louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03023592: Study of Iguratimod in Sjögren's Syndrome
Official title: A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Sjogren's Syndrome
Keywords: Sjogren's Syndrome
Iguratimod
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome

Detailed description: In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
* Positive dry eyes and (or) dry mouth symptoms
* Hyperglobulinemia

Exclusion Criteria:

* Complicated with other systemic autoimmune diseases
* Severe complications of Sjogren's syndrome
* Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit
* Active infections or chronic infectious diseases
* A history of malignancies
* Pregnancy or breathfeeding
* Inability to comply with the study protocol for any other reason

Primary outcomes:
measure: ESSDAI improvement
timeFrame: week 24
measure: ESSPRI improvement
timeFrame: week 24
Secondary outcomes:
measure: Unstimulated salivary flow rate
timeFrame: week 24
measure: Schimer's test
timeFrame: week 24
measure: SF-36
timeFrame: week 24
measure: HAQ
timeFrame: week 24
measure: Immunoglobulins
timeFrame: week 24
measure: Rheumatoid Factors
timeFrame: week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yan Zhao, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00735592: Value of Radiological Follow up in Children Hospitalized With Lobar Pneumonia
Official title: The Study Intend to Evaluate the Usefulness of Performing a Follow up X Rays in Children Admitted With Lobar Pneumonia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: X rays findings
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pediatric patients admitted during the years 2006 and 2007 with the diagnosis of lobar pneumonia.

Brief summary: The study intends to assess the utility of performing a follow up X rays in children admitted to pediatric wards with lobar pneumonia. Usually those children are discharged with a recommendation for a follow up X rays but there are no enough studies proving that this recommendation is really necessary.

Detailed description: Thew study will include follow up data in a group of about 200 patients admitted with lobar pneumonia during the years 2006 to 2007. All the clinical and laboratory data will be collected and also the X rays findings.

The findings of follow up X rays if they were performed will also be summarized.

Eligibility criteria: Inclusion Criteria: All pediatric patients discharged with the diagnosis of lobar pneumonia.

Exclusion Criteria: Patients with diagnosis of chronic diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Dpt B - Ha'Emek Medical Center
Study officials:
affiliation: Pediatric Dpt B - Ha'Emek Medical Center - Afula - 18101 - Israel
name: Sakran Waheeb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Dpt B - Ha'Emek Medical Center - Afula - Israel
name: Ronza Andraws, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753492: Trabeculectomy With Ologen
Official title: Trabeculectomy With Ologen-Pilot
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma
Keywords: Intraocular pressure
glaucoma
trabeculectomy
Ologen
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Aeon Astron Europe B.V.
First posted: 2012-12-20
Enrollment: 7
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: Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma. Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs, and increased risk to infection, blebitis and endophthalmitis.

Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery.Although a few studies on filtering surgery with Ologen implantation have been performed, there is yet no conclusive evidence on effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.

This is a prospective intervention pilot study to determine the degree of intraocular pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of the two procedures will be compared.

The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.


Eligibility criteria: Inclusion Criteria:

* Primary open-angle glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication.
* Indication for trabeculectomy with mitomycin-C

Exclusion Criteria:

* Unability to discontinue oral anticoagulants
* Difficulty in reading or speaking Dutch
* Previous ocular surgery (cataract surgery allowed)
* Pregnant and breastfeeding women

Primary outcomes:
measure: Postoperative intraocular pressure level
timeFrame: 3 months
Secondary outcomes:
measure: Number of glaucoma medications
timeFrame: 3 months
Other outcomes:
measure: bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3)
timeFrame: 3 months
measure: surgery time
timeFrame: 3 months
measure: complexity of surgical procedure
timeFrame: 3 months
measure: number of patients withdrawn from study because of failure
timeFrame: 3 months
Locations:
city: Maastricht
country: Netherlands
facility: University Eye Clinic
Study officials:
References:
Clinical trial NCT04850092: Dynamic Arterial Elastance to Predict Postural Change Induced Hypotension
Official title: Investigation on Dynamic Arterial Elastance as a Predictor of Hypotension Caused by the Positional Change From Supine to Prone (SuProne Study).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 44
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 who are scheduled for spine surgery and need positional change from supine to prone positioin.

Brief summary: During general anesthesia, hypotension might occur during positional change. It is reported that hypotension after positional change from supine to prone is mainly caused by the decrease in preload. The investigators aimed to investigate whether dynamic arterial elastance might predict hypotension associated with positional change from supine to prone.


Eligibility criteria: Inclusion Criteria:

* Patients planned for invasive arterial catheter insertion, undergoing elective spine surgery in prone position under general anesthesia

Exclusion Criteria:

* arrythmia
* pulmonary disease
* increased intracranial pressure
* decreased cardiac function (ejection fraction \< 50%)
* obesity (body mass index \> 40)

Primary outcomes:
measure: Dynamic arterial elastance before positional change
timeFrame: 1 minute before positional change
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References:
Clinical trial NCT01698892: Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy. (TORSIV)
Official title: Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sedation During Bronchoscopy
Keywords: I.V. sedation, midazolam, bronchoscopy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Bronchoscopy is a technique which currently allows the investigation of many respiratory diseases (infections, neoplasia, inflammation...) as well as endobronchial therapeutic procedures.

Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication before endoscopy, but practices concerning the use of sedation further to the completion of the endoscopy are very heterogeneous.

We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy


Eligibility criteria: Inclusion Criteria:

* Men or women aged between 18 and 80, who will undergo bronchoscopy
* FEV1≥ 50% of theorical value
* Ambient air saturation at rest ≥ 94%
* No allergy to midazolam, to hydroxyzine, Lidocaine (used for local anesthesia) or one of their compound
* fasting for at least 6 hours
* No indication against bronchoscopy, nor to premedication
* Informed consent signed

Exclusion Criteria:

* Pregnant or lactating, women
* PAH patients
* patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial biopsy
* Patients with oral anticoagulants

Primary outcomes:
measure: Intensity of dyspnea
timeFrame: 1 day
Secondary outcomes:
measure: VAS Individual scores
timeFrame: 1 day
measure: Blood pressure
timeFrame: 1 day
measure: Desaturation frequency
timeFrame: 1 day
measure: heart rate
timeFrame: 1 day
measure: OAAS Score
timeFrame: 1 day
measure: Bronchoscopy duration
timeFrame: 1 day
measure: Comparison of midazolam total dose
timeFrame: 1 day
Other outcomes:
Locations:
city: Nantes
country: France
facility: Cavailles
Study officials:
References:
Clinical trial NCT05665192: A Study to Assess Real-World Patient-Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib
Official title: Real-World Clinical and Patient Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelofibrosis
Keywords: Primary Myelofibrosis
Thrombocythemia Myelofibrosis
Fedratinib
Ruxolitinib
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 150
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: The study population will consist of participants who have discontinued RUX and will be initiating FEDR prospectively.

Brief summary: The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Primary myelofibrosis (PMF), post- Essential thrombocythemia (ET) Myelofibrosis (MF), or post- Polycythemia vera (PV) MF
* Treated with FEDR and initiated treatment after 16 August 2019.
* Received prior treatment with RUX.
* Had spleen assessed at time of initiation of FEDR by palpation.
* Able to read and speak English
* Willing to provide informed consent
* Willing to provide permission to the site to release her/his medical information to the study investigators according to the study-specific eCRF
* Willing to complete the baseline survey prior to first FEDR

Exclusion Criteria:

* Past or current participant in any FEDR-related clinical trial

Primary outcomes:
measure: Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
timeFrame: Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
measure: Absolute change in TSS assessed by MFSAF
timeFrame: At Baseline, 3 and 6 months post-FEDR initiation
measure: Proportion of participants reporting individual symptoms in TSS assessed by MFSAF
timeFrame: At Baseline, 3 and 6 months post-FEDR initiation
measure: Severity of each reported symptom in TSS assessed by MFSAF
timeFrame: At Baseline, 3 and 6 months post-FEDR initiation
measure: Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC)
timeFrame: At Baseline, 3 and 6 months post-FEDR initiation
measure: Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)
timeFrame: At Baseline, 3 and 6 months post-FEDR initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Cardinal Health Specialty Solutions
state: Ohio
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00196092: Zenith® AAA Endovascular Graft Clinical Study
Official title: Zenith® AAA Endovascular Graft Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 819
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.


Eligibility criteria: Inclusion Criteria:

1. Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.
2. Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.
3. Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.

Exclusion Criteria:

1. Patients less than 18 years of age.
2. Patient with a life expectancy less than 2 years.
3. Patients who are pregnant.
4. Patients unwilling to comply with the follow-up schedule.
5. Patient inability or refusal to give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Roy Greenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03017092: Tobacco Pilot Study for Low Income Smokers
Official title: Tobacco Pilot Study for Low Income Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pilot study to test feasibility of delivering a motivational smoking cessation intervention to low income smokers via a computer tablet.

Detailed description: Twenty Salvation Army clients will be recruited to pilot test a motivational smoking cessation counseling intervention that is delivered via a tablet computer. Study participants will be given brief instructions on how to use the tablet. They will then complete a brief survey on the tablet. This will be followed by the researcher using the tablet to provide the motivational intervention. Finally, study participants will be interviewed to establish this perceptions of the intervention.

Eligibility criteria: Inclusion Criteria:

* current smoker (≥ 10 cigarettes/week for the past six months who are not currently trying to quit)
* age ≥ 18 years
* English speaking/writing

Exclusion Criteria:

* not receiving services for the Salvation Army

Primary outcomes:
measure: Ease of use of tablet-guided tobacco intervention assessed by interview and summarized across study participants
timeFrame: Immediately after exposure to intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
state: Wisconsin
Study officials:
References:
Clinical trial NCT01367392: Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System
Official title: Confirmation of Clinical Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Accurate Navigation to the Lesion
Lead sponsor: ActiViews Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations . The device used in this study is designed to assist the physician in guiding the needle towards the suspected area. This device does not change the procedure of liver biopsy or ablation. The only difference is that a small adhesive pad is placed on the skin and a miniature video camera is attached to the end of the needle. This camera does not enter the body.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
* Subjects scheduled for clinically indicated CT guided percutaneous needle placements in the liver who meet the desired target population described above.
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures.
* Verified home address and phone number to facilitate study follow-up.

Exclusion Criteria:

* Significant coagulopathy that cannot be adequately corrected.
* Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
* Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
* Subjects who are uncooperative or cannot follow instructions.
* Mental state that may preclude completion of the study procedure.
* Pregnant or nursing female subjects.

Primary outcomes:
measure: accuracy
timeFrame: during the procedure
Secondary outcomes:
measure: time
timeFrame: during the procedure
measure: time
timeFrame: during the procedure
measure: radiation
timeFrame: during the procedure
measure: total number of scans
timeFrame: during the procedure
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT04937192: SNP-based Prediction of Recurrence Risk in Kidney Stone Patients
Official title: SNP-based Prediction of Recurrence Risk in Kidney Stone Patients: a Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Stone
Keywords: SNP
Kidney stone
Recurrence
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Xiangya Hospital of Central South University
name: Wuhan University Renmin Hospital
name: The Second Affiliated Hospital of Kunming Medical University
name: Tianjin Medical University Second Hospital
name: Shenzhen People's Hospital
name: 301 Hospital
name: Zhongda Hospital
name: People's Hospital of Xinjiang
name: ZhuZhou Central Hospital
name: Baoshan No.2 People's Hospital
name: Guangdong No.2 People's Hospital
name: Dehong People's Hospital
name: Second Affiliated Hospital of Guangzhou Medical University
name: Jiangmen Central Hospital
name: Huizhou Municipal Central Hospital
name: Yongzhou Center Hospital
name: Longgang District People's Hospital of Shenzhen
First posted: 2021-06-23
Enrollment: 1300
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: Kidney stone former who the stone was removed completely

Brief summary: The goal of this study is to gain new knowledge about genetic risk factors that may affect the kidney stone recurrence. The study seeks to understand if different forms of genes result in an increased risk of kidney stone recurrence.

Detailed description: In this study, investigators are prospectively testing whether SNP are associated with kidney stone recurrence. Investigators will test the hypothesis that SNP predispose kidney stone patients to recurrence.

Investigators hope to identify predictors for the kidney stone recurrence. This would allow the identification of a subpopulation of kidney stone patients that would benefit most from prevention measures.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Kidney stone former who the stone was removed completely.
* Ability to give informed consent

Exclusion Criteria:

* Patient refuses or is unable to give consent

Primary outcomes:
measure: Stone-free survival
timeFrame: From date of stone-free until the date of first stone recurrence (up to 7 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Guohua Zeng, M.D.
role: PRINCIPAL_INVESTIGATOR
References: