louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06344819: An Acupuncture Study for People At High Risk for Sepsis
Official title: Acupuncture to Improve Outcomes in Sepsis Patient: The ACTIONS Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sepsis
Keywords: sepsis
acupuncture
Memorial Sloan Kettering Cancer Center
24-062
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Having MSK sepsis order-set placed within the previous 48 hours

Exclusion Criteria:

* The study Principal Investigator will review the medical record again prior to enrollment to exclude non-sepsis patients (Even though the placement of sepsis order set already screens out such patients, subsequent clinical development after sepsis order set placement may generate new information that deems the patient not septic.)
* Admitted to ICU before being approached for consenting
* Having an implanted medical device, such as a pacemaker or implantable cardioverter-defibrillator (ICD), with which electroacupuncture
* Unable to obtain informed consent due to a participant's mental status and absence of an individual authorized to give consent on the participant's behalf
* The patient is on an interventional clinical trial and its Principal Investigator does not give approval to enrollment to this study (e.g. genomic profiling, biospecimen, or observational studies do not require PI approval).

Primary outcomes:
measure: Number of participants recruited compared to the number of participants who complete study treatment.
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gary Deng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02151318: Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies
Official title: Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having glaucoma and undergoing a trabeculotomy

Brief summary: In this study, the investigators will collect tissue from patients undergoing trabeculectomy for primary open-angle glaucoma treatment. This tissue would normally be discarded. These trabecular meshwork (TM) cells can be cultured and used experimentally to better understand the mechanisms of glaucoma. These TM biopsies will be cultured on the same day as the trabeculectomy using established techniques.


Eligibility criteria: Inclusion Criteria:

* Patients having glaucoma and undergoing a trabeculotomy
* Sign ICF (Informed Consent Form)

Exclusion Criteria:

* None

Primary outcomes:
measure: Efficacy of new glaucoma medications to reduce TM cellular pathologies associated with the disease glaucoma.
timeFrame: 6 weeks
Secondary outcomes:
measure: Cultured TM cell toxicity caused by new glaucoma medications
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hosipital
state: Florida
city: Tampa
country: United States
facility: Byrd Alzheimer's Institute
state: Florida
Study officials:
affiliation: University of South Florida department of Molecular Medicine and Byrd Alzheimer's Institute
name: Chad A Dickey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida and Tampa General Hospital
name: Carla Bourne, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00148018: Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma
Official title: A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hodgkin Disease
Keywords: Hodgkin disease
Bortezomib
Relapse
Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: German Hodgkin's Lymphoma Study Group
name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First posted: 2005-09-07
Enrollment: 37
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 primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.

Detailed description: The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.

Eligibility criteria: Inclusion Criteria:

* Hodgkin's lymphoma
* Second or higher relapse (first relapse if high-dose chemotherapy not possible)
* Age \>/= 18 years
* No major organ dysfunction or intercurrent disorder
* Written informed consent

Exclusion Criteria:

* Pregnant or nursing

Primary outcomes:
measure: Overall response rate (complete and partial responses)
Secondary outcomes:
measure: Toxicity
measure: Event free survival
measure: Overall survival
measure: Duration of response
measure: Treatment administration (dose-intensity, total dose)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
state: NRW
Study officials:
affiliation: University of Cologne
name: Andreas Engert
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trelle S, Sezer O, Naumann R, Rummel M, Keller U, Engert A, Borchmann P. Bortezomib in combination with dexamethasone for patients with relapsed Hodgkin's lymphoma: results of a prematurely closed phase II study (NCT00148018). Haematologica. 2007 Apr;92(4):568-9. doi: 10.3324/haematol.10797.
Clinical trial NCT02217618: A Study of LY2409021 in Healthy Participants
Official title: A Single Dose Pharmacokinetic Study of LY2409021 Tablet Administered in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of the drug after the dose. This study will last approximately 28 days, not including screening. Screening can occur within 30 days prior to the start of the study.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females as determined by medical history
* Satisfactory clinical laboratory and physical examination tests
* Have a body mass index (BMI) of 18 to 32.0 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

- Abnormal electrocardiograms (ECGs)

Primary outcomes:
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
measure: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03990818: Continuous Registration of Bioimpedance During Hemodialysis
Official title: Continuous Registration of Bioimpedance During Hemodialysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dialysis Related Complication
Dehydration
Lead sponsor: Mode Sensors AS
Sponsor class: INDUSTRY
Collaborators: name: Helse Nord-Trøndelag HF
First posted: 2019-06-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for hemodialysis

Brief summary: This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.

Detailed description: The purpose is to test the sensitivity and specificity of a new electronic patch in the indication of the relative change in the fluid balance. If possible, the change in hydration level should be quantified. The test is done on patients during hemodialysis. Extracted amount of fluid is used as the primary reference to the bioimpedance measurements, but other references will also be used.

The measurement is made using bioimpedance measured with four electrodes and over a large frequency spectrum. Impedance measurements are made every 20 seconds throughout the test period. The measurement is recorded in a memory (flash) on each patch. At the same time as measuring bioimpedance, the temperature in the patch is recorded.

After completion of the test, the data is transferred to a computer for analysis. As a reference, extracted amount of fluid, weight change, blood samples and clinical evaluation are used.

Eligibility criteria: Inclusion Criteria:

* Patients for hemodialysis

Exclusion Criteria:

* Acute in-current disease.
* Known adverse reaction to medical adhesive

Primary outcomes:
measure: Sensitivity and specificity of patch performance
timeFrame: August - December 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Levanger Hospital
Study officials:
affiliation: Mode Sensors AS
name: Magnus Nordahl
role: STUDY_CHAIR
References:
Clinical trial NCT05818618: Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus
Official title: Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Lichen Planus
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The main aim of the study is to analyze the impact of topical clobetasol on gingival crevicular fluid miRNAs expression in subjects affected by oral lichen planus.
Primary purpose: TREATMENT

Brief summary: According to recent research, microRNAs (miRNAs) may function as early disease indicators and contribute to the severity of a number of precancerous and malignant oral disorders. The aim of the present study, through a double-blind randomized controlled trial design, is to analyze in the gingival crevicular fluid (GCF) as a non-invasive approach the impact of topical clobetasol on miRNAs expression in subjects affected by oral lichen planus (OLP).

Detailed description: A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical clobetasol on GCF miRNAs expression in subjects with OLP and determine the statistical significance of the outcome variables.

At least 60 patients with OLP, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the clobetasol group with the same gel containing clobetasol propionate 0,05%.

Eligibility criteria: Inclusion Criteria:

* The complete correspondence of the most recent WHO clinical and histopathological criteria (2020) for OLP diagnosis.

Exclusion Criteria:

* 1) Previous therapies for OLP during the last six months preceding the study; 2) State of pregnancy or breastfeeding; 3) Contact or drug oral lichenoid lesions; 4) Allergies to the molecules used in the study; 5) HIV seropositivity.

Primary outcomes:
measure: miRNAs GCF levels
timeFrame: 8 weeks
Secondary outcomes:
measure: OLP disease severity scores
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: University of Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06610318: Feasibility and Acceptability of a Single Session of Imagery Rescripting in a Community Sample of Adults
Official title: Brief Strategies for Improving Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Feasibility Studies
Acceptability
Depressive Symptoms
Disordered Eating Behaviors
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Negative experiences related to eating and appearance (NEREAs), such as critical commentary from parents about food, are common. They are also associated with depression and disordered eating, predictors of early mortality. Imagery rescripting (IR) is a therapeutic process during which individuals are guided through recalling distressing memories, like NEREAs, and generating ideas for bringing support into these memories. Single sessions of IR demonstrate promise in shifting the primary negative consequences of NEREAs in clinical samples of women. The current study examined the feasibility and acceptability of a remote-delivered, single session of IR in a community sample of men and women with NEREAs.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years old
2. endorse a history of at least one negative experience related to eating and/or appearance

Exclusion Criteria:

1. endorsed a current major medical condition;
2. met criteria for a full threshold psychiatric disorder (of moderate intensity when severity ratings are necessary, such as for substance use disorders and binge eating disorder);
3. were at high risk for suicide;
4. endorsed current or recent pregnancy or anticipated becoming pregnant within the next year;
5. were taking medication known to affect eating, weight and/or chronic disease risk;
6. were participating in eating, weight, or diabetes programming;
7. experienced weight loss \&gt; 10% in the past six months; and/or
8. could not complete study procedures in English.

Primary outcomes:
measure: enrollment
timeFrame: once, at baseline, over the duration of recruitment to obtain the sample size of interest
measure: fidelity
timeFrame: during the intervention session only
measure: data collection completeness
timeFrame: baseline, intervention, 1-month, and 3-month
measure: intervention acceptability
timeFrame: these data will be collected during the 1-month follow-up visit
measure: safety
timeFrame: these data will be collected during and between all study visits, from baseline though the 3-month follow-up visit
measure: retention
timeFrame: from baseline through the 3-month follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
References:
Clinical trial NCT00163618: Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children
Official title: Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Encephalitis, Tick-borne
Keywords: tick-borne encephalitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.


Eligibility criteria: Inclusion Criteria:

* Male and female children who participated in Study 146A if:
* they and/or their parents/legal guardians understand the nature of the study and agree to its provisions
* written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians
* they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A
* they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A

Exclusion Criteria:

* Subjects who received any further TBE vaccination since their first TBE booster vaccination
* Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A
* Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination
* Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A
* Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hermagor
country: Austria
facility: Bahnhofstraße 9
city: Linz
country: Austria
facility: Freistädter Strasse 290
city: Voitsberg
country: Austria
facility: Conrad-von-Hoetzendorf-Strasse
city: Wels
country: Austria
facility: Grieskirchner Strasse 17
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter BioScience Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00574418: Far Infrared Radiation Treatment for Uterine Fibroids
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Leiomyoma
Keywords: Fibroid Tumor
Fibroid Uterus
Fibroids, Uterine
Fibromyoma
Uterine Neoplasms
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 2
Sex: FEMALE
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: A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.

Detailed description: Uterine fibroids are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape and often highly vascular. On MR imaging exams, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid.

We are postulating that energy specific electromagnetic radiation of the uterus will shrink the benign tumors.

Eligibility criteria: Inclusion Criteria:

* Women age 18 or older with symptomatic fibroids

Exclusion Criteria:

* Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
* Metallic implants that are incompatible with MRI or ultrasound
* Known intolerance to the MRI contrast agent (e.g. Gadolinium)

Primary outcomes:
measure: The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids
timeFrame: 2 years and 9 months
Secondary outcomes:
measure: The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related uterine conditions, for example, bleeding.
timeFrame: Two years and nine months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken B Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05744518: Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast DCE-MRI
Official title: Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast Dynamic Contrasted-Enhancement Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible female breast cancer patients receiving NAC at Fudan University Shanghai Cancer Center

Brief summary: The study will assess whether changes in kinetic parameters of tumor and peritumoral vasculature using ultrafast dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) during neoadjuvant chemotherapy (NAC) are predictive of pathologic complete response (pCR) in patients with breast cancer appropriate for NAC. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.


Eligibility criteria: Inclusion Criteria:

1. Female;
2. Age 18 years or older;
3. Diagnosis of invasive breast cancer by ultrasound guided biopsy;

3. Planed for receiving neoadjuvant chemotherapy (NAC) 4. Planned definitive breast surgery following completion of NAC.

Exclusion Criteria:

1. Stage IV breast cancer;
2. Previous ipsilateral breast cancer;
3. Previous treatment (chemotherapy or radiation) to involved breast;
4. Medically unstable;
5. Pregnant or nursing.

Primary outcomes:
measure: Complete Pathologic Response (pCR)
timeFrame: 6 Months Post Surgery
Secondary outcomes:
measure: Image Quality
timeFrame: 6 Months Post Surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: