louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03916042: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease
Official title: A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 206
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: A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects with Dry Eye Disease


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age of either gender and any race;
* Have a reported history of dry eye for at least 6 months prior to Visit 1;
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

* Have any clinically significant slit-lamp findings at Visit 1, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle;
* Have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have used any eye drops within 2 hours of Visit 1;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
* Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
* Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period

Primary outcomes:
measure: Change From Baseline in Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
timeFrame: Efficacy assessment period (Day 1 through 85) - assessed at Weeks 1, 2, 4, 6, 8, 10, and 12. Baseline was Day 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT06653842: A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations
Official title: A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cutaneous Venous Malformations
Lead sponsor: Palvella Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-22
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX022 (sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations


Eligibility criteria: Inclusion Criteria: The participant must have a clinically confirmed superficial/ cutaneous (visible on the skin) venous malformation (cVM), referred to as the treatment area. The treatment area may contain a minority (\<30%) lymphatic component (mixed venous / lymphatic malformation).

-

Exclusion Criteria:

* The participant's treatment area is mainly in any wet mucosa or within the orbital rim. For clarification, no part of the venous malformation should be evaluated or treated if it in mucosa. External genital presentation is permitted.
* The participant has a known pervasive extension of the lesion into mucosa, bone or tissue (as determined by diagnostic or the investigator) that would impair the ability of the investigator to evaluate the cutaneous components of the lesion.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Week 12
Secondary outcomes:
measure: Change in Investigator Global Assessment (cVM-IGA) From Baseline to Week 12
timeFrame: Change from baseline to Week 12
measure: Overall Patient Global Impression of Change (PGI-C) From Baseline to Week 12
timeFrame: Change from baseline to Week 12
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Colorado Children's Hospital
state: Colorado
city: Baltimore
country: United States
facility: John's Hopkins
state: Maryland
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
References:
Clinical trial NCT04348942: A COVID-19 Symptom, Exposure and Immune Response Registry
Official title: COVID-19 Study - A Primarily Prospective Observational Study of COVID-19 Clinical Characteristics and Acquired Immune Response Within the General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: ObvioHealth
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults residing in the USA, regardless of past or current COVID-19 status

Brief summary: This is a 6-month, 100% remote study that will collect a broad range of data that may provide insight into the COVID-19 global pandemic. Data collected will include participant medical histories, history of prior SARS-CoV-2 infection and exposure to known cases. On an ongoing basis data will be collected on new contacts with known cases, the presence of COVID-19 symptoms, including severity and outcome, and information on the immune system response to SARS-CoV-2 infection.

Detailed description: This is a 6-month, 100% remote study that will collect a broad range of data that may provide insight into the COVID-19 global pandemic. All data will be collected by participant entry into a mobile app designed for this study.

Upon entering the study, participants will be asked a series of questions about their prior exposure to the SARS-CoV-2 virus including reporting prior test results, and identification and description of contact with known or cases or other high risk encounters. Participants will also provide a detailed medical history.

On on ongoing basis, participants will be asked to report any symptoms associated with COVID-19 that they develop, and any new contacts they experience with known cases. Some participants will be sent an at-home SARS-CoV-2 antibody test and asked to report the results. In addition, participants will be asked to report the result of any other test they receive for COVID-19 outside of the study.

Eligibility criteria: Inclusion Criteria:

* Open to any adult individuals (18 years of age or older) permanently residing in the United States
* Have regular access to smartphone and internet sufficient to support registry demands
* Willing and able to follow the procedures of the study
* Willing and able to provide informed consent

Exclusion Criteria:

* Participants unable to understand the study protocol or provide informed consent
* Participants unable or unwilling to perform all requested study tasks

Primary outcomes:
measure: Registry Data
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: ObvioHealth
state: Florida
Study officials:
References:
citation: Shah P, Magee K, Buccellato KH, Ismond M, Watson J. Real world data on cardiometabolic diseases in U.S. adults during the SARS-CoV-2 pandemic: a decentralized registry study. Cardiovasc Diabetol. 2022 Feb 14;21(1):24. doi: 10.1186/s12933-022-01462-3.
Clinical trial NCT05370742: Comparison of Clinical and Radiological Results of Using Only Screws and Plate Use in Latarjet Operation in Shoulder Instability
Official title: Comparison of Clinical and Radiological Results of Using Only Screws and Plate Use in Latarjet Operation in Shoulder Instability
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Shoulder Dislocation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-05-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Randomized controlled comparison of the clinical and radiological results of using only screws and plate use in latarjet surgery in shoulder instability

Detailed description: Randomized controlled comparison of the clinical and radiological results of using only screws and plate use in latarjet surgery in shoulder instability

2 groups will be determined in the study, while the first group will include the group in which corocoid fixation with cannulated screws was performed, while the second group will include the group that underwent osteosynthesis with plate and screw

The results will be evaluated statistically based on clinical scores (constant, vas) and radiological findings (a angle).

Eligibility criteria: Inclusion Criteria:

- Recurrent shoulder dislocation; 18-65 age

\>%10 glenoid loss or Hill Sacs Lesion

Exclusion Criteria:

- \<18 age \<%10 glenoid loss shoulder dislocation due to epilepsy Dislocations associated with other upper extremity injuries

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Unıversıty faculty of medicine
state: Fatih/Topkapı
Study officials:
References:
Clinical trial NCT02895542: Preparatory Work to Assess Adherence to Oral Chemotherapy
Official title: Preparatory Work to Assess Adherence to Oral Chemotherapy Among Patients With Chronic Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Conducting brief structured interviews, to further understand potential patient characteristics and barriers associated with non-adherence of medication. With this knowledge of identified patient barriers, interventional strategies can be designed to improve CML care, monitoring and adherence.

Brief summary: This study to find out more about how patients take their anticancer medications and challenges related to taking cancer medications.

Detailed description: 120 patients with Chronic Myeloid Leukemia (CML) who are currently prescribed an oral anti-cancer agent from up to 6 CCDR NCORP sites to complete a brief interviewer administered survey to assess medication adherence and related factors.

Eligibility criteria: Inclusion Criteria:

* Patient is diagnosed with Chronic Myeloid Leukemia (CML) and is receiving care for CML at a participating CCDR NCORP practice,
* Patient had been prescribed one of the following oral anticancer agents for CML for ≥30 days (Imatinib, Nilotinib, Dasatinib, Bosutinib, Ponatinib). Prior use of any of these medications is allowed, as long as they have been on a stable regimen for at least 30 days prior to enrollment.
* Patient is 18 years of age or older

Exclusion Criteria:

* Patient does not speak English or requires an interpreter for medical visits
* Patient is cognitively impaired, as determined by the referring provider

Primary outcomes:
measure: Patient Demographic and Health Behaviors Questionnaire
timeFrame: Study 1 day Visit
measure: Brief Medication Questionnaire (BMQ)
timeFrame: Study 1 day Visit
measure: Single Item Adherence Measure 1
timeFrame: Study 1 day Visit
measure: Single Item Adherence Measure 2
timeFrame: Study 1 day Visit
Secondary outcomes:
measure: REALM-SF
timeFrame: Study 1 day Visit
measure: Medications Adherence Reasons Scale (MARS)
timeFrame: Study 1 day Visit
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kathryn Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06694142: Feasibility of Addressing Sexual Dysfunction in Women with Breast and Gynecologic Cancers with a Novel Mobile Application
Official title: Not Always ROSY-Feasibility of Addressing Sexual Dysfunction in Women with Breast and Gynecologic Cancers with a Novel Mobile Application
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexual Dysfunction
Keywords: breast and gynecologic cancer patients
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to identify breast and gynecologic cancer patients with sexual dysfunction, to measure sexual dysfunction with the Female Sexual Function Index (FSFI) and to provide Patients with the opportunity during this six-month period to follow up with a healthcare provider to discuss the sexual dysfunction needs and to see if a medical intervention can be of aid.


Eligibility criteria: Inclusion Criteria:

* Patient with a current or historic diagnosis of breast cancer or gynecologic cancer (uterine ovarian, fallopian tube, peritoneal, cervical, vulva, or vaginal cancers)
* Agree to participate in the study with completion of survey and use of ROSY mobile application

Exclusion Criteria:

* Currently pregnant
* Non-English speaking (ROSY is currently is only available is in English).

Primary outcomes:
measure: Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI)
timeFrame: Baseline, 6 months
measure: Change in sexual dysfunction as assessed by the Social Determinants of Health (SDOH) questionnaire
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in ethnic minority groups
timeFrame: end of study (6 months after baseline)
measure: Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in sexual and gender minority groups
timeFrame: end of study (6 months after baseline)
measure: Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in unpartnered women
timeFrame: end of study (6 months after baseline)
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: Lavanya P Parsons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04940442: Outreach and Choice in Colorectal Cancer Screening
Official title: Outreach and Choice in Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer Screening
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this clinical trial will be to compare overall colorectal cancer (CRC) screening participation between an active choice (fecal immunochemical test \[FIT\] or colonoscopy) and a sequential choice (FIT offered first, then colonoscoscopy offered in those still unscreened) arm. Secondarily, we will (1) compare the proportions of FIT vs. colonoscopy per arm, (2) compare active choice vs FIT only in the initial 3 months of the study, (3) characterize changes in physician knowledge and attitudes regarding CRC screening before and after an educational seminar delivered at the launch of the initiative, (4) characterize perceptions regarding the effect of the intervention on clinical practices, and (5) compare detection rates of CRC, adenomas and SSLs per arm, and the operational results of the outreach program across arms.


Eligibility criteria: Inclusion Criteria:

1. Adults 45-75 years of age not up to date with CRC screening, and without precancerous polyp history (i.e. not in post-polypectomy surveillance; ascertained based on problem list or colonoscopy results letter).
2. The assessment of screening status will happen monthly, on a rolling basis.
3. Definition of being up to date with CRC screening includes any one of the following:

   i) FIT or guaiac-FOBT within 1 year, OR

ii) Colonoscopy within 10 years, OR

iii) Sigmoidoscopy within 5 years, OR

iv) CT colonography within 5 years, OR

v) Cologuard within 3 years

Exclusion Criteria:

1. Age outside the 45-75 range.
2. History of precancerous polyps requiring colonoscopy surveillance.
3. Already being up to date with CRC screening, as defined above.
4. Evidence of total removal of the colon which would eliminate the need for screening.

Primary outcomes:
measure: Number of patients with screening completion
timeFrame: 6 months from initial offer
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Primary Care Clinics
state: California
Study officials:
References:
Clinical trial NCT06498570: Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus
Official title: Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus; A Retrospective Non-Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cornea Ectasia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus

Detailed description: a retrospective non- randomized controlled clinical study. The study included twenty-three grade 3 keratoconic eyes of twenty-three patients, the keratoconus staging was based on Amsler-Krumeich classification The ICRS surgery was performed with the patient under topical anesthesia. A tunnel channel was created by femtosecond laser using a 60-kHz infrared neodymium glass femtosecond laser at a wavelength of 1053 nm (Abbott Laboratories Inc., Abbott Park, Illinois, USA). Two symmetrical kerarings (Mediphacos Inc., Belo Horizonte, Brazil), were implanted in all cases with 160° arc and 0.25, 0.30 mm according to corneal thickness in implantation site. After surgery, the patients had a full ocular evaluation on days 1, 7, and 14, and again after a month. For a period of 1-year, corneal topography readings were taken quarterly.

Eligibility criteria: Inclusion Criteria:

* stable keratoconus.
* corneal cross-linking performed at least 6 months.
* contact lens intolerance
* minimum corneal thickness of 350 μm at the thinnest point (TP)
* mean keratometry (K mean) value less than 59 D

Exclusion Criteria:

* any other associated ocular or systemic pathology could affect the vision.

Primary outcomes:
measure: K1 and K2 post-operative by Pentacam
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Elshimaa A.Mateen
Study officials:
References:
Clinical trial NCT02952170: Impact of Weight Loss Surgery in Adolescents With NAFLD
Official title: The Impact of Weight Loss Surgery in Adolescents on Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Obesity, Adolescent
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-11-02
Enrollment: 11
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will assess the impact of weight loss surgery (WLS) on non-alcoholic fatty liver disease (NAFLD) in adolescents as well as the interaction between NAFLD and cardiometabolic risk.

Detailed description: While the impact of WLS has been studied in adults, little is known about NAFLD in adolescents undergoing WLS. At present, only a small number of adolescents undergo WLS each year and thus this area has not been well studied. However, as the prevalence of severe obesity continues to rise the investigators anticipate that so will WLS in adolescents.

This study will establish the impact of WLS on NAFLD in adolescents. Currently, it is assumed that adolescents with NAFLD diagnosed at the time of WLS have universal resolution of their disease with appropriate weight loss, and no further evaluation is conducted. Our group has shown that up to 40% of adolescents who undergo WLS have persistently abnormal aminotransferase levels, suggesting that many may have persistent NASH and are at risk of progressive liver disease. The study will elucidate the history of NAFLD following WLS. Such data have not been previously published and will represent a significant contribution to this field.

Eligibility criteria: Inclusion Criteria:

* Obese
* Meets institutional requirements for weight loss surgery

Exclusion Criteria:

* Alcohol consumption or other causes of chronic liver disease
* Intolerance to MRI
* Weight \>435 lbs

Primary outcomes:
measure: Change in hepatitis steatosis after weight loss surgery
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kathleen Corey, MD
role: PRINCIPAL_INVESTIGATOR
References: