louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06447259: Drug Burden Index is Associated With Malnutrition in Community-dwelling Dementia Patients
Official title: A Rising Drug Burden Index, Not Anticholinergic Burden, is Related With Malnutrition in Community-dwelling Older Adults With Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition Severe
Dementia
Drug Use
Anticholinergic Toxicity
Keywords: Drug burden index,
older adults
malnutrition
anticholinergic drugs
dementia
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-07
Enrollment: 415
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data of patients (65 years of age and older) who were applied to a tertiary geriatric outpatient clinic

Brief summary: Malnutrition leads to poor clinical outcomes in dementia patients. The investigator aimed to examine the association between drug burden index (DBI) and anticholinergic burden (ACB) scores with nutrition status in community-dwelling older adults with dementia, considering that drugs may contribute malnutrition.

A total of 415 outpatients with dementia, evaluated by Mini Nutrition Assessment test and registered drug information, are included in the study. The investigator calculated the DBI as the sum of all sedatives and anticholinergics taken continuously for at least four weeks prior to admission and evaluated the ACB score.

Practice Impact: Due to accompanying chronic diseases and symptoms, cholinergic and/or sedative-loaded drugs are often prescribed to dementia patients. In this study, İnvestigators emphasized that in addition to the cholinergic loads of the drugs used, their sedative loads and the drug doses they use are also important. Avoiding prescribing these medications to patients with dementia will protect them from malnutrition and its negative consequences.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of any type of demantia
* Must be able to swallow tablets
* Must be recorded data of medications and doses

Exclusion Criteria:

* Psychiatric disorders
* Mild cognitive impairment
* End-stage diseases (renal, liver, cardiac)
* Uncontrolled thyroid functions

Primary outcomes:
measure: Number of participants with malnutrition, malnutrition risk and healthy
timeFrame: Baseline
measure: Number of participants with high DBI (Drug Burden Index) score
timeFrame: Baseline
measure: Number of participants with high ACB (Anti Cholinergic Burden) score
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sultan Keskin Demircan
Study officials:
References:
Clinical trial NCT04326959: Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid
Official title: Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Keloid
Keywords: Keloid
Allogeneic Mesenchymal Stem Cells
Umbilical Cord
Conditioned Medium
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical trial will be carried out at the Gatot Soebroto Army Central Hospital, Jakarta and planned from June 2020 to December 2020. Clinical trials of Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) and Conditioned Medium Umbilical Cord-Mesenchymal Stem Cells (CM UC-MSCs) for Keloid were designed in three groups. Group 1 injected with The UC-MSCs at a dose of 2 million cells / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at a dose of 1 cc / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at the same dose 3 weeks later. Group 3 injected with Triamcinolon acetonide (TA) at a dose of 40 mg / cc / cm3 using 1 cc (27 G) syringe and booster with TA at 3 weeks later. The study subjects each group amounted to 7 patients suffering from Keloid. Patients were evaluated for 3 months after injection.


Eligibility criteria: Inclusion Criteria:

* Surgery history of more than 3 months
* Has keloid that the maximum size is 15 cm and thickness is 3-5 mm

Exclusion Criteria:

* Patients with kidney failure
* Pregnancy
* Breastfeeding
* Liver dysfunction
* Blood disorders
* Currently receiving immunosuppressant therapy (chemotherapy or steroids)
* Refusing to participate in the study

Primary outcomes:
measure: Alfa SMA-1
timeFrame: 3 month after injection
measure: Collagen type 1
timeFrame: 3 moth after injection
Secondary outcomes:
measure: Core Biopsy/Histopathology
timeFrame: 3 month after injection
measure: Ultrasonography
timeFrame: 3 month after injection
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01182259: The Incidence and Risk Factors of Side Effects During the Initial Phase of Rifater Therapy - a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2010-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed TB patient in E-DA hospital

Brief summary: Tuberculosis remains one of the largest health problems in the world today. Multidrug therapy is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant mutants, however, which may increase the incidence of side effects during the course of treatment. These side effects may be mild as well as fatal. A severe side effect against one of the anti-TB drugs, which influences drug compliance, may lead to the discontinuation of that drug. At the same time, the risk of treatment failure and relapse are higher. Therefore monitoring the rate of anti-TB drugs induced adverse effects and the related risk factors is crucial. Awareness of the risk groups may decrease the incidence of serious drug-related side effects and medical cost.

The fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO, which simplify the prescription of drugs and prevent the development of drug resistance. However, the FDC regimen is not consistent with the dosages that are usually given, the higher risk of drug toxicity and adverse reactions should be considered. To our knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan. The aim of the present study is to investigate the current incidence of side effects and the risk factors related to FDC drugs for side effects during the initial phase of therapy.


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed pulmonary TB and extrapulmonary TB patients
2. No previous anti-TB drugs treatment
3. Age more than 18years old

Exclusion Criteria:

1. Expected life \< 6months
2. Baseline AST and ALT \> 3 fold upper limit of normal (ULN) or total bilirubin\>2mg/dl
3. Age less than 18years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-DA hospital
Study officials:
References:
Clinical trial NCT03822559: A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension
Official title: A Randomized, Double-masked, Controlled Parallel Group, Multi-center Study of DE-111A (Fixed Dose Combination of Tafluprost and Timolol Eye Drops) on the Treatment of Open Angle Glaucoma or Ocular Hypertension (With Tafluprost Eye Drops as a Comparator)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma, Ocular Hypertension
Keywords: Glaucoma
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 219
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 objective of this study is to investigate whether the IOP (intraocular pressure) -lowering effect of DE-111A (preservative-free fixed dose combination of 0.0015% tafluprost and 0.5% timolol eye drops, administered one drop a time, once daily for 3 months) is superior to the monotherapy of tafluprost 0.0015% eye drops administered one drop a time, once daily for 3 months) in subjects with open-angle glaucoma or ocular hypertension in China as well as comparison of safety.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open angle glaucoma (including primary open angle glaucoma, exfoliation glaucoma or pigmentary glaucoma) in one or both eyes or ocular hypertension for which the subject has been using prostaglandin or beta-adrenergic blocker IOP (intraocular pressure) -lowering drugs before the screening visit
* Those who have signed the informed consent form

Exclusion Criteria:

* Women who are pregnant, nursing or planning pregnancy, or women of child-bearing potential who are not using a reliable method of contraception
* Anterior chamber angle in either eye to be treated with the level \<2 according to Shaffer classification as measured by gonioscopy
* Corneal disorder or other disease preventing reliable applanation tonometry in the treated eyes, including refractive surgery of ocular anterior segment)
* Alcohol or drug abuse
* Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within 30 days before Screening visit

Primary outcomes:
measure: Change from baseline in the average diurnal IOP (intraocular pressure)
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Aier Eye Hospital Group Co., Ltd Changsha Aier Eye Hospital
city: Shanghai
country: China
facility: Eye & Ent Hospital of Fudan University
Study officials:
References:
Clinical trial NCT01914159: Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age Related Macular Degeneration
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration
* Written informed consent

Exclusion Criteria:

* Time of diagnosis more than 6 months before study recruitment
* Ocular surgery of the study eye within 1 month before study recruitment
* Extensive subretinal fibrosis or retinal atrophy of the study eye
* Significant opacification of optical media of the study eye
* Uncontrolled glaucoma of the study eye
* Active ocular inflammation of the study eye
* Best-corrected visual acuity of the contralateral eye below 20/200
* Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs

Primary outcomes:
measure: Best-corrected Visual Acuity
timeFrame: 12 months
Secondary outcomes:
measure: Retinal Morphology
timeFrame: 12 months
measure: Vision-related Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Department of Ophthalmology
city: München
country: Germany
facility: University of München (LMU), Department of Ophthalmology
city: Münster
country: Germany
facility: Universityof Münster, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT00117559: Improving Quality of Life for Veterans Undergoing Interferon Treatment
Official title: Improving Quality of Life for Veterans Undergoing Interferon Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Hepatitis C
Keywords: Psychotherapy,group
Rehabilitation
Telecommunications
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-07-07
Enrollment: 19
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 a group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus. It is hypothesized that the cognitive behavioral therapy (CBT) condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status.

Detailed description: The purpose of the proposed pilot study is to evaluate a rehabilitative cognitive-behavioral group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus (HCV). The specific objectives of the proposed pilot study are: 1) develop study methods and materials; 2) evaluate study feasibility; and 3) assess the efficacy of a cognitive-behavioral group therapy approach and a telehealth approach as compared to care as usual in a randomized design. Participants will be 45 patients (15 participants in each condition) from the VA Boston Healthcare System who are undergoing interferon treatment for HCV. Assessment will occur at pre-treatment, post-treatment, and 3-month follow-up. Assessments will measure key areas, including adherence, quality of life, and psychological distress. Analyses will examine study feasibility and the effects of the treatment condition. It is hypothesized that the CBT condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status. This treatment approach addresses initiatives by the National VHA Hepatitis C Program by optimizing the care of veterans experiencing the devastating side effects of interferon treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hepatitis C.
* Must be on the interferon treatment
* Need to have access to telephone.

Exclusion Criteria:

* Life threatening or acute illness
* Current alcohol or substance abuse or dependence
* Individuals already receiving psychological interventions specifically to manage the side effects of the IFN treatment.

Primary outcomes:
measure: BDI
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Medical Center, Jamaica Plain Campus
state: Massachusetts
Study officials:
affiliation: VA Medical Center, Jamaica Plain Campus
name: Amy Silberbogen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002559: Narrow Band Imaging (NBI) Against Lugol for Squamous Esophageal Cancer
Official title: Endoscopic Surveillance Comparing Narrow Band Imaging (NBI) Against Lugol Chromoendoscopy for Detection of Synchronous Superficial Squamous Esophageal Neoplasia Among High Risk Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Esophageal Neoplasia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with Head and Neck Cancer
2. Patients with esophageal cancer treated by chemoradiotherapy and in remission for 2 years
3. Patients with esophageal cancer treated by endoscopic resection

Brief summary: This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for diagnosis of early esophageal cancers among high risk patients.

Detailed description: The investigators recruited consecutive patients with head and neck cancers, history of squamous esophageal cancers treated by chemoradiotherapy or endoscopic resection. Endoscopic surveillance first started with NBI for detection and characterization of early esophageal cancers through observation of abnormal intrapapillary capillary loops (IPCL). Superficial esophageal neoplasia were diagnosed by IPCL Type IV, V1,V2 and Vn. Lugol chromoendoscopy would be performed subsequently and suspicious neoplasia were classified as understain or unstain lesions. The diagnostic accuracy, sensitivity and specificity of NBI were compared to Lugol chromoendoscopy with histology serving as a gold standard.

Eligibility criteria: Inclusion Criteria:

1. Patients with Head and Neck Cancer
2. Patients with esophageal cancer treated by chemoradiotherapy and in remission for 2 years
3. Patients with esophageal cancer treated by endoscopic resection
4. Age 18 to 80

Exclusion Criteria:

1. Allergy to Lugol iodine
2. Pregnancy
3. Previous esophagectomy

Primary outcomes:
measure: Diagnostic accuracy of superficial esophageal neoplasia
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Philip WY Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03553459: Trendelenburg Maneuver Predicts Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation (TEMPLE)
Official title: Hemodynamic Changes Induced by Trendelenburg Maneuver to Predict Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation
Keywords: fluid responsiveness
trendelenburg
extracorporeal membrane oxygenation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to verify the efficacy of using trendelenburg maneuver to predict fluid responsiveness in patients with extracorporeal membrane oxygenation


Eligibility criteria: Inclusion Criteria:

* patients with ECMO and mechanical ventilator support
* hypotension (MAP\<65mmHg)
* required volume expansion by clinical judgement of the intensivists

Exclusion Criteria:

* severe hypotension with high dose of vasopressors
* severe valve regurgitation
* cardiac arrhythmia

Primary outcomes:
measure: responders
timeFrame: within 1 minute after volume expansion
measure: nonresponders
timeFrame: within 1 minute after volume expansion
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
Study officials:
affiliation: Fudan University
name: Zhe Luo, Doctor
role: STUDY_CHAIR
References:
citation: Luo JC, Su Y, Dong LL, Hou JY, Li X, Zhang Y, Ma GG, Zheng JL, Hao GW, Wang H, Zhang YJ, Luo Z, Tu GW. Trendelenburg maneuver predicts fluid responsiveness in patients on veno-arterial extracorporeal membrane oxygenation. Ann Intensive Care. 2021 Jan 26;11(1):16. doi: 10.1186/s13613-021-00811-x.
Clinical trial NCT02538159: Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.
Official title: Randomized, Prospective, Single-center Study to Compare the Effectiveness and Safety in Terms of Catheter Bacteraemia, Between Peripherally Inserted Central Catheters and Non-tunneled Central Venous Catheter in Tertiary Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Infections
Keywords: Non-tunneled Central venous catheter
Bacteraemia
Peripherally inserted central venous catheter
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare the rate of bacteremia associated between non-tunneled Central venous catheter and peripheral inserted central catheter.


Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥ 18 years.
* Patients hospitalized at our institution requiring at least 6 days of intravenous treatment in a conventional ward of our hospital.
* Signed informed consent by the patient and / or when necessary parent / legal guardian.

Exclusion Criteria:

* Patients with bacteremia at the time of catheter insertion.
* Patients admitted to hematology or intensive care units, for considered a type of patient characteristics very different from other patients.
* Patients with severe clinical situation.
* Patients in whom peripheral venous access is technically impossible, patients outpatient and express refusal of the patient.
* Pregnant patients.

Primary outcomes:
measure: Number of participants with Bacteraemia
timeFrame: 30 days
Secondary outcomes:
measure: morbidities in catheter insertion
timeFrame: 1 day
measure: Comparison of morbidities during manipulation of the catheters
timeFrame: 30 days
measure: 30 days Mortality
timeFrame: 30 days
measure: Visual analogic scale of Pain
timeFrame: 30 days
measure: Health-care costs
timeFrame: 30 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: