louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03714269: Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy
Official title: Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: children
medial gastrocnemius muscle
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. This study assess efficacy of an acute high intensity and long-time stretching session of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Single stretching session is characterized by high intensity and long time (5 minutes).


Eligibility criteria: Inclusion Criteria:

* Children with cerebral palsy of the spastic type
* Children with a maximum dorsal ankle flexion amplitude limitation of less than 10°.

Exclusion Criteria:

* Children who have undergone surgery on the lower limbs.
* Children with a botulinum toxin injection and/or a series of elongation casts for less than three months.
* Children with ongoing analgesic treatment

Primary outcomes:
measure: slope of the torque curve force-ankle joint angle in the joint area -25° plantar flexion/maximum dorsal flexion
timeFrame: baseline
Secondary outcomes:
measure: Maximum dorsal flexion angle of ankle, knee in maximum extension position
timeFrame: at 5 minutes
measure: slope of the force-displacement torque curve myotendinous junction of the Sural Triceps in the articular sector -25° plantar flexion/maximum dorsal flexion
timeFrame: at 5 minutes
measure: lengths of the musculotendinous unit of the Triceps Sural muscle, the muscular body of the gastrocnemius muscle and the Achilles tendon in cm measured at rest, knee in maximum extension position, ankle angle in neutral plantar/dorsal flexion position.
timeFrame: at 5 minutes
measure: visual analogue scale of discomfort
timeFrame: at 5 minutes
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: Vincent GAUTHERON
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boulard C, Gautheron V, Lapole T. Acute passive stretching has no effect on gastrocnemius medialis stiffness in children with unilateral cerebral palsy. Eur J Appl Physiol. 2023 Mar;123(3):467-477. doi: 10.1007/s00421-022-05046-7. Epub 2022 Nov 1.
Clinical trial NCT03506269: Perception and Knowledge About Menopause Among Pakistani Woman
Official title: Perception and Knowledge About Menopause Among Pakistani Woman
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Lead sponsor: OBS Pakistan
Sponsor class: INDUSTRY
First posted: 2018-04-24
Enrollment: 910
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females aged 35 to 55 were enrolled after taking their oral informed consent. The survey for was conducted in various location and clinics all over Pakistan. 1200 numbers of questionnaires were distributed of which 910 numbers responded from 1st January 2018 to 28th February 2018. Those who agreed to be part of study where ask a self-structured questionnaire related to awareness and symptoms of menopause.

Brief summary: This study is conducted to find out perception and knowledge about Menopause among Pakistani Woman.

Detailed description: The survey for was conducted in various location and clinics all over Pakistan. 1200 numbers of questionnaires were distributed of which 910 numbers responded from 1st January 2018 to 28th February 2018. Those who agreed to be part of study where ask a self-structured questionnaire related to awareness and symptoms of menopause. Data was analyzed using SPSS Version 23.0. Frequencies were calculated for categorical data.

Eligibility criteria: Inclusion Criteria:

* Female aged 35 to 55
* Oral Informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: To Find Perception and Knowledge of Menopause in Pakistani Woman
timeFrame: 0-28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Faizan Shaukat
state: Sindh
Study officials:
References:
Clinical trial NCT05469269: Cleveland African American Prostate Cancer Project
Official title: Cleveland African American Prostate Cancer Project: Equivalence of Passive Navigation, Active Navigation, and Community-based Screening for Completion of Prostate Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 800
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this research is to test intervention strategies that encourage and support Black or African American men who are 40 and older to complete prostate cancer screening, and specifically to complete a prostate-specific antigen (PSA) test.

Detailed description: This intervention is designed to evaluate the effectiveness of three different approaches to increasing PSA screening in African American men, starting at age 40. The approaches are 1) education and passive navigation, 2) education and active navigation, and 3) education and active navigation with community based outreach. Completion of a PSA blood test is the primary outcome of this study, which will be evaluated four months following the recruitment phase at each shop. At the 4 month follow-up, participants will be asked about PSA completion; participants who completed PSA screening will be asked to provide outcomes from their PSA screening (ie. PSA results and provider recommended next steps), as well as their feelings regarding their screening experience, trust in the screening process, and knowledge about prostate cancer.

Eligibility criteria: Inclusion Criteria:

* ≥40 years old
* Self-identify as Black or African American
* Have a prostate gland (includes biological males, transwomen)
* PSA-naïve or has not received a PSA test in the past 12 months
* Has not had a previous prostate cancer diagnosis
* English speaking
* Ability to consent to study

Exclusion Criteria:

* Individuals who have had a prostatectomy

Primary outcomes:
measure: PSA Screening Test
timeFrame: At 4 months
Secondary outcomes:
measure: PSA Screening Test
timeFrame: At 14 months
measure: Primary Care Physician Visit
timeFrame: At 4 months
measure: Primary Care Physician Visit
timeFrame: At 14 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Barbershops Local to Cleveland
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Erika Trapl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00737269: A Complicated Skin and Soft-tissue Infection Patient Registry
Official title: A Prospective, Multi-center, Observational Registry Involving Patients Hospitalized With Complicated Skin and Soft Tissue Infections (cSSTI) for IV Antibiotic Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcal Skin Infections
Diabetic Foot Infections
Surgical Wound Infection
Abscess
Cellulitis
Keywords: Complicated Skin and Soft-Tissue Infection
Skin Infection
Skin Infection Registry
cSSTI Registry
Lead sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 1081
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complicated skin and soft tissue infections (specifically, diabetic foot infections, surgical site infections, deep soft tissue abscess, cellulitis)

Brief summary: The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic therapy.

Detailed description: A prospective, multi-center, observational study involving 1200 patients hospitalized for the treatment of cSSTIs. The study will be conducted at approximately 50 hospitals in the US. Patients who consent to participate in the registry will be enrolled in the registry within 24 hours of initial IV antibiotic therapy for treatment of one or more cSSTI types. Sites will treat patients according to their usual clinical practice. The objective of this registry is to characterize cSSTIs with respect to patient characteristics and describe patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of complicated skin and soft-tissue infection
* Patients who require IV antibiotic therapy as a primary treatment regimen
* Patients who are deemed to be cognitive and able to provide written informed consent and follow-up information.

Exclusion Criteria:

* Patients with a diagnosis at the index infection site of necrotizing soft tissue infection, burn, gangrene, decubitus ulcer, animal or human bites, known or suspected osteomyelitis, or mediastinitis
* Patients for whom amputation or a complete resection of the infection site is a planned component of treatment
* Patients who are pregnant
* Patients simultaneously participating in any interventional clinical trial
* Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements
* Patients who are employees of the investigator or study hospital

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC
name: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT05482269: Adverse Outcome of Acute Pulmonary Embolism by Artificial Intelligence System Based on CT Pulmonary Angiography
Official title: Prediction of Adverse Outcome of Acute Pulmonary Embolism by Artificial Intelligence System Based on CT Pulmonary Angiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism and Thrombosis
Deterioration, Clinical
Artificial Intelligence
Keywords: Pulmonary Embolism and Thrombosis
Deterioration, Clinical
Artificial Intelligence
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 2000
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: Chinese

Brief summary: The investigators aim to build a predictive tool for Adverse Outcome of Acute Pulmonary Embolism by Artificial Intelligence System Based on CT Pulmonary Angiography.

Detailed description: This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital. The investigators aim to build a predictive tool for Adverse Outcome of Acute Pulmonary Embolism by Artificial Intelligence System Based on CT Pulmonary Angiography.

Eligible patients were randomized in some ratio into derivation and validation cohorts. The derivation cohort was used to develop and evaluate a multivariable logistic regression model for predicting the outcomes of interest. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.

Eligibility criteria: Inclusion Criteria:

* age of ≥ 18 years and a pulmonary embolism diagnosis based on CT pulmonary angiography

Exclusion Criteria:

* pregnancy
* reception of reperfusion treatment before admission
* missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 2 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: DONG JIA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02164669: Exploration of Neuroimaging and Biochemical Prognostic Indicators for POCD
Official title: Exploration of Neuroimaging and Biochemical Prognostic Indicators for Post-operative Cognitive Dysfunction After Coronary Artery Bypass Graft
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Cognitive Impairment
Keywords: Inflammation
Coronary artery bypass graft
Magnetic Resonance Imaging
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will selective undergo Coronary Artery Bypass Grafting (CABG) surgery. Health adult

Brief summary: Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and biochemical indicators will be used to explore the underlying mechanisms and represent a promising precursory target for diagnosis and treatment of POCD.

Detailed description: Postoperative cognitive dysfunction (POCD) is one of the most common complications in patients undergoing cardiac surgery. POCD will not only increase the incidence of complications and mortality, but also influence the quality of life after discharging from the hospital. Many factors are associated with POCD, such as neuroinflammation, age, anesthetics, surgery stress response and genetic factors. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI, which could monitor the peripheral neuron spontaneous activity according to the ratio of oxyhemoglobin and deaeration hemoglobin in blood, will be used to investigate whether POCD is induced by the variance in neurons metabolism and spontaneous activity in brain regions. Meanwhile, biochemical indicators will be detected to explore the prompting indicators of POCD. The present study is aimed to represent a promising precursory target for diagnosis and treatment of POCD, and provide novel evidence and insights on the brain changes induced by POCD.

Eligibility criteria: Inclusion Criteria:

* Aged 18-80 years old
* Underwent selective CABG surgery

Exclusion Criteria:

* History of central nervous system or psychiatric disorders
* History of taking sedative, antidepressants, or alcoholism
* MMSE score less than 23
* Visual or auditory disorders
* Educated less than 7 years
* Claustrophobia
* Can not be supine
* Can not tolerate iodinated contrast agents

Primary outcomes:
measure: The brain structure changes
timeFrame: 7 days postoperatively
Secondary outcomes:
measure: Mini-Mental State Examination
timeFrame: preoperative and 7 days, 3 months and 1 years postoperative
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijign Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Qiang Wang, MD, PhD
role: STUDY_DIRECTOR
affiliation: Xijing Hospital
name: Zijun Gao, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00990769: The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children
Official title: The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Agitation
Keywords: Emergence delirium
Bispectral Index
Depth of anesthesia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. The study will randomize 40 children undergoing ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.


Eligibility criteria: Inclusion Criteria:

* Children age 2 - 8 (inclusive) undergoing ophthalmologic surgery
* American Society of Anesthesiology (ASA) physical status 1 or 2

Exclusion Criteria:

* Surgery precluding placement of BIS monitor
* Non-English speaking, until additional language consent forms are approved
* Previous history of severe emergence agitation

Primary outcomes:
measure: Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)
timeFrame: Within 30 minutes of arrival in recovery room
Secondary outcomes:
measure: Time to Emergence From Anesthesia
timeFrame: After the completion of surgery
measure: Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)
timeFrame: Within 30 minutes of arrival in recovery room
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center - Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Heather J Frederick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03610269: Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
Official title: Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Subject has given written informed consent to participate in the study

Exclusion Criteria:

* (\*) Pregnant or positive human chorionic gonadotropin (hCG) test
* (\*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis
* (\*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
* (\*) Subjects who are currently taking anticoagulant medication
* (\*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic
* (\*) Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.
* (\*) Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
* (\*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.
* (\*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw
* Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff

Note: (\*) May be self-reported by subject

Primary outcomes:
measure: Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation
timeFrame: Up to 2 hours per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Lomita
country: United States
facility: Torrance Clinical Research
state: California
Study officials:
References:
Clinical trial NCT00219869: Galantamine in the Treatment of Post-Traumatic Headache
Official title: Galantamine in the Preventive Treatment of Chronic Post-Traumatic Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-Traumatic Headache
Head Trauma,Closed
Retention Disorders,Cognitive
Keywords: Post
Traumatic
Headache
Cognitive
Lead sponsor: Rapoport, Alan, M.D.
Sponsor class: INDIV
Collaborators: name: Ortho-McNeil Neurologics, Inc.
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Most patients with CPTH present with additional major cognitive, behavioral and somatic problems. Most drugs used currently have a negative influence on cognition. Therefore, treatment strategies addressing both the headache and cognitive disturbances in patients with CPTH are necessary. (CPTH; Chronic Post Traumatic Headache).

Detailed description: Headache is the most common symptom after a closed head injury, persisting for more then 2 months in 60% of the patients. CPTH is an important cause of consultations in neurology offices and headache clinics, posing a severe burden and affecting the quality of life of sufferers.

Eligibility criteria: Inclusion Criteria:

Age range 18-75 CPTH according to ICHD-2 Fertile woman using adequate birth control Willing and able to give informed consent Willing and able to complete the entire course of the study to comply with study instructions Stable does of preventive medication

-

Exclusion Criteria:

Subject is pregnant or lactating Significant medical or psychiatric disease Previous failure to 4 or more adequate trials of preventive medication Patient on non-stable dose of medication used to prevent CPTH

-

Primary outcomes:
measure: Primary Headache Efficacy Measure; number of pain free days after 3 months
Secondary outcomes:
measure: Consumption of rescue medication
measure: Number of days with moderate or severe headache after 3 months.
Other outcomes:
Locations:
city: Stamford
country: United States
facility: The New England Center for Headache
state: Connecticut
Study officials:
affiliation: The New England Center for Headache
name: Alan Rapoport, MD
role: PRINCIPAL_INVESTIGATOR
References: