louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04017767: Motor Plasticity, Intermittent Hypoxia and Sleep Apnea
Official title: Intermittent Hypoxia (IH), Respiratory and Motor Plasticity, and Sleep Apnea in Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Spinal Cord Injuries
Hypoxia
Keywords: Neuroplasticity
Respiratory Function
Motor Function
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2019-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older,
2. Chronic (≥ 1-year post-injury), non-progressive SCI,
3. Asia Impairment Scale (AIS) C or D,
4. Resting Saturated oxygen (SaO2) ≥ 95%,
5. Cervical injury (C5-C8)

Exclusion Criteria:

1. Currently hospitalized,
2. Resting heart rate ≥120 Beats per minute (BPM),
3. Resting systolic blood pressure \>180 mmHg,
4. Resting diastolic Blood Pressure \>100 mmHg,
5. Self-reported history of unstable angina or myocardial infarction within the previous month,
6. OSA that is being treated with positive airway pressure therapy,
7. Women who know or suspect they may be pregnant or who may become pregnant,
8. Known underlying lung disease,
9. Pregnant Women,
10. Prisoners,
11. Unable to consent

Primary outcomes:
measure: The difference in Motor Function assessed via hand grip strength measured by maximum grip strength (MGS) between participants with moderate to severe OSA and without OSA.
timeFrame: Baseline
measure: The difference in Motor Function assessed via hand grip strength measured by electromyographic (EMG) recordings between participants with moderate to severe OSA and without OSA.
timeFrame: Baseline
Secondary outcomes:
measure: Change in Motor Function assessed via hand grip strength measured by MGS.
timeFrame: Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
measure: Change in Motor Function assessed via hand grip strength measured by EMG recordings.
timeFrame: Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
measure: Change in biomarker levels
timeFrame: Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Shirin Shafazand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04006067: The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication
Official title: The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication. A Single Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decreasing Wound Infection
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Armed Forces Hospitals, Southern Region, Saudi Arabia
First posted: 2019-07-02
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aim to compare the effect of changing their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure versus no intervention in the incidence of postoperative wound infections in pregnant women undergoing Caesarean section. The primary outcome is the incidence of any post cesarean wound related complication, including wound seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery, while the secondary outcomes are Postoperative fever: defined as greater than 38 degrees Celsius or post cesarean endometritis: defined as a clinical diagnosis, usually involving fever, uterine fundal tenderness, or purulent lochia requiring antibiotic therapy or Combined wound complications and endometritis.

Detailed description: The investigators conduct a prospective randomized study at Department of Obstetrics and Gynecology, AFHSR since April 2019 till October 2019, after approval of the study protocol by the Local Ethical Committee.

Patients undergoing Both elective and emergency cesarean sections and Patients received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. All patients received appropriate pre-operative antibiotics, chlorohexidine skin prep except where allergies prohibited, and hair clipping as indicated.

The patients (600) are divided into two groups, Group A (300) during CS the surgical team change their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure, while in Group B (300) no intervention

Eligibility criteria: Inclusion Criteria:

1. Both elective and emergency cesarean sections.
2. Patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case.

Exclusion Criteria:

1. Women with active infection during the procedure.
2. Women did not receive the standard preoperative antibiotic prophylaxis.
3. Women with diagnosis of chorioamnionitis.

Primary outcomes:
measure: The incidence of any post cesarean wound related complication
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Khamis Mushait
country: Saudi Arabia
facility: AFHSR
Study officials:
References:
Clinical trial NCT00797667: MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)
Official title: A Phase IIa, Multicenter, Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK0974 for Migraine Prophylaxis in Patients With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 660
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 study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.


Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has had a history of migraine with or without aura
* Patient is able to complete study questionnaire(s) and paper diary

Exclusion Criteria:

* Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study
* Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions
* Patient was older than 50 years of age at migraine onset
* History of gastric or small intestinal surgery or has a disease that causes malabsorption
* Patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the study
* Currently participating or has participated in a study with an investigational compound or device within 30 days of starting the study
* Currently participating in a study with MK-0974 or MK-3207

Primary outcomes:
measure: Change From Baseline in Mean Monthly Headache Days
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Monthly Migraine Days
timeFrame: Baseline and Week 12
measure: Percentage of Participants Who Experienced an Adverse Event
timeFrame: up to 14 days after last dose of study drug (up to 12 weeks)
measure: Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days
timeFrame: Week 12
measure: Change From Baseline in the Mean Monthly Migraine Attacks
timeFrame: Baseline and Week 12
measure: Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ho TW, Connor KM, Zhang Y, Pearlman E, Koppenhaver J, Fan X, Lines C, Edvinsson L, Goadsby PJ, Michelson D. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology. 2014 Sep 9;83(11):958-66. doi: 10.1212/WNL.0000000000000771. Epub 2014 Aug 8.
Clinical trial NCT05046067: Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
Official title: Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial assesses the feasibility of creating a 3 dimensional (D) model of the lung and lung nodule(s) from computed tomography (CT) scan images performed during lung surgery. Unlike solid organs (like the kidney, brain, and liver), the lung changes shape (they inflate when a person breathe in and collapse when they breathe out). This makes it difficult to predict where, exactly, the tumor(s) will be on the lungs during surgery. A 3D model may help surgeons better predict where the location of the tumor(s) will be during surgery.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the feasibility of developing an anatomical model to predict the location of the tumor in a deflated lung to assist in guidance during lung surgery.

SECONDARY OBJECTIVES:

I. Develop a registration technique to register the tumor onto the 2D/3D optical image obtained during surgery.

II. Determine the accuracy of mapping major segmental vasculature and bronchial structures onto 2D/3D optical images obtained during surgery.

OUTLINE:

Patients undergo 4 CT scans during standard of care surgery.

Eligibility criteria: Inclusion Criteria:

* Patients must have previous CT images demonstrating a lung mass or masses amenable to lung resection (open or minimally invasive)
* Patient is scheduled for surgical resection in a room equipped with intraoperative CT
* Patient must sign informed consent, with risks and benefits of CT imaging explained
* Patients with lung tumors \>= 1cm to =\< 3 cm based on preoperative CT scan. (Patients with lung tumors from \< 1 cm or \> 3 cm will be reviewed and approved for inclusion on an individual assessment by clinical collaborators)

Exclusion Criteria:

* Pediatric patients less than 18 years of age
* Patients who have undergone previous ipsilateral thoracic surgery, sclerotherapy, or radiation therapy as intraoperative adhesions may limit lung collapse intraoperatively
* Patients who received neoadjuvant immunotherapy
* Women who are pregnant or nursing

Primary outcomes:
measure: Feasibility of anatomical modeling for image guided thoracic surgery
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ravi Rajaram
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04917367: Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen
Official title: Second Affiliated Hospital, College of Medicine, Zhejiang University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Keywords: Migrating foreign body; Upper aerodigestive tract; Neck; Laryngoscopy endoscopy; Positioning
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People from vulnerable groups are excluded

Brief summary: Objective: To improve the success rate of the treatment of migrating foreign bodies in the upper aerodigestive tract.

Methods: The medical records of inpatients conforming to the diagnosis of migrating foreign bodies between 2020 and 2025 were reviewed. Data regarding age, gender, time from onset to hospitalization, computed tomography (CT) and endoscopic scans, surgical procedures，and follow-up were collected.


Eligibility criteria: Inclusion Criteria:

* The foreign body of pharynx or esophagus was confirmed by surgical exploration

Exclusion Criteria:

* The foreign body is in the pharynx or esophagus or is not found during surgery.

Primary outcomes:
measure: Success rate
timeFrame: 5 years
Secondary outcomes:
measure: surgery time
timeFrame: intraoperative
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, College of Medicine, Zhejiang University
name: Hong-Gang Duan, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02530567: Non-invasive Evaluation of Portal Pressure by MRI
Official title: Using MRI for a Non-invasive Evaluation of Portal Pressure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Liver Disease
Keywords: portal pressure
portosystemic pressure gradient
azygos blood flow
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this research is to study the correlation between the portosystemic pressure gradient and azygos blood flow measured by MRI.

Detailed description: All patients will benefit from:

* Pressure gradient measurement portosystemic
* MRI measurement of azygos flow, aortic, portals, spleen and lower cellar
* Liver biopsy
* Laboratory tests

Eligibility criteria: Inclusion Criteria:

* Suspicion of chronic liver disease
* Indication to perform a liver biopsy transjugular
* Patient able to consent

Exclusion Criteria:

* contraindication to MRI:
* Holders of a pacemaker or a defibrillator, an implanted material activated by electrical, magnetic or mechanical
* Holders of hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants
* claustrophobic
* Severe hepatic encephalopathy
* Inability to MRI in the week surrounding the first jugular

Primary outcomes:
measure: Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and azygos flow measured by MRI.
timeFrame: 1 week
Secondary outcomes:
measure: Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and aortic flow measured by MRI.
timeFrame: 1 week
measure: Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and throughput inferior vena measured by MRI.
timeFrame: 1 week
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
affiliation: UH TOULOUSE
name: Phillipe OTAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008 Mar 8;371(9615):838-51. doi: 10.1016/S0140-6736(08)60383-9.
citation: Garcia-Pagan JC, De Gottardi A, Bosch J. Review article: the modern management of portal hypertension--primary and secondary prophylaxis of variceal bleeding in cirrhotic patients. Aliment Pharmacol Ther. 2008 Jul;28(2):178-86. doi: 10.1111/j.1365-2036.2008.03729.x. Epub 2008 May 2.
citation: Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.
citation: Thabut D, Moreau R, Lebrec D. Noninvasive assessment of portal hypertension in patients with cirrhosis. Hepatology. 2011 Feb;53(2):683-94. doi: 10.1002/hep.24129.
Clinical trial NCT01211067: Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia
Official title: Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Indirect Inguinal Hernia
Keywords: Inguinal hernia
Inguinal ring
Histology
Hernioplasty
Lichtenstein
Lead sponsor: Cirujanos la Serena
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 72
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indirect inguinal hernia submitted to elective surgery with the Lichtenstein hernioplasty technique

Brief summary: The histology of the internal inguinal ring in patients with indirect hernia submitted to elective surgery was studied. In contrast with recently published studies, the investigators believe that histological findings of the internal inguinal ring would reflect those associated and expected with normal aging.


Eligibility criteria: Inclusion Criteria:

* Male gender
* Older than 15 years-of-age
* Unilateral indirect inguinal hernia
* Non-smokers
* Non-diabetics
* Non-connective tissue conditions
* Primary inguinal hernia

Exclusion Criteria:

* Female gender
* Younger than 15 years-of-age
* Bilateral inguinal hernia
* Direct or combined direct-indirect inguinal hernia
* Femoral hernia
* Smokers
* Diabetics
* Other connective tissue diseases
* Recurrent inguinal hernia

Primary outcomes:
measure: Histology of the internal inguinal ring
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Serena
country: Chile
facility: Hospital de La Serena
state: Coquimbo
city: La Serena
country: Chile
facility: Hospital de La Serena
state: Iv Region
Study officials:
affiliation: Hospital de La Serena
name: Marcelo A Beltrán, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barria C, Beltran MA, Contreras MA, Cruces KS. Histology of the internal inguinal ring: it is really a novelty? Hernia. 2010 Jun;14(3):339-40. doi: 10.1007/s10029-010-0661-4. Epub 2010 May 1. No abstract available.
Clinical trial NCT00817167: Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy
Official title: Open Label, Randomized, Comparative, Single Center, Pilot Study to Assess the Added Value of inReach Technology Software on Performance Characteristics of Standard Bronchoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Disease
Keywords: Known or suspected lung disease
Candidates for non-emergency bronchoscopy
Lead sponsor: superDimension Ltd.
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* Candidates for non-emergency bronchoscopy
* Must provide signed informed consent
* Male or female above 18 years old
* Lung lesions up to 3 cm in size (in largest diameter), non-visible by standard bronchoscope

Exclusion Criteria:

* CT done over a month before the bronchoscopy procedure

Primary outcomes:
measure: Bronchoscopy Diagnostic Yield, compared between two study groups and calculated as percentage of true diagnoses from total number of bronchoscopy procedures.
timeFrame: Until the definitive diagnosis is obtained
Secondary outcomes:
measure: Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events.
timeFrame: At discharge from bronchoscopy unit
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Pulmonology Department, Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Pulmonology Department, Tel Aviv Sourasky Medical Center
name: Avi Mann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest. 2006 Apr;129(4):988-94. doi: 10.1378/chest.129.4.988.
citation: Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27.
citation: Eberhardt R, Anantham D, Herth F, Feller-Kopman D, Ernst A. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest. 2007 Jun;131(6):1800-5. doi: 10.1378/chest.06-3016. Epub 2007 Mar 30.
Clinical trial NCT04461067: Gastric Volume and Colorectal Surgery
Official title: Ultrasonographic Evaluation of the Evolution of the Gastric Volume After Colorectal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Postoperative ileus (POI) is a serious complication after colorectal surgery. One of its most frequent consequences is the replacement of nasogastric tube because of the vomiting. Vomiting is due to the distension of the stomach and information on the evolution of gastric filling after surgery could help to better understand the physiopathology of POI. It could also give indication to help the physician in the management of POI.

The ultrasonography has been shown to be a reliable technic to assess the gastric emptying.

To date, there is no indication in the literature about the evolution of the gastric filling after colorectal surgery while these information could help to identify patients at risk for POI and to predict the need for POI replacement.


Eligibility criteria: Inclusion Criteria:

* patient undergoing colorectal resection whatever the surgical access

Exclusion Criteria:

* contra-indication to ultrasonography performance
* history of gastrectomy

Primary outcomes:
measure: Diameter of the gastric antrum
timeFrame: immediately before the procedure and each postoperative day up to discharge (mean 7 days)
Secondary outcomes:
measure: postoperative ileus
timeFrame: in the morning up to 30 postoperative days
measure: Postoperative quality of life: GIQLI
timeFrame: before discharge
measure: postoperative morbidity
timeFrame: within 30 postoperative days
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: Aurélien VENARA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: