louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00426673: An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
Official title: A Multi-Center, Open-Label, Unilateral Interaction Study of Ucb 34714 on Stable Phenytoin Monotherapy During a 45 Day b.i.d. Administration Period in 15 Adult Subjects Suffering From Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Keywords: partial onset seizures, phenytoin, dilatin, brivaracetam, interaction
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this Phase I study in 15 adult subjects suffering from epilepsy and chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.


Eligibility criteria: Inclusion Criteria:

* Well-characterized epileptic syndrome according to the ILAE classification.
* Patients currently treated with stable phenytoin monotherapy for at least three months and with at least one plasma measurement of pheyntoin within the target range (7 - 23 µg/ml) during the screening period.

Exclusion Criteria:

* History of status epilepticus in the last year.
* Subjects taking any drug that may significantly influence the metabolism of ucb 34714 (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been stable at least three months before entry into the study and will be kept stable for the entire trial duration.
* Subjects with a creatinine clearance of ≤50 mL/min.

Primary outcomes:
measure: to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.
measure: Blood samples for PK calculations collected at different time points, on Visit 2 and Visit 7, for determination of phenytoin plasma concentrations (Phenytoin levels at pre-dose, 1, 2, 4, 6, 8, 12 (24 if PHT od) hours at V2 and V7)
measure: The drug interaction on phenytoin will be assessed by comparison of AUCτ and Cmax between Visit 2 (phenytoin alone) and Visit 7 (combination of ucb 34714 and phenytoin).
Secondary outcomes:
measure: information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Charlottesville
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: UCB Pharma
name: Philipp von Rosenstiel, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05122273: Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases
Official title: Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuromuscular Diseases
Lead sponsor: EGZOTech
Sponsor class: INDUSTRY
First posted: 2021-11-16
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with confirmed genetic Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD), limb-girdle dystrophy, spinal muscular atrophy (SMA), myopathy or neuropathy

Brief summary: The aim of this study is to assess the impact of individually planned therapeutic procedures, using, among others, the concept of EMG biofeedback, to improve the general functional state, selected motor activities, stimulation and strength of specific muscle syndromes as well as postural parameters in children, adolescents and adults with neuromuscular diseases.


Eligibility criteria: Inclusion Criteria:

* confirmed genetic Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD), limb-girdle dystrophy, spinal muscular atrophy (SMA), myopathy or neuropathy
* continued/uninterrupted rehabilitation process for 3 months
* patient's condition allowing full understanding of commands

Exclusion Criteria:

* patients using a respirator
* painful complaints
* after injuries and fractures in the last 6 months
* significant weakening of muscle strength, preventing movements and activation of selected muscle groups, visible in the EMG examination
* cognitive impairment-lack of or poor cooperation between the patient and the therapist,

Primary outcomes:
measure: Change in functional assessment
timeFrame: baseline, after 12 weeks
measure: Change in postural assessment by plurimeter (Rippstein)
timeFrame: baseline, after 12 weeks
measure: Change in range of motion in upper and lower limb by goniometer
timeFrame: baseline, after 12 weeks
measure: Change in strength assessment
timeFrame: baseline, after 12 weeks
measure: Change in EMG assessment
timeFrame: baseline, after 12 weeks
measure: Hammersmith Functional Motor Scale Expanded
timeFrame: baseline, after 12 weeks
measure: North Star Ambulatory Assessment
timeFrame: baseline, after 12 weeks
measure: Change in postural assessment by scoliometer
timeFrame: baseline, after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Orthos
Study officials:
References:
Clinical trial NCT03286673: Comparison of Three Calcium Supplements
Official title: Comparison of Three Calcium Supplements With Regard to Their Metabolic Effects in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: calcium carbonate
calcium phosphate
metabolic effects
human study
calcium and phosphorus metabolism
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study was conducted to investigate the metabolic effects of three different calcium compounds in healthy adults.


Eligibility criteria: Inclusion Criteria:

* age 18 - 40 years

Exclusion Criteria:

* diseases of the gastrointestinal tract
* pregnancy
* the intake of any medication (e. g. for thyroid gland)
* intake of dietary supplements

Primary outcomes:
measure: Serum mineral concentration
timeFrame: after 4 weeks of each intervention
measure: Stool mineral concentration
timeFrame: after 4 weeks of each intervention
measure: Urine mineral concentration
timeFrame: after 4 weeks of each intervention
measure: Lipids in blood
timeFrame: after 4 weeks of each intervention
measure: Sterols
timeFrame: after 4 weeks of each intervention
measure: Dietary intake
timeFrame: after 4 weeks of each intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Friedrich Schiller University Jena, Institute of Nutrition
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02606773: "Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects
Official title: Open-label, Randomized Comparator Study for Evaluation the Bioavailability of "Novo C Plus" Vitamin C Containing Dietary Supplement in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vitamin C Deficiency
Keywords: vitamin C supplementation
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Novonex Pharma Kft
First posted: 2015-11-17
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the bioavailability of "Novo C Plus" vitamin C containing dietary supplement compared to licensed vitamin C medications. The novelty of this product is the liposomal formulation.


