louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05078281: Patients With Severe Eosinophilic Asthma Treated With Benralizumab
Official title: Predictive Response Factors in Respondent Patients and Results After Monoplane Switch in Patients With Severe Eosinophilic Asthma Treated With Benralizumab
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma; Eosinophilic
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with severe eosinophilic asthma receiving benralizumab belonging to the health area of each center, in the Pulmonology and Allergology units, will be included. Patients must have at least 4 months of benralizumab treatment at the start of the study.

Brief summary: Retrospective, multicenter, routine clinical practice study with consecutive inclusion of adult patients with severe eosinophilic asthma receiving benralizumab treatment.

Detailed description: Retrospective study studying severe eosinophilic asthma. Patients with this disease who are on benralizumab treatment for at least 4 months before the start of the study will be included.

The purpose of this study is to analyze the predictive factors of response in patients with this type of disease treated with benralizumab, who obtain a complete response during their follow-up.

The results of the study will be obtained through the review of medical records, where demographic characteristics such as age, gender and smoking will be assessed; presence of comorbidities; clinical-functional variables; response variables (exercises, cycles of oral corticosteroids, admissions, visits to the emergency room or unscheduled, cumulative dose of oral corticosteroids, absenteeism from work) and side effects.

Eligibility criteria: Inclusion Criteria:

* Adult patients (over 18 years of age) diagnosed with severe eosinophilic asthma on benralizumab treatment for at least 4 months from the start of the study.

Exclusion Criteria:

* Patients for whom no previous history is available or who do not meet the inclusion criteria.

Primary outcomes:
measure: Response predictors in patients treated with benralicumab.
timeFrame: Up to 60 weeks.
Secondary outcomes:
measure: Study the response variables to benralizumab.
timeFrame: Up to 60 weeks.
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Ana Gómez-Ballesteros Fernández
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01332981: An Observational Follow-up Study of 1st-Line Treatment With Herceptin (Trastuzumab) in Patients With Metastatic Breast Cancer (Post-HERMINE)
Official title: Overall Survival Estimation After a 7 Year Follow-up in Metastatic Breast Cancer Patients Treated by Herceptin® as 1st Line Therapy (Post-HERMINE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: metastatic breast cancer patients treated by Herceptin® as 1st line therapy

Brief summary: This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of treatment.


Eligibility criteria: Inclusion Criteria:

* Female patient, \>/= 18 years of age
* Metastatic breast cancer
* 1st-line treatment with Herceptin initiated in 2002
* Included in pharmaco-epidemiologic HERMINE study

Exclusion Criteria:

* Patient died before scheduled follow-up visit (March 2005)

Primary outcomes:
measure: Median Overall Survival
timeFrame: Up to 7 years
Secondary outcomes:
measure: Median Time to Progression-Free Survival
timeFrame: Up to 7 years
measure: Median Time to Progression
timeFrame: Up to 7 years
measure: Median Treatment Duration and the Duration of Exposure to Trastuzumab
timeFrame: Up to 7 years
measure: Prognostic Factors for Overall Survival
timeFrame: Up to 7 years
measure: Prognostic Factors For Time to Progression
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Neuilly-sur-seine
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00694681: Working Toward Wellness
Official title: Enhanced Services for the Hard to Employ Demonstration: Telephonic Care Management for Depressed Medicaid Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Telephonic care management
Lead sponsor: MDRC
Sponsor class: OTHER
Collaborators: name: United Behavioral Health
name: Kaiser Permanente
name: Department of Health and Human Services
First posted: 2008-06-10
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Working toward Wellness is a telephone care management and outreach monitoring program designed to help Medicaid recipients who are experiencing major depression to enter and remain in evidence-based treatment. To study the effects of Working toward Wellness, individuals receiving Medicaid in Rhode Island who are eligible for mental health services through United Behavioral Health were screened by telephone for depression. Those who were found to have major depression and who agreed to be in the study were randomly assigned. Program participants received intensive monitoring from Master's level clinicians called care managers to facilitate and support clinical treatment. The control group received usual care that included only referrals to mental health treatment providers. The study hypothesis is that telephonic care management would increase visits to mental health professionals and use of appropriate medication, which in turn would reduce depression severity and lead to greater employment and productivity at work.


Eligibility criteria: Inclusion Criteria:

* Score of 5 or higher on Quick Inventory of Depression Symptomatology
* receiving Medicaid
* at least one child in household

Exclusion Criteria:

* Bipolar disorder
* alcohol or substance abuse
* currently in active treatment for depression
* receiving Supplemental Security Income

Primary outcomes:
measure: Use of mental health services
timeFrame: Through 36 months
Secondary outcomes:
measure: Depression severity
timeFrame: 6, 18, and 36 months
Other outcomes:
Locations:
city: Warwick
country: United States
facility: United Behavioral Health
state: Rhode Island
Study officials:
affiliation: MDRC
name: David Butler
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SE, Le Blanc AJ, Michalopoulos C, Azocar F, Ludman EJ, Butler DM, Simon GE. Does telephone care management help Medicaid beneficiaries with depression? Am J Manag Care. 2011 Oct 1;17(10):e375-82.
citation: Kim S, Leblanc A, Morris P, Simon G, Walter J. Working toward wellness: Telephone care management for Medicaid recipients with depression, thirty-six months after random assignment. New York: MDRC. December 2011.
Clinical trial NCT01650181: Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
Official title: Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Disease
Keywords: nafld, nash, fatty liver
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Non-alcoholic steatohepatitis represents 10 - 15% total cases of hepatic cirrhosis. In the upcoming years, the economic burden of this disease will increase and will mean an important problem for our health system due to obesity epidemic.

There are several treatments for non-alcoholic steatohepatitis; however, none of them have overcome a healthy lifestyle including diet, exercise and some drugs related with insulin metabolism.

There after, using hepatoprotective drugs and antioxidants have been recommended as an eligible therapy to reduce the progression from fatty liver to steatohepatitis and cirrhosis. Being this approach not only an experimental item yet but also an unavoidable reality.

The purpose of this randomized controlled study is explore the effects of siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic parameters.


Eligibility criteria: Inclusion Criteria:

* Patients with Metabolic Syndrome according to ATP III Criteria
* Non smokers
* Without intake of vitamins or herbal medicine for at least one month
* Without uncontrolled glycemic levels
* Compatible ultrasound and/or histological report

Exclusion Criteria:

* Alcohol ingest \> 50 gr weekly or chronic alcoholism
* Creatine serum \> 2 mg/dL
* Potassium serum \> 5.5 mEq/L
* Allergic to metformin or any components of the study
* Pregnancy
* Anomalies of blood coagulation or liver anatomic
* Patients with diseases and/or treatment that cause fatty liver or steatohepatitis
* Body weight change \> 10% in the last 5 weeks

Primary outcomes:
measure: Impact on biochemical and echosonographic parameters
timeFrame: 6 months
Secondary outcomes:
measure: Identify changes in anthropometric parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aldo Torre Delgadillo, M.D., M. Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195481: Study Evaluating Sirolimus in Kidney Transplant Recipients in India
Official title: A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure
Graft vs Host Disease
Keywords: Kidney
Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.


Eligibility criteria: Inclusion Criteria:

* Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
* Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.

Exclusion Criteria:

* Evidence of major infections at the time of sirolimus administration
* Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.
* Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception

Primary outcomes:
measure: Safety evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
state: Karnataka
city: Bangalore
country: India
state: Karnataka
city: Saket
country: India
state: South Delhi
city: Chennai
country: India
state: Tamil Nadu
city: New Delhi
country: India
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01638481: Chronology of Occult and Gross Coagulopathy in Burn Patients
Official title: Determining the Chronology of Occult and Gross Coagulopathy in Thermally Injured Patients: A Systems Biology Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thermal Burns
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2012-07-11
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Burn injury patients will be enrolled in the study upon arrival at Trauma Center.

Brief summary: The purpose of the study is to identify the inflammatory and coagulation pathways and mechanisms that are activated immediately following burn injury, and how they affect outcomes in terms of organ failure and death. This study also addresses the limitation of current tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in severely injured patients both in a comprehensive and rapid manner.


Eligibility criteria: Inclusion Criteria:

* Patients, male or female, \> or = 18 years of age, who arrive at Burn/Trauma Center with anticipated admission to The Burn Center within 4 hours of injury, with a thermal burn injury due to flash, flame, contact with hot object or liquid.

Exclusion Criteria:

* Patients suffering concomitant trauma that are in hemorrhagic shock. Patients with a preexisting history of coagulopathy, or currently taking anti-coagulants. Children and pregnant women. Patients with chemical or electrical injury. Patients who do not fluently speak either English or Spanish.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Jeffrey Shupp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03633981: Multimodal Assessment of the Neurological Prognosis of Patients With Brain Lesions on ExtraCorporeal Life Support
Official title: Multimodal Assessment of the Neurological Prognosis of Patients With Brain Lesions on ExtraCorporeal Life Support
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain-injured Patients on Extracorporeal Life Support
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 50
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 with brain lesions on veno-arterial ECLS after cardiac arrest or cardiogenic shock, requiring at least 24 hours sedation

Brief summary: It seems of the greatest importance to evaluate the neurological prognosis of patients with brain lesions after cardiorespiratory arrest or circulatory failure requiring circulatory assistance.

However, to date, there is no clinical or paraclinical diagnostic test to reliably assess the future of these patients.

The objective of this study is to highlight the clinical and imaging factors for establishing a neurological prognosis in patients at risk of brain lesions under ExtraCorporeal Life Support (ECLS).


Eligibility criteria: Inclusion Criteria:

* Patients with brain lesions on veno-arterial circulatory support after cardiac arrest or cardiogenic shock who require at least 24 hours of sedation

Exclusion Criteria:

* Extubation expected within the first 24 hours of management
* Minor patient
* Pregnant women

Primary outcomes:
measure: Early mortality assessment
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
affiliation: CHU Dijon Bourgogne
name: Mohamed Omar ELLOUZE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05738681: Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
Official title: Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Tuberculosis
Drug Induced Liver Injury
Hepatitis
Keywords: Tuberculosis
DILI
Anti tuberculosis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tuberculosis patients who had standard regimen treatment, non-HIV, no severe co-morbidity, no chronic hepatitis B or C were randomized to using NAC-long 1,200 mg/day for 8 weeks (NAC long group) or using anti-TB alone (non-NAC group). Genetic test, CBC, Cr, coagulogram were assessed at baseline. LFT were assessed at baseline, 2 weeks, 8 weeks and 24 weeks.
Primary purpose: PREVENTION

Brief summary: To determine the efficacy of NAC to prevent clinically significant anti-TB drugs induced liver injury (AT-DILI).

Detailed description: Tuberculosis is one of the most important infectious diseases and treatment related hepatitis from anti-TB drug was observed for 5-28%. Slow acetylator status in the N-acetyltransferase 2 (NAT2) genotype is a significant risk factor of anti-tuberculosis drug-induced liver injury (AT-DILI). We assessed the effect of N-acetylcysteine to prevent hepatitis from anti-TB drug in Thai population.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed TB
* Received standard dose of anti-TB drugs regimen (National Tuberculosis Control Programme guideline Thailand 2018)
* Aged ≥18 years
* Informed consent

Exclusion Criteria:

* Previous TB infection or MDR TB
* TB liver
* Allergy to NAC
* Abnormal baseline LFT
* (AST or ALT\>2.5 times UNL, ALP\> 2 times UNL, TB\> 1.5 mg/dl)
* Chronic hepatitis B, C infection
* Decompensated cirrhosis
* HIV infection
* Active malignancy
* Pregnancy or lactation
* Severe co-morbidity i.e. severe heart diseases, severe lung diseases, ESRD

Primary outcomes:
measure: Prevalence of hepatitis at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Prevalence of hepatitis among NAT2 slow acetylator patients
timeFrame: 8 weeks
Other outcomes:
measure: Prevalence of hepatitis at 2 weeks
timeFrame: 2 weeks
measure: Prevalence of hepatitis at 24 weeks
timeFrame: 24 weeks
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Supot Nimanong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05031481: Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.
Official title: National, Multicenter, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Vulvovaginal Candidiasis
Keywords: Vulvovaginal Candidiasis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 0
Sex: FEMALE
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 evaluate the efficacy and safety of different doses of Venus association in the treatment of vulvovaginal candidiasis.


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Age greater than or equal to 18 years;
* Female participants, post-menarche;
* Clinical diagnosis of vulvovaginal candidiasis, defined as white, fluid or creamy vaginal discharge, in addition to the following findings:
* Itching and one or more of the following signs and symptoms characterized as moderate or severe: vulvar/vaginal erythema, edema, burning, irritation, and excoriation;
* Normal vaginal pH;
* Preparation of KOH or saline from a sample taken from inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or growing yeast.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to any of the formula compounds;
* Virgin participants;
* Postmenopausal participants or with vaginal atrophy;
* Participants with other vaginal infections;
* Participants with recurrent vulvovaginal candidiasis;
* Participants using immunosuppressive drugs;
* Participants diagnosed with serious systemic diseases.

Primary outcomes:
measure: Time to first relief of symptoms
timeFrame: 0-24 hours
Secondary outcomes:
measure: Adverse events
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00004781: Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Candidiasis, Oral
Keywords: HIV-associated candidiasis
candidiasis
disease-related problem/condition
fungal infection
immunologic disorders and infectious disorders
infection
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Columbia University
First posted: 2000-02-25
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Evaluate the development of oral manifestations of human immunodeficiency virus infection in relationship to the onset of immunologic alterations and systemic symptoms in different risk groups: gay/bisexual men, male intravenous drug users, and female intravenous drug users.

II. Evaluate the immune and inflammatory response to periodontal and other microbial pathogens.

III. Evaluate the bacterial species infecting the oral cavity in patients in these risk groups.

Detailed description: PROTOCOL OUTLINE:

Patients undergo a periodontal assessment every 6 months until medically unable to continue. The oral/dental exam includes saliva and gingival crevicular fluid analysis and, as indicated, oral photographs.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Human immunodeficiency virus infection (HIV) seropositive or seronegative At risk for HIV, i.e.: Gay/bisexual men Male intravenous drug users Female intravenous drug users No acquired immunodeficiency syndrome Currently enrolled in Columbia Presbyterian Medical Center protocol "The Natural History and Progression of HIV Infection"

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Ira B. Lamster
role: STUDY_CHAIR
References: