louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02489253: Atherosclerosis in Familial Hypercholesterolemia
Official title: Incidence and Characteristics of Coronary Atherosclerosis in Asymptomatic Patients With Familial Hypercholesterolemia According to Monogenic Versus Polygenic Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Familial Hypercholesterolemia
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2015-07-02
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: 50 monogenic FH and 50 polygenic hypercholesterolemia

Brief summary: Familial hypercholesterolemia (FH) is a common inherited disorder with a frequency of 1 in 500 in the UK. Our aim is compare the carotid and coronary artery atherosclerosis in monogenic FH and polygenic hypercholesterolemia with means of a carotid ultrasound, a coronary CT angiogram and biochemical biomarkers.

Detailed description: Familial hypercholesterolemia (FH) is a common inherited disorder with a frequency of 1 in 500 in the UK. Previous Studies showed that risk of heart attack in these patients is at least 50% higher in men and 30% higher in women compared to the general population as they have high blood cholesterol since birth. We propose to develop a screening model based on non-invasive visualisation of the heart blood vessels (coronary arteries) by CT scan, ultrasound of the neck vessels (carotid arteries) and blood tests to access the extend of cholesterol deposit in the blood vessels in these patients. Participants with confirmed diagnosis of FH would be recruited from FH database registry at Royal Free Hospital. They would have a CT coronary angiogram, an ultrasound of carotid arteries and a blood test. The study is divided into overlapping stages of recruitment and data collection and data analysis. If CT scan shows more than 70% obstruction in their coronary arteries, they would be offered a coronary angiogram and an intracoronary Optical Coherence Tomography for assessment of their blood vessel blockage.

Eligibility criteria: Inclusion Criteria:

* The subjects must give written informed consent to participate in the study, Male and female subjects ≥ 18 years old, documentation of clinical diagnosis of familial Hypercholesterolemia

Exclusion Criteria:

* Estimated GFR \<45, pregnant women, Atrial fibrillation or unstable heart rate, Established ischemic heart disease, previous Percutaneous Coronary Investigations (PCI) or Coronary Artery Bypass Surgery (CABG), Known allergy to iodine contrast

Primary outcomes:
measure: carotid Intima Media thickness measurement
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: University College Hospital and Royal Free Hospital
name: Roby Rakhit
role: STUDY_DIRECTOR
References:
Clinical trial NCT00372853: Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma
Official title: A Phase 1 Dose Escalation Trial To Evaluate The Safety And Tolerability Of CP-675,206 Administered In Combination With SU011248 To Patients With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Renal Cell
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.


Eligibility criteria: Inclusion Criteria:

* Histologically proven renal cell carcinoma with metastases
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1

Exclusion Criteria:

* Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma
* History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan

Primary outcomes:
measure: To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug
timeFrame: 6 weeks after first dose
Secondary outcomes:
measure: To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported
timeFrame: 18 months
measure: To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination
timeFrame: up to 18 months
measure: To monitor for an antibody response to CP-675,206
timeFrame: up to 18 months
measure: To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled
timeFrame: 6-18 months after last subject enrolled
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: New Brunswick
country: United States
facility: Research Site
state: New Jersey
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
Study officials:
References:
Clinical trial NCT01626053: The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
Official title: The Efficacy and Treatment Adherence With an Integrated Program on HbA1c Scores in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: psychological
intervention
stages of change
motivational interviewing
coping skills
HbA1C
psychological testing
integrated care
behavioral health
Lead sponsor: KRJG Services Inc.
Sponsor class: OTHER
Collaborators: name: K21 Health Foundation
name: Kosciusko County Health Department
First posted: 2012-06-22
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is hypothesized for this study that the coupling of the Millon Behavioral Medicine Diagnostic, biopsychosocial evaluation, motivational interviewing, relapse prevention, and ongoing support can produce improved outcomes with diabetics who have previously been unsuccessful with the traditional care. This study examined the relationship between patients' HbA1c levels and patients' involvement in the ASMART program, a multifaceted program involving psychological intervention. The study was conducted through the Kosciusko Health Department and funded by K21 Health Foundation.

Detailed description: The study involved 182 Type 2 Diabetes patients with an HbA1c score above 7, reflecting poor control of diabetes. The experimental group consisted of 124 patients who joined the ASMART program, while the control group consisted of 60 patients who continued to receive traditional care. Statistical analysis involved comparing pretest \& posttest HbA1c levels for the experimental group and the control group.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes patients with an HbA1c score over 7

Exclusion Criteria:

* No Type 1 patients
* No children under the age of 18

Primary outcomes:
measure: Changes in A1c levels for pretest and post test (Preset baseline and post-test 2 years
timeFrame: Pretest / posttest
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: Northern Lakes Medicine
state: Indiana
Study officials:
affiliation: Grace College
name: Kevin W Roberts, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kosciusko Community Hospital
name: Dana L Coates, D.O.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03395353: A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Official title: A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Depressive Disorder
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2018-01-10
Enrollment: 151
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.


Eligibility criteria: * a) Participants extended from B058(1701A3631) study.
* b) New participants.

Inclusion Criteria

* a) Participants who have completed 7 weeks of dosing in the B058(1701A3631) study and give signed informed consent to continue duloxetine administration in this study.
* b) Participants diagnosed with Major Depressive Disorder or persistent depressive disorder and completely meet the criteria of major depressive episode as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) ver.7.0.2.
* b) Participants whose incipient age of depression was ≥7 years old.

Exclusion Criteria:

* a, b) Have a current or previous diagnosis (DSM-5) of the following as judged by the investigator:

  * Neurodevelopmental disorders
  * Schizophrenia spectrum and other psychotic disorders
  * Bipolar and related disorders
  * Trauma and stressor-related disorders
  * Disruptive · Impulse Control · and Conduct disorders
* a, b) Have a current diagnosis (DSM-5) of the following as judged by the investigator:

  * Obsessive-compulsive and related disorders
  * Anorexia nervosa, Bulimia nervosa, Binge-eating disorder
  * Sleep-wake disorders
  * Neurocognitive disorders
  * Disruptive mood dysregulation disorder
* a, b) Have personality disorders, in the judgment of the investigator.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
timeFrame: Baseline through Week 53
Secondary outcomes:
measure: Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Baseline, Week 50
measure: Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S)
timeFrame: Baseline, Week 50
measure: Pharmacokinetics (PK): Trough Concentration of Duloxetine
timeFrame: Week 4 through Week 50
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Shionogi
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References:
Clinical trial NCT00262353: Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis
Official title: Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Failure, Chronic
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial hepatic system

Detailed description: After inclusion, patients will be dialysed with low-flux artificial kidneys. 1 week of dialysis exists of 3 days of dialysis. In week 4, day 2, patients will be treated once with the Prometheus artificial hepatic system or with high-flux dialysis. The other days low-flux kidneys will be used. Week 5 and 6 are a wash-out period. Week 7 is identical to week 4 but the other system than in week 4 is used. Blood samples are taken at regular moments in week 3, week 4 (day 2) and week 7 (day 2).

Eligibility criteria: Inclusion Criteria:

* Stable patients
* At least 3 months on dialysis
* Arterio-venous fistula

Exclusion Criteria:

* Diabetic patients
* Malignancies
* Acute illnesses

Primary outcomes:
measure: Determination of the concentration of protein-bound toxins after treatment with different artificial devices
Secondary outcomes:
measure: Determination of the kinetics of protein-bound toxins after treatment with different artificial devices
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Vanholder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01749553: Effectiveness of an 8-week Posterior Shoulder Stretching Program on Varsity-level Overhead Athletes
Official title: Effectiveness of an 8-week Posterior Shoulder Stretch Program on Varsity-level Overhead Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athlete's Shoulder
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Determine whether an eight-week posterior shoulder stretch was effective in increasing dominant arm internal rotation(IR) and horizontal adduction (HAd) range of motion (ROM) in a group of overhead athletes identified as having tightness of their posterior shoulder structures.


Eligibility criteria: Inclusion Criteria:

* varsity level athletes involved in volleyball, tennis and swimming with internal rotation deficit of greater than or equal to 15 degrees

Exclusion Criteria:

* previous surgical procedure or fracture of either shoulder or presently receiving treatment for condition affecting either shoulder

Primary outcomes:
measure: Shoulder internal rotation and horizontal adduction range of motion
timeFrame: 8 weeks
Secondary outcomes:
measure: Rate of change in internal rotation and horizontal adduction range of motion
timeFrame: 0 - 4 weeks and 4 - 8 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Department of Physical Therapy, Universiy of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Judy C Chepeha, PT,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03648853: Effect of Location of Tetanic Stimuli on Photoplethysmogram
Official title: Effect of Location of Tetanic Stimuli on Photopethysmogram During General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Reaction
Keywords: photoplethysmography
stress response
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia.

Detailed description: A 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order in patients who are under general anesthesia. Tetanic stimuli are used routinely during general anesthesia to assess effectiveness of neuromuscular blockade. These tetanic stimuli are noxious stimuli that elicit a stress response which can be quantified using photoplethysmography. This study investigates if the magnitude of the tetanus induced stress response is dependent on the location of the tetanic stimulus as measured by photoplythysmography.

Eligibility criteria: Inclusion Criteria:

* Surgical patients general anesthesia able to consent in english

Exclusion Criteria:

* regional anesthesia unable to consent in english under 18 yrs of age

Primary outcomes:
measure: Photoplethysmography (PPG)
timeFrame: 1-2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
References:
Clinical trial NCT01123551: Efficacy Study of Nebulized Morphine and Intravenous Morphine in Post Traumatic Pain
Official title: Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Traumatic Pain
Keywords: Nebulized morphine
Intravenous morphine
Post traumatic
Pain
Emergency department
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the emergency department, 60% of patients have an acute pain. Appropriate management of acute pain is a public health priority according to who recommendations. Nebulized morphine has been extensively studied in children but less well in adults.

It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than intravenous (IV) method.


Eligibility criteria: Inclusion Criteria:

* Post-traumatic pain with visual analog pain scale( VAPS) ≥ 50%
* Age between 8 and 50 years.

Exclusion Criteria:

* Glasgow coma scale (GCS)\< 14,
* Severe injury ,
* Hypotension : blood systolic pressure \< 90 mmhg,
* Bradypnea \< 12 cpm or SaO2\< 90%,
* Chronic pain treatment,
* Aspirin or paracetamol treatment within 6 hours of emergency presentation,
* Nasal trauma, rhinitis, nasal obstruction,
* Incapacity to cooperate,
* Opiate allergy,
* Drug addiction,
* Pregnancy, breast feeding,
* Severe renal and liver failure and chronic obstructive pulmonary disease(COPD)

Primary outcomes:
measure: 1. Resolution rate
timeFrame: one hour
Secondary outcomes:
measure: rate of side effects
timeFrame: one hour
measure: Resolution time
timeFrame: one hour
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital
Study officials:
References:
Clinical trial NCT03728751: Optimal Time for In-situ Dry Needling to Affect the Autonomic Nervous System
Official title: Optimal Time for In-situ Dry Needling to Affect the Autonomic Nervous System: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Dry needling
Autonomic nervous system
pupillometry
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pre-test post test study design
Primary purpose: TREATMENT

Brief summary: Assessing for optimal time dry needles need to remain inside the body to have positive effect on the nervous system

Detailed description: The purpose of this study is to determine what most optimal dry needling duration effect on the autonomic nervous system.

Design: The researchers will conduct a pilot study to assess the effect of dry needling on the autonomic nervous system

Eligibility criteria: Inclusion Criteria:

1. Age between 18-65 years old
2. No pain at all anywhere in the body at the time of testing.
3. No caffeine containing products 3 hours before measurement and no use of over the counter Non-Steroidal Anti-Inflammatory Drug (NSAID) before the testing.

Exclusion Criteria:

1. Red flags identified during the subjects intake. If needling is contraindicated the subjects will be removed from the study and if necessary will be referred to an appropriate health care provider.
2. Use of blood thinners
3. History of surgery and or injury within the past six weeks
4. Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
5. Prior surgery to the neck or thoracic spine
6. Chiropractic, Physical Therapy, Dry needling or Acupuncture treatment for their neck pain in the last 3-months
7. Inability to follow directions and keep the eye open during the measurement phase of this study

Primary outcomes:
measure: Pupil diameter
timeFrame: 1.) 1 minute measure will be taken after accommodation of 2 minutes to the dark environment, 2.) needle placement and an immediate 1 minute second measure, 3.) every 2 minutes a measure of 1 minute to 8 post needle measures (24 minutes) total
Secondary outcomes:
Other outcomes:
Locations:
city: Hobart
country: United States
facility: Integrated Therapy Practice PC
state: Indiana
Study officials:
affiliation: Faculty
name: Rob Sillevis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00802451: Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
Official title: A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Bioavailability
Mesalamine
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects.


Eligibility criteria: Inclusion Criteria:

* healthy men or women, 18 to 55 years of age
* weight within +/- 25% for height and weight for body frame
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to mesalamine
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 28 days prior to study dosing

Primary outcomes:
measure: Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: