louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03497169: Bariatric Surgery and Pharmacokinetics of Lisdexamphetamine
Official title: Bariatric Surgery and Pharmacokinetics Lisdexamphetamine: BAR-MEDS Lisdexamphetamine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Lisdexamfetamine Dimesylate
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-04-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lisdexamphetamine are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Lisdexamphetamine concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03888469: Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1
Official title: Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Myopia
Keywords: Visual acuity
VA
Daily disposable contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-03-25
Enrollment: 92
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 was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Acuvue Moist contact lenses.

Detailed description: Subjects were expected to attend 3 study visits and wear study lenses for approximately 14 - 20 days (7 - 10 days for each product).

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
* Willing and able to attend all scheduled study visits as required per protocol.
* Current wearer of spherical soft contact lenses.

Key Exclusion Criteria:

* Any ocular condition that contraindicates contact lens wear.
* Previous or current habitual wearer of ACUVUE® MOIST or DAILIES TOTAL1® contact lenses.

Primary outcomes:
measure: Least Squares Mean Distance Visual Acuity With Study Lenses
timeFrame: Day 8, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Alcon Investigative Site
state: Florida
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
city: Orlando
country: United States
facility: Alcon Investigative Site
state: Florida
city: Powell
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
Study officials:
affiliation: Alcon Research
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT01079169: Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation
Official title: Evaluation of the Effect of Cranberry Capsules on the Occurrence of Urinary Tract Infections During Post-acute Rehabilitation of Spinal Cord Injured Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Urinary Tract Infection
Rehabilitation
Keywords: urinary tract infection
prevention
rehabilitation
spinal cord injury
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 3
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to establish whether cranberry capsules reduce rates of urinary tract infections during initial rehabilitation immediately after spinal cord injury.


Eligibility criteria: Inclusion Criteria:

1. Previously essentially healthy
2. Newly acquired spinal cord injury, T12 level or higher
3. Receiving in-patient care on the rehabilitation ward.
4. Expected admission duration \>= 4 weeks
5. 16 years old or older

Exclusion Criteria:

1. Current or previous disorder that increases the risk of urinary tract infection including diabetes, urological disorder, previous operation on urinary tracts or kidneys, immune dysfunction
2. Severe head injury with impairment of cognitive function
3. Allergy to cranberry
4. Renal failure
5. Warfarin (Coumarin) treatment with unstable INR
6. Current symptomatic urinary tract infection

Primary outcomes:
measure: Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation
timeFrame: At end of study
Secondary outcomes:
measure: Percentage of in-patient rehabilitation days on which patients were unable to participate in active rehabilitation due to urinary tract infection.
timeFrame: At end of Study
measure: Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.
timeFrame: At end of study
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Dept of Rehabilitation Medicine, University Hospital
Study officials:
affiliation: University Hospital Uppsala
name: Alison K Godbolt, MbChB MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04148469: Dry Needling Effectiveness and Post-punction Pain
Official title: Benefits and Harms of Dry Needling vs Transcutaneous Nerve Stimulation and Dry Needling in Patients With Chronic Myofascial Neck Pain and Relationship With Psychological Influences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Miofascial pain syndrom.
Trigger point.
Dry needling.
Transcotaneous Nerve Stimuilation.
Hipoalgesia
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this estudy was to dertermine if the application of Transcutaneous Nerve Stimiulation (TENS) current have an hypoalgesic effect on pattientes suffering from miofascial neck pain, compared with a only dry needling treatment. Psicological varaibles were also mesured in order to determine how they change after each treatment.

Detailed description: All patients suffered from mechanical neck pain and were randomized into three groups of treatment. A doible blinded control was carryed out. The main outcome messures were Visual Analogue Scale (VAS). The scondary outcome messures were Pressure Pain hreshold (PPT) and Active Range of Movement (ROM). Also psicologicla messures were taken, like Neck Dissability Index, Level of stress and ansiety, Fear Pain and Pain Avoidance Strategies.

Eligibility criteria: Inclusion Criteria:

* Mechanical Neck pain of at least 6 months.
* VAS 2 or greather.
* Existance of miofascial trigger point in trapezius muscle assesed by an expert PT.

Exclusion Criteria:

* Neck pain due secondary to ostheoporosis, metastasis, neoplasias, fractures, infections, cervical stenosis or infexious procces.
* Headache secondary to medular compression presenting one o the following signs: abnormal sensitivity, hiperreflexia, clonus, spread weakness, cervical hernia.
* Neck pain with radiculopathy.
* Whiplash.
* Vertebrobasilar syndrome.
* Dizzyness.
* Pregnancy.
* Having received dry needling treatment before.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Patients will be reassed in four days.
Secondary outcomes:
measure: Active Cervical Range of Movement
timeFrame: Patient will be reassed in four days.
measure: Pressure Pain Threshold
timeFrame: Patients will be reassed in four days.
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universitdad Rey Juan Carlos
name: Jose Vicente León Hernández, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205669: Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
Official title: A Randomized Controlled Trial Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scabies
Households
Lead sponsor: Centre de Recherche Médicale de Lambaréné
Sponsor class: OTHER
Collaborators: name: Bernhard Nocht Institute for Tropical Medicine
name: University Hospital Tuebingen
name: Medical University of Vienna
First posted: 2019-12-19
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study therefore compares these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné and surroundings in Gabon.

Subjects presenting with uncomplicated scabies are randomized into either the Individual Treatment group, where only the affected subjects receive treatment, or the Household Treatment group, where all family members are treated in parallel to the affected subjects regardless of signs and symptoms. The primary endpoint is clinical cure after 28 days; the secondary endpoint is the proportion of affected household members per household after 28 days.


Eligibility criteria: Inclusion Criteria:

* diagnosed with active, uncomplicated scabies
* no known hypersensitivity or allergy against benzyl benzoate

Exclusion Criteria:

* hypersensitivity or allergy against benzyl benzoate
* severe superinfection of scabies lesions

Primary outcomes:
measure: Number of Participants With Clinical Cure
timeFrame: after 28 days from baseline
Secondary outcomes:
measure: Proportion of Affected Household Members Per Household
timeFrame: after 28 days from baseline
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Centre de Recherches Médicales de Lambaréné
Study officials:
References:
citation: Matthewman J, Manego RZ, Dimessa Mbadinga LB, Sinkovec H, Volker K, Akinosho M, Haedrich C, Tardif d'Hamonville J, Lell B, Adegnika AA, Ramharter M, Mombo-Ngoma G. A randomized controlled trial comparing the effectiveness of individual versus household treatment for Scabies in Lambarene, Gabon. PLoS Negl Trop Dis. 2020 Jun 26;14(6):e0008423. doi: 10.1371/journal.pntd.0008423. eCollection 2020 Jun.
Clinical trial NCT05694169: A Study of Participants With Chronic Kidney Disease Previously Treated With REACT
Official title: A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetic Kidney Disease
CAKUT
Chronic Kidney Diseases
Keywords: REACT
CAKUT
DKD
Lead sponsor: Prokidney
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 1
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.

Detailed description: A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.

Eligibility criteria: Inclusion Criteria:

1. The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.
2. The participant is male or female, 30 to 80 years of age on the date of informed consent.
3. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.
4. The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.

Exclusion Criteria:

1. The participant has a history of renal transplantation.
2. The participant has received dialysis for more than 30 days.
3. The participant has received any other investigational products after completion of REACT injections within 3 months of screening.
4. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.
5. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.

Primary outcomes:
measure: Primary Endpoints is as follows:
timeFrame: through 12 months after last supplemental injection
Secondary outcomes:
measure: First Secondary Endpoint
timeFrame: 12 months after the last supplemental injection
measure: Second Secondary Endpoint
timeFrame: 12 months after the last supplemental injection
Other outcomes:
Locations:
city: Boise
country: United States
facility: Boise kidney and Hypertension Institute
state: Idaho
Study officials:
affiliation: Prokidney
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02273869: Assessment of Ovarian Reserve in Women With Rheumatologic Diseases
Official title: The Influence of Rheumatologic Diseases on Fertility and Ovarian Reserve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatologic Diseases
Ovarian Reserve
Infertility
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in reproductive age with rheumatoligic disease

Brief summary: Our infertility unit has started a clinic for women with rheumatological diseases. those women are prone to infertility problems and it might be due to their illness or cytotoxic treatment . In our study we are going to observe the effect of their disease on ovarian reserve. we will assess it by using intravaginal sonography and blood test such as hormonal profile and anti-mullerian hormone (AMH).


Eligibility criteria: Inclusion Criteria:

* Rheumatologic disease

Exclusion Criteria:

* none

Primary outcomes:
measure: hormone profile
timeFrame: 4 years
measure: antral follicular count
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Sapir Medical Center, Meir Hospital
Study officials:
References:
Clinical trial NCT00998569: Neurocognitive Enhancement in Major Depressive Disorder
Official title: Neurocognitive Enhancement in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 examine the effects of neurocognitive enhancement on cognitive abilities and related social and adaptive behaviours in individuals diagnosed with major depressive disorder. Subjects in this study will be randomized to receive Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET . Secondary aims include examining whether the cognitive benefits are potentiated by repeated exposure during in-home practice with complementary exercises. Additionally, the investigators will examine the durability of the effects and their generalization to functional capacity and everyday functional performance after completion of the groups.


Eligibility criteria: Inclusion Criteria:

1. Male or Female.
2. Subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data.

Exclusion Criteria:

1. Presence of a medical diagnosis that is associated with known cognitive impairments, such as multiple sclerosis, cerebrovascular accident, dementia, or history of traumatic brain injury.
2. Subjects with a reading level below grade 6, as assessed with the Wide Range Achievement Test - Reading Recognition Subtest, will be excluded because of the likelihood of not understanding task instructions.
3. Subjects with uncorrectable vision or hearing impairment that would preclude valid assessments or intervention procedures.

Primary outcomes:
measure: Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Christopher Bowie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00654069: Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of the Safety and Efficacy of Acuroc Tablets Following Bunionectomy Surgery in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Pain
Lead sponsor: Acura Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 405
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 purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.

Detailed description: This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery.

Patients underwent a primary unilateral first metatarsal bunionectomy with or without ipsilateral hammer toe repair during standardized local anesthesia with intravenous (IV) sedation. Eligible patients who reported moderate or severe pain within 6 hours after surgery entered the Treatment Phase and were randomized to 1 of 3 double blind treatments: placebo tablets or 1 of 2 dose levels of Acurox™ Tablets (ocyxcodone HCl/niacin). The Treatment Phase continued with study medication every 6 hours (irrespective of rescue medication use) for 48 hours (8 doses of study medication). Toradol (ketorolac tromethamine) was available as a rescue medication upon request.

Eligibility criteria: Inclusion Criteria:

* Patient is male or female at least 18 years of age
* For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Patient is scheduled to have a bunionectomy
* Patient must be willing to stay at the study site for at least 48 hours from the initial dose of study medication post-surgery

Exclusion Criteria:

* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen
* Patient is hypersensitive to any of the medications to be used in the study
* Patient has taken another investigational drug within 30 days prior to Screening

Primary outcomes:
measure: SPID48
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Daniels SE, Spivey RJ, Singla S, Golf M, Clark FJ. Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery. Curr Med Res Opin. 2011 Mar;27(3):593-603. doi: 10.1185/03007995.2010.548291. Epub 2011 Jan 13.
Clinical trial NCT03788369: Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization
Official title: Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization, a Non-randomized, Prospective, Open-label Registry in Real-world Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Percutaneous Coronary Revascularization
Coronary Stenosis
Coronary Artery Disease Progression
Coronary Artery Bypass Grafting
Keywords: Hybrid coronary revascularization
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2018-12-27
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)

Brief summary: This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in real-world practice.


Eligibility criteria: Inclusion Criteria:

* Age 20 and more
* Hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)
* Written consent

Exclusion Criteria:

* Previous CABG(coronary artery bypass graft)
* Life expectancy ≤1 year

Primary outcomes:
measure: a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.
timeFrame: 5 years
Secondary outcomes:
measure: All death
timeFrame: 5 years
measure: Cardiac death
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 5 years
measure: a composite event of all death or myocardial infarction
timeFrame: 5 years
measure: a composite event of cardiac death or myocardial infarction
timeFrame: 5 years
measure: TVR(Target Vessel Revascularization)
timeFrame: 5 years
measure: TLR(Target Lesion Revascularization)
timeFrame: 5 years
measure: Stent thrombosis
timeFrame: 5 years
measure: Cerebrovascular event
timeFrame: 5 years
measure: Procedural success
timeFrame: 5 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: