bioihbjkbjnl/mcl2 huggingface dataset:
Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To find alternatives to caudal analgesia that could be more safe and effective and to
      demonstrate the analgesic efficacy of topical ketamine.
    

Detailed description: 
      The most commonly performed inguinal surgeries in children include inguinal hernia repair
      with or without orchidopexy (orchiopexy). Eighty children aged 6 months to 6 yr of ASA
      physical status I or II, undergoing elective unilateral inguinal herniotomy will be included.
      In caudal group, patients will receive a mixture of 0.5 mg/ kg ketamine in 1 ml/kg
      bupivacaine 0.25% (maximum volume = 20 ml) by caudal route after anesthesia and before start
      of surgery. In topical group, at the end of the procedure, after identification and ligation
      of the hernial sac, a mixture of 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% will be
      sprayed around the spermatic cord and upon the ilioinguinal nerve in a fan shaped manner by
      the surgeon. The primary outcome measure will be the time to first request for analgesia.
      Secondary outcome measures will include the number of analgesic doses required in the first
      24 h postoperative, pain scores, sensory and motor block, agitation scores, parent
      satisfaction and adverse effects in the first 48h postoperative.
    

Intervention name(s): Ketamine; Ketamine; Bupivacaine; Bupivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.; 0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.; 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route; 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure
Other intervention name(s): Katalar; Katalar; bucaine; bucaine
Intervention MeSH terms: Ketamine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anesthesia; analgesia; caudal; ketamine; bupivacaine
Antibiotic Prophylaxis in Gynecologic Laparoscopy
Condition: Infection Secondary to Surgical Procedure
MeSH terms: Infections
Study type: Interventional

Summary: 
      Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents
      numerous advantages over laparotomy, among them lower rates of surgical site infection and
      less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted
      and performed by most gynecologists. However, there isn't literature evidence to support the
      routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic
      surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis
      in gynecological laparoscopies not including opening hollow viscera.
    

Detailed description: 
      It is a clinical, prospective, double-blind, randomized study. 114 women with gynecologic
      disease, in which there is indication of laparoscopic surgical approach, will be
      consecutively select. These women will be allocated in two arms, control and study, where
      control group will use placebo and study will receive intravenous cephazolin. These patients
      will be followed for 30 days according to Centers for Disease Control and Prevention
      criteria.
    

Intervention name(s): gynecologic laparoscopy; Cefazolin; Placebo
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Gynecological laparoscopy without opening hollow viscera.; Intravenous administration of 1 g of cefazolin; Intravenous administration of saline sterile solution
Other intervention name(s): pelvic laparoscopy; gynecologic laparoscopic surgery; Cephazolin; Cefazoline; Cephazolin Sodium for Injection; Kefzol; placebo treatment
Intervention MeSH terms: Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: laparoscopy; surgical wound infection; antibiotic prophylaxis; gynecologic surgical procedures
Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
Condition: Altitude Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a research study on Altitude Illness. From the information collected and studied in
      this project we hope to learn more about Altitude Illness, including factors that may affect
      and prevent the development and progression of this condition. We hope to learn if the
      commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude
      illness. Possible participants in this study are healthy adults who indicated they would like
      to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford
      University researchers hope to enroll about 100 participants.
    

Detailed description: 
      This study was designed to bring together elements of prior studies and go one step further
      for definitive data on several points. The trial will employ two pharmaceutical intervention
      arms, which will compare placebo (the standard of care - information on prevention of
      altitude sickness) with the widely used NSAID ibuprofen. We will also determine Optic Nerve
      Sheath Diameter (ONSD) measurements via ultrasound in both the control and interventional
      arms. We will accomplish these objectives with a prospective, double blinded view of a large
      population of hikers who are ascending at their own rate in a true hiking environment: The
      White Mountain Research Station Owen Valley Lab (OVL) and Bancroft Station (BAR).

      Primary hypothesis: Ibuprofen 600 mg TID will be superior to placebo in decreasing both the
      incidence and severity of AMS in high altitude travel.
    

Intervention name(s): Ibuprofen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total); identical number of visually identical tasteless pills as ibuprofen arm
Other intervention name(s): motrin
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety Study of SPC3649 in Healthy Men
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy
      men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.
    


Intervention name(s): SPC3649
Intervention type(s): Drug
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: antisense; microRna antagonist; anti-miR-122; Safety in healthy volunteers; Hepatitis C
Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension
Condition: Pulmonary Artery Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional

Summary: 
      This study investigated the effect of 12 weeks of aerobic training on sleep quality and
      aerobic fitness in patients with Pulmonary arterial hypertension(PAH).
    

Detailed description: 
      Thirty male PAH patients were included in the study. They were randomized into two equal
      groups; Training group (A) and Control group(B). Right ventricular systolic pressure (RVSP)
      measured using Doppler Echocardiography , Pittsburg sleep quality index (PSQI) questionnaire
      with the wrist worn actigraph used for the assessment of sleep disturbance, and
      Cardiopulmonary exercise testing (CPET) measurements included maximal heart rate and VO2max
      .All were measured before and after the study period for both groups.The training was a
      moderate intensity aerobic training on a bicycle ergometer (corresponding to 60% to 70% of
      the maximal heart rate they reach during peak oxygen uptake in the initial exercise test) for
      30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions).
    

Intervention name(s): Moderate intensity aerobic training
Intervention type(s): Other
Intervention description(s): The exercise program consisted of 5 minutes warm-up, 15-30 minutes of moderate aerobic exercises and 10 minutes cool-down, respectively.
Frequency: 3 sessions/week , and Duration:12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Strong Men, Strong Communities Diabetes Risk Reduction in American Indian Men
Condition: Diabetes
Study type: Interventional

Summary: 
      SMSC will inform the design and implementation of culturally informed, community-based
      lifestyle interventions for diabetes prevention in AI men in our partner communities and
      elsewhere, as well as in men of other minority groups who experience a heavy burden of
      diabetes.
    

Detailed description: 
      American Indian (AI) males experience profound health disparities compared to their
      counterparts in all other U.S. racial and ethnic groups. AI men have the highest age-adjusted
      prevalence of type 2 diabetes (~18%) among U.S. men, while non-Hispanic White men have the
      lowest (~7%). In recent decades, AIs have seen a disproportionate increase in
      diabetes-related complications and mortality compared to all other groups, such that
      age-adjusted diabetes death rates in AI men are now almost twice those in White men.

      Several large randomized, con trolled trials in non-AIs confirm that type 2 diabetes can be
      prevented or delayed by interventions that promote healthy lifestyles, but little empirical
      data exist on interventions to prevent diabetes in AI men. In the clinic-based U.S. Diabetes
      Prevention Program (DPP), only 55 out of 3,234 participants were AI men. Similarly, in the
      diabetes prevention programs in Native communities, participation by AI males is low, ranging
      from 33% to 74%. Many explanations have been posited for the low participation rates among
      men of all races in lifestyle interventions. Recruiting AI men in clinic-based programs is
      difficult because they tend to seek clinical care less often than women. AI men's perceptions
      of normative health behaviors and gender roles may also discourage participation,
      particularly in mixed-gender groups. Therefore, an urgent need exists for diabetes risk
      reduction programs tailored to the unique values and habits of AI men, with a particular
      focus on recruitment and retention
    

Intervention name(s): Diabetes Prevention Program
Intervention type(s): Behavioral
Intervention description(s): An adapted version of the Diabetes Prevention Program will be delivered to intervention participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Block randomized
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
ADME Study in Healthy Male Subjects With TA-8995
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to measure the absorption, metabolism and excretion of a single dose of radiolabelled
      TA-8995 (10mg) in healthy male subjects.
    


Intervention name(s): TA-8995
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation
Condition: Atrial Fibrillation; Stroke; Transient Ischemic Attack; Bleeding; Aortic Stenosis
MeSH terms: Stroke; Ischemic Attack, Transient; Atrial Fibrillation; Aortic Valve Stenosis; Hemorrhage
Study type: Observational

Summary: 
      The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and
      major bleeding events in patients undergoing aortic valve replacement. This retrospective
      multicenter registry will include 850 patients with aortic valve replacement using
      bioprosthesis.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All-comers design of patients undergoing aortic valve bioprosthesis implantation
mFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer
Condition: Apatinib
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal
      cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these
      patients were randomly divided into two groups, one group will accept adjuvant chemotherapy
      of mFOLFOX6; another group will use mFOLFOX6 combined with apatinib. The efficacy and safety
      of adjuvant chemotherapy will be compared between the two groups. Disease-free survival,
      overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of
      life will be recorded.
    


Intervention name(s): Apatinib; Oxaliplatin; 5-fluorouracil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Apatinib tablet; Oxaliplatin Intravenous; 5-fluorouracil Intravenous
Other intervention name(s): YN968D1; Eloxatin; Adrucil, Carac, Efudex, Efudix
Intervention MeSH terms: Fluorouracil; Oxaliplatin; Apatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has one Intervention Type of Drug.
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      In 2007 the Expert Committee published recommendations on the prevention and treatment of
      childhood obesity. These recommendations outlined four interventions intended for advancement
      based on the child's age, body mass index (BMI), and response to treatment. The initial
      stage, Prevention Plus, is to be implemented in the primary care setting and focuses on
      primary care providers monitoring growth monthly and delivering intervention messages that
      target dietary and leisure-time behaviors that most contribute to energy imbalance in
      children. Little research has evaluated the efficacy of these recommendations. Thus the
      primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus
      stage for treating childhood overweight and obesity in a primary care setting. As the cost of
      interventions is a large barrier to the translation of evidence-based research into primary
      care settings, a second goal of the project is to evaluate program cost-effectiveness.
    


Intervention name(s): growth monitoring; Growth Monitoring plus Family-based Behavioral Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Caretakers will be encouraged to monitor child growth monthly.; Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment of childhood obesity
Trajectory of Recovery in the Elderly
Condition: Delayed Emergence From Anesthesia; Postoperative Delirium; Postoperative Cognitive Dysfunction
MeSH terms: Delirium; Emergence Delirium; Postoperative Cognitive Complications; Delayed Emergence from Anesthesia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to understand how elderly individuals regain their cognitive
      skills following general anesthesia. The investigators will compare an age stratified group
      of volunteers who will be evaluated with a series of cognitive tests and a functional MRI.
      The participants will then be administered general anesthesia for two hours. The
      investigators will then assess the participants using state of the art tools to determine
      when participants return to their cognitive baseline.
    

Detailed description: 
      Elderly patients undergoing anesthesia and surgery frequently suffer from postoperative
      cognitive dysfunction (POCD) and postoperative delirium (PD). The cause of these entities is
      unknown. It is unclear what part anesthetics play in the development of POCD and PD. The
      investigators hypothesize that elderly patient's cognitive capacities recover more slowly
      after receiving general anesthesia, perhaps because they have more limited cognitive reserve.
      A more prolonged recovery would confound diagnoses of POCD and PD and potentially puts
      patients who are discharged on the day of surgery at risk of not understanding postoperative
      instructions. The trajectory of postoperative cognitive recovery has never been explored and
      elderly participants have been explicitly not included in any type of emergence research. To
      explore this vital area the investigators propose to study young and elderly volunteers with
      a combination of two state of the art neuropsychological tests (Postoperative Quality of
      Recovery Scale and the NIH Toolbox) and functional magnetic resonance imaging. Starting from
      baseline, the investigators will determine multiple cognitive domains and resting state
      networks, treat the participants with general anesthesia for two hours while continuing to
      examine network activity, and then explore the recovery of the cognitive domains and
      alterations in functional networks using both the PQRS and the NIH Toolbox Cognitive
      Measures. Participants will be evaluated at 1 month, 6 months, and 12 months.
    

Intervention name(s): Functional magnetic resonance imaging
Intervention type(s): Procedure
Intervention description(s): Diffusion tensor imaging
Other intervention name(s): fMRI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: General Anesthesia, Postoperative Delirium, Recovery
A Study To Assess Single Dosage Strength Of GW685698/GW642444 Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of a single dosage strength of
      GW685698/GW642444 in subjects with Chronic Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): GW685698/GW642444
Intervention type(s): Drug
Intervention description(s): GW685698/GW642444
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; Novel Dry Powder Inhaler; Chronic Obstructive Pulmonary Disease (COPD); GW685698/GW642444
Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Condition: Acute, Perforated Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for
      decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis.
      Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal
      irrigation.
    

Detailed description: 
      Postoperative intra-abdominal abscesses are common occurrences after perforated appendicitis
      in pediatric patients despite utilization of evidence-based practices. Povidone-iodine is a
      commonly used antiseptic in surgical procedures and has been shown to be effective in
      reducing postoperative abscesses in adults with perforated appendicitis. This trial will be
      the first to rigorously test the efficacy of povidone-iodine irrigation in children and to
      verify its safety profile in this patient population.
    

Intervention name(s): Povidone-iodine irrigation; No irrigation
Intervention type(s): Drug; Procedure
Intervention description(s): Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.
1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister.; Patients allocated to the control group will not undergo intra-abdominal irrigation.
Intervention MeSH terms: Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Povidone-iodine irrigation