bioihbjkbjnl/mcl2 huggingface dataset:
APIOC Sphere and APIOC Astigmatism
Condition: Myopia; Hyperopia; Astigmatism
MeSH terms: Astigmatism; Hyperopia
Study type: Interventional

Summary: 
      Vision and comfort, both objective and subjective, will be assessed for single vision contact
      lens wearers for either the APIOC™ Sphere or the APIOC™ Astigmatism contact lenses.
    


Intervention name(s): APIOC Sphere and APIOC Astigmatism
Intervention type(s): Device
Intervention description(s): Single Vision Contact Lenses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multimodal MRI-guided rTMS to Treat Refractory Hallucinations
Condition: Hallucinations; Schizophrenia; Perceptual Disorders
MeSH terms: Hallucinations; Perceptual Disorders; Schizophrenia
Study type: Interventional

Summary: 
      -  The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from
           drug-resistant multisensory hallucinations will be tested by the implementation of a
           double-blind randomized controlled trial (RCT)

        -  This study will use a combination of different MRI modalities (fMRI and DTI) to define
           with precision rTMS brain-targets in the case of multisensory hallucinations

        -  The investigators anticipate that multimodal MRI-guided rTMS will allow a significant
           improvement in the efficacy of neuromodulation treatment of refractory hallucinations
    


Intervention name(s): MagPro X100 repetitive Transcranial Magnetic Stimulation; MagPro X100 repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): Target defined using both fMRI during hallucinations occurence and tractography.
Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session; Target: T3-P3 (10-20 EEG international System). Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation; Neuronavigation; Functional Magnetic Resonance Imaging; Diffusion Tensor Imaging
Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)
Condition: Apnea, Sleep
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime
      sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS)
      who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy.
      The goal of this study is to determine the effect of MK-7288 after single dose administration
      on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests,
      and on driving performance as measured by standard deviation of lane position in simulated
      driving (country vigilance driving).
    


Intervention name(s): MK-7288; Placebo to MK-7288; Modafinil; Placebo to modafinil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): one or two 10 mg capsules, orally, single dose; one or two capsules, orally, single dose; two 100 mg tablets, orally, single dose; two 100 mg tablets, orally, single dose
Other intervention name(s): PROVIGIL®
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Change From Baseline to Chronic Kidney Disease Patient Before and After Administration Drug
Condition: Chronic Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic renal failure is a syndrome that renal function is decreased, and the patient number
      is increasing. In addition, patients on dialysis have also increased. Depending on the
      chronic renal failure aggravated, the deterioration of life caused by the conduct of dialysis
      patients is caused. In addition, a problem in dialysis treatment is ongoing economic burden
      surface to increase the life of the patient and family. A solution to this problem is, or
      stops the progression of chronic renal failure prior to dialysis, it is necessary to delay.
      As a treatment for inhibiting the progression of chronic renal failure is present, along with
      diet and blood pressure-lowering drugs or a drug therapy used by kremezin. However, the
      effect is not enough, new drug development is required.

      HD-003 is a novel compound, and found to inhibit the renal failure progression. It was found
      during the search active substance that appear when the inflammation in animals. The
      investigators confirmed that the substance is present in the urine of a person during the
      study, and later established a link between kidney disease hypotheses. When performing the
      test in animal model renal failure, chronic renal Through the non-clinical testing of the
      HD-003(general toxicity studies, reproductive, developmental toxicity test, mutagenicity test
      and antigen tests) showed that a very low toxicity. When going through the review of the
      safety and pharmacokinetic Phase 1 clinical study, it was confirmed a very satisfactory
      safety and tolerability. And pharmacokinetic results from the body's absorption in healthy
      subjects had been done well, a linear correlation was observed. Finally, it was confirmed
      that the most rapidly excreted into the urine.

      This study is a Phase 2a clinical trials performed in patients with chronic renal failure in
      3, 4 steps. The evaluation of changes in serum creatinine(sCr) in vivo indicator of renal
      failure according to the progress. Evaluating the inhibitory effect of HD-003 renal failure
      progression and dose setting, and to determine the safety.
    


Intervention name(s): Placebo; HD-003 (800mg/day); HD-003 (1600mg/day)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 24 weeks, once daily oral administration; 24 weeks, once daily oral administration; 24 weeks, once daily oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: in stage 3 or 4 steps
Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort
Condition: Pain
Study type: Interventional

Summary: 
      This single blinded randomized pilot study was performed on 21 Caucasian females to determine
      if injections through follicular openings were less painful than traditional injections for
      cosmetic botulinum toxin type A injections.
    

Detailed description: 
      Objective: To investigate whether injection of botulinum toxin type A is less painful if
      performed through follicular openings versus traditional non-specific approach.

      Design: Prospective, randomized, single-blinded study.

      Setting: Academic dermatology department.

      Patients: A volunteer sample of twenty female patients aged 25-55 who had no prior history of
      botulinum toxin injection.

      Intervention: Each patient received six randomized injections of botulinum toxin type A
      (Botox® Allergan). Two injections into the procerus muscle and two into each corrugator
      muscle. Three of the injections were performed through follicular openings and three were
      performed traditionally.

      Main Outcome Measure: Patient discomfort on a 1-10 scale and direct comparison between the
      two injection techniques.
    

Intervention name(s): botulinum type a
Intervention type(s): Drug
Intervention description(s): 12 Units total were injected into 6 sites in the glabellar complex to determine if injecting through the follicle versus a traditional approach would decrease patient discomfort
Other intervention name(s): Botox
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: botulinum toxin a; botox; Decreasing botox injection pain; injections
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
Condition: Major Depressive Disorder; Bipolar Disorder
MeSH terms: Sleep Deprivation; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the efficacy of sleep deprivation treatment in accelerating
      antidepressant responses when administered during the first week of medications and
      augmenting a sustained response with chronobiological interventions. Sleep deprivation and
      chronobiological augmentation may offer a rapid and sustained antidepressant response in mood
      disorder patients treated with medication, sleep deprivation, bright light therapy and sleep
      phase advance compared with medication only. The chronobiological treatment is rapid,
      non-invasive and has few side effects and could be of significant clinical benefit.
    


Intervention name(s): chronobiological augmentation; sertraline, lithium; one night of sleep deprivation and two FDG PET scans
Intervention type(s): Other; Drug; Radiation
Intervention description(s): Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days; Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.
Mood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks.; MDD Mechanism Only depressed subjects will have two FDG PET scans consisting of a baseline FDG PET scan and a sleep deprived FDG PET scan. One night of regular sleep,one night of sleep deprivation and one night of recovery sleep for a total of four nights at a sleep laboratory facility.
Other intervention name(s): Zoloft; Lithium
Intervention MeSH terms: Lithium Carbonate; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep deprivation; antidepressant; depression; chronobiological
Taste Acuity and Caloric Intake After Acute Morphine Administration
Condition: Taste Sweet; Taste Salty; Feeding Behavior
Study type: Interventional

Summary: 
      This study will investigate the effects of acute morphine administration on taste acuity and
      how much a person eats. It is hypothesized that there will be a dose dependent decrease in
      taste acuity and dose dependent increase in food intake associated with acute morphine
      administration. Knowledge from this study will impact the future of feeding behavior and
      obesity research in the general population. Results will also promote exploration of the
      long-term effect of opioid abuse on taste acuity and feeding behavior in substance abusing
      populations.
    


Intervention name(s): taste acuity assessment; Recorded meal
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Quantitative measurement of for tasting detection and recognition thresholds, magnitude of perception and hedonic response.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Taste acuity; Feeding behavior; opioid; Quantitative assessment
Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants
Condition: Safety and Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and
      Pharmacodynamics of ESK-001 in Healthy Participants
    

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): Experimental drug: ESK-001; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Multiple doses of ESK-001; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      This study assessed the safety and efficacy of autologous bone marrow concentrate and
      injected intra-cavernously into patients with erectile dysfunction (ED). Specifically, this
      study will evaluate ED treatment >18 year old men, a demographic where the etiology of ED is
      attributable primarily to the loss of corporal smooth muscle in the penis. Study endpoints
      will evaluate the safety and efficacy of intracavernosal bone marrow concentrate
      administration for treating ED patients.
    

Detailed description: 
      Erectile dysfunction (ED) is characterized by abnormalities of the vascular system; most
      commonly, venous leakage (or veno-occlusive dysfunction) resulting from loss of integrity of
      the surrounding corporal smooth muscle. In the penile vascular system, the corporal smooth
      muscle is responsible for trapping the blood delivered to the corpora cavernosa via the
      arterial system.

      Bone marrow is enriched for cells with regenerative potential, including mesenchymal stem
      cells, which accelerate healing of damaged tissue. The possibility of using bone marrow cells
      in the treatment of ED is enticing since stem/progenitor cell populations are known to
      secrete various growth factors, possess anti-inflammatory activities, and can differentiate
      into cells of the penile architecture.

      This study will evaluate safety and efficacy of autologous bone marrow concentrate generated
      by a closed system device and injected intra-cavernously in 40 patients aged > 18 years of
      age diagnosed with erectile dysfunction with low dose 30 cc (20 patients) or high dose 60 cc
      (20 patients). Safety and efficacy will be evaluated at baseline (prior to treatment) and at
      1,3,6 and 12-month follow up visits. The study will determine whether injection of bone
      marrow cells intra-cavernously is a clinically feasible, safe and reproducible approach for
      treating erectile dysfunction. A clinical registry will also be enrolling treating the same
      patient population (100 patients (20 cc)).
    

Intervention name(s): CaverStem
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Caverstem 1.0 - Low dose - 30 cc - 20 patients Caverstem 1.0 - High dose - 60 cc - 20 patients Caverstem 2.0 - 20 cc - 100 patients
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Probiotics Supplementation in Premature Infants
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The main objective is to assess the nutritional benefit of probiotics supplementation on
      premature infants growth. As secondary objectives, different parameters related to probiotics
      tolerance will be measured.
    


Intervention name(s): Probiotic supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): 1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Prematurity; Nutrition; Growth
Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of multiple doses of DVS SR and
      paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
    


Intervention name(s): desvenlafaxine SR; desipramine; paroxetine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paroxetine; Desvenlafaxine Succinate; Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; Major Depressive Disorder; Depression
Identification and Semi-Quantification of Ki-67 Protein Expression Status
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of the study is the identification and semi-quantification of Ki-67 protein
      expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual
      reading of the same slides.

      The imaging system is intended for diagnostic use as an aid to the pathologist in the
      detection, counting and classifying ER/PR IHC stained samples
    

Detailed description: 
      The anti Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67
      protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue
      specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the
      protein status of breast cancer patients. While the p53 kit provides the antibody that offer
      direct visualization and semi-quantification of the protein expression through a brightfield
      microscope, the GenASIs GoPath system is designed to complement the routine workflow of the
      pathologist in the analysis and review of immunohistochemically stained histologic slides.
    

Intervention name(s): Women with Breast Cancer
Intervention type(s): Procedure
Intervention description(s): IVD Study
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Women having breast cancer aged 21 and up
      
Keywords: Immunohistochemical; Ki-67; Breast cancer; IHC
EC95 of Remifentanil for Preventing Cough
Condition: Drug Usage
Study type: Interventional

Summary: 
      The investigator designed this study to investigate remifentanil effect-site concentration in
      95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol
      anesthesia.
    

Detailed description: 
      At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to
      predetermined (initial concentration 1.0 ng/ml for the first patient). Extubation was
      performed when the patients opened their eyes and spontaneous respiration and adequate tidal
      volume and ventilatory frequency were confirmed.
    

Intervention name(s): Remifentanil; Propofol anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size); Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 μg/ml.
Other intervention name(s): Ultiva; Fresofol
Intervention MeSH terms: Remifentanil; Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extubation; Remifentanil; Laryngomicrosurgery
To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics
      and Pharmacodynamics of a Single Dose of AZD1656
    


Intervention name(s): AZD1656; Gemfibrozil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose,oral tablet; Oral tablet bid on day 1 - 5.; Oral tablet bid on day 1-5
Intervention MeSH terms: Gemfibrozil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Gemfibrozil
Way to Be Active IV (Framing vs Incentives)
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      Employers are increasingly looking for opportunities to motivate sedentary employees to
      become more physically active. Workplace walking programs have had mixed success and
      typically show most improvement among participants that are already fairly active at a
      baseline. The goal of this study is to determine whether a financial incentive program can
      motivate sedentary employees to increase the number of steps they walk per day to meet a
      minimum threshold.

      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or
      more is achieved. Outcomes will be assessed each week for 3 months using incentives followed
      by 3 months of follow-up without incentives. Secondary outcomes will include the average
      steps walked per day.
    


Intervention name(s): Financial incentives; Teams; Framing of feedback; Daily Feedback
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Pedometers; Walking; Financial incentives; Sedentary lifestyle; Behavioral economics
Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Doses of BIIL 284 BS in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to obtain information about the safety and tolerability
      of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by
      determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary
      pharmacokinetic data concerning steady state and accumulation factor
    


Intervention name(s): BIIL 284 BS - rising dose; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment