louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03436368: Continuous Spinal Anesthesia in Renal Transplantation
Official title: Continuous Spinal Anesthesia for Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Renal Failure Chronic
Transplant;Failure,Kidney
Anesthesia
Keywords: Continuous spinal anesthesia
General anesthesia
Renal transplantation
Chronic renal failure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using computer \& sealed envelope randomization, patients are assigned to receive either continuous spinal anesthesia \[CSA group: n =30\] or general anesthesia \[GA group: n=30\]
Primary purpose: SUPPORTIVE_CARE

Brief summary: Renal transplantation is now recognized as a treatment of choice for patients with end-stage renal disease. An adequate anesthetic technique should achieve hemodynamic stability and enhance perfusion of the transplanted kidney. The aim of this study is to assess the use \& effects of continuous spinal anesthesia for kidney transplantation recipients, compared with balanced general anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA class III or IV
* End-stage renal disease
* Renal transplantation candidate patients

Exclusion Criteria:

* Any condition contra-indicating regional anesthesia
* Coagulopathy
* Allergic to any of the drugs used during the procedure

Primary outcomes:
measure: Mean ABP
timeFrame: 12 hours
Secondary outcomes:
measure: Visual Analogue Score for pain "VAS"
timeFrame: 12 hours
measure: Patient satisfaction score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al-Ainy Hospital, Cairo University
Study officials:
affiliation: Kasr Al-Ainy Hospital, Cairo University
name: Nazmy E Seif, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04411368: Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure
Official title: Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure
Acute Respiratory Distress Syndrome
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 540
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with presentation to ICU with critical illness compatible with acute respiratory failrue.

\* Definition of acute respiratory failure: Patients who met one of following criteria

1. SaO2 \< 90% on room air
2. SaO2 \< 92% on \> 6L/min of oxygen
3. Respiratory rates \> 30/min, or sign of respiratory distress

Brief summary: This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure


Eligibility criteria: Inclusion Criteria:

* Male or female aged ≥ 19 years
* Written informed consent by the patient or legally authorized representative
* Critical illness consistent with acute respiratory failure, to be enrolled within 24 hours of presentation

Exclusion Criteria:

* No informed consent
* A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability

Primary outcomes:
measure: Rate of respiratory viral infections
timeFrame: within 24 hours after intensive care unit (ICU) admission
Secondary outcomes:
measure: ICU mortality rate
timeFrame: Through study completion, an average of 1 year
measure: Hospital mortality rate
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Jongmin Lee
role: STUDY_DIRECTOR
References:
Clinical trial NCT01088568: Randomized, Prospective Comparison of the Outcome of Toric Implantable Contact Lens (TICL) and Q-LASIK for the Correction of Myopia With Astigmatism
Official title: Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Astigmatism
Keywords: Keratomileusis, laser in situ
Phakic Intraocular Lenses
myopia
astigmatism
Implantable Collamer Lens, Toric
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Staar Surgical Company
First posted: 2010-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism.


Eligibility criteria: Inclusion Criteria:

* Age: 21-45 years old
* Documented stable refraction for at least 1 year
* (-3.0 to -8.0D of myopia with -1.0 to -4.0D of astigmatism or SE from -3.5 to -10D
* BSCVA: 20/20 or better
* Pupil diameter: smaller than 7mm under mesopic condition
* Contact lens discontinued 3 weeks and 1 week for hard and soft wearers respectively

Exclusion Criteria:

* Evidence of progressive or acute disease
* Evidence of connective tissue disease or clinically significant atopic disease
* ACD less than 2.8mm from endothelium
* ECC less than 2200 cells/mm2
* Narrow angle of anterior chamber
* Residual stromal thickness less than 280 microns

Primary outcomes:
measure: Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK
timeFrame: 1week, 1,3,6 months
Secondary outcomes:
measure: Comparing wavefront aberrometry of TICL vs Q-LASIK Comparing contrast sensitivity of TICL vs Q-LASIK Comparing patient satisfaction of TICL vs Q-LASIK
timeFrame: 1, 3, 6 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Eye hospital of Wenzhou Medical College
name: Qin Mei Wang
role: STUDY_DIRECTOR
References:
citation: Sanders DR. Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters. J Refract Surg. 2007 Jun;23(6):537-53. doi: 10.3928/1081-597X-20070601-02.
citation: Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.
citation: Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea. 2003 May;22(4):324-31. doi: 10.1097/00003226-200305000-00009.
Clinical trial NCT02759068: Beneficial Effects of Preference on Behavior in DOC Patients (COGNICOMA)
Official title: Beneficial Effects of Preference on Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorders of Consciousness
Keywords: vegetative state
minimally conscious state
music
preference
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Preferred music improves cognitive function in patients with disorders of consciousness (DOC). However, it is still unknown whether it is a general effect of music (because of its acoustic features) or an autobiographical effect (because of its emotional and meaningful contents).

The aim of the present study was to investigate the effect of sensory modality (auditory versus olfactory) and preference (preferred versus neutral) of the testing context on the performance of four items from the coma recovery scale-revised


Eligibility criteria: Inclusion Criteria:

* Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
* Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
* Lack of autonomic crisis since one week minimum
* Medical condition considered stable
* Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.

Exclusion Criteria:

* Hearing Problem
* Uncontrolled Epilepsy
* Autonomic crises
* Medical unstable state
* Pregnant or likely to be (interrogation data) or breastfeeding woman

Primary outcomes:
measure: Cognitive Function measured using the Coma Recovery Scale
timeFrame: within the first 30 days
Secondary outcomes:
measure: Reaction time
timeFrame: within the first 30 days
Other outcomes:
Locations:
city: Saint Genis Laval
country: France
facility: Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique
Study officials:
References:
Clinical trial NCT01477268: Cognitive Correlates of Antidepressant Treatment Response in Elders
Official title: Determining the Impact of Dementia and Executive Impairment on Antidepressant Treatment Response in Older Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: antidepressants
depression
zoloft
psychiatry
psychology
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Major depression is a very common health problem affecting older persons. The present standard of treatment is with medications called "antidepressants". Antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. However, certain types of brain dysfunction called "executive impairment" (inability to do higher order thinking) may lead to poor treatment outcomes. This study will compare how older depressed people with different levels of executive impairment respond differently to standard antidepressant treatment. Knowing this information will lead to more rational targeting of available treatments, leading to improved treatment outcomes.


Eligibility criteria: Inclusion Criteria:

* above the age of 65,
* speak English fluently,
* experience depression, AND
* not yet on active treatment.

Exclusion Criteria:

* active delirium,
* substance abuse,
* mental illness other than major depression,
* active CNS disease,
* unstable systematic medical disease, OR
* current of past psychotic disorder.

Primary outcomes:
measure: depression
timeFrame: June 1, 2007 - June 1, 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michaels Hospital
name: Corinne Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02954068: IV Versus IM Administration of Oxytocin for Postpartum Bleeding
Official title: Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Keywords: Oxytocin
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Centro Rosarino de Estudios Perinatales (CREP)
First posted: 2016-11-03
Enrollment: 543
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM


Eligibility criteria: Inclusion Criteria:

* She is present to give birth to a live fetus
* Vaginal delivery
* Willing to participate in the study
* Able to give informed consent

Exclusion Criteria:

* Scheduled for a cesarean
* Reject the placement of an IV during labor (for intravenous infusion)
* Cannot give informed consent for any reason
* Not willing and / or cannot answer questions about background

Primary outcomes:
measure: Amount of blood loss (mL)
timeFrame: 1 hour postpartum
measure: Proportion of women who had postpartum blood loss ≥500 ml
timeFrame: 1 hour postpartum
Secondary outcomes:
measure: Proportion of women who had postpartum blood loss ≥1000 ml
timeFrame: 1 hour postpartum
measure: Average change in hemoglobin level
timeFrame: pre-delivery and at least 24 hours postpartum
measure: Average time required until expulsion of the placenta
timeFrame: 1 hour postpartum
measure: Proportion who needed additional Interventions
timeFrame: Through study completion, an average of 24-48 hours postpartum
measure: Side effects
timeFrame: 1 hour postpartum
measure: Blood pressure
timeFrame: 15, 30, 45 and 60 minutes postpartum
measure: Heart rate
timeFrame: 15, 30, 45 and 60 minutes postpartum
Other outcomes:
Locations:
city: Corrientes
country: Argentina
facility: Hospital J.R. Vidal
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Ilana Dzuba, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Rosarino de Estudios Perinatales (CREP)
name: Guillermo Carroli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
Clinical trial NCT00450268: Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
Official title: Analysis of Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graft Versus Host Disease
Keywords: Graft versus host disease
Allogeneic hematpoietic stem cell transplantation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: We plan to investigate prospectively and simultaneously skin and blood DC subtypes, their donor/recipient origin and the correlation of DC reconstitution kinetics with treatment, clinical outcome and incidence of aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.

Detailed description: Blood and skin DC reconstitution shall be investigated in patients affected by hematological diseases and receiving HLA-matched, mobilized peripheral blood stem cells from related or unrelated donors. We plan to simultaneously collect and process double biopsies, i.e. from graft versus host disease affected and non-lesional skin of patients at onset of acute graft versus host disease following allogeneic hematopoietic stem cell transplantation. Emigration assay, Chimerism analysis and immunohistochemistry will be performed.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing an allogeneic hematopoietic stem cell transplantation
* Older than 18 years
* WHO-Performance-Status 0 to3
* Informed consent
* Graft versus host disease of the skin

Exclusion Criteria:

* Clotting parameters more than double of normal
* Infection of the skin
* Leucocytes \< 1000/µl; Thrombocytes \< 20 000/µl

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinik Carl Gustav Carus
Study officials:
affiliation: Universität Carl Gustav Carus Med Klinik I
name: Susanne Gretzinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235468: Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)
Official title: Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Umbilical Cord Blood
Stem Cell Transplantation
Hematological Malignancies
Keywords: umbilical cord blood
ex vivo expansion
engraftment
GVHD
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2010-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.

Detailed description: Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* hematological malignancy
* standard indication for allogeneic transplantation
* expected survival time over 12 weeks
* no related or unrelated donor
* availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Prior allogeneic transplantation
* Pregnant or nursing women
* Positive serology for hepatitis B or C
* HIV positive
* Left ventricular ejection fraction \< 50%
* DLCO \< 50%
* Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study
* Treatment with other investigational drugs within 4 weeks of enrolling in this protocol

Primary outcomes:
measure: Safety
timeFrame: 1 month
measure: engraftment
timeFrame: 3 months
measure: treatment-related toxicity
timeFrame: 3 months
measure: GVHD
timeFrame: 1 year
Secondary outcomes:
measure: Immunological reconstruction
timeFrame: 5 years
measure: relapse
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Chaim Sheba Medical Center
name: Arnon Nagler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03139968: Reduction of Catheterization Radiation Exposure Pad
Official title: Reduction of the Operator's Radiation Exposure During CAG and PCI With RADPAD, a Randomized Controlled Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Radiation; Exposure Occupational
Coronary Interventions
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 766
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 RECAP-trial is a randomized controlled, double blinded, superiority trial studying the efficacy of the RADPAD®, a protective drape, that potentially reduces the scattered radiation received by the operator during diagnostic angiograms and percutaneous coronary interventions.

Detailed description: A total of 750 consecutive diagnostic angiograms and percutaneous coronary interventions were randomly assigned to the radiation-attenuating (RADPAD®), a dummy drape or a control group in a 1:1:1 ratio. The drapes will be used in addition to conventional shielding material. Primary radiation exposure is measured blindly by a dose aware meter (Philips) positioned at a set location on the operator. Radiation exposure is measured by the X-ray systems (DAP in Gy·cm2). The primary outcome is the effective dose received by the first operator (mSv/Gy·cm2).

Eligibility criteria: Inclusion Criteria:

* All CAGs and PCI's

Exclusion Criteria:

* Other interventional procedures

Primary outcomes:
measure: Primary operator radiation exposure (mSv)
timeFrame: immediately post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
References:
citation: Vlastra W, Delewi R, Sjauw KD, Beijk MA, Claessen BE, Streekstra GJ, Bekker RJ, van Hattum JC, Wykrzykowska JJ, Vis MM, Koch KT, de Winter RJ, Piek JJ, Henriques JPS. Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. Circ Cardiovasc Interv. 2017 Nov;10(11):e006058. doi: 10.1161/CIRCINTERVENTIONS.117.006058.
Clinical trial NCT05884268: Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy
Official title: Evaluating Safety and Tolerability of Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent studies on the impact of perioperative venlafaxine for treatment of acute postoperative pain have yielded positive outcomes . The aim of the present study is to investigate the role of perioperative venlafaxine on the management of postoperative pain in patients undergoing LC.


Eligibility criteria: Inclusion Criteria:

* 1. Patients who are scheduled to undergo elective LC

Exclusion Criteria:

1- Patients with acute pancreatitis 2. Patients undergoing chronic pain treatment 3. Patients who received analgesics or sedatives 24 h before scheduled surgery 3. Patients had alcohol or drug addiction 4. Severe hepatic and renal dysfunction 5. Previous allergic response to duloxetine 6. Pregnancy and lactation 7. Patients with communication problems, cognitive dysfunction, or psychological disorders

Primary outcomes:
measure: Change in postoperative pain between the two groups using visual analogue score (VAS)
timeFrame: 24 Hours postoperative
Secondary outcomes:
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 24 Hours postoperative
Other outcomes:
Locations:
Study officials:
References: