bioihbjkbjnl/mcl2 huggingface dataset:
Tamoxifen Treatment in Patients With Motor Neuron Disease
Condition: Amyotrophic Lateral Sclerosis; ALS Functional Ration Scale; TAR-DNA-binding Protein-43; Tamoxifen; mTOR
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to survey the effect of Tamoxifen in motor neuron disease (MND)
      patients, amyotrophic lateral sclerosis (ALS) with regular riluzole usage. TDP-43 is related
      to ALS. Increased the ubiquitinated or phosphorylated TDP-43 can cause animal model of ALS,
      and TDP43 can be degraded either by proteasome or autophagy pathway system. Autophagy pathway
      can be activated by mTOR inhibition, resulting in ameliorating TDP-43 accumulation and rescue
      in motor function in animal model. Tamoxifen had shown ability of enhance both proteasome and
      autophagy pathway, therefore the investigators assume that Tamoxifen probably can ameliorate
      TDP-43 accumulation and inclusion body formation in ALS.
    

Detailed description: 
      The investigators will assess the ALSFR-s in ALS patients at start, 1, 3, 6 and 12 months and
      correlate the score to the neurological outcome of the patients with and without tamoxifen
      treatment at dose of 40mg daily for one year.

      The study will be able to prove the investigators hypothesis: Tamoxifen, a protease and
      autophagy enhancer, has synergic effect with riluzole in ALS patients to slowing the
      progression of neurological dysfunction, and respiratory insufficiency.
    

Intervention name(s): tamoxifen 40 mg daily for one year
Intervention type(s): Drug
Intervention description(s): both arms with riluzole daily
Other intervention name(s): Nolvadex
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: amyotrophic lateral sclerosis; ALS functional ration scale; TAR-DNA-binding protein-43; tamoxifen; mTOR
New Generation Enlite Accuracy Study
Condition: Diabetes
Study type: Interventional

Summary: 
      The trial will investigate the accuracy and performance of a new sensor for continuous
      glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction with
      the new Medtronic 640G system components.

      To evaluate the accuracy and performance of the new generation Enlite sensor. This is a
      postmarket, interventional, open-label, non-randomized, single center clinical research
      trial.

      The trial will adopt a prospective single-sample design using the Yellow Spring Instruments
      (YSI) plasma glucose reference sampling procedure in the clinic and self-monitoring of blood
      glucose (SMBG) plasma glucose reference sampling procedure at home.
    

Detailed description: 
      The trial will investigate the accuracy and performance (i.e. the life-time) of a new sensor
      for CGM, the (new generation) Enlite glucose sensor, CE-marked in 2013, in conjunction with
      the new Medtronic 640G system components. Accuracy and life-time of the sensor are important
      parameters contributing to the safety of patients and patient acceptance of this still fairly
      new technology.

      The current trial investigates the accuracy of the new sensor in conjunction with the new
      640G system components both in the clinic and at home. This enables us to assess the sensor
      accuracy in a well-controlled environment using a highly accurate laboratory glucose analyzer
      as reference as well as sensor accuracy during real-life conditions using a blood glucose
      meter as reference analyzer.

      The data gathered in this trial will help to understand the effect of technological
      advancements made and can guide future development of glucose sensor for continuous glucose
      monitoring.
    

Intervention name(s): Glucose sensor (Enlite)
Intervention type(s): Device
Intervention description(s): This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial. The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and selfmonitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home. The trial will consist of 6 visits to the investigational site: a visit for informed consent procedures (Visit 0), a screening visit (Visit 1), 3 study visits (Visit 2-4) and a final examination (Visit 5).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Glucose sensor; Sensor accuracy and performance; CGM
The Use of Visual Feedback in Airway Clearance
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Cystic Fibrosis (CF) patients perform airway clearance incorporating various breathing
      strategies, to clear secretions from their lungs. Hand held devices may aid mucus
      expectoration, and also motivate the patient to manage by themselves. Our aims was to study
      if resistive expiration through "volumetric incentive spirometer" (VISex) can improve lung
      function in the short term in Cystic Fibrosis (CF) patients.
    


Intervention name(s): Tri-Gym
Intervention type(s): Device
Intervention description(s): 40 CF patients performed airway clearance using the VISex, by exhaling against chosen resistance being motivated by visual feedback of raising colored balls. The level of resistance was set to cause longest expiration/volume, until mucus was transported from the peripheral to the central airways, to be expectorated by the subsequent cough.
Other intervention name(s): incentive spirometer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound
Condition: Septum; Uterus
MeSH terms: Septate Uterus
Study type: Observational

Summary: 
      This study aims to assess the relation between the vascularity of uterine septum and
      obstetric performance with Transvaginal 3D Power Doppler Ultrasound
    

Detailed description: 
      Research hypothesis:

      In women with uterine septum vascularity of the septum may affect obstetric performance.

      Research question:

      In women with uterine septum does vascularity of the septum affect obstetric outcome?
    

Intervention name(s): Transvaginal 3D Power Doppler Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Samsung H60 ultrasound machine with 4-9 MHz volume transducer using VOCAL system and Histogram Facility
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with primary infertility or recurrent abortion attending to Early Cancer Detection
        Unit at Ain Shams Maternity Hospital
The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis
Condition: Inflammatory Lung Diseases; Hemoptysis
MeSH terms: Lung Diseases; Hemoptysis
Study type: Observational

Summary: 
      Vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) are major mediators of
      angiogenesis and are induced by tissue inflammation and hypoxia. While elevated serum VEGF
      levels have been reported in inflammatory lung diseases, especially with hemoptysis, there
      was no study to evaluate the Ang-2 levels in lung inflammatory diseases according to the
      presence of hemoptysis, inflammatory biomarker and hypoxia.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients visited Samsung Medical Center for the treatment of benign inflammatory disease
        such as bronchiectasis, aspergilloma, peumonia and post-tuberculosis destroyed lung
      
Keywords: Vascular endothelial growth factor; angiopoietin-2
Learning Skills in Young Specialists and Residents in Operative Vaginal Delivery Using Simulator Models
Condition: Birth Disorder; Delivery Complication
Study type: Observational [Patient Registry]

Summary: 
      Evaluation of different learning programs on persistence of skills in operative vaginal
      delivery
    

Detailed description: 
      Investigators enrolled residents and young specialist randomly exposed to simulation of
      operative vaginal delivery or a lecture before and after experience on simulator program. The
      two groups were exposed after 8-12 weeks to a second experience of simulator program due to
      evaluate the improve, deterioration of skills in operative vaginal delivery.

      12-months persistence of skills were evaluated
    

Intervention name(s): the better retaining of skills
Intervention type(s): Other
Intervention description(s): identify which teaching program has the better retaining of skills
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        participants were residents in ObGyn or young specialists in ObGyn (less than 5 years)
      
Keywords: vaginal birth; vacuum delivery; operative vaginal birth; mannequin training program
Acute Exercise and Pancreatic Endocrine Function
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient
      hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise
      bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Computer-Aided Learning for Managing Stress
Condition: Psychosis
MeSH terms: Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to learn whether a new family therapy using computer games with
      biofeedback might help people at clinical high risk for psychosis and their family members
      learn to experience less stress and have fewer mental health challenges.
    

Detailed description: 
      CALMS revolves around the use of Emotional Manipulatives (EM) developed at Boston Children's
      Hospital (BCH). EM are single and multi-user biofeedback games designed to enhance executive
      control of emotion. The intervention and EM in CALMS were adapted from those used in Anger
      Control Training (ACT) with Regulate and Gain Emotional Control (RAGE-Control). In a
      randomized controlled trial at BCH, ACT and RAGE-Control relative to "sham" video-game play
      without biofeedback led to significantly greater reductions of aggression in adolescents and
      greater improvement in family functioning.

      In this feasibility study, family dyads will participate in 12 sessions aimed at

        1. enhancing engagement through the use of video and other games,

        2. enhancing stress resilience through biofeedback, education, and individualized
           stress-reduction practice, and

        3. harnessing the power of the family to enhance contextual learning and the generality and
           duration of effects.

      Clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12
      week assessments.
    

Intervention name(s): CALMS
Intervention type(s): Behavioral
Intervention description(s): Family Therapy; Multi-user Biofeedback Videogames
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prodrome; family therapy; clinical high risk
Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal
Condition: Wisdom Teeth
Study type: Observational

Summary: 
      Under this study, patients who require removal of their third molars (wisdom teeth) will be
      diagnosed, evaluated and treated. In addition, tooth, bone and gum tissue samples will be
      collected for use in bone, wound healing, microbiology and genetic research.

      Patients 16-50 years of age who require wisdom tooth removal may be eligible for this study.
      Participants may have one or all of their wisdom teeth removed at one time. The surgery is
      done under local anesthetic. In addition, conscious sedation may be administered, if the
      patient wishes.

      Besides wisdom tooth removal, patients are asked to donate a small sample of jaw bone (from
      the lining of the inner wall of the tooth socket) and gum tissue (from the area of the
      surgical site). The samples are collected at the same time as the tooth extraction. The bone
      sample is about the size of a pencil point (1.5 millimeters wide and 3 millimeters long) and
      the gum tissue sample is 1 millimeter. Removal of these samples should not cause any
      additional discomfort or increase the time required for the surgery or for healing.
    

Detailed description: 
      OBJECTIVE:

      The objective of this protocol is to obtain oral tissue for analysis by various research
      groups at the National Institutes of Health (NIH).

      STUDY POPULATION:

      The protocol will enroll a convenience sample of 1,000 subjects between the ages of 18 to 50
      years who are in need of third molar (wisdom tooth) extraction.

      STUDY DESIGN:

      Subjects will report to the National Institutes of Dental and Craniofacial Research (NIDCR)
      for up to three visits. The first study visit will involve a screening evaluation to
      determine protocol eligibility. Eligible subjects will be invited back for a second visit for
      wisdom tooth extraction and collection of oral tissue for research purposes. All subjects
      will remain on the protocol for three weeks after surgery, and they will have the option to
      schedule a follow-up visit to the NIH for post-operative evaluation.

      OUTCOME MEASURES:

      This study does not involve any outcome measurements.
    

Keywords: Bone; Microbiology; Dental Pulp Stem Cell; Wisdom Teeth; Biopsy; Third Molar Extraction
A Swiss Study With Atorvastatin in Hyperlipidemic Patients Measuring LDL-Cholesterol
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The proportion of patients achieving LDL-C target as defined by Swiss cholesterol
      recommendations (AGLA-recommendations) across starting doses of 10 mg, 20 mg, 40 mg, and 80
      mg of atorvastatin.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FUTURE 3 Study Extension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety,
      tolerability and efficacy of the pediatric formulation of bosentan two versus three times a
      day in children with Pulmonary Arterial Hypertension (PAH).
    


Intervention name(s): Bosentan
Intervention type(s): Drug
Intervention description(s): Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
Other intervention name(s): ACT-050088
Intervention MeSH terms: Bosentan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; pulmonary arterial hypertension; bosentan; Tracleer
Vagus Nerve Stimulation for Autonomic Nervous System Activity
Condition: Autonomic Nervous System Imbalance
Study type: Interventional

Summary: 
      There are no generally accepted values for transcutaneous vagus nerve stimulation (taVSS
      application parameters (amplitude, frequency, intensity, duration, side) yet, therefore there
      are heterogeneous applications in studies. Although positive effects have been shown in
      different neurological, psychiatric and musculoskeletal diseases, taVSS treatment is not
      available yet. It is not clear which parameters are important in patient selection.In this
      study, it was aimed to investigate the change of taVSS effect in healthy individuals
      according to the level of autonomic nervous system activity before stimulation.
    

Detailed description: 
      Healthy individuals between the ages of 18-45 without any disease will be included in the
      study. Male and female participants will be included in the study. Heart rate variability
      will be measured after participants are included in the study. A short 5-minute measurement
      will be made with the Polar H7 device, which can be measured with the belt attached to the
      chest. Heart Rate Variability measurement will be analyzed with the Kubios HRV program.
      Participants will be distributed to groups according to the SNS index and PNS index values
      obtained as a result of the Kubios analysis. According to the index scores obtained, the
      distribution of the groups will be made as <-2, between -2 and +2 and >2. Afterwards, 20
      minutes of taVSS stimulation will be performed. As a vagus stimulation protocol, bilateral
      auricular stimulation and stimulation frequency of 10 Hz (Heartz), pulse width of 300 µs
      (microseconds) for 20 minutes, biphasic application will be given to each participant 2
      times, with at least 48 hours between them.
    

Intervention name(s): Transcutaneous Vagus Nerve Stimulation
Intervention type(s): Device
Intervention description(s): As a vagus stimulation protocol, bilateral auricular stimulation and stimulation frequency of 10 Hz, pulse width of 300 µs, biphasic application for 20 minutes, each participant will be stimulated twice, with at least 48 hours between them.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Autonomic Nervous Systems; Vagal Nerve Stimulation; Heart Rates
Image-Guided Stereotactic Biopsy of High Grade Gliomas
Condition: Brain Cancer; Glioma
MeSH terms: Glioma; Brain Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate high and low areas of growth, or proliferation,
      within the tumor. An imaging technique using a very small amount of a radioactive tracer
      called 18Ffluoro-deoxy-L-thymidine (18F-FLT) can detect areas of rapid growth within the
      tumor. This imaging technique is called a FLT PET imaging. This present study involves
      obtaining one scan using FLT PET imaging. The goal of this study is to investigate
      associations between the imaging findings showing differences in growth rate within the tumor
      and the biology of the tumor that is measured in the sampled tumor tissue. This information
      may be used in future brain tumor patients to determine the best combination of treatment for
      individual patients. These studies may also improve our understanding of the types of changes
      taking place in brain tumor tissue that could improve individual patient outcome. FLT is
      produced for human use by the MSKCC cyclotron facility under an investigational new drug
      (IND) approval issued by the US Food and Drug Administration (FDA). This means that FLT is
      produced under strict rules and regulations, is considered safe, and has been approved for
      use in humans for certain disease conditions. 18F-FLT has been used in several research
      studies to date at this institution.
    


Intervention name(s): 18F-FLT PET Scan
Intervention type(s): Drug
Intervention description(s): The patient will undergo MRI and 18F-FLT PET scans of the brain. A IV catheter will be placed in a superficial hand or arm vein for administration of 18F-FLT (approximately 370 MBq), prepared by the MSKCC Radiochemistry Core Facility. A second venous catheter will be placed in the opposite hand or arm for venous blood sampling. If a central venous catheter is present, it will be used for blood sampling or radiopharmaceutical administration, and only a single venous catheter will be placed. Sequential blood samples may be obtained following 18F-FLT infusion for assaying whole blood and plasma radioactivity. All catheters will be removed at the end of the day.
Other intervention name(s): As part of the standard surgical care for brain cancer, the patient will undergo; biopsy of the tumor. A few small tissue samples will be collected from different; sites within the tumor and used for examining the biology of the tumor tissue.; Associations will be made between the 18F-FLT imaging findings at these biopsy; sites, which reflect differences in tumor growth rate, and the corresponding; biology of the tumor measured in the sampled tumor tissue.
Intervention MeSH terms: Alovudine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PET scan; CT scan; 09-060; CNS
A Study To Assess Distribution Of RO7248824 In The Central Nervous System Following Single Intrathecal Doses Of [89zr] Labeled RO7248824 In Healthy Male Participants
Condition: Angelman Syndrome
MeSH terms: Angelman Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of Study BP41660 is to quantify the amount and concentration of [89Zr]DFO-RO7248824
      in the brain with positron emission tomography (PET) following a single sub-pharmacological
      dose of RO7248824 and [89Zr]DFO-RO7248824 administered via IT injection to healthy
      participants.
    


Intervention name(s): RO7248824
Intervention type(s): Drug
Intervention description(s): A single dose of 10 mg RO7248824 will be used for this PET study in healthy participants.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment