louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02254629: The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients
Official title: The Effects of Laxative-probiotic Sequential Treatment on the Symptoms and Fecal Microbiota in the IBS Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Keywords: Fecal microflora
IBS
Sequential treatment
Probiotic
Laxative
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 56
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 laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the fecal microbiota of the patients in a more robust manner .

Detailed description: Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert therapeutic effects on IBS patients. The laxatives could also alter the gut microflora significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and the composition of fecal microbiota in the IBS patients in a more robust manner .

Eligibility criteria: Inclusion Criteria:

* the presence of Rome III criteria for IBS ;
* Patients scheduled for colonoscopy examination or having negative screening examinations
* Aged between 18 and 65 years old

Exclusion Criteria:

* Antibiotic, probiotic or laxative usage within 4 weeks.
* organic gastrointestinal diseases
* Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
* pregnancy or lactation.
* previous major or complicated abdominal surgery.
* severe endometriosis and dementia

Primary outcomes:
measure: Subject's Global Assessment of Relief
timeFrame: 8 months
Secondary outcomes:
measure: The changes of symptom scores
timeFrame: 8 months
measure: IBS patients'quality of life
timeFrame: 8 months
measure: Composition of Microorganisms in stool
timeFrame: 8 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, MD.PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li M, Xu R, Li YQ. Sequential laxative-probiotic usage for treatment of irritable bowel syndrome: a novel method inspired by mathematical modelling of the microbiome. Sci Rep. 2020 Nov 9;10(1):19291. doi: 10.1038/s41598-020-75225-z.
Clinical trial NCT06760429: Comparative Evaluation of Pectoral Nerve Block Type II Versus Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Mastectomy for Postoperative Analgesia: a Randomized, Controlled Trial
Official title: Comparative Evaluation of Pectoral Nerve Block Type II Versus Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Mastectomy for Postoperative Analgesia: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Lead sponsor: Inner Mongolia Baogang Hospital
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to investigate the analgesic effects of Pectoral Nerve Block Type II and Rhomboid Intercostal and Subserratus Plane Block after radical mastectomy for breast cancer.This prospective, double-blind, randomized controlled trial recruited 67 female patients with complete follow-up records who underwent unilateral modified radical mastectomy (MRM) at Inner Mongolia Baotou Steel Hospital from December 1, 2023 to December 1, 2024. Subjects were assigned to the observation group and the control group at a 1:1 ratio using a random number table. Among them, 30 patients who received pectoral nerve block (PECS II) for analgesia were included in the observation group, and 30 patients who received Rhomboid Intercostal and Subserratus (RISS) block for analgesia were included in the control group. The primary outcomes included the 40-item Quality of Recovery (QoR-40) scores at 6 hours and 24 hours after surgery, and the Visual Analogue Scale (VAS) pain scores in the Post-Anesthesia Care Unit (PACU), as well as at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.T he secondary outcomes included the consumption of sufentanil in patient-controlled intravenous analgesia (PCIA) after surgery, the number of effective compressions, the use of remifentanil during the operation, the number of additional analgesic administrations, the sleep quality on the first day after surgery, and the incidences of block-related complications and postoperative adverse events.


Eligibility criteria: Inclusion Criteria:

* patients met the diagnostic criteria of breast cancer;
* tolerance to surgery and anesthesia

Exclusion Criteria:

* Patients with severe systemic diseases or anesthesia problems: Such patients were excluded to ensure safety and avoid the occurrence of irrelevant complications;
* Those with coagulation disorders;
* Patients with puncture contraindications or infections;
* Those allergic to local anesthetics;
* Those who refused to sign the informed consent form;
* Patients with cognitive or communication problems

Primary outcomes:
measure: visual analog scale
timeFrame: From PACU entry to 48 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Baotou
country: China
facility: Inner Mongolia Baogang Hospital
state: Inner Mongolia
Study officials:
References:
Clinical trial NCT02856529: Effects of Basic Infection Control Skills License on Knowledge and Practice of Health Care Workers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection Control Training
Lead sponsor: Madinah Saudi Board Community Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Madinah directorate - Ministry of Health
First posted: 2016-08-05
Enrollment: 66
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Considering the importance of infection control practices, Madinah Public Health Department launched a new license program for healthcare workers, the Basic Infection Control Skills License program (BICSL). BICSL has been launched to train healthcare workers all over the region in a scientific standardized way.

To assess BICSL effectiveness, a non-randomized control study will be conducted in two of the general hospitals in Madinah. An electronic bilingual self-administrated valid and reliable questionnaire will be used to evaluate the workers knowledge and practices before and after three and six months of the intervention. The knowledge and practice answers were scored and the scores were categorized to facilitate the comparison. A BICSL certified trainer will be conducting the intervention, a one to one training session. A SPSS program will be used to analyze the data. Administrative and ethical approval was obtained from Madinah health authority. The participants will complete an electronic consent before they fill the questionnaire. Confidentiality and privacy as well as freedom to participate or not will be insured to all participants. This study will assess the license effectiveness in improve knowledge and compliance.


Eligibility criteria: Inclusion Criteria:

1. Working in the chosen hospitals.
2. Health care worker (Physician, nurse or technician) of any gender, age, or experience.

Exclusion Criteria:

1. Refuse to participate in the study.
2. Have BICSL certificate before the study implemented.
3. On leave during study period.

Primary outcomes:
measure: Self administered knowledge
timeFrame: 3 months
measure: Self administered practice
timeFrame: 3 months
Secondary outcomes:
measure: Self administered knowledge
timeFrame: 3 months
measure: Self administred practices
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06230029: Music's Impact on Preoperative Anxiety: Heart Rate Variability Study During Cataract Surgery
Official title: Impact of Music on Preoperative Anxiety Level Measured by Heart Rate Variability During Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Cataract Surgery
Heart Rate Variability
Lead sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this Randomized Controlled Trial is to evaluate heart rate variability (HRV)before and after listening to music in patients scheduled for cataract surgery under topical anesthesia, compared to patients who do not listen to music. Our hypothesis is that the anxious population with a low HRV benefits from an anxiolytic effect of music to increase HRV levels.


Eligibility criteria: Inclusion Criteria:

* information and consent of the patient,
* age greater than or equal to 18 years,
* affiliation to a social security system,
* benefiting from non-emergency ambulatory cataract surgery under topical anesthesia
* not being under legal protection.

Exclusion Criteria:

* Refusal to participate,
* language barriers that are incompatible with a reliable assessment
* use of beta-blockers, including eye drops
* use of adrenergic, antiadrenergic, cholinergic and anticholinergic drugs
* use of psychotropic drugs, anxiolytics.

Primary outcomes:
measure: Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia.
timeFrame: Baseline vs pre-surgery
Secondary outcomes:
measure: Evaluation of the impact of music on the incidence of surgical complications
timeFrame: Immediately after the surgery
measure: Measurement of subjective anxiety level
timeFrame: Before surgery
measure: Measurement of subjective anxiety level
timeFrame: Before surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin/Port-Royal
city: Cagliari
country: Italy
facility: Eye Clinic, Department of Surgical Sciences, University of Cagliari
city: Catanzaro
country: Italy
facility: University of Catanzaro
Study officials:
References:
Clinical trial NCT05711329: Comparison of Methodology Proposed by the SFAR for the Detection by Videoconference of Obstructive Sleep Apnea.
Official title: The Aim of This Study is to Determine the Accuracy of the Self-reported Parameters (Compared to Measurement Performed by the Physician) and the Influence of OSA Screening Scores.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population to validate the method proposed by the SFAR to detect OSA patients via videoconference.

Brief summary: The SFAR (French society of anesthesiology and ICU) proposed a method to detect OSA (Obstructive Sleep Apnea) patients via videoconference. The aim of this study is to compare the result of this method with the results of polysomnography (PSG) which remains the gold standard in the detection of OSA patients.

Detailed description: The SFAR (French society of anesthesiology and ICU) proposed a method to detect OSA (Obstructive Sleep Apnea) patients via videoconference. The aim of this study is to compare the result of this method with the results of polysomnography (PSG) which remains the gold standard in the detection of OSA patients.

Other methods, such as a predictive score, also exist. The accuracy of the French method compared to PSG and the predictive scores is to be determined.

Eligibility criteria: Inclusion Criteria:

* All patients admitted in the Clinique Saint-Luc of Bouge for a polysomnography

Exclusion Criteria:

* Patient's refusal

Primary outcomes:
measure: Validation of the method proposed by the SFAR by comparison with results of polysomnography.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Astes
name: Eric Deflandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750529: Alzheimer and Sleep
Official title: Effects of Galantamine and Donépézil on the Amount and the Quality oh the Sleep in Patients Suffering From Alzheimer Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: sleep
Alzheimer
old patients
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Farmaceutica Ltda.
First posted: 2008-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without Alzheimer's medication.

Detailed description: Feasibility study, open, randomized, controlled, cross-over study in 65 years old patients.

Eligibility criteria: Inclusion Criteria:

* 65 and over years old
* Patients suffering from Alzheimer disease
* Patient living with someone at home
* Written consent given

Exclusion Criteria:

* Galantamine or Donepezil hypersensibility
* Patient living alone and in a medicalized structure
* Concomitant medication
* Chronical diseases

Primary outcomes:
measure: Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil
timeFrame: administration of galantamine or donépézil
Secondary outcomes:
measure: Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep
timeFrame: during the iatrogenic modifications
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Clermont-Ferrand
country: France
facility: CPC-CIC
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Dubray Claude, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06318429: Effect of Stretching Exercises Applied to Diabetes Patients Physiological Parameters
Official title: Evaluation of the Effect of Stretching Exercises Applied to Diabetes Patients on Physiological Parameters and Compliance to Treatment: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes
exercise
blood sugar
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will be carried out as a pretest-posttest randomized controlled study to determine the effect of stretching exercises performed 2 days a week for 12 weeks for one hour each session on physiological parameters and treatment compliance in individuals with diabetes.

Detailed description: This research will be carried out as a pretest-posttest randomized controlled study to determine the effect of stretching exercises performed 2 days a week for 12 weeks for one hour each session on physiological parameters and treatment compliance in individuals with diabetes.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Those who have been diagnosed with diabetes and have been on the same diabetes treatment for at least three months
3. Non-pregnant
4. Those who agreed to participate in the research
5. Those without any physical exercise disability

Exclusion Criteria:

1. Illiterate
2. Persons with severe mental disorders
3. Those who do not wish to answer the survey questions
4. Those who do not agree to participate in the research

Primary outcomes:
measure: blood sugar
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of İstanbul-cerrahpaşa (IUC)
Study officials:
References:
Clinical trial NCT00608829: GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta
Official title: Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aortic Aneurysm, Thoracic
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.


Eligibility criteria: Inclusion Criteria:

1. Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair

   * Fusiform (≥50 mm), or
   * Saccular (no diameter criteria)
2. All proximal and/or all distal landing zone inner diameters between 37-42 mm

   * Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications
3. Proximal and distal landing zone length greater than 2.0 cm

   * Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
4. Life expectancy \> 2 years
5. Subject is open surgical candidate defined as:

   * Able to tolerate thoracotomy
   * American Society of Anesthesiologists class I-IV (class V excluded)
   * New York Heart Association class I-III or not applicable (class IV excluded)
6. Male or infertile female
7. Age greater than 21 years
8. Able to comply with study protocol requirements, including follow-up

Exclusion Criteria:

1. Mycotic aneurysm
2. Hemodynamically unstable aneurysm rupture
3. Aortic dissection
4. Planned occlusion of left carotid or celiac arteries
5. Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
6. Myocardial infarction or stroke within 6 weeks of treatment
7. Pre-treatment creatinine \> 2.0 mg/dL
8. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
9. Participation in another drug or device study within 1 year of treatment
10. History of drug abuse within 6 months of treatment

Primary outcomes:
measure: Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Michel Makaroun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06075329: Dementia Caregivers and Contemplative Practice: A Pilot Study
Official title: Dementia Caregivers and Contemplative Practice: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the contemplative practice is feasible and acceptable among informal dementia caregivers population at all stages.

Detailed description: It will also examine the benefits of this intervention and compare the outcomes between two groups (intervention and wait-list control).

Eligibility criteria: Inclusion Criteria:

* Dementia Family Caregivers
* At least cared for dementia care receipient more than 6 months

Exclusion Criteria:

* If they have meditated less than 2 months ago
* Cognitive or language barrier that would make it difficult to understand and sign the informed consent

Primary outcomes:
measure: Change in Loneliness
timeFrame: baseline, at 10 days and 21 days of Matribodh Sambodh Dhyaan practice (meditation), and at 30 days and 60 days follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
affiliation: University of Nevada, Las Vegas
name: Nirmala Lekhak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03874429: Efficacy of T2259 in DED
Official title: Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 101
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: The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.


Eligibility criteria: Main inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old
* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection

Main exclusion Criteria:

* Far best-corrected visual acuity≤2/10
* Severe Blepharitis

Primary outcomes:
measure: Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)
timeFrame: Baseline and Day 35
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: C.H.N.O des XV-XX
Study officials:
References: