louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00594945: Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Official title: A Phase 2a, Open-label,Proof -Of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of refractory epilepsy
* No Nasal conditions that would preclude the use of intranasal product

Exclusion Criteria:

* Subject with a clinical significant unstable medical abnormality
* Subject currently or regularly taking Clonazepam

Primary outcomes:
measure: Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
timeFrame: Change from baseline to treatment day
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Trials. inc.
state: Arkansas
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy & Sleep Center
state: Maryland
city: New York
country: United States
facility: Columbia Comprehensive Epilepsy Center, Neurological Institute
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dallas
country: United States
facility: Neurological Clinic of Texas, PA
state: Texas
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Jazz Pharmaceuticals
name: Beverly Benson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01872845: A Trial Comparing the Effect of Pravastatin and Rosuvastatin on Atherosclerosis Progression Measured by Carotid Intima Media Thickness in Patients With Coronary Artery Disease After Biolimus Eluting Stent (Nobori®) Implantation: CPR IMT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Occlusive Disease
Keywords: Statin
CIMT
BES
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 671
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current consensus papers recommend statin medication to reduce Low density lipoprotein (LDL) cholesterol level less than 100mg/dL (optional 70mg/dL) in patients with coronary artery disease. However, there is lack of solid evidence whether a specific kind of statin have the superiority against other statins in clinical outcomes. Furthermore, recent data have showed that several kinds of statin could have an adverse effect on glucose metabolism and increase the risk of development of diabetes. Carotid Intimamedia thickness (CIMT) is a surrogate marker of atherosclerosis to predict long term cardiovascular outcomes in not only general population but also patients with established coronary artery disease. Consequently, we will evaluate the efficacy of high dose of pravastatin on CIMT, comparing with moderate dose of rosuvastatin in patients with established coronary artery disease. Additionally, we will assess the clinical outcomes of pravastatin after percutaneous coronary intervention as well as adverse outcomes including insulin resistance and new onset diabetes compared with rosuvastatin. Our main hypothesis is that pravastatin 40mg would be non-inferior to rosuvastatin 20mg regarding CIMT at 1 year follow up.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 20 years old
* Patients with coronary artery disease who are candidate for coronary revascularization with DES implantation.
* Significant coronary de novo lesion (stenosis \> 70% by quantitative angiographic analysis)
* Patients eligible for statin treatment (initial LDL cholesterol \>70mg/dL or patients taking lipid-lowering agent)

Exclusion Criteria:

* Severe hepatic dysfunction (3 times normal reference values)
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year

Primary outcomes:
measure: Change of carotid intima media thickness 1 year after pravastatin or rosuvastatin treatment
timeFrame: 1 year after drug-eluting stent implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT01788345: Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure
Official title: Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute-on-chronic Respiratory Failure
Keywords: non-invasion ventilation
Boussignac
Lead sponsor: Vygon GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the new Boussignac-system of non-invasive ventilation is as good as the conventional non-invasive System in patients presenting with acute hypercapnic respiratory failure.


Eligibility criteria: Inclusion Criteria:

* 7,25 ≤ pH ≤ 7,35
* PaCO2 ≥ 45 mmHg

Exclusion Criteria:

* pH \< 7,24
* incapable of collaboration

Primary outcomes:
measure: Sinking pCO2
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
state: Bavarian
Study officials:
name: Stephan Budweiser, PD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02288845: Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia
Official title: An Open-Label Positron Emission Tomography (PET) Study to Demonstrate Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of ITI-007 in Stable Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the relationship between ITI-007 dose, plasma levels and brain receptor occupancy in patients with stable schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenia who are drug-free with regard to their antipsychotic medication
* In clinical remission and free from acute exacerbation of their psychosis
* In good health

Exclusion Criteria:

* Clinically significant medical conditions considered inappropriate for trial participation

Primary outcomes:
measure: Brain Receptor Occupancy as Measured by Positron Emission Tomography
timeFrame: Up to 14 days
Secondary outcomes:
measure: Safety and Tolerability as Measured by Number of Participants with Adverse Events
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Intra-Cellular Therapies, Inc. (ITI)
name: Kimberly Vanover, Ph.D.
role: STUDY_DIRECTOR
affiliation: Johns Hopkins University
name: Dean F. Wong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07006545: Return to Activity After Total Knee Arthroplasty
Official title: Prospective, Multicenter Study of Clinical Rehabilitation and Return-to-activity After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Total Knee Arthroplasty
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end-stage gonarthrosis, who have received a total knee arthroplasty

Brief summary: This multicenter research project aims to correlate objective testing of muscle mass, muscle strength, neuromuscular activation, walking speed and other functional tests with everyday activity and subjective quality of life after total knee arthroplasty. For this purpose, 400 patients from 5 orthopedic departments in Germany and USA will be examined at the time points pre-op, six weeks, three, six and 12 months post-op.


Eligibility criteria: Inclusion Criteria:

* Patients receiving a total knee arthroplasty
* Ability to perform the return to activity battery

Exclusion Criteria:

* Inability to perform the return to activity battery

Primary outcomes:
measure: Muscle Mass
timeFrame: Pre-OP to 12 months Post-OP
measure: Muscle Strength
timeFrame: Pre-OP to 12 Months Post-OP
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University Munich
state: Bavaria
city: Bonn
country: Germany
facility: University Hospital Bonn
state: NRW
Study officials:
References:
Clinical trial NCT02669745: The Study of Molecular Risk Panels (70-gene Assay) in Chinese Breast Cancer Patients
Official title: The Study of Molecular Risk Panels in Chinese Breast Cancer Patient Using Mammaprint, TargetPrint, BluePrint and Research Gene Panel Assays.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chinese
Keywords: Chinese women
Breast cancer
Lead sponsor: Agendia
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of Chinese Descent with Stage I or Stage II Breast Cancer

Brief summary: This study is experimental and will prospectively assess the proportion of patients in the two (2) MammaPrint Risk categories in patients of Chinese descent.

Detailed description: The incidence of breast cancer in Chinese women is lower than that of a Western population. Breast cancer is the most common cancer in Chinese women and the incidence is rising. Moreover there are more premenopausal women with breast cancer where the breast cancer incidence peaks in the forties and the postmenopausal rise in incidence is less commonly seen. As the genetic predisposition to breast cancer is increasingly understood, it has been suggested that the differences in breast cancer incidence in different ethnic populations is potentially due to interactions between lifestyle and genetic characteristics. To date, the use of Agendia's gene expression assays in Chinese women has not been studied. In this study, the feasibility of the gene-expression prognostic assays for risk assessment in this specific group will be assessed. Moreover, the specific molecular characteristics and potential biomarkers will be studied, focusing especially on the large group of premenopausal breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* Females aged 18 year to 70 year,
* diagnosis of Stage I or Stage II (excluding those involving more than 3 lymph nodes) Breast Cancer
* Chinese descent

Exclusion Criteria:

* Stage II Breast Cancer with more than 3 positive lymph nodes

Primary outcomes:
measure: Comparing MammaPrint with Clinical Risk Assessment
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05245045: Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris
Official title: Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne
Keywords: Acne
Photodynamic Therapy
Shengtaibufen
Efficacy
Safety
Lead sponsor: Shanghai Dermatology Hospital
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to evaluate the efficacy and safety of Shengtaibufen photodynamic therapy (STBF-PDT) for treatment of moderate or severe acne vulgaris.

Detailed description: This study is a split randomized controlled trial and being done to evaluate the efficacy and safety of Shengtaibufen photodynamic therapy (STBF-PDT) for treatment of moderate or severe acne vulgaris.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosed with moderate to severe acne;
2. Male and female patients of age between 18-30 years old ;
3. All patients read the instructions of the subject, willing to follow the program requirements;
4. No other topical treatment received within 2 weeks prior to enrollment;
5. No systemic treatment was given within 4 weeks prior to enrollment;
6. Patients were unsuitable for surgery for various reasons,unwilling to undergo surgery, and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion.

Exclusion Criteria:

1. Those who did not complete the informed consent;
2. The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound;
3. Patients with skin photoallergic diseases, porphyria;
4. Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs;
5. Patients with other obvious diseases that may affect the evaluation of efficacy;
6. Scars or patients with a tendency to form scars;
7. Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants;
8. Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy
9. Those with severe neurological, psychiatric or endocrine diseases; (10)Women who are pregnant, breast-feeding or using inappropriate contraceptives; those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment.

Primary outcomes:
measure: The clearance rate of Moderate or Severe Acne
timeFrame: The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment
Secondary outcomes:
measure: Adverse effect
timeFrame: Immediately, 1 hour, 12 hours, 24hours and 48 hours after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Skin Disease Hospital
name: Xiuli Wang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06344845: Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases
Official title: Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurodegenerative Diseases
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 80
Sex: ALL
Minimum age (years): 49
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In terms of the diagnostic technology of brain neurodegenerative diseases, the injection of positron tracers into the human body, so that it can combine with the corresponding protein, and show its distribution through PET imaging is a mature technology in the industry. At present, several research groups around the world are working on the development and clinical efficacy evaluation of their respective tau imaging agent compounds.This clinical research project intends to display the abnormal changes of tau protein in living brain through \[18F\]PM-PBB3 PET imaging, which is a second-generation tracer further optimized on the basis of \[11C\]PBB3, and has the advantages of closer binding to tau protein entanglement and less non-specific binding than similar imaging agents. Better image quality and a wider range of clinical applications.


Eligibility criteria: Inclusion Criteria:

* Between 45 and 90 years old; No gender limitation. Brain MRI supported the diagnosis of neurodegeneration, and there was no evidence of other neurological diseases.

Informed consent signed in person by the subject or his legal guardian or caregiver.

Exclusion Criteria:

* Have other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases.

Received an experimental drug or device within 1 month (whose efficacy or safety is unclear).

patients who were unwilling to undergo PET/CT scans. pregnancy.

Primary outcomes:
measure: Diagnostic Performance
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Clinical Stage
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Ruixue Cui, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06963645: Augmented Reality-based Telerehabilitation Platform for Patients With Stroke
Official title: Augmented Reality-based Telerehabilitation Platform for Patients With Stroke: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
First posted: 2025-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is to 1) determine the feasibility of the use of our augmented reality (AR) rehabilitation program, including its preliminary efficacy, 2) determine the feasibility of obtaining an augmented reality assessment based on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE).


Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. ≥3 months post ischemic or hemorrhagic stroke
3. Upper extremity deficit with an FMA-UE score between 20-50
4. Able to operate the AR device independently or with the help of a caregiver
5. Sufficiently proficient in the English language to follow instructions from Reia

Exclusion Criteria:

1. History of developmental, neurological or psychological impairment leading to functional disability
2. Vision or visual field impairment that interferes with the use of the AR headset
3. Severe photosensitivity that makes use of the AR headset uncomfortable
4. History of visually provoked seizures
5. Hearing aids
6. Cardiac pacemaker
7. Implantable cardioverter-defibrillator (ICD)

Primary outcomes:
measure: Adherence
timeFrame: 8 weeks
measure: Percentage of participants who successfully complete the vFMA-UE
timeFrame: Day 70
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Maarten Lansberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01222845: Glycaemic, Insulinaemic and Appetite Responses to Two Different Types of Porridge
Official title: Glycaemic, Insulinaemic and Appetite Responses to Two Different Types of Porridge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glycaemia,
Postprandial Insulinaemia
Appetite
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the postprandial glycaemic, insulinaemic and appetite responses to porridge made with oats processed differently.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Aged 18-40 years

Exclusion Criteria:

* Food allergies
* Metabolic disorders

Primary outcomes:
measure: Blood glucose
timeFrame: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal
Secondary outcomes:
measure: Plasma insulin
timeFrame: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal
measure: Subjective appetite ratings
timeFrame: Measured at baseline, 15, 30, 45, 60, 90 and 120 min after ingestion of a test meal
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Brain, Performance and Nutrition Centre, Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Emma J Stevenson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez JT, Stevenson EJ. Postprandial glycemia and appetite sensations in response to porridge made with rolled and pinhead oats. J Am Coll Nutr. 2012 Apr;31(2):111-6. doi: 10.1080/07315724.2012.10720016.