bioihbjkbjnl/mcl2 huggingface dataset:
CX717 in the Treatment of Adult ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Two-Period Crossover Study to Assess the Efficacy And Safety of
      the Ampakine® Compound, CX717, versus Placebo in Adults with Attention-Deficit Hyperactivity
      Disorder
    

Detailed description: 
      This study examined the clinical efficacy, tolerability and safety of CX717 in the treatment
      of adults with ADHD. The study was a double-blind, 2-period crossover study that compared 2
      different doses of CX717 with placebo. Subjects were randomized to 1 of 4 different treatment
      sequences: placebo - low dose; low dose - placebo; placebo - high dose; or high dose -
      placebo. Each treatment period was 3 weeks with a 2-week washout between treatment periods.
      The doses chosen were 200 mg b.i.d. and 800 mg b.i.d.
    

Intervention name(s): CX717 200 mg; CX717 800 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CX717 200 mg capsules BID; CX717 4 X 200 mg capsules BID; Placebo 200 mg or 800 mg capsules BID
Other intervention name(s): Low Dose; High Dose
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Randomized, Double-Blind, Two-Period Crossover Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD, ampakine, Phase II clinical trial
Study Evaluating Safety, Tolerability and Pharmacokinetics of EYP001a in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids
      pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of
      hepatitis B.

      This Phase 1 study is designed primarily to evaluate the single ascending dose (SAD) followed
      by a multiple ascending dose (MAD) safety, tolerability, and pharmacokinetics of EYP001a in
      healthy male subjects.
    

Detailed description: 
      This is a two-part, randomized, double-blind, placebo-controlled study. Healthy male subjects
      will be randomly assigned to receive EYP001a or placebo.

      In the SAD part, up to 6 cohorts will receive EYP001a single doses of 30 mg, 60 mg, 120 mg,
      250 mg, 500 mg, and 800 mg. In the MAD part, 4 cohorts will receive EYP001a doses of 60, 120,
      250 and 500 mg, once daily for 14 days over 15-day period. Each cohort will include 6 active
      & 2 placebo subjects. Dose escalation will depend on evaluation of safety parameters.

      Participation will include up to 21-day screening period followed by dosing period (1 to 15
      days). A follow-up evaluation will occur at 6 ± 2 days post final dose.

      Safety and tolerability will be assessed by monitoring adverse events, laboratory values, ECG
      parameters, and vital signs.
    

Intervention name(s): EYP001a; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg and 100 mg capsules. Number of capsules to be ingested will depend on the dose cohort. Administered orally once daily. Single dose (SAD) or 14 days treatment (MAD).; Placebo capsules, identical in appearance to the EYP001a 10 mg and 100 mg capsules.
Other intervention name(s): EYP001
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Planned single doses of 30 mg, 60 mg, 120 mg, 250 mg, 500 mg, and 800 mg, and planned multiple doses of 60 mg, 120 mg, 250 mg, and 500 mg, of EYP001a will be explored in this study. Subjects will be enrolled in dose escalation cohorts that will occur sequentially based upon review of safety and PK parameters.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Analyzing the Effect of Trunk Training on Limbs in Children With Spastic Cerebral Palsy
Condition: Cerebral Palsy, Spastic
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to analyze if trunk training has effects on trunk, upper, lower
      extremity motor functions in children with spastic Cerebral Palsy. Second purpose is to
      analyze the relation between trunk control and prematurity, birth weight, upper and lower
      extremity motor functions in children with spastic Cerebral Palsy.
    

Detailed description: 
      Cerebral Palsy (CP) is a condition caused by a lesion occurred in immature brain during
      prenatal, natal or postnatal period. Children with CP may have motor, cognitive, sensory,
      auditory, behavioral problems during their lifespan. Spastic type CP is most common type of
      CP and many children with spastic CP have both trunk and limb impairment. Physiotherapy is
      very important for improving motor function and protect from secondary impairments in this
      children and should start as early as possible. The aim of this study is to analyze if trunk
      training has effects on trunk, upper and lower extremity motor function in children with
      spastic CP. 38 children with spastic CP between 4-18 years age are included in this study.
      Both genders are included. The Participants randomized according to their gross motor
      function classification system levels and their age. Before intervention all groups assessed
      with assessment tools which assess muscle spasticity, balance, gross motor function, trunk
      control and walking characteristics. After randomization there wasn't any intervention for
      control group; they continued their regular physiotherapy in special education centers two
      times a week. Study group received trunk training two times a week in addition to their
      regular physiotherapy in special education centers during 8 weeks. After 8 weeks all groups
      assessed with the same assessment tools.
    

Intervention name(s): Functional Trunk Training
Intervention type(s): Other
Intervention description(s): The intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Trunk Training; Motor Function
Egg Effects on the Immunomodulatory Properties of HDL
Condition: Lipid Metabolism; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of egg intake on markers of HDL
      function and immune inflammation in healthy adults.
    

Detailed description: 
      28 healthy men and women (age 18-35 years old) will be recruited to participate in a 16-week
      randomized crossover study. Upon enrollment, all subjects will enter a 4-week run-in egg-free
      period where they will refrain from consuming any egg-based foods (Period 1). Subjects will
      then enter the first intervention period, where they be randomly assigned to consume either 3
      whole eggs/day or the equivalent amount of egg white-based egg substitute/day for 4 weeks
      (Period 2). Afterwards, subjects will enter a 4-week washout period where egg-based foods are
      restricted (Period 3), followed by a second intervention period, where they be assigned to
      the alternative whole egg- or egg white-based treatment for 4 weeks (Period 4). Subjects will
      come to the Department of Biology at Fairfield University every two weeks to check-in, and to
      pick up their egg products during the intervention periods. Subjects will be asked to
      maintain their normal diet and physical activity practices throughout all periods of the
      study. Subjects will complete 5-day dietary records and physical activity logs at the end of
      each study period.
    

Intervention name(s): Whole Eggs; Egg White-Based Egg Substitute
Intervention type(s): Other; Other
Intervention description(s): 3 whole eggs per day for 4 weeks; 3-egg equivalent of egg white-based egg substitute per day for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Egg; HDL; Inflammation
Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth
Condition: Posttraumatic Stress Disorders; PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to show whether D-cycloserine in combination with cognitive
      behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of
      posttraumatic stress disorder (PTSD) in 7-12 year old children.
    

Detailed description: 
      While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show
      improvement, they still have some enduring symptoms and functional impairment. Accordingly,
      there is a need for treatment advances.

      D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found
      to have positive effects on cognition and anxiety. DCS was found to enhance learning and
      memory, and also facilitates extinction of fear reactions. However, DCS only produces an
      extinction effect when paired with behavioral training, not when simply given alone. Thus,
      the medication only needs to be given for seven doses in this research and youth do not need
      to take the medication long term. The research also includes a three-month follow-up
      assessment.
    

Intervention name(s): D-cycloserine; Placebo pill; CBT
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.; Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.; 12-session CBT protocol, called Youth PTSD Treatment.
Other intervention name(s): Seromycin (brand name); cognitive behavioral therapy
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavior Therapy; Children; Pharmacotherapy
Bioequivalence of the New Formulation of WAL 801 CL Dry Syrup Compared to the Conventional Formulation of WAL 801 CL Dry Syrup in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the
      conventional formulation of WAL 801 CL dry syrup
    


Intervention name(s): WAL 801 CL dry syrup new formulation; WAL 801 CL dry syrup conventional formulation
Intervention type(s): Drug; Drug
Intervention MeSH terms: Epinastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma
Condition: Urothelial Carcinoma
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Study type: Observational

Summary: 
      The purpose of this study is to assess the prevalence of pre-treatment tumor tissue PD-L1
      expression in patients diagnosed with advanced urothelial carcinoma.
    

Detailed description: 
      Advanced urothelial carcinoma (UC) (locally advanced/unresectable or metastatic UC) is a
      fatal disease with 5-year survival rate of 5%. The most frequently studied diagnostic for
      advanced UC is the programmed death-ligand 1 (PD-L1) protein expression in tumor tissue. A
      better understanding of PD-L1 expression in a "real world" setting could help understand its
      clinical utility in the management and decision making in advanced UC and clinical trial
      design
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient population with care managed in a community setting in the United States
      
Biospecimen description: 
      Tissue, Plasma
    
Keywords: Urothelial Carcinoma; Registry
Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Post-hoc analysis of psychotherapy outcome data suggest that psychodynamic techniques for
      Major Depressive Disorder are differentially efficacious dependent on personality traits of
      the patient. More specifically, supportive techniques are hypothesized to be more efficacious
      for dependent patients, interpretative techniques to be more efficacious for self-critical
      patients, and mixed supportive/interpretative techniques to be more efficacious for mixed
      dependent/self-critical patients. Moreover, supportive techniques are hypothesized to impact
      on depressive symptoms through increased relational capacities while interpretative
      techniques impact through increased self-understanding.

      These hypotheses are tested in an experimental single case design with three dependent, three
      self-critical and three mixed dependent/self-critical depressive patients. These patients go
      through a time-limited (50 sessions) experimental treatment which exists of a sequence of
      four A phases (control conditions), one B phase (supportive techniques only), one C phase
      (interpretative techniques only), and one BC phase (mixed supportive/interpretative
      techniques).
    


Intervention name(s): psychodynamic techniques.
Intervention type(s): Other
Intervention description(s): the patients go through a time-limited (50 sessions, 45 minutes, 2 sessions/week) experimental treatment which exists of a sequence of four A phases (control conditions), one B phase (supportive techniques only), one C phase (interpretative techniques only), and one BC phase (mixed supportive/interpretative techniques).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Condition: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out if an investigational drug, called RT001 Topical
      Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called
      lateral canthal lines, also known as crow's feet wrinkles.
    

Detailed description: 
      RT001, a new drug, may be effective for the temporary improvement in the appearance of
      moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study,
      researchers want to find out if RT001 is more effective than three comparator groups by
      examining the effect on the improvement of crow's feet by both the patient and physician.
    

Intervention name(s): RT001 Botulinum toxin type A (Dose A); RT001 Botulinum Toxin Type A (Dose B); Vehicle; Placebo
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): RT001 Botulinum Toxin Type A (Dose A); RT001 Botulinum Toxin Type A (Dose B); Vehicle Control; Placebo Comparator
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lateral Canthal Lines; Crow's Feet Wrinkles; Facial Wrinkles
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacodynamic response (the effect of the investigated drug on the body) of insulin
      degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.
    


Intervention name(s): insulin degludec; insulin degludec/insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).; Single dose administered subcutaneously (s.c., under the skin).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess in healthy male and female subjects the safety and pharmacokinetic
      (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.
    


Intervention name(s): CTP-692
Intervention type(s): Drug
Intervention description(s): Placebo or CTP-692
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Impact of Exercise Training on Cardiac Function in Man
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to monitor the impact of exercise training on cardiac functions
      and lipoprotein lipids.
    

Detailed description: 
      Exercise can increase the mass of left ventricle, which is also called athletic heart.
      Athletic heart is most frequently encountered as a pathological manifestation of
      cardiovascular disease, and the early determinants of athelitic remodeling in the general
      population are largely unknown. We will recruit 45 men aged 18-25 years who will run 5000
      meters 2/day for 3 months. caridac function is examined by ECG and echocardiogram, blood
      pressure, lipoprotein, heart rate, body weight, cardiac troponin will be examined prior to
      exercise program and 3 months after exercise.
    

Intervention name(s): exercise training
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Exercise; Lipid; Left ventricular; heart function
The Impact of Red Meat and Whole-grains Intake on the Colonic Mucosal Barrier
Condition: Mucus Colitis; Inflammation, Colon; Dietary Exposure
MeSH terms: Inflammation
Study type: Observational

Summary: 
      This study evaluates the impact of red meat and whole-grain intake on the colonic mucosal
      barrier and the dietary impact of these groups on the induced low-grade inflammation
    

Detailed description: 
      The mucus layer in the colon is a continuous barrier separating the epithelial cells from
      faecal enzymes, bacteria, toxic and other components. The colonic mucus layer in patients
      with Crohn's Disease and Ulcerative Colitis was previously demonstrated to be thinner and
      more permeable compared to healthy subjects.

      The colonic mucus is composed of glycoproteins held together trough unstable disulfide
      bridges. The digestion of red meat is associated with monosulfide production, which could
      bind to the disulfide molecules, make more stable trisulfide molecules, and thus destroy the
      mucus architecture. Moreover, different bacteria were previously linked to red meat intake
      and were associated with a degradation of the colonic mucus such as akkermansia muciniphila.

      From the other side, the fermentation of the undigested fibres, primarily in whole-grains, is
      associated with the production of short-chain fatty acids, which was related to a local
      anti-inflammatory effect.

      In this study, we hypothesise:

        1. High consumption of red meat is associated with a thinner colonic mucus layer;

        2. High consumption of whole-grain fibres is associated with a thicker colonic mucus layer;

        3. Mucin-2 gene expression is different between patients with high red meat consumption vs
           low red meat consumption;

        4. Mucin-2 gene expression is different between patients with high whole-grain consumption
           vs low whole-grain intake;

        5. The level of inflammatory markers in blood "IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and
           TNF-alfa is higher in subjects with high red meat and low whole-grain intake.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects referred to a colonoscopy in the Hospital of Southern Denmark, and who met the
        eligibility criteria of this study were included.
      
Biospecimen description: 
      -  Fecal samples in DNA- stabilizing medium

        -  Biopsies from the colon sigmoideum immediately frozen in nitrogen liquid

        -  Biopsies from the colon sigmoideum in RNAlater, and frozen under -80 degree celsius

        -  Blood samples

        -  Spot-urine
    
Keywords: Colonic mucus; Mucosal barrier; Red meat; Whole grain; Dietary fibers; Inflammation; Muc-2
Phase I Study on Multiple Oral Dosing of CG100649
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of
      3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7
      total days in healthy volunteers.
    

Detailed description: 
      Data dictionary that contains detailed descriptions of each variable used by the registry,
      including the source of the variable, coding information if used CTCAE and normal ranges if
      relevant.
    

Intervention name(s): CG100649; Placebo; Naproxen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6 subjects: study drug 2 subjects: placebo; 6 subjects: study drug 2 subjects: placebo; 6 subjects: study drug 2 subjects: placebo
Other intervention name(s): NAXEN
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteers