louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00630318: Testing New Method of Analyzing MR Images
Official title: Imaging Protocol Design for Anti-Angiogenesis Tracking With MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Abnormalities
Keywords: MR scanning
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-03-07
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Preliminary imaging study to test for future use of this MRI-imaging for evaluating anti-angiogenesis treatment.

Detailed description: The purpose of this study is to develop and evaluate new MR imaging techniques and protocols for non-invasive monitoring of anti-angiogenesis treatment of breast cancer. This feasibility study is a preliminary imaging study to test this imaging protocol on subjects already undergoing MR for clinical purposes.

The specific objective of this research study is to develop and validate both MRI and functional MRI data acquisition methods, task paradigms, and post-processing techniques to ensure reliability of results.

The information derived from this research is intended to be applied to a future study of subjects undergoing experimental anti-angiogenesis drug therapy.

Eligibility criteria: Inclusion Criteria:

* Females
* Age 18 years or greater
* Undergoing breast MRI exam

Exclusion Criteria:

* Pregnancy
* Contraindication for MRI on standard screening checklist for clinically indicated examinations (i.e. metal devices/implants; history of claustrophobia)
* History/presence of any of the following to the breast: injury; breast implant; surgical or interventional procedure; clinically significant abnormality

Primary outcomes:
measure: To provide preliminary data for a larger study that this type of imaging can be used to monitor the effectiveness of anti-angiogenic therapy.
timeFrame: After analysis of images
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Susan E. Clare, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03674918: Reliable Hypertension Diagnosis Based on 24 ABPM
Official title: How to Reliably Diagnose Arterial Hypertension: Lessons From 24h Blood Pressure Monitoring.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2018-09-18
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Arterial hypertension, HBPM, 24h ABPM, optimal diagnosis

Brief summary: 24 h blood pressure monitoring can help to define which is the optimal timing and frequency of measurements

Detailed description: Hypertension is a common condition in modern society. As blood pressure fluctuates with time, a single blood pressure measurement is useless to diagnose hypertension. Nevertheless, a questionable not well-defined number of measurements still is often used for this purpose. Diagnosis and therapeutic control of hypertension are therefore suboptimal. This study's objective is to determine the number and timing of measurements needed to give a trustworthy approximation of an individual's average blood pressure. Therefore, 24 h ambulatory blood pressure measurements were retrospectively analyzed.

Eligibility criteria: Inclusion Criteria:

* 70 per cent of valid measurements

Exclusion Criteria:

* none

Primary outcomes:
measure: Timing of measurement
timeFrame: day 1
Secondary outcomes:
measure: The correct number of measurements
timeFrame: day 1
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: University of Leuven
name: Caro Brenard, student
role: STUDY_CHAIR
affiliation: Universiteit Antwerpen
name: Vincent Raymaekers, student
role: STUDY_CHAIR
affiliation: Hasselt University
name: Paul Dendale, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Ines Frederix, dr. MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01280318: Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery
Official title: Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Growth Factor
Surgery
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 60
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 obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome


Eligibility criteria: Inclusion Criteria:

* Age 18 years and over

  _ histological proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharinx or larynx
* Patients selected for a primary surgical treatment
* no distant metastases
* no active second malignancy during the last 5 years except non melanoma skin cancer or carcinoma in situ of the cervix
* no prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery
* life expectancy of more than 3 months
* not pregnant or nursing; fertile patients both male and female, must use effective contraception
* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* signed informed consent
* performance status ECOG 0-1

Exclusion Criteria:

* Nasopharynx cancer
* past or current malignancy other than HNSCC
* performance ECOG status more than 2
* concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
* use of any investigational agents within 4 weeks prior to entry
* Previous exposure to EGFR targeting therapy
* known grade hypersensitivity to cetuximab
* legal incapacity or limited legal capacity or medical or psychological condition which in the opiniion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.

Primary outcomes:
measure: identification of the biomarkers could lead to the development of peri-operative targeted therapies to decrease the risk of local and distant tumor growth
timeFrame: 5 months
Secondary outcomes:
measure: Compare the results of group I with groups II and III
timeFrame: 5 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Jean-Pascal Machiels
Study officials:
affiliation: Cliniques Universitaires St Luc-UCL
name: Jean-Pascal Machiels, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01558518: Handheld Echocardiography in Clinical Practice
Official title: Handheld Echocardiography in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: Handheld echocardiography
V-scan
Handheld ultrasound
Portable ultrasound
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Mayo Clinic Echocardiography Laboratory

Brief summary: Transthoracic echocardiography (TTE) represents an established and fundamental tool for the evaluation of patients with known or suspected cardiovascular disease. Recently, manufacturers have developed handheld echocardiograms small enough to fit in the pocket of a physician's lab coat. Studies assessing these handheld devices have several limitations. While they have generally evaluated the handheld devices favorably, previous studies has not consistently studied handheld devices under the best possible clinical conditions and have not necessarily highlighted the devices' limitations.

In this proposal, we seek to analyze the applicability of handheld echocardiograms to standard clinical practice. The investigators plan to use trained sonographers to perform handheld examinations on patients referred for TTE without established cardiovascular disease. The handheld images will be interpreted by experienced, consultant-level echocardiographers. The investigators then plan to compare findings from the handheld echocardiogram to the patient's standard clinical TTE.


Eligibility criteria: Inclusion criteria

* Adult patients referred for a resting transthoracic echocardiogram.

Exclusion criteria

* Referral for quantitative assessment of valvular heart disease
* Referral for strain imaging
* Referral for measurement of left atrial mechanical function or cardiac resynchronization studies
* Known diagnosis of congenital heart disease, restrictive cardiomyopathy, constrictive pericardial disease, or pulmonary hypertension
* Patients who have received left ventricular assist devices or those who have undergone cardiac transplants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Patricia Pellikka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cullen MW, Blauwet LA, Vatury OM, Mulvagh SL, Behrenbeck TR, Scott CG, Pellikka PA. Diagnostic capability of comprehensive handheld vs transthoracic echocardiography. Mayo Clin Proc. 2014 Jun;89(6):790-8. doi: 10.1016/j.mayocp.2013.12.016. Epub 2014 Mar 29.
Clinical trial NCT04527718: Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
Official title: A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.

Detailed description: Total duration of the study period per subject is about 4 months broken down as follows:

The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).

Eligibility criteria: Inclusion Criteria:

1. Able to understand and willing to sign the ICF
2. Healthy male and female subjects, non-smokers, 18-55 years of age
3. In the opinion of the investigator, with no significant medical history, and in good health.
4. Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
5. Subjects are able to follow the study protocol and complete the trial.

Exclusion Criteria:

1. History of hypersensitivity to similar drugs to 611 or their excipients.
2. Pregnant, or nursing females.
3. HepBsAg or HepCAb positive.
4. Human immunodeficiency virus (HIV) positive.
5. Positive urine drug screen, or cotinine test.
6. Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.

Primary outcomes:
measure: Percentage of Participants With TEAEs
timeFrame: up to 71days (90 days for Cohorts 1 and 2)
Secondary outcomes:
measure: PK
timeFrame: up to 71days (90 days for Cohorts 1 and 2)
measure: Incidence of immunogenicity
timeFrame: up to 71days (90 days for Cohorts 1 and 2)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Dallas Clinical Research Unit
state: Texas
Study officials:
References:
Clinical trial NCT01776606: Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Aging
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-28
Enrollment: 247
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: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe crow's feet lines
* Female or male, 18 to 65 years of age and in good general health
* Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active skin disease or irritation at the treatment area
* Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
* Treatment with botulinum toxin type A for crow's feet lines in the last 6 months

Primary outcomes:
measure: Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines
timeFrame: Week 4
Secondary outcomes:
measure: Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment
timeFrame: Week 4
measure: Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment
timeFrame: Week 4
measure: Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment
timeFrame: Week 4
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Dermatology Research Institute
state: Florida
Study officials:
References:
Clinical trial NCT06357806: The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients
Official title: The Safety and Efficacy of PD-1 Antibody Combined With Pegylated Interferon-α Therapy to Promote the Clinical Cure in Nucleoside (Acid) Analogues-suppressed Chronic Hepatitis B Patients: A Protocol for the Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Hepatitis B
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 45
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: TREATMENT

Brief summary: This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.


Eligibility criteria: Inclusion Criteria:

1. 18 - 65 years old;
2. Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
3. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening;
4. HBV DNA and HBeAg turn negative after NAs treatment;
5. HBsAg ranged 200-1000 IU/ml.

Exclusion Criteria:

1. Cirrhosis;
2. platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, neutrophil count \< 1.3×10\^9/L, ALT \> ULN（40U/L）, total bilirubin \> 2ULN;
3. History of or suspicion of hepatocellular carcinoma
4. Patients received interferon therapy within 12 months;
5. Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
6. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
7. Alcohol or drug abuse/dependence;
8. Investigator judges that the participants are not suitable for this study.

Primary outcomes:
measure: The rate of HBsAg loss at 24 weeks and 48 weeks.
timeFrame: 48 weeks
measure: Incidence of treatment-emergent adverse events/serious adverse events
timeFrame: 48 weeks
Secondary outcomes:
measure: The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks
timeFrame: 48 weeks
measure: The rate of HBsAb positive at 24 weeks and 48 weeks.
timeFrame: 48 weeks
measure: The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.
timeFrame: 48 weeks
measure: The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.
timeFrame: 48 weeks
measure: The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks.
timeFrame: 48 weeks
measure: Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: the Fifth Medical Center, Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06491706: Long-term Outcomes in Older Patients With Physical Restraint
Official title: The Association of Biological Sex and Long-term Outcomes in Older Patients With Physical Restraint at the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Restraint
Biological Sex Diffrences
Morality
Keywords: physical restraint
emergency department
biological sex
long-term mortality
Lead sponsor: Beaujon Hospital
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 149
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive older patients ≥ 75-year-old

Brief summary: The worldwide population is ageing. Biological sex is first and foremost a genetic modifier of disease. To prevent self-arm many techniques can be used in older patients. Among them coercive measure consisting of physical restraint (PR) is one of the techniques.

This study aims to assess the effects of the biological sex on the long-term survival after PR in geriatric patients during the initial emergency department (ED) visit.

This retrospective study included patients between November 2019 to March 2021. All consecutive hospitalized patients after emergency department visit older than 75 years with PR were included.

The population was compared according to the biological sex. One-year all-cause mortality was plotted with the Kaplan-Meier curve. Hazard ratios (HRs) for 1-year mortality were calculated using a Cox proportional hazards regression model. Mortality was monitored over a 3-year period.


Eligibility criteria: Inclusion Criteria:

* All consecutive older patients ≥ 75-year-old hospitalized to the observation unit or to the ward from the ED were included from November 2019 to March 2021 if PR were mentioned in their medical records

Exclusion Criteria:

* if patients were less than 75 years old, without PR or not hospitalized. If a patient was admitted more than once, only the first episode was taken as index admission

Primary outcomes:
measure: one year mortaliy
timeFrame: ONE year
Secondary outcomes:
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hopital BEAUJON
Study officials:
affiliation: Hôpital Beaujon
name: Prabakar VAITTINADA AYAR, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01936506: Cognitive Training for Depression
Official title: Cognitive Training for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Keywords: Cognitive training
Depression
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.

Detailed description: There is an urgent public health need to develop more effective and well tolerated treatments for patients with major depressive disorder (MDD); cognitive training interventions aiming to modify cognitive and affective processing abnormalities underlying MDD represent a promising new strategy. This research project translates a well established cognitive bias in major depressive disorder (MDD), working memory bias, into a novel intervention target. In a double-blind, randomized, controlled study, MDD participants undergo 4 weeks of cognitive training sessions, with two sessions per week.

Eligibility criteria: Inclusion Criteria:

* Primary, current Axis I diagnosis of Major Depressive Disorder according to DSM-IV criteria and Ham-D-17 score between 16-27
* Age 18-55
* Able to give informed consent

Exclusion Criteria:

* A history of drug or alcohol abuse or dependence (DSM-IV criteria) within 6 months
* Visual impairment that would affect the ability to observe the computerized presentation of faces.
* Motor impairment that would affect the ability to provide a response by quickly pressing a button.
* Lifetime history of Bipolar spectrum disorders or schizophrenia spectrum disorders.
* Primary, current Axis I diagnosis other than Major Depressive Disorder
* Primary, current Axis II personality disorder.
* Currently attending a cognitive-behavioral psychotherapy regimen
* Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
* Pregnancy in women.

Subjects must exhibit no or only moderate alcohol use. Subjects with current excessive use of alcohol (\> 8 ounces/day for men and \> 6 ounces/day for women) are ineligible for participation, as such drug use could confound the results.

Primary outcomes:
measure: change in Hamilton Depression Rating Scale (Ham-D)
timeFrame: baseline and week 4
Secondary outcomes:
measure: change in Self-referential Information Processing Task
timeFrame: baseline and week 4
measure: change in Working Memory
timeFrame: baseline and week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Brian M Iacoviello, PhD
role: PRINCIPAL_INVESTIGATOR
References: