louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04319588: Parasternal Block for Cardiac Surgery
Official title: Parasternal Block for Postoperative Analgesia in Cardiac Surgery: a Pilot Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Analgesia
Acute Pain
Postoperative Pain
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.

Detailed description: 60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups:

1. Interventional (parasternal group)
2. Case control group The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.

The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective cardiac surgery
* Age over 18 years
* ASA I-IV
* Approval by the patient of informed consent

Exclusion Criteria:

* Allergy to local anesthetics
* Puncture site infection
* Lack of signing of informed consent
* Weight \<30 Kg
* Age \<18 years
* Emergency interventions
* ASA \> IV
* Sternal dehiscences
* Dementia (for difficulties in managing weaning from mechanical ventilation and pain)

Primary outcomes:
measure: Maximum Pain Score
timeFrame: 24 hours
Secondary outcomes:
measure: Respiratory performance at the TRI-FLOW
timeFrame: 24 hours
measure: Intraoperative opioid administration
timeFrame: 4 hours
measure: Total opioids consumption
timeFrame: 24 hours
measure: Time to first opioid
timeFrame: 48 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Campus Biomedico University
state: Roma
Study officials:
References:
citation: Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
Clinical trial NCT02400788: Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)
Official title: A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Yakult Honsha Co., LTD
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 179
Sex: ALL
Minimum age (years): 20
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 assess efficacy and safety in combination of resminostat and sorafenib in Asian patients with advanced HCC previously untreated with systemic chemotherapy.


Eligibility criteria: Main Inclusion Criteria:

* Patients with advanced or metastatic hepatocellular carcinoma
* Patients with ECOG PS of 0-1
* Patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications

Main Exclusion Criteria:

* Patients with a history of treatment with HDAC inhibitors
* Pregnant women and lactating mothers
* Patients with brain metastases or suspected brain metastases based on the clinical symptoms

Primary outcomes:
measure: Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability
timeFrame: 6 months
measure: Phase 2 : Time To Progression (TTP)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chiba
country: Japan
city: Ishikawa
country: Japan
city: Kanagawa
country: Japan
city: Kochi
country: Japan
city: Kyoto
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Shizuoka
country: Japan
city: Tokyo
country: Japan
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
References:
Clinical trial NCT00484588: A Multi-Center Observational Surveillance Study of VAP Causing Bacteria
Official title: A Multi-Center Observational Surveillance of VAP Causing Bacteria Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Associated Pneumonia
Keywords: VAP
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-11
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by the bronchoalveolar lavage (BAL) method.

Detailed description: Any patient admitted into the chosen ICU will be a potential patient for this study. One of the main purposes of this study is to discover the various types of bacteria that cause VAP, and their frequency of occurrence. In order to obtain accurate and applicable results, as many subjects should be tested as possible. Approximately 500 patients will be included in this study.

VAP is defined as any lower respiratory tract infection that developed after 2 day of MV.

The criteria for clinical suspicion of pneumonia are as follows:

Presence of a new or persistent lung opacity on chest radiographs, plus two of the following items:

1. Fever \> 38.3ºC or hypothermia \< 36ºC;
2. WBC count \> 10,000/mm3 or \< 5,000/mm3, and/or purulent endoctracheal aspirate;
3. Purulent endotracheal aspirate.

Every patient suspected of having pneumonia will undergo fiberoptic bronchoscopy to obtain samples by means of a bronchoalveolar lavage (BAL). VAP will be diagnosed based on results of BAL where BAL cultures yielding \> 104 cfu/ml.

Eligibility criteria: Inclusion:

* Patients hospitalized and mechanically ventilated for more than 48 hours are eligible for the study.
* Fever \> 38.3ºC or hypothermia \< 36ºC or WBC count \> 10,000/mm3.
* Presence of a new or persistent lung opacity on chest radiographs.
* Willing to provide informed legal consent. If the patient is a minor or incapacitated, legal consent may be given by a legal guardian or representative.

Exclustion:

* Patients whose antibiotic strategy had been changed during the 3 days preceding the diagnostic procedure will not be included.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00251888: CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto
Official title: Etude de Recherche de Dose de l'Association Irinotecan (Campto(R)) - Cisplatine (Cisplatyl(R)) Avec la radiothérapie Pelvienne Dans Les Cancers avancés du Col de l'utérus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cervix Cancer
Keywords: cervix cancer
advanced cervix cancer
radiochemotherapy
pelvic radiotherapy
campto
cisplatin
irinotecan
cisplatyl
maximum dose search
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2005-11-11
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.

Detailed description: To determine the maximum and the recommended tolerated dose of irinotecan with increasing doses associated with weekly cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer, IIB-IVA FIGO stage.

Eligibility criteria: Inclusion Criteria:

* Histologically proven primitive epidermoid or andenocarcinoma Cervix
* FIGO stage IIB (obviously parameter attack), III or IVA
* No previous chemotherapy nor radiotherapy
* Patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma
* PS ECOG \< 2
* Life expectancy \> 12 weeks
* Written consent given

Exclusion Criteria:

* Other malignant cervix tumor histology
* Visceral remotly metastasis
* Other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer
* Anormal labs values
* Peripheric neuropathy CTC \> 2
* Auditory loss \> 2
* Cardiopathy
* Inflammatory digestive pathology
* Evolutive infection
* Other experimental concommitant treatment
* Lacting or pregnant women

Primary outcomes:
measure: To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer
Secondary outcomes:
measure: To evaluate :
measure: the global response rate judged on standard clinical criteria, echography, tomodensiometry, and MRI. The histologic response rate will be appreciated in patients who had a second surgery after pelvic radiochemotherapy
measure: local and general relapse frequency
measure: progression free survival
measure: global survival
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CRLC Val d'Aurelle
city: Toulouse
country: France
facility: Centre Claudius Régaud
Study officials:
affiliation: Hôpital St Louis, Paris, France
name: Christophe Hennequin, Physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Bordeaux Nord, Bordeaux, France
name: Nadine Dohollou, physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01866488: The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor
Official title: The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor: A Double-Blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Labor Induction
Keywords: Labor induction
Misoprostol
Cytotec
Cook Obstetric Double Balloon Catheter
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is a randomized, controlled, double-blinded trial of Obstetric Cook Catheter combined with oral misoprostol for induction of labor in pregnant patients. The primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in combination with oral placebo and the Obstetric Cook Catheter in combination with oral misoprostol. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity.

The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive both the Obstetric Cook Catheter and the oral misoprostol.


Eligibility criteria: Inclusion Criteria:

1. Single, live fetus
2. Cephalic (head-first) presentation
3. Reassuring fetal health assessment
4. Gestational age between 23 and 42 weeks
5. Maternal age 18 and above
6. Bishop score less than 8 in primigravidae
7. Bishop score less than 6 in multigravidae

Exclusion Criteria:

1. Fetal demise 2. Fetal malpresentation 3. Estimated fetal weight less than 500 grams or more than 4000 grams 4. Placenta previa 5. Non-reassuring fetal health assessment 6. Active maternal asthma exacerbation requiring additional medications from the usual medication requirements.

7. History of cesarean section 8. Rupture of amniotic membrane 9. Latex allergy 10. Spontaneous labor 11. Other contraindication to vaginal delivery 12. Allergy to misoprostol of cook catheter

Primary outcomes:
measure: Occurence of cesarean section
timeFrame: Within 96 hours from the commencement of the Induction of Labor
Secondary outcomes:
measure: Time from start of induction of labor to vaginal delivery
timeFrame: 24, 48 and 72 hours
Other outcomes:
measure: Change in cervical bishop score with allotted treatment
timeFrame: 6 hours
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Meg Hill, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03351088: Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical Prostatectomy
Official title: Outcomes of a Phase III Randomized Controlled Trial Comparing Preventive Versus Delayed Ligation of Dorsal Vascular Complex During Robot-assisted Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 226
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard surgical approach for the treatment of prostate cancer in the United States and then in Europe. Continuous refinements of surgical technique has been described in order to maximise outcomes while minimizing morbidities.

The management of DVC is a crucial steps during RARP. It could be done prior or after its transection thanks to haemostatic effects of the pneumoperitoneum. This topic has been already investigated by some authors. However, no high quality evidence is available to opt in favour of either of the two approaches. Findings about estimated blood loss, positive surgical margins and urinary recovery differ among these studies and only one is a randomized controlled trial in a laparoscopic setting with a limited number of patients.

Therefore, our objective was to evaluate in a prospective randomised setting whether a delayed ligation of the dorsal vascular complex impacted on perioperative, functional and oncological outcomes as compared to preventive ligation during robot-assisted radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

* male patients, aged 18-80 years
* patients willing and able to provide written informed consent
* voluntary partecipation
* clinical indication to robot-assisted radical prostatectomy

Exclusion Criteria:

* coagulation impairment at the time of surgery
* salvage radical prostatectomy

Primary outcomes:
measure: Intraoperative estimated bool loss
timeFrame: intraoperative
Secondary outcomes:
measure: Transfusion rate
timeFrame: 30 days from surgery
measure: Overall positive surgical marigins
timeFrame: intraoperative
measure: Apical positive surgicals margins
timeFrame: intraoperative
measure: 1-month continence
timeFrame: 30 days from surgery
measure: 1-month PSA
timeFrame: 30 days from surgery
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Clinical Department of Urology, university Hospital Spedali Civili di Brescia
Study officials:
References:
Clinical trial NCT01883388: NovellusDx Cancer Early Detection Blood Test- Clinical Trial
Official title: Assessing the Ability of An Innovative Screening Method To Identify Proteomic Changes In Cancer Patients- Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung Cancer
blood sample
Lead sponsor: Fore Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2013-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects and subjects with primary / relapsed lung cancer

Brief summary: NovellusDx early detection test is a simple to perform blood test, which identifies the deregulated signaling pathways within the patient tumor based on protein secretion to the blood, thus enabling early stage disease signature detection. The investigators' current clinical trial is focused on proving the main feature of NovellusDx's Early Detection Test- discriminating between cancer patients and healthy subjects.


Eligibility criteria: Inclusion Criteria:

* subjects ages 18 and above ICF obtain

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of Participants with a significant cancer fingerprint as measured by NovellusDX Cancer Early Detection test
timeFrame: 3.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam MC
Study officials:
affiliation: Rambam MC. Haematology Department
name: Yishai Ofran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06640088: Determining ICU Staffs Conceptions, Opinions, Views, Experiences and Reflection of Brain Death and Organ Donation
Official title: Determining ICU Staffs Conceptions, Opinions, Views, Experiences and Reflection of Brain Death and Organ Donation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Death
Keywords: Organ Donation
Intensive Care Unit
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible healthcare professionals in the ICU at the University Hospital Basel

Brief summary: The study aims to gather information regarding the individual perceptions, opinions, beliefs, and conceptual understanding of healthcare professionals working in the intensive care units at the University Hospital Basel and to determine associations of individual beliefs, personal, educational, and professional experiences with individual perceptions, opinions, and conceptual understanding regarding brain death and organ donation.

Detailed description: To achieve the study objectives, the investigator will employ a questionnaire-based survey administered to the consenting/participating nurses and physicians. The questionnaire will address various aspects related to personal background, religious affiliation, beliefs about life after death, the conceptual understanding of brain death and organ donation, as well as experiences and opinions related to these topics.

Eligibility criteria: Inclusion Criteria:

* Consenting nurses and physicians currently working in the intensive care unit (ICU) at the University Hospital Basel
* Only nurses and physicians consenting to participate will be included

Exclusion Criteria:

* Nurses and physicians not currently working (any more) in the intensive care unit (ICU) at the University Hospital Basel
* Nurses and physicians who do not consent

Primary outcomes:
measure: Information on individual perceptions regarding brain death and organ donation
timeFrame: at baseline
measure: Information on individual opinions regarding brain death and organ donation
timeFrame: at baseline
measure: Information on individual beliefs regarding brain death and organ donation
timeFrame: at baseline
measure: Information on conceptual understanding regarding brain death and organ donation
timeFrame: at baseline
measure: Identification of interprofessional variations
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Raoul C. Sutter, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01459588: Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 315
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: This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Dry eyes
* Current use of eye drops for dry eye at least twice daily, on average for at least 3 months

Exclusion Criteria:

* Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
* Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
* Active ocular allergy

Primary outcomes:
measure: Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
timeFrame: Baseline, Day 30
Secondary outcomes:
measure: Change From Baseline in Tear Break-up Time
timeFrame: Baseline, Day 30
measure: Change From Baseline in Corneal Staining
timeFrame: Baseline, Day 30
measure: Change From Baseline in Conjunctival Staining
timeFrame: Baseline, Day 30
measure: Change From Baseline in Schirmer Test Results
timeFrame: Baseline, Day 30
Other outcomes:
Locations:
city: Petaluma
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Simmons PA, Carlisle-Wilcox C, Vehige JG. Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial. Clin Ophthalmol. 2015 Apr 15;9:657-64. doi: 10.2147/OPTH.S74849. eCollection 2015.