louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06250361: Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease
Official title: Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease: the FAST Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Crohn Disease
Keywords: IBD
CROHN
CD
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crohn's disease, going to ANGH (expert hospitals), GETAID (expert university hospitals) and CREGG (expert private practice) centres, who have been diagnosed within the year before the inclusion visit.

Brief summary: The goal of this observational study is to determine the factors associated with a delayed diagnosis and/or an immediately complicated disease for CD patients.

A questionnaire will be completed by the patients, each questionnaire has a patient section and a physician section.

Detailed description: Number of patients expected : at least 600, coming from all types of practices (ANGH (expert hospitals), GETAID (expert university hospitals) and CREGG (expert private practice)).

Recruitment period : 1 year

Primary endpoint : The primary endpoint is the description of the factors linked to:

* The IBD
* The patient (see patient questionnaire in annex 1)
* The health care system
* The patient's self-care

Secondary endpoint :

* Validation of the "red flags" in a prospective cohort.
* Comparison with the EPIMAD population, especially the location and severity.

Eligibility criteria: Inclusion Criteria:

* Crohn's disease diagnosed less than a year prior to inclusion
* Written consent
* Age ≥ 18 years

Exclusion Criteria:

* Diagnosis of Crohn's disease more than one year before inclusion
* Patient protected by the law
* Patient without health cover

Primary outcomes:
measure: Number of patient's visits to doctors between the appearance of the first symptoms and the diagnosis of the disease.
timeFrame: Day 1 from appearence of first symptoms and the diagnosis of the disease.
measure: Number of exams performed between the appearance of the first symptoms and the diagnosis of the disease.
timeFrame: Day 1 from appearence of first symptoms and the diagnosis of the disease.
measure: Number of medical specialties consulted between the appearance of the first symptoms and the diagnosis of the disease.
timeFrame: Day 1 from appearence of first symptoms and the diagnosis of the disease.
Secondary outcomes:
measure: Number of predictive factors associated with a delayed diagnosis
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Stéphane Nahon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06548061: D20054;LITT for Spine Tumors
Official title: Single Center Observational Study Using Spinal Laser Interstitial Thermal Therapy (sLITT) in the Treatment of Spine Metastases and Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Metastases
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to evaluate the efficacy and safety of spinal laser interstitial therapy in the treatment of metastatic spinal tumors. The investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.


Eligibility criteria: Inclusion Criteria:

1. Histology confirmed spinal tumor involving the T2-T12 spine segments.
2. Indication for spine stereotactic radiosurgery or palliative intervention.
3. Normal neurologic exam at the time of presentation (Frankel grade E).

Exclusion Criteria:

1. Contraindication to MRI
2. ANY neurologic deficit
3. Tumor spanning more than 3 consecutive vertebral segments
4. Contraindication to general anesthesia
5. Pregnancy

Primary outcomes:
measure: Local tumor control
timeFrame: Local control rate at 12 months
Secondary outcomes:
measure: Evaluate neurologic function before and after sLITT.
timeFrame: 3, 6, 9, and 12 months post-operatively
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Health
state: New Hampshire
Study officials:
References:
Clinical trial NCT01292161: Effects of Silybum Marianum on Treatment of Patients With Chronic Hepatitis C
Official title: Study of Silymarin for Improving Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: Hepatitis C
Silymarin
Quality of life
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of silymarin on outcomes of patients with hepatitis C.

Detailed description: Silymarin has been claimed to have a beneficial effect in various types of liver injury, including alcoholic liver disease, drug and toxin induced hepatotoxicity, and acute and chronic viral hepatitis.

Eligibility criteria: Inclusion Criteria:

confirmed chronic hepatitis C (HCV Ab (+), HCV RNA (with PCR) (+)) normal or increased liver enzymes (ALT and AST) not using interferon or ribavirin due to patient sensitivity or not consenting.

Exclusion Criteria:

The pregnant patients patients with side effect which confirmed with rechallenge test

Primary outcomes:
measure: Serum aminotransferases (ALT, AST)
timeFrame: at six months after admission
Secondary outcomes:
measure: HCV-RNA
timeFrame: at six months after admission
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
affiliation: Associate Professor,Gasteroentrology department
name: hamid kalantari, A.Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00926861: Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative Age Related Macular Degeneration (AMD) to Develop Exudative AMD
Official title: Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative AMD to Develop Exudative AMD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Age-related Macular Degeneration
Detachment of the Posterior Hyaloid
Keywords: age-related macular degeneration
detachment of the posterior hyaloid
AMD
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2009-06-24
Enrollment: 320
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male or female persons aged over 50 years with dry AMD

Brief summary: Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown. Genetic factors, oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may transform to a wet form. From a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet AMD. This study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.


Eligibility criteria: Inclusion Criteria:

* Dry MD
* Age over 50 years

Exclusion Criteria:

* Macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole)
* Prior vitrectomy or buckle surgery
* Uveitis posterior, multifocal chorioiditis
* Pathologic myopia
* Diabetic retinopathy
* Visualization of the macula not possible (dens cataract, vitreous haemorrhage)

Primary outcomes:
measure: Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD
timeFrame: 24 months
Secondary outcomes:
measure: Distance acuity
timeFrame: 24 months
measure: Age
timeFrame: 24 months
measure: Smoking
timeFrame: 24 months
measure: Obesity
timeFrame: 24 months
measure: Lesion classification (AREDS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Study officials:
affiliation: Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
name: Susanne Binder, Prof MD
role: STUDY_CHAIR
References:
Clinical trial NCT04111861: Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain
Official title: Singing for Chronic Pain, a Pilot Study of a New Intervention for the Management of Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the project is to determine the feasibility of delivering a Singing for Chronic Pain (SCP) programme to patients with chronic pain attending a pain clinic.

The investigator will also be looking to provide a preliminary estimate of the benefit of SCP on self-efficacy, self -management skills, mindfulness and well-being as measured by standardized outcome measures.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older and have a diagnosis of chronic pain with a duration of 6 months or more.

Exclusion Criteria:

* Having a mental health and/or physical health diagnosis that might prevent active engagement/participation in group sessions; Severe hearing impairment; Severe/profound cognitive impairment that may limit active engagement/participation in group sessions.

Primary outcomes:
measure: Completion rate
timeFrame: One year
measure: Consent rate
timeFrame: One year
Secondary outcomes:
measure: Self reported self efficacy
timeFrame: One year
measure: Self reported ability to self-manage pain
timeFrame: One year
measure: Increased mindfulness Increased mindfulness Increased mindfulness
timeFrame: One year
measure: Self reported well-being
timeFrame: One year
measure: Self reported anxiety depression
timeFrame: One year
measure: Self reported quality of life
timeFrame: One year
Other outcomes:
measure: Patient Focus Group
timeFrame: One year
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
Study officials:
References:
Clinical trial NCT05177861: The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy
Official title: The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulnar Neuropathies
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Regardless of the cause of ulnar nerve entrapment neuropathy, we are planning to investigate the relationship between sleep quality disorder that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.


Eligibility criteria: Inclusion Criteria:

* having ulnar nerve entrapment neuropathy with clinical examination and EMG (electroneuromyography)
* to be between the ages of 18-65
* be give informed consent

Exclusion Criteria:

* malignancy
* surgical history in the ipsilateral upper extremity
* sleep apnea
* narcolepsy

Primary outcomes:
measure: Pittsburg Sleep Quality Index
timeFrame: 10 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
Study officials:
affiliation: Yüzüncü Yıl Üniversitesi Tıp Fakültesi
name: Volkan Şah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01946061: A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Keywords: Oxaliplatin, S-1, Gastric cancer, Adjuvant chemotherapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 3
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.


Eligibility criteria: Inclusion Criteria:

* Age, between 19 and 75
* Histologically proven advanced gastric cancer
* R0 resection after D2 gastrectomy
* Stage III (according to the AJCC 7th criteria)
* ECOG status 0 to 2

Exclusion Criteria:

* Malignancy history other than gastric cancer
* Previous chemotherapy history for gastric cancer
* Previous radiotherapy history for gastric cancer
* Pregnancy or breast milk feeding
* Grade 3 or more of neuropathy
* Active infection
* Severe hepatic dysfunction
* Severe renal dysfunction
* Severe bone marrow dysfunction
* Significant neurologic or psychologic disease
* Inadequate condition for receiving chemotherapy due to significant systemic disease
* Patients who receives drugs which can be interacted with S-1

Primary outcomes:
measure: 3-year disease-free survival
timeFrame: 3 years from the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severnace Hospital
Study officials:
References:
citation: Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.
Clinical trial NCT02414061: Metabolic and Appetite Parameters Following Addition of Whey Protein to a Carbohydrate-based Breakfast
Official title: The Influence of Whey Protein Addition to a Carbohydrate-based Breakfast on Metabolic and Appetite Parameters Following a Second Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Postprandial glycemia
metabolic health measures
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate whether the addition of whey protein to a breakfast high in carbohydrate content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.


Eligibility criteria: Inclusion Criteria:

* Aged 18-40 years old (male)
* Recreationally active (\>30 minutes of structured exercise, 5 times/week)

Exclusion Criteria:

* Metabolic disease (e.g. Type 2 diabetes, thyroid disorders)
* Taking any prescribed medication
* Regular breakfast skipper
* Food allergies or intolerances
* Eating disorders
* Smoker

Primary outcomes:
measure: Postprandial blood glucose responses
timeFrame: 0-360 minutes post breakfast
Secondary outcomes:
measure: Acute subjective appetite responses
timeFrame: 0-360 minutes post breakfast
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Faculty of Health and Life Sciences, Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Emma J Stevenson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03472261: Integrated Management of Pronation Deformity in Cerebral Palsy
Official title: A Randomized Controlled Trial on Integrated Management of Pronation Deformity of Children With Cerebral Palsy Treated by Botulinum Toxin-A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Palsy
Keywords: cerebral palsy
botulinum toxin-A
pronator deformity
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .

Detailed description: Spasticity is not only the most common motor disorder but also the main cause of slowly developing contractures in children with cerebral palsy. Pronation deformity which is a very common problem in children with cerebral palsy is primarily due to spasticity of the pronator muscles. Reduced strength and loss of control of the supinator muscles and soft tissue and joint contractures usually coexist with spasticity of pronator muscles. There is very limited information about how to treat this deformity in the current literature.

In this prospective, randomized, controlled clinical trial the aim is to show the effectiveness of twister, and home exercise program in an integrated approach with BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having pronation deformity.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cerebral palsy
* MAS score of pronator muscles at least 2
* Gross Motor Functional Classification Scale level of I-IV
* Scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles

Exclusion Criteria:

* Severe cognitive or behavioural problems
* Less than 40 degrees of available passive range of motion in pronation
* Severe dystonia in the affected upper limb
* Received orthopedic surgery to affected upper limb

Primary outcomes:
measure: Mean change from baseline Modified Ashworth Scale (MAS)
timeFrame: Week 12
Secondary outcomes:
measure: Mean change from baseline passive range of supination
timeFrame: Week 12
measure: Mean change from baseline angle of catch (XV3) Tardieu scale
timeFrame: Week 12
measure: Mean change from baseline active range of supination
timeFrame: Week 12
Other outcomes:
measure: Assisting Hand Assessment (AHA)
timeFrame: Week 12
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Melike Akarsu, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00937261: Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
Official title: Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2009-07-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to better understand brain function and psychiatric and neurological illness when taking Invega or Risperdal. The objective is to compare the brain effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be evaluated with PET imaging, fMRI, and neurological ratings and assessments.


Eligibility criteria: Inclusion Criteria:

* are currently taking Risperdal and have been on the medication for at least three weeks
* are diagnosed with schizophrenia
* are able to provide written informed consent
* can safely have an MRI

Exclusion Criteria:

* are treatment resistant or intolerant to Risperdal
* have participated in another drug study in the past 28 days
* are pregnant or trying to become pregnant or are breastfeeding
* are colorblind
* have a history of alcohol, cannabis, or cocaine abuse within two weeks prior to the study
* have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant
* certain medications are also exclusionary including aripiprazole.

Primary outcomes:
measure: Comparison of BOLD signal activation and FDG metabolism of the DLPFC, superior temporal gyrus and amygdala, and their interaction between Invega and Risperdal
timeFrame: approximately 6-10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine
state: California
Study officials:
affiliation: UC Irvine
name: Steven G Potkin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: