louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04915105: Personal Precise Treatment on Psoriasis and Psoriatic Arthritis
Official title: Personal Precise Treatment on Psoriasis and Psoriatic Arthritis and Investigate the Mechanisms of Biological Agents Induced Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dermatologic Disease
Keywords: PSO, PSA, SLE, PBMC
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Part of psoriasis and psoriatic arthritis patients treated with biologics and met primary failure. Therefore, we are going to create a cell based platform to evaluate the treatment effects of different biologics on psoriasis and psoriatic arthritis patients before prescribed by physicians

Detailed description: PBMCs isolated from psoriasis and psoriatic arthritis and incubated with Group A streptococcus and different biologics for 24 hours. Cytokines expression in the culture supernatants will be measured and the data can be reference for physician's prescription.

Eligibility criteria: Inclusion Criteria:

* 1. Healthy control without underline disease such as psoriasis and psoriatic arthritis. 2. Psoriasis been diagnosed for over six months and PASI \>10. 3.Psoriatic arthritis been diagnosed for over six months and \>1 swallow and tender joints

Exclusion Criteria:

* nil

Primary outcomes:
measure: PASI score
timeFrame: 2 weeks to 3 months
measure: swelling joint count and tenderness joint count
timeFrame: 2 weeks to 3 months
Secondary outcomes:
measure: CRP
timeFrame: 3-6 months
measure: DLQI
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Attending Physician
name: Chung-Yang Yen, MDPhD
role: STUDY_CHAIR
References:
Clinical trial NCT03966105: Prevalence of Wild Type ATTR
Official title: Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wild-type Transthyretin Amyloidosis
Keywords: wild-type TTR amyloidosis
lumbar spinal stenosis
prevalence
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: University of Kiel
name: Ente Ospedaliero Cantonale, Bellinzona
First posted: 2019-05-29
Enrollment: 94
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective population of 100 patients undergoing LSS surgery.

Brief summary: Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).

Detailed description: The study will include patients that receive surgical management and treatment for LSS, and will consist in the prospective, longitudinal collection of peripheral blood, urine samples, tissue biopsies and clinical data. The results of the project could provide a future benefit for patients with the same condition by: i) identifying accessible and sensitive biomarkers for the identification of patients at risk for having an underlying ATTRwt; ii) optimizing the therapeutic strategies in an era of innovative but cost-intensive treatments; iii) provide the proof of principle for a regular follow-up of patients who eventually will become symptomatic for overt organ ATTRwt involvement; and iv) providing the rationale for future studies based on early access disease-modifying approaches.

Eligibility criteria: Inclusion Criteria:

* Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Lumbar spinal stenosis (LSS) confirmed by MRI
* Availability of the baseline and follow-up annotations
* Informed consent will be obtained from the patient before any study related procedures

Exclusion Criteria:

* Previous diagnosis of amyloidosis

Primary outcomes:
measure: Report the prevalence of ATTRwt in patients with CTS and/or LSS.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
state: Ticino
Study officials:
affiliation: Oncology Institute of Southern Switzerland
name: Adalgisa Condoluci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04584905: Nutritional Assessment of Children With Chronic Kidney Disease
Official title: Nutritional Assessment of Children With Chronic Kidney Disease Attending Assuit University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutrition Disorders, Child
Keywords: chronic kidney disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children of both sexes. Diagnosed as chronic kidney disease. Age: 2 years up to 15 Years Children

Brief summary: Primary outcome is assessment of nutritional status of children with CKD. Secondary outcome is assessment STAMP screening tool for detection of malnutrition of CKD children.

Detailed description: Pediatric Chronic Kidney Disease (CKD) has systemic implication on all aspects of normal development, including nutrition, growth, bone and mineral metabolism and neurocognitive function .

Chronic Kidney Disease (CKD) introduces a unique set of nutritional challenges for the growing and developing child .

Eligibility criteria: Inclusion Criteria:

* Children of both sexes.
* Diagnosed as chronic kidney disease.
* Age: 2 years up to 15 Years Children.

Exclusion Criteria:

* • Age: less than 2 years old child and more than 15 years old child.

  * Previously diagnosed to have any co- morbid or systemic disease other than CKD.
  * Irregular dialysis.
  * Renal transplant.

Primary outcomes:
measure: Assessment of nutritional status of children with CKD.
timeFrame: from January 2021 to June 2021
Secondary outcomes:
measure: Assess STAMP screening tool
timeFrame: from January 2021 to June 2021
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Universty Hospital
Study officials:
References:
Clinical trial NCT01450605: Korean Post-marketing Surveillance for Reyataz®
Official title: Korean Post-marketing Surveillance for Reyataz®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 601
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA

Brief summary: The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Reyataz® so that the regulatory authority can manage the marketing approval properly


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA

Exclusion Criteria:

* According to Warning/Caution in local label

Primary outcomes:
measure: Adverse events occurrence
timeFrame: 30 days after last dose of study drug
Secondary outcomes:
measure: Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration
timeFrame: Baseline and 16 weeks after first treatment
measure: CD 4 T-cell count before and after drug administration
timeFrame: Baseline and 16 weeks after first treatment
measure: Overall efficacy evaluation by investigator's discretion
timeFrame: Baseline and 16 weeks after first treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02208505: Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion
Official title: Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion During Emergence in Adults After Thyroidectomy: Comparison With High-dose Remifentanil Infusion Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroidectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: After thyroid surgery, the incidence and severity of coughing is important because it may cause serious complications, such as bleeding in the surgical field, laryngospasm, and cardiovascular disturbance. Several studies have shown that the single-dose of dexmedetomidine is effective for reducing cough and agitation during emergence from general anesthesia.

To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose remifentanil infusion during emergence from general anaesthesia could reduce coughing as good as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and reduction of side effect of remifentanil using non-inferiority trial.


Eligibility criteria: Inclusion Criteria:

* Thyroid disease undergoing thyroidectomy
* age 20-65
* Amerian society of anesthesgiologist class 1 or 2

Exclusion Criteria:

* chronic cough
* difficult intubation
* liver disease
* uncontrolled hypertension

Primary outcomes:
measure: Incidence of coughing during emergence from general anesthesia
timeFrame: from 5min before extubation to 5min after extubation
Secondary outcomes:
measure: side effect of remifentanil
timeFrame: up to 1 day after surgery
Other outcomes:
measure: quality of recovery from anesthesia
timeFrame: upto 1day after surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam severance hospital
Study officials:
affiliation: Yonsei University
name: Jeong Soo Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000605: Estrogen and Graft Atherosclerosis Research Trial (EAGER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Coronary Arteriosclerosis
Coronary Disease
Heart Diseases
Myocardial Ischemia
Postmenopause
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine if postmenopausal hormone replacement therapy in women following coronary bypass surgery would reduce the occurrence of graft occlusion and delay the development of graft atherosclerosis.

Detailed description: BACKGROUND:

Coronary atherosclerosis is a major cause of death in women in the United States. Although coronary artery bypass surgery decreases symptomatic and clinical evidence of ischemia, it does not alter the underlying process. Patients may present several years later with recurrent symptoms that may be a result of occlusion of saphenous vein grafts, development of atherosclerotic disease in vein grafts, or progression of underlying disease. Any intervention that can reduce the rate of progression of coronary atherosclerosis following bypass surgery would provide significant benefit for women following bypass surgery and possibly for other women with atherosclerotic disease. Observational studies suggest that postmenopausal estrogen replacement therapy is associated with a reduction in cardiac morbidity.

DESIGN NARRATIVE:

The study was a randomized, double-blind, controlled trial. Subjects were randomized to conjugated estrogen with daily medroxyprogesterone or placebo within two weeks of bypass surgery. Graft occlusion and development of vein graft atherosclerosis were measured by comparing quantitative coronary angiographic and vascular ultrasonic assessment of disease severity and extent performed at six months and three and a half years after randomization. The primary outcome variables included the occurrence of graft occlusion at six months and the change in severity and extent of atherosclerosis in the saphenous vein grafts over three years. The trial determined the influence of hormone replacement therapy on the primary outcome variables.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: Postmenopausal women who had undergone coronary artery bypass graft.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Pamela Ouyang
References:
Clinical trial NCT04724005: Project Affinity: Excess Cancer Blood Testing
Official title: Project Affinity: Excess Cancer Blood Testing Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
First posted: 2021-01-26
Enrollment: 613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Above 18 years of age. Undergoing SACT treatment. Going to hospital for routine blood tests.

Brief summary: Study investigating cancer blood samples on an iterative measurement systme


Eligibility criteria: Inclusion Criteria:

* Undergoing SACT
* Routine blood tests

Exclusion Criteria:

* Not had first cycle of SACT

Primary outcomes:
measure: Viability of measurement technique
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References:
Clinical trial NCT06130605: Subjects Perceived as Embarrassing During a Consultation in General Medical Practice
Official title: Subjects Perceived as Embarrassing During a Consultation in General Medical Practice
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: General Practice
Keywords: general medical consultation
gene
modesty
fear of judgment
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people over the age of 18 agreeing to take part in the study

Brief summary: Optimal medical care requires transparency and honesty. However, it is not always easy to address some issues that may be considered too personal, intimate or taboo, such as mental health, sexuality, addiction and death. Patients' approach to these issues may be influenced by the profile of their general practitioner, or by the atmosphere of the consultation.

This retention of information by the patient, whether voluntary or not, can lead to adverse events related to care due to a misunderstanding between doctor and patient.

Detailed description: The main objective is to describe the proportion of patients limiting the subjects addressed during a general medicine consultation by gene, modesty and/or fear of judgment The secondary objective is to study the factors associated with limitation of subjects addressed by patient by gene, modesty and/or fear of judgment during a general medicine consultation.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Agreeing to take part in the study

Exclusion Criteria:

* Minors
* Protected by law (guardianship, curatorship, safeguard of justice)
* Refusing to take part in the study

Primary outcomes:
measure: limitation of subjects addressed by gene, modesty and/or fear of judgment
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Ufr Medecine Urca
city: Reims
country: France
facility: Université de Reims Champagne Ardenne
Study officials:
affiliation: Université de Reims Champagne-Ardenne
name: THERY MERLAND Emilie, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06755905: Indocyanine Green Lymphography in Management of Lingual Lymphatic Malformation
Official title: Application Value of Indocyanine Green Lymphography in Management of Microcystic Lymphatic Malformation of the Tongue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphatic Malformation
Keywords: indocyanine green
tongue
Lymphatic Malformation
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 42
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To elucidate the application of indocyanine green (ICG) fluorescence angiography in the treatment of childhood tongue cLM (clinically localized malignancy, presumed context here), providing a clearer scientific basis for subsequent targeted interventions.


Eligibility criteria: Inclusion Criteria:

* No previous intervention
* more than 6 months post-treatment follow-up
* Stage I or Stage IIa

Exclusion Criteria:

* History of iodine allergy
* Syndromic cLM
* Severe liver and kidney dysfunction

Primary outcomes:
measure: Cured (Reduction in dimension greater than 90%)
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Children's hospital of nanjing medical university
state: Jiangsu
Study officials:
References:
Clinical trial NCT01576198: Studying Biomarkers in Samples From Younger Patients With Wilms Tumor
Official title: Validation of Copy Number Changes by MLPA as Predictors of Relapse in Wilms Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: Wilms tumor and other childhood kidney tumors
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-12
Enrollment: 2227
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Wilms Tumor

Brief summary: RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

Detailed description: OBJECTIVES:

* To analyze 250 favorable-histology Wilms tumor (FHWT) samples from patients registered on NWTS4 for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by subtelomeric multiplex ligation-dependent probe amplification (MLPA), and to determine their association with relapse-free and overall survival.
* To develop a robust multiplex MLPA test using multiple synthesized probes to those targets identified as significantly associated with relapse in Aim 1.
* To validate the multiplex MLPA test designed and tested in Aim 2 on an independent set of 1727 FHWT and 250 anaplastic WT registered on NWTS-5.

OUTLINE: Archived DNA samples are analyzed for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by MLPA. Assay results are then researched for accuracy, clinical validity, sensitivity, precision, and potential analytical interferences.

Eligibility criteria: DISEASE CHARACTERISTICS:

* DNA samples from FHWT patients registered on:

  * NWTS-4
  * NWTS-5 with focal and diffuse anaplasia tumors

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Validation of copy number changes (gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q) in FHWT by the MLPA assay
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Elizabeth J. Perlman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05616598: Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
Official title: Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Male Infertility
HCV
Keywords: Semen
DAA
Male infertility
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: DAA oral therapy for HCV.
Primary purpose: BASIC_SCIENCE

Brief summary: Hepatitis C virus is commona viral infection. Direct-acting antiviral (DAA) oral drugs has been used in treatment of HCVs. the effect of these drugs on male infertility is still under investigation.

Detailed description: Semen analysis will be done to male patients with HCV before and after treatment with DAA. The included men will take therapy for 3 months and HCV RNA titter will be evaluated. changes of seminal parameters will be recorded and analyzed.

Eligibility criteria: Inclusion Criteria:

Men patients with HCV

Exclusion Criteria:

Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.

Primary outcomes:
measure: Treatment of HCV
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Qalyūbīyah
country: Egypt
facility: Faculty of Medicine, Benha University
state: Benha
city: Banhā
country: Egypt
facility: Benha Faculty of Medecine
Study officials:
References: