louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01332773: The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
Official title: The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Head Cancer
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-04-11
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To show whether the artery first approach leads to equal or less rate of positive resection margins in pancreatic head cancer than the standard technique (ppWhipple only with standard Kocher's manoeuvre)

Detailed description: This is a prospective non-randomized trial with two study groups. The trial is designed to show if the ARTERY FIRST approach reduces the rate of R1 resections in patients undergoing surgery for cancer of the pancreatic head.

After the diagnosis of cancer of the pancreatic head by clinical, laboratory and imaging evaluation patients who are scheduled for resection will be screened for inclusion into the trial. Informed consent is obtained at least on the day before surgery and patients meeting the eligibility criteria will be enrolled into the study.

Eligibility criteria: Inclusion Criteria:

* Pancreatic head cancer (diagnosis by clinical, laboratory and radiological evaluation)
* Patients scheduled for curative resection
* No evidence of distant metastases
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Expected lack of compliance
* Impaired mental state or language problems
* patient having had neoadjuvant radiochemotherapy

Primary outcomes:
measure: Rate of R1 resections
timeFrame: up to 1.5 years
Secondary outcomes:
measure: Exploratory analyses
timeFrame: up to 1.5 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of General, Visceral and Transplantation Surgery, University of Heidelberg
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT06656273: Habit Building Software Application to Increase Engagement of Vulnerable Populations in the National Diabetes Prevention Program (NDPP) Lifestyle Change Program (LCP)
Official title: Science-based Habit Formation App As an Adjunct to the National Diabetes Prevention Program (DPP) Lifestyle Change Program (LCP) to Increase Engagement, Participation and Outcomes of Underserved Populations and Others Eligible for the DPP LCP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: The Institute for Iterative Thinking
Sponsor class: INDUSTRY
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2024-10-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn whether a companion software application can improve program engagement in the National Diabetes Prevention Program in adults with prediabetes. The main question\[s\] it aims to answer \[is/are\]:

Do participants using the software application (the intervention group) have better engagement with the Diabetes Prevention Program than those who do not use the companion software application (the control group)? Are participants using the software application (the intervention group) more likely to stay in the Diabetes Prevention Program longer than those who do not use the companion software application (the control group)?

Participants are those who have signed up for their local Diabetes Prevention Program and agree to be in the study.


Eligibility criteria: Inclusion Criteria:

* is eligible for and enrolls in a live or distance LCP at a designated study site during the enrollment period of the study
* has a smartphone or other device able to engage with the FT LCP app
* can read basic 5th grade English, as used in the FT LCP app

Exclusion Criteria:

* Cohorts and sites enrolled in concurrent, similar health app-based studies

Primary outcomes:
measure: Engagement
timeFrame: From enrollment to end of the Lifestyle Change Program, up to 12 months.
measure: Retention
timeFrame: From enrollment to end of the Lifestyle Change Program, up to 12 months.
measure: Efficacy
timeFrame: From enrollment to end of the Lifestyle Change Program, up to 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Felton
country: United States
facility: The Institute of Iterative Thinking
state: California
Study officials:
References:
Clinical trial NCT04065373: ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues
Official title: ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infiltration of Peripheral IV Therapy
Lead sponsor: ivWatch, LLC
Sponsor class: INDUSTRY
First posted: 2019-08-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch SmartTouch and fiber optic sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Pass health screen
* 18 years or older

Exclusion Criteria:

* Fail health screen

Primary outcomes:
measure: Normal Tissue Red Notification Rate
timeFrame: 24 Hours
Secondary outcomes:
measure: Normal Tissue Yellow Notification Rate
timeFrame: 24 Hours
measure: Significant Skin Irritation or Disruption to Skin Integrity
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Williamsburg
country: United States
facility: ivWatch, LLC
state: Virginia
Study officials:
affiliation: Employee
name: Marisa Cole
role: STUDY_DIRECTOR
References:
Clinical trial NCT06071273: Online Platform for Self-service of Patients With Chronic Cardiovascular Diseases
Official title: Development of an Online Platform for Self-service of People Living With Chronic Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to define the requirements and characteristics of the software that will be developed for the project "Creation of a platform for self-service of people living with chronic cardiovascular diseases in an understandable, clear, complete, consistent and verifiable manner.

The project concerns the design and implementation of a long-term program of therapeutic exercise and evaluation, by exercise and health professionals, of the anatomical and functional adaptations of exercise in patients and athletes with cardiovascular diseases. Essentially, it is a program of recording and monitoring cardiovascular rehabilitation in the form of systematic exercise of the patient both at home and in sports venues, which will contribute to the prevention of cardiovascular events in conditions of fatigue and at rest as well as to the gradual rehabilitation of the patient who performs a physical activity.

Depending on the individual's functional capacity and health issues, combined with monitoring the patient's vital signs (such as blood pressure, heart rate, oxygen saturation, body temperature) the exercise professional will create an individualized, targeted exercise program with ultimate aiming at its rehabilitation with the help of physical activity and the improvement of its functional performance and by extension the quality of life of the individual. At the same time, the project will seek to motivate patients to remain committed to the physical activity program, with the aim of faster reintegration into their daily life.


Eligibility criteria: Inclusion Criteria:

* Patients with cardiovascular disease and recent myocardial infarction (\>4weeks)
* Patients shall be in a clinical stable condition.

Exclusion Criteria:

* Uncontrolled T1 or T2 diabetes mellitus.
* Comorbidities precluding exercise training (e.g., orthopaedic/neurological conditions).
* Uncontrolled arrhythmias

Primary outcomes:
measure: Physical activity levels
timeFrame: 6 months
Secondary outcomes:
measure: Cardiorespiratory fitness (CRF)
timeFrame: 6 months
measure: Percentage of body fat mass
timeFrame: 6 months
measure: Body muscle mass
timeFrame: 6 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki
state: Thermi
Study officials:
References:
Clinical trial NCT00964873: A Phase 1 Study of the HSP90 Inhibitor, STA-9090 in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia
Official title: A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Blast-phase Chronic Myelogenous Leukemia
AML
ALL
CML
Keywords: Synta
STA-9090
ganetespib
Hematologic Cancers
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Blast-phase Chronic Myelogenous Leukemia
AML
ALL
CML
HSP90 Inhibitor
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 29
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: An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML.


Eligibility criteria: Inclusion Criteria:

* Subjects with a pathologic confirmation of the diagnosis of AML, ALL, or blast-phase CML
* ECOG Performance Status 0-2
* Adequate organ function as defined in the protocol.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Hyperleukocytosis
* Acute Promyelocytic Leukemia (FAB-M3) subtype
* Uncontrolled Disseminated Intravascular Coagulation (DIC)
* Active central nervous system leukemia
* Concomitant radiation therapy, chemotherapy, or immunotherapy
* Women who are pregnant or lactating
* Neuropathy ≥ grade 2 (NCI CTCAE) at time of enrollment
* Chemotherapy (with the exception of hydroxyurea) or radiotherapy within two weeks or within six times the agent's half life
* Require ongoing therapy with either G- or GM-CSF, or long-acting versions of these molecules
* Use of any investigational agents within two weeks or within six times the agent's half life --Treatment with chronic immunosuppressants
* Other medical/psychiatric condition that may increase the risk associated with study participation as defined by the protocol.

Primary outcomes:
measure: To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria
timeFrame: every 8 weeks
Secondary outcomes:
measure: To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML
timeFrame: ongoing
Other outcomes:
Locations:
city: Tampa
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Durham
country: United States
state: North Carolina
Study officials:
References:
Clinical trial NCT03351673: Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding
Official title: Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Disorder
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Endometrial thickness has been used as an indicator of risk for endometrial hyperplasia and carcinoma in asymptomatic perimenopausal women. However, there is no cutoff value in perimenopausal women and the same thickness does not express the same endometrial volume in different endometrium because uterine lengths may be different and endometrial irregularities may exist. Many studies assessed endometrial volume measured by three-dimensional (3D) TVS as a predictor of malignancy in women with postmenopausal bleeding. To our knowledge there is no study assess endometrial volume measured by two dimension TVS in prediction of endometrial pathology, however it is cheap and available than 3D TVS.


Eligibility criteria: Inclusion Criteria:

\*perimenopausal women with abnormal bleeding e.g. menorrhagia, metrorrhagia and polymenorrhea.

Exclusion Criteria:

\*general or local causes of bleeding, drug intake or recent hormonal contraception

Primary outcomes:
measure: accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT03720873: EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC
Official title: An Multicenter,Phase II Trial of EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: EGFR Gene Mutation
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2018-10-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single arm study: EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant non-small-cell lung cancer (NSCLC).

Detailed description: This trial investigated the efficacy and safety of EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant NSCLC.

Eligibility criteria: Inclusion Criteria:

* - Age ≥ 18 years
* ECOG performance status 0-1
* Adequate haematological function, coagulation, liver function and renal function
* Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)
* TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)
* Measurable or evaluable disease (according to RECIST 1.1 criteria).
* Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)

Exclusion Criteria:

* - Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.

Patients with any known significant ophthalmologic anomaly of the ocular surface

* Patients who received prior chemotherapy for metastatic disease
* CNS metastases
* Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF
* Pregnancy

Primary outcomes:
measure: Progression free survival
timeFrame: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient
Secondary outcomes:
measure: Objective response
timeFrame: through study completion,an average of three years
measure: Safety - Adverse events graded according to NCI CTCAE V4.03
timeFrame: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient
measure: Overall survival
timeFrame: Three years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian cancer hospital
state: Fujian
Study officials:
affiliation: Fujian Cancer Hospital
name: Zhiyong He, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maemondo M, Fukuhara T, Sugawara S, et al. NEJ026: Phase III study comparing bevacizumab plus erlotinib to erlotinib in patients with untreated NSCLC harboring activating EGFR mutations[J]. Annals of Oncology, 2016, 27
Clinical trial NCT01844973: Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Maruho North America Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to evaluate the pharmacokinetics and safety of M518101 in male and female plaque psoriasis patients.


Eligibility criteria: Inclusion Criteria:

* Who are able and willing to give signed informed consent
* Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
* Who have ≥20% of body surface area (BSA) afflicted with plaques
* Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

* Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
* BMI \> 32.0 kg/m2
* Who are pregnant or lactating.
* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
* Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
* Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
* Whose serum calcium levels exceed the upper limit of reference range
* Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
* Who have taken any durg with known effects on calcium metabolism within 30days of randomization
* Who have been treated with any drug with a known risk of QT prolongation within 30days of randomization.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of M5181
timeFrame: 0, 1, 2, 4, 6, 9 12h after dosing
measure: Peak Plasma concentration (Cmax) of M5181
timeFrame: 0, 1, 2, 4, 6, 9 12h after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orenge County Research Center
state: California
Study officials:
References:
Clinical trial NCT02131831: Telomeres Parameters in Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Keywords: telomere
telomerase
cirrhosis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with cirrhosis

Brief summary: There are several factors that influence telomere length in patients with cirrhosis, such as metabolic derangements and infectious etiologies, The aim of the study is to compare telomere length and other parameters related to genetic instability in telomere/ telomerase system, in peripheral blood lymphocytes in cirrhosis from different etiologies.


Eligibility criteria: Inclusion Criteria:

* cirrhotic patients from different etiologies

Exclusion Criteria:

* decompensated cirrhosis (Child C)
* age under 18 years
* any known malignancy, including hepatocellular carcinoma
* patient that are unable to sign for informed consent

Primary outcomes:
measure: telomerase activity
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT06815731: Multicenter Study on the Correction of Prolapse Via Laparoscopy
Official title: Multicenter Study on the Correction of Prolapse Via Laparoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Floor Disorders
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 181
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: In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

Detailed description: In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

Eligibility criteria: Inclusion Criteria:

* Patients with Stage II- IV primary or recurrent prolapse affecting the anterior or middle vaginal compartment with or without minimal posterior defect (Stage I) according to the POP-Q.

Exclusion Criteria:

* History of abdominal prolapse reconstructive surgery.
* History of prolapse reconstructive surgery with vaginal meshes.
* Stage I according to the POP-Q classification or asymptomatic prolapse.
* Medical contraindication for general anaesthesia.
* Patient preference for vaginal surgical treatment.
* Patient does not wish to participate in the study.

Primary outcomes:
measure: Pelvic Organ Prolapse Distress Inventory
timeFrame: up to 12 months
measure: Colorectal-Anal Distress Inventory
timeFrame: up to 12 months
measure: Urinary Distress Inventory
timeFrame: up to 12 months
measure: Number of patients with symptomatic failure
timeFrame: up to 12 months
Secondary outcomes:
measure: Intestinal and pain symptoms
timeFrame: up to 12 months
measure: Anatomical result
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: HCUVA
Study officials:
References: