TLFB) interview, an
      instrument providing a retrospective estimation of the number of drinks per drinking days,
      the number of drinking days, the number of abstinence days, the number of heavy drinking days
      and the total number of drinks. Patients were also evaluated with Alcohol Dependence Scale
      (ADS), Obsessive Compulsive Drinking Scale (OCDS), State-Trait Anxiety Inventory Scale (STAI
      Y1 and STAI Y2),Zung Self-Rating Depression Scale.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Repetitive Transcranial Magnetic Stimulation of the dorsolateral prefrontal cortex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment