louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00207571: Partner Notification Intervention for STD Clinics.
Official title: Computer-assisted STD Partner Notification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Contact Tracing
Keywords: computer
video
partner notification
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-21
Enrollment: 150
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: To help public health professionals (DIS) in interviews of patients infected with STD for the names of their sex partners, this project used a computer-based partner elicitation program before the actual DIS interview. The main outcome was the mean number of partners named by those who had the intervention versus those those who did not.

Detailed description: The primary goal of this project is to develop and evaluate an intervention that will increase the number of people who, having been exposed to a sexual partner with chlamydia, gonorrhea or syphilis, (a) are notified and (b) receive evaluation and treatment. The intervention program will be presented entirely by an automated multimedia computer system with touch screen interface. The intervention will be tailored to user, based on demographic and recent sexual history factors. The intervention is designed to (a) motivate and prompt STD clinic clients to recall and identify sexual partners, (b) teach clinic clients a set of social skills for minimizing negative reactions while informing partners that they may be infected with an STD; (c) increase client's self-efficacy relative to disclosing partners names and informing them of their STD exposure, and (d) provide clients with tools for motivating their partners to seek treatment.

Eligibility criteria: Inclusion Criteria:

* 18 or older AND
* Anglo, Hispanic, or Black AND
* STD diagnosis positive

Exclusion Criteria:

* Non-English speaker

Primary outcomes:
measure: 1. Numbers of partner named.
measure: 2. Amount and quality of identifying information.
Secondary outcomes:
measure: 1. Willingness to name partners.
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Matthew Hogben, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Research Institute
name: Christy Sherman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01865071: Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
Official title: Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: ileostomy
rectal resection
proctectomy
stoma closure
rectal cancer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

Detailed description: The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer.

Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.

Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma.

A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation.

If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed.

Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection.

Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.

LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* All patients aged 18 years or older.
* All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
* Written informed consent was obtained from all patients

Exclusion Criteria:

Primary outcomes:
measure: Mortality
timeFrame: Death occurring during the first 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense Universityhospital
state: Fyn
Study officials:
affiliation: Odense Universityhospital
name: Mark Ellebæk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05863871: Real World Study of Linperlisib for Lymphoma Treatment
Official title: Real World Study of Linperlisib for Lymphoma Treatment: Multicenter, Non-interventional and Observational Real-world Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Focus on the Lymphoma Including B/T-cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2023-05-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical diagnosis of lymphoma

Brief summary: This is a multicenter, non-interventional and observational real-world study to evaluate the efficacy and safety of linperlisib in patients with lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Clinical diagnosis of lymphoma patients
3. Patients signed informed consent, volunteered to join the study, and had the willingness and ability to cooperate with the data collection in this study;
4. The researchers' assessment can use Linperlisib treatment

Exclusion Criteria:

1. The nature of the study could not be understood or informed consent was not obtained
2. Other ineligible conditions were assessed by the investigator

Primary outcomes:
measure: Rate of adverse events (AEs)/ serious adverse events (SAEs)
timeFrame: up to 4 weeks after the last dose
Secondary outcomes:
measure: Complete response rate
timeFrame: 6 months
measure: Progression-free survival
timeFrame: 1 years and 2 years
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: Duration of response
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Tianjin
country: China
facility: Tianjin Cancer Hospital/ Tianjin medical university cancer institute & hospital
Study officials:
References:
Clinical trial NCT02975271: Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pruritus
Burns
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of the Efficacy, Safety \& Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury


Eligibility criteria: Key Inclusion Criteria:

* Male or female, age 18-65 years at consent.
* History of serious burn injury
* Pruritus (itchiness) prior to the initial screening visit and during the screening period
* Judged to be in good health in the investigator's opinion.

Key Exclusion Criteria:

* Prior treatment with study drug or similar drug
* Pruritus (itchiness) due to another reason besides burn injury/ healing.
* Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
* History of hypersensitivity to study drug or any of its components.
* Currently pregnant or male partner of pregnant female.
* Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding.

Primary outcomes:
measure: Change in Itch Intensity - Numeric Rating Scale
timeFrame: Week 6
Secondary outcomes:
measure: Itch Intensity Responder Rate - Numeric Rating Scale
timeFrame: Week 6
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Study Site 404
state: Arizona
city: Washington
country: United States
facility: Study Site 402
state: District of Columbia
city: Gainesville
country: United States
facility: Study Site 412
state: Florida
city: Tampa
country: United States
facility: Study Site 403
state: Florida
city: Lincoln
country: United States
facility: Study Site 409
state: Nebraska
city: Winston-Salem
country: United States
facility: Study Site 401
state: North Carolina
city: Seattle
country: United States
facility: Study Site 413
state: Washington
Study officials:
References:
Clinical trial NCT00350571: Brief Interventions for Drop-out Re-engagement
Official title: Adaptive Brief Interventions for Drop-out Re-engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Abuse
Keywords: behavior therapy
counseling
drug abuse therapy
outpatient care
therapy compliance
clinical trial phase I
coping
outcomes research
satisfaction
social psychology
patient oriented research
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2006-07-11
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: We will evaluate a series of interventions intended to help individuals who drop out of substance abuse treatment re-engage in order to improve treatment outcome.

Detailed description: We propose a 5-year Stage I behavioral therapy development study to: 1) prospectively evaluate risk factors for premature drop-out from outpatient treatment; 2) develop and test a manual of single session phone-and office-based interventions to re-engage these individual in treatment.

Eligibility criteria: Inclusion Criteria:

* admission to outpatient treatment

Exclusion Criteria:

* need for hospitalization

Primary outcomes:
measure: retention into outpatient treatment
timeFrame: 4, 8, 12, 24 weeks
Secondary outcomes:
measure: substance abuse
timeFrame: 4, 8,12,and 24 weeks
measure: psychiatric symptoms
timeFrame: 4, 8, 12, and 24 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Foundation
state: Connecticut
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Sam Ball, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06841471: Role of Corneal Nerves in Dry Eye Disease
Official title: Association Between Corneal Sensitivity, Nerve Morphology, Tear Film Homeostasis and Dry Eye Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye Disease (DED)
Dry Eye
Dry Eye Sensation
Corneal Nerve
Lead sponsor: University of Applied Sciences and Arts Northwestern Switzerland
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults as well as adult with dry eye disease

Brief summary: This study aims to determine whether corneal nerve function and morphology are affected by tear film instability and ocular surface homeostasis loss. Additionally, it seeks to investigate whether these factors vary based on the severity of dry eye symptoms.


Eligibility criteria: Inclusion Criteria:

* Group with DED: Diagnosis of DED based on the TFOS DEWS II report
* Group without DED: No diagnosis of DED

Exclusion Criteria:

* Exclusion criteria:
* Systemic disease that may affect ocular health and innervation
* injury or history of operations on the anterior or posterior segment of the eye, which can affect the corneal structure and physiology
* regular application of systemic or ocular medication known to affect the tear film except from DED medications
* eye drops or makeup on the day of measurement.

Remarks:

Contact lens wearers are asked not to wear contact lenses for 1 week before the first appointment.

Participant with DED medications will be asked to use only conservative-free eye drops on the days of examination

Primary outcomes:
measure: Differences of corneal nerve function and morphology in relation with DED signs
timeFrame: within one week
Secondary outcomes:
measure: Differences of corneal nerve function and morphology in relation with DED symptoms
timeFrame: within one week
Other outcomes:
Locations:
city: Olten
country: Switzerland
facility: Institute of Optometrym FHNW
Study officials:
References:
citation: Belmonte C, Nichols JJ, Cox SM, Brock JA, Begley CG, Bereiter DA, Dartt DA, Galor A, Hamrah P, Ivanusic JJ, Jacobs DS, McNamara NA, Rosenblatt MI, Stapleton F, Wolffsohn JS. TFOS DEWS II pain and sensation report. Ocul Surf. 2017 Jul;15(3):404-437. doi: 10.1016/j.jtos.2017.05.002. Epub 2017 Jul 20.
Clinical trial NCT01637571: Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain
Official title: The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chest Pain
Gastrointestinal Reflux Disease
Keywords: GERD
NCCP
chest pain
reflux
GERD related non-cardiac chest pain
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP.

The patient will undergo esophageal balloon distention testing (EBDT) before and after taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical properties of the esophagus. A catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will be done throughout the study as a measurement of safety.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-75 years
2. NERD, or GERD LA Class A-B (endoscopy)
3. Subjects with positive pH testing
4. At least one episode of chest pain a week in the past month
5. Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram)
6. Negative esophageal evaluation for a motility disorder (Nutcracker esophagus, achalasia)

Exclusion Criteria:

1. Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy
2. Subjects with previous upper gastrointestinal surgery
3. Pregnancy
4. Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities
5. (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric).
6. Subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm).
7. Medications such as baclofen, and prokinetic agents.
8. History of substance abuse

Primary outcomes:
measure: Frequency of chest pain episodes in treatment vs placebo groups
timeFrame: 12 weeks
Secondary outcomes:
measure: Intensity of chest pain episodes
timeFrame: 12 weeks
measure: Sensory thresholds for first sensation
timeFrame: 12 weeks
measure: Sensory thresholds for discomfort
timeFrame: 12 weeks
measure: Sensory thresholds for pain
timeFrame: 12 weeks
measure: duration of chest pain episodes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Ron Schey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02990871: Efficacy of an Early Rehabilitation on Decannulation Time of Patients With Severe Acquired Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injury
Tracheostomy
Neurological Rehabilitation
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with tracheostomy, affected by severe acquired brain injury, hospitalized in our Neurorehabilitation department.

Brief summary: All the patients hospitalized in the neuro-rehabilitation after a severe acquired brain injury carrying a tracheal cannula will be retrospectively analyzed. Patients coming from emergency department started a rehabilitative treatment during their hospitalization in ICU. Patients transferred from an external ICU started the rehabilitation in neurorehabilitation department. Aim of the study is to evaluate if an early rehabilitation, started since the acute stage of the damage, is able to reduce the decannulation time in this group of patients.


Eligibility criteria: Inclusion Criteria:

* presence of a tracheostomy at admission in NRehab
* patient moved from an ICU
* GCS≤11 at admission in ICU
* tracheostomy performed for decreased mental status due to the ABI,

Exclusion Criteria:

* tracheostomy performed prior to admission to the ICU
* need for ventilation support.

Primary outcomes:
measure: decannulation time
timeFrame: at data collecting, an average of 1 day
Secondary outcomes:
measure: length of stay ICU
timeFrame: at data collecting, an average of 1 day
measure: decannulation time in NRiab
timeFrame: at data collecting, an average of 1 day
measure: Coma Recovery Scale revised score at discharge
timeFrame: at data collecting, an average of 1 day
measure: Glasgow Coma Scale score at discharge
timeFrame: at data collecting, an average of 1 day
measure: Disability Rating Scale Score at discharge
timeFrame: at data collecting, an average of 1 day
measure: Levels of Cognitive Functioning score at discharge
timeFrame: at data collecting, an average of 1 day
Other outcomes:
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Ospedale Generale di Zona Moriggia Pelascini
state: CO
Study officials:
References:
Clinical trial NCT01299571: AVODART(Dutasteride) Post-marketing Surveillance(PMS)
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVODART(Dutasteride) Administered in Korean BPH(Benign Prostatic Hyperplasia) Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 3977
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Korean BPH Patients administrated dutasteride

Brief summary: An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information


Eligibility criteria: Inclusion Criteria:

* The Korean BPH Patients administrated dutasteride according to the prescribing information

Exclusion Criteria:

* women and children and adolescents.
* patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.

Primary outcomes:
measure: Number of Participants With an Adverse Event
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With a Serious Adverse Event
timeFrame: 6 months
measure: Number of Participants With the Indicated Unexpected Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03508271: Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure
Official title: Real-World Comparative Effectiveness Research Among Elderly Non-valvular Atrial Fibrillation (NVAF) Patients With Heart Failure (HF) Using Oral Anticoagulants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Heart Failure
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-04-25
Enrollment: 60000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly individuals diagnosed with NVAF (non-valvular atrial fibrillation) and HF (heart failure) who are new initiators of DOAC's (direct oral anticoagulants)

Brief summary: Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners


Eligibility criteria: Inclusion Criteria:

* Were age greater than or equal to 65 years as of the index date
* Had greater than or equal to 1 diagnosis of AF prior to or on the index date
* Had greater than or equal to 1 diagnosis claim of HF during the 12 months prior to or on the index date
* Had 1 or more pharmacy claim for oral blood thinners

Exclusion Criteria:

* Claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
* Pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period
* Greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day
* Had medical claim indicating VTE in the 12 months prior to index date

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of stroke/systemic embolism (SE)
timeFrame: Approximately 195 weeks
measure: Incidence of major bleeding
timeFrame: Approximately 195 weeks
Secondary outcomes:
measure: Incidence of miocardial infarction (MI)
timeFrame: Approximately 195 weeks
measure: Incidence of all cause mortality
timeFrame: Approximately 195 weeks
measure: Incidence of all cause hospitalization
timeFrame: Approximately 195 weeks
measure: Incidence of major adverse cardiac event
timeFrame: Approximately 195 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Local Institution
state: Michigan
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: