louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04692935: Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis
Official title: Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenocarcinoma of Lung
Keywords: Lung adenocarcinoma
Next-generation sequencing
Tumor genomic profiling
Ethnic differences
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Berry Genomics Co., Ltd.
name: Memorial Sloan Kettering Cancer Center
First posted: 2021-01-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital.

Brief summary: Lung adenocarcinomas (LUADs) from Asian ancestry are reported to have different genomic architectures compared with LUADs from Caucasian ancestry. However, due to lack of available cases, few studies controlled the clinical attributes during the comparisons of the genomic alterations. In this study, the investigators will identify Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital. Then, Caucasian LUADs patients who had targeted NGS (Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets \[MSK-IMPACT\]) will be identified in the GENIE database, which consists of 6673 primary lung adenocarcinoma samples with clinical annotations. Finally, genomic alterations regarding somatic mutations, copy number variations, fusions, mutational signatures, oncogenic pathways, and therapeutic actionability will be comprehensively compared between these two cohorts after adjusting age, sex, smoking status, and pathologic stage using propensity score matching. This study will elucidate important ancestry differences between Asian and Caucasian lung adenocarcinoma patients.


Eligibility criteria: Inclusion Criteria:

* Primary lung adenocarcinoma
* Broad-panel next-generation sequencing
* Asian

Exclusion Criteria:

* Inadequate clinicopathological information
* Low-quality next-generation sequencing

Primary outcomes:
measure: Oncoprint of somatic mutations
timeFrame: July 2021
measure: Copy number variations (CNVs)
timeFrame: July 2021
measure: Mutational signatures
timeFrame: August 2021
measure: Oncogenic pathways
timeFrame: September 2021
measure: Therapeutic actionability
timeFrame: October 2021
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06549335: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)
Official title: The Efficacy and Safety of Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) Regimen in High-risk Treatment-naive Patients with Follicular Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Follicular Lymphoma
Keywords: Zanubrutinib
Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 66
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 prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas


Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
2. Treatment naive
3. Age ≥ 18 years
4. Indications for treatment confirmed
5. Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
6. Must has measurable lesion in CT or PET-CT prior to treatment
7. Considered suitable for ZGR regimens
8. Informed consented

Exclusion Criteria:

* Transformed follicular lymphoma or 3B follicular lymphoma;
* HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
* Any drug contraindication in the treatment plan
* Pregnant or lactating women
* Patients judged by other researchers to be unsuitable for inclusion in the study

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes:
measure: Complete response rate (CR)
timeFrame: At the end of Cycle 6 (each cycle is 28 days)
measure: Partial response rate (PR)
timeFrame: At the end of Cycle 6 (each cycle is 28 days)
measure: Duration of response
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: 2-year progression free survival rate
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: 2-year overall survival rate
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References:
Clinical trial NCT01723735: Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
Official title: A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-11-08
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Primary Objective:

To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).

Secondary Objectives:

* To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.
* To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.

Detailed description: Total duration of the study per subject (excluding screening) is about 22 weeks.

Eligibility criteria: Inclusion criteria :

* Healthy male /or female subjects,
* aged 18 to 65 years old,
* with LDL-C \> 130 mg/dL
* not receiving lipid lowering therapy.

Exclusion criteria:

* Healthy subjects with history or presence of clinically relevant illness.
* Subjects currently taking statins, ezetimibe or fenofibrate.
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Assessment of the effect of alirocumab on LDL-C
timeFrame: Up to 18 weeks
Secondary outcomes:
measure: Assessment of the pharmacodynamic profile of alirocumab
timeFrame: Up to 18 weeks
measure: Pharmacokinetics: Assessment of serum concentrations of alirocumab
timeFrame: Up to 18 weeks
measure: Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)
timeFrame: Up to 18 weeks
Other outcomes:
Locations:
city: Rennes
country: France
facility: Investigational Site Number 250001
city: Rueil Malmaison
country: France
facility: Investigational Site Number 250002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid-Lowering Strategies. J Am Heart Assoc. 2016 Jun 10;5(6):e003323. doi: 10.1161/JAHA.116.003323.
Clinical trial NCT03990935: Remineralization Potential of Ginger and Rosemary Herbals Versus Sodium Fluoride in Treatment of White Spot Lesions
Official title: Remineralization Potential of Ginger and Rosemary Herbals Versus Sodium Fluoride in Treatment of White Spot Lesions: "A Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: White Spot Lesions
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of ginger and rosemary herbals versus sodium fluoride in remineralization of incipient enamel caries.

Detailed description: Group 1 (intervention)

Ginger and rosemary gel application:

First the participant will be asked to brush his/her teeth thoroughly with 1450 ppm fluoride toothpaste (Colgate total healthy clean toothpaste). Then an application of a thin ribbon of this gel to the teeth using a brush. The medication will be left for at least 1 minute. The participant will be asked to spit out the medication after use and not to swallow it. Also the participant will be asked not to rinse his/her mouth, eat, or drink for at least 30 minutes after use to get the best results.

Group 2 (control group). Sodium fluoride varnish The fluoride varnish will be bifluorid 10 single use by voco (Germany). It Contains 5 % sodium fluoride (equal to 22,600 ppm fluoride).

A thin coat will be applied on the tooth surface by using a brush. 10-20 s are sufficient for the varnish to be absorbed and then dry with air. Participants will be informed that they should not brush their teeth for 12-24 hours after the application and not to eat, or drink for at least 30 minutes after use to get the best results.

Eligibility criteria: Inclusion Criteria:

* Patient who has just completed a comprehensive orthodontic treatment.
* Presence of at least one WSL, DIAGNOdent score (0-20).
* Age range between 13 and 35years.

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease
* Patients with developmental hypo-calcified lesions

Primary outcomes:
measure: (white spot lesion progression)
timeFrame: T0 Baseline T1 1 months T2 3 months T3 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT06488235: Qualitative Evaluation of Pediatric Obesity Therapeutic Education Programs
Official title: Evaluation Qualitative de Programmes d'Education Thérapeutique d'obésité pédiatrique
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pediatric Obesity
Keywords: pediatric obesity
attrition
Educational care program
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-07-05
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents who have stopped their Educational Care Programme (early in 1 of the 4 centers over the last 3 years.

They may still be receiving individual follow-up at their center, or may have had a break in care.

Brief summary: Obesity concerns almost the entire planet and is considered in France as a major public health issue: 17% of children are overweight and 4% obese.

Because of this situation, the public authorities have set up programs in order to overcome obesity. Accompanying the child and its family in a process of change through Educational care program seems to be the most suitable. Unfortunately, the abandonment rate of these programs is often high.

Detailed description: The main aim of this study is to explore, describe and understand the phenomenon of attrition in different pediatric obesity Educational care program since 2017 by collecting their experience by describing and characterizing the reasons for attrition reported by the patients included.

Eligibility criteria: Inclusion Criteria:

* Children who have started an educational care program between 2017 and 2022 at one of the four participating centers.
* Children whose parents or legal guardians have signed the program participation letter.
* Children who have participated in at least one group session and have stopped the educational care program early.
* Children whose parents have agreed to take part in the focus group for themselves and their child.
* Children over 12 years of age at the time of the focus group.

Exclusion Criteria:

* Child who has completed the Educational Care program
* Parent/child pairs where at least 1 of the 2 refused to take part in the study

Primary outcomes:
measure: Categorization of the reasons given by children and parents
timeFrame: during the data analysis, either 6 months following the focus group period
Secondary outcomes:
measure: Mirroring of the respective experiences of attrition by children
timeFrame: during the data analysis, either 6 months following the focus group period
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Angers
name: Emmanuelle Labarre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06271135: Assessing the Quality of Life of Patients With Rosacea
Official title: Assessing the Quality of Life of Patients With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Keywords: quality of life
cosmetics procedures
lifestyle
dietary antioxidants
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
Collaborators: name: University of Lomza
First posted: 2024-02-21
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study population consisted of 160 patients (123 women and 37 men) with rosacea, who agreed to participate in this study. Patients were qualified for the study among people visiting the cosmetic studio in Choroszcz in the period from June 2017 to November 2018, based on the diagnosis of a dermatologist and cosmetologist. The cosmetic intervention was performed using CAPILLARY REPAIR SERUM (30ml). Study participants completed self-reported questionnaire and standardized questionnaires.


Eligibility criteria: Inclusion Criteria:

* the inclusion criteria were: age ≥ 30 years,
* diagnosis of rosacea according to the criteria of the National Rosacea Society Expert Committee (NRSEC) from 2019,
* tolerance to the ingredients of the preparation used in the cosmetic intervention,
* lack of pregnancy and lactation,
* completion of a survey,
* signed informed consent

Exclusion Criteria:

* age \< 30 years,
* patients with other facial skin diseases (e.g. acne, psoriasis, eczema),
* intolerance to the ingredients of the preparation used in the cosmetic treatment,
* patients with neuropsychiatric diseases, pregnancy, lactation,
* patients who did not sign informed consent to participate in the study
* did not complete the survey questionnaire.

Primary outcomes:
measure: Elements influenced on quality of life of participants with rosacea
timeFrame: 17 months
Secondary outcomes:
measure: Self-reported questionnaire
timeFrame: 17 months
measure: Dietary Questionnaire
timeFrame: 17 months
measure: The Physical Activity Questionnaire
timeFrame: 17 months
measure: DLQI (Dermatology Life Quality Index)
timeFrame: 17 months
measure: SWLS (Satisfaction With Life Scale)
timeFrame: 17 months
measure: BDI (Beck Depression Inventory)
timeFrame: 17 months
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Medical University of Bialystok
Study officials:
affiliation: Medical Univeristy of Bialystok
name: Małgorzata E Zujko, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139035: Effects of Cyclosporine A on Pancreatic Insulin Secretion
Official title: Effects of Cyclosporine A on Pancreatic Insulin Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Failure
Keywords: glucose intolerance
insulin
microvascular function
genotyping
CYP3A5
pharmacokinetics
renal transplantation
Lead sponsor: University of Oslo School of Pharmacy
Sponsor class: OTHER
First posted: 2005-08-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our primary aim is to investigate if cyclosporine A reduces insulin secretion.

Detailed description: Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or more. In order to get cyclosporine A naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. In addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine A treatment in these patients. Since these patients will be treated with cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.

Eligibility criteria: Inclusion Criteria:

* Renal failure patients on dialysis which is planned to receive a renal transplant

Exclusion Criteria:

* Age below 18 years or above 75 years
* Pregnancy
* Breast feeding mothers
* Diabetes mellitus /WHO criteria)
* Dialysis treatment less than 2 months
* Serious coronary heart disease
* Unstable angina pectoris
* Recent acute infarction (less than 3 months)
* Non-compensated heart failure
* Simultaneous treatment with glucocorticosteroids (e.g. prednisolone, dexamethasone), diltiazem, verapamil, erythromycin, clarithromycin, telithromycin, rifampicin, fluconazole, itraconazole, ketoconazole, voriconazole, indinavir, nelfinavir, ritonavir, nefazodone, bosentan, carbamazepine, St. John's worth, grapefruit.

Primary outcomes:
measure: Insulin secretion
Secondary outcomes:
measure: Peripheral insulin sensitivity
measure: Endothelial function
measure: Pharmacokinetics
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet, Section of Nephrology
Study officials:
affiliation: University of Oslo
name: Anders Åsberg, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00792935: A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)
Official title: A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Between the ages of 18 and 70

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or ketoacidosis.
* Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
* Patient has had surgery within 30 days of starting the study or has planned major surgery during the study

Primary outcomes:
measure: Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose
timeFrame: Baseline and Week 6
measure: Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
timeFrame: Baseline to Week 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02707835: Edema Control in Patients With Breast Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping
Official title: The Effect of Edema Control in Patients With Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping With Ultrasonography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Edema,taping,ultrasound
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ultrasound imaging could be used to examine the thickness of dermis and the space between dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to other measurement of edema is unknown.

The purpose of this study is to investigate

1. The reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools.
2. The different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment.

Our hypothesis :

1. The measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation.
2. Ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.


Eligibility criteria: Inclusion criteria:

1. age:20\~80 y/o
2. female patients with unilateral breast cancer after surgery
3. unilateral lymph edema ( circumference of affected side 2cm bigger than sound side）
4. do not receive any treatment of lymph edema Exclusion criteria

1. skin problems on affected side 2. neurological sign involved affected side, ex:stroke, brachial plexus impairment 3. involved other diseases may cause extremity edema, ex: heart failure or chronic kidney disease (stage one to stage five) 4. have medicine which may cause extremity edema 5. pregnant

Primary outcomes:
measure: thickness of epidermis and dermis
timeFrame: 10 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jing-Lan Yang
role: PRINCIPAL_INVESTIGATOR
References: