bioihbjkbjnl/mcl2 huggingface dataset:
Melatonin in Patients With Multiple Sclerosis (MS).
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To date, there are no published data on the role of melatonin supplementation or the
      appropriate dose for patients with multiple sclerosis. Because of the potential benefits of
      melatonin, this pilot study will be an exploratory investigation to evaluate the effect of
      supplementing melatonin in subjects with multiple sclerosis who are taking an oral disease
      modifying therapy (DMT) for 6 months or longer. It is our intent that the results of this
      study will support the rationale and be a prelude to a larger trial which can focus on
      clinical efficacy of melatonin therapy outcomes.
    

Detailed description: 
      The primary objective of this study is to evaluate the change in 24 hour urinary
      6-sulfatoxymelatonin (6SMT) collected for 24 hours in two twelve hour sessions. The secondary
      objectives are to evaluate the change in serum morning melatonin level. In addition, quality
      of life (QOL) measures will be assessed including the Modified Fatigue Impact Scale (MFIS),
      Multiple Sclerosis Impact Scale (MSIS-29), and the Pittsburgh Sleep Quality Index (PSQI).
      Clinical objectives include the number of relapses during the trial and a change in the
      Patient Determined Disease Steps (PDDS) & Performance Scales (PS).

      The pilot study is a one-year randomized, rater- and dose-blinded trial evaluating the
      potential role of melatonin in subjects with relapsing multiple sclerosis who have been
      taking a stable dose of an oral disease modifying therapy (DMT) for at least 6 months. The
      oral DMTs include dimethyl fumarate, fingolimod, teriflunomide, diroximel fumarate,
      siponimod, and ozanimod. Thirty subjects with relapsing forms of multiple sclerosis who meet
      all of the eligibility criteria will be enrolled at Providence Neurological Specialties in
      Portland, Oregon.
    

Intervention name(s): 3 mg Melatonin; 5 mg Melatonin
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg melatonin once each day; 5 mg Melatonin once each day
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to receive melatonin at 3 milligrams (mg) once a day or 5mg once a day. The study drug will be taken at 21:00 each day ± 2 hours.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; MS; Melatonin; Supplement
Case Series With Saneso 360° Gastroscope
Condition: EGD Procedure
Study type: Interventional

Summary: 
      To confirm the procedural performance of the Saneso 360° gastroscope in
      Esophago-gastro-duodenoscopy (EGD) procedures.
    

Detailed description: 
      This study is a prospective, multicenter case series per standard of care EGD procedures
      using a nonsignificant risk Saneso 360° gastroscope. 20 cases will be included at up to five
      (5) clinical sites. Patients who meet all eligibility criteria will be included and will have
      a clinically indicated EGD procedure performed using the study device. Immediately
      thereafter, patients will have an EGD procedure using a standard Gastroscope (Olympus GIF180)
      by a second endoscopist. Enrolled subjects will be followed for 7 days after their procedure.
      If the procedure is not successful with the study device, the endoscopist will complete the
      procedure with a traditional gastroscope used at each facility.
    

Intervention name(s): Saneso 360° gastroscope
Intervention type(s): Device
Intervention description(s): Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy
Condition: Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, 2-period crossover, 12-week trial to
      be conducted in 50 subjects with painful diabetic neuropathy. The objective of this trial is
      to assess the safety and efficacy of NO gel, a NO donor, as compared with a placebo gel, in
      symptom relief of subjects with painful diabetic neuropathy.
    

Detailed description: 
      Neuropathic pain is a common symptom of diabetic neuropathy, and predominantly involves the
      lower limbs. Current strategies for the management of painful diabetic neuropathy include
      improved glycemic control, use of analgesics and addition of tricyclic antidepressants and
      anticonvulsants. However, many patients experience unsatisfactory responses and some
      undesired side effects. Considerable evidence implicates impaired nitric oxide synthesis
      plays an important role in the pathogenesis of diabetic neuropathic pain. Several small
      studies have shown that topical nitroglycerin ointment has local vasodilating properties, and
      a previous study has demonstrated that isosorbide dinitrate in spray form as a nitric oxide
      donor relieved some neuropathic symptoms in patients with painful diabetic neuropathy. Based
      on the findings, the investigators hypothesize that nitric oxide gel could be used as an
      alternative pain-relieving agent for patients with resistant diabetic neuropathic pain.
    

Intervention name(s): nitric oxide gel; placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): st gel: sodium nitrites,BID local use X 28 days
nd gel: maleic/ascorbic acids ,BID local use X 28 days; placebo gel,BID local use X 28 days
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Spot Drug-Eluting Stenting for Long Coronary Stenoses
Condition: Angioplasty
MeSH terms: Coronary Stenosis
Study type: Interventional

Summary: 
      Most doctors who use the new drug-eluting stents for the treatment of long coronary
      narrowings tend to cover the full length of the lesion with long or multiple stents. The
      investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very
      tight parts of the coronary narrowing, might result in better outcomes by means of avoiding
      multiple stents that have been associated with significant complications such as late stent
      thrombosis.
    

Detailed description: 
      Coronary artery lesion length is an independent predictor of restenosis following coronary
      intervention and the deployment of multiple or long bare metal stents has been associated
      with an increased risk of adverse clinical outcome. Spot stenting, ie discrete stenting of
      only the most severe stenoses of long, diffuse lesions has been proposed as an alternative in
      this clinical setting. The introduction of drug-eluting stents has resulted in longer lesions
      being stented and the use of multiple, overlapping DES in patients with diffusely diseased
      coronary arteries has been considered safe and effective. However, there has also been
      evidence of increased major adverse cardiac events (MACE) with the use of multiple,
      overlapping DES,10-12 while long DES have been associated with increased probability of
      intraprocedural stent thrombosis.13 We hypothesized that an approach based on spot-stenting
      with the use of DES might result in superior clinical outcomes compared to full cover of
      atheromatic lesions with long or multiple stents. We are therefore conducting a randomized
      comparison of spot versus multiple overlapping stenting on consecutive patients with long
      (>20 mm) lesions and indications for percutaneous coronary intervention.
    

Intervention name(s): Drug-eluting stents (Cypher and Taxus)
Intervention type(s): Device
Intervention description(s): Spot or full length stenting of a coronary lesion
Other intervention name(s): Sirolimus-eluting stents (Cypher, J&J); Paclitaxel-eluting stents (Taxus, Boston Scientific)
Intervention MeSH terms: Sirolimus; Paclitaxel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield
      Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the
      pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS).
      The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC
      HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of
      participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for
      cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).
    

Detailed description: 
      Following a screening period, participants will receive DAC HYP over a 24-week treatment
      period (6 monthly injections) and then enter a 20-week washout period for assessment of
      immunogenicity, PK, pharmacodynamics, safety, and tolerability. The 20-week washout is
      necessary to ensure measurement of anti-DAC HYP binding antibodies (ADAbs) and neutralizing
      antibodies (NAbs) in the absence of drug interference. After washout, the participants may
      resume monthly treatment with DAC HYP 150 mg for an additional 3 years. All participants will
      be followed for 6 months after their last dose for safety monitoring. Additionally, two
      sub-studies will be performed: (1) an intensive serial PK sampling performed over the first
      and last dosing interval following DAC HYP doses administered at week 0 and at week 20, and
      (2) a therapeutic protein-drug interaction (TP-DI) sub-study, during which a probe drug
      cocktail will be administered at weeks 43 and 53 followed by serial probe-drug PK sampling up
      to 96 hours after probe-drug administration. A maximum of 20 participants will be enrolled in
      the TP-DI sub-study.
    

Intervention name(s): Midazolam; Caffeine; S-warfarin; Vitamin K; Omeprazole; Dextromethorphan; BIIB019 (Daclizumab)
Intervention type(s): Drug; Other; Drug; Other; Drug; Drug; Biological
Intervention description(s): 5 mg; 200 mg; 10 mg; 10 mg; 40 mg; 30 mg; 150 mg in 1 ml PFS
Other intervention name(s): Daclizumab High Yield Process; DAC HYP
Intervention MeSH terms: Vitamin K; Midazolam; Dextromethorphan; Caffeine; Omeprazole; Warfarin; Daclizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pre-filled syringe; Pharmacokinetic; Daclizumab High Yield Process; immunogenicity
Can Imaging Techniques Contribute to the Proper Insertion of Double-lumen Tubes?
Condition: Double-Lumen Tube; Ultrasonography; Computed Tomography
Study type: Observational

Summary: 
      In thoracic surgery, one-lung ventilation using a double-lumen tube (DLT) is often performed
      to protect dependent lung and provide comfortable surgical conditions. However, serious
      complications and adverse events can be encountered during DLT placement. One of the most
      important steps to avoid these drawbacks is to choose the appropriate size of DLT. The width
      of the trachea can be measured by using different imaging methods such as computed tomography
      (CT) and ultrasonography (US) to predict the appropriate DLT size. CT can also contribute to
      the proper placement of DLT by giving us the length of the trachea and main bronchi. In this
      study, we hypothesized that the size of the DLT can be determined more accurately by
      measuring the trachea diameter by using US and CT before DLT intubation. At the same time, we
      aimed to determine whether the evaluation of tracheobronchial anatomy with CT would
      contribute to the placement of DLT at a more appropriate level.
    


Intervention name(s): Ultrasound-guided tracheal width measurement
Intervention type(s): Device
Intervention description(s): Ultrasound measurements will be made with a 5-10 MegaHertz linear probe positioned in the horizontal plane at the midline of the anterior neck. After identifying the vocal cords as paired hyperechoic linear structures, the probe was moved caudally to visualize the cricoid arch. The transverse air column diameter was measured at the lower border of the cricoid cartilage.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 100 patients with a body mass index between18-35 kg/m2 in the ASA I-II-III risk
        group, aged 18-80, who will undergo elective thoracic surgery, require intubation with a
        double-lumen tube will be included in the study.
Investigation of Administration of MCT/ω-3 Fatty Acids is Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates.
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to
      inflammation and lipid peroxidation in preterm neonates. The aim of the present study was to
      investigate the effects of a medium-chain triglyceride (MCT)/n-3 polyunsaturated fatty acid
      (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile in preterm
      neonates. Methods: In this double-blind randomized study, 92 preterm neonates (gestational
      age <32 weeks, birth weight <1500g) were assigned to receive either MCT/n-3 PUFA-enriched
      IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Neonates' parents gave
      their informed written consent for inclusion in the study. Levels of FAs were measured at
      baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography
      mass-spectrometry.
    


Intervention name(s): MCT/ω-3 fatty acids; soybean oil-based IVFE
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The provision of ω-3 fatty acids to premature neonates in the Parenteral Nutrition.; soybean oil-based IVFE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Risk of Recurrence After Incisional Hernia Repair With Mesh Fixation With Absorbable Versus Non-absorbable Tacks
Condition: Incisional Hernia
MeSH terms: Hernia; Recurrence; Incisional Hernia
Study type: Observational

Summary: 
      Laparoscopic incisional hernia repair a variety of fixation methods has been proposed to
      ensure the correct and stable intra-abdominal placement of the mesh, in order to prevent
      recurrence, but on the other hand avoiding long-term pain and discomfort. The optimal method
      is unclear.

      In Denmark the investigators have a nationwide database that records 80% of all ventral
      hernia repairs. The investigators combine data from the Danish Hernia Database, the National
      Patient Registry, and prospective questionnaire and clinical follow-up in order to get the
      true recurrence rate (clinical and reoperation rate) and the degree of long-term discomfort.

      Purpose The purpose of this national prospective kohort study is to compare the risk of
      developing recurrence of incisional hernia after laparoscopic incisional hernia repair with
      either absorbable or non-absorbable tacks, and to investigate possible. late complaints in
      terms of pain and discomfort after the two mesh fixation devices.

      The investigators include 355 laparoscopic incisional hernia repairs with absorbable tacks
      and 726 with non-absorbable tacks. It is expected that about 300 patients will be offered
      physical examination.

      Material and Method Register-based cohort study of perioperative entry of patient data and
      prospective questionnaire follow-up and depending on the answer to any. clinical trial.

      Follow-up is done by searching the Danish Hernia Database and the National Patient Register
      (to ensure data completeness) and distribution of patient questionnaire as reoperation for
      hernia recurrence is an underestimate of the true recurrence risk.

      Statistics There will be performed frequency analyzes and Kaplan Meyer statistics on the 2
      groups supplemented with multivariate Cox regression analysis. Using non-parametric
      statistics. P <0.05 considered statistically significant.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        During the period 1 January 2008 to 31 June 2012 were recorded 355 laparoscopic incisional
        hernia operations with absorbable tacks and 726 with non-absorbable tacks were registered
        in the Dansih Hernia Database. Thus, we include 1081 patients in the study. It is expected
        that about 300 patients will be offered physical examination.
      
Keywords: incisional hernia; mesh fixation; absorbable tacks
The Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective: To evaluate the efficacy of robot-assisted gait training (RAGT) in MS patients
      with severe walking disabilities (Expanded Disability Status Scale [EDSS] 5.5-7) as compared
      to regular physiotherapy.

      Methods: Prospective, randomized, controlled clinical trial comparing RAGT with conventional
      walking training (CWT) in a group of stable MS patients (n=40) during an outpatient
      rehabilitation program. Inclusion criteria are chronic or secondary progressive MS patients
      with EDSS between 5.5-7, stable treatment 3 months before study entry, without generalized
      diseases. All patients will sign an informed consent. Following randomization, 20 patients
      will be treated with RAGT, 12 sessions over three weeks. The control group will be treated by
      CWT, 12 sessions in three weeks. The primary outcome measures will be the Functional
      Ambulatory Capacity (FAC) scale and the 6-minutes walking distance. The secondary outcome
      measures will be the Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS
      score, FIM score and RAND questioner for quality of life. All tests will be performed by an
      external blinded assessor at baseline, after three weeks, and at follow-up after 3 months and
      six months.

      Importance: We anticipated that Robot-assisted gait training will be found as feasible and
      may be an effective therapeutic option in MS patients with severe walking disabilities.
    


Intervention name(s): robot-assisted gait training (RAGT); conventional walking training (CWT)
Intervention type(s): Device; Device
Intervention description(s): 20 patients will be treated with RAGT, 12 sessions over three weeks.; The control group will be treated by CWT, 12 sessions in three weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Trichomylin® Safety, Tolerability & Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation
Condition: Healthy; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human, randomized, double-blind, placebo-controlled SAD (with food effect)
      followed by a MAD study of Trichomylin® conducted in healthy adult participants.
    

Detailed description: 
      The study is designed to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics, and food effect of Trichomylin® in healthy adult participants.

      A total of up to 40 participants were planned to be enrolled into Part A and Part B of the
      study. Part A consisted of 3 SAD cohorts (n = 8 per cohort) and Part B consisted of 2 MAD
      cohorts (n = 8 per cohort). Participants underwent a Screening period beginning up to 21 days
      for the SAD cohorts and 28 days for the MAD cohorts prior to randomization/dose
      administration. The Screening period was followed by admission to the clinical research unit
      (CRU), pre-dose assessment, post-dose assessment(s), and a final end of study (EOS)/follow-up
      visit.

      Safety and tolerability endpoints are to report the percentage and severity of unexpected or
      serious adverse events, including clinically significant vital signs, laboratory test
      results, physical examination, and/or reported clinical symptoms, and use of concomitant
      medications. Other endpoints to be assessed are neurocognitive impairment, altered state of
      consciousness, and overall well-being.

      Other assessments include pharmacokinetic (fasted and fed states) and pharmacodynamic
      endpoints.
    

Intervention name(s): Trichomylin for SAD; Placebo for SAD; Trichomylin for MAD; Placebo for MAD
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.; Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.; Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered daily oral doses for a total of 9 days.; Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered daily oral doses for a total of 9 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabinoid; Safety and Tolerability; Pharmacokinetics; Pharmacodynamics; Chronic Pain