louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05497232: Clinical Analysis of Simultaneous Pancreas-kidney Transplantation for End-stage Renal Disease Associated With Diabetes Mellitus
Official title: Clinical Analysis of Simultaneous Pancreas-kidney Transplantation for End-stage Renal Disease Associated With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus；Uremia
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The first pancreas transplantation was performed in 1966, by 2015, more than 40,000 pancreas transplantation have been performed worldwide. Nevertheless, only several Chinese organ transplant centers carry out SPK because of surgery complications. simultaneous pancreas-kidney transplantation is a new and promising therapeutic option for the treatment for type 1 diabetes mellitus patients and end-stage renal disease. the preliminary treatment results are summarized to promote the further development of this work in China.

Detailed description: simultaneous pancreas-kidney transplantation using the surgical technique was performed in our department from September 2016 to January 2023 in the Department of Transplantation of the Second Affiliated Hospital of Guangzhou Medical University. Patients were followed up for 2 to 36 months to summarize the efficacy and complications. we examined the influence of SPK on patient and graft survivals.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Diabetes patients with end-stage renal disease;
2. First time receiving SPKT;

Exclusion Criteria:

1. Pulmonary infection, urinary tract infection, hematuria CMV or BK virus infection occurred during treatment;
2. Using a large number of abnormal biological products (blood transfusion, plasma or coagulation factors) may contain foreign DNA;
3. Loss of graft due to thrombosis or AR;
4. Patients who are pregnant or have malignant tumors or patients with a history of cell therapy, whose tumor signals interfere with dd-cfDNA detection;
5. Patients who have poor compliance during treatment or suffer from mental illness.

Primary outcomes:
measure: Patient survival & pancreas graft survival & renal graft survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: 1Department of Organ Transplantation, Second Affiliated Hospital of Guangzhou Medical University,
state: Guangdong
Study officials:
References:
Clinical trial NCT05490732: Pharmacokinetic Modeling of Methadone
Official title: Pharmacokinetic Population Modeling of Methadone in Patients Managed for Opioid Opioid Addiction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Toxicomania
Keywords: pharmacokinetics
methadone
microsampling
modeling
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. Understanding this variability is potentially to be able to adjust a priori a dosage and to identify the factors of clinical response. Few population pharmacokinetic models exist for methadone and they generally concern the management of pain in palliative care patients or the management of opioid withdrawal syndrome in neonates. The hypothesis is therefore that the creation of such a model would make it possible to reduce patients' withdrawal periods, to set a target for plasma concentrations with a view to reducing dosages, and to empower the patient in his choice to monitor blood concentrations facilitated by a minimally invasive sampling device.


Eligibility criteria: Inclusion Criteria:

* Major patients on methadone on the same dosage for at least 7 days.
* Hospitalization for withdrawal in the addictology department of La Colombière or consultation within the unit for the treatment of drug addiction and dependence (Addictology Department).
* 24 hours monitoring is possible and accepted

Exclusion Criteria:

* Patients that cannot be sampled because of weakened veins
* Unable to received information about the study
* Exclusion period determined by previous study
* Adult protected by law or patient under guardianship
* Not affiliated to french social security system
* Not able to give written inform consent
* Pregnant or breastfeeding woman
* Underaged patients (under 18 years old)
* Patient under court protection

Primary outcomes:
measure: Peak concentration (Cmax)
timeFrame: 18 months
Secondary outcomes:
measure: C12h-24h concentration
timeFrame: 18 months
measure: Residual concentration (C0)
timeFrame: 18 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Yoann Cazaubon, phD,pharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00163332: Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)
Official title: Comparison of Inhaled Ciclesonide (160 mcg b.i.d. or 320 mcg b.i.d.) and Fluticasone Propionate (250 mcg b.i.d. or 500 mcg b.i.d.) in Pretreated Patients With Mild to Moderate Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Fluticasone propionate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 30
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 aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria: Main Inclusion Criteria:

* Patients who have had a history of bronchial asthma for at least 6 months
* FEV1 \>60% of predicted for at least 24 h
* Patients who are hyperresponsive to methacholine and to AMP
* Patients who are in good health with the exception of asthma

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Patients suffering from COPD and/or other relevant lung diseases except asthma
* Current smokers and ex-smokers both with ≥10 pack years

Primary outcomes:
measure: AUC(0-24h)/24 h of serum cortisol level
measure: 24 h urinary cortisol excretion adjusted for creatinine.
Secondary outcomes:
measure: 8 am measurement of bone formation markers
measure: PC20FEV1 to methacholine
measure: PC20FEV1 to AMP
measure: lung function (FEV1, FVC)
measure: pharmacokinetics
measure: safety and tolerability.
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Altana Pharma/Nycomed
city: Ghent
country: Belgium
facility: Altana Pharma/Nycomed
city: Lanaken
country: Belgium
facility: Altana Pharma/Nycomed
city: Liege
country: Belgium
facility: Altana Pharma/Nycomed
city: Liége
country: Belgium
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT01348932: The Relationship Between Single Nucleotide Polymorphisms of Chitinase 3-like 1 Gene,YKL-40 Serum Levels and Adult Asthma
Official title: The Relationship Between Single Nucleotide Polymorphisms of Chitinase 3-like 1 Gene,YKL-40 Serum Levels and Adult Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: asthma
Chitinase 3-like 1 (CHI3L1)
YKL-40
single nucleotide polymorphism(SNP)
Real time PCR
gene
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Taiwan

Brief summary: The objective of this study was to investigate the relationship between single nucleotide polymorphism of chitinase 3-like 1 and human asthma.

Detailed description: Chitinase 3-like 1 (CHI3L1) is a member of human chitinases family. According to previous studies in literatures, increased expression of CHI3L1 has been proven to be correlated with the presence of different diseases, including cancers, autoimmune diseases, and chronic inflammatory conditions. Elevated serum levels of YKL-40 are associated with increased disease severity, poorer prognosis and shorter survival for many other diseases. When monitored over time, increases in serum YKL-40 parallel with disease progression. It can serve as an measurable marker of changes in disease status.

There were indicated that chitinase 3-like 1 might be associated with some clinical diseases. The C-allele of the -131 C→G (rs4950928) polymorphism of CHI3L1 has been shown to associate with bronchial hyperresponsiveness and reduced lung function. It is suggesting that variations in CHI3L1 may influence risk of asthma.

The objective of this study was to investigate the relationship between single nucleotide polymorphism of chitinase 3-like 1 and human asthma. The association between CHI3L1 SNPs and the continuous outcomes were examined by real time PCR and gene sequencing analysis.

In Korean reports there was no significant associations between CHI3L1 SNPs and asthma were observed. On the other hand, there were association between CHI3L1 and asthma observed in the majority of Caucasian populations. However, similar research has not been conducted in Taiwan. In contrast to preliminary studies, the investigators predict the rs4950928 G allele, and not the C allele, was found to be associated with asthma. The g.-247C/T polymorphism in the CHI3L1 promoter region is associated with the risk of atopy.

Eligibility criteria: Inclusion Criteria:

* ages 20 to 60 years
* asthma patients
* atopy patients
* control (non-asthma and non-atopy)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: 2 Yuh-Der Road
country: Taiwan
facility: China Medical University Hospital
state: Taichung
Study officials:
affiliation: Partners
name: Chen Chia Hung, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06331832: Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL
Official title: Treatment Guidelines for Expanded Access of Imvotamab (IGM-2323) in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas From IGM-2323-001
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Relapsed/Refractory Non-Hodgkin Lymphomas
Lead sponsor: IGM Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial.


Eligibility criteria: Inclusion Criteria:

* Demonstrated clinical benefit (SD, PR, or CR) on clinical trial protocol IGM-2323-001
* There is no adequate alternative treatment available for the patient.
* Provided consent to continue treatment on expanded access program.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to the first dose.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive measures.
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive.

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions to mAb (or recombinant antibody related fusion proteins).
* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of investigational product, or indicating patient would unlikely have potential benefit.
* Pregnant, breastfeeding, or intending to become pregnant during the program or within 2 months after the final dose of imvotamab.
* In the treating physician's judgement, the patient is unlikely to complete all procedures, including follow-up visits, or comply with the requirements for participation.
* Vaccination with live virus vaccines during treatment and for 3 months following the last cycle of Imvotamab.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Madrid
country: Spain
facility: START-Madrid Centro Integral Oncologico Clara Campal
Study officials:
References:
Clinical trial NCT00450632: Creation of a Biotheque of Patients of Seine-Maritime With Meningococcal Infection
Official title: CONSTITUTION D'UNE BIOTHEQUE DE PATIENTS DE SEINE-MARITIME AUX ANTECEDENTS D'INFECTION INVASIVE A MENINGOCOQUES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningococcal Infections
Keywords: meningococcal infections
biotheque
genetic markers
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of Seine-Maritime with a meningococcal disease

Brief summary: The main objective of this study is to constitute a biotheque of patients with meningococcal disease to enable results to be interpreted and genetic factors to be determined


Eligibility criteria: Inclusion Criteria:

* Subjects of Seine-Maritime with a meningococcal disease from the year of 2000
* parental authority assent if necessary

Exclusion Criteria:

* no parental authority assent
* child under supervision

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH Rouen
state: Seine-Maritime
Study officials:
affiliation: University Hopital of Rouen
name: François Caron, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05722132: Latinos Kick Buts: Mobile Engagement and Cessation Support for Latinos Who Smoke
Official title: Latinos Kick Buts: Mobile Engagement and Cessation Support for Latinos Who Smoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-02-10
Enrollment: 2826
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Latino Kick Buts (LKB) is a smoking cessation treatment program available to Strong Memorial Hospital patients who smoke. LKB encompasses two integrated components: (1) a 12-week text messaging counseling program with interactive capabilities and (2) pharmacotherapy support (provision of nicotine replacement therapy at no cost). LKB utilization among Latinos who smoke remains minimal. This study aims to identify the types of text messages more effective in enrolling Latinos who smoke, identified in the electronic medical record, into LKB.


Eligibility criteria: Inclusion Criteria:

* Adult Latinos who smoke and have received medical care at Strong Memorial Hospital/SHARP healthcare within the last year.
* having smoking status recorded in the EMR

Exclusion Criteria:

* none

Primary outcomes:
measure: Percentage of participant who enroll in cessation program
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00467532: Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients
Official title: A Prospective Longitudinal Study of the Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Patients Sustaining Significant Burn Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Cytomegalovirus
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2007-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the North Carolina Jaycee Burn Center within 72 hours of burn injury with at least a 10% Total Body Surface (TBSA)burn and expected length of stay at least two weeks.

Brief summary: The purpose of this study is to evaluate the effect of burn injury on the human immune system with a focus on cytomegalovirus (CMV) reactivation and the immunologic correlates of latent viral reactivation.

Subjects will be patients admitted to the North Carolina Jaycee Burn Center with burn injury.

Blood samples will be collected over time and will be evaluated for CMV reactivation and immune cell phenotype.

Detailed description: The purpose of this research study is to learn about infections and the immune system in people who suffer from burn injuries. The immune system changes after burn injury and infection is one of the most common complications. Cytomegalovirus (CMV) is a virus that most people are exposed to early in life; once you are exposed it lays inactive in your body forever. When the immune system is suppressed, this virus can reactivate. We would like to measure how this virus makes copies of itself in the blood stream in people with a burn injury and to look at cell markers of the immune system.

This study involves baseline and weekly blood draws for approximately 8 weeks. If blood tests show CMV infection, further monitoring of blood work may be needed after eight weeks.

Eligibility criteria: Inclusion Criteria:

* Burn injury,
* Positive CMV IgG level confirmative of previous CMV infection and latency.

Exclusion Criteria:

* Immunocompromising conditions including HIV/AIDS,
* End-stage renal disease,
* End-stage liver disease,
* Pregnancy,
* Rheumatologic or collagen-vascular disease requiring chronic use of steroids,
* Chronic use of immunosuppressive agents,
* Recent chemotherapy, and
* History of solid organ or allogeneic stem cell transplant.

Primary outcomes:
measure: CMV IgG and viral load PCR
timeFrame: Weekly until viremia resolved (negative viral load by PCR)
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Jaycee Burn Center, UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Bruce Cairns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02565732: Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperhidrosis
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.


Eligibility criteria: Inclusion Criteria:

* Primary axillary hyperhidrosis
* Female or male, 18 years of age or older in good general health
* Excessive sweating interferes with daily life activities and scores 3 or 4 on the HDSS at Screening and Baseline
* Axillary sweat production of at least 50 mg/5 min measured gravimetrically

Exclusion Criteria:

* Any neurological condition, that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and Myasthenia gravis
* Muscle weakness or paralysis, particularly in the upper extremities
* Active skin disease or irritation or disrupted barrier at the treatment area
* Undergone any procedures which may affect the axillary areas
* Treatment with botulinum toxin type A in the axilla in the last 9 months or anywhere in the body in the last 6 months
* Any prior axillary use of an anti-hyperhidrosis medical device
* If menopausal had symptoms of menopause such as sweating or flushing within the last year

Primary outcomes:
measure: Hyperhidrosis Disease Severity Scale (HDSS)
timeFrame: Week 4
measure: Gravimetry
timeFrame: Week 4
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Week 4
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
Study officials:
References: