bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.
    

Detailed description: 
      The study is a single-dose, randomized, cross-over study. The investigational products will
      be given as single doses at separate visits. The product administrations comprise 30 minutes
      of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36
      hours, will separate treatment visits. Before and after the start of product administration
      at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and
      during 8 hours after start of product administration. Used gums will be collected and
      analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to
      capture any adverse events that may occur. Treatment labels will be concealed from subjects,
      study personnel, monitor, and analysts.
    

Intervention name(s): Nicotine
Intervention type(s): Drug
Intervention description(s): 2 mg Single-dose
Other intervention name(s): Experimental NRT, Nicorette®
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Clinical & Biochemical Effect of Atorvastatin in Nano Particles Gel in Periodontitis Treatment
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Periodontitis is a destructive chronic inflammatory disease characterized by periodontium
      damage and pocket formation between the tooth and the gingival margin resulting in ultimate
      tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in
      periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment
      necessitates developing a syringeable modified delivery system capable of targeting
      inflammation within the periodontal pockets.
    


Intervention name(s): Atorvastatin Calcium; Atorvastatin Calcium; Scaling and debridement only
Intervention type(s): Drug; Drug; Other
Intervention description(s): Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement; Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement; Scaling and debridement only
Intervention MeSH terms: Calcium, Dietary; Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periodontitis; Non-surgical treatment; Atorvastatin; Phase 1 therapy
Articulation and Phonology in Children With Unilateral Cleft Lip and Palate
Condition: Cleft Palate; Cleft Lip
MeSH terms: Cleft Palate; Cleft Lip
Study type: Observational

Summary: 
      The purpose of the study is to assess if there are any differences in the articulatory and
      phonological competence in pre-school children with unilateral cleft lip and palate (UCLP)
      who are treated with different surgical methods of palatal repair.
    

Detailed description: 
      A cleft palate may influence important functions such as eating, function of the ear/hearing,
      speech, occlusion, and in addition social skills and acceptability related to appearance.
      Surgical treatment is aiming to minimize the impact of the cleft on these functions.
      Nevertheless there is often a need of orthodontic treatment, and if the palate is involved,
      speech therapy and speech improving secondary surgery. The incidence of otitis media with
      effusion, and related hearing problems, is high among the children. The outcome is affected
      by type of cleft as well as surgical method, although not yet fully clarified. Some consider
      the growth of the mid-face to be better if primary surgery of the hard palate is delayed,
      while speech development is considered to benefit from primary palate surgery performed as
      early as possible. Yet we don´t know which surgical method is the best. In most parts of the
      world and at three of six treatment centers in Sweden the palate is closed in one stage
      between 12 and 18 months of age. At the three other Swedish centers the cleft in the soft
      palate is closed at 4-6 months, and the cleft in the hard palate is repaired at 2-3 years of
      age.

      Video-recordings of the children at 3 and 5 years of age will be used for evaluation. The
      speech material at 3 years of age consists of spontaneous speech and word naming. At 5 years
      sentence repetition and a re-telling task is added. Blindly transcription of the material
      after randomization, according to the transcription used for cleft palate speech in Sweden
      based on the IPA and ExtIPA conventions will be performed. About 30% of the material,
      randomly selected, will be re-transcribed and about 30% will be transcribed by an additional
      listener independently, for calculation of reliability. The results will be compared between
      groups regarding articulatory deviancies and phonological processes, and will be
      statistically analyzed. Impact of ear problems, hearing and speech therapy will be assessed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children from the south or western region of Sweden born with unilateral cleft lip and
        palate.
      
Keywords: unilateral cleft lip and palate; primary palatal surgery; articulation; phonology; one stage palatal repair; two stage palatal repair
Study of Harmine in Healthy Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The
      primary goal of the trial is to determine the maximum tolerated dose of harmine.
    

Detailed description: 
      The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The
      primary goal of the trial is to determine the maximum tolerated dose of harmine. Harmine will
      be administered in an open-label, dose escalation design that will use the continual
      reassessment method to inform the next dose to test in a subject. There will be a total of
      seven possible doses that include 100 mg, 200 mg, 300 mg, 500 mg, 700 mg, 900 mg and 1200 mg.
      Each study subject will receive a single oral dose of harmine in this single ascending dose
      design. On the treatment day, subjects will undergo continuous medical monitoring. All
      adverse events will be documented and events that qualify as dose limiting toxicities (DLTs)
      will be used to inform dosing for the subsequent subjects.
    

Intervention name(s): Harmine Hydrochloride Capsules
Intervention type(s): Drug
Intervention description(s): capsules taken orally
Intervention MeSH terms: Harmine
Intervention model: Sequential Assignment
Intervention model description: This study will employ the continual reassessment method (CRM) to find an MTD of Harmine. It uses a statistical model to estimate the relationship between dose and DLT risk to inform decisions on dosing. It first starts with a selected target DLT rate and a mathematical model for the relationship between dose and toxicity, the prior dose-toxicity curve. After a patient experiences a DLT or not, the dose-toxicity curve is re-fit incorporating the latest outcome. The next dose assigned is that most likely to be associated with the target toxicity level (the MTD). At every step, the next patient is assigned the dose estimated to be nearest to the MTD.
Masking: None (Open Label)
Primary purpose: Treatment
Ketamine and Changes of the Short Portable Mental Status Questionnaire
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      - Cognitive changes are related to aging, affecting the performance of older patients in the
      solution of problems and the execution of tasks.

      This phenomenon has been observed as a decline of neurophysiological domains, especially
      memory, and the velocity of thought.

        -  Anesthesia and surgery performed contributes to its development then, is named
           post-operative cognitive dysfunction (POCD). The incidence varies due to conditions of:

             1. Anesthesia and surgery.

             2. The time elapsed after surgery.

             3. The population studied, and the type of cognitive test employed.

        -  The aim of this study is to evaluate the changes around the Short Portable Mental Status
           Questionnaire (SPMSQ-E) after ketamine administration on ophthalmic surgery on the
           common conditions of geriatric patients, -comorbid and settings as minor surgery-.
    

Detailed description: 
      Participants will be patients programmed for a vitrectomy or cataract surgery involving a
      retrobulbar block, to be carried out with a local anesthesia.

      - Administration of ketamine will be suspended during the study for any cause considered as a
      risk to the patient according to the judgment of the researchers.
    

Intervention name(s): Ketamine; physiological solution
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.; physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.
Other intervention name(s): Ketalin; Ketalar; Ketanest; Control; Placebo
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Ketamine; acute cognitive dysfunction; geriatric patients
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders
Condition: Effect of High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      Prospective interventional trial in lowlanders evaluating the effect of acute exposure,
      acclimatization and re-exposure to high altitude on psychomotor vigilance to measure
      sustained attention.
    

Detailed description: 
      Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3
      days. Participants will then travel by commercial airline (2 h flight) and by bus (2 h ride)
      to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile.
      Participants will stay there for the next 7 nights and they will spend the days (6 total; 6-8
      h daily) at the telescope station at 5050 m while undergoing testing as described above at
      the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h
      ride, one way). After the first 7 day altitude sojourn participants will return to the
      Santiago area (520 m) for a 7 day recovery period. A second altitude sojourn with an
      identical schedule as the one described above and a final low altitude stay of 3 days will
      follow.
    

Intervention name(s): altitude exposure
Intervention type(s): Other
Intervention description(s): altitude exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: high altitude; cognition; sleep
Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and
      glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients
      with T1DM.
    

Detailed description: 
      The study is planned as open, randomised 3-period cross-over in patients with T1DM. The study
      will include a total of 6 completing patients. The study is not blinded due to the
      exploratory nature.

      At each of the 3 periods, different blood glucose level will be established in 4 steps (8, 6,
      4, and 2.8 mmol/L), and a prefixed glucagon dose will be given per glucose level. The
      sequence of glucagon dose strength for the three dosing days will be randomized.
    

Intervention name(s): Glucagon
Intervention type(s): Drug
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
Condition: Hallux Valgus and Bunion
MeSH terms: Hallux Valgus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, randomized, double blind, placebo and active controlled study with an
      Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing
      bunionectomy.
    

Detailed description: 
      Near the completion of surgery, a single dose of study drug (CPL-01, saline placebo, or
      ropivacaine HCl) will be infiltrated. Subjects will remain in the hospital/research facility
      for a minimum of 72 hours after the start of study drug administration to undergo
      postoperative assessments. Subjects will return to the study site on Day 7 to complete follow
      up assessments, on Day 28 for follow-up assessments including an X-Ray, and on Day 42 for the
      end-of-study (EOS) visit.
    

Intervention name(s): Analgesic Non Narcotic
Intervention type(s): Drug
Intervention description(s): Injection of protocol-specified volume of local analgesic
Other intervention name(s): Infiltration of local analgesic
Intervention MeSH terms: Analgesics; Analgesics, Non-Narcotic
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Bunion Surgery
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Obstructive Sleep Apnea (OSA) Anesthesia and Positive Airway Pressure
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      To determine if autotitrating positive airway pressure (APAP) naïve patients with OSA can
      successfully use APAP following general anesthesia.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary Care Clinic
      
Keywords: sleep; apnea
Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
Condition: Colorectal Cancer; Polyp; Adenoma
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Interventional

Summary: 
      To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
    

Detailed description: 
      Colonoscopy is the gold-standard method for CRC screening, as it enables detection and
      real-time removal of pre-cancerous polyps during the examination. It is well known that
      lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing
      polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by the
      colon's topography and natural folds, shallow polyps, unscreened portions of the colon (due
      to incomplete colonoscopy) and endoscope slippage. The NaviAid™ G-Eye system presents a
      unique concept that overcomes all 5 items listed above, providing an overall solution to the
      two endoscopy key challenges of limited detection/treatment yield and limited operation
      range.

      The G-Eye endoscope comprises a standard endoscope onto which a unique balloon is permanently
      integrated, at its bending section. The NaviAid™ G-Eye may be used for performing controlled
      withdrawal and endoscope stabilization.

      A major attribute of the NaviAid™ G-Eye system controlled withdrawal technique of the
      endoscope, with the balloon moderately inflated is to expand and stretch the intestinal lumen
      during endoscope withdrawal.

      This is a single-center, non randomized open-label study intended to evaluate the serious
      adverse events prevalence when using the NaviAid™ G-Eye system during colonoscopy.
    

Intervention name(s): NaviAid™ G-Eye procedure
Intervention type(s): Device
Intervention description(s): NaviAid™ G-Eye procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colorectal Cancer; Polyp; Adenoma; Detection Rate; Colonoscopy; NaviAid™ G-Eye procedure; NaviAid™ G-Eye system; G-Eye procedure; G-Eye system
Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
Condition: Psoriasis, Plaque-type Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the proportion of patients achieving reversal of chronic
      plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered
      subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive
      multiple doses of secukinumab up to week 52 to study long term effects of secukinumab.
      Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to
      better understand, why secukinumab may be effective in psoriasis patients.
    


Intervention name(s): secukinumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): secukinumab; placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis, Plaque-type psoriasis; Plaque; Secukinumab; AIN457A; PASI; DLQI; IGA
Drug Interaction Study of Isavuconazole and Tacrolimus
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Tacrolimus; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics (PK) of tacrolimus after single dose administration.
    

Detailed description: 
      Subjects will receive a single dose of tacrolimus on Day 1 followed by a 15 day wash-out
      period (time from tacrolimus dosing to isavuconazole dosing).

      On Days 16 and 17, isavuconazole will be dosed three times daily (TID). TID doses will be
      administered 8 hours apart. On Days 18 through 28 isavuconazole will be administered once
      daily (QD). All subjects will be administered a single dose of tacrolimus on Day 20. A follow
      up visit will occur approximately 7 days after the last dose of isavuconazole. Blood samples
      for pharmacokinetics will be collected throughout the study.
    

Intervention name(s): isavuconazole; tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557; BAL4815; Prograf; FK506
Intervention MeSH terms: Isavuconazole; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: isavuconazole; tacrolimus; Healthy Volunteers; BAL8557
Compare Swallowing Kinematics and Suprahyoid Muscle Activation Among Three Different Swallowing Tasks
Condition: Swallowing Disorder
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      The aim of this study is to swallowing kinematics and suprahyoid muscle activation among
      Masako, Mendelsohn Maneuvers and new-designed Mouth Open Swallowing Maneuver
    

Detailed description: 
      Swallowing disorder can result in aspiration pneumonia, dehydration, malnutrition and even
      death. Therefore, it is a condition that needs to be detected, prevented and/or treated at an
      early stage. In the rehabilitation process of swallowing disorders, many exercise approaches
      are used, as well as compensatory postures and maneuvers. In addition to creating
      compensation and increasing swallowing muscle strength, the maneuvers used also change the
      temporal parameters associated with swallowing, such as delay in the swallowing reflex and
      time to close the airway.

      Mendelson maneuver and Masako maneuver are the most commonly used swallowing maneuvers in
      swallowing rehabilitation. During the Mendelson maneuver, the patient is asked to voluntarily
      hold larynx when larynx is elevated. Masako maneuver is swallowing with tongue positioned
      between anterior teeth. Mouth Open Swallowing Maneuver is new-designed exercise. 10 mm wedge
      is comfortably positioned on the molar teeth and patient is asked to swallow in this way. We
      think that the explosive force that occurs more hyolaryngeal displacement than normal
      swallowing. Therefore, The targets of all three exercises in the swallowing physiology is
      different. It is important to investigate the effects of all three exercises on swallowing
      physiology in order to determine a patient-specific rehabilitation program and develop new
      techniques.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult individuals will be included
Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the investigators would like to test the hypothesis that in diabetic patients
      discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected
      Glargine in terms of diabetes control, compliance, and patient satisfaction and preference.
      The investigators will test this hypothesis in a randomized, crossover trial.
    


Intervention name(s): Glargine insulin
Intervention type(s): Drug
Intervention description(s): 20-180 units per day
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes
Immediate Effect of One-session MRT in Hemiparetics
Condition: Hemiparesis;Poststroke/CVA; Satisfaction, Patient
MeSH terms: Paresis
Study type: Interventional

Summary: 
      Immediate effect of one-session Matrix Rhythm Therapy on the functional status and treatment
      satisfaction of hemiparetic patients will be investigated.
    


Intervention name(s): Matrix-Rhythm Therapy; Conventional physiotherapy and rehabilitation
Intervention type(s): Other; Other
Intervention description(s): One session Matrix-Rhythm Therapy will be applied to affected body parts.; Hemiparetics wil receive one session conventional physiotherapy and rehabilitation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment