louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03164629: 3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization
Official title: 3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enlarged Prostate
Keywords: BPH
Lower Urinary Track Infection
Urine Retention
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
First posted: 2017-05-23
Enrollment: 50
Sex: MALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research study is to learn about how cone-beam Computerized Tomography scans (X-ray images taken from different angles) work together with an embolization guidance software (helps the doctor see the arteries that feed the prostate)to find and see arteries in the prostate.


Eligibility criteria: Inclusion Criteria:

* Patient is age 50 to 79, inclusive
* Patients undergoing Prostate artery embolization for BPH or urinary retention -Patient has signed informed consent.

Exclusion Criteria:

* Patients with biopsy proven prostate cancer
* Patient weight of \>300 lbs

Primary outcomes:
measure: Time for Prostatic Artery Catheterization
timeFrame: hour 2
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Professional Arts Center
state: Florida
Study officials:
affiliation: University of Miami
name: Shivank Bhatia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00467129: Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer
Official title: The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: stage IV colon cancer
stage IV rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-04-27
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.

PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with metastatic colorectal cancer.

Detailed description: OBJECTIVES:

* Collect blood samples for DNA extraction for genetic studies from patients receiving chemotherapy for metastatic colorectal cancer.
* Collect detailed clinical, pathological, and chemotherapy data from these patients.
* Identify genetic factors that relate to treatment response and outcome in these patients.

OUTLINE: Blood samples are collected and relevant genes and regions are amplified by PCR. PCR products are then sequenced or genotyped for known biological markers and single nucleotide polymorphisms. Tumor samples from surplus pathology specimens are analyzed for expression of candidate genes and mutation in the candidate genes.

Clinical and family history data is also collected by questionnaire.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of metastatic colorectal cancer
* Currently receiving chemotherapy at Weston Park Hospital

PATIENT CHARACTERISTICS:

* Not Specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Survival
measure: Progressive disease-free survival
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sheffield
name: Angela Cox, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00926029: Compare the Clinical Efficacy of Prototype Toothpastes
Official title: Compare the Clinical Efficacy of Prototype Toothpastes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2009-06-23
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.


Eligibility criteria: Inclusion Criteria:

* Male or female volunteers 18-65 years of age.
* Good general health.
* Must sign informed consent form.
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Subject unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures.
* Moderate or advanced periodontal disease.
* 5 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that currently affect salivary flow.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Use of tobacco products.
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Presence of an orthodontic appliance.
* History of allergy to common dentifrice ingredients.
* History of allergy to zinc.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

Primary outcomes:
measure: Plaque Index
timeFrame: 6 weeks
measure: Gingivitis Index
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cedar Knolls
country: United States
facility: Concordia Clinical Research
state: New Jersey
Study officials:
name: Salim A Nathoo, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03100929: Nuchal Cord Detection in Sonographic Evaluation by a First Year Resident.
Official title: The Efficiency in Nuchal Cord Detection in Sonographic Evaluation as Performed by an Unexperienced First Year Resident With Minimal Training.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Cord Entanglement
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators aim to prove that minimal sonographic training for nuchal cord detection in an unexperienced first year medical resident is more than enough to detect the phenomenon. Patients undergoing elective cesarean section will undergo a routine ultrasound (that is performed to detect the fetal heart rate and the fetal presentation) during which the resident will attempt to detect nuchal cord. The resident will then attend the patient's surgery to verify the findings.

Detailed description: Patients undergoing elective cesarean section will undergo a routine ultrasound examination during which fetal heart rate, fetal presentation and nuchal cord presence will be documented. During surgery, after the fetus is delivered, presence or lack of nuchal cord will be documented.

The aim of the study is to show that minimal sonographic training may assist even an unexperienced sonographist in detection of such a subtle yet important phenomenon.

The study will be performed utilizing the newest resident in the OBGYN department.

Eligibility criteria: Inclusion Criteria:

* Any woman undergoing elective cesarean section.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Detection rate for nuchal cord.
timeFrame: up to 6 hours from admission for elective surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03266029: Clinical Evaluation of Cordio App in Adult ADHF Patients
Official title: Single-Arm Observational Double - Blind Study Designed to Clinically Evaluate Cordio Application in Adult Patients With ADHF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Lead sponsor: Cordio Medical
Sponsor class: INDUSTRY
First posted: 2017-08-29
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitals/ CHF clinics

Brief summary: Observational study on ADHF patients at one site in Israel. After signing informed consent and undergoing screening assessments, eligible patients will record sentences into a smartphone. The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital: admittion, release. Before hospital release, if applicable and upon patient agrreement, an app will be installed in a smartphone in order to continue the recording at home.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ADHF (pulmonary congestion)
* Known diagnosis of HF, with either preserved or reduced LVEF.
* 18+ years old.
* Able to understand and provide written informed consent.

Exclusion Criteria:

* Subjects unable to comply with the daily use of the application due to mental disorders.
* GFR \<25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis.
* Subjects with congenital heart disease or mechanical right heart valve(s).
* Airway and lung infection and Sepsis
* Patients with severe alcohol or drug use.
* Women who are pregnant or lactating.

Primary outcomes:
measure: voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Facility
Study officials:
affiliation: Rambam Health Care Facility
name: Zaher Azzam, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amir O, Abraham WT, Azzam ZS, Berger G, Anker SD, Pinney SP, Burkhoff D, Shallom ID, Lotan C, Edelman ER. Remote Speech Analysis in the Evaluation of Hospitalized Patients With Acute Decompensated Heart Failure. JACC Heart Fail. 2022 Jan;10(1):41-49. doi: 10.1016/j.jchf.2021.08.008. Epub 2021 Dec 8.
Clinical trial NCT05797129: CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study
Official title: CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
Contrast-enhanced digital mammography
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 351
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women underwent CEDM screening at Kaohsiung Veterans General Hospital from January 2019 to December 2021

Brief summary: To evaluate the effectiveness of Contrast-enhanced digital mammography (CEDM) in detecting breast cancer in women at higher risk.

Detailed description: The aim of this study was to evaluate the effectiveness of different imaging techniques for detecting breast cancer in women with a higher risk due to personal or family history of the disease.

Eligibility criteria: Inclusion Criteria:

* women underwent CEDM screening

Exclusion Criteria:

* incomplete imaging exams

Primary outcomes:
measure: Total number of cases received and diagnosed with breast cancer (Number)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Total number of cases received and diagnosed as positive requiring a biopsy and MRI (Number)
timeFrame: Up to 3 years
measure: True positive results obtained by the diagnostic method (Number)
timeFrame: Up to 3 years
measure: True negative results obtained by the diagnostic method (Number)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Chen-Pin Chou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03384329: Efficacy of Resveratrol in Depression
Official title: Efficacy and Safety of Resveratrol in the Treatment of Depression: Double-blind Randomized Placebo-controlled Parallel-group Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Russian Science Foundation
First posted: 2017-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1) each morning daily for 1 month with primary outcome measures of the score change on depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times over the study period (before, in the middle, after the intervention, and in 2 week follow up).


Eligibility criteria: Inclusion Criteria (selectively):

* MDD recurrent or with single episode with melancholic features or dysthymia (DSM-5);
* current depression.

Exclusion Criteria (selectively):

* serious or unstable disease;
* antidepressants intake.

Primary outcomes:
measure: Change in Total HDRS-17 Score From Baseline to Week 4
timeFrame: 4 weeks
measure: Change in SIRT1 Activity From Baseline to Week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Total BDI-II Score From Baseline to Week 4
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Lyubomir I. Aftanas
Study officials:
References:
Clinical trial NCT02757729: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis
Official title: Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase II Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 192
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Detailed description: PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 19 - 70 years.
* Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
* Whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).
* Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
* Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
* Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
* Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
* Who has used or is expected to inevitably use prohibited concomitant medications during the study.
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
* Who has dosed other study medications within 30 days before screening.
* Who is determined ineligible for study participation by investigators for any other reasons.

Primary outcomes:
measure: Success rate of Investigator's Global Assessment (IGA)
timeFrame: 8 weeks
Secondary outcomes:
measure: Success rate of Investigator's Global Assessment (IGA)
timeFrame: 1, 3, 6 week(s)
measure: Change in SCORAD (Severity Score of Atopic Dermatitis)
timeFrame: 1, 3, 6, 8 week(s)
measure: % Change in Eczema Area and Severity Index (EASI)
timeFrame: 1, 3, 6, 8 week(s)
measure: Success rate of Pruritus Severity score
timeFrame: 1, 3, 6, 8 week(s)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Beomjoon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04306029: Improving Adherence to Postpartum Family Planning Guidance in Ghana
Official title: Improving Adherence to Postpartum Family Planning Guidance in Ghana: a Hybrid Type 2 Implementation and Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: University of Ghana
First posted: 2020-03-12
Enrollment: 2142
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Hybrid Type II implementation and effectiveness study using a quasi-experimental stepped-wedge design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Evaluating a Postpartum Family Planning Package (PPFP) in a Hybrid Type II implementation study with a stepped-wedge design.

Detailed description: Our overarching goal is to enable providers to consistently offer and deliver highly effective postpartum family planning methods in accordance with international guidelines. Our primary objective in this research is to assess the implementation and effectiveness of the "Postpartum Family Planning Package (PFPP)," an implementation strategy that consists of the following components: 1) a provider training on contraceptive methods available in the immediate postpartum period, and techniques for their placement in the case of intrauterine devices and implants, with quarterly booster trainings, and 2) promotion of the WHO MEC/Postpartum Family Planning Compendium mobile application as a provider decision tool to aid in postpartum family planning counselling.

Eligibility criteria: Provider Inclusion Criteria:

* Providers who care for postpartum women on the inpatient postpartum ward, including midwives, nurses, residents, fellows, and consultant physicians.

Provider Exclusion Criteria:

* Students caring for postpartum patients on the postpartum ward.

Client Inclusion Criteria:

- Women receiving antenatal care who have the potential to be admitted to the inpatient postpartum ward following delivery, or women admitted in the postpartum ward.

Client Exclusion Criteria:

- None

Primary outcomes:
measure: Provider discussed all guideline-appropriate contraceptive methods as defined by World Health Organization Medical Eligibility Criteria (yes/no)
timeFrame: During postpartum inpatient stay, prior to hospital discharge (approximately 2 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Nsawam
country: Ghana
facility: Nsawam Goverment Hospital
state: Eastern Region
city: Amasaman
country: Ghana
facility: Ga West Municipal Hospital
state: Greater Accra
city: Accra
country: Ghana
facility: Maamobi Hospital
Study officials:
References:
Clinical trial NCT04031729: Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
Official title: Aspirin in Adults With Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Keywords: Aspirin
Liver Disease
Anti-inflammatory
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nonalcoholic fatty liver disease (NAFLD), defined by fatty infiltration of the liver in the absence of excess alcohol consumption, affects an estimated 30% of adults in the United States. A proportion of people with NAFLD will develop progressive, inflammatory nonalcoholic steatohepatitis (NASH), which can progress to liver cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that among adults with NAFLD, aspirin will reduce intrahepatic lipid content, as quantified by 1H magnetic resonance spectroscopy (1H-MRS).


Eligibility criteria: Inclusion Criteria:

* Ages 18 to 70 years
* NAFLD, defined by confirmed hepatic steatosis by imaging or by liver biopsy, in the absence of other causes of hepatic steatosis or significant alcohol consumption. If liver imaging or biopsy has not been performed clinically, liver ultrasound assessment will be performed as part of the screening visit.
* Early-stage liver fibrosis, defined as fibrosis less than or equal to Fibrosis Stage 3 (F3), confirmed by either (1) a recent liver biopsy or (2) a recent elastography / Fibroscan study. If no recent biopsy or elastography/Fibroscan have been performed, a Fibroscan will be performed as part of the screening visit.

Exclusion Criteria:

* Liver fibrosis stage \> 3
* Current aspirin use
* Contraindications to aspirin use
* Contraindications to magnetic resonance imaging (MRI)
* Pregnancy or desire to become pregnant
* Breastfeeding

Primary outcomes:
measure: Absolute Change in Intrahepatic Lipid Content, by 1H-MRS
timeFrame: 6 months
Secondary outcomes:
measure: Relative Change in Intrahepatic Lipid Content
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Tracey G Simon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: