louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01653431: Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mild Cognitive Impairment
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 68
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will examine whether the effects of computerized brain training are enhanced when training is combined with mild brain stimulation in patients with mild cognitive impairment. We hypothesize that this combination will produce greater improvements in cognitive functioning than computerized brain training alone.


Eligibility criteria: Inclusion Criteria:

* Aged 60 - 85 years.
* Meet diagnostic criteria for amnestic mild cognitive impairment.

Exclusion Criteria:

* Inability to provide informed consent.
* Concurrent medication likely to affect mental performance.
* Current substance use or dependence in last 3 months.
* Current active psychiatric or neurological condition

Primary outcomes:
measure: California Verbal Learning Test II
timeFrame: Post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Black Dog Institute
state: New South Wales
Study officials:
References:
citation: Martin DM, Mohan A, Alonzo A, Gates N, Gbadeyan O, Meinzer M, Sachdev P, Brodaty H, Loo C. A Pilot Double-Blind Randomized Controlled Trial of Cognitive Training Combined with Transcranial Direct Current Stimulation for Amnestic Mild Cognitive Impairment. J Alzheimers Dis. 2019 Aug 12;71(2):503-512. doi: 10.3233/JAD-190306.
Clinical trial NCT03187431: Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis
Official title: Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stem Cell Transplant Complications
Keywords: Stem cell
Therapy
IPF
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently, the application status of MSCs as treatment modalities in IPF is still in its infancy and remains exploratory. Although a number of safety and efficacy clinical trials of MSCs as therapeutic options in immune-mediated and cardiac diseases have already been published with tantalizing results, to our disappointment, pulmonary and critical care medicine have traditionally lagged behind other therapeutic and research fields including hematology, gastroenterology and cardiology in translational studies of the use of reparative cells


Eligibility criteria: Inclusion Criteria:

* Age 18 to 75 years (both inclusive)
* high-resolution computed tomography (HRCT) scan that is very suggestive or consistent with a probable diagnosis of usual interstitial pneumonia.
* Bronchoalveolar lavage must be performed at any time before inclusion and must have failed to show features supporting alternative diagnoses.
* The duration of the disease should be more than three months, and bibasilar inspiratory crackles should be present.
* dyspnea score of at least 2 on a scale of 0 (minimum) to 10 (maximum).
* FVC \> 50% of the predicted normal value and DLco \> 35% of the predicted value.
* Patients under treatment with n-acetylcysteine or pirfenidone should discontinue drug and enter a wash-out period for at least 6 weeks prior study enrolment.

Exclusion Criteria:

* FVC \< 50% predicted normal value and DLCO \< 35%predicted normal value.
* lung cancer or with an evidence of active malignancyfor at least 5 years.
* uncontrolled heart failure.
* renal failure
* hepatic failure,
* neurological abnormalities including stroke and myasthenia Gravis
* Anti-coagulants therapy.
* Active infections.

Primary outcomes:
measure: number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation
timeFrame: 6 months
Secondary outcomes:
measure: Post therapy diffusing capacity of CO% (DLCO)predicted
timeFrame: 6-12 months
measure: post therapy forced vital capacity (FVC)% predicted.
timeFrame: 6-12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00688831: Single Ascending Dose Study (SAD) iv Formulation
Official title: A Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Ascending Intravenous Doses of AZD1305 in Helahty Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD1305
SAD
safety
pharmcokinetics
Safety and tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body (how it is taken up into the body, distributed around the body and disappears from the body


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* BIM 19-30 kg/m2

Exclusion Criteria:

* Potassium outside normal reference values
* ECG findings outside normal range

Primary outcomes:
measure: Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
timeFrame: During the study
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: During all dosing visits
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Helen Lunde, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göeborg, Sweden
name: Marianne Hartford, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01206231: An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia
Official title: An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Standard daily practice in managing patients with hypercholesterolemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-21
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Speciality care clinics

Brief summary: This study is aimed to collect the following Serbia-specific epidemiology data on hypercholesterolemia: patents characteristics, patients' management/treatment and physicians' standard practice. In addition, the aim is to determine the proportion of patients on lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C treatment goals.


Eligibility criteria: Inclusion Criteria:

* Patients with hypercholesterolemia currently receiving a lipid lowering agent

Exclusion Criteria:

* Pregnancy and lactation.

Primary outcomes:
measure: Proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of patients on lipid-lowering pharmacological treatment reaching the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines;
timeFrame: 24 weeks
measure: Physicians' standard practice in managing patients with hypercholesterolemia (by using physicians' questionnaire);
timeFrame: 24 weeks
measure: Local epidemiological date on patients with hypercholesterolemia (Demographic Data; Hypercholesterolemia management data: treatment, treatment changes)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Research Site
city: Cacak
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Niska Banja
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Pancevo
country: Serbia
facility: Research Site
city: Pozarevac
country: Serbia
facility: Research Site
city: Sombor
country: Serbia
facility: Research Site
city: Sremska Kamenica
country: Serbia
facility: Research Site
city: Uzice
country: Serbia
facility: Research Site
Study officials:
affiliation: Division of Cardiology-Clinical Centre of Serbia-Belgrade
name: Prof.Dr Miodrag Ostojic
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00820131: Chronic Pain After Inguinal Hernia Repair
Official title: A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inguinal Hernia
Chronic Pain
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.

A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.

Two techniques of inguinal hernia repair will be evaluated:

1. open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)

Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* primary unilateral inguinal hernia
* 18 years and older

Exclusion Criteria:

* bilateral hernia
* recurrent hernia
* incarcerated hernia
* malignant disease within the last 5 years
* not able to understand the questionaire

Primary outcomes:
measure: chronic pain
timeFrame: 3 months, 15 months
Secondary outcomes:
measure: morbidity
timeFrame: 3 months, 15 months
measure: recurrence rate
timeFrame: 3 months and 15 months
measure: quality of life
timeFrame: 3 months and 15 months
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: LKH Feldkirch, Dept. of Surgery
city: Linz
country: Austria
facility: Hospital Barmherzige Schwestern
city: Mistelbach
country: Austria
facility: LK Weinviertel Mistelbach, Surgical Department
city: Vienna
country: Austria
facility: KH Göttlicher Heiland
city: Vienna
country: Austria
facility: KFJ Hospital, Dept. of Surgery
city: Vienna
country: Austria
facility: Medical University of Vienna, Dept. of Surgery
city: Wiener Neustadt
country: Austria
facility: KH Wiener Neustadt, Surgical Department
Study officials:
affiliation: Medical University of Vienna
name: Gerhard Prager, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04235231: The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography
Official title: The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography: A Pilot Prospective Randomized Study in Neurocritical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Collapse
Keywords: Lung Inhomogeneity
Lung Collapse
Atelectasis
Mechanical Ventilation
EIT
Bed tilting
Positioning
Neurocritical Care
Unconsciousness
Acute Brain Disease
Preventive Strategy
Lead sponsor: Regional Hospital Liberec
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
name: University of Sao Paulo
name: Technology Agency of the Czech Republic
First posted: 2020-01-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prevention of lung inhomogeneity is an essential part of preventive strategy in neurocritical care, reducing the risks of secondary brain damage from hypoxemia, hypo/hypercapnia or pneumonia.

Detailed description: In the monocentric, intervention, prospective, randomized study, the investigators will examine the effect of lateral tilting (routinely used in critical care) on the lung inhomogeneity that will be analyzed by electrical impedance tomography (EIT) in the unconscious patients with acute primary brain disease and artificial pulmonary ventilation. Two types of lateral tilting will be compared: manual positioning of body by nurse versus the bed tilting (15° lateral tilt, original company (LINET) and product brand name (Eleganza 5).

Eligibility criteria: Inclusion Criteria:

* Primary brain disease
* Hospitalization in Neurocenter, Neurointensive Care Unit
* Age\>18 years
* Unconsciousness
* Artificial pulmonary ventilation

Exclusion Criteria:

* Intracranial hypertension
* History of primary lung disease
* The terminal stage of the disease
* Refractory hemodynamic instability

Primary outcomes:
measure: Atelectasis/collapse
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Evaluating oxygenation parameters
timeFrame: up to 24 weeks
measure: Evaluating hemodynamic parameters
timeFrame: up to 24 weeks
measure: Cost effectiveness measurement between two groups
timeFrame: up to 24 weeks
measure: Profiling pneumonia incidence
timeFrame: up to 24 weeks
measure: Comparing duration of stay in Neurocenter Neurointensive Care Unit
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Liberec
country: Czechia
facility: Regional Hospital Liberec
Study officials:
affiliation: NeuroCenter
name: Vera Spatenkova, MD, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04310631: Evaluation of Retinal and Vascular Features in Coats Disease After Intravitreal Injections of Ranibizumab
Official title: Optical Coherence Tomography Angiography Findings After Intravitreal Ranibizumab in Patients With Coats Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coats Disease
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 5
Sex: MALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 18 years with diagnosis of Coats disease. They did not present other ophthalmological diseases.

Brief summary: This study evaluates the retinal and vascular features in patients affected by Coats disease under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography

Detailed description: Coats disease is an idiopathic retinal vascular disorder, occurs in young males, and is characterized by retinal telangiactasias, numerous yellowish exudates in the subretinal space, macular edema, hemorrhages and, in advanced end-stage, by exudative retinal detachment.

Ranibizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment acting on vascular hyperpermeability. The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of Ranibizumab in Coats disease.

Eligibility criteria: Inclusion Criteria:

* age older than 18 years
* diagnosis of Coats disease
* treatment-naïve with Ranibizumab
* absence of other vitreoretinal and vascular retinal diseases
* absence of diabetes

Exclusion Criteria:

* age younger than 18 years
* No diagnosis of Coats disease
* previous treatments with Ranibizumab
* presence of vitreoretinal and vascular retinal diseases
* presence of diabetes

Primary outcomes:
measure: Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab
timeFrame: Three months
measure: Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
affiliation: Federico II University
name: Daniela Montorio
role: STUDY_DIRECTOR
References:
Clinical trial NCT00873431: Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47
Official title: An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Infections
Keywords: Prevention of pneumococcal infections
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
Collaborators: name: PATH
First posted: 2009-04-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination.

A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.

Detailed description: This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Healthy adults ≥ 18 to \</= 65
* female subjects: post-menopausal or practicing reliable methods of contraception during the study

Exclusion Criteria:

* History of autoimmune diseases and malignancies.
* History of severe hypersensitivity reactions and anaphylaxis.
* Immunodeficiency due to immunosuppressive therapy.
* Infection with HIV, Hepatitis B or Hepatitis C.
* Pregnancy, lactation
* Vulnerable subjects

Primary outcomes:
measure: Occurrence of any SAEs (possibly)related to the study vaccine
timeFrame: Day 0 - Day 264
measure: Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine
timeFrame: Day 0 - Day 264
measure: Occurrence of solicited local and systemic AEs within 1 week after vaccination
timeFrame: Day 0 - Day 264
Secondary outcomes:
measure: Determination of vaccine-specific IgG levels
timeFrame: Day 0 - Day 264
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH, Institute for Clinical Pharmacology
Study officials:
affiliation: Valneva Austria GmbH
name: Evelyn Hatzenbichler, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04909931: Vitamin D Supplementation on Outcome and Disease Activity.
Official title: Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients At Rajavithi Hospital : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2021-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .


Eligibility criteria: Inclusion Criteria:

* Age \> 18 yrs old
* RA diagnosed by ACR/EULAR 2010
* low to moderate disease activity
* on stable NSAIDs and DMARDs for at least 1 month
* Received Prednisolone less than or equal to 7.5 mg/day
* serum calcium, phosphorus and ALP are within normal limit.

Exclusion Criteria:

* Chronic kidney disease stage 3 or higher
* History of TB
* History of Chronic liver disease
* Pregnancy or breast-feeding
* adjustment of immuno-suppressive drugs, steroid
* other connective tissue disease
* Vitamin D allergy
* received other drugs which have vitamin D component
* serum Vitamin D less than 10 ng/mL

Primary outcomes:
measure: To study efficacy of vitamin D on disease activity RA patients at Rajavithi hospital
timeFrame: 12 weeks
measure: To study efficacy of vitamin D on IL-6 in RA patients at Rajavithi hospital
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Sirilak Nunthiyakul, Medicine
role: STUDY_CHAIR
References:
citation: Polasik K, Piotrowska E, Lipinska B, Witkowski JM, Bryl E, Tukaj S. Vitamin D status in patients with rheumatoid arthritis: a correlation analysis with disease activity and progression, as well as serum IL-6 levels. Acta Biochim Pol. 2017;64(4):667-670. doi: 10.18388/abp.2017_1636. Epub 2017 Dec 5.
citation: Gopal K, Thevarajah M, Ng CM, Raja J. Effects of vitamin D on disease activity and serum interleukin-6 in rheumatoid arthritis. Int J Rheum Dis. 2019 May;22(5):834-841. doi: 10.1111/1756-185X.13484. Epub 2019 Feb 6.
citation: Aslam MM, John P, Bhatti A, Jahangir S, Kamboh MI. Vitamin D as a Principal Factor in Mediating Rheumatoid Arthritis-Derived Immune Response. Biomed Res Int. 2019 May 7;2019:3494937. doi: 10.1155/2019/3494937. eCollection 2019.