louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01377545: Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus
Official title: Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Nerve Block
Keywords: Infraclavicular
Nerve Block
Needle
Perineural Catheter
Volunteer
Upper Extremity Nerve Block
Sensation
Strength
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose to test the hypothesis that when placing a perineural catheter for a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the insertion needle results in a faster-onset sensory block than injecting the initial bolus via the perineural catheter. The study results will help define the optimal local anesthetic bolus introduction technique-needle versus catheter-for peripheral nerve blocks when placing a perineural catheter.

Detailed description: Specific Aim: The investigators propose to test the hypothesis that when placing a perineural catheter for a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the insertion needle results in a faster-onset sensory block than injecting the initial bolus via the perineural catheter. The study results will help define the optimal local anesthetic bolus introduction technique-needle versus catheter-for peripheral nerve blocks when placing a perineural catheter.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* willing to have bilateral infraclavicular blocks/catheters placed

Exclusion Criteria:

* current daily analgesic use
* opioid use within the previous 4 weeks
* any neuro-muscular deficit of either upper extremity
* body mass index \> 30 kg/m2
* weight \< 50 kg \[100 lbs\]
* pregnancy
* incarceration

Primary outcomes:
measure: Sensory Level
timeFrame: 120 minutes
Secondary outcomes:
measure: Grip Strength
timeFrame: 120 Minutes
measure: Sensory level for individual nerves
timeFrame: 120 Minutes
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD CTRI, Hillcrest
state: California
Study officials:
affiliation: University of California, San Diego
name: Brian M Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06788145: Enhancing Social Connections Among Rural Community Members With Disordered Eating
Official title: Enhancing Social Connections Among Rural Community Members With Disordered Eating
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Eating Disorders (Excluding Anorexia Nervosa)
Disordered Eating
Disordered Eating Behaviors
Eating Disorder Symptom
Keywords: eating disorder
disordered eating
Lead sponsor: University of Montana
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
First posted: 2025-01-22
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is about testing a short program that uses social support to help people with disordered eating. The goal is to see if this program can help people build better habits and feel better about eating while reducing harmful symptoms. In the long run, this project wants to make it easier for people with eating problems to get help and recover, especially for those in rural areas or other groups who don't often get the care they need. Participants will complete self-report measures online, and complete a digital single-session program.


Eligibility criteria: Inclusion Criteria:

* Adult (18+ years old)
* disordered eating
* live in the United States of America

Exclusion Criteria:

* BMI below 18.5

Primary outcomes:
measure: eating disorder symptoms
timeFrame: 1 month post-intervention
Secondary outcomes:
measure: Help-seeking
timeFrame: 1 month post-intervention
measure: Self-efficacy
timeFrame: 1 month post-intervention
measure: Social support and sense of community
timeFrame: 1 month post-intervention
measure: Personal Growth
timeFrame: 1 month post-intervention
Other outcomes:
measure: Program feedback
timeFrame: 1 month post-intervention
measure: Acceptability
timeFrame: 1 month post-intervention
Locations:
Study officials:
References:
Clinical trial NCT05577845: 5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS)
Official title: Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: LARS - Low Anterior Resection Syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 212
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety \& Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial


Eligibility criteria: Inclusion Criteria:

* mid and low rectal cancer (AV\<15cm)
* stage II, III, preop long-course CCRT, then ileostomy repair
* about 1\~12 months after operation (no stomy)
* about 1\~6 months after ileostomy repair
* major LARS

Exclusion Criteria:

* recurred rectal cancer
* stage IV
* IBD
* uncontrolled preoperative fecal incontinence or constipation

Primary outcomes:
measure: major Low Anterior Resection Syndrome (LARS)
timeFrame: 0 weeks
measure: Difference of improvement of major Low Anterior Resection Syndrome (LARS)
timeFrame: 4 weeks
Secondary outcomes:
measure: EORTC QLQ-C30 score
timeFrame: 0 weeks
measure: EORTC QLQ-C30 score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongro-gu
Study officials:
References:
Clinical trial NCT06953245: Collecting Patient-Reported Experiences With Radiation Dermatitis in Breast Cancer Patients Undergoing Radiotherapy
Official title: Collecting Patient-Reported Experiences With Radiation Dermatitis in Breast Cancer Patients Undergoing Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer who are currently undergoing or recently completed radiotherapy

Brief summary: This study evaluates patient-reported experiences of radiation dermatitis in patients with breast cancer undergoing radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18
* Patients diagnosed with breast cancer
* Currently undergoing or recently completed radiotherapy
* Willing to provide verbal/oral consent

Exclusion Criteria:

* Persons \< 18
* Inability to provide verbal consent
* Non-English speakers (unless translations are available)

Primary outcomes:
measure: Patient experiences with radiation dermatitis
timeFrame: Baseline (at enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Kimberly S. Corbin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03725345: Genetic and Neural Factors in Alcohol-Related Cognition
Official title: Genetic and Neural Factors in Alcohol-Related Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-10-31
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is about how genetic and brain factors impact cognitive processes and behavior after alcohol consumption. Participation in this project will contribute to a better understanding of biological factors that influence alcohol misuse. This study will be completed in two laboratory visits.

Detailed description: Some study details are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Eligibility criteria: Inclusion Criteria:

* English speaking
* No current or regular use of prescribed or illicit psychoactive drugs
* Free of major health problems (e.g., diabetes, HIV, Parkinson's disease)
* Free of a neurological or psychiatric disorders
* No current drug abuse (e.g., recreational drug use).
* Right hand dominant
* Free of claustrophobia
* Free of pregnancy or suspected pregnancy
* Absent MRI risk factors (e.g., implanted medical device, body mass index \> 35, braces)
* Free of medical conditions that render individuals with overly sensitive hearing
* Non-naive to alcohol consumption

Exclusion Criteria:

* Not meeting inclusion criteria listed above

Primary outcomes:
measure: Changes in alcohol-influenced behavior
timeFrame: Approximately 7 days between alcohol consumption.
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: David Chester, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06464445: Optimization of ITBS for Depression
Official title: Defining Parameters to Optimize Neurostimulation for the Treatment of Pediatric Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromodulation
Keywords: TMS
repetitive TMS
intermittent Theta Burst Stimulation
Plasticity
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated Measure Design
Primary purpose: BASIC_SCIENCE

Brief summary: Repetitive TMS (rTMS) is a well-established method for modulating brain activity. Through successive stimulations in the form of magnetic fields, it is possible to modify the sensitivity of neurons in the brain, also known as cortical excitability. Cortical excitability is important for the induction of brain plasticity, the ability of the brain to reorganize itself and form new connections in response to stimuli. A particular class of rTMS, intermittent theta burst TMS (iTBS), is commonly used to modulate cortical excitability and induce plasticity for therapeutic purposes, notably for treatment-resistant depression.

Different iTBS stimulation parameters can be used to induce plasticity. This study will focus on two parameters, namely, the form and duration of the electromagnetic stimulation. The shape of the electromagnetic pulse refers to how the electromagnetic wave is configured over time, while the duration is simply the period during which this electromagnetic pulse remains active. These parameters are expected to influence the effectiveness of iTBS in modulating cortical activity but remain little studied.

The main aim of this study will be to compare the effectiveness of different stimulation parameters in the induction of plasticity, which will then make it possible to improve the rTMS protocols used for treatment-resistant depression.


Eligibility criteria: Inclusion Criteria:

* Be between 18 and 35 years old
* Be of right manual dominance
* In good health

Exclusion Criteria:

* Have an implant or pacemaker,
* Having tinnitus,
* Have a history of fainting,
* Have already had an epileptic seizure or have a family history of epilepsy,
* Have a known neurological disease,
* Be under psychotropic medication,
* Have suffered from substance abuse or dependence in the last 6 months,
* Have a neurostimulator,
* Have a splinter or metallic implant in the head or the rest of the body,
* Have a cochlear implant,
* Have an automated injection system implanted (insulin pump),
* Have a transdermal patch,
* Have tattoos in the area to be studied,
* Be pregnant or breastfeeding,

Primary outcomes:
measure: TMS derived measure of cortical plasticity
timeFrame: Pre-iTBS, Every 5 minutes post iTBS intervention up to 60 minutes post intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche du Centre hospitalier universitaire de Sherbrook
state: Quebec
Study officials:
References:
Clinical trial NCT00646945: Study of the Efficacy of Kalinox® 170 Bar in Adult Oncology
Official title: International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Pain
Keywords: Patient in a oncology unit who has to undergo a painful or invasive procedure
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In the oncology practice, The National Union of the Centres of Fight Against the Cancer recently published the Standards, Options and Recommendations for the coverage of the pains provoked during the invasive gestures of a short duration realized at patients affected by cancer. These support the use of the Kalinox ® 170 bar as therapeutic alternative for the preparation of the painful procedures of a short duration such as spinal taps or osseous at the adult.The objective of this study thus is to clarify the appropriate efficiency and the tolerance of the equimolar mixture protoxide of nitrogen / oxygen during invasive procedures realized in adult oncology with regard to the analgesic reference methods and to the effect placebo leads by the accompaniment of the patient during the procedure.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 year
* OMS between 0 to 3
* Patient who has to undergo an invasive gesture or a painful care
* Absence of contra-indication to the administration of the product

Exclusion Criteria:

* Patient already included in another incompatible study with this protocol
* Patient incapable of self-assessment by the EVA
* Confusional syndrome
* OMS \> 3
* Patient already included in this protocol
* Exclusion criteria linked to the product

Primary outcomes:
measure: pain measurement with visual analogue scale
timeFrame: EVA
Secondary outcomes:
measure: feasibility of the kalinox 170 bar in invasives gestures in oncology
timeFrame: opinion of the patent and the caregiver
measure: surveillance of the appearance of secondary effects
timeFrame: examination by the investigator
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
References:
Clinical trial NCT04233645: Voiding Diary Video
Official title: Effect of Educational Video on Patient Adherence and Completeness of Intake and Voiding Diaries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate patient adherence and completeness of intake and voiding diaries. The secondary goal is to compare the satisfaction and understanding of patients of the intake and voiding trial diaries directions.

Detailed description: This is a randomized prospective study. All women who need to complete an intake and voiding diary at the Yale Urogynecology outpatient facilities will be invited to participate. After completion of the consent process, they will be randomized to one of two groups. Both groups will have their voiding diaries analyzed by three blinded experts and will be graded on completeness of the information filled out. The mean grade obtained from this process and the return rate of the voiding diaries will be the primary outcomes. The secondary outcomes will include a brief patient questionnaire on their satisfaction of the instructions with the voiding diary. The primary and secondary outcomes will be evaluated between the groups to determine the effectiveness of the video intervention.

Eligibility criteria: Inclusion Criteria:

* Need for intake and voiding diary completion
* Deemed to required return visit or follow up
* Able to read and write English

Exclusion Criteria:

* Dementia
* Prisoners
* Pregnant Patients
* Medical and physical handicaps which may interfere with completion of intake and voiding diary
* Medical and physical handicaps with viewing or understanding of the educational video
* Illiterate patients
* Patients who cannot speak and understand English

Primary outcomes:
measure: Voiding Diary Grade
timeFrame: 3 days
measure: Return Rate of Voiding Diaries
timeFrame: 3 days
Secondary outcomes:
measure: Patient Satisfaction: questionnaire
timeFrame: 3 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
References:
Clinical trial NCT00260247: Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.
Official title: Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Clearance Rate
Keywords: CYP3A4
Induction
Oxcarbazepine
Carbamazepine
Quinidine
Human
In vivo
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Research Agency
name: Novartis
First posted: 2005-12-01
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree.

This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity.

It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.


Eligibility criteria: Inclusion Criteria:

* BMI \< 30
* Non smoker
* No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
* Informed consent

Exclusion Criteria:

* signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
* mental disease
* participation in another clinical trial involving drugs with 3 months of randomization
* donation of more than 500 mL blood within 3 months of randomization
* intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week

Primary outcomes:
measure: Formation clearance of 3-hydroxyquinidine
Secondary outcomes:
measure: Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: Odense University Hospital
name: Per Damkier, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04083547: Circulating Tumour Cells in Patients With Peritoneal Metastases
Official title: Cirkulerande Tumörceller Hos Patienter Med Bukhinnespridda tumörer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulating Tumor Cell
Peritoneal Metastases
Hyperthermic Intraperitoneal Chemotherapy
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients being treated in Uppsala with CRS and HIPEC will be asked to join the study.

Brief summary: This study aims to evaluate the prognostic value of circulating tumour cells (CTC) in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy due to gastrointestinal cancers that have spread to the peritoneum.

Detailed description: CTCs har extracted by way of a new method at baseline, during surgery, and postoperatively. The occurence of such CTCs will be investigated for prognostic evaluation. Patients will be follow-up by Clinical routine. Disease recurrence and overall survival will be the endpoint used.

Eligibility criteria: Inclusion Criteria:

* Peritoneal metastases being treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

* None

Primary outcomes:
measure: Prognostic value
timeFrame: 2 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset (Uppsala University hospital)
Study officials:
References: