louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01981447: IV Lacosamide: The Safety of Intravenous Lacosamide
Official title: IV Lacosamide: The Safety of Intravenous Lacosamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: epilepsy
Lead sponsor: Le Bonheur Children's Hospital
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.

Detailed description: The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4 years to 35 years, inclusive who are unable to take oral medications or require parenteral administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at LeBonheur Children's Hospital due to the complexity of their condition, or due to a long relationship with their physician. These are exceptions which are reviewed on a case by case basis and are approved by the hospital administrator for admissions and outpatient testing.

Eligibility criteria: Inclusion Criteria:

* Patient or LAR must sign informed consent
* Diagnosis of partial onset currently uncontrolled
* Patient must have received anti-epileptic drug therapy prior to initiation
* Patient must have a medical condition in which parental administration is desireable
* Male or female
* Ages 4-35

Exclusion Criteria:

* Patient has participated in a study involving IV Lacosamide
* Patient has had an episode of status epilepticus in the last 3 months
* Drug history to lacosamide pregnant or lactating
* If of child bearing age, must have pregnancy test
* Patient has participated in an experimental drug study in last 30 days
* Patients with significant active hepatic or renal disease.
* Patients with known cardiac disease.

Primary outcomes:
measure: Number of participants with treatment-related adverse events (TEAEs), reported or observed.
timeFrame: 2 years
measure: Measure post-infusion lacosamide plasma concentrations
timeFrame: 2 years
measure: Measure changes in EKG, PR interval
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Lebonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: Lebonheur Children's Medical Center
name: James W Wheless, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06801847: Exercise and Socialization in Post-partum Depression
Official title: Post-partum Depression in Kentucky: A Community Based Intervention and a Novel AI-powered Screening Tool
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Partum Depression
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This community-engaged research project aims to address the critical need for alternative treatments of post-partum depression (PPD). The goal of this research is to investigate the efficacy of a novel 8-week intervention combing exercise with social support to reduce PPD symptoms. It is hypothesized that exercise in addition to social support will more effectively reduce PPD symptom severity compared to social support alone. By collaborating with PPD mothers, clinicians, researchers, and local fitness instructors, the researchers aim to develop an intervention that is accessible, culturally appropriate, effective, and increases treatment adherence. Additionally, the researchers will investigate if mother-infant interactions during exercise can enhance bonding, thereby reducing the detrimental effects of maternal PPD on their off-spring.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18 years old
* Two-weeks to 12 months post-partum
* EPDS over 10
* Read and Speak English
* Willing to supply contact information for their clinician and consent to their clinician being contacted in the event their depression worsens.

Exclusion Criteria:

* Use of anti-depression medication(s) at time of enrollment
* Unable to give consent
* Prisoner, parolee, state probationer, or awaiting sentence for a felony conviction

Primary outcomes:
measure: Change in Edinburgh Post-natal Depression Scale (EPDS) score
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Change in Mother-Infant Bonding Questionnaire (MIBQ) score
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Kentucky
name: Laura P Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03954847: Clinical Significance of Computer Aided Image Analysis in Treatment Response Evaluation of Lung Cancer
Official title: Clinical Significance of Computer Aided Image Analysis in Treatment Response Evaluation of Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Lung cancer
Image
Treatment response
Prognosis
Radiomic
Deep learning
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 1000
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: Lung cancer patients with PET/CT or CT examination before any cancer-specific treatment

Brief summary: The investigators will evaluate the utility of computer aided image analysis in lung cancer with the aim of predicting treatment response and prognosis.

Detailed description: Tumor biological behavior is the fundamental cause of heterogeneous prognosis. The features found on medical images are also reflections of the tumor biological behavior. However, the limitations in spatial and intensity resolution of the naked eye are two inevitable shortcomings of image interpretation by naked eyes, resulting in subjective and limited analyses of images. Computer aided image analyses such as radiomic analysis and machine learning methods are emerging as promising image interpretation methods. The natural advantage of the unlimited spatial and intensity resolution of computers can overcome the shortcomings of visual inspection with the naked eye. Moreover, the massive computing power of computer is also far greater than that of humans. This study will focus on the application of computer aided analysis in predicting treatment response and prognosis in lung cancer.

Eligibility criteria: Inclusion Criteria:

1. Patients \>= 18 years old
2. Pathological diagnosis of NSCLC between 2012 and 2019;
3. PET/CT or CT examination before any cancer-specific treatment;

Exclusion Criteria:

1. A time interval between treatment and image examination greater than 1 month;
2. A history of other malignancies

Primary outcomes:
measure: Overall survival
timeFrame: 2012-2021
Secondary outcomes:
measure: Progression free survival
timeFrame: 2012-2021
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00707447: Evaluation of a Primary Type 2 Diabetes Prevention Programme
Official title: Evaluation of a Teaching and Treatment Programme for Primary Prevention of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: diabetes-prevention
lifestyle modification
behavior therapy
self-management
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
First posted: 2008-06-30
Enrollment: 182
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A type 2 diabetes prevention programme, named PREDIAS was developed. It consists of 12 lessons delivered as group sessions. Die efficacy of PREDIAS was studied in a randomized controlled study with 12 month follow up. Control group received written information about diabetes risk. Primary outcome variable was weight reduction at 12 months follow up. Secondary variables were impact of the intervention on glycemic parameters, lipids, eating and exercise behavior and other metabolic risk factors

Detailed description: The PREDIAS programme was developed based on the interventions used in the Diabetes Prevention Study (DPS, Finland) and the Diabetes Prevention Programme (DPP; USA). The main purpose of PREDIAS was to develop a prevention programme delivered as a group programme to improve cost-benefit ration of diabetes prevention programmes.

Eligibility criteria: Inclusion Criteria:

* impaired fasting glucose and/or
* impaired glucose tolerance
* overweight (BMI \> 26 kg/m²)

Exclusion Criteria:

* type 2 diabetes
* severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12 months)
* diagnosis of a current mental disease

Primary outcomes:
measure: Weight Change
timeFrame: 12 month
measure: Waist Circumference
timeFrame: 12 months
Secondary outcomes:
measure: Fasting Glucose
timeFrame: 12 months
measure: Glucose Tolerance
timeFrame: 12 months
measure: Physical Exercise
timeFrame: 12 months
measure: Eating Behavior (TFEQ) - Cognitive Restraint
timeFrame: 12 months
measure: Eating Behavior (TFEQ) - Disinhibition
timeFrame: 12 months
measure: Eating Behavior (TFEQ) - Hunger
timeFrame: 12 months
measure: Psychological Well-being (WHO-5)
timeFrame: 12 months
measure: Emotional Well-being/ Depression (CES-D)
timeFrame: 12 months
Other outcomes:
Locations:
city: Bad Mergentheim
country: Germany
facility: Research Institute of the Diabetes Academy Mergentheim (FIDAM)
Study officials:
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim
name: Norbert Hermanns, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kulzer B, Hermanns N, Gorges D, Schwarz P, Haak T. Prevention of diabetes self-management program (PREDIAS): effects on weight, metabolic risk factors, and behavioral outcomes. Diabetes Care. 2009 Jul;32(7):1143-6. doi: 10.2337/dc08-2141. Epub 2009 Jun 9.
Clinical trial NCT05808777: Validation of the ICH Score for the Prediction of 12-month Functional Outcome in Patients With Primary Intracerebral Hemorrhage
Official title: Validation of the ICH Score for the Prediction of 12-month Functional Outcome in Patients With Primary Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra Cerebral Hemorrhage
Keywords: Intracerebral hemorrhage
Functional outcome
Prognosis
Survivors
Rehabilitation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A tertiary medical center

Brief summary: The goal of this observational study is to analyze the validity of the intracerebral hemorrhage (ICH) Score and a new modified ICH score for the prediction of 12-month functional outcome in patients with primary ICH.

Participants who were admitted to NTUH rehabilitation ward will be followed up to 12 months after the onset of ICH. The follow-up will be conducted by phone interviews.

Detailed description: The ICH Score had been utilized to predict the 30-day mortality after acute intracerebral hemorrhage (ICH), but there's still no reliable tool in predicting the long-term functional outcome in ICH patients. Recently, there have been some studies that use ICH score to predict the prognosis of functional outcome in ICH patients. However, most studies included patients in western societies. Relevant studies in Taiwan were scarce. The present study will follow up the patients with ICH, who were admitted to NTUH rehabilitation ward, up to 12 months post stroke. The follow-up will be conducted by phone interviews at certain time after the onset of ICH. Investigators aim to analyze the validity of the ICH Score for the prediction of 12-month functional outcome in patients with primary ICH. Investigators will also add other variables to see if the revised score could better predict the prognosis among ICH patients.

Eligibility criteria: Inclusion Criteria:

* Aged 20 years or older
* Had been admitted to a neurology, neurosurgery, or rehabilitation ward with a diagnosis of primary intracerebral hemorrhage (ICH)
* Had a diagnosis of ICH confirmed by a brain computed tomography (CT)
* Have written informed consent given by themselves or by their legal representative

Exclusion Criteria:

* ICH related to aneurysm, arteriovenous malformation, or trauma
* Died before discharge

Primary outcomes:
measure: Barthel index
timeFrame: 12-month after ICH onset
measure: Modified Rankin scale
timeFrame: 12-month after ICH onset
Secondary outcomes:
measure: Tube retention rate
timeFrame: 12-month after ICH onset
measure: Rehabilitation treatment course
timeFrame: 12-month after ICH onset
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Mingyen Hsiao, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01370577: The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly
Official title: The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Predictors for asthma control
Asthma Exacerbation rate
Mean frequency of PFT
sputum assessments
refill adherence(%)
prescription persistence
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 297
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects aged over 60 years, articulate in Korean, and diagnosed with asthma at least 1 year in duration

Brief summary: The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly


Eligibility criteria: Inclusion Criteria:

* Patients aged 60 years or more, articulate in Korean
* Patients diagnosed with asthma, at least 1 year in duration.

Exclusion Criteria:

* Patients being followed-up for asthma treatment less than 1 year before baseline
* Patients taking immune therapy
* Patients previously enrolled/randomized in the present clinical trial

Primary outcomes:
measure: Baseline characteristics related to asthma control in the elderly
timeFrame: 6 months
measure: Asthma exacerbation rate of the elderly during guideline-based stepwise treatments
timeFrame: 6 months
Secondary outcomes:
measure: 1. Proportion of controlled, partially controlled, and controlled patients among the elderly patients with asthma in Korea
timeFrame: 6 months
measure: 2. Baseline characteristics related to asthma specific QOL in the elderly patients with asthma
timeFrame: 6 months
measure: Mean frequency of PFT, sputum assessments, refill adherence(%), prescription persistence in elderly asthma for the last 1 year before study enrollment
timeFrame: 6 months
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Research Site
state: Gangwon-do
city: Anyang
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Research Site
state: Gyeonsangnam-do
city: Changwon
country: Korea, Republic of
facility: Research Site
state: Gyeonsangnam-do
Study officials:
affiliation: AstraZeneca Korea
name: Hye Won Koo
role: STUDY_DIRECTOR
References:
Clinical trial NCT03451877: TGFB1 And LAMA1 Gene Polymorphisms in High Myopia
Official title: TGFB1 and LAMA1 Gene Polymorphisms in Turkish Children With High Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Myopia
Gene Mutations
Keywords: High myopia
TGFB1Gene Polymorphisms
LAMA1 Gene Polymorphisms
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 151
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The investigators aimed to investigate TGFB1 and LAMA1 gene polymorphisms in children with high myopia in order to determine the genetic basis of large myopic shifts causing severe visual impairment and complications.

Seventy-four children with high myopia (≥6 diopters \[D\]; study group) and 77 emmetropic children (±0.5D; control group) were included. Genetic and polymorphism analyses were performed in the Medical Genetics Laboratory using DNA purified from the patients' blood samples.


Eligibility criteria: Inclusion Criteria:

* Patients under the age of 13
* Patients with cycloplegic refraction values ≥6 D (for study group)
* Emmetropic patients (for control group)

Exclusion Criteria:

* Patients who had additional ocular pathology that may affect refraction (such as glaucoma, cataracts, corneal disease)
* Patients with history of ocular surgery

Primary outcomes:
measure: Genetic basis of high myopia
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03680677: Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
Official title: Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leukemia, Acute
MDS
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two cohorts of patients will be included in this analysis.

Arm A will include patients 60 years of age and older with a new diagnosis of either acute leukemia or MDS who are being evaluated either in the outpatient or inpatient hematologic malignancies department at the University of Pennsylvania.

Arm B will include patients 60 years of age and older with a diagnosis of any hematologic malignancy being treated with cellular therapy including allogeneic blood or marrow transplantation or CAR T-cells.

Brief summary: The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.


Eligibility criteria: Eligibility Criteria Arm A:

* Age 60 years or older.
* New diagnosis of Acute Leukemia or MDS, or suspected diagnosis.
* Able to consent to the study.

Eligibility Criteria Arm B:

* Age 60 years or older with a hematologic malignancy.
* Plan to undergo an allogeneic blood or marrow transplantation or CAR T-cell therapy.
* Able to consent to the study.

Primary outcomes:
measure: Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients
timeFrame: 1-month
Secondary outcomes:
measure: NRM by Intensity of Treatment
timeFrame: 1-month and 6-month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center
name: Shannon McCurdy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04372277: Taltz in Combination With Enstilar for Psoriasis
Official title: Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2020-05-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label
Primary purpose: TREATMENT

Brief summary: Enstilar in combination with Taltz for plaque psoriasis.

Detailed description: A single center study of 25 subjects to assess the addition of Enstilar Foam in patients receiving Taltz for ≥ 24 weeks with BSA between 3% and 8%.

Eligibility criteria: Inclusion Criteria:

* Male or female adult ≥ 18 years of age;
* Diagnosis of chronic plaque-type
* Body Surface Area between 3%-8%.
* Patient has been treated with Taltz for a minimum of 24 weeks
* Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
* Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination
* Able and willing to give written informed consent prior to performance of any study-related procedures.

Exclusion Criteria

-˂3% or \>8% BSA

* Patient not receiving Taltz, or receiving Taltz \<24 weeks
* Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
* Pregnant or breast feeding, or considering becoming pregnant during the study.
* Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
* Use of oral systemic medications for the treatment of psoriasis within 4 weeks.
* Patient used other topical therapies to treat within 2 weeks of the Baseline Visit.
* Patient received UVB phototherapy within 2 weeks of Baseline.
* Patient received PUVA phototherapy within 4 weeks of Baseline.
* Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.

Primary outcomes:
measure: Body Surface Area 0 or 1
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
Study officials:
References: