louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00295724: Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
Official title: A Multi-Center, Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 mg BID in the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Keywords: bicifadine
chronic low back pain
Lead sponsor: DOV Pharmaceutical, Inc.
Sponsor class: INDUSTRY
First posted: 2006-02-24
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: * The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients with moderate to severe chronic low back pain.
* The secondary objectives are to evaluate the effect of bicifadine on function and general quality of life, to evaluate safety following discontinuation of bicifadine treatment and to investigate the population pharmacokinetics of bicifadine.


Eligibility criteria: Main Inclusion Criteria:

* Patients with low back pain assessed as Class 1, Class 2 or Class 3 according to the Quebec Task Force Classification for Spinal Disorders and without detectable leg weakness on neurological examination.
* Patients with pain categorized as Class 1 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of \>17 at baseline to qualify. Patients with pain categorized as Class 2 or Class 3 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of at least 10 at baseline to qualify.
* Patients must have required daily analgesics for the treatment of low back pain for at least 3 months prior dosing.

Main Exclusion Criteria:

* Patients may not have persistent moderate or severe pain in a location other than the lower back (with the exception of radiation to the lower extremity).
* Patients must not have had lower back surgery within 6 months prior to baseline, nor epidural corticosteroid injections within 3 months prior to baseline.
* Patients may not have an unstable medical condition.

Primary outcomes:
measure: Pain Severity Rating (100 mm visual analog scale)
Secondary outcomes:
measure: Short-Form McGill Pain Questionnaire (SF-MPQ)
measure: Roland-Morris Disability Questionnaire (RDQ)
measure: Short-Form 36 (SF-36) Health Survey
measure: Patient's Global Impression of Change (7-point categorical scale)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05714124: Liver Embolization Approaches for Tumor Management
Official title: Liver Embolization Approaches for Tumor Management - Retrospective and Prospective Analysis of the Short-, Medium-, and Long-term Clinical Course of Patients Subjected to Embolization Treatment for Primary and Secondary Liver Neoplasms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Cholangiocarcinoma
Metastatic Colon Cancer
Metastatic Cancer
Metastatic Gastric Cancer
Primary Liver Cancer
Metastatic Pancreatic Cancer
Keywords: embolization, TAE, TACE, TARE, PVE, HVE
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary or secondary liver tumors

Brief summary: The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 yoa
* patients with patients with primary or secondary liver disease not amenable for surgery or ablation
* patients with primary or secondary liver tumors candidates for major surgery prior to induction of hypertrophy
* able and willing to sign informed consent

Exclusion Criteria:

* pregnant women
* patients with uncorrectable coagulopathy
* diffuse extrahepatic disease
* for lobar TACE and TARE - presence of bilodigestive shunt
* for TARE - \>20% hepatopulmonary shunt

Primary outcomes:
measure: Progression free survival
timeFrame: Short term (3-6 months)
measure: Progression free survival
timeFrame: From time of intervention up to 1 year (medium term)
measure: Progression free survival
timeFrame: From time of intervention up to 5 years (Long term)
measure: Residual hepatic volume
timeFrame: within 40 days of procedure
Secondary outcomes:
measure: Overall survival
timeFrame: From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT02945124: Taping for Children With and Without Movement Clumsiness
Official title: The Effects of K-Tape on Walking Pattern, Muscle Activity, and Motor Performance in Children With and Without Developmental Coordination Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Coordination Disorder
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effects of K Tape on walking pattern, muscle activity and motor performance in children with and without developmental coordination disorder (DCD).


Eligibility criteria: Inclusion Criteria:

* Children with DCD and typically developing children will need to score \<16 percentile and \>25 percentile, respectively, on MABC-2
* Study in mainstream schools
* No intellectual disabilities

Exclusion Criteria:

* Subjects who are receiving regular treatments
* Demonstrate excessive disruptive behaviour
* Unable to follow instructions
* Any diagnosis of neurological, musculoskeletal or cognitive disorder that affects test performance

Primary outcomes:
measure: Change in lower limb muscle activation as measured by electromyography
timeFrame: Day 1 and day 2 (ms)
Secondary outcomes:
measure: Change in balance performance as measured by force plate
timeFrame: Day 1 and day 2
measure: Foot posture as assessed by clinical observation
timeFrame: Day 1 and Day 2
measure: Body composition as assessed by DXA
timeFrame: Day 1 and Day 2
measure: Change in walking pattern as assessed by a motion analysis system
timeFrame: Day 1 and day 2
Other outcomes:
Locations:
city: Pokfulam
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Siu Ming Fong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fong SSM, Ng SSM, Guo X, Wang Y, Chung RCK, Stat G, Ki WY, Macfarlane DJ. Deficits in Lower Limb Muscle Reflex Contraction Latency and Peak Force Are Associated With Impairments in Postural Control and Gross Motor Skills of Children With Developmental Coordination Disorder: A Cross-Sectional Study. Medicine (Baltimore). 2015 Oct;94(41):e1785. doi: 10.1097/MD.0000000000001785.
Clinical trial NCT02586324: Comparison of Two Embryo Culture Media for IVF and ICSI
Official title: Comparison of Two Embryo Culture Media for IVF (in Vitro Fertilization) and ICSI ( Intracytoplasmic Sperm Injection ): Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Culture, ICSI, IVF
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this research, the two media used are Global medium and SSM medium with serum), which are routinely used in the reproduction biology unit. This study simply consists in setting up a methodology to compare these to media. The only constraint placed on patients is to accept randomization for the type of medium used.


Eligibility criteria: Inclusion Criteria:

* Any IVF and IVF with ICSI procedure performed in the unit can be included in the study

Exclusion Criteria:

* refusal of patients to be randomized. In this case, the biologist chose the medium to be used and the IVF procedure will not be included in the statistical analysis

Primary outcomes:
measure: Rate of pregnancies and deliveries
timeFrame: Up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03588624: Study of the TearCare System in Dry Eye Disease
Official title: Study of the TearCare System in Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease.

NOTE: All sites have been selected for this study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with dry eye disease
* Signs and symptoms of dry eye disease
* Best corrected visual acuity 20/100 or better
* Willing and able to comply with study procedures
* Willing and able to provide consent

Exclusion Criteria:

* Active ocular infection or inflammation
* History of eyelid, conjunctiva or corneal surgery within the past year.
* Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
* Contact lens wearer
* Significant ocular surface or eyelid abnormalities, recent ocular trauma
* Certain corneal surface abnormalities
* Use of medications for treatment of dry eye or medications that cause dry eye
* Systemic disease that results in dry eye

Primary outcomes:
measure: Change in Tear Break-up time from baseline to 1 month
timeFrame: 1 month
Secondary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI) score from baseline to 1 month
timeFrame: 1 month
measure: Change in Meibomian gland secretion score from baseline to 1 month
timeFrame: 1 month
measure: Change in Cornea staining score from baseline to 1 month
timeFrame: 1 month
measure: Change in Conjunctival staining score from baseline to 1 month
timeFrame: 1 month
measure: Device-related adverse events
timeFrame: 1 month
measure: Change in best spectacle-corrected visual acuity from baseline to 1 month
timeFrame: 1 month
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Institute
state: California
city: Lexington
country: United States
facility: Kentucky Eye Institute
state: Kentucky
Study officials:
References:
Clinical trial NCT05290324: Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery
Official title: Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery bypass graft
midazolam
propofol
Lead sponsor: Chaudhry Pervaiz Elahi Institute of Cardiology
Sponsor class: OTHER_GOV
First posted: 2022-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Radomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Propofol and midazolam are used frequently as sedating agents among patients who undergo coronary artery bypass graft surgery but no study in Pakistan has been done to compare their effectiveness aiming early extubation.

Detailed description: Propofol is an intra lipid and alkali phenol chemically it is unrelated to sedative agents or anaesthetic. Midazolam is a banzodiazepen. Most of its properties are similar to diazepam. It is a common practice to use sedatives to provide comfort and decrease "ventilator-asynchrony" in critically ill patients that may require prolonged invasive mechanical ventilation. The other reason to employ sedatives is to reduce the anxiety associated with the inaviseve procedures routinely conducted in the ICU.

Eligibility criteria: Inclusion Criteria:

* Patients of American Society of Anesthesiologists (ASA) III who were selected for coronary artery bypass graft surgery.

Exclusion Criteria:

* History of any psychiatric disease.
* Using antidepressants
* Alcohol abusers
* Obese
* Pregnant women

Primary outcomes:
measure: Duration of post-surgery sedation
timeFrame: Time in minutes calculated from end of surgery to the time of awakening up to 24 hours in both study groups
measure: Time taken to post-surgery extubation
timeFrame: Time taken in minutes from the end of the cardiac surgery to post-surgery extubation up to 1 week duration in both study groups
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Ch. Pervaiz Elahi Institute of Cardiology
state: Punjab
Study officials:
affiliation: Ch. Pervaiz Elahi Institute of Cardiology, Multan, Pakisan
name: Shumaila Rai, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02739334: PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers
Official title: PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a childhood obesity prevention program, will have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators hypothesize that the children participating in the intervention will have significantly lower BMI z-scores, lower intake of sugar sweetened beverages, and increased number of servings of fruits and vegetables, and minutes of physical activity.


Eligibility criteria: Inclusion Criteria:

* child is 2 - 3 years at the time of enrollment
* child is \>85th percentile for BMI
* ability of the parents to speak and read in English at the 4th grade level
* provide primarily in-home care for the children at the time of enrollment
* child is Medicaid eligible

Exclusion Criteria:

* acute secondary complications of obesity for child (e.g., severe respiratory insufficiency)
* child with endocrine abnormalities
* child with severe obesity (\>99.5th BMI percentile)
* children who have participated in an obesity treatment program within the past year
* parent with significant sensory impairments (e.g. deaf, blind)
* parent with BMI \>40.0

Primary outcomes:
measure: change in child Body Mass Index
timeFrame: baseline and 10 weeks
Secondary outcomes:
measure: change in intake of servings of sugar sweetened beverages for the child as assessed using 24 hour parent-reported recalls
timeFrame: baseline and 10 weeks
measure: change in total intake of servings fruits and vegetables for the child as assessed using 24 hour parent-reported recalls
timeFrame: baseline and 10 weeks
measure: change in daily minutes of physical activity for the child as assessed using accelerometers
timeFrame: baseline and 10 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shreela Sharma, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00372034: The Effect of Punctal Plugs on Tear Volume and Osmolality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: contact lenses
intolerance
punctal plugs
tear volume
Intolerance to contact lens wear due to dryness symptoms
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2006-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.

Detailed description: 50% of contact lens wearers have dryness/discomfort during contact lens wear. Significant decreases in lipid layer and tear film break up time during contact lens wear have been reported, leading to excessive evaporation, reduced tear volume and an increase in osmolality.

Similar tear film changes occur with Dry Eye Disease. A commonly used therapy in treating dry eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms. Punctal plugs block the tear drainage system, and often increase tear stability, and improve ocular surface health.

This study will evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity. Collagen punctal plugs will be used for this study, as these allow a temporary (3-14 days) occlusion of the ocular drainage system, are easily removed if necessary and are inserted with minimal risk.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* Corneal refractive surgery
* Contraindications to contact lens wear
* Latex allergy
* Corneal hypoesthesia
* Active corneal infection
* Acute or sub-acute inflammation or infection of the anterior chamber of the eye

Primary outcomes:
measure: Ocular comfort after 6 hours of contact lens wear
measure: Dryness sensation after 6 hours of contact lens wear
measure: Tear film volume before and after 6 hours of contact lens wear
Secondary outcomes:
measure: Objective ocular sensitivity after 6 hours of contact lens wear
measure: Tear film and contact lens osmolality after 6 hours of contact lens wear
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Vision CRC, Institute for Eye Research, School of Optometry and Vision Science
state: New South Wales
Study officials:
affiliation: VisionCRC, School of Optometry and Vision Science, Institute for Eye Research
name: Ulrike Stahl, Dipl-Optom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06970834: Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients
Official title: Using Continuous Glucose Monitoring Tools to Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: bitter melon peptides
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University, Taiwan
First posted: 2025-05-14
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 160 diabetic patients on Metformin monotherapy will be recruited and randomized into either the bitter melon peptide group or the placebo group for a 12-week clinical intervention
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn the potential of bitter melon peptides in stabilizing blood glucose in diabetic adults. It will also learn about the effects of bitter melon peptides on metabolic parameters. The main questions it aims to answer are:

* the regulatory effects of bitter melon peptides on glycemic variability
* impact on glycemic and metabolic indicators Researchers will compare bitter melon peptides to a placebo (a look-alike capsule that contains Microcrystalline Cellulose) to see if bitter melon peptides works to stabilizing blood glucose.

Participants will:

* Take bitter melon peptides or a placebo every day for 12 weeks
* Visit the clinic on day 0, day 7, day 28 and day 84 for checkups and tests
* Glucose levels were monitored continuously by CGMs in the first 7 days and fasting blood samples were drawn at first visit (day0), third visit (day 28) and fourth visits (day 84)


Eligibility criteria: Inclusion Criteria:Participants were diagnosed with type 2 DM based on criteria recommended by the American Diabetes Association and required to have fasting plasma glucose of ≥126 mg/dl or an HbA1c of

≥ 6.5%, as measured on two separate occasions

Exclusion Criteria:cancer, active liver disease, current pregnancy , acute illness and autoimmune thyroid disease.

Primary outcomes:
measure: glycemic variability
timeFrame: From enrollment (day0) to day7
Secondary outcomes:
measure: glycemic control
timeFrame: From enrollment (day0) to the end (day84)
Other outcomes:
measure: metabolic indicator
timeFrame: From enrollment (day0) to the end (day84)
Locations:
Study officials:
References: