bioihbjkbjnl/mcl2 huggingface dataset:
Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer
Condition: Colorectal Cancer Metastatic
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A phase 1/2 multi-center investigation of nab-sirolimus (also known as ABI-009,
      nab-rapamycin) in combination with mFOLFOX6 and Bevacizumab as first-line therapy in patients
      with metastatic colorectal cancer
    

Detailed description: 
      This study is a prospective phase 1/2, single arm, open-label, multi-institutional study to
      identify the RP2D and determine the efficacy and safety profile of nab-sirolimus administered
      as first-line therapy in combination with mFOLFOX6 and bevacizumab in patients with
      metastatic colorectal cancer.
    

Intervention name(s): nab-sirolimus
Intervention type(s): Drug
Intervention description(s): nab-sirolimus combined with mFOLFOX6 + bevacizumab
Other intervention name(s): bevacizumab; mFOLFOX6
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
Condition: Asthma; Diabetes Mellitus
MeSH terms: Asthma; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics
      with Asthma
    


Intervention name(s): Inhaled Insulin; Subcutaneous Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.; Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy
Condition: Post Thoracic Surgery
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      While thoracic epidural could control incisional pain after thoracotomy, an excruciating
      ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy
      patients. It is often difficult to manage and relatively resistant to opioids. The
      investigators postulate that in the presence of a functioning thoracic epidural, intrapleural
      bupivacaine administered through the chest tube could be effective in reducing post
      thoracotomy ipsilateral shoulder pain.
    


Intervention name(s): Bupivacaine-epinephrine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): See previous description; See previous descreption
Intervention MeSH terms: Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: RCT with one active group and a control (placebo) group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
An Intervention Delivered by App Instant Messaging to Increase the Acceptability of Effective Contraception Among Young People in Tajikistan
Condition: Contraception
Study type: Interventional

Summary: 
      This randomised controlled trial will establish the effect a contraceptive intervention
      delivered by mobile phone app instant messaging on the acceptability of effective
      contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to
      the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app
      plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a
      questionnaire at baseline and 4 months.
    


Intervention name(s): Contraceptive app instant messages; Mobile phone app
Intervention type(s): Behavioral; Other
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Reproductive health
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20162 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open label, crossover study to explore drug-drug interactions between DWC20155
      / DWC20156 and DWC20162 in Healthy Volunteers
    


Intervention name(s): Co-administration of DWC20155/DWC20156; DWC20162
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx
      in combination with metformin versus placebo + metformin
    


Intervention name(s): ISIS-GCCRRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin; 3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; T2DM
Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis
Condition: Inflammatory Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety of LY3114062 and to find out
      how well it is tolerated in participants with an inflammatory arthritis. The study will also
      investigate how the body processes the drug and how the drug affects inflammatory arthritis.
      The study is expected to last about 3 months.
    


Intervention name(s): LY3114062 SC; Placebo; LY3114062 IV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LY3114062 administered SC.; Placebo administered SC.; LY3114062 administered IV.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Antibody; Tumor Necrosis Factor alpha; Interleukin-17
Amylin and CGRP Head to Head Provocation in Migraine Without Aura Patients
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Interventional

Summary: 
      Amylin and calcitonin gene related peptide (CGRP) are related to the same peptide family.
      Both share 16 out of 37 amino acids and can activate each others receptor. CGRP is implicated
      in migraine pathophysiology but the role of Amylin and its receptor in migraine is not fully
      clarified.
    

Detailed description: 
      Amylin is a peptide hormone that binds to a G-protein coupled receptor (GPCR). amylin was
      originally found in the pancreas (Beta Cell of Islets of Langerhans) but also shown to be
      present in the trigeminal ganglion, hind horn ganglia and perivascular nerve fibers.

      Amylin has many similarities with CGRP. Amylin and CGRP share 16 out 37 amino acids. Both
      peptides can activate the amylin 1 subtype (AMY1)receptor with high affinity and reported to
      have more similar physiological and pharmacological effects.

      In addition, both peptides increase the intracellular concentration of cyclic AMP (cAMP)
      which has a central role in migraine pathophysiology.

      The aim of the study is pin point the role of amylin and amylin receptor compare to CGRP in
      migraine pathophysiology.
    

Intervention name(s): Amylin (Pramlintide); CGRP
Intervention type(s): Other; Other
Intervention description(s): Pramlintide is a amylin analog. It will be given intravenously at the rate of 120 micrograms over 20 minutes .; CGRP It will be given intravenously at the rate of 30 microgram over 20 minutes.
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In a Randomized, double blind, cross over experiment. Migraine without aura patients will received amylin or CGRP in two separate days apart by a week.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
Condition: Metabolic Syndrome; Hypogonadism; Cardio-vascular Disease
MeSH terms: Testicular Neoplasms; Vascular Diseases; Cardiovascular Diseases; Metabolic Syndrome; Hypogonadism
Study type: Observational

Summary: 
      The purpose of this study is to investigate the prevalence of signs and symptoms of
      hypogonadism in three groups of testicular cancer survivors.
    

Detailed description: 
      Recent studies have shown that metabolic syndrome is common among testicular cancer. Patients
      with low levels of testosterone appear to be at higher risk of metabolic syndrome.

      A substantial number of testicular cancer survivors might be in a state of "compensated
      hypogonadism" with testosterone levels low in the normal range due to an increased LH-drive
      from the pituitary gland.

      Whether this specific groups of testicular cancer survivors are at increased risk of
      cardio-vascular disease and might benefit from testosterone substitution is yet to be
      clarified.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Testicular cancer survivors
      
Keywords: Testicular Neoplasms; Hypogonadism; Metabolic Syndrome; Treatment related late effects
Breathing Exercise and Invasive Pain at Hemodialysis Patients
Condition: Pain; Arteriovenous Fistula; Breathing Exercise
MeSH terms: Respiratory Aspiration; Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      Non-pharmacological approaches applied in the prevention of invasive pain due to cannulation
      in patients treated with arteriovenous fistula and hemodialysis; It is also a cost-effective
      method that prevents the patient from feeling pain from the application. Breathing exercises
      are a method that can be easily applied before the cannulation procedure. Although it is seen
      that there are limited number of studies on the subject in the literature, it was observed
      that the duration of breathing exercise application was short (two weeks) in one study and
      the duration was not specified in the other.
    

Detailed description: 
      An average of 312 cannulations per year is performed in a patient who is treated for chronic
      hemodialysis and has arteriovenous fistula. Patients state that they experience moderate to
      severe pain at a rate of 57-60.9% when accessing the arteriovenous. In cases where access to
      the fistula cannot be achieved at one time, patients may experience pain due to; patients
      experience non-compliance with dialysis treatment and their quality of life is adversely
      affected. This situation causes an increase in the mortality rate, especially with
      cardiovascular and respiratory system complications. In recent years, breathing exercise,
      which is one of the methods of distraction, has been used to reduce the invasive pain
      experienced during blood collection and cannulation procedures. By increasing lung
      ventilation with breathing, the amount of oxygen entering the body is maximized, and this
      causes relaxation in the patient. This relaxation also causes the person to relax and reduce
      the pain they will feel. Although studies have found that breathing exercise is effective in
      reducing invasive pain; No information was given about the exercise method and duration.
      Although in practice, holding the patient's breath during venipuncture and performing the
      cannulation procedure while giving it is a method frequently applied by the nurse, no study
      with high evidence supporting the situation has been found in the literature.
    

Intervention name(s): Breathing Exercise
Intervention type(s): Other
Intervention description(s): The patient will be asked to close their eyes
He will be asked to relax his head and neck in a semi-sitting position in bed
The patient will be asked to breathe through the nose for 3 seconds by counting
Then he will be told to hold his breath for 3 seconds
As the last step, he will be asked to breathe out again in 3 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer
Condition: Cancer Cachexia; Side Effects; Quality of Life
MeSH terms: Cachexia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion
      and quality of life in patients with colorectal cancer.
    

Detailed description: 
      Primary outcomes:

        -  Weight

        -  Physical function

        -  Hand-grip strength

      Secondary outcomes:

        -  Quality of life

        -  Mid-upperarm circumference

        -  Incorporation of n-3 PUFAs into cell membranes
    

Intervention name(s): Fish Oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 8 weeks, 2.2 G EPA/day; Placebo
Other intervention name(s): Smart Fish - cancer cachexia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cancer; nutrition; fish oil
Dietary Nitrate and Healthy Older Adults
Condition: Blood Pressure; Cognitive Change; Functional Capacity; Brain Metabolism
Study type: Interventional

Summary: 
      This study investigates the influence of dietary nitrate supplementation on cardiovascular
      health and physical and cognitive performance in older adults. Participants will receive both
      a nitrate containing beetroot juice for 10 days and a nitrate depleted beetroot juice for 10
      days
    

Detailed description: 
      A recent exciting finding is that dietary nitrate supplementation (in the form of beetroot
      juice) appears to reduce the amount of oxygen needed to complete moderate intensity walking
      in healthy, young individuals. Nitrate is known to be converted in the body to nitric oxide
      (NO), a substance which reduces blood pressure and may affect the energy-producing mechanisms
      inside muscle cells. Exercise tolerance and muscle function typically declines with age and
      nitrate supplementation therefore may help improve cardiovascular health and the ability to
      carry out low-intensity daily activities in aging populations. The purpose of this study is
      to see if healthy, elderly individuals benefit from beetroot juice intake similarly to the
      effects seen in young adults. If this is indeed the case, then it may suggest that dietary
      supplementation with a relatively cheap, widely available, and natural food product may
      improve the ability of healthy elderly individuals to undergo everyday tasks and ultimately
      improve their quality of life.
    

Intervention name(s): Nitrate-rich beetroot juice; Nitrate-depleted beetroot juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): concentrated beetroot juice; concentrated beetroot juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Association Between Mitochondrial DNA Content and Risk of Coronary Heart Disease
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      Compelling epidemiological evidence indicates that alterations of mitochondrial DNA,
      including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with
      the initiation and development of cardiovascular disease. This study was undertaken to
      investigate whether mtDNA copy number in peripheral blood cells could be used as a risk
      predictor for coronary heart disease.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total of 200 eligible CHD patients were anticipated to include in this study.Moreover,
        The 200 healthy controls without previous CHD history were also recruited from individuals
        who visited investigator's hospital for physical examination during the same time period.
      
Biospecimen description: 
      Mitochondria are responsible for multiple cellular functions including regulation of energy
      production, modulation of oxidation-reduction status, generation of reactive oxygen species
      and apoptosis. Each mitochondrion possesses multiple copies of a mitochondrial genome
      comprised of independently replicating double stranded DNA (mtDNA).
    
Keywords: Mitochondrial DNA copy number; Peripheral blood cells
An Interactive Program to Improve Care for Children With CF
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of an internet based program for children
      and families (CF.DOC) with Cystic Fibrosis on health outcomes. The program provides for
      virtual visits, a personal health record, messaging with clinicians and several tools for
      monitoring self-care behaviors. We anticipate that this intervention will provide for more
      intensive monitoring and feedback of self-care behaviors and will lead to improved health
      status and in particular nutritional status
    

Detailed description: 
      Subjects will be drawn from the pool of children who receive their care at the LPCH/Stanford
      Cystic Fibrosis Center. A letter will be sent to all eligible patients inviting them to
      participate in the study. This letter will also be available in the CF clinic. All subjects
      who agree to participate in the study will have the study described to them by a research
      assistant either in person or over the phone. Informed consent will be obtained all on
      subjects. Subject who elect to participate will be randomized into either an intervention
      group or a control group . Subjects in the intervention group will be given Internet Access
      to the program CF.DOC. They will also be given training in how to use the program for
      communication with their clinicians, participating in a virtual visit and using online forms
      and surveys. Subjects in the control group will be advised that they will receive usual care
      and will have access to CF.DOC at the completion of the study. At the beginning of the study
      and at 3 month intervals subjects will be asked to complete a cystic fibrosis Quality of life
      survey. At the beginning and end of the study all subjects will complete a patient experience
      questionnaire (CAPHS 2.0 CCC supplement ) and an CF.DOC evaluation survey. As part of their
      regular care all subjects will also have their nutritional status measured and pulmonary
      function assessed. subjects in the intervention group will asked to define treatment goals
      that are important to them (e.g. attending camp or participating in sports) and to define
      health measures that will help monitor progress in meeting these goals e.g. weekly weights or
      pulmonary function. Subjects in the intervention group will be asked to log onto CF.DOC at
      least one time per month.
    

Intervention name(s): CF. DOC
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: Cystic Fibrosis;; patient education,; Internet
Comparison of Deep Extubation During Emergence Using Desflurane or Desflurane With Remifentanil in Patients Undergoing General Anesthesia
Condition: Deep Extubation
Study type: Interventional
Phase: Phase 4

Summary: 
      It has been reported that deep extubation can reduce cardiopulmonary complication against
      endotracheal tube extubation during emergence from general anesthesia. The investigators
      hypothesized that using desflurane with target controlled infusion of remifentanil is more
      effective than using desflurane alone during deep extubation. The purpose of this study is to
      evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing)
      during emergence from general anesthesia.
    


Intervention name(s): Desflurane with remifentanil; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil; During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane
Other intervention name(s): desflurane with remifetanil group; Desflurane alone group
Intervention MeSH terms: Remifentanil; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Changes in Eye Pressure and Anterior Chamber Depth With Oral Endothelin Antagonist Therapy
Condition: Glaucoma; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      There is growing evidence that a cause of glaucoma is linked to circulatory problems and poor
      auto-regulation of blood flow to the optic nerve. Pulmonary hypertension (PH)is a disease
      characterized by low oxygen levels in the blood and altered blood circulation. The decrease
      in oxygen delivery to the optic nerve could lead to the loss of nerve fiber layer(NFL)in the
      retina and the resulting visual field compromise. This situation is characteristic of
      glaucoma. The ability to identify NFL thinning early could lead to earlier diagnosis of
      glaucoma and more effective treatment to limit dysfunction from visual field loss.

      We hypothesize that the rate of structural damage to the NFL, a feature of glaucoma, is
      higher in patients with PH than expected in healthy populations lacking this disease.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with pulmonary hypertension