bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study if to investiagte the time course of PF-00258210 plasma
      concentration in the presence or absence of PF-00610335 administered via oral inhalation
      using dry powder inhalers
    


Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-00258210 220 µg using inhaler A; PF-00258210 220 µg using inhaler A and 450 µg PF-00610335 using inhaler A; PF-00258210 440 µg and 450 µg PF-00610335 using inhaler A; PF-00258210 350 µg and 450 µg PF-00610335 using inhaler A; PF-00258210 220 µg using inhaler B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy
Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in
      pediatric subjects (ages 6 to 11 years old) with plaque psoriasis:
    


Intervention name(s): ARQ-151 cream 0.3%
Intervention type(s): Drug
Intervention description(s): ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
Other intervention name(s): Topical roflumilast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder
Condition: Borderline Personality Disorder; Randomized Controlled Trial
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      Background and Objectives: Schema therapy has been shown to be of benefit in treating
      borderline personality disorder. However, it is still unclear what the most suitable
      treatment implementation format is and to what extent therapeutic gains may be generalizable
      to regular healthcare settings with limited resources.

      Methods: A pragmatic randomized controlled trial was conducted ona representative Spanish
      sample of outpatients with a DSM-5 main diagnosis of borderline personality disorder.
      Patients were allocated either to a combined (group plus individual) schema therapy format
      (n=40) or to a group-only schema therapy format (n=40). Borderline personality disorder
      severity was the primary outcome, with other clinical variables considered as secondary
      outcomes (e.g., early maladaptive schemas, functioning). The assessment protocol included
      baseline, post-treatment (after 12months of treatment), and six-month follow-up evaluations.
      Data was analyzed through a two-way repeated measures ANOVA. Limitations were a limited
      follow-up assessment and the absence of multi-center data that detracted from the long-term
      stability and generalizability of the findings.
    


Intervention name(s): Group Schema therapy; Individual Schema therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Bimonthly outpatient psychotherapy delivered in individual setting; weekly outpatient psychotherapy delivered in group setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Pegaferon and Ribavirin for Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD
      pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be
      treated using standard guidelines for hepatitis C. Response to treatment and side effects
      will be recorded.
    

Detailed description: 
      The product is locally produced and needs to be evaluated in terms of efficacy and safety.
    

Intervention name(s): Pegaferon (pegylated interferon alpha 2a) + ribavirin
Intervention type(s): Drug
Intervention description(s): pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4
Other intervention name(s): Pegaferon
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C
A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Condition: Healthy; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety of LY3537021 and any side
      effects that might be associated with it in healthy participants and participants with type 2
      diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3537021 gets into
      the bloodstream and how long the body takes to eliminate it.

      This study will last up to about 19 weeks including screening period.
    


Intervention name(s): LY3537021; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis (IPF)
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Drug discovery can take many years especially since most studies to measure effectiveness
      depend on clinical outcomes like pulmonary function tests and hospitalizations.

      This is an observational study designed to collect information, blood, and bronchoalveolar
      lavage fluid in people who have IPF and those who do not. The people who have IPF will be
      followed for 12 months to collect more biological samples and record clinically relevant
      information.

      The goal of this study is to identify new molecular markers that are measurable and reliable
      in people who have IPF. It is hoped that these markers can be used in future drug studies to
      significantly speed up the process of finding drugs that help.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        IPF
      
Biospecimen description: 
      Serum, plasma, Bronchiolavage (BAL) supernatant, and BAL cell pellets
Effects of Empagliflozin on Liver Fat Content, Energy Metabolism and Body Composition in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The effects of empagliflozin treatment on hepatocellular lipid content, liver energy
      metabolism and body composition will be investigated in a multicentre, prospective,
      placebo-controlled, double-blind, randomized, 2-arm parallel, interventional and exploratory
      pilot study in patients with newly diagnosed type 2 diabetes.
    

Detailed description: 
      In this multicentre, prospective, placebo-controlled, double-blind, randomized, 2-arm
      parallel, interventional pilot study HCL and intramyocellular lipids (IMCL) will be
      quantified with 1H magnetic resonance (MR) spectroscopy. Hepatic ATP and inorganic phosphate
      (Pi) concentrations will be assessed with 31P MR spectroscopy (1). Whole-body and hepatic
      insulin sensitivity and metabolic flexibility will be measured by combining
      hyperinsulinemic-euglycemic pancreatic clamp tests with isotopic dilution of 6,6-2H2 glucose
      and indirect calorimetry as shown (2). Abdominal fat distribution will be quantified by MR
      imaging.

      Newly diagnosed patients with type 2 diabetes (T2D) will be randomly allocated to once daily
      25 mg empagliflozin (EMPA) or placebo for 24 weeks with a computer-generated random sequence
      and will be masked to the treatment assignment. Participants will visit the clinical research
      center at baseline, 12 weeks and 24 weeks for MRS and metabolic examinations, including blood
      sampling for hepato- and adipocytokines. Anthropometric parameters (body weight, waist
      circumference, total body fat, blood pressure) and glycemic control (HbA1C, fasting blood
      glucose, FBG) will be assessed at baseline and during monitoring visits every 4 weeks.
    

Intervention name(s): Empagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg once daily; once daily
Other intervention name(s): Jardiance; No Drug Therapy
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CanCope: Digital Intervention for Coping With Cannabis Craving
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The CanCope Study is a micro-randomized trial conducted to gather evidence about and compare
      the effectiveness of a momentary intervention to help young adults cope with cannabis
      cravings as they attempt to reduce their use.
    

Detailed description: 
      The CanCope Study is designed to test the effectiveness of two distinct strategies
      (mindfulness and distraction) to cope with cannabis cravings in young adults (19 - 25 years)
      who are attempting to reduce their cannabis use. Cannabis use is determined using a
      single-item question about the number of days out of the past 30 days the individual used
      cannabis. Young adults who reported using cannabis >10 out of the past 30 days, who were not
      pregnant or breastfeeding, and who were not currently in treatment for problems related to
      substance use were eligible to enroll in this four-week study.

      The CanCope intervention was delivered to participants through the MetricWire app, which was
      available for download on the participants' personal smartphones. Participants were asked to
      complete five ecological momentary assessments (EMA) per day, which asked questions related
      to cannabis use including one question about current level of craving on a scale of 0 - 10.
      If a participant reported a craving level >4, a message was sent via the app encouraging the
      participant to try a mindfulness or distraction coping strategy, or the participant received
      a thank-you for completing the EMA which served as an attention control.
    

Intervention name(s): CanCope
Intervention type(s): Behavioral
Intervention description(s): Messages prompted participants to use mindfulness-based or distraction-based coping strategies, or a thank-you message which served as an attention control. If participants reported elevated craving (4 or greater) prior to a decision point, they received either a coping strategy message or a control message. If participants reported craving levels of less than 4 they received a control message.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Micro-Randomized Trial (MRT)
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility of 1 Hour Clear Fluid Fasting Prior to Paediatric GA
Condition: Gastric Residual Volume
Study type: Interventional

Summary: 
      The study is aim to investigate the appropriate fasting time for clear fluid in paediatric
      patients who plan for elective minor surgery.

      This is a randomize control trial, which patient will be selected randomly to fast for clear
      fluid for 1 hour or 2 hours.

      It is important to determine the gastric residual volume for paediatric age group prior to
      elective minor surgery in order to determine whether the difference between 1 hour fasting
      and 2 hour fasting for clear fluid is significant.
    

Detailed description: 
      This study is to evaluate the latest fasting protocol that is currently adopted and
      recommended by United Kingdom, France and Royal Children Hospital Melbourne.

      The research question is should investigator change fasting protocol for paediatric patients
      prior to operation.

      The anaesthesia service is being studied. Participants are patients who are 5-16 years old
      are planned for elective minor surgery in ent, eye, dental surgery, general surgery and
      orthopaedics.

      This study will be done in UMMC. 2 groups of patients will be recruit which consists of 50
      patients each. Each of the group will be instructed to fast for clear fluid for 1 hour or 2
      hours prior to surgery. Prior to induction, the amount of abdominal contents was examined
      using ultrasound scan. In addition, patients anxiety level prior to and 1 hour post general
      anaesthesia will be assess. Also, parents of patients will complete a questionnaire after the
      surgery to assess parental satisfaction toward anaesthesia service.
    

Intervention name(s): Fasting time for clear fluid prior to anaesthesia
Intervention type(s): Other
Intervention description(s): This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne.
The research question is should we change our fasting protocol for paediatric patients prior to operation The anaesthesia service is being studied. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, parents will complete a questionnaire after the surgery to assess anxiety level of patients before and after the surgery.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Clear fluid fasting; residual gastric volume; paediatric anaesthesia
Multiparametric Imaging in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography
      imaging with intravenously injected C11 Methionine to detect viable lesions.
    


Intervention name(s): C11 Methionine positron emission tomography
Intervention type(s): Drug
Intervention description(s): diagnostic positron emission tomography imaging after intravenous injection of C11 Methionine
Other intervention name(s): L-methionine [C-11] methyl positron emission tomography
Intervention MeSH terms: Carbon-11 methionine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of ALD518 in three
      different doses in patients who have not had an adequate response to methotrexate.
    

Detailed description: 
      This will be a phase II, parallel-group, double-blind, randomized, placebo-controlled study
      of ALD518 in patients with active RA with an inadequate response to methotrexate.

      Enrolled patients will be screened within a 4-week period (Day -35 to -7). within a 12-day
      period (Day-14 to -3) before initial dosing on Day 1 patients will be randomized to one of
      the following four treatment groups:

      Group A: 2x ALD518 80 mg Group B: 2x ALD518 160 mg Group C: 2x ALD518 320 mg Group D: 2x
      placebo

      In all treatment groups patients will continue to take a stable dose of methotrexate.

      There will be a total of 11 visits. The total duration of the patient study participation
      will be approximately 16 weeks (excluding the screening period).
    

Intervention name(s): ALD518; Infusion without ALD518'
Intervention type(s): Biological; Biological
Intervention description(s): Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8; 250 cc Normal saline IV over one hour Weeks 1 and 8.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy
      individuals and how well changes in (interstitial) tissue glucose levels correlate with
      changes in cognitive function as compared to blood glucose levels.
    

Detailed description: 
      Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured
      and cognitive function will be assessed.
    

Intervention name(s): euglycemic and hypoglycemic clamp
Intervention type(s): Procedure
Intervention description(s): Subjects will undergo standard euglycemic and hypoglycemic clamps, and will have concurrent assessments of cognitive function and measurement of interstitial glucose concentrations.
Other intervention name(s): clamp
Intervention MeSH terms: Hypoglycemic Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hypoglycemia, cognitive function
Effects of IC With and Without MET on Upper Trapezius Trigger Points
Condition: Upper Trapezius Trigger Points
Study type: Interventional

Summary: 
      the aim of the study is to check the effects of ischemic compression with and without muscle
      energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger
      points in the upper trapezius. In previous studies, Muscle Energy Technique and Ischemic
      Compression are compared with different conventional and combined therapy approaches,
      including most of the techniques used to treat Trigger Points in the upper trapezius. No
      study has evaluated the effects of ischemic compression with and without muscle energy
      technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in
      the upper trapezius. The outcome measures are a Numeric pain rating scale, universal
      goniometer and neck disability index questionnaire.
    


Intervention name(s): Ischemic Compression; Ischemic compression with Muscle Energy Technique
Intervention type(s): Other; Other
Intervention description(s): It includes conventional Physical therapy, hot packs (75°C) for 20 minutes, and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold, and 10-second relaxation between two repetitions) as a baseline treatment. For the Ischemic compression, the patient will be in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position physiotherapist will apply gradually increasing pressure to the Trigger points until the subject perceived the first noticeable pain. At that moment, the pressure will be maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure will be increased until the discomfort appears again. This process will be maintained for 90 seconds.; The Participants will receive all the treatments given to the active comparator group and they will also receive the Muscle Energy Technique treatment in supine position and the practitioner will stabilize the shoulder of the affected side with one hand, while the ear/mastoid area of the affected side will be held by the opposite hand. The head and neck were then bent towards the contralateral side, flexed, and ipsilaterally rotated. The subjects will then shrug the stabilized shoulder towards the ear at a sub-maximal pain-free effort (20% of the available strength). The isometric contraction will be held for 7-10s. This position will be maintained for 30 seconds and repeated three to five times per treatment session. Treatment sessions will be given on alternate days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This prospective randomized single Center study investigates to what extent the physical
      elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity
      of severely and critically ill patients with Covid-19.
    


Intervention name(s): CytoSorb-Therapy
Intervention type(s): Device
Intervention description(s): Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: critically ill; intensive care medicine; CytoSorb; hemoadsorption
Breaks in Sedentary Time and Glucose Regulation in Women
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The number of people diagnosed with Type 2 diabetes (T2DM) is increasing rapidly and about
      2.9 million people in the UK currently have diabetes. There is increasing evidence suggesting
      that prolonged sedentary time may actually increase the risk of diabetes and other chronic
      diseases. Importantly, adults can meet public health guidelines on physical activity (150
      minutes of moderate activity per week), but if they still sit for prolonged periods, their
      metabolic health is compromised. Going from sitting to standing and carrying out
      light-intensity activities (such as casual walking) may reduce diabetes risk. However, no one
      has investigated the effect of standing and walking on markers of cardio-metabolic markers in
      individuals with a high risk of T2DM. Therefore, the aim is to find out whether reducing the
      amount of time people spend sitting and replacing it with standing and light intensity
      activity (walking) reduces glucose, insulin and triglyceride levels, therefore reducing the
      risk of diabetes.
    


Intervention name(s): Sitting; Standing; Walking
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention