bioihbjkbjnl/mcl2 huggingface dataset:
Positron Emission Tomography (PET) Imaging of Pancreatic Beta-Cell Mass in Healthy and Type 1 Diabetic Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Pancreatic Islet beta-cells are responsible for synthesizing and secreting appropriate
      amounts of insulin to regulate blood glucose levels. One factor in the development of
      diabetes is the loss of beta-cells. Developing treatments to prevent or restore islet
      beta-cell mass (BCM) in diabetic patients is hampered by a lack of methods for the
      non-invasive imaging of these cells. This study is designed to evaluate a radiolabeled
      compound that binds to the pancreatic islet. The investigators will test the ability of one
      promising imaging compound, 18F-9-fluoropropyl-(+)-dihydrotetrabenazine (18F-FP-DTBZ), to
      measure the amount of pancreatic islet beta-cells in patients with long-standing type-1
      diabetes and in age-weight-matched healthy control subjects.
    


Intervention name(s): 18F-FP-DTBZ (18F-AV-133); Arginine-hydrochloride
Intervention type(s): Drug; Biological
Intervention description(s): The subjects will receive a single IV bolus of approximately 10 mCi 18F-AV-133.(Injection will contain no more than 25 µg of non-radiolabeled 19F-AV-133).; A bolus injection of 5g of 10% arginine-hydrochloride will be given over a period of 1 minute.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Biospecimen description: 
      Blood plasma
    
Keywords: diabetes; islet; pancreas; beta cell mass; PET imaging; FPDTBZ; arginine stimulus test
Bruxism and Severity of Temporomandibular Dsyfunction
Condition: Temporomandibular Dysfunction
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Bruxism
Study type: Observational

Summary: 
      The aim of the study was to investigate the effect of bruxism on Temporomanbular joint
      functionality and dysfunction severity in individuals with Temporomandibular Dysfunction
      (TMD).
    

Detailed description: 
      The study included 91 individuals aged 20-55 years with TMD. Participants who volunteered to
      participate in the study signed the Informed Consent Form and completed the Descriptive Data
      Form including demographic characteristics. The presence of bruxism in individuals with TMD
      was questioned and the maximum mouth opening measurement was recorded. TMD severity was
      assessed by Fonseca's Anamnestic Questionnaire (FAQ), pain severity was assessed by Numeric
      Pain Scale (NPS), and masticatory and TMJ functioning was assessed by JAW Functional
      Limitation Scale-20 (JFLS-20). The evaluations of the participants were performed only once.
    

Intervention name(s): Fonseca's Anamnestic Questionnaire; Numeric Pain Scale; Jaw Functionality Limitation Scale-20
Intervention type(s): Other; Other; Other
Intervention description(s): The questionnaire includes 10 questions about joint, head and neck pain, pain during masticatory activity, parafunctional habits, decreased joint motion, impaired occlusion and emotional stress.; It is a simple, reliable and short-term method that is frequently used to measure pain intensity in the clinic.; It includes a total of 20 items, with "0" indicating no limitation and "10" indicating severe limitation in each item, about the function of the TMJ during different activities, difficulty in chewing and jaw limitation.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        diagnosed with TMD
      
Keywords: temporomandibular dysfunction; bruxism; chewing functionality
AZD8683 Single Ascending Dose Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male
      subjects.
    


Intervention name(s): AZD8683; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD8683 or placebo. Starting dose 1 ug (lung deposited dose) with up to 8 dose escalation not exceeding AstraZeneca pre-defined exposure limits.; Solution for nebulisation, inhaled
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: safety; tolerability; healthy; inhalation
The Effect of Enzyme Replacement Therapy in Mucopolysaccharidosis
Condition: Mucopolysaccharidosis
MeSH terms: Mucopolysaccharidoses
Study type: Interventional

Summary: 
      Mucopolysaccharidosis (MPS) causes chronic, progressive systemic disorders due to enzyme
      deficiency. Musculoskeletal manifestations of MPS include bone and vertebral deformities,
      restricted joint function and ROM (range of motion), rib cage abnormalities, short stature
      and hip dysplasia as well as flexion contracture in the knee and interphalangeal joints and
      joint laxity. Currently, there is no treatment that cures the symptoms of MPS. However, there
      are some forms of treatment that can delay the progression of the disease. Enzyme replacement
      therapy is one such treatment and used for the management of some subtypes of MPS disease.
      Enzyme replacement therapy (ERT) is based on the concept of replacing the missing enzyme in
      the circulation to prevent the build-up of glycosaminoglycan (GAG) in the tissues. Very few
      studies in the literature have examined the impact of MPS in the lives of children affected
      by this disease. Studies investigating functional capacity, independence and quality of life
      in children receiving or not receiving enzyme replacement therapy have not provided a clear
      picture of the problems faced by these children. Secondly, psychological problems experienced
      by caregivers of children with MPS have not been studied specifically in former studies.
      Therefore, the aim of this study was to examine the impact of ERT on aerobic capacity,
      functional independence and quality of life in children with MPS and to determine the anxiety
      and depression levels of their caregivers.
    


Intervention name(s): Enzyme Replacement Agent
Intervention type(s): Drug
Intervention description(s): Enzyme replacement therapy is one such treatment and used for the management of some subtypes of MPS disease. Enzyme replacement therapy (ERT) is based on the concept of replacing the missing enzyme in the circulation to prevent the build-up of glycosaminoglycan (GAG) in the tissues
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Mucopolysaccharidosis; Aerobic capacity; Quality of Life; Functional independence
Following the Use of Gel Prosethetics in Breast Reconstruction
Condition: Breast Cancer
Study type: Observational

Summary: 
      Following placement of silicone breast prosthetics for reconstruction
    

Detailed description: 
      Patients undergoing breast reconstruction will be followed for outcomes after placement of
      silicone prostheses
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women over 18 undergoing breast reconstruction
      
Keywords: Reconstruction, Silicone prostheses
Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries
Condition: Congenital Bleeding Disorder; Haemophilia A; Haemophilia A With Inhibitors; Haemophilia B; Haemophilia B With Inhibitors
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Observational

Summary: 
      This study is conducted in Africa and Asia. The aim of this study is to evaluate in the
      participating countries the orthopaedic status and the degree of arthropathy of severe
      haemophilia patients in general.
    


Intervention name(s): No treatment given
Intervention type(s): Other
Intervention description(s): Subject will only fill out a questionaire
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male patients at least 6 years old with severe congenital haemophilia A or B (FVIII or FIX
        activities below 1% or level below 1U dL^-1) without inhibitor or with inhibitors against
        FVIII or FIX
Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-I
Condition: COVID-19; Symptoms and Signs; COVID-19 Pandemic; Coronavirus Disease 2019; Coronavirus Infections
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this clinical trial is to examine the effectiveness of intranasal-administered
      Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for
      COVID-19. The main questions it aims to answer are:

        -  To assess the efficacy of nasal spray with Chlorpheniramine (1.0%) for improving
           clinical recovery in COVID-19 patients.

        -  To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine
           (1%) as an adjunct to the standard of care in reducing hospitalizations and improving
           clinical recovery in adult patients with mild COVID-19.
    

Detailed description: 
      The main goal of the present study is to examine the effectiveness of CPM intranasal spray as
      part of early treatment for COVID-19. The study will test the hypothesis that intranasal CPM
      would accelerate clinical recovery, particularly the alleviation of sensory symptoms and URS,
      in patients with COVID-19.
    

Intervention name(s): Chlorpheniramine Maleate 1% Nasal Spray; Placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Chlorpheniramine Maleate 1% Nasal Spray; Placebo nasal spray
Other intervention name(s): ClorNasal; ClorNovir
Intervention MeSH terms: Chlorpheniramine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multi-center, Phase 2/3 Study to evaluate the efficacy and safety of nasally administered CPM in subjects with symptomatic COVID-19 with a positive PCR test.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor
Condition: Acromegaly Due to Pituitary Adenoma
MeSH terms: Adenoma; Pituitary Neoplasms; Growth Hormone-Secreting Pituitary Adenoma; Acromegaly; Pituitary Diseases
Study type: Interventional

Summary: 
      Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma
    

Detailed description: 
      Aim: To determine the importance of the GIP system in patients with acromegaly who has
      paradoxical growth hormone secretion during an oral glucose tolerance test (OGTT) using a GIP
      antagonist (GIP-A).

      Thirty participants (age 18-75 years) with normal kidney and liver parameters and hemoglobin
      levels will be included in a placebo-controlled cross-over study. The study consists of two
      study days with concomitant infusions of A) GIP-A or B) saline (placebo).

      A paradoxical growth hormone secretion to an OGTT is here defined as an increase in plasma
      growth hormone levels of ≥30% from baseline based on a mean value of the definitions in the
      literature.

      Regazzo et al. (2017) European Journal of Endocrinology 176, 543-553 Mukai et al. (2018) The
      Journal of Clinical Endocrinology and Metabolism 104(5), 1637-1644 Hage et al. (2019) The
      Journal of Clinical Endocrinology and Metabolism 104(5), 1777-1787 Scaroni et al. (2019) J
      Clin Endocrinol Metab 104(3), 856-862
    

Intervention name(s): GIP-A; Placebo
Intervention type(s): Other; Other
Intervention description(s): GIP-A; Placebo
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the safety and efficacy of BLI4700 bowel
      preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations
      prior to colonoscopy in adult patients.
    


Intervention name(s): BLI4700; Magnesium bowel preparation
Intervention type(s): Drug; Drug
Intervention description(s): Oral bowel preparation; Oral bowel preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
CoolSculpting® Elite for Non-Invasive Fat Reduction
Condition: Non-invasive Fat Reduction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to generate data that conveys participant's experiences such as their
      satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for
      non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to
      optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing
      this, the study will provide insights for doctors to better inform participants about the
      expected outcomes when one or more body areas are considered for treatment.
    


Intervention name(s): CoolSculpting® Elite System with CoolSculpting® Elite applicators
Intervention type(s): Device
Intervention description(s): A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fat Reduction Non-invasive
Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
Condition: Hepatocellular Carcinoma Non-resectable; Portal Vein Tumor Thrombosis; Stereotactic Body Radiotherapy
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Thrombosis
Study type: Interventional

Summary: 
      Macrovascular invasion (MVI) is common in HCC, Portal vein tumor thrombus (PVTT) is the most
      common form of MVI in HCC, with an incidence ranging from 44 to 62.2%. About 10% to 60% of
      HCC patients have PVTT at the time of diagnosis. the prognosis for those with PVTT remains
      poor, as their median survival is only 2-4 months via supportive care. There is currently no
      widely-accepted consensus for the management of HCC with PVTT. According to some guidelines
      in Europe and America, HCC with PVTT is regarded as Stage C per Barcelona Clinic Liver Cancer
      (BCLC) Staging system, and sorafenib alone is recommended as the treatment of choice. This
      study is to analyze the safety and efficacy of radiotherapy of hepatocellular carcinoma
      patients with portal vein tumor thrombosis.
    


Intervention name(s): stereotactic body raiotherapy
Intervention type(s): Radiation
Intervention description(s): stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
Intervention model: Single Group Assignment
Intervention model description: stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma; Portal vein tumor thrombosis; Stereotactic body radiotherapy
Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to assess the safety and pharmacokinetics of KP-1461
      given every 12 hours for 14 days when administered to HIV+ patients who have failed multiple
      highly active antiretroviral therapy (HAART) regimens. Patients currently on HAART will be
      required to discontinue all HAART medications for up to 6 weeks after screening eligibility
      has been determined.
    

Detailed description: 
      KP-1461 is a carbamate prodrug of the active nucleoside, KP-1212. KP-1212 is incorporated
      into the proviral DNA. After multiple rounds of replication, KP-1212 increases the high
      inherent mutation rate of HIV beyond the threshold of viability, a process called "viral
      decay acceleration". KP-1212 is unique from conventional nucleoside reverse transcriptase
      inhibitors in that it inserts mutations randomly across the entire 10,000 nucleotide HIV
      genome and does not exert selective pressure by targeting a specific viral or cellular
      process, thus potentially avoiding drug resistance.
    

Intervention name(s): KP-1461
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV; Treatment Experienced
Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults
Condition: Streptococcus Pneumoniae
MeSH terms: Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain
      pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged
      50-80 years, and subsequent antibody persistence and response to boosting.
    


Intervention name(s): pneumococcal conjugate vaccine
Intervention type(s): Biological
Intervention description(s): Pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II
      clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of
      clinical efficacy are promising.

      The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in
      subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to
      anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune
      responses and the safety elicited by TNF-K will also be evaluated.
    


Intervention name(s): TNF Kinoid; WFI
Intervention type(s): Biological; Biological
Intervention description(s): TNF Kinoid; WFI
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Cardiovascular disease is the second leading cause of death in Denmark, and ischemic heart
      disease accounts for the bulk of it. The purpose of this study is to clarify whether a
      mechanical method of remote ischemic conditioning in the form of short-term obstruction of
      the blood supply to the arm, can improve the heart's blood supply in patients with ischemic
      heart disease. This will be attempted through experiments on patients with ischemic heart
      disease and experimental animal studies with simulated cardiovascular disease.

      This study will help to clarify whether remote ischemic preconditioning can be used to treat
      patients with ischemic heart disease.
    


Intervention name(s): Remote Ischemic Conditioning
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: remote ischemic conditioning; ischemic heart disease
The Relationship Between CD138 Count of Endometrium and Reproductive Outcome
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      It's well known, endometritis affects reproductive outcomes. Though CD138 counting as one new
      diagnosis measure for endometritis, diagnostic criterion of this measure isn't consistent.
      And if the CD138 counting is correlation to the outcome of reproductive is not clear.

      Firstly, This study aims to explore the relationship between endometrial CD138 count and
      pregnancy outcome following frozen embryo transfer in natural cycles. Secondly , the
      investigators want to find a cut-off value which is related to reproduction outcome.
    


Intervention name(s): Endometrial biopsies
Intervention type(s): Procedure
Intervention description(s): Endometrial biopsy was performed precisely 7 days after LH surge (LH+7)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can
      affect insulin secretion after meals. The hypothesis of this study is the Disposition Index
      is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by
      glucagon-like peptide-1 (GLP-1) receptor blockade.
    


Intervention name(s): Exendin 9, 39; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Exendin 9,39 is a competitive antagonist of endogenous GLP-1.; A saline infusion will be given to match the study drug infusion.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Gastric Bypass; bariatric surgery; carbohydrate metabolism