louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04314336: The Economic Impact of Clinical Pharmacist Involvement in the Public Procurement for Medicines and in the Drug and Therapeutics Committee
Official title: The Economic Impact of Clinical Pharmacist Involvement in the Public Procurement for Medicines and in the Work of the Drug and Therapeutics Committee, Single-centre, Cost-minimisation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rationalization
Keywords: Rationalization
Clinical Pharmacist
Public Procurement for Medicines
Drug and Therapeutics Committee
Lead sponsor: Bjelovar General Hospital
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inhospital patients, all patients receiving any medicine during their stay in the hospital within 1 year period.

Brief summary: The investigators have performed cost-minimisation analysis and compared the expenses based on the plan for public procurement (without clinical pharmacist involvement) for drugs with the results of public procurement based on the revised plan for public procurement by the clinical pharmacist. The plan for public procurements was based on the 1 year quantity for each medicine used by the hospital in the previous year, based on the latest deliverable prices at the time of extracting the data to workbook for MS Excel program (ver. 2002, Microsoft, Redmond, WA, USA).

The investigators have performed cost-minimisation analysis and compared the expenses for all received requests for medicines to the drug and therapeutics committee (DTC) for a decision in the 1 year period, before and after involvement of clinical pharmacist in the committee work. The expenses were based on approval decisions in the 1 year period for approval time period. The denial decisions were also calculated and reported. The denial period calculated in rationalisation of expenses were based on 1 year treatment period.


Eligibility criteria: Inclusion Criteria:

* All patients in the hospital (inhospital patients)

Exclusion Criteria:

* None

Primary outcomes:
measure: Reducing prices of medicines
timeFrame: 1 year
Secondary outcomes:
measure: Rationalization of expenses
timeFrame: 1 year
Other outcomes:
Locations:
city: Bjelovar
country: Croatia
facility: General Hospital Bjelovar
Study officials:
References:
Clinical trial NCT00745836: Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: insulin sensitivity
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2008-09-03
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High dose atorvastatin may worsen insulin sensitivity.


Eligibility criteria: Inclusion Criteria:

* hypercholesterolemia

Exclusion Criteria:

* chronic renal disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References:
citation: Koh KK, Quon MJ, Han SH, Lee Y, Kim SJ, Shin EK. Atorvastatin causes insulin resistance and increases ambient glycemia in hypercholesterolemic patients. J Am Coll Cardiol. 2010 Mar 23;55(12):1209-1216. doi: 10.1016/j.jacc.2009.10.053.
Clinical trial NCT00944736: Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease
Official title: Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Pediatric
VSL#3
Permeability
Probiotic
Zonulin
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: VSL Pharmaceuticals
First posted: 2009-07-23
Enrollment: 12
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on intestinal permeability in pediatric patients with Crohn's disease.

Detailed description: Children with Crohn's disease have altered intestinal permeability. A pilot study in children showed that probiotics may decrease intestinal permeability. In this double blind, randomized controlled trial, we will observe the effect of VSL#3 on small bowel permeability using a double sugar absorption test. PCDAI was monitored, but not analyzed.

Eligibility criteria: Inclusion Criteria:

* Current diagnosis of small bowel or colonic Crohn's disease as defined by histological and endoscopic criteria.
* Males or females ages 11-17 years.
* Crohn's disease in remission as defined by a Pediatric Crohn's Disease Activity Index (PCDAI) \< 10
* Patients on maintenance doses of aminosalicylates, 6-MP and/or Azathioprine for at least 2 months.
* Procurement of written informed consent signed by the subject's legal guardian and study investigator(s) and patient assent.

Exclusion Criteria:

* Patients with documented intestinal stricture.
* Patients with signs of symptoms of systemic or intestinal infection.
* Antibiotic use the previous 1 month.
* Probiotic use in the previous 2 months (excluding yogurt).
* Use of the following medications; Methotrexate, Cyclosporine, Tacrolimus and Infliximab.
* Patients with diagnosis of other co-morbid diseases such as heart disease, renal disease, immunodeficiency, diabetes, or thyroid disease.
* Patients with indwelling catheters.
* Patients with short bowel syndrome
* Positive urine pregnancy test for female subjects

Primary outcomes:
measure: Intestinal Permeability - measured by Sugar Absorption Test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Julia M Bracken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02828436: Spinal Cord Stimulation to Treat Hypertension
Official title: A Pilot Study to Assess Spinal Cord Stimulation To Inhibit Afferent Feedback During Exercise in Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
High Blood Pressure
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the exercise blood pressure response during a lower-extremity dynamic exercise in postmenopausal women with hypertension and to determine if lumbar epidural spinal cord stimulation reduces blood pressure during exercise in postmenopausal women and men with hypertension.

Detailed description: This is a single center study conducted at the University of Minnesota, enrolling up to forty subjects (30 men and 30 post-menopausal women). Subjects will be a assigned to one of the two study arms, (Dynamic Exercise or Spinal Cord Stimulation) and then crossover to the other arm after the initial assignment is complete. However is the screening MRI determines the subject is not a candidate for spinal cord stimulation, then they will be assigned to the Dynamic Exercise arm only.

Eligibility criteria: Inclusion Criteria:

1. Men and post-menopausal women between the ages of 40-90 years old
2. Hypertension (defined as BP ≥ 140/90), diagnosed by a physician
3. Ability of the patient to provide consent

Exclusion Criteria:

1. History of cardiopulmonary disorders other than hypertension, as determined on the medical evaluation questionnaire.
2. History of dangerous arrhythmias (arrhythmias requiring treatment or requiring physician supervision)
3. Currently taking specific anti-hypertensive medications that may affect the exercise pressor response or influence the effect of spinal cord stimulation.

   Please contact study staff for information regarding your eligibility.
4. History of spinal fusion or laminectomy at L3 or above
5. Current prescription opioid usage
6. Contraindication to MRI
7. At physician discretion which will be documented on the case report form.

Primary outcomes:
measure: Change in Exercise Pressor Reflex From Baseline
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Manda Keller-Ross, PhD, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06783036: Long-term Recurrence and Other Complications Requiring Surgery Following Primary Ventral Hernia Repair
Official title: Long-term Recurrence and Other Complications Requiring Surgery Following Primary Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Umbilical Hernia
Epigastric Hernia
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 7200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nationwide population of patients registered in the Danish Ventral Hernia Database

Brief summary: Nationwide, registry based cohort studies on all complications requiring surgery following primary ventral hernia repair

Detailed description: Cohort based on patients registered in the Danish Ventral Hernia Database. Through cross-linking at an individual level, all subsequent operations will be identified in the Danish National Patient Registry. For all potentially related reoperations, patient charts will be retrieved and manually reviewed. Furthermore cross-linkage with the Danish Civil Registration System to retrieve information on civil status. Follow up from time of operation for primary ventral hernia repair (index operation) until reoperation, death, emigration or end of follow up (December 31, 2023), whichever comes first.

Eligibility criteria: Inclusion Criteria:

* Operation for primary ventral hernia repair registered in Danish Ventral Hernia Database
* Known body mass index and smoking status at time of surgery, as registered in the Danish Ventral Hernia Database

Exclusion Criteria:

* Hernia type misclassification (based on manual medical file review)

Primary outcomes:
measure: Operation for hernia recurrence
timeFrame: Until december 31, 2023
Secondary outcomes:
measure: Operation for non-recurrence complication
timeFrame: Until december 31, 2023
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Digestive Disease Center, Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT04869436: Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis
Official title: The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Olfactory Disorder
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
First posted: 2021-05-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group 6 months treatment with Dupilumab.
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months).

The primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* Chronic rhinosinusitis with Nasal Polyps
* Olfactory loss
* Clinical indication for treatment with Dupilumab

Exclusion Criteria:

Patients with olfactory loss from other causes such as:

* Sinonasal malignancies
* Trauma
* Idiopathic olfactory loss
* Use of cocaine
* COVID-19 related olfactory loss
* Pregnancy

Primary outcomes:
measure: Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.
timeFrame: Baseline, 12 weeks and 24 weeks.
Secondary outcomes:
measure: Change from Baseline in the Nasal Polyps score at weeks 12 and 24.
timeFrame: Baseline, 12 weeks and 24 weeks.
measure: Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.
timeFrame: Baseline, 12 weeks and 24 weeks.
measure: Change from Baseline in the QOD-NS at weeks 12 and 24.
timeFrame: Baseline, 12 weeks and 24 weeks.
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: St. Joseph's Hospital London, ON, Canada
name: Leigh J Sowerby, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00405236: Effect of Tiotropium on Inflammation and Exacerbations in COPD
Official title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Changes in Inflammatory Markers in Induced Sputum Following Treatment With Tiotropium Inhalation Capsules 18mcg Once Daily in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: inflammation
exacerbations
Lead sponsor: Royal Free and University College Medical School
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2006-11-29
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with COPD experience exacerbations that are a major cause of morbidity. Exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that this is due to a reduction in inflammation. The study will compare airway inflammation and exacerbation frequency in patients with COPD on tiotropium or placebo.

Detailed description: Patients with COPD will be randomised to tiotropium or placebo in addition to their usual medication. They will be followed prospectively over 1 year and provide sputum for quantification of IL-6 and IL-8 at baseline and at 3 monthly intervals.Serum IL-6 will also be quantified at baseline and over the year. Changes in inflammatory markers will be assessed by analysis of area under the curve of log transformed data. Exacerbation frequency will be calculated from patient diary cards using a previously validated symptom-based exacerbation definition.

Eligibility criteria: Inclusion Criteria:

* diagnosis of COPD,
* FEV1 \< 80% predicted,
* minimum 10 pack year smoking history

Exclusion Criteria:

* asthma,
* atopic disease,
* eosinophilia,
* history of malignancy,
* history of clinically significant pulmonary disease

Primary outcomes:
measure: sputum IL-6
Secondary outcomes:
measure: sputum IL-8
measure: sputum MPO
measure: serum IL-6
measure: serum CRP
measure: exacerbation frequency
measure: FEV1
measure: FVC
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London Chest Hospital
Study officials:
affiliation: Academic Unit of Respiratory Medicine, Royal Free and University College Medical School
name: Jadwiga A Wedzicha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02784236: INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.
Official title: INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Impact
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 121
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: SUPPORTIVE_CARE

Brief summary: Prospective study of 6 months of evolution in people with type 1 diabetes with insulin multidose (MDI) and HbA1c\> 7%. Patients were evaluated clinical, metabolic and psychological baseline and at 6 months, with a telematic visit at 3 months. We analyzed: glycemic control (HbA1c), glycemic variability (SD and MAGE), depressive symptoms (BDI-II), anxiety (STAI), treatment-related (DDS) distress, fear of hypoglycemia (FH-15), adhesion treatment (SCI-R), quality of life (DQOL) and treatment satisfaction (DTSQ) and the platform.


Eligibility criteria: Inclusion Criteria:

* Patients with DM1 plus 1 year of evolution.
* Age ≥18 and \<65 years.
* HbA1c prior to study inclusion\> 7%.
* MDI intensive insulin therapy in basal-bolus regimen.
* Patients candidates for telemonitoring. Approximately 50% of the patients should work with phone or tablet with Android operating system with active data rate to use wireless solution (bluetooth) OnLine MenaDiab® telemedicine. The remaining patients will work with the USB cable solution telemedicine MenaDiab® OnLine.
* Patients who have given written informed consent.

Exclusion Criteria:

* Treatment with ISCI.
* Chronic kidney disease, liver disease, thyroid dysfunction (hypothyroidism except properly treated and controlled).
* Pregnant or planning pregnancy.
* Diabetes mellitus type 2.
* Severe psychological disorders.
* Lack of cooperation (informed consent).
* Patients who are participating in other clinical studies.

Primary outcomes:
measure: To analyze the metabolic impact measured through HbA1c of a telemedicine program by MenaDiab® online platform in the care of patients with DM1.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: FIMABIS
Study officials:
affiliation: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
name: MARIA SOLEDAD RUIZ DE ADANA, MD phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02261636: Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-patient clinics in the Netherlands

Brief summary: For both induction of remission and in maintenance of remission, different doses and treatment durations are used in practice. The aim of this study is to assess how mesalazine is used in clinical practice, at which doses and for how long and how these differences impact the patient disease state and work productivity.


Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate active ulcerative colitis with disease extension beyond the rectum (≥ 10 cm) who will receive oral Pentasa treatment (Compact sachets and/or tablets) for the treatment of the current active episode or in whom on oral Pentasa maintenance treatment induction of remission treatment will be initiated by dose escalation. Treatment combined with Pentasa enema (1g/100ml) is allowed.
* Informed consent

Exclusion Criteria:

* Patients receiving treatment with one or more of the following: locally acting steroids (e.g. budesonide, beclomethasone), systemic steroids, immunosuppressants (e.g. thiopurines), biologicals (e.g. anti-Tumor Necrosis Factor-alpha)

Primary outcomes:
measure: Time to dose reduction
timeFrame: From Day 1 up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
citation: West R, Russel M, Bodelier A, Kuijvenhoven J, Bruin K, Jansen J, Van der Meulen A, Keulen E, Wolters L, Ouwendijk R, Bezemer G, Koussoulas V, Tang T, Van Dobbenburgh A, Van Nistelrooy M, Minderhoud I, Vandebosch S, Lubbinge H. Lower Risk of Recurrence with a Higher Induction Dose of Mesalazine and Longer Duration of Treatment in Ulcerative Colitis: Results from the Dutch, Non-Interventional, IMPACT Study. J Gastrointestin Liver Dis. 2022 Mar 19;31(1):18-24. doi: 10.15403/jgld-3927.