louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03118310: Treatment of NAFLD With Two Different Diets
Official title: Treatment of NAFLD With Two Different Diets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NAFLD
Keywords: Reduction of liver fat
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The impact of popular diets on liver-related health is unclear. In this randomized, controlled trial, patients with NAFLD will be randomized to one of two popular diets or a placebo diet.

Detailed description: Subjects will include patients with MRI-verified NAFLD, with no concurrent liver diseases. Randomization will be done to either a control diet, the 5:2 diet or a low-carb-high-fat diet. The subjects will follow the diet for three months, after which a new MRI is performed. Main outcomes measure is reduction in liver fat.

Eligibility criteria: Inclusion Criteria:

* Known NAFLD

Exclusion Criteria:

* Other forms of liver disease
* Bolus insulin treatment
* Cirrhosis

Primary outcomes:
measure: Liver fat
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Center for Digestive Diseases, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Hannes Hagström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmer M, Lindqvist C, Petersson S, Moshtaghi-Svensson J, Tillander V, Brismar TB, Hagstrom H, Stal P. Treatment of NAFLD with intermittent calorie restriction or low-carb high-fat diet - a randomised controlled trial. JHEP Rep. 2021 Feb 17;3(3):100256. doi: 10.1016/j.jhepr.2021.100256. eCollection 2021 Jun.
Clinical trial NCT01511510: Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeated Doses of PF-04958242 in Healthy Volunteers
Official title: A Phase I, Randomized, Subject And Investigator Blind, Sponsor Open, Multiple Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: PF-04958242
multiple dose
safety
schizophrenia
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.

Detailed description: This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non-child bearing potential Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* History of seizures or of a condition with risk of seizures
* Pregnant or nursing females, and females of child bearing potential

Primary outcomes:
measure: Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
timeFrame: Day 1-Day 2
measure: Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
timeFrame: Day 4
measure: Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
timeFrame: Day 7
measure: Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
timeFrame: Day 14-Day 18
measure: Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
timeFrame: Day 14-Day 15
Secondary outcomes:
measure: Drug Effect Questionaire Liking scale
timeFrame: Day 14
measure: Digit Symbol Substitution Test
timeFrame: Day 14
measure: Columbia Suicide Severity Rating Scale
timeFrame: Day 0-Day 14
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03366610: Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients Previously Treated With Daclatasvir-Based Regimens
Official title: A Long Term Off-treatment Follow-Up Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients in China Previously Treated With Daclatasvir-Based Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 1000 subjects diagnosed with CHC in China.

Brief summary: The purpose of this study is to assess long-term outcomes in subjects previously treated with daclatasvir-based therapy for chronic Hepatitis-C (CHC)


Eligibility criteria: Inclusion Criteria:

* Males or females 18 years of age or older at initiation of prior DCV-based therapy
* Previously treated with DCV (manufactured by BMS)-based therapy in combination with other HCV direct acting antivirals (DAAs) for at least 8 weeks
* Must enroll in this study within 12 months of end of treatment of DCV-based therapy or within 6 months of protocol availability at the clinical site for subjects treated in the AI447036 or AI447114 studies

Exclusion Criteria:

- N/A

Primary outcomes:
measure: Incidence of hepatic disease progression events
timeFrame: up to 5 years
Secondary outcomes:
measure: Durability of virologic response
timeFrame: up to 5 years
measure: Change in liver stiffness
timeFrame: baseline up to 5 years
measure: Number of subjects with HCV sequence variants
timeFrame: baseline up to 5 years
measure: Distribution of HCV retreatment patterns
timeFrame: baseline up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06780410: A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid
Official title: A Phase III Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid in Patients with Hyperlipidemia Not Adequately Controlled by Statins
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Hyperlipidemia
Keywords: Bempedoic Acid
Hyperlipidemia
Efficacy
Safety
Lead sponsor: Gan & Lee Pharmaceuticals.
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 240
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 trial is a phase III study to evaluate the efficacy , tolerability, and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.


Eligibility criteria: Inclusion Criteria:

* 1. 18 years and older, male or female.
* 2. 18 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2.
* 3. Participants must agree to use reliable contraception from the screening day until 30 days after the last dose, and must not donate sperm or eggs for assisted reproduction purposes.
* 4. Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form, capable of completing the entire study process.

Exclusion Criteria:

* 1. Known allergy to any component of the investigational drug or its excipients, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution.
* 2. Fasting triglycerides (TG) ≥ 5.64 mmol/L (≥ 500 mg/dL) at screening.
* 3. History of malignant tumors prior to screening.
* 4. History of drug, alcohol, amphetamines, or other drug abuse.
* 5. Participation in other clinical studies and use of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of the drugs (whichever is longer).
* 6. Pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (HCG) pregnancy test.
* 7. Any other factors that the investigator believes makes the participant unsuitable for the study.

Primary outcomes:
measure: Percentage change from baseline in LDL-C levels at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage change from baseline in total cholesterol (TC) levels at Week 12
timeFrame: Baseline, Week 12
measure: Adverse events (AEs) and serious adverse events (SAEs) during the study
timeFrame: Baseline, Week 13
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site 01
Study officials:
References:
Clinical trial NCT07005310: Ultra-Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult IV Access Patients
Official title: Ultra Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult Intravenous Access Patients: a Pragmatic Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Difficult Intravenous Access
Adults
Keywords: Long peripheral catheter
Accelerated seldinger technique
Pragmatic randomized controlled trial
Dwell time
complications
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to perform a comparative analysis of clinical outcomes associated with the use of an ultra-long peripheral catheter using (catheter-over-the-needle technique) versus an AST-long peripheral catheter in adult patients with difficult intravenous access (DIVA) in a real-world clinical setting. Specifically, the study will assess potential benefits, including longer mean catheter dwell time and improved catheter usability, as well as potential harms, such as increased incidence of catheter-related thrombosis, infections, phlebitis, infiltration, and unplanned catheter removal.


Eligibility criteria: Inclusion Criteria:

* Adult inpatients with DIVA, requiring placement of a long peripheral catheter, will be included in the study.
* A digital request form for venous access must be completed by the treating physician at the ward.
* Patients must be proficient in either Dutch or French
* Patients must have decision-making capacity or be represented by a legal representative.

Exclusion Criteria:

* Expected therapy duration of less than 24 hours
* pregnancy
* Need for central venous access
* Inability to locate a deep peripheral vein in the upper extremity prior enrollment in the study
* Veins located deeper than 1.6cm prior enrollment in the study
* withdrawal of consent, or presentation at a time when study personnel are unavailable.

Primary outcomes:
measure: Dwell time
timeFrame: Until study completion, an average of 14 days.
Secondary outcomes:
measure: Number of Participants with Catheter related thrombosis
timeFrame: Until study completion, an average of 14 days.
measure: Number of Participants with Midline catheter related infections
timeFrame: Until study completion, an average of 14 days.
measure: Number of Participants with Phlebitis
timeFrame: Until study completion, an average of 14 days.
measure: Number of Participants with Loss of catheter usability
timeFrame: Until study completion, an average of 14 days.
measure: Number of Participants with Unplanned removal
timeFrame: Until study completion, an average of 14 days.
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair ziekenhuis Brussel
state: Jette
Study officials:
References:
Clinical trial NCT00951210: Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
Official title: Phase I Study of Intramuscular (IM) Injections of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia. PLX-PAD Are Mesenchymal-Like Stromal Cells Derived From a Full Term Placenta.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Critical Limb Ischemia
Keywords: Peripheral Artery Disease
Peripheral Vascular Disease
Critical limb ischemia
PAD
CLI
Lead sponsor: Pluristem Ltd.
Sponsor class: INDUSTRY
First posted: 2009-08-04
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe, with ABI \< 0.6 or/and TBI \< 0.4
2. Rutherford category 4-5
3. Non candidate for revascularization or endovascular intervention based on unfavorable vascular anatomy or significant co-morbid medical conditions as confirmed by vascular study (e.g., angiogram, MRA) obtained within 3 months prior screening visit and signed approval of vascular surgeon. The decision to classify the subject as a non-candidate will be made by the investigator and confirmed by an independent third party vascular surgeon who is not participating in the study.
4. In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.
5. Those diabetic subjects who are on optimal diabetes medication, with an HbA1c \< 8%

Exclusion Criteria:

1. Uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg during screening).
2. Wounds with severity greater than Grade 2 on the Wagner Scale
3. Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged.
4. ST segment elevation myocardial infarction and/or TIA/CVA within six (6) months prior to enrollment.Patients with severe congestive heart failure (i.e. NYHA Stage IV)
5. In the opinion of the investigator, the patient is unsuitable for cellular therapy.

Primary outcomes:
measure: Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence
timeFrame: 3 months
measure: Immunological reaction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology PC
state: Alabama
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT00849810: Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate
Official title: Comparative Effects of Nebivolol Versus Metoprolol on 24-hour Blood Pressures and Basal Metabolic Rate: An Open-Label Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Beta-blockers
Ambulatory blood pressure
Basal metabolic rate
Quality of life
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2009-02-24
Enrollment: 1
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: The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* currently be treated at a University of MS Medical Center Internal Medicine Clinics
* currently taking metoprolol succinate for hypertension
* have their hypertension controlled (\<140/90).

Exclusion Criteria:

* uncontrolled hypertension
* severe renal or moderate hepatic impairment
* currently taking CYP 2D6 inducers/inhibitors
* recent stroke (less than 6 months)
* recent myocardial infarction (less than 6 months)
* congestive heart failure
* diagnosed obstructive sleep apnea
* atrial fibrillation
* arm circumference \>50 cm

Primary outcomes:
measure: Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.
timeFrame: 4 weeks (pre- and post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Deborah Minor, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130010: The Effect of Nefopam on Catheter-related Bladder Discomfort
Official title: The Effect of Nefopam on Catheter-related Bladder Discomfort: A Double-blind, Randomized, Controlled, Parallel Design Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nefopam
Catheter-related Bladder Discomfort
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 110
Sex: MALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the present study, the investigators evaluated whether nefopam 20 mg reduce the catheter-related bladder discomfort in patients undergoing foley catheter insertion


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled to insert the catheter a new foley catheter more than 14 Fr in the operation site,
2. Adults 20 to 75years of age
3. American Society of Anesthesiologists Physical Classification 1,2 patients
4. Patients who pre-agreed to the study
5. Male patient

Exclusion Criteria:

1. Neurogenic bladder
2. Patients diagnosed with irritable bladder
3. study drug sensitive or contraindicated
4. Patients with central nervous system or neurological disorder (epilepsy, patients receiving MAO inhibitor)
5. Patients with urethral and prostate disorders
6. Patients with previous history of myocardial infarction
7. Patients with closed angle glaucoma

Primary outcomes:
measure: catheter-related bladder discomfort
timeFrame: postoperative 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National Univ. Bundang Hospital
name: Eunsu Choi, pf
role: STUDY_CHAIR
References:
Clinical trial NCT00548210: Effectivity of Dermatix in Promoting Scar Maturation
Official title: Dermatix; A Randomized Controlled Trial Measuring Effectivity of Dermatix in Promoting Scar Maturation of Hypertrophic Scars.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertrophic Scars
Keywords: Hypertrophy
scarring
scar treatment
silicone
Lead sponsor: Association of Dutch Burn Centres
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2007-10-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this research is to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

Detailed description: The healing of deep thermal injuries is always associated with scarring. The healing process can lead to the formation of large scar bundles (e.g. hypertrophic scars). The scars can be discomforting, disfiguring and restrict motion if situated over or near joints. Evidence for effectivity of treatment for reduction of hypertrophic scars or the prevention of them is limited.

Different treatments are used such as intralesional injected steroids, topically used oily creams, silicone sheets or occlusive dressings. Compression garments are also frequently used. There is some evidence as to the effectivity of silicone sheets for recuction of hypertrophic scarring, however, these sheets cannot be used easily on all anatomical locations.

Valeant Pharmaceuticals International has developed a silicone based scar remodelling gel, Dermatix®, which has been empirically shown by others to have potential to reduce hypertrophic scars.

Primary objectives are to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

Eligibility criteria: Inclusion Criteria:

1. Patients with hypertrophic scarring and/or ropes, stable for at least 3 months before inclusion.
2. Written informed consent
3. Scar size enabling the definition of two distinct scar areas, with similar scar characteristics at inclusion, preferably symmetric scars.
4. Patients of 18 years or older

Exclusion criteria:

1. Known sensitivity for occlusive dressings or silicone containing products
2. Any patient condition that may influence the compliance of the treatment negatively.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverwijk
country: Netherlands
facility: Association of Dutch Burn Centres
state: Noord-Holland
Study officials:
affiliation: Association of Dutch Burn Centres
name: Esther Middelkoop, PhD
role: STUDY_DIRECTOR
References: