louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01410383: Efficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care
Official title: A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long Term Phase III Trial Assessing the Safety and Efficacy of Eprotirome in Patients With Heterozygous Familial Hypercholesterolaemia Who Are on Optimal Standard of Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heterozygous Familial Hypercholesterolaemia
Keywords: hypercholesterolemia,
dyslipidemia,
thyroid,
safety,
Heterozygous Familial Hypercholesterolaemia
coronary artery disease
Lead sponsor: Karo Bio AB
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 236
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: Eprotirome is a liver selective thyroid hormone that can reduce several independent risk factors for cardiovascular disease, while an euthyroid state is preserved in the extrahepatic tissue.

The purpose of this Phase III study is to assess the long-term efficacy and safety of Eprotirome in Patients with heterozygous Familial Hypercholesterolaemia who are on optimal standard of care.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed HeFH and 18 years of age at screening
* Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C more than 2 mmol/L (more than 80 mg/dL)
* Presence of risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C more than 2.5 mmol/L (more than 100 mg/dL)
* On an optimal standard of care, defined as being on a stable dose of statin (rosuvastatin, atorvastatin, or simvastatin) with or without ezetimibe for 8 weeks prior to randomisation

Exclusion Criteria:

* Significant health problems in recent past including heart failure,cardiac electrophysiologic instability, rheumatoid arthritis, thyroid dysfunction, liver disease, cancer, secondary dyslipidaemia

Primary outcomes:
measure: Percent reduction in low-density lipoprotein cholesterol (LDL-C) from baseline
timeFrame: 12 weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Academic Medical Center (AMC) of the University of Amsterdam
name: John Kastelein, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sjouke B, Langslet G, Ceska R, Nicholls SJ, Nissen SE, Ohlander M, Ladenson PW, Olsson AG, Hovingh GK, Kastelein JJ. Eprotirome in patients with familial hypercholesterolaemia (the AKKA trial): a randomised, double-blind, placebo-controlled phase 3 study. Lancet Diabetes Endocrinol. 2014 Jun;2(6):455-63. doi: 10.1016/S2213-8587(14)70006-3. Epub 2014 Feb 18.
Clinical trial NCT02686983: GON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study
Official title: Greater Occipital Nerve Blockade for the Treatment of Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. Corticosteroids may be helpful in reducing the pain intensity and frequency in chronic migrtaine. This RCT is set up to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Detailed description: Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. In general, there is a marked paucity of evidence concerning GON blocks in migraine. Corticosteroids may be helpful in reducing the pain intensity and frequency in these patients. This is an RCT to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Eligibility criteria: Inclusion Criteria:

* Chronic migraine

Exclusion Criteria:

* Medication overuse headache

Primary outcomes:
measure: Number of migraine days
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of days with severe headache days
timeFrame: 8 weeks
measure: Medication use
timeFrame: 8 weeks
measure: Responder rate
timeFrame: 8 weeks
measure: Number of migraine attacks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Glostrup, Copenhagen
country: Denmark
facility: Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
Study officials:
affiliation: Danish Headache Center
name: Jakob M Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01041183: The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nausea
Vomiting
Laparoscopic Cholecystectomy
Keywords: Oral plus IV ramosetron may be more effective than
IV ramosetron and oral ramosetron for the prophylaxis of
PONV after laparoscopic cholecystectomy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2009-12-31
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* ASA I-II patients, 25-65 years, electivelaparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* GI disease, pregnant or menstruating, history of motion sickness and/or postoperative emesis, antiemetics within 24 h before surgery

Primary outcomes:
measure: Incidence of PONV
timeFrame: postoperative 0-48 h
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Jung-Hee Ryu
state: Gyeonggi-do
Study officials:
References:
citation: Ryu JH, Jeon YT, Hwang JW, Oh AY, Moon JY, Ro YJ, Kim CS, Chen C, Apfel CC, Do SH. Intravenous, oral, and the combination of intravenous and oral ramosetron for the prevention of nausea and vomiting after laparoscopic cholecystectomy: a randomized, double-blind, controlled trial. Clin Ther. 2011 Sep;33(9):1162-72. doi: 10.1016/j.clinthera.2011.07.018.
Clinical trial NCT01362283: Epidemiologic Study to Evaluate the Proportion of Cardiovascular Disease Risk Factors in Korean Hypertensive Patients
Official title: A Multi-center, Observational, Cross-sectional Study to Evaluate CVD Risk Factors in Korean Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 3109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Korea, Diagnosed hypertensive patient

Brief summary: The purpose of this study is investigating the proportion of Cardiovascular disease risk factors of hypertensive patients.

Detailed description: Primary endpoint: To evaluate the Proportion of patients with Cardiovascular disease high risk factors

Secondary endpoint: To evaluate the Proportion of patients with Cardiovascular disease risk factors, To evaluate the Proportion of patients with Cardiovascular disease, To evaluate Target blood pressure achievement rate according to the proportion of Cardiovascular disease risks

Eligibility criteria: Inclusion Criteria:

* Essential hypertensive patient no less than 18 yeas old
* Patient who gave informed consent form

Exclusion Criteria:

* Patient was diagnosed as secondary hypertension
* Patient who have white-coat hypertension

Primary outcomes:
measure: Proportion of patients with cardiovascular disease high risk factors
timeFrame: 6years, average duration of hypertension
Secondary outcomes:
measure: Proportion of patients with Cardiovascular disease risk factors
timeFrame: 6years, average duration of hypertension
measure: Proportion of patients with Cardiovascular disease
timeFrame: 6years, average duration of hypertension
measure: Target Blood Pressure achievement rate according to the proportion of Cardiovascular disease risks
timeFrame: 6years, average duration of hypertension
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01446783: IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
Official title: IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ehlers-Danlos Syndrome, Classic
Keywords: COL5A1
Collagen disorders
IGF-I
Collagen synthesis
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators want to inject insulin-like growth factor-I (IGF-I) into the patella tendon of Ehlers-Danlos patients and healthy controls to evaluate the response in collagen synthesis. Furthermore collagen synthesis is measured in muscle connective tissue and in skin.

The hypothesis is that the connective tissue in Ehlers-Danlos patients is more compliant and poorer in collagen than healthy controls, but that collagen synthesis can be stimulated by IGF-I.

Detailed description: IGF-I will be injected with ultrasound guidance to one patella tendon and the other one will be injected with saline as control. Injections will be performed double blinded and timed 24 hours and 6 hours before tissue sampling.

Collagen synthesis will be measured as fractional synthesis rate based on stabile isotope technique using labelled proline.

10 patients diagnosed with Classical form of Ehlers-Danlos syndrome will be included and matched with 10 healthy controls based on age, gender, BMI and activity level.

The muscle biopsy will be taken from vastus lateralis muscle and the skin biopsy from the buttocks. The biopsies will if the size permits it also be used for histology and mRNA analyses.

Eligibility criteria: Inclusion Criteria:

* Classic form of Ehlers-Danlos syndrome OR healthy matched control

Exclusion Criteria:

* Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons

Primary outcomes:
measure: Fractional synthesis rate of collagen in tendon, muscle and skin
timeFrame: 6 hours
Secondary outcomes:
measure: Electron microscopy
measure: mRNA
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sportsmedicine Copenhagen
Study officials:
affiliation: Institute of Sportsmedicine Copenhagen
name: Michael Kjaer, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05138783: Clinical Performance of Two Daily Disposable Soft Contact Lenses
Official title: Clinical Performance of Two Daily Disposable Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 129
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: The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.

Detailed description: Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.

Eligibility criteria: Key Inclusion Criteria:

* Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
* Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
* Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
* Monovision and multifocal lens wear.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Distance Visual Acuity (VA) With Study Lenses
timeFrame: Day 8 (-0/+3 days), each study lens type
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Kindred Optics at Maitland Vision
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Eye Center
state: Florida
city: Franklin Park
country: United States
facility: Franklin Park Eye Center PC
state: Illinois
city: Shawnee Mission
country: United States
facility: Heart of America Eye Care
state: Kansas
city: Medina
country: United States
facility: Complete Eye Care Of Medina
state: Minnesota
city: Granville
country: United States
facility: ProCare Vision Centers, Inc.
state: Ohio
city: Wichita Falls
country: United States
facility: Clarke EyeCare Center
state: Texas
city: Weston
country: United States
facility: Stine Eye Center
state: Wisconsin
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT04730583: Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas
Official title: Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cutaneous Neurofibroma
Keywords: Neurofibromatosis Type 1
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2021-01-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will evaluate the tolerability and effectiveness of three FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and a Kybella injection. Each patient will have a treatment and a control site.


Eligibility criteria: Inclusion Criteria:

* Adult males and females ≥18 years of age
* Have a diagnosis of Neurofibromatosis Type 1
* Patients must be seeking treatment for cutaneous Neurofibromas
* Patients must have ≥ 6 paired cutaneous Neurofibromas (3 to be treated and 3 untreated) that are visible and measure between 2-4mm in size.
* Able and willing to comply with all visit, treatment and evaluation schedules and requirements
* Able to understand and provide written informed consent
* Access to a Smart Phone to be able to take and upload photographs to an application

Exclusion Criteria:

* Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
* Individuals who cannot give informed consent or adhere to study schedule
* Actively tanning during the course of the study
* Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
* Known allergy to injectable anesthetics or deoxycholic acid
* Any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study;
* Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Patient Report Outcomes
timeFrame: For the 12 months after treatment
measure: Clinician Reported Outcomes
timeFrame: For the 12 months after treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Wellman Center for Photomedicine, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Wellman Center for Photomedicine, Massachusetts General Hospital
name: R. Rox Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01016197: Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial
Official title: Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Finger Injury
Keywords: Soft tissue mallet finger
Lead sponsor: Mid Cheshire Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2009-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are investigating if surgical treatment of injuries to the tendon which straightens the finger tip gives a better functional outcome than treatment with a splint while the tendon heals.

Detailed description: The investigators will randomise patients to receive splinting of their finger while their tendon heals or have surgical intervention. Surgical intervention will entail fixing the tendon with bone anchors and splinting. Conservative treament involves splinting while the tendon heals. We will then monitor the functional outcome of the hand using the DASH questionare over 18 months.

Eligibility criteria: Inclusion Criteria:

* soft tissue mallet finger
* acute injury

Exclusion Criteria:

* ASA 3 or above
* Unable to give informed consent
* Infection in digit affected

Primary outcomes:
measure: DASH score
timeFrame: up to 18 months
Secondary outcomes:
measure: Range of movement at distal interphalyngeal joint.
timeFrame: 3, 6, 12 and 18 months
Other outcomes:
Locations:
city: Crewe
country: United Kingdom
facility: Mid Cheshire NHS Trust
Study officials:
affiliation: National Health Service, United Kingdom
name: Philip Holland, MBChB, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00349297: The Microbiological Spectrum in Acute Dacryocystitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dacryocystitis
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2006-07-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute dacryocystitis patients

Brief summary: Acute dacryocystitis in adults can be a very painful disease and may not respond well to medical therapy.

The purpose of this prospective non-randomised study is to determine the microorganisms causing acute dacryocystitis and the antibiotic sensitivities of these organisms.

The study also aims to correlate the microbiological findings to the severity of clinical manifestations and evaluate the effectiveness of our current practice of aspiration and empiric systemic antibiotic therapy in treating patients with acute dacryocystitis and hence review whether there is a need to alter current management strategy.


Eligibility criteria: INCLUSION CRITERIA:

* Painful localised fluctuant induration just inferior to the medial canthal tendon of less than 2 weeks duration.

EXCLUSION CRITERIA:

* Non-fluctuant lacrimal sac swelling
* Uncooperative patient
* Unwilling Patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore National Eye Centre
name: Anshu Arundhati, MRCSED, MMED
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00129597: Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
Official title: Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Breast Cancer
Keywords: Ketalar
NMDA
mastectomy
postoperative chronic pain
Chronic pain after mastectomy for breast cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-12
Enrollment: 40
Sex: FEMALE
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: Prevalence of chronic pain after mastectomy is beyond 50% 3 months after surgery. This pain is related to a sensitization of the central nervous system through N-methyl-D-asparate (NMDA) receptors. Ketalar might prevent the occurrence of chronic pain by anti-NMDA properties after mastectomy.


Eligibility criteria: Inclusion Criteria:

* Mastectomy in patients 18 to 80 years old

Exclusion Criteria:

* American Society of Anesthesiology (ASA) class \>= 3
* Renal, heart or hepatic failure
* Allergy to ketalar
* Psychiatric disease
* Chronic antalgic treatment

Primary outcomes:
measure: To evaluate the effect of perioperative ketalar on pain intensity 3 months after a mastectomy
measure: Pain intensity is evaluated by an appropriate questionnaire 1 and 3 months after surgery.
Secondary outcomes:
measure: To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia
Other outcomes:
Locations:
city: Pierre bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Vincent PIRIOU, MD
role: PRINCIPAL_INVESTIGATOR
References: