louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03814863: China Red Eye Study
Official title: China Red Eye Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Red Eye
Keywords: red eye
conjunctival congestion
ophthalmology clinic
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 4382
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with "red eye".

Brief summary: This study intends to use a hospital-based multi-center cross-sectional study to understand the disease composition of "red-eye" patients in Chinese ophthalmology clinics. This study will provide important clinical diagnosis and treatment data for common eye diseases in China with "red eye" as the main performance.

Detailed description: Red eye is a common sign of eye diseases. Eye diseases such as ocular surface inflammation, glaucoma, and uveitis can be expressed as red eyes. The disease with red eye as the main complaint is the most common condition that clinicians need to identify. It is not uncommon to be misdiagnosed and missed clinically. The collection and analysis of the disease composition of the "red eye" in Chinese ophthalmology clinics will help to understand the current status of "red eye" related diseases and provide a systematic and comprehensive clinical basis for the differential diagnosis of red eye.

Eligibility criteria: Inclusion Criteria:

* Confirmation of signs under the slit lamp is red eye

Exclusion Criteria:

* The investigator believes that there are any unsuitable reasons for participating in the trial.

Primary outcomes:
measure: medical diagnosis of each patient
timeFrame: 1 day (when the patient come the the doctor)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
state: Guangdong
city: Haikou
country: China
facility: Hainan Eye Hospital and Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Hainan
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University and Hainan Eye Hospital
city: Nanning
country: China
facility: Nanxishan Hospital of Guangxi Zhuang Autonomous Region
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Wuhan
country: China
facility: llege of Huazhong University of Science and Technology
city: Xinjiang
country: China
facility: the first affiliated hospital of Xinjiang medical university
Study officials:
References:
Clinical trial NCT05587335: Project Harmony 2.0: Relationship Education for Couples
Official title: Project Harmony 2.0: A Relationship Education Intervention for Couples
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Marital Relationship
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In person and online arms
Primary purpose: PREVENTION

Brief summary: Project Harmony directly addresses prioritized areas identified by Administration of Children and Families, emphasizing healthy marriage promotion activities and career advancement opportunities for adults. Included in service provisions are elements of: \[a\] marriage and relationship education/skills, \[b\] marriage enhancement, \[c\] divorce reduction and \[d\] job and career advancement. The targeted service population for Project Harmony includes married/committed couples in the greater Orlando metro area.

Detailed description: The primary program consists of 12 hours of relationship education. The investigators seek to conduct an impact evaluation utilizing a randomized control trial (RCT) to compare outcomes of couples enrolled in either face to face relationship education or web-based relationship education to assess the impact of program structure on outcomes. By offering both face to face and online versions of evidenced based curricula, the investigators are directly addressing requests from ongoing needs assessments of our targeted population. The project is designed for couples 18 years and older; all participants in the face-to-face group will receive the Prevention and Relationship Education Program (PREP) 8.0 + Career Pathways Program (CPP) curricula whereas couples in the online group will receive the OurRelationship Intervention + CPP curricula.

Eligibility criteria: Inclusion Criteria:

* Must be 18 years older and be in a committed relationship, must attend with partners

Exclusion Criteria:

-

Primary outcomes:
measure: Revised Dyadic Adjustment Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT00525135: Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer
Official title: A Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive, which will allow for detection of tumor and make further ablation treatment effective.

Detailed description: PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments.

Eligibility criteria: INCLUSION CRITERIA:

DISEASE CHARACTERISTICS

* Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin that is radioiodine-unresponsive
* Cumulative dose of radioiodine \< 800 mCi
* No radioiodine uptake on whole body scan within 18 months of enrollment
* Inoperable extensive locoregional tumor mass and/or metastatic spread
* Failed conventional therapy that included total thyroidectomy AND radioactive iodine I 131 ablation
* Elevated thyroglobulin level (\>2ng/ml on thyroid hormone, \>10ng/ml off thyroid hormone)or Tg-antibody positive

PATIENT CHARACTERISTICS

-18 years or older

Entry lab results:

* Hemoglobin \> 8.0 gm/dl
* Absolute Neutrophil Count \> 750 cells/mm3
* Platelet count \> 75000/mm3
* BUN \< 1.5 times upper limit of normal (ULN)
* Creatinine \< 1.5 times ULN
* Total protein \> 6.4
* Total bilirubin should be \< 1.5 times ULN.
* AST (SGOT), ALT (SGPT), ALKP and amylase \< 1.5 times ULN
* Amylase \< 1.5 times ULN
* Albumin \> 2.5
* Ammonia \< 1.5 times ULN

EXCLUSION CRITERIA:

* Not pregnant
* No nursing within the past 3 months
* No allergy to valproic acid
* No coexisting malignancy other than basal cell carcinoma
* No hepatic disease or significant dysfunction
* Karnofsky score \> 80
* No pancreatitis
* No kidney dysfunction
* Fertile patients must use effective contraception

Primary outcomes:
measure: Decrease in Thyroglobulin Level
timeFrame: Baseline, 16 weeks
measure: Decrease in Tumor Size
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Increased Radioactive Iodine Uptake
timeFrame: Baseline, 10 weeks
measure: Side Effects of Drugs Affecting Quality of Life
timeFrame: 17 weeks
measure: Survival
timeFrame: up to 10 years post-study treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Electron Kebebew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00925535: Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
Official title: Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Rifabutin And Lersivirine (UK-453,061) In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics HIV Tuberculosis Lersivirine UK-453
061 Rifabutin
HIV Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Hypersensitivity/allergic reactions to any component of the study drugs.

Primary outcomes:
measure: Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h
timeFrame: 20 days
measure: Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h
timeFrame: 20 days
Secondary outcomes:
measure: Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments
timeFrame: 58 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04920435: Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Medical Imaging
Official title: Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Magnetic Resonance Imaging, Contrast Injection Computed Tomography and Positron Emission Tomography at 18-FDG in Locally Advanced Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: locally advanced rectal cancer
radiomic
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with locally advanced rectal cancer

Brief summary: In patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. A powerful prediction model is needed to guide management of this population.

Radiomics features provide complementary information about tumor heterogenity.

The aim of the investigators is to develop a model combining clinical and radiomic criteria able to predict complete pathological response.


Eligibility criteria: Inclusion Criteria:

* locally advanced rectal cancer
* patients who received concomitant radio-chemotherapy followed by surgery
* pre-therapeutic MRI and CT-scan dicom available

Exclusion Criteria:

* age under 18 yo
* lack of MRI or CT-scan

Primary outcomes:
measure: Prediction of the complete response (pCR) to neoadjuvant chemoradiotherapy
timeFrame: TO = Immediately after biopsy and extension evaluation.
Secondary outcomes:
Other outcomes:
Locations:
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
state: Bretagne
city: Nantes
country: France
facility: ICO
state: Saint Herblain
city: Brest
country: France
facility: CHRU de Brest (Morvan)
Study officials:
References:
Clinical trial NCT05849935: abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003
Official title: A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Abionic SA
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2023-05-09
Enrollment: 61
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: Adult healthy population

Brief summary: This is a monocentric, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.


Eligibility criteria: Inclusion Criteria:

1. Male or female, aged ≥ 18 years.
2. Apparently healthy as determined by a subject questionnaire.

Exclusion Criteria:

1. Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to

   1. Renal disease
   2. Stoke
   3. Liver disease
   4. Pancreatic disease (including diabetes)
   5. HIV AIDS
   6. Receiving antibiotic therapy
   7. Suspected infection
   8. Immunosuppression
2. Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.
3. Current diagnosis of uncontrolled diabetes.
4. Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.
5. Experienced severe trauma, surgery, cardiac arrest, or severe burn within the previous 3 months requiring medical care.
6. Diagnosis and/or treatment of cancer within the last 12 months.
7. Received immunosuppressive therapy.
8. Hospitalization for more than 24 hours within the last month.
9. Reported as currently pregnant or nursing a child
10. Unable or unwilling to provide the required blood sample for testing.

Primary outcomes:
measure: To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population.
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Sundance Clinical
state: Missouri
Study officials:
References:
Clinical trial NCT03132935: Telemedical vs. Conventional Prehospital Care in Acute Coronary Syndromes
Official title: Quality Outcomes in Acute Coronary Syndromes Between Telemedically Supported Paramedics and Conventional On-scene Physician Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Non-STEMI Acute Coronary Syndrome
ST-segment elevation myocardial infarction
Telemedicine
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who called the emergency medical service and the paramedics suspect acute coronary syndrome.

Brief summary: Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups.

Detailed description: Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups. All data was collected prospectively for quality management purposes and analyzed retrospectively after ethical approval by the local ethics committee.

Eligibility criteria: Inclusion Criteria: symptoms of acute coronary syndrome -

Exclusion Criteria: secondary transfers from hospital to hospital, traumatic chest pain

-

Primary outcomes:
measure: Adverse events
timeFrame: prehospital phase (0.5-2 hours)
Secondary outcomes:
measure: Correct use of Aspirin
timeFrame: prehospital phase (0.5-2 hours)
measure: Correct use of unfractionated Heparin (UFH)
timeFrame: prehospital phase (0.5-2 hours)
measure: Correct use of Morphine
timeFrame: prehospital phase (0.5-2 hours)
measure: Use of 12-lead-ECG
timeFrame: prehospital phase (0.5-2 hours)
measure: Correct transport destination
timeFrame: prehospital phase (0.5-2 hours)
measure: Correct use of oxygen
timeFrame: prehospital phase (0.5-2 hours)
measure: Correct use of Glyceroltrinitrate
timeFrame: prehospital phase (0.5-2 hours)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
Study officials:
References:
Clinical trial NCT04542135: Sulindac and Breast Density in Women at Risk of Developing Breast Cancer
Official title: Double-blind, Randomized Phase II Clinical Trial of Sulindac for Reducing Breast Density in Postmenopausal Women at Risk of Developing Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Density
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Cedars-Sinai Medical Center
First posted: 2020-09-09
Enrollment: 62
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine if sulindac at a dose of 150 mg twice a day for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control.


Eligibility criteria: Inclusion Criteria:

1. Age ≤70 years
2. Subject must be postmenopausal.
3. Must have at least one healthy normal appearing breast (no prior diagnosis of invasive cancer, radiation or prosthetics). Prior biopsies are acceptable.
4. Must have dense breasts
5. Must be at elevated risk for developing breast cancer by abnormal pathological findings, family history, or genetic predisposition
6. A negative fecal occult blood test
7. Normal organ function
8. Hormonal therapy with aromatase inhibitors is allowed

Exclusion Criteria:

1. Daily aspirin or other daily anti inflammatory use.
2. Known intolerance to anti inflammatory.
3. Use of any selective estrogen receptor modulator therapy (e.g., tamoxifen, raloxifene) within past 12 months
4. Gastrointestinal, bleeding or coagulation, cardiovascular disorders.
5. Diabetes requiring insulin therapy.
6. Current regular smoker.
7. History of claustrophobia or inability to undergo imaging in a closed magnetic resonance imaging.
8. Cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses that would preclude MRI.
9. Uncontrolled hypertension.

Primary outcomes:
measure: Change in percent breast density by MRI between treatment arms
timeFrame: 12 months
Secondary outcomes:
measure: Change in percent breast density by MRI between treatment arms
timeFrame: 6 months
measure: Changes in in percent breast density by MRI within and between treatment arms, stratified by use of aromatase inhibitors
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai - Cancer
state: California
city: Stony Brook
country: United States
facility: Stony Brook University Cancer Center
state: New York
Study officials:
affiliation: Stony Brook University
name: Alison S Stopeck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Patricia A Thompson-Carino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02017535: An Adaptive Treatment Strategy for Adolescent Depression-Continuation
Official title: A Personalized Approach to Achieving a Sustained Response to Treatment for Adolescent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Adolescent Depression
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aim 1: Assess the feasibility and acceptability of the personalized continuation treatment strategy.

Aim 2: Estimate variances of primary and secondary outcomes with the continuation treatment.

Aim 3: Conduct exploratory hypothesis-generating analyses to inform further development of the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.

Detailed description: Male and female adolescents (ages 12-18) will be eligible for the study if they completed acute phase treatment and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)). Adolescents will enter continuation treatment having either received 12 sessions of IPT-A, 16 sessions of IPT-A, or 12 sessions of IPT-A plus fluoxetine.This is a continuation of the study "An Adaptive Treatment Strategy for Adolescent Depression (PTAD)" NCT01802437

Eligibility criteria: Inclusion Criteria:

* Adolescents and parents must be English-speaking
* Completed acute phase treatment (NCT01802437) and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)).

Exclusion Criteria:

- Did not completed acute phase treatment (NCT01802437) or did not show at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)) to acute phase treatment.

Primary outcomes:
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: 16 weeks, 32 weeks
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 16 weeks, 32 weeks
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 16 weeks, 32 weeks
measure: Social Adjustment Scale - Self Report (SAS-SR)
timeFrame: 16 weeks, 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Department of Psychiatry
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Meredith Gunlicks-Stoessel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gunlicks-Stoessel M, Mufson L, Bernstein G, Westervelt A, Reigstad K, Klimes-Dougan B, Cullen K, Murray A, Vock D. Critical Decision Points for Augmenting Interpersonal Psychotherapy for Depressed Adolescents: A Pilot Sequential Multiple Assignment Randomized Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):80-91. doi: 10.1016/j.jaac.2018.06.032. Epub 2018 Oct 27.