louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01579864: Succinylcholine or Rocuronium for Rigid Bronchoscopy Under General Anesthesia
Official title: Interventional Rigid Bronchoscopy Under General Anesthesia: Influence of the Muscle Relaxant, Succinylcholine or Rocuronium, on the Quality of the Surgical Procedure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 6
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: Myorelaxation is generally used as a part of general anesthesia for interventional rigid bronchoscopy. Succinylcholine is most often used because its short duration of action but rocuronium can be used since sugammadex permits a rapid and complete reversal of the neuromuscular block. The aim of ths study is to compare both agents.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for an interventional rigid bronchoscopy under general anesthesia

Exclusion Criteria:

* pregnant woman or woman of childbearing age,
* morbid obesity,
* drug allergy,contra-indication to succinylcholine, rocuronium, sugammadex, propofol, remifentanil,
* history of central neurological or brain damage,
* psychotropic treatment,
* pacemaker,
* renal failure,
* disease of the neuromuscular junction.

Primary outcomes:
measure: Score of quality of the surgical procedure
timeFrame: one day
Secondary outcomes:
measure: Score of quality of anesthesia
timeFrame: one day
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile de France
Study officials:
affiliation: Hopital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06296264: Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture
Official title: Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IV Line Placement With Ultrasound
Keywords: IV line
Ultra-portable ultrasound
Standard ultrasound
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.

The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room.

Detailed description: The main objective is to test the hypothesis that intravenous puncture guided by an ultraportable ultrasound machine is faster than puncture guided by a conventional ultrasound machine.

Eligibility criteria: Inclusion Criteria:

1. Patient aged at least 18 years old
2. Patient with an A-DIVA (Adult Difficult Intravenous Access) score \> 1
3. Supported by a nurse trained in all the techniques used in the protocol
4. Patient having given free, informed and oral consent -

Exclusion Criteria:

1. Patient who has already been included in the study
2. Patient whose inclusion in the study would lead to a delay in treatment
3. Adult patient protected by law
4. Pregnant woman
5. Patient not benefiting from French Social Security system -

Primary outcomes:
measure: Intravenous (IV) line placement time
timeFrame: Day 0
Secondary outcomes:
measure: Placement of the IV line successfully obtained from the first puncture
timeFrame: 12 months (estimated)
measure: Number of skin perforations
timeFrame: Day 0
measure: Overall success rate after 3 punctures
timeFrame: Day 0
measure: Use an alternative solution (central catheter)
timeFrame: Day 0
measure: Patient satisfaction with IV line placement
timeFrame: Day 0
measure: Nurse satisfaction with IV line placement
timeFrame: Day 0
measure: Immediate complications related to intravenous access
timeFrame: Day 0
measure: Delayed complications related to intravenous access
timeFrame: Day 7
measure: Date of IV line placement and removal
timeFrame: Day 7
Other outcomes:
Locations:
city: Lyon
country: France
facility: Saint Joseph Saint Luc Hospital
state: Rhone-alpes
Study officials:
References:
Clinical trial NCT00482664: The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
Official title: A Phase 2a Multi-Centre, Double Blind, Placebo Controlled Cross-Over Trial To Investigate The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women Diagnosed With Female Sexual Arousal Disorder (FSAD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sexual Dysfunction, Physiological
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-05
Enrollment: 84
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been shown in animal models to restore sexual function.


Eligibility criteria: Inclusion Criteria:

* healthy pre-menopausal women
* primary female sexual arousal disorder causing distress
* on stable use of oral contraceptives

Exclusion Criteria:

* any other significant disease causing Female Sexual Dysfunction including psychiatric disease
* subjects on drugs known to cause Female Sexual Dysfunction
* subjects who have given birth in the last 12 months or who are planning to become pregnant during the study

Primary outcomes:
measure: Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
timeFrame: 6 weeks
measure: Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.
timeFrame: 6 weeks
Secondary outcomes:
measure: Exit interview at end of study. Meaningful Benefit Question at end of study.
timeFrame: End of study
measure: Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Dulwich
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Aarhus C
country: Denmark
facility: Pfizer Investigational Site
city: Kobenhavn OE
country: Denmark
facility: Pfizer Investigational Site
city: Odense C
country: Denmark
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Westville
country: South Africa
facility: Pfizer Investigational Site
state: Kwa-Zulu Natal
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Skovde
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05321264: Educational Intervention to Promote Control Behaviors and Prevention of Dengue
Official title: Nursing Intervention in Adults to Promote Dengue Prevention and Control Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dengue
Keywords: Standardized Nursing Terminology
Prevention & control
Dengue
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the effect of an educational nursing intervention in adults to promote dengue control and prevention behaviors, in comparison with the usual strategy of a health service provider institution. The intervention uses the Nola Pender Health Promotion Model as a theoretical framework. Findings will be assessed using the nursing outcomes "risk control" and "participation in health care decisions" from the Nursing Outcomes Classification (NOC).

Detailed description: Annually, there are 390 million cases of dengue, mostly due to the inadequate application of sanitary behaviors in the management and control of the vector, having as background the lack of knowledge of the population in the appropriation and incorporation of sanitary measures in the different environments. In addition to the cognitive and behavioral component, dengue has cultural, political, social and economic causes.

The evidence indicates that, from health education, educational interventions have been developed to reduce the disease, but most of them have not been carried out in rural areas following a theoretical framework that guides the intervention that leads to an impact on health promoting behaviors.

The use of the NOC results makes it possible to visualize the impact of nursing care and constitute scientific support for the advancement of the nursing discipline.

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years old.
* Inhabitant of the rural area.
* Participant in health promotion and disease prevention programs.
* Initial score less than or equal to 3.5 on the NOC outcomes: risk control and participation in health care decisions.

Exclusion Criteria:

* People with a score less than or equal to 24 on the cognitive mini mental test.
* Incomplete registration of information in databases of a health service provider institution.
* People with dengue (dengue with warning signs, and severe dengue).
* People who do not have mobile phone availability.
* Illiterate people.

Primary outcomes:
measure: Risk control
timeFrame: 2 months
Secondary outcomes:
measure: Participation in health care decisions
timeFrame: 2 months
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Yolima Judith Llorente Perez
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Wilson Canon Montanez, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05270564: Post-operative Drainage After Pancreaticoduodenectomy
Official title: Post-operative Drainage After Pancreaticoduodenectomy: A Randomized Controlled Trial of Patients With Intermediate and Low Risk for Pancreatic Fistula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Lund University
First posted: 2022-03-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing pancreaticoduodenectomy of both sexes
* Patients with predicted risk score of 10 or less of pancreatic fistula
* Written informed consent
* Expected survival time \> 6 months

Exclusion Criteria:

* Patients with predicted high risk of fistula with a risk score above 10
* Patients with intraabdominal abscess or infection
* ASA score \> 3
* Pregnancy
* Expected lack of compliance

Primary outcomes:
measure: Overall morbidity rate
timeFrame: 90 days post operatively
Secondary outcomes:
measure: Mortality rate (in-hospital, 30 and 90 days)
timeFrame: 90 days post operatively
measure: Severe morbidity rate as classified by Clavien-Dindo >3
timeFrame: 90 days post operatively
measure: Fistula rate according to ISGPF
timeFrame: 90 days post operatively
measure: Intraabdominal abscess rate
timeFrame: 90 days post operatively
measure: Wound infection rate
timeFrame: 90 days post operatively
measure: Delayed gastric emptying according to ISGPF
timeFrame: 90 days post operatively
measure: Postpancreatectomy bleeding according to ISGPF
timeFrame: 90 days post operatively
measure: Need of interventional radiology
timeFrame: 90 days post operatively
measure: Need for reoperation
timeFrame: 90 days post operatively
measure: Hospital stay
timeFrame: 90 days post operatively
measure: Readmission rate
timeFrame: 90 days post operatively
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linkoping University Hospital
city: Lund
country: Sweden
facility: Skanes University Hospital
Study officials:
affiliation: Linkoeping University
name: Bergthor Björnsson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05637164: Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery
Official title: Second Affiliated Hosptial， School of Medicine, ZheJiang University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Norepinephrine
Post-induction Hypotension
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to determine the ED50 and ED95 of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients undergoing major abdominal surgery using up-and-down sequential method . The main question it aims to answer is:

What is the effective concentration of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients.

Participants will receive different concentrations of norepinephrine infusion at the beginning of anesthesia induction until 15 minutes after intubation.


Eligibility criteria: Inclusion Criteria:

* aged 65 to 80 years
* Undergoing major abdominal surgery
* American Society of Anesthesiologists (ASA) physical status of I/II/III

Exclusion Criteria:

* Patient refusal
* Severe untreated or uncontrolled hypertension despite medications
* Bradycardia (heart rate \< 50 beat per minute)
* Cardiac morbidities, heart block greater than the first degree
* Severe hepatic and renal dysfunction
* hyperthyroidism
* vascular diseases
* BMI\>30
* Monoamine oxidase inhibitors were used 2 weeks before surgery

Primary outcomes:
measure: Incidence of hypotension
timeFrame: 15 minutes after intubation
Secondary outcomes:
measure: incidence of bradycardia
timeFrame: 15 minutes after intubation
measure: incidence of reactive hypertension
timeFrame: 15 minutes after intubation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT02326064: Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI and Tumor Markers Such as CA125 and HE4
Official title: Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI (Risk of Malignancy Index) and Tumor Markers Such as CA125 (Cancer Antigen 125) and HE4 (Human Epididymal Protein 4)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Tumor
Ovarian Cancer
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 221
Sex: FEMALE
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 hospitalized for surgery for presumed benign ovarian tumor

Brief summary: Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor.

To date, there is only one biological tumor marker routinely performed before an ovarian cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and show a sensitivity and specificity unsatisfactory in view of the severity of the disease.

The principal investigator therefore propose to evaluate a new tumor marker, as well as its use in algorithms to help differentiate benign from malignant tumors, and allow earlier diagnosis in cases of ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* patients to undergo surgery for an ovarian cyst
* presumed benign ovarian tumor (according to the rules of the IOTA(International Ovarian Tumor Analysis Group) group)
* agreement to participate in the study

Exclusion Criteria:

* pregnant patient
* minor patient
* Patient under guardianship, trusteeship, or deprived of liberty
* Patient with ascites or metastases or malignant ovarian mass presumed under the rules of IOTA group.
* Patient with an adnexal torsion is suspected
* Patient unable to understand the proposed study

Primary outcomes:
measure: Tumor Marker CA125
timeFrame: Baseline
measure: Tumor Marker HE4
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Nantes
country: France
facility: CHU de Nantes
city: Saint Nazaire
country: France
facility: CH de Saint Nazaire
Study officials:
affiliation: CHD Vendée
name: Guillaume DUCARME, PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03247764: A Registration Study on Depression in Patients With Epilepsy
Official title: A Registration Study on Drug Treatment for Comorbid Depression in Patients With Epilepsy in East China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Depression
Keywords: epilepsy
depression
drug treatment
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with the comorbidity of epilepsy and depression present to the neurology department at 8 tertiary hospitals in East China

Brief summary: The aim of this study is to register the drug treatment of depression in patients with epilepsy in East China.

Detailed description: As the treatment rate for depression in epilepsy is unclear and the discordant voice of choosing antidepressants for most doctors, this prospective observational cohort study was designed to better understand the current situation of drug treatments in patients with the comorbidity of epilepsy and depression in East China. The secondary outcome was to investigate whether baseline depressive symptoms had an influence on seizure-control in patients with epilepsy at follow-up.

Eligibility criteria: The inclusion criteria were as follows: (1) age 18-75, no gender limited; (2) diagnosis of epilepsy according to the definition by ILAE in 2014; (3) the score of 17-item Hamilton Depression Rating Scale greater than 7; (4) Obtaining informed consent of participants. The exclusion criteria were any of the following: (1) having psychiatric symptoms such as hallucination or delusion; (2) progressive neurological diseases and malignant tumors; (3) severe cognitive dysfunction (the score of MMSE less than 10).

Primary outcomes:
measure: the drug treatment rate of depression in patients with epilepsy
timeFrame: 6 months
Secondary outcomes:
measure: the influence of depression on seizure-control
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China
state: Shanghai
city: Hangzhou
country: China
facility: Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Nanjing
country: China
facility: Nanjing Brain Hospital
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Suzhou University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
Study officials:
affiliation: Fudan University
name: Xin Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02162264: Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Factors That Affect Aricept Medication Persistence Rate and the Safety and Efficacy in Patients With Alzheimer's Disease in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
donepezil hydrochloride
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 8662
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Alzheimer's Disease

Brief summary: To investigate the factors that affect Aricept medication persistence rate and the safety and efficacy in patients with Alzheimer's Disease in clinical practice


Eligibility criteria: Inclusion criteria:

Patients diagnosed with Alzheimer's Disease and administered Aricept for the first time.

Exclusion criteria:

Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.

Primary outcomes:
measure: Change From Baseline in the Mini-Mental State Examination (MMSE) Score
timeFrame: Baseline, Month 3, Month 6, and Month 12
Secondary outcomes:
measure: Investigations on adverse events and adverse drug reactions
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
name: Kazuhiro Omata
role: STUDY_DIRECTOR
References:
citation: Geriatric Medicine 55(10): 1131-1145, 2017.