louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03009955: Comparison of Postoperative Pain Between Patients Received Primary and Repeated Caesarean Section
Official title: Comparison of Postoperative Pain Between Patients Received Primary and Repeated Caesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caesarean Section
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 168
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who receiving primary and repeated caesarean section.

Brief summary: To everyone knows, more and more patients received repeated caesarean section in China. However, at present it is not known what is it like about their postoperative pain intensity, and is it different from those patients who received primary caesarean section. Thus through postoperative follow-up, the current study aimed to investigate and compare the postoperative pain between patients received primary and repeated caesarean section.

Detailed description: According to whether or not to receive repeated caesarean patients were grouped into group P or group R. For all maternal,standardized epidural anesthesia and caesarean section were performed. Then the pain VAS scores and Ramsay scores at 4h, 8h, 12h, 24h and 48h after the surgery were recorded. And sleep quality at 1 day and 2 day after the surgery were recorded. In addition, pain situation at 1 week and 4 weeks after the surgery was followed up.

Eligibility criteria: Inclusion Criteria:

* single birth
* full-term pregnancy
* in accordance with cesarean section indications
* transverse incision of lower uterine segment

Exclusion Criteria:

* history of dementia, psychiatric illness or any diseases of central nervous system
* accompanying liver or kidney function deficiency
* alcoholism and drug dependence
* patients previously included in this study or currently included in the other clinical study
* patients who have second surgery during the study period
* difficult to follow up or patients with poor compliance
* history of chronic pain

Primary outcomes:
measure: Pain VAS at 4, 8, 12, 24 and 48 hours after the surgery
timeFrame: At 4, 8, 12, 24 and 48 hours after the surgery
Secondary outcomes:
measure: Pain intensity at 3 to 7 days after the surgery
timeFrame: At 3 to 7 days after the surgery
measure: Pain intensity at 4 weeks after the surgery
timeFrame: At 4 weeks after the surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Xinqiao Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
name: Hong Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duan G, Yang G, Peng J, Duan Z, Li J, Tang X, Li H. Comparison of postoperative pain between patients who underwent primary and repeated cesarean section: a prospective cohort study. BMC Anesthesiol. 2019 Oct 22;19(1):189. doi: 10.1186/s12871-019-0865-9.
Clinical trial NCT01764555: Pharmacokinetics of Acetaminophen in Morbidly Obese Patients
Official title: Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Morbid Obesity
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients versus normal weight patients. Specifically the different metabolic pathways of acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1 (cytochrome P450 2E1) oxidation


Eligibility criteria: Inclusion criteria for morbidly obese patients:

* BMI \> 40 kg/m2 undergoing bariatric surgery.
* Patients between 18 - 60 years old
* ASA physical classification of II or III
* All racial and ethnic groups will be included

Inclusion criteria for control group:

* BMI between 18 and 25 kg/m2 undergoing general surgery
* Patients between 18 - 60 years old
* ASA (American Society of Anesthesiology) physical classification of I, II or III
* All racial and ethnic groups will be included

Exclusion criteria for all study arms:

* Renal insufficiency
* Liver disease
* Patients with Gilbert-Meulengracht syndrome
* Chronic alcohol intake or use of alcohol within last 72 hours
* Pregnancy or breastfeeding
* Patients who are treated with drugs know to affect CYP2E1 and UGT (UDP glucuronosyltransferase)
* Diabetes mellitus type II patients
* Smoking
* Acetaminophen intake before the study (24 hours before study)

Primary outcomes:
measure: Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients.
timeFrame: 24 hours
measure: Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.
timeFrame: 24 hours
Secondary outcomes:
measure: Difference in clearance (total, glucuronidation, sulphation, CYP2E1 oxidation) of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery.
timeFrame: 8 hours
measure: Difference in volume of distribution of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery.
timeFrame: 8 hours
measure: Liver function tests in morbidly obese patients in comparison with normal weight patients.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: St. Antonius Hospital
name: Catherijne Knibbe, Prof dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03214055: Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robotic Prostatectomy
Official title: Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 39
Sex: MALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate cancer patients who undergo Robot-assisted laparoscopic radical prostatectomy.

Brief summary: We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial pressure before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position.

Detailed description: Mannitol has been frequently used for renal protection during surgery. Optic nerve sheath diameter is used to evaluate intracranial pressure noninvasively. Robot-assisted laparoscopic radical prostatectomy can induce an increase in optic nerve sheath diameter due to Trendelenburg position and carbon dioxide insufflation. We therefore aim to evaluate the change in optic nerve sheath diameters before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy.

Eligibility criteria: Inclusion Criteria:

* prostate cancer patients undergoing robot assisted laparoscopic radical prostatectomy.
* 20 year old or above, 79 year old or below.
* agreed to participate this study.

Exclusion Criteria:

* history of cerebrovascular accident.
* history of congestive heart failure.
* history of pulmonary edema.
* history of anaphylaxis to mannitol.
* conversion to open prostatectomy.
* combined with other operation.
* inability to measure optic nerve sheath diameter.

Primary outcomes:
measure: Change in optic nerve sheath diameters
timeFrame: 5 minutes after pneumoperitoneum and Trendelenburg position, 90 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Secondary outcomes:
measure: Change in optic nerve sheath diameters
timeFrame: 5 minutes after pneumoperitoneum and Trendelenburg position, 60 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
measure: Change in optic nerve sheath diameters
timeFrame: 5 minutes after pneumoperitoneum and Trendelenburg position, 30 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
measure: Optic nerve sheath diameter
timeFrame: 10 minutes after induction of anesthesia
measure: Optic nerve sheath diameter
timeFrame: Intraoperative (during skin closure)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical center
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832455: Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)
Official title: A 12 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Montelukast Sodium (Singulair®), 4 or 5 mg/Day in Pediatric Subjects With Uncontrolled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 445
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids


Eligibility criteria: Inclusion Criteria:

* Patient Is Diagnosed With Asthma For At Least 6 Months
* Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10)
* Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage
* Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To Non-Adherence With Current Therapy Through The Preceding 6 Weeks

Exclusion Criteria:

* As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol (Serevent)) Or A Combination Product (Advair Or Symbicort)
* Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy

Primary outcomes:
measure: Asthma Control Questionnaire (ACQ)
timeFrame: Week 0, 4, and 12
Secondary outcomes:
measure: Asthma Control Questionnaire (ACQ)
timeFrame: Week 0, 4, and 12
Other outcomes:
measure: Physician Global Satisfaction
timeFrame: week 0, 4, 8 and 12
measure: Patient Global Satisfaction
timeFrame: Week 0, 4, 8 and 12
measure: Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
timeFrame: Weeks 4, 8, and 12
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Berube D, Djandji M, Sampalis JS, Becker A. Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study. Allergy Asthma Clin Immunol. 2014 May 6;10(1):21. doi: 10.1186/1710-1492-10-21. eCollection 2014.
Clinical trial NCT06397755: Observational Study of Patients Who Underwent Diagnostic Investigation (Prostate Biopsy) and/or Radical Prostatectomy Surgery.
Official title: Observational Study of Patients Who Underwent Diagnostic Investigation (Prostate Biopsy) and/or Radical Prostatectomy Surgery.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 20000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the urology department who need undergo prostate biopsy and/or radical prostatectomy surgery

Brief summary: This is a single-center, observational, prospective and retrospective study on quality of life and disease status of patients who underwent prostate biopsy and/or radical prostatectomy.

Detailed description: A database was created with the intention of collecting data related to patients who underwent prostate biopsy and/or radical prostatectomy.

Only anamnesis and biopsy procedure data are collected for patients underwent prostate biopsy.

Anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy.

Each patient will be followed for 50 years from the date of radical prostatectomy surgery.

Each patient will receive a questionnaire before radical prostatectomy. A follow up questionnaire will be collected after surgery relating to quality of life. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.

Eligibility criteria: Inclusion Criteria:

* Patients with a suspicious prostate disease who underwent prostate biopsy and/or radical prostatectomy;
* Adult patients \> 18 years
* Ability to read and sign the informed consent

Exclusion Criteria:

* Patients \< 18 years
* mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
* Inability to read and sign the informed consent

Primary outcomes:
measure: Clinically significant Prostate Cancer
timeFrame: 1 month
measure: Overall survival
timeFrame: every 6 month after surgery up to 50 years after surgery
measure: Cancer-specific mortality
timeFrame: every 6 month after surgery up to 50 years after surgery
measure: Biochemical recurrence
timeFrame: every 6 month after surgery up to 50 years after surgery
Secondary outcomes:
measure: Erectile function
timeFrame: every 6 month after surgery up to 50 years after surgery
measure: Urinary continence
timeFrame: every 6 month after surgery up to 50 years after surgery
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT06220955: Quantification of the Differences in the Diagnostic Relationships Between Centric Occlusion Versus Maximum Intercuspation in Adult Orthodontic Patients : A Cross-sectional Study
Official title: Quantification of the Differences in the Diagnostic Relationships Between Centric Occlusion Versus Maximum Intercuspation in Adult Orthodontic Patients : A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Centric Relation Registration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rthodontic patient having full permanent dentition

Brief summary: The aim of the study is to quantify the differences in the diagnostic relationships between Centric occlusion versus maximum intercuspation in adult orthodontic patients with Cetric relation recoded using both conventional method utilizing semi-adjustable articulator and face bow record in addition to digital method proposed by Radu et al for finding and recording CR using a dental intraoral scanner with a leaf gauge

Detailed description: Study design Cross-sectional study PICO Components P: Adult orthodontic patient I: Centric occlusion C: Maximum intercuspation

O: -orthodontic relations:

Molar relation Canine relation Incisor relation Overjet Overbite Midline discrepancy

Eligibility criteria: Inclusion Criteria:

orthodontic patient having full permanent dentition

Exclusion Criteria:

* patients who had undergone previous orthodontic treatment, and syndromic patients, retained primary teeth , teeth heavily restored

Primary outcomes:
measure: overjet
timeFrame: 1 day between the maximum intercuspation and centric relation records
Secondary outcomes:
measure: overbite
timeFrame: 1 day between the maximum intercuspation and centric relation records records
measure: midline shift
timeFrame: 1 day between the 2 records
measure: incisor relation
timeFrame: 1 day between the maximum intercuspation and centric relation records records
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry Cairo university
Study officials:
References:
Clinical trial NCT01329055: Events Before Death
Official title: International Comparison of Evolution of Clinical and Laboratory Parameters in Chronic Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care North America
name: Maastricht University
name: University of California
name: Medical University Innsbruck
First posted: 2011-04-05
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients

Brief summary: Previous studies of the patients treated in RRI clinics suggest that hemodialysis patients undergo a certain consistent predictable pattern at the initiation of dialysis and before death. This pattern can be described as a group of patterns of patients' biological markers over a few months after starting dialysis and several months prior to death. Additional patterns can be observed that occur with changes in seasons or time of day. The aim of this study is to compare these patterns in patients treated in FMC-Asia, FMC-Europe, FMC-South America, and RRI-US populations. Noting that patterns in patient parameters are similar across continents, climates, and geographic variations only further accentuates the importance in the models that can predict patients' survival and provide an opportunity for timely intervention.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis vintage 2+ months

Primary outcomes:
measure: Date of death
timeFrame: 10 years and 5 months
Secondary outcomes:
measure: Hospitalizations
timeFrame: January 2000 - May 2010
Other outcomes:
Locations:
city: New York
country: United States
facility: Renal Research Institute
state: New York
Study officials:
affiliation: Renal Research Institute
name: Peter Kotanko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03360955: Comparison of Extubation Time Between Total Intravenous Anesthesia With Spinal Anesthesia for Cardiac Surgery
Official title: Comparison of Extubation Time Between Total Intravenous Anesthesia Guided by Bispectral Index With Spinal Anesthesia With Minimal Opioid Dose for Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Keywords: Extubation
Cardiac Surgery
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2017-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for cardiac surgery

Brief summary: This study compares the extubation time between total intravenous anesthesia guided by Bispectral Index with spinal anesthesia with minimal opioid dose for cardiac surgery.

Detailed description: This study compares the time needed to extubate of two anesthesic techniques, 1) Total Intravenous Anesthesia guided by Bispectral Index (BIS), 2) Spinal Anesthesia with minimal opioid dose for cardiac surgery.

Identify the best anesthesia technique to do ultrafast track extubation can minimize the risk of infection associated.

Eligibility criteria: Inclusion Criteria:

Patients scheduled for cardiac surgery Physical Status Classification System of the American Society of Anesthesiologists (ASA) II-III

Exclusion Criteria:

Physical Status Classification System of the American Society of Anesthesiologists (ASA) IV-V Emergency cardiac surgery Spinal defect

Primary outcomes:
measure: Extubation time
timeFrame: Up to 1 hour after anesthesia emergence
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Hospital de cardiología
state: Cdmx
Study officials:
affiliation: IMSS
name: Ana Gabriela Gallardo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06848855: Proton Pump Inhibitor Use and Dental Implant Success
Official title: Evaluation of the Relationship Between Proton Pump Inhibitor Use and Dental Implant Success: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Survival Rate
Implant Survival and Success
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was conducted with patients who had a history of PPI use for more than six months and systemically healthy individuals who had undergone regular clinical and radiological follow-ups after dental implant placement at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kocaeli University.

Brief summary: The goal of this observational study is to evaluate the effects of proton pump inhibitors (PPIs) on the surrounding bone and the survival of dental implants. The main questions it aims to answer are:

Does PPI use affect the survival rate of dental implants? Does PPI use influence crestal bone loss and fractal dimension (FD) of the surrounding bone?


Eligibility criteria: Inclusion Criteria:

* Being over 18 years old,
* Having a history of PPI use for more than six months,
* Having at least one bone-level and axially placed dental implant in the maxilla or mandible,
* Having a minimum of one year elapsed since the prosthetic restoration following dental implant placement,
* Having undergone routine clinical follow-ups and radiological evaluations with periapical radiographs taken using the parallel cone technique after dental implant placement.

Exclusion Criteria:

* Individuals with a history of PPI use for less than six months,
* Individuals with periapical radiographs of low image quality or with artifacts,
* Individuals for whom the regions selected for fractal analysis on periapical radiographs are not appropriately sized,
* Individuals who have not undergone routine clinical and radiographic follow-ups.

Primary outcomes:
measure: Fractal Dimension Value
timeFrame: Fractal analysis values were calculated on radiographs within 1 month after the data collection of the patients.
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
References: