louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01262703: Safety Study of a Bioresorbable Coronary Stent
Official title: Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Cardiovascular Disease
Lead sponsor: REVA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 49
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: To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.

Detailed description: Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.

Eligibility criteria: Inclusion Criteria:

* Evidence of myocardial ischemia or a positive functional study.
* Normal CK-MB.
* Target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line QCA and IVUS
* Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 2.
* Staged procedures are allowed in non-target vessels \>24 hours before or \> 30 days after REVA stent implantation

Exclusion Criteria:

* A myocardial infarction (CK-MB or Troponin \> 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus
* Unprotected left main coronary disease with \>50% stenosis
* The target vessel is totally occluded (TIMI Flow 0 to 1)
* Target lesion involves a bifurcation (a lesion with a side branch \>2.0 mm in diameter containing a \>50% stenosis)
* Target lesion is located within a segment supplied by distal graft
* Target lesion has possible or definite thrombus

Primary outcomes:
measure: Ischemia-driven Target Lesion Revascularization (TLR)
timeFrame: 6 months
Secondary outcomes:
measure: QCA & IVUS derived parameters
timeFrame: 12 months
measure: Major Adverse Coronary Events
timeFrame: 60 months
measure: Procedural and Technical Success
timeFrame: Acute
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Alexandre Abizaid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06672003: Assessing the Relationship Between Chronic Pain and Frailty in Older Adults
Official title: Assessment of the Prevelance of Chronic Pain and Its Relationship to Frailty in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Frailty
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 203
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The universe of the study consists of all individuals aged 65 and over registered in a family health center. Participants to be included in the study from this universe will be determined using the stratified random sampling method.

Brief summary: Pain is an unpleasant emotional sensation related to one's past experiences, originating from a certain part of the body, due to tissue damage or not. Pain is the most commonly reported symptom in the elderly. Chronic pain is persistent or recurrent pain lasting more than 3 months. It is a maladaptive process or a disease that requires multimodal treatment that causes functional decline, independent of the healing process, accompanied by affective, cognitive and motivational disorders, and deterioration in quality of life. Frailty: It is defined as a clinical condition characterized by weakness, physical disability, functional regression, inadequacy in activities of daily living, and increased dependence, which develops as a result of the decrease in physiological reserves in the body with age. It has been reported that the risk of falls, disability, hospitalization and premature death is higher in the frail elderly. The prevalence of vulnerability in societies varies. Frailty rates ranging from 4 to 59% have been reported in developed and developing countries. In this study, it was aimed to evaluate whether there is a relationship between chronic pain and frailty in individuals aged 65 and over.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic pain who are registered with a family medicine unit

Exclusion Criteria:

* Having an active malignancy,
* having a physical disability,
* being bedridden,
* having a psychotic disorder,
* having a cognitive disorder, and refusing to participate.

Primary outcomes:
measure: frailty
timeFrame: 12 months
measure: chronic pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
Study officials:
References:
Clinical trial NCT04839003: A Registry of AL Amyloidosis (ReAL)
Official title: A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AL Amyloidosis
Keywords: amyloidosis
prognosis
registry
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be entered the database pending on expressing an informed consent of the use of their data for research purposes.

Brief summary: The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.

Detailed description: Thanks to this registry, it will be possible to collect data at diagnosis and during follow up, in order to be able to describe the natural history of AL amyloidosis in a real-world setting and to define and validate prognostic models, response and relapse criteria applicable at any point of the disease.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of systemic AL amyloidosis;
2. treatment-naïve (pre-treatment data collected at participating center available for retrospective part);
3. age ≥18 years;
4. ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);
5. planned (or ongoing) follow-up at participating center.

Exclusion Criteria:

1. non-AL amyloidosis;
2. previous treatment for AL amyloidosis.

Primary outcomes:
measure: Creation of a registry of patients with AL amyloidosis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
References:
Clinical trial NCT00149903: Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients
Official title: Multicenter, Double-blind, Randomized, Parallel Group Study on Efficacy and Safety of Enteric-coated Mycophenolate Sodium vs. Mycophenolate Mofetil in de Novo Chinese Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant,
* treated with cyclosporine and corticosteroids as primary immunosuppression.

Exclusion Criteria:

* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ
* Patients who have received an investigational drug within four weeks prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients.
Secondary outcomes:
measure: Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients
measure: Other variables of efficacy: chronic rejection, graft loss, death.
measure: Safety of EC-MPS as measured by incidence of adverse events and serious adverse events.
Other outcomes:
Locations:
city: Beijing
country: China
facility: General Hospital, Friendship Hospital, Beijing, No 1 Hospital Peking University, Beijing China; Shanghai No 1 Hospital, Shanghai China; Changzheng Hospital, Shanghai, China; Shanghai Ruij
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT04423003: Endoscopic Interventions in Patients With COVID-19
Official title: Impact of the COVID-19 Pandemic on an Interdisciplinary Endoscopy Unit in a German "Hotspot" Area: a Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Change; Endoscopy, COVID-19
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 patients

Brief summary: This is a combined study including a descriptive part about the preparations for COVID-19 and the impact of COVID-19 on the daily routine of the work in an Interdisciplinary Endoscopic Unit (IEU), and a point-prevalence analysis for possible positive SARS-CoV-2 carriers among the staff of the IEU, and finally a prospective analysis of SARS-CoV-2 positive patients who required endoscopic intervention.

Results are presented in the captures: 1. SARS-CoV-2-pandemic related restructuring of the processes in the IEU, 2. SARS-CoV-2-pandemic related impact on the staff of the IEU, and 3. Analysis of endoscopic interventions in patients with confirmed or suspected SARS-CoV-2 infection.

Detailed description: This article is intended to provide an overview of the impact of the COVID-19 pandemic on an interdisciplinary endoscopy unit (IEU, gastroenterological endoscopy, surgical endoscopy, and bronchoscopy) at the University Hospital Tübingen, a center for tertiary care in South-western Germany. First, preparations for COVID-19 pandemic with respect to the IEU are presented, and compared with those of other endoscopy units (7, 8). Additionally, the direct impact of SARS-CoV-2 on the staff of the IEU will be shown, together with a point-prevalence analysis of SARS-CoV-2 of the staff at the end of the SARS-CoV-2 wave in Tübingen. Finally, to our knowledge for the first time, we conducted a prospective single center analysis of the patients infected with SARS-CoV-2, which required a diagnostic or therapeutic endoscopic intervention.

Eligibility criteria: Inclusion Criteria:

* patients with proven or suspected infections with SARS-CoV-2 infection, who required endoscopic interventions

Exclusion Criteria:

* all other patients

Primary outcomes:
measure: death in time of observation
timeFrame: 01.March 2020 to 5. May 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital of Tuebingen
Study officials:
References:
Clinical trial NCT02370303: A Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System
Official title: A Pilot Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lung Neoplasms
Cancer of Lung
Cancer of the Lung
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Carcinoma, Non-small-cell Lung
Adenocarcinoma
Squamous Cell Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Clearbridge Biomedics
First posted: 2015-02-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a stage IB or above non-small cell lung cancer or metastatic cancer undergoing lung surgery at the Mayo Clinic in Rochester, MN.

Brief summary: The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.

Detailed description: The plan is to collect both blood and tumor samples from the patient's lung cancer in order to validate this technology in detecting circulating tumor cells. The investigators will also obtain a postoperative blood sample to see if there is a decrease in the overall circulating tumor cell measurement once the tumor has been surgically removed.

Eligibility criteria: Inclusion Criteria:

* Stage IB and above non-small cell lung cancer or metastatic lung cancer
* Age \>18 years old
* Willing and able to consent to study
* No prior history of neoadjuvant therapy.

Exclusion Criteria:

* Age \<18 years old
* Unable to provide consent

Primary outcomes:
measure: Number and types of mutations in the primary tumor.
timeFrame: Within 1 year
measure: Number and type of mutations detectable in the matched circulating tumor cell samples.
timeFrame: Within 1 year
Secondary outcomes:
measure: Concordance of mutations detected by either method.
timeFrame: Within 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dennis Wigle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01218503: The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss
Official title: The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss (CHOICES)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Weight Loss
Weight Control
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: California Institute of Technology
First posted: 2010-10-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to determine whether obese, normal weight, and successful weight loss maintainers differ in their food choice decision-making and/or executive function, and whether participation in a behavioral weight loss program leads to neural and/or behavioral changes. The investigators will examine behavioral performance on several tasks involving decision-making and self-control in conjunction with brain imaging data acquired during a food-choice decision-making task. Participants enrolled in the behavioral weight loss program will also be assessed following the treatment.


Eligibility criteria: Inclusion Criteria:

* women, ages 35-55, who are either currently obese (BMI = 30-40 kg/m2), always normal weight (lifetime BMI \< 25, NW) or successful weight loss maintainers who have lost 10% of their body weight and maintained that loss for at least 1 year (lifetime maximum BMI = 30-40 kg/m2)

Exclusion Criteria:

* weight loss medications, binge eating, standard MRI contraindications (e.g., metal implants, claustrophobia, pregnancy), left-handedness, food allergies, neurological or psychiatric conditions, including but not limited to schizophrenia, bipolar disorder, epilepsy, stroke and traumatic brain injury with loss of consciousness, and, among obese participants, inability to participate at two time points and lack of interest in participating in a behavioral weight loss trial
* serious current physical disease (e.g., heart disease and cancer) for which physician supervision of diet and exercise prescription is needed, physical problems that limit the ability to exercise, participation in a weight loss program in the last 2 months and intention to become pregnant in the next 6 months

Primary outcomes:
measure: fMRI
timeFrame: pre- and post-treatment in obese group, single time point for SWLM and NW
Secondary outcomes:
measure: Behavioral data
timeFrame: pre- and post-treatment of obese group, single time point for SWLM and NW
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control & Diabetes Research Center
state: Rhode Island
city: Providence
country: United States
facility: Weight Control & Diabetes Research Center
state: Rhode Island
Study officials:
References:
Clinical trial NCT00434603: Expressive Arts as a Social and Community Integration Tool for Youth Recovering From Brain Injury
Official title: Expressive Arts as a Social and Community Integration Tool for Adolescents With Acquired Brain Injury: "I Want to Thrive, Not Just Survive!"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Holland Bloorview Kids Rehabilitation Hospital
First posted: 2007-02-13
Enrollment: 8
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth recovering from acquired brain injury

Brief summary: This study utilizes a novel technique-expressive arts therapy-to facilitate social integration for youth recovering from acquired brain injury (ABI). Expressive arts therapy is defined as the use of the arts and artistic media to explore psychological aspects of life. An expressive art (also referred to as 'creative arts' or even just 'arts') encompasses drama, music, art (visual arts such as painting, sculpture etc) and dance/movement. It has great potential to improve community integration for youth recovering from ABI, through facilitating skills required for successful social communication and social cognition. It is hypothesized to improve social and emotional functioning compared to a less structured creative arts program. It is expected that a combination of directed group activities and self-reflection within a creative learning context will improve emotional awareness and social and community integration to a greater degree than a non-expressive creative arts therapy group, in youth who have suffered an ABIAs community integration enables meaningful and productive occupational engagement, enabling opportunities for occupational engagement through increased community integration would greatly enhance the quality of life of adolescents with ABI.


Eligibility criteria: Inclusion Criteria:

* At least 6 months post injury
* Difficulties in social and emotional functioning
* Entering Grades 10 and 11 in 2007
* English fluency

Exclusion Criteria:

* Extreme behaviour, mood and cognitive disturbance

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto
name: Michelle Keightley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03107403: Dreams and Bereavement
Official title: Investigation of the Links Between Waking-life and Dream Content in the Case of the Death of a Close Relative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: dreams bereavement
emotional
regulation
bereavement
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate a possible role of dreaming in emotion regulation testing whether dreaming of a close relative recently deceased is correlated with a positive evolution of the bereavement process


Eligibility criteria: Inclusion Criteria:

* age \> or = 18 years old
* the death of a close relative in the last 3 months

Exclusion Criteria:

- history of psychiatric and neurologic disease

Primary outcomes:
measure: Frequency of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 1
measure: Frequency of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 90
measure: Frequency of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 180
measure: Frequency of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 270
measure: Frequency of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 360
Secondary outcomes:
measure: Content of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 1
measure: Content of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 90
measure: Content of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 180
measure: Content of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 270
measure: Content of dreams related to the deceased will be correlated to the score at the scale assessing the bereavement process
timeFrame: Day 360
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon Hôpital le Vinatier/Inserm
Study officials:
affiliation: Hôpital le Vinatier/Inserm
name: Alain Nicolas, MD
role: PRINCIPAL_INVESTIGATOR
References: