louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03879070: Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
Official title: Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: The National Research Council, Italy
name: Regione Lombardia
First posted: 2019-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed clinical investigation plan is a randomized controlled pivotal study with 2 parallel groups, has a total duration of two years. For the study, 30 pediatric patients suffering from acquired brain injury will be recruited at the Scientific institute Eugenio Medea.

The primary aim of this study is to assess the clinical benefit of using an ankle mobilization device for the rehabilitation of pediatric patients with acquired brain injuries, on its clinical performance and its risks, and on its safety.

The efficacy of the treatment will be evaluated in terms of ankle range of motion (primary outcome). The effects of the treatment on musculoskeletal plasticity will be studied using an isokinetic machine and functional magnetic resonance imaging will provide information on variations of reactivity in the motor cortical network. Ease of use, safety and usability of the device will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Tetraplegic and hemiplegic acquired brain injury patients, within first month of injury.
* Spastic syndrome (ankle joint Modified Ashworth Scale \> 1).

Exclusion Criteria:

* Pace maker or other contraindication to Magnetic Resonance Imaging scans.
* Other serious comorbidity.
* Behaviour and psychiatric disorders.

Primary outcomes:
measure: Passive range of motion of ankle dorsi-plantarflexion
timeFrame: Change from baseline after 4 weeks of treatment
Secondary outcomes:
measure: Ankle joint stiffness
timeFrame: Change from baseline after 4 weeks of treatment
measure: Medical Research Council (MRC) Scale for Muscle Strength
timeFrame: Change from baseline after 4 weeks of treatment
measure: Cerebral activation
timeFrame: Change from baseline after 4 weeks of treatment
measure: Time-Domain Near-Infrared Spectroscopy
timeFrame: Change from baseline after 4 weeks of treatment
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
state: Lecco
Study officials:
References:
Clinical trial NCT01402570: Glutathione and Health With Post-Polio Syndrome
Official title: Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-polio Syndrome
Physical Activity
Depression
Pain
Sleep Disorders
Keywords: disability
polio
rehabilitation
wellness
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2011-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical activity and sleep efficiency will be assessed.

Detailed description: Subjects will take a glutathione supplement by mouth for three months after an initial medical visit, blood draw and physical exam. There are four timepoints during the three months when subjects will fill out surveys and record food intake and sleep times in diaries for seven days. They will also wear a small device for seven days, a Sensewear monitor that records physical activity, body temperature and other measures.

After the fourth timepoint they will return to the medical center for another physical exam and blood draw. Physicians trained in physical medicine and rehabilitation will be monitoring the study.

Eligibility criteria: Inclusion Criteria:

* Ability to walk 100 feet with usual assistive devices (ex. cane or walker)
* Having a function score of 18-32 when tested with the IPPS (Index of Post- Polio Sequelae). This will include people with post-polio symptoms in a very specific range of severity.

Exclusion Criteria:

* Having another serious medical condition (cancer, multiple sclerosis, etc.)or inflammatory disease (ie., lupus)
* Currently taking glutathione or other antioxidants

Primary outcomes:
measure: PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: Sleep Efficiency
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: Steps Per Day
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue
timeFrame: Baseline, 1 month, 2 months and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Claire Kalpakjian, PhD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Mark Ziadeh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00478270: A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
Official title: An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pain
Bone Neoplasm
Neoplasm Metastasis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* breast cancer;
* bone metastases;
* mean worst pain score \>=4 during 3 day baseline period;
* stable dose of analgesics over a 3 day baseline period;
* adequate renal function.

Exclusion Criteria:

* bisphosphonate treatment within 3 weeks of study enrollment;
* a change in antineoplastic treatment within 6 weeks of study enrollment;
* bone radiation within 2 weeks of study enrollment;
* active infection.

Primary outcomes:
measure: Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
timeFrame: Days 5 - 7
Secondary outcomes:
measure: Mean worst pain score over first 7 days
timeFrame: Day 7
measure: Analgesic consumption
timeFrame: Day 7
measure: Karnofsky index
timeFrame: Day 7
measure: AEs, laboratory parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Haidari
country: Greece
city: Patras
country: Greece
city: Piraeus
country: Greece
city: Thessaloniki
country: Greece
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00643370: Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds
Official title: Quantifying Lung Tumor Movement Under Dep Inspiration Breath Holds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: lung cancer
tumor motion
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2008-03-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with any primary lung cancer who are undergoing radiotherapy or chemoradiotherapy

Brief summary: Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath


Eligibility criteria: Inclusion Criteria:

* biopsy confirmed primary lung cancer
* undergoing radiotherapy or chemoradiotherapy
* able to perform adequate deep inspiration breath hold
* patients of childbearing potential must practice adequate contraception
* signed study-specific informed consent form

Exclusion Criteria:

* unable to perform adequate deep inspiration breath hold
* prior tumor resection
* prior chest or neck RT
* pregnant

Primary outcomes:
measure: tumor movement
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Don Yee, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06694870: Transcutaneous CO2 Measurement - From Hospital to Home
Official title: Transcutaneous CO2 Measurement - From Hospital to Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Respiratory Failure
Hypercapnic Respiratory Failure
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2024-11-19
Enrollment: 129
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: Demographics Total Subjects (n) 129 Male 76 (59.0%) Age (mean) 54,9 ±18.0 Diagnosis Neuromuscular disorders: 85 (65.9%) COPD 9 (7.0%) Obesity hypoventilation syndrome: 24 (18.6%) Restrictive: 11 (8.5%)

Brief summary: Long-term non-invasive ventilation (LT-NIV) is the main treatment modality for chronic hypercapnic respiratory failure.To assess the adequacy of alveolar ventilation during sleep and potential sleep hypoventilation, nocturnal transcutaneous CO2 (PtcCO2) monitoring is necessary. There is an increased tendency to monitor patients at home, but there is a lack of robust data comparing the technical success rates between the home and inpatient setting of PtcCO2 monitoring. The primary aim of the current study was to evaluate the rate of successful nocturnal PtcCO2 monitoring in a home setting in a population of patients with chronic hypercapnic respiratory failure receiving LT-NIV. The secondary aim was to compare these data with PtcCO2 registrations performed during regular follow up of a similar population of patients in a hospital setting.

Detailed description: Patients scheduled for LT-NIV follow-up at Oslo University Hospital, Ullevål in the time-period January 2020 to December 2022 were prospectively identified. Follow-up monitoring occurred either at home or in the hospital. Two physicians blinded to the location of the monitoring, retrospectively classified the PtcCO2 as successful or unsuccessful, and identified the causes of failure for the latter.

Eligibility criteria: Inclusion criteria for both groups were:

1. LT-NIV treatment for at least 3 months,
2. that the monitoring was due to a scheduled follow-up appointment,
3. at least one follow-up visit at the hospital after LT-NIV initiation. Inclusion in the study required a signed consent from all participants.

There were three additional criteria for the home monitoring group:

1. home address in reasonable proximity to the hospital,
2. the subject/spouse/assistant/home health care provider was assumed capable of operating the equipment, and
3. the subject consented to undertaking the monitoring at home.

Primary outcomes:
measure: Success rate home vs hospital
timeFrame: January 1st 2020 - December 31st 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Sigurd Aarrestad, Dr.med
role: STUDY_DIRECTOR
References:
Clinical trial NCT05436470: Treatment (Compassionate) Use of Device - PK Papyrus
Official title: Treatment (Compassionate) Use of Device - PK Papyrus
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Pseudoaneurysm, Carotid
Pseudoaneurysm
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-06-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate the clinical use of the PK Papyrus Coronary Stent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under a Humanitarian Device Exemption.


Eligibility criteria: Inclusion Criteria:

1. Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery.

Exclusion Criteria:

1. Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
2. Adults who are cognitively impaired, pregnant women, and prisoners.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Robert Starke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00824070: Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
Official title: An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cataract Extraction
Keywords: Bioavailability
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
* Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.

Exclusion Criteria:

* Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
* Subjects who had any corneal refractive surgery in the study eye.
* Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
* Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
* Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
* Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
* Subjects who are monocular.

Primary outcomes:
measure: The Aqueous Humor Drug Concentration.
timeFrame: Visit 2, 1-14 days following screening visit
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville Center
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: Eric Donnefeld
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06326970: SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease
Official title: SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myocardial Fibrosis
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected or confirmed myocarditis, pulmonary hypertension, arrhythmia, myocardial infarction, dilated cardiomyopathy, and cardiac tumors.

Brief summary: This observational study aims to learn about the preliminary exploration of 99mTc-FAPI imaging in heart diseases and its potential application.

Participant involves patients with myocarditis, pulmonary hypertension, arrhythmia, myocardial infarction, dilated cardiomyopathy, and cardiac tumors, health conditions may also studied as control.

The main questions it aims to answer are 1, radionuclide 99mTc labeled fibroblast-activated protein inhibitors (99mTc-FAPI) imaging in the use of cardiac diseases and its limitations. 2, the performance in subjects with different control of hypertension to evaluate myocardial injury and fibrosis for providing a molecular biological basis for the study of diseases and mechanisms.

Participants will undergo 99mTc-FAPI imaging by Single-photon emission computed tomography (SPECT) and record their cardiac disease characterization and treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis or suspected of cardiac injury
* Must be able to receive PET/CT scan

Exclusion Criteria:

* Pregnant women
* Severe claustrophobia

Primary outcomes:
measure: positive uptake
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fuwai central China hospital
name: Muwei Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuwai central China hospital
name: Jing Cui, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04880070: Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging
Official title: Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Connective Tissue Defect
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open label, multi-center clinical study to collect additional data and imaging for the ViaSure device.The intended use of the ViaSure device used in this study is to assess the usability and tissue response to shock wave treatment.

Detailed description: Up to 50 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the study device. Follow up visits may occur 30 and 90 days post last treatment visit.

Eligibility criteria: Inclusion Criteria:

* A healthy male or female 18 - 65 years of age.
* Willing to undergo treatments with the SoftWave device.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
* The subject has a pacemaker or implantable defibrillator.
* The subject has a severe coagulation disorder.
* The subject has open epiphyseal plates.
* The subject has recently had a steroid injection.
* The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study.
* The subject has any condition or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may

Primary outcomes:
measure: # of Subjects With Altered Gene Expression
timeFrame: 14 days post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Westford
country: United States
facility: Cynosure, Inc.
state: Massachusetts
Study officials:
affiliation: Cynosure, Inc.
name: Jennifer Civiok
role: STUDY_DIRECTOR
References:
citation: Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
Clinical trial NCT06302270: CFTR Modulators in Pregnancy and Postpartum
Official title: Monitoring of Women and Children Exposed to the Combination of Elexacaftor-tezacaftor-ivacaftor During Bregnancy and Through Mother's Own Milk.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2024-03-08
Enrollment: 75
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Woman with cystic fibrosis who is pregnant and treated with Kaftrio and her newborn infant

Brief summary: Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.


Eligibility criteria: Inclusion Criteria:

Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman

Exclusion Criteria:

none

Primary outcomes:
measure: Health effects in the newborn infant
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm CF center
Study officials:
References: