louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06830174: tDCS for Laryngeal Dystonia
Official title: Network Targeted Transcranial Direct Current Stimulation (tDCS) as a Treatment for Laryngeal Dystonia (LD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laryngeal Dystonia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Spasmodic Dysphonia Association
First posted: 2025-02-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project will apply transcranial direct current stimulation (tDCS) to multiple brain areas to evaluate the effects as a potential treatment for laryngeal dystonia (formerly spasmodic dysphonia).

Detailed description: Baseline neuroimaging data will be acquired from all participants via MRI, EEG. Each participant will be seen for multiple testing sessions over a five day period. LD participants will undergo the neuromodulation (HD-tDCS Stimulation) for twenty minutes while engaged in watching videos/movies or performing a word production task.

Eligibility criteria: Inclusion Criteria:

* Participants must be clinically evaluated for the diagnosis of LD or have the proof of LD diagnosis. (Not applicable for control participants)
* No other known or history of speech, voice disorder other than LD.
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Must not be pregnant.

Exclusion Criteria:

* All individuals who do not meet the above mentioned criteria are excluded from the study.
* Subjects with a history of epilepsy or depression or is claustrophobic.

Primary outcomes:
measure: Change in Cepstral peak prominence (CPP)
timeFrame: daily on Day 1-Day 5
measure: Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
timeFrame: daily on Day 1-Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Nabin Koirala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03990974: Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection
Official title: Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Postoperative Infection
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This trial is a multi-center, double-blinded, randomized (1:1) clinical trial. The aim is to compare the postoperative infection rate between the 3 days postoperative AMP group and the placebo group in HCC patients undergoing hepatectomy.

Detailed description: This trial includes two phase. The first phase is the internal pilot study to explore the expulsion rate and recruited population. The second phase is the main phase III trial.

Eligibility criteria: Inclusion Criteria:

* Age: over 18 years;
* Diagnosed as primary HCC according to the EASL criteria and plan to receive hepatectomy;
* Child-Pugh A class;
* No history of antibiotics in 1 week before surgery, except for antimicrobial prophylaxis in the 24h before surgery.
* No evidence of infection during preoperational assessment

Exclusion Criteria:

* Underwent hepatectomy combined with resection of other organs, except for gallbladder;
* Found obvious infection during operation;
* Combination with other operations, such as biliary reconstruction or tube drainage, bile duct exploration and stone remove, etc.;
* Allergic to the antibiotics used in the 24h before surgery;
* Emergency surgery;
* Tumor rupture;
* Did not underwent hepatectomy because of any reasons;
* Admission to ICU after surgery;
* ASA grade ≥ 3;
* Denial of informed consent.

Primary outcomes:
measure: 30-day postoperative infection rate
timeFrame: 30 days after hepatectomy
Secondary outcomes:
measure: Surgical site infection rate
timeFrame: 30 days after hepatectomy
measure: Postoperative complication rate
timeFrame: 3 months after hepatectomy
measure: Severe infection rate
timeFrame: 30 days after hepatectomy
measure: Distant infection rate
timeFrame: 30 days after hepatectomy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05592574: IL17 Rate and Spondyloarthritis
Official title: Feasibility of an Il-17a Assay and Impact on Therapeutic Response in Patients With Active Axial Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spondylarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spondyloarthritis recruited during rheumatology consultations in rheumatology department of CHU of NICE

Brief summary: There are, to date, no validated biomarkers or head-to-head RCTs of biologics to guide choice of biologic agent in axSpA. While there are now two head-to-head studies of a TNF inhibitor (TNFi) vs an IL-17 inhibitor (IL-17i) in psoriatic arthritis. Recommendations refers to biological DMARDs (bDMARDs) including TNFi and IL-17i for patients with high disease activity despite the use (or intolerance/contraindication) of at least two non-steroidal anti-inflammatory drugs (NSAIDs) in axial SpA (axSpA) and in failure of a strategy including methotrexate for psoriatic arthritis. A tool to help us to decide which bDMARDs to use is necessary.

In SpA, the method of determination of IL17 seems to be questionable.

The determination of cytokines after stimulation of immune cells in patients with active SpA requiring a biological treatment could provide us with a tool to assist in the choice of therapy.

The aim of the study was to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment. And secondly, to show the predictive character of this expression on the therapeutic response at three months after the implementation of a biological treatment.


Eligibility criteria: Inclusion criteria

* Patients with spondyloarthritis meeting the ASAS criteria
* Patients who were to benefit from the implementation of a biological treatment after failure of at least two NSAIDs.
* Patients having an active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) higher than four,

Exclusion criteria

* No predominant axial manifestation,
* Having received a previous biological treatment
* Patients presenting contraindication to the implementation of these treatments.

Primary outcomes:
measure: to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.
timeFrame: 18 months
Secondary outcomes:
measure: predictive value of IL17 rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
Study officials:
References:
Clinical trial NCT03983174: Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula
Official title: Drainage Seton Around the External Anal Sphincter With Mucosal Advancement Flap Versus External Anal Sphincter Preserving Seton in Treatment of Trans-sphincteric Anal Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 100
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: TREATMENT

Brief summary: Patients with high trans-sphincteric anal fistula will be randomized to one of two equal group: group 1 will have drainage seton with mucosal advancement flap and group 2 will undergo external anal sphincter sparing seton


Eligibility criteria: Inclusion Criteria:

* Patients suffering from high trans-sphincteric anal fistula

Exclusion Criteria:

* Acute sepsis.
* Specific cause of fistula e.g. Crohn's disease
* Strictured anorectum.
* Any degree of incontinence
* Recurrent anal fistula.
* Low anal fistula.
* Previous anorectal surgery.

Primary outcomes:
measure: fecal incontinence
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06661174: A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy
Official title: A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgeries
Diabetic Nephropathy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients with DKD treated with intensive weight loss or traditional treatment

Brief summary: Establish a cohort of diabetic kidney disease(DKD) patients with intensive weight loss treatment to evaluate the impact of intensive weight loss treatment on the renal prognosis of DKD and construct a prediction model for the improvement of renal outcomes after weight loss.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years old;

  * BMI\>25Kg/m2 or abdominal obesity (i.e. waist circumference\>90cm for men and\>85cm for women);

    * eGFR\<30ml/min/1.73m2 or urinary microalbumin≥300mg/g, eGFR\<60ml/min/1.73m2.

Exclusion Criteria:

* Patients who are taking glucocorticoids;

  * Combined with tumors; ③Combined with autoimmune diseases; ④Serum albumin\<25g/L.

Primary outcomes:
measure: Total weight loss
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Secondary outcomes:
measure: Serum creatinine
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
measure: Glomerular filtration rate
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
measure: Fasting blood glucose
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
measure: Average blood glucose from continuous glucose monitoring
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
measure: Postprandial 2-hour blood glucose
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
measure: HbA1c
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
measure: Waist circumference and hip circumference
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
measure: Urinary microalbumin and other Urinalysis indexes
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
measure: Medication status
timeFrame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Hua Meng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06213974: A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
Official title: Post Authorization Study to Monitor Efficacy, Effectiveness, and Safety of Maribavir (LIVTENCITY®) in Adult Patients With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cytomegalovirus (CMV)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with post-transplant CMV infection/disease that are refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet, that are treated with maribavir according to approved indications.

Brief summary: The main aim of this study is to learn about the safety of Maribavir in adults with post-transplant cytomegalovirus (CMV) infection in routine clinical practice in Argentina.

The other aim is to study the effectiveness of the treatment with Maribavir in routine clinical practice in Argentina.

Participants will be treated by their doctors according to normal medical practice. Study data will be collected either from information already available in the medical records or during study conduct.


Eligibility criteria: Inclusion Criteria:

* Adult participants (18 years or older) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet in the real-world setting of common clinical practice in Argentina.
* Have received at least one dose of maribavir according to approved indications.
* Have signed the mandatory informed consent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion Criteria

- There are no specific exclusion criteria.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From start of treatment up to Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved Clearance of Plasma Cytomegalovirus -Deoxyribonucleic Acid (CMV-DNA) (CMV Viremia Clearance) at End of Weeks 8 and 16
timeFrame: At Weeks 8 and 16
measure: Percentage of Participants Who Achieved CMV Infection Symptom Control at End of Weeks 8 and 16
timeFrame: At Weeks 8 and 16
Other outcomes:
Locations:
city: City of Buenos Aires
country: Argentina
facility: IC Projects
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02895074: Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts
Official title: Subfoveal Choroidal Thickness After Femtosecond Laser-assisted Cataract Surgery for Age-related Cataracts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: femtosecond laser-assisted cataract surgery (FLACS)
subfoveal choroidal thickness (SFCT)
conventional phacoemulsification surgery (CPS)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
First posted: 2016-09-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) on subfoveal choroidal thickness (SFCT) in age-related cataracts.

Detailed description: It is not clear whether femtosecond laser-assisted cataract surgery (FLACS) alters retinal and choroidal thickness. The goal of the present study was to determine the changes of retinal and choroidal thicknesses in patients who have undergone FLACS compared to patients who have undergone conventional phacoemulsification surgery (CPS).

Eligibility criteria: Inclusion Criteria:

* The cataract stages of the patients were between N2 and N4 according to the LOCS III.

Exclusion Criteria:

* eyes with histories of ocular surgery, trauma, and ocular diseases, including diabetic retinopathy, age-related macular degeneration (AMD), high myopia, psudoexfoliation, uveitis, retinal vein occlusion, and other inflammatory and vascular retinal disorders.

Primary outcomes:
measure: The change of subfoveal choroidal thickness
timeFrame: baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery
Secondary outcomes:
measure: The change of subfoveal retinal thickness
timeFrame: baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D., Ph.D
role: STUDY_CHAIR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Weirong Chen, M.D.
role: STUDY_DIRECTOR
References:
citation: Chen X, Xiao W, Ye S, Chen W, Liu Y. Efficacy and safety of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification for cataract: a meta-analysis of randomized controlled trials. Sci Rep. 2015 Aug 13;5:13123. doi: 10.1038/srep13123.
Clinical trial NCT02922374: Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis
Official title: Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Severe Colitis (ASC)
Keywords: acute severe colitis
corticosteroids
UCEIS
fecal calprotectin
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the first-line treatment in the guideline, but patients have a great risk of requiring colectomy or turning to second-line treatment. This study aim to verify the effectiveness of ulcerative colitis endoscopic index of severity(UCEIS) in predicting the reaction to corticosteroids, and explores the possibility that noninvasive marker fecal calprotectin (FC) could act as an alternative to UCEIS.


Eligibility criteria: Inclusion Criteria:

1. Patients with a confirmed diagnosis of ASC according to Truelove and Witt's criteria;
2. Patients were generally able to tolerate the flexible colonoscopy before start of CS treatment;

Exclusion Criteria:

1. Patients with incomplete colonoscopy, inadequate fecal sample;
2. Patients with indeterminate diagnosis of ASC (colorectal cancer, Crohn's disease) according to colonoscopy;
3. Patients with infectious colitis, Clostridium difficile and CMV infection, primary immunodeficiency, recent history of immunosuppressant within 3 months.
4. Patients with bowel resection, intestinal anastomotic, and ileum enterostomy.

Primary outcomes:
measure: stool frequency at day 3
timeFrame: 3 days
measure: C-reactive protein (CRP) at day 3
timeFrame: 3 days
Secondary outcomes:
measure: ulcerative colitis endoscopic index of severity (UCEIS) before treatment
timeFrame: 3 days
measure: Fecal Calprotectin before treatment
timeFrame: 3 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01233674: Examination of Left Atrial Fibrosis Using MRI
Official title: Examination of Left Atrial Fibrosis Using MRI
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Fibrosis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients referred for standard of care MRI

Brief summary: This study evaluates images obtained from a standard clinical cardiac MRI for evidence of fibrosis.


Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* being scheduled for a standard of care MRI

Exclusion Criteria:

- patient unable to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC CVI
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05272774: Stress Recovery Program FOREST+ for Healthcare Workers
Official title: Efficacy of the FOREST+ Stress Recovery Program for Healthcare Workers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2022-03-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated either to the intervention or control groups. The control group will use the intervention without feedback from therapist but with support on-demand. The control group will participate in the program at the same time as the intervention group with therapist support.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the efficacy of an online stress recovery intervention for healthcare workers receiving therapist-assisted or on-demand support.

Detailed description: The intervention will be delivered as an online stress recovery program for healthcare workers, consisting of six modules. Modules include an introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These modules have been chosen after considering themes that could be most useful for healthcare workers under high stress. Each module consists of a psychoeducational and an exercise component. During the program, a therapist provides individual feedback on the exercises completed and can also be available on request.

The effect of the intervention will be compared with a control group that will use the program with support on-demand. The intervention will be delivered in Lithuanian.

Eligibility criteria: Inclusion Criteria:

* licensed healthcare professionals currently working under license;
* at least 18 years old;
* comprehending Lithuanian language;
* access to internet.

Exclusion Criteria:

* acute psychiatric crisis;
* high suicide risk;
* interpersonal violence.

Primary outcomes:
measure: Change on Recovery Experience Questionnaire
timeFrame: Pre-treatment, post-treatment, 3 months follow-up
Secondary outcomes:
measure: Change on Perceived Stress Scale
timeFrame: Pre-treatment, post-treatment, 3 months follow-up
measure: Change on Patient Health Questionnaire
timeFrame: Pre-treatment, post-treatment, 3 months follow-up
measure: Change on Generalized Anxiety Disorder Questionnaire
timeFrame: Pre-treatment, post-treatment, 3 months follow-up
measure: Change on Well-being Index
timeFrame: Pre-treatment, post-treatment, 3 months follow-up
measure: Change on Moral Injury Outcome Scale
timeFrame: Pre-treatment, post-treatment, 3 months follow-up
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
affiliation: Vilnius University
name: Evaldas Kazlauskas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: