louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02545465: A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice
Official title: Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary Arterial Hypertension
Inoperable Chronic Thromboembolic Pulmonary Hypertension
Persistent Chronic Thromboembolic Pulmonary Hypertension
Recurrent Chronic Thromboembolic Pulmonary Hypertension
Switch of therapy
Titration phase
Retrospective chart review
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Source population of the study are patients with Pulmonary arterial hypertension(PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH). Patients with this rare condition are mostly diagnosed and managed at specialist centers. This includes initiation or any change of Pulmonary Hypertension (PH) therapy. The participation of these specialized centers in the study is going to ensure the representativeness of the study population. In order to reduce selection bias physicians will be asked to include all eligible patients.

Brief summary: The aim of this study is to understand the treatment patterns in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a switch of treatment to Adempas in real-life clinical practice.

In addition, this study will describe patient demographics and reason for switching


Eligibility criteria: Inclusion Criteria:

- Female and male adult patients diagnosed with PAH or inoperable/recurrent/persistent CTEPH who have been switched from a PH treatment (i.e. Endothelin Receptor Antagonist(ERAs), Phosphodiesterase-5 inhibitor(PDE5i) or Prostacyclin Analog (PCA) to Adempas

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice
* Patients who have not switched their therapy from an Endothelin Receptor Antagonist (ERA) or Prostacyclin Analog (PCA) but received Adempas purely as an add-on therapy

Primary outcomes:
measure: Starting Dose
timeFrame: Up to a total of 8 weeks of titration period
measure: Dose Increments
timeFrame: Up to a total of 8 weeks of titration period
measure: Final Dose
timeFrame: Up to a total of 8 weeks of titration period
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Belgium
city: Many Locations
country: Canada
city: Many Locations
country: Colombia
city: Many Locations
country: Germany
city: Many Locations
country: Japan
city: Many Locations
country: Sweden
city: Many Locations
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04833465: Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
Official title: Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Juvenile Idiopathic Arthritis
Systemic Lupus Erythematosus
Fibromyalgia
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 subjects from each of the three populations of interest will be enrolled for this study.

Brief summary: The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.


Eligibility criteria: Inclusion Criteria:

In order to be eligible for inclusion in the study, an individual must meet all of the following criteria:

* Male or female ≥ 5 years of age at screening.
* Documentation of a JIA, SLE or FM diagnosis as evidenced by history

Exclusion Criteria:

Any individual who meets any of the following criteria will be excluded from participation in this study:

• Documented history of eye disease precluding pupillometry

Primary outcomes:
measure: Index Characterization
timeFrame: 1 Year
Secondary outcomes:
measure: Treatment Effect
timeFrame: 1 Year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
References:
Clinical trial NCT04724265: Cytomegalovirus (CMV) Perilymphatic Fluid
Official title: Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss, Cochlear
Cytomegalovirus Congenital
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.

Detailed description: Data on etiology of hearing loss and CMV status are collected. Perilymphatic liquid is collected after cochleostomy using a 1ml seringue. The drop of liquid is deposited on a Guthrie card; on another card, a drop of blood is deposited on another card. CMV PCR (polymerised chain reaction) is then performed in order to assess for the presence of CMV. The sensibility, specificity, positive and negative positive values are then calculated.

Eligibility criteria: Inclusion Criteria:

* Children (under 18-year-old) presenting with a Sensorineural Hearing Loss with an indication of cochlear implantation

Exclusion Criteria:

-

Primary outcomes:
measure: Sensitivity and specificity of CMV PCR in perilymphatic fluid
timeFrame: 7 days after the collection of the sample (biological collection)
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré Hospital
Study officials:
References:
citation: Chebib E, Vauloup-Fellous C, Benoit C, Noel Petroff N, Van Den Abbeele T, Maudoux A, Teissier N. Is CMV PCR of inner ear fluid during cochlear implantation a way to diagnose CMV-related hearing loss? Eur J Pediatr. 2023 Jan;182(1):375-383. doi: 10.1007/s00431-022-04691-6. Epub 2022 Nov 12.
Clinical trial NCT05288465: Hair Repigmentation During Cerebrolysin Therapy
Official title: Hair Repigmentation in Patients Undergoing on Cerebrolysin Treatment for Neurological Diseases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Problems
Keywords: Hair graying
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Dr. Jose E. Gonzalez
First posted: 2022-03-21
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal study of hair repigmentation in patients receiving cererbolisin treatment for neurological diseases
Primary purpose: BASIC_SCIENCE

Brief summary: Open-label histological study of scalp biopsies from patients undergoing treatment with Cerebrolysin as therapy for cerebrovascular disease. The aim is to assess by histological techniques the causes of follicular repigmentation that occurs during the Cerebrolysin treatment.

Detailed description: Patients who fulfill the study requirements will receive the standard Cerebrolysin protocol as follows: Intravenous (iv) infusions of 5 vials per week, 2 vials on Mondays and 3 vials on Thursdays for 4 weeks, followed by an 8-week resting period prior to the next cycle of treatment. Each patient will receive 3 cycles giving a total of 9 months of follow-up. For intravenous infusions, each 10 ml vial containing 215.2mg / ml of Cerebrolysin (Ever Pharma) is diluted with physiological saline solution (NaCI 0.9%) to a final volume of 100 mL.

A pre- and post-treatment biopsies will be collected from the achromotrichia area of each patient. Antisepsis of the area will be performed prior to each biopsy with chlorhexidine, followed by local anesthesia with lidocaine 2% and epinephrine. The biopsy will be collected using a 4mm punch and the wound will be sutured with non-absorbable stitches with Prolene 4-0.

Eligibility criteria: Inclusion Criteria:

* Known neurologist prescription for Cerebrolysin treatment due ischemic or hemorrhagic stroke, traumatic brain injury or dementia.
* Age-related white or gray hair.
* Above 40 years old
* Voluntarily consents in written informed consent by the principal or legal representative

Exclusion Criteria:

* Patients with a diagnosis of Chronic Kidney Disease (CKD).
* Known history of seizures, epilepsy, or hypersensitivity to one or any drug components.
* Pregnant patients.
* Patients with a history of recent treatment of hair coloring products.

Primary outcomes:
measure: Macroscopic evaluation of scalp repigmentation
timeFrame: From the beginning of the treatment until 9th month.
measure: Microscopic evaluation of scalp repigmentation
timeFrame: From the beginning of the treatment until 9th month.
measure: Evaluation of scalp melanocytes function.
timeFrame: From the beginning of the treatment until 9th month.
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario. Dr. José Eleuterio González
state: Nuevo Leon
Study officials:
References:
Clinical trial NCT04964674: Psychometric Testing and Cue Utilization During Cued Visual Search
Official title: Psychometric Testing and Cue Utilization During Cued Visual Search
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: attention
visual search
Lead sponsor: Lehigh University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-subjects measures, individual differences analysis
Primary purpose: BASIC_SCIENCE

Brief summary: The experimenters will examine the relationship between utilization of positive (target cue) and negative (distractor cue) templates during a cued visual search task with performance on a set of measures related to executive functions associated with attentional control: shifting, updating, and inhibition.

Detailed description: The experimenters will utilize the typical procedures for the cued attentional task, while also deploying the Miyake executive function analysis. Data will also include a working memory capacity measure.

Eligibility criteria: Inclusion Criteria:

* Normal or corrected-to-normal visual acuity, normal color vision

Exclusion Criteria:

* age

Primary outcomes:
measure: Positive, Negative, Neutral Attention Task Performance Speed
timeFrame: 1 day
measure: Positive, Negative, Neutral Attention Task Performance Accuracy
timeFrame: 1 day
measure: Miyake Executive Attention task- Updating
timeFrame: 1 day
measure: Miyake Executive Attention task-Shifting
timeFrame: 1 day
measure: Miyake Executive Attention task-Inhibition
timeFrame: 1 day
measure: Working Memory Capacity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Lehigh University
name: Nancy Carlisle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arita JT, Carlisle NB, Woodman GF. Templates for rejection: configuring attention to ignore task-irrelevant features. J Exp Psychol Hum Percept Perform. 2012 Jun;38(3):580-4. doi: 10.1037/a0027885. Epub 2012 Apr 2.
citation: Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD. The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cogn Psychol. 2000 Aug;41(1):49-100. doi: 10.1006/cogp.1999.0734.
Clinical trial NCT05976074: A Study of Wearable Device in Essential Tremor Patients
Official title: A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Quantify Tolerance to Deep Brain Stimulation in Essential Tremor Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Essential Tremor
Keywords: Deep Brain Stimulation Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 50
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: The purpose of this research is to observe the daily loss of benefit from DBS therapy by performing a standardized set of tasks throughout the day while wearing an Apple Watch to collect movement and other physiological data.


Eligibility criteria: Inclusion Criteria:

* Patients with well-classified essential tremor, who are already receiving regular DBS therapy at Mayo Clinic for their movement disorder.
* Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
* Patient agrees to perform daily tasks in BrainRISE app and consents to the study collecting video and audio recordings during those tasks.
* Proficient in the use of a smart phone.

Exclusion Criteria:

* Cognitive or psychiatric condition rendering a patient unable to cooperate with data collection, or to manage and recharge smart watch and tablet computer devices.
* Presence of open or healing wounds near monitoring sites (infection risk).
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Primary outcomes:
measure: Acquire high-quality physiological signal characteristics from movement disorder patients.
timeFrame: 12 Months
measure: Acquire high-quality physiological tremor signals from movement disorder patients.
timeFrame: 12 Months
Secondary outcomes:
measure: Subject feedback
timeFrame: 12 Months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bryan Klassen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00465374: A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Respiratory Distress Syndrome, Adult
Keywords: ARDS
Pressure/time curve
Stress Index
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2007-04-25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of hyperinflation. Functional analysis of pressure-time curve (Stress Index=SI) has been shown to identify this condition in experimental settings. We tested the hypothesis that the SI is an accurate predictor of mechanical stress due to overdistention in ARDS patients.

Detailed description: The study presents two parts : a preliminary validation study and a clinical study.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of ARDS based on American-European Consensus Conference criteria

Exclusion Criteria:

* \>3 days since ARDS criteria were met and mechanical ventilation was started
* History of ventricular fibrillation or tachyarrhythmia, unstable angina or myocardial infarction within preceding month
* Pre-existing chronic obstructive pulmonary disease
* Major chest wall abnormalities
* Chest tube with persistent air leak
* Abdominal distension
* Body mass index \>30
* Pregnancy
* Known intracranial abnormality
* Enrollment in another interventional study

Primary outcomes:
measure: reduction of pulmonary inflammatory mediators
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin, Department of Anesthesia and Intensive Care Medicine
Study officials:
affiliation: University of Turin, Italy
name: V. M. Ranieri, MD
role: STUDY_DIRECTOR
affiliation: University of Turin, Italy
name: P. Terragni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranieri VM, Zhang H, Mascia L, Aubin M, Lin CY, Mullen JB, Grasso S, Binnie M, Volgyesi GA, Eng P, Slutsky AS. Pressure-time curve predicts minimally injurious ventilatory strategy in an isolated rat lung model. Anesthesiology. 2000 Nov;93(5):1320-8. doi: 10.1097/00000542-200011000-00027.
citation: Grasso S, Terragni P, Mascia L, Fanelli V, Quintel M, Herrmann P, Hedenstierna G, Slutsky AS, Ranieri VM. Airway pressure-time curve profile (stress index) detects tidal recruitment/hyperinflation in experimental acute lung injury. Crit Care Med. 2004 Apr;32(4):1018-27. doi: 10.1097/01.ccm.0000120059.94009.ad.
Clinical trial NCT04778774: Compare the Quadriceps Function of Adductor Canal Block Versus Femoral Nerve Block With Electromyography Following Total Knee Arthroplasty
Official title: Compare the Quadriceps Function of Adductor Canal Block Versus Femoral Nerve Block With Electromyography Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quadriceps Function Monitored With Electromyography
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adductor canal block and femoral nerve block are the most commonly used nerve blocks for pain control after total knee arthroplasty. The block area for adductor canal is a sensory branch near the knee area, which can potentially reduce the effect of motor blockage of quadriceps muscle. We try to proof adductor canal block can reduce the pain level after surgery effectively and preserve the muscle power of quadriceps muscle. Therefore, the rehabilitation course can be reduced and further lowering the risks of falling and complications.


Eligibility criteria: Inclusion Criteria:

* Age at least 50 years old, not exceed 100 years old
* Diagnosed Primary Knee Osteoarthritis
* Accepted Total Knee Arthroplasty

Exclusion Criteria:

* Diagnosed Osteonecrosis
* Diagnosed inflammatory Arthritis、Rheumatoid Arthritis
* Accepted Revision Total Knee Arthroplasty
* Quadriceps muscle rupture, suture or repair history
* Neurological or orthopedic disorders that could affect quadriceps muscle power
* Allergy to amide anesthetics
* Patients who cannot obey or follow directions

Primary outcomes:
measure: Quadriceps muscle Electromyography voltage level change before and after nerve block
timeFrame: compare difference of Quadriceps muscle Electromyography voltage level 12 weeks after surgery,data were measured post operation day 1, day 2, day 5, 2 weeks, 6 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Ta-Tung Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Hsuan-Ti Huang, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01552174: Management of Eyelid Disorders by Ophthalmologists in Usual Medical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palpebral Pathologies
Ocular Surface Disease
Meibomian Gland Dysfunction
Keywords: MGD
ocular surface pathologies
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
Collaborators: name: Iris Pharma
name: Axial Biotech, Inc
First posted: 2012-03-13
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be eligible for inclusion if all these criteria are respected:

* Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation
* Patients informed of the objectives of the survey and agreeing to participate.
* Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.

Brief summary: The purpose of this study is to determine the incidence and characteristics of eyelid inflammatory disorders during general ophthalmological consultations and to demonstrate association between palpebral pathologies and ocular surface pathologies.


Eligibility criteria: Inclusion Criteria:

* Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation
* Patients informed of the objectives of the survey and agreeing to participate.
* Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.

Primary outcomes:
measure: Incidence of eyelid disorders in general ophthalmological practice
timeFrame: Day 1
Secondary outcomes:
measure: Association between palpebral pathologies and ocular surface pathologies
timeFrame: Day 1
measure: Impact of eyelid disorder on patient's daily life
timeFrame: Day 1
measure: Current recommended strategy to treat eyelids disorders
timeFrame: Day 1
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Consultation office
city: Madrid
country: Spain
facility: USIO Departamento de Oftalmologia Hospital Clínico San Carlos
Study officials:
affiliation: USIO, Departamento de Oftalmología, Hospital Clínico San Carlos, 28040 Madrid, Spain
name: José Manuel Benitez del Castillo, Professor
role: PRINCIPAL_INVESTIGATOR
References: