louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03126500: Post - Hospital Syndrome: Profile of Functional Status by Malnutrition
Official title: Post-Hospital Syndrome: Evaluation of Functional Status in Malnourished, Geriatric Patients at Hospital Discharge
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Sarcopenia
Keywords: Malnutrition
Disease-related malnutrition
Frailty
Sarcopenia
Hospital discharge
Geriatrics
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants are assessed upon discharge from the hospital. Only malnourished patients were analyzed.

Brief summary: Malnutrition is common problem in hospitalized geriatrics at discharge. Malnutrition is a high risk for functional limitations, impaired muscle strength and reduced quality of life.

Detailed description: The majority of geriatric hospitalized patients are at high risk for malnutrition at discharge, which has negative impact on post-hospital outcomes. In a cross-sectional analysis in malnourished, geriatric patients we will evaluate frailty-status and functional status using objective and subjective methods at hospital discharge. Moreover, we will investigate the association between nutritional Status and frailty, sarcopenia, quality of life and fatigue.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years
* Informed written consent
* Existing or risk of malnutrition
* Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
* Life expectancy of \> 3 months according to treating doctor

Exclusion Criteria:

* Age \< 60 years
* Lack of informed written consent
* No risk of malnutrition
* Low cognitive status according to Mini-Mental State Examination (MMSE \< 24 points)
* Life expectancy of \< 3 months according to treating doctor

Primary outcomes:
measure: Functional Parameter: gait speed
timeFrame: Baseline (hospital discharge)
Secondary outcomes:
measure: Functional Parameter: timed up & go (TUG) time
timeFrame: Baseline (hospital discharge)
measure: Functional Parameter: stair climbing time
timeFrame: Baseline (hospital discharge)
measure: Functional Parameter: Peak expiratory flow rate
timeFrame: Baseline (hospital discharge)
measure: Strength Parameter: Hand grip strength
timeFrame: Baseline (hospital discharge)
measure: Strength Parameter: Knee extension strength
timeFrame: Baseline (hospital discharge)
measure: Index of quality of life
timeFrame: Baseline (hospital discharge)
measure: Body composition
timeFrame: Baseline (hospital discharge)
measure: Frailty-Status
timeFrame: Baseline (hospital discharge)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University, Berlin, Germany
Study officials:
References:
Clinical trial NCT01682200: Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne
Official title: An Open Label Pilot Clinical Trial on the Efficacy and Safety of ProOxy Facial Spray (Topical 15% Oxygen Solution) in the Treatment of Moderate Facial Acne Vulgaris Among Filipino Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: moderate
facial acne
acne vulgaris
Lead sponsor: Medivet Pty Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was conducted to determine the effects and side effects of ProOxy facial spray in the treatment of acne.

Detailed description: A study on the effects and side effects of ProOxy facial spray was done. Sixty people were selected and approved to participate in this study. Pictures of the face (frontal,left side and right side) were taken upon acceptance, during and after treatment at 4,8 and 12 weeks intervals.

Eligibility criteria: Inclusion Criteria:

* patients with acne on their faces only
* patients who are at least 18 years of age
* patients who have normal and disease free skin at the dorsal surface of the upper arm.
* patients who are willing to follow instructions on both the Patch Test Part one and Part Two procedures and to follow scheduled visits.

Exclusion Criteria

* patients with systemic illnesses(such as but not limited to heart disease, hypertension, diabetes, cancer, liver disease, kidney disease)
* patients with very dark skin color, Fitzpatrick skin type V-VI, who are prone to post=inflammatory hyperpigmentation.
* patients with intake of oral medications including glucocorticoids or any immuno-suppressants or who have undergone ultraviolet phototherapy for the past 2 weeks prior to the patch test.
* patients with history of contact dermatitis, dermatographism or anaphylaxis.
* patients with history of eczematous and inflammatory dermatitis, seborrheic dermatitis and psoriasis.

Primary outcomes:
measure: Changes in the appearances,sizes of the acne lesions as well as the disappearance of acne on the face.
timeFrame: 4,8,12 weeks post application of the spray
Secondary outcomes:
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Mary Chile General Hospital
state: Metro Manila
city: Quezon City
country: Philippines
facility: Far Eastern University Hospital, Dept of Family Medicine
state: Metro Manila
Study officials:
References:
Clinical trial NCT01333800: Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma
Official title: Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Grünenthal Colombiana S.A.
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 94
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and Beclomethasone in pediatric asthma control.

Detailed description: Cost-effectiveness study, of cohorts, observational, analytic, prospective, from health institution perspective. Based on published data related to percentage of patients free of crisis for both molecules, it was estimated that the sample size to detect significant differences between the two alternatives was 20 patients per alternative. Medical records of 94 patients with diagnosis of uncontrolled asthma were included, aged between 6 and 15 years, 47 received Beclomethasone randomly, and 47 received Ciclesonide randomly, treatment physician was blind related to this assignation, both cohorts were followed for 6 months, and primary effectiveness variable was defined as number of patients free of crisis with each alternative. Cost generating variables were defined as medication use, and hospital stay. Decision analysis was based on a decision tree.

Eligibility criteria: Inclusion Criteria:

* Patients with uncontrolled asthma diagnosis
* Patients with only one controller medication

Exclusion Criteria:

* Patients without lung infection
* Patients without antibiotic use

Primary outcomes:
measure: Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Hospital San Rafael
Study officials:
affiliation: Grünenthal Colombiana S.A.
name: Francisco Hinestrosa, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02421900: Analysis of the Role of T-cell Response in Patients With Atrial Fibrillation for Clinical Application
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with atrial fibrillation

Brief summary: The purpose of this study is 1) to characterize T-cell response in patients with atrial fibrillation, and 2) to analyze the changes of T-cell response after radio-frequency catheter ablation of atrial fibrillation. First, immune-phenotyping and cytokine profiling of T cells from patients with atrial fibrillation will performed. Next the difference of T-cell immunity among various type of atrial fibrillation patients will be analyzed. Finally the changes of T-cell response and cytokines after radio-frequency catheter ablation of atrial fibrillation will be assessed.


Eligibility criteria: Inclusion Criteria:

* Patients who consent with study
* patients with age more than19
* patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Exclusion Criteria:

* Patients who do not agree with study inclusion
* Permanent AF refractory to electrical cardioversion
* AF with rheumatic valvular disease
* Patients with left atrial diameter greater than 60mm
* Patients with age less than 19
* Patient with malignant tumor and chronic infection disease
* Patient are given immune inhibitor and steroidal anti-inflammatory drug within 2weeks

Primary outcomes:
measure: The frequency (%) of specific marker-expressing cells among CD4 or CD8 T-subsets
timeFrame: 1 year
Secondary outcomes:
measure: The frequency (%) of cytokine-secreting cells among CD4 or CD8 T-subsets
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT04366700: Evaluate the Effect of Graft and Membrane on Healing of Apicomarginal Defects
Official title: Evaluate the Effect of Graft and Membrane on Healing of Apicomarginal Defects: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apicomarginal Defects
Keywords: apicomarginal defects
autograft
prf
collagen membrane
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effect of guided tissue regeneration using a mixture of autograft and PRF covered with a collagen membrane as compared to the membrane alone in the healing of apicomarginal defects. Healing of the lesions will be compared 2 dimensionaly and 3 dimensionaly using CBCT.

Detailed description: Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups -in test group 1 -the defects will be filled with a mixture of autograft(which will be obtained from the surrounding buccal cortical plate by using a trephine bur) and prf(will be prepared by Choukron's method) and the defects and denuded root surface will be covered with a collagen membrane and in test group 2 -the defects will be filled with a blood clot and over that the collagen membrane will be placed. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) and will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.. The criteria for a successful outcome included the absence of clinical signs and/or symptoms and radiographic evidence of complete or incomplete healing.

Eligibility criteria: Inclusion Criteria:

* Patients with age 16 years to 55 years
* Periapical defects with periodontal communication.
* Apicomarginal defects with probing depth \> 6mm on mid-buccal and interproximal surfaces

Exclusion criteria

* Presence of buccal bone on flap elevation.
* Fractured /perforated roots.
* smokers.
* pregnant females and lactating mothers

Primary outcomes:
measure: change from baseline in periapical radiolucency at 12 months
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Clinical success
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Science
state: Haryana
Study officials:
References:
Clinical trial NCT01579500: Neuropathic Pain Study With Botulinum Toxin A in Spinal Cord Injury Patients
Official title: The Effect of Botulinum Toxin A in Post Spinal Cord Injury Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Cord Injury
Neuropathic Pain
Lead sponsor: Catholic University of Korea Saint Paul's Hospital
Sponsor class: OTHER
Collaborators: name: National Health Insurance Service Ilsan Hospital
name: Medy-Tox
First posted: 2012-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
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 determine whether botulinum toxin A is effective in the treatment of neuropathic pain in spinal cord injury patients.

Detailed description: Neuropathic pain remains a significant cause of life quality deterioration. This study includes spinal cord injury patients with refractory chronic neuropathic pain and investigates whether injection with botulinum toxin A improves pain scores.

Eligibility criteria: Inclusion Criteria:

* more than twenty years of age
* paraplegic or tetraplegic due to cervical and thoracic spinal cord injury
* more than 12 months since spinal cord injury and ASIA impairment scale unchanged for more than 6 months
* persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
* a pain score of 40mm or more on the visual analogue scale

Exclusion Criteria:

* neuropathic pain caused by confounding factors other than spinal cord injury
* contraindicated for botulinum toxin type A
* a change in pain medication one month prior to study enrollment
* a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
* person who received botulinum toxin type A within three months prior to study enrollment

Primary outcomes:
measure: Visual analogue scale
timeFrame: 4 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic University Saint Paul's Hospital; National Health Insurance Corporation Ilsan Hospital
Study officials:
References:
Clinical trial NCT00965900: Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Official title: Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Variceal Bleeding
Cirrhosis
Keywords: Cirrhosis
Esophagus Disorders
Varicose Veins
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.

Detailed description: Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis
* Age between 18 and 70 years
* Esophageal varices with high bleeding risk: more than F2 and red color sign
* No previous history of upper gastrointestinal bleeding
* No previous history of endoscopic, radiologic, or surgical therapy for varices or ascites
* Do not take beta-blocker, ACE inhibitor, or nitrate
* Child-Pugh score \<12

Exclusion Criteria:

* Patients with systolic blood pressure \<100 mmHg or basal heart rate \<60/min
* Portal vein thrombosis
* Uncontrolled ascites or hepatic encephalopathy
* Severe coagulation disorder: prothrombin time \<40% (or INR \>1.7) or platelet count \<30,000/mm3
* Medium or large sized gastric or duodenal varices
* Coexisting malignancy
* Severe cardiovascular disorder, renal failure, peritonitis, sepsis
* Severe erosive esophagitis, severe esophageal stricture, active gastric or duodenal ulcer
* Contraindication to beta-blocker
* Pregnancy
* Refusal to give consent to participate in the trial

Primary outcomes:
measure: First esophageal variceal bleeding
timeFrame: 3 years after enrollment
Secondary outcomes:
measure: Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events
timeFrame: 3 years after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University
name: Soon Ho Um, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04436900: Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy
Official title: Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study is a semi-experimental clinical trial that 20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms. The variables of contrast sensitivity, macula thickness under fovea , BCVA, the width of thyroid under fovea , RNFL thickness in the four areas around the disc, and the quality of life questionnaire of all patients were recorded at the beginning of the study.Retinal and choroid under fovea thickness and RNFL thickness were assessed in four areas, one week and one month after the end of treatment, and all the variables mentioned earlier were evaluated three months after PRP surgery.

This study is single group that the outcomes are compared before and after the intervention


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus, Type 2 with PDR
* Having conscious satisfaction

Exclusion Criteria:

* Patients with a history of other eye diseases
* Patients with a history of previous laser treatment
* Patients with a history of injection of Anti-VGEF
* Patients with Vitreous hemorrhage
* Patients with Macula edema
* Patients with myopia more than -3 diopters or hyperopiamore than +3 diopters

Primary outcomes:
measure: Life Quality
timeFrame: up to 3 months
measure: RNFL
timeFrame: up to 30 days
measure: BCVA
timeFrame: up to 3 months
measure: Retinal thickness in the central part of Fovea
timeFrame: up to 30 days
measure: Choroid thickness in the central part of Fovea
timeFrame: up to 30 days
measure: Physical examination of PDR
timeFrame: up to 3 months
measure: Contrast sensitivity
timeFrame: up to 3 months
measure: Angiography with fluorescein
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mohammad Sadegh Bagheri Baghdasht
Study officials:
References:
Clinical trial NCT01618500: Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus
Official title: Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Normal Pressure Hydrocephalus
Keywords: Normal Pressure Hydrocephalus
Neuropsychological Test
Assessment of cognitive disorders/dementia
Neuropsychological assessment
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eighty INPH-patients. Consecutively included.

Brief summary: A novel computerised neuropsychological test battery for normal pressure hydrocephalus (NPH) has been developed. The aim is to provide the clinician with a free of charge, standardized tool, assessing the cognitive decline or improvements in the cognitive domains specific for NPH. Results from the battery indicate good reliability and validity for the computerized tests

Results from the computerised battery seems promising. However, ability for the battery to detect cognitive improvements after a shunt operation remains to be tested.

Study objectives

1. Improvement after shunt. The aim of this study is to evaluate the effects of shunting on neuropsychological performance in NPH patients, using a computerized battery.
2. Feasibility. The ability to complete the test battery by the intended patient group will be tested.
3. Baseline profile. Baseline scores for NPH-patients will be compared to scores of healthy individuals (from previous study).


Eligibility criteria: Inclusion Criteria:

* Older than 60 years of age

"Probable INPH" according to the NIH guidelines

Planned shunt surgery based on a diagnosis of INPH.

Exclusion Criteria:

* Known cause for hydrocephalus (i.e., secondary NPH). Medical condition preventing cognitive testing (e.g. deafness, blindness).

Patients not considered for shunt operation.

Primary outcomes:
measure: Neuropsychological outcome
timeFrame: 4.5 ± 1.5 months
Secondary outcomes:
measure: Mini mental state Examination
timeFrame: 4.5 ± 1.5 months
measure: Feasibility
timeFrame: 4.5 ± 1.5 months
measure: Baseline cognitive profile compared to healthy
Other outcomes:
Locations:
city: Ålborg
country: Denmark
facility: Ålborg University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Umeå
country: Sweden
facility: Umeå University
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
Study officials:
References:
citation: Behrens A, Elgh E, Leijon G, Kristensen B, Eklund A, Malm J. The Computerized General Neuropsychological INPH Test revealed improvement in idiopathic normal pressure hydrocephalus after shunt surgery. J Neurosurg. 2019 Feb 8;132(3):733-740. doi: 10.3171/2018.10.JNS18701. Print 2020 Mar 1.