louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01616121: Preemptive Lung Impedance-Guided Therapy in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-06-11
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study the interventional group was treated preemptively according to the lung-impedance protocol and the control group was treated only according to clinical assessment.
Primary purpose: TREATMENT

Brief summary: It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedance-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure

Exclusion Criteria:

* Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission

Primary outcomes:
measure: Prevention of acute heart failure development in acute MI patients
timeFrame: Three years
Secondary outcomes:
measure: Improvement of clinical outcome in patients with lung impedance-guided treatments
timeFrame: Three years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05172284: Registry and Monitoring of ImmuNe-mediated Inflammatory Diseases
Official title: Registry and Monitoring of ImmuNe-mediated Inflammatory Diseases (IMIDs) REMIND Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ImmuNe-Mediated Inflammatory Diseases
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this study (registry) will be included all IMID patients afferent to the UO of Dermatology of IRCCS Istituto Ortopedico Galeazzi for an estimated total of 5 years of recruitment.

Brief summary: Formation of a registry of IMID patients to assess the evolution of resistance to conventional and target therapies. This aim is achieved by evaluating the achievement of PASI 50 and PASI 75 scores at week 16 from the start of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of IMID.
* Patients of any age, including minors.
* Patients treated with approved medications for the condition in question and/or phototherapy.
* Patients who agree to sign informed consent.

Exclusion Criteria:

* Patients without a diagnosis of IMID.
* Patients who do not consent to sign informed consent.

Primary outcomes:
measure: Registry of ImmuNe-mediated inflammatory Diseases (IMIDs)
timeFrame: 15 years
Secondary outcomes:
measure: PASI 50
timeFrame: 15 years
measure: PASI 75
timeFrame: 15 years
Other outcomes:
measure: Special populations
timeFrame: 15 years
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCSS Ortopedico Galeazzi
name: Giovanni Damiani, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00966784: The Effect of 2 Months Daily Supplementation of Orange Juice With Fibers
Official title: The Effect of 2 Months Daily Supplementation of Orange Juice With Fibers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Healthy People
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: The study hypothesis is that 2 Months Daily Supplementation of Orange juice with fibers will effect the weight and the plasma lipids.

This will be a double-blind parallel controlled study. Study population will include 50 subjects, who will be divided randomly into two groups. The first group will get the Orange juice with fibers, and the second group will get Orange juice with out the fibers.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* Age 60\>18 years
* Written informed consent
* Consumers of orange drinks: freshly squeezed juices, commercial pasteurized juices and / or orange soft drinks
* Regular eating pattern

Exclusion Criteria:

* Patients with chronic disease sach as:

  * diabetes,
  * cancer,
  * C.O.P.D.,
  * metabolic syndrome,
  * over weight,
  * kidney failure,
  * heart disease and
  * osteoporosis.
* Antibiotic treatment in the last 4 weeks
* Subjects on regular probiotic or prebiotic supplementation, unless the subject will do 2 weeks of wash out before commencing the study.
* Subjects with intestinal disorders such as: IBD, IBS, celiac, colon cancer.
* Subjects after intestinal surgery.
* Use of medicines for lowering cholesterol (simvastatin), sugar control
* Pregnancy
* Subjects with abnormal base-line blood test results: liver functions and/or kidney functions, cholesterol level above 200 mg/dL and glucose level above 50 mg/dL (during fast)

Primary outcomes:
measure: To examine the effect of 2 Months Daily Supplementation of Orange Juice with fibers on the weight and the plasma lipids
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Suorasky Medical Center
Study officials:
References:
Clinical trial NCT03852784: Osteoarticular Infections With Pneumococcal
Official title: Osteoarticular Infections With Pneumococcal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Keywords: Bone and Joint Infection
Streptococcus peumoniae
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had a bone and joint infection with S pneumoniae, with or without device managed at the Croix-Rousse hospital

Brief summary: Osteoarticular infections at pneumococcal are rare, potentially serious and remain under diagnosed. They represent 3 at 10% of the arthritis septic in the literature. 190 cases have been published of 1965 at 2003. They represent 0.3% at 0.6% of the bacteraemia at Streptococcus peumoniae.


Eligibility criteria: Inclusion Criteria:

* patients having had a bone and joint infection with S pneumoniae, with or without device.

Exclusion Criteria:

* none

Primary outcomes:
measure: Description and rate of bone or joint infection with S. pneumoniae
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes:
measure: Rate of Treatment Failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Tristan Ferry, Md,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04264884: Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab
Official title: Daratumumab Subcutaneous Pre-approval Access Study
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-02-11
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT05817084: Patients With Acl Injury and Varus Knee Will Undergo Acl Reconstruction Alone, or Combined With High Tibial Osteotomy in the Same Session.
Official title: Outcomes of Anterior Cruciate Ligament Reconstruction With and Without High Tibial Osteotomy in Knees With Varus Malalignment. Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL - Anterior Cruciate Ligament Deficiency
Varus Deformity of Tibia (Disorder)
ACL Injury
Knee Deformity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the results of single-stage anterior cruciate ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament reconstruction alone in knees with varus malalignment and anterior cruciate ligament deficiency. Evaluation will be clinically, radiologically and time needed to return to pre injury activity level. Our Hypothesis: Simultaneous anterior cruciate ligament reconstruction and high tibial osteotomy provides good functional scores, low rate of graft failure and early return to pre injury activity level with minimal added morbidity.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 50.
* Knee varus malalignment 7-10°.
* ACL injury with clinical anterior instability confirmed by MRI.

Exclusion Criteria:

* Osteoarthritis (Kellgren-Lawrence grade IV).
* Inflammatory joint disease.
* Knee flexion \< 120°
* Knee fixed flexion deformity \> 10°.
* BMI \>30
* Any ligamentous or meniscal knee injury other than ACL injury.

Primary outcomes:
measure: Lysholm knee score
timeFrame: 1 month post operative
measure: Lysholm knee score
timeFrame: 3 month post operative
measure: Lysholm knee score
timeFrame: 6 month post operative
measure: Tegner activity level
timeFrame: 1 month post operative
measure: Tegner activity level
timeFrame: 3 months post operative
measure: Tegner activity level
timeFrame: 6 months post operative
measure: Return to pre injury level
timeFrame: through study completion, an average of 7 months
Secondary outcomes:
measure: knee range of motion
timeFrame: pre operative, 1 month, 3months, and 6 months post operative
measure: knee stability
timeFrame: pre operative, 1 month, 3months, and 6 months post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT00238784: SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults
Official title: A Comparison of Symbicort® Single Inhaler Therapy (Symbicort® 200 Turbuhaler® 1 Inhalation b.i.d. Plus as Needed) & Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents & Adults-a 26-Week, Randomised, Open-Label, Parallel Group, Multicentre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 1300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice in patients with persistent asthma


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma \< 3 months
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1

Exclusion Criteria:

* Smoking history \> 10 pack-years
* Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
* Any significant disease or disorder that my jeopardize the safety of the patient.

Additional inclusion and exclusion criteria will be evaluated by the investigator.

Primary outcomes:
measure: Time to first severe asthma exacerbation
Secondary outcomes:
measure: Number of asthma exacerbations
measure: Mean use of as-needed medication
measure: Prescribed asthma medication
measure: Patient reported Outcomes
measure: Health care resource use
measure: Safety: Adverse Events, Serious Adverse Events and discontinuations due to Adverse Events
measure: Induced sputum will be sampled from a subset of patients
measure: All variables assessed over the 6 months treatment period
Other outcomes:
Locations:
city: Aldergrove
country: Canada
facility: Research Site
state: British Columbia
city: Bolton
country: Canada
facility: Research Site
state: Ontario
city: Brampton
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Rita Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Sears MR, Boulet LP, Laviolette M, Fitzgerald JM, Bai TR, Kaplan A, Smiljanic-Georgijev N, Lee JS. Budesonide/formoterol maintenance and reliever therapy: impact on airway inflammation in asthma. Eur Respir J. 2008 May;31(5):982-9. doi: 10.1183/09031936.00104007. Epub 2008 Jan 23.
Clinical trial NCT00700284: Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
Official title: Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV-I
Reverse transcriptase inhibitors
HIV Seronegativity
Lead sponsor: International Partnership for Microbicides, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tibotec Pharmaceutical Limited
First posted: 2008-06-18
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.


Eligibility criteria: Inclusion Criteria:

* Female, 18-50 years, inclusive
* Willing and able to provide written informed consent
* HIV-uninfected and otherwise healthy
* Willing to abstain from sexual activity and use of vaginal products while participating in the trial
* Currently using oral contraceptives for pregnancy prevention
* Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial

Exclusion Criteria:

* History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements.
* History of allergy to TMC120 or to the constituents of the vaginal ring.
* History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
* History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months.
* History of genital tract surgery within the last month
* Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
* Currently or within one month of participating in any other clinical research trial
* Current (during screening) diagnosis of any genital infection
* Current vulvar of vaginal symptoms
* Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption

Primary outcomes:
measure: safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
timeFrame: 7 days
measure: TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Drug Research Unit, UZ Gent
Study officials:
affiliation: Drug Research Unit, UZ Gent
name: Dr Luc Van Bortel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02329184: Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
Official title: Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 in Patient Volunteers With Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: MyoKardia, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-31
Enrollment: 15
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: The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with HCM
* Normal left ventricular ejection fraction (LVEF)
* NYHA class I, II or III

Exclusion Criteria:

* Inherited metabolic disorders, myocardial infiltration or cardiofaciocutaneous syndrome (e.g., Noonan's, Fabry's).
* History of clinically important atrial or ventricular arrhythmias
* History of positive human immunodeficiency virus (HIV) test and/or seropositive for hepatitis C virus (HCV) or hepatitis B virus (HBV)..

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 28 Days
Secondary outcomes:
measure: Determination of pharmacokinetics parameters as measured by Cmax
timeFrame: 28 Days
measure: Determination of pharmacokinetics parameters as measured by Tmax
timeFrame: 28 Days
measure: Determination of pharmacokinetics parameters as measured by AUC
timeFrame: 28 Days
measure: Determination of pharmacokinetics parameters as measured by t1/2
timeFrame: 28 Days
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Cypress
country: United States
state: California
city: Stanford
country: United States
state: California
city: Boston
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Durham
country: United States
state: North Carolina
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: MyoKardia, Inc.
name: Jonathan C Fox, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03831984: Topical Bromfenac for Intraoperative Miosis and Pain Reduction
Official title: Topical 0,09% Bromfenac for Intraoperative Miosis and Pain Reduction in Femtosecond Laser-assisted Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract
Keywords: Phacoemulsification
femtosecond laser
bromfenac
NSAID
pupil
Lead sponsor: Hospital de La Luz
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.

Detailed description: This prospective cross-sectional randomized clinical study included 60 patients with senile cataract in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery and pain quantification was assessed by analogous pain scale at one day follow-up.

Eligibility criteria: Inclusion Criteria:

* Male and female
* Subjects 18 years or older
* Patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract surgery with posterior chamber (PC) IOL implantation.

Exclusion Criteria:

* Presence of corneal abnormalities
* History of intraocular surgery
* History of ocular or systematic diseases (glaucoma, diabetes, uveitis
* Regular, systemic use of steroid or NSAIDs during the previous 3 months

Primary outcomes:
measure: intraoperative miosis
timeFrame: 2 days
Secondary outcomes:
measure: postoperative pain
timeFrame: 1 day
Other outcomes:
Locations:
city: Ciudad de Mexico
country: Mexico
facility: Maria Camila Aguilar Sierra
Study officials:
affiliation: FELLOWSHIP
name: MARIA AGUILAR SIERRA, MD
role: PRINCIPAL_INVESTIGATOR
References: