bioihbjkbjnl/mcl2 huggingface dataset:
Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether fish oil supplements may reduce the
      frequency and duration of paroxysmal atrial fibrillation episodes.

      Atrial fibrillation is a heart condition which effects a large percentage of the population .

      Atrial fibrillation is a condition frequently experienced by people who have had pacemakers
      inserted .

      Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes
      of atrial fibrillation.

      Fish oil supplements may be of benefit to patients with heart problems.Recent evidence
      suggests that fish oils may be beneficial to patients with rhythm disturbances.

      By interrogating pacemakers this study will investigate the effect of fish oil supplements on
      the frequency and duration of episodes of atrial fibrillation.
    


Intervention name(s): Fish oil
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage
Condition: Skin Care
Study type: Interventional

Summary: 
      This study will assess the cosmetic changes of a cosmetic topical retinoid product in
      participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging
      instrumentation.
    


Intervention name(s): Retinol Complex 0.5; Facial cleanser; Moisturizing lotion; Sunscreen; Skin Imaging
Intervention type(s): Other; Other; Other; Other; Device
Intervention description(s): Retinol Complex 0.5 topically in the evening.; Facial cleanser in the morning and in the evening.; Fragrance free moisturizing lotion in the morning and in the evening.; Sunscreen broad spectrum sun protection factor (SPF) 35 topically in the morning and as needed.; Non-invasive in vivo skin imaging will be taken with the VivoSight Dx Optical Coherence Tomography (OCT) and VivaScope 1500
Other intervention name(s): SkinMedica Retinol Complex 0.5; SkinMedica Facial Cleanser; Cetaphil Fragrance Free Moisturizing Lotion; SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35
Intervention MeSH terms: Vitamin A; Retinol palmitate; Sunscreening Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Resilience Skills Self-Management for Chronic Pain.
Condition: Chronic Spine Pain; Fibromyalgia
MeSH terms: Fibromyalgia; Chronic Pain
Study type: Interventional

Summary: 
      The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced
      CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT
      self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with
      chronic pain will undergo a comprehensive pre-intervention assessment that includes a blood
      draw (T1). Participants will then be randomized 2:2:1 as follows: e-CBT (n=120), PRISM
      (n=120) and usual care (n = 60). Immediately post-intervention (T2) and at 6 months (T3) and
      12 months (T4) after that, participants undergo the same in-person assessment including blood
      draw. Telomerase activity will be assessed at T1, T2 and T3; and telomere length at T1 and T4
    


Intervention name(s): Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management; Promoting Resilience through Innovative Self-Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Already noted.; Already noted.
Other intervention name(s): PRISM
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60).
Masking: None (Open Label)
Primary purpose: Treatment
Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly
      information processing speed (IPS) which also influences with other cognitive functions such
      as attention, working memory and executive functions. The investigators validated a
      computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect
      disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for
      multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT),
      a test of the IPS, and two measures of episodic memory. On the same principle, the
      investigators propose to validate a short computerized battery to improve the feasibility
      (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test
      of visual episodic memory.

      Purpose: to establish the screening value of a brief computerized cognitive assessment
      (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized
      episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as
      compared to a reference battery (MACFIMS).
    


Intervention name(s): Cognitive evaluation; Expanded Disability Status Scale (EDSS) score
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Questionnaires for assessment of confounding factors
Cognitive evaluation
Walking tests and 9 Hole Peg Test; - EDSS score
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cognition; brief computerized cognitive assessment; impairment prediction
TAP vs. ESP Block for Gynecological Post Operative Pain
Condition: Nerve Block; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The goal of this double blind randomized controlled trial is to compare transversus abdominis
      plane block and erector spinae plane block in gynecological surgery patients. The main
      questions it aims to answer are:

        -  What are the numerical post-operative pain scores in these two groups?

        -  Is there any significant difference in the numerical post-operative pain scores between
           subjects who underwent TAP block and subjects who underwent ESP block?

        -  What are the differences in the time needed for additional morphine in these two groups?

        -  Is there any significant differences in the time needed for additional morphine between
           subjects who underwent TAP block and subjects who underwent ESP block?
    


Intervention name(s): Transversus Abdominis Plane Block using 0.25% Bupivacaine; Erector Spinae Plane Block using 0.25% Bupivacaine
Intervention type(s): Procedure; Procedure
Intervention description(s): TAP block regional anesthesia with ultrasound guidance with administration of 20 mL of 0.25% Bupivacaine in the abdominal wall before the operation is completed. The patient was also fitted with a morphine PCA device with a background dose of 5 µg/kgBW/hour and a rescue dose of 1 mg with a lockout interval of 10 minutes.; Regional anesthesia ESP block under ultrasound guidance with 20 mL of 0.25% bupivacaine at the tip of the transverse process at the T9 level before completion of surgery. The patient was also fitted with a morphine PCA device with a background dose of 5 µg/kgBW/hour and a rescue dose of 1 mg with a lockout interval of 10 minutes.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Transversus Abdominis Plane Block; Erector Spinae Plane Block; Postoperative Pain; Gynecological Surgery
Study of CT001 in Healthy Volunteers
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1, three arms, cross over comparison study to evaluate bioavailability,
      pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.
    

Detailed description: 
      A single site phase 1 study including a randomised, open label, three periods, single dose,
      cross over design in 12 healthy male volunteers.
    

Intervention name(s): CT001; Ketamine; sufentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nasal spray; iv single dose; iv single dose
Intervention MeSH terms: Sufentanil; Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent
      chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is
      thought to improve cough and help clear the airways of sticky sputum. Traditionally,
      physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece,
      called the Acapella device) has been developed to make physiotherapy practise easier. This
      study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients
      with severe bronchiectasis.
    

Detailed description: 
      Study being carried out in the Department of Respiratory Medicine, Royal Infirmary of
      Edinburgh.

      The study is entitled "Is regular chest physiotherapy an effective treatment in severe, non
      cystic fibrosis bronchiectasis?" This is a small randomised controlled pilot crossover study
      assessing the efficacy of regular chest physiotherapy using an Acapella mouthpiece in severe
      non cystic fibrosis bronchiectasis. 10 patients will be randomised to receive full
      instruction in use of the Acapella device (twice daily therapy) and ten patients will
      continue with their standard treatment regimen. The study will be conducted over seven
      months.

      At the beginning we will randomly allocate them to receive either the current standard
      treatment regimen for bronchiectasis or to receive instruction in the use of the Acapella
      physiotherapy device for the first 3 months.

      After these 3 months all will receive the current standard treatment regimen for 1 month.

      Following this, those that received current standard treatment will receive Acapella
      physiotherapy device for 3 months and those that received Acapella physiotherapy device will
      stop this and receive current standard treatment for 3 months.

      All participants will be reviewed on 6 occasions (start of study and then at months 1, 2, 3,
      4 and 6). At each review, sputum samples will be collected, routine bloods, spirometry and
      exercise testing performed and health related quality of life questionnaires be completed.

      At the end of the study should patients have felt benefit with the physiotherapy with the
      Acapella device, they should continue using it regularly on a twice-daily basis.
    

Intervention name(s): Acapella Physiotherapy
Intervention type(s): Device
Intervention description(s): twice daily- around 20 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physiotherapy; bronchiectasis
Hybrid Exercise Training for Weight Loss
Condition: Circuit-based High Intensity Interval Training; Body Composition; Resting Metabolic Rate; Habitual Physical Activity; Performance
Study type: Interventional

Summary: 
      In this study the investigators utilized a novel hybrid HIIT (high intensity interval
      training) exercise training approach, the Hybrid Interval Training (DoIT) workout that
      combines interval training, resistance exercise training and functional training in order to
      test the hypothesis that DoIT will be able to: i) reduce body mass, ii) improve body
      composition and iii) alter energy balance, of previously inactive, overweight/obese women.
    

Detailed description: 
      In a controlled randomized, two-group, repeated measures design, 65 healthy, sedentary,
      premenopausal overweight or obese women were randomly assigned to one of three groups: (a) a
      control group (C, N=21) that participated only in measurements, (b) a training group (TR,
      N=14) that participated in a supervised 40-week DoIT workout exercise training program and
      (c) a training-detraining group (TRD, N=14). During the first 20 weeks, TR and TRD followed
      exactly the same training protocol. At the end of this period, TR continued training for 20
      more weeks whereas TRD terminated training for 20 weeks (detraining). Anthropometric,
      metabolic, daily nutritional intake, habitual physical activity and performance measurements
      were performed in all groups at baseline, at 20 weeks and 40 weeks.
    

Intervention name(s): DoIT workout; DoIT workout - Detraining; Control - No training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A hybrid small-group (5-10 women/session) training modality, that combines interval training, resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management. FFIT was performed 3 times/week with 48 hours recovery between sessions for 40 weeks.; A hybrid small-group (5-10 women/session) training modality, that combines interval training, resistance exercise and functional training, performed according to a periodized model of exercise prescription for a 20-week period (3 times/week). Immediately after a 20-week detraining period (no training was performed) was followed.; No training was performed during a 40-week period. Participation only in measurements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
Condition: Hepatitis A; Viral Hepatitis Vaccines
MeSH terms: Hepatitis A; Hepatitis B; Whooping Cough; Hepatitis
Study type: Observational

Summary: 
      This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV)
      and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.
    

Detailed description: 
      A random sample of subjects constituting adolescents and young adults (≥10 - ≤25 years of
      age) will be selected from the total population that participated in the Encuesta Nacional de
      Salud y Nutrición (ENSANUT) 2012 in Mexico.

      Data (through structured questionnaires and interviews) and stored serum samples of the
      selected subjects obtained from the ENSANUT 2012 will be used in this study. A subset
      database will be designed by the National Institute of Public Health (NIPH) for the purpose
      of this study. Extracted data and laboratory results of the selected subjects will be
      captured in this database.
    

Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): Data of the selected subjects (through structured questionnaires and interviews) and stored serum samples obtained from the ENSANUT 2012. A subset database will be designed by the NIPH for the purpose of this study. Extracted data and laboratory results of the selected subjects will be captured in the study database.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects constituting adolescents and young adults (≥10 - ≤25 years of age) from the total
        population that participated in the ENSANUT 2012 in Mexico.
      
Biospecimen description: 
      Stored serum samples of the selected subjects obtained from the ENSANUT 2012
    
Keywords: Mexico; Adolescents; Hepatitis; Seroprevalence; Pertussis; Young adults
Transporter Cocktail Mutual Interaction
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Main objective is to investigate mutual pharmacokinetic drug-drug interactions of digoxin,
      furosemide, metformin, and rosuvastatin when given all together as a cocktail
    


Intervention name(s): Digoxin; Furosemide; Metformin; Rosuvastatin; Digoxin; Furosemide; Metformin hydrochloride; Rosuvastatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose; single dose; single dose; single dose; 0.25 mg digoxin as single dose (all 4 drugs given together as a cocktail at the same time point); 1 mg furosemide as single dose (all 4 drugs given together as a cocktail at the same time point); 10 mg metformin hydrochloride as single dose (all 4 drugs given together as a cocktail at the same time point); 10 mg rosuvastatin as single dose (all 4 drugs given together as a cocktail at the same time point)
Intervention MeSH terms: Metformin; Digoxin; Furosemide; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder: A Treatment Development and Pilot Study
Condition: Avoidant/Restrictive Food Intake Disorder (ARFID)
MeSH terms: Avoidant Restrictive Food Intake Disorder
Study type: Interventional

Summary: 
      The primary aim of this study is to pilot cognitive behavioral therapy (CBT-AR)for
      avoidant/restrictive food intake disorder (ARFID) in one study for children and adolescents
      (ages 10-17 years) and one study for adults (ages 18-65 years).
    

Detailed description: 
      This study is designed to pilot the CBT-AR treatment in youth with ARFID to determine
      treatment acceptability and efficacy.This includes evaluating the efficacy and acceptability
      of CBT-AR in reducing primary ARFID symptoms from pre- to post-treatment, and to assess
      whether improvement in individual symptoms is related to the timing of relevant
      interventions. The investigators hypothesize that from pre-treatment to post-treatment,
      subjects with ARFID will decrease severity of self-reported ARFID symptoms, decrease
      self-reported anxiety and depression, and improve psychosocial functioning. The investigators
      further hypothesize that overall, subjects with ARFID will have reduced phobic avoidance,
      sensory sensitivity, and/or low appetite in comparison to their pre-treatment symptoms.
    

Intervention name(s): CBT-AR
Intervention type(s): Behavioral
Intervention description(s): 20-30 sessions of cognitive behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR), held once per week in an outpatient setting
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was the extension of the LANTU_C_02761 study named EASIE and identified as
      NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve
      patients treated with metformin and not adequately controlled).

      All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had
      the possibility to enter this extension study if they met the other inclusion criteria and
      did not present with any exclusion criteria.

      The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension
      study which consisted of a 12-week treatment period.

      The objectives of this extension study were:

        -  To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with
           metformin, insulin glargine and sitagliptin in patients not adequately controlled by a
           previous treatment with metformin plus either insulin glargine or sitagliptin.

        -  To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level,
           fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight
           and overall safety.
    


Intervention name(s): Insulin Glargine; Sitagliptin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).; Oral administration. 100mg film-coated tablets.; Patients continued with metformin as usual oral anti-diabetic treatment.
Other intervention name(s): Lantus®; Januvia®
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina
Condition: Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional

Summary: 
      In this study the investigators will use careful scientific blinding of patient and their
      subsequent healthcare staff so that the investigators can determine exactly how much
      difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6
      weeks blinded phase, all patients will be unblinded and the patients who had undergone sham
      procedure will be offered the active therapy.
    

Detailed description: 
      The investigators will perform a multi-centre prospective randomised double-blinded
      comparison of the treatment of stable angina with percutaneous coronary intervention (PCI)
      and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with
      stable angina and one or more angiographically significant coronary stenosis of 70% or more
      in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation
      of functional capacity and myocardial ischaemic burden will be performed. This will be
      followed by a coronary angiogram and invasive physiological investigation followed by
      randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and
      myocardial ischaemic burden at 6 weeks will then be performed.
    

Intervention name(s): Coronary angioplasty
Intervention type(s): Procedure
Intervention description(s): Percutaneous coronary intervention with drug-eluting stents and modern techniques
Other intervention name(s): Percutaneous coronary intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stable angina; Percutaneous coronary intervention; Optimal medical therapy; Sham-control