louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04346810: Burnout Among Caregivers Facing COVID-19 Health Crisis at a Non-conventional Intensive Care Unit Compared to a Conventional Intensive Care Unit
Official title: Burnout Among Caregivers Facing COVID-19 Health Crisis at a Non-conventional Intensive Care Unit Compared to a Conventional Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Burnout, Caregiver
Intensive Care Unit
Stress, Psychological
Lead sponsor: Hôpital Raymond Poincaré
Sponsor class: OTHER
Collaborators: name: Dominique FLETCHER MD-PhD
name: Guillaume GERI MD-PhD
name: Clement DURET MD
First posted: 2020-04-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers working in the recovery room shifted into an intensive care unit or in the conventional intensive care unit

Brief summary: The intense health crisis due to COVID-19 led to a profound reorganization of the activities at theatres, recovery rooms and the intensive care units. The caregivers are facing several issues and are daily exposed to an intensification of the work. Assessing the stress and the well-being of the caregivers is very important in this context.

Detailed description: The current period of intense and prolonged health crisis has necessitated a profound reorganization of the activities and organizations of the intensive care hospital services in order to be able to cope with it.

Caregivers are at the heart of the management of this crisis and are exposed daily to these situations of repeated emergencies, an intensification of the pace of work and difficulties in care.

In this context, it seemed important to us to try to quantify this pressure of care, in order to be able to offer in second care adapted to caregivers who would like it.

The assessment of the mental state of the caregivers as well as the collection of the feelings and perceptions on the current crisis and its management will be carried out by anonymous and voluntary self-questionnaire in collaboration with the service of professional pathologies and occupational medicine of the hospital structure

Eligibility criteria: Inclusion Criteria:

* Consent to participation; caregivers working at recovery room; caregiver working at intensive care unit

Exclusion Criteria:

* refusal of participation

Primary outcomes:
measure: Stress in a recovery room transformed into an intensive care unit versus a conventional intensive care unit
timeFrame: A 3 months period from the starting of the pandemic
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Staloff J, Diop M, Matuk R, Riese A, White J. Caring for Caregivers: Burnout and Resources for Caregivers in Rhode Island. R I Med J (2013). 2018 Nov 1;101(9):10-11. No abstract available.
citation: Pastores SM. Burnout Syndrome in ICU Caregivers: Time to Extinguish! Chest. 2016 Jul;150(1):1-2. doi: 10.1016/j.chest.2016.03.024. No abstract available.
Clinical trial NCT01220414: Attenuation of Pain in Men and Women
Official title: Attenuation of Pain in Men and Women: Mechanisms of Exercise-Induced Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women.


Eligibility criteria: Inclusion Criteria: Healthy men and women

-

Exclusion Criteria:

* current cardiac or other chronic diseases (e.g., cancer, diabetes, hypertension, kidney disease); routine use of prescriptive medications; history of vasovagal response to phlebotomy; an allergy to naltrexone; pregnancy; current smokers; current use of recreational drugs; history of substance abuse

Primary outcomes:
measure: Time for Subject to Reach Pain Threshold
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
References:
Clinical trial NCT02520414: Symphion® System In-Office Study
Official title: A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Leiomyomas
Endometrial Polyps
Lead sponsor: Minerva Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-11
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.

Detailed description: The purpose is to determine the safety and feasibility of using an intrauterine tissue resection system in the office setting, as well as to expand the national discussion regarding in-office hysteroscopic procedures as it relates to the highest standards of care and cost containment.

Eligibility criteria: Inclusion Criteria:

* Subjects must meet the approved Instructions for Use for the Symphion® bipolar hysteroscopic tissue resection system
* Confirmation hysteroscopic evaluation to access appropriate pathology type and size meets the Protocol guidelines for inclusion
* Subject has signed written Informed Consent

Exclusion Criteria:

* Subjects who are pregnant
* Subjects who have an active genital tract infection (as assessed by the physician)
* Subjects who have cervical malignancies
* Subjects who have previously been diagnosed with endometrial cancer
* Subjects who have Type 2 intracavitary myomas
* Type 0 or 1 intracavitary myoma greater than 3.0 cm

Primary outcomes:
measure: Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Center for Women's Surgery
state: New Mexico
Study officials:
References:
Clinical trial NCT04021914: Feasibility of EnChroma Use in the Emergency Department Setting
Official title: Demonstrating Feasibility of Color Vision Deficient Provider Use of EnChroma Products in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Color Vision Defects
Keywords: CVD
color vision deficiency
healthcare providers
emergency department
Enchroma glasses
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 6
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 study addresses whether the use of EnChroma products are feasible for use in the emergency department by color vision deficient providers.

Detailed description: This study addresses whether it is feasible for color vision deficient (CVD) physicians and other healthcare providers to wear EnChroma products in the clinical setting. It is known that color vision is important to the practice of medicine. Identifying red skin or red ear drums, noticing whether lips have turned blue or a patient is pale, and identifying colors under a microscope all are aided by or dependent upon color vision. While color vision deficiency does not preclude a person from becoming and succeeding as a physician, it may be appropriate and desired to utilize devices to improve color vision during patient care.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Red-Green color deficiency

Exclusion Criteria:

* Achromatopsia
* Cataracts
* Glaucoma
* Legal blindness
* Macular degeneration
* Retinitis Pigmentosa

Primary outcomes:
measure: Overall Quality of Color Vision Perception Based on Patients' Description
timeFrame: 2 weeks post-intervention
measure: Overall Quality of Color Vision Perception in Normal Daylight Based on Patients' Description
timeFrame: 2 weeks post-intervention
measure: Overall Quality of Color Vision Perception in Dim Light Based on Patients' Description
timeFrame: 2 weeks post-intervention
measure: Number of Participants Reporting More Positive Than Negative Comments About the Use of the EnChroma Glasses
timeFrame: 2 weeks post-intervention
Secondary outcomes:
measure: Number of Participants That Reported an Impact of Using the Glasses on Patient Care
timeFrame: 2 weeks post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
Study officials:
affiliation: Emory Univer
name: Jeffrey Siegelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04799314: PD-1 Inhibitor Tislelizumab Maintenance Therapy in R/R DLBCL Patients After ASCT
Official title: PD-1 Inhibitor Tislelizumab Maintenance Therapy in Relapsed/Refractory DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lymphoma, Large B-Cell, Diffuse
Transplantation
Chemotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 132
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: This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT).

Detailed description: This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT). 94 patients were randomly divided into two groups according to the ratio of 1:1. The whole trial included screening period (day-28 to day-1), treatment period (Tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).

Eligibility criteria: Inclusion Criteria:

1. Male and female, aged 18-65;
2. relapsed/refractory DLBCL patients after autologous stem cell transplantation;
3. Laboratory tests (blood tests, liver and renal function) meet the following requirements:

   1. Blood tests: white blood cell count ≥ 3.0 × 109 / L, absolute neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 90g / L, platelet ≥ 75 × 109 / L
   2. Liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value;
   3. Renal function: serum creatinine 44-133 mmol / L;
4. The score of ECOG was 0-2;
5. The subject or his legal representative must provide written informed consent before the special examination or procedure of the study.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Severe complications or infection;
3. Lymphoma involving central nervous system;
4. Participate in other clinical trials at the same time;
5. According to the judgment of the researcher, the patients who are not suitable for this study were selected.

Primary outcomes:
measure: progression-free survival
timeFrame: 2-years after enrollment
Secondary outcomes:
measure: complete remission rate
timeFrame: 90 days after 12 cycles of treatment (each cycle is 8 weeks).
measure: overall survival
timeFrame: 2-years after enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Shanghai, Shanghai, China, 200020
name: Weili Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04393714: Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation
Official title: Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation. Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split-mouth prospective randomized clinical trial with 1:1 assignment
Primary purpose: TREATMENT

Brief summary: The reduction in alveolar bone dimensions is an inevitable outcome after tooth extraction due to the healing events that results in bone modeling/remodeling. Alveolar ridge preservation is a successful approach that aids in reducing these changes greatly. Various techniques have been employed to achieve that outcome utilizing bone grafts and/or membrane. Dentin graft is a promising type that can overcome many of the limitations facing mainstream grafts. Autogenous source serve the advantage of providing graft with no cross-infection risk or immunogenicity. Moreover, the unique structure of dentin makes it suitable for osteoinduction and osteoconduction that yields favorite bone regeneration outcomes. Demineralization of dentin is essential to release trapped growth factors, expose collagen fibrils and enhance the grafts degradability and replacement by native tissues. Many acids have been investigated for the use in chairside preparation of the dentin graft and hence, clinicians are faced with different choices but little evidence regarding the acid which yield s better outcomes.


Eligibility criteria: Inclusion Criteria:

* Non-restorable teeth
* medically healthy
* able to provide informed consent and attend follow-up period

Exclusion Criteria:

* pregnant
* smokers or alcoholic
* severe bone loss

Primary outcomes:
measure: Radiographic bone changes
timeFrame: 6 months
Secondary outcomes:
measure: histological analysis
timeFrame: 6 months
measure: soft tissue healing
timeFrame: Biweekly for 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00651014: Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10mg or 20mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease and/or Type II Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypercholesterolemia
Atherosclerosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Merck Frosst Canada Ltd.
First posted: 2008-04-02
Enrollment: 82
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: The study was designed to assess whether 6 weeks of co-administration of ezetimibe and simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD risk strata of the NCEP III guidelines to achieve their LDL-C target goal of \<=3.0 mmol/L. As this study was to be conducted in Canada, the target LDL-C goal for patients with CHD, or type II diabetic patients \>30 years old with no CHD, was \<2.5 mmol/L.


Eligibility criteria: Inclusion Criteria:

* \>=18 years of age and treated with simvastatin 10 mg or 20 mg for at least 6 weeks and LDL-C levels of \> 2.5 mmol/L to \<=4.20 mmol/L (97 mg/dL to 160 mg/dL) at Visit 1.
* history of coronary heart disease (type II diabetic patients \> 30 years old with no CHD)
* triglycerides \<= 4.00 mmol/L drawn, and liver transaminases (ALT, AST) \<=50% above the upper limit of normal at Visit 2, with no active liver disease, and/or creatine kinase (CK) \<=50% above the upper limit of normal

Exclusion Criteria:

* subjects with Body Mass Index \>=35 kg/sqm at Visit 1
* alcohol consumption \> 14 drinks per week
* pregnant or lactating
* treated with any other investigational drug within 30 days prior Visit 1
* previously treated with ezetimibe or participated in a clinical study with ezetimibe
* any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study

Primary outcomes:
measure: Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint.
timeFrame: 6 weeks
Secondary outcomes:
measure: Percent change from baseline to endpoint in LDL-C.
timeFrame: 6 weeks
measure: Percent change from baseline to endpoint in total cholesterol (TC) triglycerides, HDL-C, non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C ratio, and apolipoprotein B.
timeFrame: 6 weeks
measure: Safety/tolerability: adverse events, laboratory test results, vital signs.
timeFrame: Throughout study
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00173914: The Association of Endothelial Dysfunction and Cardiac Allograft Vasculopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplantation
Keywords: 1. Transplant vasculopathy
2. Endothelial dysfunction
3. Myocardial perfusion imaging
4. Intravascular vascular ultrasound
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Progressive cardiac allograft vasculopathy (CAV) is a serious complication in long-term survivors after heart transplantation. Therefore, we hypothesize that CAV is a diffuse and progressive process, and endothelial function may play an important role in predicting clinical outcome after heart transplantation. Therefore, this single-blinded study is designed to evaluate endothelial function, microvascular flow response and morphology of coronary artery in cardiac allografts,

1. The simultaneous use of IVUS and Doppler wire instrumentation in different pharmacological stress;
2. Tl-201 SPECT (dipyridamole stress/rest); to evaluate the correlation of endothelial function, coronary morphology change and Tl-201 dipyridamole stress myocardial perfusion image.


Eligibility criteria: Inclusion Criteria:

1. Heart transplant receipients who undergoing the coronary angiographic follow-up as standard protocols.

Exclusion Criteria:

1. Acute illness conditions including infection, congestive heart failure (NYHA Fc III, IV), etc.
2. Coronary angiographic finding: coronary stenosis\>30% (as grade III, IV by Klauss V et al, Am J Cardiol 1995; 76:463-6).
3. Creatinine \>3.0 mg/dl

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chii-Ming Lee, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00991614: EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet Obstruction Caused by Malignant Neoplasms
Official title: Treatment of Duodenal or Gastric Outlet Obstruction and Duodenal Strictures Caused by Malignant Neoplasms With the EVOLUTION® Duodenal Stent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenal Obstruction
Gastric Outlet Obstruction
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2009-10-08
Enrollment: 110
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: Patients who are referred into regional specialty centers for treatment of GI malignancy.

Brief summary: The objective of this investigation is to compile clinical experience on the use of the Evolution® Duodenal Stent (Cook Ireland), a CE marked device intended for the palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms. It is not the goal to change the usual treatment practice of the investigator or the center, nor to collect information on uses outside the product's indications. Patients will be treated as per usual medical practices.


Eligibility criteria: Inclusion Criteria:

* Patients for whom this device would be chosen in standard practice

Exclusion Criteria:

* Patients for whom this device would not normally be chosen in standard practice

Primary outcomes:
measure: Patency of the stent
timeFrame: 14 days
Secondary outcomes:
measure: Procedural success, implant duration, symptom resolution
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Westmead Hospital
city: Montreal
country: Canada
facility: Hopital Saint-Luc / CHUM
state: Quebec
city: Praha
country: Czech Republic
facility: Institution for Clinical and Experimental Medicine
city: Milan
country: Italy
facility: IRCCS Instituto Clinico Humanitas
city: Rome
country: Italy
facility: U.O. Endoscopia Digestiva Chirurgica
city: Rotterdam
country: Netherlands
facility: Erasmus MC University Medical Center
Study officials:
affiliation: U.O. Endoscopia Digestiva Chirurgica
name: Professor Guido Costamagna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tringali A, Didden P, Repici A, Spaander M, Bourke MJ, Williams SJ, Spicak J, Drastich P, Mutignani M, Perri V, Roy A, Johnston K, Costamagna G. Endoscopic treatment of malignant gastric and duodenal strictures: a prospective, multicenter study. Gastrointest Endosc. 2014 Jan;79(1):66-75. doi: 10.1016/j.gie.2013.06.032. Epub 2013 Aug 6.
Clinical trial NCT04430114: MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms
Official title: DediCated MuLtibranchEd DacrOn Graft for OPen RepAir of ThoRacoabdominal Aneurysms - CLEOPATRA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysm Abdominal
Aneurysm Thoracic
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec "TAAA spinal loop graft" "custom made "CE equivalent" branched prosthesis, compared with the patient cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli Thoracoabdominal Grafts.


Eligibility criteria: Inclusion Criteria:

* patients aged ≥ 18 years;
* patients candidates for surgical treatment of thoraco-abdominal aorta of the II and III type sec. Crawford using "TAAA spinal loop graft" "custom made CE equivalent" prosthesis

Exclusion Criteria:

• patients aged ≤ 18 years

Primary outcomes:
measure: number of participants who obtain technical success
timeFrame: 12 month
measure: incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries
timeFrame: 12 month
measure: incidence of aneurysmal dilatation of visceral and replanted intercostal arteries
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Hospital
Study officials:
References: