bioihbjkbjnl/mcl2 huggingface dataset:
Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will
      be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled
      concurrently.
    

Detailed description: 
      This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of
      BG-00012 given in capsule form..
    

Intervention name(s): Experimental
Intervention type(s): Drug
Intervention description(s): Bioequivalence of two drug formulations
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence
Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia
Condition: Juvenile Primary Fibromyalgia Syndrome (JPFS); Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research is to conduct an open, pilot trial to assess the efficacy and
      safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).
    

Detailed description: 
      Fibromyalgia is a common condition that is often challenging to treat. It is defined by the
      American College of Rheumatology (ACR) as widespread pain of at least 3 months duration in
      combination with tenderness at 11 or more of 18 specific tender point sites on the body. The
      prevalence of JPFS in children and adolescents in the general population of the United States
      is unknown. Studies from Israel, Mexico, and Italy have estimated that the prevalence rate of
      JPFS in school children ranges from 1.24% to 6.20%, with girls making up the majority of
      cases. Information from a national registry in the United States indicates that JPFS accounts
      for about 7.7% of new patient diagnoses in a pediatric rheumatology setting. The mean age of
      onset of pediatric JPFS is 12 years. As in adults, JPFS has been diagnosed in children and
      adolescents using the ACR criteria. JPFS often leads to substantial morbidity and disability.
      For example, adolescents with JPFS reported significantly greater functional disability and
      greater number of school absences than those with other rheumatic diseases such as juvenile
      RA or lupus. The presence of high levels of pain and disability at this critical
      developmental stage place adolescents with JPFS at greater risk for long term social and
      occupational difficulties. Early diagnosis and effective intervention are therefore of
      critical importance.
    

Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention description(s): Fluoxetine po 10-60 mg/day for 12 weeks. Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibromyalgia; Juvenile
Determination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This study is intended to be an evaluation of the properties of human sputum collected from
      patients with COPD. It is hypothesized that cationic airway lining modulators will have
      beneficial effects on the rheological properties of sputum derived from patients with COPD.
      Approximately 10 patients with COPD will collect sputum at home for 5 days. Samples will be
      collected and tested in laboratory tests.
    


Sampling method: Non-Probability Sample
Study population: 
        Outpatient clinic setting
      
Biospecimen description: 
      Sputum samples
    
Keywords: Sputum; chronic obstructive pulmonary disease
Additive Effects of Pravastatin and Valsartan
Condition: Hypertension; High Cholesterol
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that pravastatin combined with valsartan may have additive
      effects in hypertensive, hypercholesterolemic patients.
    


Intervention name(s): pravastatin, valsartan, pravastatin+valsartan
Intervention type(s): Drug
Intervention description(s): pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment
Intervention MeSH terms: Valsartan; Pravastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: insulin resistance; hypertensive; hypercholesterolemic patients
Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters
Condition: Occlusion; Quality of Life
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The temporomandibular joint (TMJ) is closely related to neuromuscular components. A problem
      occurring in any of these components or parts of the TMJ interferes with the harmonic
      functioning of the TMJ and invites temporomandibular joint disorders (TMD).Management of TMD
      can be conservative or surgical. Physiotherapy, local steam application, external muscle
      massage, occlusal adjustment, analgesic and physiotherapeutic medication and splint
      treatments are the most frequently recommended conservative treatments. Today, occlusal
      adjustments are made with the help of a prosthetic or orthodontic appliance. With these
      intraorally used occlusal splints, a balanced occlusal contact is achieved without applying
      any force to the mandible in the resting position. Occlusal splints are available in
      different designs and different construction materials. The stabilization splint, which is
      one of the most frequently used occlusal splints, and the modified Hawley splint are
      appliances produced from hard materials. However, some researchers have commented that soft
      splints produced from resilient materials may also be useful in the distribution of excessive
      force formed in parafunctional habits. While there are studies stating that hard splints
      provide more successful results than soft splints in functional problems of the chewing
      system, there are also studies reporting that they have similar efficacy on muscle pain after
      short-term use. However, there are no studies in the literature that compare their efficacy
      in short-term and long-term myalgia patients and demonstrate their efficacy using an
      objective test such as digital occlusion analysis. There was no study on the effectiveness of
      different splints on the patient's quality of life. It would be appropriate to carry out our
      study to fill this gap in the literature.The main purpose of this study is to digitally
      examine and compare the effects of three different treatment methods (medical therapy,
      medical therapy+soft splint, medical therapy +hard splint) applied to patients diagnosed with
      facial myalgia after temporomandibular joint examination on the existing occlusion changes.
    


Intervention name(s): Etodolac 400 MG; Thiocolchicoside
Intervention type(s): Drug; Drug
Intervention description(s): Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.; Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.
Other intervention name(s): Etol Fort; Muscoflex
Intervention MeSH terms: Etodolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T Scan; Facial Myalgia
Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus
Condition: Idiopathic Normal Pressure Hydrocephalus
MeSH terms: Hydrocephalus; Hydrocephalus, Normal Pressure
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy of shunt operation for idiopathic normal pressure
      hydrocephalus, and determines the diagnostic value of noninvasive procedures commonly
      practiced in the clinic.
    

Detailed description: 
      Idiopathic normal pressure hydrocephalus (iNPH) is a syndrome characterized by ventricular
      dilatation due to disturbed cerebrospinal fluid (CSF) circulation, accompanied by gait
      disturbance, dementia and/or urinary incontinence without causative disorders. With the aging
      of Japanese society, the number of patients is increasing, requiring diagnostic and
      therapeutic guidelines for the improvement of the patients' quality of life and social care.
      Under such conditions, this project was made as the prospective study of iNPH on Neurological
      Improvement (SINPHONI ). This study aims 1) to establish methods for non-invasive diagnosis
      of iNPH, and 2) to demonstrate therapeutic outcome of shunting operation by Codman Hakim
      programmable valve (CHPV). In this protocol, the evaluation of validity on MRI, tap test, CT
      cisternography, and CBF (3D-SSP) will be done in the diagnosis, and manual of initial setting
      pressure in CHPV for prevention of overdrainage problems will be estimated by modified Rankin
      scale (as primary endpoint) and some another scales during 1 year.
    

Intervention name(s): ventriculo-peritoneal shunt
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: idiopathic normal pressure hydrocephalus; shunt
Role of Parenting Skills and Parenting Style in Pediatric Weight Loss Programs
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the role of different parenting skills and parenting
      styles in the success of children enrolled in a family-based behavioral weight control
      program and to compare these skills and styles to those used by families with normal weight
      children.
    

Detailed description: 
      Pediatric overweight has nearly tripled in the past several decades and while family-based
      behavioral weight control programs are the mainstay of treatment, there is considerable
      variability in their outcomes. Parents play an important role in the success of their
      children, particularly by implementing new behavioral skills. However recent evidence has
      also suggested that parenting style, or the way a parent interacts with their child and
      provides emotional support and discipline, may be another key element in pediatric weight
      control. Our goal is to evaluate the role of specific parenting (behavioral) skills and
      parenting style in the success of children enrolled in a standard family-based behavioral
      weight control intervention. Our goal is to examine whether specific parenting (behavioral)
      skills and parenting style change during the intervention and whether or not this change is
      related to changes in the child's BMI z-score.
    

Intervention name(s): Family-based behavioral weight control intervention
Intervention type(s): Behavioral
Intervention description(s): Standard behavioral weight control program for children ages 8-12 years old and their parents in a family-based intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric obesity; parenting style; feeding style; behavioral skills; parenting skills; family meals
Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years
      and 7 months who have been vaccinated with IXIARO in study IC51-323.
    

Detailed description: 
      This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years
      and 7 months who have been vaccinated with IXIARO in the previous study IC51-323.
    

Intervention name(s): IXIARO; IXIARO
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 ml i.m. (milliliter, intramuscular); 0.5 ml i.m. (milliliter, intramuscular)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immune response; IC51-325; Japanese Encephalitis; Intercell AG
Can Ultrasound Replace Computed Tomography (CT) Scan in Those Unable to Have Computed Tomography (CT) Contrast Agents
Condition: Nephrotoxicity of CT Contrast Agents; CT Scans in Those With Renal Compromise; Sensitivity to CT Contrast Agents; US With CEUS as Replacement for Unenhanced CT Scan
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Computed tomography (CT) scan, performed with contrast enhancement, is one of the most
      commonly requested examinations in diagnostic imaging. In a patient with an elevated
      creatinine or an allergy to contrast agents, the scan may be performed without the benefit of
      contrast enhancement. Ultrasound (US), performed with contrast agent enhancement does not
      have any nephrotoxicity and may be performed on patients with CT contrast allergy. The
      investigators propose that US with Contrast enhanced ultrasound (CEUS) is superior to
      unenhanced CT scan in this population.
    

Detailed description: 
      Contrast enhanced computed tomography (CT) is one of the most common investigations performed
      in any radiology department, used widely in evaluating pathology in any part of the body.

      Historically, it is well known that the use of contrast agents for CT scans may result in
      nephropathy, or renal failure. Nephrotoxicity associated with the injection of CT contrast
      agents may occasionally occur in healthy individuals and more commonly in those with
      borderline renal function. If abnormal kidney function is known to exist in a patient sent
      for CT scan, the examination is performed without the valuable assistance of contrast
      enhancement. Further, if prior hypersensitivity to the contrast agent for CT scan is known,
      again, the scan will be performed without the use of contrast agent.

      Ultrasound (US) performed conventionally in grayscale and with Doppler is able to evaluate
      most abdominal and pelvic organs and also provides vascular information related to large
      vessel blood flow. Contrast enhanced ultrasound (CEUS) provides more precise information on
      blood flow than is available with Doppler and has been shown to be comparable to CT scan in
      some circumstances. We believe that a comparison of conventional US, with CEUS, and
      unenhanced CT scan would clearly favor ultrasound for detection of soft tissue pathology on
      the basis of its inherent tissue contrast differentiation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients referred for unenhanced CT scan on the basis of renal compromise of CT contrast
        agent sensitivity will be eligible for recruitment for our study.
      
Keywords: Ultrasound; Contrast enhanced Ultrasound (CEUS); Nephrotoxicity; CT contrast agents
Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      We compare laparoscopic and classic open operation for inguinal hernia in children. Attention
      is focused on the recovery, surgical result and the duration of the operation and hospital
      stay.
    

Detailed description: 
      Background and objective : In adults the advantages laparoscopic inguinal hernia are less
      pain, shorter recovery, shorter sick leave and better cosmetic result. It is not known
      whether laparoscopic hernia repair produces similar results in children.The objective is to
      compare the duration of recovery, postoperative pain and long-term surgical results between
      day case laparoscopic and open inguinal hernia repair in children.

      Key inclusion criteria: Children included in the study must be aged four months to sixteen
      years of age and not have undergone any previous surgery. Of male patients those with
      completely descended testes are accepted.

      Study type: The study is randomized, single-blinded prospective comparison between
      laparoscopic and open day case inguinal hernia repair in children.

      Target sample size: For the assumption that there is a difference of one day in time to
      restore normal activities after laparoscopic and open hernia repair, target sample size of
      100 patients in the laparoscopic and 100 in open repair arm should reach 90% power with p <
      0.05.

      Recruitment status : From 10/ 2002 to 1/2007 89 patients (laparoscopic repair LH 47, open
      repair OH 42) are recruited. Primary outcome: The time to restore normal activity after
      surgery . Secondary Outcomes : The degree of postoperative pain, the duration of the
      operation, sick leave of parents, surgical result 6 months and 2 years after the repair.
    

Intervention name(s): Hernia repair
Intervention type(s): Procedure
Intervention description(s): Hernia repair laparoscopically (LH) or by open operation (OH)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: inguinal hernia; laparoscopic repair; open repair; randomized
Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function
Condition: Secondary Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in
           overweight male subjects with hepatic impairment and in volunteers with normal hepatic
           function.

        -  To compare the safety profile of a single dose of 25 mg Androxal in overweight male
           subjects with hepatic impairment and in volunteers with normal hepatic function.
    


Intervention name(s): Androxal 25 mg
Intervention type(s): Drug
Other intervention name(s): enclomiphene citrate
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral
      antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral
      antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
    


Intervention name(s): Insulin lispro mid mixture (MM); Insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks; Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
Other intervention name(s): Humalog; Mid Mix
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; type 2
Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II
      clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of
      clinical efficacy are promising.

      The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in
      subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working
      anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be
      enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K
      will also be evaluated.
    


Intervention name(s): TNF-Kinoid; Placebo
Intervention type(s): Biological; Other
Intervention description(s): IM administration; IM administration
Other intervention name(s): ISA 51; ISA 51
Intervention MeSH terms: Freund's Adjuvant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
Condition: Forehead Rhytides; Forehead Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether there is a difference in clinical effect,
      duration of effect, level of discomfort and patient satisfaction in patients receiving
      topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to
      Botulinum Toxin Type A administration for the treatment of forehead rhytides.
    

Detailed description: 
      This is a prospective, randomized, double-masked, comparative study in patients who present
      at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with
      botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA).

      The objective of this study is to determine whether there is a difference in clinical effect
      (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and
      patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 %
      prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum
      ointment on the other prior to BTX-A administration for the treatment of forehead rhytides.

        -  Primary outcome variable is change of eyebrow excursion on each side of the forehead
           from baseline to each follow-up visit.

        -  Secondary outcome variables

             -  Duration of effect, defined as the elapsed time from injection to the end of
                botulinum, such that return of baseline frontalis function, i.e. within 2 mm of
                baseline value

             -  Perception of pain immediately after injection at each side

             -  Patient satisfaction for each side

             -  Patient's perception of difference in efficacy
    

Intervention name(s): Botulinum toxin type A; 2.5% lidocaine/2.5% prilocaine; petrolatum ointment
Intervention type(s): Drug; Drug; Device
Intervention description(s): Botulinum toxin type A will be administered to both sides; 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead; petrolatum ointment will be applied to one side of the forehead
Other intervention name(s): BTX-A; EMLA; Aquaphor
Intervention MeSH terms: Lidocaine; Prilocaine; Petrolatum; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Rhytides; Forehead Wrinkles