bioihbjkbjnl/mcl2 huggingface dataset:
Understanding the Role of Dietary Fatty Acids on Liver Fat Metabolism in Humans
Condition: NAFLD
Study type: Interventional

Summary: 
      High levels of fatty substances in the blood increase the risk of developing heart disease.
      Investigators know a lot about one of these fatty substances, cholesterol. However, there is
      another fatty substance in the blood called triglyceride. Investigators do not understand
      much about what regulates the rate at which the liver produces triglyceride and liberates it
      into the bloodstream after eating a meal(s). It is known that taking fish oil lowers the
      amount of blood triglyceride however, it remains unclear how this happens. Investigators will
      study if changes in liver fat metabolism, after taking fatty acids found in fish oil (n-3
      fatty acids)can explain the lowering of blood triglyceride. Investigators also want to know
      if taking fish oil alters the amount of fat that accumulates within the liver.
    

Detailed description: 
      Investigators will recruit men and women with no medical condition or relevant drug therapy
      that affects liver fat metabolism.

      Purpose and design:

      Investigators are asking the research question: "How do specific fatty acids, such as those
      found in fish ((n-3) fatty acids) influence postprandial liver fat metabolism?"

      It is known that n-3 fatty acids lower plasma triglyceride concentrations but it remains
      unclear how this happens.

      To address this research question investigators want to undertake detail physiological
      studies, in a randomised study where individuals will be studied before and after taking n-3
      fatty acids or a placebo oil.
    

Intervention name(s): Dietary supplement: fatty acid; Dietary supplement: fatty acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of n-3 fatty acids for 8 weeks; Consumption of olive oil for 8 weeks.
Other intervention name(s): n-3 fatty acids (EPA and DHA); Olive oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: plasma triglycerides; dietary fat; liver fat metabolism; human
Factorial Study of Metoprolol Succinate TOPROL-XL (324A)
Condition: High Blood Pressure (Hypertension).
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to determine if treatment with the combination of
      metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure
      than treatment with either of the two drugs alone. The study will also determine which
      combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering
      blood pressure (without unacceptable side effects), and whether it is possible to combine
      both drugs in a single tablet to simplify blood pressure treatment.
    


Intervention name(s): Metoprolol Succinate; Hydrochlorothiazide
Intervention type(s): Drug; Drug
Other intervention name(s): TOPROL-XL
Intervention MeSH terms: Metoprolol; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: High blood pressure; hypertension; (TOPROL-XL); metoprolol succinate; hydrochlorothiazide
Imaging Dopamine Release in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to determine whether ventral striatal dopamine release is a mechanism of
      reward motivation in major depression, whether dopamine release is low in depression, and
      whether DA release and reward motivation predict response to dopamine-targeted treatment with
      pramipexole.
    

Detailed description: 
      Better understanding of the basic neurobiology of mood dysfunction appears necessary to
      enable further progress in the treatment of depression. Reward motivation (and the closely
      related construct of "reward learning") is a core neurobehavioral domain.(1,2) In major
      depressive disorder (MDD), low reward motivation is a key aspect of anhedonia, a cardinal
      symptom of MDD, and is related to resistance to treatment.(2,3) Although much has been
      learned about reward motivation's neurobiology and relevance to psychopathology, important
      gaps in our knowledge have impeded the application of basic science findings to improving
      treatment of MDD. Reward motivation in healthy subjects involves ventrostriatal (VST)
      dopamine (DA)(4,5), and reduced reward motivation is linked to MDD and anhedonia.(3,6) These
      data suggest that VST DA dysfunction might be present in MDD and manifested clinically by
      anhedonia. While DA neuroreceptor imaging studies have failed to verify this, they have been
      methodologically compromised. Limitations include imaging methods with poor resolution of
      functional striatal subregions, MDD samples heterogeneous for antidepressant use, and use of
      self-report measures of anhedonia, rather than objective behavioral testing of the specific
      domain of reward motivation. This will be the first study of both VST DA release (by PET
      imaging) and reward motivation, and will include patients with MDD and healthy volunteers.
      Reward motivation will be captured and operationalized as reward learning in a probabilistic
      reward task (prior to imaging). This will clarify if VST DA dysfunction is linked to impaired
      motivation in MDD. To test clinical implications in MDD patients, we will assess the
      relationship of VST DA release, reward motivation, and anhedonia to outcome of subsequent
      open label treatment with the DA D2 receptor agonist pramipexole.
    

Intervention name(s): Pramipexole
Intervention type(s): Drug
Intervention description(s): Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day.
Other intervention name(s): Mirapex (brand name)
Intervention MeSH terms: Pramipexole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Major depressive disorder; MDD; depression; pramipexole
Antimuscarinic Treatment for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing
Condition: Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive; Syndrome
Study type: Observational

Summary: 
      The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more
      effective in treating patients with nocturia.
    


Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        We will perform a retrospective study to review the data of bladder diary, urodynamic
        studies and clinical data of patients who underwent tolterodine SR treatment once per day
        for 12 weeks in Department of Obstetrics & Gynecology in National Taiwan University
        Hospital and Far Eastern Memorial Hospital.
A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of topiramate (96, 192, and
      256mg daily) with placebo in long-term treatment of obesity.
    

Detailed description: 
      Topiramate is not approved for the treatment of obesity. This double-blind,
      placebo-controlled study assesses long-term effectiveness and safety of topiramate in
      patients with obesity. After completing 6 weeks of run-in phase (a single-blind
      placebo-treatment phase during which patients begin non-pharmacological therapy), patients
      will be randomized to receive either topiramate or placebo. Topiramate group will receive
      16mg of topiramate and the dose will be titrated over 8 weeks. Patients will then receive two
      years of treatment. Effectiveness will be evaluated by body weight, Body Mass Index (BMI),
      anthropometric measurements (waist circumference, hip circumference, waist/hip ratio),
      fasting lipid profile, fasting plasma glucose, HbA1c, fasting uric acid, fasting insulin,
      blood pressures, body fat compositions, mass of left ventricle of the heart (as measured by
      echocardiography), and Health Related Quality of Life scores. Safety evaluation (incidence of
      adverse events, laboratory tests, electrocardiogram, vital signs) will be performed
      throughout the study. The study hypothesis is that topiramate will be effective in achieving
      and maintaining weight reduction in obese patients. During the initial 8 weeks, the doses of
      topiramate or placebo will be gradually increased to the target dose (either 96mg, 192mg, or
      256mg daily by mouth) and the doses will be maintained for 2 years.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obesity; Hypertension; Hyperlipidemia; Type 2 Diabetes Mellitus; Body Mass Index
A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to estimate the effects of different strong enzyme
      (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose
      pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18
      subjects that are randomized to 1 of 3 treatment groups. The study is also intended to
      determine the safety and tolerability of single-dose PF- 00489791 when it is administered
      with steady-state itraconazole, diltiazem, or verapamil.
    


Intervention name(s): itraconazole; diltiazem; SR verapamil; PF-00489791
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): itraconazole dosed at 200 mg; diltiazem dosed at 240 mg; SR verapamil dosed at 240 mg; PF-00489791 20 mg single dose administration
Intervention MeSH terms: Itraconazole; Verapamil; Diltiazem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to
      evaluate the efficacy, safety and acceptability of newly-developed vaginal contraceptive gel,
      the optimized benzalkonium chloride (BZK) gel containing 18mg BZK, with comparison to a
      currently marketed (in China)contraceptive gel LELEMI® containing 50mg Nonoxynol-9 (N-9).
    

Detailed description: 
      A phase II, multicentric,randomized, controlled clinical trial.
    

Intervention name(s): a novel Benzalkonium Chloride (BZK) contraceptive gel; LELEMI® contraceptive gel containing 50mg nonoxynol-9
Intervention type(s): Drug; Drug
Intervention description(s): insert 1 piece of the gel (containing 18mg BZK) into vagina before every coital act.; insert 1 piece ofLELEMI® contraceptive gel within half an hour before every coital act
Intervention MeSH terms: Benzalkonium Compounds; Contraceptive Agents; Nonoxynol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: contraceptive efficacy
Art Therapy Pain Management Adolescents Pediatric ED
Condition: Pain
Study type: Interventional

Summary: 
      This project is studying adolescents between the ages of 12 to 18 years that come to the
      emergency department and are in pain. We want to find out how well art therapy is able to
      decrease the pain they are experiencing. Art therapy will involve making art and working with
      an art therapist to find new ways of expressing thoughts and feelings through art making.

      In adolescents presenting to the emergency department with a painful condition, our aims are
      as follows:

      Aim #1: To determine the degree that art therapy intervention reduces pain and anxiety.

      Aim #2: To determine the degree that art therapy reduces pain and anxiety 1 hour after the
      intervention.

      Aim #3: To explore the qualitative experience of patients undergoing art therapy
      intervention.
    

Detailed description: 
      Pain is one of the most common reasons for patients to visit the emergency department (ED),
      and can be treated using both complementary and pharmacological strategies. However, children
      are often undertreated for pain which results in not only short term problems, but long term
      consequences such as trauma and stress-induced disorders; health care avoidance as adults;
      increased pain sensitivity; and decreased response to future analgesia. There have been
      variable efforts made to improve the ED management of pain in children, but adolescents are
      frequently overlooked. A review of the literature revealed that art therapy for pain
      management in adolescents is understudied. The majority of studies describe the effects of
      art therapy on the emotional well-being in surgical and oncology populations in adults and
      children. The studies that did evaluate the effectiveness of art therapy for pain management
      in children focused primarily on surgical and medical oncology populations with children aged
      2-14 years. Of these studies, none evaluated adolescents in the ED, which is a high volume
      and high stress environment that confers a distinct experience for patients compared to other
      medical settings. Evaluation of art therapy interventions using quantitative self-report
      measures with strong validity in children and further delineation of the patient experience
      related to art therapy is necessary. Advanced evaluation of aforementioned interventions
      would expand the evidence base needed to describe effectiveness of these interventions and
      support greater implementation and dissemination. These are the gaps in knowledge that the
      investigators aim to fill with the proposed study.
    

Intervention name(s): Art Therapy Intervention
Intervention type(s): Other
Intervention description(s): Standardized mixed media art directives.
Intervention model: Single Group Assignment
Intervention model description: Prospective observational pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Art Therapy; Pain Management; Pediatrics; Emergency Medicine
Neck Joint Position Error Among Taibah Students University; Saudi Arabia; Cross Section Design
Condition: Proprioception
Study type: Observational [Patient Registry]

Summary: 
      this study was done to answer the following: Is there a difference between students without
      and with varying degrees of text neck in cervical proprioception defect? Is there a
      correlation between JPE and severity of text neck among Taibah students University?
    


Intervention name(s): inclinometer, smart phone goniometer and laser beam
Intervention type(s): Device
Intervention description(s): devices to objectively assess proprioception of the neck
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All four groups were recruited from the college of medical rehabilitation sciences, Applied
        Medical Sciences, and Business administration faculty through posters, word of mouth, and
        by WhatsApp groups.
Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The overall purpose of PA-SCOPE is to determine why black and rural residents of Pennsylvania
      might be at higher risk for deadly, debilitating, and costly hospitalizations for chronic
      obstructive pulmonary disease (COPD)- and then to show that repeat acute exacerbations in
      high-risk patients can be reduced with one simple intervention. We believe that 1) COPD
      patients who are black or who live in rural areas of Pennsylvania are at higher risk of acute
      exacerbations requiring hospitalization and 2) this elevated risk can be reduced with one
      simple intervention: access to a 1-800 Temple Call Center where patients can get immediate
      customized advice on managing COPD exacerbations in their early stages. We will test these
      beliefs in PA-SCOPE. The collaborators with Temple University Hospital on the PA-SCOPE
      project are Lancaster General Hospital, Western Pennsylvania Hospital, and the Philadelphia
      College of Osteopathic Medicine.
    

Detailed description: 
      -  Overall objective: To determine why African American and rural residents of Pennsylvania
           might be at higher risk for deadly, debilitating, and costly hospitalizations for
           COPD-and to show that repeat acute exacerbations in high-risk patients can be reduced
           with one simple intervention--access to a 1-800 Temple Call Center phone number where
           patients can get immediate customized advice on managing COPD exacerbations in their
           early stages.

        -  Phase 1: To compare and contrast the influence of race and geographic location in COPD
           exacerbation in relation to severity, comorbidities, treatment patterns, infection rate.
           To identify potential risk factors for COPD exacerbations leading to hospitalization.

        -  Phase 2: To reduce hospitalizations and deaths due to COPD exacerbations and to improve
           patient quality of life, lung function, and everyday activity levels
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Phase 1: inpatients hospitalized for COPD exacerbations Phase 2: Moderate to severe COPD
      
Biospecimen description: 
      Ancillary studies collect blood specimens for gene expression and genetic factors.
    
Keywords: Chronic Obstructive Pulmonary Disease; COPD; COPD Exacerbation; Genetic markers COPD; Gene expression in COPD exacerbations; COPD Exacerbation Symptom Reporting; COPD Exacerbation Disease Management; COPD Treatment; Breathing disorders; Emphysema; COPD with Healthy Control comparators for genetic association studies.
Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative
      bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.
    


Intervention name(s): combination drug: DW330SR, DW1030; DW340
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stereotactic Radiosurgery in Treating Patients Undergoing Chemotherapy and Radiation Therapy For Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less
      damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may
      kill more tumor cells.

      PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic
      radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well
      it works in treating patients with stage III non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the maximum tolerated dose of stereotactic radiosurgery in patients with
           locally advanced non-small cell lung cancer undergoing concurrent chemoradiotherapy.
           (Phase I)

        -  Assess the response rate (complete and partial response) in these patients by RECIST
           criteria. (Phase II)

      Secondary

        -  Determine the tolerability. (Phase I)

        -  Assess the quality of life of these patients by QLQ-C30 v3. (Phase I)

        -  Assess the overall and disease-free survival of these patients. (Phase II)

        -  Assess progression-free survival of these patients. (Phase II)

      OUTLINE: This is a multicenter, phase I dose escalation study of stereotactic radiosurgery
      followed by a phase II study.

      Patients receive docetaxel IV and cisplatin IV on days 1, 22, 43, 50, 57, and 64 in the
      absence of disease progression or unacceptable toxicity. Beginning on day 43, patients
      undergo concurrent radiotherapy to the mediastinum 5 days a week. Beginning 2-3 weeks after
      chemoradiotherapy, patients undergo stereotactic radiosurgery on days 1, 3, and 5.

      Quality of life is assessed by the QLQ-C30 v3 questionnaire at baseline, after radiosurgery,
      and at 6 and 12 months after completion of study treatment.

      After completion of study treatment, patients are followed up monthly for 6 months, every 3
      months for 1 year, and then every 6 months for 3 years.
    

Intervention name(s): CK
Intervention type(s): Device
Intervention description(s): Cyberknife Irradiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage II non-small cell lung cancer
The Safety and Efficacy of a Bone Broth Diet on Weight Loss in Obese Adults
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The primary objective of this study is to investigate the safety and efficacy of a bone broth
      diet on weight loss in obese adults. The change in weight and body mass index (BMI) following
      the bone broth diet will be measured from baseline at Days 22 and 50. Additionally, the
      safety and tolerability of the bone broth diet will be measured by the occurrence of
      post-emergent adverse events (AEs).
    


Intervention name(s): Dr. Kellyann's Bone Broth
Intervention type(s): Other
Intervention description(s): Participants will have two bone broth phases, each three weeks in length. Bone broth phases will be separated by a one-week maintenance phase. A one-week maintenance phase will also occur after the second bone broth phase. Each week of a broth phase will consist of five feeding days and five fasting days. On feeding days, participants will consume one packet of bone broth, twice each day, as snacks between meals. On fasting days, participants will consume one packet of bone broth every two hours for a total of seven packets each day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety and efficacy; Weight loss; Obesity; Bone broth