louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02545075: A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
Official title: A Randomized, Open-Label, Two-arm, Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Chinese males and females ≥ 18 years of age
* Histologic diagnosis of malignant melanoma
* Chemotherapy naive Stage IV melanoma (AJCC 2010)
* Life expectancy of ≥ 16 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Evidence of brain metastases on brain imaging
* Primary ocular or mucosal melanoma
* Any other malignancy from which the patient has been disease-free for less than 5 years
* BRAF status cannot be determined by Screening test
* Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg) positive, or active Hepatitis C infection

Primary outcomes:
measure: Two-Years Survival Rate
timeFrame: 24 months
Secondary outcomes:
measure: One-Year Survival Rate
timeFrame: Approximately 43 months
measure: Overall Survival (OS)
timeFrame: Approximately 43 months
measure: Progression Free Survival ( PFS)
timeFrame: Approximately 43 months
measure: Disease Control Rate ( DCR )
timeFrame: Approximately 43 months
measure: Best Overall Response Rate ( BORR )
timeFrame: Approximately 43 months
measure: Duration of Response ( DoR)
timeFrame: Approximately 43 months
measure: Duration of Stable Disease ( DoSD )
timeFrame: Approximately 43 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Xi'an
country: China
facility: Local Institution
state: Shanxi
city: Tianjing
country: China
facility: Local Institution
state: Tianjin
city: Hanghzou
country: China
facility: Local Institution
state: Zhejiang
city: Beijing
country: China
facility: Local Institution
city: Kunming
country: China
facility: Local Institution
city: Shanghai
country: China
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03007875: High-activity Natural Killer Immunotherapy for Small Metastases of Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer Metastatic
Keywords: Metastatic lung cancer
High-activity natural killer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of non-small cell lung cancer.

Detailed description: By enrolling patients with small metastases of non-small cell lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00003075: Fenretinide in Treating Patients With Cervical Neoplasia
Official title: A Randomized Double-Blind Study of N-(4-hydroxyphenyl) Retinamide (4-HPR) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Precancerous Condition
Keywords: cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-05-27
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: RATIONALE: Chemoprevention uses drugs to try and prevent development of cancer. Fenretinide may be effective in treating cervical neoplasia and preventing cervical cancer.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of fenretinide to placebo in treating patients with cervical neoplasia.

Detailed description: OBJECTIVES: I. Determine the efficacy of fenretinide (N-(4-hydroxyphenyl) retinamide; 4-HPR) at regressing cervical intraepithelial neoplasia (CIN). II. Document the qualitative and quantitative toxicity of 4-HPR in women with CIN.

OUTLINE: This is a double blinded study. Patients are randomized to receive either fenretinide or placebo. Patients are administered fenretinide or a placebo by mouth (PO) daily for 6 months with 3 days of rest every month. Patients undergo colposcopy, colpophotography, and Pap smears at 3, 6, 9, and 12 months. Patients undergo cervical biopsy at 6 and 12 months to assess changes.

PROJECTED ACCRUAL: 84-100 patients will be accrued.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically diagnosed new or recurrent cervical intraepithelial neoplasia grade 2-3 lesion involving at least one quadrant of the transformation zone of the cervix

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 months Hematopoietic: Absolute granulocyte count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: Fertile patients must use effective contraception Fasting triglyceride less than 2 times normal No prior malignancy Must consent to colposcopy and cervical biopsy

PRIOR CONCURRENT THERAPY: Not specified

Primary outcomes:
measure: Efficacy of Fenretinide at Regressing CIN
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michele Follen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05323175: Erector Spinae Plane (ESP) Block for Renal Colic
Official title: Can Erector Spinae Plane (ESP) Block Better Relieve Acute Renal Colic Pain Than Standard of Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Renal Colic
Keywords: Erector spinae plane block
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Standard of care group + sham normal saline ESP block vs Standard of care + Ropivacaine ESP nerve Block group
Primary purpose: OTHER

Brief summary: Comparing standard of care to erector spinae plane block for acute renal colic pain.

Detailed description: Will compare at times 0, 10 minute, 20 minute, 40 minute and 60 minutes after local nerve block given.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* ASA Level I and II
* flank pain concerning for renal colic in ED

Exclusion Criteria:

* pregnant women
* subjects unable to appreciate ESP block landmarks under ultrasound
* skin infection over needle site insertion
* Allergy to local anesthesia (lidocaine/Ropivacaine)
* bleeding disorders
* serious cardiac, lung, liver or kidney dysfunction
* history of spine surgery
* history of spinal infection
* history of epidural injection within 6 months
* acute exacerbation of serious mental disease
* unable to consent
* unable to communicate pain level

Primary outcomes:
measure: Baseline Pain before intervention
timeFrame: Before the ESP Block
measure: Pain score at 10 minutes
timeFrame: 10 minutes after the ESP Block
measure: Pain score at 20 minutes
timeFrame: 20 minutes after ESP Block
measure: Pain score at 40 minutes
timeFrame: 40 minutes after ESP Block
measure: Pain score at 60 minutes
timeFrame: 60 minutes after ESP Block
Secondary outcomes:
measure: Need for extra opiates
timeFrame: Starting from time 0 after the ESP Block intervention completed till discharge or urology intervention
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: StonyBrook University Hospital
state: New York
Study officials:
affiliation: StonyBrook University Hospital
name: Michael Secko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aydin ME, Tekin E, Ahiskalioglu EO, Ates I, Karagoz S, Aydin OF, Ozkaya F, Ahiskalioglu A. Erector spinae plane block vs non-steroidal anti-inflammatory drugs for severe renal colic pain: A pilot clinical feasibility study. Int J Clin Pract. 2021 Mar;75(3):e13789. doi: 10.1111/ijcp.13789. Epub 2020 Nov 9.
Clinical trial NCT05694975: Efficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients.
Official title: Clinical Efficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients (CEMVISCC): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Vitamin C
COVID-19 Pneumonia
Keywords: Vitamin C
COVID-19
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, multi-center, randomized, single-blind, placebo-controlled clinical trial
Primary purpose: TREATMENT

Brief summary: The main aim is to determine whether vitamin C can reduce 28-day all-cause mortality or persistent organ dysfunction compared with placebo in patients with severe and critical ill COVID-19 patients.

Participants will randomly receive HIVC or placebo for 4 days once enrolled. The primary outcome is a composite of death or persistent organ dysfunction (defined as dependency on vasopressors, mechanical ventilation, or CRRT) at day 28 after randomization.


Eligibility criteria: Inclusion Criteria:

1. Adults (age 18 years or older).
2. Diagnosed with COVID-19 according to the Diagnosis and Clinical Management of COVID-19. (trial version 10).
3. severe and critical ill patients with COVID-19.
4. Patients who voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Patients with a history of allergy to VC.
2. Pregnant or lactating women.
3. Patients with end-stage malignant tumour.
4. Patients with an expected survival duration of less than 24 hours.
5. Patients with cerebral hernia and severe craniocerebral injury.
6. Patients with diabetes.
7. Patients with a previous history of G-6-PD deficiency.

Primary outcomes:
measure: The 28-day mortality or persistent organ dysfunctionat day 28.
timeFrame: 28 days.
Secondary outcomes:
measure: Changes in the Sepsis-Related Organ Failure Assessment (SOFA) score.
timeFrame: 4 days.
measure: Change in Plasma Inflammatory Biomarker Concentrations.
timeFrame: 4 days.
measure: Changes in oxygenation index and partial pressure of carbon dioxide in arterial blood gases.
timeFrame: 4 days.
measure: The duration of ventilation and vasopressor use.
timeFrame: 28 days.
measure: The length of ICU stay and hospital stay.
timeFrame: 28 days.
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Department of Critical Care Medicine of Zhujiang Hospital
state: Guangdong
city: Yunfu
country: China
facility: Yunfu People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Department of Critical Care Medicine of Zhongshan People's Hospital
state: Guangzhou
city: Hengyang
country: China
facility: the Affiliated Nanhua Hospital
state: Hunan
Study officials:
affiliation: Southern Medical University, China
name: Liu Zhanguo, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05473975: Search for a Recanalization of the Sylvian Artery Electro-Physiological Biomarker
Official title: Search for a Recanalization of the Sylvian Artery Electro-Physiological Biomarker
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AIS
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2022-07-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusions 15 patients hospitalized for an ischemic stroke for whom an MRI identified a proximal sylvian artery occlusion, treatable by mechanical thrombectomy.

Brief summary: Early recanalization is a major prognostic factor in vascular accidents ischemic brain injury (AIC). The acute phase therapies of AIC aim to recanalization by intravenous thrombolysis and/or mechanical thrombectomy. Recanalization is identified immediately during thrombectomy by per-procedural arteriography. For the thrombolysis, only a performed MRI will validate the recanalization. This "proof of concept" study aims to identify an Electro-Encephalographic biomarker (EEG) of the recanalization in real time, the EEG being easy to set up. This biomarker will be sought during recanalization certified by thrombectomy in order to identify the window time for which the biomarker must be sought on the EEG. During this study, the identified EEG biomarker can be used to validate the recanalization during the intravenous thrombolysis in future studies


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Presenting a cerebral infarction with proximal occlusion of the sylvian artery requiring thrombectomy
* No objection to participation in the study

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient benefiting from legal protection
* Absence of affiliation to a social protection scheme
* Recent cranial surgery not allowing the installation of a scalp EEG

Primary outcomes:
measure: IElectro-Encephalographic (EEG) marker of recanalization
timeFrame: inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
affiliation: HOPITAL FONDATION Adolphe de ROTHSCHILD
name: Michael OBADIA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05247775: Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor
Official title: Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Radical Prostatectomy
Urethral Pressure Profile
ICIQ-UI SF
Pads
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Urinary incontinence (UI) is one of the most common complications of radical prostatectomy (RP). Impaired urethral sphincter function is generally considered to be the most important contributing factor of UI however, the mechanism of onset and recovery of urinary continence has not been fully elucidated. In this research, the urodynamic method of Urethral Pressure Profile (UPP) was used to evaluate Functional Urethral Length (FUL) and Maximal Urethral Closure Pressure (MUCP) and correlate with the postprostatectomy continence recovery. Objective of this research is to evaluate preoperative FUL and MUCP as an early continence recovery predictors after open retropubic RP (ORRP).

The research was conducted at the Department of Urology of the University Hospital Centre Zagreb on a group of 43 patients in the period from July 15th , 2019 to May 07th , 2021.The severity of UI and bothersome were assessed using fully validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and number of pads used in 24h. Patients were interviewed about the use of urinary pads and asked to fill out the ICIQ-UI SF before and 2, 8, 16 and 24 weeks after RP.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with localized prostate cancer
2. Open Retropubic Radical Prostatectomy (ORRP) is planned as a treatment

Exclusion Criteria:

1. Incontinent patients prior to ORRP
2. Previous surgery in the area of the prostatic urethra
3. Previous procedures that can damage the innervation of the pelvis
4. Radiotherapy performed in the pelvic area prior to ORRP
5. Adjuvant radiotherapy in the first postoperative year

Primary outcomes:
measure: Functional Urethral Length as a predictor of Urinary Incontinence
timeFrame: 24 weeks
measure: Maximum Urethral Closure Pressure as a predictor of Urinary Incontinence
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: UHC Zagreb
Study officials:
affiliation: Clinical Hospital Centre Zagreb
name: Mirko Bakula
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakula M, Hudolin T, Kolar Mitrovic H, Kastelan Z. Urethral pressure profile before radical prostatectomy as a predictor of early postoperative continence. Neurourol Urodyn. 2022 Aug;41(6):1431-1439. doi: 10.1002/nau.24978. Epub 2022 Jun 7.
Clinical trial NCT02816359: Position and Esophageal Pressure
Official title: Impact of Patient Position on the Value of Esophageal Pressure. pEsition Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: Position patient
Esophageal pressure
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Esophageal pressure measurements are used in moderate/severe Accurate Respiratory Distress SyndromeARDS patients in order to set ventilator settings. There might be variations of the measured value according to the patient position (0° vs 30°) at the time of measurements.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Acute respiratory failure defined by PaO2/FIO2\< 300 mmHg or pH\<7,35 and pCO2\>45mmHg or Moderate or severe Accurate Respiratory Distress Syndrome ARDS defined by:

  * New or worsening respiratory symptoms in the previous week.
  * Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or Nodules
  * Respiratory failure not fully explained by cardiac failure or fluid overload
  * PaO2/FIO2\< 200 mmHg and PEEP ≥ 5 cm H2O and VT ≤6 ml/kg of Ideal Body Weight
* Patient intubated or tracheotomized and receiving mechanical ventilation
* Indication of esophageal measurement decided by the clinician

Exclusion Criteria:

* Contraindication to naso-gastric tube insertion :

  * Recent gastro-duodenal ulcer
  * Stage III esophageal varices
* Refractory intracranial hypertension
* Unstabilized spine fracture
* Surgical contraindication
* Burns on more than 20 % of the body surface
* Underlying disease with a life expectancy of less than one year
* End-of-life decision before inclusion
* Pregnant or breast-feeding patients
* Subject deprived of freedom, minor, subject under a legal protective measure
* Research team unavailability
* Lack of medical care plan

Primary outcomes:
measure: Total End-expiratory esophageal pressure
timeFrame: 30min after change of position
Secondary outcomes:
measure: End-inspiratory esophageal pressure
timeFrame: 30min after change of position
measure: Gastric pressure
timeFrame: 30min after change of position
measure: End-expiratory lung volume
timeFrame: 30min after change of position
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Claude Guerin, Pr
role: PRINCIPAL_INVESTIGATOR
References: