louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02738645: A Clinical Cohort Study of Pneumonia in Respiratory Intensive Care Unit
Official title: A Clinical Cohort Study of Pneumonia in Respiratory Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients of RICU

Brief summary: From 2003 when Severe Acute Respiratory Syndromes (SARS) appeared，many new types of respiratory viruses emerge in endlessly. Therefore, the epidemiology and the clinical character has changed quietly, especially severe pneumonia. This cohort study aim to obtain the contents of severe pneumonia patients in Respiratory Intensive Care Unit (RICU). Through the clinical data analysis, the investigators could get the information of the pneumonia caused by different reasons, such as morbidity and mortality, risk factors, clinical symptoms and radiographic changes, the respiratory support parameter and so on. The investigators hope the result could guide them do the clinical work of severe pneumonia better in the future.


Eligibility criteria: Inclusion Criteria:

* admit in RICU because of pneumonia of any causes
* anticipated length of hospital stay more than 72h

Exclusion Criteria:

* admit in RICU because of other causes except pneumonia
* do not agree to join this study
* admit in RICU for the second time
* anticipated length of hospital stay less than 72h

Primary outcomes:
measure: the mortality caused by any reasons in RICU
timeFrame: one years
measure: the morbidity caused by any reasons in RICU
timeFrame: one years
Secondary outcomes:
measure: the symptoms description of pneumonia caused by any reasons in RICU
timeFrame: the first 48hours after admitted in RICU
measure: the respiratory support of pneumonia caused by any reasons in RICU
timeFrame: the first 5 days after admitted in RICU
measure: the treatment options of pneumonia caused by any reasons in RICU
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao-Yang Hospital, China
name: Bing Sun, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105245: Understanding How Anaesthesia Affects ECT Outcomes
Official title: Understanding How Anaesthesia Affects ECT Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: electroconvulsive therapy
anaesthesia
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Wesley Mission
First posted: 2017-04-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will receive all four treatment conditions in randomly allocated sequence during their ECT course. That is, participants will receive either short or long anaesthetic-ECT stimulus time interval treatments, and normal or hyperventilation treatments - this results in four possible combinations, which individual participants will cycle through in random order during their ECT course (e.g. short-hyperventilation, long-normal ventilation, short-normal ventilation, long-hyperventilation).
Primary purpose: TREATMENT

Brief summary: This study will examine how anaesthetic technique affects ECT outcomes. Specifically, the investigators will examine how: 1) the time interval between anaesthetic and ECT stimulus, and 2) the ventilation rate before ECT stimulus, impacts on the quality of the EEG (this is a recording of brain activity during ECT and is used to judge the quality of a seizure and to guide individual patient dosing).

Detailed description: This study aims to examine how the time interval between administration of anaesthetic agent and ECT stimulus delivery impacts upon measures of EEG quality (seizure quality).

Eligibility criteria: Inclusion Criteria:

* Patients treated with a course of ECT

Exclusion Criteria:

* Use of non-standard anaesthetic agents in ECT (e.g. ketamine)

Primary outcomes:
measure: EEG Seizure Quality Rating using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al
timeFrame: Outcome measures will be collected immediately after each ECT treatment from the first treatment until the end of the ECT course, an estimated total of four to six weeks for most participants
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Wesley Hospital Kogarah
state: New South Wales
Study officials:
affiliation: The University of New South Wales
name: Colleen Loo, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04310345: Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
Official title: Exploring the Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Relapsed Cancer
Refractory Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-03-17
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the effects of human-animal interaction on reducing anxiety, depression, worry, and pain and enhancing quality of life in children ages 6-17 years old with a life threatening cancer and their parent caregivers.

Detailed description: Objectives:

* To examine the feasibility of human-animal interaction (HAI) sessions for children with a life threatening cancer and a primary caregiver, specifically to:

  * To identify and document necessary modifications for a safe and feasible intervention
  * To obtain recruitment estimates and determine potential recruitment barriers
  * To evaluate elements of implementation fidelity (design, training, delivery/receipt of treatment, enactment)
  * To verify safety
* To determine the preliminary efficacy of human-animal interaction sessions:

  * On children with a life threatening cancer for the outcomes of qualify of life, anxiety, depression, worry, and pain
  * On caregivers of children with a life threatening cancer for the outcomes of stress and anxiety

Exploratory Objective:

- To explore mechanisms (reduced salivary cortisol and urinary norepinephrine levels) associated with 8 weeks of human-animal interaction.

Eligibility criteria: Inclusion Criteria:

Child:

* Children age 6-17 years old that have been diagnosed with advanced cancer as defined by any stage of relapsed, recurrent or refractory cancer
* Able to understand English or Spanish to complete consents and surveys

Parent or Guardian:

* Parent or guardian as determined by person who brings child to \>50% of their clinic visits
* Able to understand English or Spanish to complete consents and surveys

Exclusion Criteria for both Children and Parent/Guardian:

* Self-reported fear of or allergies to canines
* Cognitive impairment as identified by healthcare team or inability to complete consenting process

Primary outcomes:
measure: Pediatric Quality of Life
timeFrame: Up to 2 months
measure: Anxiety
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt Medical Center
name: Maryjo Gilmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06825845: Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy
Official title: Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: CARsgen Therapeutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-13
Enrollment: 1500
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: Before any study procedure, informed consent must be signed by the participants, or by the participant's legal guardian for patients with no full civil capacity

Brief summary: This is a prospective long-term follow-up (LTFU) study to evaluate the long-term safety and survival benefit for patients who received at least one of CARsgen's GM T cell product in a clinical trial or as a commercially available product. In this study, patients will be followed for up to 15 years after last GM T-cell infusion for the evaluation of delayed adverse events (AEs), vector persistence, potential risk for integration, and survival time due to GM T-cell exposure.

Detailed description: As recommended by Health Authorities guidelines for human gene therapy products containing an integrated transgene, during the LTFU for 15 years after infusion, the information of the enrolled patients will be collected, including medical history, physical and laboratory-related examination data, AEs, survival information, etc. AEs recorded will include new malignancy, new or exacerbation infection, new or exacerbation neurological disease, new or exacerbation autoimmune disease etc. Samples will be obtained according to the schedule of activities, and laboratory tests will be conducted or preserved for future use.

All participants are recommended to be followed at least every six months for the first 5 years, and annually from the 6th year until at least 15 years or until informed consent withdrawal, loss to follow-up, or death, whichever occurs first.

Eligibility criteria: Inclusion Criteria:

- 1. All patients who have received at least one GM T-cell infusion in the parent clinical study or in the post-approval setting.

2. Patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For patients incapable of providing consent, the signed ICF of their legally accepted guardians must be obtained.

Exclusion Criteria:

* There are no specific exclusion criteria for this study.

Primary outcomes:
measure: To assess the risk of delayed AEs following exposure to GM T cells
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05818345: Pricing Interventions Based on Energy Content in Restaurants
Official title: Socioeconomic Position and the Effectiveness of a Pricing Intervention Based on Energy Content in Restaurants: a Real-world Experiment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Healthy Diet
Eating Behavior
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: European Research Council
First posted: 2023-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to examine the impact of price decreases based on energy content in a full-service restaurant on immediate dietary consumption (in terms of kilocalories (kcals), sugar, fat, and salt intake) and dietary consumption the rest of the day following the intervention; and whether the intervention effects differ based on socioeconomic position (SEP).

Participants will be asked to visit the restaurant twice. At visit 1, participants will receive a control study menu with the existing pricing structure of the restaurant. At visit 2, participants will receive the same study menu with the pricing intervention introduced.

For comparative purposes a smaller subgroup of participants will receive the control menu at both visit 1 and 2 to allow the researchers to estimate whether any pre-post changes occur in the absence of a pricing intervention (and whether change differs by SEP).


Eligibility criteria: Inclusion Criteria:

* UK resident, aged 18 and older, fluent in English, have an out-of-home meal at least once a month and have no dietary allergies

Exclusion Criteria:

* No further exclusion criteria as it is a real-world study

Primary outcomes:
measure: Total kilocalories (kcal) ordered at the restaurant
timeFrame: 1 hour
measure: Total kcal consumed at the restaurant
timeFrame: 1 hour
Secondary outcomes:
measure: Later kcal intake
timeFrame: 10 hours
measure: Total sugar, fat and salt intake
timeFrame: 1 hour
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
city: Liverpool
country: United Kingdom
facility: University of Liverpool
Study officials:
References:
Clinical trial NCT02624245: The Movement Control Training Associated With Conventional Physical Therapy is More Effective Than Conventional Physical Therapy Alone in Pain and Functional Performance?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess pain, performance function, hip and knee strength and kinematics of trunk and lower limbs during single leg hop test after movement control training associated to hip and knee muscle strengthening.


Eligibility criteria: Inclusion Criteria:

* Sedentary women,
* Previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping

Exclusion Criteria:

* Lower limb surgery,
* Patella displacement
* Knee instability
* Heart or locomotor disorders which might influence the evaluation

Primary outcomes:
measure: Pain
timeFrame: 4 weeks
measure: Functional Performance
timeFrame: 4 weeks
Secondary outcomes:
measure: Strength of hip and knee extensor muscles measured through hand-held dynamometer
timeFrame: 4 weeks
measure: 3D kinematic range of motion of hip adduction during single leg hop test
timeFrame: 4 weeks
measure: 3D kinematic maximum angular value of hip adduction during single leg hop test
timeFrame: 4 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
state: SP
Study officials:
References:
Clinical trial NCT00878345: Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation
Official title: Dexmedetomidine Versus Pentobarbital Sedation Protocol for Non-painful Procedural Sedation in Pediatrics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sedation
Keywords: Pediatric sedation
Pentobarbital
Dexmedetomidine
Procedural sedation in children
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory procedure center. These protocols are both routinely used for sedation in our unit. The investigators propose to study these two protocols in children ages 6 months to 6 years presenting to the ambulatory procedure center for non-painful procedural sedation. The investigators will compare failure of sedation, side effect profile, recovery and discharge times between the two pharmacologic protocols.


Eligibility criteria: Inclusion Criteria:

* Requiring sedation for non-painful procedures
* Normal airway per exam

Exclusion Criteria:

* Congenital syndromes with known difficult airways
* Known difficult airway during past anesthesia or sedation experience
* Parent/guardian refusal of participation

Primary outcomes:
measure: failure of sedation
timeFrame: day of sedation
Secondary outcomes:
measure: side effect profile
timeFrame: 48 hours
measure: post-sedation recovery and discharge time
timeFrame: day of sedation
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
Study officials:
References:
citation: Mason KP, Zgleszewski SE, Prescilla R, Fontaine PJ, Zurakowski D. Hemodynamic effects of dexmedetomidine sedation for CT imaging studies. Paediatr Anaesth. 2008 May;18(5):393-402. doi: 10.1111/j.1460-9592.2008.02451.x. Epub 2008 Mar 18.
citation: Mukhtar AM, Obayah EM, Hassona AM. Preliminary experience with dexmedetomidine in pediatric anesthesia. Anesth Analg. 2006 Jul;103(1):250. doi: 10.1213/01.ANE.0000228303.92422.73. No abstract available.
citation: Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006 Jul;103(1):63-7, table of contents. doi: 10.1213/01.ANE.0000219592.82598.AA.
Clinical trial NCT05369845: Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome
Official title: Evaluation of Prognostic Criteria for Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Continuous Positive Airway Pressure
Adherence
Perception and Beliefs
Keywords: Obstructive Sleep Apnea Syndrome
Continuous Positive Airway Pressure
Adherence
Perception and Beliefs
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Moderate to severe obstructive sleep apnea syndrome (OSAS) (HAI hypopnea apnea index ≥ 15) is a common pathology, which affects 6 to 17% of the general population. The Alaska study, which involved 480,000 apneic patients newly fitted with CPAP, showed that 76.9% of patients were still under treatment for one year, 62.9% after two years, and 52.3% after three years.

All patients who recently diagnosed with OSAS in the Sleep Disorder Unit (unity de Pathologies du Sommeil et de la Vigilance, CHU d'AMIENS-PICARDIE, FRANCE) and who are requiring CPAP will be included. On the day of their hospitalization for the implementation of the CPAP therapy, patients will answer validated questionnaires to assess their level of motivation and adherence to the initiation of treatment but also to assess their knowledge and understanding of the disease and its treatment. These questionnaires will be repeated at the four-month and one-year follow-up consultations (+/- 21 days).

The aim of the study is to identify the prognostic factors of adherence to CPAP, leading to a better understanding and management of patients with sleep apnea syndrome.


Eligibility criteria: Inclusion Criteria:

* Adult patient (≥ 18 years old)
* Diagnosis of moderate to severe obstructive sleep apnea syndrome OSAS (AHI ≥ 15) by polygraphy or polysomnography performed in our Sleep disorder Unit
* Requiring CPAP therapy
* Informed consent

Exclusion Criteria:

* Patient previously treated with CPAP therapy
* Psychiatric illness destabilized
* Unstable medical condition (i.e. COPD exacerbation, acute cardiac dysfunction, etc.)
* Planned obesity or ENT surgery (because CPAP treatment is planned for a short period)
* Central or mixed apnea syndrome
* Patient under 18 years old
* Pregnant, parturient or breastfeeding woman
* Patient under guardianship, curators or deprived of liberty
* Patient participating in another research including an exclusion period still in progress at the pre-inclusion.

Primary outcomes:
measure: Time (in minutes) for the daily use of the CPAP therapy
timeFrame: at 4 weeks
measure: Time (in minutes) for the daily use of the CPAP therapy
timeFrame: at 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT04834245: Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing
Official title: Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing: A Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetic foot ulcer
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: The wound dressings perform a crucial role in the cutaneous wounds' management due to their ability to protect wounds and promote dermal and epidermal tissue regeneration. Objective: the aim of the present study to evaluate the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing.

Approach: Sixty patients with type-2 diabetes hospitalized for diabetic foot wound treatment were recruited from selected Surgical departments at Kasr Al-Aini university hospital.

Detailed description: Data Collection: The patients of group-I wounds were cleaned using normal saline; then, the wounds were closed firmly with hyderogel\\nano silver dressing. The dressing was changed every two days according to dressing manufacture instruction. When the dressing was opened after three days, the wound was assessed for granulation tissue, wound, and discharge size.

The patients of group II wounds were dresses using a traditional method, cleaned by normal saline, use of betadine antiseptic; then they were secured with clean linen gauze. The dressing was changed once daily. The wound healing process of the two groups was then assessed for three consecutive weeks.

Eligibility criteria: Inclusion Criteria:

Diabetes Type I and Type II patient with diabetic foot ulcer age ranged 35-55 years old Willing to participate

Exclusion Criteria:

unwilling to participate.

Primary outcomes:
measure: the percentage of a reduction rate of the diabetic foot ulcer after intervention
timeFrame: 3 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: