louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04730531: Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery
Official title: Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Spinal Fusion
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-opioid methods of pain management following posterior spinal fusion (PSF) have become increasingly popular given the rise of opioid abuse and opioid-related deaths. Orthopedic surgery remains one of the highest prescribing subspecialties. Local wound infiltration is an effective method of acute pain management following surgical intervention and is the standard in some surgical subspecialties, however, no randomized control trials (RCT) exist in the pediatric spine literature. This would be the first (RCT) to assess the use of local would infiltration in postoperative pain control following PSF for adolescent idiopathic scoliosis patients (AIS). The primary aim of this study is to investigate the efficacy of local wound infiltration with anesthetic agents in reduction of postoperative pain scores and post-operative opioid use during hospital admission following fusion surgery in AIS patients. The proposed single-center, double-blind prospective randomized study will be conducted by recruiting patients meeting the inclusion criteria of age 10-26 years and diagnosis of AIS undergoing posterior fusion surgery. Study participants will be randomized into either a local injection of 0.25% bupivacaine with epinephrine or a placebo of equal volume injectable saline. Patient-reported outcomes will be collected at 1-, 6-, 12- and 24-months postoperatively.


Eligibility criteria: Inclusion Criteria:

* ≥10 years old and ≤17 years old at assessment
* Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
* Planned surgical treatment of progressive spinal deformity with posterior spinal fusion

Exclusion Criteria:

* Diagnosis of neuromuscular, syndromic, or congenital scoliosis
* History of known allergy to local anesthesia
* Chronic pre-operative opioid consumptions
* Any other analgesic treatment for chronic pain before surgery
* Psychiatric or neurological disorders
* Cannot fluently read or speak English

Primary outcomes:
measure: Visual Analog Scale (VAS) pain score
timeFrame: 24 hours post-operatively
Secondary outcomes:
measure: Average use of morphine equivalents
timeFrame: 24 hours post-operatively
measure: Scoliosis Patient Questionnaire - Version 30 (SRS-30)
timeFrame: 1-, 6-, and 12-months post-operatively
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Craig Birch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06498531: HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women Compared to Men
Official title: HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women. A Randomized, Placebo-Controlled, Double-Blind Parallel Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sleep-Disordered Breathing
Keywords: Sleep disordered breathing
Periodic breathing
Prevention
Acetazolamide
Altitude
Hypoxia
Women
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
name: University Hospital Heidelberg
name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
First posted: 2024-07-12
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized clinical trial evaluating the effect of acetazolamide on sleep disordered breathing in women compared to men travelling to 3600 m.


Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).
* BMI \>18 kg/m2 and \<30 kg/m2
* Born, raised and currently living at altitudes \<1000 m
* Written informed consent
* Premenopausal women with an eumenorrheic cycle

Exclusion Criteria:

* Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
* Pregnancy or nursing
* Anaemic (haemoglobin concentration \<10g/dl)
* Any altitude trip \<4 weks before the study
* Allergy to acetazolamide and other sulfonamides

Primary outcomes:
measure: Nocturnal oxygen desaturation index (ODI)
timeFrame: Night 1 at 760 m and Night 1 at 3600 m
Secondary outcomes:
measure: Nocturnal oxygen saturation (SpO2)
timeFrame: Night 1 at 760 m and Night 1 at 3600 m
measure: Nocturnal oxygen saturation (SpO2)
timeFrame: Night 1 at 760 m and Night 2 at 3600 m
measure: Apnea/hypopnea index (AHI)
timeFrame: Night 1 at 760 m and Night 1 at 3600 m
measure: Apnea/hypopnea index (AHI)
timeFrame: Night 1 at 760 m and Night 2 at 3600 m
measure: Subjective sleep quality
timeFrame: Night 1 at 760 m and Night 1 at 3600 m
measure: Subjective sleep quality
timeFrame: Night 1 at 760 m and Night 2 at 3600 m
measure: Nocturnal oxygen desaturation index (ODI)
timeFrame: Night 1 at 760 m and Night 2 at 3600 m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center for Cardiology and Internal Medicine
Study officials:
affiliation: University of Zurich
name: Michael Furian, Prof. Dr.
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant Sooronbaev, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03132831: Influence of the Operative Day on the Average Duration of Stay in Primary Hip and Knee Replacements
Official title: Influence of the Operative Day on the Average Duration of Stay in Primary Hip and Knee Replacements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Length of Stay
Arthroplasty
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 1663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary hip and knee arthroplasty

Brief summary: Reducing the length of stay (LOS) after primary arthroplasty is a relatively new target that arouses the attention of orthopedic surgeons in order to return home early through the fast recovery protocols but this goal is also wanted in public health for the sake of overall decline health spending in public costs.

Detailed description: Reducing the length of stay (LOS) after primary arthroplasty is a relatively new target that arouses the attention of orthopedic surgeons in order to return home early through the fast recovery protocols but this goal is also wanted in public health for the sake of overall decline health spending in public costs.

Reducing the LOS after primary hip arthroplasty and knee is studied through many publications that found an LOS influenced by the own medical factors of patients (ref) However, no study to our knowledge research the influence of the operative day and the LOS.

For historical reasons, the organization of care is modified on the weekend (Saturday and Sunday) in particular by reducing the caregiver and also the lack of physical therapist to make the early postoperative get up (D0 or D1).

The hypothesis is that a patient operated the friday did not have the same care the first 48 hours that a patient who had surgery at the beggening of the week and that his recovery was therefore extended.

The investigator can also suppose that LOS was shorter for patients returning home for those who were transferred to a rehabilitation center or other structure.

The results will be adjusted according to the literature data on the age more than 80 years, sex, diabetes, cardiovascular diseases, respiratory diseases.

Eligibility criteria: Inclusion Criteria:

* All major patients operated at the University Hospital of Amiens between 1 January 2015 and 31 December 2016 for primary hip and knee arthroplasty

Exclusion Criteria:

* All patients undergoing surgery for hip or knee surgery (reoperation).
* All patients undergoing total arthroplasty on fracture of the femoral neck from all causes.

Primary outcomes:
measure: Analysis of the average length of stay in total hip and knee arthroplasty (defined as the time in days between in and out of the orthopedic unit for all destinations)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT00376831: The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Conscious Sedation
Keywords: colonoscopy
conscious sedation
midazolam
ketamine
fentanyl
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2006-09-15
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure.

There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion.

This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method.

The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies.

The results will be compiled from objective data and patient and physician interviews.


Eligibility criteria: Inclusion Criteria:

* Candidates for elective colonoscopy at the Soroka Medical Center who have signed an informed consent.

Exclusion Criteria:

1. Hypersensitivity to benzodiazepines
2. Hypersensitivity to benzyl alcohol
3. Hypersensitivity to ketamine
4. Hypersensitivity to opiates
5. Pregnancy
6. Uncontrolled hypertension
7. Myocardial infarct in the last 6 months
8. CVA
9. Chronic pulmonary disease
10. Renal failure
11. Chronic liver disease (CHILD B or C)
12. Elevated ICP, cerebral hemorrhage or cranial SOL.
13. Hypovolemic shock
14. Glaucoma
15. Mental illness
16. Drug or alcohol addiction

Primary outcomes:
measure: Recovery time
timeFrame: 24 hours following colonoscopy
Secondary outcomes:
measure: Sedative effect
timeFrame: 24 hours following colonoscopy
measure: Patient compliance
timeFrame: 24 hours following colonoscopy
measure: Side effects
timeFrame: 24 hours following colonoscopy
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel
name: pavel krugliak, md. professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01672931: The Association Between Overweight and Oocyte Diameter in Women Undergoing Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Obesity
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-08-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing IVF treatments

Brief summary: We believe that there is an association between BMI and oocyte diameter in women undergoing IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF. One group will have BMI 20-25 and the other group will have BMI above 30.


Eligibility criteria: Inclusion Criteria:

* IVF treated patients
* BMI between 20-25 or over 30

Exclusion Criteria:

* Everyone else

Primary outcomes:
measure: Larger Size of Oocyte Diameter
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Gai Shrem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atzmon Y, Shoshan-Karchovsky E, Michaeli M, Aslih N, Shrem G, Ellenbogen A, Shalom-Paz E. Obesity results with smaller oocyte in in vitro fertilization/intracytoplasmic sperm injection cycles-a prospective study. J Assist Reprod Genet. 2017 Sep;34(9):1145-1151. doi: 10.1007/s10815-017-0975-6. Epub 2017 Jun 17.
Clinical trial NCT01974531: Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study
Official title: Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study on Risk and Protective Psychobiological Aspects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Pregnancy
Stress
Psychological Distress
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Goethe University
First posted: 2013-11-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women either with risk of with no risk of preterm birth from the obstetric ward or from the antenatal class of the obstetric department and their partners

Brief summary: The purpose of the present prospective study is the analysis of risk and protective factors of perinatal stress and psychological distress of parents with or without a preterm child. Stress is measured biologically by Cortisol levels and psychologically by a questionnaire. Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress disorder, burnout) are measured by various questionnaires. We analyze the influence of different aspects as personality traits, social support, partnership.


Eligibility criteria: Inclusion Criteria:

* pregnant women and their partners from the 24th week of gestation on
* 18 years of age

Exclusion Criteria:

* psychiatric, mainly psychotic diseases
* drug abuse
* severe neurological disorders
* stillbirth

Primary outcomes:
measure: stress
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine
state: Hessen
Study officials:
affiliation: University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine
name: Frank Louwen, Prof.
role: STUDY_DIRECTOR
References:
citation: Sommerlad S, Schermelleh-Engel K, La Rosa VL, Louwen F, Oddo-Sommerfeld S. Trait anxiety and unplanned delivery mode enhance the risk for childbirth-related post-traumatic stress disorder symptoms in women with and without risk of preterm birth: A multi sample path analysis. PLoS One. 2021 Aug 31;16(8):e0256681. doi: 10.1371/journal.pone.0256681. eCollection 2021.
Clinical trial NCT00310531: 3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
Official title: A Multicenter, Double-Blind, Double-Dummy, Randomized, Active- Controlled, 3-Year Study to Evaluate the Antiresorptive Efficacy, Safety and Tolerability of a Ultra-Low Dose Estradiol Transdermal Delivery System Releasing 0.014 mg / Day Versus Oral Raloxifene Hydrochloride 60 mg / Day - as a Therapy for the Prevention of Osteoporosis in Postmenopausal Female Osteopenic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteopenia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 500
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this trial is to investigate whether the Menostar patch is as safe and effective in the prevention of bone loss in postmenopausal women as raloxifen, a drug already registered for prevention and treatment of osteoporosis.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Last (regular) menstrual period more than 5 years ago
* Relative good state of health
* Intact, normal uterus

Exclusion Criteria:

* Bone and musculoskeletal diseases
* Clinically significant vertebral fracture within the last 12 months
* Pre-existing cardiovascular disease (e.g. uncontrolled high/low blood pressure, stroke, thromboembolic event etc)
* Uncontrolled diabetes mellitus (or treated with insulin)
* Uncontrolled thyroid disorders
* Relevant renal disorder or significant liver dysfunction (including cholestasis)
* History of alcohol or drug abuse
* History of immobilization of more than 2 months in the last 6 months
* Smoking of more than 10 cigarettes per day
* Unexplained uterine bleeding
* Known or suspected malignant or premalignant disease (e.g. cancer of breast or uterus, melanoma)

Primary outcomes:
measure: Percentage change in Bone Mineral Density at the lumbar spine
timeFrame: after 3 years
Secondary outcomes:
measure: Percentage change in Bone Mineral Density of the hip
timeFrame: after 3 years
measure: Percentage change in biochemical markers of bone turnover
timeFrame: after 6 months
measure: Proportion of patients with hot flushes
timeFrame: after 3 year
measure: Change in Women's Health Questionnaire
timeFrame: after 2 years
measure: Proportion of patients with an abnormal endometrial biopsy
timeFrame: after 3 years
measure: Pharmacogenetic analysis
timeFrame: after 2 years
measure: Digital breast density analysis
timeFrame: after 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01461031: Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
Official title: Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Orthognathic Surgery
Keywords: pain
orthognathic
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2011-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery.


Eligibility criteria: Inclusion Criteria:

* aged 20-60 years
* undergoing elective orthognathic surgery

Exclusion Criteria:

* pregnancy
* psychiatric disease
* hepatobiliary or renal disease
* monoamine oxidase inhibitor-taking patients

Primary outcomes:
measure: pain score on the visual analogue scale
timeFrame: after orthognathic surgery (up to postoperative 24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
Study officials:
References:
citation: Park HJ, Park JU, Yoo W, Moon YE. Analgesic effects of nefopam in patients undergoing bimaxillary osteotomy: A double-blind, randomized, placebo-controlled study. J Craniomaxillofac Surg. 2016 Feb;44(2):210-4. doi: 10.1016/j.jcms.2015.11.012. Epub 2015 Dec 1.
Clinical trial NCT00448331: Facilitated Referral for Children Screening Positive for Mental Illness
Official title: Facilitated Referral for Children Screening Positive for Mental Illness in the Pediatric Emergency Department and Readiness to Seek Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorders
Mentally Ill Persons
Emergency Medicine
Keywords: Mental Disorders
Mentally Ill Persons
Emergency Medicine
Emergency Department
Screening
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-03-16
Enrollment: 551
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Department patients ages 6-18 who present without any history of mental health issues.

Brief summary: The purpose of this study is to find out how prevalent unidentified Mental Health issues are in the pediatric population that visits the Emergency Department in an urban city.

Detailed description: The purpose of this research study is to find out how many children in the Emergency Room have emotional issues and how many of them go unnoticed. In particular the study looks at how well a questionnaire for children and teenagers, the DISC Predictive Scales, Version IV (DPS-IV) works and what is the best way to ask the questions. In addition, for children aged 9-17 this study will look at families' readiness to seek care when a problem is indicated.

Eligibility criteria: Inclusion Criteria:

* Child Must be With Biological Mother
* Child Presenting to Emergency Department with an Urgent But Stable condition
* Child must be between the ages of 6 years and 18 years
* Child must have no prior history of Behavioral Health concerns or diagnoses

Exclusion Criteria:

* Child has prior Behavioral Health history, diagnosis, or concerns
* Child not between ages of 6 years and 18 years of ages
* Child presenting without Biological Mother present
* Child acuity level outside of Urgent But Stable for presenting complaints

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center Emergency Department
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jackie Grupp-Phelan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: