louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01745718: Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
Official title: Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
targeted biopsies
cytological imprints
histology
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer.

It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue.

The strategy is used in other types of cancer, e.g lung, breast etc

Detailed description: Background:

When substituting a random biopsy procedure with a few targeted biopsies, it is of outmost importance to know immediately if the biopsy is positive or not. A recent study has demonstrated a high sensitivity and specificity of imprint cytology of random biopsies.

Aim:

The correlation between cytological imprints and histology of targeted prostate biopsies

Material\&Method:

All patients in this study are already participating in an ongoing randomized biopsy study (NCT01455792) comparing:

1. Preoperative MRI and targeted biopsies + random biopsies .
2. Random biopsies (gold standard).

Only patients with a positive MRI were included in this collateral study.

The cytological imprints (negative/positive) of each targeted biopsy is compared to the histology (negative/positive) and Gleason score.

Eligibility criteria: Inclusion Criteria:

* Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination
* No previous prostate biopsies
* Positive MRI
* Signed letter of informed concent

Exclusion Criteria:

* Contraindications to MRI
* Previous prostate biopsies

Primary outcomes:
measure: The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
timeFrame: 15 months
Secondary outcomes:
measure: Interobserver variability
timeFrame: 15 months
Other outcomes:
measure: The detection rate of high grade cancer
timeFrame: 15 months
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital , Aker
Study officials:
affiliation: Oslo University Hospital
name: Eduard Baco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06744218: Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery
Official title: Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery: Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: telerehabilitation
physiotherapist
rotator cuff repair surgery
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to verify whether telerehabilitation as an alternative to in-person treatment (both conducted by a physiotherapist) can be a valid option in terms of pain, recovery of the rom, shoulder functionality compared to those provided by therapy alone. face-to-face rehabilitation in patients undergoing arthroscopic rotator cuff repair surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged between 40 and 70 years
* Patients undergoing arthroscopic repair surgery of the rotator cuff tendons
* Start of outpatient treatment within 7 days of discharge from the Orthopedic Department of the Argenta and Delta hospitals
* Continuation of rehabilitation care at the IOR Physical and Rehabilitation Medicine service in Argenta or at the Physical Therapy Rehabilitation Medicine service of the Delta Hospital.
* Patients who have provided informed consent

Exclusion Criteria:

* Previous shoulder surgeries
* difficulty understanding the Italian language/language barrier
* unavailability of IT devices or stable wi-fi connection by the patient

Primary outcomes:
measure: Constant-Murley Score
timeFrame: At baseline (day 0), after one months, after 3 months
Secondary outcomes:
measure: Mobility of the shoulder
timeFrame: At baseline (day 0), after one months, after 3 months
measure: Numeric rating scale
timeFrame: At baseline (day 0), after one months, after 3 months
measure: Disabilities of the Arm, Shoulder and Hand
timeFrame: at baseline, after 3 months and after 6 months
Other outcomes:
Locations:
city: Lagosanto
country: Italy
facility: Ospedale del Delta
state: Ferrara
city: Bologna
country: Italy
facility: IRCCS Istituto ortopedico Rizzoli
state: Italia
Study officials:
References:
Clinical trial NCT00064818: Acupuncture Needling on Connective Tissue by Ultrasound
Official title: Acupuncture Needling on Connective Tissue by Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: connective tissue
ultrasound
acupuncture
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-07-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to investigate the effect of acupuncture needling on connective tissue using ultrasound techniques both in animals and in humans.


Eligibility criteria: * Healthy Humans
* No bleeding disorders
* No anticoagulant therapy
* Cannot be pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Helen M. Langevin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02237118: Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
Official title: Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Acute
wound
management
measured
Visual analoge scale
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 123
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: To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.


Eligibility criteria: Inclusion Criteria:

1. Acute wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring the use of dressings
2. Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum)
3. Wound whose duration is ≤ 3 days
4. Both gender with an age ≥ 18 years
5. Subject able to understand and voluntarily sign the informed consent
6. Subject able to follow the protocol
7. Subject insured to the French social security system

Exclusion Criteria:

1. Surgical wound
2. Infected, moderately to strongly exudative and haemorrhagic wound
3. Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, ...) which, as judged by the investigator, could interfere with the pain assessment
4. Known allergy/hypersensitivity to any of the components of the investigational products
5. Participation in other clinical investigation within one month prior to start of investigation
6. Pregnant or breast-feeding women
7. Person protected by a legal regime (tutorship or guardianship)

Primary outcomes:
measure: Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)
timeFrame: 21 days
Secondary outcomes:
measure: Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.
timeFrame: 21 days
measure: Condition of the Wound, Will be Assesst by the Investigator.
timeFrame: 21 days
measure: Safety
timeFrame: 21 days
measure: Assessment of the Surrounding Skin.
timeFrame: 21 days
Other outcomes:
Locations:
city: Lespare
country: France
facility: Clinique Mutualiste du Medoc
Study officials:
affiliation: Clinique Mutualiste du Medoc
name: Anna Solanilla, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00712413: Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori
Official title: Pilot Study Assessing the Safety, Tolerability, Compliance and Efficacy of Twice Daily Dosed Pylera Plus Omeprazole as a First Line Treatment of Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori infection
Quadruple therapy
Safety
Efficacy
Tolerability
BID dosing
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.

Detailed description: This study will include three phases: screening, treatment and follow-up.

Screening: this phase will last a maximum of 15 days and subjects eligibility will be evaluated after informed consent signature. Urea breath test (UBT) will be performed in addition to routine baseline evaluations (physical, lab test, etc).

Treatment: subjects will be treated for 10 days. A "confirmation of eligibility" visit will take place on Day 0 and an "end-of-treatment" visit will take place between days 9-14.

Follow-up: approximately one month post-treatment, eradication of H. pylori will be confirmed through UBT

Eligibility criteria: Inclusion Criteria:

* Positive H. pylori status through UBT testing

Exclusion Criteria:

* Documented allergy to any of the drugs contained in the treatment regimen
* Severe renal insufficiency, renal failure or azotemia
* Previous surgery of the upper gastrointestinal tract
* Hepatic failure
* Pre-existing peripheral neuropathies
* Use of any experimental drug within 30 days prior to randomization

Primary outcomes:
measure: H. pylori status confirmed by Urea Breath Test
timeFrame: at 6 and 10 weeks following treatment
Secondary outcomes:
measure: Tolerability
timeFrame: at the end of treatment, one and two months post-treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
city: Hamilton
country: Canada
facility: McMaster University Medical Center, Division of Gastroenterology
state: Ontario
Study officials:
affiliation: Axcan Pharma inc
name: Monique Giguère, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01453413: Blood Glucose Testing and You
Official title: Blood Glucose Testing and You
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine the difference between self-reported, estimated blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.


Eligibility criteria: Inclusion Criteria:

1. Males and females, 18 years of age and above
2. Type 2 diabetes
3. Able to speak, read, and understand English
4. Willing to complete all study procedures

Exclusion Criteria:

1. Type 1 diabetes
2. Currently a user of continuous glucose monitoring system
3. Currently pregnant
4. Hemophilia or any other bleeding disorder
5. Employee of competitive medical device company
6. Cognitive disorder or other condition which, in the opinion of the investigator (or designee), would put the person at risk or seriously compromise the integrity of the study

Primary outcomes:
measure: Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
timeFrame: 1 visit 15-20 minutes
Secondary outcomes:
measure: Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
timeFrame: 1 visit 15-20 minutes
Other outcomes:
Locations:
city: San Diego
country: United States
facility: TCOYD at San Diego Convention Center
state: California
city: Tampa
country: United States
facility: TCOYD Conference at Tampa Convention Center
state: Florida
Study officials:
affiliation: Founder TCOYD
name: Steven Edelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pettus J, Stenger P, Schachner HC, Dunne N, Parkes JL, Pardo S, Edelman SV. Testing versus guessing blood glucose values: impact on self-care behaviors in type 2 diabetes. Curr Med Res Opin. 2014 Sep;30(9):1795-802. doi: 10.1185/03007995.2014.929097. Epub 2014 Jun 30.
Clinical trial NCT06943313: Breast Cancer PET/CT Imaging With 68Ga-pAKTi
Official title: 68Ga-Labeled pAKTi Molecular Probe Combined With PET/CT for Breast Cancer Imaging
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancers
PIK3CA Mutation-Related Tumors
PI3K Pathway Activated Tumors
PET / CT
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 20
Sex: FEMALE
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: Breast cancer patients.

Brief summary: Abnormal activation of the PI3K-AKT signaling pathway in breast cancer patients is closely associated with tumor progression. Phosphorylated AKT (p-AKT) serves as a key indicator of pathway activation. In this study, we utilize a novel probe, 68Ga-pAKTi, which enables precise targeting of tumor p-AKT expression levels to monitor PI3K-AKT pathway activation. The aim of this study is to evaluate the diagnostic accuracy of 68Ga-pAKTi PET/CT in detecting p-AKT expression in breast cancer and to compare its performance with that of 18F-FDG PET/CT.

A total of 20 patients with breast cancer will be enrolled. Screening will be conducted within 14 days prior to administration of 68Ga-pAKTi (from Day -14 to Day -1). Subjects who meet all inclusion criteria and none of the exclusion criteria will receive an intravenous injection of 68Ga-pAKTi on Day 0, followed by PET/CT imaging. Biopsy/pathological results and conventional imaging findings will be followed up to validate the diagnostic efficacy of 68Ga-pAKTi PET/CT in accurately detecting p-AKT expression in breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily signs the informed consent form.
2. Age ≥ 18 years.
3. Pathologically confirmed or highly suspected breast cancer based on conventional imaging.
4. Estimated life expectancy \> 3 months as determined by the physician.
5. Agrees to practice strict contraception for at least 28 days following the PET/CT examination.
6. Willing and able to comply with the study protocol.
7. Has not undergone surgical resection of the lesion.
8. Has participated in molecular testing at the Precision Oncology Center of Fudan University Shanghai Cancer Center, and harbors a PIK3CA mutation, PTEN mutation, or upregulation of the PI3K-AKT-mTOR pathway.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Unable to lie still on the PET/CT scanner bed during the examination or intolerant to PET imaging.
3. Participation in another interventional clinical trial within 1 month prior to screening.
4. Patients who are lost to follow-up.
5. Any other condition that, in the opinion of the investigator, may interfere with the study or make the subject unsuitable for participation.

Primary outcomes:
measure: Standard uptake value
timeFrame: From enrollment to the end of imaging at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References:
Clinical trial NCT06994013: Acute Effects of High- vs. Low-frequency Vibration Foam Rolling
Official title: Acute Effects of High- vs. Low-frequency Vibration Foam Rolling on Flexibility, Dynamic Balance and Vertical Jump in Young Male Recreational Athletes: a Randomized Controlled Cross-over Study Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myofascial Release
Keywords: Recreational athletes
Flexibility
Dynamic balance
Vertical jump
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled cross-over study design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to compare the acute effects of low- and high-frequency vibration foam rolling on flexibility, dynamic balance, and vertical jump in young male recreational athletes. Fourteen athletes will be included in this study, planned as a randomized controlled cross-over study. All athletes wil be completed three interventions: 1) low-frequency vibration foam rolling (LFVFR), 2) high-frequency vibration foam rolling (HFVFR), 3) rest control. Pre- and post-test assessment will be included flexibilty, assessed with the sit-and-reach test; dynamic balance, assessed with the Y balance test; and vertical jump, assessed with the vertical jump test.


Eligibility criteria: Inclusion Criteria:

* To volunteer to participate in the study
* To engage in sports activities at least 2-3 days a week

Exclusion Criteria:

* Players with a history of major sports injury or time-loss injury that required surgery
* Musculoskeletal problems that compromised their performance in the study
* A history of lower extremity pathology in the 3 months before the study
* used any drugs or supplements

Primary outcomes:
measure: Flexibility
timeFrame: two weeks
Secondary outcomes:
measure: Dynamic balance
timeFrame: two weeks
measure: Vertical jump
timeFrame: two weeks
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
Study officials:
References:
Clinical trial NCT00457613: Effects of Alkaline Phosphatase on Renal Function in Septic Patients
Official title: Effects of Alkaline Phosphatase on Renal Function in Patients With Severe Sepsis or Septic Shock.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe
Septic
Shock
Keywords: alkaline phosphatase
sepsis
kidney function
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2007-04-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Septic shock is the most common cause of death in patients requiring intensive care. The kidney is one of the first organs to fail, stressing the importance to search for clinical interventions that may protect the kidneys during sepsis.

Alkaline phosphatase functions as a host defence molecule and is present in many cells and organs (e.g. intestine, placenta, liver, kidney and bone). Alkaline phosphatase has a dual mode of action. First, it binds to and, subsequently, dephosphorylates lipopolysaccharide (LPS). Second, the enzymatic reaction product monophosphoryl-LPS is a non-toxic substance for mammals which acts as a partial antagonist on the LPS receptor complex. In several animal studies, administration of alkaline phosphatase attenuates the inflammatory response and reduces mortality.

It is unknown whether these results can be extrapolated to septic patients . We studied the effects of alkaline phosphatse administration on kidney damage and function in patients with severe sepsis or septic shock.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Proven or suspected Gram-negative bacterial infection
* Two out of four Systemic Inflammatory Response Syndrome (SIRS) criteria existing for less than 24 h
* Acute onset of end-organ dysfunction in the preceding 12 h

Exclusion Criteria:

* Prior therapy with alkaline phosphatase
* Known allergy for cow milk
* Probable death within 24 h
* Chronic renal failure requiring hemodialysis or peritoneal dialysis
* Acute pancreatitis with no established source of infection
* HIV seropositive
* Pregnant or lactating
* Confirmed Gram-positive or fungal sepsis
* Treatment with immunosuppressants including high doses of glucocorticosteroids

Primary outcomes:
measure: Biomarkers of kidney damage
measure: kidney function
measure: markers of inflammation
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Peter Pickkers, MD, PhD
role: STUDY_DIRECTOR
References: