louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03212066: Master Mind Program Evaluation Study
Official title: Elementary School Mindfulness-Based Substance Use Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Mindfulness
Lead sponsor: Innovation Research & Training
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-07-11
Enrollment: 518
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to conduct a randomized controlled trial to evaluate the efficacy of the Master Mind program, a mindfulness education substance abuse prevention program. The program has the goal of enhancing coping strategies and decision-making skills and preventing substance abuse in late elementary school students.


Eligibility criteria: Inclusion Criteria:

* English Fluency

Exclusion Criteria:

-

Primary outcomes:
measure: Change in score on Positive and Negative Affect Scale for Children - Shortened Version (PANAS)
timeFrame: 6 weeks
measure: Change in score on Self-Report Coping Measure
timeFrame: 6 weeks
measure: Change in score on Intentions to use alcohol or tobacco
timeFrame: 6 weeks
measure: Change in score on Willingness to use alcohol or tobacco
timeFrame: 6 weeks
measure: Change in score on The Peer Relations questionnaire
timeFrame: 6 weeks
measure: Change in score on The Emotional Self-Efficacy Scale for Youth
timeFrame: 6 weeks
measure: Change in scores on Flanker Inhibitory Control and Attention Test
timeFrame: 6 weeks
measure: Change in score on Childhood Executive Functioning Inventory (CHEXI)
timeFrame: 6 weeks
measure: Change in score on The Child Behavior Scale (CBS)
timeFrame: 6 weeks
measure: Change in Iowa Conners Teacher Rating Scale
timeFrame: 6 weeks
measure: Change in Iowa Conners Teacher Rating Scale
timeFrame: 14 weeks
measure: Change in Student grades
timeFrame: 6 weeks
measure: Change in Student grades
timeFrame: 14 weeks
Secondary outcomes:
measure: Student Consumer Satisfaction Questionnaire
timeFrame: 6 weeks
measure: Teacher Program Feasibility Questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: innovation Research & Training
state: North Carolina
Study officials:
affiliation: Innovation Research & Training
name: Alison Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker AE, Kupersmidt JB, Mathis ET, Scull TM, Sims C. The impact of mindfulness education on elementary school students: Evaluation of the Master Mind Program. Adv Sch Ment Health Promot. 2014;7(3):184-204. doi: 10.1080/1754730X.2014.916497. Epub 2014 May 19.
Clinical trial NCT05935566: Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study
Official title: Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tonsillectomy
COVID-19
Adenoidectomy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at SMIT for severe COVID-19 infection between 01/03/20 and 31/11/21, not previously vaccinated against COVID-19.

Brief summary: Little is known about the impact of tonsillectomy and/or adenoidectomy on the severity and presentation of respiratory infections, let alone COVID-19. Current knowledge of the role of NALT suggests that its absence may be associated with an increased risk of severe disease.

Assessing the impact of tonsillectomy and adenoidectomy on the risk of adverse evolution in COVID-19 would help to better identify patients at risk of adverse evolution, so that they can be rapidly offered appropriate treatment. It would also provide a better understanding of the pathophysiology of this infection.

Primary objective: to determine whether there is a link between a history of tonsillectomy or adenoidectomy and the risk of severe COVID-19.

Primary endpoint: proportion of patients with a history of tonsillectomy or adenoidectomy among those hospitalized for severe COVID-19.

The results of this study will be compared with a data-driven study of Covid patients without severe disease.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 80
* Hospitalized in SMIT at CHU d'Angers between 01/03/2020 and 30/11/2021 for severe COVID-19 infection (at least 1 severity criterion)

Exclusion Criteria:

Long-term home oxygen therapy prior to COVID-19 infection

* Vaccination against COVID-19 with at least one dose of vaccine received prior to COVID-19 infection Confidential Page 11 of 15
* Inability to ascertain the presence or absence of a history of tonsillectomy or adenoidectomy
* Person objecting to participation in research

Primary outcomes:
measure: Proportion of patients with a history of tonsillectomy or adenoidectomy.
timeFrame: immédiat
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06488066: Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)
Official title: Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cataract
Pseudophakia
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 50 commercial patients who have been implanted with the LAL and who have completed Light Delivery Device (LDD) light treatments.

Brief summary: The objective of this investigator initiated study (IIT-002) is to collect data on commercial patients implanted with the RxSight Light Adjustable Lens (LAL).


Eligibility criteria: Inclusion Criteria:

* Sign a written Informed Consent Document
* Implanted commercially with the LAL and completed LDD light treatments

Exclusion Criteria:

* Previous corneal or intraocular surgery other than removal of cataract and implantation of the LAL

Primary outcomes:
measure: Manifest refraction
timeFrame: Pre operatively and immediately post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
References:
Clinical trial NCT03364166: Recurrence in Buccinator Muscle Excision With the Skin Versus Without the Skin in Buccal Squamous Cell Carcinoma
Official title: Evaluation of Local Control in Buccinator Muscle Excision With the Skin Versus Buccinator Muscle Excision Without the Skin in Buccal Squamous Cell Carcinoma: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Squamous Cell Carcinoma of the Oral Cavity
Keywords: buccal squamous cell carcinoma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of local control in buccinator muscle excision with the skin versus buccinator muscle excision without the skin in buccal squamous cell carcinoma: A randomized clinical trial.

Detailed description: Preoperative Multi Slice CT scan or MRI carried out for evaluation the lymph node of the neck. Also, ultrasound carried out for measuring the depth of invasion of the tumour in the cheek (The invasion in the buccinator muscle).

* Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour.
* A neck dissection will be done in all cases of negative or positive neck lymph node.
* Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from buccal squamous cell carcinoma.
* Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
* Both sexes and all ages will be included in the study.
* Cooperative patients, who accept the procedure and return for follow up , examination and evaluation.

Exclusion Criteria:

* Patients with any systemic disease that may affect normal healing.9,10
* Patients who physically and psychologically not able to tolerate the procedures.
* Patients may discontinue the follow up.

Primary outcomes:
measure: local control
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: ragia mounir, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01532466: The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fentanyl-induced Coughing
Keywords: fentanyl-induced coughing, rocuronium
Lead sponsor: Taichung Armed Forces General Hospital
Sponsor class: OTHER_GOV
First posted: 2012-02-14
Enrollment: 260
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: PREVENTION

Brief summary: An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.

Detailed description: Fentanyl is widely used for analgesia and anesthesia because of its rapid onset, its intense analgesic effect, and is associated with lessened cardiovascular depression and low histamine release. Although the cough reflex is usually transient and self-limiting, it should be avoided in situations such as elevated intracranial, intraocular, or intra-abdominal pressure, and unstable hemodynamics.

The cause of FIC is unclear. One hypothesis is that vocal cord spasms might induce coughing because of fentanyl-induced muscle rigidity and histamine release. Muscle relaxants are commonly used to treat this condition. This study hypothesizes that priming muscle relaxants could prevent or suppress FIC. This study investigates whether the muscle relaxant rocuronium attenuates FIC effectively.

Eligibility criteria: Inclusion Criteria:

* 260 ASA I-II patients,
* aged between 18 and 80 years, and undergoing various elective surgeries at Taichung Armed Forces General Hospital.

Exclusion Criteria:

* a history of asthma,
* chronic cough,
* smoking,
* upper respiratory tract infection in the previous 2 weeks, and
* medication containing angiotensin-converting enzyme inhibitors or anesthetic premedication.

Primary outcomes:
measure: Incidence of fentanyl-induced coughing
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Armed Forces General Hospital
Study officials:
affiliation: Cathay General Hospital
name: Chih-Shung Wong, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03279666: Biopsy Size and Pain Perception During Colposcopic Biopsy
Official title: A Randomized Controlled Study: Patients' With or Without Tenaculum Placement and Intracervical Blockage/or Not During Colposcopic Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Uterus
Tenaculum
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2017-09-12
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage.

Detailed description: The study was designed four arms. The investigators will perform colposcopy because of various causes. The first arm is used tenaculum and performed intracervical blockage. The second arm is not used tenaculum and performed intracervical blockage. The third arm is used tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and not performed intracervical blockage and then we will study patients pain and biopsy size during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and diagnose of the cervix cancer.

Eligibility criteria: Inclusion Criteria:

* 18-80 year-old women who had colposcopic biopsy

Exclusion Criteria:

* Had orthopedical problems
* Analgesic allergy
* Have previous cone biopsy
* Analgesic use until six hours before colposcopy
* Advanced cervicovaginal atrophy
* Linear Visual Analog Score for pain is used

Primary outcomes:
measure: Patients' Biopsy Sizes
timeFrame: 6 months
measure: Patients' Biopsy Sizes
timeFrame: 6 months
Secondary outcomes:
measure: Patients' pain perceptions
timeFrame: 6 months analgesic
measure: Patients' pain perceptions
timeFrame: 6 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Cihan Comba
Study officials:
References:
citation: Comba C, Demirayak G, Erdogan SV, Karaca I, Demir O, Guler O, Ozdemir IA. Comparison of pain and proper sample status according to usage of tenaculum and analgesia: a randomized clinical trial. Obstet Gynecol Sci. 2020 Jul;63(4):506-513. doi: 10.5468/ogs.19185. Epub 2020 Jun 19.
Clinical trial NCT04904666: Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients
Official title: Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Issues
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non critical hospitalized patients in internal medicine that met inclusion criteria. Subjects should be hospitalized por 1 week.

Brief summary: Non critical hospitalized patients were bathed daily with 4 substances: bleach at .005%, bleach at .0125%, clorhexidine 2% and soap and water.

76 patients were enrolled and divided 19 subjects per group. Each patient was cultured with swab technique in palm, antecubital fold and armpit at day 0, day 3 and day 7 of enrollment.

Bacterial cultures were incubated and compared if decolonization occurred. Adverse events were evaluated in all patients.

Only 1 patient had and adverse event and was dry skin. Before patient was enrolled, he had dry skin because of his baseline disease. Moisturizing lotion was applied and patient continue in the study.


Eligibility criteria: Inclusion Criteria:

* Non critical hospitalized patients in internal medicine
* 18 years old and older

Exclusion Criteria:

* Burn patients
* Pregnant women
* Chloride hypersensitivity

Primary outcomes:
measure: Safety of Bleach baths as determined by the incidence of adverse or serious adverse events
timeFrame: November 26, 2019 - October 25, 2020
Secondary outcomes:
measure: Identification of bacterial colonization from pathogens belonging to the ESKAPE group
timeFrame: November 26, 2019 - October 25, 2020
measure: Percentage of patients remaining colonized 3, 5 and 7 days after daily baths
timeFrame: November 26, 2019 - October 25, 2020
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario José E. Gonzalez
state: Nuevo Leon
Study officials:
References:
Clinical trial NCT02125266: Safety and Preliminary Efficacy Study of V404 PDS in Uveitis
Official title: A Prospective, Multi-Center, Randomized, Controlled Clinical Trial Designed to Evaluate the Safety and Preliminary Efficacy of V404 PDS in Chronic Noninfectious Uveitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Uveitis, Posterior
Uveitis, Intermediate
Lead sponsor: Forsight Vision4
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 7
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: This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Confirmed diagnosis of active uveitis
* Sufficient lens/media clarity
* Meet best-corrected visual acuity criteria
* Willing and able to use contraception

Exclusion Criteria:

* Pregnant, breast feeding
* Uncontrolled glaucoma
* Intraocular surgery or periocular/intraocular injections within 6 weeks
* Periocular or intraocular steroid within 3 months
* Prior vitrectomy
* Prior corneal transplant
* Prior fluocinolone implant
* Allergy or sensitivity to study drug
* Participation in other trial within 30 days
* Abnormal liver function
* History of positive serum tuberculosis test

Primary outcomes:
measure: Frequency of adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Change in vitreous haze score
timeFrame: Baseline, 6 Months
Other outcomes:
measure: Change in macular thickness by ocular coherence tomography
timeFrame: Baseline, 6 Months
Locations:
city: Golden
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Omaha
country: United States
state: Nebraska
city: Cleveland
country: United States
state: Ohio
city: Arlington
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT04239066: Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes
Official title: Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes. A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypospadias
Hypospadias, Coronal
Hypospadia, Repair
Tourniquet
Keywords: Tourniquet
Hypospadias
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 110
Sex: MALE
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although haemostasis aimed to maintain bloodless surgical field for better exposure for the surgeon, cosmetic impact, and decreased breakdown of repair, there is no trials regarding the impact of haemostasis techniques on surgeon satisfaction during surgery and patients reported outcomes.


Eligibility criteria: Inclusion Criteria:

* distal penile hypospadias were eligible for tubularized incided plate (TIP) urethroplasty repair

Exclusion Criteria:

* coagulopathy
* sickle cell disease or sickle cell trait
* circumcised patient
* history of previous failed surgery
* severe chordee (\>30 degree after degloving).

Primary outcomes:
measure: assess Intraoperative blood loss
timeFrame: 12 months
measure: bipolar diathermy use
timeFrame: 12 months
measure: Surgeon satisfaction about haemostasis
timeFrame: 12 months
Secondary outcomes:
measure: Patient-reported satisfaction
timeFrame: 24 months
measure: Long term complication rate
timeFrame: 60 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and nephrology center
state: Outside U.S./Canada
Study officials:
affiliation: Mansoura University
name: Mohammed Dawaba, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02329366: Development of a Cellular Biomarker for the Diagnosis and Treatment of Diabetic Foot Ulcers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Type 2 Diabetes
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both male and female patients at Winthrop University Hospital over the age of 18 with Type 2 Diabetes and a Diabetic Foot Ulcer are eligible for enrollment.

Brief summary: This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype.

Detailed description: The goal of this project is to identify objective, quantitative biological and molecular markers that correlate with healing outcomes for diabetic foot ulcers (DFUs) using debrided tissue of patients with wounds. This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype. The ability to differentiate between healing and non-healing tissue at the onset of wound care will allow for the use of targeted therapies and earlier initiation of aggressive treatments where indicated.

Eligibility criteria: Inclusion Criteria:

* Male or female, age ≥ 18
* Type 2 Diabetes
* A break in the skin on the foot ≥ 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system
* Hemoglobin A1c ≥ 5.9%
* Ability to provide written informed consent

Exclusion Criteria:

* Any experimental drugs taken orally or topically within 4 weeks of study entry
* Malignant disease at/or in proximity to the DFU
* Target wound of malignant origin
* Failure to satisfy at least one inclusion criterion for one of the two study groups.

Primary outcomes:
measure: To identify objective, quantitative biological and molecular markers that correlate with healing outcomes for diabetic foot ulcers (DFUs) using debrided tissue of patients with wounds
timeFrame: Undetermined
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Harold Brem, MD
role: PRINCIPAL_INVESTIGATOR
References: