bioihbjkbjnl/mcl2 huggingface dataset:
Macronutrient Effects on Alzheimer's Disease (MEAL-2)
Condition: Prediabetic State; Insulin Resistance; Middle Age; Prehypertension; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Prehypertension; Insulin Resistance; Prediabetic State; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study compares the effects of a one-month diet high in saturated fat (SF), glycemic
      index (GI), and salt (Na+) to a diet low in these nutritional parameters on memory and other
      cognitive functions, on MRI measures of brain structure, function, and perfusion, as well as
      on blood and cerebrospinal fluid levels of amyloid-beta (Aβ), insulin, lipids (total
      cholesterol, HDL, LDL, oxidized LDL, and triglycerides), cytokines, apolipoprotein E (ApoE),
      apolipoprotein J, cortisol, soluble low density lipoprotein receptor-related protein (sLRP),
      and glucose in middle-aged adults (45-65 years of age) with normal cognition or mild
      cognitive impairment.
    


Intervention name(s): Low Diet; High Diet
Intervention type(s): Other; Other
Intervention description(s): a 28-day course of 3 meals per day plus 2 snack that are either low in saturated fats, glycemic index and salt.; a 28-day course of 3 meals per day plus 2 snack that are either high in saturated fats, glycemic index and salt.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Intensive Insulin Treatment and Ischemic Foot Ulcer
Condition: Ischemic Foot Ulcer
MeSH terms: Foot Ulcer; Ischemia; Ulcer
Study type: Interventional

Summary: 
      We aim to investigate the relationship between skin microvascular function and the first
      hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized
      during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard
      insulin treatment (ST).
    

Detailed description: 
      The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified
      insulin treatment were feasible and led to less serious diabetic complications. 102 patients
      with type 1 diabetes mellitus were randomiz (October 1982 to March 1984) to intensified
      conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS
      study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients
      were assigned to their regular clinical visits.

      In the present study, 96 patients from the SDIS study were asked to participate in current
      study and to investigate their skin microcirculation, in which 72 patients agreed (ICT; n=35
      vs. ST; n=37). Also, nineteen healthy subjects participated as controls for the method of
      iontophoresis, with no intention to be followed-up. Exclusions criteria were; any history or
      ongoing ischemic foot ulcer or peripheral artery disease or osteoartropathy. The
      iontophoresis investigation took place 5.5 years ± 2 months, after the primary randomization
      ceased (7.5 years). All participants (except the control subjects) were then followed-up
      until first time hospitalization for ischemic foot ulcer or until 31 december 2011.
    

Intervention name(s): Intensified insulin treatment; Standard treatment
Intervention type(s): Drug; Drug
Intervention description(s): The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.; Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months
Other intervention name(s): Monotard; Actrapid; Premixed Insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HbA1c; Iontophoresis; Intensified insulin treatment; Ischemic foot ulcer; Type 1 diabetes
Study of Molecular Markers in Cutaneous Inflammation Between Psoriatic Lesional Skin and Healthy Non-lesional Skin
Condition: Psoriasis
MeSH terms: Psoriasis; Inflammation
Study type: Interventional

Summary: 
      The project topic consists on re-conciliating the fine tuners of the gene expression
      "microRNAs" and the immunopathogenic occasions responsible for skin disorders in context of
      skin infection and inflammation such as psoriasis. The skin is a network of effector cells
      and molecular mediators that constitute a highly sophisticated "Skin Immune System (SIS)
      described by Jan D Bos in 1986. The cutaneous homeostasis maintenance is dependent on the
      cross talk between several immune sentinels present in the different compartments of the skin
      as well as the interplay between innate and adaptive immune responses. The whole is under the
      control of gene regulation. However, cutaneous homeostasis disruption occurs when the SIS
      safe framework erroneously sends aggravation signals due to gene regulation disbalance via
      inflammatory cellular and molecular mediators into the site of infection causing chronic
      inflammation characterized by thick red irritated skin lesions. The latter was showed to have
      a characteristic microRNA (regulators of gene expression) signature.
    


Intervention name(s): Biopsy
Intervention type(s): Procedure
Intervention description(s): the sample will be taken by superficial cutaneous biopsy in psoriasic patients
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: psoriasis; IL-22; miR-21
A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of single- and multiple-dose of rifampin on
      the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy male
      and female participants.
    

Detailed description: 
      This is an open-label, fixed-sequence, single-center, multiple-dose study in 14 healthy
      adults. All participants will receive a single oral dose of 40 milligram (mg) JNJ-42847922 on
      3 separate occasions: Day 1 (JNJ-42847922 alone), Day 5 (JNJ-42847922 with a single dose of
      rifampin), and Day 12 (JNJ-42847922 in combination with steady-state rifampin). A daily dose
      of 600 mg (2 * 300 mg) rifampin will be administered from Day 5 through Day 12. Following
      JNJ-42847922 dosing, serial blood samples will be collected over 48 hours for the evaluation
      of plasma concentrations of JNJ-42847922 and its metabolites. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): JNJ-42847922; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of 40 milligram (mg) (=2*20 mg) dose of JNJ42847922 on Day 1, Day 5 and Day 12.; Oral dose of rifampin 600 mg (2*300 mg) on Day 5 and once daily dosing of rifampin with an oral dose of rifampin 600 mg (2*300 mg) on Days 5 to 12.
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42847922; Rifampin; Pharmacokinetics
Study of the Long-term Effects of Exercise on Heath Indicators in Older People
Condition: Hypertension With Complications and Secondary Hypertension; Overweight and Obesity; Lipid Metabolism Disorders; Sarcopenia; Osteoporosis; Personal Satisfaction
MeSH terms: Osteoporosis; Sarcopenia; Hypertension; Overweight; Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly
      population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are
      among the main risk factors for CVD. In contrast, mortality from CVD is inversely related to
      levels of physical activity, and is lower in individuals who exercise and have higher
      functional fitness levels. Thus, the Centers for Disease Control and Prevention, the American
      College of Sports Medicine, and the American Heart Association have recommended 20-30 min of
      moderate-to-vigorous aerobic training for the elderly, preferably every day or at least 3
      days a week in the case of vigorous exercise.The same organizations also suggest the
      inclusion of resistance training in order to improve functional fitness. Therefore, the
      purpose of this study was to compare different exercise modalities in long-term changes of
      CVD risk factors and physical fitness among older adults.
    


Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
Other intervention name(s): Aerobic training; resistance training; Combined training; multicomponent training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Exercise; Blood pressure; Lipids; Body composition; Fitness; Bone density; Quality of life
Validation Study CARES
Condition: Cancer
Study type: Interventional

Summary: 
      This study aims to validate the CARES, a needs assessment instrument which can be used to
      inventorize cancer patients biopsychosocial distress and care needs.

        -  QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package
           containing questions about social-demographic and medical data, the CARES and convergent
           measures: Karnofsky Performance Scale (KPS), Hospital Anxiety Depression Scale (HADS),
           Social Support List (SSL), Maudsley Marital Questionnaire (MMQ), European Organisation
           for Research and Treatment of Cancer Quality Of Life Core 30 (EORTC-QOL-C30), Distress
           Thermometer (DT) and a Care Needs Questionnaire. One week after the first questionnaire
           package participants have to fill in the CARES a second time and answer some questions
           to evaluate the feasibility of the CARES.

        -  QUALITATIVE PART OF THE STUDY: Participants from the quantitative part of the study and
           other (ex-) cancer patients who not have to fulfill the criteria of age and cancer stage
           can participate in a focus group interview. In these focus groups the content validity
           and preferences on psychosocial screening in care are discussed.
    


Intervention name(s): Questionnaire, focus group participation
Intervention type(s): Other
Intervention description(s): participants of the quantitative part of the study are asked to fill in a questionnaire, participants of the qualitative part are asked to participate in a focus group interview.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
DIMS-myopia Progression ADN Axial Length Growth
Condition: Myopia, Progressive
MeSH terms: Myopia; Myopia, Degenerative
Study type: Interventional

Summary: 
      To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a
      prospective randomized controlled clinical study.
    

Detailed description: 
      The subjects were randomly assigned into two groups: the control group (SV) and the
      experimental group (DIMS). The clinical trial assistant took the glasses before examination
      and returned them after examiners had performed all tests. Examiners were unaware of the
      spectacle type until the end of the follow-up period. However, the lens type was known by
      children and parents since the unique appearance of the DIMS lens.

      The subjects were provided details about the study design and methodology and their rights as
      subjects at first visit. We conducted visual acuity tests, subjective and objective
      refraction measurements, AL measurements, heterophoria at distance and near, and
      accommodation after obtaining written informed consent from them and their parent.

      We conducted follow-up examinations 6 and 12 months after the first visit. In the follow-up
      examinations, we measured all the examination as do ate the firt visit.

      Either the VA with the current spectacles dropped to < 0.8(20/20) or SE of cycloplegic
      subjective refraction increased ≤-0.50D, the lens power of the spectacles was replaced on the
      basis of the cycloplegic subjective refraction.
    

Intervention name(s): frame lens
Intervention type(s): Device
Intervention description(s): The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: myopia; axial length; DIMS
Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Phonak Hearing Systems pass through different development and study stages. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing
      Systems undergo a final quality control in terms of clinical trials. This is a pre-validation
      study, investigating optimized algorithms, features, functions and wearing comfort. This will
      be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters
      based in Stäfa (Switzerland).
    

Detailed description: 
      The study will compare different features of the Phonak behind the ear device activated and
      deactivated, for example the noise reduction feature. There shall be differences in listening
      effort, awareness and sound quality shown. The study shall show the advantages especially for
      people with severe to profound hearing losses. This will be a clinical investigation which
      will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
    

Intervention name(s): Feature for noise reduction (on); Feature for noise reduction (off)
Intervention type(s): Device; Device
Intervention description(s): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.; To show the advantage of the noise reduction feature there is a comparison without the feature necessary.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenic Disorders; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a long-term, open-label clinical study designed to enable longer-term treatment of
      patients completing other clinical studies with intramuscular olanzapine depot.

      Key objectives of the study are to:

        -  Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,

        -  Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,

        -  Determine the blood levels of IM olanzapine depot in patients during long-term treatment
    


Intervention name(s): Intramuscular olanzapine depot
Intervention type(s): Drug
Intervention description(s): 45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
Other intervention name(s): LY170053; Zyprexa Adhera
Intervention MeSH terms: Olanzapine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and
      female participants with painful knee osteoarthritis.
    


Intervention name(s): CNTX-4975-05; Qutenza; Lidocaine (without epinephrine)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 mg (2mL) IA injection; 8% topical patch; 15 mL IA injection of 2% lidocaine (without epinephrine)
Other intervention name(s): trans-capsaicin; cis-capsaicin
Intervention MeSH terms: Lidocaine; Epinephrine; Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee
Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease
Condition: Coronary Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      stress cMRI with Dobutamine stress agent (stress cMRI), represent the combination of two
      orders of exams routinely performed (cMRI and stress diagnostic series of exams) without
      additional risk for the patient, but with the advantage of non-invasiveness and lack of
      radiation, and less laborious for the participants
    

Detailed description: 
      Surgical revascularization or angioplasty are therapeutic options for coronary lesions even
      in infants and children. Pharmacological stress induced cMRI could provide crucial
      information such as coronary arteries origin and proximal pathway, wall motion abnormalities,
      myocardial perfusion and viability, enabling accurate monitoring of symptomatic and
      non-pediatric patients. Investigators would build a prospective series of stress cMRI exams
      in pediatric symptomatic and non-patients, with suspected or previously diagnosed coronary
      artery disease. Investigators would put the results in comparison with ECG, Exercise test,
      stress Cardiac Ultrasound and Angiography. At the end of the study, if supported by results,
      the aim is to replace the current diagnostic procedure (ECG, Exercise test, stress Cardiac
      Ultrasound and Angiography) which need long hospitalization, expose the patient to radiation
      dose, is uncomfortable for the patient, and is characterized by a non-negligible risk due to
      invasive procedure, with a single exam (stress cMRI) which is dose-free, minimal risk
      related, without hospitalization, and less expensive for National Care System.
    

Intervention name(s): stress cardiac MRI
Intervention type(s): Diagnostic Test
Intervention description(s): pharmacological stress testing has evolved as an alternative to physical exercise for the detection of inducible myocardial ischemia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Absolute Bioavailability of Reslizumab in Healthy Subjects
Condition: Absolute Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the absolute bioavailability of reslizumab
      following administration of a single subcutaneous (sc) dose to healthy non-Japanese
      participants
    

Detailed description: 
      The study is designed to assess the pharmacokinetics, safety and tolerability,
      immunogenicity, and pharmacodynamics of reslizumab
    

Intervention name(s): Reslizumab IV; Reslizumab SC
Intervention type(s): Drug; Drug
Intervention description(s): Reslizumab 220-mg intravenous (IV); Reslizumab 220 mg administered subcutaneous (SC)
Intervention MeSH terms: Reslizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Reslizumab; monoclonal antibody
Curcumin Paste as an Adjunctive Therapy in Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The turmeric (Curcuma longa) plant, a herb belonging to the ginger family. The most active
      component of turmeric is curcumin, which makes up 2 to 5% of the spice. Curcumin showed has
      antibacterial effect against periodontal pathogen and positive result regarding conventional
      treatment of periodontal disease due to its anti-inflammatory, anti-oxidant and wound healing
      properties. This study will be carried out to examine the effect of curcumin when used in
      conjunction with open flap debridement treating deep periodontal pockets. (suggesting that it
      may have positive effect)
    

Detailed description: 
      The present study entailed twenty four patients having stage II or stage III, Grade A
      periodontitis with 24 intrabony defects. Patients were divided into two groups; group I was
      subjected to open flap debridement only. Group II was subjected to curcumin paste
      (2%curcumin)in conjunction with open flap debridement Clinical parameters including plaque
      index, sulcus bleeding index, probing depth and clinical attachment level were recorded
      pre-surgical. Moreover, radiographic examination was performed by cone beam computed
      tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full
      thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was
      performed. Group II received local application of curcumin paste.The same initial clinical
      parameters were recorded three and six months postoperatively. Radiographic measurements were
      recorded six months post surgically.
    

Intervention name(s): curcumin paste; curettage
Intervention type(s): Drug; Procedure
Intervention description(s): curcumin is a herb used for medical purpose; open flab debridement surgery
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: curcumin; CBCT; HPLC; periodontitis
The Effect of Oral Contraceptive Pills On Eyes
Condition: Adverse Effect of Oral Contraceptives, Subsequent Encounter
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula,
      retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT).
      The present clinical study is the first research reported in the literature which is
      investigating the posterior ocular segment changes in women using OCP by using OCT.
    

Detailed description: 
      Spectral-domain optical coherence tomography (OCT) which is used to evaluate retina both
      qualitatively and qualitatively is a non invasive process. And also OCT makes it possible to
      perform retinal exams repeatedly without eye drops and dilatation.
    

Intervention name(s): oral contraceptive pills
Intervention type(s): Drug
Other intervention name(s): yasmin
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: optical coherence tomography; oral contraceptive pills