bioihbjkbjnl/mcl2 huggingface dataset:
Psychoeducational Groups for Adults With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This pilot study aims to assess patient satisfaction and preliminary efficacy of a
      psychoeducational group treatment, using a randomized waitlist-controlled trial, at two
      different outpatient clinics in mid-Norway. All participants will receive standard treatment
      during the intervention period. Assessment of client satisfaction (CSQ 8), general
      self-efficacy (GSE-6), ADHD-related quality of life (AAQoL) symptoms of ADHD (SCL-9; ASRS),
      and work participation will be conducted at time of recruitment prior to randomization (T0),
      pre- (T1), post-treatment (T2), with a 10 week follow-up.
    


Intervention name(s): Psychoeducational group therapy; Waiting list; Standard treatment
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): The group-based psychoeducational program consists of 10 sessions, run over 10 consecutive weeks. Each session consist of a lecture, given by a recruited expert on the topic of the session (20 minutes) with a following discussion of the topic (45 minutes), facilitated by the course leader. All sessions are organized and led by the course leader, which also includes keeping structure in time, discussion and closing of the session. Psychoeducation comes in addition to standard treatment (ADHD treatment as usual).; Waiting list and standard treatment (ADHD treatment as usual); Standard treatment consists of diagnostic assessment of ADHD and comorbidity, as well as treatment with medication. In addition, some patients receive cognitive behavioral therapy, although this is not systematically given to every patient. If needed, patients are also offered assistance with regard to economy, housing, education and work. As well as contact with family and network.
Other intervention name(s): Treatment as usual
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: a Norwegian multicenter study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotherapy, group; Adults
Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT
Condition: Erythema; Sensitisation
MeSH terms: Erythema
Study type: Interventional

Summary: 
      The primary objective of this study was to assess the sensitization potential of Omeza
      Collagen Matrix compared to that of a negative control based on a Modified Human Repeat
      Insult Patch Test.
    


Intervention name(s): Test Article; Negative Control
Intervention type(s): Device; Other
Intervention description(s): Omeza Collagen Matrix; Occlusive Patch of 0.9% sodium chloride, NaCl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The study design is based on a Modified Draize Human Repeat Insult Patch Test.
Masking: None (Open Label)
Primary purpose: Basic Science
2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty
Condition: Ischemia Limb
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      A custom-made, 2D-perfusion digital subtraction angiography (PDSA) algorithm has been
      designed and implemented towards foot perfusion quantification following endovascular
      treatment of critical limb ischemia (CLI), in order to assist intra-procedural
      decision-making and enhance clinical outcomes.
    

Detailed description: 
      This is a prospective, single-center, study investigating the feasibility of 2D-PDSA using
      newly-developed, non-commercially available, color-coded software for the quantification of
      foot perfusion following infrapopliteal angioplasty for the treatment of CLI. In total, 7
      consecutive patients scheduled to undergo infrapopliteal endovascular treatment of CLI were
      enrolled. Perfusion Blood Volume (PBV), Mean Transit Time (MTT), and Perfusion Blood Flow
      (PBF) maps were extracted by analyzing Time-Intensity Curves and signal intensity on the
      perfused vessel mask. Mean values calculated from user-specified ROIs on perfusion maps were
      employed to evaluate the patient's pre- and post- endovascular treatment condition.
    

Intervention name(s): 2D perfusion digital subtraction angiography of the foot.
Intervention type(s): Diagnostic Test
Intervention description(s): 2D perfusion digital subtraction angiography of the foot was performed after infrapopliteal angioplasty and Perfusion Blood Volume (PBV), Mean Transit Time (MTT), and Perfusion Blood Flow (PBF) maps were extracted by analyzing Time-Intensity Curves and signal intensity on the perfused vessel mask.
Other intervention name(s): Infrapopliteal angioplasty
Intervention model: Single Group Assignment
Intervention model description: In total, 7 consecutive patients were included in the study. The 2D-perfusion imaging and analysis of the DICOM files were performed after revascularization.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Infrapopliteal angioplasty; Tissue perfusion; Quantification
A Study to Investigate the Efficacy of AlphaWave® L-Theanine on Stress
Condition: Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      AlphaWave® L-theanine will be compared against placebo to evaluate how the investigational
      study product effects on salivary cortisol, EEG readings, blood pressure, and heart rate in a
      moderately stressed and otherwise healthy adult population. It is hypothesized that
      participants taking the AlphaWave® L-theanine will have reduced stress levels as assessed by
      the parameters stated. Participants will be consuming the investigational study product or
      placebo in the clinic only.
    


Intervention name(s): AlphaWave® LTheanine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 200 mg of AlphaWave® LTheanine; microcrystalline cellulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
To Evaluate the Cardiac Safety and PK Following a Single Oral Dose Administration of Pacritinib in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the cardiac safety of a single oral dose (400 mg) of
      pacritinib compared to placebo on the QT calculated using the Fridericia correction (QTcF)
      interval in healthy subjects.
    

Detailed description: 
      This is a randomized, pacritinib- versus placebo-blind, placebo- and active-controlled,
      single-dose, single-center, 3-period crossover study to evaluate the cardiac safety of a
      single 400-mg dose of pacritinib compared to placebo, and to characterize the PK of
      pacritinib and major human metabolites of pacritinib. The study is blinded for pacritinib and
      placebo, and open-label for moxifloxacin.

      Subjects were to receive 3 treatments (400 mg pacritinib, placebo, and 400 mg moxifloxacin)
      in a crossover fashion. Each treatment is administered as monotherapy during 1 of 3 treatment
      periods with a 7-day washout period between administration of each study medication.
      Screening occurred up to 28 days before Check-in (Day -1) of Period 1. On Day -1 of Period 1,
      subjects checked into the Clinical Research Unit (CRU) for baseline assessments and were
      confined to the CRU for the remainder of the study until Study Completion (Day 22)/Early
      Termination. Continuous 12-lead cardiodynamic ECG monitoring and recording was performed from
      predose (at least

      1 hour before administration of study medication) through 24 hours after the administration
      of study medication, then for 15 minutes every 12 hours (on Days 2 to 7 of each period).
      Blood samples for PK analysis were also collected predose (Hour 0) and at each cardiodynamic
      ECG timepoint postdose. Safety endpoints (eg, adverse events [AEs], clinical laboratory
      evaluations, vital signs) were monitored throughout each period. Subjects were discharged at
      Study Completion (Day 22). Subjects were scheduled to return for a Follow-up Visit 14 days
      (±3 days) later on Day 36.
    

Intervention name(s): A: pacritinib; B: Placebo; C: moxifloxacin
Intervention type(s): Drug; Other; Drug
Intervention description(s): Treatment A; Treatment B; Treatment C
Other intervention name(s): A: pacritinib 400mg; C: moxifloxacin 400mg
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: To Study pharmacokinetics and Cardiac safety
ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether or not ACT01 is effective and tolerable
      alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with
      facial and/or scalp keratosis.
    


Intervention name(s): ACT01; Comp01; Comp02; Comp03; Comp04
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The purpose of this study is to compare the single-dose oral bioavailability of oxcarbazepine
      300 mg/5mL oral suspension of OHM Laboratories, USA (a subsidiary of Ranbaxy Pharmaceuticals
      Inc.) with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of
      Novartis Pharmaceutical Corporation, USA in healthy, adult, male, human subjects under fed
      conditions.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover bioavailability study comparing oxcarbazepine 300 mg/5mL
      oral suspension of OHM Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with
      Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis
      Pharmaceutical Corporation in healthy, adult, male, human subjects under fed condition.

      Following an overnight fast of at least 10 hours, all subjects were served a high-fat high
      calorie breakfast. Thirty minutes after the start of the meal, a single oral dose of 10 mL of
      oxcarbazepine 300 mg/5 mL oral suspension was administered using a 10 mL graduated syringe,
      during each period of the study under the supervision of trained study personnel, along with
      240 mL of drinking water at ambient temperature.

      During the course of the study safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Laboratory parameters of hematology and
      biochemistry were repeated at the end of the study.

      A total of forty (40) subjects were enrolled into the study, to be administered a single oral
      dose of the test or reference formulation of 10 mL of oxcarbazepine 300 mg/5 mL oral
      suspension according to a randomization schedule. Thirty-three (33) subjects completed both
      the periods of the study.
    

Intervention name(s): oxcarbazepine 300 mg/5 mL oral suspension
Intervention type(s): Drug
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Oxcarbazepine oral suspension fed study
Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response
Condition: Nutrition, Healthy
Study type: Interventional

Summary: 
      To compare subjective appetite, satiety and glycemic responses for 3 h after consumption of
      investigational products containing 0, 3, 5 and 7 grams of chia seeds, controlling for energy
      intake. The primary objective is to compare total area under the curves (tAUC) of hunger and
      fullness ratings. The hypothesis is that chia seeds have a significant effect on hunger
      and/or fullness.
    

Detailed description: 
      Current nutrition guidelines in the United States and Canada recommend meeting protein needs
      with nutrient-dense foods among which include legumes, nuts, and seeds. Chia seeds are very
      high in dietary fiber, low in available-carbohydrate (avCHO), and good sources of
      alpha-linoleic acid, protein, and micronutrients. Chia has attracted interest as a functional
      food with studies showing several potential beneficial effects on health, among them their
      ability to increase satiety and/or reduce food intake. The effect on satiety of doses of chia
      less than 7g is not known. The primary objective of this study is to compare total area under
      the curves (tAUC) of hunger and fullness ratings for 3h after consumption among test-meals
      containing 0, 3, 5 and 7g of chia seeds, controlling for energy intake.

      Secondary objectives are tAUC of desire to eat and prospective consumption, tAUC of average
      appetite, tAUC of subjective appetite ratings from 0-2, 2-3 and 0-3h, Effects of time and
      dose and the time×dose interaction of plasma glucose concentrations and increments for 3h
      after consuming the test products, Incremental area under the curve (iAUC) of plasma glucose
      over 0-2h, 2-3h and 0-3h, and Plasma glucose peak rise.

      Main effects of chia dose, time, and the dose×time interaction will be examined. After
      demonstrating a significant interaction, individual endpoints will be assessed for the main
      effect of dose. The significance of differences between doses will be assessed.
    

Intervention name(s): 140 calories per 30 gram test meal
Intervention type(s): Other
Intervention description(s): Food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: chia seeds; chia; Salvia hispanica L.; hunger; fullness; satiety; glycemic response
Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk
Condition: Coronary Heart Disease; Type-2 Diabetes
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Metabolic Syndrome
Study type: Interventional

Summary: 
      To investigate the effect of milk delivered from mountain-pasture grazing cows on risk
      markers of the metabolic syndrome and type-2 diabetes with the effect of conventional Danish
      milk. The study should reveal the importance of phytanic acid content for these effects.
    


Intervention name(s): milk fat
Intervention type(s): Dietary Supplement
Intervention description(s): 39 g milk fat per day in 12 weeks
Other intervention name(s): Yellow feed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults
Condition: Chronic Hepatitis C Virus (HCV Infection Genotype 1)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label study will evaluate the safety and efficacy of co-formulated
      ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or
      without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic
      HCV-genotype 1 infection without cirrhosis
    


Intervention name(s): ombitasvir/paritaprevir/ritonavir, dasabuvir; sofosbuvir (SOF); ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; tablet; tablet
Other intervention name(s): Viekira PAK; ombitasvir also known as ABT-267; paritaprevir also known as ABT-450; dasabuvir also known as ABT-333
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment naive; Hepatitis C Genotype 1
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine whether creatine slows disease progression in
      subjects with amyotrophic lateral sclerosis (ALS). ALS is a progressive uniformly lethal
      neurodegenerative disorder for which there is no known cure. Recent genetic and biochemical
      studies implicate free radical toxicity, glutamate excitotoxicity and mitochondrial
      dysfunction as possible causes of familial ALS (FALS) and sporadic ALS (SALS). It has been
      hypothesized that in ALS there may be involvement of oxidative free radical damage and
      impaired mitochondrial energy metabolism that could in turn lead to excitotoxic cell death.
      Creatine, an agent that improves mitochondrial function, has been shown to be neuroprotective
      in animal models of ALS and Huntington's disease.

      This study is a double-blind, randomized, placebo-controlled trial of the safety and efficacy
      of creatine in patients with ALS enrolled at sites distributed throughout the United States,
      including Northeast ALS (NEALS) sites. The study will provide preliminary data on the safety
      and efficacy of creatine in ALS. If creatine slows disease progression in ALS and is well
      tolerated, a phase 3 study with survival as the primary outcome measure will be initiated.

      114 eligible subjects will be randomized to receive treatment for 6 months of (1) active
      creatine or (2) placebo. After randomization, subjects will be followed prospectively for 6
      months. The primary outcome measure for the study is the change in upper extremity motor
      function after 6 months of experimental therapy as tested with the Tufts Quantitative
      Neuromuscular Exam. Strength in eight arm muscles will be measured (bilateral shoulder and
      elbow flexion and extension). Secondary outcome measures include grip strength, motor unit
      number estimates (MUNE), the ALS functional rating score-revised (ALSFRS-R), and rate of
      change of a well established biochemical marker of oxidative damage to DNA (8OH2'dG levels in
      urine), and the safety and tolerability of creatine.
    


Intervention name(s): Creatinine
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: ALS
Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants
Condition: Continuous Positive Airway Pressure
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      In this study, the investigators want to observe how continuous positive airway pressure
      delivered by two different modalities affects breathing pattern in small preterm infants.
      Using a specialized feeding tube in the stomach, the investigators can measure and compare
      how the diaphragm (a large breathing muscle) might be affected by those two modalities.
    

Detailed description: 
      Many preterm very low birth weight infants require continuous positive airway pressure(CPAP)
      for breathing support because of lung immaturity. CPAP can be delivered by the infant
      flow(TM) device which is well studied. Prolonged use of nasal prongs CPAP has been shown to
      cause discomfort and, rarely, nasal injury leading to long term disfigurement. On the other
      hand, High flow nasal cannula (HFNC) ,which is another modality of delivering CPAP, creates
      less pressure on the nose and less disfiguring effect but previous research showed that the
      use of HFNC may be less effective than IF-CPAP in providing breathing support in these
      infants.

      We plan to study 10 stable preterm infants born less than 32 weeks' gestation and 1.5
      kilograms at birth after being stable for at least 48hours on IF-CPAP. babies will be
      randomized to start on IF-CPAP or HFNC for 30 minutes. After 45 minutes of adaptation, baby
      will be switched to the other modality for another 30 minutes. By inserting a specialized
      feeding tube with sensors into the stomach, we can measure the electrical activity of the
      diaphragm (EAdi). By analysing EAdi with each modality of delivering CPAP, we want to
      directly assess how HFNC affects breathing compared to IF-CPAP.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        clinically stable preterm infants with birth weight less than 1.5 kilograms and gestational
        age less than 32 weeks admitted to the neonatal intensive care unit at Sunnybrook Health
        Sciences centre on nasal continuos positive airway pressure(CPAP) of 5-6 cmH2O support for
        at least 48 hours, treated with Methylxanthines for apnea of prematurity and in less than
        35% oxygen.
      
Keywords: infant, premature; infant, very low birth weight; diaphragm; apnea; continuous positive airway pressure