louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06036537: Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease
Official title: Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis Associated Interstitial Lung Disease
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 1200
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: rheumatoid arthritis patients

Brief summary: Rheumatoid arthritis (RA) is one of the most common autoimmune diseases, characterized by chronic inflammatory bone and cartilage destruction. Although treatment including anti-tumor necrosis factor (TNF) and interleukin-6 (IL-6) receptor antibodies has been successful, only 20% to 30% of patients have achieved complete remission. Interstitial lung disease (ILD) is a common complication of rheumatoid arthritis (RA). Approximately 5-10% of RA patients have clinically significant rheumatoid arthritis associated interstitial lung disease (RA-ILD), with a mortality rate of 2-10 times that of RA-non ILD patients. The median survival after diagnosis is between 3-8 years. Although there are multiple biomarkers for RA-ILD, such as anti citrullinated protein antibody (ACPA), MUC5B mutant gene, KL-6, etc., none of these biomarkers can reliably predict the disease and prognostic risk of RA-ILD. Therefore, improving the prediction of RA complicated with ILD and exploring risk factors for the progression and prognosis of RA-ILD can contribute to early diagnosis and treatment, and is of great significance in preventing RA lung injury and death.

This study aims to screen differential serum biomarkers between RA patients and RA-ILD patients through prospective cohort studies, to explore whether these differential serum biomarkers are a risk factor for RA patients complicated with ILD, and whether they affect the clinical prognosis of RA-ILD patients.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of rheumatoid arthritis patients based on the 2010 ACR/EULAR RA classification criteria; 2. age ≥18 years; 3. Interstitial lung disease was diagnosed by lung high resolution computed tomography (HRCT)

Exclusion Criteria:

1. age \<years; 2. Being treated with urate-lowering medications; 3. Other systemic/organ specific autoimmune diseases other than rheumatoid arthritis (such as SLE, ANCA associated vasculitis, pSS, SSc, myositis, etc.); 4.Tumor, pulmonary tuberculosis, glomerular filtration rate less than 30ml/min/1.73m2

Primary outcomes:
measure: Occurrence of interstitial lung disease
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT06451237: Acne Remission Maintenance by Weekend Systemic Isotretinoin
Official title: Weekend Systemic Isotretinoin for Maintaining Acne Remission: A Novel Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study on 3 parallel groups, with random assignment and longitudinal follow up, conducted in two phases (treatment and maintenance).
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn if isotretinoin oral tablets as a weekend regimen are safe and effective to maintain freedom from acne lesions in young adults who have completed a full course of isotretinoin on daily basis and achieved total control of the acne activity.

Detailed description: Three groups of adult acne patients will be given a full course of isotretinoin with a cumulative dose of 120-150 mg/Kg weight in the 1st two groups, and till lesional clearance in the 3rd group with an additional month of maintenance. Afterwards, the 1st group will use adapalene gel every other day for maintenance, the 2nd and 3rd groups will use weekend oral isotretinoin. Patients will be followed for a year for reappearance of acne lesions, and safety of maintenance regimens. Patients opinion will be also sought.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years) with moderate to severe facial acne, as per the Investigator Global Assessment (IGA) scale

Exclusion Criteria:

* patients on systemic acne medications in the past 3 months or topicals in the last month, pregnant or breastfeeding females, those with evidence of endocrine disturbances or using medications for comorbidities

Primary outcomes:
measure: Incidence of acne relapse during maintenance phase
timeFrame: one year
measure: Timing of acne relapse after initiating maintenance
timeFrame: one year
measure: Maximum severity of acne relapse during follow up
timeFrame: One year
measure: Incidence of adverse effects
timeFrame: One year
Secondary outcomes:
measure: subjective patient satisfaction by maintenance regimen
timeFrame: one year
measure: Subjective convenience of maintenance regimen to patient
timeFrame: one year
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Professor of Dermatology
name: Carmen Farid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02136537: Electrical Stimulation in Peripheral Arterial Disease
Official title: Electrical Stimulation in Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 40
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 investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of stable intermittent claudication (\>6 months) with confirmation by medical imaging
* ABPI\<0.9
* Absolute walking distance \<500m

Exclusion Criteria:

* Pregnancy
* Cardiac pacemaker
* Previous lower limb major amputation

Primary outcomes:
measure: Absolute walking distance
timeFrame: 6 weeks
Secondary outcomes:
measure: Claudication distance
timeFrame: 6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: AH Davies
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02737137: Dynamic Multimodal Monitoring for Ultrasound Guided Peripheral Nerve Blockade
Official title: Monitoring Combining Neurostimulation and Ultrasound Guidance During the Realization of a Peripheral Nerve Block: Value of Objective Measurement of the Pressure of Injection of the Local Anesthetic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Surgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.

The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection during peripheral nerve blocks

Detailed description: Current recommendations for peripheral nerve block (PNB) procedure advocate combining ultrasound guidance and nerve stimulation.

Despite these different means of identification, nerves contacts and intraneural injection are frequent. Even rare, nerve damage may occur.

The nerve damage may be related to direct trauma with the needle or inadvertent intra-neural injection. High injection pressure of local anesthetic (AL) is an indicator that further characterize the location of the needle in terms of tissue density. In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.

The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection.

Group 1: ultrasound-guided technique PNB "in plane" needle approach, nerve stimulator set to sentinel mode. Manual injection pressure control Group 2: ultrasound-guided PNB, "in plane" approach, Nerve stimulator set to detection mode. Electronic Injection Pressure controlled with low flow local anesthetic during procedure

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Orthopedic surgery

Exclusion Criteria:

* Allergy to local anesthetics
* ASA score \>III
* Severe neuropathy
* puncture site disease
* parturient or breastfeeding

Primary outcomes:
measure: Manual measurement
timeFrame: Intraoperative
Secondary outcomes:
measure: Measured by a pressure gauge
timeFrame: Intraoperative
Other outcomes:
Locations:
city: France
country: France
facility: CHOQUET
state: Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Olivier CHOQUET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01325337: Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia
Alopecia, Androgenetic
Baldness
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 307
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
* Willingness to have micro-dot-tattoo applied to scalp
* Willingness to maintain same hair style, length and hair color during study

Exclusion Criteria:

* Drug or alcohol abuse within 12 months
* HIV positive
* Received hair transplants or had scalp reductions
* Use of hair weaves, hair extensions or wigs within 3 months
* Oral or topical minoxidil treatment within 6 months
* Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Primary outcomes:
measure: Change From Baseline in Target Area Hair Count (TAHC)
timeFrame: Baseline, Month 6
measure: Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
timeFrame: Baseline, Month 6
measure: Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
timeFrame: Baseline, Month 6
measure: Change From Baseline in Target Area Hair Width (TAHW)
timeFrame: Baseline, Month 6
measure: Change From Baseline in Target Area Hair Darkness (TAHD)
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Portland
country: United States
state: Oregon
city: Berlin
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05428137: Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals
Official title: Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Live and Heat Treated Bacteria Strain on Body Composition in Overweight Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Abdominal Obesity
Lead sponsor: The Archer-Daniels-Midland Company
Sponsor class: INDUSTRY
First posted: 2022-06-22
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arm parallel design
Primary purpose: TREATMENT

Brief summary: Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.

Detailed description: This study aims to investigate the safety and efficacy of live and heat treated bacteria on body composition of overweight individuals. The trial will be run in a single research centre and will recruit adult men and women, with BMI of 25-33kg/m2 with abdominal obesity.

Eligibility criteria: Inclusion Criteria:

* Body mass index 25-33kg/m2
* Abdominal obesity (female waist circumference\>85cm; male waist circumference\>90cm)
* written informed consent

Exclusion Criteria:

* Taking the following medication within 1 month before starting the study: appetite stimulants/suppressants, lipid lowering drug, contraceptive
* taking antibiotics within 2 months before starting the study
* secondary obesity or secondary hypertension, diabetes type 1, GI disease, dyslipidaemia, type 2diabetes, hypertension
* consumption of pre- and probiotic-enriched products or dietary supplement for at least 4 weeks prior to the first screening visit
* nicotine, drug or alcohol abuse,
* other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit or confound the Study's results

Primary outcomes:
measure: Change in visceral fat area
timeFrame: From week 0 to Week 16
Secondary outcomes:
measure: Change in body weight
timeFrame: Week 0, Week 12, Week 16
measure: Change in waist circumference
timeFrame: Week 0, Week 12, Week 16
measure: Change in body fat composition
timeFrame: Week 0, Week 12, Week 16
measure: Change in peripheral blood cholesterol
timeFrame: Week 0, Week 16
measure: Change in serum insulin concentration
timeFrame: Week 0, Week 16
measure: Change in peripheral blood glucose
timeFrame: Week 0, Week 16
measure: Change in plasma leptin levels
timeFrame: Week 0, Week 16
measure: Dietary survey
timeFrame: Week 0, Week 16
measure: Microbiome analysis
timeFrame: Week 0, Week 16
measure: Mood questionnaire
timeFrame: Week 0, Week 16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
Study officials:
affiliation: ADM Biopolis
name: Daniel Ramon Vidal
role: STUDY_CHAIR
References:
Clinical trial NCT06598137: Study to Examine Lesions of the Skin Using Confocal Laser Microscopy
Official title: Multicenter, Prospective Study to Examine Pigmented, Non-pigmented, Tumorous and Inflammatory Lesions of the Skin With Regard to Cut Margin Control, Differentiation, Grading and Tumor Thickness Using Confocal Laser Microscopy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Benign Skin Tumor
Basal Cell Carcinoma
Melanoma
Squamous Cell Cancer
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 645
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with benign and malignant skin tumors

Brief summary: Using ex-vivo confocal laser scanning microscopy, a reliable statement can be made about the extent, histological structure and possible significance of a skin change without having to send tissue samples for demanding and lengthy histological examinations.

Detailed description: Using ex-vivo confocal laser scanning microscopy, a reliable statement can be made about the extent, histological structure and possible significance of a skin change without having to send tissue samples for demanding and lengthy histological examinations.

Eligibility criteria: Inclusion Criteria:

* Patients with benign and malignant skin tumors

Exclusion Criteria:

* Patients unable to consent

Primary outcomes:
measure: Reaching the planned number of patients &gt;640
timeFrame: approx. 1-4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Clinic for Dermatology and Allergy LMU Munich
state: Bavaria
Study officials:
References:
Clinical trial NCT01122537: Characterization and Differential Diagnosis of Postneurosurgical Meningitis
Official title: Clinical Features, Microbiological Characteristics, and Differential Diagnosis of Postneurosurgical Meningitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurosurgery
Keywords: Meningitis
infection
cerebrospinal fluid
procalcitonin
adenosine deaminase
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 78
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patient who develop meningitis after neurosurgical operation

Brief summary: Meningitis is a rare complication following neurosurgical procedures and is associated with high morbidity and mortality. The aim of this study is to describe the clinical characteristics and microbiological characteristics in patients who develope meningitis following neurosurgical operations, and investigate the useful tips for the differential diagnosis of postneurosurgical meningitis.

Detailed description: Besides description of characteristics of patients with postneurosurgical patients, we also will investigate the usefulness of prolonged cerebrospinal fluid (CSF) culture, and profiles of blood and CSF inflammatory markers for the differential diagnosis of meningitis. CSF culture will be extended upto 2 weeks. Serum procalcitonin and C-reactive protein, CSF adenosine deaminase levels will be monitored and analyzed for the differential diagnosis of meningitis.

Eligibility criteria: Inclusion Criteria:

* Cerebrospinal fluid corrected WBC \>6/mm\^3 and/or fever (\> 38℃) and/or neck stiffness

Exclusion Criteria:

* Patients already treated more than 48 hours for meningitis before cerebrospinal fluid examination

Primary outcomes:
measure: Development of meningitis
timeFrame: within 4 weeks after neurosurgical operation
Secondary outcomes:
measure: All-cause mortality
timeFrame: within 4 weeks after the diagnosis of meningitis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sang-Ho Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198937: Investigation on the Effect of Smoking on the Expression of Pro- and Anti-thrombotic, Anti-oxidative, and Inflammatory Markers in Humans
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Inflammation
Thrombosis
Smoking
Keywords: smokers
non-smokers
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Smokers and non-smokers

Brief summary: Investigation on the effect of smoking on thrombus formation in humans. The expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers will be assessed in 25-50 year old healthy smokers and non-smokers. The investigators are interested in possible differences between the two groups.


Eligibility criteria: Inclusion Criteria:

* Smoker
* Non-smokers

Exclusion Criteria:

* Disease
* Pregnancy

Primary outcomes:
measure: Expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers in blood
timeFrame: Single time point, no follow-up (cross sectional)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital
Study officials:
References:
Clinical trial NCT00650637: A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
Official title: A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diarrhea
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine the efficacy and safety of calcium carbonate for the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea.


Eligibility criteria: Inclusion Criteria:

* Antiretroviral-naive patients with HIV-1 infection
* not more than 2 loose stools per day or any preexisting or emerging medical condition that would interfere with the evaluation of therapeutic response of the study drug
* No antidiarrheal medication within 7 days prior to entry

Exclusion Criteria:

* Greater than or equal to 2 loose stools per day lasting 2 or more days within 7 days prior to study entry
* Bloody stools within 7 days prior to study entry
* Any unstable or severe intercurrent medical condition, including active opportunistic infections

Primary outcomes:
measure: Number of patients who experienced protocol-defined diarrhea in each treatment group during study
timeFrame: Week 12
Secondary outcomes:
measure: Time to first occurrence of protocol-defined diarrhea
measure: The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea
timeFrame: Weeks 2, 4, 6, 8, and 12
measure: Frequency and severity of diarrhea collected from the subject daily diary during the study will be summarized before and after subjects receive calcium carbonate plus loperamide
timeFrame: Weeks 2, 4, 6, 8, and 12
measure: Safety evaluations including physical exam, weight and vital signs measurements
timeFrame: Screening, baseline, Weeks 2, 4, 6, 8, and 12
measure: Safety assessment of laboratory parameters
timeFrame: Screening, baseline, Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Ft. Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Huntersville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: