louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01722682: Bone Marrow vs Liver as Site for Islet Transplantation
Official title: Bone Marrow vs Liver as Site for Islet Transplantation in Patients With Type 1 Diabetes: Pilot Study to Evaluate Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes
Keywords: Diabetes
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2012-11-07
Enrollment: 9
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 goal of this study is to evaluate safety and efficacy of bone marrow (BM) as site for pancreatic islet transplantationin humans. Our hypothesis is that BM represents a better site than liver (currently the location of choice for this procedure) thanks to its potential capacity to favor islet engraftment. To address our hypothesis we propose herein a randomized phase II trial to compare BM and liver as sites for islet transplantation in T1D patients.

Detailed description: The study is a phase II, single center, open label, pilot study. We will recruit 12 patients with T1D to be randomly (1:1) assigned to receive islet either into the liver through the portal venous circulation (standard procedure; arm A, n=6) or directly into the BM at the level of the iliac crest (arm B, n=6). Patients will be selected from those eligible for islet Tx based on local practice and guidelines.

Eligibility criteria: Inclusion Criteria:

* diabetic patients eligible for pancreatic islet transplantation based on local accepted practice and guidelines. This includes at least: a)clinical history compatible with T1D with insulin-dependence for \>5 years; b) undetectable stimulated (arginine or MMTT) C-peptide levels (\<0.3 ng/mL) in the 12 months before transplant c)presence of severe hypoglycaemic events

Exclusion Criteria:

* presence of hematologic disease

Primary outcomes:
measure: Insulin secretion under stimulation
timeFrame: month 12 post-Tx
Secondary outcomes:
measure: Incidence and severity of Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: throughout the study up to 1 year after first transplant
measure: Insulin requirement
timeFrame: month 1, 3, 6, 9, 12 post- transplant
measure: Islet function
timeFrame: month 1, 3, 6, 9, 12 post-Tx
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Raffaele
Study officials:
affiliation: Ospedale San Raffaele
name: Lorenzo Piemonti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maffi P, Nano R, Monti P, Melzi R, Sordi V, Mercalli A, Pellegrini S, Ponzoni M, Peccatori J, Messina C, Nocco A, Cardillo M, Scavini M, Magistretti P, Doglioni C, Ciceri F, Bloem SJ, Roep BO, Secchi A, Piemonti L. Islet Allotransplantation in the Bone Marrow of Patients With Type 1 Diabetes: A Pilot Randomized Trial. Transplantation. 2019 Apr;103(4):839-851. doi: 10.1097/TP.0000000000002416.
Clinical trial NCT01222182: Statin Interchange by Pharmacist Collaborative Practice Agreement (CPA)
Official title: Statin Therapeutic Interchange by Pharmacist Collaborative Practice Process
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: low density lipoprotein (LDL) cholesterol
statin
dose equivalent
Hypercholesterolemia (defined by LDL guidelines)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 260
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 225 insured eligible subjects, 35 Primary Care Internal Medicine (PCIM) physicians

Brief summary: A group of \~ 225 patients were switched from atorvastatin to an equivalent statin either by their physicians usual management or by an collaborative pharmacist coordinated process. We will compare the results of pharmacist process to the standard medical practice to find potentially which process is more effective, safer and efficient. We are surveying a total of 35 physicians, 12 using the pharmacist coordinated process and 23 not, comparing their satisfaction of the 2 processes.

Detailed description: This study is a retrospective analysis of patients converted from atorvastatin to another equivalent statin. It is observational because the patients were all on atorvastatin, had been informed by their prescription drug plan that it would not be covered, and that if agreed they would be changed to an equivalent that is covered by their plan. The patients were either converted with the help of pharmacist by collaborative practice agreement (CPA)or upon contacting their physician requesting a different medication. We are comparing the percentage first converted to the equivalent dose in each group and whether patients continued to be at hyperlipidemia treatment goal after the interchange.

Eligibility criteria: 225 insured eligible subjects, 35 PCIM physicians

Primary outcomes:
measure: Determine if a process of pharmacist practice agreement is effective in changing from atorvastatin 10, 20mg to a therapeutic equivalent dose.
timeFrame: 3 to 9 months after conversion from atorvastatin
Secondary outcomes:
measure: Was the process regarded as efficient and satisfying to physician compared to usual practice.
timeFrame: 5 months post conversion
measure: Did the patients' low density lipoprotein(LDL) cholesterol require further statin dose intervention?
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Laura Odell, PharmD, RPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03131882: Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger
Official title: Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection With Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Trigger Digit
Keywords: trigger finger
trigger thumb
ultrasound guided
hyaluronic acid
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 120
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: Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger

Detailed description: Randomized controlled trial which designed to compare the success rate, recurrence rate and functional outcomes of patients with trigger finger whom was treated with ultrasound guided hyaluronic acid injection to ultrasound guided corticosteroid injection

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years old
* Quinnell grade I, II, III
* Acute (\< 6 months)

Exclusion Criteria:

* Quinnell grade IV
* Diabetes mellitus
* Rheumatoid arthritis
* Pregnancy
* Patient with prior injection or surgery of trigger finger
* Patient who are allergy to hyaluronic acid

Primary outcomes:
measure: Success rate
timeFrame: 1 month, 3 month, 6 months
Secondary outcomes:
measure: Pain score
timeFrame: 1 month, 3 month, 6 months
measure: Functional outcome
timeFrame: 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Faculty of medicine Ramathibodi hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Thepparat Kanchanathepsak, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05158582: Specific Modified Exercise Program for Low Back Pain in Racketlon Players
Official title: Comparison of Conventional Exercise Protocols and Specific Modified Exercise Program for Low Back Pain in Racketlon Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of conventional exercise protocol and specific modified exercise program to prevent low back pain in racketlon players.

Detailed description: Racketlon is a combination sport in which competitors play a sequence of the four most popular racket sports: Table Tennis, Badminton, squash and tennis. Squash (racquet sport) is an intermittent high-intensity competitive racquet sport that requires quick movements as maintaining control over the placement of the ball with the greatest spatial awareness that is played globally through racquet sports are enjoyed throughout the world and are increasing in their popularity. Since this game encumbers a high level of fitness from the players, who are usually active for the majority of the playing time. Squash players are physically challenged as they are engaged in continuous repetitive training and frequent participation in game to improve their fitness and skills.

The purpose of this study is to find the effects of modified exercise program on LBP in racketlon players. The modified exercise program is a 5-Week Linear Periodization Program, which had effects on Maximal Strength and Speed on elite squash players. This study will find whether this 5-week linear periodization program has an effect to prevent low back pain in racketlon players.

Eligibility criteria: Inclusion Criteria:

* Active Male Racketlon player involved in sport activities for at least 3 times per week
* Age between 20-30 years.
* Players having ≥ 2 episodes of mechanical low back pain in past 6 months.

Exclusion Criteria:

Any upper and lower limb injury.

* History of metabolic diseases.
* History of recent fractures.
* History of spinal radiculopathy

Primary outcomes:
measure: Micheli functional scale (MFS):
timeFrame: 5 weeks
measure: 1 Minute Push-up Test (PUT):
timeFrame: 5 Weeks
measure: Kraus -Weber Test for lower back muscles
timeFrame: 5 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Safari Sports Club
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aadil Omer, Ph.D*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443482: Study to Demonstrate Equivalence of Formoterol 12 and 24 µg Delivered Via Two Types of Single Dose Dry Powder Inhalers (Concept1 and Aerolizer)
Official title: A Randomized, Multi-centre, Double-blind, Double Dummy Placebo Controlled Single-dose Cross-over Study to Demonstrate That 12 and 24 µg of Formoterol Delivered by Concept1 Has a Bronchodilator Efficacy Which is Equivalent to the Same Dose of Formoterol Delivered by Aerolizer in Adult Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
adults
B2 agonist
formoterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to demonstrate that formoterol 12µg and 24µg delivered by a new inhalation device (Concept1) are equivalent to the corresponding dose of formoterol delivered by the Aerolizer device in terms of efficacy, in patients with persistent asthma.


Eligibility criteria: Inclusion Criteria:

* History of asthma attacks
* Forced expiratory volume in 1 second (measure of how well the lungs are working) is greater than 60% of the predicted value

Exclusion Criteria:

* Asthma is not stable: patients were admitted to hospital or received emergency room treatment
* Patients whose asthma drugs need changing within the month prior to the start of the study

Primary outcomes:
measure: • Efficacy assessed by 12 hour Area Under the Curve (AUC) of FEV1 (forced expiratory volume in 1 second, is a measure of how well the lungs are working)
Secondary outcomes:
measure: • Efficacy assessed by forced expiratory volume in 1 second at pre-dose, 15, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours post dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bovenden--Lengler
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_DIRECTOR
References:
Clinical trial NCT03087682: Pituitary Gland Enlargement Was First Diagnosed by Optical Coherence Tomography (OCT)
Official title: Pituitary Gland Enlargement Was First Diagnosed by OCT Before There Were Any Changes at All in the Computerized and Automated Eighty Degrees Peripheral Visual Fields
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Mass
Diagnoses Disease
Lead sponsor: Dr. S.S. Michel Clinic
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 2
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient who presents with frequent or persistent headache of unknown reason.

Brief summary: OCT is now an established way to measure the thickness of the Retinal Nerve Fiber Layer (RNFL) in the retina of the eye. The thickness of the RNFL is always a reflection of the number of the RNFs in any particular area of the retina. Each single RNF runs a long course starting from the cell body which is the retinal ganglion cell in the retina and ends in the thalamus of the brain where it relays visual information to other nerve cell in the thalamus. Along this long course RNFs are in close anatomical relationship with the pituitary gland crossing just above this gland about midway along their course. Hence enlargement of this gland can interfere with the RNFs.

Detailed description: The inferior chiasmal syndrome is known to be caused by pituitary gland enlightenment because the pituitary gland lies just below the optic chiasma. The visual RNFs are organized in a very specific way along their long course from the retina to the Lateral Geniculate Body (LGB) in the thalamus. Pituitary enlargement would compromise particular RNFs. It is well known and established that pituitary enlargement, if not properly treated in time, would possibly cause bitemporal hemianopia due to interference with the crossing RNFs of the nasal half of each retina. In this study pituitary enlargement was suspected by OCT findings while the patient still had perfect peripheral visual field in each eye.

Eligibility criteria: Inclusion Criteria:

* healthy patients with frequent or persistent headache of unknown reasons.

Exclusion Criteria:

* patients who were previously diagnosed with or treated from pituitary enlargement

Primary outcomes:
measure: Thinning of the retinal nerve fibers (RNF) that are nearest to the pituitary gland, measured in micro-millimeters in OCT, were the first indication of possible enlargement of this gland.
timeFrame: through study completion, an average of one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Dr. S.S. Michel Clinic
state: Alberta
Study officials:
affiliation: Dr. S.S. Michel Clinic
name: Shawkat S Michel, FRCS Ed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00241982: Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis
Official title: Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
long circulating liposomes
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Utrecht University
First posted: 2005-10-19
Enrollment: 22
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: Trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.

Detailed description: A proof of concept, dose-escalating trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.

Secondary goals: To compare the therapeutic effect of this intervention with that of a single intramuscular administration of 120 mg methylprednisolone (Depo-Medrol, Pharmacia). The latter is commonly used in the clinics as bridging therapy. To assess the effect of these interventions at the synovial tissue level.

On the longer term, the goal of liposomal corticosteroids is to achieve an increased efficacy/safety ratio compared to standard treatment with free corticosteroids.

Eligibility criteria: Inclusion Criteria:

In order to be enrolled in the study a patient must:

Be aged 18 years or older Fulfill the revised 1987 ARA criteria for the classification of RA Have an active RA as defined by a Modified Disease Activity Score (DAS28) of more than 3.2 Have been on stable treatment with disease modifying anti-rheumatic drugs within 12 weeks prior to trial initiation Be able and willing to give voluntary written informed consent The indication for bridging therapy with systemic corticosteroids has been established by the caring rheumatologist -

Exclusion Criteria:

The patient must not Have been treated with oral corticosteroids within 2 weeks prior to baseline or with intraarticular or intramuscular corticosteroids within 8 weeks prior to baseline Have diabetes mellitus or abnormal renal, liver or haematological tests Have a clinically severe or unstable medical condition involving cardiac, pulmonary, liver and endocrine disorders or malignancies Have a previous history of bleeding or infectious disorders Be currently pregnant or breastfeeding

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: P. Barrera, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01462682: Perception of Fatigue Among Surgeons During Night Shifts
Official title: Perception of Fatigue Among Surgeons During Night Shifts, a Focus Group Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Keywords: focus group study
sleep deprivation
surgery
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
First posted: 2011-10-31
Enrollment: 13
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Doctors working at a department of surgical gastroenterology

Brief summary: The aim of this study was to illustrate surgeons' own perception of fatigue and the impact they felt it had on their performance. This was accomplished through a focus group study, where 13 surgeons participated.


Eligibility criteria: Inclusion Criteria:

* Doctors working at department of surgical gastrointerology, who gave informed consent

Exclusion Criteria:

* Withdrawal of consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: University of Copenhagen, Herlev Hospital
Study officials:
References:
Clinical trial NCT04860882: HEart Surgery In Atrial Fibrillation and Supraventicular Tachycardia
Official title: HEart Surgery In Atrial Fibrillation and Supraventicular Tachycardia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, heart surgery, cabg, valve surgery, preoperative, mortality, grafts
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 10000
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: Patients with atrial fibrillation referred for cardiac surgery in the 5 Polish participating centers.

Brief summary: Atrial fibrillation is the most common cardiac arrhythmia, the incidence of which increases drastically with age. As more and more elderly patients undergo heart surgery, the proportion of patients in this population will increase. Atrial fibrillation has been shown to be a poor prognostic factor in several surgical situations. The aim of our study was to assess long-term mortality among patients with preoperative AF under various cardiac surgery settings, with a particular emphasis on the strategy of coronary revascularization.


Eligibility criteria: Inclusion Criteria:

* Referred for heart surgery,
* preoperative atrial fibrillation

Exclusion Criteria:

* age\<18 years old

Primary outcomes:
measure: Death from any cause
timeFrame: 2008-2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05544682: Cefiderocol in the Treatment of Multidrug-resistant Gram-negative Bacilli Infections, a Retrospective Study
Official title: Cefiderocol in the Treatment of Multidrug-resistant Gram-negative Bacilli Infections, a Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multidrug Resistant Bacterial Infection
Keywords: Multidrug Resistant Bacterial Infections
Gram-negative bacilli infections
Cefiderocol
Antibiotics
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) taken care of in the HUS and treated as part of routine care with Cefiderocol between 04/01/2020 and 08/31/2022.

Brief summary: Cefiderocol is a new antibiotic from the siderophore cephalosporin family for which there are few real-life data on its use in the treatment of infections with multidrug-resistant Gram-negative bacilli.

The circulation of bacterial strains multi-resistant to antibiotics is important at the Strasbourg University Hospital, so the investigators wish to report their local experience of the 1st uses of Cefiderocol in the treatment of infections with multi-resistant Gram-negative bacilli to antibiotics in order to better clarify the use of this antibiotic (therapeutic indication, method of administration)


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* taken care of in the HUS and treated as part of routine care with Cefiderocol between 04/01/2020 and 08/31/2022.
* Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.

Exclusion criteria:

- Patient who has expressed his opposition to the retrospective reuse of his data for scientific research purposes.

Primary outcomes:
measure: Retrospective evaluation of the therapeutic management of patients treated as part of routine care with Cefiderocol
timeFrame: 30 days post treatment with Céfiderocol
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des maladies infectieuses et tropicales - CHU de Strasbourg - France
Study officials:
References: