louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01884064: Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia
Official title: Multiple Sessions of Low-frequency Repetitive Transcranial Magnetic Stimulation in Focal Hand Dystonia: Clinical and Physiological Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dystonia, Focal, Task-specific
Keywords: focal hand dystonia
rehabilitation
rTMS
writer's cramp
clinical
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Dystonia Medical Research Foundation
name: National Institutes of Health (NIH)
name: National Center for Research Resources (NCRR)
First posted: 2013-06-21
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigated the short term effects of repeated administrations of repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate neurophysiologic responses to rTMS of the activated motor system in patients with FHD.

Detailed description: Purpose: The ability of low-frequency repetitive transcranial magnetic stimulation (rTMS) to enhance intracortical inhibition has motivated its use as a potential therapeutic intervention in focal hand dystonia (FHD). In this preliminary investigation, we assessed the physiologic and behavioral effects of multiple sessions of rTMS in FHD. Methods: 12 patients with FHD underwent five daily-sessions of 1 Hz rTMS to contralateral dorsal premotor cortex (dPMC). Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. We hypothesized that an active but non-dystonic motor state would increase beneficial effects of rTMS. Five additional patients received sham-rTMS protocol. The area under curve (AUC) of the motor evoked potentials and the cortical silent period (CSP) were measured to assess changes in corticospinal excitability and intracortical inhibition, respectively. Behavioral measures included pen force and velocity during handwriting and subjective report.

Eligibility criteria: Inclusion Criteria:

* Task specific Focal Hand Dystonia

Exclusion Criteria:

* any neurologic condition other than FHD
* medication for dystonia
* botulinum toxin within the past three months
* seizure history
* pregnancy
* implanted medical devices

Primary outcomes:
measure: Cortical Silent Period
timeFrame: Baseline and Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Program in Physical Therapy, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Teresa J Kimberley, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kimberley TJ, Borich MR, Arora S, Siebner HR. Multiple sessions of low-frequency repetitive transcranial magnetic stimulation in focal hand dystonia: clinical and physiological effects. Restor Neurol Neurosci. 2013;31(5):533-42. doi: 10.3233/RNN-120259.
Clinical trial NCT01760564: Application of Miglustat in Patients With Niemann-Pick Type C
Official title: Application of Miglustat in Patients With Niemann-Pick Type C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Niemann-Pick Disease Type C
Keywords: Niemann-Pick disease type C
miglustat
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the changes in cognitive function after miglustat treatment in Niemann-Pick type C patients.

Detailed description: Patients with Niemann-Pick C disease will be treated with Miglutat 200mg tid. Neurologic evaluation and safety will be monitored periodically.

Eligibility criteria: Inclusion Criteria:

* Confirm diagnosis of Niemann-Pick C disease
* Symptomatic including motor or mental symptoms

Exclusion Criteria:

* Unknown severe diarrhea for more than 7 day
* Allergy to miglustat

Primary outcomes:
measure: Swallowing
timeFrame: 12th month
Secondary outcomes:
measure: Mental
timeFrame: 12th month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Whu-Liang Hwu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chien YH, Peng SF, Yang CC, Lee NC, Tsai LK, Huang AC, Su SC, Tseng CC, Hwu WL. Long-term efficacy of miglustat in paediatric patients with Niemann-Pick disease type C. J Inherit Metab Dis. 2013 Jan;36(1):129-37. doi: 10.1007/s10545-012-9479-9. Epub 2012 Apr 5.
Clinical trial NCT02150564: 3D Ultra Sound for Resection of Brain Tumors
Official title: Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Resectable Brain Tumors
Keywords: Malignant gliomas
Sono RCT
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2014-05-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Phase 3 randomized open labeled trials will evaluate the 3 D navigable ultrasound (SonoWand) in improving the extent of resection in intra-axial brain tumors. All patients will undergo resective surgery. In the experimental arm, a navigable 3 D ultrasound will be used. In the standard arm, only navigation will be used. This study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of SonoWand in predicting residue (histopathological correlation).

Detailed description: Routine presurgical evaluation of all patients will be conducted. The preoperative use of steroids, antiepileptics and other medications would be as per standard procedure and would be documented. In addition detailed MRI evaluation will be performed (including contrast enhanced MRI study, diffusion MRI, perfusion MR, MR spectroscopy, dynamic-contrast-enhanced MRI for permeability studies, as well as functional MRI, and tractography if required) not more than 1 week prior to the date of surgery.

Navigation specific MR sequences would be performed in all patients (both arms).

Eligibility criteria: Inclusion Criteria:

1. All radiologically-suspected, previously untreated, supratentorial malignant gliomas being considered for debulking surgery.
2. Adults (above 18 years)
3. Eligible for surgical therapy (craniotomy not stereotactic biopsy )
4. Resectability : A lesion would be considered "resectable" if the surgeons feel that all the radiologically imaged lesion can be removed (with reasonable certainty). Only deemed resectable lesions will be included

Exclusion Criteria:

1. Unfit for GA
2. Unwilling for the study
3. Unresectable lesion

Primary outcomes:
measure: Percentage of patients where Gross total resection (GTR) achieved
timeFrame: Post operative within 72 hrs.
Secondary outcomes:
measure: Accuracy of US
timeFrame: Post operative within 72 hrours
Other outcomes:
measure: Further resection prompted
timeFrame: Intraoperative
measure: Survival
timeFrame: 3 years
Locations:
city: Mumbai
country: India
facility: Advanced Centre for Treatment Research and Education in Cancer
state: Maharashtra
Study officials:
affiliation: Prof and Neurosurgeon
name: Aliasgar V Moiyadi, Neurosurgery
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02177864: Fiber Health Benefits
Official title: Health Benefits and Tolerance of Dietary Fiber Supplements in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that fiber supplementation will provide measurable differences in indices of children's health (fewer complaints of abdominal pain and constipation, lower body mass index) compared to placebo.

Detailed description: This prospective study proposes supplementing children with fiber or placebo for four months. Children in elementary school, ages 5-12, will be randomized to receive fiber supplemented bars vs low-fiber snack bars (placebo).

Eligibility criteria: Inclusion Criteria:

-Children bewteen ages of 5-12 years

Exclusion Criteria:

* History of allergy/intolerance to components of the snack bars (e.g. celiac disease)
* History of Hisrchsprungs disease, abdominal surgery to intestine or colon
* Unable to take a fiber bar by mouth

Primary outcomes:
measure: Change in stool frequency
timeFrame: 4 months
measure: Change in stool consistency
timeFrame: 4 months
Secondary outcomes:
measure: Change in weight
timeFrame: 4 months
measure: Change in quality of life score
timeFrame: 4 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Warren Bishop, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00773864: Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community-Healthcare Workers
Official title: Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community- the Role of Healthcare Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Methicillin-Resistant Staphylococcus Aureus
ESBL
Keywords: Healthcare employees who work in the rehabilitation center
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-10-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare employees) including: doctors, nurses, nurse aids, physical therapists, dietitians, Janitors and other medical staff) who work in the rehabilitation center

Brief summary: Medical staff will be screened for MRSA and ESBL (including: doctors, nurses, nurse aids, physical therapists, dietitians, Janitors and other medical staff).

PURPOSE:

To define the carriage of, and risk factors for carriage of resistant organisms among healthcare employees of carriers of resistant bacteria.

To define activities of healthcare employees who likely to lead to dissemination of resistant bacteria in rehabilitation centers.

Detailed description: Detailed activity:

Medical staff will be screened for MRSA and ESBL (including: doctors, nurses, nurse aids, physical therapists, dietitians, Janitors and other medical staff).

Screening will be performed by obtaining nares and perirectal cultures. Nares cultures will be obtained by ward staff or research personnel who are experienced in performing this activity: a moisture swab will be applied gently to the distal part of both nares. Perirectal cultures, will be taken by swab, who will be applied to the perirectal area, either by staff as mentioned above, or will be given to the healthcare workers to perform by himself (with explanation on how to perform it).

Eligibility criteria: Inclusion Criteria:

* Health care employees

Exclusion Criteria:

* Age 18 years or less

Primary outcomes:
measure: Healthcare employees) including: doctors, nurses, nurse aids, physical therapists, dietitians, Janitors and other medical staff) who work in the rehabilitation center
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-aviv
country: Israel
facility: Tasmc
Study officials:
affiliation: TASMC
name: Yehuda carmeli, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albrich WC, Harbarth S. Health-care workers: source, vector, or victim of MRSA? Lancet Infect Dis. 2008 May;8(5):289-301. doi: 10.1016/S1473-3099(08)70097-5.
citation: Carmeli Y, Venkataraman L, DeGirolami PC, Lichtenberg DA, Karchmer AW, Samore MH. Stool colonization of healthcare workers with selected resistant bacteria. Infect Control Hosp Epidemiol. 1998 Jan;19(1):38-40. doi: 10.1086/647705.
Clinical trial NCT00537264: A Comparison of Computerised Versus Interviewer-administered Approach for Assessing Health-related Quality of Life
Official title: A Randomized Controlled Trial Comparing Computer- Versus Interviewer-administered Approach for Assessing Health-related Quality of Life in Multi-Ethnic Singapore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Heart Disease
Hypertension
Stroke
Keywords: health-related quality of life
primary care
computer-assisted instruction
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2007-10-01
Enrollment: 4800
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to compare a multimedia, computerised approach vs. interviewer administration of health-related quality of life (HRQoL) instruments.

Detailed description: There are no drug treatments involved in this study. The administration of health-related quality of life questionnaires is the intervention being studied. Health-related quality of life questionnaires measure the physical, mental and social well-being of an individual, are recognised as important patient-reported outcomes and are increasingly being used in clinical trials and routine clinical practice. By asking study participants to complete a questionnaire assessing their physical, mental and social well-being, we are increasing their awareness of these aspects of their health and may directly or indirectly prompt them to take actions and/ or have thoughts that may improve or worsen their health status. Hence, we have considered this an interventional study. This survey will be conducted in Chinese.

Eligibility criteria: Inclusion Criteria:

* Patients aged 21 and above
* Singaporean citizens or permanent residents
* Speaks Mandarin

Exclusion Criteria:

* Patients who are mentally incapable of completing a questionnaire

Primary outcomes:
measure: Health-related quality of life outcomes
timeFrame: Past 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Geylang Polyclinic, 21 Geylang East Central
Study officials:
affiliation: Singapore General Hospital
name: Julian Thumboo, FRCP (Edin)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thumboo J, Wee HL, Cheung YB, Machin D, Luo N, Fong KY. Development of a Smiling Touchscreen multimedia program for HRQoL assessment in subjects with varying levels of literacy. Value Health. 2006 Sep-Oct;9(5):312-9. doi: 10.1111/j.1524-4733.2006.00120.x.
Clinical trial NCT02055664: The Tap Block Technique Via the Anterior Approach in Elective Surgery of the Spine
Official title: THE TAP BLOCK TECHNIQUE VIA THE ANTERIOR APPROACH IN ELECTIVE SURGERY OF THE SPINE: Prospective, Randomised, Double Blind Trial, Comparing TAP BLOCK With Continuous Infiltration of Ropivacaine Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Elective Surgery of the Spine by Laparotomy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo.

Procedure:

Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a catheter inserted by the anaesthetist.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 yo who have provided written informed consent
* Patients with an indication for elective spinal surgery using laparotomy
* Patients with national health insurance cover

Exclusion Criteria:

* Adults under guardianship
* Pregnant or breast-feeding women
* allergies or contra-indication for paracetamol, morphine-based drugs
* Contra-indication for ropivacaine
* Contra-indication for sodium chloride
* inability to understand PCA (patient-controlled anaesthesia)
* Hypersensitivity to ropivacaine or to other aminoamide local anaesthetics
* Hypovolemia

Primary outcomes:
measure: Consumption of morphine in mg
timeFrame: First 48 hours following the surgery
Secondary outcomes:
measure: Intensity of pain
timeFrame: First 48 hours following the surgery
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
Clinical trial NCT03925064: Fetal Myocardial Performance Index in Diabetic Pregnancies
Official title: Fetal Myocardial Performance Index in Diabetic Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Myocardial Dysfunction
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-40 years old pregestational or gestational diabetic women

Brief summary: The myocardial tissue is the most likely structure affected by hyperglycemia. The myocardial performance index (MPI) is a pulsed wave Doppler-derived index of global myocardial function. It is defined as the sum of the isovolumetric contraction time (ICT) and isovolumetric relaxation time (IRT) divided by the ejection time (ET) The fetal right heart contributes more to the cardiac output than the left heart; therefore, it is important to assess the right ventricular function. The investigators will measure right ventricular MPI in diabetic and normal pregnancies.

Detailed description: Gestational diabetes mellitus (GDM) is the most common metabolic disorder in pregnancy, with an overall prevalence of 3-7 % during pregnancy. The myocardial tissue is the most likely structure affected by hyperglycemia. The myocardial performance index (MPI) is a pulsed wave Doppler-derived index of global myocardial function. It is defined as the sum of the isovolumetric contraction time (ICT) and isovolumetric relaxation time (IRT) divided by the ejection time (ET) The fetal right heart contributes more to the cardiac output than the left heart; therefore, it is important to assess the right ventricular function. The investigators will measure right ventricular MPI in diabetic and normal pregnancies.

Eligibility criteria: Inclusion Criteria:

* 18-40 years old pregnant women

Exclusion Criteria:

* fetal cardiac anomalies
* multiple gestations

Primary outcomes:
measure: ultrasonographic myocardial performance index values
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni SSRTH
Study officials:
References:
Clinical trial NCT06369090: Effect of Breast Size on the Electrical Impedance Tomography Measurement
Official title: Effect of Women Breast Size on Lung Monitoring Using Electrical Impedance Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Breast Tissue on EIT Lung Monitoring
Keywords: Breast tissue
Electrical impedance tomography
Regional ventilation
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monitoring of 22 subjects, each subject was measured twice with electrode belt in two different positions.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Twenty-two healthy female volunteers were monitored using electrical impedance tomogprahy (EIT) in two different situations. First, with electrode belt placed over the breast tissue and second, with the electrode belt under the breast tissue. The EIT measurement was performed with adjunct spirometric measurement. The changes of regional ventilation related to the breast tissue and the size of breast tissue were evaluated.

Detailed description: The EIT measurement (PulmoVista 500, Dräger Medical, Germany) was performed in supine lying position. On every subject, an electrode belt of proper size based on the measured thorax circumference was placed. It was crucial to find a right position where it was possible to place the electrode belt over the breast tissue and then underneath the breast tissue, without changing the level and the position of the electrode belt on the thorax. Also, the position of the belt had to be between 4th and 6th intercostal space, as recommended by the manufacturer. The change of the position of the belt relative to the breast tissue was performed in a lying position by a slight pull of the buckled belt away from the subject´s body, so the subject could relocate the breast tissue over the belt using her own hands into the position as desired by the researcher.

Eligibility criteria: Inclusion Criteria:

* healthy female volunteers

Exclusion Criteria:

* morbid obesity
* standard exclusion criteria for electrical impedance tomography according to the manufacturer

Primary outcomes:
measure: Regional ventilation changes possibly caused by the breast tissue
timeFrame: 30 minutes
Secondary outcomes:
measure: Female subjects enrollment in EIT studies and clinical applications
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Faculty of Biomedical Engineering, Czech Technical University in Prague
Study officials:
affiliation: Faculty of Biomedical Engineering, Czech Technical University in Prague
name: Karel Roubik, Prof. Ph.D.
role: STUDY_DIRECTOR
References: