louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04753801: What Are the Ingredients for the Best Form of the Best Possible Self (BPS) Intervention?
Official title: What Are the Ingredients for the Best Form of the Best Possible Self (BPS) Intervention? Combining the BPS Intervention With Mindfulness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious and test whether the BPS's efficacy can be enhanced by including mindfulness aspects.

Detailed description: The best possible self (BPS) intervention is a brief positive psychology intervention to increase a person's positive affect and optimism. The BPS has been used in different forms (writing vs. imagining/visualizing vs. writing + imagining/visualizing the best possible self). However, it remains unclear which 'ingredients' are necessary to let the BPS unfold its effects. This online study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious. Since mindfulness interventions have recently indicated promising effects on positive and negative affect, another goal of this study is to test whether the BPS's efficacy can be enhanced by including aspects of mindfulness.

Eligibility criteria: Inclusion Criteria:

* fluent in the German language
* access to a computer/tablet/smartphone with audio output/headphones

Exclusion Criteria:

* not willing to take part in an online-intervention (duration: 60 minutes)
* no access to a computer/tablet/smartphone with audio output/headphones

Primary outcomes:
measure: Change in emotions (PANAS)
timeFrame: Change from pre (baseline) to post scores (approx. 30 minutes later)
Secondary outcomes:
measure: Change in state optimism ratings
timeFrame: Change from pre (baseline) to post scores (approx. 30 minutes later)
measure: Change in emotional responses to imagery of neutral, pleasant and aversive narrative scripts
timeFrame: Change from pre (baseline) to post scores (approx. 30 minutes later)]
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Study officials:
affiliation: Philipps University Marburg
name: Winfried Rief, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Millstein RA, Chung WJ, Hoeppner BB, Boehm JK, Legler SR, Mastromauro CA, Huffman JC. Development of the State Optimism Measure. Gen Hosp Psychiatry. 2019 May-Jun;58:83-93. doi: 10.1016/j.genhosppsych.2019.04.002. Epub 2019 Apr 4.
Clinical trial NCT01108601: Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity
Official title: Transtympanic Administration of Lactate: An Innovative Otoprotection for Patients Receiving Cisplatin or Carboplatin Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hearing Loss
Keywords: Ringer's
lactate
cisplatin
ototoxicity
hearing loss
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Cisplatin and carboplatin induce ototoxicity manifested as sensorineural hearing loss, tinnitus, and/or vestibular disturbances. Ototoxicity is induced via damage to inner ear structures by reactive oxygen species. Previous animal studies demonstrated that transtympanic injection of Ringer's Lactate (RL) provided near complete otoprotective effect against cisplatin. The purpose of this study is to determine if transtympanic administration of Ringer's Lactate via a pressure equalising (PE) tube in patients undergoing platinum based chemotherapy treatment will prevent tinnitus, vestibular dysfunction and hearing loss especially at high frequencies. Pre- and post- chemotherapy treatment audiometry will be measured and statistically analysed for significance.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 14
* Patients undergoing platinum based chemotherapy
* Patients who agree to participate in the study

Exclusion Criteria:

* Patients unable to provide consent
* Patients with head and neck cancer
* Patients undergoing radiation of the head and neck
* Patients who develop a tympanic perforation
* Patients with persistent otorrhea

Primary outcomes:
measure: Audiogram
timeFrame: Before and after chemotherapy treatment
Secondary outcomes:
measure: Otoacoustic Emissions
timeFrame: Before and after chemotherapy treatment
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Sam J Daniel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choe WT, Chinosornvatana N, Chang KW. Prevention of cisplatin ototoxicity using transtympanic N-acetylcysteine and lactate. Otol Neurotol. 2004 Nov;25(6):910-5. doi: 10.1097/00129492-200411000-00009.
Clinical trial NCT05241301: Perspectives of Family Carers of Older People From Turkish and Moroccan Origin in Belgium on Advance Care Planning
Official title: Perspectives of Family Carers of Older People From Turkish and Moroccan Origin in Flanders and Brussels, Belgium, on Advance Care Planning: An Exploratory Interview Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Ethnic Minorities
Family Caregivers
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one to one interviews
Primary purpose: OTHER

Brief summary: In this study, we will explore the perspective of family carers of older adults from Turkish and Moroccan origin in Flanders and Brussels, Belgium, concerning advance care planning (ACP), more specifically concerning their knowledge about ACP, their experiences with and their points of view on ACP for their family member and their own preferences regarding how to be involved in the process of ACP for their relatives.

Detailed description: Whether or not someone wants to engage in ACP, is often the result of a complex interplay of meanings, events, processes and assumptions constructed by the patient and is best approached by qualitative methods. Semi-structured interviews will be used in order to explore the respondents' knowledge about and experience with ACP, also their views concerning ACP for their relatives and how do they prefer to engage in the process of ACP for their relatives will be explored.

Eligibility criteria: Inclusion Criteria:

* Family carers of older adults with a Turkish or a Moroccan origin who have participated in our previous studies with NCT03930823 and NCT04335214, as identified by the older adults as the most significant family carer. Older adults in our previous studies were men and women, all 65 years and older and living in Flanders and Brussels.
* and who live in Belgium and are 18 years or older and fluent in French or Dutch language.
* and who have also given informed consent to participate in this qualitative interview study

Exclusion Criteria:

* None

Primary outcomes:
measure: Knowledge of family carers of older adults from Turkish and Moroccan origin about advance care planning
timeFrame: 12 months
Secondary outcomes:
measure: Experiences of family carers of older adults from Turkish and Moroccan origin have with engaging in the process of ACP for their relatives
timeFrame: 12 months
Other outcomes:
measure: Family carers from Turkish and Moroccan origin views regarding their relatives engaging in the process of ACP?
timeFrame: 12 months
measure: How do family carers of older adults with Turkish and Moroccan origin prefer to engage in the process of ACP for their relatives?
timeFrame: 12 months
Locations:
city: Brussels
country: Belgium
facility: Faculteit Geneeskunde en Farmacie
Study officials:
affiliation: Vrije Universiteit Brussel
name: Hakki Demirkapu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02554201: Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction
Official title: Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lower Urinary Tract Symptoms
Dysuria
Incontinence
Keywords: pudendal nerve modulation
transanal/transvaginal electrical stimulation
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2015-09-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent from late complications. The present study is to evaluate the efficacy of electrical pudendal nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in NLUTD.The study design consists of a non-randomized, parallel controlled trial. A total of 60 eligible patients will be involved and divided into EPNS or TES group according to their location of medical treatment. The primary endpoint is lower urinary tract syndromes (ICIQ-FLUTS/MLUTS). The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and residual urine volume.


Eligibility criteria: Inclusion Criteria:

* Age 18+ years;
* Diagnosed as NLUTD;
* Incomplete spinal cord injury (SCI), including but not limited to conus medullaris syndrome, cauda equina syndrome, etc.;
* Radical pelvic surgery: including but not limited to total hysterectomy etc.;
* Informed consent signed.

Exclusion Criteria:

* Anatomical bladder outlet obstruction (e.g., prostate enlargement, tumors);
* NLUTD induced by stroke, multiple sclerosis, HIV, diabetes mellitus, drug, and inflammation or tumor of central nervous system etc.;
* Lower urinary tract infections;
* Unwillingness to participate.

Primary outcomes:
measure: A questionaire to measure the severity of lower urinary tract symptoms (male/female)
timeFrame: 1.5 years
Secondary outcomes:
measure: A questionaire to evaluate the Qol
timeFrame: 1.5 years
measure: Residual urine volume
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai research institute of acupuncture and meridian
Study officials:
affiliation: Shanghai research institute of acupuncture and meridian
name: Siyou Wang, Master
role: STUDY_CHAIR
References:
Clinical trial NCT04435301: Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness
Official title: Acoustic-electric Therapy in Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consciousness Disorder
Keywords: disorders of consciousness
electric stimulation
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: Zhejiang Mingzhou Brain Rehabilitation Hospital
First posted: 2020-06-17
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Altered gamma activity has been observed in several neurological and psychiatric disorders, including a reduction in gamma synchronization in patients with disorders of consciousness. Modulation of gamma oscillations with rhythmic stimulation has been used as a possible therapeutic tool. Hence, we try to use acoustic and electric stimulation at gamma frequency to restore brain oscillation and thereby to improve conscious awareness in patients with disorders of consciousness.

Detailed description: We propose a matched-pair parallel study in patients with disorders of consciousness to investigate whether combined acoustic and trigeminal nerve stimulation can modulate brain oscillations, as measured by electroencephalography (EEG), and whether the brain activity changes are coupled with improvements in consciousness.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of disorders of consciousness based on CRS-R
* Time post-injury ranging from one to twelve months
* No history of acquired brain injury or psychiatric or neurological diseases

Exclusion Criteria:

* Not medically stable
* Any contraindication to electric stimulation
* Hearing impairment before brain injury

Primary outcomes:
measure: Coma Recovery Scale-Revised scores
timeFrame: Day 1-5, Day 11-15
measure: Neuropsychological assessment
timeFrame: Day 5 and Day 11
measure: Glasgow Outcome Scale-Extended
timeFrame: 1 year after stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital,Zhejiang University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital, Zhejiang University
name: Benyan Luo
role: STUDY_DIRECTOR
References:
citation: Fan S, Wu X, Xie M, Li X, Liu C, Su Y, Chen Y, Wu S, Ma C. Trigeminal nerve stimulation successfully awakened an unconscious patient. Brain Stimul. 2019 Mar-Apr;12(2):361-363. doi: 10.1016/j.brs.2018.11.001. Epub 2018 Nov 3. No abstract available.
Clinical trial NCT02005601: Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Official title: Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 106
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are investigating the impact of duloxetine ("Cymbalta"), a serotonin and norepinephrine reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores 2 weeks after TKA.


Eligibility criteria: Inclusion Criteria:

* Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
* Age 25 to 75 years
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
* Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

* Concurrent use of duloxetine or other SNRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
* Hepatic insufficiency
* Renal insufficiency
* Patients younger than 25 years old and older than 75
* Patients intending to receive general anesthesia
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients with major prior ipsilateral open knee surgery

Primary outcomes:
measure: NRS Pain With Ambulation at 2 Weeks
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Total Daily Opioid Use (mg Oral Morphine Equivalents)
timeFrame: POD 1
measure: Nausea Severity
timeFrame: POD 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques T YaDeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07000201: Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled Trial
Official title: the Sedative Efficacy of Preoperative Pregablin Versus Gabapentin in Elderly Undergoing Abdominopelvic Surgery : a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Anxiety Disorder (Panic Disorder or GAD)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-02
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Several studies have evaluated the efficacy of pregabalin in reducing preoperative anxiety, with inconsistent results. Similarly, inconclusive results have been reported regarding gabapentin and its effects in reducing preoperative anxiety. A previous study reported that a single dose of gabapentin or pregabalin administered 60 minutes before surgery in adults under general anesthesia was effective in reducing acute preoperative anxiety and elevated levels of sedation before and after surgery, with pregabalin having better anxiolytic and sedative effects than gabapentin. However, no previous studies have compared the efficacy of preoperative pregabalin or gabapentin as premedication to reduce intraoperative anxiety and induce sedation in geriatric patients undergoing major surgery with regional anesthesia


Eligibility criteria: Inclusion Criteria:This study will include :

1. geriatric patients, aged 65 years or older,
2. Both sex,
3. scheduled for elective abdominopelvic surgery with regional anesthesia
4. American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion Criteria:We will exclude patients with any of the following:

1. history of allergy to gabapentin or pregabalin;
2. current use of gabapentin or pregabalin for other indications
3. history of chronic pain or chronic daily use of analgesics; a
4. history of epilepsy, other neurological disorders, cognitive impairment, or severe psychiatric disorders;
5. severe cardiovascular or respiratory diseases;
6. impaired renal function; and a history of drug or alcohol abuse.
7. patients with anticipated prolonged duration of surgery for more than two hours

Primary outcomes:
measure: Intraoperative sedation levels are assessed using the Ramsay Sedation Scale .
timeFrame: 1 hour after giving the drug
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralaini medical school
state: Giza
Study officials:
References:
Clinical trial NCT02519101: Effects of Continuous Noninvasive Arterial Pressure Measurement on Anaesthesia
Official title: Impact of Continuous Noninvasive Arterial Blood Pressure Monitoring on Blood Pressure Stability During General Anaesthesia in Orthopedic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure Stability in General Anaesthesia
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 160
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: Continuous noninvasive blood pressure monitoring may help to avoid intraoperative Hypotension or Hypertension


Eligibility criteria: Inclusion Criteria:

* orthopedic surgery in general anaesthesia
* American Society of Anesthesiologists - Physical Status (ASA) 2 or ASA 3
* arterial Hypertension

Exclusion Criteria:

-invasive blood pressure monitoring required

Primary outcomes:
measure: Number of Patients with Hypotensive Events in comparison between both groups
timeFrame: During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
measure: Dosage of Norepinephrine given to the patient to maintain blood pressure normotensive
timeFrame: During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
Secondary outcomes:
measure: Incidence of acute kidney failure postoperatively
timeFrame: during hospital stay after surgical procedure (in average 3 days)
Other outcomes:
measure: mean arterial blood pressure
timeFrame: consecutive full hours of general anaesthesia (estimated average 3 hours)
Locations:
city: Munich
country: Germany
facility: Klinik für Anaesthesiologie am Klinikum der Universität München
state: Bavaria
Study officials:
References:
citation: Meidert AS, Nold JS, Hornung R, Paulus AC, Zwissler B, Czerner S. The impact of continuous non-invasive arterial blood pressure monitoring on blood pressure stability during general anaesthesia in orthopaedic patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):716-722. doi: 10.1097/EJA.0000000000000690.