louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04728906: Heart Patch for Myocardial Infarction COVID-19
Official title: Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Heart Diseases
Lead sponsor: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Sponsor class: OTHER
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
name: RSUPN dr. Cipto Mangunkusumo
name: Rumah Sakit Universitas Indonesia
name: Pusat Jantung Nasional Harapan Kita
First posted: 2021-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Myocardial infarction (MI), as one of the many complications of COVID-19, is one of the contributing patients of patients' death. This study attempts on developing an intervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygen in cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patch developed from amnion bilayer seeded with amnion epithelial stem cells and patient's autologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG) surgery are given heart patch, and then patients condition are observed by ECG, Echo, blood test, and radiology (technetium-99m)


Eligibility criteria: Inclusion Criteria:

* Aged 40 - 60 years old
* Ischemic burden \>10% and ischemic gradients red-violet
* Ischemic area is not feasible to be grafted (bypass) due to other conditions such as diffusion and deep intramuscular vascularization
* Ejection fraction \>30-35%
* Euro score \<8

Exclusion Criteria:

* Scanning of Technetium-99 showed black colored ischemic area
* Patients undergoing other procedures other than bypass such as valve repair
* Chronic kidney failure
* Patients have went through several bypass surgeries prior
* Patients are still COVID-19 positive
* Immunocompromised patients

Primary outcomes:
measure: Change of the ischemic burden (%)
timeFrame: Comparison from the imaging within 3 months before intervention, and after 6 months post treatment.
measure: Change in the regional heart wall motion abnormality
timeFrame: Observation of the heart wall motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Secondary outcomes:
measure: Change of the electrocardiographic wave
timeFrame: Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention
measure: Change of the ejection fraction
timeFrame: Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: RSUPN dr. Cipto Mangunkusumo
state: DKI Jakarta
city: Depok
country: Indonesia
facility: Rumah Sakit Universitas Indonesia
state: Jawa Barat
city: Jakarta
country: Indonesia
facility: Pusat Jantung Nasional Harapan Kita
Study officials:
References:
Clinical trial NCT06676306: Patient and Caregiver Priorities in Neuro-oncology Care
Official title: Patient and Caregiver Priorities in Neuro-Oncology Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Central Nervous System Neoplasm
Metastatic Malignant Neoplasm in the Central Nervous System
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of primary or metastatic CNS tumor with a primary caregiver.

Brief summary: This study is being done to identify patient and caregiver burdens regarding their experience with diagnosis and treatment of CNS tumors. These results will help doctors find areas where patients and caregivers may need more support.

Detailed description: PRIMARY OBJECTIVES:

I. Describe the patient experience and characterize the symptom burden related to primary or metastatic central nervous system tumors.

II. Describe the caregiver experience and caregiver needs related to patients with primary or metastatic central nervous system tumors. III. Establish which interventional treatment outcomes are important to patients and caregivers, within a wider understanding of their lived experience with CNS tumors and their treatment.

OUTLINE: This is an observational study.

Patients and their caregivers participate in interviews on study. Patients also have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* \* Age ≥ 18 years.

  * Diagnosis of primary or metastatic CNS tumor with a primary caregiver, should patient wish to involve one.
  * Willing and able to participate in a semi-structured interview lasting approximately 60 minutes. Dyad interviews conducted for participants who elect to involve a caregiver.
  * Willing and able to participate in a single follow-up interview. Dyad follow up interviews conducted for participants who elect to involve a caregiver.

Exclusion Criteria:

* \* Uncontrolled and/or intercurrent illness which limits participation in study interview.

  * Vulnerable populations: pregnant or nursing persons, prisoners, or persons lacking capacity for understanding.
  * Unable to read and speak English.

    * Note: English does not need to be primary language.

Primary outcomes:
measure: Patient experience
timeFrame: Up to 6 months
measure: Symptom burden related to primary or metastatic central nervous system tumors
timeFrame: Up to 6 months
measure: Caregiver experience
timeFrame: Up to 6 months
measure: Caregiver needs
timeFrame: Up to 6 months
measure: Importance of treatment outcomes
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Ugur T. Sener, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02882906: Myofascial Trigger Points in the Upper Limb in Stroke Patients
Official title: Myofascial Trigger Points Are Associated in the Upper Limb in Stroke Patients: a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Pain
Shoulder
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a complaint of shoulder pain following a stroke were recruited to be subjects in the study following referral to physical therapy to the outpatient department at orthopedic rehabilitation facility by a family practice physician.

Brief summary: One source of shoulder pain can be myofascial trigger points (MTrPs). MTrPs are localized, hyperirritable points in the skeletal muscles that are associated with palpable nodules in muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the same clinical characteristics as active MTrPs but they do not provoke spontaneous pain. Numerous studies have shown that MTrPs are prevalent in patients with chronic non-traumatic neck and shoulder pain.


Eligibility criteria: Inclusion Criteria:

* Unilateral shoulder pain and a physician-diagnosed stroke.

Exclusion Criteria:

* Rheumatic inflammatory,
* Systemic diseases,
* Acute traumatic conditions,
* Postoperative conditions, neck and elbow disorders, and
* Serious aphasias in which there was a communication problem.

Primary outcomes:
measure: Change of Pain intensity
timeFrame: Baseline
measure: Pressure Pain Thresholds (PPT)
timeFrame: Baseline
Secondary outcomes:
measure: Barthel index
timeFrame: Baseline
measure: DASH
timeFrame: Baseline
Other outcomes:
Locations:
city: Piossasco
country: Italy
facility: Jorge Hugo Villafañe
state: Turin
Study officials:
affiliation: IRCCS Don Gnocchi Foundation
name: JORGE H VILLAFAÑE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05558306: Radiological vs Clinical Outcome in DRF
Official title: Association Between Radiographic and Clinical Outcome in Distal Radius Fractures: A Prospective Cohort Study With a 1-year Follow-up in 368 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 451
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Several studies have investigated the degree of final displacement and its association with clinical outcome. There is still no consensus on the importance of radiological outcome and published studies do not use the same criteria for an acceptable alignment. Previous reports have used a linear or a dichotomized exposure in the statistical analysis, but no study has investigated a nonlinear association.

Methods: We included 438 patients treated for a distal radius fracture (DRF) with either reduction and cast immobilization or surgery. Radiographic outcomes were determined by radiographs 3 months after the injury. Clinical outcome was determined by QuickDASH (qDASH), ROM and grip strength at 1-year after the injury. Nonlinear correlations were analysed with cubic splines.


Eligibility criteria: Inclusion Criteria:

- Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna.

Exclusion Criteria:

* Dementia
* Previous fracture to the ipsilateral wrist
* Open fracture
* Other concomitant or existing damage or injury to the wrist
* Galeazzi fracture
* Rheumatoid arthritis
* Alcohol or drug abuse
* Neurologic impairment

Primary outcomes:
measure: quickDASH
timeFrame: 12 months
measure: Range of motion
timeFrame: 12 months
measure: Grip strength
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00821106: Left Versus Right Transradial Approach for Percutaneous Coronary Procedures
Official title: Transradial Approach [LEft vs Right] aNd Procedural Times During Percutaneous Coronary Procedures: TALENT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Angiography
Angioplasty, Transluminal, Percutaneous Coronary
Keywords: Coronary angiography
percutaneous coronary intervention
Transradial approach
Lead sponsor: Policlinico Casilino ASL RMB
Sponsor class: OTHER
First posted: 2009-01-13
Enrollment: 1540
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: Transradial approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Transradial procedures may be performed by cannulation of the right or left radial artery and at present, the choice of the right or left radial artery depends largely on the operator' s preference.

The aim of this study is to evaluate safety and efficacy of transradial approach comparing the right radial versus the left radial approach in coronary diagnostic and interventional procedures.

The investigators will enroll consecutively for 12 months all patients who undergo to diagnostic or interventional procedures through trans radial approach in two Italian centers (Casilino Policlinic, Catholic University-Rome).

Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the patients. Secondary end-points are: contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.

The investigators pre-specified a sub-study in patients older than 75 years old with the same end-points.


Eligibility criteria: Inclusion Criteria:

* All patients who undergo to diagnostic or interventional procedures

Exclusion Criteria:

* Previous coronary artery by-pass
* Acute myocardial infarction with ST segment elevation myocardial infarction
* Cardiogenic shock
* Ischemic Allen Test

Primary outcomes:
measure: Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients
timeFrame: 7 days
Secondary outcomes:
measure: Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.
timeFrame: 7 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Casilino-ASL RMB
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore
Study officials:
affiliation: Policlinico Casilino ASL RMB
name: Alessandro Sciahbasi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01585506: Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues
Official title: Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-04-26
Enrollment: 3618
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians who switched therapy from biphasic human insulins to a biphasic insulin analogue providing questionnaires for completion to patients whose therapy was switched from biphasic human insulins to biphasic insulin analogues

Brief summary: This study is conducted in Europe. The aim of this study is to investigate psychosocial factors related to compliance with treatment with biphasic insulin analogues.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes in whom therapy with biphasic insulin analogues was started

Primary outcomes:
measure: Frequency and level of difficulty in introducing changes in compliance with the guidelines for biphasic insulin analogue use in subjects previously treated with biphasic human insulins
timeFrame: Up to 3 months
Secondary outcomes:
measure: Correlations between the difficulty in introducing changes in compliance with the guidelines for biphasic insulin analogue use in subjects previously treated with biphasic human insulins, and psychosocial factors
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kokoszka A. Treatment adherence in patients with type 2 diabetes mellitus correlates with different coping styles, low perception of self-influence on disease, and depressive symptoms. Patient Prefer Adherence. 2017 Mar 17;11:587-595. doi: 10.2147/PPA.S124605. eCollection 2017.
Clinical trial NCT00944606: Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children
Official title: Vitamin D vs Placebo in the Treatment of Vague Musculoskeletal Pain in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypovitaminosis D
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain.

Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal pain in children.


Eligibility criteria: Inclusion Criteria:

* ages 5-14
* healthy
* vague musculoskeletal pain without diagnosis

Exclusion Criteria:

* medications (steroids, seizure medications, birth control pills or shot)
* endocrinopathies

Primary outcomes:
measure: Lessening of musculoskeletal pain level and frequency
timeFrame: 6 weeks
Secondary outcomes:
measure: Improvement of serum 25 OH Vitamin D level
timeFrame: 6 weeks
measure: Decline of serum parathyroid hormone levels
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico General Clinical Research Center
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Elizabeth A Szalay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02041806: Assessing Peripheral Nerve Block Scoring Systems for Intra-Operative and Post-Operative Analgesia
Official title: The Effectiveness of Peripheral Nerve Block Scoring Systems in Predicting the Success of a Block for Intra-Operative and Post-Operative Analgesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication of Anesthesia
Lead sponsor: The Adelaide and Meath Hospital
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 40
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 undergoing orthopaedic or vascular surgery who would receive a peripheral nerve block as part of their care.

Brief summary: The purpose of this study is to determine if Peripheral Nerve Block scoring systems are effective in predicting the achievement of intra-operative anaesthesia and post-operative analgesia.

Detailed description: Upper and lower extremity surgery is particularly suited to regional anaesthesia. Peripheral nerve blocks (PNB) can produce surgical anaesthesia in less than 30 minutes. PNBs have been associated with early outcome improvements when surgery is conducted awake or with light sedation. These benefits include reduced nausea and vomiting, improved patient satisfaction and accelerated recovery room and hospital discharge. PNBs can also provide effective postoperative pain relief.

Currently there is no globally accepted standard by which to assess when surgical anaesthesia has been achieved following administration of PNBs. The decision as to when adequate surgical anaesthesia has been achieved and when surgery can then proceed is usually left to the discretion of the anaesthetist. The anaesthetist can assess nerve blockade though several motor and sensory function tests: cold, heat, touch and pinprick sensitivity. Several scoring systems have been described using these tests to estimate when surgical anaesthesia has been achieved but none have been independently validated outside of the original studies in which they have been described.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Grade I-IV

Exclusion Criteria:

* Contraindications to regional anesthesia
* Language barrier
* Existence of neurologic disease affecting the operative site
* Severe psychiatric disease
* Pregnancy

Primary outcomes:
measure: Predictive value of block assessment score
timeFrame: 30 mins post block completion
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Tallaght Hospital
Study officials:
affiliation: The Adelaide and Meath Hospital
name: Patrick H Conroy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05391906: Intravoxel Incoherent Motion (IVIM) Magnetic Resonance Imaging in Multiple Sclerosis
Official title: Intravoxel Incoherent Motion (IVIM) Magnetic Resonance Imaging in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-05-26
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: DIAGNOSTIC

Brief summary: Intravoxel incoherent motion (IVIM) is technique based on diffusion-weighted imaging (DWI). In this study, the investigators evaluate the use of IVIM in patients with Multiple Sclerosis.

Detailed description: Intravoxel incoherent motion (IVIM) is technique based on diffusion-weighted imaging (DWI), it is achieved through an MRI acquisition with multiple small b value to extract perfusion data. It has been shown to be a promising technique in evaluation of many brain conditions. This study seeks to assess intravoxel incoherent motion (IVIM) parameters in characterizing plaques and specific tissues in multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

1. Patients who are 18 years or older.
2. Relapsing-remitting MS diagnosed as per Macdonald criteria

Exclusion Criteria:

1. Contraindication to MRI. For example, metal implantation in the body, claustrophobia and pregnancy.
2. Patients who are unable to tolerate the scans without moving the head as a result of symptoms such as tremor, spasticity, involuntary movements and spasms, cognitive impairment, coughing, and shortness of breath.

Primary outcomes:
measure: IVIM parameters (including ADC,D,D*,f) in Multiple Sclerosis brain regions.
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: CUHK
Study officials:
References: