bioihbjkbjnl/mcl2 huggingface dataset:
Assessing the PK and Effect on Glucose and GI Hormone Concentrations of Metformin Delayed-Release in Subjects With T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate how EFB0027 and EFB0026 behave in subjects with type 2 diabetes
      mellitus.

      In addition, this study will compare the effects of EFB0027 and EFB0026 on circulating
      concentrations of glucose and gastrointestinal hormones in subjects with type 2 diabetes
      mellitus.
    


Intervention name(s): EFB0027 (metformin delayed release); EFB0026 (metformin immediate-release)
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of enteric-coating to assess effect on PK; Active comparator
Other intervention name(s): Met DR; Met IR; metformin; Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      STUDY OBJECTIVES:

        1. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in
           decreasing pain in orthopedic trauma patients with fractures of the extremities, face,
           pelvis and/or ribs compared to patients not receiving the medication.

        2. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in
           decreasing the use of opioid analgesics among orthopedic trauma patients with fractures
           of the extremities, face, pelvis, and/or ribs compared to compared to patients not
           receiving the medication.
    

Detailed description: 
      Eligible patients were trauma patients between the ages of 18 and 75 years old with adequate
      IV access who were able to self-report and communicate pain severity and who were
      consecutively admitted to the trauma intensive care unit (ICU) or trauma step-down units with
      a fracture of the ribs, face, extremities and/or pelvis.

      Eligible patients who signed the informed consent were randomized to either IV Ibuprofen
      (Caldolor®) or Placebo via a computer-generated randomization list.

      Patients had pain measured using a Numerical Rating Scale (NRS) that ranged from 0 (no pain)
      to 10 (worst possible pain)
    

Intervention name(s): IV Ibuprofen; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): IV Caldolor; iv saline
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: , randomized, double-blind, parallel-group, placebo-controlled study. Eligible patients who signed the informed consent were randomized to either IV Ibuprofen (Caldolor®) or Placebo via a computer-generated randomization list.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Ibuprofen; Caldolor; orthopedic trauma
Clinical Evaluation of a Wearable Sleep Diagnosis Technology
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of
      sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.
    

Detailed description: 
      The clinical investigation will be performed at the Royal Free London Hospital. Physiological
      signals will be pseudo-anonymized and only viewed by the research team.

      The Study will involve patients who will have been referred for diagnosis of sleep apnoea,
      will aim to determine AcuPebble's positive and negative predictive ratios, sensitivities as
      specificities. Likelihood ratios for diagnosis of sleep apnoea. Clinical experts will
      determine patients' diagnostic information using the current diagnostic standards. AcuPebble
      will also generate diagnostic results independently and automatically. Both set of results
      will be subsequently compared and the relevant performance metrics listed above will be
      determined.

      Consecutive patients referred for sleep study will be recruited to the study. Patients that
      are willing to participate will be consented on the day of their sleep study and sent home
      with both - the Trusts usual multichannel polygraphy and the Acupebble.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea,
        consecutive 160 patients coming to the clinic.
Bioavailability, Pharmacokinetic and Mechanistic Study of Sinetrol® Xpur, a Polyphenol-rich Ingredient
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the metabolization and the bioavailability of
      bioactive compounds from Sinetrol® Xpur, a polyphenol-rich ingredient, during a 16-week long
      chronical supplementation. It will be investigated the mechanism of action in adipocyte cells
      to try to explain the beneficial effects of the ingredient on body composition, especially on
      both abdominal subcutaneous and visceral fat mass.
    


Intervention name(s): Verum900; Verum1800
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 900 mg for 16 weeks; Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 1800 mg for 16 weeks
Other intervention name(s): Sinetrol® Xpur; Sinetrol® Xpur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Topical Itraconazole in the Treatment of Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research is being done to study the molecular effects of topically applied itraconazole
      ointment on the growth of basal cell carcinomas.
    

Detailed description: 
      Basal cell carcinoma is the most common type of skin cancer in Caucasians worldwide. Although
      rarely metastatic, it can be locally destructive causing disfigurement and pain. Current
      therapies include surgical removal, local destruction, radiotherapy and others.

      Advances in understanding the molecular basis behind BCCs indicate that mutations in the
      hedgehog signaling pathway can lead to the development of many sporadically occurring basal
      cell carcinomas (BCCs). An oral drug that targets the hedgehog signaling pathway has been
      shown to be effective in treating patients with metastatic and inoperable BCCs. There is
      evidence that itraconazole, a commonly prescribed antifungal medication may also affect this
      pathway. It is not known whether itraconazole ointment applied topically can affect the
      growth of BCCs.
    

Intervention name(s): Itraconazole
Intervention type(s): Drug
Intervention description(s): Itraconazole comes in the form of capsules and liquid (oral solution). It is FDA approved for treatment of systemic Blastomycosis, Histoplasmosis and Aspergillosis in immunocompromised and non-immunocompromised patients at doses ranging from 200mg to 400mg daily. The current FDA approved dosage recommendation for treating toenail onychomycosis (nail fungus) is 200mg PO per day for 3 months. Test materials in this study will be prepared as an ointment (compounded in petrolatum jelly).
Other intervention name(s): Sporanox
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: skin cancer; basal cell carcinoma
TRK-100STP Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Condition: Chronic Renal Failure; Glomerular Disease; Nephrosclerosis
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Nephrosclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as
      the primary disease:

        -  To confirm the superiority of TRK-100STP over placebo

        -  To determine the recommended therapeutic dose in the 2 doses of TRK-100STP

        -  To assess the safety of TRK-100STP
    


Intervention name(s): TRK-100STP high dose; TRK-100STP low dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Epoprostenol; Beraprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ESRD; Chronic Renal Failure; Prostaglandin; Prostacyclin; Asian Multinational Study
Impact of Specialised Renal Care in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney
      disease (CKD) in order to determine the impact of specialised care by nephrologists compared
      to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical
      outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation
      RRT) and c) patient satisfaction.
    


Intervention name(s): specialised renal care
Intervention type(s): Behavioral
Intervention description(s): Combined management PCP - nephrologists (at least 4 nephrology visits/year). Agreement of the PCP is required for this combined management.
Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG. Requested Email or over the phone advices to PCPs will be provided by the nephrology division of HUG.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Kidney disease; Nephrologists; Primary Care; Death; Renal Replacement Therapy; Specialised renal care
NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
Condition: Subclinical Hypothyroidism; Autoimmune Thyroid Disease; Alteration of Mitochondrial Membrane
MeSH terms: Thyroid Diseases; Hypothyroidism
Study type: Observational

Summary: 
      Previously, studies have shown that children of women with thyroid autoantibodies experience
      more birth complications and poorer health in their first days. Studies have also shown later
      signs of cognitive developmental challenges (risk of attention deficit/hyperactivity
      problems) among children of mothers with autoimmune thyroid disease and/or subclinical
      hypothyroidism. In Denmark there is no formalized screening or treatment of subclinical
      thyroid disease - with or without Thyroid Peroxidase Antibodies (TPO-antibodies) - among
      pregnant women.

      The hypothesis of this study is that the offspring of women with subclinical thyroid disease
      have a mitochondria-dysfunction which leads to more complications during birth, poorer health
      and well-being in the early childhood. The investigators will test this by recruiting mothers
      by a blood sample in the third trimester of pregnancy, screen the cord blood at birth and
      later on test the children with Bayley test two times in the early childhood.
    

Detailed description: 
      Prior to a planned caesarean section, maternal blood samples are drawn and at the cesarean,
      cord blood samples are drawn, when the cord is clamped and cut. Thyrotropin, free T3, free
      T4, anti-TPO and lipids are measured on maternal as well as cord samples. Flow cytometry is
      performed to measure mitochondrial function. At age 6 months and 15 months the child´s
      development is evaluated by the Bayley-III test.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be selected among pregnant women in region Zealand that will give
        birth by cesarean section
      
Biospecimen description: 
      Blood samples from 77 women and their children´s cords will be stored for 15 years for
      supplementary analyses
    
Keywords: Mitochondria Function; TPO-antibodies; Subclinical Thyroid Disease; Thyroid Disease In Pregnancy; Children´s Development
A Study of the Safety of IMOVAX Polio™ in China
Condition: Poliomyelitis; Polio
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in
      China.

      Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™
      administered at 2, 3, and 4 months of age in population aged over 2 months old living in the
      study city China.
    

Detailed description: 
      Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months
      of age, respectively. Each participant will make a total of 7 visits. Safety will be
      monitored at each visit and up to 30 days after each vaccination.
    

Intervention name(s): IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, at 2, 3, and 4 months; Intramuscular
Other intervention name(s): IMOVAX POLIO™
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Poliomyelitis; IMOVAX POLIO™; Polio
Exposure, Relaxation, & Rescripting Therapy-Child
Condition: Post Trauma Nightmares; Traumatic Stress
Study type: Interventional

Summary: 
      The study implements a trauma-related nightmare treatment for children aged 8 to 13 years.
      Relevant outcome progress and outcome measures on symptoms, nightmare distress and duration,
      academic indicators, and sleep quality will be examined.
    

Detailed description: 
      Untreated trauma-related nightmares and sleep-related disorders are associated with chronic
      health problems, burdening both the suffering individual and the health-care system. The
      study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed
      children. It is one of the first randomized clinical trials with children, adapting an
      efficacious adult therapy to a 5-session nightmare treatment for 8-13 year-olds. Trauma
      nightmares are a mechanism in development and maintenance of secondary post-trauma
      psychopathology, medical problems, and family dysfunction. Therefore, this treatment may
      prevent long-term secondary health and behavioral problems. It provides a viable health care
      option to Montanans, lessening long-term financial, medical, and behavioral health expenses.
      Scientific models currently view PTSD treatment as primary, often leaving nightmares
      untreated. That approach does not address the pernicious impact of trauma-nightmares in
      individuals with sub-threshold PTSD or whose nightmares are a primary condition. The
      theoretical innovation of this therapy can advance the field's understanding of the
      development of trauma sequelae.
    

Intervention name(s): Exposure, Relaxation, & Rescripting Therapy-Child
Intervention type(s): Behavioral
Intervention description(s): Exposure, Relaxation, & Rescripting Therapy (ERRT) will be conducted once a week for five consecutive weeks for approximately two hours per session. Each treatment session focuses on one of the following topics/skills: psycho-education and investment in treatment, psycho-education, Progressive Muscle Relaxation, diaphragmatic breathing, child-friendly exposure to the trauma-nightmare, and rescription.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nightmare; PTSD; trauma; children; Children Age 8 to 13
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety of AMG 623 in subjects with systemic lupus
      erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period,
      and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.
    


Intervention name(s): AMG 623; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses of AMG 623 administered as subcutaneous and intravenous doses; Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Double-blind, Randomised Study of A3384 in BAM/BAD
Condition: Bile Acid Malabsorption
MeSH terms: Malabsorption Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine the efficacy and safety of A3384 administered to
      patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).
    


Intervention name(s): A3384
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Effect of immersion bathing and showering applications on comfort level and physiological
      parameters of Newborn
    

Detailed description: 
      This study aims to determine the effect of immersion bathing and showering on comfort levels
      and physiological parameters of newborns in neonatal intensive care units.

      This is a randomized controlled experimental study. The sample consisted of a total of 69
      newborns who were born at the 37th gestational week and above, were referred to the neonatal
      intensive care unit of a training and research hospital, and met the study inclusion
      criteria. Study groups were determined through randomization by throwing a dice (immersion
      bathing group:35, showering group:34). Environmental variables were kept the same for both
      groups. Physiological parameters (respiration, high heart rate, oxygen saturation, body
      temperature) and comfort levels of newborns in both groups were compared before, just after
      and 15 minutes after the bath. Their comfort levels were measured using the Newborn Comfort
      Behavior Scale (NCBS).
    

Intervention name(s): bathing
Intervention type(s): Other
Intervention description(s): immerson bathing and showering
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A power analysis was performed to determine the sample size, which was calculated to include 31 newborns for each study group under the conditions of 0.05 significance level, 0.95 confidence interval and 0.95 power. Due to possible missing data, the sample size was increased by 10%, and the study was completed with a total of 69 newborns, including 35 in the immersion bathing group and 34 in the showering group.In this study, randomization by throwing a dice was used to allocate newborns into study groups. A dice was rolled for each newborn who met the study inclusion criteria, whereby the newborn was assigned to the immersion bathing group when an even number was observed, and to the showering group when an odd number was observed.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Immersion bathing; showering; comfort; physiological parameters
A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors
Condition: Advanced Malignancy; Advanced Solid Tumors; Neoplasm; Metastasis
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated
      dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage
      solid tumors.
    

Detailed description: 
      This is a Phase 1 dose escalation study to assess the safety and tolerability of
      subcutaneously administered SDX-7320 in patients with advanced refractory or late-stage solid
      tumors.

      Once the MTD has been determined up to 12 patients will be treated at this dose level, to
      further characterize treatment emergent adverse events (TEAEs).
    

Intervention name(s): SDX-7320
Intervention type(s): Drug
Intervention description(s): SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Oncology; Solid Tumors; Phase 1; SDX-7320; SynDevRx; MetAP2; Breast; Post menopausal; Colorectal; Pancreatic; Ovarian; Endometrial; Esophageal; Lung; Renal; Prostate; Liver
Effects of Hypothermia on Delayed Neurocognitive Recovery (DNR): an Observational Trial Among Patients Undergoing Cardiac-Surgery
Condition: Cognitive Dysfunction; Emergence Delirium; Hypothermia
MeSH terms: Emergence Delirium; Hypothermia; Cognitive Dysfunction
Study type: Observational

Summary: 
      Post-operative cognitive dysfunction is a common disease in patient undergoing general
      anaesthesia, especially in older patients. No correlations have been yet studied between
      intraoperative hypothermia and incidence of Delayed Neurocognitive Recovery. Investigators
      are going to estimate the Relative Risk of Hypothermia and emergence of Post-operative
      cognitive dysfunction in cardiac-surgery patients.
    


Intervention name(s): Hypothermia during Extracorporeal Circulation
Intervention type(s): Procedure
Intervention description(s): Normothermia during Extracorporeal Circulation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective Observational Case-Control
Maintenance of Vitamin D Level by UVB Radiation
Condition: Vitamin D Status
Study type: Interventional

Summary: 
      The purpose of the study is to determine the frequency of UVB radiations necessary to
      maintain the Vitamin D level during winter time.
    

Detailed description: 
      The work is addressing vitamin D production after UVB exposure and explore how much UVB
      radiation which is necessary to maintain a sufficient vitamin D level during the winter
      period in Denmark. 4 different UVB exposure times and 2 different UVB doses to 2 different
      body surface areas.
    

Intervention name(s): Broadband UVB; Broadband UVB; Broadband UVB; Broadband UVB; Control group
Intervention type(s): Radiation; Radiation; Radiation; Radiation; Other
Intervention description(s): UVB dose: 1 SED every week; UVB dose: 4 SED every second week; UVB dose: 1 SED every second week; UVB dose: 1 SED every month; No intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Vitamin D; UVB; Frequency; Body surface area; Dose-Response