louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01515592: Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers
Official title: A Randomised, Double-blind Within Dose Group, Single Centre, Placebo-controlled, Dose Escalation, Multiple s.c. Dose Study to Assess the Safety and Tolerability of Liraglutide 20 ug/kg and 25 ug/kg in Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese subjects
* BMI (Body Mass Index) between 18.0-27.0 kg/m\^2 inclusive

Exclusion Criteria:

* Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening
* Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
* History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* History of significant allergy or hypersensitivity
* Known or suspected allergy to trial product or related products
* History of drug or alcohol abuse
* The subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure

Primary outcomes:
measure: Adverse events
measure: Body weight
measure: Antibody against liraglutide
Secondary outcomes:
measure: Area under the plasma liraglutide concentration curve
measure: Cmax, maximum concentration
measure: tmax, time to reach Cmax
measure: Terminal elimination rate constant
measure: t½, terminal elimination half-life
measure: 24-hour profiles of plasma glucose
measure: 24-hour profiles of serum insulin
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Irie S, Matsumura Y, Zdravkovic M, Jacobsen LV, Kageyama S. Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study. Int J Clin Pharmacol Ther. 2008 Jun;46(6):273-9. doi: 10.5414/cpp46273.
Clinical trial NCT05281692: Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )
Official title: Prospective, Non-Randomized, Parallel Assignment and Single Site Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Keywords: EPM-IX
Covid-19
SARS-CoV-2
Nasopharyngeal swab
Med Schenker's STM viral media
Lead sponsor: Convergent Genomics, Inc.
Sponsor class: NETWORK
First posted: 2022-03-16
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects ≥ 18 years of age who are being tested for COVID-19

Brief summary: This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)

Detailed description: This is a minimal risk study where patients at UroPartners Urology Group will consent to SARS-CoV-2 nasopharyngeal swab testing using both, a standard of care test with standard Viral Transport Medium and a second test using Convergent Genomics' proprietary Enhanced Preservation Media (EPM-IX). Subjects will self-swab each nostril during their medical appointment at UroPartners. UroPartners designated staff with then send the collection kits out for testing. Clinical information will be collected that includes age, gender, race, ethnicity and history of cancer. All of these data points will be anonymized.

Eligibility criteria: Inclusion Criteria:

* Subject must be ≥18 years of age
* Subject is a current patient at UroPartners and is willing to be tested for Covid- 19 during a routine visit
* Subject must be able to understand and willingly provide informed consent

Exclusion Criteria:

* Cannot provide informed consent

Primary outcomes:
measure: Comparison of Diagnostic Performance
timeFrame: At the time of inclusion
Secondary outcomes:
measure: Comparison of Lab Processing
timeFrame: At the time of inclusion
measure: Quantitative PCR CT-values
timeFrame: At the time of inclusion
measure: Difference in case rate or detection of viral load samples observed
timeFrame: At the time of inclusion
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UroPartners Urology Group
state: Illinois
Study officials:
affiliation: UroPartners, LLC
name: Paul Yonover, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00038792: Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD
Official title: A Phase I/II Trial of Recombinant Human Keratinocyte Growth Factor (rHuKFG) for the Treatment of Steroid Refractory Gastrointestinal Acute Graft-versus-host Disease (aGvHD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Acute Graft Versus Host Disease
Keywords: Acute Graft Versus Host Disease
Refractory
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2002-06-07
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II efficacy evaluation, phase I/II efficacy and toxicity trial of recombinant human keratinocyte growth factor for the treatment of steroid refractory gastrointestinal graft versus host disease.

Detailed description: There are two processes that cause diarrhea as the clinical manifestation of graft versus host disease. The first is the obvious immunologic attack on the colonic epithelium of the recipient. Once this immunologic attack has been abated the recipient is left with a colonic mucosa that is devoid of microvilli and has a smooth intestinal boarder. This is frequently subject to superinfections from bacteria all of which cause the diarrhea to continue. Researchers only endpoint to measure clinical response of immunosuppression is the resolution of diarrhea. The human recombinant keratinocyte growth factor stimulates the growth of colonic epithelium. The growth of colonic epithelium will in turn probably ameliorate some of the diarrhea associated with graft versus host disease.

Eligibility criteria: Inclusion criteria:

* Patients post allogeneic bone marrow transplant with watery diarrhea progressed on 2mg/kg of steroids after 3 days or failed to improve after 5 days.
* Patients may have skin or liver involvement with graft versus host disease.
* Patients should not have any infections etiology for diarrhea.

Exclusion criteria:

* None

Primary outcomes:
measure: Number of Participants with resolution of diarrhea
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: James L. Gajewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03334292: Natural History of Wilson Disease
Official title: Natural History of Wilson Disease: Registry for Patients With Wilson Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wilson Disease
Keywords: Wilson Disease
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Wilson Disease Association
First posted: 2017-11-07
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric patients being evaluated for or with a diagnosis of WD who are willing to participate in the registry at designated study sites around the United States and in the United Kingdom.

Brief summary: The purpose of the registry/repository is to provide a mechanism to store data and specimens to support the conduct of future research about Wilson disease (WD). The overall aim is to determine the optimal testing for diagnosis and parameters for monitoring treatment of WD that will aid product utilization and development.

Detailed description: There are three aims outlined as part of this research study.

Aim 1 is to study the natural history of a carefully characterized cohort of patients with WD followed longitudinally at Centers of Excellence for WD in the United States and in the United Kingdom.

Aim 2 seeks to evaluate parameters for diagnosis and treatment monitoring for patients on chelation therapy and zinc treatment for their WD. Data gathered in Specific aim 1 will be used for analyzing the components of the diagnostic scores for patients.

Aim 3 is intended to determine whether a composite index or a biomarker can be used as surrogate marker for treatment monitoring for current patients on therapy that can be used for future patient treatment trials.

Eligibility criteria: Inclusion Criteria:

* Known diagnosis of WD
* Able and willing to provide informed consent for adults (Parental/guardian permission (informed consent) and if appropriate, child assent for participants \<18 (or per local Institutional Review Board (IRB) regulation)

Exclusion Criteria:

* Diagnosis of WD has been excluded
* Unwilling to provide informed consent or assent

Primary outcomes:
measure: Create registry for Wilson disease
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Guildford
country: United Kingdom
facility: Royal Surrey Country Hospital
state: Surrey
Study officials:
References:
Clinical trial NCT03794492: Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome
Official title: Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-01-07
Enrollment: 169
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients

Detailed description: This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid

Eligibility criteria: Inclusion Criteria:

1. Over 19 years old(male or female)
2. Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor
3. Agreement with written informed consent

Exclusion Criteria:

1. Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0
2. Patients with high sensitization who need desensitization therapy
3. Multi organ recipients or previous transplant with any organs
4. Diagnosed with cancer within five years
5. Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor
6. Patients who have positive HIV, HBsAg or Anti-HCV test result
7. At screening

   * Under treatment for active liver disease, or Over 3times upper than normal range of liver function test (T-bilirubin, AST, ALT)
   * WBC\<2,500/mm3, PLT \<50,000/mm3, ANC\<1,500/mm3
8. Pregnant or lactating women
9. In investigator's judgment

Primary outcomes:
measure: DSA(Donor-specific Anti-HLA Antibody)
timeFrame: 36 months
Secondary outcomes:
measure: Incidence of composite efficacy failure
timeFrame: 12, 24, 36months
Other outcomes:
Locations:
city: Suwan
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Chang-Kwan Oh, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01995292: Comparison of Two Different Types of "Spray as You go" Technique for Awake Fiberoptic Intubation
Official title: Comparative Clinical Trial of Conventional and Modified "Spray as You go" Technique With the "Enk Fiberoptic Atomizer Set" for Awake Fiberoptic Intubation (Atomizer Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Awake Fiberoptic Intubation
Keywords: awake fiberoptic intubation
spray as you go technique
anesthesia
Enk Fiberoptic Atomizer Set
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether modified "spray as you go" technique using the Enk Fiberoptic Atomizer Set during awake fiberoptic intubation is more comfortable for the patient.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* no concurrent participation in another clinical trial
* German language in speaking and writing
* Capability of giving consent
* written informed consent
* an elective surgery under general anesthesia, in which an awake fiberoptic intubation is indicated

Exclusion Criteria:

* Age \< 18 years
* pregnant women
* patients unwilling or unable to give informed consent
* ASA classification \> 3
* Known allergy to local anesthetics
* Participation in another clinical trial

Primary outcomes:
measure: Comfort evaluation by the patient
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Comfort evaluation by the performing as well as assisting anesthetist
timeFrame: up to 4 weeks
measure: Comfort evaluation by the present nurses
timeFrame: up to 4 weeks
measure: Patient response (coughing, gagging, grimacing, defenses)
timeFrame: up to 4 weeks
measure: Vital signs
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes Gutenberg - Universität
state: Rhineland Palatinate
Study officials:
References:
Clinical trial NCT04772092: Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older
Official title: Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Geriatrics Immunosenescence
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A person at least 70 years of age admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.

Brief summary: An individual's immune profile changes with age, and can sometimes be involved in the development of certain diseases such as infections or cancers, in a process called immunosenescence. Some data tend to show that there is a link between this immune profile and geriatric fragility (autonomy, difficulties with walking, memory, undernutrition, co-morbidities, depression). The aim of this study is to describe this profile, or immune phenotype, and to see if there is a link with the different aspects of geriatric assessment in patients without cancer or infection. In addition, these data will serve as a basis for comparison with the same analyses performed on breast cancer patients at the Centre Georges François Leclerc.


Eligibility criteria: Inclusion Criteria:

* Person who has not opposed to inclusion in the study
* Male or female aged 70 and over admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.

Exclusion Criteria:

* Person not affiliated to national health insurance system
* Person subject to a measure of legal safeguard (curatorship, etc)
* Person with an acute infection
* Person with suspected cancer or active cancer
* Long-term immunosuppressive or corticosteroid therapy
* HIV and/or HBV and/or HCV positive serology

Primary outcomes:
measure: percentage of immune cells in peripheral blood
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04320992: A Multicenter Prospective Study of "High Risk" Molecular Typing in Patients With Adult T Lymphoblastic Lymphoma
Official title: A Multicenter Prospective Study of "High Risk" Molecular Typing in Patients With Adult T Lymphoblastic Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: T-Lymphoblastic Lymphoma/Leukemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults

Brief summary: The purpose of this study is to determine the indicative value of "high risk" molecular typing in patients with adult T lymphoblastic lymphoma


Eligibility criteria: Inclusion Criteria:

* biopsy proved T lymphoblastic lymphoma
* newly diagnosed patients

Exclusion Criteria:

* patients with biopsy samples unavailable

Primary outcomes:
measure: progression free survival
timeFrame: 3-years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
Study officials:
References:
Clinical trial NCT01169792: Study of Cytochrome P450 Polymorphisms (CYP2D6, CYP3A4/5 and CYP2C19) in Breast Cancer Patients
Official title: Association Between Genetic Polymorphisms of CYP2D6 and Outcomes in Breast Cancer Patients With Tamoxifen Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Survival Analysis
Antineoplastic Agents
Therapeutic Uses
Keywords: Tamoxifen
Cytochrome P-450 CYP2D6
Polymorphism
Single nucleotide
Antineoplastic Agents, Hormonal
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Inje University
First posted: 2010-07-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer survivors who underwent surgery at Severance hospital, Yonsei University Health System.

Brief summary: The genetic polymorphisms of the cytochrome P450 may influence on the metabolism of tamoxifen.

The investigators want to

* evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450 subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and
* analyze the association between the genetic polymorphisms of cytochrome P450 subfamilies and clinical outcomes in breast cancer patients treated by adjuvant tamoxifen therapy.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* Breast cancer patients who underwent surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients
measure: The frequency of the genetic polymorphisms of CYP3A4/5 in breast cancer patients
measure: The frequency of the genetic polymorphisms of CYP2C19 in breast cancer patients
Secondary outcomes:
measure: The association between the genetic polymorphisms of CYP2D6 and outcomes in breast cancer patients with tamoxifen therapy
measure: The association between the genetic polymorphisms of CYP3A4/5 and outcomes in breast cancer patients with tamoxifen therapy
measure: The association between the genetic polymorphisms of CYP2C19 and outcomes in breast cancer patients with tamoxifen therapy
Other outcomes:
Locations:
city: Jin-Gu
country: Korea, Republic of
facility: Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine
state: Busan
city: Saedaemoon-gu
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine
state: Seoul
Study officials:
affiliation: Department of Surgery and Brain Korea 21 Project for Medical Science, Yonsei University College of Medicine
name: Byeong-Woo Park, M.D.,ph.D.
role: STUDY_CHAIR
affiliation: Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine
name: Jae-Gook Shin, M.D.,ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00536692: Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)
Official title: Phase 2 Study of the Safety and Bioactivity of Topical Ocular Mecamylamine for the Treatment of Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: macular edema
DME
diabetic
mecamylamine
Comentis
Lead sponsor: CoMentis
Sponsor class: INDUSTRY
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2007-09-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label study evaluating the safety and tolerability of topical ocular mecamylamine given twice a day in patients with diabetic macular edema (DME). Patients will be treated for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* macular edema due to diabetic retinopathy

Exclusion Criteria:

* vision loss from other ocular disease
* intraocular surgery within 3 months
* intraocular anti-VEGF or steroids within 3 months
* HbA1c \>12

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: East Bay Retina Consultants, Inc.
state: California
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine / Wilmer Eye Institute
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
Study officials:
References:
citation: Campochiaro PA, Shah SM, Hafiz G, Heier JS, Lit ES, Zimmer-Galler I, Channa R, Nguyen QD, Syed B, Do DV, Lu L, Monk J, Cooke JP, Kengatharan MK, Hsu HH. Topical mecamylamine for diabetic macular edema. Am J Ophthalmol. 2010 May;149(5):839-51.e1. doi: 10.1016/j.ajo.2009.12.005. Epub 2010 Feb 26.