louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00747097: Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study
Official title: Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Time to Progression
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-09-04
Enrollment: 43
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 purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically proven locally advanced or metastatic unresectable adenocarcinoma of the biliary tract
* signed written informed consent
* age \> 18
* WHO PS 0 or 1 at study entry
* measurable (diameter ³ 1 cm) / evaluable disease, according to RECIST criteria
* adequate renal (serum creatinin\<1.5x upper reference range), liver (total bilirubin\<2x upper reference range) and hematopoietic functions (PMN\>1,5x109/L, platelets\>100x109/L)
* life expectancy of at least 12 weeks
* effective contraception throughout the study for both male and female patients if the risk of conception exists

Exclusion Criteria:

* uncontrolled concurrent CNS, cardiac, infectious diseases
* previous exposure to epidermal growth factor targeting therapy
* known hypersensitivity to any components of study treatments
* previous chemotherapy for this cancer
* previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
* pregnancy or breast feeding
* medical or psychological conditions that would not permit the patient to complete the study or sign informed consent

Primary outcomes:
measure: Progression-free survival
timeFrame: 6 months
Secondary outcomes:
measure: overall survival, objective response, safety
timeFrame: 12 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St.-Luc
Study officials:
References:
citation: Borbath I, Ceratti A, Verslype C, Demols A, Delaunoit T, Laurent S, Deleporte A, Vergauwe P, Van Maanen A, Sempoux C, Van Cutsem E, Van Laethem JL; Belgian Group of Digestive Oncology. Combination of gemcitabine and cetuximab in patients with advanced cholangiocarcinoma: a phase II study of the Belgian Group of Digestive Oncology. Ann Oncol. 2013 Nov;24(11):2824-9. doi: 10.1093/annonc/mdt337. Epub 2013 Aug 23.
Clinical trial NCT04761497: Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.
Official title: Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
cognition.
behaviour
function
motor function
active music therapy
passive music therapy
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine what type of music therapy (active versus passive) approach has higher effects on clinical symptoms in advanced Alzheimer's disease patients

Detailed description: Ninety AD patients from six nursing homes participated in the study. Nursing homes were randomly and blindly assigned to receive for three months either active music intervention, passive music listening or usual care. Effects on cognition, behaviour, daily living activities and motor function were assessed after the intervention.

Eligibility criteria: Inclusion Criteria:

* Nursing-home dwelling
* Diagnosis of probable Alzheimer's disease
* Mild or moderate stage (Clinical Classification of the Dementia)

Exclusion Criteria:

* Aphasia
* Hearing impairment that may affect participation in the activities.

Primary outcomes:
measure: Mini Examination of the Mental State
timeFrame: 0-3 months
measure: Neuropsychiatric Inventory
timeFrame: 0-3 months
measure: Geriatric depression scale
timeFrame: 0-3 months
measure: Barthel index
timeFrame: 0-3 months
measure: Tinneti scale.Higher scores indicate better motor function
timeFrame: 0-3 months. Range 0-28
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCMurcia
Study officials:
References:
Clinical trial NCT02183597: Whole-body MRI for the Detection of Metastasis
Official title: Whole-body MRI for the Detection of Metastasis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Metastases
Keywords: Magnetic Resonance Imaging
Data Accuracy
Reproducibility of Results
Diagnosis
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in Mid Norway living with advanced breast cancer

Brief summary: Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate diagnostic accuracy through application of optimized protocols for screening of cancer patients.


Eligibility criteria: Inclusion Criteria:

- Cancer patient

Exclusion Criteria:

* Poor general condition
* Pacemaker or other MRI contraindications

Primary outcomes:
measure: Number of metastasis in skeleton
timeFrame: Baseline and after 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Beathe Sitter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02305797: EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
Official title: A Randomized Double-Blind, Placebo Controlled, Flexible Dose, Parallel Group Study of Extended-Release Lorazepam (EDG004) for the Treatment of Generalized Anxiety Disorder (GAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder (GAD)
Lead sponsor: Edgemont Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2014-12-03
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 18-65 years and
* Diagnosed with GAD and
* No other psychiatric conditions, and are otherwise medically healthy.

Exclusion Criteria:

* Women who are pregnant or lactating.

Primary outcomes:
measure: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)
timeFrame: Day 42 (Visit 7)
Secondary outcomes:
measure: Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)
timeFrame: Day 42 (Visit 7)
Other outcomes:
Locations:
city: Multiple Locations
country: United States
facility: Multiple Investigational Sites
state: California
Study officials:
References:
Clinical trial NCT06911697: Study on c-Met Targeted PET/CT Imaging in NSCLC
Official title: In Vivo Detection of c-Met Activation Status by Specific PET/CT Imaging Based on 18F Labeled Small Molecule TKI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PET/CT Imaging
NSCLC
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Henan Provincial People's Hospital
First posted: 2025-04-04
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators developed a 18F labeled small molecule, 18F-TSPF, based on c-Met TKI, as a targeted molecular imaging agent for noninvasive and repeatable detecting c-Met activation status.

Detailed description: In the study, NSCLC patients with different c-Met activation status (c-Met overexpression, MET exon 14 skipping mutation, MET amplification, MET wild type) confirmed by pathology or gene detection will receive 18F-TSPF PET/CT and 18F-FDG PET/CT respectively. The goal of the study is to evaluate specificity and accuracy of 18F-TSPF as a novel PET radiotracer to detect c-Met activation status and potentially identify c-Met-TKIs benefited NSCLC patients.

Eligibility criteria: Inclusion Criteria:

1. Age range 18-75 years, open to both male and female participants;
2. Normal hepatic/renal function and cardiac function;
3. Expected survival of at least 12 weeks;
4. Good adherence to follow-up;
5. Presence of at least one measurable target lesion according to RECIST 1.1 criteria;
6. Women of childbearing age (15-49 years) must undergo a pregnancy test within seven days prior to the commencement of the study and test negative; sexually active male and female participants must agree to utilize effective contraception to prevent pregnancy during the study and for three months following the final examination;
7. Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors;
8. Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form.

Exclusion Criteria:

1. Severe abnormalities in liver and renal function and blood counts;
2. Patients planning to conceive;
3. Pregnant or lactating women;
4. Individuals unable to lie flat for thirty minutes;
5. Individuals who refuse to participate in this clinical study;
6. Individuals suffering from claustrophobia or other psychiatric disorders;
7. Other situations deemed unsuitable for trial participation by the researchers.

Primary outcomes:
measure: Standardized Uptake Values
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: Department of Nuclear Medicine, Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
References:
Clinical trial NCT00137397: A Study to Measure the Effect of Tolterodine Extended Release on the Thickness of the Bladder Wall in Patients With Overactive Bladder
Official title: A Multi-centre, Randomised, Placebo Controlled, Double Blind, Parallel Group Study in Female Patients to Evaluate Whether Tolterodine ER Can Reverse the Increased Bladder Wall Thickness in Patients With Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to investigate whether taking Tolterodine for overactive bladder symptoms can reduce the thickness of the bladder wall, as measured by intra-vaginal ultrasound. This will help doctors to understand whether there is a link between changes in the thickness of the bladder wall and progression of symptoms.


Eligibility criteria: Inclusion Criteria:

* Symptoms of overactive bladder (described as urinary urgency, with or without urge incontinence, usually with frequency and nocturia for more than 6 months
* Bladder wall thickness of 5mm or more

Exclusion Criteria:

* Treatment in the previous four weeks with an anticholinergic drug or any drug for the treatment of overactive bladder.
* Significant stress incontinence - Urinary tract infection or a history of intermittent urinary tract infections (more than four episodes in the last two years).
* Conditions considered significant by the investigator (e.g. cystocoele, significant bladder prolapse, bladder stone, indwelling catheter etc)

Primary outcomes:
measure: The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.
Secondary outcomes:
measure: Secondary outcomes are the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 24
Other outcomes:
Locations:
city: Blackburn
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Harrow
country: United Kingdom
facility: Pfizer Investigational Site
state: Middx
city: Oxford
country: United Kingdom
facility: Pfizer Investigational Site
state: Oxfordshire
city: Livingston
country: United Kingdom
facility: Pfizer Investigational Site
state: West Lothian
city: Basingstoke
country: United Kingdom
facility: Pfizer Investigational Site
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Cambs
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Northampton
country: United Kingdom
facility: Pfizer Investigational Site
city: Pl6 8Dh
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01620697: Visceral Obesity and Colorectal Surgery
Official title: Value of Perirenal Fat Surface as a Risk Factor for Morbidity After Elective Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visceral Obesity
Colorectal Surgery
Risk Factor
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 224
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: We included all elective colorectal resections for benign, malignant and inflammatory diseases, admitted to the Geneva university hospital, Geneva, Switzerland

Brief summary: While perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value as independent parameter in predicting postoperative complications after colorectal resection remains poorly investigated.

The investigators want to test the value of perirenal fat as surrogate of visceral obesity as risk factor for morbidity in colorectal surgery and to compare it to the effect of Body mass index (BMI) and Waist- Hip ratio (WHR).


Eligibility criteria: Inclusion Criteria:

* elective colorectal resection

Exclusion Criteria:

* age under 18
* emergency condition
* immunosuppression

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Duration of the operation
timeFrame: From incision to dressing of the wound
measure: Rate of conversion
timeFrame: From incision to dressing of the wound
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Minoa Jung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Francesco Volonte, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Philippe Morel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01972997: SENSIMED Triggerfish Sensor Sizes
Official title: A Single-center, Randomized, Double-blinded, Prospective Study to Assess the Changes in the 24-hour IOP (Intraocular Pressure) Pattern in Relation to SENSIMED Triggerfish® Sensor Sizes in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2013-10-31
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4 24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor lens sizes is placed on the eye in the different sessions. Subjects visit the study site for installation and removal of the device and accompanying exams, but remain ambulatory during the recording.


Eligibility criteria: Inclusion Criteria:

* Healthy subject without previous ocular disease
* Aged ≥ 18 years, of either sex
* Central corneal radius (flat meridian) between 7.75 mm and 8.25 mm in at least one eye
* Not more than 6 diopters spherical equivalent in the study eye
* Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Corneal or conjunctival abnormality precluding contact lens adaptation
* Severe dry eye syndrome
* Subjects with allergy to corneal anesthetic
* Subjects with contraindications for silicone contact lens wear
* Subjects not able to understand the character and individual consequences of the investigation
* Participation in other clinical research within the last 4 weeks
* Any other contra-indication listed in the TF user manual

Primary outcomes:
measure: The effect of the sensor lens size on IOP patterns as recorded by TF (SENSIMED Triggerfish) as compared to the recommended sensor lens fit
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References:
Clinical trial NCT04605497: Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus
Official title: A Single Center Open-label Randomized Control Pilot Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Subjects With Gestational Diabetes to Increase Glucose Time-in-range
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Female
pregnancy
gestational diabetes
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2020-10-28
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes


Eligibility criteria: Inclusion Criteria:

* Age 18-55 years
* Singleton pregnancy ≥20 weeks gestation
* Diagnosed with GDM by either 1-step (IADPSG) or 2-Step (Carpenter-Coustan)
* Compatible, validated phone and operating system to support Dexcom G6 CGM App (See Supplementary Table 1) or option to use receiver

Exclusion Criteria:

* Chronic immunosuppression
* Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder
* Known allergy to medical grade adhesives
* Pre-gestational diabetes
* Multifetal gestation
* Current alcohol or illicit drug use
* Simultaneous participation in another clinical study with investigational medicinal product(s) that might have an impact on the study objectives.

Primary outcomes:
measure: Average time-in-range over a 24 hour period
timeFrame: From enrollment to10 days after discharge from hospital following delivery
Secondary outcomes:
measure: Average time-in-range during waking hours
timeFrame: From enrollment to10 days after discharge from hospital following delivery
measure: Average time-in-range while asleep
timeFrame: From enrollment to10 days after discharge from hospital following delivery
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Amy Valent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00995397: Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms
Official title: Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Lotion) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Insect Bite Related-symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Insect Bites
Keywords: Insect bites
Dexchlorpheniramine
Lotion
Cream
Lead sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.


Eligibility criteria: Inclusion Criteria:

* Presence of papules resulting from insect bites within the last 72 hours
* Presence of symmetric lesions to compare one side to the other
* Compliance of the subject to the treatment protocol
* Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old

Exclusion Criteria:

* Pregnancy or risk of pregnancy
* Lactation
* Use of topical or systemic anti-inflammatory, anti-histaminics or immunosuppressive drugs within the last 48 hours prior to the study
* History of atopy or allergic diseases
* History of allergy of any component of the formulations
* Other conditions considered by the investigator as reasonable for non-eligibility

Primary outcomes:
measure: Pruritus intensity at insect bite site, evaluated with a 10 point Visual Analogic Scale (VAS)
timeFrame: 7 days
Secondary outcomes:
measure: Composite clinical evaluation of erythema, pruritus and papule formation, performed by the investigator using a 4-point scale for each one of the parameters (absent, mild, moderate, intense). This evaluation constitutes the Insect Bite Score.
timeFrame: 7 days
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto da Pele Ltda.
state: São Paulo
Study officials:
References: