bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Beta-blocker Versus Angiotensin Receptor Blocker for Suppression of Aneurysm Expansion in Patients With Small Abdominal Aortic Aneurysm and Hypertension (BASE Trial)
Condition: Small Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Interventional
Phase: Phase 4

Summary: 
      Various medical therapies have been proposed to prevent abdominal aortic aneurysm expansion.
      However, there have been very few randomized clinical trials to support use of any of these
      treatments. Several animal studies and observational reports suggest that ARBs can be useful
      in reducing abdominal aortic aneurysm (AAA) growth. However, so far, ARBs have not been
      evaluated in a randomized clinical trial. Therefore, the purpose of the study is to evaluate
      the effect of valsartan, an ARB, on annual growth rate in comparison with atenolol, a
      beta-blocker. Our hypothesis is that valsartan is superior to atenolol in the suppression of
      the aneurysm growth at 12 months. The BASE trial is designed as a investigator-initiated,
      multi-center, randomized controlled open-label trial. Patients with small AAA (aorta diameter
      <5cm) will be randomized 1:1 either to valsartan or to atenolol group. Randomization will be
      stratified by the AAA size (max. diameter >4 cm or ≤4 cm). Patients will receive either
      valsartan (daily dose 80 mg or more) or atenolol (daily dose 50 mg or more) for 12 months. A
      CT scan will measure the maximal diameter of AAA at baseline and 12 months. The annual growth
      of AAA will be compared between the valsartan and the atenolol group.
    


Intervention name(s): Beta-blocker-Atenolol 50mg, PO(peroral), Once daily; Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atenolol; Valsartan; Angiotensin Receptor Antagonists; Adrenergic beta-Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
GIP/GLP-1 Co-Activity in Subjects With Obesity: Lowering of Food Intake
Condition: Obesity; Adiposity; Type 2 Diabetes
MeSH terms: Obesity
Study type: Interventional

Summary: 
      We aim to delineate the effects of separate and combined infusion of GIP and GLP-1 on food
      intake, appetite, bone health and fat metabolism in overweight/obese subjects.
    

Detailed description: 
      The gut-derived incretin glucagon-like peptide-1 (GLP-1) is a potent regulator of gastric
      emptying, appetite and food intake in humans whereas its sister incretin hormone,
      glucose-dependent insulinotropic polypeptide (GIP), does not seem to have independent effects
      on these variables in humans. Interestingly, recent data from rodents have shown that
      concomitant activation of the GIP and the GLP-1 receptor may potentiate the satiety-promoting
      and body weight-reducing effects of GLP-1. Also, evidence suggests that GIP may be an
      important mediator of bone remodelling and lipid deposition. The effect of simultaneous
      activation of the GIP and GLP-1 receptors on appetite, food intake, fat metabolism and bone
      health has not been thoroughly examined in humans. The aim of this study is to delineate the
      effects of GIP/GLP-1 receptor co-activation on food intake, mechanisms regulating food
      intake, fat and bone metabolism in obese subjects.

      Material and methods:

      The investigators plan to include 18 obese/overweight men without diabetes. The primary
      endpoint of the study is food intake during continuous intravenous infusions of saline
      (placebo), GIP, GLP-1 and GIP+GLP-1, respectively. Secondary endpoints includes resting
      energy expenditure (measured by indirect calorimetry), appetite, satiety and hunger
      assessments (measured by visual analogue scales), plasma insulin, C-peptide and glucagon
      secretion, plasma triglycerides, cholesterols, and free fatty acid responses and changes in
      plasma bone turnover markers.
    

Intervention name(s): IIGI+GIP; IIGI+GLP-1; IIGI+NaCl (placebo); OGTT; IIGI+GIP+GLP-1
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia; glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia; i.v. NaCl during isoglycemia; 50 g oral glucose tolerance test; i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: incretin hormones; GIP; GLP-1
Motivators and Barriers to Physical Activity in Knee Osteoarthritis Patients: a Qualitative Study
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      This study sought to better identify the motivators and barriers to osteoarthritic patients
      practising regular physical activity. This is a crucial step towards enabling each health
      professional to adapt their therapy recommendations, while taking into account the patient's
      overall lifestyle.
    

Detailed description: 
      The qualitative research design is well-suited to this type of issue. This choice was
      justified by need to investigate and understand the actions from the participants' point of
      view. This exploratory method, conducted in the form of individual interviews and focus
      groups, enabled us to document the personal experiences, practices, and personal history of
      each individual
    

Intervention name(s): Qualitative study
Intervention type(s): Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with symptomatic knee osteoarthritis
      
Keywords: Physical activity; Knee osteoarthritis; Non pharmacological treatment; Qualitative study
A Phase 2 Study of Tomudex & Iressa as Second Line Chemotherapy in Subjects With Colorectal Carcinoma
Condition: Colorectal Cancer
MeSH terms: Carcinoma; Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to compare the activity of raltitrexed and ZD1839
      versus raltitrexed alone as second line chemotherapy in subjects with colorectal carcinoma by
      estimating progression free survival (PFS) in each treatment arm.
    


Intervention name(s): Gefitinib, raltitrexed
Intervention type(s): Drug
Intervention MeSH terms: Gefitinib; Raltitrexed
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Colorectal carcinoma advanced disease
Effect of Imatinib Mesylate and the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
Condition: Chronic Myeloid Leukemia (CML)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1

Summary: 
      A non-randomized, open-label study to investigate the effects of imatinib mesylate on the
      pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously
      untreated chronic myeloid leukemia in chronic phase (CML-CP)
    


Intervention name(s): Imatinib/Acetaminophen
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen; Imatinib Mesylate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; STI571; imatinib; CML; Chronic Myeloid Leukemia; Philadelphia Chromosome; acetaminophen
Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single centre, open-label, randomised, 5-way crossover study.
    

Detailed description: 
      This was a single centre, open-label, randomised, 5-way crossover study design to compare the
      PK of Infacort® versus immediate-release hydrocortisone tablets and to evaluate the dose
      proportionality of 0.5 mg, 2 mg, 5 mg and 10 mg Infacort®. The study was conducted in 1
      cohort of 16 healthy male subjects and comprised a Screening Visit, 5 treatment periods
      (Treatment Periods 1 to 5) and a Post-study Visit.
    

Intervention name(s): Infacort; Hydrocortisone
Intervention type(s): Drug; Drug
Intervention description(s): Multi-particulate granules; Tablet
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Addressing Colorectal Cancer in South Florida Firefighters
Condition: Colorectal Cancer; CRC
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The standard way of screening for colorectal cancer is to have a series of fecal blood tests,
      where a sample is taken from a participant's stool, or an endoscopic procedure performed by a
      doctor, where a camera is used to look inside the bowel. This research study will use a test
      performed by the participant. This test will look for changes in the stool that can identify
      if participants are at higher risk for cancer.

      Another aim of this study is to better understand what firefighters and retired firefighters
      think about colorectal cancer and other health issues. This information will help us develop
      programs that may improve colorectal cancer outcomes in the firefighter community.
    


Intervention name(s): Fecal Immunochemical Test; Septin9 Test
Intervention type(s): Other; Other
Intervention description(s): The Fecal Immunochemical Test (FIT) is self-administered one-time for participants, per standard of care. This allows participants to obtain their own stool specimens from bowel movements without having a regular colorectal screening procedure in the doctor's office. Participants will use the FIT at the time of their next bowel movement and return their specimens to the laboratory by mail on the same or next day.; Septin9 (SEPT9) is a blood-based test that will be offered to eligible participants one-time who refused the FIT. Participants will undergo a blood draw collected by a nurse or certified phlebotomist, 90 days after their refusal of the initial offer of FIT.
Other intervention name(s): FIT; SEPT9
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Two-Part Study to Determine: Best Medication Formulation and Food Effect
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study. Part 1 is designed to find the best modified release formulation of
      GW423753; Part 2 is designed to use the selected formulation(s) from Part 1 to find out if
      food affects the way the medication is processed by the body.
    


Intervention name(s): Solabegron
Intervention type(s): Drug
Intervention MeSH terms: Solabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GW427353 oral tablets,; healthy adult subjects,; food effect
Effect of Acupuncture on Patients With Mild Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a large scale, open-label, multicenter, randomized controlled clinical trial with
      four parallel arms. This trial aims to evaluate the effectiveness of affected meridian
      acupuncture for patients with mild hypertension,with respect to decreasing their blood
      pressure, safety of acupuncture ,and improving their quality of life as well.
    

Detailed description: 
      Investigators plan to recruit 428 hypertensive patients. Eligible patients will be randomized
      to four different groups.ⅰ. the affected meridian acupuncture group (AMA, n=107) will be
      treated with acupoints on affected meridians.ⅱ.the non-affected meridian acupuncture group
      (NMA, n=107) will be treated with acupoints on non-affected meridians.ⅲ.invasive sham
      acupuncture group(ISA, n=107)will be provided with sham acupoints treatment.ⅳ.waiting-list
      group(WL, n=107)will not be given any intervention.
    

Intervention name(s): acupuncture; Sham acupuncture
Intervention type(s): Other; Other
Intervention description(s): In each session, acupuncture are applied bilaterally. Except the acupoints around the neck(ST9.GB20.non-acupoints 4) ,6 auxiliary needles will be punctured at 2mm lateral to each acupoints or non-acupoints.as to auxiliary needle we will not do any manipulation. We use transcutaneous electric acupoints stimulation to stimulate the acupoints and non-acupoints.; In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.
Other intervention name(s): electroacupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Essential Hypertension; Acupuncture; Specificity; Acupoints effect; randomized controlled trials
Participatory Organizational Intervention for Improved Use of Assistive Devices for Patient Handling
Condition: Musculoskeletal Disorders; Occupational Injuries
MeSH terms: Musculoskeletal Diseases; Occupational Injuries
Study type: Interventional

Summary: 
      Epidemiological studies have shown that patient transfer is a risk factor for back pain, back
      injuries and long term sickness absence, whereas consistent use of assistive devices during
      patient transfer is associated with reduced risk of back injury. In consequence, Danish
      hospitals have made great efforts to increase knowledge, availability and use of assistive
      devices to reduce work-related physical strain due to patient transfer. Yet, a recent survey
      among more than 300 nurses and nurses' aides showed that two thirds rarely uses assistive
      devices during patient transfer. Thus it seems relevant to investigate barriers,
      opportunities and practical solutions for increasing use of assistive devices among
      healthcare workers. The purpose of this study is to evaluate a participatory organizational
      intervention for improved use of assistive devices during patient transfer.
    


Intervention name(s): Participatory Organizational Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Chiropractic Treatment for Headache Among Children Aged 7-14
Condition: Chronic Headache
MeSH terms: Headache Disorders; Headache
Study type: Interventional

Summary: 
      The primary aim of the study is to assess the effectiveness of chiropractic manipulation
      treatment versus placebo treatment in children suffering from headache for more than six
      months.
    

Detailed description: 
      The study is a two-armed parallel, randomized controlled clinical trial where children
      suffering from chronic headache and at the same time having one or more biomechanical
      dysfunctions of the spine are randomized to either chiropractic manipulation treatment or
      placebo manipulation treatment.

      The outcome is based on weekly sms responses collecting the number of days with headache the
      past week, intensity of headache and use of medication for headache. These are answered four
      weeks prior to initiation of treatment and 16 weeks thereafter. After the 16 weeks follow-up,
      a final questionnaire is completed including information about the course and the present
      headache status.

      The primary outcome is the number of days with headache. Secondary outcomes are intensity of
      headaches and use of medication for headache.

      Covariates are collected via baseline questionnaires on patient demographics; medical
      history; factors known to initiate, worsen or ease the headache; prevalence of headache in
      the nearest family; and behavioral patterns known to influence headache.
    

Intervention name(s): Chiropractic treatment; Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): The child receives chiropractic manipulation treatment in the neck and in the spine and pelvis according to individual needs. They also receive a written list of general advice regarding lifestyle and habits.
The parents and the child are unaware of group allocation.; Non-therapeutic placebo treatment: a broad non-specific contact outside the spinal column is taken on subject's scapula and gluteal region lying in a side posture position, on the scapulae in a prone position and on trapezius muscles in a sitting position. In those positions the chiropractor pushes in a non-intentional and non- therapeutic directional line with a low-amplitude, low velocity push maneuver. All contacts are performed without soft tissue pre-tension and gentle contact, to insure that no joint cavitation occurs. To obtain a noise that many people associate with a chiropractic spinal adjustment, a de-activated Activator Instrument is used on the arm of the chiropractor to give a click-sound. General advice on lifestyle and habits is handed out to the placebo group as well.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chiropractic spinal manipulation; Children; Pediatric; Headache
Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome
Condition: Polycystic Ovarian Syndrome; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of whole body vibration on insulin
      resistance in females with polycystic ovarian syndrome
    

Detailed description: 
      polycystic ovarian syndrome is a complex endocrine condition characterized by metabolic
      abnormalities such as insulin resistance, excess weight or obesity, diabetes, and an
      increased risk of cardiovascular disease.Despite previous studies reported that physical
      exercise improves insulin resistance in females with polycystic ovarian syndrome, there is no
      study yet investigate the effect of whole body vibration on insulin resistance
    

Intervention name(s): whole body vibration; Treadmill
Intervention type(s): Device; Device
Intervention description(s): the patients will stand on whole body vibration device with maintaining squatting position while keeping their trunk extended. The first training session will be consisted of three sets of 1 min and will be separated by a 1-min of standing rest. intensity will 1 mm. Then one set will be added every session; Females will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease
Condition: Thyroid Eye Disease
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases
Study type: Interventional

Summary: 
      Patients with Thyroid Eye Disease (TED) often have enlarged extraocular muscles and higher
      orbital fat contents due to their disease process. The confined space of the orbit cannot
      hold the enlarged orbital contents creating a forward displacement and/or compression of the
      globe with a rise in intraocular pressure (IOP). Many of these patients undergo surgical
      decompression, a procedure that fractures orbital bones, in order to allow more space for the
      enlarged orbital contents to occupy. To date, there is no data that shows intraocular
      patterns over a 24-hour period in patients with mechanical compression on the globe as in
      TED. It is not know if the pattern of IOP is more consistent with normal IOP patterns,
      glaucomatous patterns, or perhaps completely different then either. The goal of this project
      is to investigate patterns of IOP in patients requiring orbital decompression because of
      orbital congestion. Changes in IOP during a 24-hour period will be studied with a
      contact-lens embedded sensor that provides continuous data. This device has previously been
      investigated and shown to be safe and well-tolerated. Monitoring the pattern in these
      patients will allow us to compare Thyroid TED patterns of IOP with those of normal and
      glaucomatous patients. Also, testing these patients before and after orbital decompression
      surgery will allow characterization of how intraocular pressure changes once the mechanical
      compression on the globe is relieved.
    


Intervention name(s): SENSIMED Triggerfish
Intervention type(s): Device
Other intervention name(s): Contact lens sensor intented to continuously record IOP pattern for up to 24 hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic