louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05759806: Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Official title: Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Decompensated Heart Failure
Lead sponsor: Nephronyx LTD
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 10
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: The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to the hospital with a primary diagnosis of ADHF
* Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score
* Patient with Left Ventricular Ejection Fraction LVEF \>15%
* Patient has compromised response to diuretics
* NT-proBNP \>450 pg/mL if aged \<55 years, \>900 pg/mL if aged between 55 and 75 years and \>1800 pg/mL if aged \>75 years

Exclusion Criteria:

* Patient with active DVT or history of DVT
* Patient has documented or evidence of Renal artery stenosis
* BMI\>35 Kg/m\^2
* Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
* Patient is in Cardiogenic shock
* Patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
* Temperature \> 38°C, or sepsis, or active systemic infection requiring IV anti-microbial treatment
* Patient has shown liver cirrhosis or has signs of liver damage

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 24 hours post device retrieval
measure: Performance/ Procedural success
timeFrame: procedure day
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Poriyya 'Illit
country: Israel
facility: The Baruch Padeh Medical Center, Poriya
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Doron Aronson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05274906: Red and Processed Meat Effects on the Metabolome and Microbiome
Official title: Red and Processed Meat Effects on the Metabolome and Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Controlled Feeding Trial
Healthy Eating Index
Red Meat
Meat
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-03-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over
Primary purpose: OTHER

Brief summary: This controlled feeding trial will identify biomarkers in the metabolome and microbiome that may differ when consuming a healthy diet with or without red and processed meat.

Detailed description: This is a randomized cross-over feeding trial to test whether red and processed meat consumption, in the context of a controlled diet based on HEI-2015, will cause shifts in the metabolome and the microbiome compared to a controlled HEI-2015 diet with no red or processed meat. Twenty healthy adult volunteers will consume two diets in random order: 1) Diet A is based on the Healthy Eating Index-2015 (HEI-2015) and includes no red or processed meat; 2) Diet B is based on the Healthy Eating Index-2015 and includes red and processed meat (HEI-2015-M) as some of the protein sources. Both diet periods last 21 days and an approximately 21-day washout period occurs between diets.

Eligibility criteria: Inclusion Criteria:

* Healthy adult,
* 18-50 years of age,
* able to read, speak, and understand English, and
* willing to come to the Fred Hutchinson Cancer Research Center campus twice weekly during study

Exclusion Criteria:

* known allergy to red or processed meat,
* vegetarian or vegan,
* any religious or personal reason(s) to avoid red and processed meat,
* pregnant an/or exclusively breastfeeding, and/or
* alcohol or recreational drug abuse

Primary outcomes:
measure: Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome
timeFrame: Day 21
measure: Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome
timeFrame: Day 21
measure: Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome
timeFrame: Day 21
measure: Test the Effects of Red and Processed Meat on Gut Microbiome
timeFrame: Day 21
measure: Test the Effects of Red and Processed Meat on Fecal Bacterial Functional Genes
timeFrame: Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Marian L. Neuhouser, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01309906: Evaluation of the Feasibility a New Silicone Hydrogel Contact Lens
Official title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study is to determine the clinical feasibility and to evaluate the product performance of an investigational contact lens.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Be myopic and require lens correction in each eye.
* Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria:

* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study care products.

Primary outcomes:
measure: Visual Acuity
timeFrame: At 1 week follow up
Secondary outcomes:
measure: Percentage of Eyes With > Grade 2 Slit Lamp Findings
timeFrame: At 1 week follow up
measure: Symptoms and Complaints
timeFrame: At 1 week follow up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Tara Vaz, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01543906: Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65)
Official title: An Open-Label, Phase 1b, Safety/Proof-of-Concept Study to Evaluate the Effects of Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Retinitis Pigmentosa (RP)
Lead sponsor: QLT Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

* To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in RP subjects with an autosomal dominant mutation in RPE65.
* To evaluate duration of visual function improvement (if observed) in RP subjects with an autosomal dominant mutation in RPE65 after 7-day treatment with oral QLT091001.
* To evaluate the safety of oral QLT091001 administered once daily for 7 days in RP subjects with an autosomal dominant mutation in RPE65.


Eligibility criteria: Inclusion Criteria:

* Subjects will have RP caused by an autosomal dominant mutation in RPE65, as diagnosed by an ocular geneticist or ophthalmologist.
* Subjects who have a best-corrected standard ETDRS visual acuity of 3 letters or better (20/800 Snellen equivalent) or visible photoreceptor outer segments on OCT/FAF.

Exclusion Criteria:

* Subjects with any clinically important abnormal physical finding at Screening.
* Subjects who have taken any prescription or investigational oral retinoid medication (e.g., Accutane/Roaccutane® or Soriatane/Neotigason®) within 6 months of Day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure.
* Subjects with a history of diabetes or chronic hyperlipidemia, hepatitis, pancreatitis, or cirrhosis.
* Subjects who have taken any supplements containing ≥10,000 IU vitamin A within 60 days of Screening.

Primary outcomes:
measure: Visual field
timeFrame: 12 months
Secondary outcomes:
measure: Safety will be assessed by evaluating the following: adverse events, clinical laboratory results, ECG's and vital signs
timeFrame: 12 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital, McGill University Health Centre
state: Quebec
city: Dublin
country: Ireland
facility: Royal Victoria Eye and Ear Hospital
Study officials:
affiliation: QLT Inc.
name: Sushanta Mallick
role: STUDY_DIRECTOR
References:
citation: Schwartz SG, Wang X, Chavis P, Kuriyan AE, Abariga SA. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa. Cochrane Database Syst Rev. 2020 Jun 18;6(6):CD008428. doi: 10.1002/14651858.CD008428.pub3.
Clinical trial NCT01173406: Education Programme on Continuous Positive Airway Pressure Treatment
Official title: The Efficacy of a Brief Motivational Enhancement Education Programme on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Continuous Positive Airway Pressure treatment
Adherence
Education
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 100
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 purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (CPAP) adherence.

Detailed description: Obstructive sleep apnoea (OSA) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent both in populations of western and eastern countries. Continuous positive airway pressure (CPAP) therapy is an effective standard treatment and is widely prescribed for patients with OSA. However, the use of CPAP for such patients is disappointingly low. Low patient CPAP adherence limits the effectiveness of treatment. To determine whether there is a need for an extended education programme for the OSA patient in order to improve CPAP usage.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or over.
2. Newly diagnosed of OSA and will be starting CPAP therapy

Exclusion Criteria:

1. Not suitable for CPAP therapy
2. Previously received CPAP therapy
3. Possesses restrictive and obstructive pulmonary diseases
4. Possesses hypoventilation
5. Under unstable health conditions
6. pregnant
7. History of psychiatric illness

Primary outcomes:
measure: CPAP usage
timeFrame: 12-week
Secondary outcomes:
measure: Daytime Sleepiness
timeFrame: 12-week
Other outcomes:
measure: Self-efficacy measure for Sleep Apnea
timeFrame: 12-week
Locations:
city: Hong Kong Island
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Agnes YK Lai, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lai AYK, Fong DYT, Lam JCM, Weaver TE, Ip MSM. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial. Chest. 2014 Sep;146(3):600-610. doi: 10.1378/chest.13-2228.
citation: Lai AY, Fong DY, Lam JC, Weaver TE, Ip MS. Linguistic and psychometric validation of the Chinese version of the self-efficacy measures for sleep apnea questionnaire. Sleep Med. 2013 Nov;14(11):1192-8. doi: 10.1016/j.sleep.2013.04.023. Epub 2013 Sep 16.
Clinical trial NCT01896206: CNAP Accuracy in the Bariatric Surgery Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare accuracy of a newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) that provides beat-to-beat BP readings with two of the current and more commonly used intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive arterial line (IBP).


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for laparoscopic bariatric surgery for the treatment of obesity
* Patients in whom an indwelling arterial cannula will be placed for the surgical procedure

Exclusion Criteria:

* Patients with history of a peripheral neurologic or neuropathic disorder
* Patients in whom an invasive arterial cannula cannot be placed
* Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
* Edematous patients

Primary outcomes:
measure: The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.
timeFrame: Participants will be followed for the duration of surgery, an expected average of 2 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04129606: Bladder Perforation Post-TURBT: Definition, Incidence and Natural HistoryStudy
Official title: Bladder Perforation Post-TURBT: Definition, Incidence and Natural History. A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Bladder Urothelial Carcinoma
Trauma
Injuries
Perforation of Bladder
Recurrence Tumor
Resection Margin
Seeding, Neoplasm
Keywords: Perforation of Bladder
Bladder Cancer
Resection Margin
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In view of sparse data of precise definition, risk factors, natural history and management of bladder perforation following Transurethral resection of bladder tumour (TURBT). We aim to correlate the relation between the site, depth and extent of resection with bladder perforation. Also, correlation between vertical depth, horizontal extent of resection and recurrence and progression of tumor


Eligibility criteria: Inclusion Criteria:

* papillary bladder tumor (denovo or recurrent)
* resectable nodular bladder tumor

Exclusion Criteria:

* Refuse to complete study requirements
* muscle invasive bladder tumor

Primary outcomes:
measure: Prevalence of bladder perforation post-Transurethral resection of bladder tumour
timeFrame: 24 months
Secondary outcomes:
measure: Correlation between the cystoscopical and radiological bladder perforation
timeFrame: 24 months
measure: assess the recurrence free rate in bladder perforation groups at 2 year follow up
timeFrame: 24 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Mansoura University
name: Nasr Eltabey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04277806: Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age
Official title: Study on the New Feeding Protocol of Promoting Very Preterm Infants to Attain Full Oral Feeding Earlier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study. Standard group: old protocol. Intervention group: New protocol.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators plan to use a new process to shorten the time of attaining full oral feeding in preterm infants less than 30 weeks gestational age.

Detailed description: In the neonatal intensive care unit, the attention of oral feeding of premature infants is far less than that of mechanical ventilation, antibiotics and other medical treatment, the use of parenteral nutrition, etc., and it is often not until the premature infants are enough mature and stable, or even before discharge that the caregivers pay attention to the problem of oral feeding. At this time, the corrected gestational age of premature infants is almost 36 weeks, but in fact the study shows that preterm infants have the ability of self feeding when they are about 32 weeks old. And oral feeding is very helpful to improve their nutritional status, reduce the use of parenteral nutrition and other forms of enteral nutrition, prevent complications and shorten the length of stay. Therefore, this study plans to use a new process to promote oral feeding and to verify whether it is feasible to earlier attainment of full oral feeding in premature infants.

Eligibility criteria: Inclusion Criteria:

* Preterm infants with gestational age less than 30 weeks
* The parents are positive to treat the infants

Exclusion Criteria:

* Fetal edema
* Very critical with OI more than 40
* Apgar score less than 5 at ten minutes after birth
* The parents refuse to treat the infants
* Severe IVH (more than grade IV )
* PVL
* Died before oral feeding starts

Primary outcomes:
measure: Age at full oral feeding
timeFrame: During the procedure
Secondary outcomes:
measure: The length of hospital stay
timeFrame: During the procedure
measure: Incidence of complications
timeFrame: During the procedure
measure: Corrected gestational age at full oral feeding
timeFrame: During the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT03058406: A Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas
Official title: Special Use Investigation of HALAVEN (HAL03T) - Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma, Soft Tissue
Keywords: Sarcoma, Soft Tissue
Halaven Injection
E7389
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-20
Enrollment: 256
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice.

Brief summary: The purpose of this study is to understand safety and efficacy in participants with soft tissue sarcomas.


Eligibility criteria: Inclusion Criteria:

- Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
timeFrame: up to 2 years
Secondary outcomes:
measure: Survival Rate at Year 2
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
References:
citation: Kawai A, Narahara H, Takahashi S, Nakamura T, Kobayashi H, Megumi Y, Matsuoka T, Kobayashi E. Safety and effectiveness of eribulin in Japanese patients with soft tissue sarcoma including rare subtypes: a post-marketing observational study. BMC Cancer. 2022 May 11;22(1):528. doi: 10.1186/s12885-022-09527-y.
citation: Kobayashi E, Naito Y, Asano N, Maejima A, Endo M, Takahashi S, Megumi Y, Kawai A. Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes. Jpn J Clin Oncol. 2019 Oct 1;49(10):938-946. doi: 10.1093/jjco/hyz096.
Clinical trial NCT00630006: Genetic Polymorphisms of Interleukin-10 and TNF-α on Outcome of HCV-Related Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C Virus Infection
Chronic Liver Disease
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2008-03-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The prognosis of chronic hepatitis C virus (HCV)infeciton varies from minimal progressive disease to cirrhosis or hepatocellular carcinoma. Host genetic factors contribute to disease severity. It is known that cytokine gene (including tumor necrosis factor-alpha (TNF-alpha) and interleukin-10 (IL-10) polymorphism affect disease prognosis.This study aims to assess the effect of TNF-alpha and IL-10, and their interaction,on prognosis of HCV-related chronic liver disease


Eligibility criteria: Inclusion Criteria:

* Anti-HCV-positive patients

Exclusion Criteria:

* Anti-HCV-negative patients

Primary outcomes:
measure: cytokine gene polymorphism
timeFrame: years
Secondary outcomes:
measure: cytokine gene polymorphism on severity of disease
timeFrame: years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Assistant Professor
name: Jen-Eing Jeng, M.D.
role: PRINCIPAL_INVESTIGATOR
References: