louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00543634: Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women
Official title: Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: MDS Pharma Services
First posted: 2007-10-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).


Eligibility criteria: * Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea
* BMI in the range of 18 to 35 kg/m2
* History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic)
* History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
* Use of any prescription or investigational drug within 30 days before test article administration

Primary outcomes:
measure: Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
state: Nebraska
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01462734: MicroRNA Expression in Human Blood Serum and Vitreous Body
Official title: MicroRNA Expression in Human Blood Serum and Vitreous Body
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MicroRNA Expression Profile in Human Vitreous
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2011-10-31
Enrollment: 8
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female pateints undergoing vitrectomy for macula hole without previous ocular or systemic disease

Brief summary: MicroRNAs are important regulators of many cellular functions but their expression profile in human vitreous is still unclear. Aim of this study is to investigate microRNA expression profile by PCR in human vitreous of macula hole patients which is suggested to be similar to that of healthy patients.


Eligibility criteria: Inclusion Criteria:

* Female macula hole patients without previous ocular or systemic disease.

Primary outcomes:
measure: MicroRNA expression profile in human vitreous investigated by PCR
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Kyorin University School Of Medicine
state: Mitakasi Sinkawa6-20-2
Study officials:
References:
Clinical trial NCT04799834: Genotype and Susceptibility to COVID-19
Official title: Study of the Genetic Factors That Influence the Susceptibility to and Severity of COVID-19
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Keywords: COVID-19
Genotype
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥18 years) living in Bergamo and in all the towns of its territory

Brief summary: COVID-19 is a viral disease induced by infection with the novel SARS-CoV-2 coronavirus. Infection arises from the inhalation of viral particles spread by an infected individual. The main virus entry pathways are the nose and mouth mucous membranes, particularly rich in ACE2 receptors, that are used by the virus to enter cells and begin its replication.

Not all individuals who contract the virus fall ill, and most of those who do (about 70-80%) experience mild symptoms (fever, cough, headache, muscle aches, loss of taste and smell). If the immune system is unable to rapidly fight the virus back, the latter can attack the lungs, affeting oxygen absorption inside the alveoli and lead to pneumonia. This more severe form is observed in 20% of patients and can develop into even more serious complications requiring intensive care, with a high mortality rate. In severe cases (about 5%), the disease spreads to the entire body reaching the cardiovascular system and brain, with the risk of heart attacks, encephalitis and stroke, but it can also affect the liver, kidney and bowel.

Reasons why some subjects develop a highly severe disease while others have little or no symptoms at all still remain unclear. Many researchers are trying to find an answer by investigating the human genome, and the Mario Negri laboratories are also working in this direction.

The general hypothesis underlying this research project is that inter-individual genetic variations can explain the different responses to viral infection in a population, and that COVID-19 severity is, therefore, genetically determined in each infected subject.


Eligibility criteria: Inclusion Criteria:

- Age \> 18 years

Exclusion Criteria:

None

Primary outcomes:
measure: Identification of the genetic determinants of COVID-19 severity.
timeFrame: Through study completion, an average of 10 months.
measure: Identification of genetic factors affecting risk of SARS-Cov-2 infection.
timeFrame: Through study completion, an average of 10 months.
Secondary outcomes:
measure: Identification of polymorphic variants or mutations affecting treatment response in severe COVID-19 patients.
timeFrame: Through study completion, an average of 10 months.
Other outcomes:
Locations:
city: Ranica
country: Italy
facility: Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"
state: BG
Study officials:
References:
Clinical trial NCT03001934: Super Chinese Nephrotic Syndrome Registration System (SUCCESS)
Official title: Super Chinese Nephrotic Syndrome Registration System (SUCCESS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nephrotic Syndrome
Keywords: Nephrotic syndrome
Treatment response
Renal function
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nephrotic syndrome patients

Brief summary: The investigators are registering all nephrotic syndrome (NS) patients regardless of the primary causes and developing a NS database in China. Patients will be followed-up and both baseline and follow-up information will be recorded in the registration system. The treatment response, longitudinal changes of renal function, renal survival, patient survival, infection events and acute kidney injury etc, will be analyzed using the NS database.

Detailed description: The investigators are registering all NS patients regardless of the primary causes in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of NS, and lab measurements of serum, urine), pathological characteristics, treatment and treatment response, complications and outcomes. Patients will be followed up, the demographic, clinical characteristics, treatment, lab tests of blood and urine and complications of patients will be collected and recorded at each visit. The investigators also record the outcome at each visit, such as treatment response, longitudinal changes of renal function, hospitalization, occurrence of infection or cardiovascular events etc. The outcomes will be analyzed using the NS database.

Eligibility criteria: Inclusion Criteria:

* Nephrotic syndrome patients regardless of the primary causes

Exclusion Criteria:

* No

Primary outcomes:
measure: The patient survival in NS patients
timeFrame: 10 years
Secondary outcomes:
measure: Renal survival in NS patients
timeFrame: 10 years
measure: Longitudinal changes of renal function of NS patients
timeFrame: 10 years
measure: Treatment response of NS patients
timeFrame: 10 years
measure: Infection rate of NS patients
timeFrame: 10 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01739634: The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
Official title: The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diarrhea
Medullary Thyroid Cancer
Keywords: Diarrhea
Medullary thyroid cancer
Lead sponsor: Salient Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care, reduced quality of life, and treatment delays. Not all patients benefit from conventional anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the incidence and ameliorate the severity of diarrhea in patients with MTC.


Eligibility criteria: Inclusion Criteria:

* Patients with medullary thyroid cancer
* Men and women from all ethnic and racial groups
* Diarrhea ( \>=3 loose bowel movements per day)
* Duration of diarrhea of at least 1 week

Exclusion Criteria:

* Patients with MEN 2b (since these patients may have megacolon)
* Patients taking any clay products
* History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
* Patients who cannot comply with medications
* Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications.
* Pregnancy or lactation
* Patients receiving systemic chemotherapy (includes tyrosine kinase inhibitors)

Primary outcomes:
measure: Efficacy in treatment of diarrhea
timeFrame: 1 week
Secondary outcomes:
measure: Functional impact of CASAD
timeFrame: 1 week
measure: Effect on thyroid function tests
timeFrame: 1 week
measure: Changes in MDASI-THY scores
timeFrame: 1 week
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT00463034: Genes That Affect Disease Progression in Women With Newly Diagnosed or Metastatic Breast Cancer
Official title: Genetic Factors Affecting Breast Cancer Progression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: stage IV breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-04-19
Enrollment: 1800
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.

PURPOSE: This clinical trial is assessing how changes in genes affect disease progression in women with newly diagnosed or metastatic breast cancer.

Detailed description: OBJECTIVES:

Primary

* Correlate inherited and acquired variations in candidate genes with breast cancer progression and survival in women with newly diagnosed or metastatic breast cancer.

Secondary

* Establish a repository of blood and tumor samples from these patients, linked to a database of clinical, pathological, and treatment outcome data for future research studies.

OUTLINE: Patients complete epidemiological questionnaires and undergo blood sample collection. Tumor tissue specimens are requested from the pathology departments.

Blood samples are analyzed for single nucleotide polymorphisms and other polymorphic variants in candidate genes by polymerase chain reaction. Candidate genes include genes involved in the DNA damage response, programed cell death, inflammation, and angiogenesis. Tumor samples are analyzed by tissue microarrays using immunohistochemistry, denaturing high-performance liquid chromatography, and DNA sequencing to study genetic changes in the tumor.

PROJECTED ACCRUAL: A total of 1,800 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Newly diagnosed or metastatic disease
* Resides within the North Trent Cancer Network (NTCRN) region
* Undergoing therapy at NTCRN centers
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* No concurrent participation in another genetic study

Primary outcomes:
measure: Correlation of inherited and acquired variations in candidate genes with breast cancer progression and survival
Secondary outcomes:
measure: Establishment of a repository of blood and tumor samples
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield School of Medicine and Biomedical Sciences
state: England
Study officials:
affiliation: University of Sheffield
name: Angela Cox, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03915834: Biomarkers to Predict Hemorrhage and Outcomes After Endovascular Treatment in Patients With Acute Large Vessel Occlusion
Official title: Biomarkers to Predict Hemorrhage and Outcomes After Endovascular Treatment in Patients With Acute Large Vessel Occlusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: Biomarker
Mechanical thrombectomy
Intracerebral Hemorrhage
Acute Ischemic stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 300
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: Acute ischemic stroke patients

Brief summary: The main aim of the biomarkers to predict Hemorrhagic transformation(HT) after endovascular treatment in Acute Ischemic Stroke Patients.

The study has three main parts. During the first part, the investigators propose to conduct an enrollment of patients after thrombectomy in acute Ischemic Stroke and healthy controls. Serum biomarkers levels were analyzed (before and after) endovascular treatment patients and controls respectively.

During the second part, HT was evaluated and classified on cranial computed tomography and/or MRI post- treatment and was considered as symptomatic HT (sHT) if associated with neurological deterioration.

During the third part, the investigators aim to demonstrate the level of biomarkers can significant predict HT and outcomes in stroke patients undergoing revascularization.


Eligibility criteria: Inclusion Criteria:

1. be 18 or older;
2. have a clinical diagnosis of acute ischemic stroke
3. a score of 6 or more points on the NIHSS(the National Institutes of Health Stroke Scale);
4. be scheduled to undergo intraarterial (IA) therapy for acute hemispheric stroke;
5. patients eligible for IV alteplase should receive IV alteplase;
6. Intracranial arterial occlusion of the distal intracranial carotid artery, middle (M1/M2) ,anterior (A1/A2) cerebral artery,vertebral artery,basilar artery or posterior cerebral artery,demonstrated with CTA, MRA or DSA;
7. begin intra-arterial therapy within 24 hours of symptom onset;
8. have provided informed consent.

Exclusion Criteria:

1. have any pre-existing illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke;
2. patients with known infectious, inflammatory, or neoplastic diseases at the time of treatment and non-availability of blood samples;
3. are pregnant.

Primary outcomes:
measure: Hemorrhagic transformation
timeFrame: 24 to 72 hours
Secondary outcomes:
measure: Modified Rankin scale
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuan Wu Hospital，Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT02827734: Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)
Official title: Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Healthy Controls
Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Non-specific Interstitial Pneumonia
Sarcoidosis
Granulomatosis With Polyangiitis (Wegener's Disease)
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with indication for routine lung function testing

Brief summary: Current diagnostic tools used in interstitial lung disease (ILD) do not meet the challenges set by the complex pathophysiology of this heterogenous group. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of patients with various ILDs.


Eligibility criteria: Inclusion Criteria:

* known or suspected interstitial lung disease

Exclusion Criteria:

* pregnancy
* inability to participate

Primary outcomes:
measure: lung clearance index (LCI) as determined by multiple breath washout
timeFrame: 30 minutes
measure: airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry
timeFrame: 30 minutes
Secondary outcomes:
measure: repeatability of lung clearance index (LCI)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
state: Deutschland
Study officials:
References:
Clinical trial NCT00724334: A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis
Official title: An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myelofibrosis
Keywords: myelofibrosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.

Detailed description: SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is an extension study for a first-in-man, dose escalation study (MF-TG101348-001). The safety, tolerability and clinical activity of SAR302503 (TG101348) in subjects with myelofibrosis will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Completion of MF-TG101348-001 study
* Diagnosis of myelofibrosis
* At least 18 years of age

Exclusion Criteria:

* Any acute or chronic medical abnormality that may increase the risk associated with study participation

Primary outcomes:
measure: Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Clinical activity and pharmacodynamics
timeFrame: 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Investigational Site Number 840103
state: California
city: Stanford
country: United States
facility: Investigational Site Number 840102
state: California
city: Boston
country: United States
facility: Investigational Site Number 840105
state: Massachusetts
city: Ann Arbor
country: United States
facility: Investigational Site Number 840106
state: Michigan
city: Rochester
country: United States
facility: Investigational Site Number 840104
state: Minnesota
city: Houston
country: United States
facility: Investigational Site Number 840101
state: Texas
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Ayalew Tefferi, MD
role: STUDY_CHAIR
References: