bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of AZD2066 using
      multiple escalating dose panels. There will be separate panels for young healthy volunteers
      and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly
      receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After
      the completion of each panel, a Safety Review Committee will decide if the study can proceed
      to the next dose panel.
    


Intervention name(s): AZD2066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.; Administered orally as a solution once per day on day 1, and then day 3 through to day 12.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Safety; tolerability; AZD2066; Pain conditions
A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of
      JNJ-42165279 in healthy Japanese male participants after single and multiple oral dose
      administration.
    


Intervention name(s): JNJ-42165279; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg JNJ-42165279 tablet will be administered orally.; Matching placebo tablet will be administered orally.
Intervention MeSH terms: JNJ-42165279
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Rehabilitation for Head and Neck Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain
      and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight
      loss is attributed to lean muscle wasting that is associated with decline in physical
      function, substantial fatigue and significantly decreased quality of life. Rehabilitation
      that includes physical exercise, nutritional counselling and oral nutritional supplements
      (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot
      randomised trial is to assess feasibility, evaluate patient experiences and assess
      preliminary effects on muscle mass, physical function, nutritional status and quality of life
      of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC
      patients referred for curative RT with or without chemotherapy, will be randomised to a)
      rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be
      carried out at an outpatient facility during the treatment period (6-7 weeks) and
      rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.
    


Intervention name(s): Exercise and nutrition during radiotherapy; Multidimensional rehabilitation after radiotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of physical exercise, nutritional counselling and supplements. The exercise sessions will be conducted twice a week for 30 minutes each time during the RT treatment period, and include a main part of progressive resistance training (PRT). The PRT will be conducted by conventional upper and lower body exercises at a load of 60 - 80 % of 1 repetition maximum (RM) in 3-4 sets of 6-12 repetitions. The patients will receive nutritional information and dietary advice, and up to 2 energy dense oral nutritional supplements (ONS) daily. A nutrition interview will be conducted at study baseline and individual goals and targets will be set during the first counselling and monitored during the intervention period.; The intervention consists of physical exercise, nutritional counselling and supplements and patient education. The exercise sessions will be conducted 3 times a week for 45 minutes each time during the 3 week rehabilitation programme, and include a main part of progressive resistance training (PRT). PRT will be conducted as described in the intervention during treatment. The nutritional intervention will be carried out as described in the intervention during treatment. Patient education will be run as 45-60 minutes lecture/group discussion on relevant topics, lead by health professionals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Radiotherapy; Exercise; Diet therapy; Rehabilitation; Patient Compliance; Feasibility Studies; Sample Size; Patient satisfaction
Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the
      present commercially available Asasantin ER formulation (Aggrenox®)
    


Intervention name(s): Asasantin ER, new formulation; Asasantin ER, present commercial formulation
Intervention type(s): Drug; Drug
Other intervention name(s): Aggrenox®
Intervention MeSH terms: Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short Repeated Nickel Exposures
Condition: Allergic Contact Dermatitis Due to Nickel
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
Study type: Interventional

Summary: 
      The former Nickel Directive was introduced in EU in 1994 limiting the release of nickel from
      items intended for prolonged contact with skin. The nickel regulation entered into full force
      in 2001 and became a part of REACH (the EU chemicals regulation) in 2009. Since then the
      prevalence of nickel allergy has declined in some countries, but not in others, following the
      implementation. Young individuals still become allergic to nickel (2, 3) and a high
      prevalence of nickel allergy, exceeding 10%, is seen among young women (below 30 years) in
      the general population.

      The EU nickel regulation has been changing over time. The present limits of nickel release
      for metallic items intended for direct and prolonged contact with the skin is <0.5
      μg/cm2/week and <0.2 μg/cm2/week for any post assemblies inserted into pierced holes. In
      2014, EU defined prolonged contact with the skin as: at least 30 minutes on one or more
      occasions within two weeks for items with continuous skin contact, or to at least 10 minutes
      on three or more occasions within two weeks (7).

      The overall objective is to evaluate how well the EU nickel regulation protects individuals
      against developing nickel dermatitis. More specifically we will:

        1. Study the penetration of nickel in normal and irritated skin after short repeated skin
           exposure under controlled temperature in nickel sensitized patients and in healthy
           controls

        2. Reveal the potential of short repeated nickel skin exposure on normal and irritated skin
           to elicit dermatitis, during controlled climate factors in nickel sensitized patients
           and controls using the time restrictions of the definition of prolonged skin contact in
           the nickel regulation.
    


Intervention name(s): Experimental stimulation with nickel discs
Intervention type(s): Other
Intervention description(s): All participants will be exposed to 8 metal discs, 3 cm in diameter, 4 on each arm, placed on the volar side of the forearms (figure 1). Three of the metallic discs consists of >99 wt.% nickel one consist of >99wt.% Aluminium.The latter is used as a negative control. The discs will be applied under occlusion and with initial pressure and friction.
One metallic disc with nickel, and one with aluminium, will be randomized for the earlobes on the patients with nickel allergy
Intervention MeSH terms: Nickel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Genicular Artery Embolization for the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis; Degenerative Joint Disease of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
Study type: Interventional

Summary: 
      The purpose of this clinical research study is to examine whether Embozene treatment of the
      genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a
      medical device made by Boston Scientific approved in the United States for the treatment of
      hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic
      spheres that are injected into the artery in the knee going to the region of pain. One of the
      causes of pain in the setting of knee arthritis is increased blood flow going to the specific
      area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the
      specific region of the knee that is causing your pain. This is done by infusing Embozene
      particles into the specific blood vessel (genicular artery) supplying the area of pain in the
      knee.
    

Detailed description: 
      This is a phase 2, single-center, prospective, single arm investigational study to evaluate
      the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic
      knee osteoarthritis (OA). Subjects will be treated with a genicular artery embolization (GAE)
      procedure performed with Embozene Microspheres. The microspheres will be delivered in a
      saline-contrast medium solution and will be delivered to the arteries supplying the areas of
      the subject's pain. The primary objective of this investigation is to assess safety of
      genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.
    

Intervention name(s): Embozene MicroSpheres
Intervention type(s): Device
Intervention description(s): Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
Other intervention name(s): Color-Advanced Microspheres; Microspheres for Embolization
Intervention model: Single Group Assignment
Intervention model description: The stratification will not be randomized, but each category will be limited to 20 patients.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microspheres; Artery Embolization; Knee Osteoarthritis; Chronic Pain; Embozene
Evaluation of Covid 19 Knowledge Anxiety and Expectation Levels of Turkish Physicians, Survey Study
Condition: COVID-19; Physician-Patient Relations
MeSH terms: COVID-19
Study type: Observational

Summary: 
      It is aimed to measure the general health information of Turkish physicians about covid 19
      pandemic, to evaluate anxiety levels and to evaluate future expectations in this period.
    


Intervention name(s): turkish physicians
Intervention type(s): Behavioral
Intervention description(s): turkish physicians, who work active in pandemic hospital.
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        turkish physicians, who work active in pandemic hospital
      
Keywords: covid-19; turkish physicians
A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT)
      in participants with uncontrolled hypertension.
    

Detailed description: 
      This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study. It will
      include up to approximately 48 participants with mild to moderate hypertension who have
      uncontrolled blood pressure (˃ 130 - ≤ 170 millimeters of mercury [mmHg] systolic) and have
      been on one or more anti-hypertensive medications for at least one month. Following an up to
      4-week screening period, eligible participants will receive multiple doses of ION904 during a
      13-week treatment period, followed by a 13-week post-treatment follow-up period.
    

Intervention name(s): ION904; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ION904 will be administered by SC injection.; Placebo will be administered by SC injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors
Condition: Pelvic Girdle Pain; Pubic Symphysis Diastasis; Diastasis Recti
MeSH terms: Pubic Symphysis Diastasis; Pelvic Girdle Pain
Study type: Observational

Summary: 
      Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly
      after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the
      posterior iliac crest and the gluteal fold, particularly in the vicinity of the Sacroiliac
      joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction
      with/or separately in the symphysis. The endurance capacity for standing, walking, and
      sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes.
      The pain or functional disturbances in relation to PGP must be reproducible by specific
      clinical tests. Lack of accurate and early diagnosis of the PGP reasons postpartum may
      contribute to development of chronic condition, lowering quality of life years after
      delivery.

      Objectives: The aim of the project is to evaluate the underlying cause of the severe pelvic
      girdle pain postpartum (whether it is real PGP or diastasis pubic symphysis) and to assess
      the differences between females with severe postpartum PGP, mild and moderate PGP and with no
      PGP in terms of: presence of diastasis pubic symphysis, presence of diastasis recti and linea
      alba dysfunction, factors associated with labour and maladaptive mental processing
      (catastrophizing).

      Materials and methods: Because of low incidence of researched conditions, a case control
      study will be the study design of choice. The subjects with PGP will be matched with those
      with no PGP. Subjects' assessment will consist of palpation and ultrasonography evaluation of
      diastasis recti(inter-recti distance), ultrasonography assesment of pubic symphysis
      (inter-pubic width) and mental processing (catastrophizing assessed with Pain Catastrophizing
      Scale) analysis. Factors connected with labour (time from epidural anaesthesia injection to
      full dilatation and delivery) will be also investigated.

      Expected results: To the investigators' knowledge, postpartum pelvic girdle pain has not been
      extensively studied so far. The study will bring information about the possible underlying
      cause of postpartum PGP: whether it is PGP or diastasis pubic symphysis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women in early postpartum period (during hospital stay)
Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single doses of
      BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is
      absorbed and eliminated.
    


Intervention name(s): BLI-489; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: BLI-489
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Subjects
Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study was to evaluate the effect of ESN364 on the severity and
      frequency of hot flashes in early postmenopausal women suffering from hot flashes, in terms
      of changes in weekly Hot Flash Score from baseline to Week 12.

      This study also evaluated the effect of ESN364 on the severity and frequency of hot flashes
      at additional timepoints; hot flash interference on daily life, in terms of changes from
      baseline over time in Hot Flash Related Daily Interference Scale (HFRDIS); the effect of
      ESN364 on climacteric symptoms, in terms of changes from baseline over time in Leeds Sleep
      Evaluation Questionnaire (LSEQ), Greene Climacteric Scale (GCS), and Sheehan Disability Scale
      (SDS); pharmacodynamic (PD) effect; and safety and tolerability.
    


Intervention name(s): Fezolinetant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Capsule; Oral Capsule
Other intervention name(s): ESN364; ASP2693
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hot flashes; ESN364; ASP2693; fezolinetant; menopause; postmenopausal
Prevalence of Fabry's Disease in a Population of Patients With Chronic Pains
Condition: Pain; Fabry's Disease
MeSH terms: Fabry Disease; Chronic Pain
Study type: Interventional

Summary: 
      Fabry disease (FD) is a rare X-linked multisytemic lysosomal disorder caused by
      alpha-galactosidase deficiency. Globotriaosylcéramide (Gb3) deposits are observed in almost
      all tissues examined. Signs of the disease appear earlier and are more severe in affected
      males than in females. Myocardiopathy, renal failure and neurological signs including chronic
      pain and peripheral neuropathies are the most frequent signs. The availability of two
      enzymatic replacement therapies now provides a specific and effective treatment for patients.
      The prevalence of FD is estimated between 1/40,000 and 1/117,000. The frequency of Fabry
      disease has previously been estimated in several series of patients presenting one single
      sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. However, no data
      are available about the prevalence of FD in populations of patients suffering from chronic
      pains of unknown origin.

      The diagnosis of FD will be performed by standard procedures following international
      recommendations. These require the search for a deficiency of alphagalactosidase A activity
      on leucocytes in males and genetic analysis of the GLA gene in females (Lidove et al. 2007).

      The patients in whom the diagnosis of FD is established during this study, will be call in
      for an additional visit in the Investigating Centre in order to confirm the diagnosis and
      propose suitable assessment and care.
    


Intervention name(s): Blood sampling for biological and genetic analysis
Intervention type(s): Genetic
Intervention description(s): Clinical examination
Blood sampling for biochemical enzymatic measures of alphagalactosidase A activity in males, and genetic analysis using direct sequencing of GLA in females.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: chronic pains; unknown aetiology
A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This Study is looking at whether high blood glucose levels after a meal affect arterial
      stiffness more or less than low blood glucose levels, and whether certain cardiovascular
      markers influence the outcome of this.
    


Intervention name(s): Lispro
Intervention type(s): Drug
Intervention description(s): Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.
Other intervention name(s): Humalog; LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Role of PET/MRI in Head and Neck Cancer
Condition: Head and Neck Cancer; Benign Neoplasm; Malignant Neoplasm
MeSH terms: Neoplasms; Head and Neck Neoplasms
Study type: Observational

Summary: 
      Study aim was to investigate the diagnostic role of Positron Emission Tomography / Magnetic
      Resonance Imaging (PET/MRI) in head and neck cancer.
    

Detailed description: 
      This study was assessed the role of Diffusion weighted imaging (DWI) in discriminating
      between benign and malignant lesions in Head and neck cancer as well as studying the
      relationship between glucose metabolism (18F-FDG) and Apparent diffusion coefficient (ADC)
      for better tumor assessment.
    

Intervention name(s): Radiotherapy
Intervention type(s): Radiation
Intervention description(s): Patients have received radiotherapy as a treatment modality for Head and neck cancer
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population were patients who have been diagnosed with head and neck cancer.
Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)
Condition: Mild-moderate Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and safety of DHP1401 in patients
      with mild-moderate Alzheimer's disease treated with donepezil
    


Intervention name(s): Donepezil; DHP1401; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5mg or 10mg, once a day, 24 weeks; Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks; Placebo was administrated in two divided dosed a day for 24 weeks
Other intervention name(s): Aricept®; DHP1401 500mg or 1,000mg; DHP1401 placebo
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease