louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06304389: Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Official title: Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Epilepsy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with refractory epilepsy (divided in non responders \& responders), and healthy subjects
Primary purpose: BASIC_SCIENCE

Brief summary: Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.


Eligibility criteria: Inclusion Criteria:

Patients:

VNS implanted since at least 3 months age \>18-60 years; IQ \>55 on Wechsler scale (normal status or mild cognitive impairment)

healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease)

Exclusion criteria:

Patients:

other medical implanted devices than VNS, ocular diseases

Helthy participants:

medical implanted devices, cerebral trauma, ocular disease

Primary outcomes:
measure: Effect of blue light on VNS biomarkers
timeFrame: 4 years
measure: Effect of blue light on VNS biomarkers
timeFrame: 4 years
measure: Effect of blue light on VNS biomarkers
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
References:
Clinical trial NCT00143689: NRTI-Sparing Pilot Study
Official title: A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Mitochondrial Toxicity
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Abbott
name: Boehringer Ingelheim
name: CIHR Canadian HIV Trials Network
First posted: 2005-09-02
Enrollment: 13
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 study will compare a nucleoside reverse transcriptase inhibitor-sparing (NRTI-sparing) regimen (Kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based regimens (Combivir + nevirapine and Combivir + Kaletra).

Participants will be randomly assigned to receive one of the following drug combinations:

* lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;
* Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;
* Combivir and lopinavir/ritonavir twice a day.


Eligibility criteria: Inclusion Criteria:

* Be HIV-positive
* Be at least18 years of age
* Have viral load above 5 000 copies/ml
* Be likely to comply with the study protocol
* Agree not to take, for the duration of the study, any drug that is contraindicated with the study drugs
* Agree not to take any medication, including over-the-counter medicine, alcohol, or street drugs without the knowledge and permission of the principal investigator

Exclusion Criteria:

* Have ever received antiretroviral therapy
* Pregnancy or breastfeeding
* Have abnormal laboratory tests (see investigator)
* Have received an investigational drug within 30 days of study drugs administration
* Be receiving systemic chemotherapy
* Have an acute illness

Primary outcomes:
measure: Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.
timeFrame: 48 weeks
Secondary outcomes:
measure: Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks
timeFrame: 96 weeks
measure: Proportions of patients with viral load below 50 and below 400 copies/mL
measure: Viral load changes from baseline
measure: Rates and extent of immune reconstitution (CD4 count increase)
measure: Rates and severity of dyslipidemia and insuline resistance/diabetes
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Health Services
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Clinic
state: Ontario
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuel
state: Quebec
Study officials:
affiliation: University of British Columbia/Providence Health Care
name: Julio Montaner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06253689: Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair
Official title: Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Constipation
Pelvic Organ Prolapse Vaginal Surgery
Defecation Function
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel movement following pelvic reconstructive surgery, specifically posterior repair.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery by one of the sub investigators including a posterior compartment repair

Exclusion Criteria:

* Anyone currently using a defecation posture modification device
* Unwillingness or unable to participate in the study
* Presence of ileostomy/colostomy
* Wheelchair bound
* Device may pose fall or safety hazard risk to patient
* Patients weighing over 250 lbs, as per device manufacturer guidelines
* Inability to understand English
* Pregnant women

Primary outcomes:
measure: Straining with first postoperative bowel movement
timeFrame: 1 week
Secondary outcomes:
measure: postoperative stool consistency
timeFrame: 1 week
measure: Time to first bowel movement
timeFrame: 1 week
measure: pain with postoperative bowel movements
timeFrame: 1 week
measure: Postoperative use of laxatives and pain medication
timeFrame: 1 week
measure: Satisfaction with device and ease of use
timeFrame: 1 month
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT05724589: The Effectiveness of Epidermal Growth Factor Serum in Improve Facial Skin Hydration, Elasticity, Pigmentation, and Wrinkles.
Official title: The Effectiveness of Epidermal Growth Factor Serum for the Improvement of Facial Skin Hydration, Elasticity, Pigmentation, and Wrinkles at the Institute of Dermatology: a Single-centered Pilot Study With a One-group Before-and-after Design
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging
Lead sponsor: Institute of Dermatology, Thailand
Sponsor class: OTHER_GOV
First posted: 2023-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: EGF is a polypeptide that promotes cell differentiation and collagen production while decreasing melanin production. This study is designed to study its effectiveness in improving the texture and appearance of facial skin after daily topical application. We hypothesized that EGF would improve facial skin hydration, elasticity, pigmentation, and wrinkles.

Detailed description: All patients gave written informed consent for epidermal growth factor serum application on the face. The pilot study enrolls thirty patients compared to pre and post-serum used to evaluate facial skin hydration, transepidermal water loss, elasticity, pigmentation, and wrinkles measured by corneometer, tewameter, cutometer, visioscan, and mexameter respectively on day 0, then 8, 12, and 16 weeks. The study evaluates subject satisfaction and side effects after serum application as secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Thai
* Mild to moderate facial skin condition, as measured by 1-2 points on the hyperpigmentation status scale or 2-3 points on the wrinkle severity grading scale.

Exclusion Criteria:

* Use of lotions or skin care products containing ingredients such as vitamin A/C, hydroquinone, or anti-aging agents.
* Sunbathing
* Hypersensitivity to serum components
* Pregnancy and breast-feeding
* Active skin diseases such as eczema or atopic dermatitis at the application site

Primary outcomes:
measure: Facial skin hydration
timeFrame: 4 months
measure: Transepidermal water loss
timeFrame: 4 months
measure: Facial skin elasticity
timeFrame: 4 months
measure: Facial skin wrinkles
timeFrame: 4 months
measure: Facial skin pigmentation
timeFrame: 4 months
measure: Overall facial skin photograph
timeFrame: 4 months
Secondary outcomes:
measure: Subject satisfaction in improving skin hydration, elasticity, wrinkles, and pigmentation
timeFrame: 4 months
measure: Adverse effects
timeFrame: 4 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Institute of Dermatology
Study officials:
affiliation: Institute of Dermatology
name: Chumsaeng Chumsaengsri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832689: Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Cancer
Keywords: toxicity
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 39
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local control of cancer and prolong survival in patients with inoperable biliary tract cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed inoperable biliary tract cancer
* Age: 18 \~75 years old
* Performance status: ECOG 0-2
* Hematopoietic:

  * Granulocyte count at least 1,500/mm3
  * Platelet count at least 100,000/mm3
* Hepatic:

  * Bilirubin No greater than 2 fold the upper normal limit
  * AST/ALT : No greater than 3 fold the upper normal limit
* Renal:

  * Creatinine - no greater than 1.5 mg/dL
* Not pregnant
* No other serious medical or psychiatric illness that would preclude giving informed consent or limit
* No prior chemotherapy within 6 months
* No other concurrent anticancer radiotherapy within 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Assistant professor of division of Gastroenterology
name: Jeong Youp Park, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00944892: A Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee
Official title: A Randomized,Double Blind,Placebo-controlled,Parallel Group,Repeat Dose Study of the Safety and Efficacy of REGN475 in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis of the Knee
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2009-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 4 treatment arms (3 active and 1 placebo).

Each patient will receive two doses of active medication or placebo, with study drug administered intravenously (IV). The primary goal of the study is to assess the safety and tolerability of repeat administrations of REGN475 compared to placebo in patients with osteoarthritis (OA) of the knee.


Eligibility criteria: Inclusion Criteria:

1. Men and women ≥ 40 and ≤ 75 years of age.
2. Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.
3. Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.

Exclusion Criteria:

1. Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.
2. Patients with joint replacement in the affected knee.
3. Patients with peripheral neuropathy due to any reason.

Primary outcomes:
measure: The incidence of TEAEs in patients treated with REGN475 or placebo, reported between administration of study drug on Day 1 and the completion of study at the end of week 24 (Day 169).
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC) (total score as well as all 3 subscales: pain, stiffness and function).
timeFrame: 24 weeks
measure: Patient assessment of response to treatment over time using the Patient Global Impression of Change.
timeFrame: 24 weeks
measure: Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Salt Lake City
country: United States
state: Utah
Study officials:
References:
Clinical trial NCT00222092: Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers
Official title: Effect of Octreotide, Somatostatin, Pentoxyfilline or Placebo in the Prevention and the Course of Post-ERCP Pancreatitis and Study of Molecular Markers in Post-ERCP Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-ERCP Acute Pancreatitis
Keywords: post-ERCP pancreatitis
prophylaxis
prognosis
natural course
molecular markers
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing endoscopic retrograde cholangiopancreatography

Brief summary: Octreotide, somatostatin and pentoxyfilline commercially available drugs that are used in various clinical situations. They are safe and known for years. Octreotide and somatostatin have been used in many studies for the prophylaxis and treatment of pancreatitis and post-ERCP pancreatitis, while pentoxyfilline has shown effect on patients with alcoholic hepatitis, obstructive vasculitis etc. The aim of the study is to evaluate the efficacy of any of those treatments for the prophylaxis and treatment of post-ERCP pancreatitis. In addition some molecular markers of acute and chronic inflammation will be measured before and after the endoscopic procedures according to the study protocol.


Eligibility criteria: Inclusion Criteria:

* patients undergoing endoscopic retrograde cholangiopancreatography

Exclusion Criteria:

* children, pregnant or breastfeeding women
* patients with coagulation disorders
* inability to access the papilla of Vater due to technical difficulties (previous surgery, malignant obstruction)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Hepato-Gastroenterology Unit, Medical School of Ioannina - Greece
Study officials:
affiliation: University of Ioannina
name: Dimitrios Sigounas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06009692: Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome
Official title: Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pronator Teres Syndrome
Keywords: Upper limb functions
Neurodynamics
Pronator Teres Syndrome
Task Oriented training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and sensory functions and to compare the effects of slider versus tensioner neuro-dynamic techniques on upper limb motor and sensory functions in pronator teres syndrome.

Detailed description: The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and sensory functions and to compare the effects of slider versus tensioner neuro-dynamic techniques on upper limb motor and sensory functions in pronator teres syndrome.

Pronator teres syndrome is a rare condition and easily overlooked and mistaken for the more prevalent carpal tunnel syndrome. The median nerve may also be squeezed between the heads of the pronator teres muscle in addition to the carpal tunnel. Patients report pain, numbness, or paresthesia over the lateral 3.5-digit area and anterior forearm, which worsens with forced pronation. This condition is most common in the dominant hand or sometimes can be associated with advanced forearm muscle.in our routine clinical practice, The neuro-dynamic techniques is not that common in neurological physical therapy practice so the effects of neuro -dynamics with conventional therapy needs to be evaluated for better outcomes in upper limb functions.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with pronator teres syndrome
* At least 6 working hours/ day
* Positive Tinel's sign at pronator area (Hoffman's sign)
* Positive Pronator teres syndrome test

Exclusion Criteria:

* Any previous history of metabolic disease, liver disease/ diabetes
* History of previous injuries to the cervical spine including radiculopathies and myelopathies as well as spinal stenosis and/or spinal disc herniation

Primary outcomes:
measure: Numeric visual analogue scale (VAS)
timeFrame: 2 weeks
measure: Upper Extremity Functional Scale (UEFS)
timeFrame: 2 weeks
measure: Jamar hand held dynamometer
timeFrame: 2 weeks
measure: Range of Motion
timeFrame: 2 weeks
measure: Nottingham sensory assessment Scale
timeFrame: 2 weeks
measure: Wolf Motor Function Test
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Al-Nafees hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Abrish Habib Abbasi, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04343092: Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management
Official title: Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (An Externally Controlled Pilot Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID 19
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 16
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: Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)

Detailed description: Comparing effectiveness of single dose 0.2mg/kg Ivermectin (IVM) plus hydroxychloroquine (HCQ) 400mg BID in first day then 200mg BID for 5 days plus azithromycin (AZT) 500mg in first day then 250mg for 5 days.

The comparison group was a historical control population and data collected from the current study were compared to that historical control population

Eligibility criteria: Inclusion Criteria:

-1. Patients with age above 18 years and any gender with definite Dx of covid19 and pneumonia in the ward according to the clinical, laboratory, and imaging criteria.

2. Understands and agrees to comply with planned study procedures.

Exclusion Criteria:

1. Patients with hypersensitivity or severe adverse effects to Ivermectin
2. Renal impairment
3. Hepatic impairment.
4. Pregnancy or a desire to become pregnant (drug considered pregnancy category c)
5. Breast feeding.
6. Patient with covid 19 positive and mild no pneumonia
7. Children under the age of five or those who weigh less than 15 kilograms

Primary outcomes:
measure: Number of Cured Patients
timeFrame: 4 weeks
Secondary outcomes:
measure: Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group
timeFrame: 4 week
Other outcomes:
Locations:
city: Bagdad
country: Iraq
facility: General Directorate of Medical City
state: Baghdad
Study officials:
affiliation: University of Baghdad
name: Faiq I Gorial, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Arab Board for Health Specialiazation in Iraq
name: Jawad I. Rasheed
role: STUDY_CHAIR
References: