louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01244412: Assessment of Prototype Hand-held Fundus Camera
Official title: Assessment of Prototype Hand-held Fundus Camera
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Evaluate Performance of New Fundus Camera
Keywords: Fundus photography
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years or older

Brief summary: This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.

Detailed description: We tested a novel fundus camera. The images obtained were acceptable to move to the next step in development.

Eligibility criteria: Inclusion Criteria:

* Greater than 21 years of age
* Ability to give informed consent
* Willingness to spend up to 2 hours for photos
* 5 patients presumed to be normal
* 5 patients with abnormalities of the posterior pole of the retina or the optic nerve will be studied

Exclusion Criteria:

* Any known pathology felt by the Principal Investigator to be significant so as to preclude participation as a normal subject
* Monocular subjects
* Potential subjects may be excluded based on the Principal Investigator's judgement that they are not good subjects to photograph
* Children and vulnerable subjects will not be included in the study

Primary outcomes:
measure: Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera
timeFrame: estimated 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Flaum Eye Institute-University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT03787212: MiBo ThermoFlo Lid Temperature Evaluation
Official title: MiBo ThermoFlo Lid Temperature Evaluation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective, contralateral, single-site, single-visit unmasked evaluation of external and internal eyelid temperature after treatment with the MiBo ThermoFlo.


Eligibility criteria: Inclusion Criteria:

* Potential subjects must satisfy all the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Between 18 and 80 (inclusive) years of age at the time of screening.
  4. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or breastfeeding.
  2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with participation in the study.
  3. Clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection).
  4. Grade 3-4 Percentage of Partial Meibomian Glands on the Pult 5-point grading scale.
  5. Any active Ocular Infection or Inflammation
  6. Any history of eyelid surgery or abnormality
  7. History of Metal Implants in the Eyelids
  8. Any known hypersensitivity or allergic reaction to ultrasound coupling gel.
  9. LASIK Surgery within 2 weeks of the Baseline Visit.
  10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  11. History of MiBo ThermoFlo or Lipiflow treatment Within the Last 6 months.
  12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

Primary outcomes:
measure: Posterior Eyelid Temperature (Palpebral Conjunctiva)
timeFrame: 12-minutes post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston, College of Optometry
state: Texas
Study officials:
References:
Clinical trial NCT03167281: Early Intrapleural TPA Instillation Versus Late
Official title: Early Intrapleural TPA Instillation Versus Late
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Tissue Plasminogen Activator
Keywords: Chest tube
Thoracostomy
Pleural Diseases
Lung Neoplasms
Pulmonary Embolism
Pneumothorax
Thoracic Surgery
Deoxyribonucleases
Fibrinolytic Agents
Drainage
Pleural Effusion
Lead sponsor: Prisma Health-Midlands
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase immediately after chest tube placement will help with better fluid draining.

Detailed description: The purpose of this study is to determine the timing and efficacy of early administration and late administration of t-PA/DNase via thoracostomy (n=60). Patients will be identified from the Intensive Care Unit, Coronary Care Unit, and wards/stepdown units. Prior to chest tube placement, patients will be randomized to one of the two treatment arms (early use of t-PA-DNase verus late use of t-PA-DNase). Route of administration will be via their thoracostomy tube over a period of three days twice daily.

Eligibility criteria: Inclusion Criteria:

* Adult patients, age 18 years or older
* Patients with an indication for a thoracostomy tube placement for a pleural effusion

Exclusion Criteria:

* Patients that require a thoracostomy tube for a pneumothorax
* Pregnant women
* Sensitivity to t-PA, or DNase
* Patients taking carbamazepine or nitroglycerin
* Lung volume reduction surgery on side of pleural effusion

Primary outcomes:
measure: Chest tube removal
timeFrame: 7 days
Secondary outcomes:
measure: Fluid drainage
timeFrame: 3 days
measure: Need for other interventions
timeFrame: 4 days
measure: Discharge
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Palmetto Health Richland
state: South Carolina
Study officials:
affiliation: Prisma Health-Midlands
name: Rohan Mankikar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02119481: Effects of Mindfulness Meditation and Stress Management After Breast Cancer
Official title: Effects of Mindfulness Meditation and Stress Management Training on Perceived Stress, Psychological Well-being, and Sleep Quality Among Patients Diagnosed With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Mindfulness stress reduction training
Expressive writing condition
Waiting list control condition
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 142
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 primary aim of this study is to examine the effects of a mindfulness-based stress reduction training program, delivered in individual web-based sessions, among breast cancer patients. The objectives are to study and answer questions regarding effects of the such training in a randomized controlled trial including the following outcome measures: physical and mental health status, perceived stress, post-traumatic stress symptoms, psychological well-being, and sleep quality. In addition to the primary aim, the investigators plan to explore potential mechanisms through which mindfulness training lead to improvement in perceived stress, well-being and sleep-quality. This will be studied by mediational analyses.


Eligibility criteria: Inclusion Criteria:

* Breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously
* Access and regular use of the internet

Exclusion Criteria:

* Non Swedish speaking
* Previous sever psychiatric illness

Primary outcomes:
measure: Change in Perceived Stress
timeFrame: Baseline to 8 week follow-up change
measure: Change in Psychological Well-Being
timeFrame: Baseline to 8 week follow-up change
measure: Change in Sleep quality
timeFrame: Baseline to 8 week follow-up change
Secondary outcomes:
measure: Change in Perceived stress
timeFrame: Change from baseline to 12 months follow-up
measure: Change in Psychological well-being
timeFrame: Change from baseline to 12-month follow-up
measure: Change in Sleep quality
timeFrame: Change from baseline to 12-month follow-up
Other outcomes:
measure: Sickness-absence for work
timeFrame: At 24 months follow-up
measure: All cause morbidity
timeFrame: At 24 months follow-up
measure: All cause mortality
timeFrame: At 24 months follow-up
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of clinical neuroscience
Study officials:
References:
Clinical trial NCT03622281: Quality Improvement Intervention in Colonoscopy Using Artificial Intelligence
Official title: Quality Improvement Intervention in Colonoscopy Using Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality Control
Artificial Intelligence
Colonoscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 676
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Quality measures in colonoscopy are important guides for improving the quality of patient care. But quality improvement intervention is not taking place, primarily because of the inconvenience and expense. To address the difficulties above, we used artificial intelligence for quality control of colonoscopy.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 80;
* agree to give written informed consent.

Exclusion Criteria:

* patients with the contraindications to colonoscopy examination;
* patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
* patients with prior failed colonoscopy and high suspicion of polyposis syndromes, IBD and typical advanced CRC;
* patients refused to participate in the trial;
* the colonoscopyprocedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
* the colonoscopy procedure have to be terminated due to complications of anaesthesia.

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
citation: Su JR, Li Z, Shao XJ, Ji CR, Ji R, Zhou RC, Li GC, Liu GQ, He YS, Zuo XL, Li YQ. Impact of a real-time automatic quality control system on colorectal polyp and adenoma detection: a prospective randomized controlled study (with videos). Gastrointest Endosc. 2020 Feb;91(2):415-424.e4. doi: 10.1016/j.gie.2019.08.026. Epub 2019 Aug 24.
Clinical trial NCT00914381: Behavioral Treatment for Cocaine Dependent Women
Official title: Behavioral Treatment for Cocaine Dependent Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: Community reinforcement approach
Contingency management
12-step facilitation counseling
Cocaine dependence
Women
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-06-05
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent voucher control (VC) for the treatment of cocaine dependent pregnant women or women with young children.

Detailed description: Subjects were randomly assigned to 1 of 4 treatment groups (CRA+VBRT, CRA+VC, TSF+VBRT, TSF+VC). VBRT voucher value increased for each successive cocaine-free urine sample obtained twice weekly during the 1st 12 weeks and was faded from the final earned value to $5 during the last 12 weeks. All subjects earned vouchers for attendance at scheduled twice weekly counseling sessions. Manual-guided CRA and TSF were provided by experienced clinicians.

Eligibility criteria: Inclusion Criteria:

* Pregnant women meeting DSM IV criteria for cocaine dependence
* Women meeting DSM IV criteria for cocaine dependence with custody of a young child

Exclusion Criteria:

* Opioid dependence
* Psychosis
* Severe depression
* Current treatment with any anti-depressant or anti-psychotic medication
* Medical instability
* Inability to understand or read English

Primary outcomes:
measure: Cocaine abstinence
timeFrame: 24 weeks
Secondary outcomes:
measure: Reduced HIV risk behavior
timeFrame: 24 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The APT Foundation, Inc. MRU
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard S. Schottenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05947981: Pre-operative 5% Dextrose Infusion & PONV
Official title: Is Pre-operative Infusion of 5% Dextrose Effective in Reducing the Incidence of PONV in Middle Ear Surgery? A Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea, Postoperative
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: With this study, we aim to compare the efficacy of pre-operative dextrose-containing fluid infusion with other fluid for the prevention of PONV in middle ear surgeries.

Detailed description: We hypothesized that maintenance of stable level of blood glucose in addition to adequate hydration through preoperative intravenous dextrose 5% infusion will have a rule in decreasing the incidence and severity of PONV; as it reduces insulin resistance and decreases gastric acid secretion; which may contribute to PONV.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I and ll.
* Patients undergoing middle ear surgeries, mastoidectomy, or tympanoplasty

Exclusion Criteria:

* history of dependence or use of antiemetics
* history of motion sickness
* presence of psychiatric illness
* pregnant and lactating women
* cardiovascular disorders (Ischemic heart diseases, congestive heart failure and valvular diseases)
* Diabetic patients

Primary outcomes:
measure: PONV
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine- Cairo University
Study officials:
References:
Clinical trial NCT02418481: Safety and Efficiency of γδ T Cell Against Breast Cancer(Her-, er-, and pr-)
Official title: γδ T Cell Immunotherapy for Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: γδ T Cell
breast cancer
her2-
er-
pr-
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
First posted: 2015-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, effects of γδT cells on human breast cancer (her2-, er-,pr-) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

Detailed description: Breast tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as immunotherapy.

Eligibility criteria: Inclusion Criteria:

1. Age:18-75
2. Karnofsky performance status \>50
3. Diagnosis with breast tumors based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery, gd Tcells/ DC-CIK.
6. Life expectancy: Greater than 3 months
7. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other kinds of cancer
2. History of coagulation disorders or anemia
3. Patients with heart disease and diabetes

Primary outcomes:
measure: Reduced size of the tumors
timeFrame: Up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06050681: Calm Athlete: Feasibility of App-based Mindfulness Training on Collegiate Student-Athletes' Mental Wellbeing
Official title: Calm Athlete: Feasibility of App-based Mindfulness Training on Collegiate Student-Athletes' Mental Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Mental Health Wellness
Keywords: Athlete
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group intervention feasibility
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate the feasibility of a mobile app-based mindfulness training program in collegiate student-athletes. The main questions it aims to answer are:

* Is a app-based mindfulness program feasible for use with collegiate student athletes?
* What, if any, benefits are seen in the mental wellbeing of collegiate student athletes following mindfulness training?

Participants will use the Calm app to complete semi-structured program of 21 mindfulness sessions over 6 weeks. Participants will complete each 8-15 minute sessions at a location and time of their choosing.


Eligibility criteria: Inclusion Criteria:

* 18-30 years old
* NCAA athlete academically eligible to practice and compete in sport, and physically cleared by university sports medicine staff for participation
* Not a regular user of mindfulness meditation in the last 6 months (\<4 sessions/month)
* Willingness to create an account on the Calm app and share usage data with researchers
* Fluent in English

Exclusion Criteria:

* Regular mindfulness meditation practice (\>4 sessions/month)
* Not currently an NCAA eligible athlete
* Hospitalization or intensive outpatient treatment for mental illness within the past 2 years
* Not cleared by sports medicine staff to participate in sport due to injury at time of enrollment
* Not willing to download the Calm app and/or create an account
* Not willing to share app usage data with researchers
* Not fluent in English

Primary outcomes:
measure: Feasibility- Adherence
timeFrame: Measured at end of 6 week intervention
measure: Feasibility- Participant Intervention Satisfaction
timeFrame: Measured at end of 6 week intervention
measure: Feasibility- Retention
timeFrame: Measured at end of 6 week intervention and at 4 week follow up
Secondary outcomes:
measure: Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: Measured at baseline, at end of 6 week intervention and at 4 week follow-up
measure: College Student Athlete Life Stress Scale (CSALSS)
timeFrame: Measured at baseline, at end of 6 week intervention and at 4 week follow-up
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana Champaign
state: Illinois
Study officials:
References:
Clinical trial NCT00361881: Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
Official title: A Randomized, Double-Blind, Active Controlled, Vehicle-Controlled, Subject Initiated Study Comparing Efficacy and Safety of ME-609 Versus Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Labialis
Lead sponsor: Medivir
Sponsor class: INDUSTRY
First posted: 2006-08-09
Enrollment: 1443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.

Detailed description: This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.

Eligibility criteria: Inclusion Criteria:

* Generally good health
* History of recurrent herpes labialis with at last three episodes during the prior 12 months

Exclusion Criteria:

* Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization
* Pregnant and/or nursing women
* Continuous daily treatment with pain medication
* Significant skin condition that occur in the area of herpes recurrences

Primary outcomes:
measure: Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage.
timeFrame: 5 days
Secondary outcomes:
measure: Episode duration
timeFrame: until healing
Other outcomes:
Locations:
city: Mt. Pleasant
country: United States
facility: Coastal Caroline Research Center
state: South Carolina
Study officials:
name: Christopher M Hull, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hull CM, Harmenberg J, Arlander E, Aoki F, Bring J, Darpo B, Levin MJ, Tyring S, Spruance SL; ME-609 Study Group. Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial. J Am Acad Dermatol. 2011 Apr;64(4):696.e1-11. doi: 10.1016/j.jaad.2010.08.012. Epub 2010 Sep 20.