louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00074698: Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
Official title: A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic pulmonary fibrosis
IPF
Pulmonary fibrosis
Respiratory disease
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2003-12-22
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FG-3019, a therapeutic antibody designed to block the pro-fibrotic activity of connective tissue growth factor (CTGF). CTGF triggers the production of collagen and fibronectin, which cause scarring and thickening of the lungs. Participants will be assigned sequentially to one of the 3 dose group: Low, medium, and high FG-3019.


Eligibility criteria: Key Inclusion Criteria:

* have a diagnosis of idiopathic pulmonary fibrosis (IPF) by clinical features and surgical lung biopsy or according to the American Thoracic Society criteria

Key Exclusion Criteria:

* have a history of significant exposure to organic or inorganic dust or drugs known to cause pulmonary fibrosis
* have interstitial lung disease other than IPF
* have pulmonary fibrosis associated with connective tissue disease
* have other forms of idiopathic interstitial pneumonia, such as desquamative interstitial pneumonia, acute interstitial pneumonia, nonspecific interstitial pneumonia, or cryptogenic organizing pneumonia
* have end-stage IPF (total lung capacity of less than 45% of predicted value)
* are listed for lung transplantation at the time of study enrollment
* have significant heart problems
* are pregnant or lactating (if female)

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline up to 12 months
measure: Area Under the Plasma Concentration Vs Time Curve (AUC) of FG-3019
timeFrame: Through 30 hours postdose
measure: Number of Participants With Human Anti-human Antibody (HAHA)
timeFrame: Baseline up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan Health Sciences
state: Michigan
city: Dallas
country: United States
facility: Southwestern Medical School
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT03549598: d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Official title: d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Sarcoidosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT.

Detailed description: Prospective study of 15 consecutive patients with suspected or newly diagnosed cardiac sarcoidosis (CS) who are referred for a clinically indicated 18FDG (and 13NH3) PET/CT scan for cardiac sarcoidosis (CS) will be approached to undergo a 68Ga-DOTATATE PET/CT scan. Comparison will then be made between the 68Ga-DOTATATE PET/CT and the 18FDG and 13NH3 PET/CT to determine if 68Ga-DOTATATE detects CS.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

Exclusion Criteria:

* Pregnant
* Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan

Primary outcomes:
measure: 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
timeFrame: 3 days
measure: 18FDG Uptake With Cardia Sarcoidosis (CS)
timeFrame: 2 days
measure: 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)
timeFrame: 2 days
Secondary outcomes:
measure: Physician Confidence in Study Interpretation
timeFrame: 2 days
measure: Subject Satisfaction
timeFrame: 2 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John P Bois
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02588898: B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes
Official title: B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Complications
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 212
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female subjects with or without diabetes.

Brief summary: This case-control study investigated B-vitamin and homocysteine in relation to the presence or the absence of type 2 diabetes and clinical signs of polyneuropathy.

Detailed description: Blood samples were collected and clinical investigations were performed at the same time.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects with or without diabetes.

Exclusion Criteria:

* Usage of supplements containing B-vitamins, methotrexate treatment, cerebral or cardiac events in the last three months
* Liver or renal dysfunction.

Primary outcomes:
measure: Red blood cell cobalamin levels
timeFrame: Baseline
measure: Polyneuropathy grade estimated using a score including a combination of data from questionnaire and electrophysiology investigations
timeFrame: Baseline
Secondary outcomes:
measure: Plasma methylmalonic acid levels
timeFrame: Baseline
measure: Plasma choline levels
timeFrame: Baseline
measure: Plasma cobalamin levels
timeFrame: Baseline
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University of Saarland
state: Saarland
Study officials:
affiliation: University Hospital of the Saarland, Department of Clinical Chemistry
name: Rima Obeid, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Obeid R, Jung J, Falk J, Herrmann W, Geisel J, Friesenhahn-Ochs B, Lammert F, Fassbender K, Kostopoulos P. Serum vitamin B12 not reflecting vitamin B12 status in patients with type 2 diabetes. Biochimie. 2013 May;95(5):1056-61. doi: 10.1016/j.biochi.2012.10.028. Epub 2012 Nov 17.
citation: Obeid R, Awwad HM, Rabagny Y, Graeber S, Herrmann W, Geisel J. Plasma trimethylamine N-oxide concentration is associated with choline, phospholipids, and methyl metabolism. Am J Clin Nutr. 2016 Mar;103(3):703-11. doi: 10.3945/ajcn.115.121269. Epub 2016 Feb 10.
Clinical trial NCT01944098: Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients
Official title: Systemic Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients: A Randomized, Placebo-Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bariatric Surgical Pain
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.


Eligibility criteria: Inclusion Criteria:

* Adult patients between the ages of 18-65 years old
* BMI ≥ 40 kg/m2, ≤ 60 kg/m2
* Undergoing a primary laparoscopic RYGB by Dr. Murr
* Agree to be followed 24 hours postoperatively
* Normal K+ and Mg++ serum levels

Exclusion Criteria:

* BMI less than 40 kg/m2, \> 60 kg/m2
* Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr
* Allergy to lidocaine
* Allergy to hydromorphone or ketorolac
* Allergy to corn or amide anesthetics
* Use of (thioridizine)
* Pregnancy
* Abnormalities of ALT or AST
* Intra-operative diagnosis of cirrhosis or portal hypertension
* Intraoperative complications per surgeon
* Intraoperative extensive adhesions per surgeon
* Chronic pain syndrome and chronic use of narcotics
* Severe back pain secondary to degenerative joint disease

Primary outcomes:
measure: Postoperative Pain
timeFrame: 6 hours post-surgery
measure: Postoperative Pain
timeFrame: 12 hours post-surgery
measure: Postoperative Pain
timeFrame: 18 hours post-surgery
measure: Postoperative Pain
timeFrame: 24 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: Florida Gulf-to-Bay Anesthesiology
name: Rachel Karlnoski, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02887898: Efficacy of Automated Bolus Calculation in Type 2 Diabetes
Official title: Efficacy of Advanced Carbohydrate Counting and Automated Bolus Calculation in Insulin-treated Type 2 Diabetes Patients: The BolusCal2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 80
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 investigators hypothesize that non-optimal basal-bolus insulin treated patients with type 2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use of an automated bolus calculator. Additionally, the investigators propose that this intervention will lead to improvement in patient related outcomes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes \> 1 year
* Age 18 years or older
* HbA1C \> 64 mmol/mol (8.0 %)
* Treatment with multiple daily insulin injections (basal and prandial insulin) ≥ 6 months
* GAD-antibody negative
* Naïve to bolus calculators

Exclusion Criteria:

* Pregnancy or breast feeding
* Gastroparesis
* Severe nephropathy (eGFR\<30 mL/min/1,73 m2)
* Use of sulfonylurea

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM)
timeFrame: 6 months
measure: Frequency of blood glucose measurements assessed by meter download before randomization and at each visit
timeFrame: 6 months
measure: Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance)
timeFrame: 6 months
measure: Change in diet habits/diet composition
timeFrame: 6 months
measure: Change in treatment satisfaction
timeFrame: 6 months
Other outcomes:
measure: Adherences to bolus calculator use
timeFrame: 6 months
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
citation: Christensen MB, Serifovski N, Herz AMH, Schmidt S, Hommel E, Raimond L, Perrild H, Gotfredsen A, Gaede P, Norgaard K. Efficacy of Bolus Calculation and Advanced Carbohydrate Counting in Type 2 Diabetes: A Randomized Clinical Trial. Diabetes Technol Ther. 2021 Feb;23(2):95-103. doi: 10.1089/dia.2020.0276. Epub 2020 Sep 21.
Clinical trial NCT06945198: Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability
Official title: Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Instability
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 200
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 clinical trial is to compare at 5 years the sporting activity of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability. The main question it aims to answer is:

What is the long-term sporting activity status of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability ?

Participants will visit the clinic once every year during 5 years for clinical checkup.


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, aged ≥ 18 years
* Patient with chronic ankle instability defined by:
* A history of trauma including a severe ankle sprain.
* Clinical symptoms persisting for at least 3 months at the time of inclusion: pain, swelling, sensation of 'giving way', sensation of instability, recurrent sprains; Clinical tests (drawer test, varus provocation test) confirming grade III laxity; Imaging results (MRI) confirming clinically suspected ligament damage.
* Patient affiliated to or benefiting from a social security scheme
* French-speaking patient who has signed an informed consent form

Exclusion Criteria:

* Patient with deltoid ligament injury, severe fracture or open trauma
* Patient with insufficient ligament remnant and/or in too poor a condition to allow Broström-type repair.
* Patient with a symptomatic osteochondral lesion
* Patient with ankle hyperlaxity (Beighton score \> 3)
* Patient with early ankle arthropathy (Takakura arthritis classification ≥ stage 3)
* Patient with neuromuscular disorders, systemic inflammatory disorders or tumours.
* Patient requiring surgery on both ankles
* Patients with a bony deformity of the ankle or foot on the affected side;
* Patients with professional athlete status
* Patient already included in another study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Sporting activity
timeFrame: Year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
Study officials:
References:
Clinical trial NCT03367598: Longitudinal Interaction Between APOA5 -1131T>C and Overweight Accelerates Arterial Stiffness
Official title: Longitudinal Interaction Between APOA5 -1131T>C and Overweight
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 503
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We performed a 3-year prospective cohort study that included 800 heathy subjects (30-65 years old), of these, 503 nondiabetic and nonobese individuals were finally selected.

Brief summary: The aim of this study is to evaluate whether the longitudinal interaction between APOA5 -1131C variants and overweight could accelerate age-related increases in arterial stiffness and circulating triglycerides in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Nondiabetic (fasting serum glucose concentration \< 126 mg/dL)
* Nonobese (BMI ≥ 25 kg/m2)

Exclusion Criteria:

* Current and/or past history of cardiovascular disease
* Diabetes mellitus (fasting glucose levels ≥126 mg/dL)
* Abnormal liver or renal function
* Thyroid or pituitary disease
* Pregnancy or lactation
* Regular use of any medication

Primary outcomes:
measure: Brachial-ankle PWV (baPWV)
timeFrame: at baseline
measure: Brachial-ankle PWV (baPWV)
timeFrame: 3-year follow-up
Secondary outcomes:
measure: Triglyceride
timeFrame: at baseline
measure: Triglyceride
timeFrame: 3-year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Food and Nutrition, Colleage of Human Ecology, Yonsei University
name: Jong Ho Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01730898: Lutein Absorption in Healthy Adults
Official title: Lutein Absorption in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Subjects
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the absorption of lutein when consumed in different oil blends.


Eligibility criteria: Inclusion Criteria:

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

* BMI ≥ 18 and ≤ 25 kg/m2
* Between 18 and 45 years of age, inclusive
* Male or a non-pregnant, non-lactating female, nulliparous or at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential. If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study):

  * Condoms, sponge, diaphragm or intrauterine device;
  * Oral or parenteral contraceptives for 3 months prior to screening visit;
  * Vasectomized partner;
  * Total abstinence from sexual intercourse.
* If on a chronic medication, subject has been on constant dosage for at least two months prior to screening visit

Exclusion Criteria:

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

* Current smoker
* Current chronic disease, including malabsorption or gastrointestinal disorders; hyperlipidemia; anemia; hemophilia; excessive bleeding; cystic fibrosis; kidney disease requiring dialysis; diabetes; active malignancy; wasting condition
* Current chronic contagious, infectious disease, such as active tuberculosis, Hepatitis B or C,or HIV
* Vegetarian, or has very selective food habits/dieting
* Average intake of alcoholic beverages greater than 2 drinks per day
* Medication or dietary supplement use to lower plasma lipids or affect lipid absorption or transport, including antibiotics
* Supplement use that contains carotenoids (multi-vitamin as an example)
* Known allergy or intolerance to any ingredient found in the study products

Primary outcomes:
measure: Plasma lutein
timeFrame: baseline and 336 hours
Secondary outcomes:
measure: Plasma carotenoids
timeFrame: 2, 4, 6, 8, 12, 24, 48, and 336 hours
measure: Plasma lipid concentrations
timeFrame: baseline and 48 hours
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis Clinical Research
state: Illinois
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams
role: STUDY_CHAIR
References:
Clinical trial NCT02678598: A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections
Official title: A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Infections
Keywords: Micafungin
Candida
Aspergillosis
Antifungal
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-02-10
Enrollment: 2555
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: The hospitalized patients who received intravenous micafungin for treatment according to the clinical judgment of the treating physician before the end of April 2015

Brief summary: The objective of this study is to evaluate the efficacy of intravenous micafungin for the empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy patients with invasive fungal infections caused by Candida sp. or Aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.


Eligibility criteria: Inclusion Criteria:

* Patients who received Micafungin as empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy
* Patients received Micafungin treatment at least 1 dose

Exclusion Criteria:

* Patients received Micafungin treatment combined with other antifungal drugs at the same time
* Neither efficacy or safety can be evaluated because of missing data, confused record

Primary outcomes:
measure: Overall success rate
timeFrame: Up to 12 months
Secondary outcomes:
measure: Overall incidence and severity of adverse events
timeFrame: Up to 12 months
measure: Overall incidence and severity of adverse drug reactions
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
city: Changchun
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Guizhou
country: China
city: Haikou
country: China
city: Hangzhou
country: China
city: Harbin
country: China
city: Hengyang
country: China
city: Langfang
country: China
city: Shanghai
country: China
city: Shijiazhuang
country: China
city: Wuhan
country: China
city: Xiamen
country: China
city: Zhengzhou
country: China
Study officials:
affiliation: Astellas Pharma China, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Zheng X, Huang X, Luo J, Li J, Li W, Liu Q, Niu T, Wang X, Zhou J, Zhang X, Hu J, Liu K. Effectiveness and Tolerability of Micafungin in Chinese Patients with Invasive Fungal Infections: A Retrospective, Multicenter Study. Adv Ther. 2018 Sep;35(9):1400-1410. doi: 10.1007/s12325-018-0762-5. Epub 2018 Aug 13.