louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05788198: Integrated Depression Care
Official title: Integrated Depression Care Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression Mild
Depression Moderate
Depression Severe
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: Janssen-Cilag Ltd.
First posted: 2023-03-28
Enrollment: 150
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
Intervention model description: Pre/Posttest implementation study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).

Detailed description: The following deliverables apply:

1. Development and implementation of a shared care protocol for depression management involving primary, secondary and tertiary care levels;
2. Training module for physicians and other care providers in population health management for patients with depression;
3. Training module for case managers/integration of a case management function into existing depression service offerings;
4. A patient education module for depression self-management;
5. A financing model for integrated depression care.

Eligibility criteria: Inclusion Criteria:

* persons between 18-65
* presenting to the general practitioner's office
* with depressive symtomatology

Exclusion Criteria:

* Severe depression warranting direct referral to specialized services

Inclusion criteria are kept broad on purpose as it's one of the research questions to define for which patients the intervention (namely the case management) is appropriate.

Primary outcomes:
measure: Intervention integration
timeFrame: 14 months
Secondary outcomes:
measure: Depression
timeFrame: 12 months
measure: Depression and anxiety
timeFrame: 12 months
measure: Medication adherence and self-efficacy
timeFrame: 12 months
measure: Resource use
timeFrame: 12 months
measure: Health-related Quality of Life
timeFrame: 12 months
measure: Health literacy
timeFrame: 12 months
Other outcomes:
Locations:
city: Mechelen
country: Belgium
facility: ELZ Mechelen-Katelijne
city: Zoersel
country: Belgium
facility: ELZ Voorkempen
Study officials:
affiliation: University Ghent
name: Liesbeth Borgermans, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Lieven Annemans, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00006198: Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Cancer
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-09-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is a clinical trial to test the safety and efficacy of the drug thalidomide in combination with a procedure called chemoembolization in patients with inoperable liver cancer. Chemoembolization is the process by which chemotherapy is instilled directly into the blood vessels feeding the tumor, so that the blood vessels feeding the tumor may be blocked. Chemoembolization consists of two separate procedures. It will be done by infusing chemotherapy with the drug doxorubicin through the hepatic artery into the liver and then by infusing collagen to cut off the blood supply to the tumor. A catheter will be inserted at various times to allow for these infusions.

The objectives are to investigate the feasibility and potential activity of chronic administration of thalidomide in patients with unresectable hepatocellular cancer who receive chemoembolization to predominant tumor masses. The toxicity of thalidomide in these patients will be evaluated. Overall safety will also be assessed. Serum levels of angiogenic cytokines such as VEGF, bFGF, and TNF-a, that are believed to have a role in hepatocellular carcinoma, will be collected.


Eligibility criteria: Inclusion Criteria:

* Patients with unresectable hepatocellular carcinoma.
* MRI of liver must show discrete tumor nodules. Lesions on angiography must be hypervascular.
* Patient must have the following minimum labs: ANC\> 1200/mm3; Hemoglobin \> 8 mg/dl; platelets \> 50,000 mm3; hepatic transaminases \< 5x normal; bilirubin \< 3.0 mg/dl; and creatinine \< 1.5 mg/dl.
* ECOG performance status \> 2.
* No history of prior chemotherapy or biologic therapy for hepatocellular carcinoma.
* No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix.
* Patients must not be pregnant or lactating.
* Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Kaplan Comprehensive Cancer Center
state: New York
Study officials:
References:
citation: Wu J, Ng J, Christos PJ, Goldenberg AS, Sparano J, Sung MW, Hochster HS, Muggia FM. Chronic thalidomide and chemoembolization for hepatocellular carcinoma. Oncologist. 2014 Dec;19(12):1229-30. doi: 10.1634/theoncologist.2014-0283. Epub 2014 Oct 31.
Clinical trial NCT03024398: Evaluation of the Fluorescent Green of Indocyanine in the Detection of Sentinel Lymph Node in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of the Endometrium
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 50
Sex: FEMALE
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: Patient with confirmed biopsy endometrial cancer

Brief summary: Selective lymphadenectomy Sentinel (LSS). This technique is already well established in breast cancer and melanoma and more recently in vulvar and cervical cancer.

Compared to lymphadenectomy, it has several theoretical advantages:

* this is a sensitive technique with a detection rate of\> 90% and a false negative rate of \<5%.
* the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin antibodies, serial sections) are more sensitive than the standard histological analysis of lymphadenectomy, which allows an improvement in the detection of metastases (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in 15% of intermediate-risk patients.
* it avoids short-term and long-term operative and post-operative morbidity of lymphadenectomy.

Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric method coupled with the Technetium 99m isotopic method with an overall detection rate of 78% \[95% CI: 73-84\]. The fluorescent green of indocyanine appears to give better results with an overall detection rate of 94% and a bilateral detection rate of 80%.

It seemed useful to take stock of this technique using this new dye.


Eligibility criteria: Inclusion Criteria:

* Major patient, without guardianship or curatorship.
* patient with endometrial cancer confirmed by biopsy.
* Invasive cancer stage FIGO I at intermediate risk and high risk and II according to the FIGO classification.
* need for surgical staging.
* performing an endovaginal ultrasound or a pelvic MRI in preoperative, if contraindication to MRI, performing a CT scan.
* subject affiliated to a social health insurance scheme.
* speaking and reading French.
* subject having dated and signed informed consent.

Exclusion Criteria:

* pregnancy in progress.
* FIGO III and IV stage diagnosed preoperatively or intraoperatively.
* Cure or pre-surgery that may alter the uterine lymphatic drainage (conization, myomectomy).
* MRI or CT scan of suspected lymph nodes.

Primary outcomes:
measure: Detection of sentinel node
timeFrame: 1 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de gynécologie-obstétrique - Hôpital de Hautepierre
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Cherif Youssef AKLADIOS, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01099098: Prevalence of Latent Tuberculosis (TB) Infection Diagnosed by Interferon-gamma Release Assay and Tuberculin Skin Tests in Patients With Old Healed TB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: People who have fibrosis or nodules in their upper lobe of the lung
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-04-06
Enrollment: 480
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with TB sequelae in their CXR

Brief summary: We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma release assay and tuberculin skin tests in patients with old healed TB.


Eligibility criteria: Inclusion Criteria:

* Age \> 20 years
* Patients with TB sequelae in their CXR

Exclusion Criteria:

* Patients on immune-suppressants

Primary outcomes:
measure: Prevalence of latent TB infection
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01251198: Stent For Life Observatory
Official title: Stent For Life Observatory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2010-12-01
Enrollment: 460
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 affected are patients with acute coronary syndrome with ST segment elevation ST (myocardial infarction) in 48 hospitalized in one of the centers (emergency, ambulance, intensive care unit, cardiac catheterization lab).

Brief summary: Observatory multicenter, prospective, to support the acute phase of acute coronary syndromes with ST segment elevation ST (myocardial infarction).


Eligibility criteria: Inclusion Criteria:

* Any patient with a myocardial infarction less than 48 hours during the November 2010 is eligible and should be considered for inclusion in the study.
* Every patient who agreed to participate in the study

Exclusion Criteria:

* Patients with myocardial infarction after a coronary revascularization, or after cardiac surgery or extra heartbeat.
* Patient denying that his personal data are subject to treatment automated

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Martine Gilard
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cambou JP, Simon T, Mulak G, Bataille V, Danchin N. The French registry of Acute ST elevation or non-ST-elevation Myocardial Infarction (FAST-MI): study design and baseline characteristics. Arch Mal Coeur Vaiss. 2007 Jun-Jul;100(6-7):524-34.
citation: Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.
Clinical trial NCT00520598: Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
Official title: A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Vulvar Cancer
Vaginal Cancer
Genital Warts
Human Papillomavirus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-08-24
Enrollment: 511
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)


Eligibility criteria: Inclusion Criteria:

* Female between 16 to 26 years old
* Has never had Pap testing or have only had normal Pap test results
* Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

* History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
* History of severe allergic reaction that required medical attention
* Are pregnant
* Received a marketed HPV vaccine
* Currently enrolled in a clinical trial
* Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)

Primary outcomes:
measure: Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
timeFrame: 4 weeks post dose 3
Secondary outcomes:
measure: Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen
timeFrame: 4 weeks post dose 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04837898: Haskap and Endurance Running Performance
Official title: The Influence of Haskap Berry on Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance
Keywords: berry
running
time trial
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Mibelle Group Biochemistry
name: Haskapa Ltd
First posted: 2021-04-08
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will employ a randomised, double-blind, placebo-controlled, independent groups experimental design. Submaximal, maximal and 5 km time trial running performance will be assessed before and after supplementation with haskap berry or a placebo.

Detailed description: Participants will consume haskap berry powder or an isocaloric placebo for 7 days. They will be required to run on a treadmill before and after supplementation to asses the influence on the intervention on aerobic performance parameters. Other performance parameters such as blood lactate, heart rate, ratings of perceived exertion and respiratory variables will also be monitored throughout the various elements of the exercise trials.

Eligibility criteria: Inclusion Criteria:

* healthy non-smoking males
* completed a 5 km run (in less than 25 minutes) within the 6 weeks prior to the study

Exclusion Criteria:

* female
* allergies to fruit or dairy, currently taking any nutritional supplements (e.g. vitamins, antioxidant, herbal or sports enhancing supplements) or medication that might affect the study outcome
* history of gastrointestinal, renal or cardiovascular disease

Primary outcomes:
measure: 5km time trial
timeFrame: Change from baseline at 7 days
measure: V̇O2peak test
timeFrame: Change from baseline at 7 days
Secondary outcomes:
measure: Blood lactate response during submaximal tests, maximal and time trial
timeFrame: Change from baseline at 7 days
measure: rating of perceived exertion during submaximal tests, maximal and time trial
timeFrame: Change from baseline at 7 days
measure: heart rate during submaximal tests, maximal and time trial
timeFrame: Change from baseline at 7 days
measure: VO2 during submaximal tests, maximal tests
timeFrame: Change from baseline at 7 days
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
References:
Clinical trial NCT00488098: GSK372475 Bioequivalence Study
Official title: An Open Label, Randomized, Parallel Groups, Bioequivalence Study to Compare a Single Oral Dose of GSK372475B or GSK372475C in Male and Female Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Depressive Disorder
Keywords: Healthy Bioequivalence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-06-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.


Eligibility criteria: Inclusion Criteria:

* Healthy Males/Females aged 18-45 years
* Non-smokers
* BMI 19-30 kg.m2
* QTc\<450msec

Exclusion Criteria:

* Use of oral contraception
* Positive breath alcohol and drug screen
* Regular alcohol consumption
* Current psychiatric illness or within 1 year.
* History of GI, hepatic or renal disease
* Uncontrolled hypertension

Primary outcomes:
measure: GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax
timeFrame: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.
Secondary outcomes:
measure: Adverse events
timeFrame: all visits
measure: vitals (all visits) + ECG
timeFrame: at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.
measure: labs
timeFrame: at screening and 2 weeks post dose
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03206398: Influence of an Anti-gravity Treadmill on Functional Outcome in Non-operatively Treated Pelvic Fractures - a Pilot Study
Official title: Influence of an Anti-gravity Treadmill on Functional Outcome in Non-operatively Treated Pelvic Fractures - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight-bearing
Rehabilitation
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: anti-gravity treadmill for a total of 40 days in addition to physiotherapy
Primary purpose: TREATMENT

Brief summary: Non-operative treatment of pelvic fractures is possible. Immobilisation implies different adjustment processes. Patients with pelvic ring fractures and partial weight bearing have to obtain theses. The aim of this pilot study was to prove the additional effect of the anti-gravity treadmill in patients with non-operatively treated pelvic fractures.

Detailed description: We prospectively included patients with non-operatively treated pelvic fractures as the intervention group (IG) and healthy volunteers of different age, sex and body mass index (BMI) as the reference group (RG).

Patients of the IG participated in a training session every three days with an anti-gravity treadmill (Picture 1, alterG®, www.alterg.com) for a total of 40 days in addition to physiotherapy, lymph drainage massage and manual therapy.

Patients were evaluated on three successive dates: Baseline (S1), after mobilization without crutches with full weight-bearing (20 days, S2) and after 40 days (S3)

Eligibility criteria: Inclusion Criteria:

* patients with non-operatively treated pelvic fractures

Exclusion Criteria:

* pregnancy, neuromuscular disorders, preexisting muscle atrophy

Primary outcomes:
measure: standardized gait analysis
timeFrame: Day 1 - 40 days
Secondary outcomes:
measure: numeric rating scale
timeFrame: Day 1 - 40 days
measure: dynamic gait index
timeFrame: Day 1 - 40 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00497198: Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes
Official title: An Exploratory Study of MCI-196 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel-Assignment, Placebo-Controlled Manner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
anion-exchange resin
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2007-07-06
Enrollment: 183
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.


Eligibility criteria: Inclusion Criteria:

* Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL.
* Patients whose HbA1c is 7.0% or above during the observation period.

Exclusion Criteria:

* Patients with serious cardiac, hepatic or renal complications.
* Patients with serious diabetic complications.
* Patients with complete biliary obstruction or ileus.
* Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception.

Primary outcomes:
measure: Fasting Plasma Glucose at Baseline
timeFrame: 0 weeks
measure: Change From Baseline in Blood Glucose at Week 12
timeFrame: 12 weeks (baseline to week 12)
measure: Hemoglobin A1c (HbA1c) at Baseline
timeFrame: 0 weeks
measure: Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12
timeFrame: 12 weeks (baseline to week 12)
Secondary outcomes:
measure: Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12
timeFrame: 12 weeks (baseline to week 12)
Other outcomes:
Locations:
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Kondo K, Kadowaki T. Colestilan monotherapy significantly improves glycaemic control and LDL cholesterol levels in patients with type 2 diabetes: a randomized double-blind placebo-controlled study. Diabetes Obes Metab. 2010 Mar;12(3):246-51. doi: 10.1111/j.1463-1326.2009.01159.x. Epub 2009 Sep 22.