louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05144204: Evaluation of Treatment Effect of Low FODMAP Diet in Treatment of IBS Patients
Official title: Evaluation of Treatment Effect and Mechanism of Low FODMAP Diet in Treatment of Irritable Bowel Syndrome Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Low FODMAP diet
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder, affecting 15% of the population. IBS is characterized by recurrent abdominal pain/discomfort without identifiable organic lesions. The pathophysiology of IBS can be multi factors which included immune activation/inflammatory reactions, visceral hypersensitivity, gastrointestinal dysmotility, changes in gut microflora, brain-gut dysfunction and food intolerance. Many short-chain carbohydrates can induce abdominal symptoms, and these carbohydrates were called, Fermentable, Oligosaccharides, Disaccharides and Monosaccharides and Polyols (FODMAPs). Around 50- 86% of the IBS patients will have a clinically meaningful response to the low-FODMAP diet. To evaluate the efficacy of low FODMAP diet. Experimental design: Health control and patients meeting the ROME III criteria for IBS will be enrolled in this study. The basic profiles, patient characteristics, intestinal microbiota profiles and MRI images will be obtained before and after low FODMAP diet intervention.


Eligibility criteria: Inclusion Criteria:

Patients are eligible for the study if all of the following criteria are met:

1. Patients with irritable bowel syndrome as per Rome IV diagnostic criteria Symptom characteristics of IBS according to Rome III and IV criteria
2. Patients must provide witnessed written informed consent prior to any study procedures being performed
3. Patients aged between 20-65 years
4. Male or female patients

Exclusion Criteria:

* Exclusion criteria including:

  1. Unable to provide or understand written informed consent.
  2. Pregnancy.
  3. Receiving antibiotics or narcotics within 90 days prior to enrollment.
  4. Receiving new prebiotics, probiotics within 90 days prior to enrollment.
  5. Current infection.
  6. History of inflammatory bowel disease.
  7. Thyroid disease.
  8. Major psychiatric disorders, including clinical anxiety or depression and previous use of anxiolytics and antidepressants.
  9. Previous stroke, intracerebral hemorrhage, or central nervous system diseases.
  10. Malignancy.

Primary outcomes:
measure: irritable bowel syndrome Severity Scale (IBS-SS)
timeFrame: Baseline, end of study approximately 6 to 8 weeks ]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02367404: Prospective RCT on Post Prostatectomy Urine Leak
Official title: A Prospective Randomized Controlled Study Comparing the Efficacy of Pelvic Floor Muscle Training and Oral Duloxetine in the Recovery of Continence After Robotic Assisted Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Urinary Incontinence
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 240
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives:

Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.

Secondary:

* Comparison of time to achieve continence between the four arms.
* Comparison of urinary symptoms and quality of life improvement between the four arms.
* Assessment of adverse events in Duloxetine arms.

Primary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as "using no pad"or "only security pad".

Secondary outcome:

* time to achieve continence
* Quality of life tested in relation to incontinence according to Visual Analog Scale (VAS) and King's Health Questionnaire (KQH).
* Urinary symptoms measured with International Prostate Symptom Score (IPSS).

No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.

Statistical methods

* Proportion of patients who achieve continence and time to achieve continence will be compared between the four arms.
* Comparison of quality of life outcomes between the four arms
* Comparison of clinical variables that can affect the primary/secondary outcome - univariate and multivariate analysis (ITT).


Eligibility criteria: Inclusion Criteria:

1. All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer

Exclusion Criteria:

1. Prior urethral, bladder or prostate surgery
2. Pelvic radiotherapy.
3. Overactive bladder
4. Known neurological disease associated to LUTS
5. Hepatic impairment with hepatic insufficiency.
6. Severe renal impairment (creatinine clearance \< 30ml/min)
7. Hypersensitivity to duloxetine
8. Uncontrolled hypertension
9. Narrow angle glaucoma

   Post-operative criteria:
10. Post-void residual urine volume \> 100ml measured 15 days after the RARP

Primary outcomes:
measure: Urinary continence proportion
timeFrame: 6 months
Secondary outcomes:
measure: Urinary continence time
timeFrame: 6 months
measure: Urinary quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste montsouris
Study officials:
affiliation: Institute Mutualiste Montsouris
name: Rafael Sanchez-Salas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01259804: Study of Tolerance to Oral Peanut
Official title: Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peanut Allergy
Keywords: peanut
food allergy
anaphylaxis
immunotherapy
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 22
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy

Detailed description: Background Peanut allergy is severe and rarely resolves.

Objective To test the efficacy and safety of a new oral immunotherapy protocol for peanut allergy.

Method 22 peanut-allergic children will undergo oral challenge. Oral immunotherapy will be administered by gradual updosing with 2-weekly increments (8-38w) to 800mg protein (5 peanuts/day) followed by 30-weeks maintenance. Oral challenge will be repeated after 6 and 30 weeks maintenance.

Eligibility criteria: Inclusion Criteria:

* Peanut allergy defined by oral challenge

Exclusion Criteria:

* Major immunodeficiency

Primary outcomes:
measure: Pass/fail peanut challenge
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge Biomedical Campus
state: Cambridgeshire
Study officials:
affiliation: Cambridge Biomedical Campus
name: Andrew T Clark, MB BD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clark AT, Islam S, King Y, Deighton J, Anagnostou K, Ewan PW. Successful oral tolerance induction in severe peanut allergy. Allergy. 2009 Aug;64(8):1218-20. doi: 10.1111/j.1398-9995.2009.01982.x. Epub 2009 Feb 17.
citation: Santos AF, James LK, Kwok M, McKendry RT, Anagnostou K, Clark AT, Lack G. Peanut oral immunotherapy induces blocking antibodies but does not change the functional characteristics of peanut-specific IgE. J Allergy Clin Immunol. 2020 Jan;145(1):440-443.e5. doi: 10.1016/j.jaci.2019.09.005. Epub 2019 Oct 30. No abstract available.
citation: Anagnostou K, Clark A, King Y, Islam S, Deighton J, Ewan P. Efficacy and safety of high-dose peanut oral immunotherapy with factors predicting outcome. Clin Exp Allergy. 2011 Sep;41(9):1273-81. doi: 10.1111/j.1365-2222.2011.03699.x. Epub 2011 Mar 18.
Clinical trial NCT03525704: Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
Official title: Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Complication
Debris in Post Lens Tear Reservoir
Keywords: Fogging
Insertion Solutions
RGP
Scleral
Contact Lenses
Lead sponsor: Contamac Ltd
Sponsor class: INDUSTRY
Collaborators: name: Andre Vision and Device Research
name: The Contact Lens Center at Optique
name: Premiere Vision Group
name: Havasu Eye Center
First posted: 2018-05-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: One-month, approximately 36 subjects enrolled (\~12/site), randomized, double-masked crossover trial.
Primary purpose: TREATMENT

Brief summary: Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir

Detailed description: One-month, approximately 36 subjects enrolled (\~12/site), randomized, double-masked crossover trial.

Existing scleral rigid gas permeable (RGP) contact lens wearing subjects are randomly assigned (block) to different arms of the trial and receive different saline solutions for use sequentially for 2-week periods. The subjects will continue to wear their existing scleral GP lenses if lens fit is acceptable following an initial evaluation. Subjects will agree to complete a survey administered daily (via email) that will address contact lens wear time and subjective symptoms.

Eligibility criteria: Inclusion Criteria:•

* Daily wear large diameter (scleral) rigid gas permeable contact lens wearers in design with acceptable fit
* 18 years old or above.
* Agree to and sign Informed Consent.
* Correctable to at least 20/40 distance visual acuity in each eye.
* Presence of debris or "fogging" in post lens tear film reservoir (PLTR).

Exclusion Criteria:

* Extended wear contact lens wearers
* Require concurrent ocular medication.
* Grade 2 or more slit lamp findings (does not include fogging assessment).
* Eye injury or surgery within twelve weeks immediately prior to enrolment for this trial.
* Currently enrolled in an ophthalmic clinical trial.
* Pregnant or lactating
* Evidence of active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.

Primary outcomes:
measure: Patient Subjective Symptoms and Wear Time Survey
timeFrame: 1 Month
Secondary outcomes:
measure: Biomicroscopy Findings
timeFrame: 1 Month
measure: Visual Acuity
timeFrame: 1 Month
Other outcomes:
Locations:
city: West Linn
country: United States
facility: Andre Vision and Device Research
state: Oregon
Study officials:
affiliation: AVD Research
name: Bret Andre, MS, ABOe
role: STUDY_DIRECTOR
References:
Clinical trial NCT04967001: 68Ga-PSMA PET in the Prostate Cancer
Official title: Efficacy of 68Ga PSMA PET in the Diagnosis of Lymph Node Metastasis in Patients With Prostate Cancer: a Single Center Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostatic Neoplasms
Metastases
PSMA-PET
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 300
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Efficacy of 68Ga PSMA PET / CT in the diagnosis of lymph node metastasis in patients with prostate cancer: a single center prospective randomized controlled trial.

To identify and compare the diagnostic efficacy of 68Ga-PSMA PET/CT and mpMRI for lymph nodes in patients with newly diagnosed prostate cancer.


Eligibility criteria: Inclusion Criteria:

* High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND
* ISUP Gleason grade group ≥ 4

Exclusion Criteria:

* Prior history of any other cancer in the last 5 years excluding basal cell carcinoma Proven metastases in bones or other distant metastases
* General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
* Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
* Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.

Primary outcomes:
measure: Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shannxi
Study officials:
References:
Clinical trial NCT03314701: Mechanical Ventilation in Multiple Fracture Ribs
Official title: Biphasic Intermittent Positive Airway Pressure (BIPAP) Versus Airway Pressure Release Ventilation (APRV) in Patients With Multiple Fracture Ribs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation
Keywords: Resting Energy Expenditure
Multiple Fracture Ribs
Ventilation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chest trauma is the most common injury in the emergency trauma and rib fractures is the most common trauma in chest trauma. Severe rib fractures can cause paradoxical respiration and mediastinal swing, which has large effects on respiratory and circulatory system, result in acute respiratory distress syndrome. Mechanical ventilation can significantly improve the hypoxemia of the patients, correct paradoxical respiration, and treat the pulmonary atelectasis

Detailed description: To compare between Biphasic Intermittent Positive Airway Pressure (BIPAP) ventilation and Airway Pressure Release Ventilation (APRV) mode in patients with multiple fracture ribs as regard:

* Resting Energy Expenditure
* Oxygenation
* Stability of Physiological Status as cardiovascular activity
* cardiac output
* arterial blood gas measurement including \[ blood PH, arterial oxygen tension, arterial carbon dioxide tension, bicarbonate level and base deficit\]
* lung and chest compliance
* Length of intensive care unit stay.
* The ICU mortality rate.
* The development of major complications as nosocomial infection (hospital acquired pneumonia and ventilator associated pneumonia), major atelectasis and pneumothorax.

Eligibility criteria: Inclusion Criteria:

• Isolated chest trauma patient with Multiple fracture ribs patients \[ \>3 ribs\] who will be admitted to the surgical ICU for ventilatory support and will be expected to continue for 2 days or longer

Exclusion Criteria:

* Age \< 18 years old.
* Pregnant patient.
* Patient who will require fraction of inspired oxygen more than 0.6.
* Air leak from the chest tube.
* Patient with body temperature \> 39 Celsius.
* Acute hepatitis or severe liver disease (Child-Pugh class C).
* Left ventricular ejection fraction less than 30%.
* Heart rate less than 50 beats/min.
* Second or third-degree heart block.
* Systolic pressure \< 90 mmHg despite of infusion of 2 vasopressors.
* Patients with known endocrine dysfunction.
* Patient with hypothermia
* Patient on Positive end expiratory pressure more than 14 cmH2o

Primary outcomes:
measure: Duration of mechanical ventilation
timeFrame: within one month
Secondary outcomes:
measure: Resting Energy Expenditure
timeFrame: within the first 48 hours
measure: Physiological dead space
timeFrame: within the first 48 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT05691101: Comparison of Using CIBPB With or Without IV-PCA After Arthroscopic Rotator Cuff Repair
Official title: Comparison of Quality of Recovery in Patients Using Continuous Brachial Plexus Block With or Without Intravenous Patient-Controlled Analgesia After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia, Patient-Controlled
Brachial Plexus Block
Arthroscopic Rotator Cuff Repair
Keywords: Postoperative pain
IV PCA
Continuous interscalene brachial plexus block
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to compare the continuous brachial plexus block with or without intravenous patient controlled analgesia(PCA) in patients undergoing arthroscopic rotator cuff repair, in terms of quality of recovery, postoperative pain score, and adverse event.

Detailed description: The Bellomic® M silicone balloon infuser, dual continuous petite type (cebika, Uiwang-si, Gyeonggi-do, Republic of Korea) has 2-channel infusion elastomeric pump with two balloon chambers.

This structure allows the simultaneous use of continuous nerve block and intravenous PCA. In addition, intravenous PCA can be continued even when continuous nerve block is discontinued due to discomfort such as numbness, tingling sense or motor block.

This is expected to contribute to the patient satisfaction and quality of recovery.

Eligibility criteria: Inclusion Criteria:

* Having arthroscopic rotator cuff repair
* American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

* Contraindication to interscalene brachial plexus block
* Contraindication to fentanyl

Primary outcomes:
measure: Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery)
timeFrame: Postoperative 24 hour
Secondary outcomes:
measure: Pain score
timeFrame: Postoperative 6, 24, 48 hour
measure: Cumulative consumption of PCA and rescue analgesics
timeFrame: Postoperative 24, 48 hour
measure: Occurrence of adverse effects
timeFrame: Postoperative 24, 48 hour
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul national univercity Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: JI IN PARK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04219501: Ventricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology
Official title: Saving Time During Ventricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Premature Ventricular Contraction
Ventricular Tachycardia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Researchers are trying to determine if the use of software called VIVO, made by Catheter Precision, Inc. can shorten the length of time it takes to perform an ablation procedure for either premature ventricular contractions (PVCs) and ventricular tachycardia (VT).


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Structurally normal heart
* Cardiac MRI/CT as part of standard of care
* Diagnosed with premature ventricular contractions or ventricular tachycardia and scheduled to undergo an ablation to treat these conditions

Exclusion Criteria:

* Less than 18 years of age
* Structurally abnormal heart

Primary outcomes:
measure: Standard of care invasive electroanatomical mapping system duration
timeFrame: Baseline
measure: VIVO non-invasive mapping system duration
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Fred Kusumoto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02844101: Assess Whether Knowledge by the Younger of the Function of the Accelerometer Determines Its Amount of Physical Activity
Official title: Assess Whether Knowledge by the Children and Adolescents of the Function of the Accelerometer Determines Its Amount of Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded and the non-blinded group. The blinded subjects will be informed that we were testing the reliability of a new device for body posture assessment and these youngsters will did not receive any information with regards to physical activity. Conversely, the non-blinded subjects were informed that the device was an accelerometer that assessed physical activity levels and patterns. Participants will be instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall duration and the duration relative to the quality of the physical activity patterns (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group during the 4-day monitoring, then compared between the two groups using the Student's t test.


Eligibility criteria: Inclusion Criteria:

* 10-18 years old adolescent
* normal clinical examination,
* normal nutritional status at baseline defined by a weight / height ratio between - 2 and + 2 DS DS

Exclusion Criteria:

* abnormal ECG
* known chronic disease
* acute infection dating back at least a week.

Primary outcomes:
measure: physical activity by GT3X Actigraph accelerometer.
timeFrame: during 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandre - CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Frédéric Gottrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanhelst J, Vidal F, Drumez E, Beghin L, Baudelet JB, Coopman S, Gottrand F. Comparison and validation of accelerometer wear time and non-wear time algorithms for assessing physical activity levels in children and adolescents. BMC Med Res Methodol. 2019 Apr 2;19(1):72. doi: 10.1186/s12874-019-0712-1.
citation: Vanhelst J, Beghin L, Drumez E, Coopman S, Gottrand F. Awareness of wearing an accelerometer does not affect physical activity in youth. BMC Med Res Methodol. 2017 Jul 11;17(1):99. doi: 10.1186/s12874-017-0378-5.