louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01709136: Pharmacokinetics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Tacrolimus Toxicity
Official title: Pharmacokinetics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Early Nephrotoxicity and/or Hypertension Due to Tacrolimus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Hypertension
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-10-17
Enrollment: 3
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics of Tacrolimus and Sirolimus alone and in combination in liver transplant recipients.

Detailed description: Liver transplant patients receiving tacrolimus, and who experience side effects such as hypertension and renal dysfunction, will be converted to sirolimus with low-dose tacrolimus, or Tacrolimus withdrawal. This study will evaluate allograft function by serial clinical lab testing, the pharmacokinetics of sirolimus and tacrolimus, the glomerular filtration rate (GFR) and the potential side effect of sirolimus, such as marrow suppression and hyperlipidemia. Two pharmacokinetic evaluations are planned: once around the third post-transplant month and another one at about 12 months. Expected outcomes are, a better understanding of sirolimus pharmacokinetic parameters over time in pediatric/adult liver recipients and early efficacy and safety data of the sirolimus as a non-nephrotoxic alternative to tacrolimus.

Eligibility criteria: Inclusion Criteria:

* Recipients of primary liver (cadaver/liver, whole/segmental) transplants 5- 30 years old.
* Rejection-free post-transplant course for at least 3 months
* Renal dysfunction (15% decrease in age-adjusted calculated creatinine clearance)
* Hypertension requiring anti-hypertensive mediations.
* Informed consent.
* Weight ≥15 kg.

Exclusion Criteria:

* Rejection or infections within 3 months of enrollment.
* Intent to continue TAC
* Active participation in ongoing studies of immunosuppressive agents.
* Lack of informed consent.
* Pregnant or breast feeding
* HIV positive

Primary outcomes:
measure: Early and Late Pharmacokinetics of Sirolimus (SRL)
timeFrame: 1 year
Secondary outcomes:
measure: PK Parameters for Tacrolimus and Sirolimus
timeFrame: 12 months
measure: SRL Can Substitute TAC
timeFrame: 12 months
measure: SRL Prevent TAC-related Side Effects
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: UPitt
name: Rakesh Sindhi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06819436: Effect of Dexamethasone on Post-spinal Hypotension
Official title: Effect of Dexamethasone on Post-spinal Hypotension in Geriatric Patients Undergoing Orthopaedic Surgery at Tertiary Care Hospital Karachi.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post Spinal Anaesthesia Hypotension
Geriatric Population
Orthopedic Surgeries
Lead sponsor: Shaheed Mohtarma Benazir Bhutto Institue of Trauma
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 170
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if intravenous dexamethasone is effective for prevention of post spinal hypotension in geriatric population undergoing orthopedic surgeries. The main question aim to answer is:

Does intravenous dexamethasone in participants undergoing orthopedic procedures of lower limb under spinal anesthesia prevents post spinal hypotension? Researchers are comparing two groups of participants

* Participants in (Dexamethasone Group) Group D are receiving intravenous dexamethasone 8mg preoperatively
* Participants in (Placebo Group) Group P are receiving placebo preoperatively.


Eligibility criteria: Inclusion Criteria:

Patient undergoing orthopedic surgery in spinal anesthesia. ASA ≤ 2.

Exclusion Criteria:

Patients with history of cardiac arrhythmias. Patients with history of acute coronary syndrome. Patient with history of polytrauma. Patients with contraindication to SA (e.g., coagulopathy, thrombocytopenia, allergy to local anesthetic agent) and those on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor) will be excluded.

Primary outcomes:
measure: Post spinal Anesthesia Hypotension
timeFrame: From enrollment to 30 minutes after spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Shaheed Mohtarma Benazir Bhutto Institute of Trauma
state: Sindh
Study officials:
References:
Clinical trial NCT06974136: tES Modalities for the Treatment of ADHD
Official title: Transcranial Electrical Stimulation Modalities for the Treatment of Clinical Symptoms and Cognitive Deficits in Attention-deficit Hyperactivity Disorder Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Neurodevelopmental Disorders
Lead sponsor: The National Brain Mapping Laboratory (NBML)
Sponsor class: OTHER
Collaborators: name: Leibniz Research Centre for Working Environment and Human Factors
name: RWTH Aachen University
name: Institute for Research in Fundamental Sciences
First posted: 2025-05-15
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project investigates the efficacy of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents.

Detailed description: This project aims to evaluate the therapeutic potential of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), as innovative, non-invasive interventions for managing Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. ADHD is a neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsivity that impair daily functioning. Conventional treatments, such as pharmacological interventions and behavioral therapies, may have limitations, including side effects or variable efficacy, prompting the exploration of neuromodulation techniques like tES.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ADHD by a licensed psychiatrist and a behavioral checklist
* being 7-18 years old
* providing written informed consent signed by parents

Exclusion Criteria:

* comorbidity with other neurodevelopmental disorders
* Comorbidity with other neurological disorders
* previous history of neurosurgery
* Presence of any ferromagnetic metal in the head
* implanted medical devices in the head or neck region
* history of non-controlled epilepsy with seizures in the last year

Primary outcomes:
measure: ADHD symptoms- Clinical rating scale
timeFrame: Baseline, week 2, up to 1 month after the intervention
Secondary outcomes:
measure: Executive function- Performance accuracy and reaction time
timeFrame: Baseline, week 2, up to 1 month after the intervention
measure: electroencephalogram (EEG) power
timeFrame: Baseline, week 2
measure: electroencephalogram (EEG) functional connectivity
timeFrame: Baseline, week 2
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Institute for Research in Fundamental Sciences
Study officials:
References:
Clinical trial NCT01883336: Long Term Follow up of Small Non-inflammatory Pancreatic Cysts
Official title: Long Term Follow up of Small Non-inflammatory Pancreatic Cysts - a Retrospective Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cysts
Keywords: Incidental pancreatic cysts
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter referred to the University Hospital Hamburg Eppendorf, Israelitic Hospital Hamburg, Sana Klinikum Lichtenberg, Berlin and Krankenhaus Märkisch-Oderland,Strausberg.

Brief summary: This study intends to investigate the long term follow-up of small non-inflammatory pancreatic cysts.

Detailed description: This study intends to investigate the long term follow-up of small non-inflammatory pancreatic cysts in a multicenter setting.

Inclusion criteria:

Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter referred to the University Hospital Hamburg Eppendorf, Israelitic Hospital Hamburg, Sana Klinikum Lichtenberg, Berlin and Krankenhaus Märkisch-Oderland,Strausberg from 2002 to 2007 identified from EUS database.

Study design:

At least 5 year-long term follow up by inclusion of clinical data, cross sectional imaging if available or actual US findings.

Primary outcome:

To determine the proportion of patients with increase is size and/or changed appearance

Secondary outcomes:

Rate of patients undergo pancreatic surgery (indication, histology of resected specimen). Rate of patients undergo FNA (fluid analysis, cytology).

Eligibility criteria: Inclusion Criteria:

* Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter

Exclusion Criteria:

* acute or chronic pancreatitis
* pancreatic cysts \> 3 cm
* Lesion suspicious for malignancy

Primary outcomes:
measure: Progress of pancreatic cyst
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Thomas Roesch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00429936: Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Official title: A Phase II Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose-Comparison Study of the Safety and Efficacy of Fenretinide in the Treatment of Geographic Atrophy in Subjects With Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Geographic Atrophy
Dry Age Related Macular Degeneration
Keywords: Dry Age Related Macular Degeneration
Geographic Atrophy
Lead sponsor: Sirion Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ReVision Therapeutics, Inc.
First posted: 2007-02-01
Enrollment: 245
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this phase II study is to determine the efficacy of fenretinide in the treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* males or females, 50 to 89 years of age
* must have GA from AMD in one or both eyes

Exclusion Criteria:

* GA due to any disease other than AMD (eg, drug-induced)

Primary outcomes:
measure: GA lesion progression
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ReVision Therapeutics Advisor
name: Roger Vogel, MD
role: STUDY_DIRECTOR
References:
citation: Yeong JL, Loveman E, Colquitt JL, Royle P, Waugh N, Lois N. Visual cycle modulators versus placebo or observation for the prevention and treatment of geographic atrophy due to age-related macular degeneration. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD013154. doi: 10.1002/14651858.CD013154.pub2.
Clinical trial NCT06199336: A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With Moderate to Severe Glabellar Lines
Official title: A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Moderate to Severe Glabellar Lines
Keywords: Recombinant Botulinum Toxin Type A, Glabellar Lines
Lead sponsor: JHM BioPharma (Tonghua) Co. , Ltd.
Sponsor class: NETWORK
First posted: 2024-01-10
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo and active controlled
Primary purpose: TREATMENT

Brief summary: This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety, immunogenicity and efficacy of JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo and BOTOX® in moderate to severe glabellar lines.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age.
2. Moderate to severe glabellar lines at maximum frown at baseline.

Exclusion Criteria:

1. Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
2. Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
3. Suffering from any neurological disorders that increase the risk of exposure to botulinum toxin type A, including peripheral motor nerve diseases (such as amyotrophic lateral sclerosis and motor neuropathy), as well as neuromuscular junction diseases (such as Lambert-Eaton syndrome and myasthenia gravis).
4. Known allergy or hypersensitivity to any component of the study products.
5. Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
6. History of alcohol or drug abuse.

Primary outcomes:
measure: Phase1
timeFrame: Within 28 days
measure: Phase2
timeFrame: within 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT01103336: Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)
Official title: Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study): A Investigator-initiated, Control- Randomized, Phase IV Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Failure
Keywords: Patients with chronic renal failure undergoing coronary angiography
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2010-04-14
Enrollment: 173
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy in patients with renal insufficiency undergoing coronary angiography.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 20 years
* Patients undergoing elective coronary angiogram due to documented myocardial ischemia or symptoms of angina
* Estimated Cr clearance ≤60 mL/min by Cockcroft-Gault formula or serum Cr ≥1.1 mg/dL
* Signed written informed consent to participate in the study

Exclusion Criteria:

* Acute myocardial infarction requiring primary or rescue coronary intervention
* Allergic reaction to contrast dye or nicorandil
* Cardiogenic shock or significant hypotension
* Previous use of nicorandil within the preceding 7 days
* Exposure to contrast medium within the preceding 7 days
* Pregnancy or women at age of childbearing potential
* Heart failure (NYHA class III or IV; LV ejection fraction \<40% by echocardiogram)
* Acute renal failure or chronic dialysis
* Mechanical ventilation
* History of kidney transplantation
* Life expectation less than 6 months
* Previous renal artery angioplasty within the last 6 months
* Use of nonsteroidal anti-inflammatory drugs, intravenous use of diuretics, dopamine, mannitol, N-acetylcysteine, ascorbic acid or sodium bicarbonate within 48 hrs before the procedure
* Severe liver disease

Primary outcomes:
measure: Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl
timeFrame: at 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Young-Guk Ko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02827136: Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy
Official title: Ajou University School of Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Diseases
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effect of lidocaine patch on the shoulder pain score after end of surgery.

The secondary purpose of this study is to investigate the effect of lidocaine patch on the total number of analgesic request on ward.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* Infection, trauma, or bleeding on shoulder
* Allergy to lidocaine
* Chronic pain
* Renal dysfunction
* Liver dysfunction
* Seizure
* History of shoulder surgery

Primary outcomes:
measure: Shoulder pain score
timeFrame: Change from baseline shoulder pain score up to 24 hr after end of surgery
Secondary outcomes:
measure: Total number of analgesics request on ward
timeFrame: Up to postoperative day 3
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Seoum
Study officials:
References:
Clinical trial NCT00000236: Buprenorphine Pharmacology Related to Addiction Treatment - 18
Official title: Buprenorphine Pharmacology Related to Addiction Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the interactions between buprenorphine and naltrexone, and to assess how they may directly impact the clinical issues involving: transferring patients from buprenorphine to naltrexone, developing a non-abusable form of buprenorphine, and enhancing patient acceptability of naltrexone.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Opioid agonist effects
measure: Opiate withdrawal
measure: Psychological changes in: pupil diameter, blood pressure, heart rate, respiration
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04778436: Macula Evolution in Patients With AMD Taking Oral Food Supplementation
Official title: Macular Drusen Evolution in Patients With Intermediate Age-related Macular Degeneration (AMD) Taking Oral Food Supplementation: an Open-label,Single-arm Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Macular Degeneration
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: an open-label, single-arm, pilot study
Primary purpose: OTHER

Brief summary: LT7082-001 is an open-label, single-arm pilot study. Patients with intermediate age-related macular degeneration (AMD) wil take T7082 during 12 months , an association of 4 food supplementations .

The study objectives are to describe morphological changes and evolution of drusen in macula after a 12-month of food supplementation and to assess the safety of T7082


Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated
* Age ≥ 50 years old
* At least one Eligible Eye, defined by following conditions :

  1. Far Best Corrected Visual Acuity (BCVA) ≥ 75 ETDRS letters (or ≥ 20/32 Snellen equivalent)
  2. At least one drusen with a minimal diameter of 125 µM assessed by SD-OCT / intermediate age-related macular degeneration
  3. Macula sparing
  4. Clear ocular media
  5. Adequate pupillary dilation

Exclusion Criteria:

* Presence of other macular disease such as epiretinal membrane or macular telangiectasia.
* Presence of any geographic atrophy including macular region
* Any history of retina neovascularization
* Macula or retinal diseases other than age-related macular degeneration
* A concurrent ocular pathology that may contribute to vision loss (eg, choroidal neovascularization, glaucoma, visually significant cataract, optic neuropathy, history of retinal surgery) or interfere with acquisition of high-quality images
* Ocular or periocular infections
* Presence of congenital retinal pathologies that may impact data collection
* Exudative AMD

Primary outcomes:
measure: evolution of drusen in the macula
timeFrame: 2 months, 5 months 8 months and 12 months
measure: morphological changes in the macula
timeFrame: 2 months, 5 months 8 months and 12 months
measure: Treatment-Emergent Adverse events (TEAE), Serious treatment-emergent adverse events (STEAE), Treatment-Emergent Adverse Reaction (TEAR)
timeFrame: 2 months, 5 months 8 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Wilfried Roquet
Study officials:
References: