louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02069717: Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule)
Official title: Multi-center, Prospective, Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule) Add-on to Statin Therapy in Patients Who Have History of Acute Myocardial Infarction and Are Diagnosed With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Metabolic Syndrome
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2014-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects aged more than 20 with history of acute myocardial infarction and diagnosed with metabolic syndrome

Brief summary: The purpose of this study was to assess the incidence rate of the major adverse cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin therapy in patients who have history of acute myocardial infarction and are diagnosed with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* patients \>20 years of age.
* history of acute myocardial infarction
* metabolic syndrome diagnosis

Exclusion Criteria:

* current liver disease or AST or ALT greater than 3 times the upper limit of reference range
* pre-existing gallbladder disease
* moderate to severe renal disorder (serum creatinine \>2.5mg/dL)
* pancreatitis diagnosis

Primary outcomes:
measure: The incidence rate of the major adverse cardiovascular events (MACE)
timeFrame: 24 months
Secondary outcomes:
measure: The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE)
timeFrame: 24 months
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam national university hospital
Study officials:
References:
Clinical trial NCT01180517: The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations
Official title: The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Angioplasty
Keywords: Angioplasty Balloon
Lead sponsor: Heart Centre Rotenburg
Sponsor class: OTHER
Collaborators: name: B. Braun Melsungen AG
First posted: 2010-08-12
Enrollment: 64
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 intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention (PCI) of Medina 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.


Eligibility criteria: Inclusion Criteria (main):

* De-novo Medina type 0,0,1 bifurcational native coronary artery lesion (reference diameter:\>2.0 mm \<3.5 mm, length of stenosis: ≤ 10 mm), the diameter of the side branch shall be smaller or equal to the diameter of the distal end vessel

Exclusion Criteria (main):

* Reference side branch diameter \> 3.5 mm
* Evidence of extensive thrombosis within target vessel
* Patients with another coronary stent implanted previously into the target branch or bifurcation ≤ 15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD- BIF

Primary outcomes:
measure: In-segment late lumen loss in the side branch at 9 months
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
Study officials:
affiliation: Klinikum Ernst von Bergmann Potsdam, Germany
name: F. X. Kleber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01587417: Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL
Official title: A Randomised, Double-blind, Placebo-controlled Trial in Healthy Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 2.5 mg to 360 mg of BI 187004 CL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 187004 CL within a predefined dose range


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects
2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: up to 15 days postdose
Secondary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 96 hours postdose
measure: AUC0-8 (area under the concentration-time curve of the in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 96 hours postdose
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
timeFrame: up to 96 hours postdose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: 1307.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Bianzano S, Heise T, Jungnik A, Schepers C, Scholch C, Grafe-Mody U. Safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of BI 187004, an inhibitor of 11beta-hydroxysteroid dehydrogenase-1, in healthy male volunteers with overweight or obesity. Clin Diabetes Endocrinol. 2021 Aug 15;7(1):16. doi: 10.1186/s40842-021-00130-x.
Clinical trial NCT05110417: Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine
Official title: Pilot Study of the Efficacy of Pyridostigmine for Reversal of Post Injection Dysphonia Following Botulinum Neurotoxin Laryngeal Chemo-Denervation in Spasmodic Dysphonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dysphonia, Spastic
Dysphonia
Laryngeal Dystonia
Keywords: pyridostigmine
dysphonia
spasmodic dysphonia
Mestinon
botulinum neurotoxin
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot study so all 10 participants will be assigned to the pyridostigmine (Mestinon) treatment arm.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of pyridostigmine (Mestinon) on patient vocal outcomes after undergoing laryngeal botulinum neurotoxin (BoNT) injections, which is a standard treatment for spasmodic dysphonia. Pyridostigmine (Mestinon) has been used for treatment of BoNT overdose, and it is our hope that it will be beneficial in the management of post BoNT breathy phase.

Detailed description: The study will enroll 10 subjects and will involve 1 clinic visit with two sessions over 2 hours.

Participants' voices will then be analyzed via sentence/passage reading, sustained vowel holding, maximum phonation time, as well as subjective ratings of effort. During the second clinic visit, participants will then be administered one 60mg tablet of pyridostigmine (Mestinon) orally, and asked to return to the clinic in 2 hours, when Mestinon has reached peak plasma concentration. Upon returning, participants will repeat the vocal analysis and results will be evaluated for any change in outcome.

Patients who are pregnant, lactating, or have kidney or heart disease should not participate.

Eligibility criteria: Inclusion Criteria:

* Males and Females Aged 21-100
* Scheduled for Botulinum Neurotoxin (BoNT) Treatment for Spasmodic Dysphonia (SD)

Exclusion Criteria:

* Subjects who are Pregnant or Lactating
* Subjects with Compromised Renal or Cardiac Function
* Subjects with Spasmodic Dysphonia with Superimposed Vocal Tremor

Primary outcomes:
measure: Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon)
timeFrame: 15 Minutes
measure: CAPE-V Pre- and Post-Pyridostigmine (Mestinon)
timeFrame: 15 Minutes
measure: Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)
timeFrame: 15 Minutes
measure: Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)
timeFrame: 15 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Eastern Virginia Medical School Ear, Nose, and Throat Surgeons
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery
name: Benjamin Rubinstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01781624: Evaluation of an Oral Nutritional Supplement
Official title: Evaluation of an Oral Nutritional Supplement With a New Protein Blend
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-intestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.


Eligibility criteria: Inclusion Criteria:

Subjects will be eligible for the study if they meet all of the following inclusion criteria:

1. Age ≥ 60 and ≤ 90 years
2. Body Mass Index (BMI) \> 20 but \< 35

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

1. History of diabetes
2. Currently taking or has taken antibiotic within 1 week prior to enrollment
3. Major surgery less than 3 months prior to enrollment in the study
4. Current active malignant disease or was treated within the last 6 months for cancer
5. Immunodeficiency disorder
6. Myocardial infarction within the last 3 months prior to enrollment
7. Chronic obstructive pulmonary disease (COPD)
8. Allergy to any of the ingredients in the study product
9. Aversion to flavor of product being tested
10. Obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product, inflammatory bowel disease, ulcer, gastric reflux disease, short bowel syndrome, or other major gastrointestinal disease
11. Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder
12. Pursuing or has unintentional weight loss or weight gain ≥ 5% in last 4 weeks
13. Medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility

Primary outcomes:
measure: Gastro-Intestinal Tolerance
timeFrame: Study Day 1-7
Secondary outcomes:
measure: Study Product Compliance
timeFrame: Study Day 1-7
measure: Weight
timeFrame: Study Day 1 and 8
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Jeffrey Nelson, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06568224: Therapeutic Effect of Methalazine on 27 Cases of Suppurative Hidradenitis
Official title: Treatment for Hidradenitis Suppurativa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The symptoms of the patients were papules, nodules, cysts, sinuses, pustules, fistulas and scars in the armpits, groin, buttocks, etc., often accompanied by significant pain and tenderness.

Brief summary: Background: Hidradenitis suppurativa (HS) is a chronic inflammatory relapsing disease involving the axillae, breast ,groin and anogenital regions. The therapies of the disease are diverse, including medication and surgery. However, responses to treatments are variable and relapse is common, with no single agent being consistently effective.

Objective: To evaluate the efficacy and safety of oral mesalazine treatment for hidradenitis suppurativa .

Methods: Investigators reported a series of cases of patients who received oral mesalazine(1g qid) for hidradenitis suppurativa in our institution between May 2020 and September 2023. A total of 27 patients, 22 in the mild to moderate group and 5 in the severe group, were included in this study.


Eligibility criteria: Inclusion Criteria:

* Recurrent painful or suppurative lesions
* Typical clinical manifestations: the distribution of apocrine sweat glands is deep in painful nodules, abscesses, sinuses, scars;

Exclusion Criteria:

* Severe neurological and psychiatric diseases
* Tumor diseases
* Pregnant women in lactation period

Primary outcomes:
measure: Therapeutic Effect of Methalazine on 27 Cases of Suppurative Hidradenitis
timeFrame: Three and a half years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Nanjing
Study officials:
References:
Clinical trial NCT05237024: (VIII): The Eight Study and Immunologic Response Sub-study
Official title: Monitoring of Physiologic Changes Associated With Immune System Activation Associated With Vaccination Against the SARS-CoV-2 Virus: Vaccine-Induced Inflammation Identification
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaccine Reaction
Lead sponsor: physIQ, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults that plan to receive COVID-19 vaccine.

Brief summary: The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. In the sub-study, the objective is to explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.


Eligibility criteria: Inclusion Criteria:

* Is 18 years of age or older.
* Is able to speak and read English.
* Plan to receive either the Moderna or Pfizer vaccine (mRNA vaccine).
* No known prior COVID-19 infection.

Exclusion Criteria:

* Known allergy to the adhesive used on the VitalPatch.

Primary outcomes:
measure: Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors.
timeFrame: December, 2022
measure: Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants.
timeFrame: December, 2022
measure: Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.
timeFrame: December, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: physIQ
state: Illinois
city: Montréal
country: Canada
facility: Cell Carta
state: Quebec
Study officials:
affiliation: CMO
name: Steve Steinhubl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03478124: Neuropsychological Evaluation for Early Diagnosis of PSP
Official title: The Role of the Neuropsychological Evaluation for Early Diagnosis of Progressive Supranuclear Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progressive Supranuclear Palsy
Cognitive Impairment
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 112
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 56 PSP patients (PSPp) and 56 PD patients (PDp) were enrolled and matched for sex, age and disease duration.

Brief summary: The aim of this study is to better understand the nature of the cognitive decline in Progressive Supranuclear Palsy, the time of its development and the relation with the other cardinal features of the disease.

Detailed description: Progressive Supranuclear Palsy (PSP) is a neurodegenerative disease characterized by vertical supranuclear gaze palsy, early balance dysfunction and falls. Tau-protein aggregation, mainly in the brainstem, is the disease hallmark. Because of the similarities with Parkinson's disease (PD), the diagnosis is made approximately 4 years after the symptoms onset. Cognitive deficits are a leading feature of PSP and they actually represent one of the four functional core domains in the revised diagnostic criteria. The aim of this study is to better understand the nature of this cognitive decline, the time of its development and the relation with the other cardinal features of the disease.

Eligibility criteria: Inclusion Criteria:

* Patients fulfilling the criteria for idiopathic PD
* Patients fulfilling the criteria for PSP

Exclusion Criteria:

* Any other neurodegenerative disorders or medical conditions different from PD / PSP

Primary outcomes:
measure: MMSE
timeFrame: 1 year
measure: FAB
timeFrame: 1 year
measure: MoCA
timeFrame: 1 year
measure: WCST
timeFrame: 1 year
measure: ST
timeFrame: 1 year
measure: TMT-A and B
timeFrame: 1 year
measure: VFT
timeFrame: 1 year
measure: ROCF copy and delayed recall
timeFrame: 1 year
measure: RAVLT
timeFrame: 1 year
Secondary outcomes:
measure: 6MWT
timeFrame: 1 year
measure: TUG
timeFrame: 1 year
measure: BBS
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04594824: Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth
Official title: Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Adaptation
Keywords: percentile
cerebral oxygenation
neonate
immediate after birth
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 192
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates immediatley after birth

Brief summary: Especially in neonates non-invasive methods are required for monitoring the complex changes during immediate transition after birth to improve assessment of neonate and eventually resuscitation. During this period especially, the brain is vulnerable and monitoring the brain and possible influencing factors of cerebral oxygenation and perfusion are of great interest. To initiate and guide therapies based on cerebral oxygenation, it is important to define reference ranges.


Eligibility criteria: Inclusion Criteria:

* Term and preterm neonates observed routinely at the resuscitation desk
* Decision to conduct full life support
* Written informed consent
* Neonates who require no respiratory or medical support

Exclusion Criteria:

* No decision to conduct full life Support
* No written informed consent
* Congenital malformation
* Neonates who require respiratory and/ or medical support

Primary outcomes:
measure: Change of cerebral tissue oxygen saturation (crSO2) level
timeFrame: At each minute from minute 1 to minute 15 after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Division of Neonatology, Medical University of Graz
Study officials:
References:
Clinical trial NCT06466824: Observational Study on the Outcome of Patients With ITP Who Underwent Splenectomy After 2010
Official title: Observational Study on the Outcome of Patients With Primary Immune Thrombocytopenia (ITP) Who Underwent Splenectomy After January 1st, 2010
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Immune Thrombocytopenia
Keywords: splenectomy
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ITP who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled

Brief summary: Retrospective data collection on ITP patients who underwent splenectomy from 01/01/2010 to 12/31/2022. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.

Detailed description: Observational, longitudinal, retrospective study on ITP patients. Patients with ITP who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled. All useful data will be collected exclusively through consultation of outpatient medical records. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients with primary ITP according to international criteria \[2\], who underwent to splenectomy from 01/01/2010 to 12/31/2022.
* Obtaining Informed Consent.

Exclusion Criteria:

* none

Primary outcomes:
measure: evaluation of complications' incidence after splenectomy
timeFrame: at 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UO Ematologia AOU Policlinico S.Orsola-Malpighi di Bologna
name: Nicola Vianelli
role: PRINCIPAL_INVESTIGATOR
References: