louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02590458: Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer
Official title: Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Breast Cancer
Short Breast MRI Scan
SBMRI
Routine MRI
High risk for breast cancer
Screening
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2015-10-29
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this clinical research study is to test if a short breast MRI scan (about 10 minutes) can be used for breast cancer screening in high risk people and to learn if it is as effective as a routine breast MRI scan (30-60 minutes).

Detailed description: If you agree to take part in this study, you will have the short breast MRI scan (the scan for research purposes) with contrast on a different day than your scheduled routine MRI screening scan with contrast. You will have your routine scan the first day and the research scan at least 1 day after. The research scan will take about 10 minutes to complete.

After your short breast MRI scan is completed, you will complete a questionnaire about your comfort level and experience of the research scan. It should take about 10 minutes to complete the questionnaire.

This is an investigational study. The short breast MRI is considered investigational.

Up to 200 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Eligibility criteria: Inclusion Criteria:

1. 18 years and older female patients
2. BMRI indication: high risk screening per ACS guidelines
3. No contraindications to undergo MRI
4. Creatinine \</=1.3 and GFR\> 40
5. No requirement for sedation.

Exclusion Criteria:

1. \<18 years
2. Male
3. Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother
4. Contraindication to Gd contrast agents
5. Previous documented history of moderate to severe hypersensitivity to Gd contrast agents
6. Contraindications to MRI

Primary outcomes:
measure: Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Marion E. Scoggins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04436458: Niclosamide In Moderate COVID-19
Official title: Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID
Lead sponsor: Entero Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 0
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: This is a Phase 2, multicentre, randomized, double blind, 2 arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for treatment of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.
* Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least 3 stools per week and no more than 3 stools per day.
* SARS-CoV-2 infection confirmed by RT-PCR in rectal swab (or stool test) ≤2 days before randomization by local or central lab.
* Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment

Exclusion Criteria:

* At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
* Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.

Primary outcomes:
measure: The primary endpoint is the rate of faecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR in the niclosamide group, compared to the placebo group
timeFrame: From Day 1 to 42
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05440058: BIS Monitoring in Relation to Muscle Relaxant Administration
Official title: Effect of Timing of Commencement of Bispectral Index Monitoring in Relation to Muscle Relaxant Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Surgery
Bispectral Index
Anesthesia
Keywords: BIS
Paralysis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing elective cardiovascular surgery, for whom BIS monitoring will be used.

Brief summary: The purpose of this study is to determine the overall optimal timing of when the Bispectral Index (BIS) monitor should be started: before or after the muscle relaxant is given.


Eligibility criteria: Inclusion Criteria:

* Undergoing elective cardiac surgery
* Muscle relaxation administration by rocuronium

Exclusion Criteria:

* Patient refusal
* Pediatric patients
* Emergency procedure
* Patients with known or suspected carotid or cerebrovascular disease
* Patients with prior stroke
* Skin condition or anatomy preventing proper sensor placement
* Patients who receive ketamine during the study timeframe

Primary outcomes:
measure: BIS Values
timeFrame: 25-minute period in the operating room
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Ritter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00544258: Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
Official title: A Phase I, Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005, When Applied as 0.05% PEP005 Topical Gel to a 100 cm2 (5 cm x 20 cm) Contiguous Actinic Keratosis(AK) Treatment Area on the Extensor (Dorsal Aspect) Forearm.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Keratoses
Keywords: Pharmacokinetic study
Actinic Keratosis
Topical
Dermatology
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 8
Sex: MALE
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 determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.

Detailed description: Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

Eligibility criteria: Inclusion Criteria:

1. Male patients at least 18 years of age.
2. A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm.
3. Written informed consent has been obtained.
4. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study package.

Primary outcomes:
measure: To evaluate the extent of systemic absorption of PEP005 when applied as 0.05% Topical Gel on two consecutive days (Day 1 and Day 2) to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.
Secondary outcomes:
measure: To evaluate the safety and tolerability of two consecutive days of application of 0.05% PEP005 Topical Gel, when applied to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.
Other outcomes:
Locations:
city: Silverton Place, 101 Wickham Terrace, Brisbane
country: Australia
facility: Siller Medical
state: Queensland
Study officials:
affiliation: Peplin
name: Janelle Katsamas
role: STUDY_DIRECTOR
References:
Clinical trial NCT03903263: Sleep Disturbances in Dermatology Patients
Official title: Sleep Disturbances in Dermatology Patients- a Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder
Keywords: dermatologic disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: outpatients of the dermatologic university clinic Basel

Brief summary: This study is to investigate sleep disorders in patients with dermatologic diseases by taking into consideration dermatologic (itch, pain) and non- dermatologic (medication, depression) factors.


Eligibility criteria: Inclusion Criteria:

* Outpatients of the dermatologic university clinic

Exclusion Criteria:

* Insufficient knowledge of German language
* Illiteracy

Primary outcomes:
measure: Regensburg Insomnia Scale (RIS)
timeFrame: single time point assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
Study officials:
affiliation: Department of Dermatology, University Hospital Basel
name: Simon Müller, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00360763: Study of Optimal Treatment Plan in Hypertensives With Anti-AT1-Receptor Autoantibody
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2006-08-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The autoantibodies against AT1 receptor (ATR-AA), behaving like an agonist were detected in patients with hypertension. ATR-AA which can blocked by ARB may play a role in the pathogenesis of hypertension. The present study is to explore whether AT1 receptor blocker has superior anti-hypertensive effect in patients with positive ATR-AA hypertension. Patients with 2 grade hypertension were recruited and ATR-AA was assayed by ELISA. A study was carried out and the efficacy of anti-hypertension was compared between candesartan cilexetil and ACE inhibitor imidapril.


Eligibility criteria: Inclusion Criteria:

* Hypertension (2 grade)

Exclusion Criteria:

* Secondary hypertension
* Known sensitivity or intolerance to an angiotensin II receptor antagonist or ACE inhibitor
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Cardiology, Wuhan Union Hospital
state: Hubei
Study officials:
affiliation: Union Hospital, Tongji Medical College
name: Yu-Hua Liao
role: STUDY_DIRECTOR
References:
citation: Liao YH, Wei YM, Wang M, Wang ZH, Yuan HT, Cheng LX. Autoantibodies against AT1-receptor and alpha1-adrenergic receptor in patients with hypertension. Hypertens Res. 2002 Jul;25(4):641-6. doi: 10.1291/hypres.25.641.
citation: Wei F, Jia XJ, Yu SQ, Gu Y, Wang L, Guo XM, Wang M, Zhu F, Cheng X, Wei YM, Zhou ZH, Fu M, Liao YH; SOT-AT1 Study Group. Candesartan versus imidapril in hypertension: a randomised study to assess effects of anti-AT1 receptor autoantibodies. Heart. 2011 Mar;97(6):479-84. doi: 10.1136/hrt.2009.192104. Epub 2011 Feb 4.
Clinical trial NCT05175963: Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection
Official title: Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV2 Infection
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any HCWs of any staff category at the study hospitals

Brief summary: This study aims to investigate the epidemiology of SARS-CoV-2 infection among: i) HCW who triage patients with suspected SARS-CoV-2 infection and provide care to COVID-19 patients; and ii) laboratory personnel who test clinical samples for SARS-CoV-2 infection. After the second wave of the pandemic enrolment will be widen to any person working at the study hospitals.


Eligibility criteria: Inclusion Criteria:

* HCWs of any staff category at the study hospitals.

Exclusion Criteria:

* None

Primary outcomes:
measure: To determine the prevalence of symptomatic and asymptomatic SARS-CoV-2 infections among HCW.
timeFrame: 2020
Secondary outcomes:
measure: To define the duration of viral "shedding".
timeFrame: 2020
measure: To do sero-epidemiology assessment.
timeFrame: 2022
measure: To analyse immune responses to SARS-CoV-2 infection.
timeFrame: 2022
measure: To investigate the possibility of viral re-infection in this population during the study period.
timeFrame: 2022
measure: To establish if common cold coronaviruses (CCCV) immunity confers protection against SARS-CoV-2 infection or disease severity
timeFrame: 2022
measure: To evaluate COVID-19 vaccine effectiveness (VE) amongst HCWs, against any PCR-confirmed SARS-CoV-2 infection.
timeFrame: 2022
measure: To measure humoral and cell mediated immune responses to COVID-19 vaccines stratified by previous SARS-CoV-2 infection.
timeFrame: 2022
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
state: GP
Study officials:
References:
Clinical trial NCT02794363: Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus
Official title: Autologous Platelet Rich Plasma Intradermal Injections for Vulvar Lichen Sclerosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Sclerosus
Lead sponsor: Center for Vulvovaginal Disorders
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period and a 12-week treatment period. Participants will receive two separate treatments of autologous platelet rich plasma separated by 6 weeks. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection

Detailed description: 15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period. A 4mm vulvar punch biopsy will be obtained at the initiation of the screening period to confirm that the participant have active lichen sclerosus. 12 weeks after the biopsy, the participants will receive an injection of 5cc of autologous platelet rich plasma into the affected vulvar skin. Six weeks later, participants will receive an additional injection of 5cc of autologous platelet rich plasma. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection. The inflammation on both biopsy specimens will be determined by a dermatopathologist.

Eligibility criteria: Inclusion Criteria:

* Active lichen sclerosus
* no current treatment
* symptomatic 4/10 on visual analogue scale

Exclusion Criteria:

* history of vulvar carcinoma or VIN

Primary outcomes:
measure: Decrease in inflammation on post treatment biopsies
timeFrame: 14 weeks
Secondary outcomes:
measure: Decrease in Pruritus
timeFrame: 14 weeks
measure: Investigator Global Assessment
timeFrame: 14 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01578863: Predictors of Success in an Intervention Program for the Treatment of Childhood Obesity
Official title: Predictors of Success in a Multidisciplinary Intervention Program for Obese Children and Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood obesity
Adolescence
Predictors
Success
Intervention program
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 176
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The child health and sports center, at the Meir Medical Center, runs for over 10 years an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment. A similar program exists in the nearby city of Hadera. The aim of the programs is to promote weight loss, encourage physical activity and modify behavior in order to get long term results. The aim of the present study is to try and identify the demographic and behavioral characteristics of children who succeed in the program.


Eligibility criteria: Inclusion Criteria:

* Obese / overweight children

Exclusion Criteria:

* Children that has an organic illness that cause obesity

Primary outcomes:
measure: Characteristics of the children who succeed in the program
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Dan Nemet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04860063: Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH.
Official title: Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metabolic Syndrome
HIV-1-infection
Glucose Intolerance
Dyslipidemias
Lipodystrophy
Lipoatrophy
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With current antiretroviral therapy, people living with HIV reach virological suppression faster, which in turn leads to a higher life expectancy. Nevertheless, this improved survival rate is not free of other comorbidities, such as metabolic syndrome, characterized by a decrease in glucose tolerance and an increase in insulin resistance.

Berberine is an alkaloid that has proven beneficial effects on both glucose tolerance and insulin resistance, but has not been tested in people living with HIV under virological suppression. We hypothesize that berberine will improve inflammatory markers and metabolic profile in this population without significant interactions nor adverse effects.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 years
* Documented HIV-1 infection
* Stable antiretroviral therapy at least 6 months before enrollment
* Viral suppression
* Metabolic syndrome , defined by Adult Treatment Panel-III criteria
* No previously known kidney or liver disease
* Signed informed consent

Exclusion Criteria:

* People younger than 18 years and older than 60 years
* Prior atherosclerotic cardiovascular disease
* Diabetes mellitus type 1 or 2
* Previous use of glucose and/or lipid modifying medications
* Pregnancy
* Withdrawal of informed consent

Primary outcomes:
measure: Insulin resistance
timeFrame: 24 weeks within randomization
measure: Change from baseline lipid profile at 6 months
timeFrame: At the beginning and 24 weeks within randomization
Secondary outcomes:
measure: Change from baseline weight
timeFrame: At the beginning and 24 weeks within randomization
measure: Inflammatory profile
timeFrame: At the beginning and 24 weeks within randomization
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02523963: Effects of Family Work Shop for Children With Developmental Delays
Official title: Effects of Family Work Shop for Children With Developmental Delays
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Developmental Delays
Keywords: family work shop
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to identify the effects of family work shop for children with developmental delays.

Detailed description: Methods：

1. The family work shop has 5 courses, with 6 families in one course. 2. Intervention: 2-3 hours per session, one time per week, for a total of 6 weeks.

Effect：

1. Investigate the effects of family work shop for children with developmental delays, including health related quality of life, functional performance.
2. Investigate the effects of family care giver strain on family work shop for parents of children with developmental delays.
3. Investigate the differences of family impact between children with development delays and children with normal development.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of developmental delays and must be able to attend 6 weeks of work shop

Exclusion Criteria:

* Failed to obtain written informed consent

Primary outcomes:
measure: change in health related quality of life questionnaire
timeFrame: baseline and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: visiting staff of Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: