bioihbjkbjnl/mcl2 huggingface dataset:
Doppler Ultrasound in Rewarming After Targeted Control Management in Cardiac Arrest
Condition: Cardiac Arrest; Doppler Ultrasound
MeSH terms: Heart Arrest
Study type: Observational

Summary: 
      The aim of the study is to describe CBF modifications during rewarming after targeted
      temperature management in cardiac arrest patients
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cardiac arrest with GCS<8
Mobile CHESS Research on Emergency Medical Services for Children
Condition: Asthma
MeSH terms: Asthma; Emergencies
Study type: Interventional

Summary: 
      The primary aims are to test whether an asthma care management system (M-CHESS) delivered via
      a smartphone (cellular phone with internet access) can support low income teenagers (ages
      12-18) with significant asthma and can improve asthma control and reduce asthma-related
      emergency or urgent care visits and hospitalizations. Secondary aims include whether M-CHESS
      increases adherence to asthma control medication and reduces absenteeism from school, work or
      an event they wanted to attend.
    

Detailed description: 
      Four hundred Milwaukee Medicaid recipients (ages 12-18), with an asthma-related emergency
      care visit or hospitalization in the last twelve months, will be recruited through their
      managed care organization (MCO). They will be randomly assigned to one of two study arms and
      will participate in a 12-month intervention plus a 12-month follow-up period. Subjects in the
      control group will receive a smartphone with internet access & text messaging service. These
      devices will provide the ability to collect smartphone use data electronically. The
      experimental group will also receive the same smartphone devices (with internet access and
      text messaging service and ability to collect usedata. In addition the experimental group
      will have access to the Mobile CHESS (M-CHESS) interface. The M-CHESS smartphone interface
      features an interactive, internet based asthma education program, peer support mechanisms and
      automated reminders for asthma control medicines and data collection.
    

Intervention name(s): M CHESS
Intervention type(s): Behavioral
Intervention description(s): Smartphone with access to MCHESS, an asthma control system that provides easy-to-access, just-in-time information and support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Persistent asthma; Asthma related emergency room visits; Asthma control, adolescents; Adherence, asthma control medications
Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this trial is to establish the dose response
      relationship on glycaemic control of five dose levels of NNC90-1170.
    


Intervention name(s): placebo; liraglutide; glimepiride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily injection, under the skin (s.c.) for 12 weeks; Once daily injection, under the skin (s.c.) for 12 weeks; Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response
Other intervention name(s): NNC 90-1170
Intervention MeSH terms: Liraglutide; Glimepiride
Study to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome
Condition: Non-constipation Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of different doses of
      SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with
      non-constipation.
    


Intervention name(s): SKI3246 Low Dose; SKI3246 High Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SKI3246 Low Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening; SKI3246 High Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening; SKI3246 Placebo will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mindfulness Training in Special Operations Forces (SOF) Candidates
Condition: Cognitive Change
Study type: Interventional

Summary: 
      The overarching goal of this study is to develop, deliver, and investigate the utility and
      feasibility of train-the-trainer delivery of mindfulness training (MT) in support of improved
      readiness (across cognitive, affective, and social domains of the human dimension) and
      improve retention of candidates in the SOF qualification pipeline at the U.S. Army John F.
      Kennedy Special Warfare Center and School (referred to as SWCS).
    


Intervention name(s): MBAT course
Intervention type(s): Behavioral
Intervention description(s): The MBAT will involve:
(i) 4 weekly 1.5-hour course sessions. The sessions will provide guided exercises, didactic information, and discussions to promote greater mindfulness.
(ii) Daily mindfulness practice that will be facilitated by the Measuring Mindfulness App (MMA) and/or instructor-delivered mindfulness practices. The daily mindfulness practice will require about 15 minutes to complete.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Stress
The Effect of Drinking-Water pH on the Human Gut Microbiota
Condition: Healthy Participants
Study type: Interventional

Summary: 
      This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on
      the gut microbiota of healthy male volunteers.
    


Intervention name(s): Alkaline drinking-water; Neutral drinking-water
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis
Condition: Allergy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a clinical study in children and adolescents (5-17 years) with allergy to pollen from
      birch (or related trees). It compares the tree SLIT-tablet with placebo in relieving
      rhinoconjunctivitis symptoms during the birch/tree pollen season based on the average
      allergic rhinoconjunctivitis daily total combined score.

      The study will also collect health-related quality of life information in the groups treated
      with the tree SLIT-tablet or with placebo during the pollen season.

      The trial medication used is already approved to treat allergic rhinitis caused by birch/tree
      pollen in adults in several countries?.
    

Detailed description: 
      This is a phase III, parallel-group, double-blind, placebo-controlled study to evaluate
      efficacy and safety of the tree SLIT-tablet in children and adolescents (5-17 years) who have
      rhinoconjunctivitis (with or without asthma) induced by pollen from birch trees or by trees
      belonging to the birch homologous group. Approximately 1000 children and adolescents will be
      enrolled in the trial and will receive either the tree SLIT-tablet or placebo.

      The trial consists of 3 periods: a screening period, a treatment period, which includes
      pre-seasonal and co seasonal treatment, and a follow-up period. The duration is up to 13
      months for each participant.

      The trial is conducted in several European countries and in Canada.
    

Intervention name(s): SQ tree SLIT-tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sublingual allergy immunotherapy tablets; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic rhinoconjunctivitis; Children; Adolescents; Birch
Clinical Trial on the Articular Pain With a Cucumber Supplement in Patients Diagnosed With Arthrosis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Randomized, controlled, double-blind clinical trial of two parallel branches to analyze the
      efficacy of a supplement extracted from the cucumber on the joint pain of patients diagnosed
      with osteoarthritis.
    

Detailed description: 
      The subjects that meet the selection criteria will make a total of two visits to the research
      laboratory and will carry out the pre-established tests in the protocol. Subsequently, a
      statistical analysis will be carried out with the variables measured in the study to obtain
      results.
    

Intervention name(s): nutraceutical
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will consume two capsules for eight weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery
Condition: Anesthesia; Nasal Surgery; Pharyngeal Packing; Gastric Volume; Postoperative Nausea
MeSH terms: Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Pharyngeal packing is a frequently used application to reduce the incidence and severity of
      postoperative nausea and vomiting (PONV) in patients who undergo nasal surgery. This study
      aims to research the effects of PP on gastric antral cross-sectional area (ACSA) and hence
      gastric volume as assessed by ultrasound, therewithal PONV and sore throat were evaluated as
      secondary outcomes in rhino logic surgeries (Septorhinoplasty, Septoplasty, Functional
      endoscopic sinus surgery).
    

Detailed description: 
      Postoperative nausea and vomiting (PONV) after nasal surgery (Septorhinoplasty, Septoplasty,
      Functional endoscopic sinus surgery) is a very common complication (34-60%). Therefore,
      pharangeal packing was performed to prevent blood ingestion so as to decrease the incidence
      of PONV and the risk of aspiration. Also, gastric blood is known to be a powerful emetic.
      Actually, there is not any evidence in the literature reporting the quantitative values of
      gastric volumes due to blood ingestion. The aim of this study is to research the effect of
      pharyngeal packing on the perioperative gastric antral cross-sectional area (ACSA) so the
      gastric volumes.

      Measurements were performed by ultrasound with convex probe in right lateral decubitus
      position, in order to evaluate the effectiveness of pharyngeal packing in patients undergoing
      nasal surgery, and to show its effects on PONV and sore throat.
    

Intervention name(s): Pharyngeal packing
Intervention type(s): Device
Intervention description(s): Placing gauze-like material in the nasal cavity to absorb blood or other fluids right after tracheal intubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to investigate the safety and tolerability of AZD4017 when
      given as multiple oral ascending doses to healthy volunteers. This will be done by comparing
      the effect of AZD4017 to placebo. The study will aslo investigate the absorption,
      distribution and disappearance of AZD4017 in the body. Information about plasma
      concentrations of AZD4017 vs time after dose intake will also be collected and some measures
      of pharmacokinetics versus pharmacodynamics will be included. The future indication for
      AZD4017 is planned to be Type 2 Diabetes Mellitus.
    


Intervention name(s): AZD4017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ascending multiple doses(start dose 75mg od), oral suspension
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Safety and tolerability
A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this phase 1 trial are to evaluate the effect of food on the
      pharmacokinetics (i.e. how long and how much a compound is present in the blood) of
      ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam, a
      CYP3A4 substrate.
    

Detailed description: 
      Food effect will be assessed by comparing the pharmacokinetic (PK) parameters of a single
      dose of ACT-541468 under fasted (Treatment B) and fed (Treatment C) conditions.

      Potential CYP3A4 inhibiting / inducing effects of ACT-541468 will be assessed by comparing
      the PK parameters of midazolam alone (Treatment A) and midazolam given with a single dose of
      ACT-541468 (Treatment B) or with multiple doses of ACT-541468 (Treatment D).
    

Intervention name(s): Midazolam; ACT-541468
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg/mL oral solution; Hard gelatin capsules for oral use at a strength of 25 mg
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: food-drug interaction; drug-drug interaction; pharmacokinetics
Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective

      - Evaluation of the pharmacokinetic properties and safety of CKD-393 0.25/50/750 mg oral
      administration in healthy adults under fed condition.
    


Intervention name(s): CKD-393; CKD-501, D759, H053
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      General objective of the research project: To evaluate the alterations of systemic
      microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to
      cardiac surgery for repair of congenital heart defects.
    

Detailed description: 
      • Specific objectives:

        -  To test the usefulness of skin laser Doppler flowmetry monitoring (LDPM) in the
           non-invasive evaluation of endothelium-dependent microvascular reactivity during CPB in
           children.

        -  To investigate whether skin LDPM could be proposed as a clinical monitoring of tissue
           perfusion during CPB in pediatric cardiac surgery.

        -  To investigate the effects of different anesthetic agents on microvascular reactivity
           during CPB.

        -  To investigate the effects of cardiovascular and vasoactive drugs used during CPB on
           microvascular reactivity.

        -  To evaluate the correlation of microcirculatory alterations observed during CPB with
           classical markers of tissue perfusion and oxygenation, including plasma lactate levels.

        -  To evaluate the correlation of microcirculatory alterations observed during CPB with
           markers of systemic inflammation, including pro- and anti-inflammatory cytokines.

        -  To evaluate the correlation of microcirculatory alterations observed during CPB with the
           plasma bioavailability of nitric oxide.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        infants and children with congenital heart defects scheduled to corrective cardiac surgery
      
Keywords: congenital heart defects; systemic microcirculation; laser Doppler perfusion imaging; cardiac corrective surgery
Bioavailability of EPA/DHA in of Ruby-O and Krill Oil
Condition: Bioavailability
Study type: Interventional

Summary: 
      The objective of this study is to assess the relative bioavailability of eicosapentaenoic
      acid (EPA) and docosahexaenoic acid (DHA) in two supplement products in healthy adult men and
      women.
    


Intervention name(s): EPA + DHA Ruby-O; EPA + DHA Krill Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subject will receive a single 1000 mg oral dose of EPA + DHA Ruby-O capsule; Subject will receive a single 1000 mg oral dose of EPA + DHA krill oil capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the mass balance recovery and metabolite profile, and will identify
      metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male
      subjects.
    


Intervention name(s): 14C-XEN1101
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: XEN1101; Mass Balance; Phase 1
The Effect of L-lysine on Human Gastrointestinal Secretion: A Dose-finding Study Applying Magnetic Resonance Imaging (MRI)
Condition: Healthy
Study type: Interventional

Summary: 
      This is a pilot dose-finding study, which is performed with a randomized, double-blind,
      3-armed, unbalanced, cross-over study design. Three of four different doses of L-lysine
      Monohydrate (A = 0.5 g, B = 1.2 g, C = 3.0 g and D = 7.5 g) will be applied in a randomized
      sequence on three different study days in six healthy volunteers. Each study day involves the
      repeated measurement of gastric content volume, gastric secretion volume and intestinal fluid
      volume using MRI before and after intragastric infusion of L-lysine Monohydrate test meals.
      Additionally, symptoms for hunger, fullness, nausea, bloating, abdominal cramps and urge to
      defecate will be recorded using a scale from 0-10. In parallel, samples of gastric juice to
      measure intragastric pH and pepsin concentration, samples of venous blood to assess blood pH
      and haematocrit as well as L-lysine, Serotonin, chloride bicarbonate and albumin plasma
      concentration and samples of arterialized blood from ear lobe to measure glucose blood
      concentration will be collected
    


Intervention name(s): L-lysine
Intervention type(s): Drug
Intervention description(s): Dose finding study for L-lysine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Condition: Prostatic Hyperplasia, Benign; Enlarged Prostate With Lower Urinary Tract Symptoms
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      Investigator-initiated study to evaluate the safety and efficacy of prostate artery
      embolization for the treatment lower urinary tract symptoms in patients with benign prostatic
      hyperplasia
    

Detailed description: 
      This is a phase I/II, single center, prospective, single arm, investigational study to
      evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of
      severe lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) in
      patients that have either failed or are intolerant to medical management. Once eligibility is
      confirmed, patients will undergo PAE with Embosphere Microspheres. Embolization will consist
      of a minimally invasive angiogram and treatment of the prostate arteries with the Embosphere
      particles to reduce blood flow to the prostate. Following treatment, patients will return for
      follow-up visits at 1, 6, 12, and 24 months post PAE.
    

Intervention name(s): Embosphere microparticles for prostate artery embolization
Intervention type(s): Device
Intervention description(s): Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate artery embolization (PAE); benign prostatic hyperplasia (BPH); lower urinary tract symptoms (LUTS)
Effect of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid-19 Syndrome.
Condition: Corona Virus Infection
MeSH terms: Coronavirus Infections
Study type: Interventional

Summary: 
      The aim of this work is to study the incidence of diaphragmatic dysfunction after COVID 19
      infection and the efficacy of different types of diaphragmatic strengthening exercises on
      diaphragm muscle function.
    


Intervention name(s): diaphragmatic positioning; incentive spirometer; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Traditional medical treatment plus diaphragmatic strengthening exercises through patient self-positioning in prone on elbows then do diaphragmatic breathing 10-15 min ,twice/day, 7days/ weak; Traditional medical treatment plus diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak; Traditional medical treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diaphragmatic function; Post Covid; Exercises
Effectiveness and Safety Study of the Iovera Device for the Temporary Reduction in the Appearance of Forehead Wrinkles
Condition: Forehead Wrinkles
Study type: Interventional

Summary: 
      Evaluate the effectiveness and safety of the iovera device for the temporary reduction in the
      appearance of forehead wrinkles.
    


Intervention name(s): iovera
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment