louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03247010: Bone Marrow Suppression and Recovery During Radionuclide Treatment
Official title: Characterization of Bone Marrow Suppression and Recovery During Radionuclide Treatment Using Functional Tests of Thrombocytes and Hemostasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Castration-resistant Prostate Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 68
Sex: MALE
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 metastatic castration-resistant prostate cancer, who initiate therapy with Radium-223 at Rigshospitalet, Copenhagen, Denmark

Brief summary: Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant prostate cancer and bone metastases. More than 20 % of patients treated at Rigshospitalet develop bone marrow suppression as a side effect to Radium therapy The aim of the study is to examine biomarkers of bone marrow suppression and recovery during Radium therapy as well as markers of bone remodeling.

Detailed description: Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant prostate cancer and bone metastases. Therapy is administered intravenously every 4 weeks for up to 6 cycles. More than 20 % of patients treated at Rigshospitalet develop bone marrow suppression as a side effect to Radium therapy, which delays or excludes the patient from further oncological therapy. Especially thrombocytopenia is a frequent side-effect and can be long lasting.

The aim of the study is to examine whether biomarkers of bone marrow recovery (immature platelets, platelet volume, reticulocytes, red cell distribution width) can predict development of hematological toxicity during Radium therapy. Furthermore, to investigate whether these biomarkers can predict recovery from toxicity in patients who develop bone marrow suppression during therapy.

A secondary aim of the study is to evaluate whether dynamics in biomarkers of bone remodeling during Radium therapy is correlated to overall survival and time to symptomatic skeletal event. Optimally these biomarkers can aid in monitoring therapy.

Eligibility criteria: Inclusion Criteria:

* Metastatic castration resistant prostate cancer
* Planned to initiate Radium therapy
* Age \> 18 years
* Able to understand study protocol and give informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Thrombocytopenia
timeFrame: Within 1 year from inclusion
measure: OS
timeFrame: within 1 year from inclusion
measure: Bone markers
timeFrame: Within 12 months from inclusion
Secondary outcomes:
measure: Leucopenia
timeFrame: Within 1 year from inclusion
measure: Anemia
timeFrame: Within 1 year from inclusion
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
name: Jann Ø Mortensen, DMSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02460510: Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF
Official title: Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF: A Randomized Open -Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations. Patients would also be screened for the assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of 144-155 mmol/L .Both the groups would receive other supportive measures such as head end elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard medical treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with Acute Liver Failure with age \>18 yrs
* Grade III or grade IV HE with raised ICP
* Patient's next-of-kin consenting for the study protocol.

Exclusion Criteria:

* Patients with ocular trauma.
* K/c/o DCM, congestive heart failure, cerebral aneurysm, intracranial pathology
* Serum Na\>160 and s creat\>1.5 mg% with oligurea

Primary outcomes:
measure: To study response to therapy at 12 hr in HTS Vs mannitol group in reduction of ICP (Intra Cranial Pressure)
timeFrame: 12 hours
Secondary outcomes:
measure: Correlation of arterial NH3 to raised ICT (Intra cranial Tension).
timeFrame: 2 years
measure: Survival.
timeFrame: 28 days
measure: Length of ICU/hospital stay.
timeFrame: 2 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT00787410: An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Official title: An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mesothelioma
Keywords: malignant mesothelioma
IRESSA
ZD1839
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 23
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: This study is a multicentre, open label, non-comparative, two stage phase II trial to assess the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will receive trial treatment as first-line therapy, administered continuously once daily until the completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity or withdrawal of consent. Patients continuing to show evidence of response, disease stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond completion of the trail.


Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed malignant mesothelioma (based on pleural biopsy); eligibility for first line therapy for malignant mesothelioma
* Uni or bi- dimensionally measurable disease
* No prior radiotherapy within 3 weeks of enrolment into the trial
* No significant comorbid disease

Exclusion Criteria:

* Other malignancies, either co-existing or diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
* Brian metastasis or leptomeningeal carcinomatosis
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or St. John's Wort

Primary outcomes:
measure: To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure
timeFrame: Proportion of patients responding at trial closure, ITT population
measure: To further characterize the safety profile of ZD1839 at a 250mg daily dose
timeFrame: Proportion of patients responding at trial closure, ITT population
Secondary outcomes:
measure: To estimate PFS (progression free survival)
timeFrame: Proportion of patients alive and progression-free at trial closure, ITT population; Median time to progression or death; Proportion of patients alive and progression-free at 6 months
measure: To estimate overall survival
timeFrame: Proportion of patients alive at trial closure, ITT population; Median time to death; Proportion of patients alive at 6 months
measure: To estimate duration of response
timeFrame: Median time from objective response to progression or death; only patients who responded are included in this analysis
Other outcomes:
Locations:
Study officials:
affiliation: Fraser Valley Cancer Centre Surrey Memorial Hospital, Surrey BC, Canada
name: Christopher Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730010: Discerning the Impact of ctDNA Detection on Patient Decision Making in Early Stage Breast Cancer: a Conjoint Analysis
Official title: Discerning the Impact of ctDNA Detection on Patient Decision Making in Early Stage Breast Cancer: a Conjoint Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Triple Negative Breast Cancer
Keywords: breast cancer, ctDNA
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 200 subjects will be recruited by Research Advocacy Network (RAN) and their partner organizations through email and social media solicitation.

Brief summary: This study will examine how ctDNA and additional prognostic genomic information in patients with early stage breast cancer might influences patient decision- making regarding systemic therapy options.

Detailed description: This study is an electronically delivered, one time cross sectional survey study. The investigators want to understand how patients with triple negative breast cancer at high risk for disease recurrence will prioritize additional benefit over toxicity when considering treatment options, and if their knowledge of ctDNA positivity versus negativity will further shift this balance toward benefit.

Eligibility criteria: Inclusion Criteria:

* Self- reported history of non-metastatic breast cancer
* Self- reported history of receiving chemotherapy for breast cancer
* Self- reported history of chemotherapy completed at least 6 months ago but no more than 10 years ago
* Able to complete an online survey
* English speaking

Exclusion Criteria:

N/A

Primary outcomes:
measure: Examine whether knowledge of ctDNA negativity influences patient decision-making
timeFrame: Once all surveys in the sample size are completed, 6 months anticipated
Secondary outcomes:
measure: Estimate at what degree of benefit a given treatment would be acceptable to patients
timeFrame: Once all surveys in the sample size are completed, 6 months anticipated
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
Study officials:
References:
Clinical trial NCT03406910: Egg Intake and Risk of Type 2 Diabetes
Official title: Egg Intake and Risk of Type 2 Diabetes in a Low Meat Intake Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Heart Diseases
Keywords: egg
meat
western diet
type 2 diabetes
Adventist Health Study
Vegetarian cohort
Adventist
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2018-01-23
Enrollment: 55851
Sex: ALL
Minimum age (years): 31
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The AHS-2 is a prospective cohort of \>96,000 Seventh-day Adventist adults recruited from the USA and Canada between February 2002 and May 2007. Designed primarily to examine associations between diet and health outcomes, the study is composed of approximately 65% females and 27% blacks. Recruitment and data collection methods for the parent cohort have been described previously. The cohort is composed of participants with different dietary patterns and a wide variation in egg and meat intake ranging from non-consumption to daily consumption. Approval for the AHS-2 study was obtained from the Loma Linda University Human Subjects Committee Institutional Review Board and written informed consent was acquired from all AHS-2 participants upon enrollment.

Brief summary: This is a longitudinal study that will collect demographic, anthropometric and dietary data to determine the relationships between meat and egg intake and the incidence of Type 2 Diabetes.

Detailed description: Subjects of the Adventist Health Study who are non-diabetic will provide demographic, anthropometric and dietary data at baseline. Meat and egg intake will be assessed with a validated quantitative food frequency intake questionnaire. The relationship between meat and egg intake and the incidence of Type 2 Diabetes will be determined using multivariate-adjusted logistic regression.

Eligibility criteria: Inclusion Criteria:

* AHS 2 Participants who filled out Hospital History Questionnaire version 3 or 5 Age \> 30 years

Exclusion Criteria:

* Subjects with missing values in dietary variables were excluded from the analytic sample,
* missing gender
* age \< 30 years
* improbable questionnaire response patterns
* extremes of BMI (less than 16 or greater than 60)
* estimated energy intake (less than 500 or greater than 4,500 kcal/d)
* existing cases of type 1 or type 2 diabetes at baseline
* inconsistent reports of T2D between HHQ version 3 and 5

Primary outcomes:
measure: Risk for Type 2 Diabetes (T2D) in subjects who consume different frequencies/amounts of eggs and meat.
timeFrame: Change between baseline and 5 Years of follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Joan Sabate, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02704910: Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
Official title: Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients.

Several mechanisms could cause lateral postural inclination. Available data allow to suggest three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of perception of corporal axis

Detailed description: Inclusion Criteria:

* 30 to 75 years old patient
* Parkinson disease's diagnosed since 5 years
* Treated by deep brain stimulation
* Patient with at least 6 degree lateral deviation
* Without vestibular troubles nor peripheral sensorial trouble.

Exclusion Criteria:

* Dementia (Mattis \< 130 ou MMS \<24), or severe depressive episode according to DSM IV-R criteria
* Camptocormia or incompatible anteflexion with the dispositive of measure device
* Pregnant woman, nursing mother

Eligibility criteria: Inclusion Criteria:

* 30 to 75 years old patient
* Parkinson disease's diagnosed since 5 years
* Treated by deep brain stimulation
* Patient with at least 6 degree lateral deviation
* Without vestibular troubles nor peripheral sensorial trouble.

Exclusion Criteria:

* Dementia (Mattis \< 130 ou MMS \<24), or severe depressive episode according to DSM IV-R criteria
* Camptocormia or incompatible anteflexion with the dispositive of measure device
* Pregnant woman, nursing mother

Primary outcomes:
measure: Lateropulsion measured by computerized Posturography
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble - Médecine Physique et de Réadapatation
city: Grenoble
country: France
facility: CHU de Grenoble - Unité des troubles du mouvement
Study officials:
affiliation: University Hospital, Grenoble
name: Paul Krack, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01733810: The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis
Official title: The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagitis
Reflux Esophagitis
Gastroesophageal Reflux Disease
Keywords: Esophagitis
Reflux esophagitis
Gastroesophageal reflux disease
Acid
Inflammation
Esophagus
Cytokines
Esophageal squamous cell
Reflux
Squamous epithelium
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-11-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on the production of inflammatory cytokines that lead to reflux esophagitis.

Detailed description: Reflux esophagitis is thought to be caused by gastric acid that refluxes into the esophagus, causing injury. Newer data suggest that reflux of gastric juice into the esophagus stimulates HIF-2a, which increases production of inflammatory cytokines. These cytokines are thought to lead to reflux esophagitis. The investigators plan to study the relationship of HIF-2a to inflammatory cytokines in patients with known gastroesophageal reflux disease and reflux esophagitis.

Eligibility criteria: Inclusion Criteria:

* U.S Veteran
* History of Los Angeles Grade C erosive esophagitis

Exclusion Criteria:

* Inability to provide informed consent
* Esophageal varices
* Warfarin use
* Coagulopathy that precludes safe biopsy of the esophagus
* Comorbidity that precludes safe participation in the study
* Allergy to fluorescein sodium
* Pregnancy

Primary outcomes:
measure: change in esophageal inflammation from baseline to 14 days
timeFrame: day 0 and day 14
Secondary outcomes:
measure: change in HIF-2a levels from baseline to 14 days
timeFrame: day 0 and day 14
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: Dallas VA Medical Center
name: Stuart J Spechler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huo X, Agoston AT, Dunbar KB, Cipher DJ, Zhang X, Yu C, Cheng E, Zhang Q, Pham TH, Tambar UK, Bruick RK, Wang DH, Odze RD, Spechler SJ, Souza RF. Hypoxia-inducible factor-2alpha plays a role in mediating oesophagitis in GORD. Gut. 2017 Sep;66(9):1542-1554. doi: 10.1136/gutjnl-2016-312595. Epub 2016 Sep 30.
citation: Dunbar KB, Agoston AT, Odze RD, Huo X, Pham TH, Cipher DJ, Castell DO, Genta RM, Souza RF, Spechler SJ. Association of Acute Gastroesophageal Reflux Disease With Esophageal Histologic Changes. JAMA. 2016 May 17;315(19):2104-12. doi: 10.1001/jama.2016.5657.
Clinical trial NCT04237610: Reward and Punishment Sensitivity in Bipolar Disorders
Official title: Reward and Punishment Sensitivity in Bipolar Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Keywords: reinforcement learning
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bipolar disorder, type I and II, in a inter critical phase (euthymic period defined by the mood scales scores mentioned in the inclusion criteria)

Brief summary: Bipolar disorder (BD) represents a chronic mood disorder and one of the leading causes of disability worldwide. Complexity of its clinical presentations leads to delayed diagnosis and difficult management in routine clinical settings. Whereas distinguishing BD-I and BD-II main subtypes has a significant relevance for treatment strategy and for outcome, there are currently no clinical determinants of the BD subtype which could be used as early diagnostic predictors.

* While neurobiological specificity of each BD subtype is still controversial, available evidence suggest different dopaminergic abnormalities in each subtype. Dopaminergic function is involved in decision making and reward processing which may represent useful BD subtype markers.
* This study aims at assessing decision making during appetitive and punitive reinforcement learning in patients with BD I and BD II subtypes compared to healthy controls


Eligibility criteria: Inclusion Criteria:

* bipolar disorder (BD) type I or II, according to DSM (Diagnostic and Statistical Manual)-5 criteria
* Montgomery and Asberg Depression Rating Scale (MADRS) score \< 15
* Young Mania Rating Scale (YMRS) score \< 12

Exclusion Criteria:

* other main diagnosis than bipolar disorder
* other medical condition leading to cognitive deterioration

Primary outcomes:
measure: Response performance in reward and loss trials
timeFrame: one day visit
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
Study officials:
References: