louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06045065: Preclinical Brain Tumor Models
Official title: Establishment of Pre-clinical Stem Line and Tumoroid Models of Brain Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Metastases
Diffuse Gliomas
Keywords: Brain metastases
Glioma
Glioblastoma
Preclinical models
Tumoroids
Cell lines
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with primitive tumor or with brain metastasis

Brief summary: Background: Primary or secondary brain tumors (metastases) remain associated with a very poor prognosis linked to significant therapeutic resistance. Thus, glioblastoma, which is the most common and aggressive primary brain tumor in adults, is associated with inevitable relapses within 7 to 10 months and median survival of approximately 12 to 14 months. At the same time, brain metastases are increasingly increasing following better systemic control of other metastatic sites and improvement in detection methods. However, they remain resistant to the latest therapeutic innovations such as immunotherapies or targeted therapies.

In this context, innovative strategies are necessary to identify new therapeutic targets and implement new treatments to overcome resistance phenomena in the clinic.

Objective: Our goal will be to generate tumoroids and stem-like cell lines (PDX) from patient tumor samples.

Methods: We will establish tumor tumoroids and stem cell lines from patient samples. These preclinical models will allow us to test a large number of drugs, quickly and efficiently thanks to models as close as possible to patient tumors and limiting the use of animal models (3R).

Overall, this project should enable major advances in the treatment of glioblastoma and brain metastases and enable the rapid testing of new molecules in clinical trials thanks to the homology of our models with our patients' diseases.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Brain tumor neuro-imaging
* Eligible for neurosurgery

Exclusion Criteria:

* unresectable tumor

Primary outcomes:
measure: Tumoroid and stem cell line generation
timeFrame: 4 weeks after generation
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance publique hopitaux de marseille
Study officials:
References:
Clinical trial NCT00769665: A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Keywords: Dry Eye
re-wetting drops
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 47
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: community sample

Brief summary: To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a currently marketed contact lens rewetting drop will be included as a control.


Eligibility criteria: Inclusion Criteria:

* Participants must be between 18 and 65 years of age.
* Provide written Informed Consent.
* Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality, or a Rigid Gas Permeable (RGP) contact Lens
* Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
* Sodium fluorescein (NaFl) corneal staining score sum of \< 2 in both eyes (NEI scoring system).
* Must be willing to maintain pre-enrollment systemic medication regimens during the study.
* Must be available for study visits and to fill out study questionnaires.

Exclusion Criteria:

* Has modified their systemic medications within 30 days prior to enrollment.
* Has a history of allergy to any study product ingredients
* Is unwilling or unable to meet the study visit timeline.
* Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
* Is currently using any topical eye medications (not including rewetting drops, artificial tear products or Restasis).

Primary outcomes:
measure: Adverse Events and Visual Acuity
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01080365: Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions
Official title: A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Bosutinib In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study comparing 2 formulations of bosutinib in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Men or women of nonchildbearing potential age 18 to 50 years

Exclusion Criteria:

* Any clinically significant medical condition

Primary outcomes:
measure: Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02181465: Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.
Official title: Phase II, Open Label, Single Center, Two Arm Study Study to Assess the Safety, Tolerance and Efficacy of a 2 mg Dose of G17DT Via Intramuscular Injection in Patients With Advanced Metastatic Colorectal Adenocarcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.


Eligibility criteria: Inclusion Criteria:

* Histologically verified adenocarcinoma of the colon or rectum
* Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
* measurable/ evaluable lesions
* Life expectancy \> 3 months
* Karnofsky index \> 50% or WHO performance rating of 0-2
* Biochemical markers:

  * renal function \< 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven)
  * liver function \< 25% above upper limit of normal range (bilirubin \~25 mcmol/1 unless malignant involvement proven)
* Haematological status:

  * haemoglobin, 11 g/ dl
  * WBC, 4 X 109/1
  * platelets, 100 x 109/l
* Written consent

Exclusion Criteria:

* Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
* H 2 receptor antagonist or proton pump inhibitor therapy
* Previous gastric surgery (including vagotomy)
* Active uncontrolled infection
* Autoimmune disorders
* Anticancer treatment within the last three months unless progression of the disease occurred in the interim
* Women of child-bearing age
* Patient is a poor medical risk because of non-malignant systemic disease
* Previous radiotherapy to all measurable or evaluable lesions.

Primary outcomes:
measure: Number of participants with adverse effects
timeFrame: Up to week 16
Secondary outcomes:
measure: Measure serum anti gastrin-17 antibodies to determine immunological response to medication
timeFrame: Up to week 16
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University Hospital, Queen's Medical Centre
state: Nottinghamshire
Study officials:
References:
Clinical trial NCT02455765: Glycemic Response of Co-ingesting Carbohydrate and Amino Acids
Official title: Glycemic Response of Co-ingesting Carbohydrate and Amino Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: Cerebos Asia Pacific Pte Ltd
First posted: 2015-05-28
Enrollment: 23
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The study will investigate if consumption of amino acid mixtures results a change in glycemic response of carbohydrate (white rice) and insulinemic response at different doses and timing (before consumption of carbohydrate).

Detailed description: Healthy male subjects will be served with amino acid mixtures in combinations of two doses and three time points along with white rice as control. The combinations were either low or high levels of amino acid mixtures. This was consumed together or 15 min, 30 min before consumption of white rice. Postprandial blood glucose and plasma insulin concentrations were measured at fasting and every 15 min after consumption of treatment meal until 60 min after the consumption of white rice. Subsequent blood sample were taken at 30 min interval until 210min. The glucose and insulin in the blood will be analysed.

Eligibility criteria: Inclusion Criteria:

* Male
* Chinese ethnicity
* Age between 21-50 years
* Body mass index (BMI) between 18-24.9 kg/m2
* Waist circumference ≤ 90 cm for men
* Normal blood pressure (\<120/80 mmHg)
* Fasting blood glucose \< 6 mmol/L

Exclusion Criteria:

* dislike the consumption of Essence of Chicken
* participating in competitive sports
* allergic to amino acids and rice
* metabolic diseases (such as diabetes, hypertension and the metabolic syndromes)
* Glucose-6-Phosphate-Dehydrogenase (G6PD) Deficiency
* on prescription medication
* smokers

Primary outcomes:
measure: Glycemic response
timeFrame: 210 minutes post consumption of carbohydrate
measure: Insulinemic response
timeFrame: 210 minutes post consumption of carbohydrate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06363565: Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults
Official title: Study on the Effect of Compound Nutrients on Reducing Homocysteine -- A 3-month Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Homocysteine
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether supplementation of compound nutrients, including folic acid, vitamin B6, vitamin B12, and betaine, will decrease the level of plasma homocysteine in Chinese adults with homocysteine levels above 10 μmol/L.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 - 65 years;
2. Concentration of plasma homocysteine is between 10 and 100 μmol/L;
3. Free from any supplements or drugs that may decrease plasma homocysteine concentration for at least 1 month prior to the beginning of study;
4. Willing to participate in the study and sign informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Allergic physique or allergic to our compound nutrients tablets;
3. Complicated with severe diseases;
4. Unable to conduct study procedures;
5. Participating in any other intervention studies.

Primary outcomes:
measure: levels of homocysteine
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SunYat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huilian Zhu, professor
role: STUDY_CHAIR
References:
Clinical trial NCT05505565: Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes
Official title: Continuous Glucose Monitors in the Management of Youth With Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Obesity
Insulin Resistance
Keywords: pediatrics
prediabetes
obesity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-08-17
Enrollment: 33
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, non-blinded, parallel, intervention vs control group
Primary purpose: PREVENTION

Brief summary: We are evaluating whether intermittent use of continuous glucose monitors (CGMs) in addition to standard nutritional counseling and physical activity counseling is associated with improved metabolic health for youth with pre-diabetes (PD).

Detailed description: The purpose of this research study is to test if CGMs are tolerable to youth with pre-diabetes (PD) and their caregivers. We are also evaluating if CGMs add benefit to standard treatment in youth with prediabetes. The CGM in question, Abbott Freestyle Libre 2 is approved by the Food and Drug Administration (FDA) to treat patients aged 4 and up with diabetes. We want to determine if this CGM may benefit people who have PD. People who enter the study will either receive standard medical care for prediabetes or receive standard medical care for prediabetes plus use a CGM for 2 weeks each month to receive real-time biofeedback on their glucose levels during the day.

There will be 3 visits over a 6-month period, baseline, 3-month, and 6-month visits. At each visit fasting labs will be obtained including: complete metabolic panel, lipid panel, pro-insulin, c-peptide, insulin. Anthropomorphics including body mass index, waist circumference, and hip circumference will be monitored.

Eligibility criteria: Inclusion Criteria:

* Age 14 or older
* English-speaking
* stable metformin dose for 1 month prior to enrollment or no metformin use
* baseline A1c of 5.7-6.4%
* tanner stage 3 or above
* BMI \> = 85% for age

Exclusion Criteria:

* BMI \< 85% for age
* chronic steroid use
* diagnosis of type 1 diabetes, type 2 diabetes, other forms of diabetes
* current or history of malignancy

Primary outcomes:
measure: CGM Acceptability
timeFrame: 6 months
measure: Progression of prediabetes
timeFrame: 6 months
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 6 months
measure: Hyperlipidemia
timeFrame: 6 months
measure: Transaminitis
timeFrame: 6 months
measure: Glycemic metrics
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jessica A Schmitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02054065: Effect of CAUTI Prevention Alert - A Randomized Control Trial
Official title: Effect of CAUTI Prevention Alert - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection Due to Indwelling Urinary Catheter
Keywords: Urinary Catheter
urinary tract infection
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 108
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study proposes to expand upon previous research by studying the effects of a urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs with a large, randomized controlled trial within a three-hospital academic medical center.

Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter days and decrease the number of catheter associated urinary tract infections (CAUTIs), but will not affect the catheter re-insertion rate.

Detailed description: Primary Objectives

* Specific Aim 1: Investigate the effect of a urinary-catheter removal alert on the rate of catheter associated urinary tract infections (CAUTIs).
* Specific Aim 2: Investigate the effect of a urinary-catheter removal alert on the number of catheter days.
* Specific Aim 3: Evaluate the effect of a urinary-catheter removal alert on the rate of catheter re-insertion.
* Specific Aim 4: Evaluate the effect of a urinary-catheter removal alert on overall mortality in patients with indwelling catheters.

Eligibility criteria: Inclusion Criteria:

* All admissions with an indwelling urinary catheter will be randomly assigned to intervention vs. control (usual care) conditions.

Exclusion Criteria:

* Neonatal Intensive Care Unit and pediatric patients

Primary outcomes:
measure: Number of CAUTIs
timeFrame: One Year
Secondary outcomes:
measure: Number of catheter days
timeFrame: One year
measure: Rate of catheter re-insertion
timeFrame: One Year
measure: Patient mortality due to CAUTI
timeFrame: One year
Other outcomes:
Locations:
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Jason S Adelman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01978665: The Effect of Prednisone on Physical Exercise in COPD Patients
Official title: The Effect of Prednisone and Solu-Medrol on Physical Exercise in COPD Patients and the Inflammaroty Response During and After Exercis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Exercise Performance in Copd Patients
Keywords: COPD exercise inflammation prednisone
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 14
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT study with steroid.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to investigate if there is an effect on exercise performance og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic obstructive pulmonary disease(COPD)

Detailed description: RCT study with 4 days of steroid

Eligibility criteria: Inclusion Criteria:FEV1\< 60% FEV1/FVC ratio \<70 %

* able to use a ergometer bike

Exclusion Criteria: Haemodynamicaly unstable heart conditions

* exacerbations before 6 week entry of the study exacerbation during the study period treatment with beta blockers malignancy the last 5 years allergi toward IMP

Primary outcomes:
measure: effect on muscle power
timeFrame: jan 2013 to july 2013 (6 months)
Secondary outcomes:
measure: the inflammatory response
timeFrame: jan 2013 to july 2013 (6 months)
Other outcomes:
measure: vo2max
timeFrame: jan 2013 to july 2013 ( 6 months)
measure: VO2max
timeFrame: jan 2013 until july 2013 (6 months)
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
Study officials:
affiliation: Bispebjerg Hospital
name: Vibeke Backer, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00899665: Proteases in Patients With Prostate Cancer That Has Spread to the Bone
Official title: Proteases in Prostate Cancer Bone Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Metastatic Cancer
Myelodysplastic Syndromes
Precancerous Condition
Prostate Cancer
Keywords: stage IV prostate cancer
bone metastases
anemia
monoclonal gammopathy of undetermined significance
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 31
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Collecting and storing samples of bone marrow and tissue from patients to test in the laboratory may help the study of cancer.

PURPOSE: This laboratory study is comparing proteases (enzymes that break down protein) in patients with prostate cancer that has spread to the bone with patients who do not have cancer that has spread to the bone.

Detailed description: OBJECTIVES:

* Examine the roles of proteases and protease-associated molecules in bone metastases in patients with metastatic prostate cancer.

OUTLINE: Patients undergo bone marrow aspiration and core bone biopsies. Tissues are analyzed by immunohistochemistry methods, in situ hybridization assays, gelatin zymography and/or Western blot analysis, and gene profiling analysis in order to visualize and quantitate protease or protease-related levels.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of metastatic prostate cancer

    * Patients with documented bone metastases on radiologic imaging studies must undergo bone marrow biopsy
  * Male patients ≥ 50 years of age without cancer who are scheduled to undergo bone biopsy for other clinically indicated reasons, including any of the following:

    * Myelodysplasia
    * Anemia
    * Monoclonal gammopathy of undetermined significance
  * Male or female patients ≥ 40 years of age without metastatic bone cancer who are scheduled to undergo an orthopedic procedure involving removal of bone specimen

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Expression and activity of proteases and related molecules
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Michael L. Cher, MD
role: STUDY_CHAIR
References: