louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01216228: Food Patterns, Inflammation Markers of Cardiovascular Disease Risk and Incidence of CVD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Diet
Inflammation
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2010-10-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Malmö Diet and Cancer Cohort (MDC), a large-scale, population-based, prospective cohort study, was designed in the early 1990s to identify dietary and lifestyle risk factors related to the incidence of cancer. Men aged 46-73 years (n =11 063) and women aged 45-73 years (n = 17 035) living in Malmö, the third largest city in Sweden, at that time, were examinedinvited to participate. Baseline examinations took place at the MDC CentreCenter at the Skåne Malmö University Hospital in Malmö between March 1991 and October 1996.

Brief summary: Health outcome studies should examine food patterns, because foods are consumed together and nutrients are metabolized jointly. To examine associations between food patterns and markers of systemic and vascular inflammation at baseline, in a population-based cohort in Malmö, Sweden, and after 13 years of follow-up food pattern associations with CVD incidence.


Eligibility criteria: Inclusion Criteria:

* The "cardiovascular sub-cohort" is a random sample (i.e., 50 percent) of those who joined from November 1991 to February 1994. This group underwent additional examinations to assess carotid arteriosclerosis by ultrasound (n = 6103) and donated blood after fasting (n = 5533).

Exclusion Criteria:

* Subjects were excluded, either because they were using medication for diabetes mellitus or had previously been diagnosed as having diabetes mellitus.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06039228: School-based Group Acceptance and Commitment Therapy for Adolescents
Official title: Thriving Through the Storms: A School-based Mental Health Promotion Program for Building Psychological Flexibility and Resilience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Stress
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the investigators' mental health promotion intervention premised on the Acceptance and Commitment Therapy (ACT) framework in secondary school settings aims to enhance young people's psychological flexibility and reduce their emotional distress. ACT is an evidence-based approach that encourages individuals to act in alignment with their identified values. The investigator's team will employ an ACT protocol for adolescents developed by Louise Hayes and Joseph Ciarrochi. The study includes a single-group study design. The investigator will compare the pre- and post-intervention data to assess the feasibility and potential effectiveness of the group intervention.


Eligibility criteria: Inclusion Criteria:

Eligible participants are adolescents who reported mild to moderate severity of psychological distress, including those who report:

* a score of 5-19 on the Patient Health Questionnaire (PHQ-9), or
* a score of 5-14 on the General Anxiety Disorder-7, or
* a score ≥14 on the Perceived Stress Scale.

Exclusion Criteria:

Adolescents will be excluded if they exhibit or report:

* violent or aggressive behavior, or
* active self-injurious or suicidal thought, or
* active psychotic symptom.

Primary outcomes:
measure: Acceptance and Action Questionnaire - II
timeFrame: Baseline and 4 weeks
measure: The 14-item Resilience Scale
timeFrame: Baseline and 4 weeks
measure: Patient Health Questionnaire - 9
timeFrame: Baseline and 4 weeks
measure: General Anxiety Disorder - 7
timeFrame: Baseline and 4 weeks
measure: Perceived Stress Scale
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Satisfaction with Life Scale
timeFrame: Baseline and 4 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Educational Psychology, The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT04659928: Evaluation of Aerosol in a Dental Clinic
Official title: Evaluation of Aerosol in a Dental Clinic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Covid19
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of external evacuation units and mouth rinses during aerosol generating procedures in a dental clinic and to determine the risk level to the dental practitioners during aerosol generating procedures.


Eligibility criteria: Inclusion Criteria:

* prepping natural teeth at the appointment
* at least an hour long procedure
* procedure will be the first one in the morning

Primary outcomes:
measure: Number of bacterial colony forming units (CFUs) .
timeFrame: 24 to 48 hours after treatment
Secondary outcomes:
measure: Change in number of CFUs
timeFrame: Baseline,1 hour after treatment
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: Claudia Ruiz Brisuela, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06522828: A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open, multicenter Phase II clinical study of SSGJ-707 combined with chemotherapy in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer. The objective is to evaluate the safety, tolerability and antitumor activity of SSGJ-707 in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer.


Eligibility criteria: Inclusion Criteria:

1. Age:18-75 years old
2. Advanced endometrial cancer and platinum-resistant ovarian cancer
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=12 weeks.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: ORR
timeFrame: 12 months
measure: Safety and tolerability
timeFrame: 12 months
Secondary outcomes:
measure: PFS
timeFrame: 24 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
Study officials:
References:
Clinical trial NCT00525928: Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients
Official title: Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Smoking
Depressive Disorder
Keywords: craving
smoking
depression
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2007-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study of psychiatric inpatients will assess mood effects of varenicline, as well as assess if varenicline decreased nicotine cravings acutely.

This study will also measure side effects of varenicline when given in addition to other psychiatric and non-psychiatric medications.

Detailed description: This study will measure mood effects and rapid anti-craving effects of varenicline in psychiatric inpatients. Patients will be offered to participate in the trial if they wish to stop smoking or wish to decrease nicotine cravings while in the hospital. They will not be able to use nicotine replacement products when taking varenicline.

Patients will be assessed with the QIDS-SR16, Minnesota Nicotine Withdrawal Scale as well as the Frequency, Intensity, and Burden of Side Effects (FISER) at baseline and daily during the trial; patients will be asked to enroll for the duration of their hospitalization. Patients will be assessed as to whether they wish to continue varenicline post-discharge.

Eligibility criteria: Inclusion Criteria:

1. Admission to Butler Hospital during study period.
2. Current tobacco users ages 18-65.
3. Able to give written, informed consent.

Exclusion Criteria:

1. Past adverse reaction to varenicline.
2. Treatment with varenicline on admission to Butler Hospital.
3. Renal failure or dialysis

(3) Current pregnancy or breastfeeding.

Primary outcomes:
measure: improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)
timeFrame: duration of hospitalization
measure: improvement in Minnesota Nicotine Withdrawal Scale
timeFrame: days (duration of hospitalization)
Secondary outcomes:
measure: no significant intolerability, measured by the Frequency, Intensity, and Burden of Side Effects (FIBSER) and Adverse Events Checklist (SAFTEE-SI)
timeFrame: duration of hospitalization
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Noah S Philip, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Lawrence H Price, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06764628: A Study of SHR-4375 in Subjects With Solid Tumors
Official title: An Open-label, Single-arm, Multicenter Phase I/II Clinical Study of SHR-4375 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-08
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.


Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily joined the study and signed the ICF.
2. Measurable disease, as defined by RECIST v1.1.
3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.
5. Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.

Exclusion Criteria:

1. Symptomatic, untreated or active central nervous system metastases.
2. With any active autoimmune disease or history of autoimmune disease.
3. Patients with active hepatitis B or hepatitis C.
4. Severe infections prior to initiation of study treatment.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: From Day 1 to 90 days after last dose.
measure: Dose limiting toxicity (DLT)
timeFrame: From Day 1 to 12 months.
measure: Maximal tolerable dose (MTD)
timeFrame: From Day 1 to 12 months.
measure: Recommended phase 2 dose (RP2D)
timeFrame: From Day 1 to 12 months.
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: From Day 1 to 12 months.
measure: Objective response rate (ORR)
timeFrame: From Day 1 to 12 months.
measure: Disease control rate (DCR)
timeFrame: From Day 1 to 12 months.
measure: Duration of response (DOR)
timeFrame: From Day 1 to 12 months.
measure: Overall survival (OS)
timeFrame: From Day 1 to 12 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00663728: Assessment of Duration of Erection With Vardenafil 10 mg
Official title: A Randomized, Double-blind, Crossover Study to Evaluate the Duration of Erection Following Vardenafil (10mg) Administration for Four Weeks in a Fixed Dose Regimen Compared to Placebo in Males With ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-22
Enrollment: 201
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.


Eligibility criteria: Inclusion Criteria:- Males with erectile dysfunction- Stable heterosexual relationship Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months nitrate use

Primary outcomes:
measure: Effect of vardenafil on the duration of erection
timeFrame: 4 weeks
Secondary outcomes:
measure: Perception of erection to be hard enough for penetration
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06654128: The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial
Official title: The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lynch Syndrome
Keywords: lynch syndrome
artificial intelligence
tandem colonoscopy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparison of 2 groups of patients undergoing tandem colonoscopy
Primary purpose: DIAGNOSTIC

Brief summary: We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE).

We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Patients will undergo tandem colonoscopy, the second colonoscopy with either HD-WLE or an AI- assisted device.

Detailed description: We will include patients with a known pathogenic variant (PV) / likely PV in one of the MMR genes, who are undergoing endoscopic screening and surveillance in our institute. Patients will undergo a first colonoscopy with HD-WLE, and will be randomized at 1:1 ratio to undergo a second colonoscopy with either HD-WLE or an AI- assisted device. All visualized polyps will be removed and size, histology and numbers of polyps detected on each exam will be recorded. We will evaluate the adenoma detection rate and polyp detection rate in each arm and the number of adenomas / polyps in each arm.

Eligibility criteria: Inclusion Criteria:

* patients with a known pathogenic variant in one of the mismatch repair genes, who are undergoing endoscopic screening and surveillance in our institute

Exclusion Criteria:

* patients \< 18 years old
* lack of informed consent
* concomitant inflammatory bowel disease
* previous total colectomy
* inadequate bowel cleansing (Boston Bowel Preparation Scale (BBPS) ≤5 or \< 2 in one of the 3 segments)

Primary outcomes:
measure: adenoma incremental detection rate
timeFrame: At the date of enrollment, from the start of colonoscopy until the end of the colonoscopy, in which number of lesions will be detected.
Secondary outcomes:
measure: incremental detection rate for advanced neoplasia and any polyp
timeFrame: At the date of enrollment, from the start of colonoscopy until the end of the colonoscopy.
measure: The increment in adenoma detection rate / polyp detection rate
timeFrame: At the date of enrollment, from the start of colonoscopy until the end of the colonoscopy.
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT00679328: OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions
Official title: Study #91-01 - A Randomized Study of the Stryker OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Nonunions
Lead sponsor: Olympus Biotech Corporation
Sponsor class: INDUSTRY
First posted: 2008-05-16
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.

Detailed description: This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Device to that of traditional bone autografts to repair nonunions.

Eligibility criteria: Inclusion Criteria:

1. Patients must show radiographic skeletal maturity
2. Documented evidence of previous fracture management
3. Nonunion in the tibia and candidate to receive bone autografts and intramedullary (IM) Nail fixation
4. Nonunion gap must not exceed half the diameter of the bone at the site of fracture, as assessed radiographically prior to study treatment

Exclusion Criteria:

1. Patients who do not have adequate vascularity to permit healing
2. Patients with inadequate skin coverage
3. Patients with chronic use of steroidal medications
4. Patients with active infection systemically or at the site of nonunion.

Primary outcomes:
measure: No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging.
timeFrame: 3, 6, 9, 12, 24 months
Secondary outcomes:
measure: Medical events, treatment related events, laboratory tests, medication use.
timeFrame: 3, 6, 9, 12, 24 months
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Modesto
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Fort Carson
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: New Orleans
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Galveston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT00267228: Funen Anorexia Nervosa Study - Retrospective Cohort Study and 10 Year Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia Nervosa
Eating Disorder
Keywords: Anorexia Nervosa
Eating disorder
Quality of life
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-12-20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The aim of the study are:

1. Retrospectively to study the clinical characteristics and features (somatic, psychological and social variables) of patients treated in Center for Eating Disorders, Odense University Hospital 1994-2004.
2. To study the predictive power of the psychosocial and morphometric data with regard to drop outs, relapse and outcome.
3. To investigate eating habits, social functions and quality of life in weight recovered and chronicly ill patients with eating disorder.


Eligibility criteria: Inclusion Criteria:

* Patients treated in Center for Eating Disorders, Odense University Hospital 1994 - 2004.

Exclusion Criteria:

* Patients, who according to the primary clinical evaluation was found not to suffer from eating disorder.
* Patients who at admission did not live in the Funen County.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: René K. Stovring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frolich J, Winkler LA, Abrahamsen B, Bilenberg N, Hermann AP, Stoving RK. Assessment of fracture risk in women with eating disorders: The utility of dual-energy x-ray absorptiometry (DXA)-Clinical cohort study. Int J Eat Disord. 2020 Apr;53(4):595-605. doi: 10.1002/eat.23245. Epub 2020 Feb 12.
citation: Frolich J, Winkler LA, Abrahamsen B, Bilenberg N, Hermann AP, Stoving RK. Fractures in women with eating disorders-Incidence, predictive factors, and the impact of disease remission: Cohort study with background population controls. Int J Eat Disord. 2020 Jul;53(7):1080-1087. doi: 10.1002/eat.23223. Epub 2020 Jan 10.