bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of XT-150 in Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 safety and efficacy study of XT-150 in adult participants experiencing
      moderate to severe pain due to osteoarthritis of the knee.
    

Detailed description: 
      In this Phase 2 study, Baseline (Day 0) confirmation of study eligibility will be completed
      the day before or day of study drug administration.

      Study drug will be administered by intra-articular (IA) injection into the joint space of the
      index knee (knee selected for treatment).

      Up to 270 participants will be randomly enrolled into 1 of 6 treatment sequences (45
      participants/ group). Treatment Groups:

        1. 0.15 mg/mL XT-150 (1mL), 0.15 mg/mL XT-150 (1mL)

        2. 0.15 mg/mL XT-150 (1mL), 0.45 mg/mL XT-150 (1mL)

        3. 0.45 mg/mL XT-150 (1mL), 0.15 mg/mL XT-150 (1mL)

        4. 0.45 mg/mL XT-150 (1mL), 0.45 mg/mL XT-150 (1mL)

        5. Placebo (1mL), 0.15 mg/mL XT-150 (1mL)

        6. Placebo (1mL), 0.45 mg/mL XT-150 (1mL)

      The study will be conducted in 2 stages, A and B. Participants will be randomized at Day 0 to
      a treatment regimen, one treatment assignment for Stage A and one treatment assignment for
      Stage B:

      Stage A (Up to Day 180): Participants will receive placebo, 0.15 mg/mL XT-150 or 0.45 mg/mL
      XT-150 to the index knee at Day 0.

      Stage B (Day 180 to Day 360): Participants will have the option to receive a pre-randomized
      dose (XT-150 0.15 mg/mL or 0.45 mg/mL) to the index knee anytime between Day 180 and Day 330.

      Final assessments will be 12 months after the first IA dose.
    

Intervention name(s): XT-150; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): plasmid DNA; Placebo is a sterile phosphate-buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammation; Pain; Interleukin; Gene Therapy; plasmid DNA
Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 1

Summary: 
      The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly
      population. One mainstay of therapy for patients suffering from DES is the use of topically
      administered lubricants. However, despite many efforts, no "ideal" formulation has yet been
      found.

      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for
      treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with
      favourable biological properties such as high biocompatibility and low toxicity.
      Additionally, the new formulation comprises N-acetylcysteine, which has been used in
      ophthalmology because of its mucolytic properties for several years. Based on theoretical
      considerations, one can hypothesize that the new chitosan derivative may show an increased
      adhesion to mucins of the ocular surface and may therefore be particularly beneficial in
      reducing the symptoms associated with DES.
    


Intervention name(s): Chitosan- N- Acetylcysteine eye drops
Intervention type(s): Device
Intervention description(s): Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days
Intervention MeSH terms: Acetylcysteine; Chitosan; Ophthalmic Solutions; N-monoacetylcystine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Dry eye syndromes
Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of
      a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on
      adult women undergoing mastectomy.

      The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of
      ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.
    


Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0.; Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mastectomy
A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in
      participants with mild to moderate onychomycosis.
    

Detailed description: 
      Onychomycosis (also known as tinea unguium) is a contagious infection of toe nails by fungal
      organisms including dermatophytes, yeast, and molds.

      This is phase 1, first in human, randomized, double-blind, placebo-controlled, MAD study
      designed to assess the safety, tolerability, and PK of ATB1651 when administered in
      participants with mild to moderate onychomycosis.

      The study consists of 2 parts. In both parts, participants will receive multiple doses of
      ATB1651 applied to 1 affected great toenail and the remaining toenails (affected or not)

      Part A: Participants will be enrolled into 1 of 3 cohorts and randomized to receive either
      ATB1651 or placebo at a ratio of 2:1.

      Up to 2 additional cohorts may be added at the discretion of the Sponsor and Safety
      Monitoring Committee, if deemed necessary

      Part B: Participants will be randomized within a single cohort to receive either ATB1651 or
      placebo at a ratio of 4:1

      There will be 18 participants enrolled in part A, 30 participants in part B
    

Intervention name(s): ATB1651, 2 mg/mL; ATB1651, 5 mg/mL; ATB1651, 10 mg/mL; ATB1651, 20 mg/mL; ATB1651, 30 mg/mL; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): The participants will apply daily doses of ATB1651, 2 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days; The participants will apply daily doses of ATB1651, 5 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days; The participants will apply daily doses of ATB1651, 10 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days; The participants will apply daily doses of ATB1651, 20 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days; The participants will apply daily doses of ATB1651, 30 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days; The participants will apply placebo to all 10 toenails including at least 1 affected great toenail for 28 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate Pharmacokinetics of A Modified Release Formulation of PF-06650833 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study
      to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted
      and high fat meal fed conditions in healthy subjects.
    

Detailed description: 
      This is the third study of PF-06650833. The goals of the study are to assess the PK in
      healthy subjects of single doses of modified release (MR) tablets of PF-06650833 when orally
      administered under fasting and high fat meal fed conditions.
    

Intervention name(s): PF-06650833; PF-06650833; PF-06650833; PF-06650833; PF-06650833; PF-06650833
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Up to 400mg modified release tablets administered under fasted conditions; 100mg modified release tablet administered under fasted conditions; 20mg modified release tablet administered under fasted conditions; Up to 400mg modified release tablets administered with high fat meal food intake; 100mg modified released tablet administered with high fat meal food intake; 20 mg modified release tablet administered with high fat meal food intake
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Metabolic Impact Assessment of Tenofovir Disoproxil Fumarate on Non-HIV-1 Infected Healthy Adult Male Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the
      impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg
      compared with placebo in non-HIV-1 infected healthy adult males. Additionally, endothelial
      function, adipocytokines and lipids will be monitored.
    

Detailed description: 
      Double-blind, randomized, placebo-controlled study using a two-sequence two-period crossover
      structure. Sixteen HIV-1-negative males will be randomized 1:1 to one of two treatment arms.

      Group 1:

        -  Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the first 14
           days of the study.

        -  Tenofovir DF placebo tablet QD for the last 14 days of the study.

      Group 2:

        -  Tenofovir DF placebo tablet QD for the first 14 days of the study.

        -  Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil) for the last 14
           days of the study.

      Physical examinations and laboratory analyses are conducted at screening, baseline, Day 14,
      and Day 28. A euglycaemic clamp protocol and an ECG are performed at the baseline, Day 14 and
      Day 28 visits.

      The primary efficacy endpoint of this study is insulin-mediated glucose disposal during a
      hyperinsulinaemic euglycaemic clamp study. Endothelial function will be monitored by Selectin
      P/E and PAI-1 levels; adipocytokine levels will be monitored by measuring adiponectin and
      leptin levels; and lipid subfractions, including cholesterol (large and small subfractions of
      HDL and LDL) triglycerides and non-esterified fatty acids will be measured. Safety will be
      evaluated by adverse event and clinical laboratory test reporting.
    

Intervention name(s): Tenofovir Disoproxil Fumarate; Tenofovir DF placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil); Tenofovir DF placebo tablet QD
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV-1; tenofovir DF
The Efficacy of Vitamin K2 n Human Osteoporosis, Blood-vessel Calcification and Sclerosis
Condition: Healthy
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to
      produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There
      are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of
      bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis
      improvement; (4) safety evaluation.
    


Intervention name(s): Vit K2+ Vit D3+ calcium carbonate (CaCO3); Vit K2+CaCO3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin K2; Vitamin D3; Bioavailability of calcium; volunteers; Men; non-pregnant women; twenty years of age
Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery
Condition: Brain Concussion; Post-Concussion Symptoms; Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome
Study type: Interventional

Summary: 
      This study is part of a larger, multi-centered project done with the collaboration of
      University Of Victoria. This study holds three separate studies on the mild traumatic brain
      injured population and the use of perceptual-cognitive training (3D-MOT).
    


Intervention name(s): 3D-MOT Neurotracker; Visual Attention Intervention
Intervention type(s): Other; Other
Intervention description(s): A predetermined number of spheres (eight) are presented in the 3D-MOT task. The spheres are all identical in shape and color. Before each trial, four spheres are highlighted, and then returned to their original color. Participants will be asked to track those four spheres for the duration of the trial (8 seconds). Spheres will be moving, bouncing, colliding, until they finally stop moving and the participant has to identify the spheres that were initially highlighted. Previous work with healthy individuals has shown that the minimum optimal number of sessions (3 blocks) necessary to induce brain plasticity and enhance other, "non-trained" brain functions is between 5-6. The training protocol will therefore include 6 sessions (3 blocks each), at intervals of 48 to 72 hours, over a maximum of 3 weeks.; The visual attention intervention will consist of the 2048 game, a single-player sliding block puzzle game of which the objective is to slide numbered tiles on a grid to combine them to create number 2048. 2048 is played on a gray 4×4 grid, with numbered tiles that slide smoothly when a player moves them using the four arrow keys. Every turn, a new tile will randomly appear in an empty spot on the board with a value of either 2 or 4.Tiles slide as far as possible in the chosen direction until they are stopped by either another tile or the edge of the grid. If two tiles of the same number collide while moving, they will merge into a tile with the total value of the two tiles that collided. Higher-scoring tiles emit a soft glow. Children will play for a time equivalent to that of the 3D-MOT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mechanism Underlying Beta-cell Failure in Obese African Americans With History of Hyperglycemic Crises
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Obesity is common in African American (AA) patients with newly diagnosed diabetes who present
      with diabetic ketoacidosis (DKA). Despite the presentation with severe symptoms of
      insulinopenia and ketoacidosis, clinical and immunogenetic observations indicate that most
      obese AA patients with DKA have type 2 diabetes. In such patients, previous studies reveal
      that: a) at presentation, obese AA patients with DKA have markedly decreased pancreatic
      insulin secretion, lower than in obese non-DKA patients admitted with comparable
      hyperglycemia, but significantly greater than in lean patients with DKA; b) aggressive
      diabetic management results in significant improvement in beta-cell function and insulin
      sensitivity sufficient to allow discontinuation of insulin therapy within 3 months of
      follow-up. Based on these observations the researchers conclude that similar to obese
      patients with hyperglycemia, most obese AA with DKA have type 2 diabetes, and that although
      defects in both insulin secretion and insulin action are present, transient b-cell failure is
      the primary defect in the development of ketoacidosis.
    

Detailed description: 
      Obese AA patients with a history of DKA who later experience near-normoglycemia remission
      represent an ideal population in which to define the sequence of events that lead to b-cell
      dysfunction in type 2 diabetes. The researchers hypothesize that obese AA with DKA will prove
      particularly susceptible to beta-cells dysfunction due to sustained elevations of plasma
      glucose (glucose toxicity) and/or free fatty acid levels (lipotoxicity). This study will test
      beta-cell response by administering a glucose infusion to diabetic African Americans with a
      history of DKA, diabetic African Americans without a history of DKA, and non-diabetic African
      Americans.
    

Intervention name(s): Intralipid 20%; Glucose infusion
Intervention type(s): Drug; Drug
Intervention description(s): Participants receive a 48-hour infusion with Intralipid at 40 milliliters per hour (mL/hr).; Participants receive a glucose infusion consisting of 10% dextrose infused intravenously at a rate of 200 mg/m^2/min for 20 hours.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperglycemia
Movement-based Infant Intervention
Condition: Infant Development; Infant,Premature; Infant, Very Low Birth Weight; Infant, Small for Gestational Age; Infant Conditions
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      The objective is to pilot test the effectiveness of an evidence-based intervention to promote
      positive neurodevelopmental outcomes in infants at risk for developmental delay. The
      intervention promotes movement experience from 3 months to sitting onset.
    

Detailed description: 
      Aim: Our purpose was to assess daily leg movement rate before and after a caregiver-provided
      in-home intervention for infants at risk for developmental disability. We also assessed
      adherence and quality of caregiver-child interaction.

      Methods: Twelve infants, at risk for developmental disabilities, and their caregivers
      participated in an intervention focused on increasing leg movements. Intervention started
      between 3- and 6-months cor- rected age and ended once the infant was able to sit
      independently or at 9 months corrected age, whichever occurred first. Infants were assessed
      monthly.
    

Intervention name(s): Movement Intervention
Intervention type(s): Behavioral
Intervention description(s): At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infant; leg movement; wearable sensors; early intervention
Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome
Condition: Fragile X-Associated Tremor/Ataxia Syndrome; Fragile X Premutation Carriers
MeSH terms: Ataxia; Tremor; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine if memantine is effective in treating symptoms of
      Fragile X-associated Tremor Ataxia Syndrome.
    


Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.; Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FXTAS, Fragile X Premutation
GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
Condition: Galactose Single Point (GSP), Residual Liver Function
MeSH terms: Fatty Liver
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective is to determine the galactose single point (GSP) cutoff values to
      discriminate subjects with different hepatic function. The secondary objective is to analyze
      the correlations between GSP and other hepatic function assessment methods among this trial
      subjects.
    

Detailed description: 
      Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, including
      the potential for progression to nonalcoholic steatohepatitis (NASH), followed by fibrosis
      and ultimately cirrhosis. The gold standard to evaluate fibrosis in patients with NAFLD is
      liver biopsy. The investigators aimed to evaluate the clinical utility of using the galactose
      single point (GSP) test which recommended by the US FDA to quantitatively measure liver
      function in patients with NAFLD.
    

Intervention name(s): Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.
Intervention type(s): Drug
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: GSP; galactose single point (GSP)