louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01315106: High Resolution 3D Diffusion-weighted Breast MRI
Official title: High Resolution 3D Diffusion-weighted Breast MRI
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2011-03-15
Enrollment: 50
Sex: FEMALE
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: Stanford Radiology Department MRI facilities

Brief summary: The purpose of this study is to determine how well a new MRI technique called "High resolution 3D diffusion-weighted breast MRI" detects breast cancer.

Detailed description: The objective of this study is to assess the diagnostic accuracy of a new non-contrast MRI method for breast cancer detection. The study design is a single arm observational study. The new technique will be added on to the standard sequences that a women undergoes during a breast MRI. The resulting images will be compared with her standard breast MRI images, and with results of subsequent pathology.

Eligibility criteria: Inclusion Criteria:1. Patient scheduled for contrast-enhanced breast MRI to image possible breast cancer.

2. Female

3. Age \>18 Exclusion Criteria:1. Lactation

2. Pregnancy

3. Patient undergoing chemotherapy. These patients are excluded because chemotherapy changes the biology of breast cancers. Since the ultimate objective of the research is to develop a new imaging method for breast MRI screening (detection of previously unknown tumors), results in treated tumors would not be relevant. Including treated tumors could yield a misleading assessment of the performance of the new method since treated tumors have different imaging characteristics than de novo tumors.

4. Patient scheduled for pre-operative chemotherapy. These patients are excluded if they are going to be treated only on the basis of fine needle aspiration. The project seeks to correlate all tumors detected with standard histopathology of their untreated neoplasm. This exclusion criteria will be very unusual because most patients planning neoadjuvant chemotherapy do so on the basis of a pre-chemo core needle biopsy, which provide adequate histopathologic proof necessary for enrollment.

Primary outcomes:
measure: Sensitivity of the new MRI method
timeFrame: 8 weeks
measure: Lesion detection rate of the new MRI method
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Bruce L. Daniel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02433106: The Effects of an Exercise Programme on Neuromuscular Outcomes in Gaelic Sport
Official title: The Effects of an Exercise Based Injury Prevention Programme on Neuromuscular Outcomes in Gaelic Football and Hurling Players, a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study is Effects of Neuromuscular Training
Keywords: Balance
Exercise
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 78
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized control trial examining the effects of an exercise based injury prevention programme on postural control and jump landing mechanics. Randomization of 4 teams, 2 Gaelic football and 2 hurling teams to exercise intervention and control groups. Participants are tested using Y Balance test and Landing Error Scoring System (LESS).

Detailed description: Gaelic football and hurling, a stick and ball game, are Irish amateur games components of explosiveness with the multi-directional nature of both games, in addition to the overhead activities and the high level of contact involved; makes it a high risk of injury, especially during match-play. Recent systematic reviews found that injury prevention exercise programmes can significantly reduce the relative risk of lower extremity injuries. Several studies have successfully incorporated exercise components including balance, plyometrics, strength, neuromuscular training, running and cutting movement patterns to prevent injuries in sports such as soccer, basketball, and handball.

This study examines the effect of an injury prevention programme on 2 recognized risk factors for lower limb injury balance and jump landing mechanics.

Eligibility criteria: Inclusion Criteria:

* Participants registered on Collegiate Gaelic football or hurling team, which trained at least twice per week.
* To be over the age of 18 years
* No current injuries

Exclusion Criteria:

* Injuries of the lower limb preventing training or completing the testing

Primary outcomes:
measure: Y Balance test
timeFrame: baseline to 8-weeks
Secondary outcomes:
measure: Landing error scoring system
timeFrame: baseline to 8-weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
affiliation: UCD
name: Catherine Blake, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04543006: Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
Official title: Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: neutralizing antibodies
long-term persistence
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: sample of patients 6 and 12 months after the acute disease
Primary purpose: PREVENTION

Brief summary: Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known.

The investigators will explore patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected.

The investigators will determine whether this persistance varies according to

* the severity of the Covid-19
* a treatment by steroids during the covid-19. This will help to anticipate whether a second wave of infection is possible in a non-naive population.

Detailed description: Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known.

The investigators will explore adult patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected.

The investigators will determine whether this persistance varies according to

* the severity of the Covid-19 (3 groups: no oxyegn therapy; oxygen therapy of less than 3L/min; oxygen therapy of 3L/min or more)
* a treatment by steroids during the covid-19. Immunocompromised patients will be excluded.

Eligibility criteria: Inclusion Criteria:

* positive SARS-CoV-2

Exclusion Criteria:

* age under 18
* immunocompromised at the onset of Covid-19

Primary outcomes:
measure: anti-SARS-CoV-2 neutralizing antibody titers
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Olivier Epaulard, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580706: The Effect of Frailty and Other Geriatric Syndromes on the Prognosis of Elderly Patients With Acute Coronary Syndrome
Official title: The Effect of Frailty and Other Geriatric Syndromes on the Prognosis of Elderly Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ACS
Frail Elderly Syndrome
Elderly Patient
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This registry will include consecutive patients age ≥65 years admitted for ACS

Brief summary: This is a prospective observational clinical trail which will recruit 1000-1500 participants over 65 years with frailty and acute coronary syndrome (ACS) in Beijing Friendship hospital. The investigators will conduct frailty assessment (FRAIL scale, CFS, SPPB), comorbidities, functional status (Barthel index, ADL, IADL), nutritional risk (MNA-SF), and then observe the clinical outcomes of elderly ACS participants with frailty. Then, the investigators will follow-up these participants separately in 1,3,6 and 12months, the anticipate follow-up time is 1 year. According to the follow-up results, investigators will evaluate the impact of frailty and other senile syndromes on the short-term and long-term prognosis of ACS, and develop a scoring system for the prognosis evaluation of elderly ACS participants.


Eligibility criteria: Inclusion Criteria:

* Elderly participants over 65
* Clinical diagnosis of acute coronary syndrome
* Must be able to follow-up
* Sign in the informed consent

Exclusion Criteria:

* Myocardial infarction caused by other acute disease
* Mental disorders who cannot cooperate to complete the assessment
* Severe liver dysfunction, kidney disease (CKD 5), end-stage malignant tumor
* Totally disabled and bedridden

Primary outcomes:
measure: Death
timeFrame: During hospitalization, assessed up to 2 months
measure: Major Adverse Cardiac and Cerebrovascular events
timeFrame: During hospitalization, assessed up to 2 months
measure: Death
timeFrame: 1 year
measure: Major Adverse Cardiac and Cerebrovascular events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04263506: A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Supervisor's Role on Research Practices of Doctoral Students
Official title: A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Supervisor's Role on Research Practices of Doctoral Students Facing Dilemma Situations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Study Focus on no Specific Condition
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to evaluate the influence of supervisors on PhD students' research practice (i.e., an environment where there is a lack of opposition to detrimental research practice from the supervisor)

Detailed description: PhD students are the next generation of researchers and will present the field in the future. However, several environmental factors might influence their research practice. In this study, we will evaluate the influence of supervisors on PhD students' research practice (an environment where there is a lack of opposition to detrimental research practice from the supervisor).

Objective: To evaluate the influence of supervisors on PhD students' research practice

Design: A randomized controlled trial

1. Intervention: Participants will be shown two case vignettes describing dilemma situations in research reported with and without the role of the supervisor.
2. Participants: The participants will be PhD students in all biomedical disciplines.
3. Sample size will be 300 participants
4. Primary outcome: In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B). Participants will be forced to make a choice between the 2 solutions. The primary outcome will be the mean preference score.
5. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888

Eligibility criteria: Inclusion Criteria:

* PhD students in biomedical sciences

Exclusion Criteria:

* NA

Primary outcomes:
measure: Mean preference score
timeFrame: Immediate assessment
Secondary outcomes:
measure: Proportion of students who chose the detrimental research practice
timeFrame: Immediate assessment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05014906: Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea
Official title: Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Keywords: rosacea
Lead sponsor: Dermatology Specialists Research
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Rosacea is one of the most commonly occurring dermatoses treated by dermatologist today. Rosacea is an inflammatory condition of the skin presenting as flushing and or blushing along with redness, swelling, telangiectasia, and acne lesions. Minocycline has shown beneficial in the treatment of inflammatory acne lesions in patients with rosacea. This study is to evaluate the efficacy and tolerability of minocycline (Solodyn) alone versus minocycline (Solodyn) in combination with azelaic acid 15%(Finacea) in the treatment of rosacea.

Detailed description: This is a multicenter, randomized, outpatient, Investigator-blind study of minocycline 45 mg and minocycline 45 mg plus 15% azelaic acid for the treatment of rosacea.

Eligibility criteria: Inclusion Criteria:

* age 18 or older with clinical diagnosis of rosacea
* must have 10-40 facial inflammatory lesions and less than 2 nodules
* women of child bearing potential must be non lactating
* must have negative urine pregnancy test
* must use effective form of birth control

Exclusion Criteria:

* The use of systemic antibiotics within 30 days of study start
* the use of topical medications within 14 - 30 days of study start depending on type of topical medication
* Patients with known sensitivity to tetracyclines
* Patients who have had gastric bypass surgery or are considered achlorhydric
* Patients taking drugs known as photosensitizers

Primary outcomes:
measure: Efficacy analysis of the 12-week reduction in total lesion count
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group
timeFrame: 12 Weeks
measure: Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group
timeFrame: 12 Weeks
Other outcomes:
measure: Tolerability of treatment per group
timeFrame: 12 Week
Locations:
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
Study officials:
affiliation: Dermatology Specialists
name: James M Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01027806: Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children
Official title: A Randomized Double Blind Controlled Trial on the Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Children
Sleep
Obstructive Sleep Apnea
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-12-09
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators leading hypotheses are:

* Oral therapy with montelukast may lead to improved sleep study findings in children with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of adenoids and tonsils for OSAS.
* A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will remove the need for surgical intervention.


Eligibility criteria: Inclusion Criteria:

* Eligible for inclusion in the study will be symptomatic snoring children \>2 years of age and \< 10 years of age, who snore and have an apnea hypopnea index (AHI) \>2/hrTST (hour total sleep time), and in whom T\&A is therefore contemplated. Also among these, we will include children referred for evaluation for snoring who have a history of allergic rhinitis.

Exclusion Criteria:

* Exclusion criteria will include: Hypersensitivity to montelukast, immunodeficiency or immunosuppressant therapy, craniofacial, neuromuscular, syndromic or defined genetic abnormalities, acute upper respiratory tract infection, systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study, and children who already had adenotonsillectomy. In addition, children chronically receiving oral antihistamine preparations or nasal decongestants will be required to continue using these medications throughout the duration of the study. Patients receiving immunotherapy will continue on the same regimen without escalation of dose and frequency throughout the duration of the study. In addition, patients with severe OSA who in the opinion of their treating physicians require early surgical intervention for their OSA will be excluded from eligibility to the study.

Primary outcomes:
measure: The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment.
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Leila Gozal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02728206: Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
Official title: A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir Fixed Dose Combination Administered for Four Weeks in Patients Infected With Chronic HCV in the Peri-Operative Liver Transplantation Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.


Eligibility criteria: Key Inclusion Criteria:

* HCV-infected, male and non-pregnant/non-lactating females, who are undergoing liver transplantation

Key Exclusion Criteria:

* Receiving an HCV-infected liver
* HIV or hepatitis B virus (HBV) co-infected

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to Week 4
Secondary outcomes:
measure: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants With HCV RNA < LLOQ On Treatment
timeFrame: Days 3, 5, 7, 14, 21, and 28
measure: Percentage of Participants With Overall Virologic Failure
timeFrame: Up to Posttreatment Week 12
Other outcomes:
Locations:
city: Auckland
country: New Zealand
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01260506: Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Relapsed Glioblastoma Multiforme, GBM
Lead sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
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 evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma;
2. Measurable disease by RANO criteria;
3. Disease progression or recurrence following standard of care treatment with temozolomide and radiation;
4. An interval of at least 4 weeks between prior surgical resection and study enrollment;
5. An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol;
6. Recovered to Grade 1 or less from the toxic effects of any earlier intervention;
7. Karnofsky performance status \> 60%

Exclusion Criteria:

1. Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc);
2. Prior stereotactic radiotherapy;
3. Active infection;
4. Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;
5. Subjects who suffered from an acute cardiac event within the last 12 months;
6. Subjects with active vascular disease, either myocardial or peripheral;
7. Subjects with proliferative and/or vascular retinopathy;
8. Subjects with known active second malignancy;

Primary outcomes:
measure: Overall Survival
timeFrame: From date of study entry until the date of death from any cause (up to 10 years)
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: San Antonio
country: United States
facility: Uthsc- Ctrc
state: Texas
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References: