louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01286493: Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination
Official title: Immune Response After Booster Vaccination in HIV - Infected Patients Who Ever Received Rabies Primary Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Rabies
Keywords: HIV
booster
rabies
immune response
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.

Detailed description: The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.

Eligibility criteria: Inclusion Criteria:

* HIV infected patients 18-60 years of age
* Ever received primary rabies immunization

Exclusion Criteria:

* currently have any active opportunistic infections
* have received blood or blood product within previous 3 months
* history of allergy to vaccine or any vaccine components
* currently received anti-malarial drugs

Primary outcomes:
measure: Rabies Neutralizing Antibody Titers
timeFrame: Day 360
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute
Study officials:
affiliation: Queen Saovabha Memorial Institute
name: Suda Sibunruang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00537693: Cytokine Removal by CRRT in Pediatric Sepsis
Official title: Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: Continuous Renal Replacement Therapy (CRRT)
Sepsis
Convection
Diffusion
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Dialysis Solutions Inc.
First posted: 2007-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This pilot study will compare the effect of diffusive versus convective Continuous Renal Replacement Therapy (CRRT) in children with sepsis who require CRRT.

The hypothesis for the study is that convective forms of CRRT provide enhanced clearance of cytokines and improved clinical responses as compared to a diffusive CRRT modality.

Detailed description: The purpose of this study is to test the hypothesis that convective forms of Continuous Renal Replacement Therapy (CRRT) provides enhanced clearance of cytokines compared to a diffusive CRRT modality. Also, we plan to test the hypothesis that patients who receive convective CRRT modalities demonstrate improved clinical responses to patients who receive a diffusive CRRT modality.

Eligibility criteria: Inclusion Criteria:

* Patients with documented sepsis or suspected SIRS
* Patients initiating CRRT
* Age 1 to 21 years

Exclusion Criteria:

* Patients on ECMO
* Patients receiving concomitant plasma exchange
* Cardiopulmonary bypass procedure within 96 hours of CRRT
* Patients with new onset acute leukemia
* Patients with active autoimmune disease
* Ungrafted stem cell transplant recipients

Primary outcomes:
measure: A 25% additional decrease in IL-6 concentration change
timeFrame: The First 24 hours of CRRT
Secondary outcomes:
measure: Other cytokine removal rates
timeFrame: First 24 hours of CRRT
measure: Cytokine absorption on the CRRT membrane
timeFrame: First 24 hours of CRRT
measure: Hemodynamic parameters
timeFrame: First 24 hours of CRRT
measure: Changes in serum cytokine concentrations and clearance
timeFrame: After crossover, from 24-48 hours
measure: Changes in serum cytokine concentrations
timeFrame: From beginning to end of the study, independent of modality
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: St. Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Grand Rapids
country: United States
facility: Helen De Vos Children's Hospital
state: Michigan
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Stuart Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04320693: Expanded Access for IMMU-132
Official title: Expanded Access for IMMU-132
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Metastatic Triple-Negative Breast Carcinoma
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2020-03-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to IMMU-132.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01659593: Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients
Official title: Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Disorders
Multiple Sclerosis
Keywords: cognitive disorders
multiple sclerosis
neuropsychology
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University Hospital, Strasbourg, France
name: Centre Hospitalier Universitaire Dijon
name: Centre Hospitalier Universitaire de Besancon
First posted: 2012-08-08
Enrollment: 140
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: Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the disease. They effect personal life. Their management may be overlooked. The evidence-based program proposes exercises to both stimulate preserved functions and develop new abilities compensating for cognitive disabilities.

Aim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed for MS patients, compared to an interactive discussion program(DISINT) 140 multiple sclerosis patients will be randomly assigned in one the program for 13 sessions over a 6-month period.

Main outcome criteria is evolution of SRT-LIST before and after program.


Eligibility criteria: Inclusion Criteria:

* 18 ≤Aged ≤ 60 at baseline
* Must be able to understand and read french language
* Must sign the informed consent form
* Must be affiliate to French social security
* multiple sclerosis confirmed by Mac Donald criteria
* EDSS ≤ 6.0 at baseline
* Duration of multiple sclerosis ≤ 30 years at baseline
* mild cognitive disorder ( at least 2 cognitive tasks, at most 5 )

Exclusion Criteria:

* under legal protection
* treatment by corticosteroids in the past 4 weeks
* cognitive remedial program already done
* neuropsychologic assessment in the past 2 months
* having an other chronic disease
* having an other neurologic disease
* alcohol or drug addiction

Primary outcomes:
measure: cognitive function measured by SRT-List score
timeFrame: 0-9 months
Secondary outcomes:
measure: quality of life measured by MusiQol
timeFrame: 0 -9 months
Other outcomes:
measure: cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint
timeFrame: 0-9 months
Locations:
city: Nancy
country: France
facility: University hospital Nancy
Study officials:
affiliation: CHU NANCY
name: Marc DEBOUVERIE, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU DE BESANCON
name: Eric BERGER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Dijon
name: Thibaut MOREAU, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de STRASBOURG
name: Jérôme de Sèze, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590693: Botulinum Toxin A for Idiopathic Toe-walking
Official title: Botulinum Toxin A Does Not Improve Cast Treatment for Idiopathic Toe-walking- a Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Toe-walking
Keywords: Gait
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether botulinum toxin A (BTX) adds a favourable effect to treatment of idiopathic toe-walking with below knee walking casts. The specific hypothesis to be tested is that a combination of BTX and casting is more effective than casting treatment alone in reducing toe-walking in 5-15 year old children. Evaluation methods include 3-D gait analysis, parents' perception of toe-walking frequency, passive joint range of motion measurements, and strength of ankle dorsal extension.


Eligibility criteria: Inclusion Criteria:

* Children with idiopathic toe-walking
* 5-15 years of age

Exclusion Criteria:

* Previous treatment for idiopathic toe-walking, such as, Achilles tendon surgery, casting, orthotics, and BTX treatment.
* Flexion contracture beyond -10 degrees in the ankle

Primary outcomes:
measure: Percentage of toe-walking
timeFrame: baseline, 3month, 12 month
Secondary outcomes:
measure: Joint range of movement
timeFrame: Baseline, 3 month, 12 month
measure: Classification of idiopathic toe-walking
timeFrame: Baseline, 3 month, 12 month
measure: Gait analysis parameters
timeFrame: Baseline, 3 month, 12 month
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Astrid Lindren Children's Hospital
Study officials:
affiliation: Karolinska Institutet
name: Pähr Engstrom, MD., Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engstrom P, Bartonek A, Tedroff K, Orefelt C, Haglund-Akerlind Y, Gutierrez-Farewik EM. Botulinum toxin A does not improve the results of cast treatment for idiopathic toe-walking: a randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):400-7. doi: 10.2106/JBJS.L.00889.
Clinical trial NCT06000293: Effectiveness of Strengthened Anticipatory Guidance Used in the MOH Malaysia Infant Oral Health Care Programme
Official title: The Effectiveness of Strengthened Anticipatory Guidance Used in the Ministry of Health Malaysia Infant Oral Health Care Programme: A Cluster Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early Childhood Caries
Knowledge, Attitudes, Practice
Keywords: Early Childhood Caries
Knowledge
Practice
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 220
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to assess the effectiveness of strengthened anticipatory guidance (AG) used in MOH Malaysia Infant Oral Healthcare Programme in preventing early childhood caries (ECC) lesions and improving caries risk of infants in Negeri Sembilan and their primary caregiver's knowledge and practice on infant oral healthcare

Detailed description: This randomised control trial study will be conducted at six government Maternal and Child Health Clinics (MCHCs) in Negeri Sembilan District, Malaysia. The samples comprised of 220 primary caregivers-infant pairs (110 pairs in the intervention group, and 110 pairs in the control group). A strengthened infant oral health module named the Oral Health Infant Module Anticipatory Guidance (OHIM AG) was designed to provide anticipatory guidance to the intervention group at three-month intervals over 6 months. The control group will receive the conventional Ministry of Health Anticipatory Guidance (MOH AG). The effectiveness of OHIM AG on early signs of childhood caries lesions development, caries risk of infants, and primary caregivers's knowledge and practice on infant oral healthcare will be assessed after six months of intervention.

Eligibility criteria: Inclusion Criteria:

* The infant and primary caregivers (parents/ caregivers) are a Malaysian citizen
* Primary caregivers can read and understand Bahasa Malaysia. This is because the AG will be conducted in Bahasa Malaysia, and the questionnaires are also in Bahasa Malaysia.

Exclusion Criteria:

* Infants with special needs, chronic diseases or conditions (e.g., stunting, failure to thrive and low birth weight) who are at risk for oral problems (e.g., higher risk of caries due to presence of hypomineralisation and hyperplasia) and require special oral health care.

Primary outcomes:
measure: Early dental caries lesion and dental caries risk exposure among infants
timeFrame: 6 months
measure: Knowledge and practice score on infant oral health care among primary caregivers (parents/ caregivers)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universiti Sains Malaysia
name: Munalizaini Mukhtar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04184193: Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM)
Official title: Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM) - a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphangioleiomyomatosis
LAM
Pulmonary Rehabilitation
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with a confirmed diagnosis of Lymphangioleiomyomatosis

Brief summary: Data from patients with the orphan disease of lymphangioleiomyomatosis (LAM) which performed a pulmonary Rehabilitation program will be analyzed retrospectively. Data will be taken from the internal data base of the reference Center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where These data were collected during clinical routine. Data will be included from the year 2000 until now. A retrospectively matched COPD cohort will be included for comparison.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of Lymphangioleiomyomatosis
* performed a pulmonary Rehabilitation program at the reference center

Exclusion Criteria:

* missing data
* repeated stay for pulmonary Rehabilitation at the reference center

Primary outcomes:
measure: Change from baseline 6 Minute walk distance at week 4
timeFrame: baseline and week 4
measure: Change from baseline Quality of life at week 4
timeFrame: baseline and week 4
Secondary outcomes:
measure: Change from baseline lung function at week 4
timeFrame: baseline and week 4
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schoen Klinik Berchtesgadener Land
Study officials:
affiliation: Schoen Klinik Berchtesgadener Land
name: Rembert A Koczulla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gloeckl R, Nell C, Schneeberger T, Jarosch I, Boensch M, Watz H, Wirtz H, Welte T, Kenn K, Koczulla AR. Benefits of pulmonary rehabilitation in patients with advanced lymphangioleiomyomatosis (LAM) compared with COPD - a retrospective analysis. Orphanet J Rare Dis. 2020 Sep 22;15(1):255. doi: 10.1186/s13023-020-01540-3.
Clinical trial NCT00074893: Protective Brace to Prevent Hand and Arm Injuries
Official title: Shock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Keywords: Repetitive Strain Injuries
Vibration Damping
Protective Brace
Piezoelectric
SmartWear
Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sponsor class: NIH
First posted: 2003-12-24
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: When people use hand-held power tools, their hands and arms vibrate along with the tool they are holding. People who frequently use hand-held power tools may develop injuries related to this vibration. This study will evaluate a protective brace designed to prevent vibration-related hand and arms injuries.

Detailed description: Workers who use hand-held power tools absorb significant vibration energy in their arms and hands and may develop musculoskeletal disorders (MSDs) such as carpal tunnel syndrome and hand-arm vibration syndrome. Protective braces may be worn to decrease the incidence of occupational MSDs. The National Institute for Occupational Safety and Health has identified key attributes for protective braces; these attributes include vibration damping, comfort, non-interference with worker dexterity, and maintenance of safe hand temperature. Most currently available braces do not adequately address these NIOSH requirements. This study will evaluate the efficacy of a brace with piezoelectric damping material.

Participants in the study will be fitted with a brace on each hand. One brace will have piezoelectric damping material and the other will be a currently available, off-the-shelf commercial brace. Hand-held joysticks and handles mounted to a vibration shaker table will be used to simulate power tool use. Participants will undergo a series of tests designed to measure hand acceleration and vibration while grasping the study joysticks and handles. The tests will take approximately 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Normal hand anatomy and full range of motion

Exclusion Criteria:

* History of significant hand or wrist arthritis
* Open wounds
* Prior hand or wrist surgery
* Neuropathies
* Skin hypersensitivity
* Contact dermatitis
* Reflex sympathetic dystrophy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hand Center
state: California
Study officials:
affiliation: SmartWear, LLC
name: Michael D. Pottenger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04397393: Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation
Official title: Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation: A Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anesthesia
IVF
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: population is defined by all females of Arab origin, booked for oocyte retrieval for the first time in our center

Brief summary: The primary aim is to verify if camel milk consumption has an impact on the amount of Midazolam needed to achieve a satisfactory level of sedation for oocyte retrieval, compared to patients never having consumed camel milk.

Detailed description: A pilot study will be performed on patients undergoing oocyte retrieval (OPU) for the first time, and correlated to camel milk consumption versus never consumed camel milk, as well as age, BMI (body mass index), number of follicles at the time of OPU, number of previous OPUs in other clinics, previous vaginal delivery, past medical history positive for chemo therapy, alcohol consumption, use of prescribed or illicit drugs, or chronic pain medication.

The main objective is to analyse if the consumption of camel milk, the frequency, or lack thereof correlates with the amount of the sedative drug Midazolam needed to achieve an acceptable level of sedation in order to estimate the dosage needed in both patient groups more adequately, reducing either discomfort felt at a too low an initial dosage, as well as avoiding a deeper level of sedation than needed with subsequent prolonged stay in recovery and unpleasant feelings of dizziness and drowsiness, potentially requiring antagonizing Midazolam by the use of Flumazenil, and reducing overall costs and length of stay in recovery and bed occupancy and enhancing patient experience and satisfaction.

Would this study enable the Investigators to determine further effect of camel milk on other drugs used for various other purposes, and lead to a change in dose regimen?

Eligibility criteria: Inclusion Criteria:

* Arab origin
* Female 18 -48 years of age
* BMI \< 37 kg/m2
* All ovarian stimulation protocols

Exclusion Criteria:

* Previous oocyte retrieval at our center
* Post chemo therapy
* Illicit drug use
* Chronic pain medication
* Medication which is known to increase the activity of liver enzymes
* Any alcohol consumption
* Previous vaginal delivery

Primary outcomes:
measure: Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertility Clinic
Study officials:
affiliation: IVI Middle East Fertility Clinic LLC
name: Nils Engelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004793: Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Disorders
Keywords: constitutional growth delay
endocrine disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Michigan
First posted: 2000-02-25
Enrollment: 4
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Evaluate the effect of bromocriptine on luteinizing hormone (LH) secretion by suppression of prolactin and stimulation of dopaminergic receptors in early pubertal boys and girls.

II. Evaluate the effect of baclofen on LH secretion by stimulation of gamma-aminobutyric acid receptors in early pubertal boys and girls.

Detailed description: PROTOCOL OUTLINE:

Participants receive bromocriptine or baclofen followed by nocturnal measurements of luteinizing hormone, growth hormone, and sex steroids. Pituitary reserve is evaluated with the administration of gonadotropin-releasing hormone, and in children undergoing assessment of short stature, standard provocative stimuli.

Eligibility criteria: * Short stature and/or constitutional growth delay
* No epilepsy or risk of epilepsy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Carol M. Foster
role: STUDY_CHAIR
References: