bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis
Condition: Vulvar Diseases; Vulvar Pain; Vestibulitis; Vestibulodynia; Vulvodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis; Vulvar Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked
      localized Vulvodynia (vestibulitis, vestibulodynia).
    

Detailed description: 
      30 women aged 18-45 diagnosed with Provoked localized Vulvodynia will be included. 10 women
      will use topical Nifedipine cream 0.2% 4 times a day for 6 weeks (except for menstrual
      period). 10 other women will use topical Nifedipine cream 0.4% 4 times a day for 6 weeks
      (except for menstrual period).

      10 women will be a control group and will use a placebo cream. The study will be randomized
      and double blind. Participants will be examined before starting the treatment, at the end of
      the treatment and 3 months after completion the treatment. A special detailed questionnaire
      has been prepared in three languages and will be used to compare dyspareunia and associate
      variables between the groups.

      The Q-tip tests will be performed and findings will be drawn in each examination. Differences
      between the groups will be examined, and uni- and multi-variate analysis will be performed.
    

Intervention name(s): Nifedipine cream topical application
Intervention type(s): Drug
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Nifedipine treatment; Vestibulitis; Placebo
Registration of Tobacco, Coffee and Substance Use Among Acutely Admitted Psychiatric Patients
Condition: Substance Abuse; Tobacco Use Disorder
MeSH terms: Substance-Related Disorders; Tobacco Use Disorder
Study type: Observational

Summary: 
      This is a study of the registration of tobacco, coffee and substance abuse among acutely
      admitted psychiatric patients.
    

Detailed description: 
      We will include all patients acutely admitted to Østmarka Psychiatric Hospital to register
      this population's use of coffee, tobacco and substances. We will determine whether this
      differs from other populations, between diagnoses, age, etc.

      We will also compare results of substance in immunologic rapid urine tests taken by the nurse
      at the hospital with substance in urine tested in laboratory with LC/MS (liquid
      chromatography/mass spectrometry).
    

Time perspective: Prospective
Keywords: Emergency Services, Psychiatric; Tobacco use cessation; Coffee use cessation; substance use detection; Substance Abuse Detection
Isometric Exercise and Endogenous Pain Inhibition
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to identify the acute effects of isometric exercise on the
      inhibition of pain in individuals with fibromyalgia.
    

Detailed description: 
      Fibromyalgia syndrome (FMS) is a chronic pain condition that is characterized by widespread
      pain which affects 5-8% of the general population. Past research has shown that people with
      FMS demonstrate enhanced pain facilitation and reduced pain inhibition in the central nervous
      system. Incorporating a biopsychosocial model of pain may help develop strategies to prevent
      the functional decline and alleviate the suffering that occurs in this population. Exercise
      is a mainstay of pain rehabilitation with multiple health benefits, one of which is
      decreasing pain; a phenomenon known as exercise induced hypoalgesia (EIH). Emerging evidence
      has shown that exercise decreases pain facilitation in healthy adults and in some individuals
      with FMS. However, it's unclear whether exercise improves pain inhibition in individuals with
      FMS. The purpose of this study is to investigate endogenous pain inhibition, measured by
      conditioned pain modulation (CPM), following isometric exercise of the quadriceps muscle in
      individuals with FMS. In addition, factors that might affect this response such as physical
      activity, body composition, and psychosocial issues will be examined. Understanding how
      exercise impacts pain and the contributing factors will help guide the prescription of
      exercise to optimize pain rehabilitation.
    

Intervention name(s): Isometric Exercise
Intervention type(s): Other
Intervention description(s): Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The two groups will participate in two sessions receiving intervention or no intervention in a randomized manner.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Exercise; pain sensitivity; fibromyalgia
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
Condition: Toenail Onychomycosis; Distal and Lateral Subungual Toenail Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      This research study will evaluate the safety and efficacy of using blue light photodynamic
      therapy (PDT) for treating toenail fungal infections.
    

Detailed description: 
      This research study will evaluate the safety and efficacy of using blue light photodynamic
      therapy (PDT) for treating toenail fungal infections.
    

Intervention name(s): Aminolevulinic Acid (ALA)
Intervention type(s): Procedure
Intervention description(s): Photosensitizing
Other intervention name(s): ALA is a topical drug used in the administration of PDT.
Intervention MeSH terms: Aminolevulinic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the response rate of gemcitabine, cisplatin and
      erlotinib in metastatic pancreatic cancer.
    


Intervention name(s): Gemcitabine, Cisplatin, Erlotinib (Tarceva)
Intervention type(s): Drug
Intervention description(s): Erlotinib 100 mg po q d daily AND
Gemcitabine 1000 mg/m² with 250 mL of normal saline intravenously infusion over 30 mins on Day 1, 8
Cisplatin 25 mg/m2 with 150 mL of normal saline intravenously infusion over 60 mins on D1,8
Every 3 weeks
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gemcitabine; Cisplatin; Erlotinib
Effect of the Combination of Plant Extracts (BSL_EP025) in Cardiovascular Health
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the ability of a combination of plant extracts
      (BSL_EP025) to reduce the levels of LDL-cholesterol and oxidized LDL-cholesterol in
      individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
    

Detailed description: 
      There is a strong relationship between serum cholesterol levels and cardiovascular diseases,
      especially between coronary artery disease and LDL-cholesterol (LDL).

      LDL is the lipoprotein responsible for delivering cholesterol to cells. However, in recent
      years, special attention has been given to modified LDL, especially oxidized LDL, since it
      plays a very important role in the initiation and progression of the atheroma plaque.

      There are environmental and genetic factors that can influence the type and levels of blood
      lipoproteins. Among the modulable factors (environmental) it has been observed that some
      phytochemical compounds found in several plant extracts may reduce cardiovascular risk, due
      to their antioxidant and anti-inflammatory properties.

      The objective of the present study is to evaluate the possible effect of the intake of a
      combination of plant extracts (BSL_EP025) on the levels of LDL-cholesterol and oxidized
      LDL-cholesterol in healthy individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
    

Intervention name(s): Combination of Plant Extracts (BSL_EP025); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each participant will consume 2 capsules daily at lunch for 8 weeks.; Each participant will consume 2 capsules daily at lunch for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Plant extract; LDL cholesterol; Dietary supplement
Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
Condition: Cerebral Palsy; Prosthesis User
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in
      improving the upper extremity function of children with cerebral palsy who have limited use
      of their hands. Twelve children, aged 4-17 years, who have cerebral palsy and limitations in
      their ability to use their hands, will be enrolled. All participants will be fitted with a 3D
      printed arm/hand prosthesis and receive 8 occupational therapy sessions. Each subject will be
      evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up. The
      evaluation will include assessment of (1)passive and active arm/hand movement and
      (2)functional hand skills using several standardized tests. The results from the
      pre-treatment and the two post-treatment evaluations will be compared.
    


Intervention name(s): Occupational Therapy Treatment
Intervention type(s): Other
Intervention description(s): Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Impact of Lower Urinary Tract Dysfunction on Clinical Manifestation in Patients With Stroke
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      The course of post-stroke bladder problems and their relation with functional, mental status
      and quality of life: A six-month prospective, multicenter study
    

Detailed description: 
      Lower urinary tract symptoms is a broad term of subjective urinary symptoms such as nocturia,
      urgency, urinary incontinence, and frequency of voiding, defined by the International
      Continence Society. Several disorders and conditions affecting the nervous system that
      controls the lower urinary system can result in neurogenic lower urinary tract dysfunction
      (LUTD). Stroke is one of these conditions. The literature review reveals that there is
      insufficient data regarding the course of LUTD symptoms other than urinary incontinence in
      stroke patients, and their relation with functional and mental status. The aim of this
      prospective, multi-center study was to determine the frequency and course of post-stroke LUTD
      from early term up to a period of six months, and to investigate the relation of LUTD with
      functional and mental status and quality of life in stroke patients.

      This study was designed as a prospective study and included 70 stroke patients enrolled by
      the Neurogenic Bladder Study Group from five different centers across Turkey.

      The demographic (age, sex, education, marital status and occupation) and clinical
      characteristics (side of the stroke, cause of the stroke, stroke localization and
      anticholinergic medication use) of the patients were obtained from the patient files and
      through face-to-face interviews. In addition, patients were questioned on the post-stroke
      1st, 3rd, and 6th months in terms of bladder drainage methods (normal spontaneous urination,
      use of adjunct maneuvers such as crede, valsalva and tapping, presence of overflow, clean
      intermittent catheterization use, permanent catheter use) after stroke.

      The patients were questioned using the Danish Prostatic Symptom Score (DAN-PSS), and
      evaluated using the Brunnstrom motor staging (hand, upper and lower extremities), modified
      Barthel index, incontinence quality of life questionnaire (I-QOL), and the Mini-Mental Test
      (MMT) on the 1st, 3rd and 6th months.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): The patients were questioned using the Danish Prostatic Symptom Score (DAN-PSS), and evaluated using modified Barthel index, incontinence quality of life questionnaire (I-QOL), and the Mini-Mental Test (MMT) on the 1st, 3rd and 6th months.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stroke patients
      
Keywords: Stroke; Lower urinary tract dysfunction; Functional status; Mini mental test
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.
Condition: Hypertension, Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of
      Fimasartan and Atorvastatin in Healthy Male volunteers.
    

Detailed description: 
      This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to
      evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized
      subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin
      and co-administration of Fimasartan and Atorvastatin.
    

Intervention name(s): Fimasartan, Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combined Breast Cancer Risk Study
Condition: Hereditary Cancer
Study type: Observational

Summary: 
      A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide
      a sample for genetic testing and information about their medical and family history. The
      results of the genetic test will be combined with clinical data to validate a method of
      predicting breast cancer risk.
    

Detailed description: 
      This is a prospective, non- interventional study. Women presenting at imaging centers for
      routine breast cancer screening or breast cancer diagnostic assessment and who provide
      written informed consent will undergo genetic testing. Subjects will also provide information
      about their personal medical and cancer history and family cancer history. The results of the
      genetic test will be combined with the subject's clinical information, family history, and a
      risk assessment model to validate a new method of predicting breast cancer.
    

Intervention name(s): Diagnostic test
Intervention type(s): Diagnostic Test
Intervention description(s): Genetic diagnostic test
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women presenting at imaging centers for a breast cancer diagnostic assessment visit or
        preventative screening visit.
      
Biospecimen description: 
      Whole blood and saliva
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
Condition: Primary Hypertension
MeSH terms: Hypertension; Heart Diseases; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The Renin-Angiotensin-Aldosterone-system is important in the development of cardiovascular
      organ damage caused by arterial hypertension. This study aims at evaluating the importance of
      aldosterone with regard to hypertension induced damage to the heart. In order to do this the
      investigators will perform a comparative cross-sectional study in hypertensives and
      normotensives. In addition as interventional part the hypertensives will be treated with a
      mineralocorticoid-receptor blocker (spironolactone).
    


Intervention name(s): spironolactone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25mg per oral once daily; placebo
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: primary hypertension; aldosterone; left ventricular hypertrophy
Mesh Fixation inTEP Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Observational [Patient Registry]

Summary: 
      Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was
      to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of
      mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients
      were studied for pain interfering with sexual activety. The hyopthesis is that fixation
      causes pain.
    

Detailed description: 
      Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was
      to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of
      mesh in TEP repair for a primary inguinal hernia regarding chronic pain.

      Men between 30 and 75 years, consecutively registered in Swedish Hernia Register (SHR) for a
      TEP repair between 2005 and 2009 were included. A questionnaire was sent in 2010 including a
      general questionnaire, SF-36 and Inguinal Pain Questionnaire (IPQ). Primary endpoint was
      question two in IPQ, "worst pain you felt in the operated groin during this past week". Pain
      was defined as "pain present that could not be ignored". In adition a specific questionnair
      developed by the research group on pain and problems during sexual activiety were sent to
      patients between 30-60 years of age.

      The register was checked for long term recurrent operations.
    

Intervention name(s): Fixation of mesh in TEP
Intervention type(s): Device
Intervention description(s): An endoscopic operative technique were mesh for preperitonelal placement in patients with inguinal hernias can be fixated in Place or left without fixation
Other intervention name(s): Total Extraperitoneal Patch
Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Men between 30-75 years with primary inguinal hernia
      
Keywords: inguinal hernia; TEP; chronic pain; male sex; mesh fixation; quality of life; national register
Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will look at the treatment effect of DiaPep277 on preservation of beta-cell
      function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that
      changes the way the immune system behaves, stopping its attack on the beta-cells.

      Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10
      injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.
    


Intervention name(s): DiaPep277; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.0 mg dose in 0.5 mL of solution; 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: beta-cells; autoimmune; Diabetes; immunomodulation
Clinical Trial To Evaluate ANT-1207 In Subjects With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of
      ANT-1207 in the treatment of acne.
    


Intervention name(s): ANT-1207; Vehicle
Intervention type(s): Biological; Biological
Intervention description(s): single dose application
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Association of Apical Periodontitis With Chronic Kidney Disease
Condition: Chronic Kidney Diseases; Periapical Lesions
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      This investigation is aimed to assess the prevalence and severity of apical periodontitis
      (AP) in different stages of CKD patients and its impact on the systemic (nutritional and
      inflammatory) markers was compared to healthy individuals.
    

Detailed description: 
      105 CKD patients (35 early (EG), 35pre-dialysis (PDG) and 35 hemodialysis (HDG)groups and 105
      age and gender matched healthy controls were assessed for prevalence and severity of apical
      periodontitis and oral disease burden . Inflammatory (hsCRP and ferritin) and nutritional
      (urea and creatinine) markers were estimated and eGFR was calculated for the study
      population. Logistic regression was used to determine the possible association between CKD
      and AP in study population and Linear regression was performed to evaluate the possible
      association between systemic markers and endodontic burden (EB) in experimental group.
    

Intervention name(s): levels of CKD markers, Oral health status, apical periodontitis; systemic inflammatory marker, Oral health status, apical periodontitis
Intervention type(s): Biological; Biological
Intervention description(s): To observe levels of CKD markers :Levels of serum keratinise ,urea, eGFR, and assessment of Oral health status, apical periodontitis; estimation of hs-CRP levels, and assessment of Oral health status, apical periodontitis
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        CKD patients of different levels (Stage 1 to Stage 5) with age and gender matched controls
        will be enrolled in the study.
      
Biospecimen description: 
      Blood analysis for CRP, Serum ferritin, Albumin, Creatinine & Urea
    
Keywords: Apical Periodontitis; Root Canal Treatment