louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01299857: Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab
Official title: EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pemphigus
Keywords: pemphigus
Mabthéra (R)
B lymphocytes
desmogleines
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after Rituximab treatment for Pemphigus.


Eligibility criteria: Inclusion Criteria:

* age\>18
* consentment
* patient treated with Rituximab and included in clinical trial n°2002/020/HP - NCT00213512 "Treatment of Patients Presenting Pemphigus With Anti CD20 (Mabthera)".

Exclusion Criteria:

* age \< 18
* no consentment

Primary outcomes:
measure: Rate of relapse after 5 years of treatment
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen,
country: France
facility: UH-Rouen
state: Seine maritime,
Study officials:
affiliation: dermatological department
name: Damien PICARD, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06482957: Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
Official title: CAUSAL: Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-07-01
Enrollment: 2100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at any age with a history of sarcoma, with or without evidence of a persistent disease and parent/caregiver of pediatric patients and siblings of patients 8 years or older

Brief summary: This study evaluates the impact that a sarcoma diagnosis and treatment have had on patients over time.

Detailed description: * To evaluate the incidence and prevalence and the impact of disease, treatment, sociodemographic and lifestyle contributors on adverse oncologic outcomes (lack of response, recurrence) and non- oncologic outcomes (physical and psychosocial function, financial toxicity, short and long-term organ toxicity) and mortality in the cohort.
* To evaluate the role of drug metabolism and DNA repair genes via functional polymorphisms, known toxicity associated polymorphisms and genetically predicted gene expression levels, as well as polygenic risk scores, on treatment efficacy, cancer therapy-induced normal tissue toxicity and mortality.
* To identify genomic drivers of sarcoma and to use this information to develop personalized liquid biopsy assays for monitoring treatment response, recurrence, and minimal residual disease (MRD) and mortality.
* Evaluate family functioning, psychosocial wellbeing, and financial toxicity.

OUTLINE: This is an observational study.

Patients monitor physical activity, sedentary behavior, heart rate and sleep wearing a FitBit device, undergo blood urine, stool and/or saliva sample collection, complete surveys and have medical records reviewed throughout study.

Eligibility criteria: Patients at any age with a history of sarcoma, with or without evidence of a persistent disease

• For pediatric patients

* Parent/primary caregiver of patient
* Sibling of patient aged 8 years or older

Primary outcomes:
measure: Impact of disease on adverse oncologic outcomes
timeFrame: Approximately six years
measure: Impact of treatment on adverse oncologic outcomes
timeFrame: Approximately six years
measure: Impact of sociodemographic contributors on adverse oncologic outcomes
timeFrame: Approximately six years
measure: Impact of lifestyle contributors on adverse oncologic outcomes
timeFrame: Approximately six years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Debra Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000257: Effects of Alcohol History on Effects of Nitrous Oxide - 9
Official title: Effects of Alcohol History on Effects of Nitrous Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
subjective effects
ethanol
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To determine effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Choice of nitrous oxide vs placebo
timeFrame: After 30 min inhalation each of N2O and placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho AM, Coalson DW, Klock PA, Klafta JM, Marks S, Toledano AY, Apfelbaum JL, Zacny JP. The effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1997 Apr 14;45(1-2):63-70. doi: 10.1016/s0376-8716(97)01346-x.
Clinical trial NCT06087757: Clemastine Treatment in Individuals With Williams Syndrome
Official title: Clemastine Treatment in Individuals With Williams Syndrome- a Double-blind Placebo Control to Assess the Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Williams Syndrome
Keywords: Clemastine
Cognition
Myelination abnormalities
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2023-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study explores the neurobiological etiology of Williams syndrome and potential therapeutic targets for associated social, motor, and cognitive abnormalities. The main translational objective will be to test the effectiveness of Clemasntine on neurocognitive and other associated abnormalities in individuals with Williams syndrome.

Detailed description: The overarching aim of the research proposed is to examine the safty of Clemastine use for individuals with Williams syndrome. Further, we wish to examine the relationship between Clemastine treatment and cognitive, motor and behavioral deficits in individuals with Williams syndrome. This study is an open-label study with a blinded randomize withdrawal. Each participant will go through a baseline evaluation (see study outcomes) and will be treated with the FDA approved drug Clemastine, in an age dependent dose (dosage table below). After a substantial improvement will be noticed, the participants will be divided into 2 groups, in a randomized, double-blind, placebo-control study design.

Eligibility criteria: Inclusion Criteria:

* Individuals with Williams syndrome, which has been confirmed by genetic testing.
* Ages 6-30.
* Normal values in safety variables (e.g. Normal ECG 120-129/80-84).
* No change in psychotropic medications and dosage during the last 4 weeks.
* During the study, no pharmacological change that may impact the study (e.g. ADHD
* medications).

Exclusion Criteria:

* Individuals with another genetic disorder besides Williams syndrome.
* Individuals with Williams syndrome, younger than 6 or older than 30 years old.
* Significant change in normal values in safety variables (e.g. high or low ECG).
* Change in medications and dosage during the last 4 weeks prior the beginning and
* during the study.
* Pregnancy.
* Using addictive substances such as alcohol.

Primary outcomes:
measure: Neurocognitive measures
timeFrame: December 2024
Secondary outcomes:
measure: Motor and Neurological assessment. Motor and Neurological assessment. Motor and Neurological assessment. Motor and neurolocgial measures
timeFrame: December 2024
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Child and Adolescent Psychiatry Unit, Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
References:
Clinical trial NCT06690957: Somatostatin Receptor PET/CT in SSTR-Related Disease Patients
Official title: Somatostatin Receptor PET/CT in SSTR-Related Disease Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SSTR-related Disease
Tumor
Positron Emission Tomography
Metastasis
Keywords: PET/CT
SSTR
Angonist
Antagonist
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2024-11-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled SSTR PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Brief summary: To evaluate the potential usefulness of 68Ga/18F-TATE/JR11/LM3 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various SSTR-related disease patients.

Detailed description: Subjects with various SSTR-related disease patients underwent 68Ga/18F-TATE/JR11/ LM3 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-TATE/JR11/LM3 PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled SSTR PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04994457: Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care
Official title: Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Visual Field
Virtual Reality
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 287
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are glaucoma or glaucoma suspect who are being seen at Bascom Palmer Eye Institute and/or healthy individuals

Brief summary: The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.


Eligibility criteria: Inclusion:

* Any individual who is physically able to take a virtual reality visual field test
* Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma, or have other visual field defects, and normal individual
* Age: Individuals who are old enough to comprehend the instructions and procedures (1-90)

Exclusion:

* Adults unable to consent, prisoners
* Participants who are too tired to take a visual field test
* Participants who refuse to consent
* Individuals who are functionally unable to use VRVF

Primary outcomes:
measure: Sensitivity of VRVF compared to SAP
timeFrame: Day 1
measure: Specificity of VRVF compared to SAP
timeFrame: Day 1
Secondary outcomes:
measure: Variability of Mean Deviation
timeFrame: Day 1
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Elena Bitrian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05013957: Neuroendocrine Neoplasms Methylation Based Classifier - The NEMESIs-study
Official title: Neuroendocrine Neoplasms Methylation Based Classifier - The NEMESIs-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Keywords: Methyloma
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neuorendocrine tumor patients

Brief summary: Neuroendocrine neoplasms (NEN) are rare tumors that mainly occur in the gastrointestinal tract and the lungs. The currently available diagnostic and prognostic markers do not adequately represent the diversity of these tumors. Methylation analyzes of the tumor DNA represent a new, promising approach.

The aim of this project is therefore to improve the diagnostic and prognostic evaluation of neuroendocrine neoplasms by means of methylation analysis of the tumor DNA. On the one hand, existing tumor samples from the biobank of Basel University Hospital are evaluated, on the other hand, patients who are undergoing an operation will be prospectively inquired


Eligibility criteria: Inclusion Criteria:

* neuroendocrine tumor

Exclusion Criteria:

* insufficient amount or quality of neuroendocrine tumor sample

Primary outcomes:
measure: Methylation-based classification of NEN samples
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Endocrinology
state: Basel Stadt
Study officials:
References:
Clinical trial NCT05423457: Diets, Lipoproteins and Inflammation Markers
Official title: Effectiveness of Vegan Diet and MyPlate Diet (Taiwanese Version) on Lipoproteins, Novel Markers of Cardiovascular Diseases, and Traditional Cardiometabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Metabolic Syndrome
Diet, Healthy
Vegan Diet
Inflammatory Response
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Systematic inflammation and lipid profiles are two major therapeutic targets for cardiovascular diseases. The effectiveness of vegan diet has been reported (doi: 10.3389/fnut.2022.807810).

Aim:

To compare the effectiveness of a nutritionally balanced vegan diet and a Myplate diet ((Taiwanese version) on systematic inflammation and lipoprotein subclass.

Design: Randomized crossover design


Eligibility criteria: Inclusion Criteria:

Patients with dyslipidemia (at least one of the following)

* TG ≥ 150 mg/dL
* TC ≥ 200 mg/dL
* LDL-c≥ 130 mg/dL,
* HDL-c \< 45 mg/dL for male or \< 55 mg/dL for female or receiving statin treatment

Exclusion Criteria (fulfill one of the following condition):

* chronic kidney disease
* history of coronary artery disease
* ischemic heart disease,
* heart failure,
* stroke,
* cancer of any type

Primary outcomes:
measure: Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration
timeFrame: 12 weeks
measure: Lipoprotein particles concentration
timeFrame: 12 weeks
measure: lipoprotein particles size
timeFrame: 12 weeks
measure: Trimethylamine-N-oxide
timeFrame: 12 weeks
measure: Traditional cadiometabolic risk factors 1
timeFrame: 12 weeks
measure: Traditional cadiometabolic risk factors 2
timeFrame: 12 weeks
measure: Traditional cadiometabolic risk factors 3
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
Study officials:
References:
Clinical trial NCT01422057: Risk Prediction in Type II Diabetics With Ischemic Heart Disease
Official title: Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type-2 Diabetes Mellitus
Ischemic Heart Disease
Keywords: diabetes
coronary artery disease
ischemic heart disease
autonomic function
heart rate turbulence
deceleration capacity
severe autonomic failure
Lead sponsor: Thebiosignals.com
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with diagnose of ischemic heart disease and type-2 diabetes are included.

Brief summary: The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease

Detailed description: In patients with type 2-diabetes and ischemic heart disease autonomic function might be seriously affected.

In the present study, markers of cardiac autonomic dysfunction, repolarization and respiration abnormalities will be assessed from Holter recordings and 30-minute recordings of high-resolution three dimensional ECG, non-invasive arterial blood pressure and respiratory activity.

The correlation between markers of cardiac autonomic dysfunction and markers of severity of type-2 diabetes will be assessed. Autonomic dysfunction is assumed present when both heart rate turbulence and deceleration capacity are abnormal ("severe autonomic failure"). Assessment of severity of diabetes includes levels of HbA1c and urine albumine, duration and treatment of diabetes, and diabetes related complications (nephropathy, neuropathy, retinopathy).

Eligibility criteria: Inclusion Criteria:

* type-2 diabetes
* coronary artery disease

Exclusion Criteria:

* age \>80 years
* acute coronary syndrome
* life expectancy \<1 year
* unable to give informed consent

Primary outcomes:
measure: Major cardiovascular event
timeFrame: 2 years
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 2 years
measure: sudden cardiac death
timeFrame: 2 years
measure: Total mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Cardiology
Study officials:
References:
Clinical trial NCT05609357: The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest
Official title: The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest: Single Center Research
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Keywords: cardiac arrest
Head-up Cardiopulmonary Resuscitation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Head up CPR with impedance threshold device(ITD) and active compression-decompression (ACD) has been proved to improve both cerebral and coronary perfusion pressure during resuscitation in animal models. Increased rates of Spontaneous Circulation (ROSC) were also observed in cardiac arrest patients.

The goal of this clinical trial is to learn about the feasibility and safety of Head-up Cardiopulmonary Resuscitation in patients with non-traumatic cardiac arrest. Participants will be received head-up CPR during resuscitation. The main question it aims to answer is if there is any adverse or unfavorable event during resuscitation.


Eligibility criteria: Inclusion Criteria:

* Non-traumatic cardiac arrest
* Age ≥ 20

Exclusion Criteria:

* Trauma
* Age \< 20
* Pregnancy
* Irreversible death (e.g. liver mortis, rigor mortis, decapitation, transection and decomposition)
* Disorder of cervical spine

Primary outcomes:
measure: Number and portion of participants with serious or non-serious adverse event
timeFrame: Up to 1 day
Secondary outcomes:
measure: Number and portion of participants with repeated CPR
timeFrame: up to 1 day
measure: Number and portion of participants with survival to emergency department discharge
timeFrame: up to 1 day
measure: Number and portion of participants with sustained return of spontaneous circulation
timeFrame: Up to 1 day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wei-Ting Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Chien-Hua Huang
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Min-Shan Tsai
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Chih-Hsien Lin
role: STUDY_CHAIR
References: