louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05884086: Ataxia GAA-FGF14 - Descriptive Genetic and Clinical Study
Official title: Ataxia GAA-FGF14 - Descriptive Genetic and Clinical Study on Late Onset Ataxia Related to a GAA Expansion in the FGF14 Gene
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ataxia, Gait
Keywords: ataxia
spinocerebellar ataxia
genetic ataxia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of cerebellar ataxia of type GAA-FGF14 followed at the CHRU of Nancy

Brief summary: Cerebellar ataxias of late onset are of undetermined etiology in many cases. A new cause of late-onset cerebellar ataxia was discovered in January 2023 corresponding to an expansion of GAA triplets in intron 1 of the FGF14 gene.

However, this cerebellar ataxia is still poorly known and requires further investigations to know its clinical phenotype and its evolution in order to propose a diagnosis and a genetic counseling adapted to patients and families. The objective of our study will be to describe the clinical and genotypic phenotype of patients with GAA-FGF14

Detailed description: The objective of our study will be to describe the clinical and genotypic phenotype of patients with GAA-FGF14. We wish to describe the precise clinical phenotype by detailing each patient's clinical examination, medical history, treatment history, frequency and symptomatology of episodes, MRI radiological data, otho-rihno-laryngeal examination data etc . We would also like to describe the precise genotype for each patient, specifying the number of GAA expansions and its characteristics.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of cerebellar ataxia of type GAA-FGF14

Exclusion Criteria:

* patients not wishing to be followed

Primary outcomes:
measure: description of clinical symptoms
timeFrame: through study completion, an average of 3 years
measure: description of genotype
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre hospitalier régional universitaire
Study officials:
References:
citation: Pellerin D, Danzi MC, Wilke C, Renaud M, Fazal S, Dicaire MJ, Scriba CK, Ashton C, Yanick C, Beijer D, Rebelo A, Rocca C, Jaunmuktane Z, Sonnen JA, Lariviere R, Genis D, Molina Porcel L, Choquet K, Sakalla R, Provost S, Robertson R, Allard-Chamard X, Tetreault M, Reiling SJ, Nagy S, Nishadham V, Purushottam M, Vengalil S, Bardhan M, Nalini A, Chen Z, Mathieu J, Massie R, Chalk CH, Lafontaine AL, Evoy F, Rioux MF, Ragoussis J, Boycott KM, Dube MP, Duquette A, Houlden H, Ravenscroft G, Laing NG, Lamont PJ, Saporta MA, Schule R, Schols L, La Piana R, Synofzik M, Zuchner S, Brais B. Deep Intronic FGF14 GAA Repeat Expansion in Late-Onset Cerebellar Ataxia. N Engl J Med. 2023 Jan 12;388(2):128-141. doi: 10.1056/NEJMoa2207406. Epub 2022 Dec 14.
Clinical trial NCT01978886: Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder
Official title: Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Frozen Shoulder
Keywords: Diabetes Mellitus
frozen shoulder
adhesive capsulitis
Lead sponsor: Sygehus Lillebaelt
Sponsor class: OTHER
Collaborators: name: Amager Hospital
First posted: 2013-11-08
Enrollment: 220
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All newly referred patients to one of the involved hospitals who is diagnosed with frozen shoulder.

Brief summary: The purpose of the study is to investigate how high the prevalence of diabetes (known and unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40 %.

Another purpose is to investigate whether patients with diabetes have a worse and more painful frozen shoulder than patients without diabetes, and whether the diabetes have an influence on the prognosis.

Detailed description: Patients who are not diagnosed with diabetes would be ask to give a blood sample to investigate if they have an unknown diabetes.

All patients with frozen shoulder will be asked to fill out a questionnaire (Oxford Shoulder Score) to clarify how bad their frozen shoulder is. All patients will receive the questionnaire 6 and 24 month following the date on inclusion.

Eligibility criteria: Inclusion Criteria: All newly referred patients who is being diagnosed with frozen shoulder -

Exclusion Criteria: age below 25 or above 75, pt. who don't read or understand danish, not danish citizen, patients with mental illness, pt. with a abuse of alcohol or substances, pregnancy, pt. who within 4 months have been injected with adrenocortical hormone, arthrosis in the glenohumeral joint, avascular necrosis of caput humeri, rotator cuff lesion.

-

Primary outcomes:
measure: prevalence of known and unknown diabetes diabetes
timeFrame: 1 year
Secondary outcomes:
measure: diabetes influence on the prognosis of frozen shoulder
timeFrame: 24 months
Other outcomes:
Locations:
city: Amager
country: Denmark
facility: Amager Hospital
state: Copenhagen
city: Kolding
country: Denmark
facility: Sygehus Lillebaelt
city: Vejle
country: Denmark
facility: Vejle Sygehus
Study officials:
affiliation: Sygehus Lillebaelt
name: per h gundtoft, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gundtoft PH, Attrup ML, Kristensen AK, Vobbe JW, Sorensen L, Holmich P. Diabetes mellitus affects the prognosis of frozen shoulder. Dan Med J. 2020 Sep 8;67(10):A02200071.
Clinical trial NCT05443386: Colorectal Emergencies in Elderly Patients.
Official title: Emergency Surgery for Colon Diseases in Elderly Patients. Analysis of Complications, and Postoperative Course
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Colorectal Surgery in Ultra 80 Patients
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 32
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients older than 80 undergoing emergency surgery (within 24 hours) due to colon diseases were included in this retrospective study

Brief summary: Colon diseases can turn in a clinical emergency with the onset of some important complications. Some critical conditions are more common in aged patients because they are more frails. The aim of this study is to examine ultra 80 patients, undergoing emergency colorectal surgery, evaluating the aspects associated with post-operative complications and other problems in the short term.

From November 2020 to February 2022 we have included 32 consecutive patients older than 80 undergoing emergency surgery due to colon diseases. We have collected and analysed all demographic, and operative data and then applied CR-POSSUM score and correlated with postoperative hospital stay and the onset of postoperative complications according to Clavien Dindo classification.

Postoperative factors were selectively evaluated based on the clinical scenario and different colic pathologies. There was no statistically significant differences, in terms of postoperative hospital stay, postoperative complications, reoperation rate and 30-day mortality. The number of cases of blood transfusions was significant, more numerous in case of intestinal perforation and bleeding cases. The value of Operative Severity Score in the Bowel Perforations, was significantly higher.

The use of a score to stratify the risk is a useful tool especially in elderly patients to undergo emergency surgery. The CR-POSSUM score was important for predicting morbidity in our study. Emergency manifestations of colon diseases in the elderly show higher morbidity and mortality rates.


Eligibility criteria: Inclusion Criteria:

* age older than eighty
* emergency conditions

Exclusion Criteria:

* trauma cases

Primary outcomes:
measure: postoperative hospital stay
timeFrame: 30 days
Secondary outcomes:
measure: postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Policlinico Di Foggia
Study officials:
References:
Clinical trial NCT04902586: Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma
Official title: The Clinical Effect and Safety of Radiotherapy Concurrent of TTFields in the Treatment of Post-operation Patients With Glioblastoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Glioblastoma
Keywords: glioblastoma
TTFields
radiotherapy
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TTFields has been approved by the FDA for the treatment of patients with glioblastoma multiforme. However, the clinical effect and safety of radiotherapy concurrent of TTFields is not definite. In this study, the investigators conduct a phase II clinical trial to evaluate the efficacy and safety of this strategy.

Detailed description: the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.

Eligibility criteria: Inclusion Criteria:

* performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
* histologically confirmed glioblastoma
* no cerebrospinal fluid and distant metastatic disease.

Exclusion Criteria:

* with a history of brain radiotherapy
* severe hepatic and renal dysfunction

Primary outcomes:
measure: Disease-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan hospital
state: Hubei
Study officials:
affiliation: Wuhan University
name: Jianyin Huang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04473586: Spartan Cube CYP2C19 Method Comparison Study
Official title: Validation Protocol Spartan Cube CYP2C19- Method Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genotyping Techniques
Keywords: Method Comparison
CYP2C19
Lead sponsor: Spartan Bioscience Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mount Sinai Services
First posted: 2020-07-16
Enrollment: 425
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will experienced the same number of buccal and saliva samples collected. This means all subjects will participate in Arm 1 and have materials collected at the same time in the event they are enrolled in arm 2.

Based on enrollment numbers and their immediate genotype, it will be determined at that time if the subject will participate in the second arm of the study.
Primary purpose: SCREENING

Brief summary: The aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube CYP2C19 system and bi-directional sequencing.

Detailed description: Sample holding time - two parts

1. Sample tested in less than one-hour

   a.In the first part, buccal samples will be collected from subjects and tested using the Spartan Cube CYP2C19 system. These samples will be run immediately (within 1 h) after collection from the subject (\<1 h sample holding time). All results will be compared to bi-directional sequencing to determine percent agreement.
2. Sample tested greater than 21 hours a.In the second part (sample holding portion), samples will be tested using the Spartan Cube CYP2C19 product. These samples will be run after storage at ambient temperature. All results will be compared to bi-directional sequencing to determine the percent agreement.

Eligibility criteria: Inclusion Criteria:

* Participants who will provide buccal samples and a saliva sample who have not eaten drank or smoked in the past 30 minutes.

Exclusion Criteria:

* Participants who have eaten drank or smoked in the past 30 minutes prior to collection.

Primary outcomes:
measure: % Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing
timeFrame: Through study completion; anticipated to be less than 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Services
state: Ontario
Study officials:
affiliation: Spartan Bioscience Inc.
name: Shaimaa Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01636986: A Prospective Study of Two Daily Disposable Contact Lenses
Official title: Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: myopia
contact lenses
dry eyes
comfort
replacement
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.

Detailed description: Three study visits occurred over the course of 28 ± 3 days.

Eligibility criteria: Inclusion Criteria:

* Be of legal age of consent and sign written Informed Consent Document and HIPAA form.
* Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
* Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
* Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
* Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
* Willing and able to follow instructions and maintain the appointment schedule.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
* Requires monovision or presbyopic correction.
* Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
* Clinically significant lash or lid abnormality.
* Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.
* History of ocular surgery/trauma within the last 6 months.
* Topical or systemic antibiotics use within 7 days of enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
timeFrame: Day 0, Week 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jami Kern, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05910086: Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture
Official title: Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Keywords: Accidental dural puncture
Epidural blood patch
Intrathecal catheter
Postdural puncture headache
Epidural anesthesia
Obstetrics
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having an accidental dural puncture during the installation of an epidural anesthesia will be included.

Brief summary: Accidental dural puncture is an uncommon complication of epidural analgesia and can cause postdural puncture headache.

Detailed description: The aim of this study the effectiveness of a protocol implemented in our department, according to the recommendations of good practice, on the reduction of the use of blood patchs in patients who have had an accidental dural puncture during the implementation of their spinal anesthesia, in order to prevent the use of the blood patch. In addition, intensity of headaches is evaluated.

Eligibility criteria: Inclusion Criteria:

* patients having an accidental dural puncture during the installation of an epidural anesthesia

Exclusion Criteria:

* Patients without accidental dural puncture

Primary outcomes:
measure: Number of epidural blood patch
timeFrame: Day: 7
Secondary outcomes:
measure: headache intensity
timeFrame: Day: 7
measure: Timeframe for blood patching
timeFrame: Day: 0
measure: Number of blood patches required
timeFrame: Day: 7
measure: Safety of the technique by number of adverse event
timeFrame: Day: 7
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pascal MARTIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00999986: Low Dose Cyclophosphamide Treats Genital Warts
Official title: Phase III Study of the Treatment of Genital Warts by Low Dose Cyclophosphamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genital Wart
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Condylomata acuminata (CA) caused by human papillomavirus (HPV) is a common sexually transmitted disease with half a million new cases diagnosed in the United States per year. Recurrence is a major challenge for CA treatment. The investigators have demonstrated that FOXP3+ regulatory T (Treg) cells mediate the immunosuppression in large genital warts. And low-dose cyclophosphamide (CY), a conventional chemotherapy drug, has been reported to selectively deplete Treg cells in cancer patients. Therefore, the investigators hypothesized that low-dose CY can be used to treat genital warts. In this study, 104 CA patients have been recruited for clinical trial with a 1:2 randomization. Among them, 64 patients received low-dose cyclophosphamide and 32 received placebo. In 8 extra patients, high-dose cyclophosphamide was given.

Detailed description: Patients were first treated with CO2 laser therapy, and then treated with low-dose CY, orally 50 mg per day for 7 days.The CA recurrence were observed.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of large genital warts

Exclusion Criteria:

* HPV type 6 or 11 was detected negatively by PCR method.

Primary outcomes:
measure: low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Medical College
name: Bo Huang, PH.D, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cao Y, Zhao J, Lei Z, Shen S, Liu C, Li D, Liu J, Shen GX, Zhang GM, Feng ZH, Huang B. Local accumulation of FOXP3+ regulatory T cells: evidence for an immune evasion mechanism in patients with large condylomata acuminata. J Immunol. 2008 Jun 1;180(11):7681-6. doi: 10.4049/jimmunol.180.11.7681.
Clinical trial NCT03060486: A New Approach for Controlling Hemostasis During Canal Treatment: a Pilot Study
Official title: A New Approach for Controlling Hemostasis During Canal Treatment: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Contamination of Root Canal During Endodontic Therapy
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Blood contamination, such as apical microleakage, of root canal during preparation can be a major problem in endodontics. The purpose of this investigation was to evaluate the hemostatic properties of sulfonic/sulfuric acid solution used during root canal therapy in teeth with irreversible pulpitis.

Detailed description: A new device (HYBENX®) has been developed with the purpose of destroying dental biofilm. The material contains a concentrated aqueous mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%).

The investigators planned a clinical and microbiological study using the decontaminant device in order to destroy the dental biofilm of root canals in cases of irreversible pulpitis. The ability of the decontaminant device to immediately stop bleeding during canal instrumentation was found out accidentally during the procedures of this still unpublished trial.

Due to this fact, the investigators were interested in evaluating the coagulation property of the material. Therefore, the aim of this prospective study is to describe a new approach to obtain hemostasis during root canal therapy using a sulfonic/sulfuric acid solution.

A total of 15 teeth with irreversible and acute pulpitis were included in the study. After manual and mechanical instrumentation of the root canal, a sterile paper point was introduced in the canal, and a first score was given based on the blood quantity.

The solution was used to irrigate the bleeding root canal; then a second sterile paper point was introduced, and the same score was assessed. The null hypothesis was that there is no difference in root canal bleeding before and after the use of the solution (⎧=0)

Eligibility criteria: Inclusion Criteria:

* tooth affected by irreversible pulpitis, single-rooted teeth associated with healthy periodontium, physiologic sulcus depth (\<3 mm), and absence of bleeding on probing of the involved teeth.

Exclusion Criteria:

* patients with systemic diseases using anticoagulants, antibiotics, or anti-inflammatory therapies in the last 30 days, patients with allergy to sulfur in any form, and pregnancy.

Primary outcomes:
measure: Change From Baseline in Root Canal Bleeding Score
timeFrame: 20 sec - before and after use
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: