bioihbjkbjnl/mcl2 huggingface dataset:
Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments
Condition: Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum
      based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA)
      mutated ovarian cancer who have progressed at least 6 months after the last platinum based
      chemotherapy. Patient should have received at least 2 prior lines of platinum based
      chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.
    

Detailed description: 
      This open label, randomised, controlled, multi-centre study will assess the efficacy and
      safety of single agent olaparib vs. standard of care, based on physician's choice of single
      agent chemotherapy ( i.e paclitaxel, or topotecan, or pegylated liposomal doxorubicin, or
      gemcitabine) in platinum sensitive or partially platinum sensitive relapsed ovarian cancer
      patients who carry germline deleterious or suspected deleterious BRCA mutation and who have
      received at least 2 prior lines of platinum based chemotherapy. Patients are eligible to
      undergo BRCA testing even if they have not yet had recurrence or progression of disease >6
      months (>/=183 days) after completion of their last platinum therapy.
    

Intervention name(s): OLAPARIB; Single agent chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg olaparib tablets taken orally twice daily. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria.; Treatment of relapsed disease with single agent chemotherapy based on physician's choice of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria
Intervention MeSH terms: Olaparib
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BRCA, ovarian, platinum, chemotherapy,
The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery
Condition: Myocardial Reperfusion Injury; Cytoprotection
MeSH terms: Reperfusion Injury; Myocardial Reperfusion Injury
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to determine if treating patients who have coronary heart
      disease with hyperbaric oxygen (HBO) prior to coronary artery bypass graft (CABG) surgery
      reduces injury to the heart and vascular system during and after surgery. Furthermore, this
      study also aims to identify some of the post CABG clinical effects of HBO treatment prior to
      CABG.
    


Intervention name(s): Hyperbaric Oxygen
Intervention type(s): Drug
Intervention description(s): 100% Oxygen at 2.4 ATA for 30 minutes followed by 5 minutes break followed by 100% Oxygen at 2.4 ATA for another 30 minutes. This intervention was given about 4 to 5 hours prior to CABG
Other intervention name(s): Hyperbaric Oxygen Preconditioning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: Myocardial protection; Ischemic Reperfusion Injury; Hyperbaric Oxygen; Preconditioning
Effect of Clemastine Fumarate on Color Vision in Healthy Controls
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the
      drug clemastine has a negative effect on patients' color discrimination, which is the ability
      to distinguish different hues and arrange them in the correct order. In an upcoming clinical
      trial studying the effect of clemastine on vision outcomes, our lab aims to assess color
      visual performance adding assessment of color defectiveness as a clinical endpoint. Color
      defectiveness is the ability to see certain colors, and is commonly referred to as
      color-blindness. Color discrimination and defectiveness can be related, but do not always
      correlate. This study aims to detect the effect, if any, that clemastine has on color
      defectiveness in healthy controls, which could confound its use as an outcome endpoint in
      future clinical trials relating to clemastine.
    

Detailed description: 
      Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic
      measures and correlate blood levels of drug to color performance if seen.
    

Intervention name(s): Clemastine fumarate
Intervention type(s): Drug
Intervention description(s): 4mg 2x day clemastine fumarate orally.
Intervention MeSH terms: Clemastine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: volunteers
Acupuncture for Non-cyclical Breast Pain
Condition: Breast Pain
MeSH terms: Mastodynia
Study type: Interventional

Summary: 
      Breast pain or mastalgia is a common and troublesome symptom for many women. Whereas cyclical
      breast pain related to hormonal fluctuations can frequently be treated, non-cyclical breast
      pain can go untreated due to its various etiologies and non-specific presentation.
      Acupuncture is an ancient form of Chinese medicine that has been used for centuries to treat
      a vast array of illnesses and conditions. Research has shown that acupuncture has a link to a
      release of endorphins and other chemicals in the central nervous system. Thus, it is thought
      to help relieve pain. To date, there has been minimal research using acupuncture for breast
      pain. This pilot of 30 women will seek to determine whether four acupuncture treatments over
      a period of two weeks will significantly lower the level of pain experienced by these
      participants. Additionally, we will evaluate quality of life measures.
    


Intervention name(s): acupuncture
Intervention type(s): Procedure
Intervention description(s): acupuncture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Performance and Safety of the Medical Device Plenhyage®
Condition: Wrinkle
Study type: Interventional

Summary: 
      The Research Question of the present study is the following: in a population of men and women
      affected by face wrinkles and skin tones and irregularities (atrophies) of the skin surface
      in neck, abdomen, thighs and buttocks, will Plenhyage® significantly decrease the appearance
      of treated areas, results observed after 8 and 12 weeks?
    

Detailed description: 
      Open, non-comparative, interventional, multicenter study with the total number of screened
      subjects of 66 (60 evaluable subjects +6 potential screening failure):

        -  20 patients will be administered Plenhyage® thin for the treatment of mild wrinkles;

        -  20 patients will be administered Plenhyage® medium for the treatment of moderate
           wrinkles;

        -  20 patients will be administered Plenhyage® strong for improving the skin tones and
           irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks;
    

Intervention name(s): Plenhyage® thin; Plenhyage® medium; Plenhyage® strong
Intervention type(s): Device; Device; Device
Intervention description(s): 0.75%; 2%; 2.5%
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 20 patients will be administered Plenhyage® thin for the treatment of mild wrinkles;
20 patients will be administered Plenhyage® medium for the treatment of moderate wrinkles;
20 patients will be administered Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks
Masking: None (Open Label)
Primary purpose: Other
Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
Condition: Human Metapneumovirus and Human Parainfluenza Infection
MeSH terms: Infections; Paramyxoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653,
      a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy
      adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with
      serologic evidence of prior exposure. The safety profile of the adult cohort will permit
      enrollment of the pediatric cohort.
    


Intervention name(s): mRNA-1653; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Sterile liquid for injection; Sterile liquid for injection
Other intervention name(s): saline
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Parallel for the Adult Cohort, followed by Sequential Assignment for the Pediatric Cohort
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: ModernaTX; mRNA-1653; human metapneumovirus; human parainfluenza; human parainfluenza vaccine; virus diseases; RNA virus infections; paramyxoviridae infections; mononegavirales infections
Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery
Condition: Postoperative Pain; Wisdom Tooth
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether robust analgesic regime (protective
      analgesia) can improve postoperative pain experience for patients undergoing lower wisdom
      teeth extraction under day case general anaesthetic.
    

Detailed description: 
      The aim of the study was to demonstrate and improve postoperative pain experience using
      protective analgesia for patients undergoing oral surgery under day case general anaesthesia.

      The primary objective was to investigate the efficiency of protective analgesia using
      combined effects of sustained release ibuprofen and bupivacaine nerve block in attenuation of
      postoperative pain following impacted third molar surgery under day case general anaesthesia.

      The secondary objective was to document the safety and tolerability profile of conventional
      release versus sustained released ibuprofen with bupivacaine block in subjects undergoing
      impacted third molar surgery under day case general anaesthesia.
    

Intervention name(s): Brufen retard; ibuprofen; Bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose 2 x 800mg tablets 2 hours prior to surgery; Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery; Up to 10ml of Bupivacaine 0.5% with 1:200,000 Adrenaline given prior to surgical incision as inferior alveolar nerve block and long buccal nerve infiltration.
Other intervention name(s): sustained release ibuprofen; modified release ibuprofen; Brufen; neurofen; conventional release ibuprofen; Marcain 0.5% with 1 in 200,000 epinephrine
Intervention MeSH terms: Ibuprofen; Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Third molar
Improving Symptom Self-management in Adolescents & Young Adults With Cancer
Condition: Symptom Clusters; Cancer
MeSH terms: Syndrome
Study type: Observational

Summary: 
      This study evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which creates
      an image of the symptoms the participant is experiencing, for improving symptom
      self-management in adolescents and young adults with cancer. In this one-group trial,
      participants will complete the C-SCAT and use it during two clinic visits with their oncology
      providers.
    

Detailed description: 
      Unrelieved symptoms lead to poorer quality of life for adolescents and young adults (AYAs)
      with cancer. Strategies are needed to help AYAs manage symptoms. The investigators developed
      the Computerized Symptom Capture Tool (C-SCAT), a novel way to assess symptoms where AYAs
      create a picture of their symptoms using images and text on an iPad app. The resulting image
      shows symptoms/symptom clusters, priority symptoms and relationships between symptoms and has
      potential to support AYA's symptom self-management. Facilitating the self-management process,
      including self-efficacy, self-regulation behaviors, and patient-provider communication, is
      essential for improving symptom outcomes.
    

Intervention name(s): Computer Symptom Capture Tool
Intervention type(s): Device
Intervention description(s): C-SCAT is an investigator developed app that is delivered via an iPad. The original CSCAT included the 30 symptoms from the Memorial Symptom Assessment Scale. The recently updated version includes two additional symptoms "feeling bloated" and "sexual dysfunction" that are included in the adult version of the MSAS.21 These symptoms were added based on feedback from the initial AYA sample of 13-29 year olds and in consideration of the developmental perspectives of the AYA population.The CSCAT allows the user to create an image of his or her symptom experience.
Other intervention name(s): C-SCAT
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric and adult oncology clinics at the Virginia Commonwealth University Health System
        (VCUHS). Patients and parents of minor patients will be approached as inpatients or as
        outpatients at Massey Cancer Center Fellows Clinic and at the Pediatric Oncology Clinic.
      
Keywords: adolescents; young adults
Preventing Cognitive and Functional Decline Among Seniors at Risk
Condition: Subjective Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a
      psycho-education workshop for improving everyday life performance in older adults with
      subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of
      these approaches.
    

Detailed description: 
      Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these
      individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia.
      Many of these individuals report difficulties with complex activities of daily living.

      RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive
      training approach that compensates for age-related executive changes. The approach is
      provided within the context of individually identified everyday-life difficulties.

      The psycho-education approach is a Brain-Health Workshop supplemented by intellectually
      stimulating activities such as doing Sudoku and/or word searches. This approach provides
      information people may use to inform health behaviour changes.
    

Intervention name(s): Real World Strategy Training; Psychosocial Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.; The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sodoku puzzles. Homework will consist of reading assignments related to the session topics.
Other intervention name(s): Adopted Cognitive Orientation to Occupational Performance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Age-related cognitive changes
Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      In this clinical study, the investigators will compare vital parameters measurements obtained
      using continuous data from reference monitors and continuous wireless MultiSense® monitoring
      patch in 30 healthy volunteers under induced and controlled hypoxia.
    

Detailed description: 
      The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip
      for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in
      real-time, remotely and continuously 11 clinical key-indicators by being attached to the
      patient thorax: ECG trace, heart rate, oxygen saturation, respiratory rate and relative
      respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin
      temperature, physical activity and body position. Designed to be worn continuously for at
      least seven days, the patient can keep the patch during his sleep or in the shower.

      The aim of this study is to determine the quality of measurements of arterial blood
      saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with
      a reference Pulse Oximetry System under induced hypoxia, in terms of accuracy.

      The study population includes 30 healthy volunteers.
    

Intervention name(s): Remote Automated Monitoring System
Intervention type(s): Other
Intervention description(s): The subject will be monitored with conventional monitoring devices as well as the MultiSense patch.
Intervention model: Single Group Assignment
Intervention model description: prospective feasibility study,
Masking: None (Open Label)
Primary purpose: Other
Keywords: vital signs; connected device; real-time monitoring; hypoxia; SpO2; non-invasive blood pressure; cardio-respiratory monitoring
An Exploratory Investigation to Identify if Dame Product's "DLM" Works to Improve Sexual Desire and Mood in Females
Condition: Sexual Desire Disorder
Study type: Interventional

Summary: 
      This is a single-group, non-randomized, non-controlled, open-label observational trial to
      study and evaluate the efficacy of a commercial dietary supplement, called "DLM" ("test
      product"). It is hypothesized that the test product, which is designed as an edible gummy,
      will present a favorable result to increase sexual desire and improve mood.
    


Intervention name(s): DLM - Test product
Intervention type(s): Dietary Supplement
Intervention description(s): The group will receive 60 gummies each (to take two gummies per day) across a four-week period. Each participant shall take two gummies per day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation
Condition: Depression, Unipolar
MeSH terms: Sleep Deprivation; Depressive Disorder
Study type: Interventional

Summary: 
      From 40 to 60% of patients with depression experience a rapid and significant improvement of
      mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect
      have not been elucidated. Recent advances in functional neuroimaging have provided new
      opportunities to investigate state changes in regional brain function, along with a better
      understanding of the neural networks affected by depression and SD. Here we propose to study
      a group of N=48 antidepressant-free male and female patients with current depression symptom
      and N=12 healthy controls with no history of mood disorders before and after SD to provide
      mechanistic insight into the neural substrates underlying the antidepressant effects of SD.
      We hypothesize that SD-induced concurrent functional activity and connectivity changes in
      multiple brain networks related to different depressive symptom dimensions including emotion
      regulation, attention, arousal, self-referential, and reward processing will underlie the
      rapid and transient antidepressant effects of SD. Using an ABA design, multimodal brain
      imaging along with more traditional electroencephalographic (EEG) and neurobehavioral testing
      data will be acquired at baseline after normal sleep, during one night of total SD, and after
      one night of recovery sleep using a 5-day in laboratory protocol during which subjects will
      be continuously monitored by trained staff.
    


Intervention name(s): Sleep deprivation
Intervention type(s): Behavioral
Intervention description(s): 36-hours total sleep deprivation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparative Study About the Influence of Diabetes Diatress and Depression on Treatment Adherence in Chinese Type 2 Diabetes Patients
Condition: Compare Diabetes Distress and Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational [Patient Registry]

Summary: 
      An effective treatment adherence was a key to make the treatment success, some reports had
      shown that psychologicl factors impact patients adherence seriously,however, in China, the
      researches were only limited to depression and diabetes,diabetes distress was neglected. Some
      western studies had demonstrated the impact of diabetes distress on diabetes. Thus, we
      hypothesized that: 1.perhaps our present depression-oriented health education was inadequate
      to promote patients' adherence, diabetes distress might played a more important part than
      depression in patients' treatment adherence. 2. there might be a high prevalence of diabetes
      distress in Chinese type 2 diabetes; so, the comparative study between diabetes distress and
      depresion was conducted.

      Objectives: to explore the relationship of diabetes-related distress and depression，and to
      compare the influence of diabetes distress and depression on treatment adherence in Chinese
      type 2 diabetes .

      Research design and method:we surveyed 200 type 2 diabetic patients from 2 third-class
      hospitals using the Diabetes Distress Scale, Zung Self-rating Depression Scale, and Revised
      Treatment Adherence in Diabetes Questionnaire (RADQ)simultaneously.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with type 2 diabetes who visited the two local hospitals between December 2011 and
        April 2012, were invited to participate in this cross-sectional survey study.