bioihbjkbjnl/mcl2 huggingface dataset:
Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test
Condition: Skin Irritation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study examined the possible sensitization and irritation effects of a moisturizer with
      sunscreen SPF 50+.
    

Detailed description: 
      The design for this study is standard for human repeat insult patch tests. To test the
      moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by
      repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals
      of the moisturizer to the upper back. Patches were remained on the skin for approximately 48
      to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with
      the moisturizer at the original site and an alternative site for 48 hours.
    

Intervention name(s): Facial Moisturizer with SPF 50+
Intervention type(s): Drug
Intervention description(s): All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+
Other intervention name(s): Cetaphil Daily Facial Moisturizer with SPF 50+
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cetaphil Daily Facial Moisturizer with SPF 50+; Hypoallergenicity; Skin Irritation
Pharmacogenetic Dosage Algorithm for Acenocoumarol
Condition: Atrial Fibrillation; Venous Thromboses; Cardiac Valve Disease
MeSH terms: Atrial Fibrillation; Thrombosis; Venous Thrombosis; Heart Valve Diseases
Study type: Observational

Summary: 
      The use of coumarins has been a challenge for doctors because of its narrow therapeutic range
      and they show great inter and intra-individual variability in the dose necessary to achieve
      an international normalized ratio (INR) within the therapeutic range. Among the factors
      influencing the interindividual variability in the dose required include age, weight, Vitamin
      K in the diet, comorbidity as well as drug interactions and in recent years has also seen the
      importance of pharmacogenetic factors.
    

Detailed description: 
      Demographic and clinical factors contribute approximately 20% to the total variability of
      dose requirements. In recent years it has highlighted the close relationship between the dose
      requirements of coumarin drugs and certain polymorphisms of genes involved in
      pharmacokinetics and pharmacodynamics of these drugs. The use of dosing algorithms that
      include pharmacogenetic information may help in the dose selection, improving efficacy and
      reducing adverse events. Studies have shown the relationship between genotype variants of
      CYP2C9 and VKORC1, CYP4F2 and apolipoprotein E (ApoE), which together with the demographic
      and clinical variants can explain between 50-60% of the variability in the response to these
      drugs.
    

Intervention name(s): Acenocoumarol
Intervention type(s): Genetic
Intervention description(s): A blood sample was collected for CYP2C9, VKORC1, CYP4F2, APOE and 2 variants of POR genotypes.
Intervention MeSH terms: Acenocoumarol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving stable anticoagulant treatment with acenocoumarol for auricular
        fibrillation, venous thromboembolic disease and/or cardiac valve replacement in Hospital La
        Paz and Barrio del Pilar primary care center.
      
Biospecimen description: 
      Patients' consent was requested for the preservation of their DNA sample, in case of new
      genes related to the pharmacokinetics or pharmacodynamics of acenocoumarol are discovered in
      the future.
    
Keywords: Acenocoumarol; Cytochrome P450; Pharmacogenetics; Algorithm; CYP2C9; VKORC1; CYP4F2; P450 oxidoreductase (POR)
A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect of fluconazole, under steady
      state conditions on the pharmacokinetics of BI 425809 (Reference Treatment R: BI 425809
      alone; Test Treatment T: BI 425809 given under steady state conditions of fluconazole).
    


Intervention name(s): BI 425809; fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): Period 1 and period 2; Period 2
Intervention MeSH terms: Fluconazole; BI 425809
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ESS as a Diagnosis Resource Aid of the Syndrome of Obstructive Sleep Apnea
Condition: Sleep Apnea; Mixed Central and Obstructive Sleep Apnea; Sleep-Disordered Breathing
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a
      recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients
      attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The
      data were collected from records, wich are of questionnaires, including the ESE, prepared by
      the CESF professionals and responded, previously, by the own patients. The study compared the
      result obtained in the scale of Epworth with the data of polysomnography. The analysis of
      data was performed using the SPSS, based on descriptive and inferential statistics, being
      used the average considering the standard deviation, and, to the crossing of variables, was
      used the chi-square test of Pearson, considering as significant statistically values of
      p<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.
    


Intervention name(s): Questionnaire and polysomnography
Intervention type(s): Other
Intervention description(s): Comparison of polysomnography data records and previously made questionnaire, with the Epworth Sleepiness Scale.
Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that sought the CESF to probable diagnosis of some sleep disorder
      
Keywords: Evaluation; Obstructive sleep apnea; Polysomnography
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
Condition: Exercise Induced Asthma
MeSH terms: Asthma; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of four weeks of treatment with two
      investigational drugs (oral versus inhaled administration) plus an inhaled medication in the
      treatment of airway constriction brought on by exercise in participants with asthma.
    


Intervention name(s): Montelukast sodium; Salmeterol xinafoate; Fluticasone propionate; Montelukast matching placebo; Salmeterol matching placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Montelukast 5 mg chewable tablet once daily; Salmeterol 50 mcg dry powder per actuation inhaled twice daily; Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily; Matching placebo to montelukast oral tablet administered once daily.; Matching placebo to salmeterol dry powder for inhalation administered twice daily
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open label multicentre trial, evaluating the utility of MRI-guided thrombolysis
      for stroke beyond time window by Tenecteplase (TNK-tPA). This exploratory study was to
      describe the feasibility and outcome of thrombolytic therapy with TNK-tPA in 4.5-24 hours
      after stroke guided by a mismatch between diffusion-weighted imaging and FLAIR in the region
      of ischemia.
    

Detailed description: 
      In patients with acute stroke with an unknown time of onset, intravenous alteplase guided by
      a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia resulted in
      a significantly better functional outcome at 90 days. This trial will enroll acute ischemic
      stroke patients within 4.5 to 24 hours of onset. All the patients had an ischemic lesion that
      was visible on MRI diffusion-weighted imaging but no parenchymal hyperintensity on
      fluid-attenuated inversion recovery (FLAIR), which indicated that the stroke had a ischemic
      penumbra. Randomization will be 1:1 to TNK-tPA (experimental) or standard treatment
      (control), in compliance with guidelines for acute stroke. Clinical outcome was assessed by
      disability on the basis of the modified Rankin scale at 90 days follow-up, which will be
      performed by a blinded assessor.
    

Intervention name(s): Tenecteplase
Intervention type(s): Drug
Intervention description(s): The participants received TNK-tPA thrombolytic therapy
Other intervention name(s): TNK-tPA
Intervention MeSH terms: Tenecteplase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: TNK-tPA; stroke
Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions
Condition: Infection
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a potential generic 500 mg
      clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin
      tablet, Biaxin® following a single 500 mg dose, administered with food.
    


Intervention name(s): Clarithromycin
Intervention type(s): Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cultivating Well-being in Subclinical Paranoia
Condition: Wellbeing
MeSH terms: Paranoid Disorders
Study type: Interventional

Summary: 
      The intervention is called Feliz-Mente, with third generation therapy components that aims to
      improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is
      expected to increase positive experiences, the use of personal strengths and positive
      relationships, and aims to build a more meaningful self-narrative in persons with subclinical
      paranoia. Feliz-Mente is a group intervention of 12 sessions in which participants are
      expected to perform exercises during and between sessions by the use of a mobile application
      to improve treatment adherence and daily practice. The design for the present study is a
      randomized controlled trial, which compares the post-intervention measures of the
      experimental group (group receiving the intervention and the daily use of a mobile
      application of the program) with the post-intervention measures of the control group
      (treatment as usual + waiting list).
    


Intervention name(s): Feliz-Mente (third generation psychotherapy)
Intervention type(s): Behavioral
Intervention description(s): The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Use of CoG by Patients With Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose
      teststrips and requiering a capillary blood sample obtained from a fingerstick and in
      addition, a non-invasive optical component for prediction of tissue glucose at the fingertip.
      In this study, participants will use both devices during meal tests and also at home during
      routine care. The results from the device will be compared to a standard reference method and
      will be used to determine the accuracy of the two device components.
    

Detailed description: 
      The trial starts with a screening and training visit (V1). This is followed by an individual
      calibration period for the non-invasive device component by means of multiple parallel
      measurements with the invasive and the noninvasive device component. This will be done by the
      participants at home. Thereafter, the participants will come to the study site and will
      ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical
      safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary
      blood samples for comparator readings with the two CoG components and with a laboratory
      reference method (YSI gucose analyzer). The patients will now continue to use the devices at
      home for three months, but are not allowed to use any CoG result for treatment decisions. In
      an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety
      parameters and three comparison measurements will be made with the CoG device components and
      the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of
      the first meal test visit (V2) will be repeated, which conludes that study. In addition, the
      participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.
    

Intervention name(s): non-invasive tissue glucose prediction
Intervention type(s): Device
Intervention description(s): Generation of non-invasive and invasive glucose readings for comparison with a standard laboratory reference glucose determination method (YSI glucose analyzer)
Other intervention name(s): invasive blood glucose measurement
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with diabetes mellitus (type 1 or type 2, any treatment) of other than caucasian
        origin, who are experienced with performing blood glucose self-testing.
      
Keywords: Diabetes mellitus Type 1; Diabetes mellitus Type 2; blood glucose self-testing; non-invasive tissue glucose prediction; optical pain-free glucose testing
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      The objective of the study is to investigate the safety, efficacy and clinical utility of the
      Occlutech PDA device for closure of patent ductus arteriosus of all types.
    


Intervention name(s): Occlutech PDA occluder
Intervention type(s): Device
Intervention description(s): Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic Effects of Olanzapine in Healthy Males
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to look at how a two-week use of a medication called Olanzapine
      might change appetite, physical activity, resting metabolic rate, body composition, and
      weight in healthy men.
    


Intervention name(s): Olanzapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.; Placebo capsule administered orally at bedtime for 14 days
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The major aim of this study is to investigate and compare the drug amount delivered to the
      body after sequential application of two Rotigotine patches of two different formulations
    


Intervention name(s): Rotigotine transdermal patch
Intervention type(s): Drug
Intervention description(s): Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours
Other intervention name(s): Neupro®
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Rotigotine; Neupro®; Transdermal Patch
Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Condition: Dentine Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      An 8 week clinical study to evaluate the ability of an experimental dentifrice containing
      calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine
      hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate
      and sodium monofluorophosphate.
    

Detailed description: 
      A single centre, multi-site, randomised, examiner blind, two treatment, parallel group,
      non-inferiority design clinical study conducted in healthy subjects with self-reported and
      clinically diagnosed dentine hypersensitivity (DH). This study will compare the effectiveness
      of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium
      fluoride to a commercially available dentifrice containing 5% w/w calcium sodium
      phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from DH after
      4 and 8 weeks twice daily treatment.
    

Intervention name(s): Calcium sodium phosphosilicate; Sodium fluoride; Sodium monofluorophosphate
Intervention type(s): Device; Other; Other
Intervention description(s): 5% w/w calcium sodium phosphosilicate; 1426 ppm fluoride as sodium fluoride; 1426 ppm fluoride as sodium monofluorophosphate
Intervention MeSH terms: Listerine; Calcium; Fluorides; Sodium Fluoride; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Conservative and Operative Treatment of Jones Fracture
Condition: Fracture of Fifth Metatarsal Bone
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      The study deals with the topic of treatment of Jones fracture, comparing surgical and
      conservative approach. The fracture occurs especially in highly active individuals.
    

Detailed description: 
      The study deals with the topic of treatment of Jones fracture, comparing surgical and
      conservative approach. The fracture occurs especially in highly active individuals.

      The study proposes a supposition of recommending the active operational approach, which
      shortens the period of healing by 6 weeks, limitation of physical activity by 4 weeks, and
      sick leave by 2 months. It also completely eliminates the need to perform a rigid fixation of
      the extremity for 8-12 weeks.
    

Intervention name(s): Operational approach; Conservative approach
Intervention type(s): Procedure; Procedure
Intervention description(s): Operational approach was used to treat the Jones fracture in patients randomized into the respective study arm.; Conservative approach was used to treat the Jones fracture in patients randomized into the respective study arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients with Jones fracture were randomized into one of the two study groups - operational or conservative approach.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Jones fracture; The American Orthopaedic Foot & Ankle Society (AOFAS); Herbert screw
Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide
Condition: Diabetes in Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, single-arm, open-label, multi-dose, three-period study was conducted in
      healthy Chinese volunteers.
    


Intervention name(s): Hydrochlorothiazide、Henagliflozin Proline
Intervention type(s): Drug
Intervention description(s): Hydrochlorothiazide and Henagliflozin Proline
Intervention MeSH terms: Hydrochlorothiazide
Intervention model: Single Group Assignment
Intervention model description: Evaluation of drug-drug interaction between Henagliflozin Proline and Hydrochlorothiazide. A single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy Chinese volunteers.
Masking: None (Open Label)
Primary purpose: Treatment
Drug-drug Interaction Study(CKD-501, Amlodipine)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501
      and amlodipine after oral administration in healthy male volunteers.
    

Detailed description: 
      Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg
      alone/co-administrate, repeated doses are 10 days.
    

Intervention name(s): CKD-501; amlodiopine; CKD-501 amlodipine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.; Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.; Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
Other intervention name(s): Lobeglitazone
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-Drug interaction between the CKD-501 and Amlodipine