louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02415140: Prevalence and Predictors of Depression in COPD
Official title: Prevalence and Independent Predictors of Depression in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
COPD
Lead sponsor: Kwong Wah Hospital
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 161
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients with spirometry confirmed airflow limitation

Brief summary: Depression adversely affects quality of life in COPD patients, associated with higher rate of exacerbations, admissions and mortality. However, local prevalence rate of depression in geriatric COPD patients remains unknown.

Though BODE index is superior to FEV1 in prediction of depression in COPD, it is unclear which domain of BODE correlates best with depression. Furthermore, with multiple confounding factors, it's ambiguous that whether frequent exacerbation is an 'independent' predictor for depression among COPD patients.

The objective of this study is i.) to study the local prevalence rate of depression in geriatric COPD patients, ii.) to identify risk factors for depression especially looking at the any independent relationship between frequent exacerbations, various domains of BODE index and depression.

Detailed description: This study is a multi-centers, cross-sectional study, conducted in Kwong Wah Hospital and Wong Tai Sin Hospital, Hong Kong SAR. Age and comorbidity-matched COPD and control subjects were recruited from clinics. Depressive symptoms were measured by a validated Chinese version of Geriatric Depression Scale short form (GDS - 15 items) with 2 cut-off points. A score of 8 or above was considered significant depressive symptoms while the cut off score of 5 or above was for patients with mild depressive symptoms. Prevalence rates of depressive symptoms were measured in both COPD and control groups. Predictors for depression (GDS = or\> 8) were determined using univariate and multivariate analysis.

Eligibility criteria: Inclusion Criteria:

* aged 60 or above,
* with stable COPD suggested clinically and
* post-bronchodilator spirometry FEV1/FVC ratio \<0.7.

Exclusion Criteria:

* Patients were excluded if they had co-existing pulmonary diseases like active pulmonary tuberculosis, interstitial lung diseases etc;
* if they were too demented or physically incapacitated to participate e.g wheelchair-bound for bedbound.

Primary outcomes:
measure: Prevalence of depression (Prevalence rate)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01342640: A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
Official title: A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, age \>/=18 years
* Diagnosis of chronic renal anemia
* Not on dialysis
* Hemoglobin concentration \<10 g/dl
* No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
* Estimated glomerular filtration rate (EGFR) \<60 ml/min and \>/=20 ml/min
* Adequate iron status

Exclusion Criteria:

* Transfusion of red blood cells during the previous 2 months
* Poorly controlled hypertension
* Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
* Active malignant disease (except non-melanoma skin cancer)
* Hemolysis
* Hemoglobinopathies, e.g. sickle-cell disease, thalassemia

Primary outcomes:
measure: Change From Baseline in Mean Hb Concentration at Week 20
timeFrame: Baseline (Week 0), Week 20
measure: Change From Baseline in Mean Hb Concentration at Week 24
timeFrame: Baseline (Week 0), Week 24
measure: Change From Baseline in Mean Hb Concentration at Week 28
timeFrame: Baseline (Week 0), Week 28
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University; Endocrinology Department
city: Cairo
country: Egypt
facility: El Qahira Al Fatemeya Hospital
city: Cairo
country: Egypt
facility: Kasr El Ainy University Hospital; Endocrinology Department
city: Cairo
country: Egypt
facility: Nasser Institute
city: Mansoura
country: Egypt
facility: Mansoura Kidney Center; Nephrology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04696640: Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes
Official title: Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 39
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project explores the feasibility and utility of remote glucose monitoring for a cohort of children and adolescents with type 1 diabetes (T1D) cared for at UC Davis Health (UCDH).


Eligibility criteria: Inclusion Criteria:

* Diagnoses of type 1 diabetes with a duration of greater than or equal to 12 months
* Use of a continuous glucose monitor (CGM) for greater than or equal to 6 months
* Intention to continue receiving care at the UC Davis Health Pediatric Diabetes clinic.

Exclusion Criteria:

* Patient's CGM cannot be uploaded to Glooko

Primary outcomes:
measure: Feasibility of remote glucose monitoring for pediatric T1D patients who receive care at UC Davis Health
timeFrame: 1 month baseline period
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: Initiation = 1 month after enrollment, Study completion = 7 months after enrollment
Secondary outcomes:
measure: Data-sharing experience survey
timeFrame: 1 month after enrollment
measure: Target Glucose Range
timeFrame: Months 1-7 after enrollment
measure: Hyperglycemic range
timeFrame: Months 1-7 after enrollment
measure: Hypoglycemic range
timeFrame: Months 1-7 after enrollment
measure: Overall continuous glucose monitor (CGM) wear time
timeFrame: Months 1-7 after enrollment
measure: Remote patient monitoring survey
timeFrame: Month 7 after enrollment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis
state: California
Study officials:
References:
Clinical trial NCT01444040: Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost
Official title: A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost Ophthalmic Solution 0.004%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-angle Glaucoma
Keywords: Open angle glaucoma
POAG
Ocular hypertension
Pseudoexfoliative glaucoma
Naïve to treatment
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 196
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: Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Detailed description: Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Eligibility criteria: Inclusion Criteria:

* Phakic study eye
* IOP ≥ 21 mmHg and ≤ 40 mmHg at the screening visit (subjects with OHT require a second screening IOP measurement

Exclusion Criteria:

* Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
* Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Primary outcomes:
measure: Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
timeFrame: 12 months
Secondary outcomes:
measure: Change in mean diurnal IOP vs. screening
timeFrame: Month 24
measure: Change in screening in time-wise IOPs
timeFrame: Various Month 12-60
measure: Proportion of responders
timeFrame: Various 12-60 months
Other outcomes:
measure: Adverse event reporting
timeFrame: 0-60 months
Locations:
city: Yerevan
country: Armenia
facility: S.V. Malayan Ophthalmological Center
Study officials:
affiliation: S.V. Malayan Ophthalmological Center, Yerevan, Armenia
name: Lilit A Voskanyan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000440: Sertraline and Naltrexone for Alcohol Dependence
Official title: Sertraline and Naltrexone for Alcohol Dependents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 1999-11-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).


Eligibility criteria: Inclusion Criteria:

* Meets the criteria for alcohol dependence.
* Abstinent from alcohol for a period of at least 5 days and not greater than 30 days.
* Able to read English and complete study evaluations.
* A stable residence and a telephone to ensure that subjects can be located during the study.

Exclusion Criteria:

* Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence.
* Current use of disulfiram (Antabuse) or a MAO Inhibitor.
* Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania).
* Major depression at the time of assessment.
* Previous treatment with naltrexone (Revia) for alcohol dependence.
* Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease.
* Abstinent longer than 30 days prior to admission to program.
* Hepatocellular disease or elevated bilirubin levels.
* Females who are pregnant, nursing, or not using a reliable method of birth control.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Psychiatry, Mount Sinai School of Medicine
state: New York
Study officials:
References:
Clinical trial NCT02040467: Registry for Proton Beam Radiation Therapy
Official title: Registry for Proton Beam Radiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 1243
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient receiving proton beam therapy

Brief summary: The goal is to collect information on each patient treated with proton beam radiation therapy.


Eligibility criteria: Inclusion Criteria:

-Any patient receiving proton beam therapy is eligible for enrollment to this registry (regardless of diagnosis, age, other concurrent therapies, etc.) provided s/he consents to participate.

Primary outcomes:
measure: Treatment-specific data for all patients receiving proton beam radiation therapy
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: UF Health Cancer Center at Orlando Health
state: Florida
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: Washington University School of Medicine
name: Jeff Michalski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00260767: Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
Official title: An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV
Lead sponsor: Biosyn
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2005-12-02
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI.

Detailed description: This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI. MRIs will be performed with both a standard pelvic coil and an enhanced resolution endo-rectal coil in order to obtain maximal resolution. MRI images will be acquired before and after simulated coitus.

Eligibility criteria: Inclusion Criteria:

* 18 to 45 year old women
* not pregnant
* willingness to use effective method of contraception
* regular menstrual cycle
* normal Pap test result

Exclusion Criteria:

* abnormal pelvic exam
* pregnant or breastfeeding
* claustrophobia or other MRI contraindications
* hypertension, hemolytic anemia,latex allergy
* history of hemorrhoids or irritable bowel syndrome

Primary outcomes:
measure: 1. Number and size of bare spots, before and after simulated coitus.
measure: 2. Number of women with migration of gel into the endocervical canal and/or endometrial canal before and after simulated coitus.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Reproductive Research Unit, U of Penn Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania Medical Center
name: Kurt Barnhart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01810367: ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
Official title: ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: PFS
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 84
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: Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC


Eligibility criteria: 1.18\~75 years 2.Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer 3.Presence of at least one index lesion measurable by CT scan or MRI 4.Ecog0-1 5.Expected life time longer than 12 weeks 6.Normal laboratory values:

* leucocyte ≥ 4×109/L
* neutrophil ≥ 1.5×109/L
* platelet ≥ 100×109/L
* Hemoglobin ≥ 10g/L
* ALT and
* AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) 7.Signed written informed consent

Exclusion Criteria:

* Patients have used drugs according to protocol
* Patients were allergic to pemetrexed or cisplatin
* Patients received radiotherapy or other biological treatment 4 weeks before the trial
* Uncontrolled hydrothorax or hydropericardium
* neuropathy toxicity ≥ CTC 3
* Severe symptomatic heart disease
* Active upper gastrointestinal ulcer or digestive disfunction
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception

Primary outcomes:
measure: PFS
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT02526667: Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers
Official title: Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2015-08-18
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.

Detailed description: Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post Chlorhexidine Gluconate (CHG) application.

Eligibility criteria: Inclusion Criteria:

* Males or Females
* 18 years of age or older
* Signed informed consent
* Good Health
* Six inches of abdomen and groin areas without tattoos, or skin disorders

Exclusion Criteria:

* Dermatological Conditions
* Sensitivity to latex
* Sensitivity to CHG

Primary outcomes:
measure: Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin
timeFrame: 10 minutes, 6 hours, 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Bio High Tech SRL
Study officials:
affiliation: S.C. BIO HIGH TECH S.R.L.
name: R Olsavcszky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05716867: Salivary Cystatin S Levels in a Group of Egyptian Children
Official title: The Evidence of Early Childhood Caries Prediction by Salivary Cystatin S Levels in a Group of Egyptian Children: a Case Control Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Early Childhood Caries
Keywords: early childhood caries, salivary cystatin S protein, salivary buffer capacity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 36
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients going to diagnosis clinic of Pediatric dentistry and Dental Public Health Department, Cairo University

Brief summary: Aim of the study

1. Measuring the levels of salivary cystatin S protein and salivary buffering capacity to determine their relation to early childhood caries.
2. Predection of early childhood caries by using salivary cystatin S levels with demographic, clinical and nutrition habits characteristics of the participants.


Eligibility criteria: Inclusion Criteria:

* Medically free children aged 36 to 71 months with one or more decayed (noncavitated or cavitated lesions), missing, or filled teeth due to caries in any primary tooth(cases).
* Medically free children aged 36 to 71 months with no decayed, missing, or filled teeth due to caries in any primary tooth(controls).

Exclusion Criteria:

* Children receiving antibiotic therapy within three month and fluoride prophylaxis within one year.
* Parents who will refuse to participate or refuse to sign the informed consent.
* Children who will not agree or cooperate with participation.

Primary outcomes:
measure: Levels of salivary cystatin S protein
timeFrame: 2 months
Secondary outcomes:
measure: Buffer Capacity
timeFrame: 2 months
measure: Demographic, clinical and nutrition habits characteristics of participants Interview
timeFrame: 2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine Cairo University
Study officials:
References: