bioihbjkbjnl/mcl2 huggingface dataset:
Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors
Condition: Arthralgia; Breast Cancer
MeSH terms: Breast Neoplasms; Arthralgia
Study type: Observational

Summary: 
      RATIONALE: Gathering information over time about joint pain and stiffness from postmenopausal
      women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors
      plan treatment and help patients live more comfortably.

      PURPOSE: This observational epidemiologic cohort is designed to study arthralgia,
      patient-reported outcomes, and medication adherence in postmenopausal women with early-stage
      breast cancer who are receiving aromatase inhibitors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Estimate the incidence, time to onset, prevalence, and clinical and demographic
           predictors of arthralgia in post-menopausal women with early-stage breast cancer
           receiving aromatase inhibitors (AI).

        -  Chart the trajectory of arthralgia symptom severity over the course of AI treatment in
           these patients.

      Secondary

        -  Measure the impact of arthralgia on sleep quality, depression, and physical function in
           these patients.

        -  Develop a roster of current physician-advised or prescribed treatments, including
           self-management techniques being used for AI-induced arthralgia, for intervention
           development.

      OUTLINE: Patients complete questionnaires about joint pain and stiffness, sleep, depression,
      physical function, medications and treatment, exercise and social support, demographics,
      comorbidities, body mass index (BMI), and performance status at baseline and then
      periodically for approximately 1 year after beginning aromatase inhibitor (AI) therapy.

      Patient medical records are reviewed for comorbidities, BMI, use of prior hormone replacement
      therapy, vitamin D levels and deficiency, performance status, histological stage, prior
      treatment, and medications at baseline and then periodically for approximately 1 year after
      beginning AI therapy.
    

Intervention name(s): aromatase inhibition therapy - OBSERVATIONAL ONLY; medical chart review; questionnaire administration; assessment of therapy complications
Intervention type(s): Other; Other; Other; Procedure
Intervention description(s): Observational only - as prescribed; Observational only; Observational only; Observational only
Intervention MeSH terms: Aromatase Inhibitors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Postmenopausal women with breast cancer initiating aromatase inhibitor therapy
      
Keywords: arthralgia; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer
Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.
Condition: Constriction, Pathological
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether preventative placement of a removable
      oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the
      precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The
      stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks
      later by repeat Endoscopy. Patients will be followed up weekly following insertion of the
      oesophageal stent.
    


Intervention name(s): Fully coated, removable , self-expanding oesophageal stent
Intervention type(s): Device
Intervention description(s): Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Stricture; Dysphagia
The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aimed to investigate the relationship between administration of probiotics and
      improvement in quality of life in women with functional constipation.
    


Intervention name(s): Lactobacillus plantarum IS-10506; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.; Fermented milk containing placebo to be consumed once daily for three weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Constipation; Quality of Life; Probiotic; PAC-QOL
ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided
      focused ultrasound thermal ablation of a designated area in the brain of patients suffering
      from medication-refractory Essential Tremor, using the ExAblate transcranial system.

      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI
      scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the
      targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion
      created in the ventralis intermedius nucleus of the thalamus.

      The treatment begins with a series of standard diagnostic MR images to identify the location
      and shape of tumor to be treated. The ExAblate computer uses the physician's designation of
      the target volume to plan the best way to cover the target volume with small spots called
      "sonications". These treatment spots are cylinder shaped. Their size depends on sonication
      power and duration. During the treatment, a specific MR scan, which can be processed to
      identify changes in tissue temperature, provides a thermal map of the treatment volume to
      confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,
      and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.

      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing
      1000-element phased array transducer) positioned above the subject head. The ExAblate
      transcranial system also includes means to immobilize the subject head, cool the interface
      water, and software for CT analysis and phase correction computation.

      The ExAblate transcranial system is an experimental device and is being investigated in this
      study.
    


Intervention name(s): ExAblate Transcranial MRgFUS System
Intervention type(s): Device
Intervention description(s): Treatment with the ExAblate Transcranial MRgFUS System.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Family Strengthening Intervention for Early Childhood Development (ECD)
Condition: Child Development
Study type: Interventional

Summary: 
      Study activities were carried out to adapt and test a family-strengthening intervention to
      improve child development outcomes among families facing adversity in Rwanda.
    

Detailed description: 
      Qualitative research from past studies was used to adapt an existing family-strengthening
      intervention for HIV-AIDS affected families to extremely vulnerable families with children
      0-3 in order to improve early childhood development outcomes. This small scale pilot was
      carried out to test the feasibility and acceptability of the intervention for extremely
      vulnerable families with young children in Rwanda.

      In the first 10 families the intervention consisted of 21 modules, in the second iteration of
      the study with an additional 10 families, the curriculum was summarized into 15 modules.
      Modules were delivered by trained bachelor-level interventionists/home-visiting coaches and
      were delivered to families one on one in their respective homes. Modules were delivered on a
      weekly to biweekly basis and were flexible to the families needs and other responsibilities.
    

Intervention name(s): FSI ECD
Intervention type(s): Other
Intervention description(s): The FSI ECD intervention was delivered in a structured curriculum format, covering a range of topics from health, water and sanitation, good hygiene, early stimulation, conflict resolution, to good communication. It was designed to improve vulnerable households home environment and engagement with their children in order to improve child development outcomes. The curriculum was delivered by bachelor-level trained staff with beneficiaries on an individual, one on one basis, using active coaching to promote child well being and behaviors with caregivers.
Other intervention name(s): Family Strengthening Intervention for ECD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ECD; parenting program; home visiting
Structural and Molecular Neuroplasticity in Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The main purpose of this study is to integrate novel MRI techniques with positron emission
      tomography(PET) for the study of structural and molecular neuroplasticity in the brain of
      migraineurs, and its clinical association with changes in pain perception and modulation
      (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future,
      assist doctors in better understanding how pain is felt and regulated in migraine sufferers.
    

Detailed description: 
      To investigate interictal opioid receptor (MOR) binding potential (BPND) changes in
      migraineurs as compared to age/gender-matched healthy controls. To demonstrate that frequency
      of the headache attacks and severity of cutaneous allodynia levels in migraineurs experienced
      over multiple attacks are correlated with levels of MOR BPND in specific brain regions. To
      investigate whether dysfunction of the pain regulatory endogenous opioid system of
      migraineurs is correlated with changes in the gray matter thickness in cortical areas
      associated with pain perception and modulation.
    

Intervention name(s): Pet Scan; MRI scan; Quantitative Sensory Testing (QST)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Subjects will undergo Pet Scanning for 90 minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: migraine
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      An increasing literature shows that omega-3 fatty acids provide numerous health benefits,
      including a variety of psychiatric symptoms and disorders including stress, anxiety,
      cognitive impairment, mood disorders (major depression and bipolar disorder) and
      schizophrenia. Omega-3 fatty acids may additionally represent a promising treatment strategy
      in patients with PTSD. Moreover, given its beneficial cardiovascular effects, adjunctive
      omega-3 fatty acids may also benefit the general health status of these veterans, who
      frequently present with a variety of comorbid medical disorders.
    

Detailed description: 
      See brief summary
    

Intervention name(s): Omega-3 Fatty Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid); Matching Placebo
Other intervention name(s): Fish Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Cognition; Fish Oil; Omega-3 Fatty Acid
Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain
Condition: Leukemia; Cardiac Toxicity
MeSH terms: Cardiotoxicity
Study type: Interventional

Summary: 
      It is now accepted that the anticancer properties of anthracyclines were allowed in many
      malignancies improve the prognosis of affected populations.

      However, the cardiotoxicity of anthracyclines is responsible for an interruption of this
      treatment by alteration of potentially irreversible myocardial contraction and high
      mortality.

      An earlier detection of adverse myocardial anthracycline chemotherapy would allow the
      adaptation of the regimen by reducing the number of interruptions of antitumor and
      strengthening monitoring. Optimizing the therapeutic antitumor and generate an increase in
      survival of patients treated.
    

Detailed description: 
      Analysis of myocardial deformation in its longitudinal component, circumferential and radial,
      is a new echocardiographic technique for evaluating myocardial function, which has
      demonstrated its superiority compared to LVEF in many clinical situations. It therefore seems
      promising to evaluate this new tool in the earlier detection of adverse myocardial
      chemotherapy with anthracyclines. The ultimate goal is indeed to determine a reliable and
      reproducible parameter for cardiac toxicity diagnostic to avoid chemotherapy interruption,
      thus improving the survival of these patients.

      The main objective of this project is to evaluate the association between changes in
      myocardial deformation longitudinal 2D strain echocardiography between baseline and 6 weeks
      after initiation of anthracycline therapy for acute leukemia and the occurrence of impaired
      left ventricular function within 12 months after starting treatment.

      It is a prognostic study of clinical-looking, without randomization. The inclusion will take
      place over a period of 12 months with a total follow-up of 12 months.

      The analysis will focus on the identification of parameters predictive of alteration of Fe
      VG.
    

Intervention name(s): Echographic analysis of myocardial deformation in 2D strain
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of Negative Inspiratory Flow in Children With Acute Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      There are different inhalers used for the treatment of asthma and they work differently and
      require different technique for the optimal drug delivery to the lungs. One of the inhalers
      is the Dry Powder Inhaler (DPI). The minimal amount of Negative Inspiratory Flow (NIF)
      required to use this medication is 30ml/min. Studies have shown that children find it
      difficult to generate this NIF and studies have also shown that children generate lesser NIF
      during an Asthma exacerbation. The investigators will measure the NIF using an InCheck Dial
      on children with asthma during an exacerbation and when they are seen in clinic for a
      hospital follow up visit. This will be done on asthmatic children regardless of the inhaler
      that they use. The investigator hypothesize that children with asthma age 4-8 years cannot
      generate the required NIF during an Asthma exacerbation hence proving that a DPI cannot be
      prescribed to children at this age. This study will examine this hypothesis.
    

Detailed description: 
      Inhaler devices are the major method for delivery of asthma medication, but their
      effectiveness can be compromised if the patient uses the inhaler device incorrectly. The
      magnitude of this problem has been well documented; in several studies less than half of the
      patients used their inhaler correctly. Inhaler devices are used to deliver a variety of
      inhaled medications, including beta-agonists, anticholinergic, and glucocorticoids. Two main
      types of inhaler devices are available, the pressurized metered dose inhaler (pMDI) and the
      dry powder inhaler (DPI).

      A dry powder inhaler (DPI) is a breath-actuated device containing micronized drug particles
      with a mass median aerodynamic diameter (MMAD) of less than 5 µm that are usually aggregated
      with carrier particles (such as lactose or glucose) of greater diameter. Drug is delivered to
      the airways by the inhalation of air over a punctured drug-containing capsule or blister.

      In this study investigators will evaluate the use of DPI use in children during an acute
      asthma exacerbation. The investigators hypothesize the use of DPI in children ages 4-8 during
      an asthma exacerbation has limited benefit, as children are unable to generate the needed
      NIF. The investigators will study children who were hospitalized for an acute asthma
      exacerbation. Additionally, the investigators will evaluate the participant as an outpatient
      in the pulmonary clinic / office when the participant is without an asthma exacerbation.
    

Intervention name(s): In-Check Dial; Inhaler Device
Intervention type(s): Device; Device
Intervention description(s): Patient will have their NIF measured with In-Check Dial; Children will use inhaler per standard of care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF
Condition: Breast Cancer Female
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy
      treatment. Three group were treated with MW05 300 μg/kg or MW05 500 μg/kg or PEG-rhG-CSF 100
      μg/kg on the 3th day of each cycle randomized 1:1:1 .

      The dose of the experimental drug MW05 in phase III were determined by independent data
      monitoring committee (IDMC) according to the efficacy and safety of phase II. Subjects were
      randomly divided into two groups 1:1 to received either MW05 or PEG-rhG-CSF(100 μg/kg) on the
      3th day of each chemotherapy cycle.
    

Detailed description: 
      Study Stage: Phase II/III Study Population Female patients with breast cancer will be
      enrolled to receive at least 4 cycles of TC chemotherapy, that is: Docetaxel 75 mg/m2 and
      Cyclophosphamide 600 mg/m2.

      Study Design: A multi-center, randomized, open-label, active-controlled phase II/III clinical
      trial
    

Intervention name(s): MW05; PEG-rhG-CSF
Intervention type(s): Drug; Drug
Intervention description(s): Recombinant (yeast secreted) human serum albumin-human granulocyte colony stimulating factor (I) fusion protein injection; PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor
Other intervention name(s): MW05 injection; PEG-rhG-CSF injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision.
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Recently published studies demonstrated very high event free survival for patients with a
      normal interim PET/CT and a high hazard ratio for progression of an interim positive
      (pathological)study. These findings strongly support the integration of interim PET as a
      decision point for adjustment of chemotherapy.This study use the minimal therapy considered
      safe according to the predefined risk factors for patients with interim negative PET. Those
      with pathologic interim study considered as higher risk patients will have dose escalation of
      therapy.remission rate ,event free survival and overall survival will be evaluated.
    

Detailed description: 
      study aim is to tailor the therapy in order to administer the lowest cumulative dose of
      therapy yet considered safe in order to reduce both early and late therapy related
      complications.

      patients will be divided according to risk factors to sub groups of early favorable, early
      unfavorable, advanced disease with score less then 3 points or higher then 3 points.

      Early Interim PET will be carried out Further therapy will be based on the study results.
    

Intervention name(s): PET/CT post 2 cycles of chemotherapy
Intervention type(s): Other
Intervention description(s): sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
Other intervention name(s): F18 deoxyglucose scintigraphy
Intervention MeSH terms: Deoxyglucose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hodgkin lymphoma; PET/CT; Therapy
Renal Function During Laparoscopic Surgery
Condition: Intra Operative Fluid Management
Study type: Interventional

Summary: 
      Aim of this study was to investigate the cardiac and renal responses to the administration of
      different amount of crystalloids, with and without dopamine, during gynaecological
      laparoscopic surgery.
    


Intervention name(s): Dopamine
Intervention type(s): Drug
Other intervention name(s): Revivan
Intervention MeSH terms: Dopamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: dopamine; laparoscopy; fluid management