louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00705653: Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors
Official title: A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: cancer
advanced cancer
solid tumors
CGC-11047
PG-11047
Lead sponsor: Progen Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 46
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: This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and to establish what happens to the drug once inside the body. An escalating dose of PG-11047 will be investigated in this study and the maximum tolerated dose of the drug will be established.

Detailed description: This is an open-label phase I, dose-escalation safety study in subjects with refractory solid tumors. The primary objectives of the study are to assess the safety, tolerability, and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. The planned minimum treatment schedule is 2 cycles (8 weeks) of PG-11047 treatment. Subjects who tolerate treatment may be eligible to receive additional cycles as per investigator's medical judgment. Evaluation of anti-tumor response will be performed every 2 cycles.

Eligibility criteria: Inclusion Criteria:

* non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
* ECOG - 0-2.
* Life expectancy \> 3 months.

Exclusion Criteria:

* chemotherapy or radiotherapy within 4 weeks prior to entering the study.
* previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell transplantation.
* primary brain tumors or active brain metastases
* history of significant or symptomatic cardiac arrhythmia, prior myocardial infarction or evidence of a current significant ventricular conduction abnormality

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: The MTD had to occur during cycle 1 of treatment
Secondary outcomes:
measure: Preliminary Efficacy
timeFrame: For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Cancer Research Centre
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mark Ratain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murray Stewart T, Desai AA, Fitzgerald ML, Marton LJ, Casero RA Jr. A phase I dose-escalation study of the polyamine analog PG-11047 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2020 Jun;85(6):1089-1096. doi: 10.1007/s00280-020-04082-4. Epub 2020 May 23.
Clinical trial NCT00562653: Autoantibodies and Clinical Symptoms in Infective Endocarditis Patients
Official title: Study of Autoantibodies in Infective Endocarditis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infective Endocarditis
Keywords: profile autoantibodies
clinical symptoms
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Israel
First posted: 2007-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infective endocarditis patients

Brief summary: The purpose is to evaluate autoantibodies in infective endocarditis patients before, at the beginning of treatment, and after the end of the treatment, and to correlate the autoantibodies in the presence of clinical symptoms.


Eligibility criteria: Inclusion Criteria:

* Infective endocarditis patients by DUKES criteria

Exclusion Criteria:

* HIV positive
* Patients suffering from other infective diseases other than endocarditis.
* Patient suffering from collagen diseases for example: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), mixed connective tissue disease, and scleroderma.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Sourasky Medical Center, Internal Medicine
name: Victoria Bogusllavsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04302753: Autistic Women's Experiences of Self Compassion and Receiving Their Diagnosis in Adulthood
Official title: Autistic Women's Experiences of Self Compassion and Receiving Their Diagnosis in Adulthood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism
Keywords: Autism
Self compassion
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have received their diagnosis on the autism spectrum over the age of 18 years old.

Brief summary: Research highlights strong links between self-compassion and mental health, but there is very limited research specifically exploring autistic individual's experiences of self-compassion. The process of receiving a diagnosis on the autism spectrum can be complex and autistic women tend to experience several barriers to diagnosis. This study adds to the growing area of research exploring autistic women's experiences of receiving a diagnosis in adulthood. This study employs Interpretative phenomenological analysis to explore if receiving a diagnosis of Autism influences women's perceptions of self-compassion. The findings may inform client-centred practices in health care settings and potentially present positive aspects of autism diagnosis.


Eligibility criteria: Inclusion Criteria:

* Able to consent to participate
* Cisgender female (female at birth and raised as female).
* Speak English fluently
* Received an Autism Spectrum Disorder diagnosis, aged 18 years old or above

Exclusion Criteria:

* Lack capacity to consent to participate in the study
* Unable to speak English fluently
* Have not received an Autism diagnosis
* Have received Autism diagnosis prior to their 18th birthday
* Have an intellectual disability
* Born male

Primary outcomes:
measure: Experience of receiving ASD diagnosis in adulthood based on semi structured interviews
timeFrame: day one
Secondary outcomes:
measure: Experience of self-compassion before and after receiving ASD diagnosis based on semi structured interviews
timeFrame: day one
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: DClin Univeristy of Sheffield
state: Yorkshire And Humber
Study officials:
References:
Clinical trial NCT03133351: Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
Official title: Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coagulation
Lead sponsor: Entegrion, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-28
Enrollment: 240
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: Healthy volunteers

Brief summary: This study is intended to define the PCM normal laboratory range.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m2m with body weight ≥ 50 kg (106 lb)
3. Normal vital signs at screening

Exclusion Criteria:

1. Current daily tobacco use or previous recreational drug use
2. Pregnant or lactating at the time of the study
3. Currently taking any medications known to affect coagulation
4. History of excessive bleeding from minor trauma that required medical attention, spontaneous nose bleeds that required medical attention or multiple spontaneous abortions, liver disease, blood related diseases, congenital or acquired coagulopathies or thromboembolic diseases
5. Current diagnosis of cancer

Primary outcomes:
measure: PCM Clotting Time (CT)
timeFrame: Testing to be initiated within 4 minutes of sample collection
measure: Clot Formation Time (CFT)
timeFrame: Testing to be initiated within 4 minutes of sample collection
measure: Alpha Angle (AA)
timeFrame: Testing to be initiated within 4 minutes of sample collection
measure: Maximum Clot Firmness (MCF)
timeFrame: Testing to be initiated within 4 minutes of sample collection
measure: 30-minutes Lysis after CT (LI30)
timeFrame: Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT
measure: 45-minutes Lysis after CT (LI45)
timeFrame: Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01159951: Analysis of Trends Over Time of Hepatitis Related Incidence in Panama
Official title: Time Trend Analysis of the Incidence of Hepatitis- Related Outcomes (Viral Hepatitis A and Unspecified Viral Hepatitis) Reported to the Surveillance System of Panama, 2000-2010
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population to be studied will be all subjects reported with hepatitis related outcomes to the Epidemiologic Surveillance System of the Ministry of Health of Panama, between 2000 and 2010.

Brief summary: The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of the same outcome after introduction of Havrix™ in Panama.

Detailed description: In this study, systematic review of the databases of epidemiologic surveillance system (Ministry of Health), for hepatitis related outcomes will be performed. The analysis will be performed by age group, years and country region.

Eligibility criteria: Inclusion Criteria:

* Hepatitis related outcomes occurred during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, will be collected for the study

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Occurrence of reported hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis)
timeFrame: In post vaccine introduction period (2008-2010) compared to pre-vaccination period (2000-2007)
Secondary outcomes:
measure: Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year
timeFrame: From year 2000 until year 2010
measure: Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups
timeFrame: From year 2000 until year 2010
measure: Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region
timeFrame: From year 2000 until year 2010
Other outcomes:
Locations:
city: Clayton
country: Panama
facility: GSK Investigational Site
state: Panamá
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Estripeaut D, Contreras R, Tinajeros O, Castrejon MM, Shafi F, Ortega-Barria E, DeAntonio R. Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis. Vaccine. 2015 Jun 22;33(28):3200-7. doi: 10.1016/j.vaccine.2015.04.100. Epub 2015 May 14.
Clinical trial NCT02834351: Tissue Lesions in Exercise Related Ischemia
Official title: Atteinte Tissulaire au Cours de l'ischémie Chronique d'Effort. Validation d'un modèle d'étude du Muscle Sartorius Humain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia
Peripheral Artery Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-07-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect of muscle ischemia during claudication on mitochondrial function.

Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac group) feasibility study.

Detailed description: Assess the feasibility of the study of micro-vascular function and mitochondrial on muscle sample (sartorius) in a group of arterial disease and non arteriopathy group.

Analysis of the activity of mitochondrial chain Immunochemistry of tissue markers

Eligibility criteria: Inclusion Criteria:

* Intervention for femoropopliteal bypass (PAD group)
* Intervention for saphenous withdrawal for coronary bypass surgery (cardiac group)

Exclusion Criteria:

* Participate in another biomedical research
* Pregnant woman

Primary outcomes:
measure: Activity differences in mitochondrial complex I between the distal and proximal levy in group 1 and group 2.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Uh Angers
Study officials:
affiliation: UH ANGERS
name: Pierre ABRAHAM, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01841151: Neurofeedback and Working Memory Training for Children and Adolescents With ADHD
Official title: Does Neurofeedback and Working Memory Training Improve Core Symptoms of ADHD in Children and Adolescents? A Comparative, Randomized and Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder
Keywords: AD/HD in Children and Adolescents
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Child and Adolescent Psychiatry, Stockholm
name: Stiftelsen Sunnerdahls Handikappfond
name: Swedish Foundation for Strategic Research
First posted: 2013-04-26
Enrollment: 202
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if neurofeedback and working memory training improves core symptoms of ADHD in children and adolescents.

Detailed description: This study investigates two types of Neurofeedback (NF), one well-established and well-researched protocol called Slow Cortical Potential NF (SCP), and a newer and less researched, yet popular among private clinicians, the so-called live z-score training (LZT). These methods are compared to working memory training (WMT) and a passive control condition, treatment-as-usual only (TAU). The active conditions (SCP/LZT/WMT) are delivered high frequent, with 5 sessions/week, for a total of 25 sessions.

Outcomes measures are taken at Preintervention and Postintervention, as well as at a 6-month follow-up assessment.

Eligibility criteria: Inclusion Criteria:

* Clinical AD/HD diagnose according to DSM-IV-TR and K-SADS interview, 9-17 years old, unmedicated or under stable medication with stimulants or corresponding since at least one month.

Exclusion Criteria:

* IQ \<70 (WISC-IV or WAIS-IV), clinically instable psychiatric state e.g. severe depression, OCD, self-injurious behaviour, bipolar disorder, severe somatic (neurologic) disease, very limited knowledge in the Swedish language.

Primary outcomes:
measure: The Conners 3
timeFrame: Up to seven months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Cap Bup-Kind
Study officials:
affiliation: Karolinska Institute, Competence Center of Neurodevelopmental Disorders (KIND)
name: Sven Bölte, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04694651: Potential Acceptance of COVID-19 Vaccines in Healthcare Workers in Egypt
Official title: A National Survey of Potential Acceptance of COVID-19 Vaccines in Healthcare Workers in Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: COVID-19
Healthcare workers
COVID-19 vaccines
Vaccine
Acceptance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants were recruited by Consensus Strategies through online survey to avoid coverage bias.

Doctors, nurses, laboratory workers and radiology technicians were included

Brief summary: The COVID-19 pandemic is expected to remain as a public health threat and economic burden all over the world. The available proposed vaccines are still lacking large randomized controlled trials testing its efficacy and safety. Thus, the acceptance of vaccination between citizens as well as healthcare workers is not guaranteed. As the vaccine is starting to be distributed the acceptance of healthcare givers should be measured as they are usually the front line facing the problem and they have a responsibility to explain the need of immunization to the rest of population.

Strategies to enhance the acceptance and trust of the available vaccines may be needed.


Eligibility criteria: Inclusion Criteria: Healthcare workers

-

Exclusion Criteria:

* None healthcare workers

Primary outcomes:
measure: Measure frequency of acceptance of vaccination
timeFrame: 6 months
Secondary outcomes:
measure: Describe causes of refusal of vaccination
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
city: Assiut
country: Egypt
facility: Aliae AR Mohamed-Hussein
Study officials:
References:
Clinical trial NCT02579551: Effectiveness of Narrow Margins in Patients With Low-Risk Basal Cell Carcinoma Undergoing Surgery
Official title: Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Facial Basal Cell Carcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Basal Cell Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 179
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial studies the effectiveness of narrow margins in patients with low-risk basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the area of normal tissue around a tumor taken out during surgery to make sure all of the cancer is removed. This clinical trial studies tissue samples to determine the least amount of tissue that must be removed to give an acceptable cure rate. This may allow less normal tissue to be removed from patients and may be a less expensive surgery.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the success rate of narrow margin excisions of low-risk facial basal cell carcinoma (BCC).

SECONDARY OBJECTIVES:

I. To determine the narrowest excision margin for low-risk facial BCC that gives an acceptable (95%) cure rate over a 3 year follow-up period.

Eligibility criteria: Inclusion Criteria:

1. Location

   1. Area M (cheeks, forehead, scalp \& neck) tumor size \< 10 mm
   2. Area H (central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear) tumor size \< 6 mm
2. Well-defined borders
3. Primary BCC
4. Patient is not immunosuppressed
5. There has not been prior radiotherapy to the site
6. Nodular subtype
7. No perineural involvement-(no neurological deficits grossly) -

Exclusion Criteria:

1. Location

   1. Area M tumor size \> or = to 10 mm
   2. Area H tumor size \> or = to 6 mm
2. Poorly defined borders
3. Recurrent BCC
4. Patient is immunosuppressed
5. There has been prior radiotherapy to the site -

Primary outcomes:
measure: Success rate for 1 mm margins
timeFrame: Up to 3 years
measure: Success rate for 2 mm margins
timeFrame: Up to 3 years
Secondary outcomes:
measure: Recurrence rate after 3 years
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson Univeristy
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Jason Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01503151: Cognitive Biases Modification Treatment for Social Anxiety
Official title: Cognitive Biases Modification Treatment for Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Phobia
Keywords: attention bias modification treatment
interpretive bias modification
cognitive bias modification
attention training
social anxiety
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Adults with Social Phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns.

Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews based on DSM-IV criteria.

The investigators expect to find significant reduction in social anxiety symptoms in the Treatment groups relative to the placebo control group. The investigators want to find out the relative efficacy of attention and interpretation oriented treatments and the combination of the two.


Eligibility criteria: Inclusion Criteria:

People suffering from social anxiety

Exclusion Criteria:

Pharmacological or Psychological treatment

Primary outcomes:
measure: Social Anxiety Scale (LSAS) - diagnostic interview
timeFrame: Expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols
Secondary outcomes:
measure: The Mini International Neuropsychiatric Interview (MINI).
timeFrame: expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv University
Study officials:
References: