louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00247702: The Association of Warfarin Dosage and Plasma Enantiomer Concentration With the Gene Polymorphisms of CYP and VKOR
Official title: Study of the Association of Warfarin Dosage and Plasma Enantiomer Concentration With the Gene Polymorphisms of CYP and VKOR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Venous Thromboembolism
Keywords: CYP2C9
VKORC1
polymorphism
warfarin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-11-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Oral warfarin anticogulation for the prevention and treatment of patients with venous thromboembolism is one of the most used therapies in clinical practice. Patients require different dosage to achieve the target therapeutic anticoagulation. Optimal dosage and bleeding complication are two most clinical concerns. Besides of multiple individual factors (e.g. age, dietary intake, vitamin supplement, drug compliance etc.), some genetic factors may determine the drug requirement and safety.

The cytochrome P450 CYP2C9 is a liver enzyme required for the oxidative metabolism of warfarin. The vitamin K epoxide redutase (VKOR) is a liver enzyme associated with the reuse of the oxidative hydroquinone form of vitamin K. The VKOR enzyme is the target of warfarin. Recent studies revealed both genes may determine the pharmacodynamic of warfarin anticogualation. To date, there are more than thirteen identified polymorphism at CYP2C9 gene. Majority of those variant polymorphisms may decrease the warfarin requirement. The VKOR complex subunit 1 (VKORC1) is a newly identified gene. Some polymorphisms also were reported.

As we know, the Chinese patients need a lower dosage of warfarin in comparison with the Caucasian patients. We are interested in finding the genetic causes of Taiwneses Chinese patients. In our study we will first identify the polymorphism patterns of these two genes in normal population. Then, we will try to find the association between these polymorphism and patient warfarin requirement. Our pharmacogenetics study will be valuable for prevention of bleeding complication of warfarin treatment in Chinese population.


Eligibility criteria: Inclusion Criteria:

* Use warfarin therapy for at least two months before study
* Stable INR value during recent three months

Exclusion Criteria:

* higher age(\>80 y/o)
* liver and renal dysfunction
* alcohol abuse
* BMI\<18kg/m2
* coadministered medicine that can affect pharmacokinetics or pharmacodynamics of warfarin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan Univerisity Hospital
name: Tasy Wei, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06583902: Management of Anemia in Patients with EndocaRditis Infectious Candidates for Cardiac Surgery: the AMERICA Study
Official title: Management of Anaemia in Patients with Infectious Endocarditis Who Are Candidates for Cardiac Surgery: the AMERICA Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infective Endocarditis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the Foundation for infective endocarditis with an indication for cardiac surgery presenting anaemia.

Brief summary: Infective endocarditis (EI) is an extremely serious disease requiring prolonged hospitalisation, complex management by multidisciplinary teams and high healthcare costs. Anemia is also emerging as a virtually constant condition associated with endocarditis, as evidenced by its inclusion in the variables used to calculate risk scores.Anemia associated with infective endocarditis (EI) has a remarkably complex and multifactorial pathogenesis.It is essential to treat anaemia in patients with EI as an integral part of their overall therapy, in what is now called patient blood management. Blood transfusion is not the only approach available to treat this condition. It is essential to correct any deficiencies, whether iron or vitamins. In addition, some patients may benefit from the administration of erythropoiesis-stimulating agents.


Eligibility criteria: Inclusion Criteria: Patients with endocarditis who are candidates for elective surgery; Male and female patients aged \> 18 years; Patients who have given written consent to participate in the study and to have their clinical data processed for the purposes of the study.

Exclusion Criteria: Age \< 18 years; Patients with hypersensitivity (bronchial asthma, urticaria, allergic phenomena) to preparations of intravenous iron, folic acid, vitamin B12, erythropoietin; Patients who have not given written consent to participate in the study and who have specifically refused the use of their clinical data for the purposes of the study; Patients participating in other investigational trials; Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for the study

Primary outcomes:
measure: Assessing improvement in anemia and reduction of transfusion support in the study population
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive
Study officials:
References:
Clinical trial NCT04566302: Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
Official title: Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pigmented Lesions
Pigmented Skin Lesion
Pigmented Moles
Skin Lesion
Keywords: SECM
Spectrally Encoded Confocal Microscopy
RCM
Reflectance Confocal Microscopy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.

Detailed description: SECM provides an order of magnitude faster imaging speed than conventional confocal microscopy devices. The investigators have previously utilized the SECM technology for imaging large area of human esophagus in vivo. They have also developed endoscopic capsule devices which have been used to safely image over 60 human subjects, healthy volunteers and subjects with eosinophilic esophagitis, using SECM technology, rapidly.

When used for skin imaging, SECM can provide real-time three-dimensional confocal imaging and significantly reduce the imaging time. While SECM has been successfully used for imaging human esophagus in vivo, its utility in skin imaging needs to be tested in a new pilot study. The investigators will be taking images with a dermatoscope as well. This will the control to compare the experimental images to, as the dermatoscope is the standard of care diagnostic tool for dermatologists.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* 18 years of age or older
* Capable of giving informed consent
* Pigmented lesions (such as moles) present on the forearm

Exclusion Criteria:

* Unable to provide consent
* Open cuts/sores on the skin, skin infection, or any contagious skin condition
* Pregnant women (according to subject)
* Employees under the direct supervision of the investigator

Primary outcomes:
measure: Ability of SECM device to image skin and skin diseases
timeFrame: Imaging data is collected during the procedure, and analyzed within 1 year of collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, M.D, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04290702: Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery
Official title: The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Analgesia
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups with different regional analgesic technique
Primary purpose: SUPPORTIVE_CARE

Brief summary: The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner


Eligibility criteria: Inclusion Criteria:

* parturients requiring regional labor analgesia
* dilation less than 5cm

Exclusion Criteria:

* contraindication for regional technique
* refuse to participate
* language barriers
* obesity
* no pain

Primary outcomes:
measure: analgesic consumption
timeFrame: during the procedure/delivery
Secondary outcomes:
measure: pain intensity on a numerical rating scale (minimum=0, maximum=10)
timeFrame: during the procedure/delivery
measure: duration of labor
timeFrame: until delivery
measure: satisfaction on a numerical rating scale (minimum=0, maximum=10)
timeFrame: during the procedure/delivery
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital, University of Athens
state: Attiki
city: Athens
country: Greece
facility: Aretaieio Hospital
Study officials:
References:
Clinical trial NCT02851602: Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome
Official title: Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: HDL in obese non-diabetic patients show major alterations in their function and thus their cardio-protective effects. These alterations could be explained by the quantitative and qualitative anomalies in the phospholipids and sphingolipids in the HDL. These molecules play a major role in HDL function and probably present early modifications in obesity, even before the onset of glycaemia deregulation.

The aim of this study is to show the presence of qualitative and quantitative modifications of phospholipids and sphingolipids in HDL from obese patients compared with HDL from non-obese controls.


Eligibility criteria: Inclusion Criteria:

* aged \> 18 years
* fasting glycaemia \< 1.10 g/l
* waist circumference \> 102 cm for men and 88 cm for women (criteria NCEP/ATP III)
* 2 criteria among the following 3 (NCEP/ATP III criteria for metabolic syndrome):
* triglyceridaemia ≥ 1.50 g/l
* HDL cholesterol \< 0.40 g/l for men and 0.50 g/l for women
* arterial blood pressure ≥ 130/85 mmHg or treatment for arterial hypertension
* patients who have provided written consent INCLUSION CRITERIA FOR HEALTHY SUBJECTS
* age \> 18 years
* fasting glycaemia \< 1.10 g/l
* waist circumference \< 102 cm for men and 88 cm for women
* triglyceridaemia \< 1.50 g/l
* HDL cholesterol ≥ 0.40 g/l for men and 0.50 g/l for women
* Healthy subjects who have provided written consent

Exclusion Criteria:

* Persons without national health insurance cover
* Diabetes
* Diseases that interfere with lipoprotein metabolism (dysthyroidism not controlled with the treatment, kidney or liver disease)
* Treatments that interfere with lipoprotein metabolism (lipid-lowering agents, oestrogens, corticoids, retinoids, antiretroviral agents)
* Pregnancy/breast feeding

Primary outcomes:
measure: Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass
timeFrame: At inclusion
Secondary outcomes:
measure: Difference in the percentage of each family of phospholipids or sphingolipids compared with total phospholipids + sphingolipids
timeFrame: At inclusion
measure: Difference in the percentage of each sub-family according to the nature of the fatty acids for phosphatidylcholines on the one hand and sphingomyelins on the other in patients
timeFrame: At inclusion
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT07018102: Nurse-Led Bedside Trunk Control Care Program
Official title: Nurse-Led Bedside Trunk Control Care Program for Patients With Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: trunk impairment
diaphragmatic breathing
quality of life
respiration function
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to apply care for stroke survivors by establishing trustable professional activities competency indicators and a trunk control care module for rehabilitation ward nurses during our second year.

Detailed description: Thus, the purposes of this study were: (1) to evaluate the effect of a stepwise nurse-led bedside trunk control care module intervention on improving trunk control, respiratory function, and quality of life in patients with stroke and (2) to modify and confirm the milestones and trustable professional activities of competence in trunk impairment care for patients with stroke to provide evidence-based nursing education and cultivate new nurses' competence in trunk injury care in the future.

Eligibility criteria: Inclusion Criteria:

* (a) Patients hospitalized for stroke in rehabilitation or neurology wards, currently in stable condition; (b) Trunk Impairment Scale score below 21; (c) aged 20 or above; (d) patients willing to participate.

Exclusion Criteria:

* Patients with Trunk Impairment Scale score above 21, as this indicates that they can perform daily activities independently

Primary outcomes:
measure: Trunk function
timeFrame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
Secondary outcomes:
measure: Postural control
timeFrame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
measure: Respiratory function
timeFrame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
measure: Body awareness
timeFrame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
measure: stroke impact
timeFrame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University
name: Hsiang Chu Pai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01092884: Polypodium Leucotomos Extract for the Treatment of Melasma
Official title: Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Keywords: melasma
sunscreen
polypodium leucotomos
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Industrial Farmacéutica Cantabria, S.A.
First posted: 2010-03-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium leucotomos group will have more improvement in their melasma compared to the placebo group.


Eligibility criteria: Inclusion Criteria:

* Hispanic female with moderate to severe facial melasma

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Recent use of hydroquinone, topical retinoids, topical steroids, or mechanically abrading procedures (such as laser therapy or dermabrasion) to the face
* Frequent use of tanning parlors

Primary outcomes:
measure: Mexameter score
timeFrame: 12 weeks
Secondary outcomes:
measure: MASI Score
timeFrame: 12 weeks
measure: Melasma-Related Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05198284: Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
Official title: A Prospective Decision Impact Clinical Utility Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Kidney Disease
Chronic Kidney Diseases
Chronic Kidney Disease Stage 1
Chronic Kidney Disease Stage 2
Chronic Kidney Disease Stage 3
Lead sponsor: Renalytix AI, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.

Brief summary: The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.


Eligibility criteria: Inclusion Criteria:

* 23 years of age or older.
* Clinical history of confirmed type 2 diabetes.
* Evidence of DKD Stages 1-3:
* Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
* Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
* All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).
* The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion Criteria:

* Patients with eGFR \<30 or ≥ 60 ml/min/1.73m2 without albuminuria.
* Patients with ESRD or on renal recovery treatments at time of enrollment.
* Patients who are pregnant at the time of enrollment.
* Patients who are currently hospitalized.
* Patients who are currently on Enbrel.

Primary outcomes:
measure: Blood pressure
timeFrame: 12 Months
measure: HbA1c
timeFrame: 12 Months
measure: ACEi/ARB
timeFrame: 12 Months
measure: SGLT2/ GLP1
timeFrame: 12 Months
measure: Urine albumin to creatinine ratio
timeFrame: 12 Months
measure: Referrals
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
Study officials:
affiliation: Mount Sinai Health System
name: David W Lam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02981784: Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I
Official title: Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: chronic myeloid leukemia (CML)
Philadelphia-positive (Ph+)
Acute Lymphoblastic Leukemia (ALL)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All 128 T315I+ patients from PACE comprised the ponatinib group of this study. Fifty-six patients from the EBMT database comprised the allo-SCT group

Brief summary: Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).


Eligibility criteria: Inclusion Criteria:

* CML any phase with T315I mutation
* Ph+ ALL with a T315I mutation
* Being treated in the PACE trial according to the criteria of this phase II trial
* Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen.

Exclusion Criteria:

* Ph negative patients
* Patients under 18 years

Primary outcomes:
measure: Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)
timeFrame: From date of inclusion until the date of death, assessed up to 180 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-Sud
Study officials:
References: