louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02453152: Respiratory Muscle Function in Untreated X-Linked Myotubular Myopathy (XLMTM)
Official title: Respiratory Muscle Function in Untreated X-Linked Myotubular Myopathy (XLMTM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: X-linked Myotubular Myopathy
Keywords: myotubular myopathy
respiratory muscles
natural history
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Audentes Therapeutics
First posted: 2015-05-25
Enrollment: 28
Sex: MALE
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males with geneticially confirmed XLMTM

Brief summary: This study is a longitudinal study evaluating the severity and progression of respiratory muscle function in patients with X-Linked Myotubular Myopathy (XLMTM) aged 0-14.

Detailed description: Subjects aged 0-7 will be evaluated every six months for a total of three evaluations (Baseline, Six-Month Visit, Twelve-Month Visit). Subjects aged 8-14 will be evaluated every twelve months for a total of two evaluations (Baseline, Twelve-Month Visit). Evaluations include medical history, physical exam, respiratory muscle tests, a qualitative interview related to the child's function and use of respiratory aids, and quality of life assessments.

Eligibility criteria: Inclusion Criteria:

* Patients who have centronuclear myopathy resulting from an MTM1 genetic mutation.
* Patients who are between 0 and 14 years of age.

Exclusion Criteria:

* Patients without a confirmed genetic mutation.
* Patients unable to travel to the site for the study.
* Patients participating in an interventional treatment study for XLMTM at the time of enrollment.
* Patients who are unable to complete study procedures.
* Patients who have a condition that, in the opinion of the investigator, would make participation in this study unsafe.

Primary outcomes:
measure: Change in baseline visit off-ventilator tolerance at 6 month visit and 12 month visit.
timeFrame: Change in baseline visit, at 6 month visit and 12 month visit
Secondary outcomes:
measure: Change in baseline visit maximal respiratory pressures at 6 month visit, and 12 month visit.
timeFrame: Change in baseline visit, at 6 month visit and 12 month visit
measure: Change in baseline peak cough flow at 6 month visit and 12 month visit.
timeFrame: Change in baseline visit, at 6 month visit and 12 month visit
measure: Change in baseline tidal breathing at 6 month visit and 12 month visit.
timeFrame: Change in baseline visit, at 6 month visit and 12 month visit
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Barbara K Smith, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357052: The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Official title: The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NAFLD
Urinary Lithiasis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 subjects suffering from NAFLD histologically ascertained by routine liver biopsy performed at the P.O. liver surgeries Columbus relating to the Gastroenterology Area Units.

Brief summary: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation.


Eligibility criteria: Inclusion Criteria:

* subject \>= 18 years old
* able to sign the ICF
* Liver biopsy with report compatible with NAFLD

Exclusion Criteria:

* alchol use \> 20g/die
* other causes of liver disease
* active neoplasm

Primary outcomes:
measure: the analysis of the correlation between the degree of severity of NAFLD And urinary lithogenic profilecharacterized by reduced urinary magnesium and altered urinary ammonium excretion.
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico A.Gemelli IRCCS
Study officials:
References:
Clinical trial NCT04053452: Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome
Official title: Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Guillain-Barre Syndrome
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: GBS-CIDP foundation
First posted: 2019-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if peripheral nerve ultrasound can be used as a supplemental tool to diagnose Guillain-Barre syndrome (GBS) in the acute setting and aid in prognostication.


Eligibility criteria: Inclusion Criteria:

* For GBS group: Inpatients with acute, progressive weakness and no alternative diagnosis, with onset less than 30 days prior to examination.
* For control group: Hospitalized patients on the inpatient neurology service who are being treated for non-peripheral nerve disorders (e.g. epilepsy, multiple sclerosis, or stroke).
* For all subjects: 18+ years of age

Exclusion Criteria:

- Patients with any history of multifocal motor neuropathy (MMN), prior Guillain-Barre syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), or hereditary neuropathy (e.g. Charcot-Marie-Tooth)

Primary outcomes:
measure: Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls
timeFrame: Day 0 and approximately 7 days after admission
measure: Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
timeFrame: Day 0 and approximately 7 days after admission
measure: Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
timeFrame: Day 0 and approximately 7 days after admission
Secondary outcomes:
measure: Length of Hospital Stay in Days
timeFrame: Up to approximately 20 days
measure: Ambulatory Status on Discharge
timeFrame: At discharge, up to approximately 20 days
measure: Respiratory Dysfunction, as Measured by Number of Days Intubated
timeFrame: During admission, up to approximately 20 days
measure: Strength, as Measured by Hand Dynamometer
timeFrame: Day 0, Day 7
measure: Strength, as Measured by Medical Research Council (MRC)
timeFrame: Day 0, Day 7
measure: Number of Participants With Autonomic Dysfunction
timeFrame: During hospitalization, up to approximately 20 days
measure: Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score
timeFrame: Day 0, Day 7, Discharge (up to approximately 20 days), Day 90, Day 180
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Lisa Hobson-Webb, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02919852: Laparoscopic Retrovesical Colpopectinopexia
Official title: Laparoscopic Retrovesical Colpopectinopexia in Treatment Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Orel Regional Hospital, Russia
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify whether a new operative technic would be acceptable in female with pelvic organ prolapse.

Detailed description: A new operative technic use to treat pelvic organ prolapse in women. Investigators plan to evaluate the results of procedure in the field of recurrence rate, effectiveness, mortality,morbidity and learning curves.

Eligibility criteria: Inclusion Criteria:

* all female with cystocele 1-2-3 grade? hysterocele 1-2 (POP-Q)

Exclusion Criteria:

* rectocele more then 1 grade (POP-Q) hysterocele more then 2

Primary outcomes:
measure: POP-Q assessment
timeFrame: first post operation day
Secondary outcomes:
measure: POP-Q assessment
timeFrame: 6 month after operation
measure: POP-Q assessment
timeFrame: 1 year after operation
Other outcomes:
Locations:
city: Kiev
country: Ukraine
facility: LISOD
Study officials:
References:
Clinical trial NCT04394052: Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II
Official title: Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II: Texture Analysis and Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Soft Tissue Neoplasm
Bone Neoplasm
Keywords: MRI
CT
Texture analysis
Ultra-high resolution
Tumors
Musculoskeletal
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Lorraine Cancer Institute - ICL
name: Emille Gallé Surgical Center - CCEG
name: Diagnostic and Interventional Adaptative Imaging Laboratory - IADI
First posted: 2020-05-19
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with soft-tissue and bone tumors evaluated with MR and ultra-high resolution CT.

Brief summary: This study aims at evaluating the value of various artificial intelligence based techniques to improve the characterization and image post-processing for patients with musculoskeletal tumors.

Detailed description: Comparison of values relating to the texture parameters of tumors evaluated by MRI and ultra-high resolution CT between benign and malignant lesions using histological analysis as the standard of reference.

Comparison of the diagnostic performance of texture parameters derived from different MRI sequences and ultra-high resolution CT for musculoskeletal tumor characterization.

Evaluate the impact of ultra-high resolution with respect to standard resolution on CT images Comparison of the diagnostic performance of the texture parameters for the tumor on the diagnostic performance of texture analysis derived parameters for the characterization of musculoskeletal tumors.

Evaluate the effectiveness and accuracy of automatic artificial intelligence (AI) based tumor segmentation tools.

Evaluate the use of trabecular analysis on ultra-high resolution CT images for the evaluation of tumor-bone interfaces.

Eligibility criteria: Inclusion Criteria:

* Patients suspected to have a bone or soft-tissue tumor referred for imaging for initial tumors characterization and staging.

Exclusion Criteria:

* Pregnancy
* Breast feeding patients
* Renal insufficiency
* Contra indications to MRI or CT
* Prior surgery or treatment to the evaluated lesion.

Primary outcomes:
measure: Lesion benignancy or malignancy
timeFrame: Performed up to 6 months after CT and Magnetic Resonance (MR) imaging
Secondary outcomes:
measure: Sarcoma FNCLCC (fédération Nationale des Centres de Lutte Contre le Cancer) grade
timeFrame: Performed up to 1 year after CT and MR imaging
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU-Nancy
state: Lorraine
Study officials:
References:
Clinical trial NCT00179452: Yoga for Patients With Epilepsy
Official title: Is Yoga Safe for Patients With Epilepsy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: epilepsy, yoga
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To establish the safety and feasibility of having patients with epilepsy perform yoga.

Detailed description: Subjects will keep logs of seizure frequency prior to, during, and following training in a yoga regimen. Instruction in the yoga regimen will occur at BIDMC, and home practice following classroom instruction will occur as part of the study. Side effects, changes in seizure frequency, and quality of life assessments will be performed.

Eligibility criteria: Inclusion Criteria:

1. Must be able to give full informed consent.
2. Must have one or more of the following seizure types: simple partial, complex partial, or secondarily generalized.
3. Age 18-64.
4. Must have 4-20 during the baseline phase.
5. Must have medical clearance from their primary care giver sufficient to allow for participation in yoga exercises.
6. Must be stable enough to allow for all anticonvulsant levels to remain constant for the duration of the study.

Exclusion Criteria:

1. Having primary generalized epilepsy or atonic seizures.
2. Having a history of status epilepticus in the past two years.
3. Any medical problem that would preclude participation in a yoga class.
4. Nonepileptic or psychogenic seizures.
5. Pregnancy.

Primary outcomes:
measure: Improvement in quality of life assessments.
timeFrame: 3 months
measure: Improvement in mood.
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in seizure control.
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Kaarkuzhali Krishanmurthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05391152: Comparison Between Robotic-arm Assisted Total Knee Replacement and Traditional Total Knee Replacement
Official title: Comparison Between Robotic-Arm Assisted Modified Kinematic Alignment Total Knee Replacement And Traditional Manual Alignment Total Knee Replacement：A Prospective Multicenter, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: robotic-arm assisted
total knee replacement
kinematic alignment
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, prospective, and case-control study. Five joint centers and 100 participants will be included. The study group used robotic-assisted modified kinematic alignment total knee replacement, and the control study used traditional alignment manual total knee replacement. The knee society score (KSS), Hip-knee-ankle(HKA) angle, mechanical lateral distal femoral angle(mLDFA), mechanical medial proximal tibial angle(mMPTA), sagittal femoral component angle(SFCA), range of motion(ROM), WOMAC score, SF-36, Visual Analogue Scale(VAS score), surgical time, blood loss, and complications are evaluated and compared.


Eligibility criteria: Inclusion Criteria:

* age between 18 years and 85 years
* primary total knee replacement

Exclusion Criteria:

* obvious bone defect
* infection
* BMI\>\>35kg/m2
* severe osteoporosis
* mental disease

Primary outcomes:
measure: KSS score
timeFrame: 3 months
Secondary outcomes:
measure: HKA angle
timeFrame: 3 months
measure: mLDFA
timeFrame: 3 months
measure: mMPTA
timeFrame: 3 months
measure: SFCA
timeFrame: 3 months
measure: knee ROM
timeFrame: 3 months
measure: blood loss
timeFrame: intraoperative
measure: surgical duration
timeFrame: intraoperative
measure: complication
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04379752: Cold Plasma to Treat Hair Loss
Official title: Using Indirect Cold Atmospheric Pressure Plasma (Plasma Activate Liquid) for the Treatment of Hair Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: The Skin Center Dermatology Group
Sponsor class: INDUSTRY
First posted: 2020-05-07
Enrollment: 14
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: Self applied cold plasma activated medium used for androgenetic alopecia


Eligibility criteria: Inclusion Criteria:

* diagnosis of mild-to moderate androgenetic alopecia
* ability of applying treatment regularly
* ability to keep in-person follow-up appointments

Exclusion Criteria:

* any inflammatory scalp condition
* starting or discontinuing any hair loss treatments within 6 months of start date
* allergy to any components of the carrier solution

Primary outcomes:
measure: Presence of detectable hair growth
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Adverse effects related to the treatment
timeFrame: throughout study completeion, 6 months
Other outcomes:
Locations:
city: New City
country: United States
facility: The Skin Center Dermatology Group
state: New York
Study officials:
References:
citation: Khan A, Malik S, Walia J, Fridman G, Fridman A, Friedman PC. Tolerability of Six Months Indirect Cold (Physical) Plasma Treatment of the Scalp for Hair Loss. J Drugs Dermatol. 2020 Dec 1;19(12):1177-1180. doi: 10.36849/JDD.2020.5186.
Clinical trial NCT03754452: Evaluation of the Sarcopenia in Hepatobiliary Surgery
Official title: Evaluation of the Prevalence, the Diagnosis Tests, and the Associated Morbimortality of Sarcopenia in Hepatobiliary Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sarcopenia
Hepatobiliary Disease
Postoperative Complications
Surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-11-27
Enrollment: 45
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: - all patients who should have a hepatobiliary surgery for malignant and benign tumor in the universitary hospital center of Angers

Brief summary: The sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength or performance). Some studies showed that the sarcopenia increase the postoperative complications and the overall survival in abdominal surgery. But the sarcopenia is not evaluated in the Hepatobiliary surgery. This prospective, monconcentrique study aim to evaluate the prevalence of sarcopenia, and its associated morbimortality in hepatobiliary surgery for malignant or benign tumors.


Eligibility criteria: Inclusion Criteria:

* hepatobiliary surgery
* scheduled surgery
* oral consent

Exclusion Criteria:

* pregnancy
* patient under low protection
* emergency surgery
* hepatic encephalopathy stage II, III and IV

Primary outcomes:
measure: the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking
timeFrame: 1 month
measure: the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking
timeFrame: 1 month
Secondary outcomes:
measure: comparison between the impedancemetry and the abdominopevis CT for the diagnosis of sarcopenia
timeFrame: 3 months
measure: comparison of the postoperatives complications using the clavien dindo classsification between the patient with sarcopenia and the patient without sarcopenia.
timeFrame: 4 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: Julien BARBIEUX, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04472052: Frequency of Perforated Appendicitis in Times of COVID-19
Official title: Incidence of Perforated Appendicitis in Times of Corona Crisis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perforated Appendicitis
Covid19
Keywords: acute appendicitis, COVID-19
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 143
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with acute appendicitis

Brief summary: Appendicitis is one of the most common clinical conditions in general surgery. The diagnosis is usually made from clinical examination, imaging (sonography or CT) and laboratory parameters. The laparoscopic appendectomy without drainage has established as the gold standard. Patients usually leave the hospital two days after surgery.

In times of corona crisis, patients are unsure to visit the hospital because of fear of infection with SARS-CoV-2. A higher incidence of perforated appendicitis could be an indicator for fear-related delay of going to the hospital.

Methods: Investigators performed a retrospective analysis on the incidence of perforated appendicitis in a 10-week interval (mid-March to end of May) of the years 2018, 2019 and 2020 to evaluate possible changes in times of corona crisis. Intraoperative findings, procedures, complications and the length of hospital stay were considered.

Detailed description: The local ethics committee of the University Hospital of Tübingen, Germany, approved this study (AZ: 324/2020BO2). All patients treated for acute appendicitis in a ten week period from 16th of March to 31th of May in 2018, 2019 and 2020 were considered for the study. Investigators analysed the frequency of perforated appendicitis in the periods indicated. Informed consent was obtained from all individual participants. Patient's records as well as database were analyzed for therapy specific items.

Definition Perforation: Perforated appendicitis was defined as described perforation in the surgical or pathological results.

Delay between onset of symptoms and first presentation at the hospital: Patient's records were proved for self-declaration about the start of symptoms

Eligibility criteria: Inclusion Criteria:

* patients with acute appendicitis older than 16 years
* appendectomy in time frame 16th of march to 30th of May in the Years 2018, 2019 and 2020

Exclusion Criteria:

* patients with acute appendicitis younger than 16 years
* appendectomy not in the named time frames

Primary outcomes:
measure: rate of perforated appendicitis
timeFrame: 10 weeks from 16th of March to 31th of May
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital of Tuebingen
Study officials:
References: