bioihbjkbjnl/mcl2 huggingface dataset:
Study To Assess Local Tolerability of Crisaborole 2% Ointment and Vehicle Ointment In Healthy Participants Using Subject-reported Assessments and Objective Measurements
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind within-subject study to estimate observed application site adverse events
      following topical applications of crisaborole and vehicle in healthy participants
    

Detailed description: 
      To further understand the potential for crisaborole to evoke skin irritancy, a within-subject
      comparison study, C3291042 will assess the local tolerability of crisaborole 5 mg/cm² in
      healthy participants, who have had baseline assessments of surrogate markers of skin
      sensitivity-i.e. current perception threshold (CPT) measurements and standardized lactic acid
      stinging test (LAST) assessments. To further the clinical understanding of application site
      pain, responses to crisaborole ointment compared to crisaborole vehicle ointment will be
      assessed in comparisons based upon CPT (low versus high; symmetry versus asymmetry) and
      response to LAST ("stingers" versus "non-stingers"). This exploration of skin sensitivity
      characterizations in healthy participants exposed to crisaborole 5 mg/cm² will assess
      application site burning, stinging, and pain as well as other application site
      characteristics selected from a MedDRA-based list of terms by the participants. More advanced
      understanding of baseline application site sensation in healthy participants prior to higher
      local application rate of topical crisaborole may provide strategies for topical dermatologic
      product development programs striving to prevent or minimize application site sensory adverse
      events.
    

Intervention name(s): Within-Subject Active vs Placebo Topical Applications; Within-Subject Active vs. Placebo Topical Applications
Intervention type(s): Drug; Drug
Intervention description(s): Crisaborole 2% ointment (right side) and Placebo vehicle ointment (left side); Crisaborole 2% ointment (left side) and Placebo vehicle ointment (right side)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Using surrogate markers of skin sensitivity (current perception threshold and lactic acid stinging test responses) to stratify risk for developing application site treatment emergent adverse events (AS-TEAEs), within-subject comparisons will quantify AS-TEAE frequency and severity in healthy participants following double-blind applications of crisaborole ointment and vehicle ointment at 7 sensitive skin anatomic locations.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients
Condition: Device Induced Injury; Necrosis, Pressure; Complication of Device Insertion; Airway Morbidity
MeSH terms: Necrosis
Study type: Interventional

Summary: 
      In the following randomized non-crossover study, the investigators test the hypothesis that
      directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and
      the i-Gel in paralyzed anesthetized females.

      Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA
      Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA
      Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx;
      C, hypopharynx; and D, pyriform fossa.

      Insertion success rate and oropharyngeal leak pressure were also measured.
    


Intervention name(s): Laryngeal Mask Airway Supreme; i-Gel extraglottic airway device
Intervention type(s): Device; Device
Intervention description(s): Directly measured mucosal pressures; Directly measured mucosal pressures
Other intervention name(s): Supreme; i-Gel
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Continuous Glucose Monitoring System (CGMS) in Type 2 Diabetic Patients Inadequately Controlled by Metformine Monotherapy; Analyze of Glycemic Profile Before and After Association of Glimepiride
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2
      diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.
    


Intervention name(s): GLIMEPIRIDE
Intervention type(s): Drug
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"Program "Cerdanya on Fitness" to Improve the Lifestyle of People With Obesity in Cerdanya (CF).
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      To evaluate the effectiveness of an intervention program called "Cerdanya on fitness" based
      on the prescription of physical activity, healthy nutritional habits and the promotion of
      positive mental health, adapted to people with obesity to improve their lifestyle and
      psychoemotional wellbeing
    

Detailed description: 
      Previous phase:Presentation of the protocol to doctors and nurses of the primary health care
      center.

      Phase 1: After being informed about the study and the possible risks, all patients who give
      their written informed consent will undergo.

      -1) 4 weeks of screening to determine eligibility to enter the study. Referral of patients
      who meet the inclusion/exclusion criteria to enter the Cerdanya on fitness program by the
      nursing consultation.

      Phase I protocol data collection (physical activity scale, positive mental health scale,
      Mediterranean diet scale, sociodemographic variables will also be collected week 0) Patients
      who meet the eligibility requirements will be randomized in a non-blinded fashion. (control
      group and research group) (5 weeks)

      weeks 1-2: Initial assessment of physical fitness and dietary habits in the intervention
      group (blood test- stress test- anthropometry)

      week 3-39: Implementation of the intervention (nutritional, physical activity and
      psychosocial) to the intervention group. The control group will continue with the usual
      nursing controls in the primary care center.

      40-41 week: Final evaluation of the physical condition and eating habits of the intervention
      group (blood test, stress test, anthropometry): Final data collection of the control and
      intervention group (physical activity scale, positive mental health scale, Mediterranean diet
      scale).

      Translated with www.DeepL.com/Translator (free version)
    

Intervention name(s): Cerdanya on Fitness
Intervention type(s): Behavioral
Intervention description(s): The intervention lasts 9 months. The participants will carry out group activities and will be followed individually by the different interdisciplinary professionals. Goals will be set for each visit. Before and after the training there will be an assessment of physical exercise, nutritional and positive mental health habits.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Model pre-post test in intervention group and pre-post usual follow up in control group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity,; healthy lifestyle; Mental Health
3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
Condition: Schizophrenia; Schizophrenia Relapse; Schizophrenia Spectrum and Other Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional

Summary: 
      This open-label, non-randomized, prospective study will evaluate the risk of symptoms
      recurrence during the three years after antipsychotic discontinuation in a sample of
      functionally recovered first-episode patients with schizophrenia spectrum disorder.
    


Intervention name(s): Antipsychotic treatment discontinuation; Maintenance antipsychotic treatment
Intervention type(s): Other; Other
Intervention description(s): Withdrawal of antipsychotic medication to stabilized patients.; Maintenance antipsychotic medication to stabilized patients.
Intervention MeSH terms: Antipsychotic Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment; Maintenance
The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this research study is to compare the levels of free fatty acids and free
      bilirubin between two intravenous lipid emulsion products in premature newborns.
    


Intervention name(s): Intralipid, 20% Intravenous Emulsion; SMOF lipid
Intervention type(s): Drug; Drug
Intervention description(s): Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.; Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: parenteral nutrition; lipid emulsion; free bilirubin; free fatty acids
Group Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Attention-Deficit/Hyperactive Disorder (ADHD) in adults is associated with global impairments
      and deficits in quality of life. The ADHD functional impairments during adulthood usually
      persist even after adequate medication treatment. The Skill Training Group of the Dialectical
      Behavioral Therapy (DBT) is one of the group therapies that had been adapted for the specific
      treatment of ADHD patients. Our primary aim is to explore the feasibility of the approach in
      different culture and to evaluate the efficacy of the Skill Training Group as an add-on
      treatment for adults using ADHD medication. This is a Randomized Clinical Trial comparing the
      Skill Training Group added to stimulants to treatment as usual. 52 adults previously
      diagnosed with ADHD and treated with stimulants in our ADHD outpatient program will be
      enrolled. Only patients with residual symptoms will be included (ADHD-Self Report Scale -
      ASRS ≥ 20). The intervention comprises the standard 12 sessions therapy program. The groups
      will have between 8 and 12 patients each, and will be conducted by a trained DBT therapist
      with supervision from a senior DBT therapist. The primary outcome will be the ASRS scores.
      Secondary outcomes include scores in ADHD Quality of Life, Beck's Depression Inventory,
      Beck's Anxiety Inventory, and performance in a neuropsychological test (difference between
      pre and post-intervention) (Stop Signal Task). Adherence to the protocol will also be
      checked. The recruitment was initially scheduled for beginning in November.
    


Intervention name(s): Skill Training Group of the Dialectical Behavior Therapy; Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): A 12 session version of the Skill Training Group of the Dialectical Behavior Therapy, adapted for treatment of ADHD.; Conventional protocol using only medication (including drug adherence).
Other intervention name(s): waiting list
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactive Disorder; Skill Training Group; Dialectical Behavior Therapy
The Influence of High and Low Salt on Exosomes in the Urine
Condition: Healthy
Study type: Interventional

Summary: 
      The hypothesis is that changes in the epithelial sodium channel (ENaC) in the kidney is
      reflected in urinary exosomes and that the amount of ENaC as well as the cleavage degree is
      upregulated in conditions with low salt.
    

Detailed description: 
      Methods:

      Exosomes will be isolated from spot urine by ultracentrifugation and tested using western
      blotting. In-house developed antibodies against different parts of the ENaC gamma subunit as
      well as commercial antibodies will be used. A marker for exosomes will validate the presence
      of exosomes in the urine.

      Power considerations:

      In this cross over salt-intervention study with quantification of ENaC the investigators
      refer to a published study regarding the sodium-chloride co-transporter (NCC) in the kidney,
      were rats where given aldosterone infusion or a low salt diet. In this study n=6 was
      sufficient to detect a 2-3 fold change in NCC in urinary exosomes. Furthermore 5 patients
      with primary aldosteronism had a significant increase in NCC in urinary exosomes (N. Lubbe et
      al, Hypertension 2012).

      On the basis of this the investigators choose to test 10 persons, but are not able to make a
      regular power calculation.
    

Intervention name(s): High salt diet followed by low salt diet; Low salt diet followed by high salt diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): High salt diet (250 mmol/day) in 5 days followed by low salt diet (60-70 mmol/day) in 5 days.; Low salt diet (60-70 mmol/day) in 5 days followed by high salt diet (250 mmol/day) in 5 days.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ENaC; Exosomes; Urinary biomarker; Salt regulation
Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout
Condition: Gout; Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and
      potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult
      population with gout.
    

Detailed description: 
      Patients entering the six-week Treatment Period will receive once daily oral dosing of
      arhalofenate during Weeks 1 and 2 (Days 1 through 14), combined once daily oral dosing of
      arhalofenate and febuxostat during Weeks 3 and 4 (Days 15 through 28), and once daily oral
      dosing of febuxostat during Weeks 5 and 6 (Days 29 through 42). In addition, all patients
      will receive once daily oral dosing of colchicine throughout the Treatment Period.
    

Intervention name(s): Arhalofenate; Febuxostat; Arhalofenate; Febuxostat; Colchicine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 800 mg once daily orally for four weeks; 40 mg once daily orally for 1 week then up-titrated to 80 mg once daily orally for another three weeks; 600 mg once daily orally for four weeks; 80 mg once daily orally for 1 week then down-titrated to 40 mg once daily orally for another three weeks; 0.6 mg daily
Intervention MeSH terms: Colchicine; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Surgical Scar Treatment With the Pulsed Dye Laser in Combination With a CO2 Laser
Condition: Scars
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and
      efficacy of combined treatment for minimizing of surgical scars, including post Moh's
      surgery.
    

Detailed description: 
      Prospective, Randomized, Split lesion treatment with 4 study Arms: 1) treatment with pulsed
      dye laser (PDL) only, 2) treatment with CO2 laser only, 3) PDL and CO2 laser combined
      treatment, and 4) split scar combined lasers with an additional single CO2 laser treatment
      immediately post-surgery vs. no treatment.
    

Intervention name(s): Pulsed dye laser treatment; CO2 laser treatment; Combined PDL and CO2 laser treatment; Split PDL and CO2 Laser treatment
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Scar minimization with Pulsed dye laser treatment on suture removal day; Scar minimization with CO2 laser treatment on suture removal day; Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day; Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day
Other intervention name(s): Vbeam, Vbeam Perfecta, PDL; CO2RE, CORE; Vbeam, Vbeam Perfecta, CO2RE, CORE
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Gabapentin in Treating Overactive Bladder
Condition: Urinary Urgency; Urinary Frequency; Nocturia; Incontinence; Detrusor Uninhibited Activity; Quality of Life
MeSH terms: Urinary Bladder, Overactive; Nocturia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Overactive bladder (OAB) syndrome as defined by International Continence Society is a
      pathological condition characterized by irritative symptoms: urinary urgency, with or without
      incontinence, urinary frequency and nocturia. The syndrome often seriously compromises the
      quality of life of the patients. The etiology of the OAB is considered multifactorial. Neural
      plasticity of bladder afferent pathways is one of the proposed mechanisms of OAB. The
      detrusor muscle itself has for many years been the target for drug treatment such as
      antimuscarinics. However, depression of detrusor contractility, may results in a reduced
      ability to empty the bladder and lead to some sympathetic adverse effects, which limits the
      treatment of OAB. Currently the focus of OAB treatment has changed to other bladder
      structures/mechanisms, such as afferent nerves and urothelial signaling as targets for
      intervention. C-fiber bladder afferents nerves may be critical for symptom generation in
      pathologic states such as OAB because these fibers demonstrate remarkable plasticity.
      Up-regulation of bladder C-fiber afferent nerve function may also play a role in urge
      incontinence, overactive bladder (OAB) and sensory urgency. The mechanism of Gabapentin's
      action for neuropathic pain has not been fully elucidated but is appears to have inhibitory
      activity on afferent C-fibers nerve activity; moreover, several studies had established the
      safety of Gabapentin in its treatment of different conditions. Due to the proposed mechanism,
      the investigators suggest that Gabapentin may be a new alternative for treating OAB.
    


Intervention name(s): Gabapentin; Solifenacin Succinate; Placebo drugs
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100mg/capsule initially one capsule once a day then titrate according to the symptoms of the patient upto maximum dose of 1500mg/day; 5mg/tablet initially 1 tablet once a day then titrate up to maximum dose of 10mg/tab; will titrate medications similar to the active drug group
Intervention MeSH terms: Gabapentin; Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overactive Bladder; Gabapentin; Quality of Life; Urodynamic; safety; Efficacy
Evaluate Safety and Efficacy of Autologous Bone Marrow-derived Endothelial Progenitor Cells in Advanced Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Endothelial Progenitor Cells (EPC) represent a small cellular population of bone marrow and
      peripheral blood cells. EPCs are recruited into injured tissues and play an important role in
      regeneration and reparation. Experimental and clinical data suggest that EPCs have
      hepatoprotective activity and could improve liver regeneration during acute and chronic liver
      injury. The aim of this project is to evaluate the safety and therapeutic effects of
      autologous bone marrow-derived EPCs, when administered through the hepatic artery of patients
      with advanced liver cirrhosis.
    


Intervention name(s): Autologous bone marrow-derived endothelial progenitor cells
Intervention type(s): Other
Intervention description(s): Intraarterial administration (hepatic artery) of autologous bone marrow-derived endothelial progenitor cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking
Condition: Alzheimer Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a longitudinal, observational study evaluating the imaging characteristics of the tau
      PET radioligand [18F]MK-6240 in Alzheimer's disease (AD), Mild Cognitive Impairment (MCI) and
      Healthy Volunteer (HV) subjects. Up to 42 subjects, including approximately 28 MCI/mild AD
      subjects, up to 5 moderate AD subjects, and 9 similarly aged HV subjects will be consented
      and screened. Imaging procedures include [11C]PiB to evaluate amyloid deposition,
      [18F]MK-6240 PET, and structural MRI. All subjects complete an evaluable baseline
      [18F]MK-6240 PET scan, as well as scans at 6, 12 and 24 months post-baseline. If unable to
      complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may
      instead be scheduled, totaling a maximum of four time points.
    


Intervention name(s): All Subjects
Intervention type(s): Drug
Intervention description(s): All subjects will be given the experimental tau PET radioligand [18F]MK-6240
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic