louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03031613: Effects of PEEP on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
Official title: Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: intraocular pressure
intracerebral pressure
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted laparoscopic radical prostatectomy (RALRP)

Detailed description: Application of PEEPmay reduce pulmonary complication following RALRP. Meanwhile, it may increase ICP and IOP, which has been debated for decades. Moreover, Trendelenburg position and pneumoperitoneum, which are mandatory for RALRP, may augment elevation of ICP and IOP. This study aims to investigate the effects of PEEP on the ICP and IOP in patients undergoing RALRP.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing robotic-assisted laparoscopic radical prostatectomy

Exclusion Criteria:

* History of opthalmic disease or surgery
* History of brain disease or surgery
* Known ICP elevation
* Known IOP elevation
* Presence of lung bullae on chest x-ray
* History of pneumothorax

Primary outcomes:
measure: IOP
timeFrame: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min
measure: ICP
timeFrame: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Medical College Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Dong Woo Han
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00386113: Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly
Official title: A Phase II, Open, Controlled Study to Evaluate the Reactogenicity and the Immunogenicity of GlaxoSmithKline Biologicals' Adjuvanted Influenza Vaccine in Elderly Adults Previously Vaccinated With Either Fluarix™ or the Adjuvanted Vaccine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
improved vaccine
elderly
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 74
Sex: ALL
Minimum age (years): 67
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects previously vaccinated with Fluarix or the influenza adjuvanted vaccine, will receive a booster dose with the 2006-2007 season's formulations of either Fluarix or the adjuvanted vaccine.


Eligibility criteria: Inclusion Criteria:

* The subjects must be healthy elderly \>/= 67 years and previously vaccinated with Fluarix or the adjuvanted vaccine.

Exclusion Criteria:

* Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immunemodifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, have a history of influenza infection since previous vaccination, or if subjects have acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination

Primary outcomes:
measure: Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine, during 21 days following administration of the vaccine.
Secondary outcomes:
measure: Evaluation of the humoral immune response & cell-mediated immune response 21 days after revaccination with candidate vaccine.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06618313: One Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With r/r B-NHL
Official title: Open-label, Single-arm，Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: B-Cell Non-Hodgkin Lymphoma-Recurrent
B-Cell Non-Hodgkin Lymphoma-Refractory
Lead sponsor: Beijing GoBroad Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2024-10-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Evaluate the Safety and Efficacy of JCXH-213 in Patients with Relapsed/Refractory B-cell non-Hodgkin Lymphoma

Detailed description: Patient will receive study treatment in the treatment observation period. After the end of the treatment observation period, patients will be allowed to continue to receive treatment if there is no major safety problems and the investigator judges that the patient may continue to benefit.

Eligibility criteria: Inclusion Criteria:

* Cytologically or histopathologically confirmed CD19-positive B-cell Hodgkin lymphoma according to WHO 2022 criteria, including but not limited to pathologically confirmed (1) diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS); (2) follicular lymphoma (FL); (3)histologically transformed into diffuse large B-cell lymphoma; (4) primary mediastinal large B-cell lymphoma (PMBCL); (5) High-grade B-cell lymphoma (HGBCL) etc.
* ECOG performance status 0 to 1.
* Existing measurable lesions (Lugano 2014 criteria, as detailed in Appendix 2), meeting one of the following conditions: 1) nodal lesions with a long axis length exceeding 15 mm (short axis length is measurable); 2) extra-nodal lesions with both long axis and short axis lengths exceeding 10 mm.

Exclusion Criteria:

* Patients with other malignant tumors within 5 years before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local radical prostatectomy, radical ductal carcinoma in situ, and radical thyroidectomy.
* B-cell non-Hodgkin lymphoma with active primary or secondary central nervous system involvement.
* Life expectancy less than 3 months.

Primary outcomes:
measure: Dose limiting toxicity (DLT).
timeFrame: The DLT observation period is 21 days after first infusion of JCXH-213.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Lymphoma and Myeloma, Yuhengnan Road, Changping District, Beijing
Study officials:
affiliation: Beijing GoBroad Hospital
name: Kai Hu, Chief Physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06913413: Effects Of 8-Week Core Stabilization Exercise With Vitamin D On Pain and Functional Limitation in Adults
Official title: Effects Of 8-Week Core Stabilization Exercise With Vitamin D On Pain and Functional Limitation in Adults With Chronic Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Chronic non-specific low back pain (CNSLBP) is a prevalent condition contributing to pain, functional limitations, and reduced quality of life. Core stabilization exercises (CSE) have shown promise in enhancing spinal stability and reducing symptoms. Additionally, vitamin D supplementation plays a critical role in musculoskeletal health. Study objective will be to determine combined effect of vitamin D supplementation and core Stabilization exercises is better than core Stabilization Exercises alone in reducing pain-related and functional independence among chronic non-specific low back patient A randomized controlled trial will be conducted on 52 adults aged 25-45 diagnosed with Chronic non-specific low back pain.

Detailed description: Subjects will be divided into two groups: the intervention group will receive an 8-week Core stabilization exercises program alongside daily vitamin D supplementation, while the control group will receive either Core stabilization exercises alone Visual Analog Scale (VAS), and Oswestry Disability

Eligibility criteria: Inclusion Criteria:

* Adults aged 25 to 45 years will be included.
* Both gender Male /Female will participate.
* Subjects with diagnosed non-specific low lumber pain persisting for at least 12 weeks will be included.
* Subjects must have baseline pain score of ≥4 on the Visual Analog Scale.
* Confirmed serum vitamin D levels \<30 ng/m will be included

Exclusion Criteria:

* Low lumber pain due to specific causes such as fracture malignancy infection or inflammatory diseases (e.g. ankylosing spondylitis).
* Presence of significant comorbidities that could interfere with participation (e.g. cardiovascular neurological or respiratory disorders).
* History of spinal surgery within the last year.
* Subjects currently taking vitamin D supplements or undergoing other treatments for vitamin D deficiency.
* Use of medications such as corticosteroids or opioids that might affect pain perception or functional assessment.
* Enrolled in any other physical therapy or pain management program within the last three months.

Primary outcomes:
measure: The Visual Analogue Scale (VAS)
timeFrame: 12 Months
measure: The Oswestry Disability Index (ODI)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Shoukat Hospital Near Session Court Jhang Road Chiniot
state: Punjab
Study officials:
References:
Clinical trial NCT02549313: Effect of the Position of the Patient's Head
Official title: Study of the Effect of the Position of the Patient's Head With Brain Lesions on Cerebral Blood Flow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Lesion
Keywords: brain lesion
intracranial pressure
cerebral perfusion pressure
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 16
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: Patient with brain lesion

Brief summary: The position of the head of the patient influences the cerebral venous return and cerebral perfusion pressure (CPP). In our daily practice, it is almost routine to prescribe a Trendelenburg position 30 ° in all brain-damaged patients. However, this is based only on precarious bibliographic databases. It has been shown to decrease the Intracranial Pressure (ICP) in Trendelenburg position relative to the horizontal, with varying effects on PPC. Effects on sylvian objectified by Doppler velocities and cerebral oxygenation seem unaffected by changes of position of the head of the patient. But the whole of the literature on this subject has significant bias.

Detailed description: Registration of blood flow changes induced when the patient's head will be tilted at 0 ° (that is to say flat), 15 ° and 30 ° (the order of actions will be determined by randomization). The patient will remain 10 minutes in each of these positions and will also have a little extra blood sample of 1 ml (ie 9 samples). These measures will be carried out again the next day and then after five days to see if the results vary depending on the evolution of his condition.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years with:

  * A severe head injury
  * or subarachnoid hemorrhage before the 5th day of evolution
  * or spontaneous intracranial hematoma
  * or ischemic stroke
* Neurosurgical Patients after surgery
* Presenting intracranial hypertension

Exclusion Criteria:

* Hemodynamic and / or neurological instability. In the most unstable patients, care and mobilizations are reduced to a minimum.
* Craniectomy

Primary outcomes:
measure: Cerebral oxygenation
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Laurent GERGELE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03528213: Utility of Sodium Lactate Infusion During Septic Shock
Official title: Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Septic Shock
Keywords: sepsis
fluid balance
metabolism
ischemia-reperfusion
treatment
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: bolus then continuous infusion of molar sodium lactate (2 doses) or normal saline
Primary purpose: TREATMENT

Brief summary: ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients

Detailed description: ULIS-1 consists in three arms of treatment during the first 24hrs of septic shock treatment.

* normal saline
* sodium lactate 2.5ml/kg in 60min then
* either 0.25 or 0.5ml/kg/h during 24hrs Main criteria is fluid balance at 48hrs

Eligibility criteria: Inclusion Criteria:

* Presence of septic shock
* requiring vascular filling within 12 hours after introduction of Noradrenaline. Septic shock is defined as sepsis with persistent hypotension requiring the administration of vasopressors to maintain RTE \> 65mmHg.
* social insurance

Exclusion Criteria:

* pregnancy
* cardiac arrest
* more than 50ml/kg of fluid loading
* chronic renal failure with chronic hemodialysis or the investigators estimate a need for renal replacement therapy in the following 24hrs
* child C or acute liver failure with PT\<40% (unless AVK)
* plasmatic sodium \<120 or \>145mmol/l
* metabolic alkalosis with pH\>7.45

Primary outcomes:
measure: fluid balance
timeFrame: at 48 hours
Secondary outcomes:
measure: fluid balance at day 7
timeFrame: Day 7
measure: SOFA (Sequential Organ Failure Assessment)
timeFrame: Day 1, Day 2, Day 3, Day 7
measure: death in Intensive Care Unit (ICU)
timeFrame: Day 90
measure: number of patients dead
timeFrame: Day 28
measure: death in hospital
timeFrame: Day 90
measure: catecholamines free days
timeFrame: Day 28
measure: ventilator free days
timeFrame: Day 28
measure: renal replacement therapy free days
timeFrame: Day 28
measure: new kidney failure
timeFrame: Day 28
measure: nosocomial infections
timeFrame: day 90
measure: hypernatremia
timeFrame: Day 2
measure: hypokaliemia
timeFrame: Day 2
measure: metabolic alkalosis
timeFrame: day 2
measure: hemodynamic effects assessed by the PICCO® monitoring system
timeFrame: at 48 hours
Other outcomes:
Locations:
city: Arras
country: France
facility: CH ARRAS
city: Douai
country: France
facility: CH DOUAI
city: Dunkerque
country: France
facility: Ch Dunkerque
city: Lens
country: France
facility: CH LENS
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
city: Roubaix
country: France
facility: Hopital Victor Provo - Roubaix
city: Rouen
country: France
facility: Chu Rouen
Study officials:
affiliation: University Hospital, Lille
name: Raphaël Favory, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05359913: Podcasting Cervical Cancer Prevention for AAW
Official title: Proof of Concept and Feasibility in Podcasting Cervical Cancer Prevention for African American Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer
African American Women
Cancer Prevention
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: For African American women (AAW) in Houston, cervical cancer mortality is disproportionate to their racial and ethnic counterparts.Most notably, lack of human papillomavirus (HPV) screening, vaccination, and later diagnosis increase cervical cancer mortality. However, cervical cancer is largely preventable. While previous research has identified only a few social determinants that are specifically related to cervical cancer, there may be a host of additional social and cultural factors that contribute to a lack of preventative behavior. The overall objective of the proposed study is to gather preliminary data to determine whether the use of concept mapping methodology is useful in identifying unique sociocultural determinants of cervical cancer prevention behavior, and to pilot test the feasibility of a podcast video developed using the information garnered from the concept mapping procedure. It is hypothesized that the resulting podcast video will increase HPV knowledge and behavioral intentions. Proof of concept and feasibility are needed first, in determining the utility of both the methodology and media development procedures, as well as data on preliminary effect outcomes, before further investigation and program development.


Eligibility criteria: Inclusion Criteria:

* self-identify as African American
* biological female sex
* speak and read English
* 18 years old or older
* not currently or previously diagnosed with cervical cancer or cervix dysplasia

Exclusion Criteria:

• history of hysterectomy

Primary outcomes:
measure: Researcher-developed cervical cancer prevention measure that reflects salient socio-cultural perceptions of cervical cancer prevention (obtained through non-clinical qualitative inquiry)
timeFrame: To be measured immediately before film viewing and immediately after film viewing
measure: Pap test intentions: Do you intend to obtain a Pap cytology screening? (single item)
timeFrame: To be measured immediately before film viewing and immediately after film viewing
measure: HPV vaccination intentions: Do you intend to get vaccinated for HPV? (single item)
timeFrame: To be measured immediately before film viewing and immediately after film viewing
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05970913: PET-CT Predicting Segement Specific Lymph Nodes Metastasis
Official title: The Value of PET-CT in Predicting Segement Specific Lymph Nodes Metastasis in Non Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Lymph Node Metastasis
Positron Emission Tomography
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 280
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients had non small cell lung cancer received surgery and systematic lymph node dissection.

Brief summary: This study is a multicenter prospective clinical study that aims to evaluate the predictive value of preoperative PET-CT results (such as SUV uptake, size of tumor lymph nodes, and differences in FDG uptake compared to surrounding tissues) for lymph node metastasis in patients with non-small cell lung cancer. During surgery, all patients underwent systematic mediastinal lymph node dissection. The final pathological results were used to assess the predictive value of PET-CT for segment-specific lymph node metastasis.


Eligibility criteria: Inclusion Criteria:

* Solitary tumor, or multiple tumors with only ground-glass nodules (GGNs) apart from the primary lesion.
* Diameter of the primary lesion ≤5cm, with a CTR between 0.5 and 1.
* No enlarged mediastinal lymph nodes observed on preoperative contrast-enhanced CT.
* Pathological confirmation of non-small cell lung cancer (NSCLC) either before or during surgery.
* Systematic lymph node dissection performed during surgery.
* No prior radiotherapy or chemotherapy for initial treatment.
* No history of malignant tumors.

Exclusion Criteria:

* Locally advanced or distant metastasis.
* Pleural dissemination observed during surgery.
* History of malignant tumors.
* Received neoadjuvant therapy.
* Systematic lymph node dissection not performed during surgery.
* Histopathological examination reveals lung malignancies other than non-small cell lung cancer (NSCLC).

Primary outcomes:
measure: Predictive value of PET-CT for segment-specific lymph node metastasis
timeFrame: Preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center
Study officials:
References: