bioihbjkbjnl/mcl2 huggingface dataset:
The Disease Severity In Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      This observational study aims to evaluate new markers to predict disease activity in
      psoriasis. The main question is SGOT, SGPT, GGT, hs-CRP, and apo B related to disease
      severity in psoriasis.
    

Detailed description: 
      Psoriasis patients who had signed an informed consent were assessed for PASI scores and 5 cc
      of blood was drawn for GGT, hs-CRP, and apo B examinations. A PASI score is a tool used to
      measure the severity and extent of psoriasis. PASI is an acronym for Psoriasis Area and
      Severity Index.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Psoriasis Patients
      
Biospecimen description: 
      5 cc of blood was drawn for GGT, hs-CRP, and apo B examinations.
    
Keywords: Psoriasis; Psoriasis Area and Severity Index; Gamma-Glutamyl Transferase; CRP; Apolipoprotein B
Observational Study to Evaluate LDL-C Lowering Effect of Ezetimibe (0653-070)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the LDL-C lowering in south african patients with primary hypercholesterolaemia
      after the addition of ezetimibe 10mg /day to ongoing therapy with a statin.
    


Intervention name(s): MK0653, ezetimibe / Duration of Treatment: 4 Weeks
Intervention type(s): Drug
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Japanese Males
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of ascending single oral doses of SAM-531, an
      investigational drug, in healthy Japanese male subjects. Secondary: To obtain preliminary
      pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531 in healthy Japanese male
      subjects.
    


Intervention name(s): SAM-531
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of
      ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
    


Intervention name(s): IMBRUVICA (Treatment A); Ibrutinib (Treatment B)
Intervention type(s): Drug; Drug
Intervention description(s): IMBRUVICA (reference treatment), 4*140 milligram (mg), capsules.; Ibrutinib (test treatment), 1*560 mg, tablet.
Other intervention name(s): Ibrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety, Pharmacokinetics and Pharmacodynamics After Single and Multiple Dosing of AZD5423 in Japanese Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerability, pharmacokinetics and
      pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and
      post ACTH stimulation, dehydroepiandrosterone sulphate (DHEAS), osteocalcin and 24 hours
      urine cortisol) of AZD5423 following administration of single and multiple ascending doses in
      healthy male Japanese subjects.
    


Intervention name(s): AZD5423; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation, suspension; Inhalation, solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety; tolerability; pharmacokinetics; pharmacodynamics; AZD5423; Japanese
A Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of Topical LTX-109 in Subjects Nasally Colonized With Methicillin-resistant/-Sensitive Staphylococcus Aureus (MRSA/MSSA)
Condition: Nasal Carriers MRSA
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a pilot study conducted to evaluate the safety, local tolerability and efficacy of
      LTX-109(Lytixar™), a lytic peptide designed to kill bacterias quickly and efficient. LTX-109
      (Lytixar™)will be applied in the anterior nares in subjects who are carriers of nasal
      colonies of MRSA/MSSA.

      The extent of systemic absorption of LTX -109 when applied to the anterior nares will be
      evaluated and the effect of Lytixar™ as to clear colonies of MRSA/MSSA during the the
      observation period and Week 2 to Week 9 after treatment.
    

Detailed description: 
      Subjects with persistent colonies of MRSA/MSSA in the nostril will be recruited to receive
      either active treatment or placebo. This is a dose escalating study. First grout will receive
      either 1% Lytixar™ or placebo, next group 2% Lytixar™ or placebo and finally 5% Lytixar™ or
      placebo. Dose escalation will be performed after a brief safety evaluation of the
      tolerability after application of Lytixar™/placebo vehicle TID for three days.
      Pharmacokinetic samples will be collected from subjects who are willing. Subjects will be
      followed until 9 weeks after initiation of treatment.
    

Intervention name(s): LTX-109
Intervention type(s): Drug
Intervention description(s): 1%, 2% and 3% Lytixar (gel formulation). TID for 3 days.
Other intervention name(s): Lytixar
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: MRSA; nose
CKD-828 Drug Interaction Study (S-amlodipine)
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of
      S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine
      monotherapy.
    


Intervention name(s): S-amlodipine 5mg,Telmisartan 80mg; S-amlodipine 5mg
Intervention type(s): Drug; Drug
Intervention description(s): S-amlodipine 5mg and Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days); S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out(19 days)
Other intervention name(s): Anydipine S 5mg, Micardis 80mg; Anydipine S 5mg
Intervention MeSH terms: Niacin; Amlodipine; Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety and interaction of BMS-986177 in healthy volunteers,
      when administered with Aspirin and/or Clopidogrel
    


Intervention name(s): BMS-986177; Placebo (for BMS-986177); Clopidogrel; Aspirin
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): BMS-986177 capsule; BMS-986177 placebo match capsule; Clopidogrel tablet; Aspirin tablet
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Identification in Obese Patients of the Mechanism Involved in Intramuscular Lipid Accumulation
Condition: Obesity; Insulin Resistance; Hyperlipidemia
MeSH terms: Insulin Resistance; Hyperlipidemias
Study type: Interventional

Summary: 
      The study aims to determine in obese patients the implication of intramuscular lipid
      accumulation in relation with insulin resistance and defect in lipid oxidation.
    

Detailed description: 
      Obese insulin sensitive and obese insulin resistant patients undergo a glucose tolerance
      test, indirect calorimetry during exercise and muscular biopsy.
    

Intervention name(s): Lipid accumulation analysis
Intervention type(s): Other
Intervention description(s): The lipid accumulation will be assessed with muscular biopsies.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Obese; insulin sensitive; insulin resistant; myotubes; lipid accumulation
Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial
Condition: Post-Traumatic Stress Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether the administration of risperidone is
      effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant
      post-traumatic stress disorder (PTSD) in civilians.
    

Detailed description: 
      Individuals with PTSD often experience anxiety attacks, nightmares, or repeated unwanted
      memories after experiencing or witnessing life-threatening events, such as serious accidents
      or natural disasters, or traumatic events such as physical or sexual abuse.

      Risperidone has been approved by the Food and Drug Administration for the treatment of
      psychotic disorders and has been found helpful for PTSD and depression, but is still
      considered investigational for the purposes of this study.

      All qualified participants will be started on sertraline (Zoloft) for eight weeks. Patients
      who are still symptomatic at the end of this phase, will be invited to join the second
      portion of the study where they will be randomly assigned to receive risperidone or placebo
      (sugar pill) in addition to the sertraline. Participants will be monitored regularly for
      medication effects, adverse events, and PTSD symptoms.
    

Intervention name(s): Sertraline and Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Post-Traumatic Stress Disorder; Sertraline; Risperidone
The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test
Condition: Intradermal Test
Study type: Observational

Summary: 
      This study aims to compare skin reactivity results between morphine and histamine as a
      positive control agents in intradermal skin test.
    

Detailed description: 
      Histamine hydrochloride and different concentrations of morphine sulfate will be
      intradermally injected and wheal diameter size will be comparatively measured between 15-30
      minutes' time points after the test.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult Healthy Volunteers
Stanford Coronary Risk Intervention Project (SCRIP)
Condition: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether modification of risk factors altered the rate of progression of coronary
      artery disease in arteries with mild atherosclerosis and no mechanical intervention in
      patients who had coronary bypass surgery or percutaneous transluminal coronary angioplasty
      (PTCA).
    

Detailed description: 
      BACKGROUND:

      Because of difficulties with quantitative measurement and with feasibility of follow-up, few
      controlled studies prior to SCRIP had been completed to determine the impact of risk factor
      modification directly on the progression of coronary atherosclerosis in humans. Suggestive
      evidence existed from animal studies, especially in primates, that diet and exercise altered
      atherosclerosis as a result of risk modification. But these animal models did not accurately
      represent the potential for modifying the coronary atherosclerotic process in humans. Some
      indirect evidence had been developed in humans by studying arteries more accessible than the
      coronaries. In the several preliminary studies reported using coronary arteriography to study
      the impact of risk modification on atherosclerosis, the results had been encouraging but far
      from definitive. One angiographic follow-up study of vein bypass grafts and severely
      atherosclerotic coronary arteries reported improvement with lipid lowering therapy. None of
      these studies had included randomization of patients to systematic, intense, long-term risk
      reduction versus usual care with prospectively identified coronary artery segments with mild
      disease.

      DESIGN NARRATIVE:

      Randomized, fixed-sample. A total of 300 patients were randomized, 155 to usual care (UC) in
      the community and 145 to special intervention (SI). The SI group received intensive efforts
      directed at reducing or eliminating risk factors, including lowering LDL-cholesterol and
      increasing HDL-cholesterol, reducing blood pressure, eliminating cigarette smoking and
      obesity, increasing exercise, and decreasing stressful life experience. The major endpoint
      was the rate of coronary artery disease progression as measured by angiography, at baseline
      and at forty-eight months. Follow-up was for four years.
    

Intervention name(s): smoking cessation; diet, reducing; exercise; diet, fat-restricted
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Primary purpose: Prevention
Ultra-brief Online Mindfulness-based Intervention During COVID-19 Movement Control Order
Condition: Mental Health Wellness; Psychological Security; Psychological Distress
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The federal government of Malaysia implemented a nationwide Movement Control Order (MCO) to
      control the COVID-19 outbreak. The MCO, however, has been found to have a negative impact on
      people's mental wellbeing. Interventions that can improve mental health under restricted
      movement condition is urgently. The present study investigated the impact of a brief, online
      mindfulness-based intervention on mental health using two-arm randomized controlled trial
      design. A total of 161 participants self-reported their feeling, anxiety, psychological
      insecurity, and well-being at baseline (T1) and post-test (T2), while 61 of them answered the
      same set of measures and the fear of COVID-19 scale in a follow-up study two weeks later
      (T3).
    


Intervention name(s): Ultra Brief Online Mindfulness-based Intervention; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): We adapted and contextualized the original RAIN protocol to local pandemic-induced lockdown situation, with short journaling prompts that engage participants in self-reflection. Journaling is known to be a creative way to engage people in a therapeutic activity which promotes self-awareness (Utley & Garza, 2011). Creating a visual narration of thoughts, feelings and experiences help individuals make internal experiences more tangible and manageable, especially during these uncertain times.; The control group participants were asked to report preventive measures that they have taken to prevent COVID-19, ways that they obtained Movement Control Order news, and things that they wished to do once the Movement Control Order is lifted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Mindfulness; Online Intervention; COVID-19; Movement Control Order
E-health App and Lifestyle Changes During Pregnancy
Condition: Pregnancy; Dietary Habits; Physical Activity; Gestational Weight Gain
MeSH terms: Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      The purpose of this online follow-up study is to investigate health app use in pregnant women
      and through a pilot intervention trial investigate whether the addition of evidence-based
      information on health-promoting lifestyle delivered via the health app has an effect on
      lifestyle habits (gestational weight, diet quality and physical activity) during pregnancy.
    

Detailed description: 
      An online follow-up study with a 2-arm equal allocation parallel randomized controlled pilot
      intervention trial with pregnant women (n=1000) will be conducted. The intervention consists
      of non-personalized, evidence-based information on health-promoting lifestyle during
      pregnancy delivered via a health app. Control group uses the health app without health
      information.

      Aims of an exploratory part of the study are to characterize the health app use and users
      among pregnant women and to investigate whether the frequency of the health app use during
      pregnancy has an effect on lifestyle habits. Aim of the pilot intervention is to investigate
      whether the addition of evidence-based information on health-promoting lifestyle delivered
      via the health app has an effect on lifestyle habits during pregnancy.
    

Intervention name(s): Health information delivered via health app
Intervention type(s): Behavioral
Intervention description(s): Intervention group will use a health app with non-personalized information on health-promoting lifestyle habits during pregnancy. Control group will use a health app without health information. Intervention effects on the lifestyle habits (gestational weight gain, diet quality, physical activity) will be investigated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pregnancy; Health application; Diet quality; Physical activity; Gestational weight gain
A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of
      ASP1941 in male and female patients with type 2 diabetes mellitus
    


Intervention name(s): ipragliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): ASP1941
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; ASP1941
Ultrasound Supraspinatus Tendon Assessment After 448kilohertz Radiofrequency Stimulation in a Sporty Population.
Condition: Ultrasonography; Shoulder
Study type: Interventional

Summary: 
      448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in
      physiotherapy and its usefulness and clinical relevance is still to be investigated at both
      clinical practice and also in performance. Current studies show promising results in
      different musculoskeletal disorders, however there no studies in the assessment of quality
      soft tissue in sporty population after the used of this technique.
    

Detailed description: 
      Shoulder pain is is one of the most common musculoskeletal disorders, presenting a high
      prevalence in primary care centers and sport populations. Many factors have been proposed as
      the cause of pain, however there are no studies analysing possibilities of preventing
      shoulder injuries by using a radiofrequency stimulus.

      The use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the
      treatment looking for improve the quality of the tissue is still to be explored.

      The hypothesis of the present project is that focus treatments on 448kilohertz capacitive
      resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of
      ultrasound assessment measured by quantified elastography, and this will decreased the
      possibilities of get injured.

      The stimulus will be carried out on the shoulder region (suprascapular, axillar, subscapular,
      long thoracic or pectoralis nerves) and the thoracic region. All interventions will be
      developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.
    

Intervention name(s): Monopolar 448 kilohertz radiofrequency stimulation; Placebo comparator
Intervention type(s): Device; Device
Intervention description(s): 448kilohertz capacitive resistive monopolar radiofrequency will be applied on the dominant shoulder; To simulate a 448kilohertz capacitive resistive monopolar radiofrequency application on the dominant shoulder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Trial for People With Established Type 2 Diabetes During Ramadan
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Dual therapy with metformin and Liraglutide is more effective at helping people with
      established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite
      endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no
      severe hypoglycaemic events.
    

Detailed description: 
      Participants in the control arm will essentially continue with their standard routine care
      and those in the intervention groups will either receive Liraglutide in addition to metformin
      or those on dual therapy will switch from their sulphonylurea/pioglitazone to Liraglutide and
      continue with metformin. Informed consent and baseline data will be collected 4-8 weeks prior
      to the start of Ramadan. This will allow time for a run in period for the titration of
      Liraglutide prior to the fasting period. Ramadan is followed by Eid-al-Fitr a 3-day Islamic
      holiday that marks the end of this holy month. Tradition includes amongst early morning
      prayers/celebration through feasting. Therefore, participants will be invited to attend the
      first follow-up after this event (between weeks 2 - 4) and then at 12 weeks post Ramadan.
      Randomisation will not be revealed until after the baseline data have been collected.
    

Intervention name(s): Liraglutide; Liraglutide; Sulfonylurea or Pioglitazone; Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response; 4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.; Addition to Metformin; As per clinical guidelines for prescription
Other intervention name(s): Victoza; Victoza
Intervention MeSH terms: Pioglitazone; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Liraglutide; Ramadan; fasting