louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03857334: Efficacy of Platelet Rich Plasma in Plantar Fasciitis
Official title: Plantar Fasciitis Treatment: Double Blinded Randomized Control Study of the Efficacy of an Injection of Platelet Rich Plasma (PRP) Versus an Infiltration of Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Plantar fasciitis is a common pathology among podiatry moreover the healing time takes several months.

The main aim of this study is to evaluate the efficacy of a injection of Platelet-Rich Plasma (PRP) versus corticosteroid injection.


Eligibility criteria: Inclusion Criteria:

* Plantar fasciitis
* Average VAS greater than or equal to 5/10
* Resistance of medical reference treatment

Exclusion Criteria:

* Other plantar lesion find on RMI
* Pregnancy

Primary outcomes:
measure: Mean daily pain measured with a visual analog scale from 0 to 10
timeFrame: 6 months
Secondary outcomes:
measure: Pain intensity during the first steps of the day measured with a visual analog scale from 0 to 10
timeFrame: 6 months
measure: Pain intensity on direct compression measured with a visual analog scale from 0 to 10
timeFrame: 6 months
measure: Impairment of walking function
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hosîtal
Study officials:
References:
citation: Breton A, Leplat C, Picot MC, Aouinti S, Taourel P, Laffont I, Julia M, Cyteval C. Prediction of clinical response to corticosteroid or platelet-rich plasma injection in plantar fasciitis with MRI: A prospective, randomized, double-blinded study. Diagn Interv Imaging. 2022 Apr;103(4):217-224. doi: 10.1016/j.diii.2021.10.008. Epub 2021 Nov 26.
Clinical trial NCT06027034: Effectiveness of a Digital Health Application for Psoriasis
Official title: Effectiveness of a Digital Health Application for Psoriasis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psoriasis
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: University of Giessen
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2023-09-07
Enrollment: 348
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: This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis.

Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive 12-month-access to an online program for psoriasis in addition to treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy, pharmacotherapy, psychosocial therapy, etc.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Presence of psoriasis vulgaris or psoriatic arthritis
* Submission of a specialist medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses: Psoriasis vulgaris (L 40.0, L 40.7), Psoriatic arthritis (L40.5, M07.x)
* Impaired health-related quality of life (DLQI \> 10)
* Consent to participate
* Sufficient understanding of the German language

Exclusion Criteria:

* Presence of another subtype of psoriasis (pustular psoriasis, guttate psoriasis, inverse psoriasis, erythrodermic psoriasis, or drug-induced psoriasis) or psoriatic arthritis without skin involvement
* Presence of malignancies
* Presence of other chronic diseases with strong negative influence on quality of life
* Currently undergoing psychiatric treatment / current presence of a severe psychiatric diagnosis
* Insufficient language and/or IT skills

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: 3 months
Secondary outcomes:
measure: Psoriasis Severity
timeFrame: 3 months, 6 months, 12 months
measure: Depressive Symptoms
timeFrame: 3 months, 6 months, 12 months
measure: Body Surface Area (BSA)
timeFrame: 3 months, 6 months, 12 months
measure: Health-Related Quality of Life
timeFrame: 6 months, 12 months
Other outcomes:
measure: Patient Activation
timeFrame: 3 months, 6 months, 12 months
measure: Self-Esteem
timeFrame: 3 months, 6 months, 12 months
measure: Body Mass Index
timeFrame: 3 months, 6 months, 12 months
measure: Alcohol Consumption
timeFrame: 3 months, 6 months, 12 months
measure: Cigarette Smoking
timeFrame: 3 months, 6 months, 12 months
Locations:
city: Hamburg
country: Germany
facility: GAIA AG
Study officials:
affiliation: University of Giessen
name: Uwe Gieler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03837834: Effects of 6 Weeks High-intensity Interval Training Among Spinal Cord Injury
Official title: Effects of 6 Weeks High-intensity Interval Training on Muscle Strength and Cardiorespiratory Response Among Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: INCOMPLETE SPINAL CORD INJURY (ASIA D)
Keywords: HIGH INTENSITY INTERVAL TRAINING
INCOMPLETE SPINAL CORD INJURY
MUSCLE STRENGTH
CARDIO-RESPIRATORY FITNESS
Lead sponsor: Universiti Teknologi Mara
Sponsor class: OTHER
Collaborators: name: University of Malaya
First posted: 2019-02-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The training consists of 6 weeks of functional electrical stimulation leg cycling exercise (FES-LCE) program. The training program comprises of 2 visits per week. Each visit consists of FES-LCE for 45 minutes. Throughout the 6 weeks program, there will be testing/assessment sessions on week 1, week 3 and week 6. The FES will be applied via surface electrodes and the stimulation intensity based on the participant's tolerance level.


Eligibility criteria: Inclusion Criteria:

* Participants were diagnosed with incomplete spinal cord injury (SCI) at least one year prior to participation.
* Age between 18-75 years old.
* Both male and female.
* Have at least 90º bilateral knee flexion.
* Moderate neurological induce weakness in quadriceps muscle of 1 leg that is responsive to electrical stimulation (moderate weakness was defined as 3/5 or 4/5 on manual muscle testing).
* Able to perform cycling activity.
* Normal upper limb function.
* Able to follow command.

Exclusion Criteria:

* Had a recent history of trauma to the lower limb.
* Severely infected skin pressure sore on weight-bearing skin areas.
* Illness caused by acute urinary tract infection.
* Uncontrolled spasticity or pain.
* History of cardiovascular/cardiorespiratory problem.
* Orthostatic hypotension.
* Unhealed decubiti at electrode placement area.
* Recurrent autonomic dysreflexia.
* Active heterotopic ossification.
* Other peripheral or central neurologic injury.

Primary outcomes:
measure: Changes of peak torque of Quadriceps and Hamstring
timeFrame: Changes of peak torque at 6 week
Secondary outcomes:
measure: Changes of peak VO2
timeFrame: Changes of peak VO2 at 6 week
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
Study officials:
References:
Clinical trial NCT05051917: The Italian Coronary Artery Aneurysm and Ectasia In Patients With Acute Coronary Syndrome
Official title: ITAlian Coronary Artery Aneurysm and Ectasia Observational Study in Patients With Acute Coronary Syndrome: The ITACA Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Angiographic Evidence if Coronary Aneurysms
Ectasia
Keywords: Aute Coronary Syndrome
Coronary Artery Artery
Ectasia
Lead sponsor: Federico II University
Sponsor class: OTHER
Collaborators: name: Fondazione GISE Onlus
First posted: 2021-09-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing coronary angiography with diagnosis of ACS and contextual detection of coronary ectasia or aneurysm in accordance with the definitions specified below. Patients with coronary pseudoaneurysms are excluded.

Brief summary: The ITACA study is a prospective, observational no profit registry enrolling patients with Acute Coronary Syndrome and angiographic evidence of coronary aneurysms and/or ectasia.

Detailed description: The ITACA study is aimed at evaluating short and long term outcomes in patients with acute coronary sindrome and angiographic evidence of coronary aneurysm and/or actasia. Data regarding safety and effectiveness of invasive and pharmacological treatment strategies will be also collected.

Eligibility criteria: Inclusion Criteria:

* Signature of informed consent;
* Patients aged ≥18 years;
* diagnosis of ACS (ST-elevation myocardial infarction, non ST-elevation myocardial infarction, unstable angina), in accordance with the definition provided in the latest guidelines;
* diagnosis of ectasia or coronary aneurysm according to the definitions contained in this protocol, either in the culprit vessel of the SCA than in another vessel. Coronary pseudoaneurysms are excluded.

Exclusion Criteria:

* impossibility or unwillingness to provide signed informed consent;
* contraindications to dual antiplatelet therapy;
* contraindications to anticoagulant therapy;
* active bleeding or severe anemia (Hb \<6 g / dl);
* life expectancy \<12 months;
* female patients with potential pregnancy;

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Forlì
country: Italy
facility: Giuseppe Tarantino
state: FC
city: Naples
country: Italy
facility: Professor Giovanni Esposito
Study officials:
References:
Clinical trial NCT04382417: Prospective Observational Cohort Study of Critically Ill Patients With Covid-19 in Sweden
Official title: Characteristics and Outcomes of Critically Ill Patients With Covid-19 in a Large Swedish County Hospital - a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Critical Illness
Lead sponsor: Region Västmanland
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 57
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: Patients with Covid-19.

Brief summary: The study will prospectively collect data from patients with Covid-19 admitted to the Västerås Intensive Care Unit, Västerås Hospital. Demographic, clinical, radiographic and laboratory characteristics will be recorded. Analysis of data to identify predictors of disease severity, mortality and treatment response.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the Intensive Care Unit with biological samples positive for SARS-CoV-2.
* Patients admitted to the Intensive Care Unit with one or more negative tests but with clinical and radiological characteristics highly suggestive of SARS-CoV-2 and thus considered positive for the disease.

Exclusion Criteria:

* None.

Primary outcomes:
measure: All-cause mortality
timeFrame: At 90 days follow-up after admittance to Intensive Care
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Until 90 days after admittance to Intensive Care
measure: ICU length of stay
timeFrame: Until 90 days after admittance to Intensive Care
measure: Number of days on mechanical ventilation
timeFrame: Until 90 days after admittance to Intensive Care
measure: Number of patients receiving vasopressor support
timeFrame: Until 90 days after admittance to Intensive Care
measure: Number of patients receiving renal replacement therapy
timeFrame: Until 90 days after admittance to Intensive Care
measure: Patient characteristics
timeFrame: At admission to ICU
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Intensive Care Unit, Västerås Hospital
state: Västmanland
Study officials:
affiliation: Region Västmanland
name: Erland Östberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06320717: AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma
Official title: A Retrospective/Prospective Study of an Artificial Intelligence Derived Histological Biomarker to Select Neoadjuvant Treatment for Patients With Borderline Resectable or Resectable Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community practices and hospital clinics

Brief summary: To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.

The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers.


Eligibility criteria: Inclusion Criteria:

* Have histologically or cytologically confirmed PDAC that is borderline resectable (BR) (Cohort A) OR have histologically or cytologically confirmed PDAC that is resectable (Cohort B) using the National Comprehensive Cancer Network criteria \[35\].
* Availability of archival tumor tissue (diagnostic for PDAC) required
* Have a documented ECOG Performance Status of ≤ 1
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form (ICF) prior to receiving any study related procedure.

Exclusion Criteria:

* Has received prior systemic treatment (standard of care or experimental) for PDAC
* Participant has a concurrent malignancy requiring active treatment during the study.

Primary outcomes:
measure: Retrospective prediction of pCR in resectable patients
timeFrame: Up to 2 years
measure: Retrospective prediction of pCR in borderline resectable patients
timeFrame: Up to 2 years
Secondary outcomes:
measure: Survival status
timeFrame: Up to 2 years
measure: RECIST 1.1 response
timeFrame: UP to 2 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: West Islip
country: United States
facility: Good Samaritan University Hospital
state: New York
Study officials:
affiliation: Roswell Park Comprehensive Cancer Center
name: Christos Fountilas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556317: Effect of Resistive Exercise on Insomnia in Post Menopausal Women
Official title: Effect of Resistive Exercise on Plasma Estradiol , Sleep Quality and Insomnia in Post Menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disturbances and Insomnia
Keywords: Resistive exercise, insomnia, post menopausal women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 56
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Resistive exercise on insomnia
Primary purpose: TREATMENT

Brief summary: the aim of this study is to investigate the efficacy of resistive exercise on insomnia in post menopausal women

Detailed description: Insomnia is a prevalent condition in post menopausal women.resistive exercise might play an important role in insomnia.this trial has two groups ;one will receive advices and the second will receive advices and resistive exercise for four week

Eligibility criteria: Inclusion Criteria:

1. age from 50 to 65 years
2. non smokers
3. BMI 25:29.9
4. post menopausal women suffer from insomnia

Exclusion Criteria:

1. post menopausal women suffer from any medical problems lead to sleep disturbance and insomnia
2. women on hormone replacement therapy
3. those with diagnosed osteoporosis

Primary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: Four week
Secondary outcomes:
measure: Insomnia severity index
timeFrame: Four week
Other outcomes:
measure: Plasma estradiol
timeFrame: Four week
Locations:
city: Cairo
country: Egypt
facility: Professor of physical therapy
Study officials:
References:
Clinical trial NCT00616317: Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study
Official title: Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Antiphospholipid Syndrome
Keywords: Antiphospholipid Syndrome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Ministry of Higher Education, Science and Technology, Solvenia
First posted: 2008-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric Nephrology Clinic at University of California, Davis

Brief summary: The purpose of this study is to gather information about causes and treatment of Antiphospholipid Syndrome.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or younger at the onset of disease
* Presence of Vascular Thrombosis
* UC Davis patient
* Presence of at least one Laboratory criteria including: Anticardiolipin antibody, Anti-B glycoprotein-I antibody or Lupus anticoagulant in plasma

Exclusion Criteria:

* Infants born to mothers with APS
* Infants with congenital thrombophilia

Primary outcomes:
measure: Long term survival
timeFrame: 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Lavjay Butani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04723017: Perioperative Hypoxemia in Pediatrics
Official title: Development and Validation of Perioperative Hypoxemia Using Clinical Big Data and Deep Learning Technique in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoxemia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 17000
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients

Brief summary: The primary aim was to develop and validation of perioperative hypoxemia using clinical big data and deep learning technique in pediatric patients


Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing general or spinal anesthesia and monitored anesthesia care

Exclusion Criteria:

* none

Primary outcomes:
measure: hypoxemia
timeFrame: from induction of anesthesia to end of operation, about 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
state: Soul-t'ukpyolsi
Study officials:
References:
Clinical trial NCT03949517: 68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
Official title: A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2019-05-14
Enrollment: 14
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: This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.

Detailed description: Primary Objective: To determine feasibility of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for evaluation of HIFU or HDR local therapy in patients with known prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Known prostate cancer
* Planned HIFU or HDR local therapy
* Able to provide written consent
* Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)

Exclusion Criteria:

* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
* Metallic implants (contraindicated for MRI)

Primary outcomes:
measure: Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained
timeFrame: Up to approximately 2 hours to complete each scan
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrei H Iagaru, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duan H, Ghanouni P, Daniel B, Rosenberg J, Davidzon GA, Aparici CM, Kunder C, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Evaluation of Prostate Cancer Response to High-Intensity Focused Ultrasound Therapy. J Nucl Med. 2023 Apr;64(4):592-597. doi: 10.2967/jnumed.122.264783. Epub 2022 Nov 3.