bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy
Condition: Cow's Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Observational

Summary: 
      Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In
      industrialized countries there is an incidence of 2-3% in children younger than 2 years.
      Cow's milk allergy may present with different clinical pictures and symptoms often
      nonspecific. Among the most common are certainly food refusal and failure to thrive until
      frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a
      negative impact on the quality of life of the patient and his family.

      The treatment of this condition provides the setting of a diet that is free of the allergen
      to the base of the adverse reaction.

      There are some types of formulas for the treatment of this condition. The formulas based on
      amino acids are currently used in all cases non-responsive to treatment with the above
      formulas or in all those characterized by severe allergic reactions. Being made from amino
      acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid
      resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead
      to a rapid improvement in the quality of life of the patient and his family. However, the
      studies currently available to us concerning the effects of nutritional formulas based on
      amino acids affect short observation periods (usually less than 6 months) and were directed
      to a comparison only with hydrolysates of whey protein or casein and not with healthy
      subjects. To date thus lack consistent data on the nutritional effects in the medium to long
      term.
    


Intervention name(s): Aminoacid based formula; Hydrolyzed whey formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Formula based on aminoacid; Formula based on hydrolyzed whey protein
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with a sure diagnosis of cow's milk allergy
Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion
Condition: Prostate Adenocarcinoma; Prostate Carcinoma; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating
      prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds
      to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners
      that detect radioactivity in the body. This early phase I study will use PET to determine if
      delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA)
      administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a
      vein in the arm (intravenous (IV) administration).
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To compare the maximum standardized uptake value (SUVmax) in tumoral regions-of-interest
      during prostatic arterial and intravenous 68Ga-PSMA-11 infusions.

      SECONDARY OBJECTIVES:

      I. To compare the tumoral time-activity curves for selective prostatic arterial and
      intravenous 68Ga-PSMA-11 infusions.

      II. To study PSMA receptor saturation kinetics during selective prostatic arterial infusion
      of 68Ga-PSMA-11 (obtained only from arterial time activity curves [TACs] ipsilateral to the
      side of infusion).

      OUTLINE:

      Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over
      infusion period and for 15 minutes after on day 1. 1-14 days later, patients undergo pelvic
      angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over
      30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.

      After completion of study, patients are followed up with 24 hours after the IA infusion and
      PET scan.
    

Intervention name(s): Angiogram; Catheterization; Gallium Ga-labeled PSMA-11; Positron Emission Tomography
Intervention type(s): Procedure; Procedure; Drug; Procedure
Intervention description(s): Undergo angiogram; Undergo prostatic arterial catheterization; Given IV and IA; Undergo PET scan
Other intervention name(s): 68Ga-PSMA-11; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging
Intervention MeSH terms: Gallium 68 PSMA-11
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ga68-PSMA-11
A Randomized Study of Autologous Umbilical Cord Blood Reinfusion in Children With Cerebral Palsy
Condition: Cerebral Palsy; CP; Spastic Cerebral Palsy
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of a single intravenous infusion of
      autologous umbilical cord blood (UCB) for the treatment of pediatric patients with spastic
      cerebral palsy.
    

Detailed description: 
      Cerebral palsy results from in utero or perinatal injury to the developing brain, often
      through stroke, hypoxic insult or hemorrhage. Currently available treatments for patients
      with cerebral palsy are supportive, but not curative. Umbilical cord blood (UCB) has been
      shown to lessen the clinical and radiographic impact of hypoxic brain injury and stroke in
      animal models. UCB also engrafts and differentiates in brain, facilitating neural cell
      repair, in animal models and human patients with inborn errors of metabolism undergoing
      allogeneic, unrelated donor UCB transplantation. We hypothesize that, in the setting of brain
      injury, infusion of autologous UCB will facilitate neural cell repair resulting in improved
      function in pediatric patients with cerebral palsy.
    

Intervention name(s): Autologous UCB Reinfusion; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Autologous umbilical cord blood (UCB) reinfusion; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; CP; Spastic Cerebral Palsy; Cord Blood; Umbilical Cord Blood; Autologous Cord Blood
Comparing the Effects of Insulin Glargine on Blood Glucose Between Needle-free Jet Injection and Insulin Pen
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      To comparing the blood sugar improvement and patient sensibility of insulin glargine injected
      with needle-free jet injector and conventional insulin pen
    

Detailed description: 
      Compared with conventional pen, needle-free jet injection of insulin has faster flow rate and
      larger area of local subcutaneous absorption. The aim of this study was to investigate the
      effects of subcutaneous insulin glargine injection with needle-free jet injection and
      conventional pen on blood glucose profile and safety in type 2 diabetic patients.
    

Intervention name(s): The needle-free jet injector; Conventional insulin pen
Intervention type(s): Device; Device
Intervention description(s): Continuous insulin therapy for 2 weeks; Continuous insulin therapy for 2 weeks
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Needle-free jet injection; Insulin glargine
A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single center, open-label phase 1 study in healthy Chinese subjects. A total
      of up to 16 subjects may be enrolled to achieve a total target of 12 evaluable subjects. A
      full dose for NTM-001 will be defined as a 12.5 mg IV Loading Dose + 24-hour IV infusion (3.5
      mg/hour).
    

Detailed description: 
      This will be a single center, open-label phase 1 study in healthy Chinese subjects. A total
      of up to 16 subjects may be enrolled to achieve a total target of 12 evaluable subjects.

      Subjects will remain in-house for the entire study. All subjects will be discharged at
      End-of-Study (EOS) on Day 5.

      A full dose for NTM-001 will be defined as a 12.5 mg IV Loading Dose + 24-hour IV infusion
      (3.5 mg/hour).

      Subjects who withdraw or are withdrawn from the study will not be replaced since attrition is
      considered.

      Blood will be collected for PK analysis. Safety assessments will include the following:
      adverse events (AEs), vital sign measurements, physical examinations, 12-lead
      electrocardiograms (ECGs), and clinical laboratory evaluations. infusion site reactions will
      be recorded as AEs.
    

Intervention name(s): Ketorolac Tromethamine
Intervention type(s): Drug
Intervention description(s): Ketorolac tromethamine, alcohol free formulation, 1.0 mg/mL in saline solution (~0.9% NaCl) adjusted to a pH of ~7.4. Contained in a sterile, polyolefin bag filled with 125 mL of NTM-001.
Other intervention name(s): NTM-001 (Ketorolac Tromethamine IV Continuous Infusion)
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tin Filter Calcium Scoring
Condition: Radiation Dose Reduction
Study type: Interventional

Summary: 
      The aim of this study is to prospectively investigate the diagnostic performance and
      potential radiation dose reduction in coronary artery calcium scoring using the new tin
      filter system of the 3rd generation DSCT scanner.
    


Intervention name(s): Tin Filter
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tin Filter; Coronary Artery Calcium Scoring; Radiation dose reduction
Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT +
      concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
    


Intervention name(s): C225 (cetuximab)
Intervention type(s): Drug
Intervention description(s): one week before and then weekly during radiotherapy
Other intervention name(s): Erbitux
Intervention MeSH terms: Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiotherapy; chemotherapy; Drug Targeting; loco-regionally advanced nasopharyngeal carcinoma; Safety.; efficacy
Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
      growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such
      as satraplatin, work in different ways to stop the growth of tumor cells, either by killing
      the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may
      kill more tumor cells.

      PURPOSE: This clinical trial is studying how well giving satraplatin together with
      bevacizumab works in treating patients with metastatic prostate cancer previously treated
      with docetaxel.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the time to progression in patients with metastatic androgen-independent
           prostate cancer previously treated with docetaxel currently treated with satraplatin and
           bevacizumab.

      Secondary

        -  Determine the toxicity of this regimen in these patients.

        -  Assess the prostate-specific antigen (PSA) response rate in patients treated with this
           regimen.

        -  Determine the overall survival of patients treated with this regimen.

        -  Assess changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline
           phosphatase (BSAP) in patients treated with this regimen.

        -  Correlate urine NTX and serum BSAP levels with time to progression in patients treated
           with this regimen.

      OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral satraplatin on
      days 1-5. Treatment repeats every 2 weeks in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed for 28-42 days.

      PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
    

Intervention name(s): bevacizumab; satraplatin
Intervention type(s): Biological; Drug
Intervention description(s): 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days); 80 mg/m(2), Orally, Days 1-5, every 35 days
Other intervention name(s): Avastin ®
Intervention MeSH terms: Bevacizumab; Satraplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV prostate cancer; recurrent prostate cancer; adenocarcinoma of the prostate
Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Condition: Single Edentulous Space
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      The study will involve placing a dental implant through a guided surgery protocol developed
      using 3D CT technology. Because the implant position is planned digitally using the CT data
      from the patient, this allows investigation of an abutment that supports the implant crown
      and soft tissues to be fabricated prior to implant placement. In doing so, this makes the
      protocol for patient care simpler and faster. In fabricating the the abutment prior to
      surgery, the investigators will design the abutments at different heights below the gumline
      to see an optimal margin height for fabrication of the abutment prior to surgery. The study
      hypothesis is that more often the abutment margin placed just slightly below (.5mm) the
      gumline will be visible about half of the time while the abutment margin placed further under
      the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that
      at delivery and follow-up, the abutment margin will not show intraorally.
    


Intervention name(s): abutment margin 0.5 mm subgingival; abutment margin 1.5 mm subgingival
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The role of estrogens in the pathogenesis of breast cancer has been well documented. This has
      led to the development of "Anti-Estrogens" (selective estrogens receptor modulators and
      Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents,
      however, have significant side effects, which are not acceptable to many healthy high-risk
      women. There is preliminary evidence that grape seed extract acts as "natural" aromatase
      inhibitor (1). This study has the potential to quantify the effectiveness of a natural
      substance that mimics the action of pharmaceutical aromatase inhibitors.
    

Detailed description: 
      Early detection of breast cancer with screening mammography and the use of more effective
      medical therapies have led to a decrease in breast cancer mortality. However, breast cancer
      is still the second leading cause of cancer death in women (2). Therefore, the future lies in
      not only early detection but prevention of breast cancer. Currently available chemopreventive
      agents are associated with potentially serious side effects and can be quite costly,
      especially when taken for extended periods of time. Therefore, they are usually targeted only
      to women at high risk of disease. Identification of an inexpensive, efficacious preventive
      therapy with few or no side effects would represent a major advance in reducing the morbidity
      and mortality due to breast cancer. One exciting possibility is grape seed extract. Grapes
      and grape seeds contain procyanidins, a highly active subclass of flavonoids with actions
      similar to pharmaceutical aromatase inhibitors (AIs). These procyanidin dimers have been
      found to suppress estrogen biosynthesis both in vitro and in animal models (1). Based upon
      this knowledge we proposed this dose finding pilot study.
    

Intervention name(s): Grape Seed Extract; Grape Seed Extract; Grape Seed Extract; Grape Seed Extract
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 200 mg dose daily for 12 weeks.; 400 mg dose daily for 12 weeks.; 600 mg dose daily for 12 weeks.; 800 mg dose daily for 12 weeks.
Other intervention name(s): ActiVin®; ActiVin®; ActiVin®; ActiVin®
Intervention MeSH terms: Grape Seed Extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Grape Seed Extract; Breast Cancer; Estrogen Levels; Aromatase Inhibitor
The Effect of Self-Acupressure on Pain and Sleep in Coronary Artery Patients
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      This study will be conducted to evaluate the effect of acupressure applied to patients with
      coronary artery disease (CAD) on pain and sleep quality.
    

Detailed description: 
      Self-Acupressur application will improve pain and sleep quality in CAD.
    

Intervention name(s): Self-Acupressure
Intervention type(s): Other
Intervention description(s): Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Self-Acupressure; Sleep; Pain; Coronary Artery Patıent
Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia
Condition: Surgical Procedure, Unspecified
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy
      in adjunct to other clinical information decreases the occurrence rate of inadequate
      anesthesia events, bradycardia and hypotension in comparison to standard clinical practice
      during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy
      and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood
      pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).
    


Intervention name(s): AoA Monitoring; Routine (Standard) Anesthesia Monitoring
Intervention type(s): Device; Device
Intervention description(s): Monitoring with Entropy and SPI parameters during surgery; Standard of care monitoring
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk?
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The ATLET study will assess the effect of manual or robotic body-weight supported locomotor
      training of patients with stable motor incomplete spinal cord injury (SCI) on gait and
      overall ADL function as well as on estimated health care costs.
    

Detailed description: 
      There are approximately 100 new cases of spinal cord injuries (SCI) each year in Norway. Most
      of the SCI occur after traumatic accidents among young people and adults during the time of
      their productive life. Loss of walking and standing ability restricts their independent
      mobility and autonomy and severely impacts their quality of life.

      The study has two arms: 1) manual locomotor training (Tromsø) and 2) robot assisted training
      (Oslo). Each study arm has 30 patients, randomized to receive standard care or intervention.
      The intervention group receives 60 days of intensive locomotor training over 6 months.
      Single-blind, before/after evaluation of effect will be performed at Sunnaas hospital using a
      standardized set of evaluation tools.
    

Intervention name(s): Locomotor training with robot; Locomotor training with manual assistance
Intervention type(s): Other; Other
Intervention description(s): 60 days locomotor training during 6 months period in out-patient setting. Minimum 60 min training up to 3 times per week. Control group receives conventional training/treatment.; 60 days training during 6 months period on in-patient setting. Training 2 times per day total 120 minutes. Control group receives conventional training/treatment.
Other intervention name(s): LOKOMAT; Vigor Equipment treadmill and suspension system; Therapist assisted
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: incomplete spinal cord injury; locomotor activity; walking function; gait