louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00204581: Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases
Official title: Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: Melanoma
Soft tissue metastases
Interleukin-2
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 51
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: The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%.

However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.


Eligibility criteria: Inclusion Criteria:

* Age 18+
* Informed consent
* Histologically proven melanoma
* Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases

Exclusion Criteria:

* Pregnant or lactating women
* Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
* Patients with severe liver disease or severe renal disease
* Simultaneous immunosuppressive treatment (e.g. steroids)
* Simultaneous chemotherapy
* Pretreated soft-tissue or skin metastases (e.g. cryo-, radiotherapy)

Primary outcomes:
measure: Efficacy in regard to complete and partial response
timeFrame: 4 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: every 6 months
measure: Side-effects
timeFrame: during treament and 4 weeks afterwards
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
state: BW
Study officials:
affiliation: Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
name: Claus Garbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Radny P, Caroli UM, Bauer J, Paul T, Schlegel C, Eigentler TK, Weide B, Schwarz M, Garbe C. Phase II trial of intralesional therapy with interleukin-2 in soft-tissue melanoma metastases. Br J Cancer. 2003 Nov 3;89(9):1620-6. doi: 10.1038/sj.bjc.6601320.
Clinical trial NCT01336881: Biomarkers in Tissue Samples From Young Patients With Liver Cancer
Official title: Genetics and Biology of Liver Tumorigenesis in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Hepatoblastoma
Stage I Childhood Liver Cancer
Stage II Childhood Liver Cancer
Stage III Childhood Liver Cancer
Stage IV Childhood Liver Cancer
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-04-18
Enrollment: 99
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young patients with liver cancer

Brief summary: This research trial is studying biomarkers in tissue samples from young patients with liver cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To identify biomarker signatures associated with hepatoblastoma subtypes (by microRNA array profiling), and their potential correlation with liver developmental stages as well as outcome.

II. To correlate expression array data with copy number array data.

SECONDARY OBJECTIVES:

I. To carry out a focused sequencing interrogation of amplified or deleted genomic regions as well as genes in key cell pathways involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma.

II. To perform whole exome sequencing in a subset of tumors.

OUTLINE: This is a multicenter study.

Archived tumor tissue samples are analyzed for hepatoblastoma and other liver tumor biomarkers by microRNA array profiling and exome sequencing. Results are then compared with patients' clinical data.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of hepatoblastoma or other liver cancer including the following subtypes:

  * Pure fetal histology
  * Transitional histology
  * Small cell undifferentiated histology
* Participated on the Children's Oncology Group (COG) clinical trials
* Available data and tumor samples

Primary outcomes:
measure: Biomarkers associated with hepatoblastoma subtypes and cancer stages
timeFrame: Baseline
Secondary outcomes:
measure: Genes involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma
timeFrame: Baseline
measure: Exome sequencing
timeFrame: Baseline
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Gail Tomlinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02920281: Impact of Sleep Quality on Respiratory Function and Weaning of Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Weaning of Mechanical Ventilation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients


Eligibility criteria: Inclusion Criteria:

* Mechanical ventilation for at least 24 hours before the first weaning test
* difficult weaning of mechanical ventilation defined as failure to the first weaning test
* patients aged at least of 18 years

Exclusion Criteria:

* peripheral or central nervous system pathology
* known psychiatric pathology or agitation
* clinical worsening before polysomnography (shock with vasopressor drugs, coma with Glasgow scale \< 8, PaO2/FiO2 ratio \< 150 with respiratory distress signs)
* pregnant or breastfeeding women
* patient under legal guardianship or protection
* patient with no health insurance coverage
* age \< 18 years

Primary outcomes:
measure: Compare the length of weaning patients who have a poor quality of sleep to those who have a good quality sleep.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
citation: Thille AW, Reynaud F, Marie D, Barrau S, Rousseau L, Rault C, Diaz V, Meurice JC, Coudroy R, Frat JP, Robert R, Drouot X. Impact of sleep alterations on weaning duration in mechanically ventilated patients: a prospective study. Eur Respir J. 2018 Apr 19;51(4):1702465. doi: 10.1183/13993003.02465-2017. Print 2018 Apr.
Clinical trial NCT03472781: Demographics and Clinical Characteristics of Paediatric Intraocular Inflammation in Singapore
Official title: Demographics and Clinical Characteristics of Paediatric Intraocular Inflammation in Singapore
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Inflammation in Children
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2018-03-21
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 16 years and below diagnosed with intraocular inflammation in years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017

Brief summary: Data on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017, will be retrieved and analyzed from the uveitis database retrospectively.

The results will be compared with other published studies on different study populations.

Detailed description: Data on demographics, etiology, clinical features, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017, will be retrieved from the uveitis database retrospectively.

Data on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes will be analyzed using statistical software.

The results will be compared with other published studies on different study populations.

The results of this study will lead to an improved clinical practice with better treatment selections and an optimised monitoring protocol for follow up care for our paediatric patients with intraocular inflammation. This will lead to better clinical outcomes and prevention of serious sight threatening complications.

Eligibility criteria: Inclusion Criteria:

* Children aged 16 years and below
* Clinical diagnosis of intraocular inflammation

Exclusion Criteria:

•Children with ocular conditions other than intraocular inflammation.

Primary outcomes:
measure: Demographics and clinical characteristics of pediatric intraocular inflammation
timeFrame: January 1989 to January 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore national eye center
Study officials:
affiliation: Singapore National Eye Center
name: Samanthila Waduthantri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03774381: Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults
Official title: Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults

Detailed description: Our aim is to investigate the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in adults by a randomized, double-blind, and control-group study.

Eligibility criteria: Inclusion Criteria:

* BMI 27\~30 kg/m2

Exclusion Criteria:

* Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
* Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
* Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
* Those who are treated with hypothyroidism or hyperthyroidism
* Creatinine levels: more than twice the normal upper limit
* Aspartate transaminase (AST), Alanine transaminase (ALT) levels: more than twice the normal upper limit
* Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion
* Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking
* Participated in the commercial obesity program within the last 3 months.
* If you have participated or are planning to participate in another clinical trial within the past month If yes
* Alcohol abuser
* Smoking abstinence within 3 months
* If they are pregnant or lactating or have a pregnancy plan during the clinical trial
* Those with allergic reactions to the constituent food
* Any person deemed inappropriate by the researcher for other reasons

Primary outcomes:
measure: Body fat
timeFrame: Change from baseline body fat at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Integrated Research Institute for Natural Ingredients and Functional Foods
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02604095: Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism
Official title: Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acanthosis Nigricans
Obesity
Keywords: Acanthosis nigricans
Obesity
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.

Detailed description: The effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism in patient with obesity and acanthuses nigrican.

Eligibility criteria: Inclusion Criteria:

* Age:18-60 years old;
* BMI ≥ 28 kg/m2；
* With acanthosis nigricans。

Exclusion Criteria:

* With liver, kidney, gastrointestinal or other major organic serious diseases, cancer, lactating women, pregnancy.

Primary outcomes:
measure: insulin resistance index
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Body fat
timeFrame: 12 weeks
measure: Neck circumference
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Total Cholesterol
timeFrame: 12 weeks
measure: Triglyceride
timeFrame: 12 weeks
measure: Low Density Lipoprotein
timeFrame: 12 weeks
measure: High Density Lipoprotein
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People' Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Shen Qu, Ph.D
role: STUDY_DIRECTOR
References:
citation: Sun H, Wang X, Chen J, Gusdon AM, Song K, Li L, Qu S. Melatonin Treatment Improves Insulin Resistance and Pigmentation in Obese Patients with Acanthosis Nigricans. Int J Endocrinol. 2018 Mar 12;2018:2304746. doi: 10.1155/2018/2304746. eCollection 2018.
Clinical trial NCT06884995: Correlation of Weight Loss With Residual Gastric Volume and Shape on Computerized Tomography in Patients Undergoing Sleeve Gastrectomy
Official title: Correlation of Weight Loss With Residual Gastric Volume and Shape on Computerized Tomography in Patients Undergoing Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Regain Post Bariatric Surgery
Keywords: shape, Sleeve gastrectomy, inadequate weight loss, volumetry
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty patients who underwent Laparoscopic sleeve gastrectomy (LSG) were followed prospectively and evaluated at 12 months after operation using computed tomography CT with 3D reconstruction to evaluate the shape and volume of the residual stomach after LSG

Brief summary: Laparoscopic sleeve gastrectomy (LSG) has been accepted as a primary bariatric procedure. The aim of the study was to evaluate the volume and the morphologies of remnant stomachs after LSG and their association with weight loss

Detailed description: Twenty patients who underwent Laparoscopic sleeve gastrectomy (LSG) were followed prospectively and evaluated at 12 months after operation using computed tomography CT with 3D reconstruction to evaluate the shape and volume of the residual stomach after LSG. Total sleeve volume (TSV), tube volume (TV), antral volume (AV) and tube/antral volume ratio (TAVR) were included.

Eligibility criteria: Inclusion Criteria:

* candidate for sleeve gastrectomy

Exclusion Criteria:

* revisional surgery

Primary outcomes:
measure: volume of sleeve and shape
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Helwan University
state: Cairo
Study officials:
References:
Clinical trial NCT01322295: Human Bronchial Microdialysis in Open Aortic Aneurysm Repair
Official title: Human Bronchial Microdialysis in Open Aortic Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2011-03-24
Enrollment: 16
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 assigned for elective open aortic surgery are enrolled by invitation

Brief summary: Elective open aortic aneurysm repair has an overall reported 30 day mortality of 2-6 percent, but in patients more than 65-70 years the mortality is reported to be more than 10 percent. The phenomenon of acute lung injury (ALI)/adult respiratory distress syndrome (ARDS) after infra renal abdominal aneurysm repair caused by ischemia-reperfusion is well established. The degree of disability varies from a light degree of acute respiratory failure to mortality for patients with the same profile of risk.

Primary aim is to develop a model that monitors inflammatory marker molecules collected from the bronchial epithelial lining fluid by microdialysis. The method with examination of the bronchial epithelial lining fluid by microdialysis and analysis of multiple inflammation markers as previously done by the investigators group.


Eligibility criteria: Inclusion Criteria:

* Patients assigned for elective open aortic surgery

Exclusion Criteria:

* Moderate to severe COPD

Primary outcomes:
measure: Cytokines in bronchial epithelial lining fluid
timeFrame: Within 4 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Erik Solligård, md phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tyvold SS, Solligard E, Gunnes S, Lyng O, Johannisson A, Gronbech JE, Aadahl P. Bronchial microdialysis of cytokines in the epithelial lining fluid in experimental intestinal ischemia and reperfusion before onset of manifest lung injury. Shock. 2010 Nov;34(5):517-24. doi: 10.1097/SHK.0b013e3181dfc430.
citation: Tyvold SS, Dahl T, Dragsund S, Gunnes S, Lyng O, Damas JK, Aadahl P, Solligard E. Bronchial microdialysis monitoring of inflammatory response in open abdominal aortic aneurysm repair; an observational study. Physiol Rep. 2017 Jul;5(14):e13348. doi: 10.14814/phy2.13348.
Clinical trial NCT04910295: Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients
Official title: Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Covid19
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer who are receiving or received anti-cancer drugs at Seoul National University Hospital, Seoul, Korea

Brief summary: Serum antibody titre against COVID-19 spike protein will be measured before, after the first dose, and after the second dose (when applicable) in cancer patients who are receiving or received anti-cancer drugs. Side effects of vaccination and actual incidence of COVID-19 will be monitored.


Eligibility criteria: Inclusion Criteria:

* 20 years of age or older
* Patients who are receiving or received anti-cancer drugs
* Those who are not vaccinated against COVID-19 at the time of enrollment
* Written informed consent

Exclusion Criteria:

* Any contraindications to COVID-19 vaccines
* Those who were already vaccinated
* Those who are on immunosuppressants or infected with HIV
* Those who underwent organ transplantation
* Active infections (for example, pneumonia)

Primary outcomes:
measure: Antibody titre after vaccination
timeFrame: 21-28 days after completion of vaccination
Secondary outcomes:
measure: Antibody titer according to chemotherapy cycle, side effects, and use of corticosteroids or antipyretics
timeFrame: 21-28 days after completion of vaccination
measure: Incidence of COVID-19 infection
timeFrame: 6 months after completion of vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: