louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05475093: Impact Evaluation of Different Micturition Modes on Patients With Medullar Injury of Quality of Life and Their Occupations
Official title: Evaluation of Impact of Different Micturition Modes on Patients With Medullar Injury of Their Quality of Life and Their Occupations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medullary Injury
Micturition Disorder
Keywords: Medullary Injury
Micturition modes
Quality of life
Human occupation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with medular injury who have their follow-up care in the neuro-urology unit in raymond poincaré hospital, live at home or in long-term care facility definitively.

Brief summary: The primary objective of the study is to analysis the personal determination factors (age, sex, stage of injury, pain, urinary continence and durations of spinal cord injury) and environmental determination factors (need for medical devices, nurse care and adaptation of accommodations) which affect the quality of life and their occupations on patients with medullar injury.


Eligibility criteria: Inclusion Criteria:

* Adult patients with spinal cord injury;
* Live at home or in long-term care facility definitively;
* Have one of the following urination modes:

  1. urine with indwelling catheter in place
  2. catheter in suprapubic area
  3. intermittent catheterization by urethra
  4. intermittent catheterization by incontinent cystostomy
  5. sphincterotomy
  6. incontinent stomia (Bricker)

Exclusion Criteria:

Primary outcomes:
measure: Quality of life by QUALIVEEN-30
timeFrame: at baseline
measure: Model of human occupation
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP
Study officials:
affiliation: Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP
name: Alexia EVEN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP
name: Aurélie -Anna DUBOIS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02287493: Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
Official title: Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Replacement Therapy, Renal
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult ICU patients at University Medical Center Hamburg-Eppendorf receiving SLED and either meropenem or ceftazidim.

Brief summary: In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.

Detailed description: Antibiotic concentrations are measured whilst patients receive SLED for renal replacement therapy. The plasma specimens will be quantified using high Performance liquid chromatography (HPLC).

Primary endpoint:

- Plasma levels of antiinfectives during SLED

Secondary endpoints:

* mortality
* length of stay at the intensive care unit (ICU) and hospital
* clinical cure of infections

Inclusion criteria:

* age: \> 18 years
* patients under SLED
* antiinfective treatment

exclusion criteria:

- missing informed consent

Eligibility criteria: Inclusion Criteria:

* age: 18 or older
* patients receiving SLED and either meropenem or ceftazidim

Exclusion Criteria:

* missing informed consent

Primary outcomes:
measure: Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
timeFrame: days receiving SLED, up to 5 days
Secondary outcomes:
measure: Mortality
timeFrame: minimum duration of hospital stay, maximum 1 year
measure: Length of Stay (LOS)
timeFrame: minimum duration of hospital stay, maximum 1 year
measure: Number of Patients With Clinical Cure of Infections
timeFrame: minimum duration of hospital stay, maximum 1 year
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Department of Intensive Care
name: Stefan Kluge, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braune S, Konig C, Roberts JA, Nierhaus A, Steinmetz O, Baehr M, Kluge S, Langebrake C. Pharmacokinetics of meropenem in septic patients on sustained low-efficiency dialysis: a population pharmacokinetic study. Crit Care. 2018 Jan 30;22(1):25. doi: 10.1186/s13054-018-1940-1.
Clinical trial NCT05247593: A Study of Dayingpian Treating Bipolar Disorder
Official title: The Efficacy and Safety of Dayingpian in The Treatment of Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Keywords: Cohort study
Bipolar disorder
Traditional Chinese Medicine
Efficacy
Dayingpian
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 308
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients or inpatients with bipolar disorder in Shanghai Mental Health Center are screened to participate in this study.

Brief summary: The main purpose of this cohort study is to evaluate the efficiency and safety of Dayingpian to provide evidence-based medical evidence for the subsequent drug development.

Detailed description: Dayingpian is a kind of formula in traditional Chinese medicine with the effect of promoting blood circulation and reducing blood stasis. It has been prescribed as an add-on in the treatment of mental disorders such as bipolar disorder. However, there is not yet much high-quality evidence of the clinical effectiveness of Dayingpian treatment. In this study, we conduct a prospective, real-world longitudinal cohort study at Shanghai Mental Health Center in China to investigate the efficacy and safety of Dayingpian for bipolar disorder patients. The observation period is 12 weeks and all participants are evaluated every 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. Meets the International Classification of Diseases-10(ICD-10) criteria for Bipolar Disorder.
2. Outpatients or inpatients in Shanghai Mental Health Center.
3. Male or female subjects aged 14-65 years.
4. education of Junior high school or above.
5. The patient fully understands and signs the informed consent form.

Exclusion Criteria:

1. Apparent violent aggression/suicide within the last two weeks.
2. Other patients that the investigator believes should not be included in the study.

Primary outcomes:
measure: Change in the Young Mania Rating Scale (YMRS) scores compared with baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Response rate
timeFrame: 12 weeks
measure: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with baseline
timeFrame: 12 weeks
measure: Change in total score of the Clinical Global Impression-Severity (CGI-S) scale
timeFrame: 12 weeks
measure: Change in total score of the Clinical Global Impression-Improvement (CGI-I) scale
timeFrame: 12 weeks
measure: Change of Traditional Chinese Medicine(TCM) syndromes scale
timeFrame: 12 weeks
Other outcomes:
measure: Incidence of adverse events
timeFrame: 12 weeks
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
Clinical trial NCT05373693: Myopia-control Efficacy by Peripheral Defocus Lens (PDL)
Official title: Evaluation of Visual Performance and Myopia-control Efficacy Afforded by Bestivue Peripheral Defocus Lens (PDL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study below aims to assess the effect of customized Bestivue PDL lenses on retinal image quality and myopia control. A total of 160 subjected would be enrolled in and randomized to allcoate into four groups. Visual acuity and image blur at various gaze directions and eccentricities on children fitted with +2 to 4 D power and single vision lenses would be measured to assess the short term effect of PDL lens. Axial length and cycloplegic objective refractive error would be measured to assess the Myopia-control Efficacy.

Detailed description: The proposed study below aims to assess the short-term and long-term effect of customized Bestivue PDL lenses on retinal image quality and myopia control. To these ends, two stages of testing are planned. First, objective testing will be utilized to assess the effect of Bestivue PDL lenses on visual acuity and image blur at various gaze directions and eccentricities on 4- to 13-year-old children fitted with +2 to 4 D power and single vision lenses.In the second stage, the same children participants will wear either single or Bestvue PDL lenses with one of the four plus power designs for 2 years. Their corrected visual acuity, objective refractive error with dilation and axial length will be assessed for each eye every six months for two years. Outcomes of these studies should inform whether Bestivue PDL lenses are effective in myopia control while affording adequate visual comfort and performance.

Eligibility criteria: Inclusion Criteria:

* The subjects had spherical RE of -1.00 to -6.00 D
* Astigmatism ≤ 4.00 D
* Anisometropia ≤ 1.50 D\\
* Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.

Exclusion Criteria:

* Strabismus
* Ocular limitations
* Systemic abnormalities affecting vision and ocular motility.

Primary outcomes:
measure: changes in cycloplegic objective spherical equivalent (SER)
timeFrame: baseline, 24 months
Secondary outcomes:
measure: changes in ocular axial length
timeFrame: baseline, 24 months
measure: visual performance
timeFrame: 1 day
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
affiliation: Tianjin Eye Hospital
name: Lihua Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05155293: Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)
Official title: A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared With EU-Eylea® in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALVOEYE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular (Wet) AMD
Keywords: Macular Degeneration
Retinal Degeneration
Aflibercept
Lead sponsor: Alvotech Swiss AG
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 413
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.


Eligibility criteria: Inclusion Criteria:

* Subject must be ≥50 years of age, at the time of signing the informed consent.
* Subjects must be diagnosed with neovascular (wet) AMD in the study eye.
* Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD.
* Willingness and ability to undertake all scheduled visits and assessments.

Exclusion Criteria:

* Any prior systemic treatment with anti-VEGF therapy
* Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data
* Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment
* Subjects not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.

Primary outcomes:
measure: Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA)
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Sokolov
country: Czechia
facility: Nemocnicni lekarna Sokolov
city: Tbilisi
country: Georgia
facility: JSC Evex Medical Corporation
city: Fukuoka
country: Japan
facility: Keneikai Hayashi Eye Hospital
city: Riga
country: Latvia
facility: Riga East University Hospital Clinical Centre "Bikernieki"
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital SLLC
city: Trenčín
country: Slovakia
facility: Fakultna Nemocnica Trencin
Study officials:
References:
Clinical trial NCT02329093: Non-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA
Official title: Non-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip OA
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: As we have previously reported, the primary cause of hip OA with accompanying joint pain might be bone alterations which can be microfracture. In order to prove it, it is planned that conservative treatment will be performed on the hip OA patients with accompanying joint pain for the first year. For the second year, if the patients still have joint pain, they will do non-weght bearing walk.


Eligibility criteria: Inclusion Criteria:

* Hip OA, Joint pain

Exclusion Criteria:

* Obvious radipgraphic fracture in hip joint,

Primary outcomes:
measure: Bone Signal Changes on the Hip MRI
timeFrame: 1 - 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References:
Clinical trial NCT03296111: Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life
Official title: Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dry Eye Syndromes
Neuralgia
Pain
Quality of Life
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-09-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with ocular neuropathic pain.

Brief summary: Some patients with dry eye may have severe disabling neuropathic pain. They describe spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an important discordance between the high intensity of the symptoms and the poverty of the clinical signs. These pains are often unrecognized and therefore often not sufficiently treated. A significant impact on patient's quality of life may occur. The concept of ocular neuropathic pain being relatively recent, few studies have focused on the subject at present. Our study aims to shed light on these pains in patients consulting for dry eyes at the Ophthalmological Foundation A. de Rothschild.

The objective of our study is to describe precisely the characteristics of neuropathic eye pain and the visual, general and psychological repercussions in these patients.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older,
* Presenting at least one of the following symptoms: spontaneous pain, burning sensation in eye, dysesthesia, allodynia, hyperalgesia
* French language-skills

Exclusion Criteria:

* Severe corneal or palpebral damage explaining current pain

Primary outcomes:
measure: Scores obtained with each questionnaires.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtamologique A. de Rothschild
Study officials:
References:
Clinical trial NCT00204711: Use of the SNAP II Electroencephalography (EEG) Monitor in Outpatients Undergoing Surgery/Procedures With Sedation
Official title: Use of the SNAP II EEG Monitor in Outpatients Undergoing Surgery/Procedures With Sedation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedation
Keywords: patients having outpatient surgery with sedation
patients having procedures with sedation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing outpatient (same day) surgery/procedures with sedation

Brief summary: The purpose of this study is to determine if the SNAP II electroencephalography (EEG) monitor accurately reflects changes in sedation level in outpatients undergoing surgery or procedures with sedation.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I, II or III physical status

Exclusion Criteria:

* Use of inhalation general anesthesia
* ASA IV physical status

Primary outcomes:
measure: Assessment of participant heterogeneity between SNAP Index and OASS Score.
timeFrame: up to 1 day post op
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Scott Springman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Springman SR, Andrei AC, Willmann K, Rusy DA, Warren ME, Han S, Lee M. A comparison of SNAP II and bispectral index monitoring in patients undergoing sedation. Anaesthesia. 2010 Aug;65(8):815-9. doi: 10.1111/j.1365-2044.2010.06408.x. Epub 2010 Jun 25.
Clinical trial NCT01654211: A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers
Official title: A Three-Part Study Evaluating the Pharmacokinetics of Intravenous (IV) Danoprevir (DNV)/Oral Low-Dose Ritonavir (RTV), the Absolute Bioavailability of DNV With and Without Oral Low-Dose RTV, and the Effect of Oral Cyclosporine on IV DNV/Oral Low-Dose RTV in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Adult healthy male and female nonsmoking volunteers, 18 to 55 years of age inclusive; healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination

Exclusion Criteria:

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection

Primary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: Pre-dose and up to 12 hours post-dose
measure: Safety: Incidence of adverse events
timeFrame: approximately 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05547711: Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
Official title: Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Disorder
Depression
Depressive Symptoms
Depressive Episode
Major Depressive Disorder
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At inclusion mentally healthy and patients with a depression are monitored for five years. After study inclusion participants will be seen after four weeks and then annually for five years.
Primary purpose: OTHER

Brief summary: The POKAL-PSY project is a study that monitors participants for five years. The goal of the study is to identify distinguishable subtypes of depression on the basis of biomarkers and to gain insight into their prognostic significance.


Eligibility criteria: Inclusion Criteria:

* (PHQ\>8) if depressed
* Subjects of any sex aged between 18-70
* Sufficient ability to speak and understand the german language
* Ability to understand and sign the informed consent form

Exclusion Criteria:

* Cognitive impairment that interferes with reliable completion of questionnaires or answering questions
* Presence of manic episode, bipolar disorder, Schizophrenia or schizoaffective disorder (as well as other diseases in the F2 domain in the ICD), active eating disorder, active drug or alcohol dependence syndrome
* Presence of uncontrolled systemic disease (e.g. autoimmune disease), uncontrolles somatic (other than metabolic or cardiovascular)/ neurologic diseases, current or recent (last month) physical trauma
* Patient with acute suicidal ideation
* known deficiency of alpha-1-antitrypsin
* pregnant or lactating women

Primary outcomes:
measure: Changes in GAF
timeFrame: 4 Weeks
measure: Changes in MADRS
timeFrame: 4 Weeks
measure: Alpha-1-Antitrypsin
timeFrame: 1 year
measure: IGF-1
timeFrame: 1 year
measure: weight
timeFrame: 1 year
Secondary outcomes:
measure: Changes in GAF
timeFrame: 5 years
measure: Changes in MADRS
timeFrame: 5 years
measure: alpha-1-Antitrypsin
timeFrame: 5 years
measure: IGF-1
timeFrame: 5 years
measure: weight
timeFrame: 5 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Psychiatry and Psychotherapy, University Hospital LMU
state: Bavaria
Study officials:
References: