louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04158388: Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia
Official title: Effects of Nutritional Strategies or Manual Therapies on Physical and Psychological Parameters in Women With Fybromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: micronutrients
nutrition
therapy
chronic disease
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 24
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study had two objectives. The first main aim was to analyze the effects of tryptophan and magnesium-enriched Mediterranean diet on psychological variables (trait anxiety, self-image, mood state, eating disorders) and sleep effects in women with fibromyalgia. Our hypothesis, based on previous positive effects of tryptophan and magnesium supplementation by separate in this population, may improve psychological health and regulate sleep disruptions. The second aim was to assess the effectiveness of a manual therapy technique performed with moderate digital pressure in fibromyalgia patients on the variables of fatigue, pain, sleep, anxiety and mood. It was done to provide an alternative treatment to pharmacological therapies for fibromyalgia patients and to provide new evidence on the effects of manual therapy in fibromyalgia patients.


Eligibility criteria: Inclusion Criteria:

- Women aged 40-60 with fibromialgia (officially diagnosed).

Exclusion Criteria:

* Women used analgesics, vitamins containing supplements, and or other drugs for the treatment of fibromyalgia symptoms, or participation in other clinical trials.
* Women that be performing simultaneously to this study some other physical therapy or physical exercise treatment. Not having sufficient cognitive level to collaborate in the study or not having the possibility of attending the established sessions.

Primary outcomes:
measure: Sleep Quality
timeFrame: 4 - 16 weeks
measure: Anxiety trait
timeFrame: 4 - 16 weeks
measure: Mood state
timeFrame: 4 - 16 weeks
measure: Fatigue severity
timeFrame: 4 - 16 weeks
measure: Pain perception
timeFrame: 4 - 16 weeks
measure: Sleep quality
timeFrame: 4 - 16 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 4 - 16 weeks
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: University of Alicante
state: San Vicente Del Raspeig
Study officials:
References:
Clinical trial NCT02508688: Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax
Official title: Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax: 10 Years' Experience From a Single Large-volume Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Keywords: hepatic hydrothorax
thoracoscopic surgery
diaphragmatic defect
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The management of refractory hepatic hydrothorax is challenging and usually unsuccessful. The study will discuss the perioperative treatment, effectiveness, and morphology of diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Risk factors associated with increased three-month mortality in these critically ill patients will be studied.

Detailed description: Objective The objective was to analyze the outcomes of thoracoscopic mesh repair for hepatic hydrothorax (HH) at the institution of the investigators during the past 10 years.

Methods A total of 63 patients with refractory HH, who underwent thoracoscopic mesh onlay reinforcement to repair diaphragmatic defects from January 2005 to December 2014, were included in the study. Mesh covering alone was used in 47 patients and mesh with suturing was used in 16 patients. Patient demographics, Child-Pugh class, and model for end-stage liver disease (MELD) score were evaluated to predict morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* patients with refractory hepatic hydrothorax (\> 3 times thoracentesis and failure to maximal doses of diuretics)

Exclusion Criteria:

* Patients with systemic bacteremia, positive culture of bacteria of pleural effusion or ascites were excluded from the study because of potential mesh contamination.

Primary outcomes:
measure: one-month mortality
timeFrame: one month
measure: three-month mortality
timeFrame: three month
Secondary outcomes:
measure: recurrence of hepatic hydrothorax
timeFrame: 20.5 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Surgery, National Taiwan University Hospital
name: Pei-Ming Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01947088: Effect of Music Therapy on Cognitive Recovery
Official title: I. The Effect of Music Therapy on Cognitive Recovery From Pediatric Epilepsy Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy, seizure disorder
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participation in music therapy will result in improvement in cognitive functioning, as measured by neuropsychological testing 9-12 months following surgery.

Detailed description: Music therapy could have a significant impact on clinical outcomes for patients with epilepsy. One study found that epilepsy patients who received music therapy for six months or greater had a significant reduction in number of seizures and could potentially aid in decreasing medication dosage. The investigators would like to contribute to this sort of research, but focus on what effect music therapy has on a patient's cognitive recovery after undergoing epilepsy surgery. Although research exists regarding music therapy on memory and communication, its overall effect on this patient population is unclear.

The Dell Children's Epilepsy program hopes that this research project on memory and communication will have a positive effect on their patients with epilepsy.

Eligibility criteria: Inclusion Criteria:

* Between 6-16 years of age
* Will undergo either a brain resection or lobectomy

Exclusion Criteria:

* Pre-surgical Full Scale IQ below 70
* Primary language is not English
* Hearing or vision impairments
* Parental consent cannot be obtained

Primary outcomes:
measure: Participation in music therapy will result in improvement in neuropsychological scores 12 months following surgery for music therapy study group.
timeFrame: 12 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
Study officials:
affiliation: Seton Healthcare Family
name: Jennifer Townsend, MMT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02660788: A Randomized Trial of Letters From Family Physicians to Encourage Screening Mammography in Overdue Women
Official title: A Randomised Study of Screening Mammography Return Rates in Overdue Women Due to Standard Screening Mammography Program of British Columbia (Smpbc) Reminders Versus Reminder Letters Signed by Women's Family Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: 6-24 months overdue
screening mammography
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2016-01-21
Enrollment: 5498
Sex: FEMALE
Minimum age (years): 51
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized, double-blinded study conducted in British Columbia, Canada, where there is a publicly funded, organized screening program and screening mammography is recommended at 24-month intervals. Eligible women aged 51-73 years old and overdue for their screening mammogram by 6-24 months are identified in the database of the Screening Mammography Program of BC (SMPBC). Family physicians are recruited by mail and asked to sign letters to the overdue women in their practices. The overdue women are randomized and mailed either the signed reminder letter and the standard reminder postcard, or the standard reminder postcard alone. The primary endpoint is the proportion of overdue women attending a screening mammogram appointment 6 months after the mailing.


Eligibility criteria: Inclusion Criteria:

Active family physicians (family physicians, general practitioners or primary care physicians) who have overdue women in their practice that meet the following criteria:

* Previously been enrolled in the SMPBC and had a previous normal screening mammogram.
* Have agreed to being contacted for research on the SMPBC questionnaire
* Are 6-24 months overdue from their last screening mammogram
* Live in BC
* Have listed an active family physician as the contact to receive their mammography results

Exclusion Criteria:

* Family physicians who do not work in primary care
* Family physicians who do not have overdue women in their practice

Primary outcomes:
measure: Percentage of Overdue Women Returning for Screening Mammography
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Alan Nichol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan EK, Wilson C, Tyldesley S, Olivotto IA, Lai A, Sam J, Harry R, Nichol A. Signed family physician reminder letters to women overdue for screening mammography: A randomized clinical trial. J Med Screen. 2018 Sep;25(3):149-154. doi: 10.1177/0969141317719921. Epub 2017 Nov 20.
Clinical trial NCT03523988: Pre-emptive Analgesics in Orthodontic Treatment
Official title: Effects of Pre-emptive Use of Combined Ibuprofen and Acetaminophen on Pain Control in Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: NSAID
Pain Management
Keywords: Pre-emptive analgesics
Acetaminophen
Ibuprofen
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 73
Sex: ALL
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients of the University of Washington Graduate Orthodontics Clinic
Primary purpose: TREATMENT

Brief summary: This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone.

Detailed description: This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone. Before their orthodontic appointment, participants will be administered acetaminophen (650mg), ibuprofen (400mg), or acetaminophen (650mg) + ibuprofen (400mg). Participants will be asked to record their pain intensity using a numerical (0-10) visual analog scale (VAS) during rest, light biting, and while chewing paraffin wax during the following time intervals: immediately following drug administration, 6 hours after, the morning after, and the second morning after orthodontic treatment.

Eligibility criteria: Inclusion Criteria:

-Orthodontic patient presenting for orthodontic treatment

Exclusion Criteria:

* History of taking an analgesic in the past six hours
* Hypersensitivity to ibuprofen or acetaminophen
* Aspirin-sensitive asthma
* Renal or liver impairment
* History of GI bleeding or ulcers
* Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery
* Currently taking antibiotics or other medications for a chronic systemic disease
* Bleeding disorder
* Pregnant or nursing

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment
timeFrame: 6 hours after orthodontic treatment
measure: Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment
timeFrame: 1 day after orthodontic treatment
measure: Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment
timeFrame: 2 days after orthodontic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Anne-Marie Bollen, DDS, MS, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04730388: ATEZOLIZUMAB - BEVACIZUMAB in the Treatment Hepatocellular Carcinoma Inoperable or
Official title: Evaluation of the Efficacy and Tolerance of the Association ATEZOLIZUMAB - BEVACIZUMAB in the Treatment of a Locally Advanced Hepatocellular Carcinoma Inoperable or Metastatic in Finistère
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Hepatocellular Carcinoma
Keywords: ATEZOLIZUMAB, BEVACIZUMAB , Advanced hepatocellular carcinoma
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatocellular carcinoma locally advanced or metastatic in first line of systemic treatment

Brief summary: Evaluation of the efficacy and safety of the combination ATEZOLIZUMAB - BEVACIZUMAB in the treatment of locally advanced inoperable or metastatic hepatocellular carcinoma in Finistère

Detailed description: Patients treated by ATEZOLIZUMAB and BEVACIZUMAB for an Advanced hepatocellular carcinoma will be followed to observed their safety and the efficacy of this treatment, and to identify prongnosis factors

Eligibility criteria: Inclusion Criteria:

* hepatocellular carcinoma locally advanced or metastatic, non able to be resectable, with no prior systemic treatment
* Child Pugh A and ECOG 0 or 1
* upper digestiuve endoscopy less than 6 months, if esophageal varcices : must be treated
* non eligible to receive a locoregional therpay or progressive after this kinf of treatment
* with informed consent

Exclusion Criteria:

* refuse to participate
* under legal protection
* exclusion criteria from the tempory utilisation authorization

Primary outcomes:
measure: predictive factor for progression-free survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04511988: Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal
Official title: Evaluation of Clonal Heterogeneity and Tumor Evolution Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: BOVARY-CE is a monocentric, pilot, longitudinal, real-life study with a total duration of 36 months. The purpose of this study is to assess the feasibility of using liquid biopsy as a substitute for tissue multisampling, in order to describe clonal heterogeneity and tumor evolution in patients with ovarian cancer. The method involves the inclusion of 20 patients with high-grade ovarian adenocarcinoma, fallopian tubes or primary peritoneal origin, not pretreated, newly diagnosed, and eligible for treatment who will participate in the research. These patients will have several samples throughout their treatment for a period of 2 years: blood samples which will be taken at each therapeutic moment of interest.

Tissue samples which will be taken at the time of the diagnostic laparoscopy and at the time of surgery.

The concentration of cfDNA and tumor heterogeneity will be used to predict disease-related events defined as relapse, progression or death.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient with non-treated high grade serous and endometrioid carcinoma of ovarian, fallopian tube, or primary peritoneal origin proven cytologically or histologically at inclusion and eligible for treatment
* Patient eligible for an upfront surgery or pretherapeutic coelioscopy
* Adequate haemoglobin rate ≥ 9 g/dL
* Patient affiliated to a social security scheme
* Ability to provide written informed consent

Exclusion Criteria:

* Age \< 18 years
* Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
* Contraindication to blood samples of 20 mL
* Pregnant or breast-feeding women
* Ongoing treatment for the newly diagnosed cancer or the recurrence
* Other cancers treated within the last 5 years
* Patient under guardianship or curatorship or deprived of liberty

Primary outcomes:
measure: Using the concentration of cfDNA to predict disease events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: LEUFFLEN Léa, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00801788: Single Dose Pharmacokinetics of Egalet® Oxycodone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Egalet Ltd
Sponsor class: INDUSTRY
First posted: 2008-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® oxycodone formulations and compare to a marketed oxycodone product.


Eligibility criteria: Main inclusion criteria:

* ≥18 years and ≤55 years
* Non-smoker
* BMI ≥18.0 and ≤30.0

Main exclusion criteria:

* Any clinically significant abnormality or abnormal laboratory test results found during medical screening
* History of allergic reactions to opioids or other related drugs
* History of significant alcohol abuse or drug abuse
* Use of any drugs known to inhibit hepatic drug metabolism
* Pregnant or breast-feeding

Primary outcomes:
measure: To evaluate pharmacokinetics of Egalet® oxycodone. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el,Kel,AUC 0-12 and AUC 0-24.
timeFrame: Single-dose evaluation
Secondary outcomes:
measure: To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring.
timeFrame: Single-dose evaluation
Other outcomes:
Locations:
city: Quebec
country: Canada
Study officials:
affiliation: Egalet A/S
name: Christine Andersen, M.Sc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02307188: Multipolar Mapping and Atrial Arrhythmias
Official title: Atrial Signal Analysis Using a Multipolar Catheter in Patients Undergoing Atrial Fibrillation and Flutter Ablations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation or Atrial Flutter
Keywords: Atrial Fibrillation
Atrial Flutter
Multipolar Catheter
Atrial Arrhythmia
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 5
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the left and right atria to explore atrial signal characteristics that can guide atrial fibrillation and atrial flutter ablation procedures more effectively.

Detailed description: Atrial fibrillation (AF) and atrial flutter (AFL) are the most common cardiac arrhythmias in adults, and account for a substantial portion of patient morbidity and healthcare expenditures. Great effort has been put forth to discover effective treatments for AF/FL. Promising results of catheter ablation suggest that AF/FL may be eliminated in a majority of patients. For example, data from numerous laboratories shows that up to 85 percent of patients with the paroxysmal form of AF may be free of recurrences and off anti-arrhythmic drugs at one year follow-up.

Eligibility criteria: Inclusion Criteria:

Patients referred to the PI (Dr. Biviano) or co-investigators in the Program of Cardiac Electrophysiology at Columbia University Medical Center who are scheduled to undergo ablation will be approached for recruitment:

* Older than 45 years of age
* History of AF and/or AFL and are candidates for catheter ablation.

Exclusion Criteria:

Patients not fitting the above clinical criteria or unwilling to comply with the instructions of the monitor are excluded, as well as patients with the following:

* Permanent leads or prosthetic or stenotic valves present
* Active systemic infection
* Echocardiographically-confirmed visual presence of thrombus
* For whom the inability of obtaining vascular access exists
* Heparin-induced thrombocytopenia
* Hemodynamic instability or shock

Primary outcomes:
measure: Atrial Fibrillation Dominant Frequency
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Angelo B Biviano, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: