bioihbjkbjnl/mcl2 huggingface dataset:
A Bioequivalence Study of 15 mg ER OROS Paliperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence between the Phase 3 and the
      to-be-marketed formulations of extended release (ER) OROS paliperidone and to evaluate the
      effect of food on the highest to be marketed tablet strength. Additionally, the safety and
      tolerability of the treatments in healthy volunteers will be assessed.
    

Detailed description: 
      This study is designed as a single-center, open-label, randomized, 3 treatment-period,
      crossover study in healthy male adults. The study consists of a screening phase and an
      open-label treatment phase during which each volunteer will receive 3 treatments of study
      drug in a random order and separated by a washout period of 10 to 14 days. Treatment A
      consists of a single oral dose of 15 mg ER OROS paliperidone Phase 3 formulation in the
      fasted state; Treatment B consists of a single oral dose of 15 mg ER OROS paliperidone
      to-be-marketed formulation in fasted state; and Treatment C consists of a single oral dose of
      15 mg ER OROS paliperidone to-be-marketed formulation after consumption of a high-fat
      breakfast. There are slight formulation differences between the ER OROS paliperidone
      formulation that was used in Phase 3 efficacy studies and the formulation that is intended to
      be marketed. What is more important, however, is that the highest tablet strength used in
      Phase 3 and the tablet strength that is planned for the market as commercial formulation are
      different. For Phase 3 studies, 9 mg was the highest tablet strength and the highest dose of
      15 mg was administered as 2 tablets of 3 mg and 1 tablet of 9 mg. The highest to-be-marketed
      tablet strength is 15 mg. This study is designed to demonstrate the bioequivalence between
      the Phase 3 formulation and the highest tablet strength of the to-be-marketed formulation and
      to assess the effect of food on the highest to-be-marketed tablet strength. Safety and
      tolerability will be monitored throughout the study. All volunteers will receive each of the
      following 3 treatments in the order specified by the random assignment:Treatment A, oral ER
      OROS paliperidone Phase 3 formulation as 2 tablets of 3 mg and 1 tablet of 9 mg in the fasted
      state; Treatment B, oral ER OROS paliperidone to-be-marketed formulation as 1 tablet of 15 mg
      in the fasted state; Treatment C, oral ER OROS paliperidone to-be-marketed formulation as 1
      tablet of 15 mg after a high-fat breakfast.
    

Intervention name(s): ER OROS Paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia, Mood disorders, Antipsychotics; ER OROS Paliperidone
Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
Condition: Tennis Elbow; Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases; Tennis Elbow
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomised controlled trial will evaluate the role of manual therapy and therapeutic
      exercise and corticosteroid injections in the treatment of lateral epicondylalgia (tennis
      elbow).
    

Detailed description: 
      Musculoskeletal conditions account for the third leading cause of health systems expenditure
      in Australia. Lateral epicondylalgia (tennis elbow) is a painful musculoskeletal condition
      that is often treated in primary care. Seven out of every 1000 patients seeing their general
      medical practitioner do so for this condition, though most are not tennis related. On average
      10-30% of sufferers take 12 weeks of absenteeism from work and the condition may last 6-48
      months.

      Two popular treatment options that are commonly prescribed for the management of lateral
      epicondylalgia are manual therapy/therapeutic exercise and corticosteroid injections. To date
      there is little evidence that supports manual therapy/therapeutic exercise. This lack of
      evidence is largely due to the small number of studies of physiotherapy treatments, most of
      which are of poor quality. The small number of studies of manual therapy contrasts with the
      larger number of studies of corticosteroid injections, which show that corticosteroid
      injections are beneficial in the short term (3-6 weeks), but they are associated with
      significantly greater recurrence rates and offer no advantage in the long term (12 months).
      The efficacy of a manual therapy and therapeutic exercise programme compared to that of
      corticosteroid injections is unknown at this stage.

      This randomised controlled trial will evaluate the role of manual therapy and therapeutic
      exercise in the treatment of lateral epicondylalgia. The factors associated with success or
      failure of these common treatment options for lateral epicondylalgia will also be examined. A
      tangible outcome of this project will be the development of clinical guidelines for the most
      effective method of treating lateral epicondylalgia.
    

Intervention name(s): Manual therapy and therapeutic exercise; Corticosteroid injections
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Tennis Elbow; Physical Therapy Techniques; Evidence-Based Medicine; Primary Health Care
Fit and Trim for Diabetes Prevention
Condition: Pre-diabetes; Overweight; Obese
MeSH terms: Diabetes Mellitus; Overweight; Prediabetic State
Study type: Interventional

Summary: 
      Filipino Americans (FA) are the second largest (3.4 million) Asian group in the US. and have
      one of the highest prevalences of obesity and type 2 diabetes mellitus compared to
      non-Hispanic whites, African Americans and Hispanics. However, FA have been underrepresented
      in health related research, particularly in diabetes prevention. This proposed pilot study is
      the first clinical trial to assess preliminary estimates of the short-term effect of the
      novel social networking diabetes prevention program lifestyle intervention for this high-risk
      population.
    

Detailed description: 
      Filipino Americans (FA) are the second largest (3.4 million) Asian group in the US, and the
      largest (1.5 million) in California, and have the highest prevalence of obesity and type 2
      diabetes mellitus (T2DM) compared to non-Hispanic whites, African Americans and Hispanics.
      However, there has been little health related research among FA. Improving physical activity
      (PA) and diet can prevent or delay T2DM, as evidenced by the Diabetes Prevention Program
      (DPP) lifestyle intervention, resulting in reducing T2DM risks. However, implementing the DPP
      has been expensive and labor intensive. A more cost-effective approach may be the use of
      mobile technologies coupled with social networking. Filipinos (95%) are avid mobile phone
      users and the leading Facebook users. Thus, we propose to test a culturally competent mobile
      phone-based Diabetes Prevention Program lifestyle and social networking (in-person and
      virtual) intervention in a pilot 3-month randomized controlled trial (RCT) with a wait list
      active control design for 50 overweight FA at risk for developing type 2 diabetes.
    

Intervention name(s): Filipinos Fit and Trim Weight Loss Program
Intervention type(s): Behavioral
Intervention description(s): This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
Other intervention name(s): Fit and Trim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diabetes prevention; Filipinos; lifestyle intervention
Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      To assess: a) The prevalence of Modic changes and other findings on lumbar magnetic resonance
      imaging (MRI), among Spanish adult chronic LBP patients, b) Patient characteristics and
      radiological findings associated with Modic changes.
    

Detailed description: 
      Ten radiologists from six hospitals across six cities in Spain, consecutively recruited 487
      adult patients (263 women and 224 men) in whom lumbar MRI had been prescribed for low back
      pain lasting ≥ 3 months. Patients' characteristics and imaging findings were assessed through
      previously validated instruments. A multivariate logistic regression model was developed to
      assess the features associated with Modic changes.

      Outcome measures were: Gender, age, body mass index (BMI), life time smoking exposure, degree
      of physical activity, and image features (disk degeneration, type and extension of Modic
      changes, disk contour, annular tears, spinal stenosis and spondylolisthesis).
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients seen for chronic low back pain at the hospitals of the Spanish National Health
        Service.
      
Keywords: MODIC changes; chronic low back pain; magnetic resonance imaging (MRI); vertebrae; intervertebral disc
Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation
Condition: Microbial Colonization
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Primary purpose of the study is to see if rifaximin can improve the balance of bacteria
      within the gut, which has been shown to improve transplant outcomes. It will also assess
      whether rifaximin can reduce the risk of infection in blood/marrow transplant (BMT).
    

Detailed description: 
      This study is for patients who will be having a blood/marrow transplant (BMT) to treat
      leukemia, lymphoma or other cancer of the blood. The blood or marrow cells will come from
      another person (donor)-allogeneic BMT. Bacterial infections and acute graft versus host
      disease (AGVHD) are frequent complications of allogeneic BMT. Bacterial infections sometimes
      happen because injury to the gut during transplant allows gut bacteria to cross the injured
      gut barrier and get to the blood. AGVHD happens when certain white blood cells, called
      T-cells, in the donor cells (the graft) attack the patient's body.

      Primary purpose of the study is to see if rifaximin can improve the balance of bacteria
      within the gut, which has been shown to improve transplant outcomes. It will also assess
      whether rifaximin can reduce the risk of infection in blood/marrow transplant (BMT).
    

Intervention name(s): Rifaximin
Intervention type(s): Drug
Intervention description(s): Rifaximin will be administered twice a day orally or by nasogastric tube, at a dose of 15 mg/kg divided BID with a maximum dose of 1,650 mg, day -7 to day +28 or discharge (maximum duration 36 days).
Intervention MeSH terms: Rifaximin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Pilot, single arm prospective study with retrospective control arm
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rifaximin; Microbiome; Allogeneic hematopoietic stem cell transplantation; Blood stream infections; Acute graft versus host disease
TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI
      (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus
      glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine
      beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters
      and rate of exacerbations, as well as to assess its safety and some health economics
      outcomes.
    


Intervention name(s): CHF 5993 100/6/12.5 µg; CHF 1535 100/6 µg
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma, anticholinergics, triple combination
Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
Condition: Epidermolysis Bullosa; Epidermolysis Bullosa Simplex
MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Simplex
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the long term safety and tolerability of
      diacerein 1% ointment for 2 treatment cycles in subjects with EBS that previously
      participated in the CCP-020-301 or the CCP-020-101 studies.
    

Detailed description: 
      This is an international, multicenter, open-label, long term extension study evaluating the
      safety of topical Diacerein 1% Ointment for the treatment of subjects with EBS. At Visit 1,
      EBS subjects who completed the CCP-020-301 double-blind safety and efficacy study or
      participated in the CCP-020-101 PK study (feeder studies) who meet all the
      inclusion/exclusion criteria will be eligible to complete 2 treatment cycles of CCP-020.

      Each treatment cycle will consist of 8 weeks on treatment (once-daily, at home study
      medication applications) followed by 8 weeks off treatment (only Investigator approved bland,
      non-medicated emollient/moisturizer, routine cleansing products and sunscreens) with a
      maximum of 2 treatment cycles allowed for up to 52 weeks.

      At Baseline Visit (corresponding to the final study visit of the feeder study), the
      investigator will perform a clinical assessment and determine if any of the subject's lesions
      require treatment (up to 30% BSA). If the subject has active lesions as determined by the
      Investigator's clinical assessment, the subject will initiate a cycle of once-daily, at home
      study medication application to their EBS lesions for 8 weeks (treatment period) followed by
      an 8-week period where no treatment will be administered. Subjects presenting with no active
      lesions (as determined by the Investigator's clinical assessment) will not begin treatment
      and instead, will be instructed to return to the clinic for re-evaluation in 8 weeks or upon
      worsening of EBS lesions, whichever happens first.
    

Intervention name(s): diacerein 1% ointment
Intervention type(s): Drug
Intervention description(s): Topically apply study medication to lesions identified by the Investigator that require.
treatment
Other intervention name(s): CCP-020
Intervention MeSH terms: Diacerein
Intervention model: Single Group Assignment
Intervention model description: This is an international, multicenter, open-label, long term extension study evaluating the safety of topical Diacerein 1% Ointment for the treatment of subjects with EBS. At Baseline Visit, EBS subjects who participated the CCP-020-301 double-blind safety and efficacy study or participated in the CCP-020-101 PK study (feeder studies) and who meet all the inclusion/exclusion criteria will be eligible to enroll in this study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidermolysis Bullosa (EB); Epidermolysis Bullosa Simplex (EBS)
Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Lymph node dissection in gastric cancer surgery is a very important factor not only for exact
      acquisition of stage but also proper treatment. Realistically, it is impossible to identify
      complete removal of lymph node in dissected nodal station by naked eye. The investigators can
      assess the route of lymphatic drainage and identify residual lymph nodes in dissected area.
      In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was
      used only detection of sentinel lymph nodes. However, this novel concept can help to
      understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection
      completely.
    


Intervention name(s): Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy
Intervention type(s): Procedure
Intervention description(s): 0.75mg of ICG injection around tumor each four direction by endoscopy on one or two days before surgery. NIR fluorescence imaging application during laparoscopic or robotic gastrectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: near infrared; fluorescence imaging; indocyanine green; gastrectomy
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Observational

Summary: 
      The objectives of this qualitative study are to elicit concepts about symptoms that are
      important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts
      of symptoms on patients' day-to-day functioning.
    

Detailed description: 
      In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be
      conducted. The aims of the concept elicitation interviews are to:

        1. Identify the most common symptoms, as well as the most important symptoms, for patients
           with PSC, and

        2. Assess whether these symptoms impact day-to-day functioning

      An instrument will be developed based on the symptoms reported and in Step II of the study,
      the performance of the instrument will be assessed with further interviews.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from approximately 5 clinical sites based in the United
        States.
      
Keywords: Primary sclerosing cholangitis; PSC
Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the efficacy and safety of combination therapy of
      vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000
      mg/day.
    


Intervention name(s): vildagliptin/metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Vildagliptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; vildagliptin; metformin
Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65)
Condition: Retinitis Pigmentosa (RP)
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

        -  To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in
           RP subjects with an autosomal dominant mutation in RPE65.

        -  To evaluate duration of visual function improvement (if observed) in RP subjects with an
           autosomal dominant mutation in RPE65 after 7-day treatment with oral QLT091001.

        -  To evaluate the safety of oral QLT091001 administered once daily for 7 days in RP
           subjects with an autosomal dominant mutation in RPE65.
    


Intervention name(s): QLT091001
Intervention type(s): Drug
Intervention description(s): oral QLT091001 administered once daily for 7 days
Intervention MeSH terms: Retinol acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Urinary Continence After Radical Prostatectomy: Surgical Procedure and Anatomic Landmarks
Condition: Prostatic Cancer; Surgical Procedure, Unspecified; Urinary Incontinence
MeSH terms: Prostatic Neoplasms; Urinary Incontinence
Study type: Observational

Summary: 
      This study describes how to perform a correct prostatic apex and membranous urethra in order
      to preserve all anatomical elements that are necessary to achieve a very fast urinary
      continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical
      margins at this level.
    

Detailed description: 
      This study describes a simple technical variation, aimed at the sparing of the muscle systems
      and neurovascular bundles in order to achieve high rates of urinary continence in the early
      postoperative period ( the first two months after surgery) in prostate cancer patients
      undergoing radical prostatectomy.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A series of 120 consecutive prostate cancer patients who underwent Laparoscopic Radical
        Prostatectomy from 2012 to 2018, always performed by the same surgeon
Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube
Condition: Eustachian Tube Disorder
Study type: Interventional

Summary: 
      The study aim is to evaluate the tubal score on patients who suffer from obstructive
      dysfunction of eustachian tube before and after the eustachian tube dilatation.
    

Detailed description: 
      The study aim is to evaluate the tubal score on patients who suffer from obstructive
      dysfunction of eustachian tube before the intervention and 12 months after the eustachian
      tube dilatation.

      This patients are refractory to the reference medical treatment.
    

Intervention name(s): Balloon catheter for the Eustachian tube
Intervention type(s): Device
Intervention description(s): Balloon catheter is inserted in the Eustachian tube to dilate it.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment