louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03834675: Suitability of PICC for Transpulmonary Thermodilution Compared to CICC
Official title: Are Peripherally Inserted Central Catheters (PICC) Suitable for Cardiac Output Assessment With Trans-pulmonary Thermodilution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripherally Inserted Central Catheters
CVC
Transpulmonary Thermodilution
Hemodynamic Monitoring
Keywords: PICC
shock
cardiac output
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Claudio Sandroni
name: Sofia Cacciola
name: Antonio Maria Dell Anna
name: Mauro Pittiruti
name: Maria Giuseppina Annetta
name: Cesare Colosimo
name: Massimo Antonelli
First posted: 2019-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study we try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.


Eligibility criteria: Inclusion Criteria:

* adult patients (≥18 years) admitted to the ICU
* Patients requiring hemodynamic monitoring using EV1000TM
* Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed)

Exclusion Criteria:

* body weight \<40 kg
* severe aortic regurgitation or intra-cardiac shunt
* treatment with an intra-aortic balloon pump
* contraindication for placement of PICC, CICC or a femoral arterial catheter
* abdominal aneurism
* extracorporeal circulation
* pregnancy
* lack of informed consent

Primary outcomes:
measure: Cardiac Index comparison via PICC
timeFrame: One hour
Secondary outcomes:
measure: Comparison 4Fr PICCs to CICC
timeFrame: one hour
measure: Comparison 5Fr PICCs to CICC
timeFrame: one hour
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS
name: Massimo Antonelli, MD
role: STUDY_CHAIR
References:
citation: D'Arrigo S, Sandroni C, Cacciola S, Dell'Anna AM, Pittiruti M, Annetta MG, Colosimo C, Antonelli M. Are Peripherally Inserted Central Catheters Suitable for Cardiac Output Assessment With Transpulmonary Thermodilution? Crit Care Med. 2019 Oct;47(10):1356-1361. doi: 10.1097/CCM.0000000000003917.
Clinical trial NCT00211575: Instrument Utility for Suspected Asthma (0000-042)(COMPLETED)
Official title: Clinical Utility of an Instrument in the Evaluation of Young Children With Suspected Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 400
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This research study was designed to help improve the diagnosis and treatment of asthma in young children. An interventional strategy using a scoring system based on risk factors and symptoms/episodes was tested to determine its ability to identify children likely to benefit from induction of asthma controller therapy at an early age. The score was derived through completion of a survey instrument referred to as the asthma risk questionnaire (ARQ). The utility of the ARQ along with the health care utilization and use of controller therapy for respiratory illnesses within one year were examined.


Eligibility criteria: Inclusion Criteria:

* Children less than or equal to 6 years of age who had at least 1 year prior episode of wheezing

Exclusion Criteria:

* Children with other systemic or chronic respiratory disease and children who used an asthma controller medication with the 6 weeks prior to enrollment

Primary outcomes:
measure: Utility of ARQ as measured by the percentage of children started on any asthma medication and characteristics of those diagnosed with asthma
Secondary outcomes:
measure: Percentage of children with recurrent wheezing, placed on controller therapy, number of steroid courses and need for urgent medical care at 6 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04237675: Postoperative Relapses in MS Patients
Official title: Assessment of Risk of Postoperative Relapses in Patients With Multiple Sclerosis; an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis Relapse
Surgery
Anesthesia
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients or parturients with MS who received general or regional anesthesia for surgery or labor analgesia

Brief summary: The aim of the study is to record any relapses during one year postoperatively in patients and parturients diagnosed with MS who received general or regional anesthesia


Eligibility criteria: Inclusion Criteria: diagnosed MS -

Exclusion Criteria: refuse to participate

-

Primary outcomes:
measure: MS relapses
timeFrame: one year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital, University of Athens
state: Attiki
city: Athens
country: Greece
facility: Aretaieio Hospital
Study officials:
References:
Clinical trial NCT05787275: Effect of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid-19 Syndrome.
Official title: Effect of Different Types of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid Syndrome. A Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corona Virus Infection
Keywords: Diaphragmatic function
Post Covid
Exercises
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work is to study the incidence of diaphragmatic dysfunction after COVID 19 infection and the efficacy of different types of diaphragmatic strengthening exercises on diaphragm muscle function.


Eligibility criteria: Inclusion Criteria:

* Male and female above 18 years old
* history of probable or confirmed SARS-CoV-2 infection 3 months from the onset of symptoms or at least 2 months from the end of symptoms .

Exclusion Criteria:

* Subjects under 18.
* Patients known to have chronic lung disease .
* Patients known to have neuromuscular disorder.
* Patients known to have diaphragmatic hernia.
* Patients known to have malignancy.
* Patients with clinical evidence of phrenic nerve injury.
* Patients with recent abdominal or thoracic surgery,
* Patients with history of traumatic lesion possibly affecting diaphragm.
* Subjects with severe malnutrition.
* Patients with BMI more than 30

Primary outcomes:
measure: Diaphragmatic thickness
timeFrame: 6 weeks
measure: Pulmonary Function Test
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University
state: Sharq
Study officials:
affiliation: Beni-Suef University
name: Tamer Abo Elyazed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04561375: Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery
Official title: A Pilot Study Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery From Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Knee Arthroscopy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery.

Detailed description: A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery. The results will help us estimate treatment effect and determine sample size for a subsequent full-scale clinical trial.

Primary Endpoint: total amount of fentanyl consumed during hospital admission. Secondary Endpoints: 1) phase I recovery time; and, 2) time to fitness for discharge.

Exploratory Endpoints: 1) intraoperative hemodynamics; 2) intraoperative opioid use; 3) intraoperative sevoflurane use; 4) postoperative pain; 5) postoperative sedation and cognitive recovery 6) time to first request for analgesia; and, 7) incidence of nausea and vomiting between the end of anesthesia and hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older;
* Scheduled for elective knee arthroscopy without anticipated ligamentous repair;
* Planned general anesthesia without a regional block or wound infiltration with local anesthesia;
* Planned day-of-surgery discharge.

Exclusion Criteria:

* Opioid tolerance defined by ≥15 mg of oral morphine daily or equianalgesic dose of another opioid within 30 days of surgery;
* Known hypersensitivity to sufentanil or components of DSUVIA;
* Patients with an allergy or hypersensitivity to opioids;
* Pregnancy or actively breastfeeding;
* Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug;
* Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.

Primary outcomes:
measure: Total Consumption of Fentanyl
timeFrame: About 3 hours in PACU
Secondary outcomes:
measure: Phase 1 Recovery Time
timeFrame: 1.5 hours
measure: Time to Fitness for PACU Discharge
timeFrame: 1 - 2 hours.
Other outcomes:
measure: Total Consumption of Fentanyl in PACU
timeFrame: About 3 hours in PACU
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sabry Ayad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364675: Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects
Official title: Primary Prevention of Cardiovascular Disease in Pre-diabetic & Pre-hypertensive Subjects Using Multiple Risks Reduction Strategy: A Multi-center, Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-diabetes
Pre-hypertension
Keywords: Impaired fasting glucose
Impaired glucose tolerance
Pre-diabetes
Pre-hypertensives
Cardiovascular events
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: Ubon Ratchathani Public Health Office, Thailand
name: National Health Security Office, Thailand
name: The Government Pharmaceutical Organization
First posted: 2011-06-02
Enrollment: 8900
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether treating pre-diabetic \& pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events.

Detailed description: The risks of CVD are not confined to a subset of established "hypertensive" or "diabetic" population, but also increase among those with suboptimal blood pressure and glycemic level, namely "pre-hypertensive" or "pre-diabetic" population. Evidence on the effectiveness of drug interventions to lower CVD events in pre-clinical stage population has been scant.

Eligibility criteria: Inclusion Criteria:

* Pre-diabetes
* Pre-hypertensives
* LDL-Cholesterol \>= 100 \< 190 mg/dl
* BMI \>= 23
* Estimated GFR \>= 60 ml/min/1.73 m2 (MDRD equation)
* Willing to participate and provide written inform consent

Exclusion Criteria:

* Current involved in other studied medications
* Regular use of corticosteroids
* Current use of weight loss medication
* History of renal disease
* Active liver disease including jaundice, chronic hepatitis with ALT \>= 2.5 the upper normal limit
* Active malignancy
* Major psychiatric disorder
* Diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, Cushing's syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, antipsychotics)
* Nursing women, pregnant women, or those that plan to become pregnant in the study period

Primary outcomes:
measure: Cardiovascular Events
timeFrame: 4-year
Secondary outcomes:
measure: Micro-vascular Complications
timeFrame: 4-year
measure: Cumulative Incidence of Diabetes
timeFrame: 4-year
measure: Cumulative Incidence of Hypertension
timeFrame: 4-year
measure: Incidence of Individual Cardiovascular Disease
timeFrame: 4-year
Other outcomes:
Locations:
city: Muang District
country: Thailand
facility: Ubon ratchathani Public Health Office
state: Ubon ratchathani
Study officials:
affiliation: Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital
name: Phisitt Vejakama, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02335775: Lymph Node Counts in Endometrial Cancer Staging
Official title: A Prospective Study of the Impact of Surgical and Pathologic Tissue Sampling Methods on Lymph Node Counts and Detection of Lymph Node Metastasis in Endometrial Cancer Staging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman over the age of 18 diagnosed with grade 3, clear cell, serous or sarcoma types of endometrial cancer

Brief summary: The purposes of this study are to determine whether total lymph node count or the percentage of identified nodes with metastatic disease are influenced by (1) the method of categorizing tissue specimens or (2) the techniques of pathologic processing following lymphadenectomy.

Patients with newly diagnosed endometrial carcinoma of high risk histologic type or uterine carcinosarcoma whose risk of LN metastasis exceeds 15% will be enrolled on this study. Patients will undergo staging to include hysterectomy and selective lymphadenectomy as per the clinical judgment of the primary Gynecologic Oncologist. Type of hysterectomy and the extent and distribution of lymphadenectomy is at the discretion of the surgeon. All patients will be scheduled for surgical staging. Each subject will have lymph nodes harvested on one side divided into specific basins, and on the contralateral side classified only as "pelvic" or "aortic". Surgical node specimens in the operating room will be labeled by (1) specific nodal basins on the randomly determined side as "external iliac", "obturator", "common iliac", "aortic", or "high aortic" and by (2) "pelvic" versus "aortic" (common iliac nodes will be considered as part of the "pelvic" specimen) on the contralateral side.


Eligibility criteria: Inclusion Criteria:

* Uterine cancer with one of the following pathologies: serous, clear cell, sarcoma or grade 3 differentiation
* surgical candidate

Exclusion Criteria:

-

Primary outcomes:
measure: Total gross node identification
timeFrame: 0-14 days post op
measure: Percentage of lymph nodes showing metastatic cancer (%NM)
timeFrame: 0-14 days post op
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT00688675: Gastroesophageal Reflux Disease (GERD) Segmentation: Document How Swiss General Practitioners (GPs) Allocate Their GERD Patients to the Three GERD Patient Segments
Official title: GERD Segmentation: Document How Swiss GPs Allocate Their GERD Patients to the Three GERD Patient Segments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GERD
Keywords: GERD
Pharmacoepidemiology
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 2912
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously diagnosed GERD patients on treatment for at least 2 weeks; in Switzerland

Brief summary: Document how Swiss GPs allocate their GERD patients to the three GERD patient segments (according to King et al.) and how treated GERD patients are affected by their GERD treatment


Eligibility criteria: Inclusion Criteria:

* Previously diagnosed GERD patients
* on treatment for at least 2 weeks

Exclusion Criteria:

* none

Primary outcomes:
measure: % patients per GERD patient segment
timeFrame: single visit
Secondary outcomes:
measure: Symptom load
timeFrame: single visit
measure: Quality of life
timeFrame: single visit
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Research Site
Study officials:
References:
Clinical trial NCT05267275: Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy
Official title: Effect of Splenic Flexure Mobilization With Extended Resection of the Proximal Colon for Rectal Cancer With Neoadjuvant Radiotherapy on Postoperative Complications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Preoperative neoadjuvant therapy has become the guideline-recommended standard treatment for patients with locally advanced or mid-to-low rectal cancer with suspected regional lymph node metastasis. However, preoperative neoadjuvant radiotherapy caused radiation damage to the pelvic bowel, resulting in varying degrees of edema, vascular stiffness, and insufficient blood supply. According to the traditional rectal cancer surgery, the proximal bowel resection only needs to be more than 10cm above the upper edge of the tumor. However, this range of resection cannot remove all the damaged proximal bowel, and using the damaged proximal bowel for anastomosis may lead to the risk of anastomotic-related complications (including anastomotic leakage, anastomotic stenosis, and anastomotic proximal bowel stiffness, etc.) also increased. Therefore, extended resection of the proximal bowel with splenic flexure mobilization and using healthy proximal bowel for anastomosis may help reduce the incidence of complications related to rectal anastomosis after neoadjuvant therapy.


Eligibility criteria: Inclusion Criteria:

1. Patients with mid-low rectal cancer who received preoperative neoadjuvant therapy (tumor distance ≤12cm from the anus);
2. The preoperative local stage is cT3-4N0-2M0 or cT3-4N0-2M1 (M1 is limited to liver metastases that can be surgically removed at the same time)
3. Preoperative neoadjuvant therapy (long-course concurrent chemoradiation or TNT)
4. Aged between 18-75 years old;
5. ASA rating: 0-2
6. ECOG Score: 0-2
7. BMI 18-30 kg/m2;
8. Radical surgical resection is expected to be possible on the basis of preserving the anus;
9. Sign the informed consent document.

Exclusion Criteria:

1. History of other malignant tumors;
2. Emergency surgery patients;
3. Severe underlying diseases, unable to tolerate surgery;
4. Without informed consent.

Primary outcomes:
measure: incidence of complications related to rectal anastomosis
timeFrame: From the end of the surgery to 1 year after ileostomy closure
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT02132975: Motorised Probe Holder Assisting Prostate Biopsies
Official title: Pilot Study of a Motorised Probe Holder Assisting Prostate Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate
cancer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Pitié-Salpêtrière Hospital
name: Institute for Intelligent Systems and Robotics
name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2014-05-07
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Study, for the first time in clinical conditions, the potential contribution, in terms of accuracy, of the motorised probe holder during prostate biopsies.


Eligibility criteria: Inclusion Criteria:

* of-age patient
* patient for whom a prostate biopsies session is planned
* patient affiliated to the social security or equivalent
* patient having a target identified on MRI
* Written informed consent

Exclusion Criteria:

* contraindication
* patient wearing a mechatronic device
* patient concerned by the L1121-6 à 8 of the health public code

Primary outcomes:
measure: Distance between virtual and effective biopsy, in the two arms
timeFrame: 8 months
Secondary outcomes:
measure: Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate
timeFrame: 8 months
measure: Probe holder positions error between virtual and effective biopsy
timeFrame: 8 months
measure: User satisfaction
timeFrame: 2 hours
measure: Safety Evaluation
timeFrame: 2 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Urology, AP-HP Pitié Salpêtrière
state: Ile de France
Study officials:
affiliation: AP-HP Pitié Sapêtrière
name: Pierre Mozer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: