bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label, Adaptive Design, Positron Emission Tomography Study in Healthy Male Participants to Characterize Receptor Occupancy by MIJ821 in the Brain
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to confirm binding of MIJ821 to the NR2B-containing NMDA
      receptors in the human brain and assess the PC-RO relationship over time using positron
      emission tomography (PET).
    

Detailed description: 
      This is a Phase I, open-label, adaptive design study in healthy male participants using PET
      imaging with the radioligand [11C]Me-NB1 to measure occupancy of the NR2B-containing NMDA
      receptors by MIJ821. This exploratory study will be performed at a single clinical site and a
      separate PET imaging site.

      Up to 10 participants will be enrolled into 5 sequential cohorts. Each participant will
      receive a single dose of MIJ821 as an i.v. infusion. As part of the adaptive design, the dose
      of MIJ821 will be changed across cohorts to achieve the primary study objective in the
      smallest possible number of participants.

      After confirming eligibility during screening, each participant will undergo a baseline PET
      scan. Each participant will receive a single dose of i.v. MIJ821 during the treatment period,
      followed by up to two post dose PET scans. Post dose safety assessments will be performed up
      to End of Study visit which will happen once between Day 9 and Day 15.
    

Intervention name(s): MIJ821
Intervention type(s): Drug
Intervention description(s): MIJ821 will be administered as an i.v. infusion
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: There will be 5 Cohorts
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: NR2B receptor modulator; Healthy subject; safety; pharmacokinetics receptor occupancy; PET scan; Major Depressive Disorder; adult
Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Multicenter, Randomized, Double-Masked Placebo-Controlled, Parallel Group Phase 2
      Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the
      Treatment of Presbyopia.
    


Intervention name(s): Pilocarpine Ophthalmic Topical Cream, Dose 1; Pilocarpine Ophthalmic Topical Cream, Dose 2; Pilocarpine Ophthalmic Topical Cream, Dose 3; Placebo Ophthalmic Topical Cream
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pilocarpine Ophthalmic Topical Cream, Dose 1; Pilocarpine Ophthalmic Topical Cream, Dose 2; Pilocarpine Ophthalmic Topical Cream, Dose 3; Placebo Ophthalmic Topical Cream
Other intervention name(s): GLK-302; GLK-302; GLK-302; Placebo
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pilocarpine; Refractive errors; Loss of near vision
A Study of CNSA-001 in Women With Diabetic Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates CNSA-001 (sepiapterin) in the treatment of women with moderate to severe
      diabetic gastroparesis. Participants will be randomized in a ratio of 1:1 to receive CNSA-001
      20 (milligrams) mg/kilogram (kg)/day or placebo. All participants will receive the standard
      of care for diabetic gastroparesis.
    

Detailed description: 
      Nerves throughout the luminal gastrointestinal (GI) tract express neuronal nitric oxide
      synthase (nNOS), which generates nitric oxide (NO), a key neurotransmitter in the regulation
      of GI motility. Several co-factors are known to be important for nNOS activity, including
      nicotinamide adenine dinucleotide phosphate hydrogen (NADPH), calcium, and
      tetrahydrobiopterin (BH4). The homodimeric conformation of all 3 isoforms of nitric oxide
      synthase (NOS) is regulated by BH4. In the absence of BH4, uncoupling of NO production occurs
      and leads to super oxide production, resulting in further impaired nNOS bioactivity.

      CNSA-001 is a new chemical entity that is an endogenous, naturally occurring precursor of BH4
      via the pterin salvage pathway. Oral administration of CNSA-001 will result in increases in
      both intracellular and circulating BH4 concentrations. Increased BH4 concentration is
      hypothesized to improve nNOS function resulting in a positive effect on gastric accommodation
      and emptying.
    

Intervention name(s): CNSA-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CNSA-001 Powder for Suspension; Placebo Suspension
Other intervention name(s): sepiapterin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the
      CYP2C9 probe substrate warfarin in healthy volunteers.
    

Detailed description: 
      This is a single center open label study to assess the effect of Dexpramipexole on the PK of
      Warfarin in Healthy Volunteers. The goals of this study are as follows: to assess the effect
      of dexpramipexole on the pharmacodynamics (PD) of warfarin, to assess the safety and
      tolerability of dexpramipexole when administered alone, and with warfarin, and to assess the
      PK of dexpramipexole when administered alone; to explore the influence of genetic variation
      on the PK and international normalized ratio (INR) of warfarin when administered alone, and
      with dexpramipexole; and to explore the influence of genetic variation on the PK of
      dexpramipexole when administered alone.
    

Intervention name(s): Warfarin; Dexpramipexole
Intervention type(s): Drug; Drug
Intervention description(s): single doses at specified time periods; multiple doses
Intervention MeSH terms: Pramipexole; Warfarin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Square Stepping Exercises Training on Lower Extremity
Condition: Sedentary Healthy Young Individuals
Study type: Interventional

Summary: 
      Physical activity plays an indispensable role to lead a healthy life. Square-stepping
      exercises (SSE) are aerobic exercises.Our study was designed to investigate the effects of
      square-stepping exercise training on lower-extremity motor performance, muscle strength, and
      muscle quality of sedentary healthy young individuals.
    

Detailed description: 
      A total of 120 volunteers within the age range of 20-25 participated in the research.
      Participants were randomly divided into two groups, as 60 participants were study group (35
      females, 25 males) and 60 participants were control group (35 females, 25 males). Demographic
      data and exercise habit of the individuals were documented. Participants' lower-extremity
      motor performance was analyzed through Vertical Jumping, Side Jumping, One Leg Squat, and
      Step-Up tests. Participants' muscle strength was analyzed through Hand-Held Dynamometer.
      Also, participants' muscle quality was analyzed through Muscle Quality Index. Throughout 3
      weeks SSE training was administered 4 days a week for a length of 45 minutes in each session.
      All the analyses were conducted at the start and at the end of 3-week long training
    

Intervention name(s): Exercises Training
Intervention type(s): Other
Intervention description(s): SSE is performed on a thin exercise mat divided into 40 small squares in 250 cm x 100 cm of size (25 cm each part). Participants are given patterns of a few steps and asked to take steps that match them. Participants must, in principal, move ahead in line with the length forward with no contact on the lines forming the squares. Forward, backward, lateral and oblique stepping patterns are required. Stepping patterns get increasingly difficult. Each pattern consists of 2 to 16 steps; participants are asked to repeat step pattern till the end of exercise mat. Upon completing a pattern, another pattern in the same mirror-image is repeated. In essence each pattern is reiterated for 3-5 times and next its mirror-image pattern is repeated but if participants face challenge in performing the pattern it is repeated till the pattern is learnt
Other intervention name(s): Square-steeping exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Square-stepping exercises; Healthy young individuals; Motor performance; Muscle strength; Muscle quality
Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations.
Condition: Antithrombin Deficiency, Congenital
MeSH terms: Thrombosis; Venous Thrombosis; Antithrombin III Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous
      thrombosis and pulmonary embolism, particularly during certain high risk procedures. The
      trial is focusing on patients with confirmed hereditary antithrombin deficiency who are
      undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will
      test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior
      to, during and following the period of risk or surgical procedure.
    

Detailed description: 
      Objectives :

        1. Assess the safety of recombinant antithrombin (rhAT) in hereditary antithrombin (AT)
           deficient patients.

        2. Assess the incidence of acute deep venous thrombosis(DVT) alone in patients with
           hereditary antithrombin (AT) deficiency in situations usually associated with a high
           risk for thromboembolic events after increasing and targeting functional AT activity at
           >80% and < 120% of normal by prophylactic IV administration of rhAT.

        3. Clinically assess and determine the relevance of thromboembolic events other than acute
           DVT to rhAT administration.
    

Intervention name(s): Recombinant Human Antithrombin (rhAT)
Intervention type(s): Biological
Intervention description(s): Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
Other intervention name(s): ATryn
Intervention MeSH terms: Antithrombins; Antithrombin III
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Antithrombin Deficiency, Congenital; Antithrombin III Deficiency
Safety of Caprylic Triglycerides in ALS: A Pilot Study
Condition: ALS
Study type: Interventional

Summary: 
      The purpose of this study is to determine if AC-1204 is safe and tolerated in subjects with
      ALS. The reason why the investigator wants to use AC-1204 in patients with ALS is to
      determine if, by taking AC-1204, the body will make substances called ketone bodies. Further,
      if AC-1204 is well tolerated, the investigators want to change the amount the participant
      takes, to determine if the amount of ketone bodies in the blood increase in accordance with
      increases in the amount of AC-1204 the participant takes. The investigators want to do this
      study because when the investigators gave AC-1204 to mice with ALS, findings suggest the
      disease course is altered for the better and that the cause of this change is due to the
      presence of ketones in the blood. If AC-1204 can be proven to be safe and able to cause
      ketones to increase in the blood, the investigators will likely do subsequent studies to
      determine if the presence of ketone bodies will slow or stop the progression of the disease.
      However, this study is not designed to determine if AC-1204 will stop or slow the progression
      of ALS. It is designed to only determine if patients with ALS can tolerate AC-1204, if ketone
      bodies are produced and if the amount of ketone bodies produced increases with increasing
      dose.
    


Intervention name(s): Axona
Intervention type(s): Dietary Supplement
Intervention description(s): medical powder, supplement food
Other intervention name(s): AC1204
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Robotic Bronchoscopy for Peripheral Pulmonary Lesions
Condition: Lung; Node
Study type: Interventional

Summary: 
      In this study, the feasibility of performing robotic navigation of peripheral airways in
      human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.
    

Detailed description: 
      Successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of
      factors, one of which may be the ability to gain access to peripheral lesions due to the size
      and maneuverability of conventional bronchoscopes. In this study, the investigators will
      evaluate the feasibility of a new technique using a robotic endoscope with the Monarch
      navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch
      platform is a "robotic" assisted or electromechanical, software driven endoscopy system
      designed to be used by qualified physicians to provide bronchoscopic visualization of and
      access to patient airways for diagnostic and therapeutic procedures.
    

Intervention name(s): Robotic assisted bronchoscopy
Intervention type(s): Device
Intervention description(s): Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Other intervention name(s): Monarch platform
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bronchoscopy; Robotic bronchoscopy; Lung cancer; Peripheral lesions
A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to develop a simple, noninvasive test for evaluation of iron
      absorption as a tool to determine the cause of iron deficiency anemia. Healthy, premenopausal
      women with iron deficiency with or without anemia will be recruited for the study.
      Participants will, over the course of two months, ingest an iron solution three times; after
      each iron ingestion, participants will collect their stool and bring it to the study
      investigators for assessment of iron content.
    


Intervention name(s): stable isotope of iron, dysprosium
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: anemia; iron deficiency anemia; iron deficiency; absorption; iron absorption; iron uptake
Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The overall goal of this pilot project is to test the hypothesis that a decline in muscle
      strength precedes the decline in bone strength in men undergoing androgen deprivation therapy
      (ADT) for prostate cancer. The investigators will measure changes in serum biomarkers
      involved in muscle-bone crosstalk, anatomic changes in muscle and bone structure and strength
      that could ultimately contribute to fractures. The findings from this research will inform
      design of interventions to reduce falls and hip fractures in patients undergoing ADT as well
      as application to broader populations of at risk patients.
    

Detailed description: 
      Twenty-five men from urology clinic with prostate cancer will be recruited and enrolled prior
      to initiating ADT and studied at three time points. Baseline (before first does of ADT), and
      at approximately weeks 6 and 24 while receiving ADT for prostate cancer. Study measures will
      be the same during each of three data acquisition time points and include ascertainment of
      venous blood to determine serum biochemical markers of muscle and bone metabolic activity,
      MRI and CT imaging studies to assess muscle strength, volume, composition, bone volume,
      density and strength, and validated tests of muscle strength. Subjects will serve as their
      own controls.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men with prostate cancer prior and planning to initiate ADT therapy
      
Keywords: androgen deprivation therapy; sarcopenia; bone loss
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Interventional
Phase: Phase 3

Summary: 
      Iliac crest autogenous bone graft is accepted as the most effective method for secondary
      alveolar cleft repair. However this method is associated with complications. As an
      alternative, mesenchymal stem cells associated with biomaterials have been used for the
      rehabilitation of the alveolar bone cleft of patients with cleft lip and palate. This is a
      RCT comparing mesenchymal stem cells obtained from autogenous deciduous dental pulp
      associated with biomaterials versus iliac crest autogenous bone graft for secondary alveolar
      cleft repair.
    


Intervention name(s): Mesenchymal stem cells associated with biomaterials; Iliac crest autogenous bone graft
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.; Autogenous bone will be obtained from iliac crest.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Liraglutide Effects on Memory in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the hypothesis, that subcutaneous administration of liraglutide, an
      analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in
      healthy humans.
    


Intervention name(s): liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous self-administration of liraglutide(Victoza)by pen. The starting dose is 0.6 mg once daily(day 0 to 7), followed by 1.2 mg once daily (day 8 to 35).
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Memory; GLP-1; Liraglutide; energy output; Memory facilitation; GLP-1 analogue
Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
Condition: Fragile X Syndrome; Intellectual Disability
MeSH terms: Intellectual Disability; Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving
      social gaze behavior in children with fragile X syndrome (FXS). The investigators will use
      the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills.
      Importantly, the investigators propose to examine the effects of this treatment probe on
      brain and behavior.
    


Intervention name(s): Social gaze training
Intervention type(s): Behavioral
Intervention description(s): Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Lactobacillus Reuteri ProGastria in Helicobacter Pylori-infected Adult Subjects on Proton Pump Inhibitors
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to confirm that simultaneous use of L. reuteri ProGastria and
      omeprazole for 28 days can eradicate H. pylori in humans in the absence of antibiotics.
    

Detailed description: 
      Helicobacter pylori colonises an estimated 50% of the world´s population. Despite clear
      clinical guidelines on the treatment of this infection there is a drive to find alternative
      ways to control this infection in a wider perspective without the complications of induction
      of antibiotic resistance in the pathogen. A good alternative is to use probiotics.

      Lactic acid bacteria and in particular lactobacilli have been studied for their effects in
      humans infected with H. pylori with some success in reducing the infection load. Studies
      using supplementation with L. reuteri in both symptomatic and non-symptomatic H.
      pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and
      this was concomitant with a reduction in symptoms associated with the infection. Further,
      dietary supplementation with L. reuteri during and after the period of H. pylori eradication
      therapy has also been shown to reduce the side effects of this therapy without affecting the
      degree of eradication.
    

Intervention name(s): Progastria; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): All subjects will receive 2 x 20 mg omeprazole per day for 28 days.
L. reuteri ProGastria will be delivered at a dose of 1x108 CFU of 2 strains of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One chewable tablet is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. This dose of L. reuteri has been shown to be effective in a series of conditions earlier, including inhibition of H. pylori in humans, and is considered the optimal dose. The study products will be taken daily for 28 consecutive days.; The placebo will have identical in appearance and taste with the active study product only lacking the bacteria. It will be prescribed the same way as ProGastria: omeprazole 2x20mg and Placebo 1 tablet per day for 28 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Progastria; Lactobacillus reuteri; omeprazole; triple therapy; probiotic