Eligibility criteria: Inclusion Criteria:

* 21-65 years old healthy volunteers
* body weight \>45 kg
* body height \>150 cm
* plasma ascorbic acid at screening \<75 µmol/l
* signed written informed consent
* subject agrees avoid vitamin C containing medications and dietary supplements from screening until V0 visit (maximum 15 days)
* subject agrees to avoid high activity physical exercise 72 hours prior to V0 visit

Exclusion Criteria:

* confirmed or suspected active infection
* liver or renal failure (equal or greater than CKD3)
* chronic disease that affects absorption or vitamin C metabolism
* severe metabolic disorder
* body mass index \>35 kg/m2
* malabsorption syndrome that affects vitamin C metabolism
* heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with \>100/min ventricular rate
* gastrointestinal bleeding in past three months
* uncontrolled diabetes mellitus (HbA1c\>8,5%)
* malignant disease
* alcohol or drug abuse
* active psychiatric disorder, intention for suicidal, disorders with unconsciousness
* psychopathic disorder, lack of cooperation
* known coagulopathy
* chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
* untreated hypertension if blood pressure is greater than 165/95 mmHg
* gravidity or breastfeeding
* taking more than 100 mg vitamin C daily within 2 weeks to screening

Primary outcomes:
measure: Plasma ascorbic acid concentration area under curve
timeFrame: 360 minutes
Secondary outcomes:
measure: Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 24 hours
measure: Urine ascorbic acid excretion
timeFrame: 12 hours
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University - 1st Departement of Internal Medicine
Study officials:
References:
Clinical trial NCT02848573: the Correlation Between Non-invasive Indicators in Patients With Biliary Atresia
Official title: the Correlation Between Hepatic Fibrotic Scores and ADC and Other Non-invasive Indicators in Patients With Biliary Atresia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: to Find Out Non-invasive Indices to Predict the Status of Hepatic Fibrosis in BA Patients.
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 41
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: biliary atresia

Brief summary: we propose this study and try to find out possible clinical applicable non-invasive imaging indices or its combination with the laboratory indices to predict the status of hepatic fibrosis in BA patients.


Eligibility criteria: Inclusion Criteria:

* pathological proved diagnosis of biliary atresia, and without other distinct abnormality or malformations. All had undergone Kasai portoenterostomy. All of them received abdominal MRI study.

Exclusion Criteria:

* absence of laboratory data required.

Primary outcomes:
measure: pathologic METAVIR fibrosis score
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01119573: Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer
Official title: Micro RNA's Associated With Lymph Node Metastasis in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Keywords: stage I endometrial carcinoma
stage III endometrial carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-07
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying at biomarkers in tissue samples from patients with stage I or stage III endometrial cancer.

Detailed description: OBJECTIVES:

* To identify microRNA expression patterns associated with lymph node metastasis in samples from patients with endometrial cancer.

OUTLINE: Banked tumor tissue specimens are analyzed for microRNA expression profiling by microarray analysis and reverse transcriptase-PCR assays.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed endometrioid endometrial cancer

  * Stage IA, IB, IC, or IIIC disease
  * Any grade
* Enrolled and evaluated on GOG-0210 Molecular Staging Study of Endometrial Cancer

  * Consented to allow their specimens and clinical data to be collected and stored for future research
* Underwent complete surgical staging, including the following:

  * Hysterectomy
  * Bilateral oophorectomy
  * Washings as well as pelvic lymphadenectomy (sampling of four left and four right pelvic lymph nodes)
  * Para-aortic lymphadenectomy (sampling of one left and one right para-aortic lymph node)
* Sufficient high-quality frozen primary tumor for testing with ≥ 75% tumor cellularity and ≤ 10% necrosis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Association between microRNA expression and lymph node metastasis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Simmons Cancer Center
name: David S. Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05167773: Clinical Study of the Topcon Tonometer TRK-3
Official title: Clinical Study of the Topcon Tonometer TRK-3 to Demonstrate Conformance to ISO 8612, JIS T7312, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2021-12-22
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing routine eye exam at eye care clinic

Brief summary: The study will assess the TRK-3 for conformity to ISO 8612:2009, JIS T7312:2015, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification \[510(k)\] Submissions, and the applicable Supplemental Information Sheet.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years of age or older at the time of informed consent
2. Irrespective of sex
3. Irrespective of race or ethnicity
4. Be willing and able to provide written informed consent by subject or legally designated representative prior to any study procedures

Exclusion Criteria:

1. Have only one functional eye
2. Have one eye with poor or eccentric fixation
3. Have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye
4. Have microphthalmos in either eye
5. Have buphthalmos in either eye
6. Be a contact lens wearer (persons wearing soft contact lenses within the past 3 months and/or hard contact lenses within the past 6 months)
7. Have dry eyes (persons who have been diagnosed by a physician and are currently using prescription drugs or routinely using artificial tears)
8. Uncontrollably blink, squint, wink, twitch or squeeze eye(s) - blepharospasm
9. Have nystagmus in either eye
10. Have keratoconus in either eye
11. Have any other corneal or conjunctival pathology or infection in either eye
12. Have central corneal thickness is less than 500μm or more than 600μm
13. Be allergic to eye drop anesthetics
14. Be allergic to sodium fluorescein

Primary outcomes:
measure: fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Kato Eye Clinic
city: Tokyo
country: Japan
facility: Seiyo Clinic
Study officials:
References:
Clinical trial NCT02227173: A Phase 1 Drug-drug Interaction Study in Healthy Volunteers
Official title: Effect of BMS-986020 on the Pharmacokinetics of Montelukast, Flurbiprofen, and Digoxin as Probe Substrates for CYP2C8, CYP2C9, and P-gp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-drug Interaction Study
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is an open-label, single-sequence, drug-drug interaction study in healthy male and female subjects. There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may increase the exposure of montelukast, flurbiprofen, and digoxin.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive, with a body mass index of 18.0 to 32.0 kg/m2, inclusive
* Women of childbearing potential must agree to follow instructions for methods of contraception for the duration of the study

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of arrhythmias or palpitations associated with dizziness or fainting
* History of clinically relevant cardiac disease

Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin
timeFrame: Predose and up to 168 hours post dose
Secondary outcomes:
measure: Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.
timeFrame: Predose and up to 168 hour post dose
measure: Safety
timeFrame: From dosing (Day 1) to Day 21
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Healthcare Discoveries, LLC d/b/a ICON Development Solutions
state: Texas
Study officials:
affiliation: ICON Development Solutions
name: Emanuel DeNoia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06799273: MECKI-Amyloidosis: Assessment of the Exercise Capacity and Prognosis of Patients with Cardiac Amyloidosis
Official title: MECKI-Amyloidosis: Assessment of the Exercise Capacity and Prognosis of Patients with Cardiac Amyloidosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Amyloidosis
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective Cohort: Patients with Diagnosis of cardiac amyloidosis.

Retrospective cohort:

Population of heart failure patients selected from the MECKI score database

Brief summary: This study aims to advance the understanding of cardiac amyloidosis, its effects on exercise capacity, and its prognostic implications. By conducting a systematic investigation with particular emphasis on longitudinal evaluation, we aim to provide valuable insights to guide clinical practice and improve the management of patients with cardiac amyloidosis.

Our study intends to follow patients for a period of two years, evaluating them every six months. This longitudinal approach allows us to monitor changes in exercise capacity and other relevant clinical parameters over time. Furthermore, it enables the development of a prognostic tool similar to the MECKI score, capable of assessing the risk of adverse events in patients with cardiac amyloidosis based on their exercise performance.

By comparing our results with data from heart failure patients already included in the MECKI score database, we also aim to highlight any differences in prognosis between patients with cardiac amyloidosis and those with general heart failure. Finally, we aim to characterize cardiac amyloidosis by differentiating it from general heart failure. By comparing our results with data from heart failure patients already included in the MECKI score database, we can clarify the distinct exercise limitations in cardiac amyloidosis and shed light on how they differ from more conventional heart failure.


Eligibility criteria: Inclusion criteria

* Age \> 18 years
* Diagnosis of cardiac amyloidosis obtained by MRI or scintigraphy
* Ability to perform a cardiopulmonary exercise test

Exclusion criteria

* severe obstructive pulmonary disease
* exercise-induced angina
* significant ECG changes
* presence of clinical comorbidities that interfere with exercise performance

Primary outcomes:
measure: Evaluation of the parameters most closely correlated with two-year prognosis in patients with cardiac amyloidosis in order to create a specific risk score for these patients.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Cardiologico Monzino, Irccs
Study officials:
References: