louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04512248: Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions
Official title: Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group, parallel-randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Quit and Stay Quit Monday model is an innovative smoking cessation approach that guides smokers' behavior without requiring additional resources. The investigator will conduct a randomized control trial evaluating the effectiveness of this model as compared to usual smoking cessation care in a population of smokers with a mental health condition.

Detailed description: The overall objective of this proposal is to innovate the tobacco treatment paradigm for smokers with mental health conditions (MHC) by integrating the Quit and Stay Quit Monday Model into smoking cessation services for this vulnerable population.

The investigator will conduct a two-group, parallel-randomized controlled trial (RCT). The target population will be generated by the NYU Langone electronic medical record (EMR). The investigator will proactively contact patients to offer enrollment and randomize participants 1:1 to one of two groups (n=50/group): (1) Quit and Stay Quit Monday Model or (2) Usual Care. For evaluation, phone surveys will be conducted at baseline and 3-months to assess quit attempts, intervention satisfaction, and smoking cessation.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years old
2. Has smoked a cigarette in the past 30 days, even a puff
3. Has been diagnosed with a mental health condition or received care from a mental health clinic within the NYU Langone Health system in the prior 12 months
4. Interested in quitting smoking
5. English language
6. Has a phone that can receive text messages
7. Able to provide informed consent

Exclusion Criteria:

1. age \< 18 years of age
2. Non-smoker

Primary outcomes:
measure: Incidence of 3-month quit attempts
timeFrame: 3 months
measure: Incidence of smoking cessation
timeFrame: 3 months
measure: Number of participants who report satisfaction in intervention
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Erin Rogers, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06933030: Assessment of Customized 3D Zirconium Versus Titanium Mesh for Anterior Maxillary Ridge Augmentation With Delayed Implant Placement
Official title: Assessment of Customized 3D Zirconium Versus Titanium Mesh for Anterior Maxillary Ridge Augmentation With Delayed Implant Placement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ridge Augmentaton and Dental Implants
Bone Loss, Alveolar
Keywords: ridge augmentation
dental implant
titanium mesh
zirconium mesh
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group I (controlled group):

- Ten sites of anterior maxillary ridge atrophy will be treated by titanium mesh with bone graft with delayed implant placement.

Group II (tested group):

- Ten sites anterior maxillary ridge atrophy will be treated by zirconium mesh with bone graft with delayed implant placement.
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to assess the customized 3D zirconium versus titanium mesh for anterior maxillary ridge augmentation with delayed implant placement.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:

  1. Patients from both genders with the age range of 18-60 years with good systemic health, no contraindication for periodontal surgery and able to maintain good oral hygiene.
  2. Patient with anterior maxillary alveolar ridge deficiency (horizontal, vertical or combined defects) less than 2 mm in width or less than 6 mm in height - measured from the alveolar crest to the basal bone in order to be enrolled in this study. (56)
  3. Adequate zone of keratinized gingiva at minimum 3mms.
  4. Patient with sufficient inter-arch space for future dental rehabilitation.
  5. Subjects who are not on any medication known to interfere with periodontal tissue health or healing within 6 months of the study.

Exclusion Criteria:

Exclusion Criteria:

1. History of systemic diseases (i.e. diabetes, autoimmune dysfunction, prolonged cortisone therapy, or chemotherapy) that would contraindicate periodontal surgical treatment or affect bone turn over.
2. Patients with deleterious habits like the use of tobacco chewing or smoking ones.
3. History of previous periodontal surgical treatment of the involved sites.
4. Presence of malocclusion and pathologic movement of teeth in involved sites.
5. Patient not willing to give consent for the study and poor plaque control.(57)
6. Pregnant or nursing mothers.
7. Patients with acute odontogenic infection.

Primary outcomes:
measure: clinical evaluation
timeFrame: 6 months
Secondary outcomes:
measure: radiographic bone volume
timeFrame: 6,12 months
measure: histologically
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
Study officials:
References:
Clinical trial NCT01023230: A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
Official title: A Phase Ib Dose-Escalation Study to Assess the Safety and Tolerability of DV-601 in Subjects With Chronic Hepatitis B on Concurrent Treatment With a Nucleoside Analogue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B, Chronic
Keywords: DV-601
hepatitis B
entecavir
therapeutic vaccine
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and immunological responses in chronic hepatitis B (CHB) patients.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects 18 to 65 years of age.
* Signed informed consent.
* Diagnosis of CHB and candidates for therapy
* Normal renal function
* Women of childbearing potential must have a serum negative pregnancy test at screening. Women of childbearing potential and males whose sexual partners are of childbearing potential must agree to use dual methods of contraception.

Exclusion Criteria:

* Liver disease other than CHB
* Documented co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), or HIV
* Previous therapy with interferon alpha.
* Any other antiviral therapy for chronic hepatitis B within the previous 3 months prior to Screening Visit.
* Immunosuppressive treatment (e.g. chemotherapy, high-dose of steroids) within 6 months of Screening Visit.
* Evidence of cirrhosis
* Child-Turcotte-Pugh (CTP) score ≥ 7, either currently or at any occasion in the past
* Clinically significant acute or chronic illnesses, such as autoimmune diseases, collagen vascular disease, immune deficiencies, active or uncontrolled infections, etc. as determined by the investigator and documented in medical history.
* Malignancy other than curatively treated, superficial skin cancer or carcinoma in situ of the cervix.
* Participation in any experimental protocol or therapy within 28 days prior to the Screening Visit.
* Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of study results.

Primary outcomes:
measure: Patient diaries, adverse events, physical exams, and lab tests
timeFrame: Through Day 99
Secondary outcomes:
measure: HBV-DNA levels
timeFrame: Change from baseline to Days 43 and 99, and to Weeks 24 and 48
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Collegium Medicum Uniwersytet im. Mikołaja Kopernika
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Wojewódzki Szpital Zespolony
city: Warsaw
country: Poland
facility: Wojewódzki Szpital Zakaźny
city: Wrocław
country: Poland
facility: NZOZ Centrum Badan Klinicznych
Study officials:
References:
Clinical trial NCT04854148: Validation of a Smartphone-based Assessment of Movement Health
Official title: Validation of a Smartphone-based Assessment of Movement Health Compared to a Battery of Standardized Clinical Tests for Mobility, Stability, and Posture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mobility Limitation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling adults

Brief summary: To correlate a smartphone-based assessment of mobility, stability, and posture with those derived from standard clinical tests among a heterogeneous cohort.

Detailed description: Smartphone movement health assessment introduces a new measure of health that helps users analyze and improve their mobility, stability and posture through performance of movements and physical exercises. To verify the accuracy of this measure, the goal is to provide data-driven evidence regarding its accuracy in comparison to gold standard tests for measuring movement health. To address this challenge, the assessment scores will be benchmarked to a set of gold standard tests and sensor metrics for measuring movement health recommended by professional associations such as the American Physical Therapy Association (APTA) or American College of Sport Medicine (ACSM) and found valid in clinical studies , .

Eligibility criteria: Inclusion Criteria:

1. All participants should be able to perform the Smartphone movement health assessment and receive a score for their movement health. This will be evaluated by the research team members during the recruitment process.
2. Ages 18-85 years old
3. Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

1. Pregnant or nursing
2. Skin allergies or irritation that would prevent safe use of sensors described in protocol

Primary outcomes:
measure: Correlation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02870530: Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
Official title: Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A Treatment for Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of single anastomoses sleeve jejunal bypass as a treatment for morbid obesity

Detailed description: in this study the investigators aim to test a new technique ( single anastomoses sleeve jejunal as a treatment for morbid obesity Which is a modification of Single anastomoses sleeve ileal bypass with short biliary limb ( about one third of the small intestine from the Duodeno-jejunal junction

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 50
* patients with BMI less than 50
* patient with previous upper abdominal surgery either for obesity or other diseases
* patients with preoperative GERD clinically or by investigation

Primary outcomes:
measure: operative time
timeFrame: the 1st 24 hours
measure: intraoperative complications
timeFrame: the 1st 24 hours
measure: the postoperative weight loss
timeFrame: 12 month
Secondary outcomes:
measure: effect on metabolic syndrome if present
timeFrame: 12 months
Other outcomes:
measure: postoperative biliary reflux
timeFrame: 3 months
Locations:
city: Minya
country: Egypt
facility: Minia university hospital
Study officials:
affiliation: Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.
name: Alaa M Sewefy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02159430: Hereditary AngioEdema, Neurobiology and Psychopathology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hereditary AngioEdema
Anxiety
Depression
Lead sponsor: University Hospital, Catania
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This population-based cross-sectional study will include all Hereditary AngioEdema (HAE) patients from the Eastern Sicily HAE register.

Brief summary: Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. From this period the link between HAE and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. Clinical studies show an evident gap between genotype and phenotype of HAE. For this still controversial question, we have designed this cross-sectional study in order to establish the relationship between HAE clinical manifestations and neurobiological/psychopatological parameters.


Eligibility criteria: Inclusion Criteria:

Diagnosis of HAE

Exclusion Criteria:

* Current pharmacological treatment including ACE-inhibitors, ACE inhibitors, glucocorticoids, oestroprogestative, psychotropic drugs, drugs acting on the immune system (15 days before), anesthetics (in the previous three months).
* Inflammation / infection (eg, chronic inflammatory diseases, acute) in the last 15 days.
* Ongoing allergies.
* Night work over the past 15 days.
* Vigorous physical activity or alcohol consumption (the day before the assessment).
* Women in follicular phase of menstrual cycle.

Primary outcomes:
measure: Multivariate linear regression analysis of HAE clinical status and psychometric parameters
timeFrame: First assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele
Study officials:
References:
Clinical trial NCT06900348: Prostate Specific Antigen Levels of Individuals Living in Rural Areas
Official title: Prostate Specific Antigen Levels and Its Relationship With Some Characteristics in Individuals Living in Rural Areas: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Carcinoma
Keywords: Prostate Carcinoma, Screening
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 308
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Male 55 years or older

Brief summary: It was planned in cross-sectional design in order to determine the specific prostate antigen level and some characteristics and the relationship evaluations and prostate specific antigen formation in individuals living in rural areas. It was planned to perform socio-demographic information formula, form including social information of health, prostate specific antigen test in the project data recording.

Detailed description: It was planned in a cross-sectional design to evaluate the prostate specific antigen level and its relationship with some characteristics in elderly individuals living in rural areas and to determine the prostate specific antigen level. The research area of the project consists of 8 villages. In the collection of project data, it was planned to conduct a socio-demographic feature information form, a form including social determinants of health, and a prostate specific antigen test. This planned project is the first research to be conducted in our country in terms of determining risky groups, ensuring randomness in participants, and sampling method for universe representation. In addition, screening the rural area, which is disadvantaged in terms of socio-economic and demographic aspects, and preferring elderly individuals constitute the steps taken to ensure health equality of the disadvantaged group in terms of health service transportation opportunities.

Eligibility criteria: Inclusion Criteria:

* Male
* 55 years or older

Exclusion Criteria:

-Prostate treatment

Primary outcomes:
measure: PSA levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06029530: Delaying the Onset of Nearsightedness Until Treatment Study
Official title: Delaying the Onset of Nearsightedness Until Treatment Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Myopia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Houston
name: State University of New York
name: Pennsylvania College of Optometry
name: Southern California College of Optometry at Marshall B. Ketchum University
name: University of California, Berkeley
name: Stanford University
name: Case Western Reserve University
name: Illinois College of Optometry
name: Indiana University
name: New England College of Optometry
name: University of the Incarnate Word
name: Southern College of Optometry
name: University of Missouri, St. Louis
First posted: 2023-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)
Primary purpose: OTHER

Brief summary: Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

Detailed description: Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).

Eligibility criteria: Inclusion Criteria:

* Age: 6-11 years
* Refractive error measured in spherical equivalent, one eye meets criterion

  * 6 years old: 0.50 to +0.38
  * 7 years old: 0.50 to +0.25
  * 8-11 years old: 0.50 to plano
* Anisometropia: spherical equivalent \<1.50 D
* Astigmatism: \<1.50 in both eyes
* Myopia: Less myopic than -0.74 D, both eyes

Exclusion Criteria:

● Myopic

Primary outcomes:
measure: Compliance percentage
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Jeffrey J Walline, OD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00440830: Nicotine Patch as an Analgesic Adjuvant After Surgery
Official title: Study to Determine Whether the Use of a Nicotine Patch During the Day of Surgery Improves Postoperative Pain and Reduces Opioid Requirement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: acute pain
nicotine
nausea
sedation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2007-02-27
Enrollment: 68
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: Effect of nicotine patch as an adjutant for acute pain after surgery.

Detailed description: This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.

Eligibility criteria: Inclusion Criteria:

* Adult ASA 1-2

Exclusion Criteria:

* Cardiovascular disease
* Former smoker
* Pregnant
* Nursing
* Asthma

Primary outcomes:
measure: Postoperative Pain Score One Hour After Surgery
timeFrame: 1 hour after surgery
measure: Postoperative Pain Score Five Days After Surgery
timeFrame: 5 days
Secondary outcomes:
measure: Nausea Assessment by Patient
timeFrame: 1 hour after surgery
measure: Pain Medication Used
timeFrame: 5 days
measure: Systolic Blood Pressure
timeFrame: 1 hour after surgery
measure: Diastolic Blood Pressure
timeFrame: 1 hour after surgery
measure: Heart Rate
timeFrame: 1 hour after surgery
Other outcomes:
measure: Sedation Level
timeFrame: 1 hour after surgery
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center / New York Presbyterian
state: New York
Study officials:
affiliation: Columbia University
name: Pamela Flood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olson LC, Hong D, Conell-Price JS, Cheng S, Flood P. A transdermal nicotine patch is not effective for postoperative pain management in smokers: a pilot dose-ranging study. Anesth Analg. 2009 Dec;109(6):1987-91. doi: 10.1213/ANE.0b013e3181bd1612.
citation: Hong D, Conell-Price J, Cheng S, Flood P. Transdermal nicotine patch for postoperative pain management: a pilot dose-ranging study. Anesth Analg. 2008 Sep;107(3):1005-10. doi: 10.1213/ane.0b013e318163204f.