louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04400201: A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy
Official title: A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-22
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.


Eligibility criteria: Inclusion Criteria:

1. 18\~80 years, female or male
2. Patients scheduled for an bronchoscopy procedure
3. 18 kg/m2\<BMI\<30kg/m2
4. Patients understand clearly and participate in the study voluntarily, and sign the informed consent

Exclusion Criteria:

1. Patients scheduled for emergency surgery
2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
3. One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
4. Pregnant women or those in lactation period
5. Allergic to drugs used in the study
6. Patients have participated in other clinical trial within the 3 months prior to randomization
7. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

Primary outcomes:
measure: Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group
timeFrame: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment
Secondary outcomes:
measure: Time from start of investigational medicinal product administration to loss of consciousness
timeFrame: From the onset of administration of the study drug to unconsciousness on Day 1 of treatment
measure: Time from stop of investigational medicinal product to MOAA/S Score=5
timeFrame: From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment
measure: Time from stop of investigational medicinal product to Aldrete Score≥9
timeFrame: From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Peking Union Medical College Hospital
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02190201: Comparison of McGrath and Macintosh Laryngoscope for DLT Intubation
Official title: A Randomised Controlled Trial Comparing McGrath Series 5 Videolaryngoscope and Macintosh Laryngoscope for Double Lumen Tube Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation; Difficult
Thoracic Diseases
Intubation Complication
Keywords: videolaryngoscope
double lumen intubation
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. But it is not determined about the advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube intubation, compared with traditional Macintosh laryngoscope.

Detailed description: The investigators designed a randomised controlled study to compare of McGrath Series 5 videolaryngoscope and Macintosh laryngoscope for DLT intubation.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Thoracic surgery required one lung ventilation

Exclusion Criteria:

* Difficult ventilation
* Emergent operation

Primary outcomes:
measure: Intubation time
timeFrame: at intubation
Secondary outcomes:
measure: number of successful intubation at first attempt
timeFrame: at intubation
Other outcomes:
measure: Airway evaluation with Cormack-Lehane Score
timeFrame: At intubation
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Yuke Tian, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01628601: GANfort® in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Are Insufficiently Responsive to Monotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-06-27
Enrollment: 392
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 with primary open angle glaucoma or ocular hypertension prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) by the physician prior to study entry

Brief summary: This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their physician.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open angle glaucoma or ocular hypertension
* Prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol)

Exclusion Criteria:

* None

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, 18 Weeks
Secondary outcomes:
measure: Physician Assessment of Tolerability Using a 4-Point Scale
timeFrame: 18 Weeks
measure: Patient Assessment of Tolerability Using a 4-Point Scale
timeFrame: 18 Weeks
measure: Physician Assessment of Adherence to GANfort®
timeFrame: 18 Weeks
measure: Patients Continuing With GANfort® After 18 Weeks
timeFrame: 18 Weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT07023601: International Prospective Multicentre Study That Evaluate the Sentinel Lymph Node Detection Rate in Patients With First Local Recurrent Scamous Cell Carcinoma of the Vulva.
Official title: Sentinel Node Biopsy in Relapsed Vulvar Cancer. VULCA-NODE Study.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Recurent Vulvar Carcinoma
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acronym: VULCA-NODE Study Title: Sentinel Node Biopsy in Relapsed Vulvar Cancer Primary Objetive: To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting.

Secondary Objetives:

* To compare the utility of different tracers in the detection of SLN for recurrent disease and the injection pattern.
* To evaluate the surgical complications rate.
* To analyze the nodal status by ultrastaging .
* To assess the disease free and overall survival at 24 months from the first recurrence, as well as the dissemination pattern after the procedure.

Study Design: International prospective multicentre study

Inclusion Criteria:

* First local recurrent squamous cell carcinoma of the vulva (SCC).
* Unifocal, smaller or equal than 4 cm vulvar tumor not involving urethra, vagina or anus.
* No distant or groin metastasis.
* To be able to understand the study and sign informed consent.
* Over 18 years old.
* To be able to undergo planned follow up.

Exclusion Criteria:

* Multifocal recurrent disease of the vulva.
* Previous bilateral IFL.
* Synchronous, non-curable second malignancy. Timing: 4 years


Eligibility criteria: Inclusion Criteria:

* First local recurrent squamous cell carcinoma of the vulva (SCC).
* Unifocal, smaller or equal than 4 cm vulvar tumor not involving urethra, vagina or anus.
* No distant or groin metastasis.
* To be able to understand the study and sign informed consent.
* Over 18 years old.
* To be able to undergo planned follow up.

Exclusion Criteria:

* Multifocal recurrent disease of the vulva.
* Previous bilateral IFL.
* Synchronous, non-curable second malignancy.

Primary outcomes:
measure: To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting.
timeFrame: From enrollment to the first 30 day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
References:
Clinical trial NCT03152201: New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms
Official title: I Potenziali Somato-sensoriali Nella Chirurgia Degli Aneurismi Cerebrali
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Aneurysm
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient bearer of a not broken cerebral aneurysm

Brief summary: During surgery, electrophysiological signals will be acquired with the instrument (ISIS IOM, NeuroExplore, Software Version 4.4, Inomed) already in use at the Neurosurgery Service of the Neurocentro of the Hospital Civic Italian Switzerland in Lugano. Simultaneously to Somatosensorial Evoked Potential (SEP) will also be recorded the Electroencephalography (EEG) activity with the same detection of locations.

For the purposes of the study the signals transmitted to the neurosurgeon through the hardware and the corresponding assessments done by the neurophysiologist responsible for intraoperative monitoring will be recorded. It will also be kept track of procedures performed during surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Patient bearer of a not broken cerebral aneurysm, which has been defined per size and morphology susceptible to surgery
* Aneurysms located on cerebral arteries of the anterior circulation (carotid, middle cerebral arteries, anterior cerebral, anterior communicating, pericallose); Cases of multiple aneurysms are also eligible
* Informed consent for participation in the study

Exclusion Criteria:

* Patient with an aneurysm of the posterior circulation (vertebrobasilar system)
* The aneurysm was a source of bleeding (subarachnoid hemorrhage, intracerebral, intraventricular).
* Patient with a pace-maker (for the risk that the electric currents used in the study could compromise the operation of the pace-maker)

Primary outcomes:
measure: hardware performance
timeFrame: at the moment of the surgery
measure: Identification of sensitive electrophysiological index sensible to cerebral ischemic suffering
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Neurocentro della Svizzera Italiana (NSI)
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Luca Valci, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03529201: QLB After Nephrectomy
Official title: Effectiveness of Quadratus Lumborum Block After Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Chronic Postoperative Pain
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów
name: Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok
First posted: 2018-05-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated to one of the study arms: QLB or control group.
Primary purpose: TREATMENT

Brief summary: Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).

Detailed description: Patients undergoing nephrectomy procedures will be allocated to one of the study arms. At the end of an operation, still under general anesthesia, 50% patients will obtain QLB with ropivacaine.

Ultrasound-guided QLB will be performed on the side of surgery with 0.375% ropivacaine solution (0.2 mL per kg).

Every patient will get patient-controlled analgesia pump with oxycodone in the postoperative period.

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of the operation. 24 -hours period.

At the 1, 3, 6 months patients will be interviewed by phone to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Eligibility criteria: Inclusion Criteria:

* obtained consent
* nephrectomy procedure

Exclusion Criteria:

* coagulopathy allergy to local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs

Primary outcomes:
measure: Total consumption of oxycodone
timeFrame: 24 hours after the end of surgery.
Secondary outcomes:
measure: Pain intensity
timeFrame: 24 hours after the end of surgery
measure: Chronic pain
timeFrame: 6 months after the surgery
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok
city: Rzeszów
country: Poland
facility: Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów
Study officials:
References:
Clinical trial NCT01667172: Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices in Comparison With Laboratory CRP Testing.
Official title: Study of Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy and Acutely Ill Children & Adults
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive Protein devices (POC CRP devices) in comparison with laboratory CRP testing on children and adults.

Research questions:

1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP values measured at the clinical laboratory?
2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable? 2.1.1. Comparison of 2 measurements in the same patient on 1 device (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on 2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices equally userfriendly in a general practice surgery? (userfriendliness


Eligibility criteria: Inclusion Criteria:

* children: aged 1 month to 14 years
* adults: aged 18-65 years

Exclusion Criteria:

* children and adults not understanding Dutch language

Primary outcomes:
measure: technical accuracy
timeFrame: 3 months
Secondary outcomes:
measure: User-friendliness
timeFrame: 3 months
measure: Inter-device variability
timeFrame: 3 months
measure: Inter-observer variability
timeFrame: 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Huisartspraktijken
state: Vlaams-Brabant
city: Leuven
country: Belgium
facility: Medisch Centrum voor Huisartsen
state: Vlaams-Brabant
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
References:
citation: Van den Bruel A, Thompson MJ, Haj-Hassan T, Stevens R, Moll H, Lakhanpaul M, Mant D. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011 Jun 8;342:d3082. doi: 10.1136/bmj.d3082.
citation: Van den Bruel A, Haj-Hassan T, Thompson M, Buntinx F, Mant D; European Research Network on Recognising Serious Infection investigators. Diagnostic value of clinical features at presentation to identify serious infection in children in developed countries: a systematic review. Lancet. 2010 Mar 6;375(9717):834-45. doi: 10.1016/S0140-6736(09)62000-6. Epub 2010 Feb 2.
Clinical trial NCT03832972: Performance During Menstrual Cycle
Official title: Variation in Performance During Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Performance
Keywords: menstrual cycle
Estrogen
performance
variation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Team Denmark
First posted: 2019-02-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women, 10 using 2. generations birth control pills and 30 not using any kind of hormonal protection.

Brief summary: This project aims to investigate if muscle strength and muscle power fluctuate during the menstrual cycle.

The hypothesis is that the greatest performance will be measured right before ovulation, and at it's lowest on day 1 and 2 of the menstrual cycle in women not using any form for hormonal protection.

And that the performance in women using birth control pills, not will variated in the period where they are taking pills (day 1-21).


Eligibility criteria: Inclusion Criteria:

* Women
* 18-35 years of age
* BMI 18.5-25.

Exclusion Criteria:

* Smoking
* hormonal or metabolic disorders
* chronic sickness
* use of medication
* breast feeding, vegetarians
* diet containing a lot of soja based products
* injuries which make it impossible to do the tests

Primary outcomes:
measure: Change in jumping height
timeFrame: 8 times per month, 2 to 5 days between measurements
measure: Change in grip strength
timeFrame: 8 times per month, 2 to 5 days between measurements
Secondary outcomes:
measure: Change in hormone levels
timeFrame: 8 time per month, 2 to 5 days between measurements
measure: Change in motivation by questionnaire
timeFrame: 8 times per month, 2 to 5 days between measurements
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Section of Sport Science
Study officials:
References:
citation: He W, Dam TV, Thogersen R, Hansen M, Bertram HC. Fluctuations in Metabolites and Bone Markers Across the Menstrual Cycle in Eumenorrheic Women and Oral Contraceptive Users. J Clin Endocrinol Metab. 2022 May 17;107(6):1577-1588. doi: 10.1210/clinem/dgac112.
Clinical trial NCT04853472: Menopause Sample Collection
Official title: Menopause Sample Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 151
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy female volunteers

Brief summary: This study will provide daily urine samples from women during early and late stage peri-menopause as well as post-menopause over the course of three calendar months in order to maintain the SPD sample bank.

Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts and stored at -80˚C until required.

Symptom information will also be recorded to determine whether there are any noticeable physiological changes that can be related to stage of the menopause.


Eligibility criteria: Inclusion Criteria:

* Female
* Between the ages of 45 and 60 years
* Suspects they are going through or have been through the menopause
* Experiencing cycle irregularities:

  * Early Stage Peri-Menopause: Mild cycle irregularity over the last 3-6months (minimum), variation of \>6 days in length between consecutive cycles including shortened and longer cycles (but not \>60 days in length)
  * Late stage peri-menopause: Irregular cycles with prolonged periods of amenorrhea \>60 days in length (but less than 12 months)
  * Post-Menopause: Greater than 12 months since last menstrual period
* Willing to give informed consent

Exclusion Criteria:

* Use of hormone replacement therapy (HRT)
* Use of hormone contraception
* Hysterectomy and/or oophorectomy
* Pregnant or breast feeding
* Other medical reason for amenorrhea (absence of menstruation)

Primary outcomes:
measure: Number of daily urine samples collected from women during various stages of the menopause
timeFrame: 3 months
Secondary outcomes:
measure: Menopause Symptom Information
timeFrame: 3 months
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development Company
name: Raniero Zazzeroni
role: STUDY_DIRECTOR
affiliation: SPD Development Company
name: Jackie Boxer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03346772: Study of Immune Responses to Influenza Vaccination
Official title: Study of Immune Responses to Influenza Vaccination
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Influenza Vaccination
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Better understanding of the immune responses to influenza vaccination is needed in order to understand situations of poor vaccine response. Adults will receive influenza vaccination and then have peripheral blood drawn at pre-defined intervals in order to study the lymphocyte responses.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling adults able to provide consent who need influenza vaccination for standard of care

Exclusion Criteria:

* febrile illness at time of vaccination
* active malignancy
* use of immunosuppressing medications
* blood donation in the past 60 days
* influenza vaccinated during the preceding 6 months
* allergic reactions to influenza vaccination

Primary outcomes:
measure: Influenza neutralizing antibody titers
timeFrame: 21-42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: E.John Wherry, PhD
role: PRINCIPAL_INVESTIGATOR
References: