louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02020954: Prospective Becker-Heart-Study
Official title: Prospective Cohort Study of Patients With Mutations in the Dystrophin Gene (X Linked Dilated Cardiomyopathy and Becker Muscular Dystrophy)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dilated Cardiomyopathy
Lef Ventricular Dysfunction
Heart Failure
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
Collaborators: name: Institut de Myologie, France
First posted: 2013-12-25
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy

Brief summary: The purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and clinical outcome.

Detailed description: A cohort of 100 patients with mutations in the dystrophin gene associated with Becker muscular dystrophy and/or dilated cardiomyopathy will be included (patients with Duchenne muscular dystrophy are excluded).

Patients with undergo at baseline the following workups: electrocardiogram, echocardiography, cardiac MRI, sera biomarkers measurement.

At 3 years and 5 years, patients will be investigated according to the same protocol and occurrence of cardiac adverse events in the meanwhile will be recorded.

Statistical analysis will assess correlations between cardiac phenotype and DMD mutations and prognostic value of cardiac investigations.

Eligibility criteria: Inclusion Criteria:

* mutation in the DMD gene
* Becker muscular dystrophy and/or dilated cardiomyopathy
* age\>18 years
* affiliation to the French medical insurance

Exclusion Criteria:

* Duchenne muscular dystrophy
* Any other chronic disease that may be associated with heart disease

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 3 years
Secondary outcomes:
measure: Composite endpoint: hospitalisation for heart failure, death due to heart failure
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut de Myologie
state: Ile de France
Study officials:
affiliation: Institut de Myologie, Cochin Hospital, Paris
name: Karim Wahbi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02862054: Splenectomy as a Treatment for Patient With Relapsed Haemophagocytic Lymphohistiocytosis of Unknown Etiology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hemophagocytic Lymphohistiocytosis
Keywords: haemophagocytic lymphohistiocytosis
splenectomy
unknown etiology
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical value of splenectomy as a treatment for relapsed haemophagocytic lymphohistiocytosis (HLH) in patient with unknown etiology.


Eligibility criteria: Inclusion Criteria:

1. Patients were older than 14 years of age
2. Diagnosed as Hemophagocytic Lymphohistiocytosis (HLH) according to HLH-2004.
3. patients were excluded with infection, rheumatic and immunologic diseases, malignant tumors (especially lymphoma), and primary HLH.
4. Informed consent

Exclusion Criteria:

1. Pregnancy or lactating Women
2. Active bleeding of the internal organs
3. Uncontrollable infection
4. Contraindication of splenectomy
5. Participate in other clinical research at the same time

Primary outcomes:
measure: Evaluation of treatment response
timeFrame: Change from before and1,2,4,8,12 and 24 weeks after splenectomy
Secondary outcomes:
measure: Survival
timeFrame: from the time patients received splenectomy up to 24 months or December 2018
measure: Adverse events that are related to treatment
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: zhao wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jing-Shi W, Yi-Ni W, Lin W, Zhao W. Splenectomy as a treatment for adults with relapsed hemophagocytic lymphohistiocytosis of unknown cause. Ann Hematol. 2015 May;94(5):753-60. doi: 10.1007/s00277-014-2276-9. Epub 2014 Dec 16.
Clinical trial NCT06747754: HIV Database (DBHIV)-Establishment of a Database of HIV Patients
Official title: Database HIV (DBHIV)-Costituzione di un Database di Pazienti HIV.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Infections
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 4900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with HIV infection

Brief summary: In Italy, there are over 90,000 patients with HIV-1 infection on antiretroviral therapy (ART). The availability of different classes of antiretroviral drugs (nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), protease inhibitors (PIs), integrase inhibitors (INSTIs) and viral entry inhibitors (IEs) that act in different phases of the HIV life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of Italian patients, making this infection a chronic disease.The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease, and the number of HIV-infected patients over 50 years of age has increased significantly and the number of elderly subjects is progressively increasing. Furthermore, HIV infection seems to accelerate the aging process, causing immune system dysfunction, excess oxidative stress and increased inflammatory processes (inflammaging).


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Patients with chronic HIV infection (certified by a positive test for the detection of anti-HIV antibodies)
* Ability to sign the informed consent or signature of the declaration in lieu of consent in the case of deceased patients

Exclusion Criteria:

* lack of willingness to provide free and informed consent.

Primary outcomes:
measure: Establishment of a database
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Carlo Torti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01624454: Optimal Bowel Cleansing Trial
Official title: Osmotic or Large Volume Lavage for Optimal Bowel Preparation - a Single-blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Cleansing for Colonoscopy
Keywords: colonoscopy
bowel cleansing
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2012-06-20
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter

Detailed description: This randomized quality assurance trial aims to compare cleansing quality of two different principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however, the risk of electrolyte disturbances or renal decompensation may increase.

The study will focus on patient experience and compliance, as well as cleansing quality, endoscopic findings and other technical parameters of the colonoscopy procedure that may be adversely affected by poor bowel cleansing. Three centers will participate, ensuring a diverse patient population. 800 patients are planned for recruitment, but an interim assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to adjust the number.

Eligibility criteria: Inclusion Criteria:

* Pts for out-patient colonoscopy
* age 18-80

Exclusion Criteria:

* Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain)
* Suspicion of renal insufficiency or ileus/subileus
* Previous colonic surgery
* Pregnancy
* Inability to adhere to cleansing instructions
* Inability to consent

Primary outcomes:
measure: Bowel cleansing quality
timeFrame: 1 Day
Secondary outcomes:
measure: Colonoscopy findings
timeFrame: 1 Day
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sørlandet sykehus
state: VestAgder
city: Oslo
country: Norway
facility: OUS Rikshospitalet, dept of med gastro
Study officials:
affiliation: Prof of medicine
name: Lars Aabakken, prof of med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leitao K, Grimstad T, Bretthauer M, Holme O, Paulsen V, Karlsen L, Isaksen K, Cvancarova M, Aabakken L. Polyethylene glycol vs sodium picosulfate/magnesium citrate for colonoscopy preparation. Endosc Int Open. 2014 Dec;2(4):E230-4. doi: 10.1055/s-0034-1377520. Epub 2014 Oct 24.
Clinical trial NCT01667354: Vaccine Hesitancy Intervention--Provider (VHIP)
Official title: Vaccine Hesitancy Intervention--Provider (VHIP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Vaccination
Keywords: Parental Childhood Vaccine Hesitancy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
name: Washington State, Department of Health
name: WithinReach
First posted: 2012-08-17
Enrollment: 491
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy.

Detailed description: The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy. The investigators will train primary care teams with an initial training followed by telephone coaching and follow-up visits, and assess the outcomes of parental vaccine hesitancy (primary) and physician self-efficacy (secondary) at baseline and 6 months.

Eligibility criteria: Study population:

* Eligible pediatric and family medicine practices in three counties in Washington State; King, Pierce and Snohomish Counties.
* Mothers whose infants will receive care in participating clinics.

Inclusion Clinics:

* Located in King, Snohomish, Pierce Counties, WA;
* Family practice clinics;
* Pediatric practice clinics;
* Order \> 1000 doses of vaccine in 2009 from State of Washington Department of Health.

Exclusion Clinics: Not willing to be randomized.

Inclusion Mothers:

* Babies born at participating hospitals;
* Mother can be recruited before discharged post-birth;
* Mothers declare pediatric care at one of participating clinics;
* Singleton or twin pregnancies.

Exclusion Mothers:

* Babies born \< 36 weeks gestational age;
* Known medical vaccine contraindications;
* Parental age \< 18;
* NICU;
* Triplet or more;
* Maternal complications.

Primary outcomes:
measure: Parental Vaccine Hesitancy Measure
timeFrame: Change from Baseline in Parental Hesitancy at 6 months
Secondary outcomes:
measure: Physician Self Efficacy Measure
timeFrame: Change from Baseline in Physician Attitudes at 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: David Grossman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henrikson NB, Opel DJ, Grothaus L, Nelson J, Scrol A, Dunn J, Faubion T, Roberts M, Marcuse EK, Grossman DC. Physician Communication Training and Parental Vaccine Hesitancy: A Randomized Trial. Pediatrics. 2015 Jul;136(1):70-9. doi: 10.1542/peds.2014-3199. Epub 2015 Jun 1.
Clinical trial NCT04636554: Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia
Official title: Expanded Access Study of Phage Treatment in Covid-19 Patients on Anti-Microbials for Pneumonia or Bacteremia/Septicemia Due to A. Baumannii, P. Aeruginosa or S. Aureus
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Covid19
Bacteremia
Septicemia
Acinetobacter Baumannii Infection
Pseudomonas Aeruginosa Infection
Staph Aureus Infection
Keywords: Covid19
Bacteriophage
Phage
Bacteremia
Septicemia
Acinetobacter
baumannii
Pseudomonas
Aeruginosa
Infection
Staph
Aureus
Lead sponsor: Adaptive Phage Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Phage Treatment in Covid-19 Patients with Bacterial Co-Infections

Detailed description: The treatment approach will be to make phage therapy available to institutions who care for Covid-19 patients with bacterial co-infections due to A. baumannii, P. aeruginosa or S. aureus. Patient bacterial isolates will be tested to determine phage susceptibility prior to and during phage therapy.

The primary objectives are to determine the feasibility of developing, producing and providing a personalized intravenous phage for Covid-19 patients who have pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus and to evaluate the safety of intravenous phage in Covid-19 patients along with anti-microbial treatment for pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus.

Eligibility criteria: Inclusion Criteria:

* Covid-19 patients with pneumonia or bacteremia/septicemia who have culture-confirmed bacterial co-infection with A. baumannii, P. aeruginosa or S. aureus.
* Patient provided informed and signed consent.

Exclusion Criteria:

* Patient eligible for another APT sponsored trial.
* Patient participating in another clinical trial at the same time or patients \< 4 weeks from participating in an alternative investigational protocol/study
* Patient with known allergy to infusion of phage products
* Patients with a history of Meningitis or encephalitis at time of study entry, Primary immune deficiency disease or tuberculosis or Stroke, transient ischemic attack (TIA), or untreated deep vein thrombosis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01902654: Osteoarthritis Cardiovascular Risk Factors
Official title: Prevalence of Cardiovascular Risk Factors Between Patients With Knee or Hand Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Cardiovascular Risk Factors
Cardiovascular Disease
Metabolic Syndrome
Keywords: Osteoarthritis
cardiovascular disease
Lead sponsor: Parc Taulí Hospital Universitari
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 490
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to the rheumatology outpatient for symptomatic hand or knee osteoarthritis or soft tissue disease. Patients were referred by their primary care physician, and all patients were visited in primary care assitance.

Brief summary: We analyze retrospectively the relationship between traditional cardiovascular risk factors as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we compare the results with a control groups of patients with soft tissue disease with no other rheumatologic condition.


Eligibility criteria: Inclusion Criteria:

* Patients referred for symptomatic hand or knee osteoarthritis
* All patients referred in the same period for soft tissue disease
* \> 50 years old

Exclusion Criteria:

* Any other rheumatologic condition
* secondary osteoarthritis

Primary outcomes:
measure: Prevalence of cardiovascular risk factors in hand or knee osteoarthritis patients
timeFrame: one month
Secondary outcomes:
measure: Prevalence of cardiovascular disease in hand or knee osteoarthritis.
timeFrame: one month
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Tauli Sabadell
state: Barcelona
Study officials:
affiliation: Hospital Parc Tauli
name: jordi Gratacos, MD Ph
role: STUDY_DIRECTOR
References:
Clinical trial NCT03980054: A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Official title: A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-10
Enrollment: 1192
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pyrotinib versus Placebo
Primary purpose: TREATMENT

Brief summary: This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.


Eligibility criteria: Inclusion Criteria:

* Female patients, 18 years ≤ age ≤ 75 years；
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Histologically confirmed invasive HER2 positive breast cancer.
* Known hormone receptor status.
* Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram.
* Been treated for early breast cancer with standard of care duration of trastuzumab.
* If been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response.
* Signed informed consent form (ICF) .

Exclusion Criteria:

* Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
* History of heart disease.
* Bilateral breast cancer.
* Corrected QT (QTc) interval ≥0.47 seconds.
* History of gastrointestinal disease with diarrhea as the major symptom.

Primary outcomes:
measure: Invasive Disease-free Survival (iDFS)
timeFrame: From randomization until time of event up to 2 years
Secondary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: From randomization until time of event up to 2 years
measure: Overall Survival (OS)
timeFrame: up to 2 years
measure: Distance Disease-free Survival (DDFS)
timeFrame: distant recurrence From randomization until time of event up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
affiliation: Fudan University
name: Zhimin Shao
role: STUDY_CHAIR
References:
Clinical trial NCT02852954: Progesterone Induced Blocking Factor Expression Levels in Endometrial Cancer Cells.
Official title: Determining Levels of Expression of Progesterone-Induced Blocking Factor in Endometrial Cancer Cells.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progesterone Induced Blocking Factor in Endometrial Cancer
Keywords: Progesterone Induced Blocking Factor
Endometrial Cancer
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-08-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: There are three groups in this study; endometrial cancer,endometrial hyperplasia and normal endometrium and each of the groups contained 20 paraffin embedded blocks provided from the Pathology clinic of Kayseri Training and Research Hospital archives.

Brief summary: Immune system suppression effect of Progesterone Induced Blocking Factor(PIBF), it could be questionable whether tumor cells express PIBF for escape of immune system. There are some studies in the literature that evaluate PIBF expression of different malign cells (e.g. glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary brain tumor, lung cancer and chorionic carcinoma). According to previous studies PIBF has been used as an anti-tumor immune suppressor by tumor cells. There is no data about the PIBF expression of endometrial tumor cells. Therefore, the investigators aim to determine the PIBF expression levels in the endometrial cancer cells.

Detailed description: This retrospective controlled study will be conducted at both Obstetrics and Gynecology clinics and Pathology clinics of Kayseri Training and Research Hospital. This study will be conducted with the use of formalin fixed paraffin embedded tissue blocks immunohistochemically to determine the PIBF expression levels in the samples. There are three groups in this study; endometrial cancer, endometrial hyperplasia and normal endometrium and each of the groups contained 20 paraffin embedded blocks provided form the Pathology clinic of Kayseri Training and Research Hospital archives.

Eligibility criteria: Inclusion Criteria:

* diagnosed endometrial cancer
* diagnosed endometrial hyperplasia

Exclusion Criteria:

* diagnosed cancer except endometrial cancer

Primary outcomes:
measure: Immunohistochemically Levels of PIBF in Endometrial Cancer Cells
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: