louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03750175: OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -
Official title: OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - Feasibility Study Investigating Circulating Tumor DNA for Treatment Decisions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Metastatic
Circulating Tumor DNA
KRAS Gene Mutation
NRAS Gene Mutation
BRAF Gene Mutation
Epidermal Growth Factor Receptor Inhibitor
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer and indication for palliative chemotherapy with potential anti-EGFR monoclonal antibody.

Brief summary: The present study will investigate the feasibility and clinical value of using circulating tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic colorectal cancer.

Detailed description: The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody therapy

Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma during therapy and at time of progression

Eligibility criteria: Inclusion criteria

* Histopathologically verified metastatic colorectal cancer
* Indication for systemic palliative treatment with standard Anti-EGFR monoclonal antibodies
* Fit for therapy with EGFR inhibition
* Consent to treatment and sampling
* Measureable disease according to RECIST v 1.1
* Age ≥ 18

Exclusion criteria

* PS \> 2
* Significant other cancer disease within 5 years of inclusion
* Conditions precluding sampling during therapy and treatment breaks.

Primary outcomes:
measure: Feasibility of ctDNA analysis for RAS mutation analysis
timeFrame: maximum 7 days
Secondary outcomes:
measure: Retrospective concordance analysis
timeFrame: By end of study, expected after 3 years
measure: Disease control rate
timeFrame: 1 year
measure: OS
timeFrame: 3 years
measure: Resistance mutations
timeFrame: At time of progression, data analysis expected after 3 years
measure: Lead time
timeFrame: At time of progression, data analysis expected after 3 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Department of Oncology, AUH, Dk
name: Karen-Lise G Spindler
role: STUDY_CHAIR
References:
citation: Callesen LB, Sorensen BS, Pallisgaard N, Laugesen IG, Boysen AK, Spindler KG. Total cell-free DNA measurement in metastatic colorectal cancer with a fast and easy direct fluorescent assay. Mol Clin Oncol. 2022 Mar;16(3):64. doi: 10.3892/mco.2022.2497. Epub 2022 Jan 17.
Clinical trial NCT05964075: RASECAL-Bronchoscopic Ambusampler
Official title: A Randomized Controlled Trial to Assess the Safety and Efficiency of a Self-Contained Sampling Device /disposable Bronchoscope System Versus Usual SampLing Procedure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring clinical bronchoscopy

Brief summary: Prospective, multi-centre, open labelled, 1:1randomized controlled study.

Detailed description: 1. Patients admitted to ICU with acute respiratory failure, requiring mechanical ventilation with, suspected or confirmed COVID-19.
2. Patients admitted to ICU with acute respiratory failure due to a condition other than COVID-19, requiring mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

(All are required)

* Clinicians experienced in performing bronchoscopies (i.e. bronchoscopists should have performed a minimum 5 bronchoscopies in mechanically ventilated patients and a minimum of 5 bronchoscopies in a simulated or practice setting).
* Clinicians who have undergone the online product-training module for the use of the Ambu Bronchosampler, with self-certification documented.
* Clinicians who have simulated the online product training module using an Ambu Bronchosampler and Ambu Ascope4 a minimum of 5 times in a practice setting and have self-certified.

Population

* Patients ≥ 18 years old
* Patients on mechanical ventilation with Acute respiratory failure for \>4h
* Patients eligible for a clinically indicated bronchoscopy with fluid sampling. Patient information has been explained and verbal or written consent has been obtained

Exclusion Criteria:

Investigators

* Investigators who have not completed product training in aScope BronchoSampler by online and hands-on from Ambu product specialists or an experienced user from the site.
* Investigators with experience in \< 5 self-verified simulated fluid sampling procedures using the Ambu BronchoSampler 4.8.2 Population
* Clinician concern regarding safety of bronchoscopy
* Involved study personal not available to perform the procedure and enroll the patient

Primary outcomes:
measure: Comparison of two sampling pots
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHSFT
Study officials:
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Damon 0 Foster, 0
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03421275: Intranasal Esketamine and Fentanyl for Pain in Minor Trauma
Official title: Intranasal Fentanyl and Esketamine for Treatment of Acute Pain in Minor Trauma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Pain Due to Trauma
Keywords: fentanyl
esketamine
ketamine
analgesia
acute pain
minor trauma
Lead sponsor: Hospital District of Helsinki and Uusimaa
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intranasal esketamine, fentanyl and placebo are compared in treatment of acute pain in adult patients with minor trauma. Study is blinded randomized placebo-controlled parallel design.


Eligibility criteria: Inclusion Criteria:

* NRS 5 or more, minor trauma, no need for immediate iv cannulation, weight 45-115 kg

Exclusion Criteria:

* pregnancy, breastfeeding, head trauma, severe chronic obstructive pulmonary disease (COPD), gfr under 30, liver cirrhosis, mental illness other than mild/moderate depression, sleep apnea, unstable coronary artery disease (CAD), unstable heart failure (HF), intoxication, untreated hypertension, dementia, do not understand Finnish, contraindication to nasal spray, allergy to any of the medications, bradycardia, desaturation, suspected high intracranial pressure (ICP)

Primary outcomes:
measure: Numeric rating scale (NRS) change
timeFrame: 15 minutes and 30 minutes
Secondary outcomes:
measure: Amount of patients with NRS change more than -2
timeFrame: 15 min, 30 min, 60 min
measure: Patient satisfaction (pain management)
timeFrame: 120 min
measure: Side effects
timeFrame: 120 min
measure: Amount of study drug consumed (doses)
timeFrame: 120 min
measure: Need for rescue medication mg (oxycodone)
timeFrame: 120 min
Other outcomes:
Locations:
city: Hyvinkää
country: Finland
facility: Hyvinkää Hospital
Study officials:
affiliation: consultant
name: Anna Meuronen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04790175: Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in SIADH
Official title: Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Antidiuretic Hormone, Inappropriate Secretion
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-10
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: Patients in Japan with hyponatremia in SIADH who are planned to be newly started on Samsca therapy

Brief summary: The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan


Eligibility criteria: Inclusion Criteria:

* Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2018"

Exclusion Criteria:

-

Primary outcomes:
measure: Safety Information (Adverse Event)
timeFrame: 90 days from the initiation of tolvaptan treatment
measure: Safety Information (Special Situations)
timeFrame: 90 days from the initiation of tolvaptan treatment
measure: Safety Information (Number of off-Label Use)
timeFrame: 90 days from the initiation of tolvaptan treatment
measure: Safety Information (Serious Adverse Event)
timeFrame: 90 days from the initiation of tolvaptan treatment
measure: Safety Information (Non-serious Adverse Events)
timeFrame: 90 days from the initiation of tolvaptan treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Pharmacovigilance Department
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Yasuhiko Fukuta, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06452459: Glymphatic MRI Study
Official title: Evaluation of Glymphatic Function With MRI
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sleep Deprivation
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: This study aims at identifying neuroimaging markers of glymphatic function in humans.


Eligibility criteria: Inclusion Criteria:

* Ability to undergo MRI without anesthesia
* Calculated GFR greater or equal to 60 mL/min/1.73 m2

Exclusion Criteria:

* Inability to obtain consent
* Subject is incarcerated, pregnant, or lactating or suspects they may be pregnant
* Known allergic or hypersensitivity reactions to gadolinium
* Three or more drug allergies from separate drug classes
* Recent or expected beed for imaging with iodinated contrast
* Contraindications to MRI: claustrophobia, weight greater than maximum MRI scanner capacity, presence of metallic foreign body, or implanted devices not documented as MRI safe
* History of neurosurgical procedure or cervical surgery
* Current use of anticoagulation medications
* Contraindication to lumbar puncture (creatinine or INR elevated above laboratory standard cutoffs)

Primary outcomes:
measure: Contrast enhancement
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01563159: Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011
Official title: Assessing the Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Belgium
hospitals
Rotavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 1
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged ≤5 years undergoing a RV detection test across 11 participating hospitals.

Brief summary: This study aims to confirm the statistically significant decline in rotavirus related and in acute gastro-enteritis (AGE) related hospital admissions that was observed in 11 participating hospitals, after the introduction of RV vaccines in Belgium in 2006.

Detailed description: This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2010 until the 31st of May 2011. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.

Eligibility criteria: Inclusion Criteria:

* Child aged ≤5 years;
* A stool sample has been provided for a rotavirus detection test during the study period;
* Laboratory test result of rotavirus is available.

Exclusion Criteria:

Not applicable.

Primary outcomes:
measure: Absolute number of rotavirus related hospitalisations in children up to five years old.
timeFrame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
Secondary outcomes:
measure: Proportion of rotavirus positive tests on the total number of rota detection tests
timeFrame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
measure: The duration of rota-related hospitalisation for community acquired and nosocomial infection.
timeFrame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Standaert B, Strens D, Pereira P, Benninghoff B, Raes M. Lessons Learned from Long-Term Assessment of Rotavirus Vaccination in a High-Income Country: The Case of the Rotavirus Vaccine Belgium Impact Study (RotaBIS). Infect Dis Ther. 2020 Dec;9(4):967-980. doi: 10.1007/s40121-020-00345-y. Epub 2020 Oct 6.
Clinical trial NCT03329859: Microcomplications in Lap. Cholecystectomy: Reducing Intraoperative Interruptions by High Resolution Standardization
Official title: Impact of Microcomplications in Laparoscopic Surgery on Operative Time and Costs - Multimodal Strategy to Reduce Microcomplications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Workflow
Costs
Laparoscopy
Cholecystectomy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective: Investigators aimed to evaluate the impact of a high resolution standardized laparoscopic (HRSL) cholecystectomy protocol on operative time and intraoperative interruptions in a teaching hospital.

Background: Interruptions of the surgical workflow or microcomplications (MC) lead to prolonged procedure times and costs and can be indicative for surgical mistakes. Reducing MC can improve operating room efficiency and prevent intraoperative complications.

Methods: Audio video records of laparoscopic cholecystectomies were reviewed regarding type, frequency and duration of MC before and after the implementation of a HRSL which included the introduction of a stepwise protocol for the procedure and a teaching video. After consent operating team members were obliged to prepare the operation with these resources.


Eligibility criteria: Inclusion Criteria:

* age above and including 18 years
* indication for laparoscopic cholecystectomy
* written informed consent of patient
* written informed consent of the operating team

Exclusion Criteria:

* age below 18 years
* other laparoscopic or open surgical procedure in the same operation.

Primary outcomes:
measure: median hourly delay due to microcomplications
timeFrame: Any microcomplications are recorded between skin incision to skin closure during laparoscopic cholecysectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel/Dep. of General and Visceral Surgery
state: Basel Stadt
Study officials:
affiliation: University Hospital Basel, Department of General and Visceral Surgery, Spitalstrasse 21, CH-4031 Basel
name: Marco von Strauss und Torney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Strauss Und Torney M, Aghlmandi S, Zeindler J, Nowakowski D, Nebiker CA, Kettelhack C, Rosenthal R, Droeser RA, Soysal SD, Hoffmann H, Mechera R. High-resolution standardization reduces delay due to workflow disruptions in laparoscopic cholecystectomy. Surg Endosc. 2018 Dec;32(12):4763-4771. doi: 10.1007/s00464-018-6224-y. Epub 2018 May 21.
Clinical trial NCT01864759: Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma
Official title: Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Melanoma
Keywords: melanoma
oncolytic
adenovirus
virotherapy
locally advanced
metastatic
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus.


Eligibility criteria: Inclusion Criteria:

* Malignant melanoma advanced or metastatic.
* Other than 18 years
* Karnofsky index \> 60 %
* Life expectancy \> 3 months
* ALT/AST \<=2.5 times the upper normal limit
* Creatinine clearance \>= 50 ml/min.
* Bilirubin \<25 umol/l
* Alkaline phosphatase \<= 2.5 time upper normal limit
* Normal bone marrow function: Neutrophils \>=1.5 E9/L, platelets \>= 1E11/L, hemoglobin \>= 100 g/l, Normal prothrombin time and thromboplastin time,
* HIV negative
* Measurable disease
* Signed informed consent.

Exclusion Criteria:

* Geographical, social or psychological conditions that may impair the protocol compliance.
* Active infections or other severe medical status.
* History of liver disease.
* Other or concomitant treatments for melanoma or investigational product.
* Previous participation in studies with adenovirus.
* Virus diseases diagnosed two weeks before inclusion.
* Immunosuppressive concomitant treatments
* Concomitant malignant haematological disease.
* Patients having family members with immunodeficient status or disease
* Patients with Li Fraumeni syndrome or germinal retinoblastoma gene defects.

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 4 weeks
Secondary outcomes:
measure: Recommended dose
timeFrame: 4 weeks
measure: Anti-tumour activity
timeFrame: 4 weeks
Other outcomes:
measure: Viral pharmacokinetics
timeFrame: 1 day
measure: Viral pharmacodynamics
timeFrame: 5 days
Locations:
city: L'Hospitalet del Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet
state: Barcelona
Study officials:
affiliation: Institut Català d'Oncologia
name: Ramon Salazar, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Català d'Oncologia
name: Ramon Alemany, PhD
role: STUDY_CHAIR
References:
citation: Cascallo M, Alonso MM, Rojas JJ, Perez-Gimenez A, Fueyo J, Alemany R. Systemic toxicity-efficacy profile of ICOVIR-5, a potent and selective oncolytic adenovirus based on the pRB pathway. Mol Ther. 2007 Sep;15(9):1607-15. doi: 10.1038/sj.mt.6300239. Epub 2007 Jun 19.
Clinical trial NCT01791959: The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Official title: The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40
* Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

* Diabetes
* Taking any kind of antibiotics two weeks before recruitment
* History of alcohol consumption
* pregnancy or lactation
* Professional athletes
* Other liver disease (viral/etc)
* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
* Following program to lose weight in recent 3 mo
* A history of hypothyroidism or Cushing's syndrome

Primary outcomes:
measure: Alaninaminotransferase (ALT)
timeFrame: 28 weeks
measure: Liver fibrosis
timeFrame: 28 weeks
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 28 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National Nutrition and Food Technology Research Institute
name: Azita Hekmatdoost, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eslamparast T, Poustchi H, Zamani F, Sharafkhah M, Malekzadeh R, Hekmatdoost A. Synbiotic supplementation in nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled pilot study. Am J Clin Nutr. 2014 Mar;99(3):535-42. doi: 10.3945/ajcn.113.068890. Epub 2014 Jan 8.