louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06657378: A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures
Official title: A Multicenter, Postmarketing Observational (Noninterventional) Study to Evaluate the Safety of Fycompa for Injection in Patients With Partial-Onset Seizures (Including Secondarily Generalized Seizures) (Age 4 Years or Older) or Primary Generalized Tonic- Clonic Seizures (Age 12 Years or Older)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Partial-Onset Seizures
Primary Generalized Tonic-clonic Seizures
Keywords: Seizures
Secondarily Generalized Seizures
Fycompa
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 110
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with epilepsy who received the Fycompa for injection for the first time will be included.

Brief summary: The purpose of this study is to determine the safety of Fycompa for injection after administration in participants with epilepsy (partial-onset seizures \[including secondarily generalized seizures\]) (age 4 years or older) or primary generalized tonic-clonic seizures (age 12 years or older).


Eligibility criteria: Inclusion Criteria:

* Participants with epilepsy who received the Fycompa for injection for the first time will be included.

Exclusion Criteria:

* The exclusion criteria will not be specified in particular because this survey will be conducted in daily clinical practice.

Primary outcomes:
measure: Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)
timeFrame: Up to 4 weeks
measure: Number of Participants With ADRs Based on Participant Characteristic
timeFrame: Up to 4 weeks
measure: Plasma Concentration of Fycompa in Children Aged Greater Than or Equal to (>=) 4 Years and Less than (<) 12 Years
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: 1
Study officials:
References:
Clinical trial NCT02887378: Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps
Official title: Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy
Keywords: bronchial biopsy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A cross-over study of the impact of histologic results of bronchial biopsies performed using hot clamps compared to bronchial biopsies using standard clamps


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Patients with no known hemorrhage risk, with an indication of endobronchial biopsy
* Patients with no contra-indication for bronchial endoscopy
* Patients with or without endobronchial tumors
* Patients who have provided written informed consent
* Patients with health insurance coverage

Exclusion Criteria:

* Refusal to be examined
* Contraindication for electrocoagulation (Pacemaker or metallic endobronchial prosthesis)
* Pregnant women
* Patients unable to provide voluntary informed consent, under (tutelage) or guardianship, or unable to come to the center

Primary outcomes:
measure: use of reusable hot biopsy forceps
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Saint Quentin
country: France
facility: Ch Saint Quentin
Study officials:
affiliation: CHU Amiens
name: Youcef DOUADI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05211778: Digital Patient Education Platform in Head and Neck Cancer
Official title: Post-Operative Patient-Centred Care Education Administration in Head and Neck Cancer Patients - A Digital Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Education
Patient Satisfaction
Multimedia
Free flap
Head and neck cancer
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Head and neck cancer is a disease that has a particular propensity for treatment-related morbidity. It is hypothesized that patients who are more involved in their care in hospital and who are actively provided with more treatment-related education may report increased satisfaction and have improved overall outcomes. The investigators aim to determine whether delivery of patient-centred education in a multimedia format via a digital platform has an impact on overall satisfaction and perceived quality of medical care.


Eligibility criteria: Inclusion Criteria:

* Patients aged 19 years old or above
* Patients seen in outpatient clinic who are scheduled to undergo reconstructive head and neck surgeries for a confirmed oral or oropharyngeal cancer diagnosis.

Exclusion Criteria:

* Patients who are unable to use a digital tablet
* Patients who do not speak or read English
* Individuals unable to understand the purpose, methods and conduct of this study
* Patients unwilling to provide informed consent

Primary outcomes:
measure: Patient Satisfaction
timeFrame: From date of surgery until the date of discharge. The number of days patients will remain in hospital after surgery can range from 7-14 days.
Secondary outcomes:
measure: Perceived quality of medical care
timeFrame: From date of surgery until the date of discharge. The number of days patients will remain in hospital after surgery can range from 7-14 days.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Eitan Prisman, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03434678: Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection
Official title: Randomized Controlled Trial of Epidural-General Anesthesia Versus General Anesthesia for Open Pancreaticoduodenectomy: Influence on Complications and Overall Two Year Survival
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: General Anesthesia
Epidural
Pancreaticoduodenectomy
18-056
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled single institution trial.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if there is a difference in complications in patients who have an epidural started earlier (during their surgery) and used as part of the anesthetic in addition to using it for post operative pain compared with patients who receive an epidural later in the surgery to be used only for post operative pain.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years of age who can provide informed consent
* Scheduled for pancreaticoduodenectomy

Exclusion Criteria:

* Pregnancy
* History of documented anaphylaxis or contraindication to any of the study medications
* Significant cognitive impairment or documented psychologic impairment
* Contraindication to epidural per Pain Service guidelines
* Use of a sustained release opioid medication such as long-acting morphine, fentanyl patches, methadone, and buprenorphine within the last 3 months
* Post randomization exclusion will occur if the patient is found to have unresectable disease at laparotomy and therefore will not have the potential for the same postoperative complications.

Primary outcomes:
measure: incidence of grade 3 or greater complications
timeFrame: 90 days post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Florence Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06468878: Virtual Reality Intervention for Fear of Heights
Official title: The Influence of Music on Response to Virtual Reality-Based Exposure for Acrophobia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acrophobia
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 44
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: Exposure-based cognitive behavior therapy is an efficacious treatment for acrophobia (fear of heights) and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate the effects of liked, non-lyrical background music on the efficacy of a brief VR exposure intervention.

Detailed description: The goal of this clinical trial is to compare acrophobia (fear of heights) outcomes for VR exposure therapy in college students with elevated acrophobia when listening to music during exposure versus no music. The overarching aim of the current study is to determine how liked, non-lyrical background music will influence acrophobia outcomes after a brief exposure therapy session in VR.

The study involves three phases: (1) initial screening, (2) in-person assessment and a brief exposure intervention for a subset of participants with elevated acrophobia, and (3) a one-week follow-up assessment conducted online. Students who choose to participate and screen high on an acrophobia scale will be assigned to an experimental or control condition prior to undergoing VR based exposure therapy. Acrophobia outcomes are measured immediately post-intervention and one week later.

Researchers will compare participants in the music condition to participants in the non-music condition to see if acrophobia outcomes differ.

Eligibility criteria: Inclusion Criteria:

* Self-report of 18 years of age or older
* Current student at Boston University
* Ability to read English to provide informed consent
* Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet)
* For Phase 2: Acrophobia score of ≥ 45.45 on the Acrophobia Questionnaire (AQ) Anxiety Subscale

Exclusion Criteria:

* Previous participation (i.e. no participant may take the survey more than once).

Primary outcomes:
measure: Acrophobia (Fear of Heights)
timeFrame: Comparison of pre-exposure scores to scores from the follow-up survey one week after exposure
Secondary outcomes:
measure: Valance
timeFrame: Comparison of pre-exposure scores to scores from the follow-up survey one week after exposure
measure: Height-Relevant Interpretations
timeFrame: Comparison of pre-exposure scores to scores from the follow-up survey one week after exposure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Laura Long, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06123078: Impact of Schemas, Cognitive Emotion Regulation on Quality of Life of HIV Patients: Assessing Outcomes of CBT
Official title: Impact of Schemas, Cognitive Emotion Regulation on Quality of Life of HIV Patients: Assessing Outcomes of CBT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Islamia University of Bahawalpur
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Repeated measures design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study has investigated the impact of schemas, cognitive emotion regulation and social connectedness on the Quality of life of HIV patients in South Punjab region, Pakistan.

Detailed description: The present study has investigated the impact of schemas, cognitive emotion regulation and social connectedness on the Quality of life of HIV patients in South Punjab region, Pakistan. The main study was conducted in four steps as follows:

Step 1: Pre-testing, N=150 Baseline assessment Random assignment of willing participants to control and experimental Step 2: CBT Intervention, N=40, 20 each group Step 3: post-test Step 4: Follow up Assessmen

Eligibility criteria: Inclusion Criteria:

- Registered at ART clinics South Punjab region HIV Patients Stage 1 or stage 2 Understands urdu Age above 20

Exclusion Criteria:

AIDS converted No Other terminal illness No other diagnosis Below 20 age

Primary outcomes:
measure: Social Connectedness Scale SCS-R
timeFrame: 8 months
measure: WHOQOL-HIV Bref
timeFrame: 8 months
measure: Schema Mode Inventory
timeFrame: 8 months
measure: CERQ
timeFrame: 8 months
measure: WHOQOL
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
measure: Cognitive Behavioural therapy
timeFrame: 4 months
Locations:
city: Rahim yar khan
country: Pakistan
facility: Nai Zindagi Trust
state: Punjab
city: Rahimyar Khan
country: Pakistan
facility: Sheikh Zyed Hospital
state: Punjab
Study officials:
affiliation: The Islamia University of Bhawalpur
name: Rabia J Bhatti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04607278: The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome
Official title: Probiotics and Prebiotics as a Potential Treatment in Fibromyalgia Patients: A Randomized, Double-Blinded, Placebo-Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: probiotics
prebiotics
fibromyalgia
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 53
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 8-week randomized, double-blind, parallel-group, placebo-controlled study
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to determine the effectiveness of probiotic and prebiotic treatments in patients with fibromyalgia syndrome.

Detailed description: Fifty-three, fibromyalgia syndrome participants were randomized to receive either: 1) probiotic 4×1010 CFUs per day 2) 10 g dose prebiotic (inulin) per day or 3) placebo for 8 wk. Fibromyalgia Impact Questionnaire (FIQ), Visual Analogical Pain Scale (VAS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Pittsburg Sleep Quality Index (PSQI) and quality of life (SF-36) were measured during the baseline, 4 weeks and 8 weeks intervention phases. Finally, the adverse effects will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Women aged 20-65 years.
2. Signature of informed consent by the patient.
3. Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
4. Participants should be diagnosed with fibromyalgia at least 1 year ago.

Exclusion Criteria:

1. using of antibiotic and nutritional supplements
2. being pregnant or breastfeeding
3. the presence of any allergies
4. being involved in any medical or psychological research
5. the presence of severe gastrointestinal diseases
6. psychiatric illness other than depression and anxiety.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 8 weeks
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 8 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 8 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks
measure: SF-36 Quality of Life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
state: Kecıoren
Study officials:
affiliation: Gazi University
name: Didem Tuba Akcali, Prof Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00331578: Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent
Official title: Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: AMI
Lead sponsor: JW Medical Systems Ltd
Sponsor class: INDUSTRY
First posted: 2006-05-31
Enrollment: 2077
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of coronary heart disease and inhibition of restenosis after coronary artery stenting as well as a 12 months' long-term safety after the cessation of clopidogrel as an anti-platelet drugs used for 6 months after the implantation of degradable drug coating stent.


Eligibility criteria: Inclusion Criteria:

1. Patient who should be full fill the criteria of using Excel stent.
2. Each included patient should allowed to use Excel stent.
3. Complete revascularization can be achieved through one invasive operation.

Exclusion Criteria:

1. Patient do not suitable to use Excel stent, for example, not tolerant to anti-platelet drug or undergo cardiac/non-cardiac surgery recently.
2. Patient with multiple branch lesions, thus the single Excel stent cannot resolve the condition.
3. NYH Cardiac functional grading\>3 or Echocardiography LVEF\<0.3.
4. Patient with complete revascularization cannot be resolved by one operation.

Primary outcomes:
measure: MACE(Major adverse cardiac events)
timeFrame: 12 months
Secondary outcomes:
measure: MACE
timeFrame: 30 days and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Shenyang Northern Hospital
name: Yaling Han, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Han Y, Zhang L, Jing Q, Wang X, Yan G, Ma Y, Wang G, Wang S, Chen X, Yang L, Zhu G, Liu H, Jiang T. Clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in patients with diabetes mellitus insight from the 4-year results of the create study. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1127-33. doi: 10.1002/ccd.24649. Epub 2013 Feb 26.
citation: Han Y, Jing Q, Xu B, Yang L, Liu H, Shang X, Jiang T, Li Z, Zhang H, Li H, Qiu J, Liu Y, Li Y, Chen X, Gao R; CREATE (Multi-Center Registry of Excel Biodegradable Polymer Drug-Eluting Stents) Investigators. Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in "real-world" practice: 18-month clinical and 9-month angiographic outcomes. JACC Cardiovasc Interv. 2009 Apr;2(4):303-9. doi: 10.1016/j.jcin.2008.12.013.
Clinical trial NCT06324578: Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease
Official title: A Cross-sectional Observational Study, Based on Immunological and Ultrasonographic Evaluations, to Define the Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sjögren
Autoimmune Thyroid Disease
Keywords: Autoimmune Thyroiditis
Sjögren disease
Immune dysregulation disorders
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with autoimmune thyroiditis and previous diagnosis of SD or pre-SD

Brief summary: The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine.


Eligibility criteria: Inclusion Criteria:

* Subjects between 0-17 years with autoimmune thyroiditis
* Subjects between 0-17 years with previous diagnosis of SD or pre-SD

Exclusion Criteria:

* No informed consent from the patient's guardians
* Active or recent infection within one week

Primary outcomes:
measure: Prevalence of pre-SD in pediatric subjects with AT
timeFrame: At the enrolment (T0)
measure: Prevalence of pre-SD in pediatric subjects with AT
timeFrame: 12 months after the enrolment (T12)
measure: Prevalence of pre-SD in pediatric subjects with AT
timeFrame: 24 months after the enrolment (T24)
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Study officials:
References: