louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05705674: The Natural History Study of Patients With Sanfilippo Disease(s) (MPS3)
Official title: The Natural History Study of Patients With Sanfilippo Disease(s) (MPS3)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sanfilippo Syndrome
MPS3
Lead sponsor: Lysosomal and Rare Disorders Research and Treatment Center, Inc.
Sponsor class: OTHER
Collaborators: name: Team Sanfilippo
First posted: 2023-01-31
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with MPS3 who meet the criteria above can be enrolled.

Brief summary: The natural history study of patients with Sanfilippo disease(s) (MPS3)

Detailed description: This is a natural history study of patients with Sanfilippo Disease (MPS3). Patients will be followed over the course of 6 months in which they have blood and urine collected, hearing assessment, complete questionnaires and are evaluated by the Principal Investigator.

Eligibility criteria: Inclusion Criteria:

1. IRB - approved informed consent/assent signed by subject and/or parent(s) or legal guardian(s).
2. Genetically confirmed diagnosis of MPS III disease Genomic DNA analysis demonstrating a homozygous or compound heterozygous pathogenic variants in SGSH (type A), NAGLU (type B), HGSNAT (type C), or N- acetylglucosamine-6-sulfatase GNS (type D).
3. Male or female; five years of age and older
4. Negative urine pregnancy test at screening for female subjects with child-bearing potential

Exclusion Criteria:

1. Unwilling or unable to follow protocol requirements as per principal investigator
2. Any serious or chronic medical illness, including significant cardiac or severe debilitating pulmonary disease as determined by the investigator.
3. Any medical condition that, in the opinion of the PI, would place a subject at undue risk
4. Inability to cooperate for clinical and safety data collection
5. Use of genistein or Miglustat within one week of the study
6. Evidence of hepatitis B or hepatitis C infection upon serological testing at screening
7. Currently participating in another interventional drug trial or has completed an interventional trial less than one month prior to the screening visit

Primary outcomes:
measure: To characterize the disease natural history in patients with MPS3.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: LDRTC
state: Virginia
Study officials:
References:
Clinical trial NCT03981874: Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children
Official title: Comparative Study of Peripheral Facial Paralysis Sequelae Based on the Initial Medical Care of Lyme Disease Among Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lyme Disease
Keywords: neuroborreliosis
facial palsy
children
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Neuroborreliosis (NB) is the second most frequent manifestation of Lyme disease. Painful meningoradiculitis is the most common neurologic manifestation in adults while facial nerve palsy (FP) and lymphocytic meningitis is predominant in children. FP is a common reason for pediatric consultation and FP due to Lyme borreliosis (LB) represents about 50% of the child's FP in an endemic area.

The action to be taken is not formally defined for a child consulting for FP in a Lyme disease endemic area.

The new recommendations of the High Authority of Health of June 2018 recommend to carry out a blood serology in first intention, in search of a NB in a child consulting for a peripheral facial paralysis. If this is positive, a lumbar puncture will be performed in search of meningitis. In the case of negative serology, a close clinical surveillance and sometimes serological control is necessary, in order to reassess the diagnosis. In adult recommendations, a lumbar puncture is performed first in any patient consulting for facial paralysis in LB endemic area.

The main objective of this study was to describe the clinical and biological characteristics of pediatric NB with FP. Others objectives were to describe the diagnostic and therapeutic behavior of a child consulting at university hospital for a facial nerve palsy, to compare the initial gravity of facial nerve palsy, the duration of the paralysis and sequels depending on the diagnosis and treatment initiated.


Eligibility criteria: Inclusion Criteria:

* Children consulting for peripheral facial palsy

Exclusion Criteria:

* Children consulting for central facial palsy
* Children with congenital peripheral facial palsy
* Children with surgery and trauma in the area of the facial nerve,
* Children with peripheral facial palsy with previous diagnosis
* Children whose parents refuse the study participation

Primary outcomes:
measure: Assesment of persistent sequelae
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besancon
Study officials:
affiliation: CHU Besançon
name: Raphael Anxionnat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06458374: ATTR Cardiac Amyloidosis in a Selected Population
Official title: Prevalence and Long Tem Follow Up of ATTR Cardiac Amyloidosis in a Selected Population of Patients Operated on Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ATTR Amyloidosis Wild Type
ATTR Gene Mutation
Carpal Tunnel Syndrome
Cardiac Amyloidosis
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
First posted: 2024-06-13
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Maximum 200 patients operated at Ålesund Hospital for CTS

Brief summary: Patients operated for carpal tunnel syndrome (CTS) at Ålesund Hospital (200 patients) will have a biopsy to diagnose ATTR amyloidosis. Patients with positive biopsy will be examined to decide wether they have cardiac amyloidosis. All patients with positive biopsy will be followed closely for 10 years wit echocardiography an clinically.

Detailed description: Biopsy proven ATTR (v/wt) amyloidosis inpatients operated with CTS will undergo standard guidelines recommended examinations as 99mTcDPD SPECT CT, echocardiography, ECG, Holter, genetic testing (v/wt), and lab testing, and CMRI as indicated. Exclusion of light chain disease will be done.

All patients will be followed at least yearly as indicated by guidelines (ESC), and patients with development of cardiac amyloidosis will get standard treatment in accordance with guidelines and as approved by the Norwegian government. All patients will be followed for 10 years.

Eligibility criteria: Inclusion Criteria:

* Male \> 50 years
* Female \> 60 years
* operated CTS at Ålesund Hospital

Exclusion Criteria:

* not consented
* do not speak Norwegian
* secondary cause of CTS as traumatic or rheumatic
* cannot be followed \> 5 years due to other medical conditions
* Cardiac disease at time of operation for CTS

Primary outcomes:
measure: Frequency of ATTR in CTS
timeFrame: 2 years
measure: Cardiac involvement in patients with biopsy proven ATTR
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ålesund
country: Norway
facility: Ålesund Hospital
state: Møre og Romsdal
Study officials:
affiliation: Helse Møre og Romsdal HF and NTNU
name: Torstein Hole, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234674: Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
Official title: Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Lower Limb Lymphedema
Secondary Lower Limb Lymphedema
Keywords: Pulsating suit
lymphedema
leg volume
Lead sponsor: Stendo
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).

This study is a pilot controlled randomized study with two arms.


Eligibility criteria: Inclusion Criteria:

* Patient with a primary or secondary lympedema clinically diagnosed (Stemmer Sign) of one or two legs.
* Patient with a lympedema stage II (persistent) or III according to the classification of the International Society of Lymphoedema (ISL)
* Patient aged 18 or more

Exclusion Criteria:

* Patient with a severe heart, kidney or liver failure,
* Patient with an advanced obstructive arterial disease
* Patient with a recent and progressive deep venous thrombosis

Primary outcomes:
measure: volume of the most affected leg
timeFrame: baseline ; after 5 days intensive CDP
Secondary outcomes:
measure: Quality of Life
timeFrame: baseline ; after 5 days intensive CDP
Other outcomes:
Locations:
city: La FERTE MACE
country: France
facility: CHIC Des Andaines
Study officials:
References:
citation: Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1):26-34.
citation: Mayrovitz HN, Macdonald J, Davey S, Olson K, Washington E. Measurement decisions for clinical assessment of limb volume changes in patients with bilateral and unilateral limb edema. Phys Ther. 2007 Oct;87(10):1362-8. doi: 10.2522/ptj.20060382. Epub 2007 Aug 7.
Clinical trial NCT03613974: Minimum Anaesthesia Concentration of Lidocaine Required for Sciatic Popliteal Block
Official title: Successful Popliteal Block Using Lidocaine; What is the Minimum Effective Anesthesia Concentration (MEAC90)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Orthopedic Procedures
Keywords: foot and ankle
day case surgery
Lead sponsor: Healthpoint Hospital
Sponsor class: OTHER
First posted: 2018-08-03
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: using a biased-coin design up-down sequential method, different concentration of lidocaine will be used for popliteal block After 45 successful block (positive response), the data will be used to calculate the minimum lidocaine concentration that can result in successful popliteal block in 90% of patients

Detailed description: The response of a patient determined the lidocaine concentration given to the next patient (a biased-coin design up-down sequential method). If a patient had a negative response, the lidocaine concentration was increased by 0.1% w/v in the next patient. If a patient had a positive response, the next patient was randomized to receive the same lidocaine concentration (with probability of 0.89), or to receive a concentration 0.1% w/v less (with probability of 0.11).

Eligibility criteria: Inclusion Criteria:

* orthopedic foot or ankle surgery
* day case surgery

Exclusion Criteria: patients

* \<18y,
* ASA class greater \>III,
* obese (BMI \>30),
* patients with low body weight, who required lidocaine dose is of more than 4.5mg.kg-1
* peripheral neuropathy,
* motor weakness,
* infection at the injection site
* any contraindications for medications in the study.

Primary outcomes:
measure: successful popliteal block (positive response)
timeFrame: 30 min to 3 hour after the block
Secondary outcomes:
measure: motor block
timeFrame: 30 min after the block
measure: motor recovery
timeFrame: 3 hours till full recovery
measure: analgesic duration
timeFrame: few hours after block
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02166320: Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.
Official title: The Importance of Stent Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Cancer of Gastro Esophageal Junction
Palliative Treatment
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Blekinge County Council Hospital
name: Danderyd Hospital
First posted: 2014-06-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. The design of SEMS can be of importance since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis has therefore been formulated that a partially covered SEMS is associated with less tendency to dislocate as compared to those SEMS, recently developed, which are covered through their entire length.


Eligibility criteria: Inclusion Criteria:

* Verified Squamous Cell Carcinoma or Adenocarcinoma of esophagus or Gastro Esophageal Junction (GEJ)
* Age above 18 years.
* Dysphagia scoring grade two or worse
* Not amenable for curative treatment
* Informed consent to participate

Exclusion Criteria:

* Concomitant cancer disease
* Inability to comply with study protocol
* Previous stent treatment
* Proximal location of the tumour in the esophagus.
* Need for more than one stent deployment.

Primary outcomes:
measure: SEMS dislocation in cm during first thirty days after stent insertion.
timeFrame: Thirty days from stent deployment.
Secondary outcomes:
measure: Health Related Quality of Life (HRQOL)
timeFrame: Within three months of SEMS deployment.
measure: Need for reintervention
timeFrame: Within three months after SEMS
measure: Grade of dysphagia within three months of SEMS.
timeFrame: Three months after insertion.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Erik Johnsson
Study officials:
affiliation: Sahlgrenska University Hospital, Clinic of Surgery
name: Erik Johnsson, MdPhd
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Magnus Nilsson, ass professor
role: STUDY_CHAIR
References:
Clinical trial NCT05010720: Prevelance of Frailty and Its Associated Factors in Patients With Axial Spondyloarthritis
Official title: Prevelance of Frailty and Its Associated Factors in Patients With Axial Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Axial Spondyloarthritis
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with Axial Spondyloarthritis in a tertiary research and training hospital

Brief summary: Axial Spondyloarthritis is an inflammatory arthritis disease and its main symptoms are chronic pain and stiffness, causing structural damage to the spinal vertebrae. Axial Spondyloarthritis leads to physical disability and a decrease in the level of physical activity.

Frailty is a syndrome characterized by decline in physiological reserve and loss of muscle strength. Frailty can lead to vulnerability of individuals to possible injuries and a decrease in independence, and ultimately an increase in mortality. Although frailty is associated with older adults, it has been reported that it can be detected in patients with cancer, diabetes and rheumatological diseases and it is not related with age. Frailty has been reported to be a reversible and a treatable condition.

The aim of our study was to investigate the prevalence of frailty and the relationship between frailty and disease activity, physical functional level, quality of life and other associated factors in individuals with Axial Spondyloarthritis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Axial Spondyloarthritis by an experienced rheumatologist.
* To be between the ages of 40-65

Exclusion Criteria:

* Severe comorbidities such as cancer and stroke
* Being diagnosed with newly defined or recurrent cancer,
* Not having enough cognitive skills to answer the questions,
* Having neurological problems such as stroke
* Having cognitive impariment

Primary outcomes:
measure: Fried Frailty Phenotype
timeFrame: 1 day
measure: Kihon Checklist
timeFrame: 1 day
measure: Short Physical Performance Battery(SPPB)
timeFrame: 1 day
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: 1 day
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 1 day
measure: Depression and Anxiety
timeFrame: 1 day
measure: Ankylosing Spondylitis Quality of Life Scale
timeFrame: 1 day
Other outcomes:
measure: Gait Speed
timeFrame: 1 day
measure: Grip Strength
timeFrame: 1 day
measure: Physical Activity Level
timeFrame: 1 day
Locations:
city: Istanbul
country: Turkey
facility: Haydarpaşa Numune Research and Training Hospital
Study officials:
References:
Clinical trial NCT00429520: Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds
Official title: Prospective, Multicentre, Not Controlled Clinical Study to Investigate Efficacy and Tolerability of the Hyaluronic Acid Filler IMD1 Basic After Single Bilateral Injection for Correction of Nasolabial Folds (NLF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasolabial Folds
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2007-01-31
Enrollment: 114
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks.


Eligibility criteria: Inclusion Criteria:

* main inclusion criteria: severity rating scale grade 3 or 4

Exclusion Criteria:

* main exclusion criterion: other nasolabial fold corrections within 6 months prior to study entry

Primary outcomes:
measure: Severity rating scale assessed by independent rater
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Merz Pharmaceuticals
Study officials:
affiliation: Klinik am Sonnenberg, Wiesbaden, Germany
name: Johannes Reinmüller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02327520: Clostridium Difficile Infection: the First Report in Southeast Asia by 2010 Nationwide Study
Official title: The Burden of Clostridium Difficile Infection in Thai Population: the First Report in Southeast Asia by 2010 Nationwide Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile infection
burden
nationwide study
South East Asia
Thailand
Epidemiology
Outcome Assessment (Health Care) [N04.761.559.590]
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 204666
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: The patients with the diagnosis of Clostridium difficile (ICD10-A07) with age of more than 18 years were included.

Brief summary: The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand Nationwide Hospital Admission Database, which is part of the National Health Security Office (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes, either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was excluded. The baseline characteristics, including age, sex, co-morbidity disease and history of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital stay (LOS), mortality rate, and hospital charge.


Eligibility criteria: Inclusion Criteria:

* The patients with the diagnosis of Clostridium difficile (ICD10-A07)
* Age of more than 18 years.

Exclusion Criteria:

* Data incompleted

Primary outcomes:
measure: Death rate and length of hospital stay in CDI during admission
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Hospital charge of CDI
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Chulalongkorn Memorial Hospital
name: Rapat Pittayanon, MD
role: PRINCIPAL_INVESTIGATOR
References: