louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03959605: Genetic Determinant of Foveolar Hypoplasia in Parents of Albinos Children
Official title: Genetic Determinant of Foveolar Hypoplasia in Parents of Albinos Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Albinism, Ocular
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-05-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: parents without symptom of albinism (except fovea plana) of children with albinism

Brief summary: Fovea plana could be the phenoyipic translation of a genetic anomaly in one of the genes identified in albinisme


Eligibility criteria: Inclusion Criteria:

* children with albinism
* father and mother of children with albinism

Exclusion Criteria:

* sign of albinism except fovea plana in father or mother of children with albinism
* ophthalmological abnormalities making access to the fundus with OCT impossible

Primary outcomes:
measure: Number of genetics variants
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A de Rothschild
Study officials:
affiliation: Fondation A. de Rothschild
name: Martine MAUGET FAYSSE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753505: Clinical Significance of 64-slice Multidetector Coronary CT Angiography to Evaluate the Prevalence and Severity of Coronary Artery Disease in Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant Recipient
Keywords: multidetector coronary CT angiography, renal transplantation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 93
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the clinical usefulness of 64-slice multidetector coronary CT angiography (MDCTA) in renal transplant recipients who had no previous coronary artery disease (CAD). Primary endpoint is to assess the prevalence and severity of coronary artery disease in patients post-transplant 6 to 12 months. CAD can be diagnosed noninvasively with similar accuracy of coronary angiography using MDCTA. Early detection and intervention of CAD may provide survival benefit in renal transplant recipients.


Eligibility criteria: Inclusion Criteria:

1. age ≥ 40 yrs
2. renal transplant recipient at post-transplant 6 to 12 months
3. stable graft renal function: CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation ≥45 mL/min/1.75m2
4. patients who had no previous CAD

Exclusion Criteria:

1. unstable graft renal function
2. History of acute kidney injury within 3 months
3. Allergic history to contrast agent
4. Irregular heart beat
5. Multiorgan transplant recipients
6. Pregnancy
7. Patients who do not consent to this study

Primary outcomes:
measure: prevalence of coronary artery disease
timeFrame: at post-transplant 6 to 12 months.
Secondary outcomes:
measure: severity of coronary artery disease
timeFrame: at post-transplant 6 to 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT00588198: Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma
Official title: Study of Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: histologically confirmed melanoma of any site
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 754
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Melanoma Patients seen at Memorial Sloan-Kettering Cancer Center (MSK)

Brief summary: The purpose of this study is to determine if tumor cells can be detected in the peripheral blood and/or bone marrow of patients with melanoma.

Detailed description: Patients with melanoma can succumb to subclinical metastatic disease, not detectable at presentation by conventional physical examination, hematologic and biochemical screening, or radiologic evaluation. More intensive radiologic evaluation with CT or radioisotope scanning has not proven to be useful. What may be useful is a more sensitive method of staging melanoma patients at presentation, specifically evaluating them for subclinical systemic disease.

Eligibility criteria: Inclusion Criteria:

MSK Patients with histologically confirmed melanoma of any site and at least one of the following:

* Primary tumor \> 4.0 mm thick (AJCC Stage IIB)
* Clinically or histologically positive regional nodes (AJCC Stage III)
* Any in transit disease (AJCC Stage III)
* Any systemic metastases (AJCC Stage IV)

Primary outcomes:
measure: Assess the sensitivity of RT-PCR to detect evidence of melanoma cells in bone marrow and/or peripheral blood and estimate sensitivity separately for each of the different stage groupings for melanoma
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Danile Coit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02821598: Effects of the Proprioceptive Neuromuscular Facilitation for Promoting Muscular Irradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Disorders
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effects of Proprioceptive Neuromuscular Facilitation (PNF) patterns delivered to the upper limb, lower limb and trunk for promoting motor irradiation to the contralateral lower limb.


Eligibility criteria: Inclusion Criteria:

* right-handed
* sedentary
* healthy
* body mass index between 18.5 - 24.9 kg/m2

Exclusion Criteria:

* having any injuries that prevented the implementation of the proposed activities
* being pregnant

Primary outcomes:
measure: Muscular activity by means of Electromyography
timeFrame: Change from pre to post intervention (at least 40 min)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT01535898: Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Head and Neck, and Prostate Cancers
Official title: Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Head and Neck, and Prostate Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Prostate Cancer
Keywords: MRI
MR imaging Pulse Sequence
High Resolution Diffusion-weighted
Questionnaire
12-033
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The radiologists on the study will identify potential research participants from those patients who are scheduled for MRI examination as part of their routine clinical care.

Brief summary: Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer or prostate cancer. The extra images will be obtained using Diffusion-weighted Magnetic Resonance Imaging which provides image contrast through detection of small restrictions in the movement of water molecules. This study may help us provide additional information about the tumor along with the picture of the organ.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and over.
* Men and women without regard to ethnic background.
* Patients/Subjects able to give informed consent
* Patients/Subjects whose weight does not exceed 275 lbs.
* Patient with a known or suspected head and neck cancer or prostate cancer scheduled for an MRI scan as part of their routine care --OR--
* Volunteer with no history of the disease in that category.

Exclusion Criteria:

* Patients who are unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.

Primary outcomes:
measure: feasibility of high resolution diffusion-weighted imaging
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Amita Dave, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671098: Sinonasal Gas Exchange Dynamics
Official title: Sinonasal Gas Exchange Dynamics The Aerodynamic Theory of the Sinonasal Interface
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Keywords: nitric oxide
sinuplasty
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who had balloon sinuplasty of traditional endoscopic uncinectomy for treatment of chronic maxillary sinusitis

Brief summary: Sinonasal gas exchange is facilitated by the unique anatomy and topography of the sinonasal interface that represents a collection of airfoils creating an aerodynamic structure. The airflow during respiration generates positive and negative pressures that power the gas exchange between the sinuses and the nose. Major surgical alteration of the interface reduces the rate and velocity of the exchange. Minimally invasive procedures aimed at preserving the natural anatomy, topography and aerodynamic configuration of the interface will have negligible effects on sinonasal gas exchange.


Eligibility criteria: Inclusion Criteria:

* Control:

  * normal healthy adult volunteers ages 18-65,
* without allergies by history and allergy test,
* non-smoker,
* not using steroids. Study group 1: adult subjects who had maxillary sinus balloon sinuplasty (with intact uncinate and ethmoid complex) Study group 2: adult subjects who had endoscopic maxillary antrostomy and uncinectomy.

Exclusion criteria:

* active acute or chronic infection,
* nasal polyps,
* severe nasal or septal deformity,
* cystic fibrosis,
* systemic illness (diabetes, hypertension etc.),
* vulnerable population (children, pregnant women, institutionalized individuals etc.)
* severe nasal and/or septal deviation,
* hypersensitivity or intolerance to study medications (topical and local anesthetics) any turbinate surgery.

Primary outcomes:
measure: Sinonasal gas exchange rate
timeFrame: 2 years
Secondary outcomes:
measure: NO production rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: LSU Health ACC
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Anil A Gungor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01877798: Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Septic Shock Therapy
Official title: Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Severe Sepsis and Septic Shock Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 300
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: Reducing tissue hypoxia is the ultimate goal of severe sepsis and septic shock therapy.Venoarterial PCO2 difference /arteriovenous O2 content difference ratio (△PCO2/Ca-vO2) is considered to be a good indicator of global anaerobic metabolism.The purpose of this study was to compare the efficacy of △PCO2/Ca-vO2 and central venous oxygen saturation (ScvO2) in the treatment of severe sepsis and septic shock.


Eligibility criteria: Inclusion Criteria:

* severe sepsis and septic shock patients

Exclusion Criteria:

* \<18 years old
* pregnant and breast-feed woman
* AMI
* cerebral hemorrhage
* contraindication for central venous catheter or arterial catheter;
* brainstem death

Primary outcomes:
measure: mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital critical care medicine
Study officials:
References:
citation: Su L, Tang B, Liu Y, Zhou G, Guo Q, He W, Wang C, Zhuang H, Jiang L, Qin L, Deng Q, Shuai W, Zhang L, Wang X, Su J, Ma S, Liu D, Long Y. P(v-a)CO2/C(a-v)O2-directed resuscitation does not improve prognosis compared with SvO2 in severe sepsis and septic shock: A prospective multicenter randomized controlled clinical study. J Crit Care. 2018 Dec;48:314-320. doi: 10.1016/j.jcrc.2018.09.009. Epub 2018 Sep 11.
Clinical trial NCT03037398: Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
Official title: Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.


Eligibility criteria: Key Inclusion Criteria:

* Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
* Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
* Be at least 18 years of age.
* Device must have been implanted on label or must be on label by the time the subject gets enrolled.

Key Exclusion Criteria:

* Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.

Primary outcomes:
measure: Difference in time to program between the two arms at Programming Visit
timeFrame: at least four months post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University Berlin, Charite Virchow Standort, Wedding
city: Hamburg
country: Germany
facility: Universitaetsklinik Eppendorf
city: Kiel
country: Germany
facility: Universitätsklinikum Campus Kiel
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References:
Clinical trial NCT04910698: Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia
Official title: Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia: a Retrospective Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bloodstream Infection
Acute Myeloid Leukemia
Febrile Neutropenia
Keywords: antibiotic short course, appropriate use of antibiotics
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 104
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: All bloodstream infection episodes occuring in patients suffering from febrile neutropenia during acute myeloid leukemia between January 2017 and December 2019 in University Hospital of Poitiers were included.

Brief summary: There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia. The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia. This monocentric retrospective comparative study included all consecutive bloodstream infection episodes among acute myeloid leukemia patients with febrile neutropenia for 3 years (2017-2019). Episodes were classified regarding the length of antibiotic treatment, considered as short course if the treatment lasted ≤7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was ≤10 days and ≤14 days, respectively. The primary outcome was the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.


Eligibility criteria: Inclusion Criteria:

* Acute myeloid leukemia
* chemo-induced febrile neutropenia
* Bloodstream infection

Exclusion Criteria:

* lack of data
* endovascular infections
* surgical treatment required
* central nervous system infections
* antibiotic treatment \< 4 days
* death before the end of antibiotic treatment
* unappropriated antibiotic treatment at 48h
* relapses of bloodstream infection episodes already included
* hematopoietic stem cell transplant

Primary outcomes:
measure: Bloodstream infection relapses
timeFrame: within 30 days of antibiotic discontinuation
Secondary outcomes:
measure: Mortality
timeFrame: within 30 days of antibiotic discontinuation
measure: Epidemiology of bacteria
timeFrame: at baseline
measure: Risk factors for relapses
timeFrame: within 30 days of antibiotic discontinuation
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital
Study officials:
name: France Cazenave-Roblot
role: STUDY_DIRECTOR
References:
Clinical trial NCT01032798: Local Anesthetics New Formulations: From Development to Clinical Tests
Official title: Efficacy and Pharmacokinetics of Liposomal Mepivacaine Formulations in Dentistry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Local Anesthetic Effectiveness
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2009-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.


Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Primary outcomes:
measure: Latency period and duration of anesthesia were assessed by an electrical pulp tester
timeFrame: 10 minutes
Secondary outcomes:
measure: Plasma concentrations of mepivacaine
timeFrame: 0 to 360 minutes after the injection
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: Sao Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Eneida de Paula, PHD
role: STUDY_DIRECTOR
References:
citation: Tofoli GR, Cereda CM, Groppo FC, Volpato MC, Franz-Montan M, Ranali J, de Araujo DR, de Paula E. Efficacy of liposome-encapsulated mepivacaine for infiltrative anesthesia in volunteers. J Liposome Res. 2011 Mar;21(1):88-94. doi: 10.3109/08982104.2010.483596. Epub 2010 May 20.
Clinical trial NCT04024098: An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic Cancer Patients
Official title: An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: gynecologic cancer patients

Brief summary: This study aim is to examine the prevalence, severity, and management of CRF among Taiwanese gynecologic cancer patients.

Detailed description: The cross-sectional survey is conducted at oncology inpatients unit and outpatients clinics of hospitals in Taiwan. Furthermore, the results will elucidate not only the epidemiology of CRF in Taiwan, but will supply physicians with more understanding about CRF, and help them to enhance the quality on cancer care to being perfected in the future.

Eligibility criteria: Inclusion Criteria:

* Patients who signed the informed consent form
* The age of eligible patients should be ≥ 20 years old.
* Inpatients or outpatients who have been given a diagnosis of gynecologic cancer.
* Able to communicate verbally and completely fill out the questionnaires

Exclusion Criteria:

* Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires

Primary outcomes:
measure: Cancer-related fatigue evaluation-1
timeFrame: 10 minuts
measure: Cancer-related fatigue evaluation-2
timeFrame: 8 minuts
measure: Symptoms and Quality of Life Assessments-1
timeFrame: 4 minuts
measure: Symptoms and Quality of Life Assessments-2
timeFrame: 5 minuts
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chan Gung Memorial Hospital
Study officials:
affiliation: Kaohsiung Chan Gung Memorial Hospital
name: CHING-CHOU TSAI, Dr.
role: PRINCIPAL_INVESTIGATOR
References: