louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02117297: SCT Plus Immune Therapy in Average Risk AML/MDS
Official title: Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 26
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.

Detailed description: Reduced intensity conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) + Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk AML/MDS meeting eligibility criteria.

Eligibility criteria: Inclusion Criteria:

Disease Status:

* AML 1st CR with a matched family donor
* AML 1st CR with unrelated donor
* AML 2nd CR or CRP
* MDS and \< or = 5% bone marrow myeloblasts at diagnosis

Disease Immunophenotype:

* Disease must express a minimum of \> or = 10% CD33 positivity for patients with AML

Organ Function:

* Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function

Exclusion Criteria:

* Patients with active CNS AML disease at time of preparative regimen
* Secondary MDS
* Poor cytogenetics
* Female patients who are pregnant
* Karnofsky \<70% or Lansky \<50% if 10 years or less
* Age \>25 years
* Seropositive for HIV

Primary outcomes:
measure: to evaluate incidence of graft failure
timeFrame: Day +42
measure: to evaluate survival rates
timeFrame: 1 year
measure: to determine toxicity
timeFrame: 1 year
Secondary outcomes:
measure: Minor histocompatibility antigen
timeFrame: 1 year
measure: Chimerism
timeFrame: 1 year
measure: Graft-versus-host disease
timeFrame: 1 Year
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Mitchell S. Cairo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03644797: Second Molecular Event Identification by Exome Sequencing for Intellectually Disabled Patients Carrying 16p13.11 CNVs
Official title: Second Molecular Event Identification by Exome Sequencing for Intellectually Disabled Patients Carrying 16p13.11 CNVs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intellectual Disability
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting intellectual disability and carrying a 16p13.11 copy number variant.

Brief summary: 16p13.11 copy number variations are considered as predisposition factors for neurodevelopmental disorders but can be inherited from normal parents. SEESIC aims at identifying seond molecular events by exome sequencing that could modulate the phenotype and explain familial discrepancies.


Eligibility criteria: Inclusion Criteria:

* Patients presenting intellectual disability
* Patients carrying a 16p13.11 copy number variant
* Blood DNA available without re sampling for the patient and his parents.
* Consent for genetics analysis already for the patient and his parents.

Exclusion Criteria:

- Other diagnosis for intellectual disability (apart 16p13.11 copy number variant) already posed

Primary outcomes:
measure: Second pathogenic molecular event on exome data
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant (Groupement Hospitalier Est)
Study officials:
affiliation: Hospices Civils de Lyon
name: Nicolas CHATRON, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04591197: Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia
Official title: Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia : A Prospective, Multi-center, Single Arm Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Validity and Safety
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New diagnosed CML-CP patients who are more than 18 years old.

Brief summary: The overall survival (OS)of Chronic myeloid leukemia (CML) has been significantly improved since the advent of Tyrosine kinase inhibitors (TKIs) .Nevertheless, there still exists a amount of patients who has poor response or intolerance for TKI drugs( Imatinib, dasatinib, nilotinib). Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib,and it aslo has better security when compared to other TKIs(Imatinib, dasatinib, nilotinib).It will be a better chioce for CML patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old, both male and female;
2. New Diagnosed Chronic Phase Chronic Myeloid Leukemia.
3. Within half a year after diagnosis of CML;
4. Previous TKIs treatment was less than 2 weeks;
5. The pregnant test of female patients was negative (within 7 days before medication before enrollment);
6. Informed consent of the patient or his legal representative

Exclusion Criteria:

1. T315I mutation is known to exist;
2. Rare atypical transcript types that cannot be standardized internationally;
3. Received TKI drugs for more than 2 weeks before enrollment;
4. Received interferon therapy for more than 3 months before enrollment;
5. Received other anti-CML drugs (except hydroxyurea) for more than 2 weeks or surgical treatment (including hematopoietic stem cell transplantation)
6. patients who participate in other clinical studies at the same time;
7. patients who having had major surgery or not recovered from surgery within 4 weeks;
8. patients who having history of malignant tumor
9. Woman who is pregnant or nursing
10. Eastern Cooperative Oncology Group Physical Performance Status Score (ECOG PS) \> 3;
11. Patients known to be allergic or contraindicated to the study drug (APIs and/or excipients).
12. A clear history of neurological or psychiatric disorders, including epilepsy or dementia

Primary outcomes:
measure: MMR rates at 12 months
timeFrame: 12 monts
Secondary outcomes:
measure: VEMR rates at 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanfangH
state: Guangdong
Study officials:
References:
Clinical trial NCT05701397: Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.
Official title: Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Amyloidosis
Spinal Stenosis
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Patients undergoing surgery for lumbar spinal stenosis will have biopsies of the ligamentum flavum sent to the department of pathology for histologic screening.

If the ligament biopsy contains amyloid, patients will receive an echocardiogram, an ecg, biomarker testing, and a bone tracer scintigraphy diagnostic of cardiac amyloidosis.


Eligibility criteria: Inclusion Criteria:

* Scheduled for surgery for lumbar spinal stenosis
* Age \> 65 years
* Informed written consent

Exclusion Criteria:

* Known amyloidosis
* Myelomatosis
* Monoclonal gammopathy of unknown significance, MGUS
* Morbus Waldenstrøm

Primary outcomes:
measure: Diagnosis of cardiac amyloidosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT01762397: A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastritis
Gastric Ulcer
Lead sponsor: PharmaKing
Sponsor class: INDUSTRY
First posted: 2013-01-07
Enrollment: 37
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Male 20 year ≤ age ≤ 40 year.
* Weight ≥ 55kg, IBW ±20%.
* Patients with normal hematology, biochemistry, urinary result.
* Patients who have not congenital or chronic disease.
* Provision of written informed consent voluntarily.

Exclusion Criteria:

* Patients having known hypersensitivity to any component of the study drug.
* Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
* Patients with any gastrointestinal disorders.
* Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg.
* Drug abuser, alcoholic.
* Patients taking ETC medication within 14 days, OTC within 7 days.
* Patients taking other investigational product within 60 days prior to the participation in the study.

Primary outcomes:
measure: Safety
timeFrame: 8day
measure: Pharmacokinetics
timeFrame: 8day
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam national university hospital
state: Chungnam
Study officials:
References:
Clinical trial NCT00951197: Evaluation of Alteration by Magnetic Resonance Imaging (MRI) in Dementia Among Elderly Subjects
Official title: Estimation of Microstructure Alteration by MRI in Dementia Among Elderly Subjects Retired From Agricultural Profession and Living in Rural Area in Gironde - Participants From the AMI Cohort.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Alzheimer Disease
Keywords: dementia
Alzheimer's Disease
diagnostic
biomarkers
neuroimaging
PET
MRI
mild cognitive impairment
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 318
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population retired from agricultural profession and living in rural area in Gironde

Brief summary: Capturing the earliest stages of Dementia especially Alzheimer's Disease (AD) is a great challenge. Until now the NINCDS-ADRDA and the DSM criteria for AD were largely used as diagnostic standards in research. However, the research on AD progresses and some biomarkers have been recently suggested to improve the diagnostic criteria of AD, such as cerebrospinal fluid markers, neuroimaging with Positon Emission Tomography (PET) or Magnetic Resonance Imaging (MRI).


Eligibility criteria: Inclusion Criteria:

* participate in the AMI cohort
* be aged 65 and older
* be retired from agricultural profession
* live in rural area in Gironde

Exclusion Criteria:

* contraindication of MRI
* left-handed
* severe dementia
* Parkinson's disease
* poor health incompatible with the transport to neuroimaging service
* to be left handed

Primary outcomes:
measure: FA (Fractional Anisotropy), MTR (magnetization transfer ratio) and T2 (Transverse relaxation time) measures in patients with dementia compared to controls, in left and right hippocampus, and posterior cingulum
timeFrame: day 0
Secondary outcomes:
measure: FA, MTR and T2 measures in subjects with mild cognitive impairment no dementia
timeFrame: day 0
measure: Performances in the 7 neuropsychological tests available in the AMI cohort
timeFrame: day 0
measure: FA measures for the connexion Hippocampus-cingulum posterior
timeFrame: day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Michèle ALLARD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03877705: Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients
Official title: Effect of Dissolving Xylitol Chewable Tablets Versus Xylitol Chewing Gum on Salivary pH and Bacterial Count in Geriatric Bedridden Patients : Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Saliva Altered
Plaque
Keywords: Dental Plaque , salivary pH
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Geriatric bedridden patients
Primary purpose: PREVENTION

Brief summary: This study will be conducted to evaluate the effectiveness of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.

Detailed description: This study will be conducted to evaluate the value of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients ,as an alternative to tooth brushing and mouth rinsing, in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.plaque and salivary sampling will be taken in certain time ,at baseline T0, then after 5minutes T1, then at 15 days T3. Salivary pH will be measured by using pH meter and streptococcus mutans bacterial count will be calculated through culture in mitis salivarius bacitracin

Eligibility criteria: Inclusion Criteria:

1. Age range above 65 years old
2. Bedridden patients
3. Males or females
4. Concious patients
5. Co-operative patients approving to participate in the trial.
6. Subjects who signed informed consent

Exclusion Criteria:

1. Individuals had taken antibiotics during the last four weeks or anticipated doing so during the study
2. Subjects who wore removable prosthesis
3. Patients with systemic diseases that have any oral manifestations
4. History of Smoking
5. Allergy to any of chewing gum or tablets ingredients
6. Evidence of tempromandibular joint disorders
7. Presence of intraoral infections
8. Currently using any mouth rinse

Primary outcomes:
measure: Salivary bacterial count
timeFrame: 15 days
Secondary outcomes:
measure: Interdental plaque Bacterial count
timeFrame: 15 days
Other outcomes:
measure: Salivary pH
timeFrame: 15 days
Locations:
city: Al Manyal
country: Egypt
facility: Faculty of dentistry
state: Giza Governorate
Study officials:
affiliation: Cairo University
name: Faculty Of Dentistry, Faculty
role: STUDY_DIRECTOR
References:
citation: Oza S, Patel K, Bhosale S, Mitra R, Gupta R, Choudhary D. To Determine the Effect of Chewing Gum Containing Xylitol and Sorbitol on Mutans Streptococci and Lactobacilli Count in Saliva, Plaque, and Gingival Health and to Compare the Efficacy of Chewing Gums. J Int Soc Prev Community Dent. 2018 Jul-Aug;8(4):354-360. doi: 10.4103/jispcd.JISPCD_54_18. Epub 2018 Jul 18.
Clinical trial NCT02195505: Use of Synvisc® in Knee Osteoarthritis - Medico-economical Study
Official title: Use of Synvisc® in Knee Osteoarthritis - Medico-economical Study (U.S.A.G.E. Médico-Economique)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 374
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rheumatological practice

Brief summary: The USAGE study aims at assessing on a long-term period (two years in average) the outcome in clinical or economical term of patients with knee osteoarthritis (OA) treated or not with Synvisc®, in the 1139.4 clinical trial.


Eligibility criteria: Inclusion Criteria:

* Patients have already been followed up on a nine-month period in a pragmatic medica-economical clinical trial (BI Trial No.: 1139.4)

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in Lequesne index
timeFrame: up to 2 years
measure: Change in Womac index
timeFrame: up to 2 years
Secondary outcomes:
measure: Medical costs related to knee osteoarthritis
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03724305: Reduce Emotional Symptoms of Insomnia With SleepTreatment
Official title: Reduce Emotional Symptoms of Insomnia With Sleep Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Rumination
Keywords: insomnia
nocturnal rumination
depression
mindfulness
mindfulness-based therapy for insomnia
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 21
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 purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal in patients with treatment-resistant insomnia.

Detailed description: Cognitive-behavioral therapy and pharmacotherapy are effective interventions for insomnia. Even so, about half of patients do not adequately respond to these treatments. Non-remission has been linked to high cognitive arousal that does not improve with traditional therapies. This study will examine the effects of mindfulness-based therapy for insomnia (MBTI) in a sample of patients who previously failed cognitive behavioral therapy and/or pharmacotherapy for insomnia.

This trial utilizes a single-arm, open label trial of MBTI. MBTI is delivered via telemedicine video in an individual therapy format.

Male and female participants who have insomnia, are age 18 and older, and who are recruited into the study will complete an initial assessment of their qualifications that are based on the severity of their insomnia symptoms, depression symptoms, and physical and mental health status. Eligible participants will undergo a clinical sleep interview and then complete 8 sessions of MBTI. Study outcomes are assessed via online survey before treatment, after treatment, and then a 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Determination of insomnia (ISI\>10)
* Inadequate response to prior insomnia psychotherapy (e.g., CBTI) and/or pharmacotherapy per patient report.

Exclusion Criteria:

* Age \< 18
* Current use of antidepressants for depression
* Bipolar or Seizure disorders
* Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)
measure: Five Facet Mindfulness Questionnaire-15 (FFMQ-15)
timeFrame: Pre-treatment, post-treatment (7 weeks after initiation of treatment), and 6 months follow-up (6 months following treatment conclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Health System - Columbus
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Christopher L Drake, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01319305: BREATHE Long-Term Follow-Up Study
Official title: BREATHE Long-Term Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Sinus Disease
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-21
Enrollment: 70
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: Participants who were treated with FinESS Sinus Treatment in the BREATHE I Study

Brief summary: This is a long-term follow-up of patients that participated in the BREATHE I study.


Eligibility criteria: Inclusion Criteria:

* Participated in BREATHE I study
* Willing to sign consent and participate in long-term follow-up study

Exclusion Criteria:

* None

Primary outcomes:
measure: SNOT-20 scores
timeFrame: approximately 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Cloud
country: United States
facility: St. Cloud ENT
state: Minnesota
Study officials:
References: