louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03851731: Evaluation of Intranasal Naltrexone and Naloxone
Official title: Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2019-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Males and females 18 to 55 years of age, inclusive.
* Provide written informed consent.
* Body mass index (BMI) ranging from 18 to 30 kg/m2, inclusive.
* Adequate venous access.
* No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
* Agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
* Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.

Exclusion Criteria:

* Contact site for more information

Primary outcomes:
measure: Pharmacokinetic parameter [maximum serum concentration - Cmax]
timeFrame: 12 days
measure: Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t]
timeFrame: 12 days
measure: Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]
timeFrame: 12 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 15 days
measure: Vital Sign - Heart Rate
timeFrame: 12 days
measure: Vital Sign - Blood pressure (diastolic)
timeFrame: 12 days
measure: Vital Sign - Blood pressure (systolic)
timeFrame: 12 days
measure: Vital Sign - Respiration Rate
timeFrame: 12 days
measure: Electrocardiogram
timeFrame: 12 days
Other outcomes:
Locations:
Study officials:
affiliation: NIH / NIDA
name: Nora Chiang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00162331: CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI
Official title: AIR-MI: Assessment of Ischemia and Remodeling Following Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 74
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 study is to learn if there are any changes in how blood gets to your heart muscle and if your heart size changed after your heart attack.


Eligibility criteria: Inclusion Criteria:

* Undergoing primary or rescue PCI for acute MI with ECG evidence of a large territory at risk.

Exclusion Criteria:

* History of prior MI or CABG surgery, persistent LBBB, Atrial Fibrillation, End stage renal disease, Weight \> 350 lbs.

Primary outcomes:
measure: To better understand the interactions between the abnormalities in blood supply from the small vessels of the heart to the heart muscle after a heart attack and the changes in heart size 6 months after the heart attack.
Secondary outcomes:
measure: To estimate the frequency of residual ischemia as assessed by stress myocardial perfusion imaging (MPI) in patients undergoing primary PCI for AMI.
measure: To estimate the 6-month cardiac event rates (composite of death, another heart attack, hospitalization for heart failure, and irregular heart beats requiring treatment).
measure: To determine the relationship between changes (from baseline) in LV systolic volume index and LVEF, as measured by gated SPECT imaging 6 months following reperfusion, and the presence and severity of residual ischemia.
measure: To measure the performance of angiographic parameters of success of reperfusion therapy (TIMI frame count and TIMI myocardial perfusion grade) in predicting the presence of residual ischemia.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: Curibita
country: Brazil
facility: Local Institution
city: Sao Paolo
country: Brazil
facility: Local Institution
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
Study officials:
affiliation: Lantheus Medical Imaging
name: Qi Zhu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01866631: Using National University Cancer Institute of Singapore (NCIS) Registry to Measure Time Trends in Quality of Care for Breast Cancer Patients in a National Cancer Centre
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To retropsectively review the NCIS registry of females diagnosed with breast cancer in years 2002 to 2008 with regards to clinical quality indicators as published by the European Sociaty of Breast Cancer Oncologists (Eur J Can 2010; 46:2344-2356). We will extract data from a pre-existing breast cancer registry which belongs to NCIS, looking at data which includes the following:(1) Completeness of clinical and imaging diagnostic work-up(2) Completeness of prognostic and predictive characterization(3) Multidisciplinary discussion(4) Appropriate surgical approach(5) Appropriate post-operative radiation(6) Avoidance of over-treatment(7) Appropraiet hormonal therapy(8) Appropriate chemotherapy and other medical therapy(9) Staging, counselling, follow-up and rehabilitative procedures

Brief summary: The investigators hypothesise that the research data will enable them to elucidate local clinical practices with regard to breast cancer care and enable them to extrpolate the data to improved local clinical care for their patients through self-regulation and audit.


Eligibility criteria: Inclusion Criteria:

* Female
* 21 years old

Exclusion Criteria:

No patient involved

Primary outcomes:
measure: Quality of care at NCIS using indicators
timeFrame: 2 years
Secondary outcomes:
measure: The trends and variations in quality of care indices over a period of years
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT05593731: Platelet Rich Fibrin Versus Melatonin Around Dental Implants
Official title: Evaluation of Local Delivered Platelet Rich Fibrin Versus Melatonin Gel on the Osseointegration of Dental Implant. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients With Missing Teeth
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dental implant is a dental treatment that allow oral rehabilitation for partial and fully edentulous patients. Osteointegration is the factor that control success s or failure of dental implant that can be improved by addition of different adjunctive biological materials. Platelets Rich fibrin plays a significant role in tissue regeneration and wound healing. Melatonin is biological hormone that secreted from pineal gland and played an important role in human growth.


Eligibility criteria: Inclusion Criteria:

1. good oral hygiene participants,
2. free of any systemic diseases,
3. Patients' age ranged from 20 to 40 years old.
4. Patients who can complete surgery and the study protocol.
5. Partially edentulous patients in the posterior mandibular region (at least a single-mandibular edentulous area) with periodontal health.

Exclusion Criteria:

1. patients who had parafunctional habits,
2. current and former smokers, pregnant
3. lactating women
4. unmotivated patients
5. patients with psychological problems
6. patients who were not able to follow the treatment protocol -

Primary outcomes:
measure: gingival thickness
timeFrame: 6 months
Secondary outcomes:
measure: bone density
timeFrame: 6 months
measure: marginal bone loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of dentistry at MUST
Study officials:
References:
Clinical trial NCT05904431: The Effect of Cognitive Performance on Physical Performance in Adolescent Basketball Players
Official title: The Effect of Cognitive Performance on Physical Performance in Adolescent Basketball Players
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Performance
Physical Performance
Lead sponsor: Atılım University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 49
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Professional Basketball Athletes

Brief summary: The aim of this study is to examine the relationship between physical fitness parameters and cognitive performance levels in basketball players. It has been shown in the literature that exercise has an effect on cognitive factors. However, there is a limited number of studies examining the relationship between physical performance parameters and cognitive performance in basketball players.

Detailed description: Forty-nine male basketball players aged 14-18 years were included in the study. Vertical jump, agility t, reactive agility, 20 m sprint and Y-shaped balance test were applied to all cases as physical performance tests. Right/left discrimination (Recognise application), two-point discrimination, Stroop Test were applied as cognitive performance tests, and the level of pain threshold was evaluated. In the reactive agility test, reactive response speed was evaluated by using visual stimuli, camera and photocell doors. Pearson correlation analysis was used as statistical analysis method.

Eligibility criteria: Inclusion Criteria:

* Male basketball players between the ages of 14-18,
* To be a licensed athlete for at least 5 years,
* Being active in sports and training for the last 1 year,
* Weekly training intensity is at least 5 hours per week

Exclusion Criteria:

* Having a history of visual, mental or systemic disease,
* Having a history of major injury in the medical history,
* Any complaints of acute or chronic pain/injury

Primary outcomes:
measure: Reactive Agility
timeFrame: 25 June 2023
measure: Lower Extremity Strength
timeFrame: 25 June 2023
measure: Agility
timeFrame: 25 June 2023
measure: Running Speed
timeFrame: 25 June 2023
measure: Balance
timeFrame: 25 June 2023
measure: Right/Left Separation
timeFrame: 25 June 2023
measure: Stroop Test
timeFrame: 25 June 2023
measure: Two-Point Discrimination
timeFrame: 25 June 2023
measure: Pain Threshold Level
timeFrame: 25 June 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Atılım University
Study officials:
References:
Clinical trial NCT00713531: Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV-negative
male and female clients
ages 18-50 years
seeking HIV counseling
testing at TRCARC
Lead sponsor: SEARCH Research Foundation
Sponsor class: OTHER
First posted: 2008-07-11
Enrollment: 992
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population in Thailand who are seeking HIV counseling and testing at TRCARC

Brief summary: The purpose of this study is to assess populations in Thailand at high risk for HIV-1 infection for potential efficacy trials of candidate HIV vaccines to include:

1. assess incidence of HIV-1 and volunteer retention
2. describe early viral load and CD4 counts
3. assess participant willingness to participate in HIV vaccine efficacy trials and other HIV prevention trials
4. describe volunteer risk behavior

Detailed description: Prospective cohort study of HIV-negative participants who will receive voluntary counseling and testing (VCT) for HIV-antibody in conjunction with questionnaires on risk behavior, willingness to participate in HIV vaccine trials and other HIV prevention trials at 4 month intervals for a period of 1 year. This study will follow 1000 HIV-negative volunteers with an expected minimum of 15-20 incident HIV-infections based on a minimum incidence rate of 1.5/100 person-years. Weighted incidence estimates will be calculated with exact 95% confidence intervals.

Eligibility criteria: Inclusion Criteria:

* Man or woman aged 18-50 years
* Willing to provide location or contact information and allow contact
* Thai citizenship as identified by Thai National Identification card
* Ability and willingness to provide consent
* Availability for follow-up for the planned study duration

Exclusion Criteria:

* Persons who have a history of a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent
* Persons who are known to be HIV-positive

Primary outcomes:
measure: number of HIV-1 infections per 100 person-years
timeFrame: 5 years
measure: Lost to follow-up on an annual basis (10% or better)
timeFrame: 5 years
measure: Post-infection viral load and CD4 count
timeFrame: 5 years
measure: Willingness to participate in HIV vaccine and prevention trials
timeFrame: 5 years
measure: Risk behavior by questionnaire
timeFrame: 5 years
Secondary outcomes:
measure: HIV-1 prevalence
timeFrame: 5 years
measure: HIV-1 genotype distribution
timeFrame: 5 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: The Thai Red Cross AIDS Research Centre
Study officials:
affiliation: The Thai Red Cross AIDS Research Centre, Bangkok, Thailand
name: Nittay - Phanuphak, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02020031: Regional Prophylactic Vancomycin in Revision Total Knee Replacement
Official title: Regional Prophylactic Vancomycin in Revision Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arthropathy of Knee Joint
Keywords: Revision knee joint
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Vidacare Corporation
First posted: 2013-12-24
Enrollment: 22
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: The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.

Detailed description: Patients were assigned to one of two groups by chance (like a coin toss):

* GROUP 1 - Received 500mg of vancomycin into the tibia (shin) bone of the leg being operated on.
* GROUP 2 - Received 1g of vancomycin, which is the amount normally given to patients.

For both groups, the revision knee replacement will then be carried out as normal.

OTHER ANTIBIOTICS All patients received cefazolin IV (an antibiotic used to prevent infection) prior to the beginning of surgery to ensure effective preventive antibiotics. The patient will also received 3 postoperative doses of cefazolin over a 24-hour period (4 doses in total). This is standard of care for all total knee replacement surgeries.

TISSUE SAMPLES

* Ten (10) tissue samples were taken during the surgery, consisting of both bone and fat beneath the skin. Each sample were very small, around the size of a pinhead.
* In addition, a drain sample was taken from the knee joint drain fluid to measure vancomycin concentration the morning following surgery.
* These samples were frozen and sent to a lab for analysis.

Eligibility criteria: Inclusion Criteria:

* Revision total knee arthroplasty
* Informed consent given

Exclusion Criteria:

* Current treatment with IV Vancomycin within the preceding 7 days
* Previous hypersensitivity to vancomycin
* Significant cardiac or respiratory abnormality
* Contraindications to using the intraosseous vascular access system (EZ-IO)
* Sepsis

Primary outcomes:
measure: Mean Concentration of Vancomycin in Subcutaneous Fat
timeFrame: Baseline to 24 hours
measure: Mean Concentration of Vancomycin in Bone Samples
timeFrame: baseline to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Mark Spangehl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00278031: Quality of Life in Children Cured of Retinoblastoma
Official title: Quality of Life in Children Cured of Retinoblastoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinoblastoma
Keywords: Retinoblastoma
Quality of life
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Israel Cancer Association
First posted: 2006-01-18
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long term survivors of childhood retinoblastoma

Brief summary: The aim of the study is to assess the quality of life of children who have been cured of retinoblastoma - a malignant eye tumor. The study is questionnaire-based, and uses standardized quality of life assessment tools.

Detailed description: Retinoblastoma is the most common eye tumor of children. It can present in one eye (unilateral) or in both eyes (bilateral). The bilateral form is always hereditary.

Retinoblastoma is a highly curable tumor. Using a combination of surgery, chemotherapy, radiation and local treatment modalities to the eye, over 98% of patients are cured. This means that most children diagnosed with retinoblastoma will become long-term survivors.

The use of surgery (taking out one eye), chemotherapy, and radiation may be associated with long term side-effects, some of which may have significant impact on the quality of life of the child. In addition, in case where the disease is hereditary, additional psychological issues arise.

The aim of our study is to assess, in a comprehensive and standardized fashion, the long term quality of life in children who were treated for retinoblastoma, and who are currently alive and well.

The assessment will include the use of questionnaires that assess quality of life, as well as participation in age-appropriate activities.

Each child, and his/her parent, will be interviewed and the questionnaires completed. The process will take about one hour for each child. No risk or discomfort to the child is involved.

Eligibility criteria: Inclusion Criteria:

* Past treatment for retinoblastoma

Primary outcomes:
measure: Change in quality of life
timeFrame: Baseline and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah Medical Organization
name: Michael Weintraub, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05887531: Abdominopelvic Cancer Prehabilitation
Official title: Effectiveness of a Prehabilitation Consultation in Self-care and Physical Exercise in Patients Diagnosed With Abdominopelvic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehabilitation
Cancer of Colon
Cancer of Rectum
Cancer, Ovarian
Keywords: Selfcare
Fisical exercice
Prehabilitation
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this research is to determine the effectiveness of a Prehabilitation consultation in self-care and physical exercise aimed at patients diagnosed with abdominopelvic cancer with initial surgical indication as part of their therapeutic plan.


Eligibility criteria: Inclusion Criteria:

* Majority (greater than or equal to 18 years).
* Diagnosis of abdominopelvic cancer and initial surgical indication as part of its therapeutic plan from the General Surgery Services of the General University Hospital of Castellón.
* Ability to give informed consent.

Exclusion Criteria:

* Inability to understand the information provided or insufficient knowledge of the Spanish language.
* Inability to carry out the scheduled intervention according to the physician's criteria.
* Neoadjuvant treatment to colorectal surgery.

Primary outcomes:
measure: Post-surgical recovery time
timeFrame: More than 2 days
measure: Post-surgical readmisions
timeFrame: until 4 weeks from surgery
Secondary outcomes:
measure: Self-care capacity
timeFrame: before surgery
measure: Anxiety levels
timeFrame: before surgery
measure: Aerobic capacity
timeFrame: before surgery
measure: Flexibility
timeFrame: before surgery
measure: Strength
timeFrame: before surgery
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
Study officials:
affiliation: Universitat Jaume I
name: Suárez María Pilar
role: PRINCIPAL_INVESTIGATOR
References: