louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06694571: Sun Protection and Tanning Awareness in Rural Schools
Official title: STARS (Sun Protection and Tanning Awareness in Rural Schools)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma
Adolescents
Keywords: prevention
school-based intervention
skin cancer
adolescents
rural health
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Drawing from prior school-based skin cancer prevention programs, we have adapted intervention materials to target rural high schoolers. Program components (including in-class education) will be co-implemented by the research team and participating school staff, with a focus on sustainability beyond the immediate study period. Interviews and surveys following initial implementation will evaluate both the effectiveness of the program.

Detailed description: The STARS study pilot tests a skin cancer prevention intervention adapted for use in rural schools. Participants will be recruited from approximately 14 districts in Utah. We have established collaborations with schools, districts, and the Utah State Board of Education (USBE) and they are committed to partnering with us on this project.

The research coordinator will contact district-level officials who will be asked to express their support of the study when facilitating the coordinator's contact with school principals and teachers (e.g., health teachers, science teachers). The research coordinator will also directly contact school principals and teachers to discuss participation in the study.

An intervention visit, lasting up to 90 minutes, will take place immediately following completion of a baseline survey. This intervention visit may be divided into 2 days, depending on the length of the class periods at the participating schools. During the intervention visit, students will receive general education on skin cancer and skin cancer prevention, complete a skin cancer risk self-assessment tool, and create a sun protection action plan for an outdoor activity.

One month later, participants will receive a brief (15-minute) post-intervention survey via email and/or text.

Eligibility criteria: Inclusion Criteria:

* Students are eligible if they are enrolled in a Utah high school (e.g. grades 9-12).

Exclusion Criteria:

* None

Primary outcomes:
measure: Sun protection index scores
timeFrame: Baseline, One month
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References:
Clinical trial NCT01879371: Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen Lysinate
Official title: Relative Bioavailability of Ibuprofen From a Fixed Dose Combination (FDC) Tablet of Ibuprofen 400 mg and Caffeine 100 mg Compared to a Tablet of Ibuprofen 400 mg and a Tablet of Ibuprofen Lysinate 400 mg Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-period Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-06-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate (Nurofen Immedia®).


Eligibility criteria: Inclusion criteria:

* Healthy male and female subjects
* Age 18 to 50 years
* Body mass index (BMI) 18.5 to 29.9 kg/m2
* Subjects must be able to understand and comply with study requirements

Exclusion criteria:

- Any relevant deviation from healthy conditions

Primary outcomes:
measure: AUC(0-tz)
timeFrame: 2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration
measure: Cmax
timeFrame: 2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration
Secondary outcomes:
measure: AUC(0-inf)
timeFrame: 2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 1335.2.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04237571: Community Agriculture Nutritional Enterprises (CANE) Meal Program
Official title: Community Agriculture Nutritional Enterprises (CANE) Meal Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Life Style, Healthy
Keywords: fruits
vegetables
exercise
community
education
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Previous adult participants of the Tanglewood to Table walking program will be recruited to enroll in the CANE Meal Program. This program will encourage participants to pick up a healthy meal from the CANE Kitchen each week for five weeks. The meal will consist of at least one serving of fruit or vegetables. At each meal, educational materials will be distributed, including the recipe for healthy meals and nutrition handouts that are linked to the recipes. Additional information about the ways the nutrients in the meal may help protect from the negative effects of environmental pollutants will be included. Surveys, blood pressure, height, weight, waist circumference and carotenoid status will be assessed before and after the program.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* previous participant in Tanglewood to Table Walking Program

Exclusion Criteria:

* institutionalized adults
* children under the age of 18
* adults with impaired consent capacity
* incarcerated adults

Primary outcomes:
measure: Change in fruit and vegetable consumption.
timeFrame: Five weeks
measure: Change in weight.
timeFrame: Five weeks
measure: Change in waist circumference
timeFrame: Five weeks
measure: Change in total blood pressure
timeFrame: Five weeks
measure: Change in carotenoid status
timeFrame: Five weeks
measure: Change in knowledge of nutrition and environmental pollution.
timeFrame: Five weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Dawn Brewer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232271: The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Official title: The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Deep Vein Thrombosis
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: Sanofi
name: National Heart Foundation, Australia
First posted: 2005-10-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of the anticoagulant(blood thinner) Clexane on the development of leg clots following electrophysiology studies (EPS) and or radiofrequency ablation (RFA).

People who suffer heart palpitations will sometimes need hospital admission to undergo an electrophysiology study ( and or a Radiofrequency Ablation)in order to diagnose and or treat their condition.

Radiofrequency ablation is a procedure to stop abnormal heart rhythms. EPS/RFA studies require the puncture of the leg veins . Previous experience has shown that following the puncture of leg veins there is a small risk of developing a blood clot in the leg.

It is not known whether giving blood thinners (anticoagulants) after the procedure will decrease this risk Enoxaparin Sodium (Clexane) is an anticoagulant used extensively and safely following bone (Orthopaedic) surgery to prevent blood clots from developing in the legs


Eligibility criteria: Inclusion Criteria:

* Patients undergoing EPS/RFA for the diagnosis and or treatment of SVT based on patient history or ECG evidence.

Exclusion Criteria:

* Patients with a past history of DVT or PE.
* Patients with a history of clotting disorders
* Patients with active malignancies
* Patients requiring full heparinisation during and after the procedure.
* Chronic atrial flutter and atrial fibrillation ablation

Primary outcomes:
measure: Incidence of deep vein thrombosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Paul Sparks, MBBS, PhD. FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05177471: Efficacy and Safety of JAK Inhibitors in Systemic Sclerosis-associated Interstitial Lung Disease
Official title: Efficacy and Safety of JAK Inhibitors in Patients With Systemic Sclerosis and Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Systemic Sclerosis
Interstitial Lung Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 0
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: Patients with systemic sclerosis-interstitial lung disease

Brief summary: Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality.

Janus kinases (JAK) inhibitors are recent therapies in the field of systemic autoimmune diseases, already approved in patients with rheumatoid arthritis.

Use of JAK inhibitors in systemic sclerosis is based on their anti-inflammatory and anti-fibrotic properties. Several preclinical murine models of systemic sclerosis demonstrated the efficacy of ruxolitinib and tofacitinib on cutaneous and pulmonary fibrosis. Recently, tofacitinib was evaluated in SSc patients in two clinical studies and showed significant improvement on skin fibrosis.

The objective of this study is to evaluate efficacy and safety of JAK inhibitors in SSc patients with ILD.


Eligibility criteria: Inclusion Criteria:

* Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
* Patients with interstitial lung disease affecting at least 10 % of the lungs on HRCT chest, FVC of at least 40 % of the predicted value and DLCO between 30 % and 90 % of the predicted value
* Use of JAK inhibitors

Exclusion Criteria:

* Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)
* Patients with pulmonary arterial hypertension defined on right heart catheterization

Primary outcomes:
measure: relative change in FVC after 12 months of JAK inhibitor
timeFrame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
Secondary outcomes:
measure: relative change in DLCO after 12 months of JAK inhibitor
timeFrame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
measure: relative change in skin fibrosis after 12 months of JAK inhibitor
timeFrame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHU Nancy
state: Grand Est
Study officials:
References:
Clinical trial NCT02023671: IMMUNOPHENOTYPE ROLE IN THE EVALUATION OF CLINICAL RESPONSE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Post Allografting
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with multiple myeloma

Brief summary: The study proposed by SSCVD Allogeneic Stem Cells of this Hospital provides for the collection of a series composed of patients with multiple myeloma undergoing allogeneic stem cell transplants at our center in the period 2000-2011.

This collection is carried out with retrospective investigation , through the review of paper and electronic records and data cards already collected as part of clinical trials conducted by our own Division and approved by the Ethics Committee of Management.

The purpose of data collection is particularly retrospective analysis of the incidence of extramedullary relapse , the response in flow cytometry immunophenotypic and clinical response of the disease , will also be taken into consideration for overall survival ( OS) , event-free survival (EFS) , the cumulative incidence of treatment-related mortality and graft- versus-host disease ( GVHD ), acute and chronic.

The data were processed in a completely anonymous and as provided by law. The results of the study will not result in any diagnostic or therapeutic intervention on patients still alive.


Eligibility criteria: Inclusion Criteria:

Adult patients with multiple myeloma undergoing allogeneic stem cell transplantation in the period 2000-2011 at the University Transplant Center of the Division of Hematology.

Were taken into account both donor transplants voluntary blood relative.

Exclusion Criteria:

Patients who died early after allogeneic transplantation (\<3 months) in which has not been evaluated disease status.

In the evaluation of the response of immunophenotypic disease were excluded from the analysis of bone marrow aspirate samples with low cellularity.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Event free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01146171: Japanese Phase 1 Study of BMS-844203 (CT322)
Official title: A Phase I Multiple Ascending Dose Study of BMS-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies


Eligibility criteria: Inclusion Criteria:

* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group performance 0-1

Exclusion Criteria:

* Subject has uncontrolled diabetes or hypertension
* Clinical significant bleeding diathesis or coagulopathy
* Thrombotic or embolic cerebrovascular accident

Primary outcomes:
measure: Determine recommended dose for Phase 2 study of CT-322
timeFrame: Within the first 28 days
Secondary outcomes:
measure: To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc.
timeFrame: Cycle 1: Day 1 to 5, 8, 15, 22 to 26 and 29
measure: To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc.
timeFrame: Cycle 2 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter
measure: To assess anti-tumor activity of CT-322
timeFrame: Every 8 weeks
measure: To assess the effects of CT-322 on plasma VEGF levels
timeFrame: Cycle 1: Day 1, 3, 8, 15, 22
measure: To assess the effects of CT-322 on plasma VEGF levels
timeFrame: Cycle 3: Day 1
measure: To assess the presence of anti CT-322 antibodies
timeFrame: Cycle 1: Day 1, 15, 22 and 29
measure: To assess the presence of anti CT-322 antibodies
timeFrame: Cycle 3 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter
Other outcomes:
Locations:
city: Osaka-Sayama-Shi
country: Japan
facility: Local Institution
state: Osaka
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02326571: Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage
Official title: Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Hemorrhage
Keywords: EEG
Cortical Spreading Depression
Cerebral Hemorrhage
miRNA
Reactivity in EEG
Multimodal monitoring
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-12-29
Enrollment: 8
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: Patients eligible for neuro surgery admitted to Rigshospitalet, Copenhagen with spontaneous intracerebral hemorrhage verified by CT.

Brief summary: Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH) constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the larger population of patients suffering from cerebral thrombosis. Development of brain edema seemingly contributes to the disadvantageous prognosis. However, the mechanisms behind is only understood fragmentarily.

By using multimodal neuro monitoring, the investigators seek to investigate electrophysiological and metabolic processes, which seem to accompany the formation of edema and clinical deterioration in patients suffering from sICH.


Eligibility criteria: Inclusion Criteria:

* Diagnosis: spontaneous intracerebral hemorrhage verified by CT
* Clinical indication for craniotomy or craniectomy
* Admitted to the hospital within 24 hours from assumed ictus
* Age over 18 years

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Secondary brain injury
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, NICU
Study officials:
name: Christian K Friberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01017471: Carpal Tunnel Syndrome Release Using PSU Retractor
Official title: Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
surgery
PSU retractor
carpal tunnel syndrome who failed to conservative treatment
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators study aims to evaluate both efficacy and safety of carpal tunnel release using limited incision with the PSU retractor compared to standard incision.

The investigators will do a randomized controlled trial in 60 patients with carpal tunnel release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score and complications at 6 months.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months

Exclusion Criteria:

* Underlying disease such as : DM, neuropathy
* Previous wrist or hand surgery in the same side
* Previous wrist and hand trauma
* Pregnancy

Primary outcomes:
measure: CTS score
timeFrame: 1 year
Secondary outcomes:
measure: VAS score
timeFrame: 1 year
measure: return to work time
timeFrame: 1 year
measure: satisfaction score
timeFrame: 1 year
measure: complication rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University, Hatyai, Songkhla, Thailand
name: Sunthorn Wongsiri, MD
role: PRINCIPAL_INVESTIGATOR
References: