louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06303804: Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective
Official title: Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Misuse
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores


Eligibility criteria: Inclusion Criteria:

* Must identify as Hispanic/Latino/a descent
* Have an adolescent between the ages of 15 and 17 years old living in their home a majority of the time
* Have English or Spanish proficiency

Exclusion Criteria:

* Adolescent or parent currently in opioid treatment
* Parent self-reports a substance use (including opioid use) disorder for themselves or adolescent

Primary outcomes:
measure: Acceptability of the educational materials presented via the educational videos, including cultural congruence as assessed by a questionnaire
timeFrame: end of study (Day 7)
measure: Changes in opioid related knowledge as assessed by a questionnaire
timeFrame: Baseline, end of study (Day 7)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Alejandra Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06392204: CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique
Official title: Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mandibular Fractures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 20
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 proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.

Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.

Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.

Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.

Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.

Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.

Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.


Eligibility criteria: Inclusion Criteria:

1. Patients with unilateral mandibular angle fracture with or without associated mandibular fractures in need of open reduction and internal fixation.
2. Patients above 18 years old
3. Sufficient dentition to reproduce the occlusal relationships
4. Patient's consent to participate

Exclusion Criteria:

1. Patients with comminuted mandibular angle fracture(s)
2. Patients with any systemic disease that may affect normal healing
3. Patients undergoing chemotherapy or radiotherapy related to the head and neck region
4. Intra-bony lesions in the fracture area that may interfere with proper anatomical reduction.

Primary outcomes:
measure: Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.
timeFrame: Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)
Secondary outcomes:
measure: Postoperative occlusion
timeFrame: Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
Clinical trial NCT06550401: A Study of the BREAST-Q REACT Tool for People Having Breast Surgery
Official title: The BREAST-Q REACT: Examining the Impact of Immediate Patient-reported Outcome Feedback and Interpretation in the Perioperative Period, a Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Conserving Surgery
Mastectomy With Reconstruction
Keywords: BREAST-Q REACT
assessments
quality of life
24-184
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 69
Sex: FEMALE
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 researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the BREAST-Q Real-time Engagement and Communication Tool (REACT) on people's quality of life, interactions with their doctors, and medical interventions after undergoing routine breast conserving surgery or mastectomy. The BREAST-Q REACT tool shows scores from standard questionnaires completed before and after breast surgery about overall physical wellbeing, arm pain or tightness, the ability to move the arms and perform everyday tasks, and any symptoms related to the arms, and provides feedback including recommendations and detailed information that help explain these scores and guide topics for people and their doctor to discuss.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo BCS or mastectomy followed by breast reconstruction with tissue expander, autologous tissues, or direct-to-implant, regardless of neoadjuvant chemotherapy or radiation history
* Female sex
* Able to speak and understand English
* ≥18 years of age
* Able to access the patient portal online

Exclusion Criteria:

* Patient is male
* Younger than 18 years of age
* Cannot communicate in English
* Recurrent breast cancer
* Patients without access to the internet.

Primary outcomes:
measure: feasibility of recruitment
timeFrame: up to 3 months
Secondary outcomes:
measure: feasibility of protocol delivery
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jonas Nelson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01679301: Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
Official title: Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Disease
Keywords: oxygen
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2012-09-06
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30 participants (to allow for 20 completed data sets) with a prescription for nocturnal oxygen, and meeting all eligibility criteria.

Detailed description: All participants will undergo a single night polysomnography testing in a sleep lab while they're oxygen saturation (SpO2) is monitored. The study has a cross-over design, in which participants will receive their oxygen prescription in two different modes at different times during the night. The assignment (sleep vs. continuous mode) to which participants will initiate the night will be randomized, and all participants will utilize each of the two modes during the study. The hypothesis of this study is that there will not be a significant difference in SpO2 for participants while they use the SimplyGo Portable Oxygen Concentrator, set in 'Sleep Mode', or pulsed oxygen flow, as compared to their SpO2 while on continuous flow oxygen during sleep during the course of the one night sleep study.

Eligibility criteria: Inclusion Criteria

1. Males and Females, ages 21-80
2. Current prescription for supplemental oxygen at night; Can be pulsed dose or continuous
3. Willing and able to provide informed consent

Exclusion Criteria

1. Medically unstable participants per discretion of the principal investigator
2. Diagnosis of sleep apnea, per chart review, self report or rated high risk based on the Berlin Questionnaire
3. Participants unable or unwilling to spend one night in a sleep lab
4. Nocturnal oxygen requirements \> 5 liters per minute
5. Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
6. Employee or family member that is affiliated with Philips

Primary outcomes:
measure: Oxygen Saturation Values Obtained From Pulse Oximetry
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: Sukhdev Grover and Associates
state: Pennsylvania
Study officials:
affiliation: Medical Director, Sukhdev Grover and Associates
name: Sukhdev Grover, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01349504: Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
Official title: Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Crohn's Disease
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2011-05-06
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients taking mesalamine for maintenance of remission of ulcerative colitis

Brief summary: Hypothesis:

Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in patients with IBD. These factors can be identified using qualitative testing in order to develop a validated instrument to measure the "adherence profile" of an individual patient, and design appropriate behavioral interventions to reduce non-adherence.

Objectives:

To test a novel interview instrument that determines the medication adherence profile of patients with IBD prescribed mesalamine by correlating with objective measures of adherence

Detailed description: Specific Aims:

1. To test a novel interview instrument to classify patients into "adherence profiles"
2. To validate this instrument with quantitative scores of mesalamine adherence and objective testing.

Study Design Rationale:

Qualitative research design and prospective validation

Eligibility criteria: Inclusion Criteria:

* Adult patient (age \>18)
* Diagnosis of IBD (confirmed by endoscopy and histology) \> 3 months
* In clinical remission (based on Simple Colitis Activity Index score \<2.5)
* On mesalamine compound for maintenance of remission
* Stable mesalamine dose for 1 month

Exclusion Criteria:

* Not receiving primary GI care at BIDMC

Primary outcomes:
measure: Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data
timeFrame: 12 months
Secondary outcomes:
measure: Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6)
timeFrame: 12 months
measure: Spot Urinary 5-ASA
timeFrame: 12 months
measure: Short Inflammatory Bowel Disease Questionnaire
timeFrame: 12 months
measure: Pharmacy Refill Rates
timeFrame: 12 months
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: Alan Moss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moss AC, Lillis Y, Edwards George JB, Choudhry NK, Berg AH, Cheifetz AS, Horowitz G, Leffler DA. Attitudes to mesalamine questionnaire: a novel tool to predict mesalamine nonadherence in patients with IBD. Am J Gastroenterol. 2014 Dec;109(12):1850-5. doi: 10.1038/ajg.2014.158. Epub 2014 Jun 10.
Clinical trial NCT06938204: Single Ascending Dose, Multiple Ascending Dose, Food Effect Study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of INV-101 Administered Orally to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Innovo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-22
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 8 subjects were randomized to 6 Active and 2 Placebo in each cohort.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 2-part study. Parts 1 and 2 will be a randomized, double-blind, placebo-controlled investigations of SAD (Part 1) and MAD (Part 2) of orally administered INV-101 in healthy adult subjects. Food effect will also be assessed in one cohort in Part 1.


Eligibility criteria: Inclusion Criteria:

* Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 and agree to refrain from sperm donation until 90 days after the last dosing.
* Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee at the screening visit, including the following:

Exclusion Criteria:

1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug or study drug excipients.

Primary outcomes:
measure: Safety Analysis
timeFrame: 7 days after last dosing
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 3 days
measure: Peak Plasma Concentration (Cmax)
timeFrame: 3 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron
state: Maryland
Study officials:
References:
Clinical trial NCT03354104: Tunnel Technique With Emdogain® in Addition to Connective Tissue Graft Compared With Connective Tissue Graft Alone for the Treatment of Gingival Recessions: a Randomized Clinical Trial.
Official title: Tunnel Technique With Emdogain® in Addition to Connective Tissue Graft Compared With Connective Tissue Graft Alone for the Treatment of Gingival (Periodontal?) Recessions: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Microsurgical tunneling flap procedures using connective tissue grafts (CTG) are predictable for treating teeth with gingival recessions. Enamel matrix derivatives (EMD) can be used as an alternative to the aforementioned gold standard. The aim of this study is to evaluate clinically the use of tunnel technique with EMD applied group in addition to CTG and the same technique with CTG group for the treatment of multiple gingival recessions.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Bilateral multiple gingival recessions in homologous teeth

Exclusion Criteria:

* Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
* Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
* Smoking
* Systemic diseases with compromised healing potential of infectious diseases
* Drugs affecting periodontal health / healing
* Pregnant and lactating females
* Previous periodontal surgery in the area

Primary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Recession height (RH)
timeFrame: 6 months after surgery
measure: Recession width (RW)
timeFrame: 6 months after surgery
measure: Width of keratinized tissue (WKT)
timeFrame: 6 months after surgery
measure: Thickness of keratinized tissue (TKT)
timeFrame: 6 months after surgery
measure: Average recession coverage (ARC)
timeFrame: 6 months after surgery
measure: Complete recession coverage
timeFrame: 6 months after surgery
Other outcomes:
measure: Probing pocket depth (PPD)
timeFrame: 6 months after surgery
measure: Root coverage esthetic score (RES)
timeFrame: 6 months after surgery
measure: Post surgical pain and swelling
timeFrame: 1, 2, 4, 7 and 14 days after surgery
measure: Patient's satisfaction with treatment
timeFrame: 6 months after surgery
Locations:
city: Warsaw
country: Poland
facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
state: Mazowsze
Study officials:
References:
citation: Gorski B, Szerszen M, Kaczynski T. Effect of 24% EDTA root conditioning on the outcome of modified coronally advanced tunnel technique with subepithelial connective tissue graft for the treatment of multiple gingival recessions: a randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):1761-1772. doi: 10.1007/s00784-021-04151-9. Epub 2021 Aug 24.
Clinical trial NCT00000304: Dextroamphetamine as an Adjunct in Cocaine Treatment - 1
Official title: Dextroamphetamine as an Adjunct in Cocaine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: verifiable cocaine abstinence
timeFrame: 16 weeks of study
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: John Grabowski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01090804: The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance
Official title: The Effectiveness of BreatheMAX Breathing Device on Airway Secretion Clearance in Patients With Ventilatory Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lung Disease
Keywords: BreatheMAX breathing device
Secretion clearance
Ventilatory dependence
Intubated patients
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2010-03-23
Enrollment: 14
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determined effects of BreatheMAX on secretion clearance.


Eligibility criteria: Inclusion Criteria:

* One sign of secretion accumulation in bronchi
* Stable cardiopulmonary function
* Good consciousness and good co-operation

Exclusion Criteria:

* Massive hemoptysis
* Pneumothorax (untreated)

Primary outcomes:
measure: secretion wet weight (gram)
timeFrame: Three hours before, ten hours after treatment and night-time (02.00-07.00 am.)
measure: viscosity of secretion
timeFrame: Three hours before and after treatment
Secondary outcomes:
measure: Heart rate (beat/min)
timeFrame: Before, during breathing exercise with device and immediate after treatment
measure: Oxygen saturation (%SpO2)
timeFrame: Before, during breathing exercise with device and immediate after treatment
measure: Respiratory rate (times/min)
timeFrame: In rest interval between set (1 minute)
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University
state: Khon Kaen
Study officials:
affiliation: Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
name: Sujittra Kluayhomthong, Bachelor
role: STUDY_CHAIR
affiliation: Physical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand
name: Chulee CU Jones, Philosophy
role: STUDY_DIRECTOR
affiliation: Department of physiology, Faculty of medicine, Khon Kaen university
name: Wilaiwan Khrisanapant, Philosophy
role: STUDY_DIRECTOR
References: