louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04565171: Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD
Official title: A Single-center, Non-randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and End-stage Renal Disease Without Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir phosphate capsule in participants with End-stage renal disease without hemodialysis using matched healthy participants as a control group.


Eligibility criteria: Inclusion Criteria:

1. male or female, age 18 to 70 years of age, inclusive;
2. must have a calculated body mass index (BMI) from 18 to 28 kg/m2 at study screening;
3. Glomerular filtration rate must be \< 15 mL/min /1.73 m2 for End-stage renal disease without hemodialysis group, and ≥ 90 mL/min for Normal Renal Function group(using MDRD method);
4. matched for age (±5 years) ,gender and BMI(±15%) with a subject in the End-stage renal disease without hemodialysis group;

Exclusion Criteria:

1. allergies constitution ( multiple drug and food allergies);
2. Use of \>5 cigarettes per day during the past 3 months;
3. A positive test results for HbsAg, Hepatitis C antibody, HIV-1 antibody, or Treponema pallidum antibody；
4. History of alcohol abuse；
5. Donation or loss of blood over 400 mL within 3 months prior to the first dose of study drug；
6. Subjects deemed unsuitable by the investigator for any other reason.

Primary outcomes:
measure: Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC
timeFrame: From Days 1-5
measure: Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax
timeFrame: From Days 1-5
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: From Days 1-5
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: jia Miao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390415: A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)
Official title: A Retrospective Survey to Evaluate the Renoprotective Effect of Losartan in Type II Diabetic Patients With Microalbuminuria and Hypertension in Real Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with diabetes mellitus and hypertension treated with losartan 50 mg or 100 mg for at least 6 months in a hospital setting in Taiwan

Brief summary: This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus
* Hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months
* Microalbuminuria (defined as microalbuminuria \> 30 mg/g and \< 300 mg/g by spot urine test)
* Serum creatinine ≤1.5 mg/dL for men and ≤1.4mg/dL for women
* Urinalysis with white blood cells (WBC) \<5 cells per high power field
* Results of hemoglobin A1c (HbA1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available
* Medical history and co-morbidities (if available) listed in medical records
* Prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available

Exclusion criteria:

* Treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB) before initiated treatment with losartan 50 mg or losartan 100 mg
* Enrollment in another clinical trial

Primary outcomes:
measure: Number of Participants With Macroalbuminuria After 6 Months of Treatment
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Systolic Blood Pressure (SBP)
timeFrame: Baseline and Month 6
measure: Diastolic Blood Pressure (DBP)
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02308215: Retinal Therapy Guided by 3D OCT Image Analysis
Official title: Retinal Therapy Guided by 3D OCT Image Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Choroidal Neovascularization
Keywords: Retina
AMD
OCT
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2014-12-04
Enrollment: 77
Sex: ALL
Minimum age (years): 45
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The proposed research will be carried out in patients diagnosed with Choroidal Neovascularization associated with AMD selected from retina care clinic.

Brief summary: The main purpose is to find a better way to predict the timing of treatments given to patients with Wet Age-related macular degeneration using image analysis.

Detailed description: The study focuses on making better use of advanced three-dimensional imaging and analysis to allow physicians to know when a treatment is being effective and thus not overuse it. The study will examine how 3-D optical coherence tomography and related image analysis can be used to assess changes in the macula and retina of patients' eyes. These changes can reveal how well a person is responding to anti-VEGF treatment and thus help doctors provide proper treatment timing and care.

Eligibility criteria: Inclusion Criteria:

* fundoscopically confirmed AMD and patient eligible for treatment with anti-VEGF

Exclusion Criteria:

* Patients with a CNV due to other causes (OHS, trauma)
* eyes that have been previously treated for CNV

Primary outcomes:
measure: Measure central retinal layer thickness in µms.
timeFrame: one year
measure: Measure amount of fluid in the retina in µms.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals Dept of Ophthalmology
state: Iowa
Study officials:
affiliation: University of Iowa
name: Michael D Abramoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Milan Sonka, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02994615: Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy
Official title: Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy: The Index of MicrovAscular Resistance (IMR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Keywords: Index of Microvascular Resistance
Microvascular dysfunction
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic hypertrophic cardiomyopathy versus controls (patients undergoing coronary angiography and FFR

Brief summary: Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter monitor.


Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Already have an indication for coronary angiography
* Previous diagnosis of hypertrophic cardiomyopathy (unless control)

Exclusion Criteria:

* Fractional flow reserve found to be significant (FFR \< 0.8)
* Already have a condition associated with or likely to be associated with an elevated IMR (diabetes, cardiac syndrome X, takotsubo cardiomyopathy, hypertensive cardiomyopathy, severe aortic stenosis, STEMI)

Primary outcomes:
measure: IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls
timeFrame: 1 day
Secondary outcomes:
measure: Number of ventricular tachycardia
timeFrame: 6 months
measure: Chest pain - Canadian Cardiovascular Society (CCS) class
timeFrame: Up to 6 months
measure: Shortness of breath - NYHA class
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
Study officials:
affiliation: London Health Sceinces Centre
name: Shahar Lavi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06035315: The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
Official title: The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Care Patterns
Nutrition, Healthy
Nutritional Deficiency
Maternal-Fetal Relations
Perinatal Outcome
Maternal Outcome
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 240
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial : comparison of two clusters
Primary purpose: PREVENTION

Brief summary: To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes

Detailed description: A randomized control trial of two clusters :

1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients.

Differences between cluster : Additional multi micronutrients by giving : Complete multi micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given since 1st until 3rd trimester for interventions group. There are also additional laboratory examinations for intervention group : Vitamin D, Lipid Profile and Zinc level.

In control group : we use standard public health care micronutrients (Iron supplementation and calcium); and standard blood examinations.

Ultrasound examination was performed for both cluster since 1st until 3rd trimester.

Eligibility criteria: Inclusion Criteria:

* First trimester pregnancy
* Gestational age \< 10 weeks gestation
* Agree as research participant
* Living in DKI Jakarta

Exclusion Criteria:

* Assisted Reproductive
* History of PCOS
* History of Chronic Hypertension
* History of Diabetes Mellitus
* History of Preeclampsia
* Maternal chronic disease : Cardiovascular disease; Autoimmune condition; Malignancy)
* Plan to move from Jakarta prior or during pregnancy
* History of Recurrent pregnancy loss

Primary outcomes:
measure: Maternal Outcome
timeFrame: 1 year
measure: Perinatal Outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
Study officials:
References:
Clinical trial NCT00644215: Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early Bleb Failure
Official title: Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bleb
Keywords: injected bleb
mitomycin drop
5-Fu injection
early bleb failure
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure .

Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with low,injected bleb in first month after trabeculectomy or combined trabeculectomy\&phaco which not respond to high frequent topical steroids or removal of releasable sutures

Exclusion Criteria:

* Injected bleb due to complications of surgery such as button hole formation
* Injected bleb due to blebitis
* Bleb leakage
* Flat AC
* Pregnant or nursing mothers
* Injected bleb after bleb reconstruction

Primary outcomes:
measure: Iop and Bleb height,extent and vascularity
timeFrame: At least in 3 months of follow up
Secondary outcomes:
measure: complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,
Study officials:
References:
Clinical trial NCT01136915: Kidney Damage In Patients With Severe Fall In eGFR
Official title: A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Severe Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Stenosis
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2010-06-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration \[eGFR\] \< 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.


Eligibility criteria: Inclusion Criteria:

* Provides written Informed Consent
* Is at least 18 years of age;
* Is scheduled for or likely to undergo percutaneous coronary intervention;
* Has documented estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.

Exclusion Criteria:

* Is a pregnant or lactating female
* Has a history of severe congestive heart failure
* Has a history of hyperthyroidism
* Has unstable renal function
* Has a history of hypersensitivity to iodinated contrast agents

Primary outcomes:
measure: Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.
timeFrame: Baseline and 2,4,6,24, 48, and 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institu De Cardiologie De Montreal
state: Quebec
Study officials:
References:
Clinical trial NCT04996615: Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening Breast Cancer in High-risk Women
Official title: Peking University People's Hospital Breast Center
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Magnetic Resonance Imaging
Keywords: breast cancer
screening
high risk women
magnetic resonance imaging
deep learning
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 5000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 23

Brief summary: Use Convolutional Neural Networks Analysis for Classification of Contrast-enhancing Lesions at Multiparametric Breast MRI. Build an abbreviated protocal, and investigate whether an abbreviated protocol was suitable for breast magnetic resonance imaging screening for breast cancer in high-risk Chinese women, which can shorten the examination time and avoid enhanced imaging while ensuring the accuracy of the diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing full sequence BMRI examination
* Written informed consent and complete the clinical data questionnaire
* Through the follow-up database, at least 6 months of follow-up results can be obtained to determine whether the diagnosis result is negative/benign/malignant; for patients who need pathological biopsy, the pathological biopsy results shall prevail to determine the lesion benign/malignant.

Exclusion Criteria:

* The breast had received radiotherapy, chemotherapy, biology and other treatments before BMRI.
* Signs or symptoms of breast disease
* There are contraindications for breast-enhanced MRI examinations such as allergy to contrast agents.
* Patients during lactation or pregnancy

Primary outcomes:
measure: screening yield
timeFrame: 5 years
Secondary outcomes:
measure: The accuracy of radiologists and deep learning models
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university people's hospital
state: Bei Jing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02374515: Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.
Official title: Endocuff-assisted Colonoscopy: a Randomized Back-to-back Colonoscopy Study of Adenoma Detection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenomatous Polyps
Lead sponsor: University of Naples
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 275
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: This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.

Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.


Eligibility criteria: Inclusion Criteria:

* Colonoscopy: Screening , Surveillance, Diagnostic

Exclusion Criteria:

* Pregnancy
* age\<18 years
* age \> 80 years
* known colonic strictures
* chronic inflammatory bowel disease
* active inflammation

Primary outcomes:
measure: adenoma detection rate
timeFrame: 20 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: Federico II University
name: Giovanni D. De Palma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01200615: The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects
Official title: The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: nocebo side-effects SSRI informed consent
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: In this study we invetigate the influence of the nocebo effect (as part of obtaining informed consent) on the prevalence of side-effects. The study is prospective, focusing on the connection between what the physicians says to the patient about side-effects to the frequency of these side effects during treatment period. We also inquire whether informing the patient about the existence of the nocebo effect influences the extent of phenomena.

Detailed description: In this study the investigators wish to inquire whether the nature of the explenation given to the patient as part of informed consent has an effect on the prevalence of side-effects. The study will take place in the out-patient clinic at the Shalvata Mental health Center. Three arms are included:

1. 50 patients started on SSRI's will be updated about its common side effects
2. 50 patients started on SSRI's will be updated about its common side effects and will receive an explenation on the nocebo effect
3. 50 patients started on SSRI's will receive an explenation on the nocebo effect, but will not be updated about common side-effects. Nonetheless, they will be informed of severe side-effects.

Following the prescription of an SSRI the subjects will we enter the follow-up phase of the study. They will attend two follow-up meetings: 3 days after the initiation point and one month after the starting point. During each meeting they will be asked to fill the Antidepressant Side-Effect Checklist (ASEC)and the General Health Questionnaire (GHQ).

Eligibility criteria: Inclusion Criteria:

1. age 18-60
2. started on an SSRI

Exclusion Criteria:

* Psychotic spectrum disorder
* Suicidality
* Sensitivity to SSRI
* Has taken the prescribed SSRI in the past

Primary outcomes:
measure: The prevalence of side-effects
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
Study officials:
affiliation: Shalvata Mental Health Center
name: Uri Nitzan, MD
role: PRINCIPAL_INVESTIGATOR
References: