bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Acute Prucalopride Administration in Healthy Volunteers
Condition: Molecular Mechanisms of Pharmacological Action; Depression; Depressive Disorder; Mood Disorders; Mental Disorder; Antidepressive Agents; Cognition
MeSH terms: Depressive Disorder; Mental Disorders; Mood Disorders
Study type: Interventional

Summary: 
      This study will investigate whether administration of a single dose of the serotonin receptor
      subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and
      non-emotional cognition in healthy volunteers, compared to placebo administration. Using an
      experimental medicine approach, the effects of prucalopride on cognitive biomarkers of
      antidepressant action will be characterised. In a double-blind design, participants will be
      randomised to receive a single dose of either prucalopride (1mg) or placebo. All participants
      will come for a Screening Visit to ensure their suitability for the study. If they meet study
      criteria, they will be invited to a Research Visit, where they will receive the study
      medication and wait for two hours while the drug reaches peak levels. After two hours they
      will be asked to complete a series of computer-based tasks measuring emotional, non-emotional
      cognitive processing, and reward processing. The primary study hypothesis is that acute
      prucalopride administration will have positive effects on processing facial expressions of
      emotion. Secondary hypotheses are that acute prucalopride administration will affect other
      measures of emotional processing, and non-emotional cognition.
    


Intervention name(s): Prucalopride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 1mg prucalopride tablet, encapsulated in white capsule; Lactose placebo tablet, encapsulated in white capsule
Other intervention name(s): Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly allocated to one of two groups (prucalopride or placebo). Participants in the prucalopride group will receive 1mg of the drug. Participants in the placebo group will receive a lactose placebo. Note that the study is not assessing the safety or efficacy of prucalopride, rather it is using prucalopride to assess the behavioural and neural effects of 5-HT4 partial agonists.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: 5-HT4; Prucalopride; Resolor; Emotional Processing; Healthy Volunteers
Treatment of Diabetic Foot Ulcers With AUP1602-C
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a two-part phase 1/2A study performed in diabetic foot ulcer (DFU) patients with
      chronic non-healing wounds to investigate the safety and efficacy of AUP1602-C.
    

Detailed description: 
      Study AP-W-CLI-2018-8 is the first clinical study of AUP1602-C in humans. It is a Phase 1/2A
      clinical study to evaluate the safety, tolerability and efficacy of a single and repeated
      doses of AUP-16 as topical treatment of DFU. The Phase 1 part will be a multicenter,
      open-label, non-randomized, uncontrolled dose-finding study with sequential dose escalations
      performed in dose cohorts comparing three doses of AUP-16 administered three times per week
      (low, medium, and high dose cohorts). This part will consist of four sequentially recruited
      cohorts. It is expected that a minimum of 15 patients may be required to determine the RP2D
      in phase 1 part.

      The Phase 2A part, an extension of the Phase 1, will be a multi-center, open-label,
      randomized, placebo-controlled study of the recommended AUP1602-C dose and administration
      schedule from Phase 1 to confirm safety and to assess efficacy of the selected recommended
      phase 2 dose and schedule in DFU patients.
    

Intervention name(s): AUP1602-C
Intervention type(s): Biological
Intervention description(s): AUP1602-C is topically applied on chronic wounds and covered by wound dressing.
Intervention model: Sequential Assignment
Intervention model description: Analyses for phase 1 part will be done by cohort and analyses for phase 2A part will be done by treatment arms.
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of a Treatment Plan of Neurological Physiotherapy in Conjunction With Ultrasound-guided Ultrasound-guided Dry Needling in Stroke Patients.
Condition: Neurological Disorder
MeSH terms: Nervous System Diseases
Study type: Interventional

Summary: 
      The aim of the study is to assess the efficacy of dry needling in stroke patients in
      combination with intensive neurological physiotherapy.

      together with intensive neurological physiotherapy treatment. Randomised and blinded
      experimental study control group where the sample recruited was 20 patients, who were
      randomly assigned to a control group.

      randomly assigned to a control group, where they received intensive treatment, or to an
      intervention group, where they received intervention group, where they received
      ultrasound-guided dry needling of the tibialis anterior and posterior muscles followed by an
      intensive followed by intensive neurological physiotherapy treatment.
    


Intervention name(s): dry needling; convencional treatment
Intervention type(s): Device; Other
Intervention description(s): is a physiotherapy treatment for neurological patients and studies the efficacy of dry needling by studying several pre-treatment and post-treatment variables after the experimental treatment.; is a physiotherapy treatment for neurological patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: dry needling; physiotherapy techniques; anterior tibial muscle; posterior tibial muscle; Neurological Disorder
Comparison Between the Effectiveness of Wii Fit Plus and Core Exercise Program in Improving Core Stability in Adults
Condition: Core Stability
Study type: Interventional

Summary: 
      This study will compare the effectiveness of core stability and Wii fit plus exercise in
      improving core stability. Group A will perform Wii fit plus exercises and group B will
      perform core stability exercise.
    


Intervention name(s): Group A; Group B
Intervention type(s): Other; Other
Intervention description(s): Subjects will perform following exercises, Single Leg Extension, Arm and Leg Lift, Balance Bridge, Single-Leg Twist, Single Leg Reach, Sideways Leg Lift, Single Arm Stand, Torso Twists and Plank exercise with minimum one set and maximum two sets. 30 seconds will be rest time between each set. Subjects will be encouraged to increase the number of repetitions after every 2 weeks, except in Plank exercise in which holding position time will be initially 30 seconds in each set and will be encouraged to increase holding time after every 2 weeks.; Subjects will perform Side Bridge, Bird Dog and Beginner Curl-up exercise in the first three weeks and Side Bridge, Bird Dog and Intermediate Curl-up exercise in the last three weeks. Repetitions per set will be 5, 4, 3 in first two weeks, 7, 6, 5 in third and fourth weeks and 9, 8, 7 in last two weeks. 8-10 seconds will be holding time in each repetition. 30 seconds will be rest time between each set
Other intervention name(s): Wii fit Plus; Core Stability
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Virtual reality exercise; Exercise Therapy/methods; Health Promotion Physical Endurance/physiology; Core Stability
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of vonoprazan (20 mg) and
      lansoprazole (30 mg) following single (Day 1) and multiple doses (Day 7).
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): Vonoprazan; Lansoprazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral capsule
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vonoprazan; Lansoprazole
SARS-CoV-2 Human Challenge Characterisation Study
Condition: Covid19; SARS-CoV Infection; Corona Virus Infection; Coronavirus; COVID-19
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome
Study type: Interventional

Summary: 
      This is a dose optimisation study in healthy adults aged 18-30 who will be experimentally
      inoculated with SARS-CoV-2. The aim is to cause PCR-confirmed upper respiratory infection in
      the majority of challenged individuals with minimal or no illness, providing data on the
      course of COVID-19 and the immune response to SARS-CoV-2 infection. This will establish an
      optimised dose and study design that will then be used to evaluate the efficacy of treatment
      and vaccine candidates plus level and duration of immune protection in follow-on trials.
    


Intervention name(s): SARS-CoV-2 Virus; Remdesivir
Intervention type(s): Biological; Drug
Intervention description(s): SARS-CoV-2, intranasally, (1x10^1 TCID50, 1x10^2 TCID50 and 1x10^3 TCID50 or higher, as necessary); VEKLURY™
Other intervention name(s): VEKLURY™
Intervention MeSH terms: Remdesivir
Intervention model: Single Group Assignment
Intervention model description: Adaptive design
Masking: None (Open Label)
Primary purpose: Diagnostic
Wellness Achieved Through Changing Habits (The WATCH Study)
Condition: Weight Loss; Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this pilot, feasibility study is to investigate the acceptability of an
      acceptance-based therapy healthy lifestyle intervention in adolescent girls with
      overweight/obesity.
    

Detailed description: 
      Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT
      healthy lifestyle intervention.

      The intervention will include 15 sessions over 6 months.

      A post-treatment visit will occur.
    

Intervention name(s): ABT Weight Loss Intervention
Intervention type(s): Behavioral
Intervention description(s): This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acceptance-based therapy; adolescents; weight; weight loss; obesity; overweight
"Effect of High Fat and High Glycemic Diets
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      The investigators will determine whether people with high muscle mitochondrial capacity
      produce higher amount of reactive oxygen species (ROS) on consuming high fat /high glycemic
      diet and thus exhibit elevated cellular oxidative damage. The investigators previously found
      that Asian Indian immigrants have high mitochondrial capacity in spite of severe insulin
      resistance. Somalians are another new immigrant population with rapidly increasing prevalence
      of diabetes. Both of these groups traditionally consume low caloric density diets, and the
      investigators hypothesize that when these groups are exposed to high-calorie Western diets,
      they exhibit increased oxidative stress, oxidative damage, and insulin resistance. The
      investigators will compare Somalians and NE Americans who are matched for age, BMI, and sex.
      The investigators will measure ROS production in skeletal muscle following high fat/high
      glycemic diet vs. healthy diet. The investigators will compare the oxidative damage to
      proteins, DNA, and lipids in these two populations following 10 days of high fat/high
      glycemic index diet in comparison with low fat diet. The investigators will determine if
      elevated levels of oxidative damage in Somali immigrant populations is accompanied by high
      mitochondrial capacity, higher ROS-emitting potential, and lower insulin sensitivity than NE.
      The proposed study will be performed utilizing the state-of-the-art proteomic and metabolomic
      methods many of which were recently developed in our laboratory. The investigators expect the
      results from this study to provide seminal insights into the underlying mechanism of insulin
      resistance and type 2 diabetes, in addition to demonstrating mechanisms by which a functional
      proteome is maintained in vivo.
    


Intervention name(s): High Glycemic Diet; Control diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): NORMAL FAT AND GLYCEMIC DIET CONSUMED High FAT AND Glycemic Diet consumed; Normal fat, normal fat diet
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye-containing Tablet Formulation in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the relative bioavailability of single doses of 100 mg
      roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free
      mini-tablet solid and suspension (new formulations) compared to 100 mg roxadustat azo
      dye-containing tablet (reference formulation) under fasting conditions in healthy male and
      female adult participants.

      This study will also evaluate the safety and tolerability of single doses of 100 mg
      roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free
      mini-tablet solid and suspension (new formulations) and a single dose of 100 mg roxadustat
      azo dye-containing tablet (reference formulation) under fasting conditions in healthy male
      and female adult participants.
    

Detailed description: 
      This is a 4-period, 4-sequence single dose crossover study. Each participant will participate
      in 4 treatment periods separated by a washout of at least 7 days between study drug
      administrations in each period. Participants will be randomized to 1 of 4 sequences.

      Participants will be screened for up to 21 days prior to study drug administration on day 1
      of period 1. Eligible participants will be admitted to the clinical unit on day -1 of each
      period and will be residential for 5 days/4 nights.

      Participants will receive a single dose of 100 mg roxadustat pediatric azo dye-free tablet,
      100 mg roxadustat pediatric azo dye-free mini-tablet (suspension), 100 mg roxadustat
      pediatric azo dye-free mini-tablet (solid) (new formulations) or 100 mg roxadustat azo
      dye-containing tablet (reference formulation) under fasting conditions on day 1 of each
      period.
    

Intervention name(s): Roxadustat
Intervention type(s): Drug
Intervention description(s): Participants will receive single dose of 100 mg azo dye free tablet or mini tablet suspension or solid mini tablet or dye containing tablet.
Other intervention name(s): ASP1517
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Tolerability; Safety; ASP1517; Roxadustat
Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of this study are to study the safety, effectiveness, tolerability and dosing
      regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and
      Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these
      atypical neuroleptics may be effective in treating pediatric mania, with a lower risk of
      extrapyramidal side effects.
    

Detailed description: 
      Risperidone and olanzapine are atypical neuroleptics marketed for the treatment of psychotic
      disorders in adults. These medicines are called atypical neuroleptics because of their unique
      pharmacological profile, which include both D2 and 5HT2 antagonistic effects. The combined
      dopaminergic and serotonergic activity seems to be associated not only with antipsychotic
      effects, but also with mood stabilizing, mood elevating and tardive dyskinesia. The
      anti-climactic effects of this class of drugs led to the recent FDA approval of olanzapine as
      monotherapy for adult bipolar disorder.

      The study will consist of 8 week, open-label treatment period with random assignment to two
      determined treatment arms, risperidone or olanzapine. We plan to enroll 5 subjects for each
      arm. During the 8 weeks of treatment, patients will be seen at weekly intervals and receive
      study medication. At each week, measures of safety and efficacy will be obtained. Two teams
      of clinicians will see the patient at each visit. Team 1 will be the treating team, adjusting
      medication dosages and determining the safety of continuation in the study for the patient.
      Team 2 will be blind to the randomization status of the patient and will assess clinical
      improvement using the efficacy measures. For patients who have completed the 8-week acute
      phase without adverse event and have not responded to the medication they were assigned to
      will be allowed to then take part in additional 8-week trial with the other medication. At
      the end of the 8 weeks, patients who responded to their assigned treatment will be eligible
      to be enrolled and invited to participate in a separate10 month continuation study.
    

Intervention name(s): risperidone (Risperdal); olanzapine (Zyprexa)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: bipolar disorder; preschoolers; risperdal; zyprexa
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for
      concomitant administration with EPI vaccines to infants in South Africa.
    


Intervention name(s): HRV vaccine
Intervention type(s): Biological
Intervention description(s): Two or three oral doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation
Condition: Frozen Shoulder,; Shoulder Pain
MeSH terms: Shoulder Pain; Bursitis
Study type: Interventional

Summary: 
      To observe the effect of domiciliary physiotherapy on the upper limb applied during the
      period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The
      parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was
      significant difference between the ipsilateral and contralateral limbs for flexion, abduction
      and external rotation. There was no difference in perimetry in either group
    


Intervention name(s): evaluations; Protocol of physiotherapy exercises
Intervention type(s): Other; Procedure
Intervention description(s): Only evaluations; Oriented domiciliary physiotherapeutic exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer,; radiotherapy,; physical therapy,; upper limb
Absorption, Metabolism, Excretion and Absolute Bioavailability
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the absorption, metabolism and excretion of 14C-PF 04965842 and
      characterize plasma, fecal and urinary radioactivity and identify any metabolites, if
      possible, of 14C PF-04965842 in humans. In addition, this study will provide a better
      understanding of the pharmacokinetic disposition of PF-04965842 by obtaining intravenous (IV)
      clearance and delineating the extent of oral absorption (absolute bioavailability (F) and
      fraction absorbed (Fa)).
    


Intervention name(s): PF-04965842; Absolute Bioavailability
Intervention type(s): Drug; Drug
Intervention description(s): 14C labeled PF-04965842; Oral dose of unlabeled PF-04965842 and an IV dose of 14C labeled PF- 04965842
Intervention MeSH terms: Abrocitinib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This study will be an open label, non randomized, 2 period, fixed sequence, single dose study to characterize the absorption, metabolism and excretion of 14C- PF-04965842 and to evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-04965842 following oral administration of unlabeled PF-04965842 and IV and oral administration of 14C-PF-04965842 to healthy male subjects.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Absorption, Metabolism, Excretion, Absolute Bioavailability