louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05438225: Text Message Reminders for Hearing Healthcare
Official title: Automated Text Message Reminders to Promote Hearing Healthcare Access - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: hearing loss; elderly; primary care; text message
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 41
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Many individuals with hearing loss do not receive adequate hearing healthcare. Given their close and long-term relationships with patients, primary care providers (PCPs) could play a vital role in improving access to hearing healthcare. Unfortunately, hearing loss is often underdiagnosed in primary care settings, because hearing screening is not a routine part of primary care visits, and the responsibility often falls on the patient or family to recognize and address the issue. The investigators propose to pilot test the use of text message reminders to encourage elderly patients to discuss hearing assessment with there PCPs. The study objectives are to: 1) design an automated text-messaging reminder system; 2) assess the feasibility of deploying the intervention in a clinical trial setting; and 3) evaluate whether the intervention increases willingness to seek hearing healthcare.


Eligibility criteria: Inclusion Criteria:

* English-speaking adult patients aged 65 and older
* Have not audiometric testing within the past 5 years
* Has had at least one prior visit encounter with a Stanford primary care provider the past 1 year
* Has a cell phone with a valid phone number

Exclusion Criteria:

* History of childhood hearing loss
* Hearing aid users
* Limited English proficiency

Primary outcomes:
measure: Likelihood of patient-physician discussion of hearing loss or hearing assessment
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Likelihood of obtaining audiogram
timeFrame: 3 months after enrollment
measure: Likelihood of obtaining hearing aids
timeFrame: 3 months after enrollment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT00061425: Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG
Official title: Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immuno-LL2: Treatment With 90Y-hLL2 IgG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lymphoma, B-Cell
Keywords: NHL
recurrent B-cell lymphoma
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2003-05-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma (NHL) at different dose levels.


Eligibility criteria: Inclusion:

* Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.)
* Measureable via CT, with at least one lesion \> or = 1.5cm in one or both dimensions. (Splenic tumors in absence of other tumors will not qualify.)
* Radiological studies (ie - CT) must be performed within 4 weeks prior to study start.
* Acceptable tumor burden that will allow adequate follow-up and evaluation.
* Less that 25% bone marrow involvement, determined by bone marrow biopsy.
* Must observe the following washout periods:

At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity.

At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria.

* Must have Karnofsky score \>70% (or equivalent, ECOG 0-2) with expected survival of at least 6 months.
* Serum creatinine \< or = 1.5mg/dl or creatinine clearance \> or = 50ml/min.
* Serum bilirubin \< or = 2mg/dl.
* Hemoglobin \> or = 10 g/dl; WBC \> or = 3000/mm3; granulocyte count \> or = 150/mm3; platelet count \> or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study.
* Immunomedics ELISA assay of HahLL2 \< 100ng/ml for those with prior history of monoclonal antibody infusions.
* Cognizant informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gilead Sciences
name: William Wegener
role: STUDY_DIRECTOR
References:
Clinical trial NCT03867825: Hemodynamic Monitoring of Newborn Infants With Impedance Cardiography Versus Echocardiography; a Validation Study
Official title: Hemodynamic Monitoring of Newborn Infants With Impedance Cardiography Versus Echocardiography; a Validation Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hemodynamics
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Knut Helge Kaspersen, MD
name: Per Ivar Kaaresen, MD, PhD
name: Nils Thomas Songstad, MD, PhD
name: Ganesh Acharya, Professor
First posted: 2019-03-08
Enrollment: 0
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term healthy infants

Brief summary: Background:

Impedance cardiography (ICG) is a noninvasive method for continuous left cardiac output monitoring based on measurement of thoracic electrical bioimpedance. The objective of this study is to validate an ICG device by investigating the agreement in cardiac output (CO; left ventricular output x heart rate) measurements performed by ICG and echocardiography. The ICG device (PhysioFlow) has a new filter technology reducing signal noise and enabling measurements in patients who are moving freely.

Material and Methods

* Design: Prospective observational study.
* Inclusion: 30 healthy term infants between 24 and 48 hours of age, after parental consent
* Methods: Continuous measurement with ICG over a 30 min period and point of care echocardiography
* Primary outcome: Agreement (bis and precision) between measurement of CO with ICG and echocardiography.
* Secondary outcomes: Agreement between other echocardiographic indices of myocardial function and ICG parameters (early diastolic filling ratio, cardiac index, ventricular ejection time and left cardiac work index).
* Statistics: Agreement between ICG and echocardiography data will be evaluated using Bland-Altman statistics, including the calculation of mean bias (average difference between measurements) with corresponding standard deviation and lower and upper limits of agreements (95% confidence interval).


Eligibility criteria: Inclusion Criteria:

* Newborn infants

Exclusion Criteria:

* Infants \> 1 month of age

Primary outcomes:
measure: Cardiac output
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04811625: Pharmacodynamic and Pharmacokinetic Study of PL-ASA
Official title: A Randomized, Open-label, 2-way Crossover Pharmacodynamic and Pharmacokinetic Study of a Novel Pharmaceutical Lipid-aspirin Complex Formulation (PL-ASA) at an 81 mg Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: PLx Pharma
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized, open-label, 2-way crossover pharmacodynamic and pharmacokinetic study of a novel pharmaceutical lipid-aspirin complex formulation (PL-ASA) at an 81 mg dose

Detailed description: This study is a randomized, open-label, 2-way crossover study to assess pharmacodyamic and pharmacokinetic profiles following treatment with PL-ASA and EC-ASA administered under fasting condition at a single dose of 81 mg among the volunteers aged 50 to 75 years.

Eligibility criteria: Inclusion Criteria:

* Male or female non-smoking subjects between the ages of 18 to 75 years inclusive, without known medical conditions requiring treatment
* Consumes on average no more than 2 alcoholic drinks per day for 30 days prior to study

Exclusion Criteria:

* Abnormal baseline laboratory results
* Current prescribed use of aspirin, warfarin or other anticoagulants
* Use of other specific medications within 2 weeks of study start
* History of certain medical conditions
* Subject's platelets are unresponsive to arachidonic acid, as defined as \<60% of aggregation as measured by light transmittance aggregometry

Primary outcomes:
measure: Acetylsalicylic acid and salicylic acid
timeFrame: 24 hours after dosing
Secondary outcomes:
measure: Light transmittance aggregometry
timeFrame: 24 hours after dosing
Other outcomes:
measure: Serum thromboxane B2
timeFrame: 24 hours after dosing
measure: Adverse effects
timeFrame: 24 hours after dosing
Locations:
city: Jacksonville
country: United States
facility: University of Florida C
state: Florida
Study officials:
affiliation: University of Florida
name: Francesco Franchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franchi F, Schneider DJ, Prats J, Fan W, Rollini F, Been L, Taatjes-Sommer HS, Bhatt DL, Deliargyris EN, Angiolillo DJ. Pharmacokinetic and pharmacodynamic profiles of a novel phospholipid-aspirin complex liquid formulation and low dose enteric-coated aspirin: results from a prospective, randomized, crossover study. J Thromb Thrombolysis. 2022 Oct;54(3):373-381. doi: 10.1007/s11239-022-02687-5. Epub 2022 Aug 29.
Clinical trial NCT01838122: Prevalence of HbA1C in Women With PCOS
Official title: Prevalence of HbA1C in Different Categories of Obesity in Women With PCOS'A Propective Randomized Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovarian Syndrome
Pelvic Endometriosis
Insulin Resistance
Non-insulin Dependent Diabetes Mellitus
Tubal Obstruction
Keywords: PCOS
HbA1C
Insulin resistance
OGTT
HOMA-IR
HOMA-B-cell
Lead sponsor: Southern Cross Fertility Centre
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This population will have subjects with diagnosis of PCOS,by Rotterdam criteria regardless of complain(s)

Brief summary: Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes Association has suggested screening of women with PCOS for HbA1C.

Detailed description: In view of recent suggestion of American Diabetes Association(ADA)to screen women with PCOS for HbA1C,we intend to study its prevalence in all categories of obesity in women with PCOS.

Women with PCOS by Rotterdam criteria will be screened for insulin resistance by using different techniques or tests.

Further, the sensitivity and specificity of HbA1C will be compared with sensitivity and specificity of other insulin resistance markers such as OGTT, Free androgen index, free testosterone, fasting insulin to glucose ratio, HOMA-IR and HOMA-B-CELL.

Eligibility criteria: Inclusion Criteria:

1. BMI of 25-35 Kg/Mt2
2. Atleast three of the Rotterdam criteria for diagnosis of PCOS.
3. Subjects with well stabilized Thyroid,if they had documented evidence of previousthyroid disorder.

Exclusion Criteria:

1. Subjects with documented diagnosis of Metabolic Syndrome.
2. Subjects with laparocopic and histopathologic diagnosis of Endometriosis. 3Subjects with Primary hyperprolectineamia.

4.Subjects with basal FSH \>/=15mIU/ml. 5.Subjects with continuously elevated 17-0h-p.

Primary outcomes:
measure: Prevalence of HbA1C in both arms of the cohort of subjects
timeFrame: September 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Southern Cross Fertility Centre
state: Maharashtra
Study officials:
affiliation: Southern Cross Fertility Centre
name: Manchi R Bharucha, Ph.D
role: STUDY_DIRECTOR
affiliation: Souther Cross Fertility Centre
name: Manchi R Bharucha, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Kim JJ, Choi YM, Cho YM, Jung HS, Chae SJ, Hwang KR, Hwang SS, Ku SY, Kim SH, Kim JG, Moon SY. Prevalence of elevated glycated hemoglobin in women with polycystic ovary syndrome. Hum Reprod. 2012 May;27(5):1439-44. doi: 10.1093/humrep/des039. Epub 2012 Feb 21.
Clinical trial NCT06301230: Home- vs. Hospital-based Surgical Training
Official title: The PLET Study: A Randomized Controlled Trial of Home- Versus Hospital-based Surgical Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Training
Keywords: Surgical training
Surgical skill performance
PLET
Portable Laparoscopic Trainer
Lead sponsor: Clarunis - Universitäres Bauchzentrum Basel
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2024-03-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study was to assess the effect of training with a personal, portable laparoscopic endo-trainer (PLET) on residents' laparoscopic skills. All participants were randomised to either a home- or hospital-based PLET training group and surgical skill performance was assessed using five laparoscopic exercises. Endpoints consisted ofsubjective and objective assessment ratings as well as exercise time and qualitative data up to 12 weeks. The primary outcome was the difference in exercise time and secondary outcomes included performance scores as well as qualitative data.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* surgical resident

Exclusion Criteria:

* none

Primary outcomes:
measure: Exercise time
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Assessment rating
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Qualitative feedback
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clarunis Universitäres Bauchzentrum Basel
Study officials:
References:
Clinical trial NCT00635830: An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
Official title: An Open-Label, Single-Dose, Safety and Tolerability Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 26 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HPV Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population.


Eligibility criteria: Inclusion Criteria:

* Subject Is Female, Between The Ages Of 9 Years And 0 Days And 26 Years And 364 Days On The Day Of Enrollment
* Subject (Or, For Minor Subjects, Parent/Legal Guardian And Subject) Fully Understands Study Procedures, Alternative Treatments Available, The Risks Involved With The Study, And Voluntarily Agrees To Participate By Giving Written Informed Consent
* Subject Is Able To Read, Understand, And Complete The Vaccination Report Card

Exclusion Criteria:

* Subject Is, At The Time Of Signing Informed Consent, A User Of Recreational Or Illicit Drugs Or Has Had A Recent History (Within The Last Year) Of Drug Or Alcohol Abuse Or Dependence. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social, Interpersonal, And/Or Legal Problems As A Result Of Alcohol Use
* Subject Has A History Of Severe Allergic Reaction (E.G., Swelling Of The Mouth And Throat, Difficulty Breathing, Hypotension Or Shock) That Required Medical Intervention
* Subject Has Known Allergy To Any Vaccine Component, Including Aluminum, Yeast, Or Benzonase (Nuclease, Nycomed \[Used To Remove Residual Nucleic Acids From This And Other Vaccines\])

Primary outcomes:
measure: Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination
timeFrame: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05789030: Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement
Official title: Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autoimmune Diseases
Keywords: Immunoglobulin G4-Related Disease
treatment strategies
iguratimod
leflunomide
relapse
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of three treatment strategies in IgG4-RD patients with superficial organ involvement: Diprospan plus iguratimod, Diprospan plus leflunomide and prednisone plus leflunomide.

Detailed description: 90 IgG4-RD patients with superficial organ involvement are enrolled in this study and randomly divided into three groups at a 1:1:1 ratio: patients in group I are treated with Diprospan (1mL im) and then with iguratimod (25mg bid); patients in group Ⅱ are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd); and patients in group Ⅲ are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd). All patients will be followed up for 12 months, and clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded during follow up. The primary endpoint is the difference of relapse rate between two groups at 12 months. The secondary endpoints are relapse time, response rate and side effects.

Eligibility criteria: Inclusion Criteria:

* 1. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment; 3. The addition of glucocorticoids was started at lower than 10 mg/d.

Exclusion Criteria:

* 1. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection: HIV, HCV, HBV, TB； 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.

Primary outcomes:
measure: The difference of relapse rate of IgG4-RD among 3 groups in 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: The difference of the time at baseline to first relapse among 3 groups
timeFrame: 12 months
measure: The difference of the response rate of the treatment among the 3 groups.
timeFrame: 12 months
measure: Side effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00089830: A Safety and Efficacy Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: Subfoveal Choroidal Neovascularization
Squalamine Lactate
Lead sponsor: Genaera Corporation
Sponsor class: INDUSTRY
First posted: 2004-08-17
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of "wet" age-related macular degeneration

Exclusion Criteria:

* Prior treatment of "wet" age-related macular degeneration in the affected eye in the past 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth Meeting
country: United States
facility: Genaera Corporation
state: Pennsylvania
Study officials:
References: