louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03365141: Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
Official title: Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Treatment
Intralesional Injection
Corticosteroid
Keywords: vitiligo
intralesional injection
corticosteroid
triamcinolone
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo

Detailed description: Intralesional corticosteroid injections have been a long-standing treatment for refractory vitiligo, with some patients showing significant improvement without surgical intervention.

The investigators will perform a randomized split-body pilot trial to test the exact efficacy of intralesional triamcinolone injections. The paired symmetric vitiliginous lesions will be randomized to either control or injection groups. All lesions will be treated with narrowband UV-B phototerapy or excimer laser weekly and twice daily application of topical tacrolimus ointment for a total of 12-week period. Intralesional injections of 0.4mg/cc triamcinolone once a week are given to the experimental group. The degree of repigmentation will be assessed as % from baseline.

Eligibility criteria: Inclusion Criteria:

1. Age : 19 or older
2. A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study
3. A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk
4. A patient who has no further response to excimer laser or short wavelength ultraviolet B therapy, which is a conventional treatment for vitiligo

Exclusion Criteria:

1. Patients under the age of 19
2. Patients with enlarged or spreading lesions of vitiligo
3. Patients who do not want to do so or who refuse to write a consent form
4. Patients who are inadequate for triamcinolone acetonide administration (pregnant women, infectious and systemic fungal infections without effective antimicrobial agents, immunosuppression, hypersensitivity reactions to and concomitant use of triamcinolone or its components, spontaneous thrombocytopenia, purpura, herpes simplex, shingles, chicken pox patients)
5. Others those who are deemed unsuitable for the examination at the discretion of the examiner

Primary outcomes:
measure: The repigmentation rate (change from baseline) of the vitiliginous patch
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: The adverse effects
timeFrame: every weeks up to 13 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Gyonggi-do
Study officials:
References:
Clinical trial NCT00093041: Zalutumumab in Head and Neck Cancer
Official title: An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Neoplasms
Keywords: Head and neck cancer
squamous cell carcinoma of the head and neck
Lead sponsor: Genmab
Sponsor class: INDUSTRY
First posted: 2004-10-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx.
* Primary or recurrent disease for which no curative or established palliative treatments are amenable
* WHO performance status of 1 or 2.

Exclusion Criteria:

* Received certain other treatments within 4 weeks prior to administration of study drug
* Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis).
* Skin disease requiring systemic or local corticosteroid therapy.
* Known brain metastasis or leptomeningeal disease.
* Signs or symptoms of acute illness.
* Bacterial, fungal or viral infection.
* Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year and stomach, lung, heart, hormonal, nerve or blood diseases.
* Pregnant or breast-feeding women.
* Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
* Simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.

Primary outcomes:
measure: Adverse Events
timeFrame: From study start (Day 0) until follow-up period (up to Day 77)
Secondary outcomes:
measure: Overall Response (OR), Classification
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Copenhagen Ø
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Århus C
country: Denmark
facility: Århus Kommunehospital
city: Lund
country: Sweden
facility: Universitets Sjukhuset i Lund
city: Uppsala
country: Sweden
facility: Uppsala Akademiska Sjukhus
Study officials:
References:
citation: Bastholt L, Specht L, Jensen K, Brun E, Loft A, Petersen J, Kastberg H, Eriksen JG. Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck. Radiother Oncol. 2007 Oct;85(1):24-8. doi: 10.1016/j.radonc.2007.06.007. Epub 2007 Jun 28.
Clinical trial NCT00204841: Childhood Origins of Asthma (COAST)
Official title: Rhinovirus Infection and Asthma in Childhood and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Allergy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-20
Enrollment: 287
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High risk birth cohort of children (one or both parents have allergies and/or asthma).

Brief summary: Although asthma is likely to be a heterogeneous disease or syndrome, three factors and/or events repetitively emerge for their ability to significantly influence asthma inception in the first decade of life: immune response aberrations, which appear to be defined best by the concept of cytokine dysregulation; lower respiratory tract infections (in particular RSV); and some form of gene by environment interaction that needs to occur at a critical time period in the development of the immune system or the lung. It remains to be firmly established, however, how any one or all of these factors, either independently or interactively, influence the development of childhood asthma. Thus, our efforts to determine and define the importance of these three factors to asthma pathogenesis are the focus and goal of this current grant application.

Detailed description: No more description necessary.

Eligibility criteria: Inclusion Criteria:

* children who had one or more parent with a history of allergy or asthma

Exclusion Criteria:

* pre term infants
* low birth weight infants
* respiratory distress at birth

Primary outcomes:
measure: Evaluate the children longitudinally for the inception and progression of asthma.
timeFrame: Birth through age 19
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Daniel J Jackson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Robert F Lemanske, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05516641: Prebiotics in Rectal Cancer
Official title: Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: stage II
stage III
microbiome
prebiotic
racial disparities
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A significant racial disparity in the incidence and mortality of CRC exists in the U.S. with African Americans having CRC incidence and mortality rates that are 20% and 40% higher than the general U.S. population. It has been demonstrated that the gut microbiome impacts tumor development and progression through multiple mechanisms, including impacting the tumoral immune response. However, it is unknown if microbiome modulating treatment can have an impact on CRC outcomes.

Detailed description: A significant racial disparity in the incidence and mortality of CRC exists in the U.S. with African Americans having CRC incidence and mortality rates that are 20% and 40% higher than the general U.S. population. It has been demonstrated that the gut microbiome impacts tumor development and progression through multiple mechanisms, including impacting the tumoral immune response. However, it is unknown if microbiome modulating treatment can have an impact on CRC outcomes.

This is a pilot project to see if any changes are detected in stool and/or tissue samples in rectal cancer patients who receive a soluble corn fiber supplement during their neoadjuvant treatment.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older
2. Clinical diagnosis of stage 2 or stage 3 rectal cancer
3. Subjects who are women of child-bearing potential must not be pregnant or lactating
4. Have signed an approved informed consent form for the study
5. Be willing to comply with the protocol

Exclusion Criteria:

1. Patients with a cancer history (excluding the rectal cancer currently being addressed)
2. Allergic to corn or maltodextrin
3. Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the study

Primary outcomes:
measure: Gut Flora modulation
timeFrame: 1 year
Secondary outcomes:
measure: Microbiome changes
timeFrame: 6 months
measure: Immune Profile
timeFrame: 6 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
affiliation: Ochsner
name: Li Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02756741: Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis
Official title: Assessment of Cytokine Profile in an Open Labeled Randomized Controlled Trial of Standard Dose vs. Once a Day Intravenous Albumin in Patients With Spontaneous Bacterial Peritonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: Cirrhosis
hepatitis B virus
Alcohol
varices
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 40
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 standard recommended management of spontaneous bacterial peritonitis (SBP) includes a third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high price of albumin. In the current randomized control trial investigators compared the effect of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid and blood.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of SBP
2. Age \> 18 years
3. Consent to participate in the trial

Exclusion Criteria:

1. Secondary peritonitis
2. Malignancies including HCC

Primary outcomes:
measure: Change in neutrophils/mm in ascitic fluid
timeFrame: 3 days
measure: Change in IL-6, IL-1, TNF in ascitic fluid and serum between the two groups
timeFrame: 5 days
Secondary outcomes:
measure: Survival in days at the end of therapy
timeFrame: 5 days
measure: Differences in frequency of sepsis, renal failure and other organ failures between the two groups
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00527358: Evaluation of SAFER Latinos' Program to Prevent Youth Violence
Official title: Evaluation of SAFER Latinos' Program to Prevent Youth Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Violence
Keywords: violence
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: George Washington University
name: Latin American Youth Center
name: Latino Federation of Greater Washington
First posted: 2007-09-10
Enrollment: 1400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an evaluation of a primary prevention program to prevent youth violence by improving family cohesion, networking among families, school bonding, and access to services for Latinos in Langley Park, MD.

Detailed description: To prevent youth involvement in violence, outreach workers will work with families and youth to improve school bonding, family cohesion and awareness and utilization of existing services; and a youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.

Following implementation of the intervention, we will collect detailed process data (regarding implementation), and evaluate impact/outcome using a quasi-experimental design with baseline (prior to intervention) and two followup data collections in both the intervention and a control community (Culmore, Virginia), measuring change in a selected set of aggregate community variables that represent mediating factors and outcomes for youth violence in Langley Park. Data will be collected via a survey and focus groups.

Eligibility criteria: Inclusion Criteria:

* youth 12-24 and their caregiver

Exclusion Criteria:

* residence outside of Langley Park or Culmore

Primary outcomes:
measure: Youth violence
timeFrame: within the next 2 years after intervention started
Secondary outcomes:
measure: family cohesion
timeFrame: within the next 2 years after start of intervention
measure: school bonding
timeFrame: within the next 2 years after start of intervention
measure: exposure to antisocial, substance abusing, or violent peers
timeFrame: within the next 2 years after start of intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Mark Edberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04227158: The Association Between the Distributions MCH and RBC, and Mortality in Hemodialysis Patients
Official title: The Association Between the Distributions MCH and RBC, and Mortality in a Cohort of Chronic Hemodialysis Patients: a 3-year Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Anemia
Keywords: red blood cell
mean corpuscular hemoglobin
hemoglobin
Hemodialysis patients
Lead sponsor: University of Hyogo
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 437
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients has undergone maintenance Hemodialysis for \>1 year.

Brief summary: Patients were classified into two groups based on the values of MCH and RBC, patients with MCH ≥30 pg but \<35 pg and RBC ≤350×104/μL; and MCH \<30 pg and RBC \>350×104/μL. Associations between all-cause mortality and the distributions of MCH and RBC were assessed by Kaplan-Meier curves and Cox proportional hazards regression model.

Detailed description: The Hb levels generally provides the value of RBC and iron status because mean corpuscular hemoglobin MCH is derived from the Hb divided by RBC. MCH depends on the size and concentration of erythrocytes. Thus, the value of RBC and MCH depend on dose of ESA and iron, respectively. Guidelines for Renal Anemia in Chronic Kidney Disease of 2015 Japanese Society for Dialysis Therapy recommend administration hemoglobin (Hb) levels ≥10 g/dL but \<12 g/dL in dialysis patients.Patients whose Hb levels is maintained at 10 to 12 g/dL, Hb levels is widely distributed when divided into RBC and MCH. Therefore, the investigators examined the prognosis of life in the distribution of MCH and RBC.

Eligibility criteria: Inclusion Criteria:

* Patients will be controlled with hemoglobin levels between ≥10 g/dL and \<12 g/dL and had undergone maintenance HD for \>1 year.

Exclusion Criteria:

* Patients will be excluded if they have peritoneal dialysis combined with HD, do not have records of laboratory investigations during this period, or are transferred to another hospital or lost to follow-up.

Primary outcomes:
measure: Survival rate between high or low RBC group (all cause death)
timeFrame: three years (retrospectively)
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Graduate School of Applied Informatics, University of Hyogo
state: Hyogo
Study officials:
affiliation: University of Hyogo
name: Yuko MIZUNO, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01053858: Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity
Keywords: bevacizumab,triamcinolone, intravitreal injection
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.


Eligibility criteria: Inclusion Criteria:

* central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion

Exclusion Criteria:

* previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset
* Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders
* neovascularization on the disc or elsewhere or rubeosis

Primary outcomes:
measure: best corrected visual acuity
timeFrame: baseline, 1 month, 2 months, 3 months, 6 months, 12 months
Secondary outcomes:
measure: central macular thickness by optical coherence tomography
timeFrame: baseline, 1 month, 2 months, 3 months, 6 months 12months
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: keoung ik Na
state: Anyang
Study officials:
References:
Clinical trial NCT04427358: RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population
Official title: RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: RT-PCR SARS-CoV-2
Covid-19
Carriage
Viral shredding
Elderly
Elderly people
Geriatric
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 70 years age having COVID-19

Brief summary: Evaluation of the rate of positive RT-PCR SARS-CoV-2 test at 1 month of COVID infection among elderly people.

It is unclear how long an individual with COVID-19 will remain "sick" and "contagious". It appears that SARS-CoV-2 can be transmitted before symptoms appear and throughout the course of the disease.

They investigators did not find any study on a COVID + geriatric population reassessing carriage at 1 month even though age seems to be a risk factor for prolonged excretion as suggested in the study following study: Xu K, Chen Y, Yuan J, Yi P, Ding C, Wu W, et al. Factors associated with prolonged viral RNA shedding in patients with COVID-19. Clinical Infectious Diseases. 2020 Apr 9; ciaa351


Eligibility criteria: Inclusion Criteria:

* Age\> 70years
* Patient hospitalized on the geriatric center from March 1, 2020 to August 1, 2020 with a diagnosis of COVID-19 still alive at 1 month.
* Patient having agreed to the re-use of their data for the purposes of this research

Exclusion Criteria:

* Subject who expressed his opposition to participate in the study
* Subject under judicial protection

Primary outcomes:
measure: 1. Analysis of the rate of RT-PCR SARS-CoV-2 positive at 1 month of COVID infection
timeFrame: at 1 month of COVID infection]
measure: 2. Assess quantitative evaluation of a nasopharyngeal swab SARS-CoV-2 RT-PCR test
timeFrame: at 1 month after COVID infection
Secondary outcomes:
measure: Assessment of late stool SARS-CoV-2 RT-PCR, serological status and associated factors with death and RT-PCR results 1 month after the date of first symptom onset
timeFrame: 1 month after the date of first symptom onset
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service SSR Gériatrique
Study officials:
References: