bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the blood
      glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250
      (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.
    


Intervention name(s): insulin degludec; insulin degludec/insulin aspart; insulin aspart
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).; Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).; Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects
Condition: Symptomatic Obstructive Hypertrophic Cardiomyopathy; Healthy Subjects
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to:

        1. Learn about the safety of CK-3773274 after a single dose and multiple doses in healthy
           subjects.

        2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses.

        3. Find out how much CK-3773274 is in the blood after a single dose and multiple doses.

        4. Determine the effect of doses of CK-3773274 on the pumping function of the heart.

        5. Evaluate the effect of cytochrome genetic variants on how the body metabolizes
           CK-3773274.

        6. Evaluate the effect of a meal on how much CK-3773274 is in the blood in healthy adult
           subjects.

        7. Evaluate whether the amount of CK-3773274 in the blood is the similar for both the
           tablet and granules in capsule forms of the drug.
    


Intervention name(s): CK-3773274 - Granules in Capsule; Placebo - Granules in Capsule; CK-3773274 - Tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CK-3773274 formulated as granules in capsule; Placebo formulated as granules in capsule; CK-3773274 formulated as tablets
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: CK-3773274; CK-274; obstructive hypertrophic cardiomyopathy; oHCM
Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with
      locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to
      tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking
      status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated
      with the presence of EGFR mutations in exons 18, 19 and 21, in this population
    

Detailed description: 
      A randomized, placebo-controlled phase III trial of erlotinib versus placebo, with more than
      700 patients demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs
      survival after first or second line therapy in patients with advanced NSCLC. Statistically
      significant and clinically relevant differences were observed for overall and progression
      free survival in favour of erlotinib. Moreover, several clinical factors had been correlated
      with response to gefitinib or erlotinib, including never smoking status, female gender, Asian
      ethnicity and adenocarcinoma histology (especially bronchioalveolar carcinoma).
    

Intervention name(s): Erlotinib
Intervention type(s): Drug
Intervention description(s): Erlotinib at the dose of 150 mg orally once a day continually until progression
Other intervention name(s): Tarceva
Intervention MeSH terms: Erlotinib Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erlotinib; Biological therapy; Tyrosin Kinase Inhibitor therapy
Effects of Behavioural Activation on Emotional Cognition and Mood
Condition: Depression; Depressive Disorder; Mood Disorders; Cognition
MeSH terms: Depressive Disorder; Mood Disorders
Study type: Interventional

Summary: 
      Behavioural activation (BA) is widely accepted as an efficacious treatment for depression. It
      has been suggested that several depression treatments work via early changes in emotional
      processing (e.g. affective bias in the processing of facial expressions) and that these could
      help predict treatment success, but it has not yet been examined whether the same applies in
      behavioural interventions. The investigators will examine how BA affects early emotional
      information processing in participants who are currently experiencing low mood, to see
      whether this can predict eventual changes in mood and to gain a better understanding of the
      treatment mechanisms of BA. Participants will be in three groups undergoing either
      behavioural activation, or activity monitoring alone (active control) for 4 weeks, or they
      will be on a waiting list (passive control). The investigators will also examine whether
      other factors, such as anxiety, social support and environmental reward, can predict the
      success of BA. This could help us understand how BA works and who may be most suitable for
      this intervention.
    


Intervention name(s): Behavioural activation; Activity monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 4-week programme based on the behavioural activation treatment provided in the NHS IAPT services. The programme includes psychoeducation on the relationship between activity and depression, examining the depressed person's level of activity, helping them identify activities they would like to increase and supporting them in the planning and conduct of those activities.; 4-week programme where participants simply monitor their general daily activities in a diary.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to either the behavioural activation intervention (40 participants), activity monitoring (40 participants) or passive waiting-list control group (40 participants). This study is not intended to be administering treatment, it is investigating the possible mechanisms of this intervention.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: behavioural activation
The Effect of Tongue Cleaning in Periodontitis Patients
Condition: Periodontitis; Tongue Coating
MeSH terms: Periodontitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study was to examine in periodontitis patients with visible tongue coating
      the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper
      versus the use of a regular toothbrush to clean the tongue.
    

Detailed description: 
      Volatile sulphur compounds (VSC's) are the most important causes of bad breath. Since the
      micro-organisms that produce VSC's are also periodopathogens, intuitively, one would think
      that there is a positive correlation between VSC levels in exhaled breath and periodontitis.
      However, not all periodontitis patients have bad breath. A possible explanation can be a
      positive relationship between tongue coating an bad breath. In the past, tongue cleaning was
      already researched in an oral healthy population. This research aimed to examine in
      periodontitis patients with visible tongue coating the changes in microbial load (aerobic and
      anaerobic) of the 14 day use of a tongue scraper versus the use of a regular toothbrush to
      clean the tongue. Additionally changes in tongue coating; and patient perception about tongue
      cleaning was researched.
    

Intervention name(s): Tongue scraper; Toothbrush
Intervention type(s): Device; Device
Intervention description(s): The patients were instructed to start cleaning the tongue by two pulling strokes along the median sulcus of the tongue, followed by two pulling strokes along the lateral edges of the tongue.; The patients who were assigned to the tooth brush group were taught to perform three forward and backward strokes along the median sulcus and at each lateral part of the tongue.
Other intervention name(s): Tongue scraper (Halita® tongue cleaner (Dentaid, Spain)); Toothbrush (Oral-B® Indicator® medium tooth brush)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periodontitis; Tongue coating; Tongue cleaning; Bacterial load
Computerized Cognitive Behavioral Therapy and Electroconvulsive Therapy
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      In an open-label feasibility study, fifteen will be recruited to participate in the study
      from among those who have already chosen of their own accord to undergo ECT (standard of
      care) at Yale Psychiatric Hospital for treatment of a depressive episode. These patients will
      receive computer-assisted cognitive behavior therapy (CCBT).
    


Intervention name(s): Computerized Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): The c-CBT software focuses on the same principles of traditional CBT, namely, "identifying, labeling, and modifying automatic thoughts; the link between thought and action; identifying and modifying schemas; and identifying and correcting cognitive errors."9 C-CBT is delivered in 9 online lessons, each designed to take 30-45 minutes to complete. The software provides modeling of CBT principles (in the form of short videos), enables an interactive forum by giving users feedback based on responses to questions, and encourages participants to employ the skills learned in CBT to their situations. A 9-minute video demonstrating the functionality of Good Days Ahead can be found at: http://www.empower-interactive.com/solutions/good-days-ahead/.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression
Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
Condition: Obese; Growth Hormone Secretion Abnormality
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in
      obesity is associated with increased cardiovascular disease risk. However, it is not yet
      known how reduced GH increases cardiovascular disease risk in obesity. The investigators
      hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the
      investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH
      will improve mitochondrial function and that this improvement in mitochondrial function will
      contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The
      investigators propose to study skeletal muscle mitochondria in obese subjects with reduced GH
      secretion using magnetic resonance spectroscopy and muscle biopsies before and after
      treatment with GH.
    


Intervention name(s): Growth hormone treatment
Intervention type(s): Drug
Intervention description(s): Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Intervention MeSH terms: Hormones
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth hormone; GH; Obesity; Mitochondrial function; reduced growth hormone secretion
Physicians' Health Study
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the effect on cardiovascular mortality of alternate-day consumption of 325
      milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day
      consumption of 50 milligrams of beta-carotene.
    

Detailed description: 
      BACKGROUND:

      Thrombosis plays a major role in the late stages of coronary occlusion. Platelet aggregation
      is a large component in the formation of arterial thrombi. In pharmacologic studies, aspirin
      has been shown to inhibit platelet aggregation and, therefore, might be expected to prevent
      coronary occlusion. These effects are apparent in the dose range of l00-l000 mg/day, and may
      be most evident at l60 milligrams daily. Higher doses seem to be no more effective in either
      inhibition of platelet agreeability or prolonged bleeding time.

      Although an early case-control study by Jick and Miettinen showed a large benefit, most
      observational studies had shown a cardiovascular benefit of about 20 percent. Conclusive data
      could only result from a randomized trial with a large sample size.

      DESIGN NARRATIVE:

      Randomized, double-blind, fixed sample. Participants were randomized into one of four
      treatment groups: one 325 milligram aspirin tablet every other day, alternating with one 30
      milligram capsule of beta-carotene; one aspirin every other day, alternating with one capsule
      of beta-carotene placebo; one aspirin placebo tablet every other day, alternating with one
      capsule of beta-carotene; and one aspirin placebo tablet every other day, alternating with
      one capsule of beta-carotene placebo. Major endpoints for the cardiovascular component of the
      study were cardiovascular mortality, total mortality, and coronary events.
    

Intervention name(s): aspirin; carotene
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Carotenoids
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Concept Mapping: as a Tool for Problem Based Learning
Condition: Educational Problems; Problem;Learning
Study type: Interventional

Summary: 
      This study delves into the utilization of concept mapping as a strategic tool within
      problem-based learning (PBL) to enhance students' problem-solving skills, metacognitive
      awareness, and self-directed learning abilities. Concept mapping, a visual representation of
      knowledge structures, is explored as a means to cultivate and refine students'
      problem-solving capabilities, preparing them for challenges in various domains.
    

Detailed description: 
      This study delves into the utilization of concept mapping as a strategic tool within
      problem-based learning (PBL) to enhance students' problem-solving skills, metacognitive
      awareness, and self-directed learning abilities. Concept mapping, a visual representation of
      knowledge structures, is explored as a means to cultivate and refine students'
      problem-solving capabilities, preparing them for challenges in various domains. Additionally,
      the research investigates how concept mapping within a PBL context promotes metacognitive
      awareness, helping students become more conscious of their learning strategies and enabling
      them to identify gaps in understanding. Moreover, the study explores the role of concept
      mapping in empowering self-directed learning, fostering autonomy and a deeper sense of
      ownership over students' educational journeys. The insights gained from this research not
      only inform instructional design practices, providing evidence-based strategies for enhancing
      problem-based learning through concept mapping but also contribute to the broader educational
      research discourse, offering valuable perspectives on effective teaching and learning
      strategies.
    

Intervention name(s): Concept Mapping: as a Tool for Problem Based Learning
Intervention type(s): Other
Intervention description(s): Concept mapping is a visual representation and organizational tool that illustrates the relationships between concepts, ideas, and information. It involves creating a graphical depiction of knowledge, typically using nodes or boxes to represent concepts and connecting lines or arrows to signify the relationships between them. The central concept or main idea is often positioned in the center of the map, with subsidiary concepts branching out from it. These maps serve as a comprehensive overview of a subject, highlighting the hierarchical structure and interconnectedness of various elements.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: concept mapping
Masking: Single (Participant)
Primary purpose: Other
Keywords: education; concept mapping; Problem Solving skills
Physical Parameters in Osteoarthritis Stages
Condition: Osteoarthritis; Pain; Quality of Life
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      To investigate the extent to which pain, functionality, and quality of life change over the
      progression of osteoarthritis grades.
    


Intervention name(s): Radiographic classification
Intervention type(s): Diagnostic Test
Intervention description(s): disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        diagnosed with the same grade of knee OA in both knees by the responsible physician in the
        hospital
Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma
Condition: Intrahepatic Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional

Summary: 
      The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic
      cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional
      retrospective study have showed an increasing adoption of LND among patients undergoing
      curative resection for ICC during the last decade. The current prospective and randomized
      study based on a multi-institutional collaboration would investigate whether routine LND
      would benefit patients in short- and long-term survival remains.
    

Detailed description: 
      Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its
      incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver
      represents the best curative treatment option. However, the role of lymphadenectomy (LND) at
      the time of surgery remains controversial with some centers considering it standard while
      other surgeons perform LND only in select circumstances. The utilization of LND may not only
      vary among different institutions, but also by geographic region. Specifically, data from
      East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While
      several case series from Asia have noted that most centers do not regularly perform LND,other
      data from the West suggest that LND may be becoming more routine. Despite the lack of
      consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual
      recommends that the nodal basin be staged. Disease-specific staging for ICC was first
      introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated
      8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to
      stage a patient with ICC.

      The previous multi-institutional retrospective study from the investigators have showed an
      increasing adoption of LND among patients undergoing curative resection for ICC during the
      last decade. The current prospective and randomized study based on a multi-institutional
      collaboration would investigate whether routine LND would benefit patients in short- and
      long-term survival remains.
    

Intervention name(s): lymphadenectomy
Intervention type(s): Procedure
Intervention description(s): Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: routine hepatoduodenal lymphadenectomy
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intrahepatic cholangiocarcinoma; surgery; lymphadenectomy; lymph node metastasis; prognosis
Using Focus Group to Explore Cultural Acceptability of Contraception
Condition: Contraception
Study type: Observational

Summary: 
      The purpose of this study is to learn what women of childbearing age think of Long Acting
      Reversible Contraception. A variety of myths regarding LARCs have been described in the
      literature. This study is designed to asses women's cultural belief's regarding LARCs.
      Investigators are looking to collect information from women in general, rather than solely
      who are seeking contraception. Investigators will be recruiting women ages 18-45 years from
      seven family health centers affiliated with UPMC. Participants will be asked to a attend a
      60-90 minutes focus group session. During the session the facilitator will try to engage
      participants in a discussion about contraception in general. They will also be asked to
      complete a short demographic survey of 8-12 questions. Data from focus groups will be
      assessed for recurring themes which will be used to create a cultural survey instrument that
      will be used in the second phase of the study.
    

Detailed description: 
      Following approval by the University of Pittsburgh institutional review board (IRB), female
      participants between 18 and 45 years of age seeking care for contraception or other women's
      health services were recruited from seven Family Health Centers (FHCs) partnered with the
      Department of Family Medicine. The participants agreed to participate in one 2 hour
      facilitated focus group session (recorded for later transcription) to discuss their
      perceptions about contraception.

      Recordings were transcribed and de-identified. The resulting texts were coded by a team.
      Concepts and themes that arose from the coding were analyzed to inform the development of a
      survey on the topic of perspectives on contraception.

      Qualitative analysis of the transcripts and coding was carried out and results were shared in
      pubic fora.
    

Intervention name(s): Focus Group
Intervention type(s): Behavioral
Intervention description(s): We had recruited 64 women and completed 7 focus group sessions
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women age 18-45 years and not pregnant at the time of enrollment