louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01422187: A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
Official title: A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gaucher Disease
Keywords: enzyme replacement therapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 19
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: This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.


Eligibility criteria: Inclusion Criteria:

* Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003
* The subject signs an informed consent

Exclusion Criteria:

* Currently taking another investigational drug for any condition.
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's compliance with the requirements of the study.

Primary outcomes:
measure: Spleen Volume
timeFrame: 60 months
Secondary outcomes:
measure: Liver Volume
timeFrame: 60 months
measure: Platelet Count
timeFrame: 60 months
measure: Hemoglobin
timeFrame: 60 months
Other outcomes:
Locations:
Study officials:
References:
citation: Zimran A, Duran G, Giraldo P, Rosenbaum H, Giona F, Petakov M, Terreros Munoz E, Solorio-Meza SE, Cooper PA, Varughese S, Alon S, Chertkoff R. Long-term efficacy and safety results of taliglucerase alfa through 5years in adult treatment-naive patients with Gaucher disease. Blood Cells Mol Dis. 2019 Sep;78:14-21. doi: 10.1016/j.bcmd.2016.07.002. Epub 2016 Jul 18.
Clinical trial NCT00401687: DMP115 in Patients With an Ejection Fraction Between 25%-40% to Evaluate the Use of Contrast Echocardiography to Assess Heart Function
Official title: A Multicenter, Phase IV Study to Evaluate the Ability of Definity® Enhanced Versus Unenhanced Echocardiography to Improve the Accuracy and Reproducibility of Left Ventricular Ejection Fraction When Compared to Cardiac Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventricular Ejection Fraction
Keywords: Reduced Heart Function
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical research study is to demonstrate the ability of Definity® enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).


Eligibility criteria: Inclusion Criteria:

* Adult subjects 18 years of age or older
* Have a documented EF value ranging from 25% to 40%
* Have been scheduled to undergo or have undergone a cardiac MRI study

Exclusion Criteria:

* Severe valvular dysfunction
* Inability to remain supine for 30 minutes

Primary outcomes:
measure: Demonstrate the ability of Definity® enhanced versus unenhanced echocardiography to improve the accuracy of left ventricular ejection fraction when compared to cardiac magnetic resonance imaging (MRI) in a blinded assessment
timeFrame: Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers.
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Washington DC
country: United States
facility: Washington Hospital Center
state: Maryland
city: Kansas City
country: United States
facility: Saint Lukes Mid America Heart Institute
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Lantheus Medical Imaging
name: Veronica Lee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00558987: Parenting Videos In Primary Care
Official title: Enhancing Anticipatory Guidance About Discipline for Low-Income Families: A Video Intervention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Discipline Attitudes
Discipline Practices
Keywords: Discipline
Parenting
Primary Care
Videos
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: The Thomas Wilson Sanitarium for Children of Baltimore City
First posted: 2007-11-16
Enrollment: 122
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test the effectiveness of a video-based parent education intervention delivered in the primary care setting on parents and other caregivers discipline attitudes and practices.


Eligibility criteria: Inclusion Criteria:

* Adult caregivers of children ages 12 to 36 months with a scheduled well-child visit.
* Caregivers must be older than 18 years of age, must be considered a consistent caregiver for the child, must be the primary caregiver at least 2 days per week, and must live with the child.

Exclusion Criteria:

* Caregivers previously enrolled in the study.
* Caregivers who do not speak or read English,
* Caregivers not able to give contact information for follow-up,
* Caregivers of a child who has a severe behavioral problem or developmental delay as reported by the parent during the initial recruitment phone call.

Primary outcomes:
measure: Frequency of spanking
timeFrame: baseline and 6 week follow-up
Secondary outcomes:
measure: Attitudes about Discipline
timeFrame: baseline and 6 week follow-up
measure: Type of discipline practices used
timeFrame: baseline and 6 week follow-up
measure: Discussion with pediatric provider
timeFrame: immediately post visit
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Harriet Lane Primary Care Clinic
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Rachel A Dodge, MD, MPH
role: STUDY_DIRECTOR
affiliation: Johns Hopkins University
name: Anne K Duggan, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01852487: Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenic Alopecia
Keywords: Pumpkin seed oil
Hair growth
Men
Lead sponsor: Dream Plus
Sponsor class: INDUSTRY
First posted: 2013-05-13
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Androgenic alopecia is the most common cause of hair loss in men. Finasteride and minoxidil are available in treatment of androgenetic alopecia, although the former causes decreased libido or ejaculate volume, erectile dysfunction, the latter causes scaling, itching of the scalp. Recently, Pulpkin Seed Oil shows some improved clinical efficacy on scalp hair growth in men with androgenetic alopecia, but there is no evidence to support this.

The investigators conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Pumpkin seed oil (400mg/day)therapy in male patients with androgenetic alopecia.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years of age
* Androgenetic alopecia of Norwood-Hamilton scale grade II-V

Exclusion Criteria:

* Severe medical problems including renal problems, prostate diseases, diabetes mellitus o
* Patients who took any medicine which can affect the hair growth in recent 3 months.

Primary outcomes:
measure: investigator assessment score using photographs of scalp hair
timeFrame: at weeks 12 and 24
Secondary outcomes:
measure: patient self-assessment scores
timeFrame: at weeks 12 and 24
Other outcomes:
measure: hair analysis using phototrichogram
timeFrame: at weeks 12 and 24
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
Study officials:
References:
Clinical trial NCT05084287: Robot-assisted and Connected 6-minute Walk Test (TM6)
Official title: Robot-assisted and Connected 6-minute Walk Test (TM6)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Insufficiency
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients referred for 6MWT to the EFRED department of the Pitié Salpêtrière hospital.

Brief summary: Evaluation of the reliability of the PEPPER robot in assisting and recording the parameters of a TM6. Patients referred to the EFRED service for the performance of a 6MWT will be assisted during their test by the PEPPER robot. The PEPPER robot will also collect the parameters of the 6MWT and produce a report. The EFRED service technician will remain present during the 6MWT and will take note of the test parameters. An evaluation of patient satisfaction with the assistance of the Robot Pepper in the realization of the 6MWT will also be carried out.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* Speak fluent French.

Exclusion Criteria:

* Patient's refusal to participate in the study
* Language barrier
* Cognitive disorders.

Primary outcomes:
measure: 6MWT parameters Robot vs Technician
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: AP HP
Study officials:
References:
Clinical trial NCT00478387: Ovarian Cancer and Immune Response to Flu Vaccine
Official title: Study of the Immunogenicity of Killed Influenza Vaccine in Patients With Ovarian, Fallopian Tube, and Primary Peritoneal Cancer in Remission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Advanced Ovarian and Primary Peritoneal Cancer in Remission
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-05-24
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To gather preliminary information regarding immune response following influenza vaccination via measurement of antibody in subjects with advanced ovarian and primary peritoneal cancer in remission..

Brief summary: The purpose of this study is to determine what the immune response is of ovarian cancer patients in remission, when they are given the flu vaccine. After receiving the flu vaccine, patients will have blood drawn 5 times in 12 months to study antibody response to the flu vaccine.


Eligibility criteria: Inclusion Criteria:

* All subjects must have a histologic diagnosis of epithelial ovarian cancer or primary peritoneal carcinoma. Time from completion of chemotherapy will be no more than 6 months.
* If no clinical evidence of disease is present after diagnosis with Stage III or IV disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage.

Exclusion Criteria:

* Prior malignancy (except basal cell or squamous cell skin cancer) within the past five years.
* Presence of active CNS disease.
* Active bacterial, viral or fungal infections.
* Chemotherapy, biologic therapy, or radiation therapy \< 4 weeks prior to study entry.
* History of active autoimmunity or immunosuppression.
* Use of immunosuppressive drugs within 4 weeks prior to study entry. Patients may receive chemotherapy or other immunosuppressive medications at the discretion of their physician during the subsequent year after influenza vaccination without exclusion from the study.
* Patients with tumors of low malignant potential (borderline tumors) will not be eligible.
* Prior influenza vaccination with the current vaccine.
* History of serious sensitivity to eggs, or previous influenza vaccine.
* Pregnant of breastfeeding subjects.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Department of Obstetrics and Gynecology, Division of GYN Oncology, Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Christina S Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592487: Effects of a Breakfast and Snack on Cognitive Function in Preadolescents
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain Function
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy 4th and 5th graders

Brief summary: This study is designed to test how breakfast affects brain function, memory and learning in healthy children.

Hypotheses: Based on the results of our initial study and the relevant literature, it is hypothesized that arousal, attention, and performance will be:

1. Greater in those who eat breakfast relative to those who do not;
2. Greater in lean than in overweight children receiving the higher protein breakfast;
3. Greater in fasting lean than fasting overweight children; and
4. Improved following a morning snack in all study groups.
5. Poorer in children with higher stress-related measures (e.g., higher cortisol levels).
6. Heart rate will be lower in fasting relative to fed participants, and across groups will be higher in overweight children.


Eligibility criteria: Inclusion Criteria:

* healthy
* attending 4th or 5th grade
* lean BMI or overweight BMI
* right hand dominance
* no food allergies
* eat breakfast at least 4 mornings/week
* no medications for chronic illness/disorder that may affect outcome (as determined by the PI)

Exclusion Criteria:

* food allergies
* medications that could affect the outcome
* left hand dominance

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
References:
Clinical trial NCT02057887: Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis C Virus Genotype I
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-02-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).

Detailed description: * To evaluate the repeat-dose pharmacokinetics (PK) of HM10660A when given by weekly, biweekly, and monthly subcutaneous (SC) injection.
* To evaluate the repeat-dose pharmacodynamics (PD) of HM10660A when given by weekly, biweekly, and monthly SC injection.
* To explore the antiviral activity of HM10660A at Week 4, Week 12, and Week 24.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 65 years old, inclusive
* Willing and able to provide written informed consent.
* Previously untreated HCV infection with HCV RNA \> 75,000 IU/mL at screening.
* HCV genotype 1a or 1b.
* Body mass index (BMI) between 18 and 38 kg/m2.
* Willing and able to comply with the protocol and available to complete the study schedule of assessments.

Exclusion Criteria:

* Pregnant women or women who may wish to become pregnant during the course of the study.
* Males and females of reproductive potential who are unwilling to use 2 forms of effective birth control throughout the duration of study treatment and for at least 6 months after the last dose of RBV. One method should include a condom with spermicide for males. Males must agree to refrain from sperm donation for at least 6 months after the last dose of RBV.
* Evidence of infection or co-infection with a non-genotype 1 HCV strain.
* Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
* Lactating females

Primary outcomes:
measure: HCV RNA Viral load
timeFrame: Through study week 32
measure: Safety/tolerability
timeFrame: Through study week 32
Secondary outcomes:
measure: Rapid virologic response (RVR)
timeFrame: Study Week 4
measure: Early virologic response (EVR)
timeFrame: Study week 12
measure: Sustained virologic response (SVR)
timeFrame: Study week 24
Other outcomes:
Locations:
city: Estado de Mexico
country: Mexico
facility: Hanmi Clinical
Study officials:
References:
Clinical trial NCT06559787: Volumetric Quantification of Epicardial Fat Using Semiautomated High Resolution Atrial CT Segmentation in Patients With Atrial Fibrillation Receiving Catheter Ablation
Official title: Volumetric Quantification of Epicardial Fat Using Semiautomated High Resolution Atrial CT Segmentation in Patients With Atrial Fibrillation Receiving Catheter Ablation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Keywords: epicardial fal
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: The German Heart Foundation
First posted: 2024-08-19
Enrollment: 200
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: at least 200 patients planned

Brief summary: The goal of this prospective observational study is to learn about the influence of epicardial fat on the success of catheter ablation in patients with atrial fibrillation.

Detailed description: A volumetric quantification of epicardial fat is examined by dual source cardiac computet tomography in patients with paroxysmal or persistent atrial fibrillation prior to receiving their first catheter ablation for atrial fibrillation. After ablation the recurrence of arrhythmia is examined after 3 and 6 months respectively.

Eligibility criteria: Inclusion Criteria:

* patients with planned catheter ablation due to paroxysmal or persistent atrial fibrillation
* written informed consent
* planned computet tomography

Exclusion Criteria:

* history of left atrial catheter ablation
* minor patients or patients not capable of giving written informed consent
* contraindication for computet tomography with contrast agents (e.g. allergy to contrast agents or relevant renal insufficiency or hyperthyreosis)
* patients with congenital heart defects or history of cardial surgery

Primary outcomes:
measure: Influence of epicardial adipose tissue (EAT) volume on 1 year arrhythmia recurrences after catheter ablation
timeFrame: measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months
Secondary outcomes:
measure: associations between EAT and gender, BMI, cholesterol levels, body fat
timeFrame: measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months
measure: associations between EAT and left atrial wall thining
timeFrame: measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months
measure: associations between EAT and low voltage areas quantified by high density electroanatomical mapping
timeFrame: measurement of epicardial fat and catheter ablation at baseline
Other outcomes:
Locations:
city: München
country: Germany
facility: Deutsches Herzzentrum
Study officials:
affiliation: Deutsches Herzzentrum München
name: Nico Erhard, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: