louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02052180: Early Post-Operative Pain Control Following Wrist Operations
Official title: Bupivicaine Extended-Release Liposome Injection Versus Marcaine for Early Post-Operative Pain Control Following Wrist Operations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Carpalmetacarpal arthroplasty
Proximal row carpectomy
Post-operative pain control
Exparel
Marcaine
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate improved pain control and outcomes in wrist operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use of the standard local anesthetic, Marcaine.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* ASA physical status 1-3
* Undergoing either carpometacarpal arthroplasty or proximal row carpectomy operation
* Physically and mentally able to participate in the study and complete all study assessments
* Able to voluntarily give fully informed consent to participate in this study and complete all study assessments within the timeframes required.

Exclusion Criteria:

* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
* Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL
* Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study
* Any chronic condition requiring use of opioids for treatment of the medical condition for three (3) months or more
* Confirmed pregnancy at time of enrollment
* Patients unable to comply with the study requirements, i.e. inaccessible by phone, or deaf

Primary outcomes:
measure: Changes in Pain
timeFrame: Pre-op, Post-op days: 1,2,3,4, and 14
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: UTCOM Chattanooga Department of Plastic Surgery
state: Tennessee
Study officials:
affiliation: University of Tennessee College of Medicine Chattanooga
name: Jason P. Rehm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05883280: The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
Official title: The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergence Delirium
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 74
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The hypothesis of this study is that providing continuous binaural beats with a phase difference in alpha frequency during anesthesia can reduce the incidence of emergence agitation in pediatric patients. To test this hypothesis, the occurrence of emergence agitation will be compared between the group that received binaural beats and the group that did not receive binaural beats.


Eligibility criteria: Inclusion Criteria:

* Children under the age of 7 receiving a strabismus surgery under general anesthesia.
* American Society of Anesthesiologists Physical status classification 1-2.

Exclusion Criteria:

* Pediatric patients with hearing impairment or those who are currently using a hearing aid
* Pediatric patients with neurological disorders
* Pediatric patients with respiratory disorders

Primary outcomes:
measure: Incidence of emergence delirium in postanesthetic care unit (PACU)
timeFrame: within 1hr after the end of surgery
Secondary outcomes:
measure: Paediatric Assessment of Emergence Delirium (PAED) score
timeFrame: within 1hr after the end of surgery (every 10 minutes, the score will be checked)
measure: Pain score (The Face, Legs, Activity, Cry and Consolability score)
timeFrame: within 1hr after the end of surgery
measure: EEG analysis during emergence period
timeFrame: Time from discontinuation of sevoflurane to entering to PACU (within 1hr after the end of surgery)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06729580: Risk-Targeted Behavioural Activation for the Management of Treatment-Resistant Depression.
Official title: Risk-Targeted Behavioral Activation: a Novel Approach to the Management of Treatment-Resistant Depression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Depression (TRD)
Keywords: treatment resistant depression
catastrophic thinking
perceived injustice
behavioural activation
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Depression is the leading cause of disability worldwide. Major Depressive Disorder (MDD) is the most common diagnosis made for individuals seeking treatment for depression. Although a wide range of treatments have been developed for the treatment of MDD, a significant proportion of patients fail to respond. This study examined the effectiveness of a 10-week behavioural activation intervention for individuals with treatment-resistant depression.

Detailed description: Objective: The purpose of the present study was to examine the acceptability and impact of a standardized 10-week risk-targeted behavioral activation (RTBA) intervention as an augmentation strategy in the clinical management of treatment-resistant depression (TRD). Methods: The study sample consisted of 118 individuals with TRD, who were currently absent from work and referred to an occupational rehabilitation service. The RTBA intervention was a 10-week standardized program consisting of weekly visits with a trained clinician. The objectives of treatment included symptom reduction, resumption of important life activities (including return to work) and improvement in quality of life. Measures of depression, perceived injustice, and catastrophic thinking were completed pre-, mid- and post-treatment.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Major Depressive Disorder
* The date of diagnosis of MDD preceded referral by at least 12 months
* At least one previous prescription of an antidepressant failed to yield therapeutic response
* Currently taking an antidepressant
* A PHQ9 score in the moderate to severe range of depression at the time of enrolment

Exclusion Criteria:

- Participating in another psychotherapeutic intervention.

Primary outcomes:
measure: Depression symptom severity.
timeFrame: baseline/immediately after the intervention
Secondary outcomes:
measure: Catastrophic thinking
timeFrame: baseline/immediately after the intervention.
measure: Perceived Injustice
timeFrame: baseline/immediately after the intervention.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Michael Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Heather Adams, BSW
role: STUDY_DIRECTOR
References:
Clinical trial NCT01571180: Influence of Obesity and Gastric Bypass on Medication Absorption
Official title: Influence of Obesity and Gastric Bypass on Medication Absorption: Prospective Follow-up of Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Obesity
Gastric bypass
Medication
Medication counseling
Dietary pattern
Follow-up of patients
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have scheduled a gastric bypass

Brief summary: Patients who have scheduled a gastric bypass (RYGB) in UZ Leuven, will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. The purpose of this study is to explore current practice regarding the use of medication and medication counseling after RYGB and to examine the changes in dietary pattern before and after RYGB.

Detailed description: Target group: patients who have scheduled a gastric bypass in UZ Leuven. Patients will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. Each assessment will be performed during a routine consultation.

The following aspects will be investigated:

* Medication The investigators have composed a questionnaire to examine which drugs the patients use, adherence, information received about medication and from whom,...
* Clinical parameters Every consultation, concentrations of hemoglobin, iron, hepcidin, vitamin B12,.... and a 24h urine collection to determine calcium excretion will be collected.
* Dietary intake The investigators will ask patients to keep a food record during two non-consecutive days preceding each consultation. In this food record patients have to note all consumed foods and beverages with the right/estimated amounts. This makes it possible to see the changes of the composition of the meals before and after RYGB.
* Body composition

Eligibility criteria: Inclusion Criteria:

* Patients who have scheduled gastric bypass
* Use of at least one chronic drug (including contraception)

Exclusion Criteria:

* Patients who have undergone another form of bariatric surgery before RYGB

Primary outcomes:
measure: Medication use
timeFrame: one year
Secondary outcomes:
measure: Changes in dietary pattern before and after RYGB
timeFrame: one year
measure: Medication counseling
timeFrame: one year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven - Centre for Pharmacotherapy
Study officials:
affiliation: Katholieke Universiteit Leuven - Centre for Pharmacotherapy
name: Ina Gesquiere, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Katholieke Universiteit Leuven - Centre for Pharmacotherapy
name: Veerle Foulon, Pharm PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06882980: Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy
Official title: Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenotonsillectomy
Propofol
Ciprofol
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 236
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to compare the Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy Participants will be randomly allocated to two groups: Ciprofol group (Group C) and Propofol group (Group P). For those in Group C: they will be given ciprofol during anesthesia induction and maintenance .For those in Group P: they will be pgiven ciprofol during anesthesia induction and maintenanc This study evaluates ciprofol versus propofol under IoC1/IoC2 guidance in pediatric T\&A, providing evidence for ciprofol's efficacy and safety in pediatric anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA I/II, age 3-11 years, weight 13-50 kg.

Endoscopic T\&A or adenoidectomy.

Exclusion Criteria:

* Recent upper respiratory infection.

Difficult airway, organ dysfunction, developmental/psychiatric disorders.

Drug allergies.

Primary outcomes:
measure: Induction Compliance checklist(ICC)
timeFrame: during the time of anesthesia induction ,1 minute-10 minutes
measure: The time to loss of consciousness during anesthesia induction
timeFrame: after the injection of anesthetic ,1second-5miutes
measure: sedation/consciousness (IoC1)
timeFrame: intraoperative period,10 minutes-1 hours
measure: analgesia/pain-stress (IoC2)
timeFrame: intraoperative period,10 minutes-1 hours
Secondary outcomes:
measure: Mean arterial pressure (MAP)
timeFrame: intraoperative period,3 minutes-1 hour
measure: Heart rate (HR)
timeFrame: intraoperative period,3 minutes-1 hour
measure: Recovery time
timeFrame: Postoperative 1 minutes to 1.5hours
measure: Dosage of anesthetic
timeFrame: Intraoperative period, 20 minutes - 1.5 hours
measure: anesthetist satisfaction
timeFrame: Postoperative 30 minutes
measure: Adverse events
timeFrame: the procedure and Postoperative 24 hours
measure: Pediatric Anesthesia Emergence Delirium (PAED) Scale
timeFrame: Postoperative 1 minute-1hour
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Maternal and Child Health Hospital of Hubei Province
name: Na Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00954980: Evaluation of Endovenous Sclerotherapy for Treatment of Varicose Veins
Official title: Evaluation of Clinical Characteristics of Endovenous Sclerotherapy of Varicose Veins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins
Keywords: Varicose Veins
Superficial Thrombophlebitis
Deep Vein Thrombosis
Ulceration
leg pain
leg swelling
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vascular or primary care clinic patients who have been scheduled to undergo an endovenous sclerotherapy procedure

Brief summary: The overall objective will be to evaluate clinical predictors of outcomes in patients who undergo endovenous sclerotherapy for the treatment of varicose veins.

Detailed description: A prospective cohort study of patients who undergo endovenous sclerotherapy over 2 years. There are no deviations in usual clinical assessment and care of patients seeking varicose vein treatment. The purpose of this protocol is only to collect clinical and biomarker information related to this standard treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of varicose veins

Exclusion Criteria:

* None

Primary outcomes:
measure: Frequency of obliteratin (total or partial) of injected varicosity.
timeFrame: assessment will be at 1, 12, and 26 weeks.
measure: Improvement in venous stasis symptoms.
timeFrame: assessment will be at 1, 12, and 26 weeks
measure: Change in quality of life.
timeFrame: assessment will be at 1, 12, and 26 weeks
measure: Associations between clinical outcomes and biomarkers.
timeFrame: assessment will be at 1, 12, and 26 weeks
Secondary outcomes:
measure: Recurrence of varicosities.
timeFrame: assessment will be at 1, 12, and 26 weeks
measure: Adverse events reported following procedure.
timeFrame: assessment will be at 1, 12, and 26 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center campus at the OU Vascular Center
state: Oklahoma
Study officials:
affiliation: Oklahoma University Health Sciences Center
name: Suman W. Rathbun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03772080: Prematurity Education in High Risk Pregnancies
Official title: Early Education of Prematurity in High Risk Pregnancies-A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
High Risk Pregnancy
Keywords: Antenatal Counseling
Education
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Rainbow Babies and Children's Hospital
First posted: 2018-12-11
Enrollment: 76
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Prematurity is associated with significant morbidity and mortality. Given the high risk of death and disability, it is important for parents to understand the complications of prematurity so they can make decisions for their child. Unfortunately, these discussions often occur in the acute setting of threatened preterm labor when stress and anxiety make comprehension difficult. This study aims to improve parental understanding by providing early education of prematurity in the clinic setting for patients at high risk of preterm delivery.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women between 22 0/7 and 34 6/7 weeks gestational age at high risk for premature delivery.

   1. Premature delivery defined as \<37 0/7 weeks gestation.
   2. Any pregnant woman seen in the Maternal-Fetal Medicine Clinic deemed to be at high risk for premature delivery.
2. Pregnant women 16 years and older.
3. Pregnancy with singleton or twin gestation.
4. No major congenital malformation.
5. Women who are English speaking.

Exclusion Criteria:

1. Pregnant women \<22 0/7 or \>35 0/7 weeks gestational age.
2. Pregnant women less than 16 years old.
3. Multiple gestation greater than twins (triplets, quadruplets, etc).
4. Known major congenital malformation.
5. Women who are non-English speaking.

Primary outcomes:
measure: Parental knowledge of prematurity.
timeFrame: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
measure: Parental satisfaction with prematurity education.
timeFrame: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
measure: Parental anxiety.
timeFrame: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
Secondary outcomes:
measure: Maternal compliance with maternal-fetal medicine provider follow up.
timeFrame: Outcome will be assessed up to 9 months following completion of the counseling intervention. Data will be analyzed and reported at the completion of the study.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
Study officials:
affiliation: UH, Cleveland Medical Center
name: Rebecca A Fish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02349880: A Shared Decision-making Training for Inpatients With Schizophrenia
Official title: A Shared Decision-making Training for Inpatients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizo-affective Disorder
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: "Shared decision-making" is being promoted as a promising approach for engaging patients with schizophrenia in medical decisions and improving satisfaction and adherence.

To implement shared decision-making, both physicians and patients should commit to it and engage in a mutual decision process. Most research, however, has addressed interventions that either focus on the doctors' side (e.g. "communication skills") or on informing patients about treatment options (e.g. "decision aids"). These approaches have been shown to be feasible in clinical practice but had no strong effects on treatment patterns or adherence, possibly because they were insufficient to motivate and enable patients to engage actively in decision-making. Moreover, these interventions still rely on the doctor's willingness to share decisions, which has been shown to vary considerably.

To overcome these limitations and since many patients do not feel competent to participate in decision-making we developed an intervention that focuses on patients' communicative competencies. this intervention, a five session group-training, will be implemented for inpatients suffering from schizophrenia.


Eligibility criteria: Inclusion Criteria:

* age 18-65
* icd diagnosis F2
* sufficient German language skills

Exclusion Criteria:

* debility

Primary outcomes:
measure: adherence to antipsychotic medication
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00844480: Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
Official title: Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bone Loss
Keywords: spinal cord injury
osteoporosis
bone loss
zoledronic acid
bisphosphonate
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2009-02-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.


Eligibility criteria: Inclusion Criteria:

1. Men and women
2. Age 18 years and older
3. Spinal cord injury within 8 weeks of study entry
4. ASIA AIS A or B
5. Medically stable in the opinion of their physiatrist
6. Able to have dexa performed
7. Able to return for follow-up at 6 and 12 months

Exclusion Criteria:

1. Vitamin D deficiency
2. Hypocalcemia
3. Renal insufficiency (estimated creatinine clearance \<30ml/min)
4. Abnormal thyroid hormone status
5. Abnormal mental status
6. Osteoporosis at the hip or spine by dexa

Primary outcomes:
measure: Bone Mass Density (BMD) at Total Hip
timeFrame: 6 months
Secondary outcomes:
measure: BMD at Other Skeletal Sites
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Thomas J Schnitzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnitzer TJ, Kim K, Marks J, Yeasted R, Simonian N, Chen D. Zoledronic Acid Treatment After Acute Spinal Cord Injury: Results of a Randomized, Placebo-Controlled Pilot Trial. PM R. 2016 Sep;8(9):833-43. doi: 10.1016/j.pmrj.2016.01.012. Epub 2016 Jan 30.