louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01707511: The Investigation of the EtCO₂- PaCO₂ Relation During Laparoscopic Colon Surgery
Official title: Cohort Study on Patients Underwent Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: Arterial carbondioxide pressure
Colon surgery
End-tidal carbondioxide
Laparoscopic Trendelenburg
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 40
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 scheduled whom planned for elective laparoscopic colorectal resection.

Brief summary: Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also investigated.

Detailed description: Patient records from patients underwent colorectal surgery between 2010-2011 will be studied. It was planned to include patients undergoing laparoscopic colorectal surgery with a predetermined anaesthesia protocol.

Patients will receive a standardized general anesthetic and thoracal epidural anaesthesia. Ventilatory parameters will be adjusted to maintain ETCO2 35 mmHg, Paw 25 cmH2O.Patient age, gen-der, BMI, ASA classification, the duration of surgery, anesthesia, Trendelenburg position and pneumoperitoneum. Hemodynamic parameters, blood gas analyzes, ventilation parameters and EtCO₂ values will be recorded. We determined 6 timelines to compare the difference between PaCO₂ and EtCO₂. These timelines were the times where we could collect the most data regarding blood gas analyzes. Preoperative period: to, 10th minute after the first insuflation and trendelendburg position: t₁,the first hour after the first insuflation and trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th minute after the second insuflation and trendelendburg position: t₄, and 10th minute after the second desuflation and supine position:t₅. Primary outcome measure is the difference between PaCO₂ and EtCO₂ a difference greater than 5 mmHg was assumed to be important.

Eligibility criteria: Inclusion Criteria:

* ASA I-III patients underwent laparoscopic colorectal resection

Exclusion Criteria:

* convertion to the open surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Teaching and Research Hospital
state: Altindag
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Mustafa Ozmen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04572711: Prospective Evaluation of Biliary Tissue Sampling with ERCP
Official title: Prospective Evaluation of Biliary Tissue Sampling with ERCP
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Biliary Stricture
Biliary Tract Diseases
Cholangiocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 500
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: Adults 18 years of age or older who are undergoing ERCP with tissue sampling for an indeterminate biliary stricture will be identified at the time of their scheduled procedure.

Brief summary: The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies, transpapillary biliary biopsies (TPBx), brushings and bile aspiration for cytology and FISH in patients undergoing ERCP.


Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years
* Diagnosis of indeterminate biliary stricture
* Scheduled clinically indicated ERCP procedure

Exclusion Criteria:

• Adults \<18 years, Children

Primary outcomes:
measure: Performance characteristics
timeFrame: 1 year after ERCP procedure
measure: Number of adverse events
timeFrame: Within 30 days of ERCP procedure
Secondary outcomes:
measure: Healthcare Utilization
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vinay Chandrasekhara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01103011: Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611
Official title: A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: NeuroDerm Ltd.
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (LD/CD) and continuous delivery of ND0611


Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian males between 18 and 50 years (inclusive) of age
* Normal body weight
* Subjects with negative urinary drugs of abuse, HIV, Hepatitis B or Hepatitis C serology tests
* Subjects must be able to adhere to the protocol requirements
* Subjects must provide written informed consent to participate in the study.
* Haemoglobin level \>12.5 mg /dl

Exclusion Criteria:

* History of significant psychiatric disorder, neurological diseases or sleep disorders
* History of significant systemic diseases, by medical history or tests performed during screening examinations
* Clinically significant laboratory tests at screening
* History of drug or alcohol abuse.
* Allergy to levodopa, carbidopa or any inactive component of the test formulation.
* Subjects with dark skin
* Subjects with skin diseases or neoplasms
* Subjects with narrow-angle glaucoma
* Subjects with significant allergic response to other drugs.
* Subject with known atopic disorders
* Known allergy or hypersensitivity to adhesive tapes.
* Use of any prescription or over-the-counter (OTC) medications
* Subjects who donated blood or received blood, in the last 3 months
* Participation in another clinical trial in the last 30 days
* Subjects which do not have the ability to communicate well or will not adhere to the protocol procedures

Primary outcomes:
measure: Safety and tolerability
Secondary outcomes:
measure: Pharmacokinetics
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT06286111: Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries
Official title: Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgeries
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Inflammatory Marker
Heart; Surgery, Heart, Functional Disturbance as Result
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing open heart surgery with cardiopulmonary bypass used intraoperative, with no history of cardiac tachyarrythemia and not using rythm control drugs with normal cardiac dimensions

Brief summary: In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF

Detailed description: In this study we investigate the relation between Red Cell Distribution Width and post operative atrial fibrillation after open heart surgery as it's a major complication with high incidence, this complication prolong the in hosoital stay, postulated mechanism of Post Operative Atrial Fibrillation that it's due to inflammation and oxidative stress, after applying specific inclusion and exclusion criteria, recording the preoperative labs including RDW and follow up patients 48 hours post operative in the ICU and recording post operative labs and ECG, and compare the RDW of patients developed POAF and patients who didn't develop POAF

Eligibility criteria: Inclusion Criteria:

* Female or Male patient with range of age 35-65 years
* Elective Cardiac surgery
* Cardiopuomonary bypass machine used
* Normal Sinus Rhythm

Exclusion Criteria:

* Echo showing left atrial diameter above 4 cm
* Patient on rythm control medications
* Patient undergoing emergency surgery
* History of cardiac Tachyarrhythemia

Primary outcomes:
measure: Red cell distribution width as a predictor for Post-operative Atrial fibrillation after Open Heart Surgeries
timeFrame: 48 hours post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams University
Study officials:
References:
Clinical trial NCT02020811: Safety and Efficacy of Immages System in Patients Recieving IV Therapy
Official title: A Study to Assess the Functionality of Pro-IV's IMMAGES Infusion System in Patients Hospitalized in Bait Balev, Receiving Intravenous Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Bacteriemia
CHF
Lead sponsor: PRo-IV
Sponsor class: INDUSTRY
Collaborators: name: Bait Balev Hospital
First posted: 2013-12-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The study will evaluate the functionality of IMMAGES , an intravenous infusion device system, in patients hospitalized in Bait Balev hospital. The study will aim to determine how the IMMAGES system integrates within IV infusion therapy regime and what are the advantages and disadvantages, if any, of using this system within the prescribed setting.

Detailed description: Using the IMMAGES system in patients recieving IV therapy will provide the nursing teams on-line information regarding the infusions and will allow them to monitor and manage the treatments in real-time, providing better and safer care for the patients.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:

  1. Patients requiring infusion therapy
  2. Patients receiving infusion therapy by gravity flow or by pump
  3. patients are scheduled to receive at least once a day an infusion therapy
  4. Patients are scheduled to receive an infusion therapy for at least 3 days
  5. Adult over age of 18 years
  6. Informed consent form signed by patient.

     Exclusion Criteria:

  <!-- -->

  1. Informed consent form not signed
  2. Patients are scheduled to receive less than once a day an infusion therapy
  3. patients to receive less than 3 days of infusion therapy
  4. patients not hospitalized in a ward that is participating in the study.
  5. patients participating in another clinical study or clinical field test
  6. Patients require isolation treatment

Primary outcomes:
measure: Successful operation of IMMAGES defined by patient receiving the prescribed IV medication using the IMMAGES system , openning of the controller valve including using the smartphone application and the management software
timeFrame: as long as the patient is reciving the IV prescribed medication, and no longer than 10 days
Secondary outcomes:
measure: - Detection of medical errors by IMMAGES
timeFrame: up to 5 minutes from activating the controller on the IV line
Other outcomes:
Locations:
city: Bat Yam
country: Israel
facility: Bait Balev hospital
Study officials:
affiliation: PRo-IV
name: michal devir, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00332293: AL-15469A for the Treatment of Bacterial Conjunctivitis
Official title: An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 695
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* signs and symptoms of bacterial conjunctivitis
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* under 1 mo. age
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Clinical cure and microbiological success
Secondary outcomes:
measure: Individual signs and symptoms of bacterial conjunctivitis at each visit
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon for Trial Locations
state: Texas
Study officials:
References:
citation: Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14.
Clinical trial NCT01277393: Care of Critically Ill Patients Enteral Nutrition Guidelines for the Implementation of the Effectiveness of the Intervention
Official title: Care of Critically Ill Patients Enteral Nutrition Guidelines for the Implementation of the Effectiveness of the Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ICU Ill Patients
Enteral Nutrition Feeding
Keywords: Enteral nutrition feeding
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 100
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: ill patients

Brief summary: This study is to find out care of critically ill patients enteral nutrition guidelines for the implementation of the effectiveness of the intervention.


Eligibility criteria: Inclusion Criteria:

* ICU patients elder than 18 years of age
* (APACHE II) score \> 15
* Patients expected to remain in ICU for more than 2 days

Exclusion Criteria:

* Patients that have consented to a Do-Not-Resuscitate document
* Patients not expected survive more than 2 days
* Patients that have returned to ICU due to their condition worsening after previously leaving ICU
* Patients that have transferred from ICU of other hospitals.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Chin-Feng Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05166993: Dynamic Electronic Filter for Arterial Waveform Distortion
Official title: Arterial Pressure Waveform Distortion: a New Dynamic Electronic Filter for Automatic Correction of Underdamping/Resonance Artifact. A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Underdamping/Resonance Artifacts
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 70
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 admitted to postoperative intensive care unit.

Brief summary: Invasive blood pressure (IBP) is the gold standard for arterial pressure (AP) monitoring in critically ill patients. Nevertheless, IBP may be affected by underdamping/resonance artifacts, that eventually lead to AP overestimation. In these cases, when a pulse contour method is applied, wrong hemodynamic data are also delivered by the monitor. In order to overtake this issue, MostCareUp (a PCM powered by Pressure Recording Analytical Method, PRAM), has been implemented with a dynamic electronic filter (EFMC) that automatically corrects the resonant AP waveform.

In order to test the EFMC, the electronically corrected AP and the derived cardiac output were compared with respective raw data corrected with the Accudynamic, an adjustable damping device specifically manufactured for normalizing the pressure waveform (in our study: the reference method).


Eligibility criteria: Inclusion Criteria:

- ICU patients with invasive blood pressure (radial artery) affected by underdamping/resonance artifacts;

Exclusion Criteria:

- Arrhythmias

Primary outcomes:
measure: The present study was aimed to test the MostCareUp electronic filter
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
Study officials:
affiliation: University of Florence
name: Stefano Romagnoli, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00980993: Quantification of Respiratory-induced Prostate Motion
Official title: Pilot Study on the Quantification of Respiratory-induced Prostate Motion During Radiation Therapy Using Continuous Real-time Tracking
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: Prostate
Motion
Respiration
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Localized prostate cancer patients undergoing intensity-modulated radiation therapy.

Brief summary: Patient anatomy and position during the course of radiation therapy can vary from those used for treatment planning; a function of patient movement, uncertainty in positioning system, and organ motion. Traditionally, treatment margins are designed to compensate for interfraction prostate setup variability. This approach has the potential to lower the overall effectiveness of treatment because the prostate gland is a continuously moving target whose motion cannot be accurately accounted for solely on the basis of interfraction movement. More recently, the dosimetric relevance of intra-fraction prostate motion has been recognized, and may be compensated for by continuous real-time adaptive radiation therapy afforded by the Calypso 4D Localization System™. In the current study, the investigators propose to characterize intrafraction prostate motion. The investigators hypothesize that intrafraction prostate motion is correlated with respiratory motion.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed stage I-III adenocarcinoma of the prostate gland
* Age \> 18 years. Males of all races and ethnic groups
* Scheduled to receive radiation for definitive therapy
* Three (3) electromagnetic transponders implanted into prostate gland

Exclusion Criteria:

* Does not satisfy inclusion criteria

Primary outcomes:
measure: Motion amplitude
timeFrame: Continuously during radiation administration (generally 8 to 15 minutes in duration)
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: James A. Tanyi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615393: A Study to Compare the Bioavailability of Copegus and Vilona® in Healthy Volunteers
Official title: Prospective, Randomized, Single-blind, Cross-over, Comparative Study for Establishing Comparative Bioavailability of Copegus vs Vilona® in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This prospective, randomized, single-blind, cross-over study will compare the bioavailability of Copegus (ribavirin) administered as tablets and ribavirin administered as capsules in healthy volunteers. Volunteers will be randomized to receive a single dose of 400 mg of ribavirin either as a capsule or as tablets; after a washout phase volunteers will be crossed-over to the other treatment. The anticipated time on study treatment is 10 days.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers, 18 to 55 years of age
* Clinically healthy as confirmed by medical history, physical examination, electrocardiogram, thorax teleradiography and routine clinical laboratory measurements
* Body mass index between 18 and 28 kg/m2
* Negative testing for drugs of abuse

Exclusion Criteria:

* History or presence of any clinically significant condition that might interfere with the pharmacokinetics of the study drugs
* Volunteers require co-medications during the study
* Exposure to agents known as inducers or inhibitors of hepatic enzymatic system within 30 days prior to study start
* Having taken any medication with a clearance period of over seven half-life before study start
* Hospitalization or significant illness 30 days before study start
* Having received a investigational drug within 90 days prior to study start

Primary outcomes:
measure: Bioavailability
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Morelia
country: Mexico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: