louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06591455: A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
Official title: A Single Center, Randomized Controlled, Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Primary Biliary Cholangitis (PBC)
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective, single center, randomized controlled, exploratory clinical trial aimed at evaluating the efficacy and safety of fenofibrate in newly diagnosed PBC subjects.


Eligibility criteria: Inclusion Criteria:

* Must have provided written informed consent
* Age 18-75 years;
* BMI 17-28 kg/m2
* Male or female with a diagnosis of PBC, by at least two of the following criteria:

  1. History of AP above ULN for at least six months;
  2. Positive AMA titers (\&gt;1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
  3. Documented liver biopsy result consistent with PBC.
* Not receiving UDCA treatment before enrollment, ALP\&gt;ULN

Exclusion Criteria:

* History or presence of other concomitant liver diseases.
* ALT or AST \&gt; 5×ULN, TBIL \&gt; 3×ULN.
* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
* Allergic to fenofibrate or ursodeoxycholic acid.
* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
* Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
* Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.
* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
* Planned to receive an organ transplant or an organ transplant recipient.
* Needing Liver transplantation within 1 year according to the Mayo Rick score.
* Any other condition(s) that would compromise the safety of the subject or compromise

Primary outcomes:
measure: Percentage of patients with biochemical response
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of patients having biochemical response
timeFrame: 1 and 3 months
measure: Assessment of the pruritus and fatigue
timeFrame: 1,3 and 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT01161355: Phase I, Exploratory, Single Centre, Single Oral Dose AZD9668 and Intravenous Microdose of [C14] AZD9668, Healthy Subject
Official title: An Exploratory Study to Assess the Absolute Bioavailability of a Single Oral Dose of AZD9668 With Respect to an Intra-venous Microdose of [14C]AZD9668 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
tolerability
healthy
microdose
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-13
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of \[14C\]AZD9668 in healthy male subjects.

Detailed description: This is an exploratory study to assess the absolute bioavailability of a single oral dose of AZD9668 with respect to an intra-venous microdose of \[14C\]AZD9668 in healthy male subjects.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg and no more than 100 kg.

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination

Primary outcomes:
measure: The absolute bioavailability and evaluation of pharmacokinetic parameters (AUC, AUC (0-t), Cmax, t½, tmax, and MRT of of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668
timeFrame: Multiple Pharmacokinetic blood samples for up to 96 hours following drug administration
Secondary outcomes:
measure: Safety and tolerability of AZD9668: Adverse events, clinical chemistry, haematology, urinalysis, vital signs, electrocardiogram, physical examination
timeFrame: measured within 21 days of drug administration and up to 7 days following drug administration
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Research Site
state: Nottingham
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Joanna Marks-Konczalik
role: STUDY_DIRECTOR
affiliation: Quintiles, Inc.
name: Sharan Sidhu, MB ChB, BAO,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03588455: Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses
Official title: Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient underwent FFR during angiography between 2012 september and december 2016

Brief summary: The intermediate coronary stenoses defined by a degree of stenosis from 40 to 70 % are frequent. The Flow Fraction Reserve (FFR), realized during coronarography, is an hemodynamic evaluation by the functional impact measuring the loss of load in upstream / approval of the stenosis inthe basal state and in situation of hyperemia led by adenosine. Further to the study FAME, the threshold of definition of the significant character of one Stenosis was fixed for a value of FFR = 0,80. However, the impact forecasts intermediate values badly known rest.

We hypothetized that coronary stenosis associated with borderline values of FFR 0.81-0.85 were associated with a higher rate of clinical events than those with a FFR \>0.85


Eligibility criteria: Inclusion Criteria:

* patient with FFR\> 0,80 between september 2012 till december 2016

Exclusion Criteria:

* refusal of participation

Primary outcomes:
measure: Composite outcome
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: AZZAZ P Sofien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02952755: Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20162 in Healthy Volunteers
Official title: A Randomized, Open-label, Crossover Study to Explore Drug-drug Interactions Between DWC20155 / DWC20156 and DWC20162 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20162 in Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Accepts healthy volunteers

Exclusion Criteria:

* Who has allergy to investigational product

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 0 ~ 24 hours
measure: Area under the time versus plasma concentration curve (AUC)
timeFrame: 0 ~ 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gyunggi
country: Korea, Republic of
facility: Bundang CHA Medical Center
Study officials:
References:
Clinical trial NCT02970955: Prospecitve Observational Study on a Risk Adaptive Scheme for SBRT for Thoracic Nodes Metastases
Official title: Prospective Observational Study on a Risk Adaptive Scheme for Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable Thoracic Nodes Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Nodes Metastases
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inoperable thoracic nodes metastases from any primary, except for hematologic malignancies

Brief summary: Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body radiation therapy (SBRT).

Detailed description: The observational study is designed to evaluate safety and efficacy of a risk adaptive scheme of stereotactic body radiation therapy (SRT) in oligometastatic patients with thoracic nodes metastases, medically inoperable, using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

Eligibility criteria: Inclusion Criteria:

* Patients aged \>18 years with ECOG 0-2
* Karnofsky index \> 70% (ECOG \>2)
* Any primary, except for hematologic malignancies
* DFI (Disease-free interval) from diagnosis \> 6 months
* Unresectable lesions or inoperable patients or patients who refused surgery
* Less than 3 metastatic thoracic nodes
* No extrathoracic disease or other metastatic sites stable or responding after chemotherapy, with less than 5 metastatic sites
* No life threatening conditions
* Chemotherapy completed at least 1 week before treatment
* Chemotherapy started at least 1 week after treatment allowed
* Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
* Written informed consent

Exclusion Criteria:

* Previous RT in the same region
* Pregnant women
* Patients with inability to consent

Primary outcomes:
measure: Local control of disease
timeFrame: 7 years
Secondary outcomes:
measure: Progression-free survival for patients
timeFrame: 7 years
measure: Overall survival for patients
timeFrame: 7 years
measure: Quality of life evaluated by EORTC QLQ C30 questionnaires
timeFrame: 7 years
measure: Hematologic and non-hematologic toxicities
timeFrame: 7 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Davide Franceschini
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Davide Franceschini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04684355: Quality of Life of Colorectal Cancer Screenees in the Period Between Colonoscopy and Next Clinic Visit for Final Report: Does Real-time Endoscopic Optical Diagnosis Improve Their Quality of Life
Official title: Quality of Life of Colorectal Cancer Screenees in the Period Between Colonoscopy and Next Clinic Visit for Final Report: Does Real-time Endoscopic Optical Diagnosis Improve Their Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Colonoscopy
Quality of Life
Mass Screening
Anxiety
Keywords: Colorectal Neoplasms
Colonoscopy
Quality of Life
Mass Screening
Anxiety
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
Collaborators: name: Fu Jen Catholic University Hospital
First posted: 2020-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Colorectal cancer screening program has been proven to reduce colorectal cancer (CRC) mortality and is cost-effective. It has been adopted by most countries in the world, and colonoscopy is regarded as the most accurate test for detecting colorectal neoplasm. After screenees underwent colonoscopy, most endoscopists do not routinely explain the preliminary optical diagnosis to the subjects before they going home, which may cause unnecessary anxiety and may reduce the quality of life of the subjects before acquiring the final results. In recent years, endoscopic optical diagnostic technology has been validated by meta-analysis studies as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer. The real time feature of endoscopic optical diagnosis allows endoscopists to explain the preliminary results confidently to the subjects immediately after colonoscopy, which is expected to reduce the anxiety of the subjects before they acquired the final results and improve their quality of life. We designed a randomized controlled trial to validate whether real-time endoscopic optical diagnosis could decrease the anxiety burden and improve the quality of life for colorectal-cancer screenees after colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients who preparing to received screening or surveillance colonoscopy under general anesthesia.
* Patients who preparing to received sedated colonoscopy due to other GI tract related symptoms.

Exclusion Criteria:

* Impaired mental status that could not understand the questionnaire questions.
* Patients with major psychological disorders.

Primary outcomes:
measure: Quality of life degree
timeFrame: 2 weeks
Secondary outcomes:
measure: Anxiety and depression degree
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital
Study officials:
References:
Clinical trial NCT06309355: Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis
Official title: A Randomized, Placebo-controlled, Double-blind, Multi Center, Phase IIa Trial Investigating the Safety, Tolerability, Pharmacokinetics and Efficacy of Topical Ointment YR001 in Adult Patients With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: YR001
KV1.3
Lead sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 36
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 is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis


Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained from the subject.
2. Male or female subject is aged 18 or older.
3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
4. An Investigator Static Global Assessment (ISGA) score of 2 (mild) to 3 (moderate) at screening and Baseline.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
3. Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
4. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response.
5. Participation in another interventional clinical trial (e.g. investigational drug, biological agent, or device) within 30 days or 5 half-lives of investigational agent (whichever is longer) before entering, or during the trial, or previous participation in this clinical trial.

Primary outcomes:
measure: The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50.
timeFrame: Day1-Day 50
Secondary outcomes:
measure: all treatment-emergents AEs
timeFrame: Day1-Day 50
measure: Efficacy of YR001 Ointment
timeFrame: Day1-Day50
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Encore Medical Research -Boynton Beach
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research-Hollywood
state: Florida
city: Weston
country: United States
facility: Encore Medical Research-Weston
state: Florida
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
Study officials:
References:
Clinical trial NCT00779155: Study of Magnetic Fields for Treatment of Parkinson's Disease
Official title: A Double-blind, Sham-stimulation Controlled Study of the Application of Magnetic Fields Using the Jacobson Resonator for the Treatment of Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: pico-tesla Magnetic Therapies, LLC
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
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 low level magnetic fields may help to relieve symptoms of Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* idiopathic PD with motor fluctuations of at least 3-4 hours daily., Subject on levodopa, subject is ambulatory, maintain regular med schedule, willing and able to abstain from new PD treatments, Able to demonstrate correct completion of PD diaries, non-demented, adequate contraceptive measures, capable of giving full written consent.

Exclusion Criteria:

* any factors that will prevent subject from completing full course of therapy with the resonator, any factors preventing subject from attending clinic in the "off" state, atypical parkinsonism, no active brain tumors, strokes, hydrocephalus, any other neurologic or non-neurologic disorder which might affect the symptomatic expression of pts. parkinsonism, suffers from chronic pain, no meds that may produce parkinsonism, no psychiatric disturbance, Epilepsy, HIV, Cancer, History of ECT, Diabetic Neuropathy, Uncontrolled HTN, Advanced Pulmonary Disease, Known heart conditions such as cardiac arrythmias, previous PD surgical interventions, prosthetics comprised of ferrous metals, pacemakers, DBS, Uncontrolled, unstable or untreated medical illnesses, Consumption of more than 21 alcoholic drinks per week, Pregnant, breast feeding, developmental disability

Primary outcomes:
measure: Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State.
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Littleton
country: United States
facility: pico-tesla Magnetic Therapies
state: Colorado
Study officials:
References:
citation: O. Klepitskaya, R. Kumar, Efficacy and Safety of Low Level Electromagnetic Fields Treatment in Parkinson's Disease. Movement Disorders; Vol. 23, No. 11, 2008, pp. 1628-1637
Clinical trial NCT05486455: Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers
Official title: Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers: a "Real Life" Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers.


Eligibility criteria: Inclusion Criteria:

* Male or female 50-80 years old
* Active smoker (≥ 15 PA) or former smoker (≥ 15 PA)

Exclusion Criteria:

* Recent history of chest CT scan (within 12 months)
* Person unable to climb 2 floors
* Weight \> 140kg
* Personal history of cancer \< 5 years (currently being monitored by thoracic imaging)

Primary outcomes:
measure: Positive Predictive Value (PPV)
timeFrame: 5 years
Secondary outcomes:
measure: Sensitivity
timeFrame: 5 years
measure: Specificity
timeFrame: 5 years
measure: Early stage lung cancer detection rate (stage I and II)
timeFrame: 5 years
measure: 5-year survival rate of patients who have undergone thoracic surgery
timeFrame: 5 years
measure: Rate of smoking-related co-morbidities detected on low-dose CT scan
timeFrame: 5 years
measure: Rate of additional examinations (including invasive diagnostic tests and surgery with benign results)
timeFrame: 5 years
measure: Risk ratio of lung cancer
timeFrame: 5 years
measure: Number of false positive results
timeFrame: 5 years
measure: Penetration rate
timeFrame: 5 years
measure: Smoking cessation rates
timeFrame: 5 years
measure: EORTC QLQ-C30 score (version 3)
timeFrame: 5 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Saint Joseph
Study officials:
affiliation: Hopital Saint Joseph Marseille
name: Arnaud Boyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Saint Joseph Marseille
name: Illies Bouabdallah, MD
role: STUDY_DIRECTOR
References: