louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00317083: Cough Reflex and Obstructive Sleep Apnea Syndrome
Official title: Effect of Obstructive Sleep Apnea Syndrome Associated With Obesity on Cough Reflex Threshold to Citric Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Keywords: Cough Reflex
Citric acid
Obesity
Sleep apnea syndrome
Lead sponsor: Bichat Hospital
Sponsor class: OTHER
First posted: 2006-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Up to 70% of obese patients undergoing bariatric surgery have obstructive sleep apnea syndrome (OSAS). OSAS is responsible for laryngeal sensory impairment. As the afferent neural pathway involved in the initiation of cough is located in the laryngeal epithelium, cough reflex sensitivity may be decreased in obese OSAS patients. The researchers therefore conducted this study to determine the effect of OSAS associated with obesity on cough reflex sensitivity, assessed by cough reflex threshold to an inhaled irritant (citric acid).

Detailed description: Obese patients undergoing scheduled bariatric surgery underwent a cough challenge as part of their routine preoperative evaluation. Patients were classified as presenting OSAS if apnea-hypopnea index obtained from preoperative full-night polysomnography was greater than 5/hour. Cough threshold was measured with citric acid. Increasing concentrations of mouth- nebulized citric acid (2.5, 5, 10, 20, 40, 80, 160, 320 and 640 mg/mL) were delivered during inspiration until a cough was elicited. The citric acid concentration eliciting one cough (C1) was defined as the cough reflex threshold.

Eligibility criteria: Inclusion Criteria:

* Obese patient scheduled to undergo bariatric surgery

Exclusion Criteria:

* Age less than 18
* Active smoking
* Psychotropic medication
* Angiotensin-converting enzyme inhibitor or angiotensin II receptor antagonist medication
* Pregnancy
* Anesthesia or endotracheal intubation during the previous month
* Allergic rhinitis
* Upper airway or bronchopulmonary infection during the previous month
* Chronic cough
* Chronic respiratory disease
* Pharyngolaryngeal disease
* Neurological disease

Primary outcomes:
measure: To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients
Secondary outcomes:
measure: To correlate OSAS severity assessed by apnea-hypopnea index and cough reflex threshold to citric acid
Other outcomes:
Locations:
city: Paris
country: France
facility: Anesthesiology Department, Bichat Hospital
Study officials:
affiliation: Anesthesiology Department, Bichat Hospital
name: Jean Guglielminotti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen AT, Jobin V, Payne R, Beauregard J, Naor N, Kimoff RJ. Laryngeal and velopharyngeal sensory impairment in obstructive sleep apnea. Sleep. 2005 May;28(5):585-93. doi: 10.1093/sleep/28.5.585.
Clinical trial NCT02676583: Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children
Official title: Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children: Randomized Clinical Trial, Double-blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tonsillitis
Keywords: pain
tonsillectomy
tonsillar fossa
suture
tonsil fossa closure
Lead sponsor: Clinica Olfact
Sponsor class: OTHER
Collaborators: name: Universidade Estadual de Londrina
First posted: 2016-02-08
Enrollment: 131
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: Postoperative pain is the main complaint in children undergoing tonsillectomy. An inexpensive method and with few evidence in the literature on effectiveness in reducing pain is the closure of the tonsillar fossa by suture with absorbable sutures. The investigators will compare the pain after tonsillectomy between closure or not the tonsil fossa.

Study design: Prospective, randomized, double blind, and controlled. Method: Two hundred otolaryngologic outpatients with indication of bilateral tonsillectomy for repeated tonsillitis, tonsillar hypertrophy or sleep apnea between 5 and 12 years old will be enrolled from November 2015 to July 2016. The procedure will be performed by a single surgeon and similar postoperative medications will be prescribed. There will be two techniques: closure or not of the tonsillar fossa with catgut points. A questionnaire containing a Faces Pain Scale - filled 1 and 7 days after surgery- and other data - difficulty of detachment of the palatine tonsils, hemostasis technique, surgical complications, healing characteristics, day of total improvement of the pain, day of beginning of normal food intake, presence of postoperative bleeding, complications and observations raised by the patient - will be applied.


Eligibility criteria: Inclusion Criteria:

* no cognitive-intellectual changes;
* capacity to respond the questionnaire;
* able to help in the study

Exclusion Criteria:

* conducting invasive procedure for less than two months;
* history of any infection during last month;
* continuous use of any medication;
* postoperative fever;
* non-standard medication prescribed for the postoperative time

Primary outcomes:
measure: Pain
timeFrame: on post-operative procedure (1 day after surgery)
measure: Pain
timeFrame: on post-operative procedure (7 days after surgery)
Secondary outcomes:
measure: Resumption of normal diet
timeFrame: at 7 days after surgery
measure: Healing characteristics
timeFrame: at 7 days after surgery
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Clinica Olfact
state: PR
Study officials:
References:
Clinical trial NCT03734783: IL-35+Breg/Il-35 Effect on T Cell Immune in Patients With CHB
Official title: Regulate Effect of Il-35 Secreting Breg Cells on Tcells and on Diseases Progression in Patients With CHB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis b
Keywords: chronic hepatitis B
regulating B cells
T help 17 cells
Interleukin 35
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 55
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B infection

Brief summary: The investigators observed the level of IL-35 secreting B regulatory (IL-35+Bregs) cells in peripheral blood cells in patients with chronic hepatitis B, and analysed the relationship between the IL-35+Bregs level and disease stage, and Th1 and Th2 cells level.

Detailed description: Regulatory B cells (Bregs) are involved in the immune tolerance process through multiple pathways and Bregs are involved in the process of chronic HBV infection.

Here the investigators intended to investigate the regulating role and the mechanism of CD19+ IL-35+ cells on host T cell immune during chronic HBV infection by using in vitro cell sorting, B cell differentiation induction, Transwell cell co-culture system and other methods.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic hepatitis B virus infection
* 17\<age\<70
* Can read, understand and sign patients informed consent

Exclusion Criteria:

* Co-infection with HCV,HIV,HDV etc.
* Have malignancy
* Have uncontrollable extra-hepatic disease

Primary outcomes:
measure: IL-35+Bregs level
timeFrame: ENROLLED DAY
measure: IL-35+Bregs regulatory effect
timeFrame: enrolled day
Secondary outcomes:
measure: IL-35+Bregs phenotype
timeFrame: enrolled day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
Study officials:
References:
citation: Liu Y, Luo Y, Zhu T, Jiang M, Tian Z, Tang G, Liang X. Regulatory B Cells Dysregulated T Cell Function in an IL-35-Dependent Way in Patients With Chronic Hepatitis B. Front Immunol. 2021 Apr 12;12:653198. doi: 10.3389/fimmu.2021.653198. eCollection 2021.
Clinical trial NCT06100783: Depot-medroxy Progesterone Acetate Injectable Contraceptives in Lactating Women 1st Week Versus 6 Week Postpartum Initiation
Official title: Depot-medroxy Progesterone Acetate Injectable Contraceptives in Lactating Women 1st Week Versus 6 Week Postpartum Initiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications of DMPA Injectable Contraceptives
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to identify the effect of using Depot-medroxy progesterone acetate injectable contraceptives on lactating women mother and infant in 1st week versus 6th week postpartum initiation.

This study is open labeled -randomized clinical trial was used. It was conducted at woman's health hospital, Assuit University. This study applied on 120 lactating women, who divided into two equal group I (who used DMPA injectable in the 1st week postpartum) and group II (who used DMPA injectable in the 6th week postpartum). Each group included 60 lactating women). Follow up was carried out after 3 months from the first dose to determine the changes in the studied women's menstrual period, weight, breast feedings...etc.


Eligibility criteria: Inclusion Criteria:

Desire contraception for at least one year Apparently healthy participant Age 20- 40 years old Term delivery Birth weight \>2.5 kg multipara Intend to breastfeed at time of hospital discharge Those delivered normally or by caesarean section Ready to follow and need immediate contraception

Exclusion Criteria:

Maternal health problems (DM, HTN, cardiac disease, anaemia, or any other obvious problem) Any maternal complications during labour Preterm delivery IUGR

Primary outcomes:
measure: Pattern of vaginal bleeding postpartum
timeFrame: 2021 to 2023
Secondary outcomes:
measure: Duration and frequency of breast milk
timeFrame: 2021 to 2023
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Boshra Hussien Ahmed
Study officials:
References:
Clinical trial NCT05427097: Thermal Energy in the Treatment of Cervicogenic Dizziness
Official title: Thermal Energy of Helical® Adhesive Pads in the Treatment of Cervicogenic Dizziness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Cervical Pain
Keywords: Thermal
Vertigo
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2022-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, one placebo and one intervention
Primary purpose: TREATMENT

Brief summary: Cervical pain contributes to postural deviations and imbalance. Nanotechnology may be used for the treatment of neck pain by fixing to the skin small rounds silicone patches containing double spiral carbon nanotubes arranged in the form of a coil (Helical), which would then relieve dizziness caused by muscular contraction.

Detailed description: The selected patients should have neck pain arising from muscle contraction with loss of balance or instability lasting more than 90 days and normal electrooculography. Treatment consisted of placing 10 Helical patches, placebo or active, distributed as follows: two in the upper cervical area, two in the lower cervical area (near the 5th and 6th vertebrae), two in the upper trapezius muscle area (between neck and shoulder), and four in the tender point area (as reported by the patient). Using a Visual Analogue Scale (VAS) and specific questionnaires, the investigators will match pain, muscle tension and dizziness scores from Day 1 to those from Day 15 and Day 30.

Eligibility criteria: Inclusion Criteria:

* Cervicogenic Dizziness diagnosis
* Normal otoneurological examination
* Signed the informed consent form
* Neck without other radiological changes, which are not solely attributable to aging (osteophytosis, rectification, disc space reduction).

Exclusion Criteria:

* Active vestibular disease
* Traumatic neck injury
* Neurological
* Rheumatic or orthopedic diseases not attributable to aging (fractures, tumors) and/or that have surgical indication
* Somatoform diseases; cognitive limitations.

Primary outcomes:
measure: Improvement of dizziness
timeFrame: 60 days
Secondary outcomes:
measure: Improvement of cervical neck pain
timeFrame: 60 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
References:
citation: Bittar R, Alves NG, Bertoldo C, Brugnera C, Oiticica J. Efficacy of Carbon Microcoils in Relieving Cervicogenic Dizziness. Int Arch Otorhinolaryngol. 2017 Jan;21(1):4-7. doi: 10.1055/s-0036-1592418. Epub 2016 Oct 26.
Clinical trial NCT01686997: Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities
Official title: 'Effect of Long biLiopancrEatic Limb lenGth in lAparoscopic Roux-eN-Y Gastric Bypass on Weight Loss and Comorbidities in Patients With Morbid obEsity: a Prospective Randomized Control Trial'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Bariatric surgery
Roux-en-Y Gastric Bypass
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 280
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: Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.

The objective of this study is to investigate the effect of variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb results in more weight reduction.

The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.


Eligibility criteria: Inclusion Criteria:

Patient eligible for bariatric surgery according Fried guidelines

Primary Gastric bypass

* BMI 35 - 40 with a comorbidity
* or BMI \> 40

Redo- operation

* medical history: gastric sleeve/ mason / gastric band
* all BMI levels

Exclusion Criteria:

* Exclusion criteria for bariatric surgery (Fried Guidelines)
* Patients with language problems that interveins to follow medical advises
* Genetic diseases that intervens to follow medical advises
* Chronic bowel diseases
* Nephrologic (MDRD \<30) of liver diseases (AST/ALT more than twice the norm)
* Pregnancy

Primary outcomes:
measure: Weight reduction
timeFrame: 2 years
Secondary outcomes:
measure: Decrease in comorbidities
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
measure: Complications and re-operations
timeFrame: 2 years
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Rijnstate Hospital
name: F.J. Berends, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Homan J, Boerboom A, Aarts E, Dogan K, van Laarhoven C, Janssen I, Berends F. A Longer Biliopancreatic Limb in Roux-en-Y Gastric Bypass Improves Weight Loss in the First Years After Surgery: Results of a Randomized Controlled Trial. Obes Surg. 2018 Dec;28(12):3744-3755. doi: 10.1007/s11695-018-3421-7.
Clinical trial NCT06036797: Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia
Official title: Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Analgesia
Labor Pain
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural labor analgesia, and find out the optimal dose of hydromorphone.

Participants will be randomly allocated to four groups : Group 1, Group 2, Group 3 and Group 4. For those in Group 1 : they will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 2 : they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine for epidural labor analgesia.

The goal of this clinical trial is to provide a new treatment option for pregnant women in epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine in epidural labor analgesia.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status II
* a single fetus
* competent to provide informed consent

Exclusion Criteria:

* severe respiratory diseases including hypoxemia, respiratory failure and severe pneumonia
* severe circulatory diseases including acute decompensated heart failure and peripartum cardiomyopathy
* placenta previa

Primary outcomes:
measure: Visual Analogue Scale(VAS)
timeFrame: 30 minutes-1 hour
Secondary outcomes:
measure: Heart rate(HR)
timeFrame: 30 minutes-1.5 hours
measure: Mean arterial pressure(MAP)
timeFrame: 30 minutes-1.5 hours
measure: Pulse oxygen saturation
timeFrame: 30 minutes-1.5 hours
measure: Duration of analgesia
timeFrame: 30 minutes-1.5 hours
measure: The number of compressions
timeFrame: 30 minutes-1.5 hours
measure: Adverse reactions
timeFrame: 30 minutes-1.5 hours
measure: The Apgar scores
timeFrame: 1 minute and 5 minutes after birth
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Maternal and Child Health Hospital of Hubei Province
name: Na Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03292497: Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation
Official title: Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 110
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: Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking, as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic mitral regurgitation, or IMR, is normally treated by repairing or replacing the mitral valve. Currently, we don't have very strong evidence showing which patients might benefit from mitral valve repair and which might benefit from replacement, and surgeons tend to repair or replace valves based on their preference or experience. Some surgeons, including Dr. Vincent Chan, the Principal Investigator, believe that the decision to repair or replace the valve should be based on specific measurements of the mitral valve. This study will randomly assign patients to receive either the current standard of care for ischemic mitral regurgitation, which is valve repair or replacement based on the surgeon's preference, or to have their treatment decided by a set of criteria called an algorithm. This algorithm will assign patients with certain mitral valve measurements to repair, and others to replacement. Patients will be followed for 12 months after surgery, to compare whether patients whose treatment was decided by the algorithm did better than patients whose treatment was decided by surgeon preference.


Eligibility criteria: Inclusion Criteria:

* Severe ischemic mitral valve regurgitation

  * 18 years of age, and able to provide informed consent.

Exclusion Criteria:

* Mixed mitral valve pathology
* Acute ischemic mitral regurgitation

Primary outcomes:
measure: Left ventricle end-systolic volume indexed to body surface area
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Change in indexed left atrial volume
timeFrame: Up to 12 months after surgery
measure: Change in right ventricle systolic pressure
timeFrame: Up to 12 months after surgery
measure: Major adverse events
timeFrame: Up to 12 months after surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Vincent Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: