louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05894343: Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease
Official title: Long-term Follow-up of Glutamic Acid Decarboxylase Gene Transfer to the Subthalamic Nuclei in Participants With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Parkinson Disease
Lead sponsor: MeiraGTx UK II Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to the follow-up or active treatment group based on the group to which they were randomized in Study MGT-GAD-025.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the long-term safety of AAV-GAD delivered bilaterally to the subthalamic nuclei (STN) in participants with Parkinson's disease.

Detailed description: The duration of individual participation in this study will be approximately 54 months for participants who received AAV-GAD in Study MGT-GAD-025 and approximately 60 months for participants who received sham surgery in Study MGT-GAD-025.

Eligibility criteria: Inclusion Criteria:

* Previously enrolled in Study MGT-GAD-025.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of participants with study drug-related adverse events and serious adverse events
timeFrame: From study start until Month 60 post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References:
Clinical trial NCT00451243: Differential Clinical and Serologic Response in Psoriasis and Psoriatic Arthritis to Drug Treatment
Official title: Differential Clinical and Serologic Response in Psoriasis and Psoriatic Arthritis to Drug Treatmen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-03-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Psoriasis is a multifactorial cutaneous disorders which affects about 100000 patients in Taiwan. Psoriatic arthritis is also present in about 20\~30 percents. Many drugs have been shown to aggravate psoriasis including drugs used in the treatment of psoriatic arthritis. On the contrary, anti-psoriatic drugs are also known to aggravate or induce psoriatic arthritis. Psoriasis and psoriatic arthritis are believed to share the same pathogenic lymphocytes, but the differential responses to drugs are intriguing. This also causes problems in the treatment of psoriasis and psoriatic arthritis. Recently different serologic markers have been found for the assessment of psoriasis and psoriatic arthritis. Recent genetic study showed a different genetic susceptibility genes. We tested the serologic responses of three new biologic drugs used in the treatment of psoriasis and psoriatic arthritis. Paired blood samples of the same patients before and after 12 weeks of treatment were used. IL6 decreased after alefacept and etanercept but was increased after efalizumab treatment without statistical significance (Paired t test: 0.3336、0.2773、0.5904)。IL-8 decreased after etanercept but increased after efalizumab and alefacept without statistical significance (Paired t test: 0.4031、0.6749、0.2998)。IL10 decreased after efalizumab and etanercept, but increased significantly after alefacept treatment (Paired t test: 0.7254、0.5123、0.0350)。None of the treatment has a significant effect on TNF-alpha. HC10 decreased after alefacept and efalizumab,but increased after etanercept treatmentwithout statistical significance (Paired t test: 0.6589、0.1576、0.1988).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of psoriasis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TSEN-FANG Tsai
name: TSEN-FANG Tsai
role: STUDY_CHAIR
References:
Clinical trial NCT02578043: A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris
Official title: A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 844
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the therapeutic equivalence and safety.

Detailed description: The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
* Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

* Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
* A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
* A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.

Primary outcomes:
measure: Demonstration of Bioequivalence
timeFrame: Week 12
Secondary outcomes:
measure: Clinical response of success
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: http://catawbaresearch.com/contact/
name: Catawba Research
role: STUDY_CHAIR
References:
Clinical trial NCT05022043: Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis
Official title: At Admission Serum Presepsin as Early Predictor for Disease Severity and Positive Blood Culture for Neonates With Early-onset Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Sepsis
Keywords: Early-onset neonatal sepsis
Presepsin
Clinical scoring
Early predictors
Blood culture
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 124
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 124 neonates aged ≤7 days with suspected EOS were clinically evaluated using SNAP-II and gave blood samples for BC, total leucocytic count (TLC), lymphocytic and neutrophil count, and ELISA estimation of serum levels of PSP, procalcitonin (PCT), and tumor necrosis factor-α (TNF-α). Enrolled neonates were categorized as Confirmed EOS: neonates with evident clinical sepsis manifestations and positive BC, Suspected EOS: neonates with evident clinical sepsis manifestations but had negative BC and No EOS included neonates free of evident clinical sepsis manifestations, had negative BC and showed no deterioration till 72-hr after admission.


Eligibility criteria: Inclusion Criteria:

* included gestational age (GA) of 28-41 weeks and 5-min APGAR score of ≥7, and neonatal age of \<7 days

Exclusion Criteria:

* including small for gestational age, presence of a chromosomal abnormality, multiple congenital anomalies, genetic syndromes, history of premature rupture of membranes, chorioamnionitis, neonatal asphyxia, and missed inclusion criterion.

Primary outcomes:
measure: prediction of neonatal outcome
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
Study officials:
References:
Clinical trial NCT00485043: Effects of Modified T'ai Chi on Symptoms in Older Adults With Osteoarthritis
Official title: Effects of Modified T'ai Chi Exercise on Physical Function, Pain, and Stiffness in Older Adults With Lower Extremity Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: T'ai Chi
Osteoarthritis
Exercise
Older adults
Lead sponsor: University of Kansas
Sponsor class: OTHER
First posted: 2007-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effects of TC for Arthritis on physical function, pain, and stiffness in older adults with knee/hip OA. Two hypotheses were tested:

1. Individuals in the TC group will demonstrate greater improvements in physical function compared to control group participants.
2. Individuals in the TC group will demonstrate greater decreases in pain and stiffness compared to control group participants.

Detailed description: Exercise is considered a vital component of osteoarthritis (OA) treatment. T'ai Chi (TC) is a unique exercise intervention with low-velocity movements. Few studies have addressed the effects of TC on arthritis symptoms and function. TC for Arthritis was modified specifically for people with OA and consists of a standardized set of forms.

The purpose of this study was to evaluate the effectiveness of a low-dose TC for Arthritis on physical function, pain, and stiffness in individuals with OA.

Twenty-seven older adults with OA (mean age-81.3 years) completed an 8 week non-randomized controlled pre-post test quasi-experimental design study of TC for Arthritis. Physical function, pain, and stiffness were measured at baseline and 8 weeks for the TC and control groups using the WOMAC™ 3.1 Index. Qualitative data from interviews and participant observations were analyzed in order to understand the participants' expectations and experiences with TC.

Eligibility criteria: Inclusion Criteria:

* Ability to walk independently,
* Speak and understand English,
* Understand the consent process; and
* Give informed consent.

Exclusion Criteria:

* Participation in rehabilitation or another TC class,
* At the time of recruitment; and
* Inability to confirm medical stability for safe participation with healthcare provider.

Primary outcomes:
measure: physical function
timeFrame: 8 weeks
Secondary outcomes:
measure: pain and stiffness
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Kansas Medical Center
name: Cynthia Teel S. Teel, BSN, PhD
role: STUDY_CHAIR
affiliation: University of Kansas Medical Center
name: Geraldine R. Neuberger, BSN, EdD
role: STUDY_CHAIR
References:
Clinical trial NCT06855043: Little Lungs Study
Official title: Pilot Study of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Invasive Mechanical Ventilation
Severe Respiratory Distress Syndrome
Keywords: premature birth
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Meriter Foundation
First posted: 2025-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial is being done to evaluate the clinical response and safety of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.

The main questions it aims to answer are:

* Do the combined drugs improve the respiratory severity score (RSS)
* Is the combination safe

Participants will receive three doses of the study drug.


Eligibility criteria: Neonate Inclusion Criteria:

* Gestational age 22 0/7 to 28 6/7 weeks at birth
* Age 7-14 days
* Need invasive mechanical ventilatory support
* Have at least one parent/guardian who is able to provide parental permission in English or Spanish

Birthing Parent Inclusion Criteria:

* Have a baby who meets neonate eligibility criteria and enrolls in the study.
* Is able to provide consent in English or Spanish

Neonate Exclusion Criteria:

* Major congenital anomalies
* History of pulmonary hemorrhage
* Antibiotic use within 48 hours
* Prior treatment with corticosteroids for prevention of lung disease
* Indomethacin or Ibuprofen use within 72 hours
* Have a birth parent aged less than 18 years
* Respiratory severity score less than 2.4
* Not expected to survive for greater than 7 days at enrollment

Birthing Parent Exclusion Criteria:

* Is aged less than 18 years

Primary outcomes:
measure: Change in respiratory severity score (RSS)
timeFrame: Baseline to 48 hours
Secondary outcomes:
measure: Change in RSS
timeFrame: Baseline to 7 days
measure: Presence or absence of acute clinical deterioration
timeFrame: Up to 3 days
measure: Presence or absence of severe acute clinical deterioration
timeFrame: Up to 3 days
measure: Change in average daily apnea bradycardia desaturation (ABD) events
timeFrame: Baseline to 5 days
measure: Occurrence of pneumothorax
timeFrame: Up to 5 days
measure: Occurrence of pulmonary hemorrhages
timeFrame: Up to 5 days
measure: Compare observed Bronchopulmonary Dysplasia (BPD) grades with estimated BPD grade
timeFrame: up to 36 weeks post menstrual age
Other outcomes:
Locations:
city: Madison
country: United States
facility: Meriter Hospital
state: Wisconsin
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Dinushan Kaluarachchi, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02185443: Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
Official title: Stereotactic Body Radiation Therapy for the Treatment of Unresectable Liver Metastases in Patients With Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Liver Metastases
Colorectal Cancer
Anal Canal Cancer
Gastrointestinal Neuroendocrine Tumors
Keywords: SBRT
radiation
Neoplasm Metastasis
Colorectal Neoplasms
Anal Canal
Neuroendocrine Tumors
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Instituto do Cancer do Estado de São Paulo
First posted: 2014-07-09
Enrollment: 43
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: This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent.

Therefore, SBRT is being considered as a potentially curative procedure.


Eligibility criteria: Inclusion Criteria:

* Karnofsky Performance Scale (KPS) equal or greater than 70
* 1 to 4 liver metastases with an individual maximum diameter of up to 5 cm
* Lesions considered unresectable or patients considered unfit for surgery
* Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors.
* Absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated with curative intent.
* Minimum interval of 2 weeks between systemic chemotherapy and SBRT.
* Adequate bone marrow function defined as:
* absolute neutrophils count \> 1,800 cells / mm 3
* platelets \> 100,000 cells / mm 3
* hemoglobin \> 8.0 g / dl ( transfusion or other intervention accepted)

Exclusion Criteria:

* Concomitant chemotherapy
* Prior radiotherapy to the upper abdomen
* Pregnancy
* Underlying Cirrhosis
* Active hepatitis or clinically significant liver failure
* Prior invasive neoplasm except for non-melanoma skin cancer, or unless more than five years without evidence of disease
* Severe Comorbidity
* Current anticoagulant treatment

Primary outcomes:
measure: Local Progression Free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Progression Free Survival
timeFrame: 5 years
measure: Toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo
state: SP
Study officials:
affiliation: Instituto do Cancer do Estado de Sao Paulo
name: Andre TC Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03257943: A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%
Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ivermectin Lotion, 0.5% in the Treatment of Subjects With Active Infestation With Head Lice and Their Ova
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lice; Head Lice
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 413
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 Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%

Detailed description: A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova

Eligibility criteria: Inclusion Criteria:

* Subjects 18 years of age or older must have provided IRB-approved written informed consent and sign a HIPAA authorization.
* Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Exclusion Criteria:

* Subjects with a history of hypersensitivity or allergy to or any component of the study product.
* Subject with history of irritation or sensitivity to pediculicides or hair care products.

Primary outcomes:
measure: Demonstration of Bioequivalence in proportion of index subjects who are lice free
timeFrame: Day 15 (14 days after application of study treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: http://catawbaresearch.com/contact/
name: Catawba Research
role: STUDY_CHAIR
References:
Clinical trial NCT03520543: [11C]Yohimbine PET Study of alpha2-AR
Official title: Positron Emission Tomography Study of alpha2-adrenergic Receptors With [11C]Yohimbine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Controls
Keywords: PET imaging
Noradrenaline
Radiotracer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to model tissue specific kinetics of \[11C\]Yohimbine in healthy male participants by positron emission tomography (PET) and the appropriate arterial input function (part A) ; to determine the reproducibility of measures (classical test-retest study, part B1) and to measure the blocking of \[11C\]Yohimbine uptake in the brain following single oral dose administration of clonidine (part B2).


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* Age between 20 years and 35 years
* Weight between 50kg and 90kg
* Without neurologic or psychiatric history
* Without head trauma history including loss of consciousness superior to 30 minutes.
* Affiliated to a social security or similar scheme
* Not subject to any legal protection measures
* Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions

Exclusion Criteria:

* Allen test (assessing the arterial blood flow to the hand) indicating abnormal blood supply to the hand
* Subject with orthostatic hypotension
* Subject with alcohol or substance abuses history
* Subject with somatic drug therapies
* MRI contraindications (implanted or embedded metal objects in the head or body)
* PET contraindications
* Clonidine contraindications
* Exposed to 1 millisievert or more of ionizing radiation in the year before the start of this study
* Subject unable to sign written consent for participation in the study

Primary outcomes:
measure: Binding potentials
timeFrame: 180 minutes
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 7 days after part B
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neurologie C - Hôpital Neurologique et Neurochirurgical Pierre Wertheimer, GHE
Study officials:
affiliation: Service de neurologie C
name: Chloe LAURENCIN, MD
role: PRINCIPAL_INVESTIGATOR
References: