bioihbjkbjnl/mcl2 huggingface dataset:
3-AP and Gemcitabine in Treating Patients With Recurrent, Unresectable, or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways
      to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill
      more tumor cells by making them more sensitive to the drug.

      PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works
      in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the antitumor activity of 3-AP (Triapine®) and gemcitabine, in terms of
           complete and partial response and 6-month progression-free disease, in patients with
           recurrent, unresectable, or metastatic pancreatic cancer.

      Secondary

        -  Determine the objective response rates, median survival, 1-year survival rate, duration
           of response or stable disease, and progression-free survival of patients treated with
           this regimen.

        -  Determine the safety and tolerability of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive 3-AP (Triapine®) IV over 2 hours and gemcitabine IV over 30 minutes on days
      1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease
      progression or unacceptable toxicity. Patients achieving a complete or partial response
      receive an additional 2 courses of therapy beyond response.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 28-50 patients will be accrued for this study within 7-13
      months.
    

Intervention name(s): gemcitabine hydrochloride; triapine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer
Quadratus Lumborum Block for Congenital Hip Dislocation Surgery
Condition: Congenital Hip Dislocation
MeSH terms: Joint Dislocations; Hip Dislocation; Hip Dislocation, Congenital; Developmental Dysplasia of the Hip
Study type: Interventional

Summary: 
      Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric
      population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of
      congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction
      or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed
      during this surgical treatment and cause severe postoperative pain.Since initial description
      for abdominal surgery, the quadratus lumborum block has experienced several surgeries for
      postoperative pain management in adults and pediatrics. One of these indication is the hip
      surgery and described for adult hip arthroplasty. In addition we reported two pediatric cases
      that single dose transmuscular quadratus lumborum block is an affective analgesia for CHD
      surgery. The aim of this study was to evaluate the analgesic effect of ultrasound guided
      transmuscular quadratus lumborum block in pediatric patients undergoing CHD surgery.
    


Intervention name(s): Bupivacaine; Standard pain
Intervention type(s): Drug; Other
Intervention description(s): 0.5 ml/kg %0.25 bupivacaine; Standard pain follow up and monitorization
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Multicenter, Clinical Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With mCRC
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study to assess efficacy and tolerability of combination therapy
      FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic
      colorectal cancer.
    

Detailed description: 
      This is a single-arm, multicentre phase II study evaluating the efficacy and safety of
      Bevacizumab (BV) in combination with oxaliplatin, irinotecan hydrochloride, fluorouracil, and
      leucovorin calcium regimen ( FOLFOXIRI +BV ; Falcone et al. ASCO2013) as first-line treatment
      for Japanese metastatic colorectal cancer patients.

      This study is composed two steps because of collecting safety issue in Japanese patient.

      As First step (Step 1), It assess on the initial safety information in ten Japanese patients
      of the end of 2nd cycle. it is evaluated by DMC.

      In parallel with the confirmation of the initial safety issue, register up to 65 cases in
      total and Step 1 patient, to evaluate the efficacy and safety (Step2).
    

Intervention name(s): Bevacizumab; 5-fluorouracil; Irinotecan hydrochloride; Leucovorin calcium; Oxaliplatin
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention description(s): Given IV; Given IV; Given IV; Given IV; Given IV
Other intervention name(s): BV; 5-FU; CPT-11; I-LV; L-OHP
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Oxaliplatin; Irinotecan; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic colorectal cancer, bevacizumab, FOLFOXIRI
Physical Activity Monitoring in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Condition: Chronic Fatigue Syndrome (CFS); Myalgic Encephalomyelitis (ME)
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic; Myalgia; Syndrome; Fatigue
Study type: Observational

Summary: 
      The investigators will assess the feasibility of activity monitoring armbands for continuous
      measurement of physical activity level in ME/CFS patients, during 6 months follow-up. The
      main purpose is to assess if continuous measurement of activity level may be incorporated in
      outcome measures in future clinical interventional trials.
    

Detailed description: 
      The purpose is to assess feasibility of activity monitoring armbands for continuous
      measurement of physical activity level in patents with Myalgic Encephalopathy/ Chronic
      Fatigue Syndrome (ME/CFS), during 6 months follow-up.

      The investigators will assess which physical activity parameters that best seem to reflect
      the participant's own perception of activity level, such as mean number of steps per 24
      hours.

      The investigators will assess the agreement between continuous activity measurements by
      activity armbands, and self-reported questionnaires for health-related quality of life (SF-36
      ver.2) and for ME/CFS symptoms (DSQ-SF).

      The investigators will assess the agreement between activity monitoring by armbands, and
      previously validated activity monitoring bracelets for 5-7 consecutive days, at baseline, at
      3 months and at 6 months follow-up.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Approximately 30 patients with ME/CFS according to Canadian Consensus Criteria (2003) with
        disease duration at least 2 years, of age 18-65 years
      
Biospecimen description: 
      Blood samples (serum, plasma, full blood) will be collected at baseline
    
Keywords: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; ME/CFS; Physical activity; Activity armband
Effect of Ingestion of Human, Cow, and Modified-cow Milk, on Glucose and Hormone Responses in Humans.
Condition: Insulin Tolerance; Hormone; Aminoacidaemia
Study type: Interventional

Summary: 
      Human milk, despite a much lower protein content, is as effective as cow milk on insulin
      stimulation under iso-lactose conditions. The causes for such a similar potency are unknown.
      This effect could be due to incretin and amino-acid responses, and/or to milk-protein
      interactions.In this study the investigators will address the above question(s) by testing,
      in young healthy volunteers, the effects of natural cow and human milk, as well as of the
      manipulation of the casein and whey protein content in cow milk, on insulin, C-peptide, GLP-1
      and GIP secretion, as well as on circulating amino acids.
    

Detailed description: 
      Objective: To determine plasma glucose, insulin, C-peptide, glucagon-like polypeptide-1
      (GLP-1), glucose-inhibitory-polypeptide (GIP) and amino-acid responses, following
      administration of human and cow milk, either natural or with experimentally-modified casein
      and whey-protein content(s).

      Design. Young healthy volunteers of both sexes will receive iso-lactose loads (0.36 g lactose
      / kg body weight) of: natural cow milk; natural human milk; and of cow milk with modified
      casein and whey protein contents. Blood samples will be frequently collected over 4 hours.
      Plasma glucose, amino acids, insulin and incretin concentrations will be measured.
    

Intervention name(s): natural cow; high protein cow milk; natural human; low protein cow milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects allocated to receive one or more milk types in random order on different occasions, spaced by at least two weeks
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cow milk; human milk; incretins; casein; whey proteins
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for
      prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor
      currently in development for treatment and prevention of HIV infection. CAB possesses
      attributes that allow formulation and delivery as a LA parenteral product. CAB is being
      developed as both oral and long acting (LA) injectable formulations. This study is designed
      to evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected
      Chinese male subjects at low risk for HIV acquisition. Eligible subjects will receive oral
      CAB during oral phase of the study followed by CAB LA intramuscular (IM) injection during
      injection phase of the study. Approximately 60 subjects will be screened, of which,
      approximately 48 subjects will enter the oral phase and 40 subjects will enter the injection
      phase of the study. The maximum study duration will be approximately 89 weeks including oral
      phase, injection phase and follow-up phase.
    


Intervention name(s): Oral CAB; CAB LA
Intervention type(s): Drug; Drug
Intervention description(s): CAB tablet will be formulated as white to almost white, oval shaped, film coated 30 mg tablets, administered orally once daily. The CAB tablets will be packaged in bottles containing 30 tablets each.; CAB LA is a sterile white to slightly colored suspension containing 200 mg/mL of CAB as free acid for administration by IM injection in gluteus medius.
Intervention model: Single Group Assignment
Intervention model description: Eligible subjects will receive oral doses of CAB for 4 weeks followed by IM dosing with CAB LA at Week 5, Week 9, Week 17, Week 25 and Week 33.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK1265744; Pre-Exposure Prophylaxis; Human immunodeficiency virus; Cabotegravir; Pharmacokinetics
Biological Aging of Skeletal Muscles in Humans
Condition: HEALTHY
Study type: Observational

Summary: 
      Aging affects almost all the tissues and physiological functions, and skeletal muscle is the
      most affected organ. The progressive decline of the weight and the muscular function linked
      to the aging contributes to the lack of autonomy and dependence, but also to an increase of
      the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in
      13-24% of 60 years old, and 50% of 80 years old and more.

      However, strong inter-individual variations of this prevalence of sarcopenia exists. The key
      issue is to understand why the biological aging of the skeletal muscle is so different
      between people.

      In this study, mechanisms involved in biological aging of the skeletal muscle in aging people
      (same chronological age) will be specified.
    

Detailed description: 
      Aging affects almost all the tissues and physiological functions, and skeletal muscle is the
      most affected organ. The progressive decline of the weight and the muscular function linked
      to the aging contributes to the lack of autonomy and dependence, but also to an increase of
      the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in
      13-24% of 60 years old, and 50% of 80 years old and more.

      However, strong inter-individual variations of this prevalence of sarcopenia exists. Some
      elderly (60 years old) reveal a biological aging of 80 years old, whereas 60 years old people
      reveal a biological aging of 60 years old. The key issue is to understand why the biological
      aging of the skeletal muscle is so different between people.

      Previous sarcopenia studies in Humans did not really focus on chronological aging, they were
      all based on a comparison between young and old people. No study considered inter-individual
      modifications (biological aging) in sarcopenia. Furthermore, few studies were associated in
      the same study to "omic", histological, and epigenetic data, to obtain integrated point of
      view of Human Sarcopenia.

      In this study, mechanisms involved in biological aging of the skeletal muscle in aging people
      (same chronological age) will be specified.
    

Intervention name(s): Proof cohort : muscular assessment
Intervention type(s): Other
Intervention description(s): Clinical examination, blood appraisal, urinary collection, MVC, checking muscle functional skills and muscular biopsy will be performed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients are recruited in the Proof cohort (Barthélemy et al., 2007).
      
Biospecimen description: 
      Urinary and blood samples will be taken, and a muscle biopsy will be performed.
    
Keywords: sarcopenia; elderly; muscle biopsy
Acupuncture for Pain During Injection of Local Anaesthetic
Condition: Pain; Distress; Satisfaction
Study type: Interventional

Summary: 
      Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients
      experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and
      distress in children receiving an injection of a local anaesthetic (LA). Children scheduled
      for dental treatment using local anesthesia as a standard treatment, received bilateral
      acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the
      patients stimulated the needles by massage. Two different treatment regimes were compared: a
      standardized LA injection given 5 minutes after acupuncture, and an LA injection without
      acupuncture. The order of treatment was randomised, with the two treatments performed on
      different days. Pain intensity during LA injection, assessed by the patient with the Verbal
      Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and
      dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction
      with the received therapy were also recorded.
    


Intervention name(s): Acupuncture & acupressure
Intervention type(s): Other
Intervention description(s): Bilateral acupuncture with indwelling fixed needles 1.5 mm length with subsequent acupressure by the parents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Injection pain; local anesthesia; acupuncture
A Study In Adults With Moderate To Severe Dermatomyositis
Condition: Dermatomyositis
MeSH terms: Dermatomyositis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Study looking at Investigational drug and Placebo administered to adult Patients with
      moderate to severe Dermatomyositis
    


Intervention name(s): PF-06823859 low; Placebo Arm; PF-06823859 high
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A humanized immunoglobulin neutralizing antibody; Placebo contains histidine, sucrose, PS80, ethylene diamine, and triacetic acid; A humanized immunoglobulin neutralizing antibody
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Senescent Immunity in Elders and Vaccine Responses (SILVER)
Condition: Flu Vaccine
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the effects of age on the immune system's response to flu vaccine and to study the
      connection between the immune system and physical and cognitive changes associated with
      aging.
    


Intervention name(s): Fluzone-High Dose Quadrivalent; Fluad; Flublock
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Seasonal influenza vaccination with FDA approved vaccines for this age group.; Adjuvanted (MF59) inactivated influenza vaccine; Recombinant hemagglutinin vaccine
Other intervention name(s): High-dose flu vaccine; standard-dose, inactivated influenza (flu) vaccine; Recombinant Hemagglutinin vaccine
Intervention MeSH terms: Hemagglutinins; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: adult 65 and older
Dexmedetomidine Versus Triamcinolone Treatment of Carpal Tunnel Syndrome
Condition: Chronic Pain; Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome; Chronic Pain
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve
      in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate
      CTS.
    

Detailed description: 
      Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve
      in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate
      CTS.

      In case of failed conservative oral therapey, local hydro-dessction of the median nerve can
      be done with saline alone. local anethetics, steroids, hyalase,and ozone have been utilized
      to augment the symptoms reliefe.

      Dexmeditomidine (DEX) has been studied as adjuvant for nerve block to aumnet the pain
      reliefe. Recently, it has been discovered that DEX can offer some antinflammatory effects
      when injected in the perineural area. Upon such discovery, the goal of this study has been
      built.
    

Intervention name(s): Dexmedetomidine; Triamcinolone
Intervention type(s): Drug; Drug
Intervention description(s): injection of Dexmedetomidine ( 10 microgram/kg) + 10 cc saline injection nearby median nerve as hydro-dissection; injection of triamcinolone ( 40 mg) + 10 cc saline injection nearby median nerve as hydro-dissection
Intervention MeSH terms: Triamcinolone; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment Investigate if, and to what extent,carapl tunnel hydro-dissection using DEX or triamcinolone (TM) along with saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, non-randomized, multi-center clinical case series evaluating the
      outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects
      will be evaluated acutely and will be followed clinically at 1, 6 and 12 months
      post-treatment.
    

Detailed description: 
      Catheter ablation of ventricular tachycardia (VT) is greatly facilitated by using a substrate
      mapping approach - that is, mapping of the left ventricle during sinus or paced rhythm to
      identify diseased myocardium. Using three dimensional electroanatomical mapping, it is
      possible to reconstruct an anatomical rendering of the left ventricle based on voltage. For
      hemodynamically stable or unstable VTs, various electrophysiologic maneuvers can then be used
      to identify the critical portions of the VT circuit within the scar (entrainment mapping,
      identification of diastolic potentials, identification of electrically-unexcitable scar,
      fractionated potentials and pace mapping).

      These methods are limited by the resolution of the substrate map, accuracy of catheter
      manipulation, and operator skill. To this end, a magnetic navigation system has been
      developed that allows for remote cardiac mapping. When used in concert with a compatible
      electroanatomical mapping system, it is possible to create a high-density ventricular
      substrate map of healed myocardial infarction. By removing the necessity for technical skill
      with catheter manipulation, this system has the potential for both improving the efficacy of
      VT ablation and expanding the clinical use of this substrate mapping approach.

      Recently, a higher-powered, irrigated tip catheter has become available in certain markets
      for use in cardiac arrhythmia ablations. This study will evaluate the outcomes of using this
      magnetic irrigation ablation catheter during mapping and ablation of VT while also using
      remote magnetic navigation.
    

Intervention name(s): Magnetic irrigated ablation catheter
Intervention type(s): Device
Intervention description(s): Magnetic irrigated catheter to be used with the magnetic navigation system
Other intervention name(s): Niobe; Stereotaxis; Navigant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arrhythmia; ventricular tachycardia; ablation; mapping; electrophysiology