bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Ridaforolimus (MK-8669) in Chinese Participants (MK-8669-059)
Condition: Cancer, Advanced
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of
      ridaforolimus (MK-8669) after administration of single and multiple 40 mg doses in Chinese
      participants with advanced cancer. Part 2 of the study is optional; participants can continue
      to receive the study treatment in a weekly regimen of daily oral doses of ridaforolimus 40 mg
      for five consecutive days followed by two days off-treatment.
    


Intervention name(s): ridaforolimus
Intervention type(s): Drug
Intervention description(s): 4 enteric-coated tablets, each containing 10 mg ridaforolimus, orally (total daily dose: 40 mg)
Other intervention name(s): MK-8669; AP23573; ridaforolimus was also known as deforolimus until May 2009
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed cancer
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of UCB4940 in Patients With Psoriasis
Condition: Mild to Moderate Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in
      subjects with mild to moderate plaque psoriasis.
    


Intervention name(s): UCB4940; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Active Substance: UCB4940
Pharmaceutical Form: Solution for infusion
Concentration: 80 mg/ml
Route of Administration: Intravenous use; Active Substance: Placebo
Pharmaceutical Form: Solution for infusion
Concentration: 0.9 % sodium chloride aqueous solution
Route of Administration: Intravenous use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis; UCB4940
Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance
    

Detailed description: 
      Oral or intranasal antihistamines is the first line treatment for allergic rhinitis.
      Cetirizine is a second-generation selective antihistamine widely used in an oral formulation
      for the treatment of allergic rhinitis. Local administration of cetirizine has been shown to
      reduce symptoms after allergen challenge, and has the potential to shorten the time to onset
      and decrease systemic side effects. However, local irritation and nasal burning/pain has been
      reported after nasal administration. For the compliance of the patients taking a nasal spray,
      the taste and tolerance of the product is of particular importance. NLA Nasal Spray contains
      cetirizine in a liposomal formulation aiming to improve the tolerability. The present study
      aims to compare the NLA Nasal Spray with cetirizine in an aqueous formulation and placebo
      with regard to taste perversion and local tolerance. This will be investigated off-season in
      patients with seasonal allergic rhinitis after provocation with allergen.
    

Intervention name(s): Cetirizine dihydrochloride (10 mg/ml) liposomal formulation; Cetirizine dihydrochloride (10 mg/ml) buffer solution; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2x110μL in each nostril twice daily for 7 days; 2x110μL in each nostril, as a single dose; Citrate buffer with preservatives
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic rhinitis; Nasal spray; Anti-histamine; Tolerability
Lenalidomide and R-CHOP in B-cell Lymphoma
Condition: Lymphoma, Large B-Cell, Diffuse; Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid)
      when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin,
      vincristine and prednisone).
    

Detailed description: 
      The study is a dose escalation study of lenalidomide (Revlimid) administered orally during 14
      days in combination with fixed doses of rituximab (R), cyclophosphamide, doxorubicin,
      vincristine and prednisone (CHOP) administered every 3 weeks (R-CHOP 21) in patients with
      B-cell lymphoma.
    

Intervention name(s): Lenalidomide and R-CHOP
Intervention type(s): Drug
Intervention description(s): Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.
Other intervention name(s): REVLIMID
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lymphoma; lenalidomide; gela
Evaluation of Microglial Activation in ALS With [18F]PBR06 (Peripheral Benzodiazepine Receptor-06) PET
Condition: Healthy Volunteers; Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this protocol is to evaluate microglial activation in the brain using
      [18F]PBR06 in patients with amyotrophic lateral sclerosis (ALS).
    

Detailed description: 
      The overall goal of this protocol is to evaluate microglial activation in the brain using
      [18F]PBR06 in patients with amyotrophic lateral sclerosis (ALS). The specific objectives are:

        -  To measure the dynamic uptake and washout of [18F]PBR06 (Peripheral benzodiazepine
           receptor-06) in brain using positron emission tomography (PET) in patients with ALS and
           healthy volunteers (HV).

        -  To evaluate test/retest reliability of the tracer binding parameters in patients with
           ALS and HV.

        -  To evaluate the correlation of [18F]PBR06 binding with ALS disease clinical severity
           (ALSFRS-R, upper motor neuron burden (UMNB) and Ashworth Score), clinical disease
           sub-categorization, and other clinical data.

        -  To perform kinetic modeling using plasma-based (metabolite corrected plasma
           concentration) or reference region based methods or simplified quantification methods to
           assess the ability of [18F]PBR06 PET to measure microglial activation in brain.

        -  To acquire safety data following injection of [18F]PBR06.
    

Intervention name(s): [18F]PBR06
Intervention type(s): Drug
Intervention description(s): Subjects will undergo PET imaging using 1 single intravenous (IV) injection of [18F]PBR06, a PET radioligand for evaluation of microglial activation in the brain. PBR06 will be injected intravenously as a bolus at a dose of no more than 5.5mCi (millicurie).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HV; ALS
Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Study type: Observational

Summary: 
      Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult
      associated to a poor prognosis. MSA is clinically characterized by the association of
      extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. Histological and biological
      studies have raised the hypothesis that, beside the well known dopamine deficiency, some of
      the symptoms could be related to a dysfunction in serotoninergic neurotransmission. Serotonin
      is involved in the modulation of several functions impaired in MSA, such as mood, motricity
      or sleep. The recent description of an association between loss of brainstem serotonin
      neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role
      played by this neurotransmitter in the pathophysiology of this disease. Autoreceptors called
      5-HT1a are strongly involved in the regulation of serotonin neurotransmission. During the
      last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors,
      such as 18F-MPPF
      (4-(2'-methoxyphenyl)-1-[2'-(N-2''-piridinyl)-p-fluorobenzamide]methylpiperazine), were
      developed. Moreover, the investigators recently demonstrated the ability of this brain
      functional imaging method to investigate, in healthy volunteers, the functional properties of
      5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose
      of fluoxetine.
    


Intervention name(s): PET (Positron Emission Tomography) Study; Brain MRI (magnetic resonance imaging); Fluoxétine / Placebo
Intervention type(s): Radiation; Other; Drug
Intervention description(s): 5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study. Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.; A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.; The two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.
Intervention MeSH terms: Fluoxetine
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited by neurologists specialized in movement disorders
Risk Perception in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study was a retrospective, non-interventional, cross-sectional, multi-cohort study of
      patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to
      the immediate previous treatment in two groups, those who were prescribed with high efficacy
      treatments (HETs) and those who were prescribed with non-high efficacy treatments (non-HETs).
      HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and
      ozanimod; and non-HETs include molecules classified as with moderate or modest efficacy such
      as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.
    

Detailed description: 
      The study cohort consisted of RMS patients identified in the Adelphi Real World MS DSP, which
      was current up until the Q2/2021. The study was using waves VI-IX of the Adelphi DSP dataset.

      Study period: Q1 2017 - Q1 & Q2 2021 (waves VI-IX of Adelphi DSP dataset).

      Identification period: Q1 2017 - Q1 & Q2 2021 (waves VI-IX of Adelphi DSP dataset).

      Index date: defined as the dates when the surveys were carried out (Q1 2017 - Q1 & Q2 2021).
    

Intervention name(s): High Efficacy Therapy (HET); Non High Efficacy Therapy (Non-HET)
Intervention type(s): Other; Other
Intervention description(s): HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.; Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study cohort consisted of RRMS and SPMS patients identified in the Adelphi Real World
        MS Disease Specific Program (DSP) (2017-2021) with a current and previous treatment at
        index date, and whose physician decided to switch their treatment.
      
Keywords: Multiple sclerosis (MS),; Disease-modifying therapies (DMTs),; High efficacy treatments (HETs),; Nonhigh efficacy treatments (Non-HETs)
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
Condition: Major Depressive Disorder (MDD); Anxiety Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Anxiety Disorders; Mental Disorders; Problem Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      MAN-BIOPSY pursues the concrete research question whether novel biological and
      psycho-physiological clusters or categories can be defined to improve treatment and minimize
      side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and
      endocrinological parameters. One major aspect of our research approach is its focuses on the
      identification of dysfunctions in fundamental information processing mechanisms and
      neurocomputational mechanisms, and is not restricted to symptom-oriented tasks.

      The main objectives of MAN-BIOPSY are therefore

        -  to identify biological and psycho-physiological parameters for major depressive
           disorders and anxiety disorders, and

        -  to identify predictive markers for treatment response and type/severity of side effects
           for these disorders.
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): 2-4 weeks, 5-10mg, max 20mg
Intervention MeSH terms: Escitalopram
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Subjects will be asked to participate in a four day research study of the immune system
      effects and safety of short-term acute dosing of Cold-fX.

      The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on
      the immune system compared to a placebo (dummy pill). Safety of the acute dosing will be
      determined through various blood tests carried out during the study.
    

Detailed description: 
      Eligible volunteers from Hackensack University Medical Centre will be randomly assigned to
      either the treatment or placebo group with equal numbers in each group.

      The treatment will consist of taking three capsules of CVT-E002 (600mg) or placebo three
      times daily on Day 1, two capsules of CVT-E002 (400mg) or placebo three times daily on Day 2
      and one capsule of CVT-E002 (200mg) or placebo three times daily on Day 3.

      A fasting blood sample will be collected on all 4 days of study participation. Immunological
      assays and blood chemisty safety tests will be performed on the samples. Serum samples will
      also be collected and stored until futher analysis for various cytokines.

      Any adverse events experienced during this study will be documented.
    

Intervention name(s): CVT E002 (Cold-fX)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: NK Cells; Cytokines; Lymphocytes; Immunoglobulins; Th1 response
Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      This study is proposed to evaluate the role of motoric dysfunctions and type of refluxate in
      GERD patients, analyzed the blood monocyte/macrophage phenotypes of gastroesophageal reflux
      diseases (GERD) patients.
    

Detailed description: 
      Patients with non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE)
      and Barrett esophagus (BE) were enrolled. We investigated blood monocyte/macrophage phenotype
      in patients with different forms of GERD. We analysed of macrophages phenotype by CD25, CD80,
      CD163, CD206 expression for M2 macrophages. All patients underwent upper gastrointestinal
      endoscopy with esophagus biopsy. GERD patients underwent esophageal high-resolution manometry
      (HRM) with a 22-channel water-perfused catheter and Solar GI system (Medical Measurements
      Systems, Enschede, the Netherlands) and 24-hour impedance and pH monitoring using the Ohmega
      Ambulatory Impedance pH Recorder (Medical Measurements Systems).
    

Intervention name(s): Upper gastrointestinal endoscopy with biopsy and collection of refluxate; Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring
Intervention type(s): Procedure; Procedure
Intervention description(s): we analyzed esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects, as well as the appearance of the gastric and duodenal mucosa.; we analyzed following HRM parameters: the distal contractile integral (DCI), the lower esophageal sphincter resting pressure (LES RP) and standard measuring parameters were be collected: percentage of total time when pH was <4, longest reflux event, number of reflux events longer than 5 minutes, and number of reflux episodes in 24 hours.
Other intervention name(s): EGD (esophagogastroduodenoscopy) with esophagus biopsy; HRM and 24-h esophageal pH monitoring
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: GERD; Barrett's esophagus; macrophage; FSSG questionnaire
Effect of Lactose, Fructose, Sucrose, Whey Protein, and Soy Protein on Substrate Absorption and Oxidation: a Pilot Study
Condition: Substrate Absorption; Substrate Oxidation; Glucose Regulation
Study type: Interventional

Summary: 
      Does the consumption of various combinations of mono and disaccharides (lactose, sucrose and
      fructose) and protein isolates (whey or soy) result in altered substrate absorption,
      substrate oxidation, and glucose regulation? This proposed research will provide data to
      determine the relative contribution of source of protein (whey vs soy) and carbohydrate
      (mono- and disaccharides) on the observed effects of dairy products on absorption, substrate
      oxidation and glucoregulation mechanisms that affect body composition.
    

Detailed description: 
      Epidemiological research has shown that dairy products aid in weight loss and weight
      maintenance. Some evidence suggests that this effect is due to the whey component (which
      contains whey proteins and lactose) of milk. Previous work from our laboratory has
      demonstrated that chronic administration of whey protein concentrate results in decreased
      body fat and insulin concentration. Recent research (unpublished) from Castonguay and
      colleagues (University of Maryland, College Park, MD) has suggested that specific
      combinations of sucrose, maltose and lactose similarly alter body fat levels in rats. This
      proposed research will provide data to determine the relative contribution of source of
      protein (whey vs soy) and carbohydrate (mono- and disaccharides) on the observed effects of
      dairy products on absorption, substrate oxidation and glucoregulation mechanisms that affect
      body composition.
    

Intervention name(s): trt 1; trt 2; trt 3; trt 4; trt 5; trt 6; trt 7
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Fructose - 14 g; Lactose - 10 g; Sucrose - 16 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g; Fructose - 30 g; Lactose - 10 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g; Fructose - 24 g; Lactose - 8 g; Sucrose - 8 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g; Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g; Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g; Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g; Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: substrate absorption; substrate oxidation; glucose regulation; whey protein; soy protein; sucrose; fructose; lactose
Pharmacokinetics of Naltrexone Following Intravenous and Oral Routes of Administration in Healthy Volunteers
Condition: Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetics of naltrexone following i.v. and
      oral administration in healthy volunteers, and to assess the bioavailability of naltrexone
      following oral administration. Moreover, safety is assessed.
    

Detailed description: 
      Naltrexone blocks the effects of opioid (morphine-like) drugs by competitive binding at the
      opioid receptors in the brain. Naltrexone does not possess morphine-like properties and
      exhibits minimal pharmacologic activity. Naltrexone is marketed as an oral tablet. A wide
      range of oral bioavailability values have been reported for naltrexone. The wide range in
      oral bioavailability of naltrexone appears to be due to differences in assay specificity and
      the method of estimation of bioavailability (use of total drug, free drug, or urinary
      excretion data rather than plasma level). This was a single-center, randomized (study drug
      assigned by chance), open-label, 2-treatment, 2-period crossover study in healthy volunteers.
      Healthy volunteers were randomly assigned to 1 of 2 treatment sequences (AB or BA) with a
      washout period of 6 to 14 days between treatments. The washout period commenced the day of
      dosing, after drug administration. Blood samples for determination of blood naltrexone levels
      were collected at scheduled time points from the arm opposite to the 1 selected for
      naltrexone i.v. administration. Pulse, blood pressure, breathing rate, body temperature were
      measured at the times listed in the study schema. Healthy volunteers remained at the research
      facility for blood sample collection periods and were monitored for adverse events throughout
      the treatment periods.

      Treatment A: 1 mg naltrexone HCl administered i.v. over 15 minutes (naltrexone i.v.).
      Treatment B: 50 mg naltrexone HCl administered orally (naltrexone oral).
    

Intervention name(s): Naltrexone HCl.
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infusions, Intravenous; Safety; Pharmacokinetics; Naltrexone; Administration, Oral