bioihbjkbjnl/mcl2 huggingface dataset:
The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects
Condition: Bladder Outlet Obstruction; Lower Urinary Tract Symptoms
MeSH terms: Urinary Bladder Neck Obstruction; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      Crossover comparison of different flow meters with a digital home flow meter as a reference.
      Main hypothesis: Reapeated home flow measurements with a disposable device will provide a
      better understanding of the patients urinary flow than a single measurement performed in the
      clinic.
    


Intervention name(s): Disposable device; Digital device; Clinic flow measurement
Intervention type(s): Device; Device; Device
Intervention description(s): Disposable urine flow meter; Digital urine flowmeter; Clinic gold standard flow measurement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lower urinary tract symptoms leading to lower flow rates
Scratch and Sleep Quantification in Atopic Dermatitis
Condition: Atopic Dermatitis; Pruritus; Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias; Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Observational

Summary: 
      Atopic dermatitis (AD) is a chronic type of eczema affecting approximately 10% of adults and
      12% of children in the US. The intense itching (pruritus) associated with AD can be
      significantly disruptive to sleep and quality of life for both the patients and their
      caregivers. AD is challenging to describe and measure. The purpose of this study is to see if
      we can reliably measure how much people with AD scratch and how scratching interferes with
      sleep and quality of life by using digital sensors, sleep studies and patient-reported
      information.
    

Detailed description: 
      Wrist worn accelerometers, sleep sensors, polysomnography (PSG), and associated data analysis
      platforms would provide quantitative and qualitative knowledge regarding the action of
      scratching and sleep quantity in a symptomatic atopic dermatitis (AD) population. Our overall
      aim is to validate the use of accelerometry technology and digital measures to quantitatively
      and qualitatively evaluate scratch and sleep in AD patients in a home environment.

      Accelerometry devices appear similar to a wristwatch. The subject will be asked to wear an
      accelerometry device on each wrist during the study. The accelerometry device provides
      continuous measures of wrist activity and will be used to quantify nocturnal scratching and
      sleep behaviors to be compared to videography (annotated for scratch), sleep sensor, PSG and
      traditional patient-reported outcome (PRO) and Quality of Life (QoL) measures [Peak Pruritus
      Numerical Scale, Severity of Pruritus Scale (SPS), Patient Global Impression of Severity
      (PGIS), Medical Outcomes Study (MOS) Sleep Scale, Itch and Sleep Diary, Patient-Oriented
      Eczema Measure (POE), Patient-Reported Outcomes Measurement Information System (PROMIS)-pain
      interference, PROMIS- anxiety, Dermatology Life Quality Index (DLQI), Family Dermatology Life
      Quality Index (FDLQI), Children's Dermatology Life Quality Index (CDLQI), Device and Device
      Comfort Questionnaire] in patients with AD in a clinic and home setting in a well-controlled
      clinical study.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female subjects, aged 12-75 years old, with active mild to severe atopic
        dermatitis (AD)
      
Keywords: Atopic Dermatitis; Pruritus; Sleep Disturbance
Pain Neuroscience Education In Students
Condition: Chronic Pain; Educational Problems
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      This study was designed to evaluate the effect of a 70-minute Pain neuroscience education
      (PNE) session on physiotherapy students' knowledge of pain and their beliefs and attitudes
      about the treatment of patients with chronic pain.
    

Detailed description: 
      To investigate the effect of a 70 minute pain neuroscience education session on physiotherapy
      students' knowledge of pain and their beliefs and attitudes about the treatment of patients
      with chronic pain. This study was a single-center, cross-sectional study on the pain
      knowledge of students in a four-year physiotherapy program and their beliefs and attitudes
      about patients with back pain.Students were eligible to participate if they were enrolled at
      physiotherapy undergraduate program at Kütahya Health Sciences University Faculty of Health
      Sciences. Individuals were excluded if they had previously received in depth-teaching on pain
      neuroscience. The study was completed with 156 students from different classes (first,
      second, and third year of the program) who agreed to participate in the study. All
      participants were informed about the study and signed informed consent forms. Pain
      neurophysiology questionnaire and Pain Attitudes and Beliefs Scale for Physiotherapists were
      used to assess pain knowladge and attitudes and beliefs. After recording their demographic
      information, the participants completed the Neuroscience of Pain Questionnaire (NPQ) and Pain
      Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) at three time points: pre-PNE,
      immediately post-PNE, and 6 months after PNE.
    

Intervention name(s): Pain neuroscience education
Intervention type(s): Other
Intervention description(s): Pain neuroscience education (PNE) was conducted in physical conditions similar to the university classrooms where the study was performed. The sessions were conducted as 70-minute didactic group lessons with the same content held in separate sessions for students in each class. PowerPoint (Microsoft Corp., Redmond, WA, USA) presentations prepared by the instructor were used in all sessions. Metaphors, anecdotes, graphics, and pictures were used in an attempt to convey the information and messages about pain physiology and theory more permanently and effectively. In the PNE sessions, it was explained that the nervous system can be overprotective and that in addition to the sensitivity of the central nervous system, nociceptive transmission can be affected by an individual's thoughts, beliefs, and surroundings. At the end of the session, the students were given time to ask questions, but group discussion was limited to 15 minutes due to time restrictions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pain neuroscience education; chronic pain; physiotherapy students
Validation and Reproducibility of the Six-minute Step Test in Individuals With Obstructive Sleep Apnea Treated With CPAP
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Introduction: The Obstructive Sleep Apnea (OSA) is characterized by obstructed superior
      airway during sleeping period promoting intermittent hypoxia-reoxygenation events. These
      events cause consequences such as cardiorespiratory and peripheric muscle structure
      alterations, which can cause reduction of the exercise tolerance. In this sense the
      continuous positive airway pressure (CPAP) is important to decrease the repercussions of the
      illness and cooperate to maintain the exercise functional capacity. To measure this capacity,
      one good option is the six-minute step test (6MST), that is low cost and submaximal, in
      addition to being adaptable and portable. However, there are doubts if it´s really capable to
      determinate the functional capacity of exercise of individuals with OSA treated with CPAP.
      Objective: Evaluate the validity and reproducibility of 6MST to determine the functional
      capacity of exercise in individual with OSA treated with CPAP and develop a model of a
      reference equation for the performance of the test in this population. Material and methods:
      This is an observational, prospective and cross-sectional study, in which will be evaluated
      132 volunteers (66 men and 66 women), with age between 18 and 65 years, diagnosed with OSA of
      moderate and severe degree, treated with CPAP for a minimum of three months, recruited of the
      ambulatory of pneumology of Otávio de Freitas Hospital. Initially will be collected personal
      and anthropometric information, answered to sleep questioners, quality of sleep and physical
      exercise, also respiratory muscle strength and lung function. The realization of the tests to
      evaluate the functional capacity of exercise will be done in two days with a maximum of seven
      days between the tests. In each day, the volunteers will do two 6MST and two six-minute walk
      test (6MWT), which order will be determined by randomization. Expected Results: It is
      expected that the 6MST to be showed as reproducible and capable to quantify the functional
      capability of exercise in individuals with OSA treated with CPAP.
    


Intervention name(s): Six-minute step test; Six-minute walk test
Intervention type(s): Other; Other
Intervention description(s): Volunteers will be instructed to go up and down one step for six minutes; Volunteers will walk the longest distance possible by performing turns in a 30 meter corridor for six minutes
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Individuals adults with obstructive sleep apnea treated with CPAP
Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis
Condition: Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and
      whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT
    

Detailed description: 
      Mucositis is a serious side effect of cancer therapy and Peripheral Blood Stem Cell
      Transplant (PBSCT) which requires appropriate and effective management. Mucositis is a
      condition in which there is inflammation and ulceration of the mouth, throat and gut caused
      by damage to the mucosal barrier induced by chemo- and radiotherapy. Symptoms include pain,
      nausea, abdominal cramping, and vomiting. This study will investigate whether ATL-104, when
      administered as a swallowable mouthwash, is safe and well tolerated in patients undergoing
      PBSCT and to investigate its potential to reduce the level of severity of mucositis
      associated with PBSCT.
    

Intervention name(s): ATL-104
Intervention type(s): Drug
Intervention description(s): Daily does of ATL-104 (50,100 or 150mg) or placebo for 3 days prior to the start of chemotherapy and peripheral blood stem cell transplantation. Following stem cell transplantation patients received 3 further daily doses of ATL-104 (50, 100 or 150mg) or placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mucositis; Peripheral blood stem cell transplant
Formulation and Food Effect Study of AZD1386 in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to
      the AZD1386 oral solution.
    


Intervention name(s): AZD1386; AZD1386; AZD1386
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).; One single oral dose of 90mg (3 x 30mg AZD1386 capsules); One single oral dose of 90mg (6 x 15mg AZD1386 tablets)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Formulation; pharmacokinetics
Functional Gastrointestinal Disorders in Pediatric IBD
Condition: Inflammatory Bowel Diseases; Functional Gastrointestinal Disorders; Pediatric Disorder; Anxiety Depression; Quality of Life
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases
Study type: Observational

Summary: 
      Background: Persistent gastrointestinal symptoms have been described in patients who are
      considered in remission of their inflammatory bowel disease (IBD). These symptoms, attributed
      to Functional gastrointestinal disorders (FGID) in IBD, may have a significant impact of
      quality of life, and may be associated with fatigue, anxiety and depression. There is very
      little data regarding pediatric specificities of these FGID.

      Aims: The aim of the study is to evaluate the prevalence of FGID in pediatric patients with
      IBD in remission. Secondary aims are to investigate a possible association of FGID with
      fatigue, anxiety, depression and impacted quality of life in the patients, as well as anxiety
      and depression in the parents.

      Methods: This will be an observational, case-control study. All patients between 9 and 18
      years old , with IBD in remission will be invited to participate. Questionnaires will be
      web-based and will evaluate: presence of FGID (Fr-qPGS), fatigue (FACIT-F), anxiety
      (SCARED-R), depression (CDI), quality of life (IMPACT-III). Parents will be invited to fill
      in web-based questionnaires on their symptoms of anxiety (STAI/Y-A and STAI/Y-B) and
      depression (BDI). Clinical parameters will be retrieved retrospectively from the chart. Level
      of remission will be confirmed by most recent blood tests and fecal calprotectin. Patients
      with FGID will be compared to patients without FGID in terms of clinical characteristics,
      disease phenotype and associated psychological comorbidities.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        In the aim of recruiting a sample that will be the most representative possible of the
        population of pediatric IBD patients in remission in France, patients will be recruited for
        the study through different procedures:

          -  either during a routine visit to the pediatric gastroenterology clinic (all French
             pediatric gastroenterology clinics will be study centers)

          -  or during a routine visit to the adult gastroenterology clinic (the French adult
             gastroenterologists will be informed of the study and will be able to apply to be a
             study center)

          -  finally, the patient will be able to find information on the study through the French
             IBD patient Foundation (association Francois Aupetit) and contact the investigators in
             order to participate.
WelChol® With Metformin in Treating Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to see how safe and effective and tolerable the use of
      colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in
      combination with other anti-diabetic drugs.
    


Intervention name(s): Colesevelam hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetes Mellitus
Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      In the daily clinical practice, one of the most frequent reasons for consultation
      physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the
      approach from physiotherapy contemplates the reduction of pain through different procedures,
      including neuromodulation.

      In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is
      defined as the application through a needle with ultrasound guidance of an electrical current
      at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve
      in some point of its trajectory, or of a muscle in a motor point, with a therapeutic
      objective. The objective of the study is to analyze that the effect of PNM on the sciatic
      nerve produces statistically significant changes in pain, joint range and functionality in
      patients with chronic LBP. Forty subjects will be recruited, which will be divided into 2
      groups: group 1 to which PNM will be applied to the sciatic nerve at 250 microseconds, 3 Hz)
      during 90 seconds; group 2 to which PNM will be applied to the sciatic nerve in at 250
      microseconds, 10 Hz during 90 second. The PNM intervention with NMP will consist in the
      single application of an asymmetric rectangular biphasic current.
    


Intervention name(s): NMP
Intervention type(s): Other
Intervention description(s): Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, to cause a tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Bone Micro-Architecture Using HR-pQCT
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      In the context of male osteoporosis, we hypothesize that regional changes in trabecular bone,
      as well as changes in cortical porosity will play a major role, and thus also affect bone
      strength. In developing therapeutics the response of individual compartments, regional
      variations post-therapy will have considerable impact on selecting the therapies as well as
      monitoring response to therapy. This study, a precursor to other therapeutic trials, will lay
      the ground-work for the future.
    

Detailed description: 
      We will recruit 80 subjects who will be stratified into groups based on their T-scores. All
      subjects will be imaged at Baseline and 12 months. Measures of bone micro-architecture in the
      tibia and radius using peripheral computed tomography, bone strength measures through finite
      element analysis will be obtained at all time points. DXA measures at the spine, femur and
      forearm will be obtained as reference measures. In addition whole body DXA scans will be
      performed for assessment of body composition.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community UCSF VA Medical Center
      
Keywords: osteopenia and osteoporosis
Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction
Condition: Healthy
Study type: Interventional

Summary: 
      This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by
      that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men
      on calorie restriction on 4 study days with fat and skeletal muscle biopsies.
    

Detailed description: 
      It has been shown that calorie restriction enhances the length of life in yeast, worms, fish
      and rodent. Whether this elongation of life due to calorie restriction can be applied to
      humans is not known. However, it is a fact that calorie restriction will decrease the risk of
      developing metabolic disturbances such as diabetes, hypertension and atherosclerosis.

      On the molecular level the specific relations are not fully understood. This study will
      investigate the possible connection between SITR1 and the relation to the GH/IGF-I axis and
      STAT5b in healthy men. The participant will fast 42 and 12 hours respectively, and have GH or
      placebo infusions. The design is a classical 2x2 design and will be randomized.

      Knowledge of the interactions between calorie restriction, SIRT1, STAT5b and the GH/IGF-I
      axis will apply important information about the relations between aging, energy metabolism
      and metabolic disturbances.
    

Intervention name(s): GH hormone infusion; 42 hour fast; 12 hour fast
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Norditropin 30 ng/kg/min; The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed; 12 hour fast will be used as a control scenario to 42 hour fast
Other intervention name(s): Norditropin; Genotropin; No other name; No other name
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Calorie restriction; GH/IGF-I axis; STATb5; SIRT1; Intracellular signaling peptides and proteins; Fasting; Growth hormone; IGF-1
Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can
      reduce the amount of opioids needed for this.

      The problem is that morphine slows down digestion. That can delay pain relief from APAP
      pills. It can even change what the body does to the drug [pharmacokinetics (PK)].

      Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills.

      This study will measure the PK of APAP pills and IV when used with morphine in healthy
      volunteers.

      IV APAP will likely be more effective and cause fewer side effects when used with morphine to
      treat pain after surgery.
    

Detailed description: 
      Acetaminophen can significantly reduce the use of opioid analgesics when both are used
      concomitantly for treating moderate to severe pain. The use of IV acetaminophen used
      concomitantly with opioids has increased in practice for postsurgical pain relief over orally
      administered acetaminophen because it provides an immediate peak plasma concentration and is
      believed to provide a faster analgesic effect. Opioids used to treat pain inhibit
      gastrointestinal motility, including delaying gastric emptying. In patients receiving opioids
      the absorption of orally administered acetaminophen may be delayed and could result in
      gastric accumulation of acetaminophen thereby markedly changing the pharmacokinetic profile.
      The opioid-induced inhibition of gastrointestinal motility would not be expected to affect IV
      acetaminophen pharmacokinetics. Thus coadministered IV acetaminophen with opioid would yield
      better outcome in efficacy and reduced risk of side effects comparing with coadministration
      of oral acetaminophen and opioids.
    

Intervention name(s): Oral Acetaminophen; IV Acetaminophen; IV Morphine; Placebo Tablets; Saline
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Acetaminophen for oral administration (2 tablets, 500 mg/tablet); Acetaminophen for intravenous (IV) administration (1,000 mg/100 mL); Morphine for IV administration (0.125 mg/kg); Placebo tablets matching oral acetaminophen; Saline placebo matching IV acetaminophen
Other intervention name(s): APAP Oral; APAP IV
Intervention MeSH terms: Acetaminophen; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Post-surgical pain; Pharmacokinetics