louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05077696: Neurofilament Assay for the Diagnosis of ALS
Official title: Contribution of the Neurofilament Assay for the Diagnosis of ALS (Amyotrophic Lateral Sclerosis) in Situations of Diagnostic Standoff After Evaluation in an Expert ALS Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Progressive Motor Neuron Disease Without Definite Diagnosis
Keywords: ALS
Neurofilaments
NFL
pNFH
Amyotrophic Lateral Sclerosis
progressive motor neuron disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 100
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 progressive motor neuron disease without a definite diagnosis.

Brief summary: The aim of the study is to evaluate the interest of the determination of pNFH and NFL neurofilaments in serum for the diagnosis of ALS in patients with a diagnostic standoff after evaluation in an expert ALS center. The hypothesis is that one of these biomarkers, or their combined analysis, will make it possible to confirm or invalidate the diagnosis of ALS.

Detailed description: For this study, which aims to evaluate a test to help in the diagnosis of ALS that could be integrated into routine practice, it was preferred to use blood tests. Blood sampling is significantly less invasive than CSF sampling, and more easily generalized, including in ambulatory conditions.

Eligibility criteria: Inclusion criteria :

Subjects with first and/or second motor neuron disease, evolving clinically and/or electrically over at least 12 months, not meeting the diagnostic criteria for ALS (revised El Escorial criteria):

* Isolated peripheral motor neuron disease (at least one region of the PNM) OR
* Isolated central motor neuron involvement (at least two areas of the MNC) OR
* associated involvement of the MNP and MNC but in the presence of an associated pathology responsible for a persistent diagnostic doubt (double narrow cervical and lumbar canal, associated evolving cancer evoking a paraneoplastic syndrome without specific antibody found) Age superior to 18 years Management and follow-up in one of the French ALS centers Patient able to express his non-opposition Affiliation with social security or beneficiary of such a plan

Non-inclusion criteria:

Refusal of the patient Person under a legal protection measure (guardianship, curatorship or safeguard of justice).

Person deprived of liberty by judicial or administrative decision.

Primary outcomes:
measure: contribution of pNFH and NFL neurofilaments assays
timeFrame: 1 year
Secondary outcomes:
measure: Value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05727696: A Comparative Study Between Radius and Capitate Shortening in Ulna Minus Variance Kienbock's Disease
Official title: A Comparative Study Between Radius and Capitate Shortening in Ulna Minus Variance Kienbock's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Avascular Necrosis of Lunate
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Kienböck's disease refers to avascular necrosis of the lunate carpal bone, known as lunatomalacia. It was first recognized and described by Austrian radiologist Robert Kienböck's in 1910
2. The lunate is the central bone in the proximal row, and it articulates with the scaphoid, capitate, triquetrum, and occasionally the hamate. More proximally, the lunate is a component of the radiocarpal joint, and it also articulates with the ulna via the triangular fibrocartilage complex (TFCC)
3. The exact cause of Kienböck's is not known, though there are thought to be a number of factors predisposing a person to Kienböck's. Although there is no evidence that Kienböck's disease is inherited, it is possible that unidentified genetic factors could contribute to the development of the condition, It is multifactorial, related to the following variables:Ulnar negative variance (or ulna minus),Vascular supply to the lunate bone,Lunatemorphology,Radial inclination angle,multiple wrist trauma
4. Kienböck's disease is the second most common type of avascular necrosis of the carpal bones, preceded only by avascular necrosis of the scaphoid. The typically affected population is males aged 20-40 years
5. Patients usually present with unilateral pain over the dorsal aspect of the wrist, limited wrist motion, weakness, or a combination of the three. Wrist extension and axial loading exacerbate pain. Symptoms range from mild to debilitating. It is rarely bilateral, and trauma is often absent. Physical examination commonly reveals wrist swelling, tenderness over the expected location of the lunate, synovitis, and loss of grip strength
6. Kienböck's disease is a clinical and imaging diagnosis. Both radiography/computed tomography and magnetic resonance imaging (MRI) are highly specific. However, MRI is the most sensitive and detects radiographically occult cases


Eligibility criteria: Inclusion Criteria:

* Age : 18-65 Years.
* Stages II \& III.
* Ulna minus.

Exclusion Criteria:

* Teens.
* Serious medical condition.
* Stage I\& IV.
* Sever osteoporosis.

Primary outcomes:
measure: (Modified Mayo Wrist Score)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
Clinical trial NCT00162396: Genetic Determinants of the Response to Salbutamol Among Asthma Patients
Official title: Evaluation of Genetic Factors That May Account for Variability in the Response to Salbutamol Among Patients Suffering From Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Albuterol
β2 Adrenergic receptor
Polymorphism
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The response to salbutamol varies greatly among individuals. Data from previous studies indicate that some of the variability is accounted for by genetic polymorphisms in the gene encoding for the adrenoceptor subtype β2. The current study was designed to evaluate variability in the response to salbutamol among recently diagnosed patients who have not been treated by β2 agonists or corticosteroids.

Lung function tests will be performed prior to and following a single dose administration of salbutamol through inhalation. Additional pharmacodynamic indices will be monitored including pulse and blood pressure. Three samples of plasma will be drawn for the evaluation of salbutamol plasma concentration.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Recently diagnosed as asthmatic

Exclusion Criteria:

* Current treatment by β2 agonist
* Current treatment by corticosteroids
* Acute asthma attack

Primary outcomes:
measure: Change in lung function tests after salbutamol inhalation
measure: Change in blood pressure and pulse after salbutamol inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01741935: Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease
Official title: Is COPD Patient Mobility in Combination With Other Parameters a Sensitive Measure and Predictive Indicator for Early Detection of Exacerbations in COPD?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: CareTelCom AB
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
name: Region Skane
name: Lund University
First posted: 2012-12-05
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: An open, single group, single center Study to confirm CTC-Actiwise™ as a means to record and monitor the progression of a patient's COPD.

Chronic Obstructive Pulmonary Disease (COPD) affects growing patient groups. Current knowledge about the disease limits the investigators ability to cure or interfere with the progression of the disease. COPD is often characterized by exacerbating infections requiring emergency care.

The project aims to examine whether disease progression of COPD can be better controlled by continuously monitoring the patient's physical activity, along with the assessment of pulmonary symptoms and lung function. A key question is: can investigators find indicators that provides support for early intervention before severe symptoms arise.

The patient carries a smartphone that records physical activity real-time, daily lung function measures, lung disease related symptoms, and use of medication.

The experimental phase, the first part of the project, covers 25 COPD patients followed up to 12 weeks where the primary objective is to examine and verify both new investigational methodology and technology.


Eligibility criteria: Inclusion Criteria:

* Female or male 40 years of age and above
* Ability to use a smartphone and Bluetooth spirometer
* Subjects having COPD
* Ongoing treatment for a recent and not completely recovered COPD exacerbation

Exclusion Criteria:

* Dominating physical disability for other reasons or not related to COPD

Primary outcomes:
measure: Improved real time physical activity
timeFrame: Patients are continuously monitored up to 12 weeks
Secondary outcomes:
measure: The correlation of physical activity to disease symptom scores, lung function, and use of medication
timeFrame: Patients are continuously monitored up to 12 weeks
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Respiratory Medicine & Allergology, Skånes universitetssjukhus Lund
Study officials:
affiliation: Lund University
name: Leif Bjermer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01143935: Estimation of Standard Liver Volume in the Indian Population
Official title: Estimation of Standard Liver Volume in the Indian Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver
Keywords: Liver volume estimation
Indian population
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing CT scans for non hepatobiliary conditions. Autopsy cases in whom there is no liver disease or trauma.

Brief summary: Estimation of liver volume is important for live donor liver transplant as well as extended liver resections. Computed tomography (CT) volumetry which is currently a gold standard for liver volumetry , is a time consuming process. A quicker method to estimate liver volume is essential. The aim of the present study is to try and formulate an equation based on patients height, weight etc to estimate liver volume.


Eligibility criteria: Inclusion Criteria: Patients undergoing CT scans

* Autopsy cases

Exclusion Criteria:

* Patients with hepatobiliary disorders Autopsy cases with liver disease or trauma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AIIMS
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Tushar K Chattopadhyaya, MS Surgery
role: STUDY_CHAIR
References:
Clinical trial NCT00350935: Attention and Visual Perception in Schizophrenia: A Functional Magnetic Resonance Imaging (fMRI) Study
Official title: Attention and Grouping of Visual Information: What is Disturbed in Patients With Schizophrenia?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: fMRI
Visual perception
Attention
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre National de la Recherche Scientifique, France
name: Région Alsace
name: Faculté de Médecine de Strasbourg
First posted: 2006-07-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, residents of Strasbourg

Brief summary: The main objective of the study is to contribute to a better understanding of the physiopathology of schizophrenia, by studying causal relationships between cognitive deficits and the neurobiological basis for these deficits. Processing visual information involves both automatic grouping processes and control processes. Automatic grouping processes allow the building of a global configuration from local contour information. It is necessary in order to recognize objects. Control processes allow tending to and prioritizing information parts. The paradigm the investigators use allows to dissociate these processes, and is used in order to characterize the impairments observed in patients with schizophrenia. It is adapted to fMRI in order to explore the neurobiological basis of the deficits. The investigators will examine whether functional disconnectivity between activated areas subtend the impairments observed in patients.


Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenia (DSM-IV criteria)
* Healthy controls matched with patients on age, sex and education level
* Ages 18 to 50
* Signed informed consent
* Right-handed

Exclusion Criteria:

* No severe somatic illness
* No invalidating sensory disease
* No drug abuse, as defined by DSM-IV criteria
* No general anaesthesia in the past 3 months
* No intake of drugs affecting the CNS, except for patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Inserm U666 - Département de Psychiatrie, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Anne Giersch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00582335: Identification of New Colorectal Cancer Genes
Official title: Identification of New Colorectal Cancer Genes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Genetic testing
Genetic mutations
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: families seen at MSKCC with at least two first-degree relatives affected with colorectal cancer

Brief summary: The purpose of this study is to define new genes for family risks of developing colon cancer.

Detailed description: Colorectal cancer is one of the most significant causes of cancer morbidity and mortality in the United States. In 1997, approximately 130,000 men and woman were diagnosed with colorectal cancer (fourth most common cancer site) and approximately 55,000 died of this disease (second most common cause of cancer deaths); (Cancer Facts \& Figures, 1997).

Genetic factors clearly contribute to the etiology of colorectal cancer. Because there is evidence to suggest genetically determined susceptibility to colorectal cancer exists in a proportion of newly diagnosed cases each year, we are conducting a study to identify new genes that are associated with an increased susceptibility to familial colorectal cancer by analysis of families with a clustering of colorectal cancers.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or greater
* Able to provide informed consent
* Any family in which a minimum of two first-degree relatives either are, or have previously been, affected with primary colorectalcancer. These "minimum inclusion criteria" must be met within three generations of the proband or kindreds in which colorectal cancer and lymphoma or renal cell cancer are present or in kindreds in which lymphoma alone or lymphoma and renal cell cancer are present

Exclusion Criteria:

* Age less than 18 years
* Family not at increased risk for familial colorectal cancer (see Section 4.1)
* Family with a hereditary polyposis syndrome (e.g. classic FAP)
* Not able to provide informed consent

Primary outcomes:
measure: Evidence of mutations in selected candidate genes
timeFrame: 10 years 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kenneth Offit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00889135: Long Term Treatment With L-DOPS
Official title: Long Term Treatment With L-DOPS
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Dopamine Beta Hydroxylase (DBH) Deficiency
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-04-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study is designed to supply L-DOPS (droxidopa) on a long term basis to patients with a genetic form of profound orthostatic hypotension, most commonly DBH deficiency. It also allows us to collect medical history information on this small population of patients that would allow us to determine if there are any complications from this type of treatment.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older with orthostatic hypotension
* established diagnosis of DBH deficiency and fractionated plasma catecholamine levels that show high dopamine levels and very low norepinephrine and epinephrine levels. Blood pressure increase in response to oral treatment with L-DOPS during previous studies.

Exclusion Criteria:

* subjects with orthostatic hypotension that do not have a genetic form of the disorder and catecholamine pattern is not consistent with that above.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David Robertson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02844335: Combination of Cryosurgery and NK Immunotherapy for Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer Recurrent
Keywords: Breast Cancer
Cryosurgery
NK Immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced breast cancer.

Detailed description: By enrolling patients with breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for advanced breast cancer.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Institute in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Guifeng Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: