louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04623476: PAtophysiological, Nodal-based Approach for Crohn's Disease Excision
Official title: PAtophysiological, Nodal-based Approach for Crohn's Disease Excision: A PILOT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Crohn's Ileocolitis
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective pilot study
Primary purpose: TREATMENT

Brief summary: Single centre prospective pilot study on surgery for Crohn's disease (CD). CD universally recurs after surgery and no technique so far has been proven to reduce recurrence.

The investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of recurrence.

Consecutive CD patients with a surgical indication for ileocolic disease will receive an extended procedure including a lymphadenectomy (Pathophysiologic excision for Crohn's disease).

Primary outcome will be endoscopic recurrence rates at 6 and 12 months from surgery.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients undergoing surgery for ileocaecal/ileocolic CD in the Minimally Invasive Unit at Policlinico Tor Vergata are eligible to be enrolled.
* Informed consent

Exclusion Criteria:

* Crohn's Disease with a different localisation
* Recurrent disease
* Extensive jejunitis
* \<18 years of age
* Cancer as primary indication for surgery
* Followed by gastroenterologists outside our centre, due to loss of follow up
* Ileostomy. If a patient undergoes ileostomy fashioning he will be excluded from the study and this will be reported

Primary outcomes:
measure: Rate of endoscopic CD recurrence
timeFrame: 6 months
measure: Rate of endoscopic CD recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Rate of overall postoperative complications
timeFrame: 30 days
measure: Rate of major postoperative complications
timeFrame: 30 days
measure: Overall and Disease specific Quality of life
timeFrame: 6 months
measure: Overall and Disease specific Quality of life
timeFrame: 6 months
measure: Overall and Disease specific Quality of life
timeFrame: 6 months
measure: Overall and Disease specific Quality of life
timeFrame: 12 months
measure: Overall and Disease specific Quality of life
timeFrame: 12 months
measure: Overall and Disease specific Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Tor Vergata
state: RM
Study officials:
affiliation: Università di Roma Tor Vergata
name: Giuseppe S Sica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01301976: Nutritional State and Intake Nutrients Assessment in Ulcerative Colitis
Official title: Nutritional State in Ulcerative Colitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis in Remission
Keywords: nutritional state
nutrients intake
ulcerative colitis
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-02-23
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Ulcerative Colitis in remission

Brief summary: The purpose of this study is to determine the reason patients are deficient in nutrients intake such as antioxidants vitamins.


Eligibility criteria: Inclusion Criteria:

* Patients with Ulcerative Colitis in remission
* Age \> 18 yo

Exclusion Criteria:

* Patients with Ulcerative Colitis in activity
* Those patients with food intake trouble
* Those patients with bowel resected

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu
state: SP
Study officials:
References:
Clinical trial NCT02348476: A Study of Simbrinza™ Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Open-Angle Glaucoma or Ocular Hypertension treated in clinical practice.

Brief summary: This study is a retrospective chart review to assess the tolerability and efficacy of treatment with Simbrinza™ used for patients with Open-Angle Glaucoma or Ocular Hypertension.


Eligibility criteria: Inclusion Criteria:

* Participants treated with Simbrinza™ for Intra-Ocular Pressure (IOP) lowering in at least one eye
* Participants who had at least one-follow-up visit with tolerablity and efficacy data after Simbrinza™ treatment initiation.

Exclusion criteria:

* Active ocular disease other than glaucoma or ocular hypertension
* History of any intraocular surgery or glaucoma laser surgery within 3 months.

Primary outcomes:
measure: The time to first glaucoma therapy escalation occurrence or discontinuation of Simbrinza®
timeFrame: 2 Years
Secondary outcomes:
measure: The time to first glaucoma therapy escalation occurrence
timeFrame: 2 Years
measure: The time(s) to additional glaucoma therapy escalation occurrence(s)
timeFrame: 2 Years
measure: Specific AEs and SAEs occurring with a frequency of ≥5%
timeFrame: 2 Years
Other outcomes:
Locations:
city: Wheaton
country: United States
state: Illinois
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06106776: CAR-T Cell Induced Cardiac Dysfunction: A Prospective Study
Official title: PROSPECTIVE OBSERVATIONAL STUDY FOR THE ASSESSMENT OF CARDIAC DYSFUNCTION INDUCED BY CHIMERIC ANTIGEN RECEPTOR T (CAR-T) CELL THERAPY
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphoma
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by relapsed and/or refractory diffuse large B-cell lymphoma, follicular lymphoma, primary mediastinal B-cell lymphoma, mantle cell lymphoma or B-cell lymphoblastic leukemia, scheduled to receive treatment with chimeric antigen receptor-T cell therapy at the Hematology division of Policlinico Universitario Agostino Gemelli, Rome will be firstly evaluated. If they exclusion criteria are not present, the will be included in the study protocol and evaluated by the Cardio-Oncology outpatient service.

Brief summary: In this observational, prospective study, patients affected by B-cell Lymphoma and candidate to chimeric antigen receptor-T (CAR-T) cell infusion will be evaluated at three timepoints to establish the rate of cardiac dysfunction, defined according to 2022 European Society of Cardiology Cardio-Oncology guidelines. Echocardiography, physical examination and cardiac/inflammatory biomarkers will be performed prior to CAR-T cell infusion and followed at 7 days and 1 month.

Detailed description: Patients will perform clinical evaluation, transthoracic echocardiogram with speckle tracking analysis and blood samples (including cardiac biomarkers of damage and fibrosis) prior to CART infusion, after 7 days and 1 month following CART infusion. Rate of Cytokine Release Syndrome and use of interleukin-6 inhibitors will be also registered.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years old;
* Patients affected by relapsed and/or refractory diffuse large B-cell lymphoma, follicular lymphoma, primary mediastinal B-cell lymphoma, mantle cell lymphoma or B-cell lymphoblastic leukemia, candidate treatment with chimeric antigen receptor-T cell therapy at the Hematology division of Policlinico Universitario Agostino Gemelli, Rome;
* Patients with left ventricular ejection fraction \>50%.

Exclusion Criteria:

* Age\<18 years old;
* Patients who denied to participate to the study;
* Patients with left ventricular ejection fraction\<50%.

Primary outcomes:
measure: Incidence of Cancer Therapy Related Cardiac Dysfunction
timeFrame: 30 days
Secondary outcomes:
measure: Correlation with Inflammatory Biomarkers
timeFrame: 30 days
measure: Correlation with Cytokine Release Syndrome Occurrence
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01941576: Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
Official title: Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defects
Tetralogy Of Fallot
Keywords: Heart defects, Congenital
rhBNP
heart failure
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.

Detailed description: CVP(central venous pressure) and cardiac output are serious index in children with Tetralogy Of Fallot after the corrective repair.The purpose of this study is to investigate if the therapy of rhRNP can improve the survival and life quality after the corrective repair of Tetralogy Of Fallot.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained from patient's legally acceptable representative.
* Pediatric patients after Repair of Tetralogy Of Fallot.

Exclusion Criteria:

* Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
* Treatment or planned treatment with another investigational drug within 3 months of screening.
* Known hypersensitivity to bosentan or any of the excipients
* cardiogenic shock and inclination of hypotension（SBP\< 60mmHg）.

Primary outcomes:
measure: Changes from Baseline in BNP and CVP after the infusion of rhBNP
timeFrame: 12 months after operation of Tetralogy Of Fallot
Secondary outcomes:
measure: Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen
timeFrame: 12 months after operation of Tetralogy Of Fallot
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Zhuoming Xu, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05785676: ALN OATF Vena Cava Filter
Official title: Study of ALN's OATF Vena Cava Filter
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Keywords: Vena Cava Filter
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Aln2b SARL
First posted: 2023-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients requiring a vena cave filter

Brief summary: Migration of a thrombus in the pulmonary circulation is the leading cause of pulmonary embolism (PE). It can be prevented mechanically by implanting a vena cava filter (VCF) in the inferior vena cava. The implation of a VCF is indicated for patients with acute PE and a contraindication to anticoagulation, with an acute deep vein thrombosis (DVT) without PE and a contraindication to anticoagulation or with acute venous thromboembolism (less than 3 months) in whom an interventional gesture at hemorrhagic and thromboembolic risk contraindicates anticoagulation.

The purpose of this study is to describe the rates of implantation, removal and complications associated with the use of the optional ALN OATF VCF in current practice.


Eligibility criteria: Inclusion Criteria:

* Patient implanted with an ALN OATF VCF
* Patient informed

Exclusion Criteria:

* Minor patient
* Adult patient under a legal protection measure
* Pregnant, parturient or breastfeeding women
* Patient who refused to participate
* Patient who cannot or does not wish to be followed by the Interventional Radiology Department

Primary outcomes:
measure: Filter implantation
timeFrame: day 0
Secondary outcomes:
measure: Filter removal
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP - Hôpital Européen Georges-Pompidou Paris, France
state: Ile-de-France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier PELLERIN, MD - PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03783676: Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia
Official title: Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cough
Keywords: extubation
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators want to find a way to reduce or stop patients from coughing at the end of surgery when the breathing tube is taken out. The breathing tube is removed when the participants are waking up from anesthesia, and are at the point when the participants can breathe on your own. In most types of surgery, coughing at this point is common, and does not affect the participants very much, if at all. But for surgery involving the eye or the head and neck, coughing right after surgery can cause bleeding at the site of surgery.

This study will use a short-acting pain drug called remifentanil at the end of surgery to prevent coughing. The investigators will give the participants this medicine for 5 to 30 minutes. The point of the study is to test if using a simple computer program to guide precise delivery of how much of the drug is given to the participants is effective at reducing or preventing coughing.


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 and 80
2. ASA of 1-3
3. Undergoing any of the following elective cases:

   1. thyroidectomy (partial or complete)
   2. parathyroidectomy
   3. ophthalmological surgery
4. Will require endotracheal intubation.

Exclusion Criteria:

1. Lean Body Mass \< 20 kg,
2. BMI \> 45
3. Presence of pulmonary dysfunction
4. Any history of anaphylaxis to remifentanil
5. Requiring the use of total intravenous anesthesia.
6. Per the discretion of the anesthesia provider

Primary outcomes:
measure: Incidence of cough
timeFrame: Measured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 minutes
Secondary outcomes:
measure: Coughing grade
timeFrame: Measured from surgical end time to patient transfer out of room, approximetly 30 minutes
measure: Extubation time
timeFrame: Measured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutes
measure: Time to recovery
timeFrame: Measured from extubation to purposeful movement, approximetly 5 minutes and up to 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Resident
name: Elie Sarraf, MD.CM.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02237976: Self-hypnosis in Patients Awaiting Lung Transplantation
Official title: Interest of Learning Self-hypnosis in Patients Awaiting Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplantation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 78
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study is designed to utilize a self-hypnosis training program for patients awaiting lung transplantation. This technique can increase their well being, particularly by decreasing postoperative pain.


Eligibility criteria: Inclusion Criteria:

* patients aged 15 years or more requiring lung transplantation

Exclusion Criteria:

* patients who cannot participate in learning sessions of self-hypnosis for cultural , cognitive or environmental reasons
* patients who have participated in only one learning self-hypnosis session before transplantation

Primary outcomes:
measure: Pain after lung transplantation
timeFrame: one month
Secondary outcomes:
measure: Pain before and after lung transplantation
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Coping
timeFrame: 6 months
measure: Catastrophism
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Quality of life related to the procedure
timeFrame: 6 months
measure: Practice of self-hypnosis
timeFrame: 6 months
measure: Forced expiratory volume in one second
timeFrame: 6 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
state: Hauts De Seine
Study officials:
affiliation: Hopital Foch
name: Mireille Michel-Cherqui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01801176: Peripheral Primitive Fibromatosis
Official title: Peripheral Primitive Fibromatosis. Study Evaluating a Simple Initial Monitoring With Search of Scalability Predictive Factors and Registration of Treatments in Case of Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Primitive Fibromatosis
Keywords: proved by biopsy
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: It's a monitoring study. The aim is to assess the progression free survival up to 3 years. Patients are not treated until progression. Search for scalability predictive factors and registration of treatments if progression.


Eligibility criteria: Inclusion Criteria:

* Peripheral primitive fibromatosis
* Adults patients
* Peripheral primitive fibromatosis proved by biopsy
* Peripheral primitive fibromatosis R2 resected for which monitoring is decided
* MRI realized before inclusion
* Patient information and informed consent signed

Exclusion Criteria:

* Local recur
* Head and neck topography
* Primitive fibromatosis R0 or R1 resected
* Specific medical treatment of fibromatosis
* Patient already included in an other clinical trial with an experimental molecule
* Persons deprived of liberty
* Impossibility to submit to the trial's medical follow-up for psychological, geographical or socials reasons
* Previous history of cancer
* Counter indication to the realization of an MRI

Primary outcomes:
measure: Progression Free Survival
timeFrame: assessed up to 3 years
Secondary outcomes:
measure: Functional result
timeFrame: 1 year
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val de Marne
Study officials:
References:
Clinical trial NCT03097276: Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer
Official title: Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon and/or Rectal Resection With Anastomosis for Cancer
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Anastomotic fistula is the most feared complication after surgical resection of colorectal cancer (CCR). It occurs in 6 to 15% of patients. Beyond the risk of death in the immediate postoperative period, the pain that it induces, the resources required for its management, the need for stomata with a negative impact on patients' quality of life and the prolongation of hospitalization, it also has a now-recognized adverse effect on long-term survival.

The early detection of this complication may limit its impact. C-reactive protein (CRP) has proved to be an early, reliable marker of the onset of infectious complications of colorectal surgery.

However, the diagnostic procedure to implement in these patients is not at all codified, since this population concerned by systematic CRP assay in the postoperative period is very recent.

The procedures to implement in these patients so that they can obtain the maximal benefit of an early diagnosis have not yet been established. An algorithm for the proactive clinical management must be drawn up to be able to confirm or rule out the presence of a fistula as soon as a high level of CRP is detected, and to propose a quick treatment to ensure that patients benefit from this early diagnosis.


Eligibility criteria: Inclusion Criteria:

* patients aged 18 and older,
* with a CRP level \> 140 mg/L at D3 or CRP \> 125 mg/L at D4 following colon and/or rectal resection with anastomosis (protected or not by an upstream stoma)
* without clinical signs of severe peritonitis (fever, severe sepsis, generalized abdominal contracture)
* who have provided written informed consent.

Exclusion Criteria:

* patients who have undergone intraperitoneal chemotherapy in the context of the surgical treatment for peritoneal carcinomatosis
* patients with a diagnosis of another infection that could explain the high CRP level,
* patients who underwent eventration repair at the time of the colorectal resection
* patients with an obvious indication for revisit surgery
* persons without health insurance cover
* adults under guardianship
* pregnant or beast-feeding women

Primary outcomes:
measure: proportion of patients with total hospitalization of less than 15 days during the first postoperative month
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu de Dijon
Study officials:
References: