bioihbjkbjnl/mcl2 huggingface dataset:
Investigation Of Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Doses Of Vupanorsen In Japanese Healthy Adult Participants With Elevated Triglycerides
Condition: Healthy
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double blind, third party open (i.e., participant blind,
      investigator blind and sponsor open), placebo controlled, single ascending dose study to
      investigate the safety, tolerability, pharmacokinetic and pharmacodynamics of vupanorsen in
      Japanese healthy adult participants with elevated triglycerides.
    


Intervention name(s): Vupanorsen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg subcutaneous injection; Subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Triglycerides
A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, randomized, single dose, four period, balanced crossover study
      to assess in eligible healthy male or female subjects.
    

Detailed description: 
      This study is an open-label, randomized, single dose, four period, balanced crossover study
      to assess in eligible healthy male or female subjects:

        -  The relative bioavailability of the wet milled GSK1322322 tablet formulation with and
           without food compared to an oral mesylate salt solution.

        -  The effect of body weight on the pharmacokinetics of GSK1322322 when given either orally
           or IV.

        -  The absolute bioavailability of the wet milled tablet and the oral mesylate salt
           solution compared to the IV formulation.
    

Intervention name(s): GSK1322322 (mesylate salt) Powder for Injection; GSK1322322 (freebase) tablets; GSK1322322 (mesylate salt) Powder for Oral Solution; GSK1322322 (freebase) tablets FED
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1500 mg (mesylate salt) as free base, dissolved in sterile water for injection to a concentration of 100 mg/mL free base equivalent and sterilized via filtration. 15 mL of solution, equivalent to 1500 mg GSK 1322322, is the diluted into 0.9% Sodium Chloride Injection prior to infusion; 500 mg tablets for a 1500 mg total single dose (3 tablets). Taken with 240 mL of water; 1500 mg as a free base, dissolved in purified water to a concentration of 100 mg/mL free base equivalent. 15 mL of solution, equivalent to1500 mg GSK1322322 is administered orally with 225 mL of water; Drug 500 mg tablets for a 1500 mg total single dose (3 tablets) (FED moderate fat meal) Taken with 240 mL of water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK1322322, relative bioavailability, healthy subjects, open label, food effect, weight effect
Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
Condition: Primary Hyperparathyroidism
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Primary
Study type: Observational

Summary: 
      The present study is a randomized, controlled trial that investigates the effects of
      parathyroidectomy or medical observation in mild asymptomatic pHPT on morbidity and quality
      of life (QoL).
    

Detailed description: 
      The patients are included and randomized by block randomization to medical observation or
      parathyroidectomy by an experienced parathyroid surgeon.

      The patients will be followed up for 10 years.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
      
Keywords: QoL; Osteodensitometry; Arterial pressure; PTH
Reducing Isolation and Feeling of Loneliness During Critical Illness
Condition: Critical Illness; Social Isolation; Anxiety; Depression; Post Intensive Care Unit Syndrome
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The trial is a pilot-randomized trial testing feasibility and limited-efficacy of delivering
      social engagement using technologic strategies to reduce periods of social isolation.
    

Detailed description: 
      Patients with critical illnesses such as sepsis and acute respiratory failure (ARF) who
      require an ICU stay are at high risk of developing anxiety, depression, post-traumatic stress
      disorder, and cognitive deficits. Risk factors for emotional and cognitive impairments after
      ICU include underlying systematic illness, as well as consequences of life-saving therapies.
      In brief, patients are frequently restricted and even restrained to the bed, provided high
      dosages of sedatives, develop delirium, and are isolated from family and staff for extended
      periods of time. Moreover, the ICU environment including lights, noises, and the social
      isolation have a serious negative impact on cognitive function and emotional health status.
      Prospective data from the ICU demonstrate that critically ill patients in ICU spend
      two-thirds of their time completely alone.

      Patients who have survived describe their ICU experience as a traumatic event similar to war,
      and testimonials for the ICU Recovery clinic frequently resemble: "I felt like I was being
      held captive in an unknown basement." Periods of social isolation in daily life as well as in
      the hospital have a significant negative impact on patient-centered outcomes including
      increased risk of disability, frailty, and mortality. Our study will examine the feasibility
      of delivering social engagement interventions using technology such as virtual reality (VR)
      to reduce feelings of isolation and loneliness. There have been a handful of projects to
      reduce anxiety and depression using a myriad of delivery techniques including journaling in a
      diary, emotional-behavioral therapy, face-to-face social engagement and family engagement
      using face-time and VR. These projects, however, have not examined the impact of social
      engagement on reducing periods of isolation and loneliness. We hypothesize that social
      engagement delivered using VR technologies will reduce periods of social isolation and thus
      improve anxiety, depression, and post-traumatic stress disorder (PTSD).
    

Intervention name(s): Social Engagement
Intervention type(s): Behavioral
Intervention description(s): 30-45 minutes of social engagement provided to patients in ICU. Social engagement strategies including meaningful conversation, cognitive stimulation, and emotional support
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: pilot-randomized trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: critical illness; Post Intensive Care Unit Syndrome; social isolation
Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients
Condition: Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®)
      (95 - 190 mg) on heart rate in the Stable angina patients.
    


Intervention name(s): Succinate Metoprolol (Betaloc ZOK®); Succinate Metoprolol (Betaloc ZOK®)
Intervention type(s): Drug; Drug
Intervention description(s): treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks; Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: angina pectoris; chest pain; heart rate
Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?
Condition: Pain; Secondary Hyperalgesia; Healthy Volunteers; Magnetic Resonance Imaging
MeSH terms: Neoplasm Metastasis; Hyperalgesia
Study type: Interventional

Summary: 
      The purpose of this prospective study is to investigate the degree of association between the
      volume of important pain-relevant structures in the brain and the size of the areas of
      secondary hyperalgesia.
    

Detailed description: 
      The healthy study participants will be included from the cohort of a previous study
      (NCT02527395) where areas of secondary hyperalgesia, heat pain detection thresholds, pain
      during 1 min. thermal stimulation and test results from the Pain Catastrophizing Scale and
      the Hospital Anxiety and Depression Score will be retrieved. The study consists of 1 study
      day. The study day will be conducted at a maximum of 2 months and a minimum of 2 weeks after
      the completion of the previous study (NCT02527395).The results of the previous study
      (NCT02527395) will be blinded until all participants have completed the study day.

      All study participants will complete a MRI-scan of the brain.

      The MRI scans will be performed with a Siemens MAGNETOM Verio 3 tesla, with b17 software, and
      a 32-channel head coil. The MRI-scan sequence is as follows:

        -  3D Localiser

        -  3D T1 weighted iso

        -  AX Diffusion tensor imaging

        -  AX Epi resting state fMRI

        -  AX Gre field map

        -  AX Epi ASL

        -  AX T2-weighted blade

        -  AX T2-weighted flair

        -  AX T2-weighted* Gre

      Total MRI-scan time is estimated to approximately 40 minutes.
    

Intervention name(s): MRI-scan
Intervention type(s): Device
Intervention description(s): Magnetic resonance imaging scan of the brain
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pain; Secondary hyperalgesia; Healthy volunteers; Magnetic Resonance Imaging
Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate the cognitive changes after administration of
      tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in
      patients with mild to moderate Alzheimer's disease.

      After the 26 week core treatment period, the patients may continue in the study under blinded
      conditions for an optional extension period up to a maximum of 39 additional weeks (total
      study duration up to 65 weeks), until the last patient in the study has completed the 26 week
      of treatment.
    

Detailed description: 
      This double-blind, placebo-controlled, randomized, parallel group study will be conducted at
      multiple centers in the European Union. Patients with mild to moderate Alzheimer's disease
      will undergo a screening period, and then they will be randomized to one of these four
      groups: tideglusib 1000 mg once daily (Q.D.), tideglusib 1000 mg every other day (Q.O.D.),
      tideglusib 500 mg Q.D., or matching placebo, for a 26-week, double-blind, placebo-controlled
      treatment period.
    

Intervention name(s): tideglusib; tideglusib; tideglusib; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.; 1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension; 500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.; Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
Other intervention name(s): NP-12; NP031112; NP-12; NP031112; NP-12; NP031112; NP-12; NP031112
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tideglusib; Alzheimer; NP-12; NP031112; ARGO; Noscira
Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET
Condition: Schwannomas; Malignant Tumors
MeSH terms: Neurilemmoma
Study type: Interventional
Phase: Phase 1

Summary: 
      To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies
      and schwannoma tumors.
    

Detailed description: 
      The purpose of this protocol is to extend our existing patient base from those with prostate
      cancer to those with any solid malignancy - as well as patients with schwannoma, a
      non-malignant solid tumor that also over-expresses GCP II. Using our first generation imaging
      agent, [18F]DCFBC, we have shown that we could detect GCP II in tissue specimens of patients
      with a variety of cancers, and vestibular schwannoma. We have also shown that GCP II may not
      only be present in the neovasculature of solid (non-prostate) tumors, but also reside within
      the tumor epithelium itself. We have shown that to be the case for melanoma, in particular.
      Our goal is to leverage the broad utility of our GCP II targeted imaging agents for managing
      other cancers. In addition to schwannoma, the cancers we intend to target include but will
      not be restricted to: head and neck cancer, salivary gland tumors, renal cell carcinoma,
      transitional cell carcinoma, colorectal cancer, gastric cancer, neuroendocrine cancer,
      glioblastoma, melanoma, pancreatic cancer, non-small cell lung cancer, soft tissue sarcoma,
      breast cancer, endometrial cancer, ovarian cancer, lymphoma and multiple myeloma.
    

Intervention name(s): 18F-DCFPyL Injection
Intervention type(s): Drug
Intervention description(s): 18F-DCFPyL with whole body PET/CT scan
Other intervention name(s): PyL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Canadian Trial of Dietary Carbohydrates in Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate,
      low glycemic index diet, results in more rapid progression of diabetes; i.e. increased
      fasting glucose and glycated hemoglobin, reduced beta-cell function and insulin sensitivity
      and increased free fatty acids. The deleterious effects of a high carbohydrate diet on plasma
      lipids are only temporary and do not persist beyond 6 months. A long-term high carbohydrate,
      low glycemic index diet, compared to a high carbohydrate, high glycemic index diet, improves
      glycemic control and beta-cell function
    


Intervention name(s): Control - high carbohydrate, high glycemic index foods; high carbohydrate, low glycemic index foods; low carbohydrate, high monounsaturate fat foods
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Use of Probiotics in Oral Health of Patients With Dental Implants
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was evaluate the effects of the oral probiotic Lactobacillus reuteri
      Prodentis upon the peri-implant health of edentulous patients with dental implants and
      peri-implant mucositis, establishing comparisons versus implants without peri-implant
      disease. The hypothesis of the study is that using these probiotics are going to improve the
      periimplant health.
    

Detailed description: 
      A double-blind, placebo-controlled, prospective cross-over study was made. All the patients
      were edentulous and were divided into two groups: A) with no peri-implant disease; B) with
      peri-implant mucositis affecting one or more implants. Patients with peri-implantitis were
      excluded. All patients in both groups initially received the oral probiotic Lactobacillus
      reuteri Prodentis, followed by placebo. Only the supervisor of the study knew this
      information; clinical examiner and patients were blind. Were studied: crevicular fluid
      volume, modified plaque index, probing depth, modified gingival index, and concentrations of
      interleukin 1β, interleukin 6 and interleukin 8, and Bacterial load.
    

Intervention name(s): Probiotic tablets of Lactobacillus reuteri; Placebo tablets
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): strains of Lactobacillus reuteri ATCC PTA 5289 - 100 million; Strains of Lactobacillus reuteri DSM 17938 - 100 million; Placebo tablets with same visually aspect, flavour and texture than the probiotic but without probiotic strains
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental implants; Probiotics; Lactobacillus reuteri; Periimplant mucositis; Cytokines; Bacterial load
Attachment Image Data Set Validation in Adolescent
Condition: Emotion Dysregulation
Study type: Interventional

Summary: 
      this study aims to validate a picture data set that particularly activates the attachment
      process and that could be used in attachment studies.
    

Detailed description: 
      Pictures have been chosen to represent several emotions: distress, comfort, complicity and
      neutral.
    

Intervention name(s): image visualization and quotation
Intervention type(s): Behavioral
Intervention description(s): two sets of 60 pictures are shown to the adolescents. we ask them to quote for their valence, hedonicity, arousal and to characterize the emotion elicited in each picture.
This evaluation takes approximately 1hour.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: attachment; adolescent; picture
Subcapsular Orchiectomy in Men With Klinefelter Syndrome
Condition: Klinefelter Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome
Study type: Interventional

Summary: 
      Men with Klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed
      testicular tissue is examined for presence of sperm and cryopreserved in small pieces for
      fertility treatment and scientific purposes. Prior to operation blood samples are frozen in a
      biobank.
    


Intervention name(s): Orchiectomy
Intervention type(s): Procedure
Intervention description(s): The patients undergo subcapsular orchiectomy with basic surgical instruments. The patients are given local analgesia and sometimes universal anesthesia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Identification of New Markers in the Hypereosinophilic Syndrome
Condition: Hypereosinophilic Syndrome
MeSH terms: Hypereosinophilic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and
      more accessible compared to those that we have already thanks to a proteomic approach. This
      will help the investigators to diagnose the this disease.
    


Intervention name(s): biologie sample
Intervention type(s): Biological
Intervention description(s): comparison of biomarkers between HES, HE biomarkers data and control arms
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits
Condition: Angiogenesis; Ischemic Stroke
MeSH terms: Ischemic Stroke; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in
      patients with cerebral perfusion deficits (NIMBUS trial)
    


Intervention name(s): erythropoietin
Intervention type(s): Drug
Other intervention name(s): eporon
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of
      caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.
    

Detailed description: 
      This study will be conducted with all participants receiving a dose of caffeine 100 mg on Day
      1 followed by a 7 day washout period before commencing 5 consecutive days of PBT2 250 mg from
      Day 8 to 12 and a second dose of caffeine 100 mg on Day 12. Pharmacokinetic samples will be
      collected during after each dose of the study drugs, along with safety monitoring
      assessments.
    

Intervention name(s): PBT2
Intervention type(s): Drug
Intervention description(s): PBT2 250 mg administered
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science