louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04173403: A Long-term Study of AK102 in Patients With Hypercholesterolemia
Official title: A Long-term Study to Evaluate the Efficacy and Safety of AK102 in Combination With Lipid-lowering Therapy in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: Akeso
Sponsor class: INDUSTRY
Collaborators: name: AD Pharma (Guangdong)
First posted: 2019-11-22
Enrollment: 796
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 is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent.
2. Body weight ≥ 40 kg for both men and women.
3. Participated in the AK102-202 study, and completed the AK102-202 study last visit.

Exclusion Criteria:

1. Poor compliance in AK102-202 study per investigator's judgement.
2. AE that led to permanent discontinuation of AK102 occurred during the AK102-202 study period.
3. Prior use of PCSK9 inhibitors other than AK102.

Primary outcomes:
measure: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0
timeFrame: From baseline through 52 weeks
measure: Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol
timeFrame: From baseline through 52 weeks
measure: Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol
timeFrame: From baseline through 52 weeks
measure: Percent Change From Baseline in Serum Triglyceride (TG) cholesterol
timeFrame: From baseline through 52 weeks
measure: Percent Change From Baseline in Apolipoprotein B (Apo B)
timeFrame: From baseline through 52 weeks
measure: Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)
timeFrame: From baseline through 52 weeks
measure: Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC)
timeFrame: From baseline through 52 weeks
measure: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
timeFrame: From baseline through 52 weeks
measure: Concentrations of AK102 in Serum
timeFrame: From baseline through 52 weeks
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: From baseline through 52 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shuyang Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06616103: Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB
Official title: Utility of Quantitative Imaging Parameters from Deep Learning-based CT Segmentation in Assessing Hepatic Steatosis and Fibrosis in Chronic Hepatitis B: a Prospective Study Using MRI As the Reference Standard
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Hepatitis B
Steatosis of Liver
Fibrosis and Cirrhosis of Liver
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 111
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B who follow up at Seoul National University Hospital having no history of hepatic malignancies

Brief summary: This study aims to evaluate diagnostic performance of CT attenuation parameters acquired using deep learning algorithm in assessing hepatic steatosis and fibrosis.


Eligibility criteria: Inclusion Criteria:

* chronic hepatitis B
* no chronic liver disease other than chronic hepatitis B
* Body mass index \&gt;= 23

Exclusion Criteria:

* pregnant women
* unable to perform MRI examinations due to claustrophobia or metallic foreign body
* suspicious hepatic malignancy on previous imaging studies
* history of local treatment for hepatic lesions
* history of surgery or catheter insertion of liver or spleen

Primary outcomes:
measure: diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis
timeFrame: At the time of enrollment
Secondary outcomes:
measure: Consistency between MRI-derived body composition data and CT-derived data
timeFrame: At the time of enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03864003: Community Health Workers and Teleaudiology as a Culturally-relevant Approach to Improving Access to Hearing Health Care
Official title: Community Health Workers and Teleaudiology as a Culturally-relevant Approach to Improving Access to Hearing Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test the feasibility of a teleaudiology intervention with assistance from Community Health Workers to improve access to hearing health care.


Eligibility criteria: Inclusion Criteria:

* Bilateral hearing loss within the fitting range of study hearing aids

Exclusion Criteria:

* Medically unqualified to receive hearing aids
* Current hearing aid user
* Cognitively impaired

Primary outcomes:
measure: Self-efficacy: The Self-Efficacy for Situational Communication Management Questionnaire
timeFrame: Baseline, 2 weeks, 6 weeks, and 12 weeks after hearing aid fitting
Secondary outcomes:
measure: Hearing aid benefit
timeFrame: Baseline, 6 weeks, and 14 weeks after hearing aid fitting
measure: Satisfaction with teleaudiology service delivery
timeFrame: 2 weeks after hearing aid fitting
measure: Qualitative outcomes via semi-structured interviews
timeFrame: 14 weeks after hearing aid fitting
measure: Average hours of hearing aid usage per day
timeFrame: 2 weeks, 6 weeks, 14 weeks after hearing aid fitting
measure: Subjective hearing aid benefit
timeFrame: 2 weeks, 6 weeks, 14 weeks after hearing aid fitting
Other outcomes:
Locations:
city: Nogales
country: United States
facility: Mariposa Community Health Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Laura S Coco, AuD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
Clinical trial NCT03623503: Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis
Official title: Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn Sepsis
Keywords: newborn
neonatal spesis
clinical sriteria
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 58
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children born between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs.

Presence of early clinical signs, ie before 72 hours of life.

Brief summary: Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS. The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.

Detailed description: neonatal early onset spesis (EOS) remains animportant etiology of neonatal morbidity and mortality. Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. Diagnosis is difficults due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS.The objective of the study was to identify early clinical signs in newborn infants with suspected neonatal sepsis to differentiate a likely infection with pathogen bacteria in the gastric suction culture.The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.

Eligibility criteria: Inclusion Criteria:

* Children born at the University Hospital Center in Amiens between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs

Exclusion Criteria:

* Child born before 37 weeks of amenorrhea and / or having a failure in the birth room requiring immediate transfer to neonatal resuscitation or intensive care neonatology

Primary outcomes:
measure: clinical signs in newborn infants
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Pierre Tourneux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05366803: Women's Health Initiative Silent Atrial Fibrillation Recording Study
Official title: Women's Health Initiative Strong and Healthy Silent Atrial Fibrillation Recording Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 1257
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the WHISH STAR study is to investigate whether or not those who are randomized to exercise intervention have higher rates of atrial fibrillation on review of medical records and, in a subset, on screening with a cardiac ECG patch monitor. We will also study whether those with a known history of AF have any changes in AF hospitalizations due to exercise.

Detailed description: The Silent Atrial Fibrillation Recording study (STAR) study is an ancillary study of the NIH-funded Women's Health Initiative Strong and Healthy (WHISH). The purpose of the Women's Health Initiative Strong and Healthy study (WHISH) is to investigate if light to moderate exercise decreases incident atrial fibrillation (AF) among women over 65 who have no baseline AF. The purpose of the STAR study is to investigate the effect of exercise intervention on incident atrial fibrillation ascertained with diagnostic codes. In a subset of women, subclinical atrial fibrillation will be ascertained with cardiac patch ECG monitoring technology (iRhythm's ZIO® XT Patch). This subgroup of WHISH study participants will undergo an 8 day cardiac patch recording at baseline, six (6) months, and one (1) year.

Eligibility criteria: Inclusion Criteria:

* Subjects already enrolled in the parent WHISH study.
* Subjects who are at high risk of developing atrial fibrillation.

Exclusion Criteria:

* Subjects who have had atrial fibrillation at baseline.

Primary outcomes:
measure: Change in Incidence of Atrial Fibrillation Due to Exercise
timeFrame: One year
measure: Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch Monitoring
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Marco Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00987103: Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
Official title: Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Organ Transplantation
Keywords: renal transplantation
tacrolimus
pharmacokinetics
rectal
sublingual
rectal administration
sublingual administration
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual administration of tacrolimus and to compare with pharmacokinetics after oral administration of tacrolimus in renal transplant patients before transplantation.


Eligibility criteria: Inclusion Criteria:

* Patients that will have a kidney transplant patient and will be treated with tacrolimus. As well as hemodialysis patients as well as peritoneal dialysis patients are included.
* Age: 18 - 65 years
* Patient's informed consent

Exclusion Criteria:

* Patients that use drugs that interact with tacrolimus
* Patients that participate in other studies
* Patients that are treated with tacrolimus

Primary outcomes:
measure: Area under the curve, bioavailability, time of maximal concentration, elimination constant
timeFrame: t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
Study officials:
affiliation: Maastricht University
name: Johannes van Hooff, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831803: Nuts and Extra Virgin Olive Oil Pilot Study
Official title: A Pilot Study to Evaluate the Feasibility of Walnut and Extra Virgin Olive Oil Supplementation in Older Adults Being Treated for Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: California Walnut Growers Association
name: C.H.O. American, Natural and Organic Olive Oil Producer Association
First posted: 2016-07-13
Enrollment: 27
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to test the feasibility of asking older adults with high blood pressure to supplement their daily diets with walnuts and extra-virgin olive oil.

Detailed description: Even though cardiovascular disease (CVD) continues to be the leading cause of death in the United States, Americans have yet to widely adopt evidence-based dietary modifications necessary to reduce CVD risk factors. Encouraging evidence from the Prevención con Dieta Mediterránea (PREDIMED) trial indicates that adding olive oil and nuts to the diets of older adults in Spain substantially impacted CVD risk factors and events.

A large trial testing EVOO and nuts in a U.S. population is needed to determine if supplementing with EVOO and nuts can reduce risk of cardiovascular events and mortality in adults living in the U.S. Prior to launching a large trial, it is important to assess whether adults 55 and older would be interested in participating in a supplementation trial such as PREDIMED. Additionally, it is important to assess if they are willing to consume the nuts and EVOO and attend study related-data collection visits.

Eligibility criteria: Inclusion Criteria:

* Being treated for hypertension-defined by being prescribed at least one hypertension medication; willing to comply with study visits, as outlined in the protocol; able to read and speak English; no allergies or hypersensitivities to olive oil or nuts; ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Plans to move from the study area in the next 8 weeks; dementia that is medically documented or suspected; homebound for medical reasons; cancer diagnosis and/or treatment in the last 3 years.

Primary outcomes:
measure: Retention of study participants
timeFrame: 8 weeks
measure: Adherence to consuming walnuts and EVOO
timeFrame: 8 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 8 weeks
measure: Weight
timeFrame: 8 weeks
measure: HDL cholesterol
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mara Z Vitolins, DrPH MPH RDN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02869503: Institut Paoli Calmettes Colorectal Cancer Database
Official title: Institut Paoli Calmettes Colorectal Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Neoplasms
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 22000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a colorectal cancer diagnosis

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer


Eligibility criteria: Inclusion Criteria:

* Patients with a colorectal cancer diagnosis

Exclusion Criteria:

* Non applicable

Primary outcomes:
measure: Survival of patients with colorectal cancer
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches du Rhone
Study officials:
References:
Clinical trial NCT01797003: Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
Official title: Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: osteoarthritis
osteotomy
closing
opening
wedge
kne
tibia
Lead sponsor: Martina Hansen's Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2013-02-22
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis.

Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.

Detailed description: Determination of the time course of patient-relevant functional outcome and the time course of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge methods.

Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients.

In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.

Eligibility criteria: Inclusion Criteria:

* Medial osteoarthritis in the knee (x-ray and arthroscopy)
* Pain in medial compartment of the knee
* Correction angle of 5 degrees or more

Exclusion Criteria:

* Former or active infection in the knee
* Rheumatoid arthritis or other similar disease
* Cancer
* Neurological disease
* Kidney disease or metabolic disease

Primary outcomes:
measure: Kne injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 2 years postoperataively
Secondary outcomes:
measure: Range of motion (ROM)
timeFrame: 2 years postoperatively
Other outcomes:
measure: Oxford knee score
timeFrame: 2 years
measure: Lysholm score
timeFrame: 2 years postoperatively
measure: UCLA activity scale
timeFrame: 2 years postoperatively
measure: Tegner Activity Score
timeFrame: 2 years postoperatively
Locations:
city: Oslo
country: Norway
facility: Martina Hansens Hospital
Study officials:
affiliation: Consultant orthopaedic surgeon
name: Tor Kjetil Nerhus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06664190: Pre-operative Surgical Difficulty Stratification Using Predicted Tumor Perfusion and Consistency
Official title: Study on Preoperative Imaging for Precise Prediction of Surgical Difficulty, Efficacy, and Risks in Pituitary Adenoma Surgeries
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pituitary Adenoma
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 200
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: Patients histologically diagnosed with pituitary adenomas and who had undergone surgical treatment

Brief summary: Pituitary adenomas (PAs) are among the most prevalent lesions of the sella turcica, accounting for 10%-25% of all intracranial neoplasms. Pituitary macroadenomas (PMAs) are defined with a maximum diameter of over 1 cm. Tumor characteristics are key factors influencing surgical effectiveness and complications of PMAs, with tumor perfusion and consistency identified as major predictive factors in literature. Conventional sequences provide limited information for predicting the perfusion and consistency of pituitary adenomas. Advanced sequences offer additional insights. However, the efficacy of combining radiomic features from multiparametric sequences, incorporating both conventional and advanced sequences, has not yet been proved.

We aim to develop machine learning models that combines radiomic features developed from both conventional and advanced sequences to predict the perfusion and consistency of PMAs. Furthermore, we aim to demonstrate the clinically applicability of these models by constructing a MR-PIT stratification (Multiparametric Radiomic derived and tumor Perfusion and consIsTency based surgical difficulty stratification), which correlated with the surgical strategy and outcomes.


Eligibility criteria: Inclusion Criteria:

* patients with tumor more than 2.5 cm of maximal diameter in the coronal plane
* Functional and non-functional pituitary tumors

Exclusion Criteria:

* incomplete image data

Primary outcomes:
measure: Extent of resection
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Severe postoperative complications
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References: