louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03219788: Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries
Official title: The Recovery Profile of Different Doses of Remifentanil After Desflurane Inhalational Anesthesia for Bariatric Surgeries: Two Centers Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anesthesia Emergence
Keywords: emergence
remifentanil
recovery
desflurene
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 120
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: The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014 all over the world. Obesity results in anatomical, physiological and pharmacological changes which represent a challenge for every anesthetist. Difficult airway increases by 30% with obesity and so awake extubation are the preferred technique. Coughing can be alleviated by opioid receptors which play a role in the cough reflex. Remifentanil may be useful as an ultra-short acting opioid and its effect swiftly and predictably disappears after cessation. An emergence cough is attenuated by remifentanil administered via continuous infusion (TCI), and the expected effective effect-site concentrations investigated have ranged from 1.5 to 2.5 ng.ml/L.

Detailed description: The investigators designed this study to examine the effect of different small doses of Remifentanil on the incidence of cough reflex during emergence from anesthesia in obese patients undergoing bariatric surgery. The investigators will study if these small doses will delay the recovery of the patient or not. The other expected side effects will be observed eg. Respiratory depression. Time to the first painkiller required will be registered

Eligibility criteria: Inclusion Criteria:

1. Age≥ 18 years
2. Subject has signed informed consent for bariatric laparoscopic surgery.
3. Subject must be ASA I or ASA II according to the American Society of Anesthetists classification.

Exclusion Criteria:

1. Age \< 18 years.
2. Smoking patient.
3. Hypertension.
4. Bronchial asthma.
5. Obstructive sleep apnea syndrome.

Primary outcomes:
measure: Changes in hemodynamic
timeFrame: within the first 24 hours
measure: antitussive effect
timeFrame: within the first 24 hours
Secondary outcomes:
measure: Respiratory depression
timeFrame: within the first 24 hours
measure: Postoperative pain
timeFrame: within the first 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Associate profossor of anesthesiology
name: Mohamed S Ali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04926688: High-risk Breast Lesions: A Multicenter Retrospective Study
Official title: Outcome of High-risk Breast Lesions Diagnosed on Image-guided Core Needle Biopsy: Results From a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premalignant Lesion
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 1345
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The women with diagnosis of atypical ductal hyperplasia, lobular neoplasia, flat epithelial atypia, papilloma and radial scar on image guided core needle biopsy were studied

Brief summary: In this multicenter study, the goal was to document the excisional biopsy or follow-up results of high risk lesions diagnosed on image guided CNB/VAB, and evaluate the clinical, imaging and histologic features for associated malignancy risk. The possibility of upgrade related to histologic subtype, tissue sampling and other variables was also evaluated.

Detailed description: This is a retrospective multicentric study that include 1345 patients from 30 centers.

Patients who had a diagnosis of high risk lesions (HRL) on image guided core biopsy (tru-cut/vacuum biopsy) were reviewed in a 12 year period (between 2008 and 2020). The lesions included were ADH, LN (ALH/LCIS), papilloma (without or with atypia), RS, and FEA.

The patients who managed with an excisional biopsy or having at least 1 year follow-up documentation following the diagnosis of borderline lesion were included in the study.

Radiological findings, diameter of lesion (\>15 vs \<15 mm), needle biopsy type (14-16G vs 9-12G), sampling method and number of samplings (4 and \>4 vs \<4) were documented.

IBM SPSS Version 25.0 statistical package program was used for analysis.

Eligibility criteria: Study Population:

The women with diagnosis of atypical ductal hyperplasia, lobular neoplasia, flat epithelial atypia, papilloma and radial scar on image guided core needle biopsy were studied

Sampling Method: Non-Probability Sample Minimum Age: 12 Maximum Age: 86 Sex: Female Gender Based: No Accepts Healthy Volunteers: No

Criteria:

Inclusion Criteria:

* Image guided needle biopsy diagnosis
* Atypical ductal hyperplasia
* Lobular neoplasia
* Flat epithelial atypia
* Papilloma
* Radial scar
* Diagnosed on image guided needle biopsy

Exclusion Criteria:

* Fibroepithelial tumors
* Mucocele like tumors
* Diagnosed on surgical biopsy

Primary outcomes:
measure: upgrade rates related to histologic subtype, tissue sampling and other variables
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University
name: Aysenur Oktay, MD
role: STUDY_CHAIR
affiliation: Ege University
name: Ozge Aslan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00593788: The Gaps-in-Noise Test: Gap Detection Thresholds in Normal-Hearing Young Adults
Official title: The Gaps-in-Noise Test: Gap Detection Thresholds in Normal-Hearing Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Auditory Perception
Psychoacoustics
Keywords: GIN test
gap detection
temporal resolution
auditory perception
psychoacoustics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal-hearing adults between 18 and 31 years of age were evaluated, including 50 males (mean age 24.72 years) and 50 females (mean age 23.77 years). The youngest male subject was 18 years old, and the youngest female subject was 18.16 years old. In contrast, the oldest male subject was 31.5 years old, and the oldest female subject was 31.83 years old. All of the participants in the study were students or employees of the University of Guarulhos.

Brief summary: The aim of this study was to establish parameters for the Gaps-in-Noise test in normal-hearing young adults. One hundred subjects (50 males and 50 females) received an audiological evaluation to rule out hearing loss and auditory processing disorder. The Gaps-in-Noise test was then conducted on all subjects. The mean gap detection threshold was 4.19 msec. A psychometric function by gap duration was constructed, revealing that the percentage of correct responses was less than or equal to 5% for a gap duration of 2 msec, 10-30% for a gap duration of 3 msec, 60-70% for a gap duration of 4 msec, and over 96% for gap durations of 5 msec or longer. The results suggest that the data obtained can be applied as reference values for future testing. In the subjects evaluated, the Gaps-in-Noise test proved to be consistent with low variability.


Eligibility criteria: Inclusion Criteria:

Subject inclusion criteria were:

* all of the subjects have to have auditory thresholds lower than 20 dB HL at all of the frequencies evaluated (octave frequencies between 0.25 to 8 kHz), bilaterally;
* type A tympanometric curves with presented ipsilateral and contralateral acoustic reflexes;
* 95% or higher correct responses for each ear in the dichotic digit test.

Subject inclusion criteria also included negative histories for audiologic, otologic, head trauma, and neurologic involvement.

Exclusion Criteria:

* Hearing loss;
* Auditory processing disorder;
* Histories of audiologic, otologic, head trauma, and neurologic involvement.

Primary outcomes:
measure: gap detection test
timeFrame: half hour
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: Guarulhos University
name: alessandra G. Samelli, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05034978: Novel SARS-CoV-2 Point-of-care Testing
Official title: Point-of-care Testing for Improving the Detection of SARS-CoV-2 Infection in Healthcare Setting
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: SARS-CoV2 Infection
Keywords: SARS-CoV-2
point-of-care testing
rapid diagnostics
Hong Kong
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: persons with exposure risk to SARS-CoV-2 infection who subsequently test positive or negative to conventional PCR-based testing for the diagnosis of the infection.

Brief summary: The aim of the project is to study the feasibility of implementing a novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection. A CRISPR-based detection kit would be piloted for testing of suspected SARS-CoV-2 infection in healthcare setting, with the objectives of evaluating the performance of the new test in the detection of SARS-CoV-2, and assessing the practicability of the new test for diagnosing SARS-CoV-2 infection in healthcare settings.

Detailed description: A CRISPR-based lateral flow assay (LFA) detection kit would be designed and developed for testing for the presence of SARS-CoV-2. The aim of the project is to study the feasibility of implementing the novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection in health service setting, with the following objectives: (b) Evaluation of the performance of novel POCT in comparison with conventional quantitative PCR in diagnosis SARS-CoV-2 infection and (c) Assessment of the practicability of LFA-CRISPR-based tests in the operating environments in healthcare settings.

Patients who are admitted to the isolation wards of Prince of Wales Hospital, Hong Kong would be invited to join the study. A total of 600 persons with suspected SARS-CoV-2 infection presenting with different symptomatology and epidemiological history will be recruited. Nasal, deep saliva and/or mouth gargle samples will be collected from all recruited subjects in accordance with standard clinical protocol. The samples would be tested for SARS-CoV-2 by the new Point-of-care test, in parallel with standard diagnostic testing of the hospital.

Eligibility criteria: Inclusion Criteria:

* adult patients admitted to isolation wards of the hospital who are
* of age of 18 or above;
* presentation with symptoms of COVID-19 and/or
* demonstration of exposure risk to SARS-CoV-2 infection.

Exclusion Criteria:

* inability to communicate in English or Chinese;
* known history of mental illness;
* prisoners.

Primary outcomes:
measure: Test performance
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT02343978: Phase II Study of KWA-0711 in Patients With Chronic Constipation (CC)
Official title: Phase II, Randomized, Open-label Study of KWA-0711 Administrated Orally for 2 Weeks to Evaluate Its Safety and Efficacy in Patients With Chronic Constipation (CC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Constipation
Keywords: Chronic Constipation
CC
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of KWA-0711 in Chronic Constipation (CC) patients.


Eligibility criteria: Inclusion Criteria:

* The patients who experienced fewer than three Spontaneous Bowel Movements (SBMs) per week for more than 6 months prior to the enrollment
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation

Exclusion Criteria:

* Patients who have secondary constipation caused by systemic disorder
* Patients who have organic constipation
* Patients who received intestinal resection

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in fasting and postprandial blood glucose levels
timeFrame: 2 weeks
measure: Change in fasting and postprandial insulin levels
timeFrame: 2 weeks
measure: ECGs, vital signs, and clinical labs
timeFrame: 2 weeks
measure: Improvement of signs and symptoms associated with constipation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Tatsuro Takei
role: STUDY_DIRECTOR
References:
citation: Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25.
Clinical trial NCT06091878: Gene Expression Profiling in a Validation Cohort of Locally Advanced and Recurrent/Metastatic Salivary Gland Cancers
Official title: Gene Expression Profiling in a Validation Cohort of Locally Advanced and Recurrent/Metastatic Salivary Gland Cancers: The INDAGA-UK Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Salivary Gland Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a salivary gland cancer diagnosis

Brief summary: The INDAGA-UK trial is a retrospective, multi-centre observational study in participants with locally advanced and recurrent salivary gland to investigate t its molecular profiling, and to explore new prognostic and druggable markers. We will analyse samples and data from patients diagnosed with salivary gland cancer from 2013 - 2023. Subject and sample identification will occur over a 12-month period. Samples and data will be analysed over the next 12 months prior to study end.


Eligibility criteria: Inclusion Criteria:

1. Aged over 18
2. Histological diagnosis of salivary gland cancer (SGCs)
3. Availability of archival tissue (acceptable after 2013 up to present)
4. Ability to give informed consent (if applicable)\* for retrieving histological specimen and preform molecular analysis \*De-identified archival tissue from deceased patients will be collected as part of the study once REC approval is in place, if the patient was alive when the samples were taken and they are not part of the NHS opt out scheme.

Exclusion Criteria:

1. Different H\&N cancer of other histology
2. Thyroid cancers

Primary outcomes:
measure: • Description of the molecular and genomic profile of locally advanced and recurrent-metastatic SGCs.
timeFrame: Time Frame: Through study completion, expected duration of 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05370378: Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Clinical Outcomes in Piriformis Syndrome
Official title: Comparative Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Pain, Functional Disability and Sleep Quality in Piriformis Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Piriformis Syndrome
Keywords: Function, Pain,Hold Relax ,Sleep Quality, Mobilization
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 82
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: Hold Relax with Agonist Contraction with Routine Physical Therapy Group B: Active Release Therapy with Routine Physical Therapy
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of hold relax agonist contraction and active release therapy on reducing pain intensity, improving functioning and sleep quality in patient with piriformis syndrome.

Both these techniques are passive, non-invasive manual therapy techniques which are easy to perform and less time consuming and may yield better outcomes resulting improved quality of life.


Eligibility criteria: Inclusion Criteria:

1. Age group 25-55 years
2. Both male and female.
3. Gluteal pain with or without radicular symptoms.
4. Patients of piriformis syndrome diagnosed by orthopedic consultant.
5. Sub-acute and chronic piriformis syndrome.
6. Unilateral pain.
7. Pain score equal to and greater than 3 according to pain rating scale.

Exclusion Criteria:

1. Intermittent vascular claudication and spondylolisthesis.
2. Past history of hip, femur or vertebral fracture
3. Past history of spinal surgery.
4. Spinal tuberculosis.
5. Rheumatoid disease.
6. Disc pathology, sacroiliac joint dysfunction or mechanical back pain.
7. History of infectious disease.
8. Leg length discrepancy.
9. Any postural abnormality or deformity.

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Pain score will be measured at the baseline, at end of first session and at 6th session on 2nd week
measure: Change in Functional Disability
timeFrame: Change in functional status will be measured at the baseline, at end of first session and at end of 6th session
measure: Sleep Quality
timeFrame: Sleep quality will be measured at the baseline, at end of first session and at end of 6th session
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Ayesha Jamil, M.Phil
role: STUDY_CHAIR
References:
Clinical trial NCT02761278: Expression of HOXA10 and HOXA11 in the Endometrium of Infertility Patients With an Endometrial Polyp Before and After Polypectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-05-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to measure the expression of HOXA10 and HOXA11 in the endometrium of infertility patients with an endometrial polyp before and after polypectomy. HOXA10 and HOXA11 are well-established markers of implantation. It is uncertain as to whether an endometrial polyp interferes with embryo implantation. A higher expression of HOXA10 and HOXA11 after polypectomy can indicate that endometrial polyp does interfere with embryo implantation.


Eligibility criteria: Inclusion Criteria:

* Infertile women with endometrial polyp

Exclusion Criteria:

* Endometriosis
* Polycystic ovary syndrome
* Hydrosalpinx
* Sub-mucus myoma
* Women who have taken hormonal therapy in the preceding month

Primary outcomes:
measure: Comparison of amounts of HOXA10 and HOXA11 expressed before and after polypectomy
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Guy Shrem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01532778: Saliva Modification Related to Fat Perception in Human
Official title: Perception Ortho-nasale du Gras Chez l'Homme Sain : Relations Entre Typages olfactométriques, Sensoriels et Composition de la Salive.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fat Sensitivity
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male, healthy

Brief summary: The perception of fat represents major scientific and nutritional issues. This research aims to identify salivary markers that could predict and possibly explain this perception in healthy human being. This would help to develop nutritional strategies for a more rational consumption of fat.


Eligibility criteria: Inclusion Criteria:

* Male
* 18-60 years

Exclusion Criteria:

* Female
* Non healthy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CSGA
Study officials:
References:
Clinical trial NCT02666378: Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
Official title: Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Dana-Farber Cancer Institute
First posted: 2016-01-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast Cancer

Brief summary: This research study is evaluating the use of Cardiac Magnetic Resonance Imaging (CMR) as a method of detecting early signs of damage to the heart that can be associated with anthracycline-based chemotherapy for the treatment of breast cancer.

Detailed description: One of the side effects observed in breast cancer patients receiving anthracycline-based treatment is heart complications in which the heart muscle is weakened and no longer able to pump sufficient amounts of blood throughout the body. This complication can lead to the following symptoms: shortness of breath on exertion, swollen ankles and feet, lack of energy and a reduced capacity to carry out day-to-day activities.

This research study is focused on identifying the early signs of such heart complications using CMR, which may allow preventative treatment options to be made available in future.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Have histologic diagnosis of breast carcinoma
* Scheduled to receive standard clinical therapy designed by their treating oncologist
* Patients should receive anthracycline as part of the recommended treatment
* Able to give informed consent.

Exclusion Criteria:

* Contraindication to contrast CMR including eGFR \<30 mls/min/1.73m2
* Uncontrolled serious concurrent illness
* Pregnancy or breast feeding

Primary outcomes:
measure: Cardiotoxicity
timeFrame: 1 year after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Reza Nezafat, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: