bioihbjkbjnl/mcl2 huggingface dataset:
Single-Dose PK Study of GBT440 in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral
      dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment
      disease and healthy subjects with normal renal function.
    

Detailed description: 
      Up to 40 adult subjects will be enrolled. Safety and PK assessments will be performed at
      selected time points throughout the study.
    

Intervention name(s): GBT440
Intervention type(s): Drug
Intervention description(s): Oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Multiple-center, nonrandomized, open-label, parallel group study
Masking: None (Open Label)
Primary purpose: Other
Clinical Trial of Safety and Efficacy of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients
Condition: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      -  To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in
           treatment of obese patients (BMI 35,0-39,9 kg/m2).

        -  To assess clinical efficacy of Dietressa in the dose of 6 tablets daily after 24 weeks
           of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).
    

Detailed description: 
      In general, patients will be observed during 24 weeks of trial.
    

Intervention name(s): Dietressa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration.; Oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Running Retraining to Minimize Braking Forces
Condition: Athletic Injuries
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      The proposed research study aims to investigate whether a gait modification training program
      to decrease peak braking forces during the stance phase of running will result in a reduction
      in impact loading and the incidence of running-related injuries among recreational distance
      runners.
    


Intervention name(s): Real-time visual biofeedback during treadmill running
Intervention type(s): Device
Intervention description(s): Real-time biofeedback of braking forces during running
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Running; Biomechanics; Kinetics
Optimal Timing of Cord Clamping in Preterm Pregnancy Following Vaginal or Cesarean Delivery
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This is an experimental research study for pregnant women between 23 and 37 weeks age of
      gestation who will be having a baby sooner than term. This study is to learn if waiting 20,
      40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her
      outcome and overall health. Benefit to the baby may come by increasing the amount of blood in
      the baby's body, reducing the need for possible transfusion later, and possible prevention of
      other complications caused by too little blood in the baby. Possible reduction of cerebral
      palsy may be realized by a longer interval for cord clamping.
    

Detailed description: 
      Intention is to enroll every preterm delivery into this trial containing six groups of
      patients, vaginal or cesarean delivery with clamping of the cord at 20, 40 or 60 seconds.
      Expectation is 1500 deliveries over 2 year period of time. Randomization upon entry to L&D
      unit. Removal from study if resuscitation deemed urgent by newborn staff. Strong effort to
      keep newborn warm using appropriate measures. Evaluation to determine if there are
      differences in transfusion, anemia, time to onset of spontaneous respiration, occurence of
      IVH or CP.
    

Intervention name(s): Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery
Intervention type(s): Other
Intervention description(s): None to add
Other intervention name(s): Clamping of umbilical cord following either preterm vaginal or cesarean delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Timing of Umbilical Cord clamping; Cord Clamp 20 seconds; Cord Clamp 40 seconds; Cord Clamp 60 seconds
Efficiency of the King Vision Video Laryngoscope
Condition: Respiratory Failure; Intubation
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      The investigators studied the efficiency of Macintosh laryngoscope and the King Vision video
      laryngoscope in adult patients scheduled for general anesthesia. Best Cormack-Lehane score
      obtained, glottic view time, intubation time, time to ventilation, correlation between the
      Mallampati classification and the Cormack-Lehane grades, and complications related to
      laryngoscopy and intubation has been investigated.
    

Detailed description: 
      Securing the airway is essential in general anesthesia. Anesthetic problems related to airway
      management constitute 17% of closed claims, difficult intubation being the most common one
      with an occurrence rate of 5%. Problems like delayed intubation, misplaced tracheal tube, or
      airway trauma are frequently seen in outpatient settings and end up with either death or
      hypoxic brain damage. Therefore, preoperative visit should include detailed assessment of the
      airways according to clues of difficult intubation.Several studies compared the King Vision
      video laryngoscope with other laryngoscopes in manikins simulating difficult airway
      scenarios, and reported better glottic views. The investigators aimed to study the
      correlation between the Mallampati classification and the glottic views (Cormack-Lehane
      grade) obtained with Macintosh laryngoscopy, and the King Vision video laryngoscopy in adult
      patients scheduled for general anesthesia. Secondary outcomes will be successful intubation
      rate, time to obtain the best view, time to successful intubation, and complications related
      to laryngoscopy will be compared.
    

Intervention name(s): Macintosh laryngoscope; King Vision video laryngoscope
Intervention type(s): Device; Device
Intervention description(s): Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.; Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients scheduled for general anesthesia with endotracheal intubation will be randomized to either intubation with Macintosh laryngoscope first or King Vision videolaryngoscope first. All patients will be intubated with both laryngoscopes.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study
Condition: Ulcer; Venous Ulcer; Skin Ulcer; Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Skin Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are
      common in patients older than 65 years and cause a significant morbidity.

      Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix
      of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural
      Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of
      venous stasis and post-erysipelas leg ulcers.
    

Detailed description: 
      Ulcers of the lower extremities, particularly in patients older than 65 years, are common
      among the population. Studies estimate the prevalence of current chronic leg ulcers at
      approximately 1%. The most common cause (approximately 80%) is thought to be chronic venous
      insufficiency disease. Recurrent cellulitis is an additional common cause. The ulcers cause a
      significant morbidity and negative impact on the patients' quality of life. The care of
      chronic vascular ulcers places a significant burden on the patient and the health care
      system. Additionally, these nonhealing ulcers place the patient at much higher risk for lower
      extremity amputation.

      Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix
      of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural
      Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of
      venous stasis and post-erysipelas leg ulcers.
    

Intervention name(s): NMBM; Compression garments
Intervention type(s): Device; Other
Intervention description(s): Daily application of NMBM in addition to compression therapy; Compression garments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic venous leg ulcers; Venous ulcer; Stasis ulcer; Varicose ulcer
KJ-TFC-004 Drug-drug Interaction Study
Condition: Glaucoma; Eye Diseases; Ocular Hypertension
MeSH terms: Eye Diseases; Ocular Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male
      subjects.
    

Detailed description: 
      Clinical trial to evaluate the influence of drug and drug-drug interactions of Brimonidine
      and Dorzolamide co-administration on the pharmacokinetics of Brimonidine and pharmacokinetics
      of Dorzolamide in healthy volunteers
    

Intervention name(s): [A]; [B]; [A]+[B](1); [A]+[B](2)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One eye drop(about 40ul) / Day1 ~ Day8 / BID; One eye drop(about 40ul) / Day1 ~ Day92 / BID; One eye drop(about 40ul) / Day9 ~ Day100 / BID; One eye drop(about 40ul) / Day93 ~ Day100 / BID
Other intervention name(s): Brimonidine , Timolol; Dorzolamide; Brimonidine , Timolol , Dorzolamide; Brimonidine , Timolol , Dorzolamide
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic and Pharmacodynamic Study of Omecamtiv Mecarbil in Healthy Volunteers
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and pharmacodynamics of omecamtiv mecarbil
      infusion in healthy male volunteers.
    


Intervention name(s): placebo; omecamtiv mecarbil; omecamtiv mecarbil; omecamtiv mecarbil; omecamtiv mecarbil; omecamtiv mecarbil; omecamtiv mecarbil; omecamtiv mecarbil; omecamtiv mecarbil; omecamtiv mecarbil; omecamtiv mecarbil
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): I.V. infusion of placebo for 8 hr; I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.005 mg/kg/hr; I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.015 mg/kg/hr; I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.025 mg/kg/hr; I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.0625 mg/kg/hr; I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.125 mg/kg/hr; I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.25 mg/kg/hr; I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.5 mg/kg/hr; I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 1.0 mg/kg/hr; I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.75 mg/kg/hr (dose reduced); I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.625 mg/kg/hr (dose reduced)
Other intervention name(s): CK-1827452, AMG 423; CK-1827452, AMG 423; CK-1827452, AMG 423; CK-1827452, AMG 423; CK-1827452, AMG 423; CK-1827452, AMG 423; CK-1827452, AMG 423; CK-1827452, AMG 423; CK-1827452, AMG 423; CK-1827452, AMG 423
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
Condition: Recurrent Nasopharyngeal Carcinoma; Metastatic Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3,
      Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.

      PURPOSE: This phase II trial is studying how well famitinib works in treating patients with
      recurrent and/or metastatic NPC.
    


Intervention name(s): Famitinib
Intervention type(s): Drug
Intervention description(s): 25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of
      BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to
      assess the tolerability of such regimens in healthy subjects.
    

Detailed description: 
      Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers.
      The study consisted of three 8-day treatment periods separated by washout periods of 10-15
      days. On each of the treatment periods the volunteers received either a daily oral dose of
      BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine
      (Trileptal®) 450 mg bid.
    

Intervention name(s): BIA 2-093; Oxcarbazepine
Intervention type(s): Drug; Drug
Other intervention name(s): ESL, Eslicarbazepine acetate; OXC, Trileptal®
Intervention MeSH terms: Eslicarbazepine acetate; Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Oxcarbazepine; Eslicarbazepine Acetate; BIA 2-093
A Dietary Supplement for Early Cigarette Withdrawal
Condition: Nicotine Dependence, Cigarettes, With Withdrawal
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a dietary supplement (DS) is effective in
      protecting against sad mood during early cigarette withdrawal. This study will also assess
      whether the dietary supplement will be well tolerated during early cigarette withdrawal.
    

Detailed description: 
      100 subjects who smoke at least 20 cigarettes per day will come in on two different days, at
      least one week apart, in a randomized, double blind, within subject, placebo controlled
      design. On each day subjects will refrain from smoking cigarettes for 8 hours. On one day
      subjects will take the active DS (taken in two doses, the evening dose is taken at 22:00 of
      the night before the test day and the morning dose is taken at 8:00 of the test day) and on
      the other day subjects will take placebo (also taken in two doses at the same time points of
      the active DS). Mood symptoms and symptoms of cigarette withdrawal will be compared across
      the two different days. Measures of mood symptom monitoring will include self report on a
      scale of 1 to 10, standardized rater questions about mood, and 6 hours into withdrawal, a
      standardized mood induction will be done with mood assessment. Symptoms of cigarette
      withdrawal will be assessed over the duration of withdrawal with applied standardized rating
      scales by trained raters. For the first 15 - 30 subjects, on each day, a health assessment of
      a physical exam and blood work will be completed at the end of the withdrawal period on both
      test days as well as for the initial assessment appointment.
    

Intervention name(s): Dietary Supplement; Lactose Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The active evening dietary supplement is taken at 22:00. The active morning dietary supplement is taken at 8:00-8:15. The active evening dietary supplement is taken first. The active morning and evening dietary supplements are taken within 12 hours in time points as specified above.; This research study involves a placebo dietary supplement that does not have any of or only partial of the active ingredients in the active dietary supplement. The placebo dietary supplement will be given in identical time points to match that of the active dietary supplements.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cigarette; Withdrawal; Nicotine
An Assessment of Buprenorphine Transdermal Delivery System (BTDS) Patch Adhesion
Condition: Pain
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h.
    

Detailed description: 
      The objective is to show non-inferiority in adhesion of BTDS patch 40 µg/h compared to BTDS
      patch 20 µg/h. Safety and tolerability of both patches will also be assessed.
    

Intervention name(s): BTDS
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteer
Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery
Condition: Hemostasis
Study type: Interventional

Summary: 
      Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic
      transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but
      expensive, and has been proved to link to higher risks of serious side effects including
      renal problems, myocardial events, and strokes in patients undergoing CABG. After the
      secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac
      surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin,
      urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide
      inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic
      effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The
      objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic
      acid in cardiac surgery.
    


Intervention name(s): Ulinastatin; Tranexamic Acid; Saline Solution
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tranexamic Acid; Urinastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ulinastatin; tranexamic acid; cardiac surgery procedures; hemostasis
Translation and Validation of the Turkish Version of the ObsQoR-10 Questionnaire (ObsQoR-10T)
Condition: Quality of Recovery; Delivery
Study type: Observational

Summary: 
      The quality of recovery scoring tools for the obstetric patient population is limited. In
      2019, Ciechanowicz et al. developed and validated a postpartum recovery score; the ObsQoR-11;
      used following elective and non-elective cesarean delivery. The ObsQoR-11 was modified to the
      ObsQoR-10 by Sultan et al. and used spontaneous and operative vaginal delivery based on
      patient feedback. There is currently only a Hebrew version of this recovery score. ObsQoR has
      not yet been validated for use in Turkish, which is one of the most spoken languages in the
      World. Therefore the investigators aimed to psychometrically evaluate (assess validity,
      reliability, and clinical feasibility) the Turkish translated version of the ObsQoR-10 PROM
      in a Turkish cohort of women.
    


Intervention name(s): ObsQoR-10T Questionnaire
Intervention type(s): Other
Intervention description(s): The ObsQoR-10T questionnaire consists of 10 items assessing physical comfort and pain, physical independence, and emotional status. Each item is scored from 0 to 10 and the total score is the sum of the score for each item, which is a score from 0 to 110.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients admitted for spontaneous obstetrical labor or scheduled cesarean section.
      
Keywords: ObsQoR-10T Questionnaire
Examining the Effect of Ondansetron on Bowel Prep Success
Condition: Abdominal Pain; Inflammatory Bowel Diseases; Eosinophilic Gastroenteritis; Diarrhea; Hematochezia; Weight Loss
MeSH terms: Inflammatory Bowel Diseases; Gastroenteritis; Eosinophilic Esophagitis; Gastrointestinal Hemorrhage; Weight Loss; Diarrhea; Abdominal Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot randomized-controlled trial assessing the utility of ondansetron for
      improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation
      score, as well as assessing the impact on patient experience of bowel preparation.
    

Detailed description: 
      The study will compare two approaches to pre-colonoscopy cleanout, one with traditional
      laxatives only, and one with laxatives + anti-emetic therapy. The medication to be added will
      be Ondansetron (brand name: Zofran). Classically, the bowel prep entails drinking large
      amounts of water with an osmotic laxative and being only on a liquid diet the day prior to
      the procedure. Drinking this mixture of water with an osmotic laxative may cause nausea and
      discomfort in some patients that may prevent them from finishing the bowel prep. This will
      therefore affect the visualization of the colon during the procedure, as there will still be
      retained, hard stool. Having large amounts of stool in the colon during the procedure can
      make the colonoscopy more difficult, takes a longer time to complete, can make the study
      inconclusive, unable to properly diagnose, and difficult to take biopsies. This study
      assesses the impact of anti-emetic medication (ondansetron) on the bowel prep experience with
      the goal of improving participant tolerance and preparation success. This will eliminate
      concern for retained stool and less chance of cancelling a procedure due to improper bowel
      prep.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption.
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: non-blinded randomized control trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: colonoscopy; bowel preparation; ondansetron