louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02892188: Physician-Pharmacist Collaboration for Osteoporotic Patient Follow-up
Official title: Assessment of the Follow-up of Osteoporotic Patients by a Physician-pharmacist Collaboration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient having osteoporosis enrolled into the programm of Therapeutical Educational for patient

Brief summary: The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a physician-pharmacist collaboration.

Detailed description: Treatments allow decreasing the personal fracture risk from 48% to 85% provided that the treatment period is continued at least 3 to 5 years and that hygienic and dietary measures are applied: optimization of the dietary calcium intakes (much more efficient and less dangerous than the medicinal intakes), preservation of a physical activity, fall prevention. The ability of bisphosphonate for decreasing significantly the number of fractures was proved, but the lack of lasting adhesion (persistence) and of flanking measures leads to believe their efficiency may be enhanced: the hip-fracture rate decreases from 2.1% for the non-adherents to 1,3% for the patients with observance, which represents a one-half reduction.

The cost of surgery for a femoral neck fracture is estimated at 8500 euros. So the prevention of only one femoral neck fracture entails a huge economy.

However, 50% of women stop their treatment before a year and the implementation of hygienic and dietary measures leads to a lifestyle change, and faces long time ingrained habits. Only 42% of patients continue their treatment after two years, and only 16% after three years.

Eligibility criteria: Inclusion Criteria:

* older than 18 years old
* having an osteoporosis treatment
* following a Therapeutical Education for Patient

Exclusion Criteria:

* opposition for anonymised data gathering

Primary outcomes:
measure: Respect of treatment and of hygienic dietary measures by patients with a self-questionnaire per medical check
timeFrame: year 3
Secondary outcomes:
measure: Qualitative evaluation of the professional adhesion for the follow-up process once a year during the annual meeting
timeFrame: year 3
measure: Quantitative evaluation of it by the return rate of questionnaires
timeFrame: year 3
Other outcomes:
Locations:
city: Metz Cedex 03
country: France
facility: CHR Metz-Thionville
Study officials:
affiliation: CHR Metz-Thionville
name: Didier POIVRET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02946788: Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel
Official title: An Open Label Study to Document the Treatment Effect of 1 and 2% BPX-01 Minocycline Topical Gel in Moderate to Severe Inflammatory Non-nodular Acne Vulgaris (Protocol Number BPX-01-C04)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: BioPharmX, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi center open label study intended to provide photo documentation and time to response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism.

Detailed description: This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to treatment with 1% or 2% BPX-01 gel. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy. Photographs will be taken to document treatment effect.

Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, incidence of product related facial staining and collection of adverse events.

Eligibility criteria: Inclusion Criteria:

- moderate to severe inflammatory non-nodular acne vulgaris

Exclusion Criteria:

* female subject who is breastfeeding, pregnant or planning a pregnancy during the study
* have other skin condition or disease that would interfere with the study
* have had any prior treatment with minocycline
* have a known or suspected allergy to tetracycline class products
* have used OTC medications for the treatment of facial acne within the last 14 days
* have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days
* have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks

Primary outcomes:
measure: Change From Baseline in Inflammatory Lesion Counts at Week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Study Center
state: Florida
city: Las Vegas
country: United States
facility: Study Center
state: Nevada
Study officials:
affiliation: BioPharmX, Inc.
name: AnnaMarie Daniels
role: STUDY_DIRECTOR
References:
Clinical trial NCT03178188: Efficacy of 595 nm Pulsed-dye Laser in Treatment of Discoid Lupus Erythematosus
Official title: Efficacy of 595 nm Pulsed-dye Laser as an Adjunctive Treatment of Discoid Lupus Erythematosus, A Randomized, Patient/Assessor Blinded Placebo Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lupus Erythematosus, Discoid
Keywords: lupus erythematosus, Discoid
Pulsed-dye Laser
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: forty DLE lesions from patients will be recruited in the study. The lesions on one side of the body were block-randomized into the treatment group and the other side served as a control. The patients can continue their systemic treatments and the PDL is designed to be used as an adjunctive treatment. Treatments with the PDL will be delivered in the treatment group every 4 weeks for 4 consecutive months while the lesions in the control group received a sham. The patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up period of 4, 12 weeks after the final treatment (week 16, 24). Erythema index (EI), Texture index (TI) will be obtained and digital photographs will be taken and modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) will be assessed in every visit. The digital photographs will later be evaluated by 3-blinded dermatologists. Moreover, side effects and patients' satisfaction score will also be recorded.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Has at least two DLE lesions, located in the same anatomical location of the body, which the different of mCLASI are not more than 1 point
* Dose not undergo any procedure or laser treatment within 4 weeks before entered the study
* Dose not received any localised therapy of DLE eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study
* Dose not receive the topical chemical peeling within 4 weeks before entered the study
* Has already received at least 1 systemic standard treatment for DLE and continue until the rest of the study
* Can follow the study's protocol

Exclusion Criteria:

* Pregnancy or lactation
* History of skin cancer
* History of photo allergy
* History of bleeding tendency
* History of abnormal wound healing

Primary outcomes:
measure: erythema index (EI)
timeFrame: week 0(baseline), 4, 8, 12, 16, 24
Secondary outcomes:
measure: modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)
timeFrame: week 0, 4, 8, 12, 16, 24
measure: Physician Global Assessment (PGA) scores
timeFrame: week 0, 4, 8, 12, 16, 24
measure: texture index (TI)
timeFrame: week 0, 4, 8, 12, 16, 24
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Study officials:
References:
Clinical trial NCT06731088: Effect of Remazolam Besylate Combined With Remifentanil Analgesic Sedation on the Prognosis of Patients With Sepsis
Official title: Effect of Remazolam Besylate Combined With Remifentanil Analgesic Sedation on the Prognosis of Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Sepsis
Lead sponsor: First Affiliated Hospital of Ningbo University
Sponsor class: NETWORK
First posted: 2024-12-12
Enrollment: 100
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: In this study, midazolam was used as a control to investigate the effect of remazolam besylate combined with remifentanil on analgesia and sedation in patients with mechanical ventilation of sepsis on the prognosis of patients, and to provide evidence for the safe application of remazolam besylate in patients with sepsis.


Eligibility criteria: Inclusion Criteria:

1. Mechanical ventilation patients with sepsis who are expected to stay in ICU for ≥48h;
2. The condition was allowed to remain in shallow sedation (RASS-2 \~0);
3. Obtain informed consent from patients or family members

Exclusion Criteria:

1. pregnancy or breastfeeding;
2. General anesthesia surgery within 48 hours;
3. Severe, pre-existing parenchymatous liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis or acute liver failure;
4. Patients with acute and chronic renal insufficiency requiring dialysis treatment;
5. Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc. 6 Medical Ethics Committee of the First Affiliated Hospital of Ningbo University;
6. Patients with a history of alcohol or drug abuse;
7. Any condition that prevents the correct assessment of cognitive function, such as speech and sensory disorders or mental disorders (language difficulties or organic mental dysfunction);
8. Failure to obtain informed consent or authorization;
9. Participate in other exploratory clinical trials within 6 months prior to screening;
10. Known or suspected allergy to the study drug.

Primary outcomes:
measure: The number of days without delirium or coma during the 14-day intervention period.
timeFrame: From enrollment to the end of treatment at 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References:
Clinical trial NCT00384488: Automated Diabetes Prevention Program
Official title: Effectiveness of Automated Telephone Intervention on Behavioral and Weight Outcomes for Patients With Pre-Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Diabetes
Keywords: Diabetes mellitus
Weight control
Healthy eating
Physical Activity
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2006-10-06
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective for this pilot project is to determine the feasibility and effectiveness of the Interactive Voice Response protocol (IVR) on physical activity and eating behaviors in a group men and women who have been identified by their physician as being pre-diabetic. We hypothesize that participants receiving the IVR follow-up will have greater positive changes in their physical activity and eating behaviors when compared to those who receive only the standard-care pre-diabetes class.

Detailed description: Patients diagnosed with pre-diabetes present a unique opportunity for health care providers to implement preventive practices. Behavioral intervention strategies that target weight reduction or maintenance and increased fitness not only provide exceptional cardiovascular benefits, but also play an important role in delayed development or prevention of type 2 diabetes mellitus (DM). This study was designed to determine the feasibility and effectiveness of automated telephone support calls targeting physical activity and healthful eating as strategies for weight loss for patients with pre-diabetes.

Participants with pre-diabetes who participated in a 90-minute diabetes prevention class were consented to participate in this behavioral study and were then randomly assigned to receive automated telephone support targeting physical activity and nutrition weight loss strategies or to a no-contact control group. Objective physical activity (accelerometer), self-reported dietary intake, and body weight were assessed at baseline and at 3-months follow-up.

Eligibility criteria: Inclusion Criteria:

* Male and female Kaiser-Permanente of Colorado members age 18 and above who have been diagnosed with pre-diabetes and who have enrolled in a clinically indicated pre-diabetes class.
* Subjects must be English speaking and have a telephone

Exclusion Criteria:

Pregnant females

* Enrollment in another research study involving diabetes or weight management during the time of the study.

Primary outcomes:
measure: Weight loss
Secondary outcomes:
measure: Increased physical activity
measure: Improved healthy eating habits
measure: Weight maintenance
measure: Reduction in progression to type 2 DM
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser-Permanente of Colorado
state: Colorado
Study officials:
affiliation: Kaiser-Permanente of Colorado Clinical Research Unit
name: Paul A. Estabrooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00372788: AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen
Official title: A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Advanced Non-Small Cell Lung Cancer
AZD6244
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as long as patients receive clinical benefit.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with non-small cell lung cancer
* Previously received one or two chemotherapeutic treatments

Exclusion Criteria:

* Previous therapy with MEK inhibitor or pemetrexed
* Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases

Primary outcomes:
measure: Assess tumor growth
timeFrame: assessed every 12 weeks
Secondary outcomes:
measure: Assess safety and tolerability of AZD6244
timeFrame: assessed at each visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: New York
country: United States
facility: Research Site
state: New York
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Emerging Oncology Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02894788: Postoperative Intensive Care Surveillance
Official title: POSTOPERATIVE INTENSIVE CARE SURVEILLANCE. A Tool to Optimize ICU-beds Management?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-operative Adhesion(s)
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 2498
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: surgical population

Brief summary: Several score systems were created to stratify perioperative risk and predict mortality. The study rises from the needing of a rapid and simple system to identify the patient worthy of Postoperative Intensive Surveillance. In the first phase Authors retrospectively investigated on patients underwent to elective surgery searching for determining factors (DFs) for postoperative ICU admission. Later, Researchers prospectively studied how DFs could predict the admission in ICU of consecutive patients scheduled for elective surgery during a three-months period and created an index, named PoIS (Post-operative Intensive Surveillance), based on the results of this analysis. Authors used surgical invasiveness (SI), Diabetes Mellitus (DM), Myocardiopathy (MCP), Cerebrovascular Disease (CVD), Body Mass Index (BMI), age, serum creatinine level (sCr), Tiffenau Index (TI) and male sex for the development of the original model. Authors classified SI from G1 (lowest) to G5 (highest).

The results show that the power of prediction of postoperative morbidity of PoIS and POSSUM resulted coincident and better than the American Society of Anesthesiology scoring system.


Eligibility criteria: Inclusion Criteria:

* elective surgery

Exclusion Criteria:

* multiple surgery
* age less than 18

Primary outcomes:
measure: Post-operative intensive care surveillance scoring system
timeFrame: 1 hour after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital - Dept. Anesthesia and Intensive Care Unit
state: Milano
Study officials:
References:
Clinical trial NCT05476588: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform
Official title: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tobacco Use
Alcohol Abuse
Prescription Drug Abuse
Substance Use
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: COG Analytics
First posted: 2022-07-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, two-group design.
Primary purpose: SCREENING

Brief summary: The goal of this study is to validate the TAPS-ESP as a screen and assessment that can be used in primary care for the screening and treatment of substance use.

Detailed description: This Phase II study seeks to conduct further research to validate the TAPS-ESP as a Spanish language version of the screening and brief assessment and pave the way for its broad dissemination in the healthcare system. The investigators will use a novel application of a Type 1 hybrid effectiveness-implementation design, adapted to a screening validation study. The investigators will conduct a large-scale study to validate the TAPS-ESP against established diagnostic and biomarker metrics, replicating the design of the seminal English-language TAPS study.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Current patient of the clinic
* Spanish-language preferred
* Ability to read Spanish

Exclusion Criteria:

* Unable to provide informed consent
* Inability to comprehend or read Spanish
* Inability to self-administer the iPad tool due to physical limitations

Primary outcomes:
measure: Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP) primary criterion validation against the modified World Mental Health Composite International Diagnostic Interview (CIDI) in Spanish
timeFrame: 1 year
Secondary outcomes:
measure: Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) for concurrent and convergent validity of the TAPS Tool
timeFrame: 1 year
measure: Drug Abuse Screening Test (DAST-10) for concurrent and convergent validity of the TAPS Tool
timeFrame: 1 year
measure: CAGE (Cut Down, Annoyed, Guilty, Eye-Opener) for concurrent and convergent validity of the TAPS
timeFrame: 1 year
measure: Alcohol Use Disorders Identification Test (AUDIT) for concurrent and convergent validity of the TAPS
timeFrame: 1 year
measure: Fagerstrom Test for Nicotine Dependence (FTND) for concurrent and convergent validity of the TAPS
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott and White Community Care
state: Texas
Study officials:
affiliation: Baylor Scott and White Research Institute
name: Katherine Sanchez, PhD
role: PRINCIPAL_INVESTIGATOR
References: