louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01027013: Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye
Official title: A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2009-12-07
Enrollment: 220
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: The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Diagnosis of dry eye as defined by the protocol

Exclusion Criteria:

* Ongoing ocular disease that may interfere with study parameters.
* Inability to stop using topical ophthalmic medications throughout the duration of the study
* Inability to stop the use of contact lenses for the duration of the study.

Primary outcomes:
measure: Total fluorescein corneal staining score
timeFrame: 4 weeks
measure: Primary ocular discomfort
timeFrame: 4 weeks
Secondary outcomes:
measure: Dry eye symptoms
timeFrame: 12 weeks
measure: Ocular staining
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Waterbury
country: United States
facility: The Eye Care Group, P.C.
state: Connecticut
city: Louisville
country: United States
facility: Richard Eiferman, MD
state: Kentucky
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Andover
country: United States
facility: Ora, Inc
state: Massachusetts
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
Study officials:
affiliation: Kubota Vision Inc.
name: Nancy Boman, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06882213: Combining Transcranial Direct Current Stimulation and Core Stability Exercise on Trunk in Stroke Patient
Official title: Unlocking Trunk Potential After Stroke: A Novel Approach Combining Transcranial Direct Current Stimulation and Core Stability Exercise
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of the combining transcranial direct current stimulation with core stability exercises on trunk performance in poststroke hemiparetic patients, the secondary outcome is to evaluate the balance and the functional performance of the participants.

Detailed description: This study will conduct to 60 male and female patients with post stroke hemiparesis with age ranged between 55 to 70 years, the patients will be categorized to two equal groups.

* Group A (study group): will receive simultaneously a combination of transcranial direct current stimulation combined with core stability exercise.
* Group B (control group): will receive core stability exercise. All patients will be assessed for trunk performance, balance, and functional performance before and after interventions.

Eligibility criteria: Inclusion Criteria:

* Patients will be included if they are ≥ 55 years old of both sex, had a first-time right or left stroke within the preceding six months that damaged the cerebral cortex verified by (computed tomography or MRI report, neurological examination, and medical chart).
* Patients can stand and walk independently.
* Modified Ashworth Scale (MAS) of upper limb muscle ≤ 1+.
* All the patients received a conventional physiotherapy program in the acute stage and post-discharge from the hospital.
* None of the patients participated in any other study or placebo

Exclusion Criteria:

* Patients with neurological or orthopedic problems, paralysis neglect, behavioral abnormalities, dementia any shoulder dysfunction before or post-stroke (dislocation or subluxation), or those who using upper limb splints.
* Recurrent strokes or hemiparesis due to other neurological causes rather than stroke eg .(Brain tumor).
* Obesity (BMI ≥ 30 kg/m2).

Primary outcomes:
measure: Trunk Impairment Scale (TIS).
timeFrame: up to 8 weeks
measure: Berg Balance Scale
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni suef hospital
Study officials:
References:
Clinical trial NCT03026413: The Comparison Between the PVAM and CPVI for the Patients of PAF
Official title: The Comparison Between the Pulmonary Vein Antrum Modification by SmartTouch Ablation Catheter With Contact Force Monitoring and Circumferential Pulmonary Vein Isolation by That Without Contact Force Monitoring Plus Lasso Catheter for the Patients of Paroxysmal Atrial Fibrillation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Pulmonary Vein Isolation
Keywords: atrial fibrillation
pulmonary vein isolation
Contact Force
antrum
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.

Detailed description: This is a single centre, prospective control study. The study will enroll 180 patients with 2:1 grouped.

Eligibility criteria: Inclusion Criteria:

* patients with paroxysmal atrial fibrillation refractory to drugs
* with consent

Exclusion Criteria:

* LVEF\<50%
* history of cardiac surgery
* valvular heart disease
* abnormal thyroid function
* left atrial thrombus

Primary outcomes:
measure: any recorded atrial arrhythmias proved by 7-day holter
timeFrame: at least 18 months follow up
Secondary outcomes:
measure: procedure time
timeFrame: time during patient enrollment
measure: x ray time
timeFrame: time during patient enrollment
measure: adverse event
timeFrame: at least 18 months follow up
Other outcomes:
Locations:
Study officials:
References:
citation: Neuzil P, Reddy VY, Kautzner J, Petru J, Wichterle D, Shah D, Lambert H, Yulzari A, Wissner E, Kuck KH. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):327-33. doi: 10.1161/CIRCEP.113.000374. Epub 2013 Mar 20.
citation: Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.
Clinical trial NCT01839513: Prediction of Hemodynamic Reactivity During General Anesthesia Using Analgesia/Nociception Index (ANI)
Official title: Prediction of Hemodynamic Reactivity During Desflurane/Remifentanil General Anesthesia Using Analgesia/Nociception Index (ANI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Analgesia/nociception index
Desflurane
Remifentanil
Orthopedic surgery
Ear-nose-throat surgery
Hemodynamic reactivity
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients underoing ear-nose-throat or orthopedic lower limb surgery performed on desflurane/remifentanil general anesthesia

Brief summary: The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower limb orthopedic surgery on desflurane/remifentanil general anesthesia.

Detailed description: Measurement of analgesia/nociception index at different time points during procedure and assessment of analgesia/nociception index to predict hemodynamic reactivity by building receiver observer's characteristic curve.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Ear-nose-throat or lower limb surgery
* General anesthesia using desflurane and remifentanil

Exclusion Criteria:

* Age \<18 yrs or \>75 yrs
* Arrythmia
* Preoperative use of B-blockers
* Administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
* Psychiatric diseases
* Autonomic nervous system disorders (epilepsy)

Primary outcomes:
measure: Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes
timeFrame: Before induction of anesthesia, 1 min after incision, at steady-state anesthesia during procedure (an expected average of 30 min) and at arousal from general anesthesia in the end of procedure (an expected average of 60 min)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Édouard Herriot, HCL
state: Rhône
Study officials:
affiliation: Hôpital Edourd Herriot
name: Emmanuel Boselli, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hôpital Edouard Herriot
name: Bernard Allaouchiche, MD, PhD
role: STUDY_CHAIR
References:
citation: Boselli E, Daniela-Ionescu M, Begou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.
Clinical trial NCT01235013: Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3
Official title: Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV-1 Infection
Keywords: HIV-1 infection
Maraviroc
CD4 lymphocyte count
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2010-11-05
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: Maraviroc is an antiretroviral drug that belongs to the family of the CCR5 coreceptor inhibitors. It has proven to be effective in increasing CD4 lymphocyte counts in both in treated and naïve patients, irrespective of the viral load.

The investigators hypothesize that adding Maraviroc to the antiretroviral treatment of discordant patients, defined as those having CD4 lymphocyte counts below 200 cells /mm3 during the last year, could lead to its immunological recovery.

60 patients will be included in this unicentric, prospective, randomized and stratified clinical trial. They will be randomized to either continue with its usual high activity antiretroviral therapy (HAART) treatment or to receive 300 mg of Maraviroc every 12 hours plus its usual treatment. After 24 weeks, lymphocyte counts will be assessed, as well as safety, clinical progression, immunological profile of the patients and the potential benefit of Maraviroc for HIV+ cirrhotic patients.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* HIV infection
* Patients receiving HAART treatment for at least one year with a sustained viral load equal or below 200 copies/ml
* Viral load equal or below 200 copies/ml at the screening visit
* Discordant patients: patients without an increment over 50 copies /ml of CD4 lymphocytes during the last year
* Patients with an expected adherence to HIV treatment over 90% according to their physician.
* Signed informed consent form

Exclusion Criteria:

* Pregnancy or breast feeding or women planning pregnancy during the study duration
* Any contraindication to treatment with Maraviroc
* X4 tropism at inclusion

Primary outcomes:
measure: Median of CD4 counts change after 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Immunological profile
timeFrame: 24 weeks
measure: CD4 counts
timeFrame: 24 weeks
measure: Clinical progression
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
Study officials:
affiliation: Hospital Clínic i Provincial
name: José Luis Blanco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03051113: Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations
Official title: Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Neuroma
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peripheral nerve injury after surgery or trauma. Amputees.

Brief summary: Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. In this observational cohort study, the investigators wish to explore if the prevalence of neuromas are higher in patients with pain after peripheral nerve injury and amputation, than in patients with the same conditions but without pain.


Eligibility criteria: Inclusion Criteria:

* Subjects with peripheral nerve injury 3 months prior to participation
* Subjects with amputation 3 months or more prior to participation

Exclusion Criteria:

* Severe somatic or psychiatric diseases
* Other peripheral neuropathy
* Lack of ability to cooperate to the clinical examination

Primary outcomes:
measure: Prevalence of neuromas in patients with pain and without pain after peripheral nerve injury or amputation.
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
affiliation: Department of Anesthesiology, Aarhus University Hospital
name: Nina Buch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037213: A Real-World Patient-Reported Outcomes Study in Patients With Long-Term Use of Niraparib
Official title: Non-interventional Study to Collect Real-world Patient-Reported Outcomes Data in Platinum-Sensitive Relapsed Ovarian Cancer Patients With Long-Term Use of Niraparib
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: patient-reported outcomes
niraparib
real-world
ovarian cancer
quality of life
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 500
Sex: FEMALE
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: Patients are members of the patient assistance programme population.

Brief summary: This prospective, non-interventional study is designed to evaluate the quality of life of Chinese ovarian cancer patients with long-term niraparib use in a real-world setting. Participants will complete questionnaires or accept telephone follow-up to provide information about their quality of life.

Detailed description: In this prospective, non-interventional study, patients with platinum-sensitive relapsed ovarian cancer who have received niraparib as maintenance therapy for more than two years will agree to be contacted by questionnaire or telephone three times. The interval will be 4-6 weeks. Information on quality of life will be collected and analysed.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer
* Maintenance treatment with niraparib for ≥2 years and continuing for the next 28 days
* No significant cognitive impairment
* Understand the trial procedure and be able to sign the informed consent form before any study-related procedures

Exclusion Criteria:

* Patients who are not suitable for participation in this study according to the investigator's evaluation
* Patients receiving antineoplastic drugs for other malignancies
* Patients who are unable to comply with the protocol procedures

Primary outcomes:
measure: Patient-reported health-related quality of life (HRQoL) - EQ-5D-5L questionnaire
timeFrame: 4 months
measure: Patient-reported health-related quality of life (HRQoL) - FOSI questionnaire
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
measure: Patient population checklist
timeFrame: at baseline
measure: Niraparib medication checklist
timeFrame: at baseline
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yang Xiang, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01582113: Cognizin Citicoline Dosing in a Healthy Adolescent Male Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Neurocognitive Improvement
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 84
Sex: MALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the functional effects of Citicoline, a natural supplement, when administered for a duration of four weeks (28 days) to non-psychiatric adolescent male participants. The investigators hypothesize that citicoline will provide cognitive benefits to this population after 28 days of supplementation.


Eligibility criteria: Inclusion Criteria:

* Male
* Age 13-18 years old
* No history of co-morbid psychiatric disorder, current Axis I or II diagnosis or previous pharmacotherapeutic trial

Exclusion Criteria:

* Head injury with LOC \> 5 minutes
* Use of any psychotropic medication

Primary outcomes:
measure: Neurocognitive performance
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: The Brain Institute, University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT01253213: BR55 in Prostate Cancer: an Exploratory Clinical Trial
Official title: Exploratory Clinical Trial Using BR55 Targeted Ultrasound Contrast Agent in the Detection of Prostate Cancer by Molecular Imaging of VEGFR2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Keywords: Prostate cancer
Ultrasound molecular imaging
Contrast agent
BR55
VEGFR2
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Bracco Imaging S.p.A.
First posted: 2010-12-03
Enrollment: 26
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2 expression in human prostate by ultrasound molecular imaging.

This will be compared with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).


Eligibility criteria: Inclusion Criteria:

* Male patient, age ≥ 40 years old
* Has a histology proven focal prostate cancer lesion
* The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration
* Provides written Informed Consent and is willing to comply with protocol requirement

Exclusion Criteria:

* Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100μg) according to the indication of the EMEA guideline M3 for this type of study
* Has documented acute prostatitis or urinary tract infections
* Is known to suffer from stable angina pectoris and/or proven coronary disease, or to have symptoms suspicious of coronary disease
* With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts
* Has had severe cardiac rhythm disorders within the last 7 days
* Has severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
* Has received a prostate biopsy procedure within 30 days before admission into this study
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
* Is determined by the Investigator that the patient is clinically unsuitable for the study.
* Is incapable of understanding the language in which the information for the patient is given
* Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;

Primary outcomes:
measure: BR55 sensitivity assessment
timeFrame: Day 1
Secondary outcomes:
measure: BR55 specificity assessment
timeFrame: Day 1
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC University Amsterdam
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Hessel Wijkstra, Dr.
role: PRINCIPAL_INVESTIGATOR
References: