louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04912778: Profiling of Post Covid-19 Infection Patients: an Online Survey
Official title: Profiling of Post Covid-19 Infection Patients: an Online Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: STIMULUS research group, Vrije Universiteit Brussel
First posted: 2021-06-03
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study male and female adults who were previously infected with covid-19 will be eligible to complete the survey. No specific criteria will be imposed regarding the time frame after infection.

Brief summary: The aim of this study is to explore the relation between indicators of central sensitisation, quality of life and functional status in patients post covid-19 infection.


Eligibility criteria: Inclusion Criteria:

* male and female adults who were previously infected with covid-19

Primary outcomes:
measure: Functional status
timeFrame: Up to 18 months after infection with Covid-19.
measure: Health-related Quality of life
timeFrame: Up to 18 months after infection with Covid-19.
measure: Symptoms of central sensitisation
timeFrame: Up to 18 months after infection with Covid-19.
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
References:
citation: Moens M, Duarte RV, De Smedt A, Putman K, Callens J, Billot M, Roulaud M, Rigoard P, Goudman L. Health-related quality of life in persons post-COVID-19 infection in comparison to normative controls and chronic pain patients. Front Public Health. 2022 Oct 20;10:991572. doi: 10.3389/fpubh.2022.991572. eCollection 2022.
Clinical trial NCT03768778: Non-missile Penetrating Head Trauma,Cases Registry in Sohag University Hospital
Official title: Non-Missile Penetrating Brain Injuries, Cases Registry in Sohag University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injuries With Non Missile Penetrating Objjects
Keywords: Penetrating brain trauma (PBT),Traumatic brain injury (TBI), Intensive care unit, non missile.
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 18
Sex: ALL
Minimum age (years): 4
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A retrospective study was done in Neurosurgery trauma unit, Sohag University. Eighteen patients reported with different mechanisms of trauma. All patients clinically tested involving neurological evaluation. Computed tomography brain was done for them at the time of admission. Cautious removal of the penetrating object with local debridement of surrounding tissues including skin, skull, dura and brain tissue and watertight closure of the dura should be done. Patients transferred to the Intensive care unit (ICU) for 48 - 72 hours.

Detailed description: Traumatic intracranial penetration of foreign non-missile object rarely occurs. Early mortality may be caused by hemorrhages, major vascular injury or contusions; while epileptic seizures and infections are among the possible complications in later stages. Complete excision of the foreign object should be done for all patients and any dural and/or vascular injuries should be repaired during surgical treatment.

Neurological level, hemodynamic and respiratory status at hospital admission, type of penetrating the object, pupil size, and reactivity, as the CT findings, all these factors will affect the prognosis so they should be evaluated carefully before the decision of the line of management. Intracranial infection, CSF leak and recurrent attacks of convulsions are the most common complications.

Our goal in this study to report cases with non-missile penetrating head injuries and evaluate the possible predictive factors in a series of 18 patients sustaining penetrating head injuries, admitted to our hospital over a period of 2 years, to be used as a guide for the surgical management.

Eligibility criteria: Inclusion Criteria:

* Any patient with penetrating head trauma

Exclusion Criteria:

* missile penetrating head injuries

Primary outcomes:
measure: (Glasgow Coma Scale)(GCS) to evaluate non-Missile Penetrating Brain Injuries
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05466578: Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Severe Uncontrolled Atopic Dermatitis
Keywords: atopic dermatitis
AD
Atopic eczema
JAK inhibitors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-07-20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide pre-approval single patient Expanded Access (compassionate use) of abrocitinib for patients with severe uncontrolled atopic dermatitis

Detailed description: In Expanded Access, treating physicians are the Sponsor.

Expanded Access requests from treating physicians may be submitted at www.pfizercares.com ; availability will depend on location/country.

Eligibility criteria: Must have severe uncontrolled atopic dermatitis refractory to other available treatments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04906278: Amniotomy for Second-trimester Pregnancy Termination
Official title: Sequential Use of Foley Catheter With Amniotomy for Second-trimester Pregnancy Termination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Missed
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The termination of abortion is an important issue that has many controversies. The most common time of serious abortion-related complications is the second trimester. Missed abortion is one of the most common indications of termination of pregnancy in the second trimester. Misoprostol and mifepristone are effective drugs for induction of abortion but these drugs are now expensive, and non-available in many developing countries.

The effectiveness of Foley's catheter balloon on cervical ripping for mid-trimester pregnancy termination has been proved before. It can effectually shorten the time of the expulsion of the fetus. Amniotomy defines as an artificial rupture of the membranes; it is an ordinary obstetric practice used mainly in the induction of labor, with good results and less morbidity. The obstetricians used to combine amniotomy with other methods such as prostaglandins or oxytocin to induce labor in a woman with an unfavorable cervix.

Despite plenty of studies that investigated the role of amniotomy for induction of labor but the studies which addressed the role of amniotomy in the induction of second-trimester abortion are very scarce in the literature.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-40 years old.
* Women who are pregnant in singleton mid-trimester missed abortion (18-26 weeks).
* Bishop's score is ≤ 4.

Exclusion Criteria:

* Women who delivered before by classic caesarian section or had a history of -myomectomy, hysteroscopic uterine surgery, or cervical surgery like conization.
* Women with multiple gestations.
* Women with ultrasonography evidence of low amniotic fluid volume.
* Women with rupture of fetal membranes.
* Women with evidence of low implanted placenta by ultrasound.
* History or laboratory evidence of intra-uterine infection.
* History is suggestive of latex allergy.
* Women with severe anemia, hypertension, diabetes, or with coagulopathy.

Primary outcomes:
measure: The interval between induction to complete abortion
timeFrame: 15 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT04799678: Pilot Voice Sample Collection From People With Asthma
Official title: Collecting Anonymous Voice Samples From Users of the Smart Asthma App
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma Chronic
Lead sponsor: Smart Respiratory Products Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current user of the Smart Asthma app

Brief summary: Human speech is as unique as a fingerprint and analysing speech had advanced so much that speech can now be used instead of PIN numbers in banking.

The investigators want to find out whether changes in everyday speech can signal the worsening of asthma.

The investigators are planning to collect voice samples from people as their asthma gets better and worse in order to analyse the changes in voice quality - if any.

The participants donating the voice samples will remain anonymous and the voice files will be transferred securely to our analytic system.

Detailed description: Over 18 users of the Smart Asthma app (by Smart Respiratory Products Ltd) will be asked if they wish to participate in the study by recording voice samples. The question will be posed within the app and can be answered with a tap.

Those interested in participating will be shown a short plain English description of the goals and methodology of the project before enrolled.

A maximum of 9 voice sample recording session will be carried out on the phones of participants and take less than 2 minutes each, so participants will spend a total of fewer than 18 minutes during the entire trial.

Sessions will be offered after participants have recorded their asthma symptoms, lung function and inhaler use in the normal course of using the app. Participants may accept or decline each individual offer to record their voice.

Participants will have a chance to play each voice recording before sharing it anonymously with the investigators. Participants can discontinue their participation at any time and can ask investigators to delete all their data.

The investigators will be analyse collected voice samples for changes in voice quality. The changes in voice quality will be compared against changes in lung function and asthma symptoms to determine what changes in voice quality, if any, are indicative of a change in asthma control.

Eligibility criteria: Inclusion Criteria:

* Current user of the Smart Asthma app
* Over 18
* Volunteers to participate
* Agrees to terms

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in voice quality
timeFrame: A maximum of 9 voice sample recording session, 2 minutes each, will be carried out during the 6 months of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Managing Director
name: Thomas Antalffy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04971278: Evaluating the Impact of a Supportive Care Program
Official title: Evaluating the Impact of a Supportive Care Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Engagement
Morality
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 1201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NYU Langone adult patients (\>18 years old) at or above the 75th percentile on NYU's mortality model currently attributed to one of DSRIP's value based contracts.

Brief summary: NYU's High Risk Program targets patients who may be more likely to have increased hospitalization due to health conditions that may cause death in the near future. Community Health Workers, a home visiting doctor service, a supportive care nurse, and behavioral health specialist engage the population to address a range of biopsychosocial needs with end goal in increasing support in the community and engaging palliative and hospice care when appropriate to prevent hospital readmissions, shorten length of stay, reduce hospital utilization, and decrease overall patient cost with a focus on hospital spend.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* at or above the 75th percentile on the Mortality Model
* Attributed to a value based contract

Exclusion Criteria:

* Less than 18 years of age
* Below the 75th percentile on the Mortality Model
* Not attributed to a value based contract

Primary outcomes:
measure: Rate of Advance Care Planning note creation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leora Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00514878: Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)
Official title: Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nausea
Postoperative Nausea and Vomiting
Postdischarge Nausea and Vomiting
Postoperative Pain
Keywords: nausea
postoperative nausea and vomiting
postoperative pain
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-08-10
Enrollment: 2000
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: Adult patients scheduled for elective outpatient surgery

Brief summary: The primary purpose of this prospective cohort study is to develop a simplified risk model for post-discharge nausea and vomiting (PDNV) in adult same-day surgery patients in the US that will allow clinicians to identify those patients who would benefit from prophylactic antiemetic strategies.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* scheduled for an elective outpatient surgical procedure
* understands the nature and purpose of this survey and has signed an informed consent form
* willing and able to complete daily components of the Patient Diary from the day of surgery until the end of the 48 hour assessment
* undergoing general anesthesia requiring a tracheal tube or laryngeal mask airway

Exclusion Criteria:

* planned inpatient surgery
* inability to communicate in English
* regional anesthesia alone without general anesthesia, as PONV in this setting is known to be significantly lower \[18, 19\]
* persistent or recurrent nausea and/or vomiting before anesthesia due to other etiologies, unless clearly related only to the anxiety due to impending surgery
* minors (\< 18 years of age)
* current pregnancy by self-report (potentially confounding for etiology of nausea)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Perioperative Clinical Research Core, University of California
state: California
Study officials:
affiliation: Perioperative Clinical Research Core, University of California San Francisco
name: Christian C Apfel, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04356378: Long Term Physical Functional Limitations in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation
Official title: Long Term Physical Functional Performance in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation: a Multicentric Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection With Coronavirus SARS-CoV2
Keywords: observational study
cohort study
coronavirus infections
respiratory distress syndrome
adult
rehabilitation
physical functional performance
long term care
exercise tolerance
clinical study
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 149
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: SARS-CoV2 infected patients, hospitalized in the acute phase then requiring rehabilitation follow-up.

Brief summary: Infection with coronavirus SARS-CoV2 (COVID-19 disease) is unique with its speed of propagation, structural medical reorganizations and length of stay in intensive care needed, diversity of the affected population (in particular between young persons or fragile subjects), and impact on physical and mental health generated by confinement of populations.

Fatigue is a major component of COVID-19. Global muscular weakness is related to immobility, inflammation, corticosteroids treatment, hypoxemia due to pulmonary and/or cardiac infectious attacks and undernutrition suggests major physical functional repercussions. Thus, patients affected by COVID-19 with acute hospital management require sometimes complex rehabilitation management.

Retrospective studies on physical functional capacities in patients infected with SARS CoV1 showed long term physical activity limitations.

Detailed description: The aim of this study is to study factors associated with physical functional limitations in daily living in patients SARS-CoV2 infected and hospitalized in the acute phase then requiring rehabilitation.

Eligibility criteria: Inclusion criteria :

* patient infected with SARS-CoV2
* in-patient hospitalization in the acute phase because SARS-CoV2 infection
* patient requiring rehabilitation after SARS-CoV2 infection acute phase
* patient adult, aged more than 18 years old
* patient accepting to participate in the study

Exclusion criteria :

* patient with cognitive disorder (Folstein Mini-Mental State Examination less than 22 on 30 points)

Primary outcomes:
measure: Physical functional limitations
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT05621278: Children to Adults Mental and Psychosomatic Health Study (CAMPS)
Official title: Children to Adults Mental and Psychosomatic Health Study (CAMPS): A Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Health Wellness
Cognitive Function
Physical Symptoms
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 400000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students from 5 grade to 12 grade and their parents and teachers in Chinese schools.

Brief summary: This study titled the Children to Adults Mental and Psychosomatic Health Study (CAMPS), aims to explore the interplay between mental health, psychosomatic factors, and adverse childhood experiences (ACE) across a broad age range, from school-age children to adults in China. The study will involve participants from various educational settings, including teachers, students, and parents, who will be recruited through schools. The assessment methodology will combine validated psychometric scales and behavioral experiments to comprehensively evaluate mental and physical health aspects and the impact of ACEs. This integrative approach is designed to illuminate the complex relationships between psychological well-being, somatic symptoms, and early life stressors across different life stages.


Eligibility criteria: Inclusion Criteria:

1. Students from 5 grade to 12 grade, their parents and teachers
2. able to read, answer questionnaires and complete experiments.

Exclusion Criteria:

a. Students who suspend schooling.

Primary outcomes:
measure: Irritability
timeFrame: 1 month
measure: Alexithymia
timeFrame: 1 month
measure: Depression for adults
timeFrame: 2 weeks
measure: Depression
timeFrame: 2 weeks
measure: Generalized anxiety disorder
timeFrame: 2 weeks
measure: Anxiety and depression for adolescents and children
timeFrame: 2 weeks
measure: PTSD for adults
timeFrame: 1 month
measure: PTSD for adolescents and children
timeFrame: 1 month
measure: NSSI
timeFrame: 1 year
measure: Suicide
timeFrame: 1 year
measure: Emotion recognition
timeFrame: Half year
measure: Excutive function
timeFrame: Half year
measure: Adverse Childhood Experiences (ACE)
timeFrame: each year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
References:
Clinical trial NCT01323478: Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Official title: A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 (15 and 20 mg/Day) in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioural Symptoms
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2011-03-25
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)


Eligibility criteria: Inclusion Criteria:

Patients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major Depressive Episode immediately prior to enrolment in this extension study

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR)
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication
* The patient, in the investigator's clinical judgment, has a significant risk of suicide.

Other protocol-defined inclusion and exclusion criteria applied.

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs)
timeFrame: Baseline to end of the 4-week safety follow-up period
measure: Percentage of Patients Who Withdrew Due to Intolerance to Treatment
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: Change From Baseline in CGI-S Score After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
timeFrame: Baseline from lead-in study 13267A (NCT01140906) and Week 52
measure: Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
timeFrame: Baseline and Week 52
measure: SDS Total Score After 52 Weeks of Treatment
timeFrame: Week 52
measure: ASEX Total Score After 52 Weeks of Treatment
timeFrame: Week 52
measure: Risk of Suicidality Using C-SSRS Scores
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: