louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01674985: Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndromes
Keywords: Decitabine
microtransplantation
myelodysplastic syndromes
chemotherapy
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
Collaborators: name: The Second Artillery General Hospital
First posted: 2012-08-29
Enrollment: 43
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.


Eligibility criteria: Inclusion Criteria:

* patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
* International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
* bone marrow blasts \> 11% or \<= 10% and poor cytogenetics;
* lack of an HLA-identical donor;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
* adequate cardiac and hepatorenal functions.

Exclusion Criteria:

* have an HLA-identical donor

Primary outcomes:
measure: complete remission
timeFrame: six months
Secondary outcomes:
measure: disease-free survival
timeFrame: three years
Other outcomes:
measure: overall survival
timeFrame: three years
Locations:
city: Beijing
country: China
facility: Affiliated Hospital of Academy of Military Medical Sciences
state: Beijing
Study officials:
affiliation: Affiliated Hospital of Academy of Military Medical Sciences
name: Sheng Hui Ai, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo M, Hu KX, Yu CL, Sun QY, Qiao JH, Wang DH, Liu GX, Sun WJ, Wei L, Sun XD, Huang YJ, Qiao JX, Dong Z, Ai HS. Infusion of HLA-mismatched peripheral blood stem cells improves the outcome of chemotherapy for acute myeloid leukemia in elderly patients. Blood. 2011 Jan 20;117(3):936-41. doi: 10.1182/blood-2010-06-288506. Epub 2010 Oct 21.
Clinical trial NCT02383485: Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children
Official title: Exercise and Overweight Children's Cognition (Supplement)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Non-alcoholic Fatty Liver Disease
Keywords: arterial stiffness
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-03-09
Enrollment: 175
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. This project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program.

Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.

Detailed description: This is an ancillary study adding cardiometabolic outcome measures to an ongoing NIH-funded randomized trial of exercise in overweight children ("SMART study," R01 HL087923, P.I. Davis, NCT02227095). This presents the opportunity to obtain detailed measures of liver and vascular health to provide information about the effects of exercise on these conditions.

Eligibility criteria: Inclusion Criteria:

* 8-11 years of age
* Overweight or obese (BMI-for-age \>= 85th percentile)
* Able to participate in exercise testing and intervention
* Participating in the SMART Study

Exclusion Criteria:

* Medical condition or medications that would interfere with measurements
* Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week
* T-score \> 75 on the BRIEF Behavior Regulation scale to avoid program disruption
* Unable to complete magnetic resonance imaging.

Primary outcomes:
measure: Change in Liver Fat
timeFrame: Baseline, 8 Months
measure: Change in Arterial Stiffness
timeFrame: Baseline, 8 Months
Secondary outcomes:
measure: Change in Liver Fibrosis
timeFrame: Baseline, 8 Months
measure: Change in Liver Inflammation
timeFrame: Baseline, 8 Months
measure: Change in Quality of Life
timeFrame: Baseline, 8 Months
measure: Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices
timeFrame: Baseline
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Prevention Institute
state: Georgia
Study officials:
affiliation: 706-721-9551
name: Catherine L Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01496456: Radiographic Progression of Infiltrated Caries Lesions In-vivo
Official title: Radiographic Progression of Infiltrated Caries Lesions In-vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries
Proximal surfaces
Posterior teeth
Carious lesions
Tooth diseases
Preventive therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: DMG Dental Material Gesellschaft mbH
First posted: 2011-12-21
Enrollment: 17
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.

Detailed description: A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed incorporating a split-mouth intra-oral design. Young volunteers (14-35 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by infiltrating the lesions. The infiltration protocol included application of on-market materials and applicators, and was performed in one session.

Eligibility criteria: Inclusion Criteria:

* 14-35 year old subjects
* decayed-missing-filled permanent teeth (DMFT) ≥ 3
* having at least two early caries lesions in approximal posterior tooth surfaces
* lesion visible on radiograph

Exclusion Criteria:

* Current participation in another clinical study
* Medically compromised subjects
* Hyposalivation
* Pregnancy
* Allergic to methylmethacrylates
* Allergic to latex
* Symptomatic teeth

Primary outcomes:
measure: Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)
timeFrame: Baseline through 3 years
Secondary outcomes:
measure: Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories
timeFrame: Baseline through 3 years
measure: Lesion Survival After 3 Years
timeFrame: 3 years
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
Study officials:
affiliation: University of Michigan
name: Mathilde C Peters, DMD, PhD
role: STUDY_CHAIR
References:
citation: Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment. J Dent Res 92(Spec Iss A):377, 2013.
citation: Resin infiltration effects in a caries-active environment. J Calif Dent Assoc. 2014 Jun;42(6):372. No abstract available.
citation: Peters MC, Bula A, Nedley M, Davis W, Bayne SC. Efficacy of Resin Infiltration in High Caries-Active Environment -- 3YR Results. J Dent Res 93(Spec Iss B): 1017, 2014.
Clinical trial NCT01833156: Validation of the MoistureMeterD in Local Edema by Histamine
Official title: A Clinimetric Research to Test the Validity of the MoistureMeterD, Conducted by the Local Edema (Urticaria Acuta) Into the Administering of Intradermal Histamine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: local edema
dielectric constant values
validation study
Lead sponsor: Nij Smellinghe Hosptial
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In lymphedema there is increase in water content of the tissue. We studied a device (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the apparatus is commercially available, no validation study had been performed in vivo with local edema.

We designed a validation study for inter- and intra observer variability and the reproducibility in vivo by histamin induced local edema

Detailed description: The multiprobe Delfin MoistureMeterD is a unique and compact water-specific instrument for the measurement of water content of biological tissues. It measures the dielectric constant values of the skin and subcutaneous tissues non-invasively and locally in a few seconds. The dielectric constant value is directly proportional to the amount of water in the tissue.

As lymphedema produces local water content increase, we are interested if the device is suitable for daily use in lymphedema patients. Therefore we designed a protocol to measure the results with a moisturemeter in a standardized edema formation by histamin induced scratch test edema. This method is well known in type I allergy testing.

The aim of the study is:

1. research the inter- and intra observer variability
2. measure the reproducibility of edema formation in a standardized edema formation

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older;
* Coming for intra-cutaneous allergy scratch test;
* Gender: male and female.

Exclusion Criteria:

* Patients who have a pacemaker or other inbuilt stimulator;
* Lymphoedema;
* Patients who have an infection;
* Patients with skin problems in research area.
* No use of anti-histamines medication

Primary outcomes:
measure: amount of edema formation measured with a moisturemeterD of histamin reaction
timeFrame: october 2013
Secondary outcomes:
measure: validation of a Moisturemeter device for inter- and intra observer variability
timeFrame: october 2013
Other outcomes:
Locations:
city: Drachten
country: Netherlands
facility: Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
state: Friesland
Study officials:
affiliation: Nij Smellinghe Hospital
name: Robert J Damstra, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01131156: Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)
Official title: Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: postpartum
smoking
relapse
breastfeeding
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: Flight Attendant Medical Research Institute
name: March of Dimes
First posted: 2010-05-26
Enrollment: 54
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators hypothesized that an enriched focus on mother-infant bonding during a newborn's hospitalization in the Neonatal Intensive Care Unit would reduced the rate maternal postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had quit smoking during or just prior to pregnancy.

Detailed description: Mothers of newborns admitted to the Neonatal Intensive Care Unit (NICU), who had quit smoking during or just prior to pregnancy where randomized to either the Standard of Care or Smoking Relapse Prevention group. Mothers in both groups were encouraged to remain smoke free following the birth of their babies and were given routine lactation support for breastfeeding during their babies' hospitalization in the NICU. Mothers in the Smoking Relapse Prevention group were also given the study intervention, which was enhanced support for maternal-infant bonding by providing information about their newborn's behaviors using books, DVDs, and handouts that were appropriate for their baby's gestational age and by encouraging frequent skin-to-skin holding.

Primary outcomes included duration of smoke-free status and duration of breastfeeding.

Eligibility criteria: Inclusion Criteria:

* Mothers:

  * Who had quit smoking during pregnancy or within one year prior to pregnancy
  * Who had newborns \< 1 week old at the time of admission to our NICU.

Exclusion Criteria:

* Mothers:

  * Who were smokers at the time of delivery
  * Whose infant's length of stay \< one week
  * Who were not available (jail, adoption)
  * Who had a history of drug use
  * Who did not speak English

Primary outcomes:
measure: Duration of smoke-free status
timeFrame: 8 weeks postpartum
measure: Duration of breastfeeding
timeFrame: 8 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Children's Hospital
state: California
Study officials:
affiliation: Loma Linda University, School of Medicine
name: T. Allen Merritt, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02906956: Music and Adherence Home Programs Post Stroke
Official title: Music and Adherence in Upper Extremity Home Programs Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke
Lead sponsor: Duquesne University
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore whether adherence to upper extremity home programs changes when persons post stroke practice with preferred music.


Eligibility criteria: Inclusion Criteria:

* Ages 40-85
* Mild to Moderate hemiparesis as determined by a score of 21 to 50 on the FM- UE
* At least 6 months post stroke
* American English as primary language

Exclusion Criteria:

* Significant visual impairment as determined by "aphasia-friendly" and age appropriate screening
* Significant hearing impairment as determined by self-report
* Actively receiving occupational or physical therapy services for upper extremity motor recovery
* Severe auditory comprehension impairment such that they cannot understand one-step directions as indicated by a WAB-R score below 8/10 on Sequential Commands Subtest
* Sitting or standing blood pressure of 180/110 or HE \> 100 bpm

Primary outcomes:
measure: Number of sessions of practice
timeFrame: 4 weeks
measure: Duration of sessions of practice
timeFrame: 4 weeks
measure: Number of minutes of practice
timeFrame: 4 weeks
Secondary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: Baseline and no more than one week post intervention period
measure: Motor Activity Log
timeFrame: Baseline and no more than one week post intervention period
measure: Western Aphasia Battery - Revised
timeFrame: Baseline
measure: Cognitive Linguistic Quick Test
timeFrame: Baseline
Other outcomes:
measure: Qualitative Feedback Interview
timeFrame: No more than 3 weeks post intervention period
measure: Intensity of Practice
timeFrame: 4 weeks
Locations:
city: Pittsburgh
country: United States
facility: Duquesne University Speech, Hearing, Language Clinic
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Elena V Donoso Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00435656: Pharmacogenetics of Antiretroviral Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Human immunodeficiency virus
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Université Catholique de Louvain
First posted: 2007-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: HIV infected patients

Brief summary: In this research project, we will study the genetic determinants that influence the pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV.

Detailed description: The development of new active substances is a continuous source of progress in pharmacotherapy. However, the search for an optimal use of existing molecules constitutes another possible way of progress. In the particular field of anti-infectious therapy, an optimization of treatments could minimize the emergence of resistance phenomena that require the continuous development of new active molecules.

Pharmacogenetics is the scientific discipline seeking to improve the response to drug therapies (better clinical efficiency and reduction of side effects) by taking into consideration the genetic characteristics of the patient. Drugs with a narrow therapeutic index constitute a main target of this emerging field. The combination of therapeutic drug monitoring and pharmacogenetics already allows to optimize the use of some drugs among which oral anticoagulants, immunosuppressants, antiepileptics, antidepressors, antibiotics or antivirals....

In this research project, we will study the genetic determinants that influence the pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV. We will put a particular emphasis on viral protease inhibitors (atazanavir, saquinavir, lopinavir, ritonavir)and non-nucleosides reverse transcriptase inhibitors (nevirapine and efavirenz). For those drugs, the clinician often faces a double therapeutic risk, either of insufficient dosing (clinical inefficacy and emergence of resistance) or of excessive dosing (toxicity). The optimization of drug dosing is especially crucial because some of these drugs often represent the last choice in multi-resistant patients.

Eligibility criteria: Inclusion Criteria:

* HIV infected patients

Exclusion Criteria:

* pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires saint Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Vincent Haufroid, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03692156: Ultrasonic Morphological Study of the Great Auricular Nerve and Adjacent Structures
Official title: Morphological Study of the Great Auricular Nerve and Adjacent Structures by Ultrasound Imaging and Transcutaneous Nerve Stimulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Great Auricular Nerve
Keywords: sternocleidomastoid muscle
Superficial Cervical Plexus block
ultrasound
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent surgery in our hospital during the study, especially neck surgery, such as cervical surgery, thyroid surgery, and carotid endarterectomy.

Brief summary: Ultrasound-guided nerve block has the characteristics of high success rate, few complications, and high patient satisfaction. It has been widely used in brachial plexus and lumbar plexus nerve blocks. Studies of ultrasound-guided superficial cervical plexus block are mostly unsatisfactory, and may be due to anatomic localization of the puncture site rather than real-time ultrasound guidance. The great auricular nerve is the largest branch of the superficial cervical plexus and may be identified under ultrasound. The aim of this study is to establish the success rate of identification of the great auricular nerve by combining ultrasound imaging with transcutaneous nerve stimulation. In addition, we will study the relationship between the success rate of identification and the related factors of patients. Another purpose of this study is to locate the position where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle. The relationship between this point and the midpoint of posterior border of the sternocleidomastoid muscle and adjacent structures will also be studied.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery in changzheng hospital

Exclusion Criteria:

* Suffering from malignant tumors, poor overall condition
* Communication barriers, unable to objectively describe symptoms
* Huge mass in the neck

Primary outcomes:
measure: Success rate of identification of the great auricular nerve combining ultrasound imaging with transcutaneous nerve stimulation
timeFrame: 1 year
Secondary outcomes:
measure: Difference in gender
timeFrame: 1 year
measure: Difference in BMI
timeFrame: 1 year
measure: Difference in body fat rate
timeFrame: 1 year
measure: Difference in neck circumference
timeFrame: 1 year
measure: Success rate of identification of the great auricular nerve by ultrasound
timeFrame: 1 year
measure: Distance between GAP and M
timeFrame: 1 year
measure: SCM length
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changzheng Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01742156: Single Blind Randomized Study to Determine the Sensitivity and Specificity of 2 Non-invasive Markers of Early Coronary Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Keywords: CAD
microangiopathy
patients
more likely
to have tortuosity
of conjunctival vessels
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients (CCU) and Outpatients (CHF clinic, congenital heart clinic) who have had an angiogram within the past 12 weeks documenting the extent of coronary artery disease

Brief summary: Diagonal ear lobe crease and microcirculatory disorder in the conjunctiva are both non invasive methods documented in the literature as early signs of coronary artery disease. We wish to study the sensitivity and specificity of both signs by conducting a single blind study involving patients with documented presence or absence of coronary artery disease via angiogram.


Eligibility criteria: Inclusion Criteria:

* age 20 to 70 years old
* angiogram within past 12 weeks
* stable during post angio period
* willing to provide informed consent

Exclusion Criteria:

* previous eye surgery including cataract surgery
* previous ophthalmologic disorders
* previous surgeries involving ears or ear lobes

Primary outcomes:
measure: Presence of tortuosity of conjunctival vessels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Nadia Giannetti, MD
role: PRINCIPAL_INVESTIGATOR
References: