louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05472376: Real-Life Study in Diabetic Macular Edema
Official title: Real-World Outcomes of Anti-VEGF Treatment for Diabetic Macular Edema in Turkey: A Multicenter Retrospective Study, MARMASIA Study Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 854
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018

Brief summary: The goal of this study is to evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in diabetic macular edema (DME) patients.

Detailed description: The study included patients who were being observed in the retina departments of 8 tertiary hospitals in the Northern Marmara Region of Turkey (Istanbul's Asian Side, Kocaeli, and Sakarya). The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018 were reviewed.

Eligibility criteria: Inclusion Criteria:

* Diabetic macular edema treated with intravitreal anti-VEGF injection
* Having at least 4 or more annual examination visits

Exclusion Criteria:

* Phacoemulsification surgery in the last 1 month
* PRFK / grid / focal / micropulse in the last 4 months
* Previous intraocular surgery (excluding PPV and phacoemulsification)

Primary outcomes:
measure: Visit and Intravitreal Injection Numbers
timeFrame: First year
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
state: None Selected
city: İstanbul
country: Turkey
facility: Marmara University School of Medicine
city: İstanbul
country: Turkey
facility: Memorial Şişli Hospital
city: İstanbul
country: Turkey
facility: University Health Sciences, Kartal Dr. Lütfi Kırdar Training and Research Hospital
city: İstanbul
country: Turkey
facility: University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital
city: İstanbul
country: Turkey
facility: University of Health Sciences, Haydarpaşa Numune Training and Research Hospital
city: İstanbul
country: Turkey
facility: University of Health Sciences, Ümraniye Training and Research Hospital
city: İstanbul
country: Turkey
facility: University of Health Sciences, Şişli Etfal Training and Research Hospital
city: Kocaeli
country: Turkey
facility: University of Health Sciences, Derince Training and Research Hospital
city: Sakarya
country: Turkey
facility: Sakarya University School of Medicine
Study officials:
References:
Clinical trial NCT00332176: A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C
Official title: A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C
Celgosivir
HCV
Genotype 1
Treatment-naive
Early viral kinetics
Lead sponsor: BioWest Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 50
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: The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.


Eligibility criteria: Inclusion Criteria:

* 18-65 years of age, inclusive
* primary diagnosis of chronic HCV infection, genotype 1
* Interferon-based treatment-naïve
* Body Mass Index of 18 to 30, inclusive

Exclusion Criteria:

* patients previously treated with Interferon-based therapy
* patients with diabetes mellitus

Primary outcomes:
measure: Safety analysis
timeFrame: 12 weeks
measure: HCV viral load
timeFrame: 12 weeks
measure: Pharmacokinetics of celgosivir/castanospermine
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Liver and Intestinal Research Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Cantest
state: British Columbia
city: Toronto
country: Canada
facility: Biovail Contract Research
state: Ontario
Study officials:
affiliation: BioWest Therapeutics Inc
name: Jim Pankovich
role: STUDY_DIRECTOR
References:
Clinical trial NCT03839576: Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment
Official title: Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Fall
Keywords: gait
computerized cognitive training
falls
mild cognitive impairment
mobility
physical exercise
tai chi chuan
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2019-02-15
Enrollment: 252
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls.
Primary purpose: PREVENTION

Brief summary: A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls among 228 subjects with mild cognitive impairment, in which the influence of adherence to the intervention programs will also be examined.


Eligibility criteria: Inclusion Criteria:

* At least 65 years old
* Had a fall at least 3 months prior to the baseline assessment
* Can ambulate independently
* Has mild cognitive impairment

Exclusion Criteria:

* Cannot ambulate independently and communicate with researchers
* Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
* Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)

Primary outcomes:
measure: Mattis Dementia Rating Scale (MDRS)
timeFrame: 12 months
measure: modified Telephone Interview of Cognitive Status (TICS-M)
timeFrame: 12 months
measure: mobility
timeFrame: 12 months
measure: balance
timeFrame: 12 months
measure: falls
timeFrame: 12 months
Secondary outcomes:
measure: depressive symptoms
timeFrame: 12 months
measure: fear of falling
timeFrame: 12 months
measure: activity of daily living (ADL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Mau-Roung Lin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06197776: Investigation of Multi-omics Technique to Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy for r/m NPC
Official title: Investigation of Multi-omics Technique to Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy for Recurrent and/or Metastatic Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multi-omics Technique
Nasopharyngeal Carcinoma
Recurrent and Metastatic Nasopharyngeal Carcinoma
Efficacy of Chemoradiotherapy and Immunotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recurrent or metastatic nasopharyngeal carcinoma patients

Brief summary: The observational clinical study will recruit 50 recurrent and/or metastatic nasopharyngeal carcinoma (r/mNPC) patients, to investigate the prediction values of multi-omics technique for the efficacy of chemoradiotherapy combined with immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Recurrent or metastatic nasopharyngeal carcinoma patients
* All genders，range from 18～70 years old
* ECOG score 0 \~ 1
* Inform consent form

Exclusion Criteria:

* Have or are suffering from other malignant tumors;
* Participating in other clinical trials;
* Drug or alcohol addition;
* Do not have full capacity for civil acts;
* Mental disorder;
* Pregnancy or lactation;
* Severe complication, eg, uncontrolled hypertension.

Primary outcomes:
measure: Failure-free survival
timeFrame: 3 years
Secondary outcomes:
measure: ctDNA
timeFrame: through study completion, an average of 6 months
measure: Tumor mutation load at DNA level
timeFrame: through study completion, an average of 6 months
measure: RNA expression
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05703776: Physical Exercise and Depressive Symptoms in Moderately or Severely Depressed Adults
Official title: Do Moderately and Severely Depressed Individuals Derive the Same Psychological Benefits From a 10-weeks Long Aerobic Exercise Program ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: add-on treatment
Lead sponsor: Je Bouge Pour Mon Moral
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
First posted: 2023-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a comparative trial comparing the time course of depressive symptoms between moderately and severely depressed participants over a 10-week long exercise program

Detailed description: Sixty depressed French adults (34 with symptoms of moderate intensity and 26 with symptoms of severe intensity as defined by the PHQ-9 cutting scores) voluntarily participated in our comparative trial.

A control group (waiting list) of n = 16 including 8 severely depressed and 8 moderately depressed participants received no physical exercise.

For the remaining 44 participants (26 with moderate-intensity depressive symptoms and 18 with high-intensity depressive symptoms), two weekly Nordic Walking sessions of 1h were performed for 10 consecutive weeks.

Depressive symptoms were assessed using standard self-report questionnaires at various time points: 1/ enrollment (using the PHQ-9), and then (2) just before the beginning of the exercise intervention (pre-intervention; using the BDI-II), 2/ at the end of Week 5 (mid-intervention; using the BDI-II), and 3/ the day following the end of the exercise program (post-intervention)

Eligibility criteria: Inclusion Criteria:

* PHQ-9 (Kroenke et al., 2001) score of 10 or above

Exclusion Criteria:

* medical contraindication to moderate-intensity aerobic exercise
* inability to read French language

Primary outcomes:
measure: change in the intensity of depressive symptoms
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: association JBPMM
Study officials:
affiliation: JBPMM
name: Fabien D Legrand, PhD
role: STUDY_DIRECTOR
References:
citation: Beck AT, Steer RA, Brown GK. Beck Depression Inventory (2nd edition). San Antonio, TX: Hartcourt Brace, 1996.
citation: Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiatric Annals. 2002; 32: 509-521.
Clinical trial NCT00303576: A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
Official title: A Phase I/II Double-Blind, Randomized Study of the Safety, Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel and Matching Placebo in Healthy HIV-Negative Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: HIV-1
HIV Seronegativity
Lead sponsor: International Partnership for Microbicides, Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.


Eligibility criteria: Inclusion Criteria:

* HIV-negative
* Willing to participate and sign an informed consent
* Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
* Willing to use two forms of contraception during the study.
* Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
* Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses.
* Willing to abstain from using any vaginal product (other than the study product or placebo).
* Willing to be sexually abstinent from randomization until completion of Day 7 evaluations.

Exclusion Criteria:

* Currently pregnant or breast-feeding.
* Clinically detectable genital abnormality on the vulva, vaginal walls or cervix.
* Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed genital ulcer disease or active HSV-2 lesions.
* Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization.
* Symptomatic bacterial vaginosis and unwilling to undergo treatment.
* Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.

Primary outcomes:
measure: Local and systemic safety and tolerability.
Secondary outcomes:
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Projet Ubuzima
city: Yeoville
country: South Africa
facility: Reproductive Health Research Unit - Sheshisani IPM Clinic
state: Johannesburg
city: Bloemfontein
country: South Africa
facility: Farmovs-Parexel
city: Moshi
country: Tanzania
facility: Kilimanjaro Reproductive Health Program
Study officials:
affiliation: IPM
name: Zeda Rosenberg, ScD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01892176: Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease
Official title: Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Keywords: coenzyme Q10, Parkinson disease, oxidative damage
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesise that measuring biomarkers of oxidative damage could better inform investigators on the potential merits (and pitfalls) of CoQ10 supplementation in PD subjects.

Detailed description: Subjects with idiopathic PD will be recruited to a 10-week dose escalation study. Each dosage (400mg/day, 800mg/day, 1200/day and 2400mg/day) will be consumed daily for two weeks. Information on safety and fasting blood/urine samples will be collected. Primary endpoint is plasma F2-isoprostanes (adjusted for arachidonate) while secondary endpoint is the change in the total Unified Parkinson Disease Rating Scale (UPDRS) before and after treatment. Serum phospholipase A2 activities, plasma all trans-retinol, plasma total tocopherol (sum of α-, δ- and γ-tocopherol) and serum uric acid will be measured.

Eligibility criteria: Inclusion Criteria:

* idiopathic Parkinson disease
* age \>21 years
* able to provide written informed consent

Exclusion Criteria:

* diabetes mellitus, stroke, cardiac and renal diseases and cigarette smoking
* major psychiatric disorder or drug and/or alcohol abuse/dependence
* regular use of antioxidants, dietary supplements, traditional Chinese remedies, non-steroidal anti-inflammatory drugs or immunosuppressive drugs

Primary outcomes:
measure: Biomarkers of oxidative damage
timeFrame: 10 weeks
Secondary outcomes:
measure: Total Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Health System
Study officials:
affiliation: National University Health System
name: Raymond Seet, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139060: Organized Self-Management Support Services for Chronic Depression
Official title: Organized Self-Management Support Services for Chronic Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: chronic or recurrent depression
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Swedish Medical Center
First posted: 2010-06-08
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. All intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers.


Eligibility criteria: Inclusion Criteria:

* all patients will meet criteria for recurrent major depression or dysthymia

Exclusion Criteria:

* bipolar disorder or psychotic disorder

Primary outcomes:
measure: Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors)
timeFrame: 18 months
Secondary outcomes:
measure: Examination of moderators of treatment response
timeFrame: 18 months
measure: An estimate of the program's costs and effect on the costs of treatment for depression
timeFrame: 18 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Insitute
state: Washington
city: Seattle
country: United States
facility: Swedish Cherry Hill Clinic
state: Washington
Study officials:
affiliation: Group Health Research Institute
name: Evette Ludman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones SMW, Ludman EJ. Factor Structure and Sensitivity to Change of the Recovery Assessment Scale. J Behav Health Serv Res. 2018 Oct;45(4):690-699. doi: 10.1007/s11414-017-9563-x.
citation: Ludman EJ, Simon GE, Grothaus LC, Richards JE, Whiteside U, Stewart C. Organized Self-Management Support Services for Chronic Depressive Symptoms: A Randomized Controlled Trial. Psychiatr Serv. 2016 Jan;67(1):29-36. doi: 10.1176/appi.ps.201400295. Epub 2015 Aug 17.
Clinical trial NCT06470360: Comparison of the Safety of Absorbable and Hem-o-lok Clips in Laparoscopic Cholecystectomy
Official title: Clinical Outcomes of Absorbable or Hem-o-lok Clip Closure of the Cystic Stump in Laparoscopic Cholecystectomy: a Prospective Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Keywords: laparoscopic cholecystectomy
cystic duct closure
safety
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safe closure of the cystic duct is the critical step in laparoscopic cholecystectomy. In the literature, the investigators did not observe any prospective study analysing the use of absorbable single clip and Hem-o-lok single clip. In this prospective study, the reliability of the two methods will be compared using a single clip.

Detailed description: In this prospective randomised controlled clinical study; closure of the cystic duct in laparoscopic cholecystectomy will be performed by two different methods. Early clinical results and long-term effects on neighbouring anatomical structures will be investigated.

Eligibility criteria: Inclusion Criteria:

* elective laparoscopic cholecystectomy ASA I-III Patients who accepted the study

Exclusion Criteria:

* open surgery emergency cholecystectomy refuse to trial

Primary outcomes:
measure: Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system.
timeFrame: first 30 day
Secondary outcomes:
measure: The costs of the clips used
timeFrame: one week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Koşuyolu Higher Specialization Training and Research Hospital
state: Kartal
Study officials:
affiliation: Kartal Kosuyolu
name: Mustafa Duman
role: PRINCIPAL_INVESTIGATOR
References: