louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02150642: Probing Neural Circuitry for the Control of Movement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Movement Disorders
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: control subjects without neurological movement disorder AND patients with neurological movement disorder

Brief summary: The investigators are interested in examining 1) the basic organization of spinal and cortical circuitry for the control of movement and 2) the influence of injury of these circuits. To investigate the neuronal circuitry, the investigators use various types of mechanical or electrical stimulation of the limbs, transcranial magnetic stimulation of the cortex and galvanic vestibular stimulation in both uninjured human subjects and subjects with a neurological injury (such as spinal cord injury, or Parkinsons's disease).


Eligibility criteria: Inclusion Criteria:

* control subjects: no neurological movement disorder
* patients: neurological movement disorder

Exclusion Criteria:

patients and control subjects:

* presence of any central psychiatric disorder that precludes subject from giving informed and voluntary consent
* presence of any cardiovascular conditions or limitations that restrict the ability to walk on a treadmill continuously for more than 20 minutes
* for the electrical stimulation examination, subjects with metal implants are also excluded
* for the TMS and GVS examination, subjects with the following conditions are excluded: metal implants in the head, cardiac pacemakers, history of migraine headaches, history of major head injury, history of stroke, history of seizures, previous brain neurosurgery, unstable medical conditions, major psychiatric disorders, pregnancy -

Primary outcomes:
measure: Spinal reflex activity
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
Clinical trial NCT00181142: The Use of Daclizumab and Anti-Thymocyte Globulin in Lung Transplantation
Official title: A Phase 3 Study Comparing the Use of Daclizumab vs Thymoglobulin as Induction Therapy in Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Patients Active and Listed for Lung Transplantation
Keywords: Induciton therapy, Daclizumab, Thymoglobulin, lung transplantation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare outcomes in patients undergoing lung transplantation, using 2 different induction therapies. Primary outcome is survival and secondary outcomes include freedom from infection and freedom from rejection.

Detailed description: Acute and chronic allograft rejection are two of the common problems limiting and complicating the utility of lung transplantation. The timing and frequency of acute rejection has been shown to be a significant risk factor for the development of chronic allograft rejection. As an adjunct to standard triple immunosuppressive therapy, induction therapy is thought to decrease the incidence of acute rejection.Daclizumab is an interleukin 2 receptor (IL-2) antagonist which is FDA approved as an immunosuppressive agent. Thymoglobulin is an anti-lymphocyte immunosuppressive agent that has been shown in other solid organ transplant studies to be successful in delaying the first episode of rejection but has not decreased the incidence of Obliterative Bronchiloitis (chronic rejection)in lung transplantation.

Eligibility criteria: Inclusion Criteria:

* All patients accepted and listed for lung transplantation will be considered for randomization

Exclusion Criteria:

* Patients who demonstrate hemodynamic instability, requiring inotropes for greater than 48 hours prior to transplant
* Severe reperfusion pulmonary edema or primary graft dysfunction requiring FiO2 of \> 50% and PEEP \> 10 cm for greater than 48 hours prior to transplant
* Preoperative renal insufficiency (CrCl \< 50 gm.d or serum creatinine \> 2.0)
* Pre-operative panel reactive antibodies PRA
* Preoperative recipient bacterial or fungal colonization
* Preoperative antimicrobial suppressive therapy

Primary outcomes:
measure: All cause mortality at 2 years.
Secondary outcomes:
measure: 1)Freedom from 1st >/= A2 rejection episode and incidence of rejection over the first 2 years post-transplant
measure: 2)Freedom from infection
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: John V Conte, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05417542: Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants
Official title: Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Time Perception
Rhythm
EEG
fNIRS
ERP
Premature Neonates
Discrimination
Keywords: Time perception
rhythm
EEG
fNIRS
ERP
Premature neonates
Discrimination
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 28 and 40 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy


Eligibility criteria: Inclusion Criteria:

* Full term neonates between 28 and 40 weeks Gestational Age

Exclusion Criteria:

* Neonates outside the age range

Primary outcomes:
measure: Variations of the response of the cortical network using High Resolution Electroencephalography before auditory stimuli between the 5 infant groups
timeFrame: one day
measure: Variations of the response of the cortical network using High Resolution Electroencephalography during auditory stimuli between the 5 infant groups
timeFrame: one day
measure: Variations of the response of the cortical network using High Resolution Electroencephalography after auditory stimuli between the 5 infant groups
timeFrame: one day
measure: variations of the response of the cortical network using High Density Near Infrared Spectroscopy before auditory stimuli between the 5 infant groups
timeFrame: one day
measure: variations of the response of the cortical network using High Density Near Infrared Spectroscopy during auditory stimuli between the 5 infant groups
timeFrame: one day
measure: variations of the response of the cortical network using High Density Near Infrared Spectroscopy after auditory stimuli between the 5 infant groups
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT04911842: Midline Failures: A Comparison Between a Hydrophilic Biomaterial and Thermoplastic Polyurethane
Official title: Midline Failures: A Comparative, Retrospective Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Midline Catheter
Lead sponsor: Access Vascular Inc
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 205
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who needed a 4 Fr single lumen midline

Brief summary: Retrospective chart review to evaluate and compare the rate of failures between midlines made from different materials


Eligibility criteria: Inclusion Criteria:

* Subjects who have been inserted with the HydroMID by the vascular access group
* Subjects who have been inserted with a competitor 4 Fr single lumen by the vascular access team

Exclusion Criteria:

* Any off-label use (PICC lines cut to be midlines for any manufacturer)

Primary outcomes:
measure: The primary objective of this chart review is to evaluate the rates of failure of midlines made from different materials.
timeFrame: retrospective review- March 2021 through May 2021
Secondary outcomes:
measure: To compare the proportion of times the midline was used to successfully complete prescribed length.
timeFrame: retrospective review- March 2021 through May 2021
Other outcomes:
Locations:
city: Romeoville
country: United States
facility: Joseph Bunch
state: Illinois
Study officials:
References:
Clinical trial NCT00348842: Newcastle Disease Virus (NDV) for Cancer Patients Resistant to Conventional Anti-cancer Modalities
Official title: Phase II: Safety and Primary Efficacy of Clinical Application of Newcastle Disease Virus for the Treatment of Patients Resistant to All Conventional Modalities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Cancer
Newcastle Disease Virus (NDV)
Keywords: Immunotherapy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-07-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: NDV is a virus tht is harmful in chicken, but harmless in man. There are 2 major sub-strains of NDV, one oncolytic and one non-oncolytic. Oncolytic NDV (MTH-68H) preferentially homes and replicates in cancer cells and therefore, administration of NDV intravenously or preferentially intra-tumor, either by direct injection or by injection into an afferent artery results in direct lysis of tumor cells. NDV activates apoptotic mechanism in cancer cells and thus, results in natural cell death.

Both oncolytic and non-oncolytic NDV were used clinically in hundreds of patients with different types of cancer worldwide. NDV were proved harmless in man. Clinical studies were done for more than a decade and the efficacy of NDV was documented on pre-clinical animals models as well as in man.

For a large number of patients with metastatic cancer and chemotherapy resistant hematological malignances, no cure can be provided by conventional anti-cancer modalities, new treatment options are urgently indicated. The goal of the study is to use NDV, in order to provide such treatment for patients in need.


Eligibility criteria: Inclusion Criteria:

* Patients with the following disease category will be eligible:

Patients with metastatic lung cancer, metastatic GI cancer, metastatic urogenital cancer, skin and soft tissue cancer.

* Failure to anti-cancer modalties and evidence of progressive disease despite optimal application of all relevant available anti-cancer modalities.
* Consenting patients.
* The patient should sign a consent form stating that he/she will make sure to avoid any contact with chicken or any other species of birds.

Exclusion Criteria:

* Not fulfilling any of the above criteria.
* Moribund patients or patients with life-expectancy \<3 months.
* Karnofsky performance status \<60%.
* Pregnant or lactating women.
* Active local or systemic infections requiring treatment.
* Co-morbidity or life-threatening clinical condtion other than the basic cancer.

Primary outcomes:
measure: Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shimon Slavin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05097742: Cognitive Impairments in Children With Epilepsy
Official title: Interest of Speech Therapy in Children With Epilepsy: What Impairments of Cognitive Functions?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy Syndrome
Keywords: Speech therapy
Neurology
Children
Oral language
Attention
Type of epilepsy (focal epilepsy or generalized epilepsy)
Etiology of epilepsy (unknown, idiopathic, structural, metabolic, immune, infectious)
Epilepsy syndrome
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with epilepsy followed by Dr COLMARD at the Montpellier hospital and university center

Brief summary: Since the proportion of language and attentional difficulties in patients with epilepsy is recognized, both in the literature and in the clinical experience of practitioners, it is appropriate to propose a complete speech-language assessment of oral language and attention.This study investigates these impairments through the taking of specific tests.

The general objective of this study is to observe possible oral language and attention disorders in children with epilepsy, by age and etiology of epilepsy.

The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.


Eligibility criteria: Inclusion criteria:

The subjects should :

* Be at least 3 years old and at most 15 years old
* Be French speaker
* Be in a regular class
* Have a diagnosis of epilepsy

Exclusion criteria:

* Subjects schooled in IEM
* Subjects diagnosed with austim spectrum disorder
* Subjects with a motor or visual handicap
* Subjects with psychiatric disorders

Primary outcomes:
measure: Score in the different tests assessing oral language
timeFrame: day 1
Secondary outcomes:
measure: Score in the different tests assessing attention
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Maxime colmard, résident
role: PRINCIPAL_INVESTIGATOR
affiliation: UH MONTPELLIER
name: Moritz-Gasser Sylvie
role: STUDY_CHAIR
References:
Clinical trial NCT04520542: The Effect of Acupressure Application on Menopausal Symptoms
Official title: The Effect of Acupressure Application on Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopausal Syndrome
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted randomly controlled to determine the effect of acupressure application on menopausal complaints among women who applied to Cancer Early Diagnosis and Screening Center.

Detailed description: Research, between September 2019 and February 2020 of cancer in the body healthy life center in the east of the provincial center of Turkey was held by early diagnosis and screening center that refer to women.

The Universe and Sample of the Research The universe of the study consisted of women who applied to cancer early diagnosis and screening center for examination for any reason.

The calculation of the sample size of the study was determined according to the studies in which non-pharmacological methods were used to cope with menopausal symptoms. The calculation was determined according to the effect size of 0.5 in a moderate level, considering the effect size ranging between (0.25-0.83) reported by the studies on the subject.

Eligibility criteria: Inclusion Criteria:

* in the 45-65 age range.

Exclusion Criteria:

* receiving pharmacological treatment related to menopause,
* having a communication problem,
* have a hearing problem
* It is the presence of tissue deformity in its extremities.

Primary outcomes:
measure: Effect of Acupressure Application on Menopausal Symptoms
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Didem Simsek Kucukkelepce
Study officials:
References:
Clinical trial NCT00337142: Follow up Glucose Levels Among Infants of Diabetic Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn
Full Term
Diabetic Mother
Keywords: gestational diabetes
newborn
hypoglycemia
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-06-15
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Infants to diabetic mothers (IDM) are at risk for developing hypoglycemia after birth. Glucose level follow ups are recommended to each IDM. However, there are no recommendations as to how long this follow up should be performed for, nor are there "safe" glucose levels that allow stopping glucose monitoring.

The aim of the study is to retrospectively follow up glucose levels among IDMs in order to find risk factors for developing hypoglycemia and determine time and glucose levels that would permit monitoring cessation.

Detailed description: A retrospective study of 250-300 IDMs, born in a single large medical center. Data will be collected as follows: Gestational age, birth weight, sex, delivery mode, type of maternal diabetes, other maternal diseases, feeding mode. Glucose levels as were recorded according to newborn protocol (1,2,4,6 hours after delivery, and then every 8 hours for total of 48 hours). Data of hypoglycemia treatment, if given, will be collected.

Later we will statistically try to determine the risk factors for developing hypoglycemia and the "safe" time and glucose levels to stop monitoring.

Eligibility criteria: Inclusion Criteria:

* Full-term infants, diabetic mothers, Singleton

Exclusion Criteria:

* Preterm infants, multiple pregnancy, congenital malformations, clinically ill at birth.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Ayala Maayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00685542: Effect of Diacerein on Hand Osteoarthritis
Official title: Phase IV Study of Diacerein in Human Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: diacerein
osteoarthritis
hand
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Myungmoon Pharm. Co.
First posted: 2008-05-28
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ostearthritis is one of the most common arthritis, affecting more than 30% of aged people world-widely. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. It commonly affects knee, hip, hand and spine joints. Diacerein is a drug developed specifically for the treatment of osteoarthritis. It has inhibitory effects on interleukin-1 (IL-1) and metalloproteases which are known to play key roles in the pathogenesis of osteoarthritis while exerting no effect on phospholipase A2, cyclooxygenase or lipoxygenase. It showed anti-inflammatory effects on animal models and reduced structural changes in several animal models. Therefore, we investigate the role of diacerein in patients with hand osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Ages over 40 years-old
* Conforming to the classification criteria of American College of Rheumatology\*
* More than 1 tender joints
* Self reported hand pain which is more than 30 mm on the Australian/Canadian Osteoarthritis Hand Index visual analogue scales (VAS) after wash out period of 2 weeks

Exclusion Criteria:

* Pregnant or lactating women
* Previous history of hypersensitivity to Diacerein
* Patients who had taken oral corticosteroid or intraarticular steroid to hand joints within 3 months of enrollment
* Patients who were injected with hyaluronic acid to hand joints within 6 months of enrollment
* Patients who underwent surgery in any joints of the hands
* AST/ALT \> 2x upper normal range
* Serum Cr \> 1.4 mg/dl
* Patients who have severe comorbidities such as severe congestive heart failure or pulmonary disease
* Patients who took oral anticoagulants.
* Patients who refuse to sign the consent form

Primary outcomes:
measure: Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point
timeFrame: 12 weeks
Secondary outcomes:
measure: AUSCAN stiffness score at 4 week point
timeFrame: 12wks
measure: AUSCAN pain score at 12 week point
timeFrame: 12wk
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Eun Bong Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin K, Kim JW, Moon KW, Yang JA, Lee EY, Song YW, Lee EB. The efficacy of diacerein in hand osteoarthritis: a double-blind, randomized, placebo-controlled study. Clin Ther. 2013 Apr;35(4):431-9. doi: 10.1016/j.clinthera.2013.02.009. Epub 2013 Mar 6.