louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00683501: Safety, Efficacy, and Pharmacokinetic Profile of DNB-001 in Subjects With Elevated Intraocular Pressure
Official title: A Phase II Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients With Elevated Intraocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ocular Hypertension
Elevated IOP
Glaucoma
Keywords: ocular hypertension
elevated IOP
glaucoma
neuroprotection
Lead sponsor: Danube Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 54
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: A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase 1I Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients with intraocular Hypertension

Detailed description: To evaluate the efficacy of four dosages of mg DNB-001 administered twice daily (bid) per os (p.o.) as an anti-ocular hypertensive agent, compared with placebo administered bid po, for 28 days, in patients with ocular hypertension.

Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years old, in general good health, not presently treated for elevated intraocular pressure (IOP), with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/50 or better in each eye and lOP of 21 to 29 mm Hg at baseline.

Exclusion Criteria:

* Use of intraocular pressure lowering medication within the past 3 months or any history of ocular surgery for glaucoma
* Evidence of potential angle closure by gonioscopy
* Abnormal optic disc or visual field consistent with glaucoma
* Use of topical ocular medications during the study and any evidence of systemic disease that might interfere with the conduct of the study.

Primary outcomes:
measure: The reduction of IOP as calculated on the basis of the arithmetic mean of up to six measurements of IOP, comparing baseline to visit 6
timeFrame: 28 days of therapy
Secondary outcomes:
measure: Percentage change and responder rates - e.g., > 20% reduction in lOP values from baseline to Day 21, Day 14 and Day 7
timeFrame: 7, 14, 21 days of therapy
Other outcomes:
Locations:
city: Chippenham
country: United Kingdom
facility: Omnicare Clinical Research Center
state: Wiltshire
Study officials:
affiliation: CEO, CMO, Danube Pharmaceuticals, Inc.
name: Barrett Katz, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06904001: Study on the Construction and Application of Early Warning Model of Sepsis in Critically Ill Patients
Official title: Study on the Construction and Application of Early Warning Model of Sepsis in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sepsis
Sepsis and Septic Shock
Infection
Keywords: sepsis
septic shock
biomarker
warning model
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU with sepsis, aged over 18 years.

Brief summary: The condition of sepsis patients changes rapidly, whom are often accompanied by impaired respiratory, circulatory, renal, and coagulation functions. So far, the prognosis of sepsis at home and abroad is not ideal. Participants was randomly included in this research project on the pathogenesis and prevention of sepsis due to typical sepsis symptoms. the investigators will collect appropriate clinical specimens for analysis of immune cell functions and pathogenic microorganisms combined with individual patient research. This study will enable sepsis patients to be identified early and receive earlier anti-sepsis treatment, which is expected to improve the prognosis of sepsis, shorten hospitalization time, and reduce treatment costs.

The above-mentioned tests and analyses do not increase the economic burden on the participants, and the required expenses are all paid from the project funds; they do not affect the prognosis and rehabilitation process of participants, and do not have adverse effects on the health of participants.


Eligibility criteria: Inclusion Criteria:

1. Temperature \> 38°C or \< 36°C;
2. Heart rate \> 90 beats/min;
3. Respiratory rate \> 20 breaths/min or PaCO₂ \< 32 mmHg;
4. White blood cell count \> 12.0 × 10⁹/L or \< 4.0 × 10⁹/L, or \> 10% immature neutrophils;
5. Initial septic shock diagnosis;
6. Organ dysfunction (cardiovascular, respiratory, or ≥ 2 other organs);
7. Complete clinical data.

Exclusion Criteria:

1. Cancer history;
2. Chemotherapy;
3. Radiotherapy;
4. Incomplete data.
5. Controls were free of infectious or inflammatory diseases and glucocorticoid use.

Primary outcomes:
measure: Death
timeFrame: From the date of first ICU admission to the date of ICU discharge (whether due to death or clinical improvement), assessed up to 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03925701: Clinical Study Evaluating Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
Official title: Clinical Study Evaluating the Effectiveness of Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: dm
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 120
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: Clinical study evaluating vildagliptin versus vildagliptin/metformin on NAFLD with DM.

Detailed description: Clinical study evaluating vildagliptin versus vildagliptin/metformin on nonalcoholic fatty liver disease with DM.

Eligibility criteria: Inclusion Criteria:

* NAFLD and type 2 DM

Exclusion Criteria:

* Viral hepatitis.
* Child score more than 6.
* renal impairment.

Primary outcomes:
measure: number of patients with improved nafld and insulin resistance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
affiliation: Tanta University - Faculty of Pharmacy
name: Aya G Moussa, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof of Clinical Pharmacy
name: Osama M Ibrahim, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof of Clinical Pharmacy
name: Gamal Alazab, ass. Prof.
role: STUDY_DIRECTOR
affiliation: Tanta University-Faculty of Medicine
name: Yasser Abdel Raouf, Ass Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04253301: Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Official title: Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Venous Insufficiency
Lead sponsor: InnoVein
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 5
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 objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.

Detailed description: Chronic Venous Insufficiency occurs when the venous wall and/or valves in the leg veins are not working effectively, making it difficult for blood to return to the heart from the legs.The core etiology of the disease stems from increased venous pressure and incompetent venous valves leading to regurgitation of blood that accumulates in the legs. It has been shown that implantation or recreation of a functional valve can lead to clearance of excess blood and resolution of symptoms.

The InnoVein Valve and Delivery System is a new, investigational biocompatible valve intended to support natural flow in vessels in patients with Chronic Venous Insufficiency. The purpose of this study is to assess the safety of the InnoVein Valve and Delivery System for treatment of Chronic Venous Insufficiency.

Eligibility criteria: Key Inclusion Criteria:

* Willing and able to provide written Informed Consent
* Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein
* Willing and medically able to receive intraprocedural and post-procedural anticoagulation medication
* Life expectancy \>1yr
* Reflux time \>1s in the superficial femoral and/or popliteal vein

Key Exclusion Criteria:

* Any prior deep vein intervention within 6 months prior to the Index Procedure
* History of 2+ DVTs
* Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or IVC
* Current IVC Placement
* History of pulmonary embolism within 6 months
* Conditions that increase the risk of device thrombosis or patient bleeding
* Any planned surgical or interventional procedure within 30 days prior to or after the Index Procedure
* Investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol

Primary outcomes:
measure: Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Hollywood Private Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Adelaide
country: Australia
facility: Flinders
Study officials:
References:
Clinical trial NCT01096901: Choose to Lose for Women-Weight Loss to Reduce Breast Cancer Risk Factors
Official title: Weight Loss to Reduce Breast Cancer Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Overweight
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 19
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is investigating the changes in specific hormone levels in women age 30-45 after a 12 week weight loss intervention.

Detailed description: In sum, excess body weight and inactivity have emerged as strong avoidable causes of postmenopausal breast cancer, with the greatest potential for primary prevention occurring during the premenopausal years. However, surprisingly, no study to date has examined the effects of a standard behavioral weight loss intervention on breast cancer risk markers in premenopausal women. Understanding the effects of weight loss in premenopausal women is a critical next step in existing research and will inform the development of future breast cancer primary prevention programs. The purpose of this study is to determine the feasibility of recruiting, treating, and retaining 20 overweight/obese women in a 12-week randomized control trial examining feasibility and effects of a behavioral weight loss program on breast cancer risk markers in premenopausal women. Participants will be randomly assigned to either a 12-week comprehensive behavioral weight loss program (n=10) or control condition (n=10). All women will be assessed at baseline and after 3 months of treatment.

Eligibility criteria: Inclusion Criteria:

* Premenopausal women
* Age 30-45
* Current BMI of \>25
* English or Spanish speaking
* 5th grade reading level
* Menstrual regularity, defined as menstrual cycle length of 27-31 and \< 1 missed period within the past 12 months.

Exclusion Criteria:

* Current use or recent (\< 6 months) use of oral contraceptives, hormones, or other hormone-influencing medications
* Pregnant, lactating or planning pregnancy in the next 12 weeks
* Unwilling and able to location for intervention visits.
* Serious medical condition requiring the supervision of a physician for exercise and diet
* History of eating disorder
* History of or current use of drugs
* Current treatment for serious psychological disorder
* Donation of blood within past 6 weeks.

Primary outcomes:
measure: Weight loss for one group
timeFrame: 3 months
Secondary outcomes:
measure: Increased physical activity
timeFrame: 3 months
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
Study officials:
affiliation: California Polytechnic State University-San Luis Obispo
name: Suzanne Phelan, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03197701: Maximal Effort-dependent Respiratory Flow Rates
Official title: Maximal Effort-dependent Respiratory Flow Rates: Reproducibility and Reference Values
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Function
Keywords: Lung function
Inspiratory flow rates
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal healthy subjects

Brief summary: The general objective of this project is to determine the best method to measure maximal inspiratory flow rates, to study their reproducibility and create reference equations in healthy subjects.

Detailed description: 1. Reproducibility and reference values in normal subjects: the investigators will propose a method for measurement of the maximal inspiratory flow rates (MIFR) and establish their reproducibility in normal subjects. The variability of these inspiratory flow rates will be compared with the variability of effort dependent and non-effort dependent expiratory flow rates.

   Also, reference equations will be drawn up and compared to the only existing set of reference values (2) (needing a revision).
2. Reproducibility in disease: the investigators will evaluate the reproducibility of the MIFR in patients with neuromuscular diseases (Steinert muscular dystrophy, amyotrophic lateral sclerosis) and with upper airway obstruction (tracheal stenosis, thyroid enlargement) and compare to the reproducibility of expiratory flow rates in this population.
3. Monitoring of diseases: In the neuromuscular patients MIFR will be correlated to the existing parameters used for monitoring of these diseases (respiratory muscle strength, forced vital capacity), with a longitudinal follow-up.

In the patients with upper airway obstruction the MIFR (quantitative measurement) will be compared to the visual inspection (qualitative interpretation) of the maximal flow-volume loop and also the evolution after a therapeutic intervention (airway stenting, thyroidectomy) will be monitored.

Eligibility criteria: Inclusion Criteria:

* healthy hospital workers or visitors

Exclusion Criteria:

* current smokers or ex-smokers with a history of \> 80 PY
* Presence or history of serious illness or thorax deformity (questionnaire)
* recent respiratory tract infection (1 week)

Primary outcomes:
measure: Normal values for maximal inspiratory flow rates
timeFrame: 3 years
measure: Normal values for maximal inspiratory flow rates
timeFrame: 3 years
Secondary outcomes:
measure: Reproducibility of maximal inspiratory flow rates
timeFrame: 3 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Shane Hanon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01815801: Effect of Mechanical Ventilation on the Incidence of Pneumothorax After Subclavian Vein Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subclavian Vein Catheterization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 334
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether mechanical ventilation influences the incidence of pneumothorax after subclavian venous catheterization.


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing neurosurgery that requires the placement of subclavian venous catheterization

Exclusion Criteria:

* infection over the puncture site
* history of prior clavicular fracture
* anatomical anomaly of subclavian vein
* Pneumothorax

Primary outcomes:
measure: incidence of pneumothorax
timeFrame: an expected average of one day after surgery
Secondary outcomes:
measure: catheterization success rate
timeFrame: an expected average of one day after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03615001: T-DOC® NXT Clinical Investigation
Official title: Assessing the Performance, Safety and Usability of Our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence, Urge
Lead sponsor: Laborie Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies


Eligibility criteria: Inclusion Criteria:

* Male and Female (Adult age 21+)
* Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.

Exclusion Criteria:

* Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria)
* Patients who are pregnant
* Patients with recent (less than 2 weeks) pelvic floor surgery
* Patients who require the use of a suprapubic catheter
* Patients with significant cognitive deficiency that prevent the patient from giving informed consent

Primary outcomes:
measure: The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults.
timeFrame: 2 months
measure: The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Franklin Square Hospital/White Marsh
state: Maryland
Study officials:
References:
Clinical trial NCT00991601: Ultra Sound Guided Fine Needle Aspiration Cytology (FNAC) of Liver and Pancreas Tumours
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Tumors in Liver
Tumors in Pancreas
Keywords: liver
pancreas
cancer
tumor
FNAC
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with tumors in liver or pancreas are randomized to ultrasound (UL)-guided FNAC biopsies with guidance method or UL-guided FNAC biopsies with free-hand method.


Eligibility criteria: Inclusion Criteria:

* adult over 18 years
* tumors in liver and/or pancreas

Exclusion Criteria:

* low coagulation factors
* mentally ill patients.

Primary outcomes:
measure: quality of obtained biopsy
timeFrame: one year
Secondary outcomes:
measure: patients pain and discomfort at procedure
timeFrame: immediately
Other outcomes:
Locations:
city: DK-2730, Herlev
country: Denmark
facility: Herlev Hospital
state: Herlev
Study officials:
affiliation: Herlev Hospital
name: Jakob Burcharth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev Hospital
name: Bjørn Skjoldbye, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00716001: Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Renal Failure
Keywords: patients with chronic renal failure undergoing elective percutaneous coronary intervention
Lead sponsor: Osaka General Medical Center
Sponsor class: OTHER
First posted: 2008-07-15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.


Eligibility criteria: Inclusion Criteria:

* patients with chronic renal failure(serum creatinine \>1.1mg/dl) undergoing elective percutaneous coronary intervention

Exclusion Criteria:

* administered with sodium bicarbonate and/or N-acetylcysteine and/or contrast media within 72 hours.
* pregnancy
* congestive heart failure
* allergy to sodium bicarbonate and/or N-acetylcysteine
* hemodialysis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: