louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05547451: SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis
Official title: SARS Cov2 Vaccination in Adolescents From 12 to 18 With Juvenile Idiopathic Arthritis in Angers, Nantes and Rennes : Acceptance and Safety.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis
Keywords: SARS Cov2 vaccination
juvenile idiopathic arthritis
paediatric
safety
acceptance
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
name: Rennes University Hospital
name: Clinique de l'Anjou
First posted: 2022-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 12 to 18 years old followed up from juvenile arthritis in 2021 and 2022 at Angers, Nantes and Rennes.

Brief summary: Since june 2021, vaccination against the SARS-Cov2 virus is recommanded in France to all children from 12 to 18 years old. In the specific population of teenagers living with juvenile arthritis, the vaccine seems to be safe and well tolerated. It has been shown previously that this population has a vaccine coverage lower than the global population even though few datas are available on this topic The aim of this resarch is to study the vaccination coverage against the SARS-Cov2 virus and more specifically the reasons why adolescents were or were not vaccinated in the population of adolescents with juvenile arthitis followed up in Angers, Nantes and Rennes. For this purpose, a review of the medical record will be done and a questionnaire will be adressed to the family of patients in order to collect informations about the disease, the treatments, the motives or obstacles to vaccination. Secondaries end points are safety of the vaccination, consequences on the juvenile arthritis (such as changes in the medication, flare-up of the illness) and the occurence of covid infection after vaccination.


Eligibility criteria: Inclusion Criteria:

* Patients from 12 to 18 years old, on January the 1st 2022
* Patients followed up from juvenile arthritis
* Patients followed up in 2021 and 2022

Exclusion Criteria:

* Patients under 12 years old.

Primary outcomes:
measure: SARS Cov2 vaccination coverage of this population and factors influencing the realization of the vaccination.
timeFrame: From june 2021 to December 2022
Secondary outcomes:
measure: Tolerance of the SARS-Cov2 vaccination
timeFrame: From june 2021 to December 2022
measure: Effect of the SARS Cov2 vaccination on juvenile arthritis
timeFrame: From june 2021 to December 2022
measure: SARS-Cov 2 infection after vaccination
timeFrame: From june 2021 to December 2022
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
state: Loire-Atlantique
Study officials:
References:
Clinical trial NCT06484777: A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
Official title: An Open-label, Multi-center Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of SHR-9539 Injection in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, open-label, dose-escalation/dose-expansion clinical Phase I trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy profile of SHR-9539 Injection in patients with multiple myeloma.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years on day of signing the Informed Consent Form;
2. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
3. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria ；
4. Have a life expectancy of at least 3 months；
5. Male and female subjects with fertility must agree to use efficient contraceptive measures with their partners within 3 months after the last administration of the test drug from the time of signing the informed consent form, and have no fertility plan and avoid donating sperm / eggs. The pregnancy test during the screening period must be negative.

Exclusion Criteria:

1. Central nervous system (CNS) involvement of MM；
2. Diagnosis of amyloidosis, plasma cell leukemia, Wahl's macroglobulinemia, or POEMS syndrome;
3. Prior Grade 3 or higher CRS (Per ASTCT standards) related to any T cell redirection (eg, CD-3 redirection technology or CAR-T cell therapy).
4. Have other factors that may force the termination of the study, e.g., non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory abnormalities, associated family or social factors, which would affect the safety of the subjects or the collection of data and samples, as determined by the investigator.

Primary outcomes:
measure: RP2D of SHR-9539 injection
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Incidence and severity of AE
timeFrame: Up to follow-up period, approximately 24 months
measure: Cmax
timeFrame: Up to follow-up period, approximately 24 months
measure: Tmax
timeFrame: Up to follow-up period, approximately 24 months
measure: Overall Response Rate (ORR)
timeFrame: Up to follow-up period, approximately 24 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT03324477: The Hemodynamic Effects of Hypertonic Saline Preload Versus Coload Measured by Non-invasive Cardiometry in Patients Undergoing TURP Surgery
Official title: Cardiometrically Evaluated NaCl 3% Coload Versus Preload for TURP. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transurethral Resection of Prostate Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.

Detailed description: Benign prostatic hyperplasia is common in elderly males, and this group of patients is commonly associated with different comorbidities especially of the cardiovascular system , this make them at risk of many intraoperative complications. The associated adverse effects arising in both the cardiovascular and nervous systems are known as transurethral resection (TUR) syndrome.Therefore TURP patients need meticulous monitoring of hemodynamics and fluid therapy.

This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.

100 ASA physical status I-III male patients scheduled to electively undergo transurethral resection of the prostate under spinal subarachnoid block were included in this study

Preload group (Group P):

50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula over 15-20 min before the induction of spinal anaesthesia.

Co-load group (Group C):

50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula at the maximal possible rate at the time of identification of C.S.F .

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I - III.

Exclusion Criteria:

* Patient refusal.
* Patient in whom spinal anesthesia is absolutely contraindicated.
* Known sensitivity to local anesthetics.
* Preoperative electrolyte imbalance.

Primary outcomes:
measure: systolic blood pressure
timeFrame: two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Nazmy E Seif, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Manal M Elgohary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Manar M Elkholy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592877: A Comparative Study of the Performance of a New Type Non-contact Patient Monitor
Official title: Clinical Test of Ultra-Wideband Non-contact Heart Rate and Breath Rate Monitor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Indication for Modification of Patient's Cardiopulmonary Status
Keywords: UWB
non-contact
patient monitor
Lead sponsor: Holux Technology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Shin Kong Wu Ho-Su Memorial Hospital
First posted: 2012-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, \>18 years old.

Brief summary: To verify the accuracy and reliability of the ultra wideband (UWB) non-contact breath rate and heart rate monitor, ICU bedside monitor is used as the gold standard.

Detailed description: In this study, 50 volunteer patients are tested on the UWB non-contact breath rate and heart rate monitor. The testing time length for each patient is set to two hours. Subject is not to be restrained and nurse is allowed to take care the subject while testing. The breath rate and heart rate data will be analyzed for their accuracy against the MP60 (Philips) bedside monitor.

Eligibility criteria: Inclusion Criteria:

* conscious adult,
* \> 18 years old

Exclusion Criteria:

* non-conscious,
* pregnant women,
* epilepsy patients,
* patients with heart pacemaker or ACIDS,
* patients on respirator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Che-Ming Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595477: Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza
Official title: A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: The Center for Mind-Body Medicine
Sponsor class: OTHER
Collaborators: name: The Atlantic Philanthropies
First posted: 2012-05-10
Enrollment: 114
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized children in Gaza will result in improvement of posttraumatic stress symptoms, depression, and decreased hopelessness compared to a control group.


Eligibility criteria: Inclusion Criteria:

* having experienced a political violence or war-related criterion A stressor
* meeting the American Psychiatric Association (DSM-IV-TR) criteria for PTSD according to screening scores on the Child PTSD Symptom Scale

Exclusion Criteria:

* former psychosocial or medical treatment for mental health conditions
* significant cognitive impairment

Primary outcomes:
measure: Child PTSD Symptom Scale
timeFrame: Change from Baseline (Week 1) at 6 weeks
measure: Child PTSD Symptom Scale
timeFrame: Change from Week 6 at 18 weeks
measure: Child PTSD Symptom Scale
timeFrame: Change from Baseline (Week 1) at 18 weeks
Secondary outcomes:
measure: Children's Depression Inventory -2 Short Form
timeFrame: Change from Baseline (Week 1) at 6 weeks
measure: Children's Depression Inventory -2 Short Form
timeFrame: Change from Week 6 at 18 weeks
measure: Children's Depression Inventory -2 Short Form
timeFrame: Change from Baseline (Week 1) at 18 weeks
measure: Hopelessness Scale for Children
timeFrame: Change from Baseline (Week 1) at 6 weeks
measure: Hopelessness Scale for Children
timeFrame: Change from Week 6 at 18 weeks
measure: Hopelessness Scale for Children
timeFrame: Change from Baseline (Week 1) at 18 weeks
Other outcomes:
Locations:
city: Gaza City
country: Israel
facility: The Center for Mind-Body Medicine
state: Palestine
Study officials:
affiliation: The Center for Mind-Body Medicine
name: James S Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06330753: Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan
Official title: Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma and Stressor Related Disorders
Violence, Structural
Violence, Domestic
Violence, Sexual
Keywords: trauma
violence
abuse
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective study designed to explore the acceptability, intervention appropriateness of trauma-informed care plans and the feasibility of trauma-informed care plans by patients and members of the health care team
Primary purpose: TREATMENT

Brief summary: The goal of this prospective study is to test the: acceptability of trauma-informed care plans; the intervention appropriateness; and the feasibility of the trauma-informed care plans in the electronic health care record. Patient seen in various health care settings and how have complex health care needs will be invited to participate in this study. The aims to are:

Aim 1: Explore the acceptability of trauma-informed care plans, the appropriateness of trauma-informed care plans, and the feasibility of Trauma-Informed Care Plans(TICP) when used by clinicians on the health care team (HCTC). Hypothesis 1: HCTC using the TICP will report its acceptability, feasibility, satisfaction and ease of use. Hypothesis 2: HCTC will report heightened awareness of intersection of trauma and social determinants of health. Hypothesis 3: HCTC will report more awareness of the patient's unique preferences and will be better informed regarding the unique plan of care for their patient.

Aim 2: Explore the impact of having a TICP by patients understanding how the TICP may have improved their experience around care and treatment. Hypothesis 1: patients will report: improved satisfaction with their care. Hypothesis 2: patients will report feeling better known by HCT. Hypothesis 3: will report less stress and anxiety related to health care encounters.


Eligibility criteria: Inclusion Criteria:

* patients ( ages 18-60)
* who have frequent health care appointments
* have complex health care needs
* consent to participate in study
* English or spanish speaking.

Exclusion Criteria:

* patients less than 18 and older than 60.
* patients too ill (medically/phytologically) to consent.
* suicidal or homicidal patients.

Primary outcomes:
measure: Acceptability of Trauma Informed Care Plans
timeFrame: 6-10 months
Secondary outcomes:
measure: Intervention Appropriateness of Trauma-Informed Care plans
timeFrame: 6-10 months
measure: Feasibility of the trauma-informed care plans
timeFrame: 6- 10 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05890053: To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia
Official title: A 52-week, Open Phase III Study Evaluating the Long-term Safety and Efficacy of HSK16149 Capsules in Chinese Patients With Peripheral Neuralgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral Neuropathic Pain
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 301
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: Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with periphcral neuralgia

Detailed description: Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with Peripheral neuropathic pain

Eligibility criteria: Inclusion Criteria:

1. Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/301.
2. Able to understand and voluntarily sign informed consent.

Exclusion Criteria:

1. Medication compliance was \< 80% in double-blind studies.
2. In double-blind study, EOT visit (V10) eGFR\< 60 mL/min//1.73m2
3. Significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study.
4. Hepatitis B Surface antigen (HBsAg) positive or hepatitis C virus antibody (HCV Ab) positive during screening \[further hepatitis B virus deoxyribonucleic acid (HBV DNA) titer detection or hepatitis C virus ribonucleic acid (HCV RNA) detection (beyond the detection limit of assay need to be excluded)\], human immunodeficiency virus antibody (HIV) Ab) positive, serum antibody to treponema pallidum (TP Ab) positive (further test for treponema pallidum titer, if positive, excluded).
5. Women who are pregnant, planning to become pregnant during the study, or breastfeeding; Participants were not expected to use reliable contraceptive methods (including condoms, spermicides, or intrauterine devices) for 28 days after signing up for the ICF or planning to use progester-containing contraceptives during this period.
6. The researcher judged that the study could not be completed according to the scheme or that it was difficult to participate in the study due to safety.

Primary outcomes:
measure: To evaluate the long-term safety of HSK16149 capsules in Chinese patients with peripheral neuralgia.
timeFrame: From week 1 to week 53
Secondary outcomes:
measure: Changes in SF-MPQ scores from baseline before and after treatment to evaluate the long-term effectiveness of HSK16149.
timeFrame: From week 1 to week 53
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03677453: Interactive Perioperative Teaching Platform (IPTP)
Official title: Interactive Perioperative Teaching Platform (IPTP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillar Hypertrophy
Adenoid Hypertrophy
Cryptorchidism
Hypospadias
Hydrocele
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 151
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The proposed study will assess whether an interactive perioperative teaching platform (IPTP) provided to families of patients undergoing ambulatory pediatric surgery will reduce families' anxiety, and improve satisfaction and understanding, relative to current practice. The IPTP will educate patient families on the continuum of their child's surgical experience, from arriving at the hospital through registration, the operating room (OR), and the hospital floor. An active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management. A comparison cohort of patients undergoing surgery without access to the IPTP will be recruited to assess the benefits of the IPTP for improving metrics of family satisfaction, preoperative anxiety, and postoperative understanding of discharge instructions.


Eligibility criteria: Inclusion Criteria:

* Children aged 0-18 years
* Undergoing adenotonsillectomy or orchiopexy, hydrocele or hypospadias repair
* Only patients booked for ambulatory surgery in the main operating room (OR)

Exclusion Criteria:

* Patients will be excluded if they have previously undergone surgery or require a translator

Primary outcomes:
measure: Patient family satisfaction
timeFrame: Immediately prior to discharge
Secondary outcomes:
measure: Anxiety level
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03031353: Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity
Official title: Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transient Tachypnea Newborn
Cesarean Delivery Affecting Fetus
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising.

Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.


Eligibility criteria: Inclusion Criteria:

* Age: 18 years or more.
* Term singleton pregnancy (38 - 38+6 weeks gestation).
* Planned for elective transverse lower segment caesarean section with an indication.

Exclusion Criteria:

* Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease.
* Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol.
* Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study.
* Pregnancies with known foetal malformation/s or chromosomal aberration.

Primary outcomes:
measure: The need for admission to neonatal intensive care unit (NICU)
timeFrame: first 24 hours after delivery
Secondary outcomes:
measure: APGAR score below 6 at 5 minute
timeFrame: 5 minutes after delivery
Other outcomes:
measure: neonatal mortality
timeFrame: first month after delivery
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
state: Al Qahirah
Study officials:
References: