bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of this study is to investigate serum SCUBE-1 and SCUBE-3 levels in PCOS and non-PCOS
      cases compared with non-PCOS healthy controls with similar age and body mass index
    

Detailed description: 
      The aim of this study was to investigate serum SCUBE1 and SCUBE3 levels in PCOS and non-PCOS
      cases compared with non-PCOS healthy controls with similar age and body mass index.

      This will be a prospective clinical laboratory study,It will include women with PCOS
      diagnosis (according to the 2003 Rotherdam criteria). 40 cases of reproductive age will be
      included in the study group, which will be included in the survey after being approved for
      participation in the survey from field trials. Forty patients who will not have any
      complaints between the ages of 18-35 who will apply to the gynecology policlinic as a control
      group but who had no PCOS o rany other systemic problems and will be similar in terms of age
      group and body mass index will be included in the study after being approved for
      participation in the study. From the study and control group, 5 mL of blood will be taken
      from the untreated biochemical tube for serum SCUBE1 SCUBE2 SCUBE3. The blood samples will be
      centrifuged at 1000 g for 10 minutes and the serum fraction will be obtained and the serum
      will be stored at -80 ° C to be stored until the day of the tube operation. Serum SCUBE1,
      SCUBE2 SCUBE3 levels will be measured using ELISA kits. ,
    

Intervention name(s): study
Intervention type(s): Diagnostic Test
Intervention description(s): Scube-1 scube-2 scube-3
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        40 women diagnosed with PCOS between the ages of 18-35
      
Biospecimen description: 
      Blood serum
    
Keywords: PCOS; SCUBE; Cardiovascular disease
A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group
      comparison study in rheumatoid arthritis participants inadequately responding to biologics.
    


Intervention name(s): E6011; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous administration; subcutaneous administration
Intervention MeSH terms: Quetmolimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: E6011; rheumatoid arthritis
Open Label Extension in Adults With Binge Eating Disorder (BED)
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or
      70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults
    


Intervention name(s): Lisdexamfetamine dimesylate
Intervention type(s): Drug
Intervention description(s): 50 or 70 mg administered orally, once a day for 52 weeks
Other intervention name(s): Vyvanse; SPD489; LDX
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary aim of this exploratory mechanistic study is to investigate the effects of
      Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients.

      This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to
      placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell
      function, as well as several markers of metabolic control.
    

Detailed description: 
      This study will be performed as a multi-center study which includes 2 centres. 44 subjects
      with T2DM are to be included according to the defined in- and exclusion criteria.

      Subjects has to be on a stable metformin therapy and will receive in a first step
      empagliflozin for 30 days. Both therapies (metformin and empagliflozin) will be continued for
      another 30 days and subjects will be randomized to receive in addition Linagliptin or Placebo
      for 30 days.

      Subjects will come for two inhouse periods to their corresponding study center and will
      undergo an hyperglycaemic clamp test as well as a Meal test in each of the periods.
    

Intervention name(s): Linagliptin; Placebo; Empagliflozin
Intervention type(s): Drug; Other; Drug
Intervention description(s): 22 subjects will receive Linagliptin for 30 days; 22 subjects will receive Placebo for 30 days; 44 subjects will receive Empagliflozin for 60 days
Other intervention name(s): Trajenta; Jardiance
Intervention MeSH terms: Empagliflozin; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety
      of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
      after failure of no less than second-line chemotherapy or targeted therapy
    


Intervention name(s): Anlotinib
Intervention type(s): Drug
Intervention description(s): All patients enrolled in the study will accept anlotinib treatment as a palliative treatment .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single Dose Study Of PF-06678552 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary
      purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and
      pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.
    


Intervention name(s): PF-06678552 or Placebo; PF-06678552 or Placebo; PF-06678552 or Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.; PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Single Ascending Dose; healthy subjects; Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases
DREAM Project Community Health Worker Intervention
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community
      Health Worker (CHW) intervention to improve diabetic management and control among
      Bangladeshis with diabetes in New York City (NYC).
    

Detailed description: 
      The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community
      Health Worker (CHW) intervention to improve diabetic management and control among
      Bangladeshis with diabetes in New York City (NYC). For a two-arm, randomized controlled trial
      (RCT), investigators will recruit a sample of 256 participants, all of whom are 1) of
      Bangladeshi descent, 2) residing in NYC, 3) diagnosed with Type 2 diabetes mellitus (T2DM)
      and a recent Hemoglobin A1c (HbA1c) of ≥ 6.5, and 4) between the ages of 21-85. The treatment
      group receives a six-month CHW-led intervention consisting of five monthly group educational
      sessions, two one-on-one visits, and follow-up phone calls as needed from a CHW. The control
      group receives an introductory educational session only. Primary and secondary outcomes
      include clinical and behavioral measures, such as HbA1c and weight change, access to and
      utilization of care (i.e. appointment keeping and use of specialty care), and knowledge and
      practice of physical activity and healthful eating. Additionally, information regarding CHW
      characteristics, the processes and mechanisms for influencing healthful behavior change, and
      fidelity of the intervention are collected. Outcomes are measured at Baseline, 3-Months,
      6-Months for both groups, and at 12-Months for the treatment group.
    

Intervention name(s): CHW Intervention
Intervention type(s): Other
Intervention description(s): 5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Reliability of the Angle Measurement of the Software for Photogrammetry Postural Assessment (SAPO)
Condition: Body Posture Alignment Condition; Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      The present study aims to verify the reliability of intra and inter-examiner of angular
      measures proposed by SAPO postural assessment software. Methods: 24 subjects were
      photographed and three experienced examiners analyzed the images.
    

Detailed description: 
      The body posture in the orthostatic position has been widely utilized as in the clinical
      practice as in the research, for the diagnosis and physiotherapy treatment planning. The
      photogrammetry has been used as a valuable resource for the physiotherapist's diagnosis and
      verification of measuring postural changes, but the lack of standardization of anatomic
      references, the used angles between them and their meaning embarrasses comparison among
      studies.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        24 subjects with temporomandibular disorder
      
Keywords: reliability; photogrammetry
Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis
      of the prostate after this intervention. Thus, PAE might also play a role in the treatment of
      prostate cancer.

      This proof of concept study assess the impact of PAE in patients with proven prostate cancer.
    

Detailed description: 
      MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis
      of the prostate after this intervention. Thus, PAE might also play a role in the treatment of
      prostate cancer.

      This proof of concept study assess the impact of PAE in patients with proven prostate cancer.

      PAE is performed in patients that are planned to undergo robot-assisted laparoscopic
      prostatectomy for proven localized prostate cancer.

      The impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins
      as well as on safety parameters are assessed.
    

Intervention name(s): Prostatic Artery Embolization (PAE)
Intervention type(s): Device
Intervention description(s): PAE is performed 6 weeks before radical prostatectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate; Prostatic Neoplams; Therapeutic Embolization; Prostatectomy
A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label study will investigate whether multiple oral doses of posaconazole affect the
      single dose pharmacokinetics of alectinib in healthy volunteers.
    


Intervention name(s): Alectinib; Posaconazole
Intervention type(s): Drug; Drug
Intervention description(s): Alectinib will be administered as a single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants).; Posaconazole will be administered as a 400-mg BID oral dose after a high-fat meal on Days 8 to 14 (Period 2) and Days 15 to 18 or 21 (Period 3).
Other intervention name(s): RO5424802
Intervention MeSH terms: Posaconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Focus on Function Study for Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study will compare two treatment approaches that are currently being used for children
      with cerebral palsy. Both treatments aim to improve a child's function. The two approaches
      being compared are: 1) improving function by working with the child to improve his/her skills
      and abilities ("child-focused" approach) and 2) improving function by changing/adapting the
      task and/or environment around the child to improve his/her skills and abilities
      ("context-focused" approach). It is hypothesized that the context-focused approach will
      significantly improve activity and participation outcomes while leading to no significant
      decreases in body function and structure outcomes.
    

Detailed description: 
      Children with cerebral palsy commonly receive ongoing physical and occupational therapy to
      facilitate development and to enhance functional independence in movement, self-care, play,
      school activities and leisure. The primary objective of this project is to conduct a
      multi-site clinical trial to evaluate the efficacy of a context-focused approach in improving
      performance of functional tasks, mobility, participation in everyday activities and quality
      of life in 220 children 12 months to 5 years of age who have cerebral palsy. A randomized
      clinical trial research design will be used to examine the efficacy of the context-focused
      approach compared to a child-focused approach. 72 therapists in Ontario and Alberta will be
      randomly assigned to provide either context-focused or child-focused therapy. Therapists in
      both groups will participate in a training workshop and expert consultants will be available
      to support the therapists throughout the study. Children will receive either the
      context-focused or child-focused therapy intervention for a period of 6 months. Outcomes will
      be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period.
      Outcomes will be measured across the domains of the International Classification of
      Functioning, Disability and Health, including body function and structure (range of motion,
      spinal alignment), activities (performance of functional tasks, motor function),
      participation (involvement in formal and informal activities), and environment (parent
      perceptions of care, parental empowerment). The children's range of motion will also be
      evaluated by an independent, trained evaluator at baseline, 3, 6, and 9 months. We
      hypothesize that the context-focused approach will significantly improve activity and
      participation outcomes while leading to no significant decreases in body function and
      structure outcomes.
    

Intervention name(s): Context-focused compared to child-focused interventions
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Objective Evaluation of Depression Using Sleep EEG
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test the ability of a brainwave measurement device
      (SLEEPSCOPE) in identifying and assisting in the diagnosis of depression. The brainwave data
      from individuals with untreated depression and healthy participants will be collected and
      analyzed. The ability to obtain brainwave data from individuals in their homes while they're
      sleeping would represent a significant advance in depression research.
    

Detailed description: 
      The purpose of study is to collect and analyze human sleeping brainwave data, to better
      understand depression in humans.

      First visit:

        -  Informed consent procedures, including explanation of research background, purpose,
           details of implementation, and study benefits and risks

        -  Interview with questionnaires (MINI International Psychiatric Interview, Hamilton Rating
           Scale for Depression, Beck Depression Inventory, Patient Health Questionnaire for
           Depression [PHQ-9]), physical examination.

        -  Urine drug sample for screening of controlled substances.

        -  Inform participants that those qualifying will be informed whether or not to proceed
           with second visit

      Second visit:

        -  Explanation of EEG measurement (placement of two electrodes, one on the forehead and one
           behind the ear)

        -  Sleep diary provided for participant to complete at home for each night until third
           visit

        -  Distribution of EEG devices for home use

        -  EEG measurement conducted at participant's residence for three nights of stable
           sleep-wake cycles

      Third visit:

      - Collect EEG devices and check completeness of downloaded data
    

Intervention name(s): SLEEPSCOPE
Intervention type(s): Device
Intervention description(s): Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparing Dexmedetomidine With Bupivacaine Versus Bupivacaine Alone for Caudal Block in Supra - Umbilical Surgeries
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      dexmedetomidine is an alpha 2 adrenergic receptor agonist that is given either systemically
      or combined to local anesthetics during regional blocks. Investigators studied the
      combination of dexmedetomedine/bupivacaine versus bupivacaine alone for caudal blockage in
      pediatric patients undergoing supra - umbilical surgeries.
    

Detailed description: 
      Dexmedetomidine was combined to bupivavaine and administered via caudal route to be compared
      to caudal bupivavaine alone for analgesia following upper trunk surgery
    

Intervention name(s): Dexmedetomidine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Caudal block by dexmedetomidine and bupivavaine; Caudal block by bupivavaine alone
Other intervention name(s): Precedex; Marcaine
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vitamin D, Leptin, Vitamin D Receptor Polymorphism, and Treatment-Related Morbidity in Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will evaluate serum vitamin D (25(OH)D) and serum leptin levels at the time of
      diagnosis of ovarian, primary peritoneal, and/or fallopian tube cancer as well as vitamin D
      receptor mutation status (FokI SNP genotype). The study will evaluate the impact of vitamin D
      repletion on serum vitamin D levels, serum leptin levels, and treatment-related morbidity in
      these patients.
    

Detailed description: 
      This study will contain 2 cohorts: those with normal serum 25(OH)D and those with low serum
      25(OH)D at enrollment. The study will take place in women with ovarian, primary peritoneal,
      and fallopian tube cancer.

      Patients who have given written consent to enroll in the study will have a serum 25(OH)D
      levels, serum leptin levels, and vitamin D receptor FokI single nucleotide polymorphism
      analyzed at the time of diagnosis. Patients with vitamin D deficiency will be prescribed
      vitamin D supplementation according to current guidelines. Treatment with cholecalciferol
      will not impact cancer therapy. Participants treatment course information will be collected
      prospectively, but will not be dictated by this study. Serum 25(OH)D and leptin levels will
      be collected again at the completion of primary therapy, 6 months after the completion of
      primary therapy, and at the time of disease recurrence. If patients remain vitamin D
      deficient at any of these follow-up time points, they will be referred to an endocrinologist
      for further work-up and treatment of their vitamin D deficiency. Data collection will
      continue for up to 1 year after enrollment.
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): Vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment