louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00349193: A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
Official title: A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions.

The duration of the current study is 36 weeks.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to give written informed consent
2. Confirmed MS diagnosis as defined by the McDonald criteria
3. R-R MS disease course.
4. At least one gadolinium-enhanced lesion on screening MRI
5. Women of child-bearing potential must practice a reliable method of birth control.
6. Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion Criteria:

1. Subjects who suffer from any form of progressive MS.
2. Any condition which the investigator feels may interfere with participation in the study.
3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
5. Previous treatment with immunomodulators within two months prior to screening

Primary outcomes:
measure: Reduction of brain lesions in the last 4 months of the study
timeFrame: 36 weeks
Secondary outcomes:
measure: Relapse rate
timeFrame: 36 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Teva Pharmaceutical Industries, Ltd.
name: Prof. Giancarlo Comi
role: STUDY_CHAIR
References:
citation: Comi G, Pulizzi A, Rovaris M, Abramsky O, Arbizu T, Boiko A, Gold R, Havrdova E, Komoly S, Selmaj K, Sharrack B, Filippi M; LAQ/5062 Study Group. Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet. 2008 Jun 21;371(9630):2085-92. doi: 10.1016/S0140-6736(08)60918-6.
Clinical trial NCT03400293: Real-world Insights of People With Human Immunodeficiency Virus (HIV) Infection
Official title: RISE: Real World Insights of People Living With HIV Shared Through Electronic Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Human Immunodeficiency virus
Health Related Quality of Life
Functional Assessment of HIV Infection
Mobile app
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Evidera
name: mProve
First posted: 2018-01-17
Enrollment: 1184
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PLHIV will be recruited advertising in digital media. The study plan is to collect a complete set of data from 3000 PLHIV during a 90-180 day period in the US.

Brief summary: This study is designed to identify the burden associated with HIV and its treatment, and assess their health-related quality of life (HRQoL) by measuring key HRQoL domains, including satisfaction with treatment and care, and internalised stigma (ISAT). The study will also explore data for various important subpopulations such as subjects who are virally suppressed; who we anticipate will be the majority of study subjects. The study design is an observational, cross sectional study employing subjects' own mobile phone devices for data entry.


Eligibility criteria: Inclusion Criteria:

* \>= 21 years old
* Language:Read and Understand English / Spanish
* Positive diagnosis of HIV infection by a healthcare provider (self-reported)
* Possesses a smartphone that has internet access

Exclusion Criteria:

* Not Applicable

Primary outcomes:
measure: Percentage of virally suppressed PLHIV reporting different HRQoL scores
timeFrame: Up to 1 Week
Secondary outcomes:
measure: Percentage of virally suppressed PLHIV reporting different satisfaction with care scores
timeFrame: Up to 1 Week
measure: Percent difference in HRQoL scores among subject subgroups
timeFrame: Up to 1 Week
measure: Percentage of subjects reporting different HRQoL scores and relationship with satisfaction with care
timeFrame: Up to 1 Week
measure: Percentage of subjects reporting diffferent HRQoL and medication adherence
timeFrame: Up to 1 Week
Other outcomes:
Locations:
city: Arlington
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02175693: Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition and Safety in Patients With Cervical Dystonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Keywords: Torticollis
rimabotulinumtoxinB
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 1647
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cervical dystonia

Brief summary: Investigation of the clinical condition and safety in patients with cervical dystonia


Eligibility criteria: Inclusion criteria:

Patients with cervical dystonia

Exclusion criteria:

The patients who participated in this surveillance in the past

Primary outcomes:
measure: Overall assessments of the improvement in the seriousness of seizures
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
name: Akira Endo
role: STUDY_DIRECTOR
References:
Clinical trial NCT05702593: Immediate Effects of Hamstring Stretching Alone or Combined With Myofascial Release
Official title: The Immediate Effects of Hamstring Stretching Alone or Combined With Myofascial Release of the Hamstring Muscle on Masseter Muscle Activity, Pressure Pain Threshold, Active Mouth Opening, Hamstring Flexibility, and Forward Head Flexed Posture in Recreationally Active Participants: A Randomized, Double-Blind, Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hamstring Injury
Masseter
Myofascial Release
Stretching
Surface EMG
Temporomandibular Joint Disorders
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a randomized, double-blind, controlled trial. The participants were randomly (randomisation was performed using the website www.randomiser.org ) allocated to one of two groups
Primary purpose: TREATMENT

Brief summary: To assess the immediate effects of hamstring stretching alone or combined with myofascial release of the hamstring muscle on masseter muscle activity, pressure pain threshold, active mouth opening, hamstring flexibility, and forward head flexed posture in recreationally active participants. The young, healthy, recreationally active adults aged 18-25 years were included in the study. The participants were randomly separated into two groups of equal number. Static stretching alone was applied to one group and this was combined with myofascial release techniques (SSMR) for the other group. Masseter muscle activity was assessed using a NORAXON® surface electromyography device. Both pre-and post-intervention, mechanical pressure algometer was used to measure the pressure pain threshold, hamstring flexibility was evaluated using the maximum hip flexion and active knee extension test, the maximum mouth opening (MMO) was measured with the millimetric ruler, and forward flexed posture was evaluated using the tragus to wall distance test.


Eligibility criteria: Inclusion Criteria:

* Individuals who had no previous hamstring injury
* Individuals had a Straight Leg Raise test \<80°
* Individuals had a pressure-pain threshold difference between two symmetrical points not exceeding 2 kg/cm2
* Individuals who had no previous hamstring injury had no deviation during mouth opening and closing

Exclusion Criteria:

* acute low back pain or musculoskeletal pain in the lower extremities
* recent spinal surgery
* previous whiplash injury

Primary outcomes:
measure: superficial masseter muscles EMG activity
timeFrame: 4 weeks
measure: Pressure pain threshold
timeFrame: 4 weeks
measure: Maximum Active Mouth Opening
timeFrame: 4 weeks
measure: Hamstring Flexibility
timeFrame: 4 weeks
measure: Tragus Wall Distance
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Caglar Soylu
state: Keçiören
Study officials:
References:
Clinical trial NCT01720693: Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy
Official title: A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Partial Nephrectomy
Renal Cell Carcinoma
Keywords: partial nephrectomy
hypoperfusion
renal function
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the standard treatment with a surgical, small, clinical T1 tumor (\<7 cm). In many recent studies, partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared with the standard radical nephrectomy over the short and long term (2, 3). Partial nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar clamping, which creates the desired bloodless operative field, allowing for more precise tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic kidney injury which can compromise the functional outcomes of the remaining kidney.We are working now to develop a novel technique of Hypo-Perfusion by achieving partial renal arterial clamping, with the goal of completely eliminating surgical ischemia to the renal remnant.


Eligibility criteria: Inclusion Criteria:

* Patient must be at least 18 years old scheduled for open partial nephrectomy

Exclusion Criteria:

* No prior diagnosis of renal artery disease

Primary outcomes:
measure: To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow
timeFrame: up to 2 weeks prior to surgery and up to 24 hrs post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Michael Jewett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05055193: Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia
Official title: Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extremely preterm infants less than 29 weeks' gestation

Brief summary: Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first month of life. However, this therapy remains controversial because it may induce suboptimal neurocognitive development. Parents of infants who receive postnatal corticosteroid should be provided with information about the risks. The objective of our work was to evaluate the respiratory, neurodevelopmental and growth outcomes at 24 months corrected age of extremely preterm infants who received postnatal corticosteroid.


Eligibility criteria: Inclusion Criteria:

* Extremely preterm infants less than 29 weeks' gestation
* Infants hospitalized for at least the first 30 days of life in the neonatology department of the Croix-Rousse Hospital in Lyon
* Infants born between January 1, 2013 and December 31, 2016

Exclusion Criteria:

* Infants with a congenital heart, lung or brain malformation
* Infants with a neuromuscular disease
* Infants with a genetic disorder
* Infants who died before the age of 24 months corrected age
* Infants lost to follow-up or with incomplete data at 24 months corrected age

Primary outcomes:
measure: Composite primary outcome combining: - Respiratory evolution at 24 months corrected age - Neurodevelopmental evolution at 24 months corrected age - Growth evolution at 24 months corrected age
timeFrame: at 24 months corrected age
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civil de Lyon
state: Rhone Alpes
Study officials:
References:
Clinical trial NCT06591793: Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
Official title: A Phase 1/2 Multicenter, Open-label, Dose Escalation, Safety and Efficacy Study of Subretinal Administration of Dual AAV8.MYO7A, AAVB-081 in Subjects With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Usher Syndrome, Type 1B
Keywords: Usher Syndrome
MYO7A
USH1B
Retinitis Pigmentosa
Lead sponsor: AAVantgarde Bio Srl
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the 081-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-081 in USH1B patients with retinitis pigmentosa due to a mutation in the MYO7A gene. The study will also assess the initial efficacy following AAVB-081 administration.


Eligibility criteria: Inclusion Criteria:

* Molecular diagnosis of USB1B due to MYO7A mutation
* Willingness to adhere to protocol per informed consent

Exclusion Criteria:

* Unwillingness to meet the requirements of the study
* Participation in a clinical study with an Investigation Product in the past 6 months
* Previous participation in another Gene Therapy trial
* Any condition that would preclude subretinal surgery
* Complicating ocular and/or systemic diseases

Primary outcomes:
measure: To measure the number and severity of treatment related adverse events following treatment with AAVB-081
timeFrame: 61 months
Secondary outcomes:
measure: Change from baseline in microperimetry following treatment with AAVB-081
timeFrame: 61 months
measure: Change from baseline in static perimetry following treatment with AAVB-081
timeFrame: 61 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania Luigi Vanvitelli
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: London
country: United Kingdom
facility: Retina Clinic London
Study officials:
References:
Clinical trial NCT01827293: Promethazine vs. Lorazepam for Treatment of Vertigo
Official title: Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Vertigo.
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Background history of positional vertigo

Exclusion Criteria:

* Unable to provide informed consent
* Pregnant or possibly pregnant
* Known allergy to study medications
* Use of antiemetic agents in the previous 24 hours
* Evidence of drug-induced vertigo or orthostatic hypotension
* Central pathologies/central origin for vertigo

Primary outcomes:
measure: Mean change in vertigo intensity.
timeFrame: At 2 hours after intervention.
Secondary outcomes:
measure: Efficacy and Safety outcome measures (nausea change-second dose-adverse events).
timeFrame: At 2-8 hours after intervention.
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of Neurology, Emam Hossein Hospital
state: Nezam Abad
Study officials:
References:
Clinical trial NCT00654693: NTX Wireless Patient Monitoring System
Official title: A Pilot Study to Evaluate the Performance of Nihon Kohden's NTX Wireless Patient Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Desaturation
Bradycardia
Tachycardia
Hypertension
Hypotension
Keywords: NTX
Nihon Kohden
mobile monitoring
monitoring
nihon
kohden
monitoring device
remote monitoring
wireless
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-04-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited in the Vanderbilt University Medical Center pre-operative clinic or in the Round Wing, after the effects of anesthesia have worn off. Before performing any trial-related procedures, written Informed Consent and HIPAA authorization will be obtained.

Brief summary: * Determine the accuracy of the NTX wireless monitoring system alerts
* Evaluate patient compliance with wearing device
* Determine false alarm rates

Detailed description: Approximately 150 patients will have wireless monitors attached to their arm. They will have their vital signs filtered through software that generates alerts and records data. The alert engine will produce pager and application based pop-up alerts which will be sent to the research nurse. Low and high limit alarms will be set according to the published guidelines (Hillman, K. et. Al., Resuscitation 48(2): 105-10, 2001) and adjusted at will by the response team.

During this portion of the study, the following research related procedures will be performed:

* begin continuous vital signs monitoring (BP - 1x per hour, 3 lead ECG -continuous, HR - continuous, SpO2 - continuous)
* PI or Co-PI will review each alert that's generated. The clinical significance will be determined and recorded in the study database
* Record patient's signs and symptoms daily
* Assess concomitant
* Assess AE's, SAEs

Eligibility criteria: Inclusion Criteria:

* Ability to give written informed consent
* Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing
* Patients must be ≥18 years of age

Exclusion Criteria:

* ICU patients
* Female subjects who are pregnant
* Patients \< 18 years of age
* Patients that have a contradiction for continuous Blood Pressure monitoring

Primary outcomes:
measure: Evaluation of patient compliance with wearing device
timeFrame: 24 hour minimum post op
Secondary outcomes:
measure: Determine accuracy of the NTX wireless monitoring system
timeFrame: duration of patient involvement
measure: Determine false alarm rates
timeFrame: duration of patient involvement
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: James M Berry, M.D.
role: PRINCIPAL_INVESTIGATOR
References: