bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Mediterranean Diet in Obese Adolescents With Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effects of mediterranean and low-fat diet on
      hepatic fat, inflammation markers and oxidative stress in adolescents with nonalcoholic fatty
      liver disease. This randomized, single-blind controlled study conducted with obese
      adolescents aged 11-18 years who were admitted to Tepecik Training and Research Hospital
      Pediatric Gastroenterology Outpatient Clinic with the diagnosis of nonalcoholic fatty liver
      disease. Participants were randomly assigned to the Mediterranean diet or low-fat diet group.
    

Detailed description: 
      This study was conducted to evaluate the effect of Mediterranean and low-fat diet on hepatic
      fat, inflammation and oxidative stress in obese adolescents with nonalcoholic fatty liver
      disease (NAFLD). The study, which was designed as a single blind randomized control, was
      completed with 44 obese adolescents diagnosed with NAFLD between the ages of 11-18.
      Adolescents were randomized to either a Mediterranean diet (n = 22) or a low-fat diet
      (control diet) (n = 22) for 12 weeks. At the beginning of the study and at the 12th week,
      adolescents' blood samples, physical activity and food consumption records were taken,
      anthropometric measurements and body composition analyzes were made, and antioxidant food
      consumption frequency and Mediterranean diet quality index questionnaire were applied to
      adolescents. In the controls performed at the 2th, 4th, 6th, 8th, and 10th weeks, the
      physical activity and food consumption records of the adolescents were repeated and
      anthropometric measurements and body composition analyzes were made again.
    

Intervention name(s): Mediterranean diet; Control diet: Low fat diet
Intervention type(s): Other; Other
Intervention description(s): Diet intervention:Mediterranean diet; Low fat diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the skin irritation potential and sensitisation
      potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy
      subjects.
    


Intervention name(s): LEO 90100; Vehicle; Petrolatum ointment
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Other
Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Condition: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Leukemia; Preleukemia; Leukemia, Myelomonocytic, Chronic; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood
      transfusions and may be an effective treatment for myelodysplastic syndrome or chronic
      myelomonocytic leukemia.

      PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients
      who have myelodysplastic syndrome or chronic myelomonocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate of patients with myelodysplastic syndromes or chronic
           myelomonocytic leukemia treated with doxercalciferol.

        -  Determine the toxicity profile of this drug in these patients.

        -  Determine the time to progression and overall survival of patients treated with this
           drug.

      OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in the
      absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.
    

Intervention name(s): doxercalciferol
Intervention type(s): Dietary Supplement
Intervention MeSH terms: 1 alpha-hydroxyergocalciferol
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic myelomonocytic leukemia; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; de novo myelodysplastic syndromes; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable
Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS)
      population capturing outcomes reported by patients and by the physicians during 12 months
      after initiating or resuming Betaseron.
    


Intervention name(s): BAY86-5046_Interferon-beta-1b
Intervention type(s): Drug
Intervention description(s): Electronic questionnaires
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        "real world" population
      
Keywords: Outcomes; real world and web tool; electronic data capture
A Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative
      bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule
      formulation, after administration of single oral doses in healthy adult subjects under fasted
      conditions.

      Approximately 16 subjects will be assigned randomly to 1 of 2 treatment sequences. The
      sequences will dictate the order in which each subject receives the following treatments:

        -  Treatment A (Reference): A single dose of 0.6 mg CC-220, administered as two 0.3-mg
           formulated CC-220 gelatin capsules.

        -  Treatment B (Test): A single dose of 0.6 mg CC-220, administered as one 0.6-mg
           formulated CC-220 Hydroxypropyl methylcellulose (HPMC) capsule.
    

Detailed description: 
      The study will consist of 2 study periods. Each subject will participate in a screening
      phase, a baseline phase in each study period, a treatment phase in each study period, and a
      follow up telephone call. Subjects will be screened for eligibility. Eligible subjects will
      return to the study center on Day -1 of Period 1, and will remain domiciled at the study
      center from Day -1 of Period 1 to Day 4 of Period 2.

      On Day 1 of Period 1, eligible subjects will be randomized to 1 of 2 sequences. On Day 1 of
      each study period, each subject will receive 1 of 2 treatments according to the sequence in
      which he or she is randomized.

      Blood samples will be collected at prespecified times for PK, PD, and clinical laboratory
      safety tests. Urine samples will be collected at prespecified times for clinical laboratory
      safety tests.

      Safety will be monitored throughout the study. Safety evaluations will include AE reporting,
      review of concomitant medications and procedures, physical examinations (PEs), 12-lead ECGs,
      vital sign measurements, and clinical laboratory safety tests. Subjects will be discharged
      from the study center on Day 4 of Period 2 upon completion of scheduled study-related
      procedures and satisfactory safety review. Each subject will receive a follow-up telephone
      call within 5 to 7 days following discharge from the study center.

      The study will be conducted in compliance with the International Council on Harmonisation
      (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
      Clinical Practice (GCP) and applicable regulatory requirements.
    

Intervention name(s): CC-220
Intervention type(s): Drug
Intervention description(s): CC-220 gelatin capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; CC-220 Capsules; Relative Bioavailability; Phase 1
RCT of Methotrexate Added to Treatment As Usual in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the this study is to evaluate the effectiveness of methotrexate added to treatment
      as usual on positive and negative symptoms, cognitive and social functioning and quality of
      life of patients suffering from schizophrenia.
    

Detailed description: 
      The purpose of the study is to test the prediction that addition of methotrexate to treatment
      as usual (TAU) for patients with schizophrenia will result in following outcomes:

        -  Primary:

             -  improvement in negative symptoms

             -  improvement in positive symptoms

        -  Secondary:

             -  improvement in social functioning

             -  improvement in cognitive functions

             -  acceptability and tolerability of methotrexate added to TAU A total 72 participants
                (36 participants in intervention group and 36 in control group) meeting inclusion
                criteria of the study will be recruited and randomized in study in two arms.
                Research assistants and participating psychiatrists will assess participants for
                eligibility criteria. After providing detailed information regarding study by using
                patient information sheet, written informed consent will be taken from
                participants. Trained research assistant will asses participants at baseline, 2, 4,
                6 and 12 weeks.
    

Intervention name(s): Methotrexate
Intervention type(s): Drug
Intervention description(s): Treatment as usual or standard treatment for psychosis will be common in all arms
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Anti-Inflammatory; Methotrexate; Psychosis Not Otherwise Specified
Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to study the effect of blocking the renin angiotensin system on
      urinary free light chain excretion as compared to urine microalbumin creatinine ratio in
      subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a
      biomarker of earlier detection of kidney function impairment in subjects with diabetes
      mellitus.
    

Detailed description: 
      Free light chains (FLCs) are low-molecular-mass molecules (kappa and lambda light chains),
      which are by-products of normal immunoglobulin synthesis and are normally excreted through
      the kidneys. Presence of light chains in the urine is a marker of tubular dysfunction. In
      patients with impaired kidney function, serum concentrations and urinary excretion of
      polyclonal FLCs have been noted to be increased. Increased excretion of FLCs and other
      low-molecular weight proteins [cystatin C, NGAL] in the urine may contribute to progression
      of chronic kidney disease. Higher Cystatin C has been demonstrated to be related to
      development of albuminuria. Neutrophil gelatinase-associated lipcalin (NGAL) excretion in the
      urine is a marker of tubular injury in the kidney and has been shown to be elevated in
      subjects with type 1 and 2 diabetes mellitus (DM). Angiotensin-converting enzyme inhibitors
      (Ace Inh) and angiotensin II receptor blockers (ARB) class of drugs are renoprotective in
      nature and are the first line therapy for treatment of diabetic nephropathy. There is no
      longitudinal data evaluating the effect of Ace Inh and ARB class of drugs on urinary FLCs
      (UFLCs).

      Our hypothesis is that UFLCs are increased in patients with DM with and without kidney
      disease and that treatment with Ace Inh and/or ARB will decrease UFLCs in these patients.
      Additionally, we will explore the change in other low molecular weight proteins [cystatin C,
      and NGAL] in response to treatment with Ace Inh and ARB.
    

Intervention name(s): amlodipine, hydralazine, terazosin or hydrochlorothiazide
Intervention type(s): Drug
Intervention description(s): In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.
Other intervention name(s): Norvasc
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Hydralazine; Terazosin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Type 2 Diabetes; Hypertension
A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in
      reducing requirements for supplemental oral calcium and active vitamin D, while maintaining
      stable total serum calcium levels in adult subjects with hypoparathyroidism.
    

Detailed description: 
      Subjects either must have previously completed NPSP558 Study CL1-11-040 (REPLACE) including
      24 weeks of active therapy and 4 weeks of follow-up to Week 28 prior to enrolling in this
      study or have enrolled in REPLACE and dropped out during optimization, but currently meet
      inclusion/exclusion criteria for REPLACE.
    

Intervention name(s): NPSP558
Intervention type(s): Drug
Intervention description(s): 50, 75, 100 μg
Other intervention name(s): REPEAT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTH 1-84; Hypoparathyroidism; NPSP558; Parathyroid Hormone 1-84
Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      Ankylosing Spondylitis (AS) is a chronic painful progressive inflammatory arthritis of
      unknown etiology primarily affecting the spine and sacroiliac joints. In addition to
      formation of new bone leading to syndesmophytes and ankylosis; osteoporosis is also a
      prominent feature in AS-thus showing the paradox of new bone formation at abnormal sites
      coexisting with reduced bone mass & increased fracture risk. Osteoporosis is a common
      complication of AS, with an incidence between 18.7% and 62%. TNF alpha has a central role in
      disturbing this balance in bone metabolism--resulting in accelerated alveolar bone loss and
      decreased strength- i.e. osteoporosis. The investigators hypothesis that anti TNF therapy is
      effective in active AS resistant to conventional therapy and helps in improving the bone
      density and over all bone health.
    

Detailed description: 
      Ankylosing spondylitis not responding to conventional therapy has been effectively treated
      with Anti TNF therapy. In addition studies have shown that TNF has a role in osteoporosis of
      inflammatory diseases. The hypothesis that anti TNF therapy may decrease osteoporosis and
      tilt bone metabolism to the osteoblastic side has been tested in few studies. These have not
      been studied in an Indian population. Another great issue in the usage of anti TNF therapy in
      Indian population is the high incidence of developing infective complications; especially
      tuberculosis. The investigators are thus studying these in a north Indian population at a
      tertiary centre. The results would come to important conclusions regarding treatment and in
      the important issue of tuberculosis screening and prevention.
    

Intervention name(s): anti TNF alpha agent; Anti TNF alpha therapy
Intervention type(s): Drug; Drug
Intervention description(s): Anti TNF alpha therapy included either INFLIXIMAB or ETANERCEPY Infliximab at 3-5 mg/kg at recommended protocols for the duration of the study Etanercept at 50mg weekly for the duration of the study; Infliximab 3-5 mg/kg as per recommended protocol or Etanercept 50mg/week for 1 year
Other intervention name(s): Infliximab - REMICADE as brand name; Etanercept- ENBREL as brand name; REMICADE-infliximab; ENBREL-Etanercept
Intervention MeSH terms: Infliximab; Etanercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: TNF; BMD; Ankylosing spondylitis; bone health; Anti TNF therapy; Disease activity
Sun Protection Factor (SPF) - Static and Water Resistant Assay
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection
      Factor (SPF) on the skin of human subjects.
    


Intervention name(s): BAY 987519; SPF 15 Control
Intervention type(s): Drug; Drug
Intervention description(s): Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.; Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
Condition: Raynaud's Phenomenon; Digital Ulcers; Scleroderma
MeSH terms: Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional
Phase: Phase 3

Summary: 
      Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many
      patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity
      and adversely affects the quality of life. In an earlier study, we have observed marked
      improvement in RP attacks and rapid healing of digital ulcers following therapy with
      phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study
      the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least
      one or more vasodilators.
    


Intervention name(s): Tadalafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tab Tadalafil, 20 mg alternate day for 8 weeks; Tab Placebo every alternate day for 8 weeks
Other intervention name(s): Tadalis
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Raynaud's phenomenon; ischemic ulcers; digital ulcers; digital infarcts; gangrene; vasodilators; endothelial dysfunction; scleroderma
Examining the Effects of an Improvisation Group
Condition: Anxiety; Depression; Self Concept Alteration; Social Support
MeSH terms: Depression; Anxiety Disorders
Study type: Interventional

Summary: 
      This study is taking place to examine the preliminary effects of improvisational therapy
      (improv group) on social anxiety for youth at the Youth Wellness Centre (YWC). The improv
      group will run for 12-weeks as a drop-in group. A typical session will begin with stretching,
      simple breathing and an activity to promote group cohesion. Following this, improvisation
      games and activities will be introduced with the goal of promoting the following skills:
      assertiveness, acceptance, problem solving, co-operate skills, non-verbal communication,
      mindfulness, and memory. Youth who consent to the study will be asked to complete a set of
      brief questionnaires the first time they attend one of the sessions. Youth who have attended
      at least 3 sessions will be asked again to complete questionnaires following the completion
      of week 12 session. Youth will also rate their anxiety and distress on a simple rating scale
      at the beginning and end of each session. Additionally, all participants (who have attended
      three or more sessions) will be invited to complete a 30 to 45 minute qualitative interview
      following the 12 week session. Participants are predicted to show a decrease in social
      anxiety, generalized anxiety and depression symptoms, and an increase in self-esteem, and
      perceived social support.
    


Intervention name(s): Improvisation Group
Intervention type(s): Other
Intervention description(s): The aim of this pilot study is to investigate the effects of improvisational comedy in a group of help-seeking youth at risk of developing a range of mental health disorders, including social anxiety.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other