bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare
      the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in
      Healthy Male Subjects
    

Detailed description: 
      This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I
      study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed
      Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a
      single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for
      253 days.
    

Intervention name(s): CT-P41; US-licensed Prolia
Intervention type(s): Biological; Biological
Intervention description(s): a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS); a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm, Parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: CT-P41
A Phase I Study of 8-week Continuous Treatment With Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)
      analogue that created on the basis of the Exenatide and modified by polyethylene glycol
      (PEG).

      This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.
    


Intervention name(s): PEX168
Intervention type(s): Drug
Intervention description(s): A injection administered subcutaneously
Other intervention name(s): Polyethylene Glycol Loxenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PEX168, diabetes, phase I
Cochlear Implant With Anti-Inflammatory Agent
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      In an effort to further preserve residual acoustic hearing after cochlear implantation, it
      may be beneficial to incorporate anti-inflammatory agents into the electrode array for
      passive elution over a time course after implantation. This study aims to assess the ease and
      effectiveness of such an electrode design, and to assess the preliminary safety of use of
      such a device in the post-operative period. This study is a first-time-in-human study of the
      investigational device.

      In the first instance, the aim of the current investigation is to obtain first experience in
      use of a Combined Device in the adult clinical population, and to assess tools and techniques
      that may be considered in future clinical studies of similar devices.
    


Intervention name(s): Contour Advance electrode with controlled dose of dexamethasone base; Contour Advance electrode
Intervention type(s): Device; Device
Intervention description(s): The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.; Standard Contour Advance electrode
Intervention MeSH terms: Dexamethasone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cochlear implants; Dexamethasone; combined device
Articular Sonography: Healthy Subjects Versus Rheumatoid Arthritis Patients
Condition: Disorders of Synovium, Multiple Sites; Disorders of Subchondral Bone, Multiple Sites; Disorders of Cartilage, Hand Joints; Arthritis, Rheumatoid; Healthy People
MeSH terms: Arthritis; Arthritis, Rheumatoid; Cartilage Diseases
Study type: Observational

Summary: 
      The purpose of this study is to establish the normality of sonographic synovial measures in
      joints more affected in rheumatoid arthritis patients and establish, in those joints, a
      sonographic value of synovium predictive of rheumatoid arthritis.
    

Detailed description: 
      Rheumatoid arthritis (RA) is a chronic inflammatory, systemic and auto-imune disorder
      affecting primarily the joints. In RA, inflammatory synovium causes destruction of cartilage,
      erosion of the adjacent bone and ultimately loss of function of the affected joint. Newer
      imaging techniques, such as ultrasound (US), have shown promise in evaluation of RA. Many US
      scoring system have been used to classify and quantify the synovium, effusion, erosion and
      cartilage for assessing and monitoring AR. However, its use is considered problematical
      because there are very few data on normal joints and, at this point, there is no clear
      definition of excess amount of synovium in normal people.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        terciary care clinic (rheumatoid arthritis patients) community sample (healthy people)
      
Biospecimen description: 
      serum
Clinical Investigation to Assess Safety and Performance of Dermal Filler of Hyaluronic Acid
Condition: Skin Folds; Wrinkle
Study type: Interventional

Summary: 
      The objective of this clinical investigation is to assess the safety and performance of
      dermal filler of hyaluronic acid to provide firmness and counteract sagging for the
      correction of deep wrinkles and imperfections in the lower two thirds of the face at 2 months
      post-treatment.
    

Detailed description: 
      The primary endpoint is to assess the safety of dermal filler of hyaluronic acid by
      occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs)
      through 2 months post-treatment. Furthermore, the performance of the device will also be
      assessed as the aesthetical outcome measured by the Global Aesthetic Improvement Scale
      (GAIS), Wrinkle Severity Rating Scale (WSRS), and 2D images of subjects' faces at 2 months
      post-treatment.The secondary endpoints are the following:

      Secondary Safety Endpoint

        -  To assess the safety of dermal filler of hyaluronic acid by occurrence of
           Treatment-related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 6-,
           9-, and 12-months post-treatment.

        -  To assess the safety of dermal filler of hyaluronic acid by occurrence of all AEs
           through 2-, 6-, 9-, and 12-months post-treatment.

      Secondary Performance Endpoint

        -  To evaluate the performance of dermal filler of hyaluronic acid at 6-, 9- and 12-months
           post-treatment, assessed as the aesthetical outcome measured by the Global Aesthetic
           Improvement Scale (GAIS)

        -  Assessment of dermal filler of hyaluronic acid performance of mesofiller® Lift at 6-, 9-
           and 12-months post-treatment using the Wrinkle Severity Rating Scale (WSRS)

        -  Assessment of dermal filler of hyaluronic acid performance of dermal filler of
           hyaluronic acid at 6-, 9- and 12-months post-treatment using 2D images of subjects'
           faces

        -  Assessment of dermal filler of hyaluronic acid performance of dermal filler of
           hyaluronic acidt at 6-, 9- and 12-months post-treatment through satisfaction surveys
           related to the subject's appearance.
    

Intervention name(s): LIFT001
Intervention type(s): Device
Intervention description(s): The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face.
The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Green Banana Peel Extract for Melasma Treatment
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To develop and evaluate a pharmaceutical formula based on green banana peel extract for the
      treatment of melasma.
    

Detailed description: 
      Objective: to develop and evaluate a pharmaceutical formula based on green banana peel
      extract for the treatment of melasma. Methods: it will be a clinical, interventional,
      longitudinal study, random sampling, Sample will have 60 patients divided into two groups. In
      the Control Group, SPF 30 sunscreen plus pharmaceutical formulation without green banana peel
      extract will be used, and in the Study Group, in addition to SPF 30 sunscreen, pharmaceutical
      formulation containing green banana peel extract will be used. Patients will undergo
      treatment for 90 days, evaluated every 30 days through clinical evaluation and MELASQol.
    

Intervention name(s): SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract; SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
Intervention type(s): Biological; Biological
Intervention description(s): Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract; Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Melasma; banana; skin; sunscreen
Electrostimulation, Skeletal Muscle Function, and Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This study was designed to test the following hypothesis:

      The benefit of electrostimulation training will be greater than sham stimulation training in
      term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of
      ventilation during exercise and quality of life in COPD patients
    

Detailed description: 
      Background: Because it has little impact on ventilatory requirements and dyspnea, muscle
      electrostimulation appears as a promising alternative to general physical reconditioning in
      advanced COPD and its feasibility has been confirmed in this population. However, the
      physiological mechanisms underlying the proposed benefits of electrostimulation training have
      not been explored.

      Objective: To evaluate in COPD patients the physiological mechanisms of changes in exercise
      tolerance after electrostimulation training.

      Method: We propose to conduct a controlled, randomized and double blind clinical trial
      comparing the efficacy of muscle electrostimulation training of the lower limbs to sham
      training in 24 patients with COPD. Patients are included in either 6 weeks of
      electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation.
      Before and after training, patients perform endurance shuttle walking test, muscle function
      testing, muscle biopsy, blood sampling and health-related quality of life questionnaire.

      Planning analysis: The main outcome will be change in the strength of the quadriceps over the
      6-week electrostimulation program. The other end-points will be mid-thigh and calf muscle
      cross-sectional area, lower limb muscle endurance, ventilation, dyspnea, leg fatigue,
      operational lung volumes at iso-time and walking time during an endurance shuttle walk,
      muscle hypertrophying/atrophying pathways and muscle aerobic capacity. For each group, pre-
      and post-training comparisons will be made using a repeated measures design. The magnitude of
      the pre- and post-training changes will also compared between both groups with a two-way
      ANOVA (group, training effect) with repeated measures on the second factor (training effect).
      A p value < 0.05 will be considered statistically significant.
    

Intervention name(s): Electrostimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): 50Hz; 0.4 ms; 30 min; 5 times / week; 30 min; 5 times / week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease (COPD); Electrostimulation; Muscle function; Exercise ventilation; Anabolism/catabolism pathway
Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the effect of food on the
      pharmacokinetics of the oral tablet formulation of BI 1015550 by investigating the relative
      bioavailability of TF1 under fed and fasted conditions.

      The assessment of safety and tolerability will be an additional objective of this part.
    


Intervention name(s): BI 1015550; BI 1015550
Intervention type(s): Drug; Drug
Intervention description(s): Fed state; Fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quinoa Effects on Glycemic Index and Satiety
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to to assess the glycemic index and the satiating properties of
      different Quinoa varieties, using a Visual Analogue Scale in a sample of healthy overweight
      subjects.
    

Detailed description: 
      Pilot study to evaluate the glycemic index, and the satiating effect using different Quinoa
      varieties in a group of healthy overweight subjects.
    

Intervention name(s): Quinoa variety 1; Quinoa variety 2; Quinoa variety 3; Quinoa variety 4; Anhydrous Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): On the intervention day, the volunteers will consume the Quinoa Variety 1.
Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.; On the intervention day, the volunteers will consume the Quinoa Variety 2.
Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.; On the intervention day, the volunteers will consume the Quinoa Variety 3.
Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.; On the intervention day, the volunteers will consume the Quinoa Variety 4.
Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.; On the intervention day, the volunteers will consume the control product.
Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Quinoa; Satiety; Visual analogue scale; Cross-over studies
Quadruple and Phytomedicine-based Therapies in H. Pylori Infection
Condition: Helicobacter Pylori [H. Pylori] as the Cause of Diseases
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Helicobacter pylori is strongly associated to the development of gastrointestinal disorders.
      Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted
      in significant eradication failure. Clinical trial was conducted to see the efficacy of
      current quadruple and phytomedicine-based therapies for the eradication of H. pylori
      infection and relief in its associated symptoms in Pakistan.
    


Intervention name(s): Quadruple Allopathic therapy; Pylorex plus
Intervention type(s): Drug; Drug
Other intervention name(s): Omeprazol; Amoxicillin; Metronodazole; TRITEC (ranitidine bismuth citrate)
Intervention MeSH terms: Amoxicillin; Bismuth tripotassium dicitrate; Bismuth; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Patient-centered Communication About Healthy Weight in Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Comorbidities in breast cancer survival account for 49% of overall survival difference
      between black and white women. Many obesity-related comorbidities disproportionately affect
      black women, therefore pointing to a need to address obesity related comorbidities in
      survival disparities in early breast cancer patients. This study tinvestigates how messages
      and messaging about healthy weight can be tailored for racially diverse breast cancer
      survivors with obesity in order to ensure that clinic-based communications between patients
      and their oncology provider are patient-centered and culturally sensitive.
    

Detailed description: 
      The overall goal of this research is to collect essential input for the future development of
      a quality improvement intervention to foster "Patient-Center Communication about Healthy
      Weigh in clinical practice

      Primary Objective:

        1. Understand patient-centered perspectives on health weight communication with oncology
           clinicians by conducting focus groups

           Secondary Objective

        2. Understand oncology clinician perspectives on patient center communications for healthy
           weight interactions through semi-structured interviews.
    

Intervention name(s): Focus Group
Intervention type(s): Other
Intervention description(s): Breast cancer patients and oncology clinicians will participate in separate focus groups discussing patient-centered communication about healthy weight.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Breast Cancer patients and Breast oncology providers will be eligible for this study
Exploratory Study Using a New Head-only PET Scanner
Condition: Brain Diseases
MeSH terms: Brain Diseases
Study type: Interventional

Summary: 
      The "BPET prototype" is a small aperture PET scanner. The BPET prototype will be used with
      patients, which have just finished their regularly scheduled PET examination on a clinical
      whole body PET system. The radioactive tracer used for this procedure will still be active.
      This remaining acitivity will be used for an image acquisition with the BPET prototype
      without the need for an additional radioactive tracer dose.

      The control intervention is be a brain PET scan as part of standard clinical routine. It will
      be done immediately before the scan on the BPET prototype.
    


Intervention name(s): BPET Prototype Scan
Intervention type(s): Device
Intervention description(s): Scan on the BPET Prototype PET system and qualitative comparison with a PET image acquired on a conventional clinical PET system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome
Condition: CRPS
Study type: Interventional
Phase: Phase 4

Summary: 
      A ten week open label study intervention to evaluate the outcome for a psychological
      intervention combined with physiotherapy and medication with memantine-morphine in 10 CRPS
      patients.
    

Detailed description: 
      Ten CRPS I patients attended an intervention for 10 weeks. First, the medication was started
      with morphine 10mg adding gradually to 30 mg per day. Then, in addition to morphine,
      memantine 5 mg was started adding the dose gradually up to 40 mg per day if tolerated.
      Physiotherapy and psychological intervention were mostly carried out in a weekly group
      gathering with home exercises that were recorded to a diary. Psychological and physiotherapy
      interventions lasted for eight weeks. A neurological examination was done before and after
      the intervention as well as a separate physiotherapist examination of the hands. Patients
      filled out questionnaires of mood, quality of life, pain, and CRPS descriptions before and
      after the intervention.
    

Intervention name(s): Morphine, memantine; Psychological intervention; Physiotherapy intervention
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): Morphine up to 30 mg per day orally and memantine up to 40 mg per day orally if tolerated for 10 weeks.; To help patients shift perspective from pain and CRPS-symptoms, to increase body awareness, to create vivid imagenary, to increase the use of a CRPS hand with mindfulness exposure exercises, to increase flexibility in behavioral repertoire, to explore the fusion of emotions, automatic cognitions and learned responses and to help patients to integrate new skills in their lives.; Graded motor imagenary with group and individual weekly sessions with daily practices at home.
Other intervention name(s): Depolan (morphine), Ebixa (memantine)
Intervention MeSH terms: Morphine; Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CRPS; intervention; multimodal