bioihbjkbjnl/mcl2 huggingface dataset:
A Metabolite Identification, Mass Balance, and PK Study of [14C]-Asimadoline to Healthy Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, single center, metabolite identification, mass balance, and PK study
      in healthy male volunteers.
    

Detailed description: 
      This is an open label, single center, metabolite identification, mass balance, and PK study
      in healthy male volunteers. The purposes of this study is to determine the excretion of total
      [14C] derived radioactivity and the metabolite profile after a single oral dose of [14C]
      asimadoline as well as to identify and quantitate the metabolites of asimadoline in plasma,
      urine, and feces after single and multiple oral doses of asimadoline.
    

Intervention name(s): asimadoline
Intervention type(s): Drug
Intervention description(s): 10mg [14]C labelled asimadoline Day 1 then 7 doses 0.5 mg asimadoline bid beginning on Day 2 and ending on Day 5.
Other intervention name(s): EMD 61 753; EMR 63 320
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: asimadoline; pharmacokinetic; excretion of 14C-derived radioactivity; metabolite profile; 14C-asimadoline; metabolites; single and multiple oral doses
Effects of Vitamin D on Moderate to Severe Periodontitis
Condition: Chronic Peritonitis
MeSH terms: Peritonitis; Periodontitis
Study type: Interventional

Summary: 
      The object of the study was to evaluate the direct effect of high dose vitamin D
      supplementation on chronic periodontitis, and suggest the recommended dose for clinic use.
    

Detailed description: 
      Periodontitis is a chronic inflammatory disease characterized by periodontal tissues
      inflammation and alveolar bone loss. Vitamin D is involved in stimulating osteoblasts to
      enable normal bone growth and preservation, also the regulation of cellular proliferation,
      differentiation, innate immune response and anti-inflammatory effect.Previous studies have
      reported the association of vitamin D levels and gingivitis and periodontitis. This study was
      designed as a randomized controlled trial to evaluate the effect of vitamin D supplementation
      on chronic periodontitis.

      The study was divided into two phases. Recruitment including baseline clinical measurements
      was obtained and standard periodontal treatments were performed in Phase One. The
      randomization and intervention of vitamin D were performed in Phase Two. The 323 subjects
      were randomly divided into 3 groups (n=105,110,108) to receive a supplement kit containing 90
      capsules of 2000 IU vitamin D, 1000 IU vitamin D, or placebo capsule for 3 months. After
      intervention, all the subjects were followed up after 3 months and received standard
      periodontal examination, including attachment loss (AL), probing depth (PD), bleeding index
      (BI), and panoramic radiographs were taken to evaluate alveolar crest height (ACH).
    

Intervention name(s): vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects took vitamin D or placebo
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Vitamin D
Contrast Bath and Sympathetic Skin Response
Condition: Stroke; Sympathetic Disorder
Study type: Interventional

Summary: 
      This study evaluates the effects of contrast bath on sympathetic skin response in stroke
      patients with complex regional pain syndrome .
    

Detailed description: 
      Contrast bath(CB) is a thermal modality. It is usually performed by keeping hands in hot and
      cold water for certain periods of time. CB is a mostly advised intervention in complex
      regional pain syndrome (CRPS) altough there is no certain evidence The investigators will
      study on stroke patients. Change in sympathetic skin response after the contrast bath will be
      evaluated.

      Stroke patients who admitted to the inpatient rehabilitation programme in Istanbul Physical
      Medicine and Rehabilitation Training and Research Hospital were evaluated for this study.
      Patients who had CRPS after stroke were included in the study (CRPS group). Also patients who
      had not CRPS and had similar age, gender and stroke duration with CRPS group were included in
      control group. Stroke patients with pacemaker, polyneuropathy, neglect, sensory or motor
      aphasia, peripheral nerve injury, hand surgery and reynauld disease were excluded from the
      study.

      Age, gender, dominant arm, comorbidities, stroke side, aetiology and duration were recorded.
      Brunnstrom stages were used to evaluate arm and hand. Spasticity of upper extremity was assed
      by modified aschworth scale.

      In CRPS group, CRPS severity scale was performed to evaluate the CRPS severity. This scale
      includes sensorial, autonomic and motor function. Also, neuropathic pain was assesed by
      Douleur Neuropathique 4 (DN4) Questionnaire and visual analog scale(VAS).

      Contrast bath was performed to patients' plegic side . There were two baths , one include hot
      water and other had cold degrees. Patients hold their plegic hands in hot water for 4
      minutes, in cold water for 1 minute after hot water. Hot and cold bath were repeated four
      times.

      Sympathetic skin response (SSR) was measured before the contrast bath and 30 minutes after
      the contrast bath finished. SSR was recorded from plegic side and contralateral side. The
      active electrode was placed at the palm of the hand and the reference electrode at dorsum of
      the hand to record the median nerve SSR. The latency and the amplitude of SSR was measured.
    

Intervention name(s): Contrast bath
Intervention type(s): Other
Intervention description(s): Contrast bath (hot and cold therapy)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pupillary Diameter Under Different Concentrations of Propofol
Condition: Anesthesia
Study type: Interventional

Summary: 
      Resting pupillary diameter was measured at a randomized Effect-site target concentration of
      propofol used as a sole anesthetic.
    


Intervention name(s): Propofol; Pupillary diameter measurement
Intervention type(s): Drug; Device
Intervention description(s): Continuous infusion; Instantaneous measure
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: propofol; pupillary diameter
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of TAK-994 and to
      determine the effect of TAK-994 (compared to placebo) on sleepiness, as measured by mean
      sleep latency on the maintenance of wakefulness Test (MWT), in an acute sleep phase delay
      paradigm in healthy participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-994. The study will evaluate the
      safety/tolerability, PD, and PK of TAK-994 in an acute sleep phase delay paradigm in healthy
      participants.

      The study will enroll up to approximately 18 healthy participants. Participants will be
      randomly assigned to 1 of the 3 treatment sequences which will remain undisclosed to the
      participant and study doctor during the study (unless there is an urgent medical need):

        -  TAK-994 Dose A + Placebo + TAK-994 Dose B

        -  TAK-994 Dose B + TAK-994 Dose A + Placebo

        -  Placebo + TAK-994 Dose B + TAK-994 Dose A

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 10 weeks. Participants will be followed up
      remotely on Day 7 after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-994; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-994 tablets.; TAK-994 placebo-matching tablets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug Therapy
DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Condition: Allergic Rhinitis; Healthy Volunteer
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate safety/tolerability after a single dose intranasal administration of DSP-3025
      comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients
      out of season.
    


Intervention name(s): DSP-3025; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Masking: Double
Phase 1 Study to Evaluate the Safety and Tolerability of DS-1040b IV Infusion With Clopidogrel in Healthy Subjects
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to test the hypothesis that coadministration of clopidogrel
      with DS-1040b will be safe and well tolerated. Subjects entering the study will initially
      receive a single 12 hour infusion of DS-1040b, to generate data on the effect of DS-1040b
      alone. After a wash-out period (to ensure that no DS-1040b is left in the blood) subjects
      will receive repeated clopidogrel doses over 5 days to generate data on the effect of
      clopidogrel alone. On the sixth day subjects will receive both DS-1040b and clopidogrel, and
      the effects will be compared to when the two treatments were given alone.
    


Intervention name(s): DS-1040b; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg single 12-hour intravenous infusion; Clopidogrel (Plavix) administered orally 300 mg loading dose on Day 1 followed by 75 mg daily on Days 2-5
Other intervention name(s): Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug interaction; clopidogrel; healthy subjects
Dexmedetomidine and Adenosine: Therapeutic Use for SVT
Condition: Supraventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Supraventricular
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the
      acute termination of Supraventricular Tachycardia (SVT).
    

Detailed description: 
      In 2006 the investigator found that dexmedetomidine, an alpha-2 adrenergic agonist with
      primarily sedative properties, possesses additional anti-arrhythmic properties. So far the
      investigator has found that dexmedetomidine has the ability to prevent or terminate
      arrhythmias like atrial ectopic tachycardia (85% success) and junctional ectopic tachycardia
      (75% success). The most dramatic effect however was observed in the acute termination of
      reentrant SVT with a success rate of > 96%. More importantly we found that dexmedetomidine
      terminates SVT without causing any sinus pause or asystole (frequently seen with adenosine)
      and thus avoiding the feeling of "impending doom". In this study adenosine is being compared
      head to head with dexmedetomidine in a cross over study, for both safety and efficacy when
      given for the termination of SVT in the electrophysiology (EP) lab. Additional EP parameters
      will be measured to elucidate the exact site of dexmedetomidine's mechanism of action.
    

Intervention name(s): Dexmedetomidine; Adenosine
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine 2 mcg/kg, Intravenous push; Stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful
Other intervention name(s): Precedex
Intervention MeSH terms: Adenosine; Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Supraventricular Tachycardia; SVT; Reentrant Tachycardia; Dexmedetomidine; Adenosine
Obese Patients With Untreated Dyslipidemias
Condition: Obesity; Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the effect on weight loss and weight maintenance over a period of one year when
      prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia
    


Intervention name(s): Rimonabant (SR141716)
Intervention type(s): Drug
Intervention MeSH terms: Rimonabant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity
Effect of Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength
Condition: Saphenous Nerve Block; Regional Anesthesia Morbidity; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This research objective is to compare quadriceps strength by measuring maximal voluntary
      isometric contraction (MVIC) and risk of fall before and after subsartorial femoral triangle
      block (SSFTB)
    


Intervention name(s): SSFTB
Intervention type(s): Procedure
Intervention description(s): Patients who underwent major knee surgery and had already planned to perform subsartorial femoral triangle block (SSFTB) were included in the study. They were measured the outcomes the night before surgery. The saphenous nerve and nerve to vastus medialis were blocked at the subsartorial femoral triangle level by experienced anesthesiologists. After standard monitor, the distal femoral triangle was identified 2 cm proximal to the opening of adductor canal by ultrasound guidance. At this level, The location of nerve to vastus medialis was confirmed by nerve stimulator and it was blocked with 0.5% levobupivacaine 5 ml. Then, 0.5% levobupivacaine 10 ml would be injected perifemoral artery. The outcomes were re-assessed 30 min after block.
Other intervention name(s): nerve to vastus medialis and saphenous nerve block
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single-Dose PK Study of an Oxycodone/Acetaminophen Solution in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects
      under fasted conditions
    

Detailed description: 
      An open-label, single-dose, single-center study evaluating the oral PK of an oxycodone/apap
      solutions in healthy subjects under fasted conditions
    

Intervention name(s): Oral solution OC/APAP
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Retrospective Analysis of Colorectal Cancer Screening Results
Condition: Colorectal Cancer; Advanced Adenocarcinoma; Hyperplastic Polyp; Colorectal Neoplasms; Digestive System Neoplasm; Neoplasms
MeSH terms: Neoplasms; Colorectal Neoplasms; Digestive System Neoplasms; Gastrointestinal Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to retrospectively analyze colorectal cancer screening data of
      40-74 year old population in Shipai Town, Dongguan City.

      In this study, the data of SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT)
      were screened from about 11,000 subjects who participated in Colorectal Cancer Screening in
      Shipai Town People's Livelihood Project from May 2021 to May 2022. Data from 822 subjects
      with positive SDC2 Gene Methylation Test and/or positive Fecal Immunochemistry Test (Q-FIT)
      results and with colonoscopy and/or pathological results were selected for retrospective
      analysis.

      This retrospective study evaluated the screening performance of SDC2 Gene Methylation Test
      and/or Fecal Immunochemistry Test (Q-FIT) for colorectal cancer using colonoscopy and/or
      pathological results as the clinical standard method.
    

Detailed description: 
      This study is a retrospective and observational study. Subjects were not be given or offered
      any treatment during the study. The investigator reviewed the patient's medical history and
      examination report to determine eligibility based on inclusion and exclusion criteria.

      This study retrospectively analyse the basic information and the test results of SDC2 Gene
      Methylation Test and Fecal Immunochemistry Test (Q-FIT) of about 11,000 subjects who
      participated in the Colorectal Cancer Screening in Shipai Town People's Livelihood Project
      from May 2021 to May 2022. A total of 822 subjects with positive SDC2 Gene Methylation Test
      results and / or positive Fecal Immunochemistry Test (Q-FIT) results were screened out and
      their colonoscopy results were collected.

      822 subjects were classified according to colonoscopy and/or pathological detection results,
      and the screening performance of the SDC2 Gene Methylation Test and Fecal Immunochemistry
      Test (Q-FIT) for colorectal cancer was statistically analyzed.
    

Intervention name(s): SDC2 Gene Methylation Test and Q-FIT Test; Colonoscopy and/or pathological examination
Intervention type(s): Diagnostic Test; Procedure
Intervention description(s): Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test; Subjects underwent colonoscopy and/or pathological examination.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects live in Shipai Town, Dongguan city, the age limit is 40-74 years，822 subjects meet
        the inclusion criteria for this study.
      
Keywords: Colorectal Cancer; Colon Cancer; Stool DNA test; Fecal DNA test; Fecal Immunochemical Test; FIT; Methylation Biomarkers; Colonoscopy; Cancer Screening
A Pilot Study to Evaluate Safety and Performance of Neuromuscular Electrical Stimulation With the Inko RS Device for the Treatment of Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot clinical study taking place at one site in Berlin, Germany using
      Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of 20 women
      suffering from stress urinary incontinence. This involves a 12 week, 30 minute, 5 days out of
      7 set treatment program with the device. After the 12 week treatment programme the subjects
      will be asked to perform daily set exercises for a further 14 weeks.
    


Intervention name(s): Inko RS Device
Intervention type(s): Device
Intervention description(s): 30 minute pre-programmed treatment for 5 days out of 7. Treatment to be carried out while standing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Incontinence; NMES
Effects of Dexmedetomidine During IRE Procedures for Solid Tumours
Condition: Cancer of Liver; Cancer of Pancreas
MeSH terms: Pancreatic Neoplasms; Liver Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE
      procedures for solid tumours
    

Detailed description: 
      Pulsed electric current can be used to produce irreversible electroporation (IRE) of cell
      membranes with resulting cell death. This process has been shown to ablate tumors in animal
      and human studies. A pulsating direct current of 20 to 50 A and 500 to 3000 V is delivered
      into metastatic or primary tumors in the liver, kidney, or lung via needle electrodes
      inserted under computed tomography (CT) or ultrasound guidance. Patients usually require
      general anesthesia with muscle relaxant. Currently, circa 30 procedures have been done at our
      institution with good or excellent results. However, several patients have had severe pain
      postoperatively.

      Dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic
      effects, and it has more selective α2-adrenergic effect than clonidine. We will evaluate
      perioperative dexmedetomidine 0.4 µg/kg/hr infusion effects on hemodynamics, anesthetic
      consumption, and recovery profiles during anesthesia for IRE of solid organs tumours.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dexmedetomidine 0.4 µg/kg/hr infusion (from the start of anaesthesia until the end of anaesthesia).
Anaesthesia induction: propofol 2 mg/kg, rocuronium 0.6 mg/kg iv, and fentanyl 2-3 mikrogram/kg.
Anaesthesia maintenance: sevoflurane and oxygen 50%, rocuronium 0.1-0.2 mg/kg iv, fentanyl 1 mikrogram/kg as required
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analgesia After Total Shoulder Arthroplasty
Condition: Total Shoulder Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine which medication(s) should be included in the
      interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in
      the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The
      ideal nerve block would reduce pain after shoulder surgery without causing a great deal of
      muscle weakness.
    

Detailed description: 
      All patients will receive an intravenous pain pump (patient-controlled analgesia) and a nerve
      block with long-lasting local anesthetic. The three study groups will receive additives
      (clonidine, dexamethasone, buprenorphine plus local anesthetic) in the nerve block that may
      reduce postoperative pain. One of the study groups uses the usual concentration of local
      anesthetic, while the other two study groups use reduced concentrations of local anesthetic.
      Follow-up with study patients begins on the day of surgery and continues through
      postoperative day 2. Seen twice daily, patients will be asked about their pain and assessed
      for sensory function and strength of their shoulder muscle and hand grip.
    

Intervention name(s): Interscalene Block (ISB) - 0.375% Ropivacaine + additives; Interscalene Block (ISB) - 0.2% Ropivacaine + additives; Interscalene Block (ISB) - 0.1% Ropivacaine + additives; Interscalene Block (ISB) - Systemic Control
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline; Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline; Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline; Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment