louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03644147: Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control
Official title: Additive Effect of Intravenous Acetaminophen Administered at the End of Surgery on Postoperative Pain Control With Nefopam and Fentanyl-based Patient-controlled Analgesia: A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Gynecologic Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 84
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia.

Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing total laparoscopic hysterectomy due to uterine myoma, cervical cancer, endometriosis, uterine prolapse

Exclusion Criteria:

* Liver disease (aspartate transaminase OR alanine transaminase \> 80 IU/L)
* Chronic kidney disease (GFR \< 30 ml/min/1.73m2)
* History of drug allergy
* Chronic pain lasting more than 3 months
* Conversion to laparotomy
* Complex surgery (co-operation with colon surgeon or urologist)
* Limitation in expressing pain

Primary outcomes:
measure: Total volume of administered analgesics during postoperative 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Pain score
timeFrame: 24 hours
measure: Patient satisfaction score
timeFrame: 24 hours
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
measure: Opioid-related adverse effect
timeFrame: 24 hours
measure: Use of alternative analgesics
timeFrame: 24 hours
measure: Length of stay
timeFrame: From date of hospital admission until the date of discharge, an average of 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, Pf.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04833647: Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
Official title: Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 83
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants performed CPET on an electronically braked cycle ergometer . During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study. A CPET technician and a senior pediatrician were present and monitored the participants' condition during the study.
Primary purpose: OTHER

Brief summary: Prospective study comparing hemodynamic and respiratory changes and exercise capacity during Cardio-Pulmonary-Exercise-Testing (CPET) in 4 groups of infants; Three different groups of premature infants and term controls

Detailed description: The study population included 4 groups of infants; preterm infants born \< 300 weeks' gestation with BPD (i.e. oxygen dependence for at least 28 postnatal days 5), preterm infants born \< 300 weeks' gestation without BPD, late preterm infants (born at 340-366 weeks' gestation) and term controls.

Pulmonary function testing and spirometry were measured Participants performed CPET on an electronically braked cycle ergometer. During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained.

The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study.

Eligibility criteria: Inclusion Criteria:

* 7-10 years of age
* The ability to ride stationary bicycles as assessed by the parents.

Exclusion Criteria:

* Immobility
* An acute febrile or upper respiratory illness in the last 2 weeks
* The use systemic or inhaled steroids or antiepileptic drugs in the previous month
* Inhaled bronchodilator use in the previous 24 hours
* A chronic lung illness (with the exception of BPD and asthma)
* Congenital cardiac defect (with the exception of atrial septal defect and patent foramen ovale).

Primary outcomes:
measure: The peak oxygen consumption (VO2max)
timeFrame: During the 1 day test
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01129947: The Use of DHEA in Women With Premature Ovarian Failure
Official title: The Use of DHEA in Women With Premature Ovarian Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Premature Ovarian Failure
Lead sponsor: Virginia Center for Reproductive Medicine
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: DHEA supplementation has been used in women with infertility and diminished ovarian reserve. There is a small report in 5 women with POF that benefited from the use of DHEA over several months. The investigators aim to evaluate further the use of DHEA in women with Premature ovarian failure (POF).


Eligibility criteria: Inclusion Criteria:

* women with POF

Exclusion Criteria:

* women without ovaries

Primary outcomes:
measure: The Use of DHEA in Women With Premature Ovarian Failure
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Reston
country: United States
facility: Virginia Center for Reproductive Medicine
state: Virginia
Study officials:
References:
citation: Mamas L, Mamas E. Dehydroepiandrosterone supplementation in assisted reproduction: rationale and results. Curr Opin Obstet Gynecol. 2009 Aug;21(4):306-8. doi: 10.1097/gco.0b013e32832e0785.
Clinical trial NCT03849547: Evaluation for the Effect of Smartphone Based Training on Chronic Ankle Instability Subjects
Official title: Development of a Smartphone-based System for Training Subjects With Chronic Ankle Instability and Training Effect Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ankle Instability
Keywords: Chronic ankle instability
Smartphone
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to verify the training effect of smartphone-based training for chronic ankle instability(CAI) subjects. By randomizing subjects to App training group, clinical training group and control group, the training effect will be compared among groups.

Detailed description: Postural control ability may be damaged after ankle sprains. Poor postural control ability is the risk factors of the ankle sprain, forming a vicious circle of recurrent sprains. Proper and early assessment is the key to breaking down the circle. Smartphones have been utilized in the medical field. With built-in sensors, utilizing smartphones as assessment tools can provide quantitative data of postural control performance. This study aims to verify the training effect of smartphone-based training for CAI subjects.

CAI subjects were recruited and randomly assigned to App training group, Home training group and control group, receiving 6 weeks of intervention. Pre-test was conducted before the intervention, and the post-test was conducted after the 6-week intervention. The follow up assessment was conducted 4 weeks after the post-test.

Eligibility criteria: Inclusion Criteria:

* At least one ankle sprain history
* At least 2 times of sprain and feeling unstable
* Diagnosed as functional ankle instability
* Full recovered from injury
* Cumberland Ankle Instability Tool\<24
* Ankle Instability Instrument \>5 yes
* Identification of Functional Ankle Instability \>11

Exclusion Criteria:

* Diagnosis as mechanical instability
* Neurological deficits
* Lower extremity injury within the past 6 wk
* History of lower-extremity surgery
* Other conditions known to affect balance

Primary outcomes:
measure: Postural sway measurement
timeFrame: 30 seconds
measure: Star Excursion Balance Test
timeFrame: 5 minutes
Secondary outcomes:
measure: Foot and Ankle Outcome Score
timeFrame: 5 minutes
measure: Foot and Ankle Ability Measure-sport subscale
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yang Ming university
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Wen-Hsu Sung, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT01028547: Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients
Official title: Antiemetic Efficacy and Safety of Dexamethasone in Patients Undergoing Caesarean Sections at Mulago Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: PONV
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomised controlled double blinded clinical trial to determine the antiemetic efficacy and safety of either 8 mg of dexamethasone or normal saline (placebo) given 1 hour before induction of either spinal or general anaesthesia in 2 arms (of 150 each).


Eligibility criteria: Inclusion Criteria:

* all woman above 18 years old presenting for obstetric surgery and have consented to study.

Exclusion Criteria:

* refusal/unable to consent,
* younger than 18 years old,
* hypertensive,
* diabetic,
* preeclamptic,
* sepsis,
* ASAIIIE plus.

Primary outcomes:
measure: presence of post nausea and or vomiting
timeFrame: 24 hours
Secondary outcomes:
measure: perianal itching
timeFrame: 24 hours
measure: hyperglycemia
timeFrame: 24 hours
measure: hypertension
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago National Refferal Hospital
Study officials:
affiliation: Makerere university dept of anesthesia
name: Tindimwebwa J V B, MD
role: STUDY_DIRECTOR
References:
citation: Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.
Clinical trial NCT05388747: Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates
Official title: Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infectious Disease
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Tianjin Central Hospital of Gynecology Obstetrics
First posted: 2022-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neonatal patients with infections

Brief summary: Cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. However, population pharmacokinetic，effectiveness and safety data for cefuroxime in neonates are lacking. The aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates.


Eligibility criteria: Inclusion Criteria:

* Age: postnatal age ≤28 days;
* Cefuroxime used as part of antimicrobial treatment;
* Parental written consent.

Exclusion Criteria:

* Expected survival time less than the treatment cycle;
* Receiving other systemic trial drug therapy;
* Other factors that the researcher considers unsuitable for inclusion.

Primary outcomes:
measure: The peak plasma drug concentration of cefuroxime
timeFrame: at (5-10) minutes after intravenous administration
measure: The random plasma drug concentration of cefuroxime
timeFrame: at (0.25-10) hours after intravenous administration.
measure: The trough plasma drug concentration of cefuroxime
timeFrame: at 1-2 hours before the next administration
measure: The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC)
timeFrame: Through study completion, an average of 3 days
measure: Adverse events
timeFrame: Through study completion, an average of 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology Obstetrics
state: Tianjin
Study officials:
References:
Clinical trial NCT02042547: Study Of Factors Favoring The Onset Of Novo Atrial Fibrillation In The Immediate Aftermath Of Coronary Artery Bypass Surgery
Official title: STUDY OF FACTORS FAVORING THE ONSET OF NOVO ATRIAL FIBRILLATION IN THE IMMEDIATE AFTERMATH OF CORONARY ARTERY BYPASS SURGERY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass Graft With or Without ECC
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
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: Coronary artery bypass graft with or without extracorporeal circulation

Brief summary: Before la surgery:

Transthoracic cardiac echography will be done systematically, to measure among other things the size of the left atrium.

During surgery:

Surgery under extracorporeal circulation: tissue samples will be harvested from the right atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before declamping of the aorta (T1= post-ischemia sample).

Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG (T0) and a second sample after CABG (T1).

In parallel with the harvesting of cardiac tissue, blood samples will be taken at different times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the anesthetists.

After the surgery:

Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an observation notebook. The biological samples will be analysed immediately and the biological data obtained will be recorded in the observation notebook.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided written informed consent
* Patients covered by the national health insurance scheme
* Heart surgery (CABG) with and without extracorporeal circulation
* Elective or deferred emergency surgery
* Consecutive patients aged less than 80 years

Exclusion Criteria:

* Patients less than 18, under guardianship
* Patients over 18, under guardianship
* Patients who do not understand the study data
* Patients undergoing emergency surgery who therefore cannot be given or understand the explanations for the study (patients in shock, intubated patients with mechanical ventilation)
* History of heart surgery
* History of AF
* Treatment with Cordarone.

Primary outcomes:
measure: Onset or a de novo episode of atrial fibrillation during the 7 days following heart surgery
timeFrame: 7 days post-surgery
Secondary outcomes:
measure: Markers of ischemia: circulating Troponin I before the surgery and at the end of the procedure
timeFrame: Baseline and at the end of surgery (15 minutes after unclamping when extracorporeal circulation)
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References:
Clinical trial NCT01661647: 3D Kinematic Assessment of the Human Knee During Physical and Daily Life Activities
Official title: (Étude de la cinématique Tridimensionnelle du Genou Humain Lors de Gestes Sportifs et de la Vie Courante)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: 3D Knee Kinematics
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Eiffel Medtech
First posted: 2012-08-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Problem : Precise and personalized 3D knee kinematic assessment during physical and daily life activities is a challenge; therefore, it was never performed on an important number of individuals. However, a better understanding of 3D knee kinematics during such activities would allow a better understanding of this often injured joint.

Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation device that can be used under local anesthesiaallows for precise and reproducible assessment of 3D knee kinematics during physical and daily life activities.

Objectives :

* To study human knee 3D kinematics during dynamic activities using a novel minimally invasive measuring system
* Investigate the correlations between standard clinical knee laxity tests and measured 3D knee kinematics during dynamic activities


Eligibility criteria: Inclusion Criteria:

* Patients awaiting knee arthroscopy under local anesthesia for a medial meniscal tear

Exclusion Criteria:

* Active infection
* Severe swelling of the knee
* Knee flexion contracture
* Knee flexion less than 120 degrees
* Gross limping
* Inability to perform the various motor tasks required by the study protocol

Primary outcomes:
measure: 3D knee kinematics
timeFrame: On the day of the surgery, before knee arthroscopy
Secondary outcomes:
measure: Correlation of kinematic data with clinical laxity tests
timeFrame: On the day of surgery, before knee arthroscopy
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: CHUM
name: Frédéric Lavoie, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06314347: Reference Value of Figure of 8 Walk Test
Official title: Determination of Reference Values of the Figure of 8 Walk Test in Healthy Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: Figure of 8 walk test
healthy adults
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Adults

Brief summary: The aim of the study is to determine the reference values of the Figure 8 Walking Test in healthy adults.

Detailed description: The Figure 8 Walk Test is a standard clinical measurement used to evaluate advanced walking performance required in daily life. Beyond walking straight, the ability to turn is required in many situations in daily life, such as getting around a table, avoiding obstacles, and navigating the street. The validity and reliability of the figure of 8 walk test have been stated for different pathological conditions, but the normative values of the test in healthy individuals are unknown.

Eligibility criteria: Inclusion Criteria:

* -Above 18 years old
* No known musculoskeletal and neurological disorders
* healthy adults who are not elite or professional athletes

Exclusion Criteria:

* People with physical or cognitive impairments

Primary outcomes:
measure: Figure of 8 walk test
timeFrame: baseline and two weeks later
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: gender
timeFrame: Baseline
measure: height
timeFrame: Baseline
measure: weight
timeFrame: baseline
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep Islam Science and Technology University
Study officials:
affiliation: Gaziantep Islam Science and Technology University
name: Zekiye İpek Katırcı Kırmacı
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002047: Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
Official title: Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Kidney Failure, Chronic
Keywords: Kidney Failure, Chronic
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Renal Dialysis
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.


Eligibility criteria: Inclusion Criteria

Patients must have:

* A positive HIV antibody test (ELISA confirmed by Western blot).
* Chronic renal failure managed by a stable hemodialysis regimen.
* Acceptable hepatic function defined by specified lab values.
* Life expectancy \> 6 months.
* Enrollment is limited to 9 chronic hemodialysis patients and 9 Continuous Ambulatory Peritoneal Dialysis (CAPD) patients. These patients must be stable in their ESRD treatment regimen before entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Active, serious opportunistic infections at the time of study entry.
* Fever \> 100 degrees F at study entry.
* Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss).

Patients with the following are excluded:

* Active, serious opportunistic infections at the time of study entry.
* Fever \> 100 degrees F at study entry.
* Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss).

Prior Medication:

Excluded within 2 weeks of study entry:

- Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant hepatotoxicity.

Excluded within 4 weeks of study entry:

- Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin 2.

Excluded within 8 weeks of study entry:

- Other antiretroviral agents (e.g., zidovudine \[AZT\], suramin, ribavirin, HPA-23, foscarnet, dextran sulfate, disulfiram, ddA/ddC, or dideoxycytidine).

Active drug or alcohol abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Univ of Maryland at Baltimore
state: Maryland
Study officials:
References: