louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04830956: Evaluation of Comfort in Subjects With Moderate Dry Eye Disease
Official title: Evaluation of Comfort in Subjects With Moderate Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.


Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an information consent letter
* Willing and able to follow instructions and maintain the appointment schedule
* Has dry eye symptoms

Key Exclusion Criteria:

* Has suffered any ocular injury to either eye in the past 12 weeks
* Is pregnant or lactating at the time of enrollment

Other protocol-specified inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in comfort rating
timeFrame: Baseline, up to 12 Hours (Day 1, each product)
Secondary outcomes:
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: Alcon Investigator 8169
state: Victoria
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Dry Eye
role: STUDY_DIRECTOR
References:
Clinical trial NCT05850156: Study of a Deformability Parameter of Red Blood Cell
Official title: Study of a Deformability Parameter of Red Blood Cell. FITRED
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Drepanocytosis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 130
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult and pediatric sickle cell patients, adult sickle cell carriers (heterozygous), and adult control subjects (homozygous).

Brief summary: Sickle-cell disease is one of the most common severe monogenic disorders in the world, it results in the synthesis of abnormal hemoglobin (HbS) instead of hemoglobin A. When deoxygenated, the sickle haemoglobin (HbS) polymerizes inducing the sickling of red blood cells (RBCs) and leading to decreased deformability and increased fragility. Therefore, sickle RBCs exhibit a reduced lifespan associated with intravascular hemolysis, hemolytic anemia and low tissue oxygenation. Sickle RBCs, which exhibit abnormal adhesive properties to endothelial cells, can block the microcirculation, causing the occurrence of painful vaso-occlusive crisis (VOC), acute chest syndrome (ACS), acute and chronic organ damage (heart, lung, liver, spleen, kidney, bone...) and shortened life span.

A preliminary study performed on RBC from sickle cell patients (Hb SS) has shown an alteration of a parameter measuring the overall deformability of RBCs by evaluating the nature of their movement in a shear flow. This parameter is significantly lower in sickle cell patients in steady state compared to a population of healthy individuals. The parameter is also significantly lower in sickle cell patients during VOC when compared to patient in steady state.

The main objective of this study is to evaluate the performance of the method for measuring the deformability of RBCs on an experimental prototype. Measurements will be performed on blood samples from subjects with a normal hemoglobin electrophoretic profile, from heterozygous carriers of sickle cell disease and from patients with sickle cell disease. Samples from paediatric patients will also be tested to study any specificity in comparison to adult subjects.


Eligibility criteria: Inclusion Criteria:

* Repeatability of ftt (mechanical marker of deformability) measurements

Exclusion Criteria:

* Effect of ambient temperature on ftt measurements
* Effect of sample processing time on ftt measurements

Primary outcomes:
measure: repeatability of fTT measurements
timeFrame: 14 months
Secondary outcomes:
measure: Effect of ambient temperature during fTT measurement
timeFrame: 14 months
measure: Effect of the processing time on fTT measurement
timeFrame: 14 months
measure: Correlation of ftt with the collected data
timeFrame: 14 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00105456: A Study of Patients With HER2-Positive Metastatic Breast Cancer
Official title: registHER: An Observational Cohort Study of Patients With HER2 Positive Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: HER2-Positive Metastatic Breast Cancer
HER2
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2005-03-15
Enrollment: 1000
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 from managed care organizations, community physicians or practices, and academic centers.

Brief summary: This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent document (unless the IRB has granted a waiver of consent)
* Signed Authorization for the Use and Disclosure of Health Information document
* HER2-positive breast cancer
* Initial diagnosis of metastatic (Stage IV) breast cancer within 6 months prior to enrollment
* Availability of cancer-specific historical data points in the patient's medical records

Exclusion Criteria:

* There are no exclusion criteria for participation in this trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Isaiah Dimery, M.D.
role: STUDY_DIRECTOR
References:
citation: Yardley DA, Tripathy D, Brufsky AM, Rugo HS, Kaufman PA, Mayer M, Magidson J, Yoo B, Quah C, Ulcickas Yood M. Long-term survivor characteristics in HER2-positive metastatic breast cancer from registHER. Br J Cancer. 2014 May 27;110(11):2756-64. doi: 10.1038/bjc.2014.174. Epub 2014 Apr 17.
Clinical trial NCT03644056: Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors
Official title: A Phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-001 in Subjects With Metastatic or Locally-advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Metastasis
Locally Advanced
Keywords: IMC-001
Lead sponsor: ImmuneOncia Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-001 in Subjects with Metastatic or Locally-advanced Solid Tumors

Detailed description: IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine safety and evaluate PK, PD and clinical activity of IMC-001. Multiple dose levels of IMC-001 will be tested in subjects with metastatic or locally-advanced solid tumors. Data from this study will also help determine the recommended phase 2 dose of IMC-001.

Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent Form (ICF).
2. Adult (19 years or older).
3. Histologically or cytologically proven metastatic or locally-advanced solid tumors

Exclusion Criteria:

1. Treatment with non-permitted drugs (within the past 28 days of Screening), including but not limited to systemic immunosuppressive agents, any other investigational medicinal product (IMP), anti-coagulant, or live vaccines.
2. Any prior cancer immunotherapy
3. Concurrent anticancer treatments

Primary outcomes:
measure: Occurrence of DLTs
timeFrame: During the first 21 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Yongin-si
country: Korea, Republic of
facility: ImmuneOncia
state: Gyeonggi-do
Study officials:
affiliation: ImmuneOncia Therapeutics Inc.
name: Yun Jeong Song, CMO/CEO
role: STUDY_DIRECTOR
References:
citation: Keam B, Ock CY, Kim TM, Oh DY, Kang WK, Park YH, Lee J, Lee JH, Ahn YH, Kim HJ, Chang SK, Park J, Choi JY, Song YJ, Park YS. A phase I study of IMC-001, a PD-L1 blocker, in patients with metastatic or locally advanced solid tumors. Invest New Drugs. 2021 Dec;39(6):1624-1632. doi: 10.1007/s10637-021-01078-6. Epub 2021 Jul 16.
Clinical trial NCT06952309: Intravenous Lidocaine Plus Intratracheal Dexmedetomidine on Postoperative Sore Throat
Official title: Effect of Intravenous Lidocaine Combined With Intratracheal Dexmedetomidine on Postoperative Throat Pain in Patients Undergoing Thyroid Cancer Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Lidocaine
Sore Throat
Keywords: dexmedetomidine
lidocaine
thyroid surgery
sore throat
Lead sponsor: Anqing Municipal Hospital
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: The present study was to investigate the effect of intravenous lidocaine combined with intratracheal dexmedetomidine on postoperative sore throat in patients undergoing thyroid cancer surgery.

Methods: Investigators enrolled 144 patients with American Society of Anesthesiologists (ASA) physical status I and II, aged 18-65 years, and scheduled for elective undergoing thyroid cancer surgery with general anesthesia. The participants were randomly assigned into four groups(n=36 each group): Group L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia. Group D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia.The incidence and severity of postoperative sore throat were recorded in four groups at 1 h, 2 h, 6 h, 24 h and 48 h after operation.


Eligibility criteria: Inclusion Criteria:

* Thyroid cancer surgery with ASA grades I-II
* Aged 18-65 years
* The patient's communication is normal and they have a certain learning ability

Exclusion Criteria:

* Severe respiratory and circulatory system diseases
* There was bradycardia (HR \< 60 beats/minute) or atrioventricular block before the operation
* Nervous system disease
* Mental and psychological disorders
* Abnormal liver and kidney functions
* Pregnant and lactating women

Primary outcomes:
measure: The incidence and severity of postoperative sore throat
timeFrame: at 1 hour, 2 hour, 6 hour, 24 hour and 48 hour after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05045456: Observational Clinical Investigation of EKG Diagnostic Performance of the Apple Watch Augmented With an AI Algorithm
Official title: Investigation Clinique Observationnelle Des Performances de Diagnostic Electrocardiographique de l'Apple Watch (App ECG Version 2.0) augmentée d'un Algorithme d'Intelligence Artificielle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Cardiologs Technologies
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 participants: patients hospitalized for ablation or cardioversion or in cardiology department or patients having cardiac rhythm consultation and who have consented to participate to the study

Brief summary: This observational prospective clinical investigation will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)

Detailed description: Each patient hospitalized for ablation or cardioversion and having given consent to participate in the clinical investigation will have ECG recordings by Apple Watch performed simultaneously with a 12D ECG measurement by a cardiologist before and/or after treatment, in accordance with the existing patient monitoring protocol. Similarly, patients attending a rhythmology consultation or hospitalized in the cardiology department will have simultaneous ECG recordings with an Apple Watch during the scheduled routine 12D ECG recording.

Eligibility criteria: Inclusion Criteria:

* Patient aged 22 or older, able and willing to participate in the study
* Patient admitted to hospital for ablation, cardioversion or cardiac electrophysiological exploration or who comes for regular rhythmology consultations or hospitalized in cardiology department
* Patient who has read the information note and has given his or her consent before any procedure related to the study
* Patient affiliated to social security

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
* Subject related to the investigator or any other staff member directly involved in the conduct of the study
* Patient incapable of giving consent, minor or adult patient protected by law

Primary outcomes:
measure: Performance of AF detection
timeFrame: 1 day
Secondary outcomes:
measure: AW versus AI-AW
timeFrame: 1 day
measure: AI-AW versus AI-12lead
timeFrame: 1 day
Other outcomes:
Locations:
city: Massy
country: France
facility: Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
Study officials:
affiliation: Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
name: Laurent Fiorina, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03061656: Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma
Official title: High-dose 131I-MIBG Treatment Incorporated Into Tandem High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With High-risk Neuroblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: High Risk Neuroblastoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2017-02-23
Enrollment: 40
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCT including high-dose 131I-metaiodobenzylguanidine (MIBG) treatment. In the present study, a single arm trial of tandem HDCT/ASCT will be carried out.

Detailed description: Although the outcome of high-risk neuroblastoma has improved after the introduction of HDCT/ASCT, the outcome was still unsatisfactory with 30-40% of survival. We previously reported the results of a single arm prospective trial (SMC NB-2004 study) using tandem HDCT/auto-SCT for high-risk neuroblastoma. In the NB-2004 trial, total body irradiation (TBI) was incorporated in second transplantation. Survival rates were very encouraging; however, short- and long-term toxicities associated with tandem HDCT/auto-SCT, particularly TBI, were also very significant. For this reason, we designed a new prospective trial (SMC NB-2009 study), in which only TBI in the second HDCT/auto-SCT of NB-2004 study was substituted with high-dose 131I-MIBG treatment in order to reduce short- and long-term toxicities without jeopardizing survival rate.

Eligibility criteria: Inclusion Criteria:

* Patients with high-risk neuroblastoma

Exclusion Criteria:

* Patients with progressive disease before high-dose chemotherapy
* Patients whose parents want to stop or change the planned treatment
* Patients with organ toxicities of NCI grade \>2 before high-dose chemotherapy

Primary outcomes:
measure: Rate of event free survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: Rate of treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Ki Woong Sung
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JW, Lee S, Cho HW, Ma Y, Yoo KH, Sung KW, Koo HH, Cho EJ, Lee SK, Lim DH. Incorporation of high-dose 131I-metaiodobenzylguanidine treatment into tandem high-dose chemotherapy and autologous stem cell transplantation for high-risk neuroblastoma: results of the SMC NB-2009 study. J Hematol Oncol. 2017 May 16;10(1):108. doi: 10.1186/s13045-017-0477-0.
Clinical trial NCT03832309: Techniques to Reduce the Severity and Frequency of Emergent Reactions
Official title: Non-Pharmacological Techniques to Reduce the Severity and Frequency of Emergency Reactions After Procedural Sedation and Analgesia in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Analgesia
Lead sponsor: CHRISTUS Health
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted in the emergency department at CHRISTUS Spohn Shoreline hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn and is the only level II trauma center in south Texas. It is a major affiliate of Texas A\& M medical school, and serves an inner-city population
Primary purpose: OTHER

Brief summary: The objectives of this study are first to determine if the power of suggestion will decrease the frequency and severity of emergence reactions after procedural sedation and analgesia with ketamine in the setting of the emergency department. Second, to determine if people dream about what they were thinking about when they were induced with ketamine.

Detailed description: The proposed research will be single blinded (patient) randomized controlled trial with a retrospective component to test the hypothesis that the power of suggestion will reduce the frequency and severity of emergence reactions, even in the setting of the emergency department.

The study will be conducted in the emergency department at CHRISTU Spohn Shoreline Hospital. CHRISTUS Spohn Shore hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn, and the only level II trauma center in south Texas. It is a major teaching affiliate of Texas A\&M medical school, and serves an inner-city population.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Required need for procedural sedation and analgesia

Exclusion Criteria:

* Age\< 18
* Hypertension
* Raised Intracranial pressure
* Major psychological disorders
* Procedures involving laryngel manipulations
* History of Laryngeal sapsm History of adverse reactions to ketamine

Primary outcomes:
measure: T-Test
timeFrame: 24 months
measure: STAI-6
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Corpus Christi
country: United States
facility: CHRISTUS Health
state: Texas
Study officials:
affiliation: CHRISTUS Health
name: Paul Crapo, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02442609: Internet for Anesthesia Information : a Patient Questionaire
Official title: Does Patient Look to Internet for Anesthesia Information Before Surgery : a Prospective International Questionaire Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaesthesia
Keywords: internet
anesthesia
information
surgery
question
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (\> 18 yrs), schedulled for surgery under local, regional or general surgery

Brief summary: Patients need information for perioperative period and internet may be an interesting alternative.This study analysed by questionaire what does patient look on internet: information of perioperative period and specifically for anesthesia. Questionaire (8 questions) are distributed to the patient before surgery and after they were prepared by surgeon. Population : adult (\> 18 y), no emergency procedure.The mean question is the use of internet for anesthesia information.

Detailed description: This is a prospective study with 23 centers ( France, Suisse, Belgium, Canada) including before surgery: adult (\> 18y), no emergency procedure. Questionaires (8 questions) are distributed to the patient before surgery and after they were prepared by surgeon. After collecting all questionaires, questionaires are analysed by an independant center. The mean question is the use of internet for anesthesia information. More than 8000 patients have to be enrolled during the study period over 23 centers.

Eligibility criteria: Inclusion Criteria:

* Adult (\> 18 yr)
* surgery
* private or public hospital

Exclusion Criteria:

* refusal,
* emergency surgery
* epidural analgesia for pregnant patient

Primary outcomes:
measure: use of internet
timeFrame: 1 day
Secondary outcomes:
measure: Age
timeFrame: 1 day
measure: search of anesthesia informations
timeFrame: 1 day
measure: social activity
timeFrame: 1 day
measure: surgery
timeFrame: 1 day
measure: interest for pre operative questionaire for anesthesia
timeFrame: 1 day
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU Caremeau
state: GArd
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: ICM, CRLC, Montpellier, France
name: Gilles Leclerc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICM, CRLC, Montpellier, France
name: Philippe Cuvillon, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Nucci B, Claret PG, Leclerc G, Chaumeron A, Grillo P, Buleon C, Leprince V, Raux M, Minville V, Futier E, Lefrant JY, Cuvillon P; Anaesthesia Internet Study Group. Role of the internet as an information resource before anaesthesia consultation: A French prospective multicentre survey. Eur J Anaesthesiol. 2017 Dec;34(12):831-835. doi: 10.1097/EJA.0000000000000686.