louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01368848: Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)
Official title: Phase II Study to Investigate the Treatment of Patients With NSCLC Stage IIIB and IV Without the Option of Surgery With a Combination of Cisplatin, Docetaxel and Bevacizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC
Keywords: AGMT
NSCLC
non-small cell lung cancer
bevacizumab
Avastin
Cisplatin
Docetaxel
Taxotere
Inoperable
stages IIIB and IV
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Roche Pharma AG
First posted: 2011-06-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite recent advances in the treatment of NSCLC overall survival within these patients remains dismal and there is yet an unmet medical need for additional treatment options. In this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and bevacizumab) is tested to determine the objective response rate in patients with unresectable and advanced non-small cell lung cancer. This response rate will be compared with historical data.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented inoperable, locally advanced, metastatic or recurrent NSCLC other than squamous cell
* At least 1 measurable lesion according to RECIST criteria
* ECOG performance score 0 or 1
* Age between 18 and 70 years

Exclusion Criteria:

* Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
* History of haemoptysis
* Evidence of tumour invading major blood vessels on imaging.
* Previous neoadjuvant/adjuvant chemotherapy.
* Previous radiotherapy.
* Serious uncontrolled coagulation disorder or thrombo-embolic complications within 6 months prior to study start or history of serious bleeding complications.
* Major surgical procedures within 4 weeks prior to study entry.
* Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
* Non-healing wound, active peptic ulcer or bone fracture.
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.

Primary outcomes:
measure: Response Rate
timeFrame: 4 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Duration of response
timeFrame: 5 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Univ.-Klinik für Innere Medizin V Innsbruck, Abteilung für Hämatologie und Onkologie
state: Tirol
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
Study officials:
References:
Clinical trial NCT06997848: The Application of Ultrasound in the Evaluation of Patients With Colon Cancer-related Obstruction Receiving Colonic Stent Placement
Official title: The Application of Ultrasound in the Evaluation of Patients With Colon Cancer-related Obstruction Receiving Colonic Stent Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resolution of Bowel Obstruction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute colorectal obstruction without perforation due to malignancy or extra-colonic tumor.

Brief summary: Bowel ultrasound may serve as a diagnostic tool to detect the resolution of bowel obstruction. In this study, we aim to validate the use of bowel ultrasound to evaluate patients with colon obstruction receiving colonic stents at National Taiwan University Hospital from January 2010 to June 2023. We will investigate the association between decompression of the ascending colon and the following surgical procedure, complication, and occurrence of bacteremia.


Eligibility criteria: Inclusion Criteria: acute colorectal obstruction without perforation due to malignancy or extra-colonic tumor.

Exclusion Criteria: acute colorectal obstruction with perforation

Primary outcomes:
measure: the ascending colon diameter and wall thickness
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: Wan-Ching Lien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01505348: Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
Official title: Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Patterns
Bone Resorption
Keywords: feeding patterns
aerobic exercise
osteoclasts
Lead sponsor: QinetiQ Ltd
Sponsor class: INDUSTRY
Collaborators: name: Ministry of Defence, United Kingdom
First posted: 2012-01-06
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study examined changes in bone metabolism (markers of bone turnover, calcium metabolism) with a bout of acute treadmill running preceded by either a single, mixed meal or an overnight fast.

Detailed description: Ten physically active males aged 28 ± 4 y (mean ± 1SD) completed two, counterbalanced, 8 d trials. After 3 d on a standardised diet, participants performed 60 min of treadmill running at 65% VO2max on Day 4 following an overnight fast (FAST) or a standardised breakfast (FED). Blood samples were collected at baseline, before exercise, during exercise, for 3h after exercise and on four consecutive follow-up days (FU1-FU4). Plasma/serum were analysed for β CTX, P1NP, OC, bone ALP, PTH, ACa, PO4, OPG, cortisol, leptin and ghrelin.

Eligibility criteria: Inclusion Criteria:

* history of weight bearing exercise
* fasting vitamin D concentration of \>30 nmol•L-1 and/or a fasting parathyroid hormone (PTH) concentration of \<6.9 pmol•L-1.

Exclusion Criteria:

* smokers
* suffered a bone fracture in the previous 12 months
* musculoskeletal injury
* condition/medication known to affect bone metabolism

Primary outcomes:
measure: Change in C-terminal telopeptide region of collagen type 1 (B-CTX) concentration from baseline
timeFrame: At 08:00 h (Baseline), 09:00 h, 09:30 h, and 10:15 h (Pre-exercise), after 30 and 60 min of exercise, after 1, 2, and 3 h of recovery and at 1, 2, 3 and 4 day post-exercise
Secondary outcomes:
measure: Change in parathyroid hormone (PTH) concentration from baseline
timeFrame: At 08:00 h (Baseline), 09:00 h, 09:30 h, and 10:15 h (Pre-exercise), after 30 and 60 min of exercise, after 1, 2, and 3 h of recovery and at 1, 2, 3 and 4 day post-exercise
Other outcomes:
Locations:
city: Farnborough
country: United Kingdom
facility: QinetiQ Ltd
state: Hampshire
Study officials:
affiliation: QinetiQ Ltd
name: Jonathan PR Scott, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01471548: Phase I Dose Escalating Study of TKI258
Official title: A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: tumor
cancer
phase1
TKI258
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained prior to any screening procedures
* Advanced solid tumors
* Agreement to remaining hospitalized
* ECOG performance status of 0 or 1
* Life expectancy of at least 3 months
* Pregnant women. Male and female patients of reproductive potential must agree to employ an effective method of birth control
* Demonstrate the specific hematological /blood chemistry laboratory values

Exclusion Criteria:

* Receipt of any investigational compound within 28 days prior to the first dose of study drug or failure to have recovered from the side effects of such prior therapy
* Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and radiation therapy, within 28 days (with some exceptions)
* Patients with CNS and/or leptomeningeal disease metastases
* Presence or history of thromboembolic or cerebrovascular events
* Impaired cardiac function or clinically significant cardiac disease
* Malabsorption syndrome or uncontrolled gastrointestinal toxicities
* Patients known to be HIV- or HBV- or HCV- positive
* Patients with acute or chronic uncontrolled infection
* Patients who have undergone surgery with general anesthesia for any cause within 28 days prior to the first dose of study drug
* Patients who have been receiving anticoagulant therapy
* Receipt of any hematopoietic colony stimulating factor or blood transfusion within 14 days prior to the first dose of study drug
* Patients who have been administering concomitant medication which may prolong the QTc interval
* Patients with interstitial pneumonia or pulmonary fibrosis proven on a chest CT scan
* Patients with a large volume of ascitic and/or pleural fluid which requires drainage
* Patients with any bone fractures
* Deemed otherwise unsuitable by the investigator

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Maximum tolerated dose (MTD) of TKI258
timeFrame: 30 days
Secondary outcomes:
measure: Antineoplastic activity based on the RECIST criteria
timeFrame: 22 months
Other outcomes:
Locations:
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Hidaka
country: Japan
facility: Novartis Investigative Site
state: Saitama
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04102748: Evaluation of Esthetic Outcomes of M-shaped Flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score
Official title: Evaluation of Esthetic Outcomes of M-flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score (PES) (RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant Failed
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the soft-tissue profile around a single-tooth implant in the anterior maxilla utilizing the PES after implant uncovering using "M" flap versus I-shaped incision.The primary objective is evaluation of esthetic outcomes around implant using PES.

Hypothesis: The use of I-shaped incision exposure technique will result in better esthetic outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients with osseointegrated dental implant in the anterior maxilla.
* Patients of 20 - 50 years
* Periodontally healthy patients.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate surgical intervention.

Exclusion Criteria:

* Intraoral soft and hard tissue pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems.
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Primary outcomes:
measure: PES
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT06371248: Steady Feet: Preventing Falls in the Community
Official title: Steady Feet Falls Prevention Programme for Community-dwelling Older Adults at Risk for Falls in Singapore: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Feasibility
Older Adults
Exercise
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 65
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the feasibility of Steady Feet, a three-month community-based falls prevention exercise program.

Detailed description: Participants aged 60 or older, at high risk of falls, with Short Physical Performance Battery (SPPB) scores between 7 and 11, and without significant cognitive or vision impairment, were recruited for a non-randomized, two-arm study. They were evaluated at baseline and the third month. The intervention group (IG) underwent Steady Feet and CGH's standard care for fall prevention, while the control group (CG) received CGH's standard care for fall prevention. Feasibility was assessed across Bowen's domains, including acceptability, demand, implementation, practicality, adaptation, and limited efficacy. Measurements included SPPB, Timed Up and Go, the 6-minute walk test, the Four-Square Step Test, the CONFbal scale, and a satisfaction survey administered to IG participants. Between-groups statistical analyses will be performed.

Eligibility criteria: Inclusion Criteria:

* Aged 60 years and above
* At high risk of falls according to the FROP-COM
* Short Physical Performance Battery (SPPB) score of 7 to 11
* Able to ambulate without wheelchairs or walkers
* Able to understand basic instructions.

Exclusion Criteria:

* Possess significant cognitive impairment (Abbreviated Mental Test \< 5)
* Had visual impairment, as determined by not passing at least 2 out of 3 Vision Function Test(s) (Logarithm of the Minimum Angle of Resolution (LogMar) vision, Stereoscopic vision, and Melbourne Edge Test (MET)

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: an average of 12 weeks
Secondary outcomes:
measure: CONFbal
timeFrame: an average of 12 weeks
measure: Six-minute walk test (6MWT)
timeFrame: an average of 12 weeks
measure: Timed up and go (TUG)
timeFrame: an average of 12 weeks
measure: Four square step test (FSST)
timeFrame: an average of 12 weeks
measure: Feedback and satisfaction survey
timeFrame: an average of 12 weeks
Other outcomes:
measure: Attendance and completion rates
timeFrame: an average of 12 weeks
measure: Safety of Steady Feet
timeFrame: an average of 12 weeks
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Shou Lin Low, MRCP (UK)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05976048: Implementation of Actinic Keratosis Guideline Among General Practitioners.
Official title: Implementation of Actinic Keratosis Guideline Among General Practitioners. Retrospective Cohort Study on Prescription Patterns in the Treatment of Actinic Keratosis.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Actinic Keratoses
Keywords: actinic keratosis
general physician
5-fluorouracil cream
general practitioner
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of patients with actinic keratosis in the general practitioners extracted from the Research network family medicine (RNFM) Maastricht database between 2016 - 2021.

Brief summary: This study investigates 5-fluorouracil cream prescription trends by general practitioners for the treatment of field changes of actinic keratosis over the years 2016-2021. The aim is to analyse whether the publication of the multidisciplinary guideline on suspect skin lesions for general practitioners in 2017 has made an impact in the prescribing behaviour of general practitioners.

Detailed description: Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race. With an increase in prevalence worldwide due to an aging population and rise of ultraviolet exposure actinic keratosis are among the most frequently encountered skin lesions in clinical practice. Both dermatologists and general practitioners are increasingly confronted with actinic keratosis, entailing to higher healthcare costs and time burden.

There are many therapeutic modalities for the treatment of actinic keratosis, depending on multiple factors such as distribution, characteristics, patient preference, side effects, availability and costs. Treatment options can be divided into: lesion directed therapy en field directed therapy. Both dermatologists and general practitioners can treat actinic keratosis and 5-fluorouracil cream can also be prescribed by general practitioners.

The objective of this study was to investigate 5-fluorouracil cream prescription trends by general practitioner for the treatment of field changes of actinic keratosis over the years 2016-2021.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* diagnosis actinic keratosis (clinical diagnosed or by biopsy)

Exclusion Criteria:

* cutaneous malignancy (suspicion)
* immunosuppressive co-medication.

Primary outcomes:
measure: Percentage (%) of longitudinal changes in prescriptions of 5-fluorouracil cream
timeFrame: Measurement years 2016, 2019 and 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Ellen Oyen
Study officials:
affiliation: Maastricht UMC+
name: Klara Mosterd, prof.dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01754948: Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children
Official title: Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: asthma
reactive airway disease
cough
air pollution
nano particles
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asthmatic and control children

Brief summary: Background Ambient airborne particulate material (PM) is defined according the aerodynamic diameter into coarse, fine, and ultrafine or "nano" sized particles ranging between 2.5-10 µm (coarse), \<2.5 µm (fine), and \<0.1 µm (nano(. Many studies have examined particle effect on respiratory health in children, mainly by environmental monitoring of coarse and fine particles. Biological assessment of individual exposure to nano sized particles in correlation to adverse health effect was not previously studied.

Hypothesis individual exposure to nano sized particles in children is associated with reduction in forced expiratory volume at one second.


Eligibility criteria: Inclusion Criteria:

* age 6-18 years
* living in the Tel Aviv area
* referred to the pulmonology lab for respiratory function evaluation

Exclusion Criteria:

* Exposure to cigarette smoke
* Respiratory infection in the 4 weeks prior to recruitment and testing

Primary outcomes:
measure: spirometry values
timeFrame: 1 sec
Secondary outcomes:
measure: methacholine and adenosine challenge test results
timeFrame: 1 sec
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Shira Benor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03451448: PET MRI in Coronary Artery Disease
Official title: Combined Magnetic Resonance Coronary Angiography and Positron Emission Tomography in Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: PET/MRI
ultra-small-superparamagnetic particles
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers to undergo MRI.

Patients with stable coronary artery disease or recent acute myocardial infarction to undergo PET/MRI

Brief summary: This study will assess the use of position emission tomography/magnetic resonance imaging (PET/MRI) using ultra-small-superparamagnetic particles of iron oxide (USPIO) as a contrast agent in patients with coronary artery disease.

Detailed description: Positron emission tomography/magnetic resonance imaging (PET/MRI) has the potential to provide detailed information on coronary artery anatomy, the presence of coronary artery stenosis, the composition of atherosclerotic plaque using MRI tissue characterisation and information about the underlying biological processes using targeted PET tracers. Ultra-small-superparamagnetic particles of iron oxide (USPIO) have a long blood pool half-life so are an ideal contrast agent for PET/MRI imaging.

This study will assess the use of PET/MRI with USPIO in patients with stable coronary artery disease and recent acute myocardial infarction.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers to undergo MRI imaging will be over the age of 18 years and able to provide informed consent.
* Patients with coronary artery disease to undergo PET/MRI will have multi-vessel disease (≥2 vessel coronary artery disease with ≥ 50% cross-sectional luminal stenosis).
* able to provide informed consent
* over the age of 40 years

Exclusion Criteria:

* inability or unwillingness to undergo magnetic resonance imaging or positron emission tomography
* renal failure (Serum creatinine \>200 umol/L or estimated glomerular filtration rate \<30 mL/min
* hepatic failure
* pregnancy
* inability to provide informed consent
* contraindications to undergoing MRI scanning
* contraindications to contrast agents not included above including evidence of iron overload, known allergy to constituents of the contrast agents, and anaemia not caused by iron deficiency

Primary outcomes:
measure: PET/MRI findings
timeFrame: Immediately after PET/MRI scan
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Scotland
Study officials:
affiliation: University of Edinburgh
name: Michelle Williams
role: PRINCIPAL_INVESTIGATOR
References: