louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04593069: The COGCOV Study in ICU Patients
Official title: Long-term Cognitive Impairment in ICU Patients, Admitted for COVID-19 Pneumonia: a Single Centre, Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Cognitive Impairment
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients enrolled in the study will be contacted to answer additional questions regarding cognitive impairment
Primary purpose: OTHER

Brief summary: Acute Respiratory Distress syndrome (ARDS) is a pulmonary systematic inflammatory response, leading to acute respiratory failure with hypoxia and/or hypercarbia. COVID-19 evokes a viral pneumonia, which may result in ARDS as well. It is not yet clear if COVID-19 disease behaves like the typical ARDS. Corona virus causes primarily deep hypoxia. Hypoxia, on its own, can lead to long term cognitive impairment. However, critical illness also affects long-term neurocognitive functioning. The investigators will be researching the possibility of long-term cognitive impairment in COVID-19 ICU patients, in comparison with reference values of a healthy population as well as the values measured in critically ill patients, admitted not only for respiratory reasons.

Detailed description: The investigators will conduct a single centre, prospective cohort study. COVID-19 patients from the Ziekenhuis Oost-Limburg cohort will be contacted by phone 6 months after admission at the ICU. Patients will be asked to participate in a study surrounding long term symptoms of COVID-19. When consent is given by the patiënt, the experimenter will conduct a short questionnaire over the phone with the patient or relative that is present at the time of the call. If the participant is fluent in Dutch, the experimenter will ask permission to visit their home to conduct more testing.

Eligibility criteria: Inclusion Criteria:

* Admitted to the intensive care unit of Ziekenhuis Oost-Limburg
* Being hospitalized between March 2020 and May 2020, and therefore being admitted 6 months prior to the study
* The reason of hospitalization was COVID-19 disease

Exclusion Criteria:

* No willingness to participate, and therefore not having signed the informed consent

Primary outcomes:
measure: Neurocognitive impairment measured by RBANS
timeFrame: 6 months after admission at the intensive care unit
Secondary outcomes:
measure: Neurocognitive impairment measured by TMT
timeFrame: 6 months after admission at the intensive care unit
measure: Neurocognitive impairment by the short IQCODE
timeFrame: 6 months after admission at the intensive care unit
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Dieter Mesotten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05903469: Implicit and Explicit Assessment of Suicide Risk
Official title: Implicit and Explicit Assessment of Suicide Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implicit Association Test
Suicide
Prevention, Suicide
Suicide Risk Factor
Keywords: Implicit association test
Suicide
Prevention, Suicide
suicide risk factor
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Pinel d'Amiens
First posted: 2023-06-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In 2007 Nock \& Banaji developed a so-called implicit suicide risk measurement using a computer tool: the Implicit Association Test (IAT). This measurement, associated with traditional evaluations, makes it possible to better predict suicidal recurrence. In 2020, the Poitiers team of Tello was able to replicate these results on a French population. However, although a high IAT score predicts the onset of suicide at 1 year, there is no data on how this score changes over time nor even data concerning the measure's ability to differentiate a population with explicit suicidal ideation from a population without explicit suicidal ideation. The investigators therefore seek to demonstrate an evolution of implicit suicidal ideation over time by replicating the measurement at inclusion, at 6 months and at 12 months, for different patient profiles: Suicidal ideation vs No suicidal ideation and suicide attempt vs no suicide attempt. Patients will be recruited from the emergency-unit of CHU Amiens-Picardie and will take the suicide-IAT as well as various questionnaires.


Eligibility criteria: Inclusion Criteria:

* Person presenting to emergencies for psychiatric reasons
* Adult person
* Free and informed consent signed
* Person speaking and writing French fluently

Exclusion Criteria:

* Neurological disorders or major cognitive deterioration: presence of confusion
* Acute psychotic decompensation
* Troubled acute behavior
* Abuse Impregnation of a toxic substance and / or drug impairing cognitive functions at the time of assessment
* Adult under protective measure.

Primary outcomes:
measure: Variation of IAT score betwenn the 3 groups
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
state: Picardie
Study officials:
References:
Clinical trial NCT04750369: Enhanced Triage for COVID-19
Official title: Enhanced Triage for COVID-19 to Validate the Rapid Acute Lung Injury Diagnostic (RALI-Dx) Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV 2
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 806
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study aims to enroll patients 18 years or older, presenting to Emergency Rooms or COVID-19 Assessment Centers with clinical suspicion of COVID-19 infection.

Brief summary: This study is to evaluate of the accuracy of biomarkers (i.e. circulating endothelial and immune activation markers) that indicate progression to severe disease in patients with suspected COVID-19 in the Emergency Department. It is a prospective observational study of patients presenting to emergency departments with a clinical suspicion of COVID19. All participants will have plasma samples collected for biomarker analysis, and will be tested for SARS-CoV-2 infection with a nasopharyngeal swab. Participants will be managed according to the best local practices.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with clinical suspicion of COVID-19 infection, as per UHN case definition at the time of presentation
* Age \>18 years
* Ability to provide verbal informed consent

Exclusion Criteria:

* Patients who are not suspected of COVID-19 infection, as per UHN definition at the time of presentation

Primary outcomes:
measure: Predictive Accuracy of Biomarkers for Risk Stratification
timeFrame: 28 days
Secondary outcomes:
measure: Performance of Biomarkers as Indicators of Clinical Severity: Disposition post-ED visit (admitted vs discharged home vs discharged home and readmitted)
timeFrame: 28 days
measure: Performance of Biomarkers as Indicators of Clinical Severity: Hospital and ICU length of stay
timeFrame: 28 days
measure: Performance of Biomarkers as Indicators of Clinical Severity: Need for artificial respiratory support or hemodynamic support (mechanical ventilation, ECLS)
timeFrame: 28 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Pontifícia Universidade Católica do Rio Grande do Sul
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Turin
country: Italy
facility: Cittá della Salute e della Scienza di Torino Hospital-Molinette Site
Study officials:
affiliation: University Health Network, Toronto
name: Shahid Husain, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05059769: Relationship Between Ambulatory Arterial Stiffness Index and Left Ventricular Diastolic Function in Patients With HFpEF
Official title: Relationship Between Ambulatory Arterial Stiffness Index and Left Ventricular Diastolic Function in Patients With HFpEF
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients with preserved ejection fraction (HFpEF)

Brief summary: Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Ambulatory arterial stiffness index (AASI) is associated with arteriosclerosis and hypertension. There is no report on whether AASI is associated with left ventricular diastolic dysfunction in patients with HFpEF.

Detailed description: Heart failure with preserved ejection fraction (HFpEF) is related to various complications, such as hypertension, obesity and arteriosclerosis. Ambulatory arterial stiffness index (AASI) is associated with arteriosclerosis and hypertension. AASI is especially associated with left ventricular diastolic dysfunction in patients with hypertension. Patients with HFpEF have obvious left ventricular diastolic insufficiency. However, there is still no research investigating the the relationship between AASI and left ventricular diastolic dysfunction in patients with HFpEF.

Eligibility criteria: Inclusion Criteria:

Adult aged \>=18years old; Diagnosed with HFpEF.

Exclusion Criteria:

LVEF less than 45% at any time; Severe liver failure; Other causes of shortness of breath, such as severe pulmonary disease or severe Severe valvular disease of the left heart; Chronically bedridden or incapacitated; Age \<18 years old.

Primary outcomes:
measure: Left ventricular diastolic function
timeFrame: 1 day On admission
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The first affiliated Hospital of Chongqing Medical University
Study officials:
References:
Clinical trial NCT06554769: Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study
Official title: Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 15
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split mouth randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Indirect anchorage (In-A) has been broadly used for anchorage reinforcement during anterior segment retraction. The study compared between the efficacy of rigid vs non-rigid connections of In-A i during upper canine retraction in dentoalveolar protrusion cases

Detailed description: Fifteen female patients with dentoalveolar protrusion were included in this study. A miniscrew was inserted following levelling and alignment between the upper first molar and second premolar of both sides. Randomization was applied before first premolar extraction where one side of the arch received a rigid indirect anchorage connection (Group I) of 0.019 x 0.025-inch stainless steel (St.St) archwire from the miniscrew to the auxiliary tube of the upper first molar band, and the other side received a non-rigid indirect anchorage connection (Group II) of 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew. Canine retraction was performed on 0.017 x 0.025-inch St.St archwire applying 1.5 N retraction force. The duration of the study was 7 months. Data was collected from digitized models where anchorage loss of the upper first molar relative to the frontal plane and the vertical position of the upper second premolar were measured

Eligibility criteria: Inclusion Criteria:

Adult females Bimaxillary protrusion requiring first premolars extractions Full permanent dentition Good oral hygiene

Exclusion Criteria:

History of previous orthodontic treatment Abnormalities in teeth size and/or shape Vertical, transverse, or anteroposterior skeletal discrepancies Anti-inflammatory medication

Primary outcomes:
measure: anchorage loss
timeFrame: 4 month
Secondary outcomes:
measure: vertical position of the upper second premolar
timeFrame: 4 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01596569: Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury
Official title: Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Cognitive Dysfunction
Blast Injury
Keywords: Blast Traumatic Brain Injury
Cognitive Rehabilitation
Transcranial Magnetic Stimulation
Combined Treatment
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2012-05-11
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study investigates the efficacy of a novel neurorehabilitation program combining noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive therapy, on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

Detailed description: The most common blast-induced traumatic brain injury (bTBI)-associated problems are cognitive deficits, such as executive functioning and memory. This study evaluates a combined rehabilitation program: transcranial magnetic stimulation (TMS) and cognitive therapy for treatment of patients with bTBI. TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular brain region. Half of the study participants will receive cognitive intervention with active TMS, and a control group will receive cognitive intervention with sham TMS. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System and Beth Israel Deaconess Medical Center.

Eligibility criteria: Inclusion Criteria:

* OEF/OIF active-duty personnel or veterans exposed to blast
* Meets criteria for mild TBI
* LOC of 30 min or less
* Age: 21-50
* Primary language is English

Exclusion Criteria:

* Evidence of penetrating head injury
* History of previous neurological diagnosis
* History of previous psychotic disorder prior to the blast exposure
* Hearing or vision impairment

Primary outcomes:
measure: Post concussive symptoms in TBI
timeFrame: 4 weeks
Secondary outcomes:
measure: Daily life and functional outcome
timeFrame: 4 weeks
measure: PTSD symptoms
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Yelena Bogdanova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bogdanova Y, Verfaellie M. Cognitive sequelae of blast-induced traumatic brain injury: recovery and rehabilitation. Neuropsychol Rev. 2012 Mar;22(1):4-20. doi: 10.1007/s11065-012-9192-3. Epub 2012 Feb 17.
Clinical trial NCT02026869: Vaginal Administration of Metformin in PCOS Patients.
Official title: Impact of Vaginal Administration of Metformin in Women With PCOS.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: PCOS
Keywords: Vaginal administration, PCOS, Metformin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome is a common cause of irregular periods, poor ovulation and delay in achieving pregnancy. Certain drugs may help improve ovarian activity in such women as metformin. Oral administration of metformin is accompanied by undesirable side effects. The vagina proved to be a good alternative to the oral route for other drugs. Using metformin through the vagina and avoidance of such side effects, while maintaining its effectiveness, would help women to better tolerate this drug.

Detailed description: PCOS is the most common of all female endocrinopathies affecting 7-10% of women. A variety of drugs have been used to help improve follicular dynamics in PCOS patients. Metformin, an insulin sensitizer long known for its antidiabetic properties, has been used in PCOS patients. One of the major factors affecting compliance are the gastrointestinal side effects associated with oral administration of metformin. Knowing that the vagina is a good absorptive surface for many drugs, it is postulated that vaginal administration of metformin could be a good alternative to the oral route, if it proves effective. Both pharmacokinetic and clinical evidences of efficacy are traced for the vaginal route of administration.

Eligibility criteria: Inclusion Criteria:

* women with PCOS according to the Rotterdam criteria
* age 20-35 years
* not to have received any induction of ovulation in the preceding 3 months before enrollment

Exclusion Criteria:

* contraindications to metformin
* prior surgical management of PCOS

Primary outcomes:
measure: Ovulation rates
timeFrame: 6 months
Secondary outcomes:
measure: Therapeutic drug level
timeFrame: Over 24 hours after administration.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women's Health Hospital
Study officials:
affiliation: Professor, Women's Health Hospital, Assiut University, Egypt.
name: AHMED NASR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate professor, dept. of Obstetrics & gynecology, Sohag University, Egypt
name: MAGDY AMIN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01632969: Improving End of Life Care in Head and Neck Cancer
Official title: Improving End of Life Care in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: The Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of the
Upper Aerodigestive Tract
Keywords: 12-136
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Deceased Head and Neck Surgery patients will be queried from Dataline and screened for eligibility. Interviews with family members and next of kin of deceased patients treated at MSKCC for noncutaneous squamous cell carcinomas of the upper aerodigestive tract will be conducted via telephone, employing the survey instruments.

Brief summary: The purpose of this study is to improve the quality of care provided for head and neck cancer patients. By better understanding the end of life experiences of dying patients and their families, the investigators hope to better anticipate and improve upon the experiences of future patients and their families.


Eligibility criteria: Inclusion Criteria:

* Head and neck cancer patients who received their treatment at MSKCC who have died of noncutaneous squamous cell carcinomas of the upper aerodigestive tract and for whom family / next of kin contact information is available.
* Time of patient death must have been at least 6 months ago and no more than 4 years ago
* Patient age at time of death must be over 21 years of age.
* Those interviewed must be English-fluent.

Exclusion Criteria:

* Non-English speaking interviewees
* Next-of-kin who reported being unfamiliar with care received during the last month of life
* Next-of-kin who did not identify themselves as one of the patient's primary social supports during the last month of life
* Next-of-kin who were not physically present with the deceased at least once during the last week of his/her life
* Next-of-kin under age 21

Primary outcomes:
measure: quality of care received by patients
timeFrame: 1 year
Secondary outcomes:
measure: quality of death outcomes
timeFrame: 1 year
measure: awareness among caregivers
timeFrame: 1 year
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: Snehal Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: