bioihbjkbjnl/mcl2 huggingface dataset:
A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled, SAD and MAD study in healthy
      adult volunteers. DGX-001 is a peptide being investigated for the treatment of the major
      depressive disorder. This study will examine the safety and tolerability of increasing doses
      of DGX-001 and, in an exploratory way, potential moderators and functional markers of its
      activity.
    

Detailed description: 
      The study will be conducted in three parts, Part 1 consisting of SAD cohorts and Part 2
      consisting of MAD cohorts and Part 3 consisting of one cohorts of stress exposure resilience
      panel. In Part 1, approximately 32 adult healthy volunteers will be enrolled sequentially
      into 1 of 4 single-dose cohorts and will be randomized to receive either a dose of DGX-001 or
      a placebo. In Part 2, approximately 24 adult healthy volunteers will be enrolled into 1 of 3
      multiple-dose cohorts. An adaptive dose-escalation schedule will be employed for both the SAD
      and MAD parts of the study. In Part 3, 14 subjects will be enrolled in 1 cohorts to further
      explore the pharmacodynamic effect of DGX-001 under a physiological challenge.
    

Intervention name(s): DGX-001Dose 1; DGX-001 Dose 2; DGX-001 Dose 3; DGX-001 Dose 4; MAD dose panel of DGX-001
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose level 1 of DGX-001; Dose level 2 of DGX-001; Dose level 3 of DGX-001; Dose level 4 of DGX-001; Dose levels confirmed through SAD and MAD
Other intervention name(s): DGX-001; DGX-001; DGX-001; DGX-001; DGX-001
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1 and Part 2 of the study will have a parallel assignment and Part 3 of the study will have a parallel assignment with a crossover design.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fed Conditions
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,
      balanced, single dose pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fed
      condition in healthy adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Metoprolol Succinate 200 mg Ipca Laboratories Limited, India and the corresponding Reference
      Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 200 mg of Astrazenica LP,
      USA under fed condition in healthy adult human subjects in a randomized crossover study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single 200 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Metoprolol Succinate ER Tablet 200 mg; 'TOPROL-XL®' ER Tablets 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 * 200 mg tablet per day; 1 * 200 mg tablet per day
Other intervention name(s): Test product; Reference product
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients
Condition: Healthy Subject; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial studies glucosamine and chondroitin in preventing inflammation in overweight
      patients. Chronic inflammation contributes to cancer formation, and biomarkers of
      inflammation have been associated with cancer risk. Glucosamine and chondroitin may prevent
      inflammation and this trial may help identify the bacteria that help process them in the gut.
    


Intervention name(s): Glucosamine; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Given PO; Given PO
Other intervention name(s): PLCB
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Buprenorphine Naltrexone-P1 A-Cocaine
Condition: Cocaine-related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg,
      8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral
      naltrexone. This study will provide data to support the design of a similar study of the
      depot formulation of naltrexone and ultimately to study this combination for the treatment of
      cocaine dependence.
    


Intervention name(s): Suboxone
Intervention type(s): Drug
Intervention description(s): 4/1mg, 8/2mg 16/4mg
Other intervention name(s): buprenorphine/naloxone; Subjects will be maintained on 50mg naltrexone
Intervention MeSH terms: Naltrexone; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and activity of
      Fampridine-SR when administered for up to 36 additional months, or until it becomes
      commercially available whichever comes first, in subjects who previously participated in
      Acorda Therapeutics Protocol MS-F203.
    

Detailed description: 
      Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central
      nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal
      cord, providing communication between the brain and the arms and legs. In people with MS, the
      fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates,
      causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience
      periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of
      coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the
      ability to think and/or remember. These periods of illness may come (exacerbations) and go
      (remissions). Fampridine-SR is an experimental drug that has been reported to possibly
      improve muscle strength and walking ability for some people with MS. This study will evaluate
      the effects and possible risks of taking Fampridine-SR in MS patients over a long period of
      time.
    

Intervention name(s): Fampridine-SR
Intervention type(s): Drug
Intervention description(s): Tablets, 10 mg, BID
Other intervention name(s): 4-aminopyridine
Intervention MeSH terms: 4-Aminopyridine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; MS; walking; leg strength; demyelination
Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial
Condition: Anesthesia; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the addition of continuous infusion of lidocaine or continuous infusion
      of magnesium sufate in the duration of spinal anesthesia.
    

Detailed description: 
      Both lidocaine and magnesium sulfate have been shown to prolong spinal anesthesia.

      The number of studies using magnesium sulfate to improve spinal anesthesia is greater than
      the number of studies using lidocaine, and methodology varies significantly between studies.

      Adverse effects of lidocaine are different from magnesium sulfate's. Lidocaine has a wider
      therapeutic interval with fewer side effects, including: Drowsiness, Feeling Anxious, Feeling
      Cold, Nervous, Numbness And Tingling, Signs And Symptoms At Injection Site, Twitching.

      Magnesium sulfate's side effects include: heart disturbances, breathing difficulties, poor
      reflexes, confusion, weakness, flushing (warmth, redness, or tingly feeling), sweating,
      lowered blood pressure, feeling like you might pass out, anxiety, cold feeling, extreme
      drowsiness, muscle tightness or contraction, or headache.
    

Intervention name(s): Magnesium Sulfate; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): Magnesium Sulfate 15mg/kg/h; Lidocaine 1,5mg/kg/h
Intervention MeSH terms: Lidocaine; Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Music Therapy in Pulmonary Rehabilitation
Condition: Chronic Pulmonary Disease
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      This study explores the effects of music therapy intervention on anxiety and time perception
      during pulmonary rehabilitation.
    

Detailed description: 
      Background：

      In recent years, in many domestic and foreign music therapy literature, it can be found that
      the intervention of music therapy can alleviate the anxiety of patients in the treatment,
      surgery, and even patients with critical care using ventilators, and then affect the
      patient's physiological indicators, in addition, there are also studies that mention that
      background music affects people's waiting time perception, reduces people's waiting time, can
      reduce the generation of negative emotions, and improve the quality of hospital medical care.
      The objective of this study was to explore the effects of music therapy on anxiety and time
      perception during pulmonary rehabilitation.

      Study Design：

      This case is a one-year single-center, prospective block randomizied trial.

      Methods：

      The study is expected to be 50 people, randomly assigned to two groups (control group,
      experimental group) will be carried out in the pulmonary rehabilitation room on the sixth
      floor of the Fu Jen Catholic University Hospital, using the Baker Anxiety Scale,
      physiological monitoring instruments and cardiac output monitor as tools to test the effects
      of anxiety sensations, physiological responses (heartbeat, breathing times, blood pressure,
      heart rate variability) and perceptual time in two situations of interventional music therapy
      and non-interventional music therapy during the rehabilitation of negative pressure
      respirators.

      Effect：

      It was mainly found that the intervention of music therapy can reduce anxiety, number of
      heartbeats, number of breaths and blood pressure, and shorten the perceptual time of patients
      with pulmonary rehabilitation.

      Key words：

      Music therapy; pulmonary rehabilitation; depression; percieved time; chronic obstructive
      pulmonary disease
    

Intervention name(s): Music therapy
Intervention type(s): Behavioral
Intervention description(s): Performing music therapy during a course of pulmonary rehabilitation (25 mins)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Music therapy; Pulmonary rehabilitation; Depression; Percieved time; Chronic obstructive pulmonary disease
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Condition: Vertebral Compression Fracture
MeSH terms: Fractures, Bone; Spinal Fractures; Fractures, Compression
Study type: Interventional
Phase: Phase 4

Summary: 
      Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression
      fractures has been shown to be successful in providing acute pain relief, enabling improved
      function, and restoring of vertebral body height. However, limited prospective data exists in
      the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to
      bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to
      compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon
      kyphoplasty.
    


Intervention name(s): Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
Intervention type(s): Device
Intervention description(s): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoporosis; vertebral compression fractures
Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Giving cetuximab together with combination chemotherapy may kill more
      tumor cells.

      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination
      chemotherapy works as first-line therapy in treating patients with metastatic colorectal
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the complete response rate in patients with metastatic colorectal cancer
           treated with cetuximab and FOLFIRINOX chemotherapy comprising oxaliplatin, irinotecan
           hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.

      Secondary

        -  Determine the objective response rate in patients treated with this regimen.

        -  Assess the tolerability of this regimen in these patients.

        -  Determine the time to response and time to progression in patients treated with this
           regimen.

        -  Determine the survival of patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive cetuximab IV over 1-2 hours on days 1 and 8. Patients also receive
      FOLFIRINOX chemotherapy comprising oxaliplatin IV over 2 hours, irinotecan hydrochloride IV
      over 30-90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV
      continuously over 46 hours on days 1 and 2. Treatment repeats every 15 days for up to 12
      courses in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months.
    

Intervention name(s): cetuximab; fluorouracil; irinotecan hydrochloride; leucovorin calcium; oxaliplatin
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Cetuximab; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer
The Effect of Probiotic Supplementation on SARS-CoV-2 Antibody Response After COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This study will explore how a well-known probiotic strain L. reuteri DSM 17938 impacts
      SARS-CoV-2 specific antibody response upon and after infection in healthy adults.
    

Detailed description: 
      After giving their informed consent, the study subjects will complete screening procedures to
      assess their eligibility for the study (Visit 1). Participants deemed suitable for the study
      will be randomized into two study arms (placebo, probiotic) before undergoing a baseline
      visit (Visit 2) before the start of the intervention period. During the 6-month intervention
      period, the participants will attend study visits at 3 months (Visit 3) into the intervention
      as well as at the end of intervention (at 6 months, Visit 4). Blood, saliva, and faecal
      samples will be collected at visits 2-4. In addition to sampling, during the whole
      intervention period, the participants will fill out a weekly questionnaire in which they are
      asked to record any possible symptoms of COVID-19. The participants' dietary habits are
      assessed via a food frequency questionnaire (FFQ) before the start of the intervention
      period. Also, the participants are asked to maintain their habitual diet and lifestyle as
      well as not to consume any other probiotic or prebiotic supplements.
    

Intervention name(s): L. reuteri DSM 17938 + vitamin D; Placebo + vitamin D
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 * 10^8 CFU of L. reuteri DSM 17938 + 10 ug vitamin D3, two capsules per day for 6 months; Placebo tablet + 10 ug vitamin D3, Similar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effects of the eNOS activating agent
      triflusal on episodic memory and cognitive functions in participants under chronic stress.
    

Detailed description: 
      Randomised, placebo controlled, double blind, cross-over design

      Primary study outcome is:

      Performance in a verbal memory task.

      Main secondary outcomes are: Performance in working memory and cognitive tasks and influence
      on mood, depression and anxiety and subjective memory impairment.

      Once daily oral administration of 600 mg triflusal and placebo mannitol for 8 days in a
      cross-over trial with a washout period of at least 14 days between the two periods. Each
      participant will take triflusal as well as placebo
    

Intervention name(s): Triflusal; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily oral administration of 600 mg triflusal Disgren® for 8 days.; Once daily oral administration of placebo mannitol for 8 days.
Other intervention name(s): Disgren®; mannitol
Intervention MeSH terms: Mannitol; Triflusal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Fenofibrate and Pharmacogenetic Impact in Dyslipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      The purpose of the study is to learn whether genetics plays a role in predicting response to
      a commonly used and FDA (Food and Drug Administration) approved medication for lowering
      triglycerides and cholesterol. The hypothesis: The pharmacogenetics of genes which affect
      drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the
      body) influences how a person responds to the lipid lowering medication-fenofibrate.
    

Detailed description: 
      The investigators seek to screen over 200 subjects for select candidate genes to serve as a
      source of subjects which may participate in a genotype guided investigation as to the
      predictability of response based on genotype. Response endpoints relate to lipid parameters
      and other variables of interest to cardiovascular endpoints. Subjects with genotypes of
      interest would then be enrolled into a short term clinical trial evaluating their response to
      fenofibrate based on their genetic profile ascertained from the screening phase.
    

Intervention name(s): fenofibrate; fenofibrate
Intervention type(s): Drug; Drug
Intervention description(s): Fenofibrate 145mg tablets once daily for 4 weeks; Fenofibrate 145mg tablets once daily for 4 weeks
Other intervention name(s): TriCor® 145mg tablets; TriCor® 145mg tablets
Intervention MeSH terms: Fenofibrate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults with dyslipidemia