louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00674882: Protocol For Collecting Long-Term Follow-Up Data On Recipients of Bone Marrow and Blood Stem Cell Transplant
Official title: Protocol For Collecting Long-Term Follow-Up Data On Recipients of Hematopoietic Stem Cell Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Hematopoietic stem cell transplant
Follow-up studies
Outcomes research
Data collection
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 637
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: St. Jude patient at least one year post receipt of an autologous or allogeneic transplant for a malignant or non-malignant condition

Brief summary: This protocol allows for ongoing data collection to assess the long-term clinical and psychosocial outcomes of pediatric patients who have received a hematopoietic stem cell transplant at St. Jude Children's Research Hospital.

Detailed description: The purpose of this protocol is to provide ongoing data collection and review of long-term outcome and late effects in a large cohort of St. Jude Children's Research Hospital autologous and allogeneic hematopoietic stem cell recipients. Central coordination of clinical and psychosocial late effects monitoring and reporting can facilitate timely communication about life-threatening or unanticipated clinical outcomes as well as significant psychological, social and behavioral sequelae effects on the recipient and their family members. The resultant data may enable researchers in their development of current clinical and psychosocial studies, as well as monitoring predisposed survivors who may benefit from preventive or corrective interventions. Physicians and researchers may be able to learn how to identify these problems earlier, to take better care of these problems, or to implement preventive measures for future transplant recipients

Eligibility criteria: Inclusion Criteria:

* St. Jude patients actively monitored in the BMT-AFU clinic after receiving HSC transplant for a malignant or non-malignant condition.
* St. Jude alumnus who has received a hematopoietic stem cell transplant for a malignant or non-malignant condition and is monitored by the Tumor Registry

Primary outcomes:
measure: To provide ongoing review of long-term clinical and psychosocial outcomes and late effects of hematopoietic stem cell recipients at St. Jude Children's Research Hospital
timeFrame: Long Term Follow Up
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Brandon Triplett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05965882: A Registry Study of Biomarkers in Ischemic Heart Disease ( BIOMS-IHD )
Official title: A Registry Study of Biomarkers in Ischemic Heart Disease ( BIOMS-IHD )
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Ischemic heart disease
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
Collaborators: name: Beijing Luhe Hospital
name: The First Affiliated Hospital of Shanxi Medical University
First posted: 2023-07-28
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Partients with ischemic heart disease accorrding to Inclusion and exclusion criteria.

Brief summary: The registry study aims to discover biomarkers for accurate classification and risk assessment of ischemic heart disease.

Detailed description: The purpose of this study is to discover biomarkers for early identification, diagnosis, molecular classification, and intervention based on the mechanism of ischemic heart disease（IHD）. Using mass spectrometry-based metabolomics and multimodal imaging technology, the study aims to further construct a new system for early risk stratification of IHD based on abnormal metabolites.

Eligibility criteria: Inclusion criteria :

* Aged 18 years or older.
* Previous ischemic symptoms/signs or electrocardiographic ischemic changes and.
* \>70% stenosis of at least one epicardial coronary artery on angiography or a history of myocardial infarction or coronary revascularization.

Exclusion Criteria:

* Current known inability to follow instructions or comply with follow-up procedures.
* Eligible patients without informed consent form

Primary outcomes:
measure: Number of hospitalizations for acute heart failure (HF)
timeFrame: These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge
Secondary outcomes:
measure: Number of major adverse cardiovascular events (MACE)
timeFrame: These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases
name: Jie Du, phD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02138682: Validation of DaTscan for Detection of Parkinson Disease Related Disorders
Official title: Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Movement Disorders
Keywords: DaT-SPECT scan
Parkinson's
Diagnostic
Lead sponsor: Wisconsin Institute for Neurologic and Sleep Disorders S.C.
Sponsor class: INDUSTRY
Collaborators: name: Wisconsin Parkinson Association
name: Medical College of Wisconsin
name: GE Healthcare
First posted: 2014-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson disease patients from Wisconsin Institute for Neurologic and Sleep Disorders, SC.

Brief summary: This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. This measurement can assist in distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. Patients will be registered in the Parkinson Research Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain scanned using DaTscan, and donate their tissue for research and autopsy purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as accurately as a clinician.


Eligibility criteria: Inclusion Criteria:

* aged 75 or older
* sporadic late onset Parkinson disease or one of its variants
* registered in tissue donation program

Exclusion Criteria:

* aged less than 75 years old
* mental status preventing neuroimaging or transportation to site
* inability to remain "relatively steady" during the scanning procedure

Primary outcomes:
measure: Consistency Between Diagnostic Procedures
timeFrame: Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Institute for Neurologic and Sleep Disorders, SC
state: Wisconsin
Study officials:
affiliation: Wisconsin Institute for Neurologic and Sleep Disorders
name: Paul A Nausieda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02670382: Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids
Official title: Role of EPA and DHA in Fish Oil on Inflammation and Lipoprotein Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.

Detailed description: This is a randomized, placebo-controlled, double-blind, crossover study of the effects of EPA and DHA on inflammation and lipid metabolism in 24 men and women with metabolic syndrome. The study will characterize the effects of EPA alone and DHA alone, relative to each other and to placebo, on plasma biomarkers of inflammation, inflammatory cell activation and gene expression, and plasma lipid and lipoprotein levels.

Eligibility criteria: Inclusion criteria:

* fasting plasma TG levels between 150 and 500 mg/dL
* C-reactive protein (CRP) levels ≥2 µg/mL
* at least one of the following criteria for the definition of metabolic syndrome:

  * abdominal obesity (waist circumference \>40 inches in men and \>35 inches in women),
  * hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and
  * fasting glucose ≥110 mg/dL.

Exclusion criteria:

* high-fish diets (\>2 fish meals/week)
* taking fish oil supplements or supplements containing EPA or DHA
* allergy to sardines
* allergy to sunflower oil
* regular use of anti-inflammatory medications (NSAID, COX inhibitors, corticosteroids)
* anticoagulant therapy
* alcohol consumption \>7 drinks/week
* uncontrolled thyroid dysfunction
* insulin-dependent type 2 diabetes mellitus
* kidney or liver disease
* smoking
* alterations in coagulation
* use of lipid altering medications

Primary outcomes:
measure: Interleukin-6 (IL-6)
timeFrame: 10 weeks
measure: Tumor Necrosis Factor Alpha (TNF-alpha)
timeFrame: 10 weeks
measure: Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Stefania Lamon-Fava, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03463382: Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children
Official title: Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Pediatric Surgery
Postoperative Pain
Erector spinae plane block
quadratus lumborum block
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Postoperative pain management in children is still standing as a problem to solve. Effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new defined relatively safer and easier regional anesthesia technique which could be used for this purpose. Primary aim of this double blinded randomized controlled trial is to compare the analgesic efficacy of this two block techniques in this group of pediatric patients.


Eligibility criteria: Inclusion Criteria:

* 1-7 years of age
* ASA I-II
* Undergoing elective low abdominal surgery

Exclusion Criteria:

* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* ASA III-IV
* Patients with neurological disorders

Primary outcomes:
measure: Pain scores
timeFrame: Postoperative first 6hours
Secondary outcomes:
measure: Time to first analgesic drug
timeFrame: first 48 hour
measure: Need for analgesic
timeFrame: 24 hour
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Kocaeli University Hospital
state: Kocaeli
Study officials:
References:
citation: Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
Clinical trial NCT00262665: Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
Official title: Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test a candidate drug, Org 24448,in a phase II clinical trial in adult patients with moderately treatment-resistant unipolar major depressive disorder.

Detailed description: Major depressive disorder (MDD) is a common, severe, chronic and often life-threatening illness. Major depression contributes to significant morbidity and mortality. Available pharmacotherapies for major depression are suboptimal in terms of speed of onset, efficacy, and tolerability. Current medications for severe, chronic mood disorders are not based on pathophysiological models of illness, but rather are variation of monoaminergic-based therapies. Org 24448 represents a new treatment approach for depression, by potentiating the AMPA receptor subfamily of ionotropic glutamate receptors. This drug has been shown to have antidepressant features in preclinical models, as well as cognitive-enhancing qualities.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of MDD
* Have not responded to an adequate trial of one antidepressant in the current episode or have not completed antidepressant trials due to intolerance to ≤3 antidepressant medications in the current or a previous episode

Exclusion Criteria:

* Presence of psychotic features, OCD, drug or alcohol dependency with the preceding 3 months

Primary outcomes:
measure: mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks
timeFrame: at baseline and at 8 weeks
Secondary outcomes:
measure: change in neuropsychological function from baseline to 7 weeks
timeFrame: at baseline and at 7 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Dennis S Charney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01064765: ACT-HF: Attention, Cognition and Self-Management in Heart Failure
Official title: ACT-HF: Attention, Cognition and Self-Management in Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
Self management
cognitive dysfunction
Self management of heart failure
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Sigma-Tau Research, Inc.
First posted: 2010-02-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with history of heart failure 6 months or more meeting inclusion criteria recruited from outpatient clinic who receiving routine care for their heart failure

Brief summary: This study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure.

Detailed description: Eligible participants are those 75 years of age or less, with left ventricular ejection fractions of 40% or less, english speaking and no known cognitive deficits. Participants will be administered the Repeatable Battery for the Assessment of Neuropsychological Status and the Controlled Oral Word Association test at the study visit. They will also be asked to complete the Self-Care in Heart Failure Index and the Anosognosia Questionnaire for Dementia at their convenience and mail back to investigator. Participants will be contacted in 90 days to determine if they have been hospitalized, and if so, for how many days.

Eligibility criteria: Inclusion Criteria:

* 75 years of age or less
* ejection fraction 40% or less
* heart failure 6 months or more
* English speaking
* no known dementia
* no active substance abuse
* presence of caregiver/support

Exclusion Criteria:

* neurologic disorders potentially causing cognitive dysfunction

Primary outcomes:
measure: Self-management of heart failure as measured by the Self-Care in Heart Failure Index
timeFrame: at time of enrollment
Secondary outcomes:
measure: Duration of hospitalization(s)
timeFrame: 90 days after enrollment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Savitri E. Fedson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04804865: Secondary Prognostic Index in RefrActory Lymphoma
Official title: Secondary Prognostic Index in RefrActory Diffuse Large B Cells Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Large B Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Keywords: prognostic score
cancer
Lead sponsor: Weprom
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 180
Sex: ALL
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: The population includes adult patients, who have died with refractory or relapsed diffuse large-cell lymphoma. Patients \<65 years of age eligible for an autologous transplant should have relapsed after the autologous transplant.

Patients\> 65 years of age or not eligible after an autologous transplant must have received at least one RCHOP-type treatment line (2 cycles).

Brief summary: 60% of patients with diffuse large B cell lymphoma are healed after first-line treatment which whatever the age. For the remaining 40% of patients (relapses and primary refractories):

* 38% of patients will be cured with a 2nd line including an autologous haematopoietic cell transplantation for those under 65 years.
* for older patients who are not eligible for a autograft: only 70% of patients will be able to receive 2nd line treatment with rates response less than 50%.
* the survival rate in patients receiving 3rd line treatment or more is 15% at 2 years. Actually, no standard of chemotherapy is offered to relapsed or refractory patients after 2 therapeutic lines. Subsequent lines lead to hospitalizations for infectious complications or transfusions without clear clinical benefit with often an impacted quality of life.

Palliative care is rarely offered as part of the treatment overall load.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* died of diffuse large B cell lymphoma
* Refractory or relapsing after 2 treatment lines for young patients (RCHOP then recovery with platinum salts and autograft) and one line for elderly patients (RCHOP)

Exclusion Criteria:

* patients with HIV infection
* solid tumor treated less than 5 years ago with the exception of skin carcinoma or carcinoma in situ of the uterine cervix treated locally
* inclusion in a therapeutic trial

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Median response time after each line
timeFrame: 5 years
measure: Event-free survival since diagnosis and after each line of treatment received
timeFrame: 5 years
measure: the intensity dose of chemotherapy received
timeFrame: 6 month
measure: the Cumulative Illness Rating Scale for comorbidities score in patients over 65 years old
timeFrame: 6 month
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Clinique Victor Hugo / Centre Jean Bernard
city: Nancy
country: France
facility: Centre d'Oncologie de Gentilly
Study officials:
affiliation: Weprom
name: Katell LE DU, MD
role: STUDY_DIRECTOR
References: