louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04536064: COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA
Official title: COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION TO TREAT CANCER-RELATED LYMPHEDEMA: RATIONALE FOR A REGIONAL APPROACH
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology
Keywords: lymphedema
lva
liposuction
treatment
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 24 patients with secondary lymphedema

Brief summary: * cooperation of an International team with many years of experience in surgical management of lymphedema
* description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology
* the combination of LVA and liposuction guarantees long lasting results

Detailed description: Cancer-related lymphedema represents one of the major complications of cancer treatment, especially for breast and gynecologic cancers. Moreover, it has high impact on cancer survivors and healthcare systems. Lymphedema management still remains challenging. The better understanding of lymphedema physiopathology as well as the development of sophisticated surgical and diagnostic techniques have led to effective strategies to address lymphedema patients but, despite the considerable interest in international literature, no consensus exist.

The authors present a retrospective analysis of 24 consecutive patients affected by cancer-related lymphedema treated by the combination of LVA and liposuction in the same surgical session. Patients data regarding limb volume, lymphangitis rate and quality of life index were assessed before surgery and 1 year after surgery.

One year after surgery an average volume reduction of 37,9% was registered. Lymphangitis rate significantly decreased after surgery to 0.95 per year. Quality of life score improved.

CONCLUSIONS The combination of LVA and liposuction represents an effective strategy in treating patients with cancer-related lymphedema, ensuring a significant decrease in volume and reduction of lymphangitis rate as well as stable results in time. In addition, it appears to be minimally invasive and well tolerated by patients, since it can be performed under local anesthesia with low risk of complications.

Eligibility criteria: Inclusion Criteria:

previous lymphadenectomy

Exclusion Criteria:

free from cancer related pathology

Primary outcomes:
measure: Volume reduction of the limb
timeFrame: one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Guido Gabriele
state: SI
Study officials:
References:
Clinical trial NCT00907764: Stress Echocardiography Study With Regadenoson
Official title: An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 ug Regadenoson Bolus for Pharmacological Stress Echocardiography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Disease
Coronary Artery Disease
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2009-05-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion imaging. This study will test whether regadenoson is an appropriate stress agent for stress echocardiography.


Eligibility criteria: Inclusion Criteria:

* Patients with a clinically indicated dobutamine echocardiogram showing normal wall motion at rest and abnormal wall motion with stress
* Patients with a clinically indicated dipyridamole echocardiogram showing normal perfusion and wall motion at rest and abnormal perfusion with or without abnormal wall motion with stress

Exclusion Criteria:

* Any condition precluding the safe administration of dobutamine, dipyridamole or SonoVue for echocardiography
* Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control

Primary outcomes:
measure: Cardiac wall motion and perfusion abnormalities at rest and with regadenoson stress, with regadenoson stress and low level exercise, and with regadenoson stress and an echocontrast agent.
timeFrame: Within 12 minutes after dosing
Secondary outcomes:
measure: Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications.
timeFrame: Up to day 29 after dosing
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
Study officials:
affiliation: Northwick Park Hospital
name: Roxy Senior
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02436564: In Vitro Models of Liver and Pancreatic Cancer
Official title: A Study Designed to Develop in Vitro Models of Liver, Biliary and Pancreatic Cancer for the Investigation of Tumour Biology and Potential Therapies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholangiocarcinoma
Hepatocellular Carcinoma
Pancreatic Neoplasm
Keywords: pancreas
stem cells
tumours
in vitro models
organoids
cancer,
bile duct
liver
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: The Gurdon Institute
name: Ann McLaren Laboratory of Regenerative Medicine
First posted: 2015-05-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing surgical resenctions of liver, biliary or pancreas cancers that are able to give informed consent

Brief summary: The primary objective is to develop an in vitro model of cancer for laboratory study using liver, biliary and pancreatic cancer tissue. The secondary objective is to study the genetic and cellular biology of cancer of the liver, biliary tract and the pancreas. As well the investigators hope to compare molecular and cellular biology of cancer cells with normal cells as well as potentially test the efficacy of current and future anti-cancer therapies.

Samples will be collected from tissue that has been resected as part of the treatment for a patient diagnosed with liver, bile duct or pancreas cancer.


Eligibility criteria: Inclusion Criteria:

* All adult patients undergoing surgical resections for liver, biliary or pancreas cancers that are able to give informed consent.

Exclusion Criteria:

* Patients aged \<18 or those who are unable to give informed consent.

Primary outcomes:
measure: Number of tumour-derived organoids successfully cultured in vitro for a minimum of 3 months.
timeFrame: 3 years
Secondary outcomes:
measure: Proportion of tumour-derived organoids that are genetically identical to the source tumour.
timeFrame: 3 years
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
affiliation: Cambridge Univeristy Hospitals
name: Kourosh Saeb-Parsy, PhD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06175364: Evidence-Based Orthotics Prosthetics Practices
Official title: Investigation of the Views of Health Professionals in the Field of Orthotics Prosthetics on Evidence-Based Orthotics Prosthetics Practices
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Evidence-Based Practice
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main purpose of our research is; The aim of this study is to investigate the views of health professionals in the field of Orthotic Prosthesis in Turkey on Evidence-Based Orthotic Prosthesis Practices. This research is important in revealing the perspective of health professionals in this field on evidence-based orthotic prosthesis applications. No such study has been found in the literature in the field of Orthosis and Prosthesis. In this respect, it aims to bring a new perspective to the literature.

Detailed description: Three data collection tools will be used as data collection methods for the research. These data collection tools; demographic information form, Health Sciences Evidence-Based Practice Survey and Information Literacy Self-Efficacy Scale. Surveys will be sent to participants to be filled out via Google Forms.

Inclusion criteria: Having been working in hospitals, clinics, academic units, etc. in Turkey for at least 6 months. Being able to read and write Turkish. Exclusion criteria; Those who graduated in the field of Orthosis and Prosthesis and work in other clinics and units.

The data will be evaluated in the statistical package program IBM Statistical Package for the Social Sciences Statistics 26.0 (IBM Corp, New York, USA).

To determine the sample size in the study, G\*Power 3.1.9.4 software was used to calculate the number of people to take part in the study. The effect size of the study was determined as 134 participants with 80% statistical power and 5% significance level. Our research will be conducted between December 2023 and June 2024.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria: Having been working in hospitals, clinics, academic units, etc. in Turkey for at least 6 months.
* Being able to read and write Turkish

Exclusion Criteria:

* Those who graduated in the field of Orthosis and Prosthesis and work in other clinics and units

Primary outcomes:
measure: Health Sciences Evidence-Based Practice Survey
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: MedipolIU
name: Gizem BOZTAŞ ELVERİŞLİ, Dr.Öğr.Üye.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01777464: Role of the Central Nervous System in Allergic Rhinitis
Official title: Role of the Central Nervous System in Allergic Rhinitis: Activation of Different Brain Regions After a Nasal Histamine Provocation in Healthy and Allergic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: House Dust Mite Allergy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In order to evaluate the effects a nasal provocation on the activation of different brain regions, the investigators want to set up a clinical trial investigating the short-term effects of a nasal histamine provocation in healthy volunteers and allergic patients while in supine position under the functional MRI device in order to visualize different brain regions.

Detailed description: Evaluate the effects a nasal provocation on the activation of different brain regions

Eligibility criteria: Inclusion Criteria:

* Patients with a positive skin prick test to grass pollen and with pollen allergic symptoms during the pollen season OR patients with a negative skin prick test and with no allergic symptoms during the pollen season.
* Age \> 18 and \< 50 years
* Written informed consent
* Willingness to adhere to visit schedules
* Adequate contraceptive precautions in female patients with childbearing potential

Exclusion Criteria:

* Current or recent (finished less than 2 years) immunotherapy against grass pollen.
* Systemic steroid treatment less than 6 weeks before the inclusion in the study.
* Nasal steroid spray, oral leukotriene antagonists or long-acting antihistamines less than 4 weeks before the inclusion.
* Presence of purulent secretions in nasal cavity.
* Severe septal deviation (septum reaching concha inferior or lateral nasal wall).
* Patient is pregnant or breastfeeding.
* Patient has any disorder of which the investigators feel at the time of evaluation for participation in the study that this may compromise the ability to give truly informed consent for participation in this study.
* Patient is currently enrolled in other investigational drug trial(s) or is receiving other investigational agent(s) for any other medical condition.
* No independent medication management in daily life or disability to perform fine motoric handling of medication
* Patients with asthma will be excluded.
* Patients suffering from claustrophobia

Primary outcomes:
measure: brain activation
timeFrame: 5 minutes
Secondary outcomes:
measure: nasal symptoms and Peak Nasal Inspiratory Flow
timeFrame: before and after scans
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: uz leuven ORL
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Peter Hellings, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977664: In Vitro Maturation Induction of Oocytes From a Woman With Syndrome of Repeated Oocyte Maturation Failure in Vitro
Official title: The Factors Primarily Intrinsic to the Oocyte Are Responsible to the Oocyte Maturation Defective: a Case Report.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oocyte Maturation Failure
Keywords: oocyte maturation failure
Maturation induction in vitro
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 1
Sex: FEMALE
Minimum age (years): 32
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a patient with repeated oocyte maturation failure in IVF cycles

Brief summary: Donated oocytes is from a patient with repeated oocyte maturation failure in IVF cycles. Cytoplasm of matured metaphase II oocyte and active MPF were injected into the donated oocytes.

Detailed description: The study reported a woman with syndrome of repeated oocyte maturation failure where there is repeated production of immature oocytes.She underwent two IVF cycles in other hospital. All oocytes obtained were immature and the treatment were stopped.She underwent her third try in our hospital. The couple gave their informed consent: ICSI will be performed if maturation occurred, otherwise, the treatment would be stopped and the oocytes would be donated for study if the oocytes were not matured after 24 hours of culture. After ovarian hyperstimulation,14 oocytes were obtained. None of them was matured. The cycle was canceled and the oocytes were donated for study.To induce the immature oocytes in vitro, oocytes were 1)cultured in follicular fluid containing matured metaphase II oocyte; 2) performed intracytoplasmic sperm injection (ICSI) to induce intracellular Ca2+\]i oscillations; 3)injected with active maturation promoting factor (MPF), 4)injected with cytoplasm of matured metaphase II oocyte.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of syndrome of repeated oocyte maturation

Exclusion Criteria:

patients with matured oocytes in IVF cycles

Primary outcomes:
measure: Oocyte nucleus maturation
timeFrame: April，2012
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: The Second Affiliated Hospital of Kunming Medical University
name: Jie Yang, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03236064: Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury
Official title: Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter
Lead sponsor: WellSpan Health
Sponsor class: OTHER
Collaborators: name: Neuraptive Therapeutics Inc.
First posted: 2017-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
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 PEG 3350 for use in nerve repair.

Detailed description: To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150 years much research has been performed. PEG-Axon fusion on the other hand is relatively new in mammals. Success has already been obtained by two institutions in the rat sciatic nerve transections, demonstrating rapid return of behavioral function4. These however are very controlled injuries and unclear how well these will translate into human studies. For this reason 3 separate clinical studies in increasing order of complexity are proposed.

The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure.

Eligibility criteria: * Isolated nerve transections of the digits, forearm, wrist, and palm will be included.
* Class III nerve injury (Sunderland's 4th or 5th degree injury)
* Nerve injuries that can be prepared using minimal or acceptable tension (according to surgeon discretion).
* Pregnant and breastfeeding women cannot participate because of possible unknown and unpredictable risks to the unborn child.
* Injuries beyond 24 hours will be excluded

Primary outcomes:
measure: To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: York
country: United States
facility: WellSpanYork Hospital
state: Pennsylvania
Study officials:
affiliation: WellSpan York Hospital
name: Richard C Trevino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06571864: AL Amyloidosis and Anti-CD38-Daratunumab
Official title: AL Amyloidosis and Anti-CD38-Daratunumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyloidosis
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 14
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: AL Amyloidosis and anti-CD38

Detailed description: AL amyloidosis is a systemic disorder characterized by progressive multiorgan failure and premature death. While autologous stem cell transplantation (ASCT) is considered the standard therapy, eligibility is limited, and excludes a substantial proportion of patients. Recent guidelines recommend daratumumab-based regimens for these patients, but, particularly for cases with severe renal involvement, optimal treatment remains a challenge.

This study explore the efficacy of daratumumab monotherapy in patients with histologically proven severe renal involvement who are ineligible for ASCT

Eligibility criteria: Inclusion Criteria:

* Patients affected by AL amyloidosis
* Patients who were ineligible for high dose therapy and bone marrow transplantation due to age and/or frailty score.

Exclusion criteria:

- Diagnosis of AL amyloidosis not biospy proven

Primary outcomes:
measure: organ responses were defined according to the updated International Society of Amyloidosis criteria
timeFrame: "through study completion, an average of 1 year".
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: San Giovanni Bosco Hospital
state: Piedmont
Study officials:
affiliation: ASL Città di Torino, Torino, IT
name: Dario Roccatello
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03657264: Cardiac Safety Evaluation of P03277
Official title: Thorough QT/QTc Study to Assess the Electrocardiographic Safety of a New Gadolinium-based Contrast Agent P03277 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Gadolinium-based contrast agent
Cardiac safety
ECG
Gadopiclenol
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Williams design for a 4\*4 cross over
Primary purpose: DIAGNOSTIC

Brief summary: The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.

The primary objective is to assess the cardiac safety after administration of P03277 to 48 healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg (supra-clinical dose) by evaluating the QT and QTc intervals.

Detailed description: Each subjects will be administered with 4 products (P03277 at the 2 different doses, placebo and moxifloxacin) in a 4\*4 cross over sequence balanced for first order carry over effect. Twelve subjects will be assigned to each sequence (6 males and 6 females). The volunteers will be enrolled sequentially by cohort of 8 subjects.

ECG measurements will be compared with ECG parameters collected after administration of placebo (Nacl 0.9%). The test sensitivity will be assessed using a positive control (moxifloxacin 400 mg per os) known to induce delays in QT intervals.

Eligibility criteria: Inclusion Criteria:

* Subject assessed as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
* Subject with a Body Mass Index (BMI) \> 19 kg/m² and \< 28 kg/m² and a weight at least of 40 kg for female and 50 kg for male and at maximum of 100 kg

Exclusion Criteria:

-

Primary outcomes:
measure: Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
timeFrame: from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1 hour, 5 min, 10 min, 20 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours.
Secondary outcomes:
measure: Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
timeFrame: from 1 hour before any administration until 4 hours post-administration at the following timepoints: -1 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours.
measure: Predicted Value of ∆∆QTc at Cmax
timeFrame: from 1 hour before any administration until 24 hours post-administration.
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Clinical Pharmacology unit, SGS-Life Science Service
Study officials:
affiliation: SGS Clinical Pharmacology Unit
name: Frederic Vanhoutte, MD
role: PRINCIPAL_INVESTIGATOR
References: