bioihbjkbjnl/mcl2 huggingface dataset:
Non Invasive IDentification of Gliomas With IDH1 Mutation
Condition: Non Invasive Diagnosis of Glioma
MeSH terms: Glioma
Study type: Observational

Summary: 
      The recurrent mutation IDH1Arg132His leads to the cellular accumulation of
      D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost
      specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.

      The main objective is to identify the patients with IDH1 mutated glioma by three
      complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA),
      biochemical (2-HG dosage in the urine of patients) and radiological (2-HG
    

Detailed description: 
      Our preliminary results indicate an extremely high amount of D-2HG in gliomas and CSF of the
      patients, and therefore the possibility to detect its presence by spectro-MRI, and to
      establish a non-invasive diagnosis of glioma with IDH1 mutation. Our goal is to identify and
      quantify by high-field MRI spectroscopy the presence of D-2HG to identify gliomas with IDH1
      mutation. In parallel, we developed a technique for selective amplification of the mutated
      form of IDH1 (COLD PCR): by combining this technique with digital PCR, we already are able to
      detect IDH1 mutation from free plasma DNA with a sensitivity of 58% and a specificity of
      100%. At the same time we have shown that D-2HG levels in urine of patients correlate with
      the status of the tumor IDH1.

      The main objective is to identify using this triple approach (detection of the mutation on
      plasma DNA detection, detection of urinary D-2HG, detection of tumor D-2HG by spectro-MRI)
      patients with IDH1arg132His mutation, the secondary objective is to evaluate the value of
      these markers for patients follow-up and for differentiating recurrence from treatment
      induced damage. 40 patients with grade II and grade III gliomas (20 mutated, 20 non mutated)
      will be included and followed up for one year (five measurements are planned).

      The first interest is diagnostic: the presence of the IDH1Arg132His mutation allows the
      diagnosis of glioma. This information is particularly valuable in patients not amenable to
      biopsy, because of the location of the tumor considered at risk, the general condition of the
      patient or the co-morbidities and medications. We hope also with these parameters to better
      monitor patient's follow-up, and to have a new method to differentiate tumor recurrence and
      radionecrosis or post-radiation leukoencephalopathy.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from the active file of patients with glioma II or III, followed
        at the Pitié-Salpetrière Hospital, and whose status is known for IDH1.
      
Biospecimen description: 
      Plasma samples containing free DNA fragments Urine
    
Keywords: Glioma; IDH1; Spectroscopy; Plasma
This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357
Condition: Healthy; Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics
      (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy
      volunteers for up to 28 days.
    


Intervention name(s): BI 730357; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 730357 film-coated tablet; Placebo; Once per day (QD) on Days -1, 3, and 14. Dose groups BI 730357 200 mg fed and BI 730357 400 mg fed
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
12-Week Study in Adult Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a multi-center, randomized, placebo-controlled parallel-group study to evaluate
      nebulized fluticasone propionate (FP) dose response in adult subjects with partly controlled
      and uncontrolled asthma. Individual participation will be approximately 16 weeks, including
      12 weeks of double-blind treatment.
    

Detailed description: 
      The primary outcome measure is FEV1 (Forced Expiry Volume in 1 second) and the secondary
      outcome measure is Peak Expiratory Flow Rate (PEFR), Asthma Control Questionnaire (ACQ),
      nighttime awakenings and reduce medication usage.
    

Intervention name(s): Fluticasone Propionate
Intervention type(s): Drug
Intervention description(s): FP BID for 12 weeks
Other intervention name(s): No other names are applicable
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: partially controlled; uncontrolled
Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary
      injection of progenitor cells compared to placebo injection in patients with Dilated
      Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and
      patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo
      injection
    


Intervention name(s): granulocyte colony stimulating factor (GCSF); bone marrow mononuclear cells
Intervention type(s): Drug; Procedure
Intervention description(s): 10mcg/kg per day 5 days; intra coronary injection of stem cells or placebo
Other intervention name(s): Lenograstim, Granocyte™, Chugai Pharma UK, Limited
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dilated cardiomyopathy; adult stem cells; bone marrow progenitor cells; bone marrow stem cells; autologous; granulocyte-colony stimulating factor; intracoronary injection; left ventricular function; To determine if patient's own bone marrow derived stem cells can be used to improve cardiac function
Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and
      NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non
      change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles
      during RT(66 Gy/6.5 w).
    

Detailed description: 
      Vinorelbine (NVB) + CDDP is considered a standard trt in induction or concomitantly with RT
      (Vokes, Fournel, Krzakowski). NVBo simplifies the administration of trt and provides the same
      efficacy as intravenous NVB (NVBiv). In order to assess this and to improve the tolerance, a
      trial was started with NVBiv and NVBo + CDDP as induction followed by a fractionated
      administration of NVBo + CDDP during RT.
    

Intervention name(s): Vinorelbine cisplatin radiotherapy
Intervention type(s): Drug
Intervention description(s): During the induction period, patients received chemotherapy for two 3-week cycles. Bolus intravenous vinorelbine 25 mg/m², was administered on day 1, then cisplatin 80 mg/m² was administered over 1-hour infusion. Vinorelbine 60 mg/m² was also administered on day 8.
Patients with objective response (OR) or no change (NC) continued the concomitant period (CP) including two additional 3-week cycles of radio chemotherapy (vinorelvine 20 mg D1 D3 D5 Cisplatin 80 mg/m² 66 Gy).
Other intervention name(s): Navelbine
Intervention MeSH terms: Vinorelbine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study On Human Mass Balance And Biotransformation
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the absorption,metabolism and excretion of CBP-307 in healthy
      chinese male subjects.
    


Intervention name(s): CBP-307
Intervention type(s): Drug
Intervention description(s): CBP-307 capsules oral administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical and Functional Variables in Oncology
Condition: Cancer, Metastatic; Cancer; Survivorship
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      The aim is to analyse the effect of a Therapeutic Exercise and Education programme in several
      clinical and functional outcomes in cancer patient and survivors
    

Detailed description: 
      In the oncology field, both patients and survivors have to face several symptoms, like
      cancer-related fatigue or pain. Cancer patients also have affected quality of life, lower
      levels of function and they are at higher risk of weight gain following diagnosis. Given the
      risk of obesity, both exercise and diet play a key role in recovery from cancer.

      Hence, the aim of this study is to show the effect of a Therapeutic Exercise and Education
      programme (TEEP) in clinical and functional, including practical nutritional education in
      other clinical and functional secondary outcomes in cancer patients and survivors.

      Variables included are: body composition, mediterranean-diet adherence, quality of life (QoL)
      and functional outcomes (limb functionality, physical activity, physical function and
      handgrip strength). Furthermore, laboratory variables like muscle thickness (ecography) and
      muscle activity (electromyography) were included.
    

Intervention name(s): Therapeutic Exercise and Education
Intervention type(s): Other
Intervention description(s): Intervention will consisted of 30 minutes of strength exercises followed by 20 minutes of endurance with aerobic training, individualised based on the evaluations of muscular strength and endurance as well as the determination of the aerobic-anaerobic zone transition. Sessions lasted 1 hour, carried out twice a week, during 12 weeks. This intervention will be complemented by nutritional education.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; oncology; Metastasis; survivors; Exercise Therapy; Therapeutics; Complementary Therapies; fatigue; assesment
Clinical and Laboratory Study of Lysozyme Deposition on Daily Disposable Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel
      materials and that this protein remains largely active and promotes reduced cytokine response
      in an in vitro culture of human corneal epithelial cells. This study investigates whether
      these data transfer to the in vivo situation.
    


Intervention name(s): etafilcon A; nelfilcon A
Intervention type(s): Device; Device
Intervention description(s): etafilcon A soft contact lens; nelfilcon A
Other intervention name(s): Marketed Investigational Soft Contact Lens; Marketed Investigational Soft Contact Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity
Condition: Spasticity
MeSH terms: Muscle Spasticity
Study type: Observational

Summary: 
      The objective of this study is to evaluate the effectiveness of BoNT-A on functional
      improvement in patients with post-stroke upper and/or lower limb spasticity in the early
      stage of spasticity development, according to routine clinical practice.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Post-stroke spasticity
Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The investigators aimed to assess the efficacy and safety of Beinaglutide versus glargine ,
      in individuals with type 2 diabetes who did not achieve adequate glycaemic control with oral
      antidiabetic drug.
    

Detailed description: 
      The investigators wonder in clinical hypoglycemic treatment for patients with hyperglycemia,
      whether to reduce fasting blood glucose or postprandial blood glucose first.

      In this study, subjects with type 2 diabetes mellitus in combination with oral medication
      will be treated with basic insulin to reduce fasting blood glucose, or with beinaglutide to
      reduce postprandial blood glucose, in order to find out which one of controling blood glucose
      can be more effective and observe the change of blood fluctuation.
    

Intervention name(s): Beinaglutide; glargine
Intervention type(s): Drug; Drug
Intervention description(s): Beinaglutide for 8 weeks,
Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard ); Glargine for 8 weeks,
Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Beinaglutide; glycemic variability
Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear
Condition: Full Thickness Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      The optimal timing for surgical repair of traumatic rotator cuff tears is controversial.
      Today there are no prospective studies investigating the short to mid-term outcome after
      early arthroscopic repair of traumatic rotator cuff tears and the Swedish National
      Musculoskeletal Competence Centre requests more research to this subject. The investigators
      will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair
      during the first year after surgery.

      The investigators hypothesise that the outcome after rotator cuff repair is good.
    

Detailed description: 
      There exists controversy in the current literature regarding timing for surgical repair of
      traumatic rotator cuff tears. We have seen no prospective studies describing the progression
      of shoulder function improvement the first year after arthroscopic rotator cuff repair.

      We hypothesize that early arthroscopic repair of traumatic rotator cuff tears yields
      successful functional and structural outcomes but there will be a progression of shoulder
      function improvement during the hole first postoperative year.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A prospective trial analysing the results after early arthroscopic repair of the traumatic
        rotator cuff tear. Every consecutive patient between Nov 2010 and Oct 2013 who fulfill the
        inclusion criteria are asked to participate after oral and written information. With a
        population of 250.000 we approximate an enrollment of 60 participants.
      
Biospecimen description: 
      Peroperatively retained rotator cuff biopsy.
    
Keywords: traumatic rotator cuff tear; arthroscopic rotator cuff repair; age; early rotator cuff repair
Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis
Condition: Joint Disease
MeSH terms: Joint Diseases
Study type: Observational

Summary: 
      Sponsor is conducting this post-market study to evaluate the clinical outcome and femoral
      bone mineral density (BMD) changes associated with the PROFEMUR® PRESERVE hip stem when used
      as indicated for primary total hip arthroplasty in patients with osteoarthritis of the hip
      joint.
    


Intervention name(s): total hip arthroplasty implant
Intervention type(s): Device
Intervention description(s): PROFEMUR PRESERVE total hip arthroplasty femoral stem
Other intervention name(s): PROFEMUR PRESERVE
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the investigator's private orthopedic practice from among
        patients who require a total hip arthroplasty.
      
Keywords: dual energy x-ray absorptiometry; DEXA; DXA; total hip arthroplasty; PROFEMUR; PRESERVE; bone mineral density; BMD; osteoarthritis; THA; musculoskeletal disease
Aerobic Exercise on PETCO2 Response in Coronary Artery Disease Patients
Condition: Coronary Artery Disease; Exercise Addiction; Complication, Cardio-respiratory
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study was to evaluate: 1) the effects of continuous exercise
      training and interval exercise training on end-tidal carbon dioxide pressure (PETCO2)
      response during graded exercise test in patients with coronary artery disease; and 2) examine
      the effects of exercise training modalities on the association among PETCO2 at ventilatory
      anaerobic threshold (VAT) and indicators of ventilatory efficiency and cardiorespiratory
      fitness in patients with coronary artery disease.
    

Detailed description: 
      End-tidal carbon dioxide pressure (PETCO2) is a noninvasive index considered to be a good
      indicator in evaluating the ventilation/perfusion relationship in patients over a wide range
      conditions. Variations in PETCO2 have been shown to reflect changes in both cardiac output
      and pulmonary blood flow in animals and humans under constant ventilation. In this regard, it
      has been shown that patients with cardiac disease have an abnormally low PETCO2 during
      exercise, especially those with an impaired response of cardiac output during exercise
    

Intervention name(s): aerobic exercise training
Intervention type(s): Other
Intervention description(s): The continuous exercise training was performed on a treadmill with a 50-minutes duration and intensity at ventilatory anaerobic threshold.
The interval exercise training consisted of 7 sets of 3 minutes at respiratory compensation point and 7 sets of 3 minutes of exercise at moderate intensity corresponding to the ventilatory anaerobic threshold totaling 42 minutes
Other intervention name(s): continuous training; interval training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary artery disease; Exercise; Ventilatory efficiency
Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether this topical NF-kappaB Decoy candidate is
      safe in persons with atopic dermatitis. Preliminary evidence of efficacy (whether it is
      working) will also be evaluated.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to
      evaluate the safety of repeated application of three concentrations of NF-kappaB Decoy in
      approximately 75 subjects with mild-to-moderate atopic dermatitis. The face, hands, feet,
      scalp, or groin may NOT be treated.

      Other treatment agents are currently available for atopic dermatitis but present significant
      potential side effects (topical steroids) or are potent immunosuppressives (topical
      calcineurin inhibitors) with pending longer-term safety data.

      NF-kappaB Decoy is a double-stranded deoxyribonucleic acid (DNA) oligodeoxynucleotide that
      mimics the NF-kappaB binding sequence on the chromosomal DNA, thereby inhibiting the
      production of the inflammatory response triggered by NF-kappaB. This mechanism of action
      presents a unique treatment modality.

      A comprehensive series of nonclinical data have produced promising results.
    

Intervention name(s): NF-kappaB Decoy
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: atopic dermatitis, eczema
J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The primary objective of this post marketing survey is to prospectively investigate patients
      with hypertension treated with Micardis Tablets (hereinafter "this drug") in routine clinical
      settings for 3 years in order to determine the following:

        1. Adverse events and adverse drug reactions under long-term use

        2. Blood pressure measurements during the survey period

        3. Determination of the incidence of cerebrovascular and cardiovascular events under use of
           this drug in routine clinical settings

        4. Patient's lifestyle and background factors that are considered to affect the occurrence
           of cerebrovascular and cardiovascular events
    


Intervention name(s): Telmisartan
Intervention type(s): Drug
Intervention description(s): Oral administration
Intervention MeSH terms: Telmisartan
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Japanese hypertension patients
The Effect of PD01 on Cardiovascular Health and Microbial Environment
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, placebo-controlled trial aims to determine the effects of daily
      administration of a carotenoid-producing Bacillus strain PD01 over a 6-week period on
      cardiovascular health biomarkers, microbiota composition and functioning and intestinal
      barrier function in overweight subjects.
    


Intervention name(s): Placebo; PD01
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): maltodextrin; Carotenoid-producing Bacillus strain PD01
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Carotenoid; Bacillus; Microbiota; Cardiovascular health