louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05821595: JYB1907 in Subjects With Advanced Solid Tumors
Official title: A Phase I, Multi-center, Open-label Study With Dose-escalation and Multiple Expansion Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JYB1907 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Phase I, Multi-center, Open-label Study with Dose-escalation and Multiple Expansion Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JYB1907 in Subjects with Advanced Solid Tumors

Detailed description: Dose escalation This part is meant to evaluate the safety, tolerability, PK, immunogenicity, preliminary antitumor activity, the MTD and RP2D of JYB1907 in patients with histologically or cytologically confirmed advanced solid tumors.

Expansion cohort The antitumor activity, safety, tolerability, PK and immunogenicity of JYB1907 will be further evaluated in other cohorts.

Eligibility criteria: Inclusion Criteria:

1. Able to provide written informed consent voluntarily;
2. Age ≥18, male or female;
3. Have at least one evaluable lesion (Dose escalation) or measurable lesion;
4. Expected survival ≥12 weeks；
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;

Exclusion Criteria:

1. Received within 4 weeks before the initial treatment, or scheduled during the study to receive a major surgery, live attenuated vaccines, or any anti-tumor therapy.
2. With severe tumor complications.
3. Pregnant or lactating women, or positive serum pregnancy test;
4. Concurrent participation in another interventional study；
5. With other diseases or clinical abnormalities assessed by the Investigator as ineligible.

Primary outcomes:
measure: Adverse events
timeFrame: until either 28 days after last dose of study drug or initiation of new anticancer therapy, whichever occurs first.
Secondary outcomes:
measure: Serum concentrations of JYB1907
timeFrame: until 28 days after last dose of study drug
measure: Serum concentrations of Immunogenicity Analysis
timeFrame: until 28 days after last dose of study drug
measure: Serum concentrations of Preliminary antitumor activity
timeFrame: until 28 days after last dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Ning Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06283095: Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty
Official title: Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS.

Detailed description: Expansion palatopladty will be conducted on patients with obstructive sleep apnea patients to evaluate the outcome.

Eligibility criteria: Inclusion Criteria:

* Adult patients.
* Body mass index \< 30 kg/m2 (weight /height in m2)
* Mild to moderate OSAS
* Sagittal collapse of the lateral pharyngeal walls proved by Drug induced sleep endoscopy (DISE).

Exclusion Criteria:

* • Refusing enrollment into the study.

  * Pregnant women.
  * Refusing the surgery
  * Contraindication to anaesthesia
  * Patients with multilevel of obstruction.
  * Serious psychiatric, neurological and cardiopulmonary (COPD or corpulmonale) diseases.
  * Uncorrected hypothyroidism.
  * Severe OSAS.
  * Craniofacial anamolies.
  * Central\& mixed apnea
  * Morbid obesity.

Primary outcomes:
measure: Evaluation the outcome of expansion palatoplasty in management of OSAS.
timeFrame: Six months
Secondary outcomes:
measure: Expansion palatoplasty in Obstructive sleep apnea patients
timeFrame: Six months
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: ASSUIT
Study officials:
affiliation: Assuit U
name: Enas T Zarief
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06149195: 18F-MFBG Cardiac Imaging for Heart Failure Administration
Official title: 18F-meta-fluorobenzylguanidine Cardiac Imaging for Evaluation of Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Rest Gated Myocardial Perfusion Imaging in Heart Failure
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: enrolling patients with chronic heart failure with a heart function of NYHA Class II-III.

Brief summary: The clinical feasibility of 18F-FMBG cardiac PET imaging will be observed in sympathetic nervous system activity in patients with heart failure, predicted cardiac events, guided ICD implantation, and evaluated therapy efficiency.

Detailed description: This is a prospective, single-center clinical study, using18F-meta-fluorobenzylguanidine (18F-MFBG) cardiac PET imaging to present the sympathetic nerve status in heart failure, including ICD implantation. Through follow-up, we analyze the correlation between the distribution of the tracer in the heart and the functions and progression of the patients, including the occurrence of ventricular arrhythmias and sudden cardiac death, And further investigate the guiding value of 18F-MFBG cardiac sympathetic nerve imaging in the screening of ICD implantation patients, including primary and secondary prevention, reducing the cost of ICD implantation and related complications. Furthermore, to evaluate the therapy efficacy for these patients with heart failure using 18F-MFBG cardiac imaging has been considered.

Eligibility criteria: Inclusion Criteria:

* 1. Clinically confirmed patient with chronic heart failure, LVEF ≤ 40%, cardiac function NYHA 2-3 grade, survival period greater than 1 year, evaluated by the Heart Failure Center of Sichuan Provincial People's Hospital.
* 2. Chronic heart failure patients were evaluated by the Cardiology Department of Sichuan Provincial People's Hospital 5-10 days before ICD implantation.
* 3. All patients above have signed an informed consent form.

Exclusion Criteria:

* 1. Heart failure, heart function NYHA levels ⅠOR Ⅳ.
* 2. The patient has already implanted ICD or CRT.
* 3. Heart transplant patients.
* 4. Patients with malignant tumors.
* 5. Heart valve disease.
* 6. Myocardial infarction occurred within the past three months.
* 7. The patient has contraindications for ICD implantation surgery.
* 8. The patient does not cooperate or is unwilling to conduct the study.

Primary outcomes:
measure: observe the 18F-MFBG distribution of the myocardium in heart failure patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Zhi Ling Ding
state: Sichuan
Study officials:
affiliation: China, Sichuan Departments of Nuclear Medicine, Sichuan Provincial People's Hospita
name: Zhi Ling Ding
role: STUDY_DIRECTOR
References:
Clinical trial NCT01744795: CardioQ vs Thermodilution Measurements of Cardiac Output
Official title: Comparison of CardioQ and Pulmonary Artery Thermodilution Derived Cardiac Output Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparison of CardioQ and Thermodilution Derived Cardiac Output Measurements
Keywords: cardiac output
thermodilution
esophageal doppler
trending ability
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-12-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Minimal invasive monitoring systems of central hemodynamics are gaining increasing popularity. The present study investigates the precision of the esophageal doppler (CardioQ) derived cardiac output and its agreement with pulmonary artery catheter thermodilution (PAC TD) for measuring CO during steady state and with induced hemodynamic changes in patients scheduled for elective cardiac surgery.

Detailed description: Twenty-five patients are planned to be enrolled. After induction of anesthesia, insertion of the PAC and the esophageal-doppler probe, the patient are placed in the following successive positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm, and CO are measured simultaneously using the CardioQ and PAC TD.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective coronary artery bypass grafting (CABG), who are in stable sinus rhythm, who have a left ventricular ejection fraction \> 0.40 measured by transthoracic echocardiography, and who have no significant valve pathology

Exclusion Criteria:

-

Primary outcomes:
measure: Agreement of cardiac output determined with CardioQ, compared with thermodilution
timeFrame: Data are collected in the perioperative period (30min.)
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, University of Copenhagen
state: Capital region
city: Copenhagen
country: Denmark
facility: Department of Cardiothoracic anesthesiology; Rigshospitalet
Study officials:
References:
Clinical trial NCT05074095: Analysis of Urogenital Injuries in Polytraumatized Patients
Official title: Injuries of the Urogenital Tract in Polytraumatized Patients in Correlation With Injuries to the Spine and Pelvic Girdle- Are There Positive Predictive Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polytrauma
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective analysis of polytrauma patients.

Brief summary: Urogenital injuries occur in approximately 5-10 % of all severly injured patients. The literature lacks a thorough investigation into the mechanisms of trauma, the analysis of the whole urogenital tract and especially the correlation of thoracic and lumbar spine and pelvic injuries with urogenital injuries.

The goal of this study is to provide a thorough investigation into these primary end points in a multicenter study of university hospitals in Germany.


Eligibility criteria: Inclusion Criteria:

* ISS (Injury severity score) \> 15 points
* Patient Age \> 16
* Fracture of the thoracic and/ or lumbar spine
* Fracture of the pelvic girdle
* at least one AIS (abbreviated injury scale) \> 2

Exclusion Criteria:

* ISS \< 16 points
* no fractures of the thoracic or lumbar spine or fractures of the pelvic girdle
* no AIS \> 2
* patient age under 16 years of age

Primary outcomes:
measure: Predictive factors for urogenital injuries
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02627495: Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
Official title: Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Phantom Limb Pain
Keywords: maladaptive plasticity
Limb amputation
phantom limb pain
tDCS
non-invasive brain stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 9
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 explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.


Eligibility criteria: Inclusion Criteria:

1. Able to provide informed consent to participate in the study.
2. Subject is older than 18 years.
3. 3 months of phantom limb pain (experienced regularly for at least once a week) after the amputated limb has completely healed.
4. Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
5. If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.

Exclusion Criteria:

1. Pregnancy or trying to become pregnant in the next 2 months.
2. History of alcohol or drug abuse within the past 6 months as self-reported.
3. Presence of the following contraindication to transcranial direct current stimulation Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel) Implanted head electronic medical devices (e.g., cochlear implants)
4. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
5. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
6. Uncontrolled Epilepsy
7. Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).\*
8. History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
9. History of neurosurgery, as self-reported.

Primary outcomes:
measure: Pain as Measured by the Visual Analog Scale
timeFrame: Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT06762795: The HIEnome Study: Genome Sequencing for Perinatal HIE
Official title: The HIEnome Study: Genome Sequencing for Perinatal HIE
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypoxic Ischemic Encephalopathy of Newborn
Hypoxic Ischemic Encephalopathy
Hypoxic Ischemic Encephalopathy (HIE)
Keywords: Hypoxic-ischemic encephalopathy
Genetic testing
Genome sequencing
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Perinatal hypoxic-ischemic encephalopathy is a rare severe condition in which neonates present with encephalopathy and a clinical history suggestive of prenatal or perinatal hypoxic-ischemic injury. Emerging evidence suggests that genetic conditions are frequently identified in cases of perinatal HIE; however, it is unclear which neonates with this diagnosis warrant genetic testing. This study will offer clinical genome sequencing to neonates with HIE who are undergoing total body cooling (therapeutic hypothermia) and their parents.


Eligibility criteria: Inclusion Criteria:

* Delivery ≥35w0d gestation
* Diagnosed with moderate or severe HIE, or HIE with seizures
* Undergoing total body cooling / therapeutic hypothermia
* Able to provide blood or buccal samples during birth hospitalization
* Admitted to Texas Children's Hospital Main, West, or Woodlands NICU

Exclusion Criteria:

* Parents/family not willing to allow participation
* Inability to collect sufficient neonatal blood samples (in some circumstances, a buccal swab may be used as backup)

Primary outcomes:
measure: Diagnostic yield
timeFrame: 18 months
Secondary outcomes:
measure: Genome versus exome sequencing
timeFrame: 18 months
measure: Indeterminate results
timeFrame: 18 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
References:
Clinical trial NCT06952595: Carer Involvement in Exercises for People With Acquired Brain Injury.
Official title: Carer Involvement in Exercise Programmes for Acute Neurosciences Patients With Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury (Including Stroke)
Keywords: Stoke
Acquired brain injury
rehabilitation
exercise therapy
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of East Anglia
name: 3 Million Steps charity
First posted: 2025-05-01
Enrollment: 20
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: Increasing the amount of exercises completed has been shown to help recovery for people after a brain injury. This study will explore if providing extra training of exercises prescribed to a patient and carer team, will allow more practice of these exercises, better abilities to move and balance, and to assess if carer confidence changes with doing this. It is a repeated case design in the in-patient acute Neurosciences setting at the Norfolk and Norwich University Hospital NHS Trust (NNUH).


Eligibility criteria: Inclusion

* Adults with acquired brain injury on NNUH Neurosciences Unit with a carer physically able to complete exercises with the patient.
* Patient to be able to follow simple commands (1 stage) for exercise intervention.
* Patient able to consent along with their relative together to participation in the study.

Exclusion:

* Discharge plan for ESD from initial assessment with no care package required due to too short timeframe of being an acute in-patient.
* Patient's with severe cognitive - communication deficits meaning they cannot follow 1 stage command for exercises or consent to the study.
* Severe pain, joint abnormality or spasticity limiting participation in exercise programme.
* Carer/relative not able to physically help the patient with the required exercises or carer/relative not able to consent to the study.

Primary outcomes:
measure: Log of exercise repetitions
timeFrame: Pre and post intervention: 4 weeks or at point of discharge from acute Trust.
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
Study officials:
References:
Clinical trial NCT03662295: Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
Official title: Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Aphasia
Keywords: Cognitive Impairment
Lead sponsor: Quality Living, Inc.
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 1
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One adult with SMART syndrome will participate in this study. The person will have cognitive and language deficits typical of those exhibited by people with SMART syndrome. Given the rarity of the disorder, only one participant is anticipated.

Brief summary: Stroke-like migraine attacks after radiation therapy-also known as SMART syndrome-constitute a rare condition typically characterized by headache, seizures, vision abnormalities, hemiparesis, and aphasia. The condition usually resolves within a few days or weeks of onset with no residual impairments. However, resolution in some cases extends over a period of months rather than weeks and may be incomplete. The purpose of this case report is to provide an in-depth description of the progression of changes in cognitive and language functioning for a person exhibiting SMART syndrome characterized by slow recovery.


Eligibility criteria: Inclusion Criteria:

* exhibit cognitive and language deficits secondary to SMART syndrome
* be a former or current client of Quality Living, Inc., Omaha, Nebraska
* be a native speaker of English

Exclusion Criteria:

-

Primary outcomes:
measure: Standardized assessment
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: Spoken picture description
timeFrame: Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks
measure: Written picture description
timeFrame: Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Quality Living, Inc.
state: Nebraska
Study officials:
affiliation: Quality Living, Inc., Omaha, Nebraska
name: Karen Hux, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05085795: Evaluating Deep Breathing in Health Participants Using a Device Called Impulse Oscillometry
Official title: Impulse Oscillometry and the Bronchoprotective Effects of Deep Inspiration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breathing, Mouth
Lung Function Decreased
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to fifty (50) healthy subjects will be recruited from Mary Parkes Asthma and Allergy Center and the outpatient pulmonary clinics at the University of Rochester Medical Center, and from the Pulmonary and Critical Care Division at the University of Rochester

Brief summary: This study will determine if resistance of the airway to airflow and pressure, measured by Impulse Oscillometry, is impacted by a deep breathe maneuver in a small cohort of healthy human subjects.


Eligibility criteria: Inclusion Criteria:

* Vaccinated against COVID-19
* Ability to provide informed consent
* Willingness to perform breathing test
* Willingness to provide basic demographic data
* Must be able to speak and understand English

Exclusion Criteria:

* Unable to or unwilling to provide consent, perform test, or provide basic demographic data

Primary outcomes:
measure: Mean respiratory system impedance
timeFrame: pre deep inspiration, approximately day 1
measure: Mean respiratory system resistance
timeFrame: post deep inspiration, approximately day 1
measure: Mean change in respiratory system resistance
timeFrame: post and pre deep inspiration, approximately day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mary Parkes Asthma and Allergy Center
state: New York
Study officials:
References: