louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03151642: A PILOT STUDY OF DIFFUSION WEIGHTED MRI TO ASSESS ESOPHAGEAL TUMOR RESONSE TO NEOADJUVANT CHEMORADIATION
Official title: A PILOT STUDY OF DIFFUSION WEIGHTED MRI TO ASSESS ESOPHAGEAL TUMOR RESONSE TO NEOADJUVANT CHEMORADIATION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina

Brief summary: The purpose of this research study will be to determine the sensitivity and specificity of dwMRI metrics to assess tumor response following neoadjuvant chemoradiation in esophageal cancer. This pilot study will generate the preliminary data needed for the design of a statistically-justified trial that would investigate dwMRI as an integral biomarker to stratify patients for escalated therapy to improve outcomes. We hope to develop dwMRI as a predictive clinical tool for a personalized treatment model that can identify patients who may be candidates for organ-preservation or treatment intensification to improve outcomes in esophageal cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
* Patients with AJCC 7th edition clinical stage IIB-IIIC
* Patients will be treated with neoadjuvant chemoradiotherapy for this condition
* Patients must be \> 18 years of age
* Patients must be able to provide informed consent
* Patients must be surgical candidates
* Patients must be able to tolerate MR imaging required by protocol

Exclusion Criteria:

* Patients with primary tumors located above the carina
* Prior abdominal radiation therapy with fields overlapping the current fields
* Severe claustrophobia not relieved by oral anxiolytics per institutional standard practice
* Presence of MRI-incompatible metallic objects or implanted medical devices in the body (including but not limited to: non-MRI compatible metal objects, cardiac pacemaker, aneurysm clips, artificial heart valves with steel parts, metal fragments in the eye or central nervous system)
* Weight greater than that allowable by the MRI table

Primary outcomes:
measure: Number of MRIs
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Edgar Ben-Josef, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04803942: Clinical Intuition for PRedicting Evolution in Sepsis in the Emergency Department - CIPRES-ED Study
Official title: Clinical Intuition for PRedicting Evolution in Sepsis in the Emergency Department - CIPRES-ED Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: Sepsis
clinical intuition
emergency department
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 692
Sex: ALL
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: Patients presenting to one of the participating emergency departments with suspected infection

Brief summary: Sepsis is a syndrome involving infection and an abnormal systemic inflammatory response in the infected organism, resulting in organ dysfunction and possibly death. It is a major cause of hospital mortality. A large proportion of sepsis diagnoses are made in emergency departments. Early diagnosis and appropriate treatment have been shown to reduce mortality from this disease.

In a context of limited resources, it is therefore important to be able to quickly stratify patients presenting to the emergency department with a suspected infection into those who require rapid and intensive management because they are at risk of developing sepsis and septic shock and those who can be managed conventionally The objective of this study is to compare the clinical intuition of emergency room physicians and nurses with the qSOFA score to predict the clinical course of patients presenting to the emergency room with potential sepsis.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to one of the participating emergency departments with suspected infection, defined as the presence of at least one of these parameters:

Temperature ≥ 38°C ou \< 36°C measured in the emergency room Chills (in the emergency room or on recent history)

* No objection to participation in the study

Exclusion Criteria:

* Minor patient (\<18 years)
* Patient under guardianship or other protective measure
* Patient unable to understand research information
* Patient refusing the use of their data for research purposes

Primary outcomes:
measure: Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 30-day mortality in patients with suspected infection
timeFrame: 1 month after inclusion
Secondary outcomes:
measure: Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 72 hours mortality in patients with suspected infection
timeFrame: 72 hours after inclusion
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References:
Clinical trial NCT03022942: Efficacy of Costal Mobilization Techniques and Manual Diaphragm Release Technique in Patients COPD
Official title: Efficacy of Costal Mobilization Techniques and Diaphragm Release in Thoracoabdominal Kinematics, Diaphragm Mobility and Submaximal Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Chest Disorders
Diaphragmatic Disorder
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic release in chest cavity kinematics, diaphragmatic mobility and functional capacity in patients with chronic obstructive pulmonary disease

Detailed description: Study will be a controlled clinical trial in which participants will be randomized into 2 groups: GROUP A (costal mobilization techniques and Manual Diaphragm Release Technique), GROUP B (Manual Diaphragm Release Technique). After the initial evaluation, participants will undergo six sessions of care according to randomization and will be reevaluated in 3 following situations: immediately after the first session, at the end of treatment and one week after the last session. The evaluation will be performed through Optoelectronic plethysmography , Pollar, Ultrasound and 6-minutes walk test.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD (spirometry with FEV1 \<80% and FEV1 / FVC \<0.7) of both sexes, who are not undergoing another physiotherapeutic treatment, from to 21 years of age, clinically stable without exacerbation in the last 6 weeks.

Exclusion Criteria:

* Patients with rheumatic or orthopedic diseases;
* Deformities / abnormalities in the spine that compromise the mechanics of the respiratory system;
* Rib fracture for less than 1 year;
* Respiratory co-morbidities;
* History of thoracic or abdominal surgery for less than 1 year;
* Osteoporosis and IMC \> 30kg / m²

Primary outcomes:
measure: Mobility of the thoracic cage
timeFrame: Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
Secondary outcomes:
measure: Diaphragma mobility
timeFrame: Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
measure: functional capacity
timeFrame: Three weeks total: after two weeks of intervention and after one week without treatment (follow up)
measure: heart rate variability
timeFrame: 1 day: before and after the intervention
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: HELENA M ROCHA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03013842: Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
Official title: Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy, Abdominal
Keywords: pregnancy
fetal monitoring
fetal oximetry
fetal heart rate
pulse oximetry
near infrared spectroscopy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: CITRIS
First posted: 2017-01-09
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human subjects, in order to obtain fetal heart rate.

We want to determine if this device can accurately measure a baby's oxygen level when placed on your abdomen.

Current technology to measure a baby's oxygen levels requires a probe to be inserted into the vagina.

Detailed description: The study subject will have a brief trans-abdominal ultrasound examination.

3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. No probes will be placed into the vagina.

It is anticipated that 6 months will be required to recruit, consent and study 25 participants.

Eligibility criteria: Inclusion Criteria:

* Greater than 36 weeks pregnant
* Singleton fetus

Exclusion Criteria:

* Prisoners

Primary outcomes:
measure: Fetal Photoplethysmogram
timeFrame: 6 months
Secondary outcomes:
measure: Fetal Heart Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: 916-734-5028
name: Neil Ray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01416142: A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens
Official title: A Study to Evaluate the Product Performance of the PureVision®2 HD Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 63
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
* Subjects must be myopic or hyperopic and require lens correction in each eye
* Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.

Exclusion Criteria:

* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* Allergic to any component in the Biotrue multi-purpose solution

Primary outcomes:
measure: Visual Acuity
timeFrame: Screening visit (Visit 1) and one week follow-up(Visit 3)
Secondary outcomes:
measure: Preference for Test Lens
timeFrame: During the movie (Visit 2)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Inc.
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Bev Barna, CCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT06031142: A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy
Official title: Flexible Wearable Device for Continuous Fetal Heart Rate and Movement Monitoring.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Contractions; Prolonged
Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
Pregnancy Related
Home Range
Keywords: FECG
EHG
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 4
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A wearable and remote fetal monitoring system is specifically developed for home use. It aims to overcome the limitations of conventional cardiotocography (CTG) devices by providing great user comfort and long-term continuous monitoring.

Brief summary: The goal of this observational is to compare in describing fetal health conditions. The main questions it aims to answer are:

* fetal electrocardiogram (fetal heart rate and fetal rhythm)
* electrohysterography (uterine contractions).

Participants will wear wearable devices and CTG equipment for monitoring for 30 minutes.If there is a comparison group: Researchers will compare clinical CTG equipment to see if this wearable device.

Detailed description: The investigators put the patch of the wearable device on the abdomen of the pregnant woman and continued the test for thirty minutes.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with a gestational cycle greater than 36 weeks

Exclusion Criteria:

* male
* Pregnant women with a gestational cycle less than 36 weeks

Primary outcomes:
measure: The performance of this system in extracting fetal electrocardiogram (FECG)
timeFrame: 2022.01-2023.08
measure: The performance of this system in extracting electrohysterography (EHG)
timeFrame: 2022.01-2023.08
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: FetaCare
state: Pudong New District， Shanghai
Study officials:
affiliation: Fudan University
name: Tingting Li, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06172842: Multi-modality Echocardiography for Cardiac Assessment in Primary Electrical Disease
Official title: Multi-modality Echocardiography for Cardiac Assessment in Primary Electrical Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multi-modality Echocardiography
Primary Electrical Disease
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary electrical disease

Brief summary: From 2020 to 2023, patients with primary electrical disease (idiopathic ventricular fibrillation, long QT syndrome, Andersen-Tawil syndrome type I, Brugada syndrome, early repolarization syndrome, CPVT, and short QT syndrome) were first diagnosed at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and clinical data and echocardiographic indicators were recorded. Follow-up is until December 30, 2025 or endpoint event occurs. Endpoint events were defined as sustained ventricular tachycardia, ventricular fibrillation, sudden cardiac death, ICD discharge events, all-cause death, heart failure and heart transplantation, which were statistically analyzed as a composite endpoint of cardiovascular analysis. The predictors of primary electrical disease and the risk factors for adverse cardiovascular events were analyzed.


Eligibility criteria: Inclusion Criteria:

* primary electrical disease

Exclusion Criteria:

* Congenital heart disease, poor echocardiographic images, moderate or severe valvular disease

Primary outcomes:
measure: Multi-modality echocardiography
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hanlu Lv
Study officials:
References:
Clinical trial NCT00737542: Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.
Official title: A Prospective Randomized Double-blind, Placebo-controlled Study of the Effect of Preoperative Analgesia With Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Cesarean Delivery
Keywords: management
post
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-08-19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: The objective of this prospective, double-blinded, placebo-controlled, randomized study is to evaluate the impact of preemptive analgesia using incisional site infiltration of lidocaine as compared to saline solution on post operative pain control in women undergoing cesarean deliveries.

Detailed description: The studied population would be based on women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision.

Prior to each operation, the surgeon will be provided with a syringe containing a 20 mL solution of 1% lidocaine or 0.9% sodium chloride, which will be injected subcutaneously to the incisional site region after anesthesia and before the beginning of the surgery.

After the operation the conventional post cesarean analgesic regime will be used and recorded for all women.

The self-report of pain will be assessed by the patient using a validated visual analog scale, as instructed by the nursing staff.

The patient's mark will be used as a numerical index of pain intensity. The reports will be taken by the patients in intervals of 4 hours for 48 hours after the operation. In addition, analgesic requirements of the patient will be monitored and recorded by the nursing staff and used for comparison between the two study group

Eligibility criteria: Inclusion Criteria:

* Women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision.

Exclusion Criteria:

* More than two previous cesarean deliveries
* Other abdominal operations in the past
* Morbid obesity
* Diabetes mellitus, neurological diseases, systemic vascular disease.
* Mental disability
* Lidocaine sensitivity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Division of Obstetrics and Gynecology - Soroka University Medical Center
Study officials:
References:
Clinical trial NCT02439242: Correlation Between ΔPP/HR and ΔSV During Fluid Challenge.
Official title: Correlation Between the Pulse Pressure / Heart Rate Ratio Variations and Stroke Volume Variations During Fluid Challenge.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypovolemia
Keywords: stroke volume, haemodynamic, fluid resucitation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 100
Sex: ALL
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: General anaesthesia.Orotracheal intubation and mechanical ventilation Advanced Haemodynamic Monitoring intraoperative ( arterial pressure catheter, oesophageal Doppler)

Brief summary: In high perioperative risk patients, guidelines suggest intraoperative haemodynamic optimization by measurement of stroke volume (SV) to guide fluid resucitation.This strategy requires an invasive monitoring and learning. Some studies tried to find SV surrogates based on haemodynamic usual parameters. In an experimental hemorrhagic shock, SV was correlated to the pulse pressure (PP) / heart rate (HR) ratio.

The investigators hypothesized that SV variations (ΔSV) would be correlated to the PP/HR ratio variations (ΔPP / HR) during fluid challenge, and ΔPP / HR would be able to detect a ΔSV greater than 10%.


Eligibility criteria: Inclusion Criteria:

* a suspected hypovolemia, based on clinical or paraclinical parameters.
* a fluid challenge decision at the discretion of the anaesthesiologist physician in charge of the patient.

Exclusion Criteria:

* Minor or major patient under guardianship,
* oesophageal Diseases

Primary outcomes:
measure: correlation by linear regression between variations of the ratio PP/HR ( in percentage) and variations of SV ( in percentage) during fluid challenge
timeFrame: 18 months
Secondary outcomes:
measure: Area under the receiver operating characteristic curve (AUC roc) of the ability of variations of the ratio PP/HR ( in percentage)during fluid challenge to predict an increase of SV greater than 10%
timeFrame: 18 month
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
state: Basse Normandie
Study officials:
affiliation: CHU CAEN
name: Olivier REBET
role: PRINCIPAL_INVESTIGATOR
References: