louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03990064: Benefits of Relaxation by Music Therapy on PTSD Symptoms
Official title: Exploration of Cerebral Metabolism and Connectivity in Post Traumatic Stress Disorder (PTSD): Exploratory Study of Neurofunctional Modulation of Emotions by Music Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Disorder, Post Traumatic
Keywords: effective connectomic neurological soft signs
Lead sponsor: Institut de Recherche Biomedicale des Armees
Sponsor class: OTHER_GOV
First posted: 2019-06-18
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: musicotherapy versus waiting list
Primary purpose: SUPPORTIVE_CARE

Brief summary: PTSD is a debilitating mental disorder that may develop after experiencing or witnessing a life-threatening event. With appropriate care, treatment efficiency is variable and around 20% of the patients do not respond to psychological treatment. Complementary treatments are needed.

as PTSD implied autonomic nervous system (ANS) dysfonction, complementary treatment focusing on ANS regulation, as welle as musicotherapy, may have an interest.

Detailed description: The aim is to evaluate the impact of musicotherapy on PTSD symptoms, and severity using a RCT Symptoms will be evaluated using questionaires (PCL and quality of life) severity will be measured using neurological soft signs assessment, connectomic functions and ANS regulation

Eligibility criteria: Inclusion Criteria:

* PTSD

Exclusion Criteria:

* neurological diseases
* addiction

Primary outcomes:
measure: change in PTSD symptoms
timeFrame: change from PTSD symptoms at two months and at six months
Secondary outcomes:
measure: change in neurological soft signs
timeFrame: change from neurological soft signs at two months and at six months
measure: change in effective connectomic
timeFrame: change from effective connectomic at two months and at six months
measure: Autonomous nervous system regulation
timeFrame: change from Autonomous nervous system regulation at two months and at six months
measure: change in biological stress
timeFrame: change from biological stress at two months and at six months
Other outcomes:
Locations:
city: Paris
country: France
facility: Marion TROUSSELARD
state: IDF
Study officials:
References:
Clinical trial NCT03901664: Lymphocyte Sub-populations and Auto Immune Diseases
Official title: Lymphocyte Sub-populations and Auto Immune Diseases : What Type of Profile ? (SPLIT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Diseases
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: autoimmune diseases (lupus and Sjogren's) or chonic infection (Whipple's disease)

Brief summary: To determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary Sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases.

Detailed description: The goal of this study is to determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary Sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases.

All patients who had an evaluation of their lymphocyte subpopulations between january 2010 and december 2016 will be included in a retrospective analysis.

Eligibility criteria: Inclusion Criteria:

* autoimmune or infectious disease

Exclusion Criteria:

* No

Primary outcomes:
measure: Diagnosis of autoimmune disease
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT03109964: The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility
Official title: The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cyst Ovary
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.

Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2), Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian volume and antral follicle count.

Detailed description: Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent, and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.

Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH, LH, E2, Progesterone and AMH levels, and sonographic evaluation of ovarian volume and antral follicle count.

Antral follicle count will be performed on the cyst post-surgery using light microscopy. The difference in hormone levels, especially AMH reflects the damage done during surgery to the ovarian reserve. Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve.

Eligibility criteria: Inclusion Criteria:

* Female patients with benign ovarian cysts that are interested in future fertility ages 18-44.

Exclusion Criteria:

* Female patients with malignant ovarian cysts/masses.

Primary outcomes:
measure: Decline in ovarian reserve.
timeFrame: Up to 6 months.
Secondary outcomes:
measure: Sonographic decline in ovarian volume
timeFrame: Up to 6 months
measure: Sonographic decline in ovarian antral follicle count
timeFrame: Up to 6 months
measure: Changes in FSH levels
timeFrame: Up to 6 months.
measure: Changes in LH levels
timeFrame: Up to 6 months
measure: Changes in Progesterone levels
timeFrame: Up to 6 months
measure: Changes in E2 levels
timeFrame: Up to 6 months
measure: Number of antral follicles in the cyst removed from the ovary.
timeFrame: Up to 6 months.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871164: Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency
Official title: Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Tumor
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-05-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 18 to be treated for pancreatic tumor by ultrasound-guided radiofrequency with fine needle

Brief summary: The purpose of the study is to evaluate the oncological efficacy of pancreatic radiofrequency by the objective response rate (complete and partial responses according to RECIST 1.1.), 5 years after the end of treatment.

Detailed description: This is a prospective, longitudinal, open, non-randomized, non-interventional, multicenter study on ultrasound-guided radiofrequency endoscopy for the treatment of pancreatic tumours. The study will be offered prospectively to all patients in need of treatment. They will be taken care of in accordance with current practice.

The patient will be seen again 7 times after the end of the pancreatic radiofrequency (which will include one or two sessions): the follow-ups will be done according to current practice on D15 ± 7 days, M6 ± 14 days, M12 ± 1 month then annually until M60 ± 1 month.

The study consists to evaluate the oncological efficacy at 5 years of pancreatic radiofrequency delivered by means of a needle guided by ultrasound endoscopy.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old;
* Patient to be treated for a pancreatic tumor by ultrasound-guided RF with a fine needle;
* Indication of pancreatic radiofrequency validated in a Multidisciplinary Consultation Meeting;
* Patient able to understand the information related to the study;
* Patient accepting study follow-up visits;
* Patient having been informed and agreeing to participate in the study.

Exclusion Criteria:

* Patient with a contraindication to radiofrequency treatment;
* Pregnant or breastfeeding women

Primary outcomes:
measure: Carcinological efficacy of pancreatic radiofrequency
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toulon
country: France
facility: CHI Toulon La Seyne
Study officials:
References:
Clinical trial NCT03567564: Abdominal Muscle Thickness in Mechanically Ventilated Patients
Official title: Abdominal Muscle Thickness in Mechanically Ventilated Patients During Spontaneous Breathing Trials
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle Weakness
Weaning Failure
Keywords: abdominal muscles
spontaneous breathing trial
critically ill patients
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2018-06-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Mechanically ventilated in ICU

Brief summary: The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.

Detailed description: The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.

Eligibility criteria: Inclusion Criteria:

* greater than 18 years old
* Patients requiring invasive mechanical ventilation including patients with endotracheal tube and tracheotomies

Exclusion Criteria:

* Patients with a previously diagnosed neuromuscular disorder (acute or chronic)
* Behavioural agitation
* Patients who are not awake and cooperative
* Previously enrolled in the study

Primary outcomes:
measure: Correlation between thickening fraction and SBT outcome
timeFrame: Measurements will be performed before SBT
Secondary outcomes:
measure: Correlation between the pressures generated by respiratory muscles and SBT outcome
timeFrame: Measurements will be performed before SBT
measure: Inter-rater agreement
timeFrame: Measurements will be performed before SBT
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital Research Institute
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
Study officials:
affiliation: University Of Brescia, Spedali Civili di Brescia
name: Simone Piva, M.D.
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Ewan Goligher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schreiber AF, Bertoni M, Coiffard B, Fard S, Wong J, Reid WD, Brochard LJ, Piva S, Goligher EC. Abdominal Muscle Use During Spontaneous Breathing and Cough in Patients Who Are Mechanically Ventilated: A Bi-center Ultrasound Study. Chest. 2021 Oct;160(4):1316-1325. doi: 10.1016/j.chest.2021.05.053. Epub 2021 Jun 6.
Clinical trial NCT00164164: HalfLytely Bowel Prep System for Colonoscopy
Official title: HalfLytely Bowel Prep System for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Keywords: colonoscopy preparation
prep
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients at least 18 years of age
* All women of childbearing potential (this includes women who are single and women whose sexual partners have been vasectomized) are required to use medically acceptable contraception during their participation in the study.
* In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent
* Patient is undergoing a colonoscopy for a routinely accepted indication

Exclusion Criteria:

* ileus
* possible intestinal obstruction or perforation
* prior alimentary tract surgery
* significant gastroparesis or gastric outlet obstruction
* impaired consciousness that predisposes a patient to pulmonary aspiration

Primary outcomes:
measure: Efficacy - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner
Secondary outcomes:
measure: Safety - Review of preparation symptoms, adverse events, and laboratory testing
Other outcomes:
Locations:
city: Braintree
country: United States
state: Massachusetts
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Charles Brady, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01906164: Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing, Multiple Ascending Dosing and Food-effect in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: RSV
Lead sponsor: Alios Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, 18-55 years of age, in good health with screening laboratory values within limits specified by the protocol
* Body mass index 18-30 kg/m2
* Female subjects must be of non-childbearing potential; male subjects must be surgically sterile or practicing birth control

Exclusion Criteria:

* Clinically significant or uncontrolled medical illness
* Use, or anticipated use during conduct of the study, of concomitant medications

Primary outcomes:
measure: Safety data including, but not limited to, tabulation of adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urine)
timeFrame: 11 days
Secondary outcomes:
measure: PK parameters of ALS-008176 and metabolites in plasma following single dose administration: Cmax, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h, AUC0-inf or AUC0-last
timeFrame: 11 days
measure: PK parameters of ALS-008176 and metabolites in plasma following repeat dose administration: Cmax, Cmin, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h , AUC0-last and AUC0 tau
timeFrame: 11 days
measure: Urinary excretion and concentrations of ALS-008176 and metabolites after a single oral dose and multiple doses in healthy volunteers in fasted conditions
timeFrame: 11 days
measure: PK parameters of ALS-008176 and metabolites in plasma after a single oral dose in healthy volunteers in fasted conditions as compared with fed conditions: Cmax, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h, AUC0-inf or AUC0-last
timeFrame: 11 days
Other outcomes:
Locations:
city: Rennes
country: France
facility: Investigational Site
Study officials:
affiliation: Alios BioPharma
name: Matthew McClure, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02093364: A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)
Official title: A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis
Post-traumatic Deformity or Arthroses
Failed Open Reduction Internal Fixation (ORIF) of a Radial Head Fracture
Failed Conservative Radial Head Fracture Treatment
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care centers

Brief summary: The purpose of this focused registry is to evaluate the clinical implications of the RHP position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the RHP with a straight and curved stem.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Use of a short-or long-stemmed DePuy Synthes Radial Head Prosthesis due to any of the following indications:

  * Fresh fracture of the radial head which is not amendable to an adequate -steosynthesis
  * Post-traumatic deformity or arthroses
  * Failed open reduction internal fixation (ORIF)
  * Failed conservative radial head fracture treatment
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information / Informed Consent Form
  * Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
  * Signed and dated Ethics Committee (EC) / Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria:

* Active infection at the affected elbow
* Any not medically managed severe systemic disease
* Pregnancy
* Prisoner
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

Primary outcomes:
measure: Evaluation of the functional outcome
timeFrame: 12 Months
Secondary outcomes:
measure: Evaluation of functional outcome
timeFrame: 24 months
measure: Range of motion
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06583564: The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer
Official title: A Single Center Randomized Controlled Study of the Prognosis After Indocyanine Green Fluorescence-guided Radical Surgery in Colorectal Cancer Patients of Stage III
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer Stage III
Keywords: Colorectal cancer
Indocyanine green
prognosis
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of stage III colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging


Eligibility criteria: Inclusion Criteria:

* age \&gt; 18 years,
* confirmed diagnosis of primary CRC,
* preoperative tumor stage of cT1 to cT4, N+, M0 as determined by contrast-enhanced computed tomography (CT),
* no distant metastasis, and
* American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3

Exclusion Criteria:

* history of previous colorectal surgery, emergent surgery, or palliative resection;
* pregnancy or breastfeeding;
* allergy or history of an adverse reaction to ICG
* severe mental disorder.

Primary outcomes:
measure: Disease-free survival (DFS) rate
timeFrame: From radical surgery to the end of follow-up ,up to 36 months
Secondary outcomes:
measure: the number of harvested lymph nodes
timeFrame: From radical surgery to the end of perioperative period at 1 month
measure: Postoperative complications
timeFrame: From radical surgery to the end of perioperative period at 1 month
measure: Overall survival rate
timeFrame: From radical surgery to the end of follow-up ,up to 36 months
Other outcomes:
Locations:
city: Changning
country: China
facility: Shanghai Tongren Hospital
state: Shanghai
Study officials:
References: