bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to evaluate the potential 2-way reciprocal interaction between
      multiple doses of Epanova™ and a single dose of rosuvastatin
    

Detailed description: 
      The PK of rosuvastatin will be monitored following single-dose administration of rosuvastatin
      with and without multiple-dose administration of 4 g Epanova™ for 13 consecutive days in
      order to detect a possible interaction between rosuvastatin and Epanova™. The PK of total
      EPA, total DHA and total EPA+DHA will also be monitored following multiple-dose
      administration of Epanova™ with and without single-dose administration of 40 mg rosuvastatin.
      A single dose administration for rosuvastatin has been judged sufficient to yield plasma
      concentrations that will be detectable with an adequate validated analytical method and
      characterize adequately the PK of rosuvastatin.
    

Intervention name(s): rosuvastatin 40 mg tablet; Epanova™ QD (2 x 1 g capsules); Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose; Multiple (20) oral doses of 2 g Vascepa® every 12 hours
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1).; Multiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13); Multiple oral doses of 4 g Epanova™ QD for 13 consecutive days with coadministration of single 40 mg oral dose of rosuvastatin (Crestor®) with the 11th dose of Epanova™ on Day 24; Multiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20).
Other intervention name(s): Crestor; omega-3 carboxylic acids; omega-3 carboxylic acids; Crestor; icosapent ethyl
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epanova; omega-3 carboxylic acids; Vascepa; Eicosapentaenoic acid ethyl ester; Crestor; rosuvastatin
Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention
Condition: Environmental Exposure
Study type: Interventional

Summary: 
      The investigators recent study has found that ambient melamine exposure can cause the
      increase of biomarkers of renal tubular injury in melamine manufacturing workers. Thus, in
      this year, the investigators will examine whether the intervention by installing ventilation
      in the workplace and providing personal protective equipment and education can decrease
      ambient melamine exposure and further decrease urinary biomarkers of renal tubular injury
      such as N-acetyl β-D-glucosaminidase (NAG) and β2-microglobulin (β2-MG).
    

Detailed description: 
      The investigators through intervention trial design to examine whether the use of ventilation
      in the workplace can decrease ambient melamine exposure, oxidative stress markers (such as
      8-hydoxy-2-deoxyguanosine, malondialdehyde)and indicators of early renal damage (such as
      N-acetyl β-D-glucosaminidase, microalbumin and β2-microglobulin). The one week before
      intervention and the second week after intervention, the volunteers were asked to collect
      their urine samples for one consecutive week during mornings and afternoons. Blood samples
      were taken on Fridays morning, workplace air was sampled for 5 consecutive days. Then the
      investigators continued to trace the melamine concentration change of volunteers and
      workplace every three-month intervals after intervention, and blood samples were taken on
      12th and 24th month.
    

Intervention name(s): installing ventilation in the workplace
Intervention type(s): Device
Intervention description(s): Environmental improvement by installing/ exhaust ventilation (FUDIN SYSTEM ENGINEERING CO.,LTD.)
Intervention model: Single Group Assignment
Intervention model description: Install local ventilation or not
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Melamine; Renal damage; Workplace intervention
Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?
Condition: Cerebral Palsy; Reflexology
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Objectives: This study was planned to investigate the influence of reflexology applied to
      children with cerebral palsy together with physical therapy program involving
      neurodevelopmental approaches.

      Methods: The study involved 40 children aged,16 girls and 24 boys between 3 and 15 years and
      divided into two groups. While the children in Group 1 were given twice a week for eight
      weeks neurodevelopmental treatment, reflexology was applied to those in Group 2 together with
      neurodevelopmental treatment. Drooling Severity and Frequency Scale, Pediatric Sleep
      Questionnaire and the Children's Health Questionnaire was used to assess the drooling, status
      of sleep and quality of life in children.
    

Detailed description: 
      The study involved a total of 40 children aged between three and 15 diagnosed with CP by a
      pediatric neurologist. Children at levels 3/4/5 of the GMFCS who did not have any open wounds
      on the foot, where the application was to be performed, and whose parents consented to the
      child's participation were accepted in the study. However, those children were excluded who
      were treated with botulinum toxin in the last six months, underwent surgery, were treated
      with reflexology or any other alternative medicine method and who had refractory epilepsy.
    

Intervention name(s): physical therapy and reflexology
Intervention type(s): Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety, Tolerance, and Pharmacokinetics of Single Rising Oral Doses of BILB 1941 ZW Solution in Healthy Male Subjects, Followed With Bioavailability Comparison of BILB 1941 ZW Tablet and Solution Formulation Administered With or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study was to investigate the safety, tolerability, and
      pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5
      mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a
      high-fat breakfast was to be be investigated
    


Intervention name(s): BILB 1941 ZW - single rising dose part; Placebo; BILB 1941 ZW - solution; BILB 1941 ZW - tablet; standardized breakfast
Intervention type(s): Drug; Drug; Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Role of Proteomics in Diagnosing Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Observational

Summary: 
      Sarcoidosis is a multi-systemic disorder, meaning that it can involve any organ in the body
      and that its clinical presentation is highly variable. In 90% of all sarcoidosis cases the
      lungs are affected. It is difficult to give a concise definition of sarcoidosis due to the
      fact that its exact cause is still unknown. Consequently, diagnosing the disease is also
      rather difficult. Up till now, sarcoidosis is generally diagnosed by using general clinical
      methods to evaluate the status of the lung including a chest X-ray, lung biopsy and
      bronchoalveolar lavage (BAL). However, some of these methods are considered to be rather
      invasive and, even more important, non-conclusive. Therefore, the current study has been
      designed to evaluate the use of a new technique, called SELDI-TOF mass spectrophotometry, for
      the diagnosis of sarcoidosis. This technique enables the analysis of all enzymes present in
      the blood of sarcoidosis patients which may hopefully lead to creating a disease-specific
      protein-profile that may facilitate the recognition of sarcoidosis. Moreover, these results
      will be compared with other currently used laboratory parameters.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients visiting the out-patient clinic of the university hospital Maastricht.
      
Biospecimen description: 
      Blood will be collected from all participants, but all samples will be stored anonymously.
    
Keywords: sarcoidosis; protein profile; CYP-450; TNF-alpha polymorphisms; HLA
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of
      the acute administration of 3.2 µg of PH94B to relieve symptoms of anxiety in adult subjects
      with social anxiety disorder (SAD) during an induced public speaking challenge.

      Subject participation in the Study will last a total of 3 to 7 weeks, depending on the
      duration of the screening period and intervals between visits. Upon signing an informed
      consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting
      between 3 and 35 days. If subjects meet all eligibility criteria at the end of the screening
      period, subjects will return for Visit 2 and self-administer the nasal spray and then
      participate in a 5 minute public speaking challenge. During the public speaking challenge,
      the subject will be asked for their anxiety score, which will be recorded by a trained
      observer. At Visit 3, the subjects will undergo the same public speaking procedure once again
      as they did in Visit 2. One week after the completion of the Visit 3 public speaking
      challenge, the subject will come back for Visit 4 (Follow-up) that will involve a repeat of
      the safety and psychiatric assessments conducted at Screening.
    


Intervention name(s): PH94B Nasal Spray; Placebo Nasal Spray
Intervention type(s): Drug; Drug
Intervention description(s): Nasal spray delivered 20 minutes before the public speaking stressor; Nasal spray delivered 20 minutes before the public speaking stressor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The purpose of this study is to identify the flexibility radiograph(s) that can most
      accurately predict the curve behaviour after surgical correction of AIS. With these findings,
      the investigators hope to give further guidance for the selection of fusion levels and to
      incorporate different dynamic radiographs into the Lenke Classification, leading to a more
      universal application that can consistently lead to good surgical and clinical outcome.
    

Detailed description: 
      The Lenke Classification is the most widely-accepted classification for Adolescent Idiopathic
      Scoliosis (AIS) in the world. Its recommendations for fusion of the minor curves depend on
      its structurality. It defines a minor curve as structural if there is inflexibility on
      side-bending more than 25 . However, a recent Delphi survey from a panel of experts in AIS
      management showed that there was no consensus as to which type of dynamic radiograph was
      optimal. Up to two thirds of the surgeons did not use side-bending as a routine, and hence
      they cannot apply the Lenke Classification accurately in clinical practice nor follow its
      recommendations for fusion.

      Furthermore, the current classification does not give specific recommendations regarding the
      selection of fusion levels and does not take into account the clinical appearance of the
      patients which impact on treatment. Consequently, there are still controversies regarding the
      Upper Instrumented Vertebra (UIV) and Lowest Instrumented Vertebra (LIV) selections, and
      following the recommendations may not allow fusion of the least number of segments nor give
      best clinical results eg shoulder balance.
    

Intervention name(s): Flexibility Radiographs (supine, supine side-bend, FB); Flexibility Radiographs (awake traction); Flexibility Radiographs (STUGA)
Intervention type(s): Radiation; Radiation; Radiation
Intervention description(s): Supine, supine side-bend, fulcrum bend; awake traction; supine traction under GA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be divided into two phases. In Phase 1, an exploratory pilot study will be
        performed with up to 3 flexibility films done on the same patient in different spinal
        centres which are in Hong Kong and Turkey.
      
Keywords: AIS
Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses
Condition: Myopia
MeSH terms: Seizures; Myopia
Study type: Interventional

Summary: 
      This study aims to compare the short-term clinical performance of the three contact lenses
      (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).
    

Detailed description: 
      This will be a randomized, double-masked, crossover, bilateral non-dispensing study,
      controlled by cross-comparison. Forty subjects will wear each lens brand for approximately
      one hour, on three separate study days in random order. Lenses will only be worn during study
      visits.
    

Intervention name(s): Methafilcon A IV; Ocufilcon B; Omafilcon A
Intervention type(s): Device; Device; Device
Intervention description(s): Contact Lens; Contact Lens; Contact Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Level of Physical Activities in Patients Before and After Breast Cancer Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had
      already been treated at the Ambulatory of Botucatu School of Medicine were selected. The
      measuring tool used for the level of physical activities was the International Physical
      Activities Questionnaire (IPAQ-short version), validated by the World Health Organization -
      Physical Activities and Health International Committee (1998).
    

Detailed description: 
      Introduction: Breast cancer is the most common malignant neoplasy in women. The risk for
      breast cancer in a lifetime is high among north-american women, about one out of eight, with
      66% of the cases occurring after menopause and 15% when women are under 40 years old.
      Published cohort studies show clear evidences that women who practice intense physical
      activities have the risk for breast cancer reduced. The risk reduction for these women is
      70%, and 10% for those who practice physical activities at a low level. During adolescence
      and adult age, moderate to intense physical activities may protect against a future breast
      cancer development. But some questions still need to be answered: Were women with a breast
      carcinoma diagnosis already physically active during life? Were there changes in these
      physical activities after treatment? Why? Objectives: The aim of this study was to identify
      the level of physical activities in patients before and after breast carcinoma treatment, and
      to observe if there were changes in the level of these activities. Subjects and Methods: 303
      patients who had already had the diagnosis of breast cancer and had already been treated at
      the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the
      level of physical activities was the International Physical Activities Questionnaire
      (IPAQ-short version), validated by the World Health Organization - Physical Activities and
      Health International Committee (1998).
    

Intervention name(s): IPAQ
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Physical Activity; Breast Cancer
Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel
Condition: Prevention
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to obtain data on the pharmacokinetics (PK) and pharmacodynamics
      (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing
      regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex
      acts.
    


Intervention name(s): Tenofovir 1% vaginal gel
Intervention type(s): Drug
Intervention description(s): Tenofovir 1% gel is supplied as a clear, transparent, viscous gel packaged in pre-filled single use applicators. Each applicator contains 4.0 mL of tenofovir gel (equal to 4.4 gm) at a concentration of 1% (weight for weight) formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben and hydroxyethylcellulose, and is pH adjusted to 4-5.
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV
Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
Condition: Autoimmune Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Autoimmune
Study type: Interventional
Phase: Phase 3

Summary: 
      Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are
      corticosteroids (CS). In addition to being ineffective a substantial minority of cases,
      corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options
      for induction of remission are limited. There are reports of successful salvage therapy with
      Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have
      shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies
      comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy
      and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH
      patients.
    


Intervention name(s): Cyclosporine-A
Intervention type(s): Drug
Intervention description(s): Cyclosprorine-A will be administered to patients in group-B according to a set protocol and the patients will be followed at regular intervals with appropriate checking of clinical and para-clinical data.
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autoimmune hepatitis; corticosteroids; cysclosporine-A; treatment; treatment-naive; induction of remossion; efficacy; tolerability
Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily
      dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.
    


Intervention name(s): Letrozole
Intervention type(s): Drug
Intervention MeSH terms: Letrozole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer, ER and/or PgR positive, Letrozole
RZL-012 for Dercum's Disease Lipomas
Condition: Dercum's Disease Lipomas
MeSH terms: Lipoma; Adiposis Dolorosa
Study type: Interventional
Phase: Phase 2

Summary: 
      Thirty-eight (38) subjects will be included in the study. Subjects will be randomized in a
      ration of 1:1 to be treated with RZL-012 or placebo. Subjects will be injected with a
      different doses of RZL-012 according to their lipomas sizes. The total of 38 subjects will be
      enrolled in 3 clinical sites.
    

Detailed description: 
      This is a multi-center, randomized, double blind, placebo controlled clinical trial in DD
      subjects having lipomas. Subjects will be randomized, in a 1:1 ratio, into two groups
      injected with either RZL-012 or vehicle.

      Once the study ends and codes are opened, 84 days after dosing, placebo-treated subjects will
      be offered the option of receiving treatment with RZL-012 and followed up for an additional
      84 days.

      At least 4 lipomas/nodules, preferably 6, and no more than 8, will be injected per subject,
      two of which will be medium (4-5.9 cm), large (6-7.9 cm) or extra-large (8-10 cm) in
      diameter. Dosing will be according to lipoma size, where the total injected dose will not
      exceed 240 mg per patient (48 injections at 5mg/injection).
    

Intervention name(s): RZL-012; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): small synthetic molecule for the treatment of Dercum's Disease lipomas; Vehicle of RZL-012 drug product
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Comparing the Injection Site Pain Experience After the Injection of 2 Different Solutions of Semaglutide With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity
Condition: Healthy Volunteers Diabetes Mellitus, Type 2; Healthy Volunteers Overweight; Healthy Volunteers Obesity
MeSH terms: Obesity; Overweight; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study in healthy men and women compares the injection site experience of the DV3396 pen
      to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide
      subcutaneously (sc, under the skin). Participants will receive 2 single doses of semaglutide
      0.25 mg on 1 day. The 2 injections will be given at least 30 minutes apart, one in each side
      of the stomach. Participants will be in the clinic research center for 1 day. A follow-up
      phone call will take place between 4 and 5 weeks after the injections were given.
    


Intervention name(s): Semaglutide (administered by DV3396 pen); Semaglutide (administered by PDS290 pen)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day; Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment