louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00327483: Web Based Renal Transplant Patient Medication Education
Official title: Web Based Renal Transplant Patient Medication Education
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Renal Transplant Recipients
Keywords: Transplant
Medication error
Patient Safety
Information technology
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2006-05-18
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: Information technology will be brought directly to renal transplant recipients to help them learn about the large number of medications they are required to take on a life long basis, in order to prevent errors and improve safety.

Detailed description: Transplant recipients are particularly vulnerable to medication errors because of the large number of chronic drugs needed to prevent rejection and treat comorbidities. Compliance failures directly compromise patient safety through acute immunologic events and premature graft loss. For society, the loss of invested fiscal and organic (organs) resources is catastrophic. As the unique constant in the chain of people who provide, modify and consume prescription medications, health information technology should be focused on empowering the patient to prevent medication errors. Our principal clinical hypothesis is that HIT can be proven to improve patient safety by minimizing medication errors. Specific aims address the creation of new knowledge and evidence ( in a renal transplant population) of benefits of widely applicable HIT tools. Web enabled education of two groups, new (\<6 months) and established (\> 6 months), kidney transplant recipients is proposed.

Eligibility criteria: Inclusion Criteria:age \> 18 or capable of managing own medications

-

Exclusion Criteria:Education level below 10th grade

-

Primary outcomes:
measure: Medication errors
Secondary outcomes:
measure: Serum creatinine
measure: Rejection episodes
measure: Rehospitalizations
measure: Graft loss
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Amy L Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00557583: Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults
Official title: A Randomized, Double-blinded, Placebo-controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C Infection
Keywords: VBY-376 Hepatitis C pharmacokinetics safety
Lead sponsor: Virobay Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.

Detailed description: Single dose escalation study of 5 dose levels of VBY-376. Eight subjects per group will receive one dose of VBY-376 then have multiple blood draws for pharmacokinetic evaluation and followed for safety with laboratory evaluations, ECG's, vital signs, and adverse events. Safety data will be reviewed before proceeding to the next dose.

Eligibility criteria: Inclusion Criteria:

* males and females between 18 and 45 years of age
* screening body mass index between 20 and 29 kg/m2
* in good health with no clinically significant medical conditions
* able to comprehend and willing to sign an informed consent

Exclusion Criteria:

* history of renal, hepatic impairment, stomach or intestinal surgery or resection, malabsorption syndrome
* anemia or blood donation within 8 weeks of check-in
* plasma donation within 4 weeks of check-in
* history of alcoholism or drug addiction within 1 year prior to check-in
* use of drugs of abuse
* no tobacco-containing products within 6 months of study
* participation of any clinical trial within 30 days
* history or presence of abnormal ECG
* no prescription or over-the-counter medications within 14 days of study and during the study
* history of Gilbert's syndrome

Primary outcomes:
measure: To evaluate the safety of VBY-376 in single oral doses in healthy subjects.
timeFrame: 7 days
Secondary outcomes:
measure: To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376.
timeFrame: 7 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Covance CRU
name: Stephen D Flach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05780983: Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults
Official title: Sleep Well 24 (SWELL24): Promoting Healthy Sleep-wake Behaviors Across a 24-hour Cycle in Frail Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Disorder
Keywords: sleep-wake patterns
poor sleep
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-03-23
Enrollment: 7
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants enrolled in the pilot trial will receive the intervention, all activities will be unblinded. Older adults utilizing outpatient primary care clinics belonging Atrium Wake Forest Baptist Health. All activities will take place within a clinical setting. Participants will be asked to monitor their sleep-activity behaviors while at home.
Primary purpose: PREVENTION

Brief summary: To finalize daytime intervention components for a comprehensive sleep-wake intervention for frail older adults and explore feasibility and acceptability using a pilot trial.

Detailed description: An enhanced intervention addressing both nighttime and daytime activities will be developed based on prior evidence and further informed by data. A successive cohort design will be utilized to evaluate and refine key intervention components and gather feedback on older adults' experiences.

Eligibility criteria: Inclusion Criteria:

* Age 65 or over
* One or more outpatient primary care visits to Wake Forest Baptist Health in the prior 12 months
* Meets diagnostic criteria for Insomnia Disorder
* Less than 30 minutes of daily activity or less than 150 minutes total weekly activity for one month or longer, as reported on brief telephone screener
* Able to ambulate safely (with or without an assistive device)
* Able to follow study directions
* Able to communicate and follow study instructions
* English speaking

Exclusion Criteria:

* Untreated organic sleep disorder (e.g., central or obstructive sleep apnea, restless leg syndrome)
* Serious or unstable medical or psychiatric condition that would prevent participation in a behavioral intervention (e.g., terminal illness, uncontrolled psychiatric disorder, substance abuse disorder)
* Lack of decision-making capacity, as documented in medical record
* Referred to institutional care and/or currently residing in a nursing home or other residential facility

Primary outcomes:
measure: Sleep efficiency
timeFrame: Month 2
Secondary outcomes:
measure: Insomnia severity scores
timeFrame: Month 2
measure: total daytime activity
timeFrame: Month 2
measure: daytime consequences
timeFrame: Month 2
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jaime M Hughes, PhD, MPH, MSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992783: Resistant Starch, Antioxidant Status and Insulin Resistance
Official title: The Effect of Resistant Starch Supplementation on Antioxidant Status and Insulin Resistance in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Resistant Starch
Antioxidant Status
Insulin Resistance
Overweight
Obesity
Lead sponsor: Urmia University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate whether supplementation with resistant starch improves biomarkers associated with antioxidant status and insulin resistance in subjects with overweight and obesity.


Eligibility criteria: Inclusion Criteria:

* Overweight and obese adults
* Age: 20-50 years

Exclusion Criteria:

* weight loss or gain (more than10%) over the past 6 months, or weight loss (more than 5%) over the past 1 month
* pregnancy, lactation or menopause
* History of acute disease or clinical evidence of cancer, acute or chronic inflammatory diseases, cardiovascular disease, renal disease, liver disease, thyroid or endocrine disease
* Gastrointestinal disease of which ingredients found in the study products have adverse effects on that
* Use of antihypertensive, lipid lowering or glucose lowering medications
* Taking antioxidant, vitamin, and/or mineral supplements
* smoking

Primary outcomes:
measure: Antioxidant status
timeFrame: 4 weeks
Secondary outcomes:
measure: Insulin resistance
timeFrame: 4 weeks
measure: Lipid profile
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: 4 weeks
measure: Anthropometric parameters
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Urmia
country: Iran, Islamic Republic of
state: Azerbaijan-gharbi
Study officials:
affiliation: Assistant Professor in Nutrition
name: Mohammad Alizadeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eshghi F, Bakhshimoghaddam F, Rasmi Y, Alizadeh M. Effects of Resistant Starch Supplementation on Glucose Metabolism, Lipid Profile, Lipid Peroxidation Marker, and Oxidative Stress in Overweight and Obese Adults: Randomized, Double-Blind, Crossover Trial. Clin Nutr Res. 2019 Oct 28;8(4):318-328. doi: 10.7762/cnr.2019.8.4.318. eCollection 2019 Oct.
Clinical trial NCT03791983: Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease
Official title: Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease -The Evaluation of Scalp Acupuncture for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-01-03
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study integrates traditional Chinese medicine syndromes and pulse diagnosis, and uses laser vibration overlay and functional cerebral angiography to understand the efficacy of scalp acupuncture against Parkinson's Disease.

Detailed description: Traditional Chinese medicine does not have the term " Parkinson's disease". According to the symptoms of the disease, it is closer to the "Liver wind", "Vibration" and "Chatter" in Chinese medicine. Scalp needle stimulation can increase the content of dopamine in the brain and improve mitochondrial function and reduce the death of substantia nigra.

This study integrates TCM syndromes and pulse diagnosis, and uses laser vibration overlay and functional brain image to understand the effect of scalp acupuncture on Parkinson's disease. The project will be carried out in two phases: the first phase is the pilot study, and 200 patients with limb shakes were collected from the neurology clinic. After the laser vibration overlay test, 20 patients with mild tremors and diagnosed as Parkinson's disease were selected. , treated by Wen's scalp acupuncture. In the second phase, 80 Parkinson patients were enrolled, randomized to the treatment group and the control group, and the changes in TCM syndrome, pulse diagnosis and Parkinson scale were compared before and after treatment, and the fMRI and vibration overlay ratios were evaluated after scalp acupuncture.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed as Idiopathic Parkinsonism by Neurologist
2. Have taken first line drugs more than three months
3. Did not take any acupuncture or rehabilitation
4. Voluntary

Exclusion Criteria:

1. Taking anticancer drug now or diagnosed as depression, psychosis or other mental illnesses
2. Medical history of stroke or dementia
3. Taking anticoagulant now or having coagulation disorders
4. Scalp infection
5. Pregnant women
6. Patient with irregular heartbeat, implanted artificial cardiac pacemaker or implanted cardioverter-defibrillator
7. Belonephobia

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale
timeFrame: 2 Months
measure: Micro Vibration Scan
timeFrame: 2 Months
measure: SPECT
timeFrame: 2 Months
measure: PET/MRI
timeFrame: 2 Months
Secondary outcomes:
measure: Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: 2 Months
measure: Sphygmograph
timeFrame: 2 Months
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Fang-Pei Chen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06941883: Ultrasound-Guided Versus Anatomically Guided Botulinum Toxin Injection in Spasticity in Adults in Tanta University Hospitals
Official title: A Study of Ultrasound-Guided Versus Anatomically Guided Botulinum Toxin Injection in Spasticity in Adults in Tanta University Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound
Botulinum Toxin
Spasticity
Adults
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective case-controlled study was carried out on 68 patients aged \> 18 years old, both sexes, with muscle spasticity, planned and indicated for BoNT injection according to recent guidelines. The study was done from July 2023 to July 2024 after approval from the Ethical Committee Tanta University Hospitals, Tanta, Egypt.

Brief summary: This study aimed to compare the safety and outcome of ultrasound (US)- guided botulinum toxin (BoNT) injection and anatomically guided injection in muscle spasticity of different causes in adults.

Detailed description: One of the major complications of neurological diseases is spasticity which is defined as an increased velocity-dependent muscle tone.

A large volume of clinical data has demonstrated the efficacy and safety of botulinum toxin type A (BoNT-A) products for treating conditions such as spasticity.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old.
* Both sexes.
* Patients with muscle spasticity.

Exclusion Criteria:

- Patients with contraindications to botulinum toxin injection as allergy, myasthenia gravis, and cerebral palsy.

Primary outcomes:
measure: Assessment the range of movement
timeFrame: 6 months after the procedure
Secondary outcomes:
measure: Assessment the quality of life
timeFrame: 6 months after the procedure
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT05147883: The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)
Official title: The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Physical Inactivity
Quality of Life
Sleep
Anxiety
Depression
Keywords: PreDiabetes
Physical Inactivity
Quality of Life
Sleep
Anxiety
Depression
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the effect of exercise on quality of life, sleep quality and anxiety in patients with prediabetes.

Detailed description: Randomized controlled studies are needed to examine the effects of exercise on sleep quality, quality of life, anxiety and depression in patients with prediabetes.

The aim of this study is to determine the effect of exercise on quality of life, sleep quality and anxiety in patients with prediabetes.

Eligibility criteria: Inclusion Criteria:

* 18-59 years old
* Living a sedentary life (physical activity below 300 kcal/day will be evaluated with the Minnesota Leisure Physical Activity Questionnaire)
* Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
* Those diagnosed with prediabetes by oral glucose tolerance test and/or HbA1c measurement will be included.
* Being eligible to participate in an exercise program after a cardiac examination (resting ECG and questioning of cardiac symptoms, advanced tests such as exercise ECG test if necessary) performed by the physician

Exclusion Criteria:

* Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
* Having cardiovascular disease
* Being diabetic
* Receiving hormone replacement therapy
* Life expectancy less than 1 year
* HIV positivity
* Substance use
* Functional dependency
* Cognitive weakness
* Those who have other diseases that will affect the results of the study (respiratory diseases, muscle diseases, etc.)
* Those who use drugs or supplements that will affect the results of the study

Primary outcomes:
measure: Score of Quality of Life
timeFrame: 1 week
Secondary outcomes:
measure: Sleep Quality
timeFrame: 1 week
measure: Anxiety
timeFrame: 1 week
measure: Depression
timeFrame: 1 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdülhamid Training and Research Hospital
state: Uskudar
Study officials:
affiliation: Sultan Abdülhamid Training And Research Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00190983: A Trial for Patients With Advanced/Recurrent Cervical Cancer
Official title: A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Gynecologic Oncology Group
First posted: 2005-09-19
Enrollment: 29
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.


Eligibility criteria: Inclusion Criteria:

* Recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression
* Measurable disease
* Gynecologic Oncology Group (GOG) performance status 0-2
* Patients must have received one prior systemic chemotherapy for persistent or recurrent disease
* Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
* All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
* Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
* Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy

Exclusion Criteria:

* Prior Pemetrexed
* Patients who have received radiation to more than 25% of marrow bearing areas
* Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer

Primary outcomes:
measure: Tumor Response
timeFrame: baseline to measured progressive disease (up to 5 years)
Secondary outcomes:
measure: Duration of Response
timeFrame: time of initial response until documented tumor progression (up to 5 years)
measure: Progression-Free Survival
timeFrame: baseline until documented tumor progression (up to 5 years)
measure: Overall Survival
timeFrame: baseline until death from any cause (up to 5 years)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group 215-854-0770
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: David Miller, MD
role: STUDY_CHAIR
References: