louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01394926: Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
Official title: A Multi-Center, Open-Label, Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carotid Artery Disease
Keywords: CE-U/S - Contrast-Enhanced U/S
U/S - Ultrasound
Assess effectiveness
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison in assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.


Eligibility criteria: Inclusion Criteria:

* The subject is is greater than or equal to 18 years of age.
* The subjects has highly suspected or established carotid artery disease.
* The subject has undergone or been referred for either unilateral or bilateral intra-arterial X-ray carotid angiography for the determination of subject management (within 30 days before or after the U/S procedure).
* The subject has non-diagnostic U/S of the carotids as defined by institutional standards.

Exclusion Criteria:

* The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
* The subject has a history of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent.
* The subject has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin.
* The subject has right to left, bi-directional or transient right to left cardiac shunts.

Primary outcomes:
measure: Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.
timeFrame: Up to 10 minutes post contrast administration.
Secondary outcomes:
measure: Detecting the Presence of Greater Than or Equal to 50% Stenosis and Greater Than or Equal to 75% Stenosis in the Carotid Arteries When Comparing Pre-contrast to Post-contrast Ultrasound by Dose Group.
timeFrame: Up to 10 minutes post contrast administration.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Andrea Perrone, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00807157: Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress
Official title: Evaluation Des Effets Anti-Stress D'un Probiotique Nomme PROBIOSTICK® Sur Des Sujets Humains Volontaires Sains Sensibles Au Stress De La Vie Quotidienne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Keywords: PROBIOSTICK®
Probiotic
Anxiety
Daily stress
Lead sponsor: Institut Rosell Lallemand
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of people sensible to daily stress.


Eligibility criteria: Inclusion Criteria:

* Caucasian healthy men or women
* Age 30-60 years
* Hospital anxiety and depression score equal or below 12 and above 4
* Standard safety biology

Exclusion Criteria:

* HAD A results above 12 and below 4
* HAD D results above 12
* Neurologic or psychiatric pathology
* Consumption of psychotropic
* High level of caffeine consumption
* Any important chronic pathology
* Drugs wich impairs concentration, anxiety and stress

Primary outcomes:
measure: SCL 90 questionnaire
timeFrame: day 0 and day 30
Secondary outcomes:
measure: Stress perçu, coping de vitaliano, hospital anxiety and depression questionnaires and urinary cortisol measurement
timeFrame: day-14 ; day 0 and day 30
Other outcomes:
Locations:
city: Nantes
country: France
facility: Biofortis
Study officials:
References:
Clinical trial NCT00757757: A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases
Official title: A Phase I/II Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MCS110 in Patients With Prostate Cancer and Bone Metastases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Bone Metastases
Keywords: Prostate cancer
bone metastases
anti-M-CSF
M-CSF antibody
M-CSF
Prostate Cancer with bone metastases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases


Eligibility criteria: Inclusion Criteria:

* Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment
* 18 years old and over

Exclusion Criteria:

* Plan to be on cytotoxic or biologic therapy during study
* Active dental problems
* Active heart complications
* Active infection
* Patients with moderate to severe swelling due to fluid

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
timeFrame: every cycle - (cycle = 28 days)
measure: Type and frequency of adverse drug reactions and serious adverse drug reactions
timeFrame: every cycle - (cycle = 28 days)
Secondary outcomes:
measure: Change in markers of bone resorption and formation (pre- vs. post-treatment)
timeFrame: 3 months
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: NV Cancer Institute
state: Nevada
city: San Antonio
country: United States
facility: CTRC
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05115357: Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block in Cardiac Surgery
Official title: Efficacy of Ultrasound-Guided Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block for Postoperative Analgesia in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pecto-Intercostal Fascial Block
Transversus Thoracis Muscle Plane Block
Cardiac Surgery
Postoperative Analgesia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effect of Ultrasound-Guided Pecto-Intercostal Fascial Block versus Transversus Thoracis Muscle Plane Block on Postoperative Pain Analgesia in Cardiac Surgery

Detailed description: Perioperative pain management is an essential component of the enhanced recovery pathway in patients undergoing cardiac surgery. The incidence of severe acute postoperative pain after median sternotomy is as high as 49%.

Eligibility criteria: Inclusion Criteria:

* 90 adult patients of both sexes aged (21-60) scheduled for cardio-pulmonary bypass cardiac surgery (valve replacement) with midline sternotomy

Exclusion Criteria:

* Patients' refusal.
* Cognitive impairment.
* History of drug abuse\& chronic analgesic use
* History of allergy to local anesthetics.
* Emergency surgery
* Pre-existing major organ dysfunction including hepatic or renal failure, pulmonary insufficiency and left ventricular ejection fraction \< 30%
* Known coagulopathy

Primary outcomes:
measure: Post-operative pain score
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Total opioid consumption in first 24 hours after cardiac surgery
timeFrame: 24 hours Postoperative
measure: duration of mechanical ventilation
timeFrame: 24 hours Postoperative
measure: Incidence of complications
timeFrame: 24 hours Postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine Tanta University
Study officials:
References:
Clinical trial NCT06437457: Comparison of Gd-EOB-DTPA-enhanced MRI and Contrast-enhanced Ultrasound for Measuring Tumor Size of Solitary Hepatocellular Carcinoma ≤ 5cm:A Retrospective Study
Official title: Comparison of CE-MRI and CEUS for Measuring Tumor Size of HCC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC - Hepatocellular Carcinoma
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 194
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who underwent liver resection from January 2019 to May 2024 were included.

Brief summary: Knowing the tumor size before operation is of great significance to the choice of treatment methods of surgeons and the prognosis of patients. In this study, two commonly used imaging methods( CE-MRI/CEUS) were selected to measure and compare the tumor size before operation, in order to determine which measurement method is more accurate.

Detailed description: A total of 194 patients who met the inclusion criteria from January 2019 through May 2024 were included. Taken pathological results as the gold standard, Paired T-test and Bland-Altman analisis were conducted to assess the correlation and mean absolute error between the measured tumor sizes obtained from CE-MRI/CEUS and pathological results.

Eligibility criteria: Inclusion Criteria:

1. had no anti-HCC therapy before imaging examinations.
2. at least had one examination of Gd-EOB-DTPA-enhanced MRI and CEUS 2 weeks before surgery and confirmed as one single HCC.
3. If the patient had both imaging tests, the time interval between two examinations was less than 1 weeks.
4. both radiological and pathological results recorded the maximum tumor diameter.

Exclusion Criteria:

1. had anti-HCC therapy before imaging examinations.
2. had no examination of Gd-EOB-DTPA-enhanced MRI or CEUS 2 weeks before surgery .
3. had no radiological or pathological results recorded the maximum tumor diameter.

Primary outcomes:
measure: measuring HCC diameter
timeFrame: Jaunary 2019 - May 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
Study officials:
References:
Clinical trial NCT06727357: Next Generation Sequencing-based "Oncochip" for Therapeutic Decision in Metastatic Breast Cancer. Study SHARP
Official title: Clinical Utility of a Next Generation Sequencing-based "Oncochip" for Therapeutic Decision in Metastatic Breast Cancer. Study SHARP
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer, Metastatic Breast Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 38
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: The present trial clinical proposes to randomize patients with cancer metastatic disease of the breast progressing on standard therapy to receive a treatment selected from 4 "targeted" drugs (a MEK kinase inhibitor, an mTOR kinase inhibitor, an of the enzyme involved in DNA repair PARP and an androgen receptor inhibitor) on the basis of possible presence of mutations in a panel of 61 genes analyzed on metastatic tissue from biopsy, or receive standard chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients (women or men) with histologically confirmed metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Written informed consent obtained prior to enrollment
* Age ≥ 18 years
* Blood and tumor tissue sample available for research
* Measurable disease
* Other site accessible for biopsy, except bone lesions if this is the only accessible site, or biopsy obtained within the previous 6 months
* Medical history, blood parameters and clinical conditions do not indicate major dysfunctions of organ

To treatment:

- Maintenance of screening inclusion criteria

Exclusion Criteria:

* Presence of visceral crisis, defined according to ABC3/ESMO guidelines
* Patients with local recurrence that can be treated with surgery and/or radiotherapy alone
* Patients who have previously received palliative radiotherapy on the only site accessible to biopsy
* Patients with metastatic disease limited to bone
* Patients with metastatic disease limited to the brain, unless planned a surgical excision, in which case tissue can be collected for screening
* Severe hematopoietic, renal and/or hepatic insufficiency
* Known contraindication to biopsy
* Neoplastic pathology of different histology in the previous 5 years, except carcinoma in situ of cervical basal or squamous cell carcinoma of the skin, if adequately treated

Primary outcomes:
measure: Comparison of progression-free survival
timeFrame: from baseline to the end of treatment (up to 12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
Study officials:
affiliation: Istituto Eur
name: Giuseppe Curigliano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05953857: Knowing and Treating Kosaki/Penttinen Syndromes
Official title: " Knowing & Treating Kosaki/Penttinen Syndromes " International Collaborative Consortium. A Real-life Observational Study on the Natural History of KOGS and PS and on the Efficacy and Safety Profile of TKIs in These Patients.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kosaki Overgrowth Syndrome
Penttinen Syndrome
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with KOGS or PS due to PDGFRB activating variants

Brief summary: Kosaki overgrowth syndrome (KOGS) and Penttinen syndrome (PS) are extremely rare multisystem disorders caused by heterozygous activating variants of the PDGFRB gene. KOGS results in characteristic craniofacial, orthopedic, skin and neurological disorders. PS is a progeroid disease responsible for a prematurely aged appearance. Patients suffer significant morbidity and mortality due to various complications. Tyrosine Kinase Inhibitors (TKIs) targeting PGDFRB appear to be a potential treatment option, as evidenced by a few case reports showing clinical improvement in some patients, with modest and self-resolving side effects. The natural history of these two syndromes remains poorly understood as only case-reports have been published.

Therefore, an international consortium was created in December 2019 by Pr FAIVRE (CHU Dijon Bourgogne \& ERN ITHACA) to follow treated and untreated patients in a real-life, multicentre, observational study, in order to expand our knowledge of these ultra-rare diseases. In the longer term, we believe that TKIs could bring clinical benefit to KOGS/PS patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Kosaki or Penttinen syndrome
* Molecular diagnosis of an activating variant in PDGFRB gene
* Patient who has been informed and provide a written informed consent

Exclusion Criteria:

* Absence of clinical diagnosis of Kosaki or Penttinen syndrome
* Absence of molecular diagnosis of an activating variant in the PDGFRB gene.
* Patient who has not been informed and/or did not provide a written informed consent.

Primary outcomes:
measure: Symptom's burden
timeFrame: At various time points according to the type of symptom: from weekly to every 5 years
Secondary outcomes:
measure: Efficacy of TKI
timeFrame: Through the study completion, an average of 10 years.
measure: Safety of TKI
timeFrame: Through the study completion, an average of 10 years.
measure: Percentage of patients whose follow-up complies with recommendations
timeFrame: Through the study completion, an average of 10 years.
measure: Percentage of patients whose TKI has been chosen according to cellular studies
timeFrame: Through the study completion, an average of 10 years.
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03184857: Open Maxillary Sinus Augmentation Using Different Types of Bone Particles
Official title: Two Stage Sinus Lifting Using Nano Hydroxyapatite Particles [Nanostreams] Versus Deprotenized Bovine Bone [Tutogen] : Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus Augmentation
Keywords: maxillary sinus
augmentation
bovine bone
Nano hydroxy appatite
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two stage sinus lifting using Nano hydroxyapatite particles \[Nanostreams\] versus Deprotenized bovine bone \[Tutogen\] : Randomized clinical trial.

comparing between Height of new bone formation, Bone area percent( Histomorphometric)


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* sinus pathology
* heavy smokers
* patients with systemic disease uncontrolled

Primary outcomes:
measure: histomorphometric analysis
timeFrame: 6 months
Secondary outcomes:
measure: new height of bone gained
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mahmoud Ahmed Nour Eldeen
Study officials:
References:
Clinical trial NCT04444557: Effect of COvid-19 on Mental Health in Syrian and Turkish Maintenance HemoDialysis Patients: COST-HD Study
Official title: Effect of COvid-19 on Mental Health in Syrian and Turkish Maintenance HemoDialysis Patients: COST-HD Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Hemodialysis
Keywords: hemodialysis
depression
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 97
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: All patients undergoing in-center hemodialysis in Sisli Hamidiye Etfal Training and Research hospital (22 patients excluded from the study in accordance with exclusion criteria)

Brief summary: SARS-COV infection first has begun at Wuhan, China, and then became a pandemic. The first COVID-19 case has been reported on March 11, 2020, in Turkey. People older than 65 years old have been locked down on March 21 and people younger than 20 years old locked down at April 03. A total lockdown has been done a few times lasting for 3 or 4 days, especially at weekends.

Renal replacement modalities have been affected in different ways during the pandemic. Patients with kidney transplantation and patients performing home hemodialysis or peritoneal dialysis have been advised to perform self-isolation at homes. However, center hemodialysis patients continued to come dialysis centers obligatorily.

Syrian civil war has been continuing since 2011, and Turkey has accepted millions of Syrian people in a position called temporary protection. There are many Syrian center hemodialysis patients both in Turkey and in our unit. The investigators do not know if pandemic affected Syrian patients different than Turkish ones. The aim of this study is to compare beck depression scores of Turkish and Syrian patients undergoing hemodialysis during the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* Hemodialysis history of more than three months

Exclusion Criteria:

* Patients who can not speak Turkish or Arabic,
* Not volunteer to fill the form
* History of hospitalization for any reason during the pandemic time,
* History of COVID-19 before the questionnaire (Beck Depression Inventory)

Primary outcomes:
measure: Score of Beck Depression Inventory
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Mustafa Sevinc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04263857: Register of Blood Stem Cell Transplantation
Official title: Register of Survey and Evaluation of Blood Stem Cell Transplantations of Clinic III of Internal Medicine III
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Malignancies
Keywords: autologous & allogenic blood stem cell transplantations
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adults, Age \>= 18 years

Brief summary: Register of patients with blood stem cell transplantations (autologous, allogen).

Detailed description: Documenting the success rate in terms of complication rate, disease response, survival rate, engraftment, and details of transplantation settings, for example donor and conditioning data, remission status before transplantation.

It's a register of patients who have one or more autologous and / or allogenic blood stem cell transplants due to an existing indication for performing myeloablative / non-myeloablative high-dose chemotherapy.

The inclusion occurs at our center during preparation for blood stem cell transplantation. The written consent will be obtained separately in the context of the information on blood stem cell transplantation. Participation is voluntary and consent can be revoked at any time. This involves no additional effort for the patient and has no influence on his treatment. It may be necessary in the course of contacting the patient at home, as long as the data is incomplete. This is also explicitly explained. A copy of the declaration of consent is given to the patient.

Eligibility criteria: Inclusion Criteria:

* signed IC
* patients eligible for stem cell transplantation

Exclusion Criteria:

* unable to consent to study participation

Primary outcomes:
measure: Register of stem cell transplantation
timeFrame: approximately over 20 years
Secondary outcomes:
measure: Register of toxicities
timeFrame: approximately over 20 years
measure: Register of complications
timeFrame: approximately over 20 years
measure: Register of morbidities
timeFrame: approximately over 20 years
measure: Register of survivals
timeFrame: approximately over 20 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar der TU München
Study officials:
affiliation: Klinikum rechts der Isar der TU Munich, Germany
name: Mareike Verbeek, MD
role: PRINCIPAL_INVESTIGATOR
References: