louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00906828: Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors
Official title: Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Keywords: Levodopa/carbidopa infusion
entacapone
tolcapone
efficacy
pharmacokinetic
pharmacodynamics
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Swedish Parkinson's Disease Foundation
name: Swedish Society for Medical Research
First posted: 2009-05-21
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
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 determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.

Detailed description: The aim is to measure variability in plasma levodopa levels during the following three treatments:

Day 1: Duodopa in individually optimised dose Day 2: 80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours Day 3: 80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours Plasma samples for determination of levodopa concentrations will be taken every 30 minutes during 8 hours. Video recordings will be performed every 30 min during 8 hours, for later blinded assessments by 2-3 experts. Sequences will be in randomised order. Patient self-scores regarding mobility will be recorded, every 30 min during 8 hours.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* Duodopa treatment ongoing
* Hoehn \& Yahr stage 3-5 at worst

Exclusion Criteria:

* Ongoing treatment with COMT inhibitors
* Dementia
* Psychosis
* Treatment with typical neuroleptics
* Contraindications for entacapone or tolcapone

Primary outcomes:
measure: Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.
timeFrame: 3 days
Secondary outcomes:
measure: Difference in Treatment Response Scale between the treatments.
timeFrame: 3 days
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Dag Nyholm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nyholm D. Enteral levodopa/carbidopa gel infusion for the treatment of motor fluctuations and dyskinesias in advanced Parkinson's disease. Expert Rev Neurother. 2006 Oct;6(10):1403-11. doi: 10.1586/14737175.6.10.1403.
Clinical trial NCT00367328: To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa
Official title: To Determine The Efficacy Of A 1320nm Nd: YAG Nonablative Laser For Treatment of Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Supperativa
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: CoolTouch, Inc
First posted: 2006-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A research study to determine the efficacy of a 1320 nm laser device for the treatment of hidradenitis suppurativa.

Detailed description: Hidradenitis Suppurativa is a chronic, scarring disease. The treatments available for this condition are not very effective and work only for some patients.

Recently, a 1320nm laser device has been approved by the FDA for the treatment of acne and facial rejuvenation. Given the positive results seen with the use of this laser in the treatment of acne it is reasonable to hypothesize that a similar effect may be seen with the treatment of Hidradenitis suppurativa.

The specific aim of the study is to determine the efficacy of this device for the treatment of hidradenitis suppurativa as it relates to the patient's established treatment.

The investigators are trying to determine the efficacy of a laser for the treatment of hidradenitis suppurativa.

Patients will:

* be examined and interviewed
* have photographs taken of the treatment site
* have a 4mm punch biopsy performed
* have wound culture swabs performed

Eligibility criteria: Inclusion Criteria:

* Age equal to or greater than 18 years
* General good health and willingness to participate and ability to comply with the study protocol
* Biopsy proven hidradenitis suppurativa

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Hx of collagen vascular or photosensitive disorders
* Inability to follow-up with treatments

Primary outcomes:
measure: A successful treatment is expected to improve the quality of life significantly by causing remission of disease. The data obtained from this study will also allow the development of laser-based treatment protocols for hidradenitis suppurativa.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01831193: Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease
Official title: Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Proteinuria
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 if the oral supplementation with curcumin reduces proteinuria in patients with chronic kidney disease regardless the ethiology.

Detailed description: Curcumin is a potent antioxidant found in extracts of the rhizome of the plant Curcuma longa L.

Different studies have demonstrated that curcumin has potent biological activity and therefore is an effective therapeutic agent for the treatment of various ailments.

This compound acts as a bifunctional antioxidant:

ه is capable of reacting directly with highly reactive oxygen species. ه acts indirectly by its ability to induce the expression of various cytoprotective proteins through Keap1/Nrf2/ARE pathway.

Although RAAS blockade is the cornerstone to prevent the progression of proteinuric nephropathy, a significant number of patients remained with proteinuria and progress to end-stage renal disease.

Due to the low cost and few side effects of curcumin, this could become an adjuvant treatment of proteinuric nephropathy purposes attenuate the progression of chronic kidney disease.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of proteinuric chronic kidney disease with 1g or more of proteins in a daily recollection.
* Individuals taking Angiotensin II Receptor Blocker or ACE inhibitors in monotherapy with maximum dose or in combination.

Exclusion Criteria:

* Hepatic damage.
* Malignancy.
* Pregnancy.
* Peritoneal or hemodialysis.
* Organ transplantation.
* Heart failure classification III or IV (New York Heart Association).
* History of chemotherapy within 2 years prior to screening.

Primary outcomes:
measure: Change in proteinuria
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
state: DF
Study officials:
References:
Clinical trial NCT05827393: Muscle Transplantation in Strabismus Surgery
Official title: Muscle Transplantation for Large Angle Horizontal Strabismus: Esotropia Versus Exotropia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Strabismus, Noncomitant
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All the patients underwent standard muscle transplantation, where the resected extra stump of lateral or medial rectus muscle was transplanted to the medial or lateral rectus muscle using 6-0 prolene which wasrecessed by a standard recession technique


Eligibility criteria: Inclusion Criteria:

* Patients with esotropia or exotropia of more than 60 prism dioptre

Exclusion Criteria:

* Muscular paralysis.
* High myopia. .Dissociated vertical divergence. .Accommodative esotropias.
* Large vertical deviations associated Alphabetic syndromes
* previous surgeries in either eye

Primary outcomes:
measure: Compare the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
timeFrame: one day
Secondary outcomes:
measure: assess the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
timeFrame: six months
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena University Hospital
Study officials:
References:
Clinical trial NCT00693693: Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Official title: Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-06-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.

Detailed description: An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (\>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.

The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.

Adherence will be measured by MEMs cap.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years of age.
* Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale)
* Subjects must have \>5% TBSA and \<30% to be enrolled.
* Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.

Exclusion Criteria:

* Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the subject.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
* Requiring \>130 gm of cream in a 2 week period.
* Having facial or groin involvement of their disease.
* Pregnant women and women who are breast feeding are to be excluded. Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.

Primary outcomes:
measure: Adherence to Locoid
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steve Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815693: Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors
Official title: Evaluate the Effectiveness for Long-term Consequences of COVID-19 of Mindfulness-based Stress Reduction (MBSR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Acute COVID-19 Syndrome
Lead sponsor: Azienda Socio Sanitaria Territoriale di Lecco
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The consequences of the Intensive Care Unit and the Covid-19 disease are still uncertain. However, many studies are bringing out often psychological and dramatic consequences for many COVID-survivor patients.

Among the ex-covid patients discharged from our Intensive Care Unit and with at least one covid-related psychological consequence, we want to evaluate the effectiveness for long-term consequences of COVID-19 of mindfulness-based stress reduction (MBSR) or usual care.

Detailed description: Randomized controlled clinical study. All patients who survived COVID-19 and discharged from the intensive care unit of the Lecco hospital will be enrolled if present: chronic pain, anxiety, depression and/or insomnia in pharmacological therapy A group of patients will be observed during 12 months and evaluated with rating scales for chronic pain, anxiety, depression and insomnia.

The second (experimental) group will receive psychotherapy (mindfulness-based stress reduction and cognitive behavioral therapy) in addition to the pharmacological therapy

Eligibility criteria: Inclusion Criteria:

* Intensive care survivors
* Surviving COVID-19 patients
* Patients with Chronic Pain Anxiety Depression and/or Insomnia in drug therapy

Exclusion Criteria:

* Patients with Chronic Pain Anxiety Depression and/or Insomnia NOT in drug therapy
* Patients not hospitalized in intensive care for COVID-19

Primary outcomes:
measure: Chronic pain
timeFrame: 6 months and 1 year
measure: Anxiety
timeFrame: 6 months and 1 year
measure: Depression
timeFrame: 6 months and 1 year
measure: Insomnia
timeFrame: 6 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: ASST Lecco
Study officials:
affiliation: Azienda Socio Sanitaria Territoriale di Lecco
name: Vincenzo Damico
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06955793: Expanded Access to TAK-881 for Children and Teenagers With Primary Immunodeficiency Diseases in the USA
Official title: Expanded Access Program for United States of America: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Primary Immunodeficiency Diseases (PIDD)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2025-05-02
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This study will provide access to TAK-881 for participants with PIDD who have completed study TAK-881-3002 \[NCT06076642\], who continue to derive clinical benefit from maintenance treatment with TAK-881 and wish to continue this treatment.

All participants will receive TAK-881 as subcutaneous (SC) injection using a qualified medical device (Koru 24 G HIgH Flo Subcutaneous Safety Needle Set) that will be individualized for each participant, at the treating physician's discretion and dependent on serum IgG trough level and clinical response.

Participants will continue treatment until the benefit-risk no longer favors the participant or TAK-881 becomes commercially available in the United States (U.S.), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.


Eligibility criteria: Inclusion Criteria:

1. Participant has PIDD and has completed the end-of-study visit of Study TAK-881-3002.
2. Participant is demonstrating continued benefit from TAK-881 for the treatment of PIDD in the opinion of the treating physician.
3. Participant, or (in the case of minors) legally designated representative(s) is/are informed of the nature of the expanded access program and can provide written informed consent/assent (if applicable), including providing consent/assent for use of the investigational medical device, before initiation of any program procedures.
4. Participant does not have any condition, including laboratory test result, that in the opinion of the treating physician may compromise the participant's safety.
5. Participant does not have a known hypersensitivity to TAK-881 or its components.

Exclusion Criteria:

1. Participant has potential to become pregnant and the participant does not agree to employ a highly effective form of contraception for the duration of the program.
2. Participant is pregnant or lactating or intends to become pregnant or begin lactating during the program.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00542893: A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine
Official title: A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Melanoma
Keywords: bcl-2
CFR
DTIC
ECOG
EMEA
MedDRA
NCI CTC
SAE
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2007-10-12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense


Eligibility criteria: Inclusion Criteria:

* Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
* ECOG Performance Status of 0, 1, or 2
* Life expectancy of at least 12 weeks
* Adequate venous access
* Agreement to practice effective method of birth control

Exclusion Criteria:

* Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy
* Significant medical disease
* Known hypersensitivity to phosphorothioate-containing oligonucleotides
* Known hypersensitivity to DTIC
* Pregnancy/Lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01584193: Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Venous Access Port Implantation
Official title: Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vascular Surgical Procedures
Keywords: central venous access port
ultrasound-guided venous puncture
suclavian vein
cephalic vein
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 0
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 compare two different surgical techniques for implementation of totally implantable central venous access ports. Ultrasound-guided suclavian vein puncture is compared to cephalic vein dissection.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Informed consent
* Need for central venous access port implementation under local anesthesia

Exclusion Criteria:

* Impaired blood clotting
* Ongoing antiplatelet drugs therapy, except acetylsalicylic acid
* Trauma or surgical past history on both shoulder girdles
* Known central venous thrombosis (subclavian vein, upper vena cava)
* Known pneumothorax
* Septic state
* Agranulocytosis

Primary outcomes:
measure: surgical procedure time
timeFrame: during surgical procedure
Secondary outcomes:
measure: primary implementation success rate
timeFrame: during surgical procedure
measure: overall implementation success rate
timeFrame: during surgical procedure
measure: technique conversion rate and causes
timeFrame: during surgical procedure
measure: pain during surgical procedure
timeFrame: during surgical procedure
measure: pain at 5 days
timeFrame: 5 days post-procedure
measure: Pain at 30 days
timeFrame: 30 days post-procedure
measure: Complications rate during surgical procedure
timeFrame: during surgical procedure
measure: Complications rate at 5 days
timeFrame: 5 days post-procedure
measure: Complications rate at 30 days
timeFrame: 30 days post-procedure
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne, Department of Visceral Surgery
state: Vaud
Study officials:
affiliation: University Hospital Lausanne, Department of Visceral Surgery
name: Nicolas Demartines
role: STUDY_CHAIR
References: