louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03976219: Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion
Official title: Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject is able and willing to comply with the schedule and protocol.

For implantation of DRG stimulator;

* Subject has been diagnosed with complex regional pain syndrome (CRPS I or II).
* Subject has had chronic, intractable pain of the groin or lower limbs for at least 6 months.
* Subject is indicated for implantation of an Abbott DRG stimulation system.
* Subject will be undergoing trial implantation of an Abbott DRG stimulation system.

For implantation of SCS;

* Subject has been diagnosed with chronic, intractable pain of the trunk and/or limbs.
* Subject is indicated for implantation of a SCS system.
* Subject will be undergoing implantation of an Abbott lead.
* Subject has had stable neurologic function in the past 30 days.
* Subject is able to provide informed consent.

Exclusion Criteria:

* Subject will be implanted with 3 or more DRG leads.
* Subject is currently participating in a clinical investigation that includes an active treatment arm.
* Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by physician examination.
* Subject currently has an active implantable device including an ICD, pacemaker, spinal cord stimulator, or intrathecal drug pump.
* Subject is a prisoner.
* Female subject is pregnant.

Primary outcomes:
measure: Pain level as measured by pain scale
timeFrame: Visit 1, up to 2 hours
measure: Evoked response amplitude for ECAPS
timeFrame: Visit 1, up to 2 hours
measure: Evoked response amplitude for SSEPs
timeFrame: Visit 1, up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jonathan Viventi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Nandan Lad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01079819: Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163
Official title: Randomized, Placebo-controlled, Double-blind, Single- and Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163 in Healthy Young Male and Elderly Male and Female Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects 18-45 yrs old and 65 yrs or older inclusive and postmenopausal female 65 yrs or older

Exclusion Criteria:

* Women of childbearing potential
* Gastrointestinal disorders
* Bleeding disorders
* Peptic ulcer disease
* Abnormal ECG
* Abnormal Clinical laboratory tests
* Abnormal Thyroid
* Congestive heart failure
* Cholecystectomy
* Asthma
* Hypertension
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access

Primary outcomes:
measure: Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance
timeFrame: Study Day 1 through study completion + 30 days
Secondary outcomes:
measure: Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), T-HALF and multiple-dose pk parameters (Cmax, Tmax, Cmin, AUC(TAU), T-HALF, and accumulation index will be derived from plasma concentration versus time data
timeFrame: Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials, Llc
state: California
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
city: Eatontown
country: United States
facility: Iberica Clinical Research Center
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00834119: Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)
Official title: Assessment of the Effectiveness of Regular Use of Intranasal Steroids in Alleviating Nasal Symptoms in Allergic Rhinitis When Used Alone or in Combination With Oral Antihistamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to determine the effectiveness of regular intranasal steroid use in alleviating allergic rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine. Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if patients fail to improve nasal symptoms.


Eligibility criteria: Inclusion Criteria:

* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent form
* Subjects must be between 18-65 years of age, of either sex and any race
* Subjects must be diagnosed by the physician to have moderate to severe allergic rhinitis according to ARIA guidelines.
* Subjects must be mometasone furoate naïve.

Exclusion Criteria:

* Significant comorbid medical condition.
* Respiratory tract infection.
* Any contraindications according to mometasone furoate product monograph.
* Patients who have received antihistamine treatment within the last 5 days.
* Patients who have received corticosteroid treatment within the last 30 days.
* Patients who are likely to require the administration of systemic steroids during the course of this program.
* Any condition which in the doctor's opinion could interfere with the patient completion of this program.
* Pregnant or lactating patients.
* Patients with local infections involving the nasal mucosa.
* Patients with structural abnormalities or who have undergone nasal surgery or trauma in the past 6 months.
* Patients with hypersensitivity to mometasone furoate or are allergic to corticosteroids.
* Patients who are prone to nose bleeding.

Primary outcomes:
measure: To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine.
timeFrame: Day 28 and Day 56
Secondary outcomes:
measure: Patient satisfaction with intranasal steroid monotherapy.
timeFrame: Day 28
measure: Potential benefit of an oral antihistamine in combination with an intranasal steroid
timeFrame: Day 56
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01016119: Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke
Official title: Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.

Detailed description: Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month. Each value will be compare to evaluate whether the groups of patient improve.

Eligibility criteria: Inclusion Criteria:

* Patients with acute stroke \< 24 hours.
* Patients with impairment up to 4 on NIHSS scale.
* Family support.
* Informed consent.

Exclusion Criteria:

* Presence of another disease not well controlled.
* Patient with dementia.

Primary outcomes:
measure: Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month (4 weeks).
timeFrame: 4 weeks
Secondary outcomes:
measure: Barthel index
timeFrame: 4 weeks
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: Salvador Allende Hospital
state: Havana
Study officials:
References:
Clinical trial NCT01559519: Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy
Official title: Effect of Albumine Infusion in the Prevention of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Keywords: TIPS
albumin
hepatic encephalopathy
hyponatremia
hypovolemia
cirrhosis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post tips hepatic encephalopathy'

Detailed description: The outcome is the prevention of post tips hepatic encephalopathy

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients
* TIPS placement
* Absence of Hepatic Encephalopathy at the enrolement
* Age \> 18 years
* No pregnancy

Exclusion Criteria:

* Non-cirrhotic portal hypertension
* Previous liver transplantation
* Impossibility to attend the scheduled follow-up including the weekly visit as outpatients during the first month after TIPS (see the description of follow-up below)
* Sings of overt hepatic encephalopathy as well as a history of persistent HE at entry. The latter as a contraindication for TIPS placement

Primary outcomes:
measure: one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement
timeFrame: one month post tips
Secondary outcomes:
measure: arterial blood pressure >120/80 mmHg and natremia >130 mg/dl in cirrhotic patients one month after TIPS placement
timeFrame: one month after tips placement
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: oliviero riggio, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01768819: Multimodal Physical Activity for the Elderly
Official title: The Effects of an Elderly-specific Multimodal Physical Activity Program: a Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Physical Activity
Keywords: aging
exercise
muscle strength
physical activity
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although some authors have observed favorable effects of group physical activity programs, others have reported that the individualized prescription of exercises may be jeopardized by programs that do not allow sufficient consideration of individual characteristics. Therefore, we aim to verify the effects of an elderly-specific multimodal physical activity program on physical parameters after one year of intervention.


Eligibility criteria: Inclusion Criteria:

* Participate in the Geriatric Revitalization Program for one year
* Be on the waiting list for the Geriatric Revitalization Program

Exclusion Criteria:

* Attend less than 75% of the physical activity program's activities
* Absent any of the three follow-up physical parameter evaluations

Primary outcomes:
measure: Static Balance
timeFrame: one year
Secondary outcomes:
measure: Aerobic Endurance
timeFrame: one year
measure: Dynamic Balance
timeFrame: one year
measure: Flexibility
timeFrame: one year
measure: Handgrip Strength
timeFrame: one year
measure: Body Mass Index
timeFrame: one year
measure: Body weight
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: José Rubens Rebelatto
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade de Salamanca
name: Francisco Albuquerque-Sendín
role: STUDY_DIRECTOR
affiliation: Universidade Federal do Espírito Santo
name: Alessandra Paiva Castro
role: STUDY_CHAIR
affiliation: Universidade Federal de Sao Carlos
name: Thais Rabiatti Aurichio
role: STUDY_CHAIR
affiliation: Universidade Católica de Brasília
name: Karla Helena Coelho Vilaça
role: STUDY_CHAIR
affiliation: Universidade Federal de Sao Carlos
name: Victor da Silva Aquino
role: STUDY_CHAIR
References:
Clinical trial NCT05456919: Quality of Sexual Function in BRCA Mutated Women
Official title: Quality of Sexual Function in BRCA Mutated Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: BRCA Mutation
Sexual Dysfunction
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Keywords: brca
sexual
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TBC

Brief summary: Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire.

Detailed description: We aim to investigate and compare the impact of diagnosis of BRCA, the impact of risk reducing surgery (RRS) and oncological diagnosis.

Eligibility criteria: Inclusion Criteria:

* TBC

Exclusion Criteria:

* TBC

Primary outcomes:
measure: Measurement of SFQ28 Score
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Federico Ferrari
state: BS
Study officials:
References:
Clinical trial NCT05596019: Specific Neurodynamic Exercises on Disability and Neck Pain in Old Women
Official title: Effectiveness of Specific Neurodynamic Exercises Compared With Non-specific Exercises on Disability and Neck Pain in Women Older Than 65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: exercise
neck pain
neurodynamic
elderly
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 56
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal prospective, controlled, single-blind study
Primary purpose: TREATMENT

Brief summary: This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of multimodal exercise with specific neurodynamic exercises and multimodal exercise with non-specific exercises in disability and neck pain in women older than 65 years.

The intervention in both groups will be carried out for 4 weeks, with three weekly sessions. Two evaluations will be carried out, a pre-intervention evaluation and a post-intervention evaluation. We will assess neck pain, disability, upper limb strength, cervical mobility, cervical pressure pain thresholds, kinesiophobia and catastrophism.


Eligibility criteria: Inclusion Criteria:

* Women older than 65 years.
* Neck pain

Exclusion Criteria:

* Tumors
* Pacemakers
* Fibrillations
* Cardiac pathology or uncontrolled hypertension
* History of severe trauma/recent cervical surgery
* Uncontrolled systemic and inflammatory pathologies
* Congenital collagen compromise
* Presence of difficulties in performing the Initial Evaluation tests
* Language barriers
* Pending litigation or legal claim

Primary outcomes:
measure: Pain intensity
timeFrame: four weeks.
measure: Neck disability
timeFrame: four weeks
Secondary outcomes:
measure: Cervical range of motion
timeFrame: four weeks
measure: Hand grip strength
timeFrame: four weeks
measure: upper limb strength
timeFrame: four weeks
measure: Pressure pain threshold
timeFrame: four weeks
measure: Kinesiophobia
timeFrame: four weeks
measure: Catastrophism
timeFrame: four weeks
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University of Salamanca
Study officials:
affiliation: University of Salamanca
name: Roberto Méndez-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02461719: Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes
Official title: Multicenter, Randomized, Double-blind phⅢ Study of TJCS Eye Drops Group and Restasis Eye Drops Group for 12 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 158
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 20 or over
* Patients with moderate to severe dry eye
* Screening both eyes, the corrected visual acuity is 0.2 or more

Exclusion Criteria:

* Screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions.
* Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
* Intraocular pressure(IOP)\> 25 mmHg
* Patient using or to use punctual plug within 1 months.
* Patients with contact lens.

Primary outcomes:
measure: Corneal staining test
timeFrame: 12 weeks
Secondary outcomes:
measure: Corneal staining test
timeFrame: 4, 8 weeks
measure: Conjunctival staining
timeFrame: 4, 8, 12 weeks
measure: Corneal and Conjunctival staining sum Score
timeFrame: 4, 8, 12 weeks
measure: Ocular surface disease index (OSDI)
timeFrame: 4, 8, 12 weeks
measure: Tear break up time (TBUT)
timeFrame: 4, 8, 12 weeks
measure: Non-anesthetic Schirmer test
timeFrame: 4, 8, 12 weeks
measure: Frequency of concurrent drug use
timeFrame: 4, 8, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
Study officials:
References:
Clinical trial NCT01152619: A Study of RO4989991 in Patients With Allergic Rhinitis
Official title: A Multi-center, Randomized, Observer-blind, Placebo-controlled Safety and Tolerability Study of Repeated Administration of Two Dose Levels of RO4989991 Administered Subcutaneously to Patients With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 24
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 multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis who are otherwise healthy. The anticipated time on study treatment is 2 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18-65 years of age, inclusively
* A history of allergic rhinitis diagnosed by a physician, but otherwise healthy
* A positive skin prick test to at least one standardized allergen at screening
* A body mass index (BMI) between 18 and 32 kg/m2, inclusively

Exclusion Criteria:

* History or presence of any respiratory disease or condition other than allergic rhinitis
* Use of prescription medication or herbal remedies within 14 days of dosing the study drug
* Use of over-the-counter (OTC) medications within 7 days of dosing the study drug
* Acute infection (including viral infections) 6 weeks (8 weeks for respiratory infections) preceding dosing or any ongoing chronic infection
* Positive test for human immunodeficiency virus (HIV) or hepatitis B or C

Primary outcomes:
measure: Assessment of the safety and tolerability of RO4989991
timeFrame: 24 weeks
Secondary outcomes:
measure: Assessment of pharmacokinetics
timeFrame: 24 weeks
Other outcomes:
Locations:
city: South Miami
country: United States
state: Florida
city: Normal
country: United States
state: Illinois
city: Raleigh
country: United States
state: North Carolina
city: Spartanburg
country: United States
state: South Carolina
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: