bioihbjkbjnl/mcl2 huggingface dataset:
Determining the Optimal Adenosine Provocation Test
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is a frequently occurring inflammatory lung disease that affects the whole bronchial
      tree including the small airways (<2mm). Since the introduction of the solution
      hydrofluoroalkane (HFA) technology it is possible to generate medication with small particles
      of approximately 1-2 μm, and therefore to reach the small airways. However, at this moment
      the investigators have no reliable instruments to identify the asthmatic subjects who
      particularly benefit from treatment with inhaled small particles. Recently the investigators
      research group investigated whether provocation with small and large particles AMP is able to
      identify responders and non-responders to treatment with small and large particles of inhaled
      corticosteroids. This provocation technique gave promising results but needs further
      optimization.

      The aim of this study is to determine the optimal particle size of dry powder adenosine to
      assess small airway involvement in asthma. Secondary, to provide insight in the associations
      between the standard test, executed with nebulized AMP, and the new test, executed with dry
      powder Adenosine.
    

Detailed description: 
      This is a cross-over study. The study population consists of 10 non-smoking asthma patients
      in the age of 18-65 years who have a PC20 metacholine value ≤4.9mg/ml.

      Participating subjects perform 6 provocation tests in randomized order: one test with
      nebulized methacholine, one test with nebulized AMP, four times dry powder adenosine
      provocation test. (small particles with inhaled with a slow flow, small particles inhaled
      with a fast flow, large particles inhaled with a slow flow, large particles inhaled with a
      fast flow)
    

Intervention name(s): Bronchial provocation test
Intervention type(s): Other
Intervention description(s): Provocation tests with adenosine dry powder and nebulized AMP (adenosine-5'monophosphate). The AMP provocation test is a standard test and consists of 14 doubling concentrations in a range of 0.04mg/ml to 320mg/ml. The aerosols will be inhaled during tidal breathing for 2 minutes. The dry powder adenosine also consists of 14 doubling steps with doses in a range of 0.01mg to 20mg.
Other intervention name(s): bronchial challenge test; AMP test; adenosine bronchial provocation
Intervention MeSH terms: Adenosine
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: asthma; small airways disease; inflammation; provocation; adenosine
Heart Failure Ventricular Pressure Time Profile
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      This proposed study aim to:

        1. Determine intra-LV pressure-time profile non-invasively using recently developed echo
           Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF
           subjects (both HFNEF and HFREF) compared to normal volunteers.

        2. Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
    

Detailed description: 
      Heart failure (HF) is a common disease and its syndrome is difficult to diagnose. HF with
      reduced ejection fraction (HFREF) may be diagnosed based on impaired LVEF (<50%). However,
      diagnosis of HF with normal ejection fraction (HFNEF) is mainly based on the presence of
      signs and symptoms.

      Central to diagnosis of HF is estimation of intra-cardiac pressure, which can only be
      obtained from invasive catheterization.

      This proposed study aim to:

        1. Determine intra-LV pressure-time profile non-invasively using recently developed echo
           Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF
           subjects (both HFNEF and HFREF) compared to normal volunteers.

        2. Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
    

Intervention name(s): NTproBNP; Echocardiography; Arterial tonometry
Intervention type(s): Other; Other; Other
Intervention description(s): To assess its level in the blood, as a marker of heart failure presence and severity.; To measure heart chamber size, heart function, blood vessel size and blood vessel function. These measurements will help us understand the type and severity of heart failure.; A noninvasive method to obtain arterial pressure waveform.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        35 diagnosed heart failure patient will be recruited from primary care clinic, outpatient
        clinics and hospital ward from NHCS.

        40 Healthy Volunteer control group.
Observed Actions in Chronic Neck Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Neck Pain
Study type: Interventional

Summary: 
      The aim of the present protocol is to prove if the observed actions (AOb) will improve the
      cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This
      study is a parallel-group double blind randomized clinical. Outcome measures were CROM, and
      pressure pain detection thresholds (PPDT) with a digital algometer. The follow-up will
      consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second
      measurement (motor imagery).
    


Intervention name(s): Actions observed
Intervention type(s): Other
Intervention description(s): Patients observed movements without realize them. After this actions, movements will be imagined by patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: observed action; range of motion; mirror neuron
Neural Predictors of Social Emotion Regulation Training
Condition: Emotions; Rumination
MeSH terms: Rumination Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the basic psychological and neural mechanisms
      underlying the social regulation of emotion - that is, how one person's actions can impact,
      or regulate - the emotions of another person - and how this ability changes with practice. As
      such, this study is not designed to directly address clinical health outcomes and provide no
      treatment or intervention.
    

Detailed description: 
      Prior research has demonstrated that helping others regulate their emotions has benefits for
      the support provider. But little is known about the basic brain mechanisms underlying this
      ability or how this ability can change with practice. To address these questions, this study
      has two parts. In the first, functional magnetic resonance imaging (fMRI) is used to gain
      insight into the brain systems involved in helping others regulate negative emotions by
      comparing them to the brain systems involved in regulating the participants' own negative
      emotions. In the second part, participants engage in three weeks of structured practice, or
      training, in either socially regulating others' emotions or in self-regulating their own
      emotions. The investigators predict that helping others regulate their emotions will involve
      many of the same brain regions implicated in regulating one's own emotions, in addition to
      regions involved in perspective taking and the reward of helping others. Further, when
      relating the brain data from part 1 to the regulation practice data from part 2, the
      investigators expect that individuals who in part 1 show greater activity in brain regions
      supporting either social or self-regulation may be more likely in part 2 to show
      corresponding improvements in regulation performance. The results of these studies are
      intended to lay the groundwork for future studies investigating the social regulation of
      emotion in older adults and clinical populations for whom social support can be beneficial.
    

Intervention name(s): Social regulation; Self regulation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be instructed to help another person think about their negative events differently using an emotion regulation strategy called reappraisal.; Participants will be instructed to think about their negative events by reframing the meaning of the event. This is a typical strategy in emotion regulation research known as reappraisal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Feasibility and Reproducibility of T1 Rho MRI in the Evaluation of Hip Cartilage
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Hip osteoarthritis is a frequent and invalidating disease. Early detection of cartilage
      modifications could provide better patient treatment. The T1rho MRI sequence allows the
      quantification of the cartilage signal that is correlated to modifications of the cartilage
      matrix, notably of the proteoglycans. The primary objective is to evaluate normal values of
      hip cartilage in vivo using T1rho MRI in healthy subjects and the reproducibility of the
      measurements. T1rho and T2 mapping sequences were acquired twice during the same session with
      30 minutes interval to see if values were modified after a 30 minutes delay in a supine
      position. The secondary objective was to assess the correlation between T1rho and T2 values.
    


Intervention name(s): Hip cartilage MRI
Intervention type(s): Device
Intervention description(s): Hip cartilage MRI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: T1rho MRI; hip; cartilage; Healthy participants
Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia
Condition: Hemodialysis Patients With Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      To study the effect of mindfulness meditation combined with progressive muscle relaxation
      training on clinical efficacy and quality of life in maintenance hemodialysis (MHD) patients
      with sarcopenia. Eligible sarcopenic patients in our hospital were randomly assigned to a
      control group (n = 24) and an intervention group (n = 25). The control group received
      conventional dialysis treatment, while the intervention group received mindfulness meditation
      combined with progressive muscle relaxation training during the interdialysis period in
      addition to conventional dialysis treatment. The effect of the intervention was evaluated
      after 12 weeks.To observe whether the combined intervention training can improve the motor
      ability and quality of life of patients with sarcopenia in a short period of time.
    


Intervention name(s): The mindfulness meditation combined with progressive muscle relaxation training .
Intervention type(s): Behavioral
Intervention description(s): The first part is progressive muscle relaxation training. The second part is mindfulness meditation training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness meditation; progressive muscle relaxation; uremic sarcopenia; maintenance hemodialysis; quality of life
Augmenting Exposure Therapy With Self-Distancing
Condition: Anxiety
Study type: Interventional

Summary: 
      Anxiety is prevalent, impairing, and costly in childhood. Evidence-based treatments for
      pediatric anxiety exist; however, as many as 40-60% of youth do not demonstrate optimal
      response. By identifying psychological factors that potentiate symptom severity and treatment
      response, it may be possible to strengthen these factors to treat, or even prevent the
      development of youth emotional disorders.

      This study aims to examine whether the combination of Exposure and Self-Distancing is a
      feasible, acceptable, and efficient intervention for increasing perseverance in the face of
      exposures. This will be measured by child and parent report of treatment acceptability,
      examination of attendance and dropout rates, as well as participant and therapist report of
      participant engagement during exposures.
    


Intervention name(s): Exposure Therapy and Self Distancing
Intervention type(s): Behavioral
Intervention description(s): Weeks 1 and 2 will be introductory sessions (background, rationale, motivational enhancement); Weeks 3 & 4 will have Exposure therapy with Self-Distancing; Weeks 5 & 6 will have Exposure therapy only; Weeks 7 & 8 will have Exposure therapy with Self-Distancing;
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anxious; anxiety
VA111913 TS: First in Human Study
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the
      treatment of dysmenorrhea. This study is designed to investigate determine the safety,
      tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy
      non-pregnant female volunteers of child bearing age.
    

Detailed description: 
      VA111913 TS is a selective V1a-receptor antagonist. The hypothesised mechanism of action of a
      V1a receptor antagonist in dysmenorrhea has been described in literature. Contractions of the
      uterine muscle are required for normal menstruation. Women with dysmenorrhea have increased
      uterine myometrial tone and contractions and decreased blood flow to the uterus. These
      abnormalities have been shown to lead to the pain experienced in dysmenorrhea. Thus, if a
      drug is able to reduce the hyperreactivity of the uterus to physiological levels then the
      pain experienced in dysmenorrhea may be controlled. In humans, vasopressin, via the V1a
      receptor, is able to potently induce contractions in both uterine smooth muscle and uterine
      blood vessels. Thus, a V1a receptor antagonist will potentially inhibit these contractions
      and in turn reduce the pain experienced in dysmenorrhea.
    

Intervention name(s): VA111913 TS / placebo
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Healthy (Dysmenorrhea)
Assessment of Exercise Capacity in Virtual Reality
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The 20th century brought a dynamic development of new technologies, including virtual reality
      (VR). VR is an artificial image generated by IT technologies. It is most often associated
      with entertainment, but has a much wider application in other fields. The aim of the study is
      to assess the influence of the application of immersive virtual reality during an exercise
      capacity test on a bicycle ergometer.
    

Detailed description: 
      Scientists suggests that there are four types of virtual reality: immersive virtual reality,
      desktop virtual reality (i.e., low-cost homebrew virtual reality), projection virtual
      reality, and simulation virtual reality. The sense of presence or immersion is a critical
      feature distinguishing virtual reality from other types of computer applications. It seems
      interesting whether immersion in virtual reality can influence the assessment of exercise
      capacity. The aim of the study is to assess the influence of the application of immersive
      virtual reality during an exercise capacity test on a bicycle ergometer. It is assumed that
      an exercise capacity test on a cycloergometer will be performed in a traditional form and in
      a virtual reality.
    

Intervention name(s): Exercise capacity test; Exercise capacity test in virtual reality
Intervention type(s): Device; Device
Intervention description(s): Patients will be assessed by symptom-limited maximal cardiopulmonary exercise testing (CPET) following a 25W, tree-minute stage, beginning at 25W (healthy volunteers will start the test with a load of 50W). For both sexes and arms, participants will be instructed during the test to remain at the frequency between 60 to 80 rotations per minute (rpm). Heart rate (HR) will be continuously recorded using a monitor Polar H10.; Patients will be assessed by symptom-limited maximal cardiopulmonary exercise testing (CPET) following a 25W, tree-minute stage, beginning at 25W (healthy volunteers will start the test with a load of 50W). For both sexes and arms, participants will be instructed during the test to remain at the frequency between 60 to 80 rotations per minute (rpm).Heart rate (HR) will be continuously recorded using a monitor Polar H10. VR HTC Vive Pro goggles along with VR health care (aerobic exercise) VR Cycling software will be used for stimulation throughout the duration of the test. The HTC Vive Tracker device will be also use to link images in virtual reality with the pedal speed.
Other intervention name(s): Cardiopulmonary Exercise Testing; Cardiopulmonary Exercise Testing in virtual reality
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each individual will be evaluated by a traditional test and a virtual reality test.
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: virtual reality; COPD; exercise capacity
Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis
Condition: Liver Fibrosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with
      fibrosis of the liver.

      Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of
      10 participants who will receive simtuzumab every other week for a total of 3 infusions.
      Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a
      total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen
      in Cohort 1.

      Participants from both cohorts who have completed the main study will be allowed to continue
      on simtuzumab treatment for an additional extension period, and will receive up to 13
      additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.
    


Intervention name(s): Simtuzumab
Intervention type(s): Biological
Other intervention name(s): GS-6624
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gilead; Gilead Sciences; GSI; Liver Fibrosis; Liver; Fibrosis
Post-operative Oral Morphine Versus Ibuprofen
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive
      management of fractures, tendon release, etc. will be randomized to receive either ibuprofen
      or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will
      be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral
      morphine will result in significantly lower pain scores on the Faces Pain Scale Revised
      (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new
      option for post-operative pain management in children.
    


Intervention name(s): oral morphine; Ibuprofen
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ibuprofen; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: oral morphine; ibuprofen; post-operative pain
Bile Acids and Incretins in Pancreas Kidney Transplant Patients
Condition: Pancreas-kidney Transplantation; Kidney Transplantation
Study type: Interventional

Summary: 
      Pancreas Kidney Transplantation (PKT) is the prominent treatment for type 1 diabetic patients
      with chronic kidney disease and improves patients' outcome. However, in spite of an optimized
      systemic insulin substitution, altered glucose metabolism and beta cell function are reported
      in these patients. The mechanisms behind these abnormalities are still unclear.
      Duodena-pancreatic anastomosis is performed in a heterotopic site (ileum) and thus could
      change physical and chemical properties of intestinal secretions, gut flora, as well as
      intestinal permeability. The effect of this procedure on gut derived metabolic factors, the
      enterohepatic cycle of bile acids, incretin secretion and intestinal flora have never been
      studied. This pilot prospective, study is aimed to evaluate the modification of bile acids
      concentrations and composition in PKT subjects, and the impact in glucose and incretin
      metabolism (measured by oral glucose tolerance test) one year after transplantation. The
      results will be compared to those of kidney transplant patients and control subjects.
    


Intervention name(s): pancreas kidney transplantation; kidney transplantation
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Pancrelipase
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bile acids; pancreas kidney transplantation; incretins; intestinal flora
Human Photoallergy Test (824/2016)
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Photoallergic
Study type: Interventional

Summary: 
      To evaluate the potential of a test material to produce a photoallergic response
    


Intervention name(s): BAY987517; Untreated skin
Intervention type(s): Drug; Other
Intervention description(s): 50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. Twenty-four (24) hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. Forty-eight (48) hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation number: Z43-078); One site is patched without treatment as control
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Other
Adolescent Postpartum Contraceptive Counseling Intervention
Condition: Adolescent Pregnancy
Study type: Interventional

Summary: 
      Postpartum contraceptive counseling varies widely in its provision; no standardized practice
      has been well-established by the literature. We intend to evaluate how directed postpartum
      contraceptive counseling to adolescents aged 14-19 affects key outcomes over time. Subjects
      will be randomized to receive either the standardized contraceptive counseling intervention
      or routine postpartum care. We will then assess the difference in repeat pregnancy rates
      between the two groups
    


Intervention name(s): Brief standardized contraceptive counseling intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention employed an in-person counseling strategy that included empowerment messaging and an instrument to clarify the participants' preferences for contraception in the context of their goals for future childbearing.
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)