louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04120025: Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients
Official title: Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Keywords: Reflux
Heartburn
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 192
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: Researchers are trying to determine if abdominal breathing exercises can reduce symptoms associated with GERD (Gastroesophageal reflux disease).

Detailed description: Much like the pelvic floor controls urinary incontinence the "abdominal roof" made of the diaphragm appears to have the ability to control reflux. Other studies have had positive results but from extensive training of outpatients. Our population comes from ambulatory outpatients from family medicine at MCJ. After consent they fill out a reflux disease questionnaire (RDQ) a valid instrument for measuring symptoms of reflux. Subjects are educated on the basic concept of the study and then instructed in isolated diaphragm contraction breathing. once they are proficient they are asked to continue this program 3 x 10 repetitions, 3 times per day supplemented by 10 more repetitions after each meal to reduce post prandial symptoms.

Follow up is done at 1, 3 and 6 months and includes reassessment via the RDQ and an assessment of estimated volume of exercise compliance.

Eligibility criteria: Inclusion Criteria:

* Adults with complaints of GERD, reflux, and/or heartburn symptoms

Exclusion Criteria:

* None

Primary outcomes:
measure: Reflux Disease Questionnaire (RDQ)
timeFrame: Baseline, 1 month, 3 month, 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Christopher J Yelvington, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04933825: A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)
Official title: An Exploratory,Open-label,and Single Center Study to Evaluate the Safety and Efficacy of ET-02 in Patients With Relapsed or Refractory B-cell Malignancies(NHL/ALL).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relapsed or Refractory B-cell Malignancy(NHL/ALL)
Lead sponsor: EdiGene (GuangZhou) Inc.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Henan University of Science and Technology
First posted: 2021-06-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.


Eligibility criteria: Inclusion Criteria:

1. Patients volunteer to participate in the study and sign the ICF;
2. Male or female aged≥18 years old；
3. Patient with relapsed or refractory CD19 positive B-ALL orNHL，as evidenced by 2 or more lines of prior therapy ;
4. Estimated life expectancy≥12 weeks ;
5. ECOG performance status ≤1;
6. Adequate organ function.

Exclusion Criteria:

1. Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy；
2. History of central nervous system (CNS) involvement by malignancy；
3. Women who are pregnant or breastfeeding；
4. Any situations that may increase the risk of patients or interfere with the results of study，which judged by investigator.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: up to 2 years after lymphodepleting chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: •The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
Study officials:
References:
Clinical trial NCT03284125: Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis
Official title: Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Facial Paralysis
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients affected by facial paralysis and treated by lenthening temporalis myoplasty

Brief summary: The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.

This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .


Eligibility criteria: Inclusion Criteria:

* Chronic peripheral facial paralysis
* Freyss score inferior at 15
* Benefiting of a lengthening temporalis myoplasty

Exclusion Criteria:

* Malformative syndrome
* Other swallowing trouble
* Psychiatric trouble
* Opposed at this study

Primary outcomes:
measure: Change from baseline lips pressure at 6 months
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Drooling Severity and Frequency Scale (DSFS)
timeFrame: Baseline, 3 and 6 months
measure: Visual scale of food residue
timeFrame: Baseline, 3 and 6 months
measure: Dysphagia handicap index (DHI)
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Tours
country: France
facility: Service de chirurgie maxillo-faciale, CHRU de TOURS
Study officials:
affiliation: University Hospital, Tours
name: Boris LAURE, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205825: Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology
Official title: Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication of Surgical Procedure
Keywords: Nursing
Patient Safety
Checklist
Cardiology
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The hypothesis is that patients undergoing cardiac catheterization, in which the New Safety Checklist has been used, have fewer perioperative complications compared to patients in which the habitual practice has been used.

Detailed description: The aim of this study is to develop a New Safety Checklist in perioperative patients undergoing cardiac catheterization in interventional cardiology units and assess it impact on the incidence of perioperative complications compared to habitual practice.

The study will consist in two phases; the first phase: development of the New Safety Checklist, and the second phase will be a multicenter randomized clinical trial, a parallel two-arm corresponding to the use of the New Safety Checklist compared to the habitual practice in all patients undergoing cardiac catheterization in interventional cardiology units, according to the inclusion criteria..

The expected number of patients in this trial will be 6000. The principal outcome of this study will be: the incidence of perioperative complications. The secondary outcomes will be: socio-demographic data, clinical patient data and procedure type data. Data collection will be done through reviewing clinical history.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years) undergoing cardiological intervention in hemodynamic units and interventionist cardiology.
* Patients who accept to participate in the study.

Exclusion Criteria:

* Patients undergoing urgent procedure.
* Patients requiring ventilatory support or in a situation of hemodynamic instability.
* Patients with cognitive impairment, mental disability or other serious difficulty in communication.
* Patients with insufficient fluidity of the main languages.

Primary outcomes:
measure: INCIDENCE of PERIOPERATIVE COMPLICATIONS
timeFrame: from the discharge or up to 24 hours post-procedure
Secondary outcomes:
measure: Socio-demographic data
timeFrame: from the discharge or up to 24 hours post-procedure
measure: Clinical data
timeFrame: from the discharge or up to 24 hours post-procedure
measure: Procedure data
timeFrame: from the discharge or up to 24 hours post-procedure
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: FGS Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT05562622: Assessment of DOT Spectacles in Chinese Children
Official title: Clinical Assessment of DOT Spectacle Lenses in Chinese Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Juvenile Myopia
Myopia
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 195
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.


Eligibility criteria: Inclusion Criteria:

1. Children 6-13 years of age
2. SER error between -0.75D and -5.00D
3. Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear

Exclusion Criteria:

1. Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K)
2. Astigmatism worse than -1.50 DC (by manifest refraction) in either eye
3. Anisometropia (SER manifest refraction) greater than 1.00 D

Primary outcomes:
measure: Axial length
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Aier Eye Hospital
city: Chengdu
country: China
facility: West China Hospital
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
city: Shanghai
country: China
facility: Fudan University EENT
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
References:
Clinical trial NCT03827122: Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study
Official title: Botulinum Toxin A Injectable Solution in the Management of Bruxism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nocturnal Bruxism
Keywords: Bruxism
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group with bruxism they will be injected in masster muscles bilaterally
Primary purpose: TREATMENT

Brief summary: A Clinical Trial Study to investigate the potential performance of BTXA on masseter muscle on patient with nocturnal bruxism and to check the pain scale and share this clinical experience.

Detailed description: Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally participated in this study. The patients age 18-60 years. According to the diagnostic grading system of bruxism all subjects will have an assessment including a bruxism questionnaire (i.e., oral history taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism signs and symptoms.

Eligibility criteria: Inclusion Criteria:

1. Moderate to severe pain in relation to the masseter muscles and TMJ area related to bruxism during clinical examination.
2. Aged 20-60 patients.
3. Tooth-grinding sounds corroborated by family members or caregivers.
4. Cases where bruxism resulted in occlusal surface attrition of posterior teeth

Exclusion Criteria:

1. pain in the orofacial region,
2. insomnia,
3. known botulinum toxin allergy,
4. pregnancy,
5. neuromuscular disease,
6. bleeding disorders,
7. antibiotic therapy,
8. pulmonary disease that produced coughing during sleep,
9. infectious skin lesion at the site of the injection.

Primary outcomes:
measure: Pain reduction after botox injection subjective
timeFrame: Change in clenching after 2,8,16,48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Elm University
Study officials:
affiliation: Riyadh Colleges of Dentistry and Pharmacy
name: Baraa abdulrahman, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644722: Out-of-Hospital Intubation With Metal Single Use Laryngoscope Blades
Official title: Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Arrest
Coma
Major Trauma
Respiratory Distress
Shock
Keywords: Intubation
Out-of-hospital
Laryngoscope
Blades
Emergency
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
Collaborators: name: SFMU
First posted: 2008-03-27
Enrollment: 800
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: New single use laryngoscope metal blades are available for intubation. This type of blade is safer than the reusable ones concerning the interhuman cross infection risk. No clinical studies have compared the two types of blades in the emergency context. The primary aim of this study is to demonstrate that single use blades are as efficient as the reusable ones concerning intubation conditions.

Detailed description: All adult patients requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.

Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

Eligibility criteria: Inclusion Criteria:

* All adult patients requiring out-of-hospital intubation

Exclusion Criteria:

* Patient under 18 years old
* Patients with criteria predictive of impossible intubation under direct laryngoscopy

Primary outcomes:
measure: Intubation success rate during at the first laryngoscopy
timeFrame: 10 min
Secondary outcomes:
measure: glottis exposure assessed by Cormack and Lehane classification
timeFrame: 1 day
measure: difficult intubation rate assessed by the Intubation Difficult Score (IDS)
timeFrame: 1 day
measure: the need for alternative airway techniques and the immediate post intubation complications rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Creteil
country: France
facility: Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP
state: Ile de France
Study officials:
affiliation: Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR
name: XAVIER COMBES, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02858622: Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control
Official title: Unilateral Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: pediatric
renal transplant
pain
dual TAB
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Alleviating pain in children undergoing renal transplant is extremely challenging. Large incisions as those of renal transplant (Gibson's incision) require special techniques of pain control that don't affect hemodynamics or renal function. Since the transplant incision doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior abdominal wall together with the underlying parietal peritoneum.


Eligibility criteria: Inclusion Criteria:

* 3-16 years
* end stage renal disease
* no known allergy to bupivacaine
* both sexes

Exclusion Criteria:

* known allergy to bupivacaine

Primary outcomes:
measure: total dose of rescue analgesia
timeFrame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
Secondary outcomes:
measure: pain scoring system (objective behavioural pain score)
timeFrame: from the time of transfer to the nephrology ICU, every hour for the first 24 hours postoperative
measure: Intraoperative blood pressure
timeFrame: from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
measure: postoperative blood pressure
timeFrame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
measure: postoperative heart rate
timeFrame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
measure: intraoperative heart rate
timeFrame: from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Sherif M Soaida, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02468622: Transcriptomic and Biochemical Changes During a Migraine Attack
Official title: Transcriptomic and Biochemical Changes During Spontaneous Attacks of Migraine With Aura and Migraine Without Aura
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 patients with migraine without aura and 15 paitients with migraine with aura

Brief summary: Despite the fact that migraine is a common disorder, the pathogenesis is still not fully elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous migraine-attacks will enhance our understanding and may point to new targets for drug development.

Detailed description: Migraine is a common neurological disorder affecting approx. 16 % of the European population. Despite the fact that migraine is a common disorder, the pathogenesis is still not sufficiently known.

Studying transcriptomic and biochemical changes during spontaneous migraine-attacks will greatly enhance our understanding of migraine mechanisms and may point to new targets for drug development.

Two blood samples (one for RNA analysis and one for biochemical analysis) are taken on minimum 15 patient with migraine with aura and 15 patients with migraine without aura when they experience a spontaneous migraine attack. A second sample is taken 2 hours after treatment with subcutaneous sumatriptan. Another two blood samples are taken when the patient has been migraine free for at least 5 days and had no other headache for at least 24 hours. A fourth set of blood samples are collected after a cold pressor test.

Eligibility criteria: Inclusion Criteria:

* Migraine patients who meet IHS criteria for migraine with or without aura of both sexes,
* 18-70 years,
* 45-95 kg.

Exclusion Criteria:

* any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week),
* serious somatic or psychiatric disease,
* pregnancy,
* and intake of daily medication (except oral contraceptives).

Primary outcomes:
measure: Transcriptomic changes
timeFrame: 2 year
measure: Changes in CGRP levels during a migraine attack (CGRP1-37, CGRP1-17, CGRP18-37, CGRP1-26, CGRP27-37)
timeFrame: 2 year
measure: Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 )
timeFrame: 2 years
measure: Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP
timeFrame: 2 years
measure: Changes in Metabolomics
timeFrame: 3 years
measure: Changes in Proteomics
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Emma Katrine Hansen
state: Glostrup
Study officials:
affiliation: Danish Headache Center
name: Emma Katrine Hansen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: