louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06482372: A Pilot Study of Repetitive Transcranial Magnetic Stimulation
Official title: Effects of Repetitive Transcranial Magnetic Stimulation Combined With Mirror Therapy on Upper Limb Function in Patients With Stroke: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Mirror Therapy
Transcranial Magnetic Stimulation
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke patients often have long-term upper limb dysfunction. Currently, there is still no specific clinical treatment for nerve damage. After acute treatments of stroke, patients' motor ability can only improve by spontaneous recovery of brain and rehabilitation treatment.

Transcranial magnetic stimulation uses a magnetic field pulse generated by a coil outside the skull to pass through the skull. It uses the principle that magnetic electricity can generate currents, which activates nearby brain areas or changing the relationship between the left and right brains. Transcranial magnetic stimulation is a non-invasive, safe treatment.

Mirror therapy is an emerging rehabilitation method in recent years. As mirror therapy, therapists ask the patient to place the affected hand behind the mirror while looking at the image reflected by the unaffected upper limb. During mirror therapy, patients have to perform upper limb activities and imagine that the affected upper limb is performing the same action.

As mentioned above, transcranial magnetic stimulation and mirror therapy improve the recovery of stroke patients by two different ways. Currently, there are no studies that combine these two treatments. Therefore, our study hopes to initially explore the efficacy of transcranial magnetic stimulation and the efficacy of transcranial magnetic stimulation combined with mirror therapy.


Eligibility criteria: Inclusion Criteria:

* at least 1 month after stroke
* manual muscle strength \< 5

Exclusion Criteria:

* history of epilepsy
* has other central nervous system diseases
* has electric medication pump
* has implant at inner ear

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA) - upper extremity
timeFrame: week 0, week 6, week 12
measure: Nine-hole peg test
timeFrame: week 0, week 6, week 12
measure: Action research arm test
timeFrame: week 0, week 6, week 12
measure: Box and block test
timeFrame: week 0, week 6, week 12
measure: Functional independence measurement
timeFrame: week 0, week 6, week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05119972: Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis （IPF）
Official title: A Multi-center, Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, PK and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 15
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: This study was divided into two parts. The first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of ZSP1603 in IPF patients. The second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of ZSP1603 in the treatment of IPF at the target dose.


Eligibility criteria: Inclusion Criteria:

* IPF diagnosed, according to 2018 American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management;
* Dlco (corrected for Hb): 30%-79% predicted of normal;
* FVC\>= 50% predicted of normal;

Exclusion Criteria:

* FEV1/FVC\< 0.7;
* PaO2 in resting state without oxygen inhalation \< 50mmHg;
* Subjects who were likely to be lung transplant recipients or expected to survive less than 1 year during the study period as assessed by the investigator;
* Poorly controlled cardiovascular and cerebrovascular diseases;
* Patients who had used nidanib, pirfenidone, interferon, n-acetylcysteine, azathioprine, cyclophosphamide, cyclosporine, prednisone \> 15mg/ day (or equivalent dose of other glucocorticoids) within 4 weeks before enrollment; Those who had used Chinese herbal medicine or acupuncture treatment within 1 week before enrollment;

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: up to 16 weeks
measure: Plasma concentrations of ZSP1603
timeFrame: up to 15 Days
Secondary outcomes:
measure: Change in FVC From Baseline at 12 weeks
timeFrame: up to 12 weeks
measure: Change in FVC%Pred from baseline at 12 weeks
timeFrame: up to12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Lung Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05109572: The Impact of the Covid-19 Pandemic on Schizophrenia Patients Registered With the Community Mental Health Center
Official title: The Impact of the Covid-19 Pandemic on Schizophrenia Patients Registered With the Community Mental Health Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-11-05
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: receiving service and having been diagnosed with schizophrenia for at least two years by psychiatry who works from Kartal Dr. Lütfi Kırdar City Hospital Adatepe CMHC

Brief summary: This study aimed to examine the effect of the Covid-19 pandemic on schizophrenia patients registered to the Community Mental Health Center (CMHC) in terms of depression, suicide risk, and tendency to violence.

Detailed description: The study was conducted on patients registered to the Ministry of Health Kartal Dr. Lütfi Kırdar City Hospital Adatepe Community Mental Health Center and was followed up regularly. It was carried out on 108 individuals who met the diagnosis of schizophrenia according to the DSM-V (American Psychiatric Association 2013) and met the inclusion criteria. Individuals who were respectively classified as hospitalized group (HG) during the Covid-19 pandemic period (n=39), non-hospitalized with emergency care group (NHECG) without hospitalization (n=37), and non-hospitalized with non-emergency care group (NHNECG) (n=32). Individuals who had been diagnosed with schizophrenia for at least two years, were not in the active phase of the disease, did not have organic mental disorders, did not have any other psychiatric diseases were included in the study. In the study, the Socio-Demographic Questionnaire, the Calgary Depression Scale in Schizophrenia (CDSS), the Buss-perry Aggression Questionnaire (BPAQ), and the Suicide Probability Scale (SPS) were used.

Eligibility criteria: Inclusion Criteria:

* between the ages of 18-65,
* receiving service from Kartal Dr. Lütfi Kırdar City Hospital Adatepe CMHC,
* having been diagnosed with schizophrenia for at least two years,
* not being in the active phase of the disease,
* not having an organic mental disorder,
* not having an additional psychiatric illness, and
* being literate

Exclusion Criteria:

* Individuals with cognitive and physical dysfunction,
* mental retardation, different psychiatric diseases that would prevent interview or testing, and
* those who did not consent to participate in the study

Primary outcomes:
measure: Calgary Depression Scale in Schizophrenia
timeFrame: 6 months
measure: Buss-perry Aggression Questionnaire
timeFrame: 6 months
measure: Suicide Probability Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kartal Dr Lütfi Kırdar Şehir Hastanesi
Study officials:
References:
Clinical trial NCT02830672: Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger
Official title: Comparative Clinical Study of Ultrasound-Guided A1 Pulley Release vs Open Surgical Intervention in the Treatment of Trigger Finger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Surgical Release of Ai Pulley Trigger Finger
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome.


Eligibility criteria: Inclusion Criteria:

* Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.

Exclusion Criteria:

* Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease.
* Patients with multiple trigger fingers

Primary outcomes:
measure: Resolution of triggering expressed as the "success rate" per digit.
timeFrame: 12 weeks
Secondary outcomes:
measure: The time for taking postoperative pain killers
timeFrame: 12 weeks
measure: Range of motion recovery
timeFrame: 12 weeks
measure: QuickDASH test scores (Greek version)
timeFrame: 12 weeks
measure: Time to return to normal activities (including work)
timeFrame: 12 weeks
measure: Cosmetic results
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00564772: Raltegravir Kaletra Pharmacokinetics
Official title: An Open-Label, Sequential, 3-Period Study to Evaluate Pharmacokinetics of Coadministered Raltegravir (Isentress) and Lopinavir-Ritonavir (Kaletra) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: raltegravir
lopinavir
ritonavir
pharmacokinetics
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2007-11-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra.

Detailed description: This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects. The initial cohort, to be studied simultaneously, will be 15 subjects with intention to collect complete data from 12 subjects. Replacements will be subsequently enrolled if necessary. Subjects will be reimbursed.

The periods will be

* Period 1: Raltegravir (RAL) 400 mg q12h for 4 days (7 doses of RAL).
* Period 2: Kaletra 200 mg 2 pills bid for 10 days (19 doses of Kaletra).
* Period 3: both regimens for 4 days (7 doses of both drugs). All morning doses will be observed at Prism Research, Inc. Evening doses will be distributed each morning. 12 hour PK studies will be done on the last day of each period. Specimens will be obtained 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours after the morning dose of the last dosing day of each period.

Eligibility criteria: Inclusion Criteria:

* Healthy, male or female, age 18-55.
* Anti-HIV, anti-HCV, HBsAg negative.
* Normal history and physical at screening.
* Normal complete blood count, creatinine and ALT at screening.
* Negative urine pregnancy test at screening.
* BMI 18-30.

Exclusion Criteria:

* Donated blood in the month before Day 1.
* Participated in another research study in the month before Day 1.
* Tobacco use in the 3 months before Day 1, unwillingness to avoid tobacco use during the study.
* Use of any illegal drug in the year before Day 1, positive drug screen for an illegal drug at screening.
* Unwillingness to restrict coffee use to 6 or fewer cups of coffee during the study.
* Unwillingness on the part of fertile female subjects to be abstinent or to use two effective birth control methods, one of which is a barrier method, for any vaginal intercourse.
* Unwillingness to avoid use of any prescribed medication during the study
* Allergy to RAL, lopinavir or ritonavir.

Primary outcomes:
measure: drug levels of lopinavir, ritonavir, raltegravir
timeFrame: 2 months
Secondary outcomes:
measure: safety
timeFrame: 2 months
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Prism Research Inc
state: Minnesota
Study officials:
affiliation: Allina Hospitals & Clinics
name: Frank S Rhame, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02010372: Optimizing Application And Support Of Immunization Information Systems (OASIS)
Official title: Optimizing the Practical Application of Immunization Information System Use in Primary Care Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increase in Use of Immunization Registry
Increase in HPV Vaccination Rate
Keywords: Immunization Registry
Human Papillomavirus
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2013-12-12
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall purpose of this study is to evaluate the use of features of the New York State Immunization Information System (NYSIIS) by various types of primary care practices and determine how best to promote the use of IIS features and functionality. The primary goal is to promote the use of NYSIIS for immunization quality improvement (QI) in the practice setting. Customized training sessions will be conducted by study staff to educate practices on NYSIIS' enhanced features.


Eligibility criteria: Inclusion Criteria:

* NYSIIS administrator at a participating practice

Exclusion Criteria:

* Practices already utilizing/running reports used in the intervention

Primary outcomes:
measure: NYSIIS report usage
timeFrame: One Year
Secondary outcomes:
measure: HPV Vaccination Rate
timeFrame: One Year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Stanley J Schaffer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03201172: Univation® X Follow-Up Study
Official title: Prospective Observational 2 Year Follow-up on a Retrospective Cohort of Primary Unicompartmental Knee Arthroplasty (UKA) Patients Treated With Univation® X or iUni®.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unicompartmental Knee Arthroplasty
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design.

The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).


Eligibility criteria: Inclusion Criteria:

* Patients who underwent UKA in 2015/2016 (using one of the products under investigation)
* Signed informed consent

Exclusion Criteria:

* pregnancy
* patients \< 18 years

Primary outcomes:
measure: Knee joint function
timeFrame: 2 years after primary implantation
Secondary outcomes:
measure: KOOS
timeFrame: 2 years after primary implantation
measure: axis justice position
timeFrame: preoperative and until discharge from hospital (within 1 week postoperatively)
measure: radiolucent lines
timeFrame: 2 years after primary implantation
measure: tibial slope
timeFrame: 2 years after primary implantation
Other outcomes:
measure: Adverse Events
timeFrame: 2 years after primary implantation
Locations:
city: Brakel
country: Germany
facility: St. Vincenz Hospital Brakel
Study officials:
References:
Clinical trial NCT01521572: Effect of the Salbutamol on Mechanical Properties of Respiratory System
Official title: Effect of the Use of Salbutamol on the Mechanical Properties of the Respiratory System of Healthy Individuals, Smokers and COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Airway Obstruction
Keywords: chronic obstructive pulmonary disease,
bronchial reversibility,
bronchodilator,
respiratory impedance,
forced oscillation technique,
plethysmography,
spirometry
Diagnostic Techniques, Respiratory System
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2012-01-30
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to assess the bronchodilator response of salbutamol on respiratory mechanics of healthy individuals, smokers and COPD with varying degrees of airway obstruction.

Detailed description: Clinical evaluation will be conducted and anthropometric measurements, then the pulmonary function tests: forced oscillation technique (FOT), whole body plethysmography, spirometry and-administration of salbutamol aerosol for assessment of bronchodilator response. After 20 minutes, the individual will be evaluated again following the same sequence.

Eligibility criteria: Inclusion Criteria:

* healthy individuals, smokers and patients with chronic obstructive pulmonary disease.

Exclusion Criteria:

* healthy subjects: no history of smoking respiratory infection and disease respiratory
* smokers and chronic obstructive pulmonary disease patients: asthma and other respiratory diseases.

Primary outcomes:
measure: Respiratory function test
timeFrame: two o'clock
Secondary outcomes:
measure: Salbutamol
timeFrame: twenty minutes
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Laboratory biomedical instrumentation - State University of Rio de Janeiro
Study officials:
affiliation: State University of Rio de Janeiro
name: Gerusa M Costa, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratory biomedical instrumentation
name: Pedro L Melo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02847572: Assessment of Visual Performance Combining a Symfony IOL and a +3.25 Tecnis Multifocal IOL
Official title: A Clinical Assessment of Visual Performance of Combining the Tecnis Symfony Extended Range of Vision IOL (ZXR00) With the +3.25D Tecnis Multifocal 1-Piece IOL (ZLB00) in Subjects Undergoing Bilateral Cataract Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Crystal Clear Vision
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2016-07-28
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be a single center, non comparison clinical trial. Fifty study patients will have the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their non-dominant eye. The investigators will be evaluated vision at distance, intermediate and near as well as assessing patient satisfaction and spectacle independence.

Detailed description: Each study patient will undergo the same routine cataract extraction procedure in each eye. In their dominant eye a Tecnis Symfony IOL will be implanted and in the non dominant eye, a Tecnis +3.25D Multifocal implanted. The surgeries will be within 2 days of each other. Every patient will receive same postoperative instructions and medications. The aim is to investigate the potential benefits of implanting two different IOL's to give the patient a wider range of near vision with decreased risk of haloing and glare to enable them to be less dependent on reading glasses

Eligibility criteria: Inclusion Criteria:

* good general health,
* willing to comply with study instructions,
* Visual potential of 20/30 or better,
* less than 1.5D of corneal astigmatism,
* normal macula,
* clear lens or cataract,
* pupil size greater than 3.5mm

Exclusion Criteria:

* known pathology to affect visual outcome,
* amblyopia or strabismus,
* pupil abnormalities,
* zonule problems,
* keratoconus,
* no prior ocular surgery,use of medication that could affect vision,
* uncontrolled systemic disease

Primary outcomes:
measure: Visual Acuity
timeFrame: 3 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Crystal Clear Vision
state: Ontario
Study officials:
affiliation: Crystal Clear Vision
name: Sondra Black, OD
role: STUDY_CHAIR
References: