louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00867958: Compression Anastomosis Using the CAR™ 27
Official title: Compression Anastomosis Using the CAR™ 27
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Keywords: Colon Anastomosis
Rectum Anastomosis
Intestine
Colorectal Surgery
Colorectal Anastomosis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: novoGI
First posted: 2009-03-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.

Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.

No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment: During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.

Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.


Eligibility criteria: Inclusion Criteria:

1. Patient is over 18 years old.
2. Patient is scheduled for a non-emergency procedure.
3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

1. Patient has an allergy to nickel.
2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
3. Patient is participating in another clinical trial which may affect this study's outcomes.
4. Patient has been taking regular steroid medication.
5. Patient has contraindications to general anesthesia.
6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

Primary outcomes:
measure: Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc.
timeFrame: 3-mo
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: haemek medical center
name: Yakov Khromov, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00726258: Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.
Official title: Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thoracotomy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-07-31
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in preventing acute postoperative pain. A previous study performed in the service testing the association ketamine/morphine versus morphine PCA, postoperative, for patients who do not benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of postoperative pain associated with a reduction of nocturnal arterial desaturation following surgery when ketamine was added to morphine.

Detailed description: In this prospective double blind randomized study, intravenous administration of an analgesic dose of ketamine was started since the induction of general anesthesia and continued during the first 48 postoperative hours in association with epidural analgesia.

Eligibility criteria: Inclusion Criteria:

* Subject between 18 and 85 years
* subject of both sexes
* subject operated in the service of thoracic surgery of a lobectomy by thoracotomie lateral or postlaterale subject
* subject operated in settled surgery

Exclusion Criteria:

* Against indication in the epidural insanity,
* confusionnel, patient psychotic
* treatment in the long price by medicine which can interfere on the pain (morphine, antidepressants, psychotropic treatment)

Primary outcomes:
measure: To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural
timeFrame: 24 months
Secondary outcomes:
measure: To estimate the effect of the association ketamine IV thoracic epidural on the postoperative pain postponed in 1, 3 and 6 months
timeFrame: 24 months
measure: To estimate the effect of the association ketamine IV thoracic epidural on the incidence of the urinary side effects and hémodynamiques of the epidural
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service de chirurgie Orthopédique-Traumatologie - Hopital Sainte Marguerite
Study officials:
affiliation: Assistance Publique des Hôpitaux de Marseille
name: Françoise GAILLAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joseph C, Gaillat F, Duponq R, Lieven R, Baumstarck K, Thomas P, Penot-Ragon C, Kerbaul F. Is there any benefit to adding intravenous ketamine to patient-controlled epidural analgesia after thoracic surgery? A randomized double-blind study. Eur J Cardiothorac Surg. 2012 Oct;42(4):e58-65. doi: 10.1093/ejcts/ezs398. Epub 2012 Jul 12.
Clinical trial NCT04955158: Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery
Official title: Impact of Dexmedetomidine Versus Ketamine Soaked Pharyngeal Packing on Postoperative Sore Throat in Functional Endoscopic Sinus Surgery: a Randomized Double Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sore Throat
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized clinical trial is to evaluate the impact of dexmedetomidine versus ketamine soaked pharyngeal packing on postoperative sore throat in functional endoscopic sinus surgery (FESS).

Detailed description: A written informed consent was taken from the patients.patients will be randomly assigned to three groups of 40 subjects each; dexmedetomidine or ketamine or saline soaked pharyngeal packs were situated under direct vision. Throat packs made of gauze with a length of 20 cm and a width of 10 cm (folded transverse four times) and medications were diluted with 20 ml normal saline. The packings were placed by the surgeon blinded to the study groups.

1-Dexmedetomidine group: 75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and \& endotracheal tube (ETT).

2-Ketamine group: 50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

3-Control group: 20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

Eligibility criteria: Inclusion Criteria:

* Adults of both sex with American Society of Anesthesiologists (ASA) physical status I-II
* Elective functional endoscopic sinus surgery (FESS) with endotracheal intubation.

Exclusion Criteria:

* A history of preoperative sore throat.
* Upper respiratory tract illness
* Potentially difficult airway
* Patients with history of neck, respiratory or digestive tract pathology
* Chronic smokers
* Using steroid within the last 48 hour
* Pregnant women

Primary outcomes:
measure: Incidence of postoperative sore throat (POST)
timeFrame: 24 hour after surgery
Secondary outcomes:
measure: Postoperative nausea and vomiting (PONV) score
timeFrame: 2 hours postoperative
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Omar Soliman
Study officials:
affiliation: Omar makram
name: Omar Soliman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
Clinical trial NCT04977258: Different Hydration Strategies Associated With Aerobic Exercise In Coronary
Official title: Effect of Different Hydration Strategies on Autonomic Acceleration During Recovery in Individuals With Coronary Artery Disease Undergoing Aerobic Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Disease
Keywords: Autonomic Nervous System
Fluid Therapy
Heart Rate
Exercise
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 31
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. However, the influence of fluid replacement when administered during and after exercise on cardiac autonomic modulation with autonomic alterations known as the coronary arteries remain poorly understood. The aim of the study was to evaluate and compare whether different hydration strategies are able to promote acceleration of the recovery of autonomic modulation in individuals with coronary artery disease undergoing aerobic exercise. This study is a cross-over clinical trial, which will be developed based on an experimental procedure performed in four stages. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation (CR) sessions. The participants will perform CR with mineral water intake in phase three and four. In phase three, the consumption will be done a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the second session. In phase four, hydration will be carried out in an uncontrolled manner, according to the desire to drink water during the protocol.


Eligibility criteria: Inclusion Criteria:

* Men with coronary heart disease ischemia, over 45 years
* At least three months of cardiovascular rehabilitation

Exclusion Criteria:

* Smokers, alcoholics
* Uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases)
* Abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load
* Myocardial ischemia and / or severe ventricular arrhythmias during the exercise test

Primary outcomes:
measure: Heart rate variability
timeFrame: up to six months
measure: Heart rate variability
timeFrame: up to six months
measure: Heart rate variability
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Luiz Carlos Masques Vanderlei
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista - UNESP - Campus de Presidente Prudente
name: Luiz Carlos Vanderlei, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03630458: Digestive Properties of Carbohydrate-based Foods
Official title: Investigating Digestive Properties of Carbohydrate-based Foods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Gastric emptying rate, glycemic response, fermentation, and appetitive response are being assessed after consumption of traditional West African carbohydrate-based foods (pearl millet couscous, pearl millet thick porridge) and Western type carbohydrate-based foods (wheat couscous, white rice).

Detailed description: Anecdotal evidence suggests that couscous made from pearl millet (Pennisetum glaucum), hereby referred to as millet couscous, is highly satiating in populations living in the West African Sahel. Results from a previous human study conducted the investigators indicated that traditional West African foods made from pearl millet and sorghum (millet couscous, millet thick porridge, and sorghum thick porridge) exhibit markedly delayed rates of gastric emptying compared to Western foods (pasta, boiled potatoes, and white rice) in a population from Mali, Africa. The delayed gastric emptying rate of the thick porridges can be attributed at least partially to the impact of viscosity, while the cause of the delayed gastric emptying rate of the millet couscous remains unclear. The overall aim of this research is to determine why millet couscous exhibits a delayed rate of gastric emptying, while also assessing other digestive properties to gain a better understanding of the factors that could be contributing to this outcome. Therefore, gastric emptying rate, glycemic response, fermentation, and appetitive response are all being assessed for West African and Western foods in a population residing in the United States.

Eligibility criteria: Inclusion Criteria:

* Normal body mass index (18.5 \< BMI \< 25 kg/m2)
* Normal fasting blood glucose

Exclusion Criteria:

* Diabetes
* Allergy to millet
* Allergy or sensitivity/intolerance to gluten
* History of gastrointestinal disease
* Pregnant or nursing

Primary outcomes:
measure: Gastric emptying rate
timeFrame: Acute study; 4 hours of measurement after consumption of test food
measure: Glycemic response
timeFrame: Acute study; 4 hours of measurement after consumption of test food
Secondary outcomes:
measure: Breath hydrogen (fermentability)
timeFrame: Acute study; 4 hours of measurement after consumption of test food
measure: Appetitive response
timeFrame: Acute study; 4 hours of measurement after consumption of test food
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
Clinical trial NCT00906958: Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Official title: Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2009-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.

Detailed description: Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years
* Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
* Patients who are using ResMed masks

Exclusion Criteria:

* Patients who are unable to provide written informed consent
* Patients who are unable to comprehend written and spoken English
* Patients who are using Bilevel PAP
* Patients who are pregnant
* Patients who are suffering any of the following:

  * Acute respiratory infection
  * Acute sinusitis, otitis media or perforated eardrum
  * Pneumothorax or pneumomediastinum
  * Recent history of severe epistaxis requiring medical attention

Primary outcomes:
measure: Apnoea-Hypopnoea Index (AHI)
timeFrame: One Night On Each Arm, approximately 8 hours each night
measure: Oxygen Desaturation Index
timeFrame: One Night On Each Arm, approximately 8 hours each night
Secondary outcomes:
measure: Comfort of Breathing
timeFrame: One Night On Each Arm, approximately 8 hours each night
measure: Satisfaction of Treatment
timeFrame: One Night On Each Arm, approximately 8 hours each night
measure: Refreshed Feel
timeFrame: One Night On Each Arm, approximately 8 hours each night
Other outcomes:
Locations:
city: Bella Vista
country: Australia
facility: Centre for Healthy Sleep
state: New South Wales
Study officials:
affiliation: ResMed/The University of New South Wales
name: Klaus Schindhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03465358: Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet
Official title: Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neuromuscular disease

Brief summary: Motor Function Measure (MFM) is a validated tool assessing the motor function of neuromuscular patients constituted of 32 items. Despite standardized Motor Function Measure (MFM) training sessions, there is still an inter-individual variability in the items' scoring procedure, depending for example on the subjectivity of the therapist.

Among the 32 items of the MFM, 3 currently require the use of a paper, and could be automated by using a digital tablet. It is the item 18 where the patient traces the edge of a Compact Disc, item 19 requiring to draw loops inside a frame and item 22 requiring to place a finger on each standardized cases. The reproducibility of these 3 items could be improved with the use of a digital tablet and the development of a software allowing to computerize the scoring procedure. The second interest is to implement directly the MFM data in the MFM base.

The hypothesis is that the difference of scoring of these 3 items between digital tablet versus paper completion is enough low to use indifferently each completion in patients with a neuromuscular disease.


Eligibility criteria: Inclusion Criteria:

* Patients with a labelled neuromuscular disease
* Patients with Motor Function Measure in one of the participating services during their usual follow-up
* Patients who received the information and did not object to participating in the study or their parents for the children

Exclusion Criteria:

* Patients passing their Motor Function Measure as part of another research protocol

Primary outcomes:
measure: Comparison scoring between items completed using conventional material or on a digital tablet.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Rééducation Fonctionnelle Pédiatrique - L'Escale (Aile A1) - Hôpital Femme Mère Enfant - GHE
city: Grenoble
country: France
facility: Centre de référence MNM Adulte Grenoble Consultation Maladies Neuromusculaires Adultes - CHU Michallon
city: Lyon
country: France
facility: Centre de référence MNM adulte Lyon Hôpital de la Croix Rousse Bâtiment P
city: Saint-Priest-en-Jarez
country: France
facility: Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie
city: Saint-Étienne
country: France
facility: Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU
Study officials:
References:
Clinical trial NCT00880958: Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity
Official title: Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Biostir, Inc.
name: MIONA Co., Ltd.
First posted: 2009-04-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
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 the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy as based on medical history and physical examination
* BMI between 25 and 30 kg/m2
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Food allergy
* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 01 of this study
* Renal or hepatic dysfunction
* Heart disease
* Under medication
* Subjects who are taking functional food designed for weight loss or serum lipid reduction

Primary outcomes:
measure: Body mass index
timeFrame: 16 weeks
Secondary outcomes:
measure: Body fat mass
timeFrame: Week -4, Week 0, Week 4, Week 12
measure: Abdominal circumference
timeFrame: Week -4, Week 0, Week 4, Week 12
measure: Visceral fat area by CT scan
timeFrame: Week 0, Week 12
measure: Intestinal flora
timeFrame: Week 0, Week 12
measure: Serum lipid profile
timeFrame: Week -4, Week 0, Week 4, Week 12
measure: Serum adiponectin and leptin levels
timeFrame: Week 0, Week 12
measure: Fasting serum glucose and HbA1c levels
timeFrame: Week -4, Week 0, Week 4, Week 12
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
References: