louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06461598: Signature for Precise Chemosensitivity Prediction in PDAC
Official title: Development and Validation of the ChemoResist Signature Precisely Predictive of Chemotherapy Sensitivity in Resected Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with incident, primary, microscopically-confirmed nonmetastatic PDAC who underwent resection were initially enrolled.

Brief summary: Pancreatic ductal adenocarcinoma (PDAC) is largely heterogeneous. We sought to develop and validate a signature to precisely predict chemotherapy sensitivity in PDAC. Genetic events of the four most commonly mutated genes in PDAC and expressions of 12 PI3K/AKT/mTOR pathway markers were examined in consecutive patients with PDAC. A 9-feature signature for prediction of chemotherapy benefits was constructed using the LASSO Cox regression model, and validated in two independent cohorts.


Eligibility criteria: Inclusion Criteria:

* ECOG performance status score of 0-1 before resection
* complete clinicopathologic and follow-up data
* availability of formalin-fixed paraffin-embedded (FFPE) specimens of resected primary tumor and hematoxylin and eosin slides with invasive tumor components

Exclusion Criteria:

* any previous history of cancer
* any anticancer therapy prior to resection or adjuvant radiotherapy
* metastatic cases
* major postsurgical complications with Clavien-Dindo Grade ≥2

Primary outcomes:
measure: Overall survival
timeFrame: 3-year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
References:
Clinical trial NCT06239298: A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor
Official title: A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.


Eligibility criteria: Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* Male or female 18-70 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Dose Limiting Toxicity (DLT)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Duration of response (DOR)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Army Medical University
state: Chongqing
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT00395798: Effect of Cervical Collar in Cervical Radicular Pain.
Official title: Effect of Conservative Treatment With Cervical Collar in Patients With Cervical Radiculopathy and Radicular Pain. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Radicular Pain
Keywords: cervical intervertebral disc displacement
cervical spondylosis
radiculopathy
neck collar
brace
physiotherapy
treatment
rehabilitation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2006-11-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives:The purpose of this study is to determine if use of nech collar (stiff or soft)will improve the possibility to obtain painrelief in patients with cervical radicular pain. We will compare short term (six weeks and three months) and long term ( one year) effect of six weeks use of neck collar (stiff or soft)together with "neck school information" with "neck school information" alone.


Eligibility criteria: Inclusion Criteria:

* cervical radicular pain caused by herniated disc og spondolytic spurs
* written consent from patient

Exclusion Criteria:

* previous necksurgery
* whiplash or other necktrauma
* serious diseases somatic or psychiatric
* patients not able to speak and read Norwegian well
* insufficient correlation between clinical and radiological findings

Primary outcomes:
measure: painscore on visual analog scale 0-100mm after 6weeks treatment
Secondary outcomes:
measure: painscore visual analog scale 0-100mm after 3weeks,3months,1year
measure: Functional status on Neck pain and disability index after 3weeks,6weeks,3months,1 year
measure: Quality of life score, Cantrils Ladder Scale 3 weeks,6weeks,3 months,1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevaal University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Vibeke Graver, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00696098: Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission
Official title: Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Health
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2008-06-12
Enrollment: 80
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: BASIC_SCIENCE

Brief summary: Short chain fatty acids (mainly butyrate, acetate, and propionate) are produced in the large intestine by bacterial fermentation of undigested carbohydrates, such as dietary fibres. Butyrate is an important energy source of the intestinal epithelium and has a pivotal role in the regulation of epithelial cell proliferation and differentiation, immune function and mucosal protection.

Non-digestible carbohydrates (prebiotics) increase the concentrations of colonic butyrate, which has been proposed to be responsible for its beneficial effects. Furthermore, butyrate enemas have been proven to be effective in the treatment of active ulcerative colitis.

In the present study, the direct effects of butyrate on inflammation and parameters of colonic defence and mucosal integrity of the distal colon will be studied in 40 patients with diarrhoea predominant IBS (D-IBS) and 40 patients with ulcerative colitis in remission (UCrem) using rectal enemas. These patients groups were chosen because they have a low-grade inflammation in the large intestine, and can therefore be used as a model to study the mechanistic effects of butyrate. The design used to study the effects of butyrate in both patient groups will be a double blind randomized placebo-controlled parallel design.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of UC or Diarrhea predominant IBS
* Stable western diet
* Age between 18 and 65
* BMI between 18 and 35
* Written informed consent

Exclusion Criteria:

* All enemas and suppository during or 2 weeks prior to the study
* Use of corticosteroids during or 1 month prior to the study
* Use of antibiotics during or 3 months prior to the study
* Budesonide during or 2 weeks prior to the study
* Changes in medication during or 1 month prior to the study
* Lactation, pregnancy and planning of pregnancy
* Previous intestinal surgery
* Clinically significant systemic diseases
* Excessive drinking (\>20 alcoholic consumptions per week)
* Changes in prebiotic and/or probiotic use during and 2 weeks prior to the study
* Previous radiotherapy or chemotherapy

Primary outcomes:
measure: inflammatory parameters
timeFrame: okt 2008
Secondary outcomes:
measure: oxidative stress parameters
timeFrame: okt 2008
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University of Maastricht
state: Limburg
Study officials:
affiliation: Maastricht University
name: Fred Troost, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00280098: Docetaxel in the Treatment of Hormone Refractory Prostate Cancer
Official title: Phase IV Study of Safety and Efficacy of Docetaxel in Combination With Prednisone in Advanced Hormone Refractory Prostate Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-01-20
Enrollment: 30
Sex: MALE
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: Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.


Eligibility criteria: The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter :

Inclusion Criteria:

* Patients with advanced prostate cancer, without previous chemotherapy, progressing on hormonal treatment, performance status 1 to 2

Exclusion Criteria:

* Other cytostatic treatment, other malignity, severe comorbidity

Primary outcomes:
measure: PSA decline
timeFrame: after each docetaxel administration and after the end of treatment
measure: pain response
timeFrame: after each docetaxel administration and after the end of treatment
measure: side effects occurrence
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Zuzana MD Priborska
role: STUDY_DIRECTOR
References:
Clinical trial NCT00978198: Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers
Official title: ASP1517 Phase 1 Clinical Study - Single and Multiple Oral Dosing of ASP1517 in Healthy Non-elderly Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Safety and tolerability
Plasma concentration
ASP1517
FG-4592
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single or multiple oral administration in healthy non-elderly adult male subjects.

Detailed description: The study consists of two parts, single and multiple dose. Within each part participants will be randomized to either ASP1517 or placebo.

Eligibility criteria: Inclusion Criteria:

* Body weight: ≥50.0 kg, \<80.0 kg
* BMI: ≥18.5 kg/m2, \<25.0 kg/m2
* Eligible, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and up to the timing immediately before study medication
* Supine blood pressure: Systolic blood pressure ≥90 mmHg, ≤130 mmHg; Diastolic blood pressure ≤85 mmHg
* Pulse rate at rest in supine position: ≥40 bpm, \<100 bpm

Exclusion Criteria:

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission or is scheduled to receive medication
* History of drug allergies
* Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study
* Excessive smoking or drinking habit (measure of "excessive": alcohol: 45 g/day, smoking: 20 cigarettes/day)

Primary outcomes:
measure: Safety and tolerability of ASP1517
timeFrame: During 2 weeks
Secondary outcomes:
measure: Pharmacokinetics of ASP1517
timeFrame: During 2 weeks
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02816398: Catheter System Feasibility Clinical Trial
Official title: Vessel-Select Catheter System Feasibility Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Dr. Jose E. Gonzalez
First posted: 2016-06-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.


Eligibility criteria: Inclusion Criteria:

* Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment
* Patients diagnosed with chronic kidney disease classification stage IV or V
* Adequate quality vein \>= 2 mm with confirmed clinically significant outflow based on pre-operative assessment
* Adequate quality radial artery \>= 2 mm based on pre-operative assessment
* Adequate collateral arterial perfusion
* Radial artery-adjacent vein proximity \< = 1.5 mm
* Able to provide informed consent
* Able to travel to institution for follow up examination
* Able to intraoperatively place an .014" guidewire in artery

Exclusion Criteria:

* Suspected skin disease
* Immunocompromised patients (e.g. HIV positive)
* Edema of extremities
* Current diagnosis of carcinoma
* Pregnancy or currently breast feeding
* Diagnosed hypercoaguable state
* Active infection
* Evidence of vascular disease at target site
* Pre-existing vascular disease that could confound study results
* Vessel tortuosity or spasm preventing placement of .014" guidewire

Primary outcomes:
measure: Number of Participants With Sufficient Patency for Clinical Access
timeFrame: 6 weeks
measure: Number of Patients Achieving Dialysis Access
timeFrame: 6 weeks
measure: Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis
timeFrame: 3 months
Secondary outcomes:
measure: Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05688098: Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers
Official title: A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine High Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine High Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Healthy Volunteer
* Other inclusion applied

Exclusion Criteria:

* Clinically relevant/significant findings as evaluated by the investigator
* Other exclusion applied

Primary outcomes:
measure: AUCt of Irbesartan and Amlodipne High
timeFrame: 72 hours
measure: Cmax Irbesartan and Amlodipne High
timeFrame: 72 hours
Secondary outcomes:
measure: AUCinf of Irbesartan and Amlodipine High
timeFrame: 72 hours
measure: AUCt/AUCinf of Irbesartan and Amlodipine High
timeFrame: 72 hours
measure: tmax of Irbesartan and Amlodipine High
timeFrame: 72 hours
measure: half-life of Irbesartan and Amlodipine High
timeFrame: 72 hours
measure: CL/F of Irbesartan and Amlodipine High
timeFrame: 72 hours
measure: Vz/F of Irbesartan and Amlodipine High
timeFrame: 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References:
Clinical trial NCT00663598: Levitra® - Real Life Safety and Efficacy of Levitra
Official title: REALISE Levitra® - Real Life Safety and Efficacy of Levitra
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 30825
Sex: MALE
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: Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)


Eligibility criteria: Inclusion Criteria:

* Male outpatients \>/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment

Exclusion Criteria:

* Exclusion according to US PI

Primary outcomes:
measure: Improvement of Erectile Disfunction
timeFrame: 8 weeks
measure: Onset of Drug Effect
timeFrame: 8 weeks
measure: Second successful intercourse
timeFrame: 8 weeks
Secondary outcomes:
measure: General Safety Parameters
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02869698: Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography
Official title: Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 192
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of cortical electrical stimulation to identify major anatomical and functional networks in epileptic patients candidates for surgery and explored by stereoencephalography, to minimize risk of post-surgical cognitive deficits.

Detailed description: Cognitive deficits after epilepsy surgery are poorly known particularly because the tools used to evaluate them. In addition, the prevention of certain postoperative deficits, is extremely difficult because of the lack of robust markers to anticipate. The various examinations conventionally used for this purpose (neuropsychological testing, functional MRI and cortical stimulation) does indeed provide insufficient information or difficult to interpret, so the development of improved methods appears as an imperative in the field of the epilepsy surgery.

SID appears as such particularly adapted to the case of epileptic patients explored SEEG to provide individualized cognitive map millimeter thereof without requiring, for additional invasive act, or risk of inducing unintended crisis. In practice, this clinical research project should lead to the definition of several simple cognitive tasks which, together, could be achieved by each volunteer patient in two or three hours, and then analyzed in a similar time to provide fast, even the patient is still explored SEEG and even before cortical electrical stimulation, a list of brain regions involved in most major cognitive functions.

Eligibility criteria: Inclusion Criteria:

* Drug-resistant partial epilepsy justifying a SEEG exploration
* Intellectual capacities compatible with the award of cognitive tasks

Exclusion Criteria:

* Pregnant or lactating women
* Patient deprived of liberty by a judicial or administrative
* Major patient subject to a measure of legal protection

Primary outcomes:
measure: Functional brain mapping procedure using the EEG signal intracranial to minimize the risk of cognitive deficits associated with resection of the epileptogenic zone.
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Lyon
country: France
facility: University Hospital Lyon
Study officials:
affiliation: University Hospital, Grenoble
name: Philippe KAHANE
role: PRINCIPAL_INVESTIGATOR
References: