louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05859932: Assessing Medical Trial Experiences of Hairy Cell Leukemia Patients
Official title: A Look at the Patterns in Clinical Research Participation Among Patients With Hairy Cell Leukemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hairy Cell Leukemia
Keywords: hairy cell leukemia
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are actively considering involvement in an observational hairy cell leukemia clinical trial, but have not yet completed enrollment and registration.

Brief summary: The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.

This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for hairy cell leukemia.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of hairy cell leukemia studies.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Ability to understand and the willingness to sign a written informed consent document.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.

Primary outcomes:
measure: Rate of patients who decide to enroll in a hairy cell leukemia clinical study.
timeFrame: 3 months
measure: Number of hairy cell leukemia study participants who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Chihara D, Arons E, Stetler-Stevenson M, Yuan CM, Wang HW, Zhou H, Raffeld M, Xi L, Steinberg SM, Feurtado J, James L, Wilson W, Braylan RC, Calvo KR, Maric I, Dulau-Florea A, Kreitman RJ. Randomized Phase II Study of First-Line Cladribine With Concurrent or Delayed Rituximab in Patients With Hairy Cell Leukemia. J Clin Oncol. 2020 May 10;38(14):1527-1538. doi: 10.1200/JCO.19.02250. Epub 2020 Feb 28.
citation: Maitre E, Paillassa J, Troussard X. Novel targeted treatments in hairy cell leukemia and other hairy cell-like disorders. Front Oncol. 2022 Dec 22;12:1068981. doi: 10.3389/fonc.2022.1068981. eCollection 2022.
citation: Kreitman RJ. Hairy cell leukemia: present and future directions. Leuk Lymphoma. 2019 Dec;60(12):2869-2879. doi: 10.1080/10428194.2019.1608536. Epub 2019 May 9.
Clinical trial NCT02193932: Electroencephalogram (EEG) Triggered Functional Magnetic Resonance Imaging (fMRI) in Epilepsy Patients
Official title: EEG-triggered fMRI in Epilepsy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: EEG triggered
fMRI
epilepsy
intractable
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A prospective exploratory study in patients with drug resistant epilepsy with a target comparison of long term outcome. NeuroScan software modules and a MagLink will be used to acquire EEG in combination with MRI/fMRI data. The MagLink system is used for obtaining integrated EEG and Event Related Potential (ERP) recordings while the subject is inside the MRI machine, without compromising the raw EEG data.


Eligibility criteria: Inclusion Criteria:

1. Refractory epilepsy cases, referred by the service of Neurology. These are cases whose pathophysiology is resistant to treatment, including change in medication and or added medication.
2. Patients will be included if they agree to sign an Institutional Review Board approved written consent.

Exclusion Criteria:

1. Patients with overt symptoms or signs of anxiety than cannot cooperate during the recording inside the scanner, unless consent is given for the procedure to be performed with sedation by the anesthesia department.
2. Patients who meet the regular exclusion criteria for Magnetic Resonance Imaging (MRI) studies per the prescreening form reviewed with all patients prior to exams

Primary outcomes:
measure: Number of participants with at least 40 interictal epileptic discharges during the fMRI
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Hospital
state: Florida
Study officials:
affiliation: Baptist Health South Florida
name: Sergio Gonzalez-Arias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04557332: mHealth for ART Adherence by HIV+ African Americans
Official title: mHealth for ART Adherence by HIV+ African Americans Age 45 & Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1-infection
Lead sponsor: Environment and Health Group, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Prisma Health
First posted: 2020-09-21
Enrollment: 109
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial in which participants were randomly assigned to intervention group or control group.
Primary purpose: TREATMENT

Brief summary: The objective of this grant is to create and test a mobile app to support ART adherence among HIV+ African American adults.

Detailed description: The Phase II project will enhance the existing (Phase 1) mobile intervention by offering: 1) a two-way communication capability through which participants can: i) indicate "pill taken" in response to pill reminders, and ii) receive a positive visual icon as behavioral-economics based reinforcement for "pill taken" responses; 2) pharmacist counseling and medication support; and, 3) the addition of educational and motivational text messages. Overall aims are to: 1) expand mhealth intervention to incorporate new Phase II features; 2) evaluate effectiveness in an RCT of HIV+ African Americans; and 3) prepare marketing and commercialization plans. Our long-term goal is to increase ART medication adherence, thus decreasing health disparities, among HIV+, African-Americans.

Eligibility criteria: Inclusion Criteria:

(a) self-identify as African American, (b) age 30 or older, (c) HIV positive (d) currently on ART (e) report having problems with, and interest in improving their ART adherence (f) own a smartphone (g) report English as their primary language

-

Exclusion Criteria:

(a) not self-identified as African American, (b) under age 30 (c) HIV negative (d) not currently on ART (e) do not report having problems with, or interest in, improving their ART adherence (f) do not own a smartphone (g) do not report English as a primary language and (h) participating in another research study or clinical trial (i) receiving care at non-participating site and, (j) dementia diagnosis.

-

Primary outcomes:
measure: Self-reported ART medication adherence
timeFrame: 90 days
Secondary outcomes:
measure: HIV medication adherence self efficacy
timeFrame: 90 days
measure: Stress Burden
timeFrame: 90 days
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Environment and Health Group
state: Massachusetts
Study officials:
References:
Clinical trial NCT05406232: Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
Official title: Quantifying Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Invasive Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Artidis
First posted: 2022-06-06
Enrollment: 12
Sex: ALL
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 breast cancer that appears to be superficially accessible to a tumor punch biopsy

Brief summary: This study assesses changes to the immune cells following hypofractionated radiation-induced DNA damage in breast cancer patients. Radiation therapy may cause immune cells to enter tumors and target cancer cells. The goal of this study is to measure the change in the level of immune cells in the tumor before and after radiation therapy.

Detailed description: PRIMARY OBJECTIVE:

I. To estimate the percent change in immune infiltration at day 3 and day 7 of radiotherapy (RT) relative to baseline (before radiotherapy).

SECONDARY OBJECTIVE:

I. To estimate the degree of deoxyribonucleic acid (DNA) damage at approximately 3 and 7 days after radiotherapy compared to baseline.

II. To examine cancer cell intrinsic immune signaling following radiotherapy.

EXPLORATORY OBJECTIVE:

I. To examine the association between DNA damage and micronuclei formation. II. To examine the association between DNA damage and immune infiltration. III. To examine the association between micronuclei formation and immune infiltration.

OUTLINE:

Patients undergo RT on day 1. Patients also undergo tumor punch biopsies and blood sample collection prior to the first fraction and on days 1, 3, and 7.

Eligibility criteria: Inclusion Criteria:

* Patients \>= 18 years of age with biopsy proven invasive breast cancer
* Breast cancer that appears to be superficially accessible to a tumor punch biopsy
* Patients thought to derive clinical benefit from palliative RT to the breast/chestwall
* In discussions with the medical oncologist, if clinically reasonable, systemic therapy will be held during RT

Exclusion Criteria:

* A history of prior radiation to the area requiring radiation for which the attending physician believes reirradiation could not be safely delivered
* Pregnancy
* Active usage of anticoagulant medications that are considered to pose an increased risk of tumor punch biopsies
* Receipt of immunotherapy or chemotherapy 7 days prior to start of RT

Primary outcomes:
measure: To estimate the percent change in immune infiltration.
timeFrame: Baseline up to day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Simona F Shaitelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03332732: VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers
Official title: VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Keywords: Healthy Volunteers
Pharmacokinetics
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2017-11-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part 1: Cross-over Part 2: Parallel
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Males or non-pregnant, non-lactating females
* Body Mass Index (BMI) between 18.5 - 32.0, inclusive
* Weight greater than or equal to 50 kg
* Suitable veins for cannulation

Exclusion Criteria:

* Employee of site or the sponsor
* Any disease that poses an unacceptable risk to participants
* Abnormal ECG
* Abnormal labs
* Abnormal vital signs
* Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
* Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
timeFrame: 0-48 hours
measure: Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
timeFrame: 0-48 hours
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
timeFrame: 0-48 hours
measure: Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
timeFrame: 0-48 hours
measure: Number of Subjects with Treatment Emergent Adverse Events
timeFrame: First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days
measure: Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration
timeFrame: Part 2: 10 days
Other outcomes:
measure: Bactericidal titers (Part 2)
timeFrame: 10 days
Locations:
city: Lenexa
country: United States
facility: PRAHS
state: Kansas
Study officials:
References:
Clinical trial NCT04771832: ERAS in Gastrointerstinal Fistulas.
Official title: Enhanced Recovery After Surgery (ERAS) Protocol is a Safe and Effective Approach in Patients With Gastrointestinal Fistulas Undergoing Reconstruction: Results From a Prospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fistula
Surgery Site Fistula
Lead sponsor: Stanley Dudrick's Memorial Hospital
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients scheduled for fistula surgery

Brief summary: An enterocutaneous fistula (ECF) poses a major surgical problem. The definitive surgical repair of persistent fistulas remains a surgical challenge with a high rate of re-fistulation and mortality, and the reasons for that is not the surgical technique alone. Enhanced Recovery after Surgery (ERAS®) is an evidence-based multimodal perioperative protocol proven to reduce postoperative complications. The aim of the study was to assess the clinical value of ERAS protocol in surgical patients with ECF.

Detailed description: ERAS protocol was used in all patients scheduled for surgery for ECF at the Stanley Dudrick's Memorial Hospital in Skawina between 2011 and 2020. A multidisciplinary team (MDT) was in charge of the program and performed annual audits. A consecutive series of 100 ECF patients (44 F, 56 M, mean age 54.1) was evaluated. Postoperative complications rate, readmission rate, length of hospital stay, prevalence of postoperative nausea and vomiting were assessed.

Eligibility criteria: Inclusion Criteria:

* surgery for gastrointestinal fistula

Exclusion Criteria:

* conservative treatment

Primary outcomes:
measure: Postoperative complications
timeFrame: up to 24 weeks
measure: length of hospital stay
timeFrame: up to 24 weeks
measure: postoperative nausea and vomiting
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
Study officials:
affiliation: Stanley Dudrick's Memorial Hospital
name: Stanislaw Klek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klek S, Salowka J, Choruz R, Cegielny T, Welanyk J, Wilczek M, Szczepanek K, Pisarska-Adamczyk M, Pedziwiatr M. Enhanced Recovery after Surgery (ERAS) Protocol Is a Safe and Effective Approach in Patients with Gastrointestinal Fistulas Undergoing Reconstruction: Results from a Prospective Study. Nutrients. 2021 Jun 7;13(6):1953. doi: 10.3390/nu13061953.
Clinical trial NCT02442232: Hemodynamic Changes After Anesthesia With Propofol: Study of Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic Responses to Propofol
Lead sponsor: Conselho Nacional de Desenvolvimento Científico e Tecnológico
Sponsor class: OTHER_GOV
First posted: 2015-05-13
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under propofol anesthesia

Brief summary: The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3 and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms on biomarkers related to nitric oxide after propofol anesthesia. In addition, the investigators will evaluate the effects of propofol anesthesia on biomarkers related to nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme inhibitors.


Eligibility criteria: Inclusion Criteria:

* ASA I or II
* BMI lower 30 kg/m2

Exclusion Criteria:

* Severe hypertension
* Previous stroke
* Previous infarction
* Uncontrolled respiratory, renal, hepatic and hematological diseases.

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 10 minutes
measure: Diastolic blood pressure
timeFrame: 10 minutes
measure: Mean blood pressure
timeFrame: 10 minutes
measure: Heart rate
timeFrame: 10 minutes
measure: Plasma nitrite levels
timeFrame: 10 minutes
measure: Plasma nitrate levels
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Oliveira-Paula GH, Coeli-Lacchini FB, Ferezin LP, Ferreira GC, Pinheiro LC, Paula-Garcia WN, Garcia LV, Tanus-Santos JE, Lacchini R. Arginase II polymorphisms modify the hypotensive responses to propofol by affecting nitric oxide bioavailability. Eur J Clin Pharmacol. 2021 Jun;77(6):869-877. doi: 10.1007/s00228-020-03059-9. Epub 2021 Jan 7.
Clinical trial NCT06060132: Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection
Official title: Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adverse Reaction
Cardiotoxicity
Evaluation Study
Keywords: arsenious acid
arsenic trioxide
cardiotoxicity
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients using sodium arsenite chloride injection from January 1, 2012 to December 31, 2022 approximately 400 people.

Brief summary: To study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures.

Detailed description: Through the project study, the risk rate of cardiotoxicity caused by arsenious acid will be verified and evaluated, and a typical case analysis will be conducted to assess the risk and benefit ratio of clinical use of arsenious acid injection and to formulate preventive measures, so as to guide the holder of the marketing authorization to carry out in-depth safety studies and to ensure the public's safe use of the drug.

Eligibility criteria: Inclusion Criteria:

* the period of consultation (for inpatients, according to the time of admission) is from January 1, 2012 to December 31, 2022
* the patient used arsenite sodium chloride injection

Exclusion Criteria:

* Patients with incomplete clinical information

Primary outcomes:
measure: arrhythmia
timeFrame: through study completion, an average of 1 year
measure: adverse reaction
timeFrame: through study completion, an average of 1 year
measure: troponin
timeFrame: through study completion, an average of 1 year
measure: Echocardiogram LVEF
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: China
state: Shandong
city: Jinan
country: China
facility: First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Yi Han, doctorate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04071132: Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD
Official title: Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in Individuals Diagnosed With PTSD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Traumatic Stress Disorder
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (aged 18 and over) participants with and without PTSD

Brief summary: A psychiatric diagnosis of post-traumatic stress disorder (PTSD) is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. PTSD has physiological manifestations, some of which are likely reflected in the levels and ratios of certain stress-related proteins in the interstitial fluid and plasma. Discernable patterns of such stress-related proteins may constitute a biochemical phenotype characteristic of PTSD, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans.

The current study is a non-interventional observational study aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with PTSD.


Eligibility criteria: Inclusion Criteria:

* PTSD diagnosis (excluding controls)
* Proper ability to give informed consent

Exclusion Criteria:

* Active psychotic or suicidal symptoms
* Active/terminal oncological condition
* Dialysis patients
* Pregnancy

Primary outcomes:
measure: Changes in cortisol levels
timeFrame: 3 months
measure: Changes in c-reactive protein (CRP)
timeFrame: 3 months
measure: Changes in Interleukin 6 (IL-6) levels
timeFrame: 3 months
measure: Changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) levels
timeFrame: 3 months
measure: Changes in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels
timeFrame: 3 months
measure: Changes in volatile organic compounds (VOCs) levels
timeFrame: 3 months
measure: Changes in glucose levels
timeFrame: 3 months
measure: Correlations between biochemical changes and PTSD clinical symptoms
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: