louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04862624: Media Project and Health Study - Spanish Version
Official title: Efficacy of the Spanish Version of the "Catalina" Intervention Media Project and Health Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 56
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: We seek to test the efficacy of the Spanish version of the "Catalina" web-app intervention compared to an attention control web-app in reducing symptoms of depression and/or anxiety and motivate women to take action to get help.


Eligibility criteria: Inclusion Criteria:

* self identifies as Latina
* scores 10 or more on Patient Health Questionnaire-8 (PHQ-8) or General Anxiety Disorder (GAD)-7
* can read, write, and speak Spanish
* has access to the internet

Exclusion Criteria:

* currently getting treatment for depression or anxiety
* suicidal ideation identified at screening

Primary outcomes:
measure: Change from baseline in help seeking intention and action
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change attitudes towards seeking psychological services.
timeFrame: Baseline and 6 weeks.
measure: Change in attitudes in mental help seeking.
timeFrame: Baseline and 6 weeks.
measure: Change in Anxiety
timeFrame: Baseline and 6 weeks.
measure: Change in Depression
timeFrame: Baseline and 6 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Nursing
state: California
Study officials:
affiliation: UCLA School of Nursing
name: MarySue V Heilemann, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01335724: Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Parallel Group Phase IV Study to Evaluate the Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neck Pain
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 72
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: The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, age range 18 and over.
* Patient with acute neck pain meeting baseline pain intensity level and duration

Exclusion Criteria:

* Pain medication was taken within the 6 hours that precede randomization.
* Patient with chronic neck pain as defined as pain for 3 months or longer
* Any neck pain that is attributable to any organic disease, such as prolapsed disc, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumors.
* Any recent strains of the neck muscles documented by the clinical evaluation and anamnesis

Primary outcomes:
measure: Pain on Movement
timeFrame: 48 h
Secondary outcomes:
measure: Pain at Rest
timeFrame: 96h
measure: Neck Disability Index
timeFrame: 96h
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: NCH investigative site
city: Essen
country: Germany
facility: NCH investigative site
city: Munich
country: Germany
facility: NCH investigative site
Study officials:
References:
citation: Predel HG, Giannetti B, Pabst H, Schaefer A, Hug AM, Burnett I. Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study. BMC Musculoskelet Disord. 2013 Aug 21;14:250. doi: 10.1186/1471-2474-14-250.
Clinical trial NCT05732324: Comparison of Percutaneous Coronary Intervention Optimization With Fractional Flow Reserve Versus Intravascular Ultrasound in the Treatment of Long Coronary Artery Lesions
Official title: Comparison of Percutaneous Coronary Intervention Optimization With Fractional Flow Reserve Versus Intravascular Ultrasound in the Treatment of Long Coronary Artery Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Myocardial Infarction
Lead sponsor: Vilnius University Hospital Santaros Klinikos
Sponsor class: OTHER
Collaborators: name: Vilnius University
First posted: 2023-02-17
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with functionally significant long coronary artery lesions amenable to percutaenous coronary intervention.

Brief summary: A single center, prospective, observational study to compare fractional flow reserve (FFR) and intravascular ultrasound (IVUS) percutaneous coronary intervention (PCI) optimization strategies on the functional PCI result (assessed with FFR) immediately post PCI and at 9-12 months after the treatment of long coronary artery lesions.


Eligibility criteria: Inclusion Criteria:

* Chronic coronary syndrome (stable angina; staged PCI to other lesions after acute myocardial infarction with ST segment elevation);
* Acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without ST segment elevation);
* Functionally significant (FFR ≤ 0.8) lesion requiring a stent length of ≥ 30 mm and amenable for percutaneous coronary intervention.

Exclusion Criteria:

* Patient's age ≤ 18 years;
* Acute myocardial infarction with ST segment elevation;
* Treatment with dual antiplatelet therapy contraindicated;
* Survival expectancy ≤ 1 year;
* Known allergy to sirolimus, everolimus or zotarolimus.

Primary outcomes:
measure: The rate of optimal functional PCI result
timeFrame: One year
measure: The rate of poor functional PCI result
timeFrame: One year
measure: The rate of optimal anatomical PCI result
timeFrame: 1 day
Secondary outcomes:
measure: The rate of target vessel failure (TVF)
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Vilnius University Hospital Santaros Klinikos
name: Giedrius Davidavicius, PhD, prof
role: STUDY_CHAIR
References:
Clinical trial NCT00519324: Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer
Official title: A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Keywords: Gastric Cancer
RAD001
mTOR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-22
Enrollment: 54
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: The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.


Eligibility criteria: Inclusion criteria:

* Histological proven gastric adenocarcinoma
* Progressive disease during/ after prior treatment
* Treated with 1 or 2 chemotherapy regimen for advanced disease
* At least one measurable lesion by RECIST criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria:

* History of another primary malignancy within 3 years
* Treated with 3 or more regimens for advanced gastric cancer
* Chronic treatment with steroids or another immunosuppressive agent
* A known history of HIV or hepatitis B seropositive, or active hepatitis C infection
* Patients with active, bleeding diathesis

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
timeFrame: 18 months
Secondary outcomes:
measure: Objective response rate (ORR) assessed by RECIST criteria
timeFrame: 18 months
measure: To assess progression free survival (PFS) and overall survival (OS)
timeFrame: 18 months
measure: To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0
timeFrame: 18 months
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Novartis investigative Site
city: Chiba
country: Japan
facility: Novartis investigative Site
city: Ehime
country: Japan
facility: Novartis investigative Site
city: Hokkaido
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis investigative Site
city: Shizuoka
country: Japan
facility: Novartis investigative Site
city: Tochigi
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Doi T, Muro K, Boku N, Yamada Y, Nishina T, Takiuchi H, Komatsu Y, Hamamoto Y, Ohno N, Fujita Y, Robson M, Ohtsu A. Multicenter phase II study of everolimus in patients with previously treated metastatic gastric cancer. J Clin Oncol. 2010 Apr 10;28(11):1904-10. doi: 10.1200/JCO.2009.26.2923. Epub 2010 Mar 15.
Clinical trial NCT00000824: A Study of Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients
Official title: A Pilot Study of HIV Specific Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients With CD4+ T Cells 100-350 Cells/mm3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV Infections
Keywords: Immunotherapy, Adoptive
T-Lymphocyte Subsets
T-Lymphocytes, Cytotoxic
Dendritic Cells
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To define the safety of cytotoxic T lymphocytes (CTLs) generated from sibling-supplied dendritic cells and lymphocytes and infused into an HIV-infected patient. To determine the efficacy of these CTLs in helping the immune system to fight HIV.

With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus.

Detailed description: With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus.

Dendritic cells and lymphocytes are obtained from an HIV-negative sibling. HIV-specific CTLs are generated from these cells and then infused into the HIV-infected patient monthly for 6 months. Siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. Patients are screened over 3 months prior to study entry.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HLA A2+.
* Other HLA matching with sibling.
* CD4 count 100-350 cells/mm3.
* No active opportunistic infection or malignancy (other than cutaneous Kaposi's sarcoma).
* Current stable antiviral regimen.
* Normal lab values and chest x-ray.

Donor siblings must have:

* HLA A2+.
* HIV negativity.
* Good venous access.
* Ability to donate on multiple occasions.
* Negative status for hepatitis B and C.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Immunomodulators.
* Cytokines.
* Systemic steroids.
* IV pentamidine.
* Investigational drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Univ School of Medicine
state: California
Study officials:
References:
Clinical trial NCT01134224: A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes
Official title: A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-05-31
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index below or equal to 35.0 kg/m\^2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the glucose infusion rate curve (only for IDegAsp)
timeFrame: From 0 to 24 hours after single-dose
Secondary outcomes:
measure: Area under the insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours after single-dose administration
measure: Area under the insulin aspart concentration-time curve (only for BIAsp 30)
timeFrame: From 0 to 24 hours after single-dose administration
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03855124: The Effect of a Posture Shirt on Muscle Activity During Functional Tasks
Official title: The Effect of a Posture Shirt on Muscle Activity During Functional Tasks
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Electromyography
Musculoskeletal
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2019-02-26
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy male participants

Brief summary: This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and standing repetitive upper limb task

Detailed description: Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle activity, reduce musculoskeletal pain and discomfort. This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and a standing repetitive upper limb task.

Eligibility criteria: Inclusion Criteria:

* Pain free healthy participants
* Able to speak, read and understand Danish

Exclusion Criteria:

* Pain from the back, neck or shoulder area during the past 6 months
* Experience of delayed onset muscle soreness (DOMS) on the day of testing
* Current or previous chronic or recurrent pain condition
* Regular use of analgesics
* Previous neurologic, musculoskeletal or mental illnesses that may influence the results
* Lack of ability to cooperate

Primary outcomes:
measure: Electromyography (EMG)
timeFrame: During the test session
Secondary outcomes:
measure: Pain intensity: scale
timeFrame: During the test session
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Physiotherapy, University College of Northern Denmark
Study officials:
affiliation: Department of Physiotherapy, University College of Northern Denmark
name: Steffan W Christensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04473924: Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
Official title: Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Infection
Transplant;Failure,Kidney
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Infections are common and associated with poor outcomes as well as high financial costs after kidney transplantation. Identifying and implementing strategies to reduce infections after kidney transplantation is important for improving patient outcomes. This study seeks to determine the feasibility of body surface area-based dosing of mycophenolate compared to standard dosing of mycophenolate in a pilot randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Adult transplant recipients ≥18 years of age who have a functional allograft and have undergone kidney transplantation between six months and two years prior to study enrollment
* Receiving mycophenolate mofetil for maintenance transplant immunosuppression at the time of the screening visit

Exclusion Criteria:

* Evidence of rejection on routine six month post-transplant biopsy
* Prior intolerance to mycophenolate mofetil necessitating drug discontinuation
* Are or are planning to become pregnant, due to inability to take mycophenolate
* Are marginally housed, due to concerns regarding routine follow-up
* Are actively participating in a different interventional trial that may affect immunosuppression dosing
* Are unwilling to consent to participate
* Institutionalized individuals or prisoners
* Are actively abusing illicit drugs or alcohol
* Have a history of poor or doubtful compliance (e.g., frequently missed appointments)
* Have cognitive impairment prohibiting participation in the study

Primary outcomes:
measure: Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate
timeFrame: 6 months
measure: Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
timeFrame: 6 months
measure: Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
timeFrame: 6 months
measure: Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elaine Ku, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270724: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
Official title: A Phase II Clinical Trial of Induction Chemotherapy Regimen Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Followed by a Single Cycle of High Dose Chemotherapy (HDC) and Autologous Hematopoietic Stem Cell Rescue (AuHSCR) for Patients With Recurrent or Progressive Intracranial Germ Cell Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: CNS Germ Cell Tumor
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will look to see how well patients with relapsed or recurrent intracranial germ cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous stem cell rescue.


Eligibility criteria: Inclusion Criteria:

* ICGCT including pure germinoma and MMGCT.
* Patients with histologically proven germinoma and MMGCT, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study.
* Patients with mature/immature teratoma who have tumor marker elevations are eligible on this study.
* Patient with ONLY mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations.

Exclusion Criteria:

* Patients with ICGCTs who are newly diagnosed are excluded from the study.
* Patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study.
* Patients who are pregnant or breastfeeding are excluded from the study.
* Patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study.
* Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study.

Primary outcomes:
measure: Response rate
timeFrame: 4 months
Secondary outcomes:
measure: Toxicity levels
timeFrame: 4 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Randal Olshefski, MD
role: PRINCIPAL_INVESTIGATOR
References: