bioihbjkbjnl/mcl2 huggingface dataset:
Mild Hypothermia in Acute Ischemic Stroke
Condition: Brain Ischemia
MeSH terms: Ischemic Stroke; Brain Ischemia; Ischemia; Hypothermia
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: Mild hypothermia using non-invasive temperature management system in a stroke
      unit is safe and feasible in spontaneously breathing, alteplase-thrombolyzed patients with
      acute ischemic stroke.
    

Detailed description: 
      Fever is associated with higher stroke mortality and poor outcome, but it is yet unknown
      whether this association is causative or epiphenomenal.

      In temporary brain ischemia rodent models hypothermia results in a significant increase in
      the number of surviving neurons and smaller infarction size as measured with histological
      examination after death.

      Therapeutic effect has been shown in clinical trials in comatose cardiac arrest patients and
      newborn infants with perinatal hypoxic-ischemic brain injury.

      Design: A prospective, open, randomized single-center study.

      Study population: 36 patients, 18-85 years of age presenting with symptoms of acute ischemic
      hemispheric stroke with persisting significant neurological deficit (NIHSS 7-20 or NIHSS 2
      for dysphasia or NIHSS 3 for paralysis of upper or lower limb) at 2 hours after thrombolysis.

      Method: Patients are randomized to hypothermia- or control-group via randomization envelopes.
      Patients assigned to receive hypothermia are cooled to a core temperature of 35°C for 12
      hours by means of a non-invasive temperature management system and cold i.v. fluids.
      Induction of hypothermia is initiated within 6 hours of symptom onset. After 12 hours of
      successful cooling the target temperature is gradually raised to achieve slow re-warming of
      0.2°C/h until the core temperature reaches 36.8°C.

      Patients are breathing spontaneously and shivering is controlled with following medication;
      dexmedetomidine 0.2-0.7 µg/kg/h (i.v.), buspirone 5-20 mg x 3 (nasogastric tube), and
      meperidine 25mg (i.v.) when needed.

      Core temperature, blood pressure (BP), oxygen saturation, ECG and EEG are measured
      continuously and registered hourly. Blood tests will be taken before, during and after
      hypothermia. Brain CT will be controlled when normothermia is reached, no later than 30 hours
      from symptom onset. Brain MRI will be performed 3-7 days from symptom onset.
    

Intervention name(s): Hypothermia
Intervention type(s): Device
Intervention description(s): Hypothermia to core temperature of 35C for 12 hours, rewarming rate 0.2C until the patient reaches 36.8C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Acute; Infarction; Ischemic; Thrombolysis; Mild; Hypothermia
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Condition: Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen
      formulation to placebo and acetaminophen in the treatment of post-surgical dental pain
      following "wisdom" tooth (third molar) removal.
    


Intervention name(s): Novel Ibuprofen; Acetaminophen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single-dose of novel ibuprofen (equal to 400 mg ibuprofen); Single-dose of acetaminophen (1000mg); Single-dose of placebo
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain following third molar extraction (wisdom tooth)
Pediatric Nursing Students' Self-efficacy Regarding Pediatric Medication Administration and, Clinical Comfort and Worry: A Study on a Two-group Pre-post-test Design Comparing Nurse and Peer Mentoring
Condition: Medication Administration; Mentoring; Comfort
Study type: Interventional

Summary: 
      Children are a particularly vulnerable population to medication mistakes, and it is critical
      to improve the self-efficacy, clinical comfort, and worry levels of student nurses who will
      care with them. As a result, the purpose of this study was to investigate the effects of
      postgraduate nursing students' and clinical nurses' mentoring practice on pediatric nursing
      students' self-efficacy in pediatric medication administration, clinical comfort, and worry
      levels. The nurse mentoring group finished the study with 70 students, while the peer
      mentoring group (postgraduate nursing students) completed the study with 73 students, for a
      total of 143 students. For data collection, the "Participant Information Form," the
      "Medication Administration Self-Efficacy Scale in Children for Nursing Students," and the
      "Pediatric Nursing Students Clinical Comfort and Worry Tool" were utilized. The data is still
      being analyzed.
    


Intervention name(s): Peer mentoring; Nurse mentoring
Intervention type(s): Other; Other
Intervention description(s): Mentoring is a support network in which a more talented or experienced individual serves as a role model for a less talented individual in order to encourage professional and personal growth. Mentoring improves students' learning, abilities, and self-efficacy while decreasing stress and anxiety in nursing students through more effective communication, collaborative learning, and critical thinking.
After understanding about the study, two master's degree students from Karabük University Institute of Graduate Studies of Child Health and Diseases Nursing consented to participate on a volunteer basis and became peer mentors in the study. All postgraduate students are pediatric nurses with at least two years of clinical experience who have completed their undergraduate nursing program.; Mentoring is a support network in which a more talented or experienced individual serves as a role model for a less talented individual in order to encourage professional and personal growth. Mentoring improves students' learning, abilities, and self-efficacy while decreasing stress and anxiety in nursing students through more effective communication, collaborative learning, and critical thinking.
After providing information about the research to bachelor's degree nurses who have worked in the Children's Units of Karabuk Training and Research Hospital for at least two years, two mentors for the nurse mentoring group were chosen on a volunteer basis. Mentors were taught on the concept of mentoring, the roles of the mentor, interpersonal relationships, and communication skills prior to the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: medication administration; mentoring; nursing students
Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
Condition: Isthmic Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Observational

Summary: 
      The aim of this study is to compare outcomes and cost-effectiveness of anterior versus
      posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is
      to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry
      Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related
      adverse events. Secondary objectives are to compare treatments in terms of differences in
      pain, quality of life, health utilities, and need for re-operation. Finally, a
      cost-effectiveness analysis will be performed. This analysis will take the form of
      cost-effectiveness if there is a difference in treatment effects or cost-minimization if
      there is no difference in treatment efficacy.
    


Intervention name(s): Anterior Lumbar Interbody Fusion (ALIF); Posterior Fusion
Intervention type(s): Procedure; Procedure
Intervention description(s): Posterolateral Fusion (PLF)
Posterior Lumbar Interbody Fusion (PLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Isthmic spondylolisthesis (IS)
Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with
      insomnia.
    


Intervention name(s): MK0928, gaboxadol / Duration of Treatment - 1 year; Comparator: placebo / Duration of Treatment -1 year
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gaboxadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers
Condition: Effect of Food
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and
      determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to
      WCK 771 800 mg (intravenous, QD dose).

      This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK
      2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771,
      IV to WCK 2349, oral) in future clinical trials in patients.
    

Detailed description: 
      All the subjects will be checked-in into the clinical study facility on Day -1, the day prior
      to dosing. The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose
      in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The
      subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered
      WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study. There
      will be a washout period of three days between each period. The subjects will continue to
      remain in the clinical facility for the entire duration of the study (completion of three
      periods in the study), including wash out period. Prior to check out procedure, detailed
      clinical examination will be done to confirm that subject has no safety issues.
    

Intervention name(s): Oral WCK2349; IV WCK771
Intervention type(s): Drug; Drug
Intervention description(s): The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.; The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.
Intervention MeSH terms: Levonadifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: healthy volunteers
Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium
Condition: Thin Endometrium
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigation is devoted to the study of the effect of the introduction of autologous
      platelet-rich plasma (PRP) on the thickness of the endometrium. It was found that the
      injection of PRP and endometrial cells resuspended in PRP into the endometrium of patients
      with thin endometrium leads to an increase in the proliferation of endometrial cells, and as
      a result, to an increase in its thickness.
    

Detailed description: 
      The study enrolled 115 patients with thin endometrium (<7 mm at implantation window) and
      infertility. The cohort was divided into groups based on the treatment regimen.

      Group 1 (the control, n=30) underwent conservative therapy. Group 2 (n=42) received
      intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3
      (n=38) received identical injections after conservative therapy. Group 4 (n=5) received
      injections of the minimally manipulated autologous endometrial cells suspended in autologous
      PRP.

      Injections of PRP and endometrial cells suspended in autologous PRP into basal layer of
      endometrium facilitate the reconstitution by enhancing cell proliferation and angiogenesis.
    

Intervention name(s): Conservative therapy; PRP injection; Injection of PRP after conservative therapy; Injection of PRP with endometrial cells
Intervention type(s): Procedure; Biological; Biological; Biological
Intervention description(s): Conservative therapy to which the patients were subjected was the effect of an electrical impulse; This intervention consisted of injecting platelet-rich plasma (PRP) into the endometrium; This intervention consisted of conducting conservative therapy with an electrical impulse and then injecting PRP inside the endometrium; This intervention consisted of injecting endometrial cells suspended in prp
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients were divided into 4 groups depending on the substances introduced into the basal layer of the endometrium. Group 1 underwent conservative therapy. Group 2 received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 received identical injections after conservative therapy. Group 4 received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: platelet-rich plasma; infertility; endometrial cells
Clinical Performance of Two Cad-cam Fabricated Ceramic Restoration in Teeth Affected With MIH
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

Summary: 
      This study will be performed to evaluate the clinical performance (Plaque accumulation,
      fracture of (restoration or tooth), postoperative sensitivity, secondary caries, marginal fit
      and discoloration) of two CAD/CAM fabricated ceramic restorations (zirconia-reinforced
      lithium silicate glass ceramic and hybrid ceramic) with different preparation designs
      (modified occlusal veneer and endocrown) for rehabilitation of permanent first molars
      affected with different severity level of molar incisor hypomineralisation (MIH), evaluated
      at different time periods
    

Detailed description: 
      Clinical evaluation of all restorations will be performed according to:

      - Modified United States Public Health Service (USPHS) Ryge Criteria, at base line (1 week),
      3, 6 and 12 months after cementation.
    

Intervention name(s): occlusal veneer restorations; endocrown restorations
Intervention type(s): Procedure; Procedure
Intervention description(s): occlusal veneer preparation with circumferential chamfer finish line and proximal slot " proposed modified occlusal veneer design" for rehabilitation of moderate level of permanent first molars. OrPatients will receive endocrown restorations for rehabilitation of sever level of permanent first molars; endocrown restorations
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial (RCT)
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Circadian Rhythm of Urine Output in Healthy Infants
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to describe the 24-hour urine output including the urinary
      excretion of hormones, electrolytes and other osmotically active substances in healthy
      children age 0 to 3 years old.
    

Detailed description: 
      The purpose of this study is to describe the 24-hour urine output including the urinary
      excretion of hormones, electrolytes and other osmotically active substances in healthy
      children age 0 to 3 years old.
    

Time perspective: Prospective
Keywords: urine; circadian rhythm
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with
      atopic dermatitis
    


Intervention name(s): Placebo; Tralokinumab Dose 1; Tralokinumab Dose 2; Tralokinumab Dose 3
Intervention type(s): Other; Biological; Biological; Biological
Intervention description(s): Subcutaneous injection with placebo; Subcutaneous injection with tralokinumab; Subcutaneous injection with tralokinumab; Subcutaneous injection with tralokinumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long-term Safety of PF-00345439 (Oxycodone)
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low
      Back Pain Or Osteoarthritis
    

Detailed description: 
      This study will evaluate: (a) the long-term safety of PTI-821 during a 12-month period; and
      (b) the long-term efficacy of PTI-821 by assessing pain intensity (PI), the quality of
      analgesia, and the global assessment of study medication.
    

Intervention name(s): PF-00345439
Intervention type(s): Drug
Intervention description(s): 5-80 mg twice-a-day for 12 months
Other intervention name(s): PTI-821, Remoxy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; PF-00345439; Remoxy; PTI-821
GS3-007a Oral Solution in Healthy Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral
      administration after high-fat meals in Chinese healthy adults.
    

Detailed description: 
      This is a first-in-human, The major aims of the study are to define the safety profile of
      this new drug, and to determine a recommended
    

Intervention name(s): GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication
Intervention type(s): Drug
Intervention description(s): The dosage was calculated according to body weight and dose group once a day according to the assigned group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and pharmacokinetic effects of indacaterol in
      subjects with impaired liver function in comparison with healthy subjects
    


Intervention name(s): QAB149
Intervention type(s): Drug
Other intervention name(s): indacaterol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety study, pharmacokinetic effects, healthy subjects, hepatic impairment, liver; Subjects with mild and moderate hepatic impairment and healthy subjects
Effects of US-guided SAPB During Breast Surgery
Condition: Hemodynamic Instability; Opioid Use; Block; Breast Cancer
Study type: Interventional

Summary: 
      The serratus anterior plan (SAP) block is a technique that has recently gained popularity in
      the context of breast surgery. SAP block resulted in better hemodynamic stability, early
      ambulation and shorter hospital stay, as well as hospital costs for postoperative breast
      patients.

      We aimed to investigate the effects of the serratus anterior plane block in women undergoing
      breast surgery, in the intraoperative period.
    


Intervention name(s): Serratus anterior plane block
Intervention type(s): Procedure
Intervention description(s): local anesthetic application between serratus anterior muscle and 5th rib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: hemodynamics; serratus anterior plane block; opioid consumption; breast surgery
Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing
      Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One
      quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g
      of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter
      will receive a placebo daily.
    


Intervention name(s): Litesse powder containing 12 g polydextrose; Litesse powder containing 8 g polydextrose; Litesse powder containing 4 g polydextrose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 12 g polydextrose; 8 g polydextrose, 4 g maltodextrin; 4 g polydextrose, 8 g maltodextrin; 12 g Maltodextrin
Other intervention name(s): Litesse powder; Litesse powder; Litesse powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Constipation; Polydextrose; Dietary Fiber; PAC-QoL; Colonic Transit Time; PAC-SYM