louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02504463: A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
Official title: A Single-Center, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of Single Doses of [14c]-Samidorphan in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Alkermes
Samidorphan
ALKS 33
Healthy Volunteer
Pharmacokinetics
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-22
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the pharmacokinetics (PK) of \[14c\]-samidorphan in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of greater than/equal to 19 and less than/equal to 32 kg/m\^2 at screening (minimum weight of 50.0 kg)
* Generally good health
* Subjects must agree to reduce the risk of a female partner becoming pregnant during the study and for 30 days after the last dose of the study drug by abstinence from heterosexual relationships or use of a reliable contraceptive method
* Additional criteria may apply

Exclusion Criteria:

* Clinically significant illness within 30 days
* History of alcohol or opioid dependence, or positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
* History of oral or gastrointestinal disease
* Irregular bowel or bladder function
* History of allergy or hypersensitivity to opioid medications or opioid antagonists (eg, naltrexone, naloxone)
* Current or pending legal charges or probation that would interfere with study conduct
* Use of alcohol within 24 hours prior to admission or urine positive test for alcohol at screening or admission
* Tobacco or nicotine use within 90 days
* Anticipated need for prescription medicines during the study period
* Additional criteria may apply

Primary outcomes:
measure: AUC 0-t
timeFrame: Up to 120 hours after each dose
measure: Cmax
timeFrame: Up to 120 hours after each dose
measure: Tmax
timeFrame: Up to 120 hours after each dose
measure: Fe%0-t
timeFrame: Up to 120 hours after each dose
Secondary outcomes:
measure: Safety and tolerability will be measured by the incidence of Adverse Events
timeFrame: Up to 35 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
Study officials:
affiliation: Alkermes Medical Director
name: Arielle Stanford, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02906735: Changes of Plantar Pressure After Knee Reconstructive Surgery
Official title: Evaluation of Static and Dynamic Foot Pressure Measurement After Implantation of Knee Joint Prostheses or Alignment Surgeries of the Knee
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Pain Treated With Knee Arthroplasty
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned for knee surgery

Brief summary: Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a lack of understanding what changes of alignment of the lower limb causes to the ankle. The investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure investigated by means of static and dynamic pedography.


Eligibility criteria: Inclusion Criteria:

* Patients planned for knee surgery willing to participate at this study

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Foot pressure curve preoperatively
timeFrame: -1 day
Secondary outcomes:
measure: Foot pressure curve postoperatively
timeFrame: 1 year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar
name: Norbert Harrasser
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06655935: Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience
Official title: Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Septal Defect (ASD)
Keywords: atrial septal defects
transcatheter closure
modified technique
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
Collaborators: name: Tanta University
First posted: 2024-10-24
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure. In this study, we proposed a modified rapid method for closure of secundum atrial septal defects, to avoid material manipulation inside your heart and decrease complication rate.

Detailed description: Delivery sheath can be advanced over multipurpose catheter instead of stiff wire

Eligibility criteria: Inclusion Criteria:

* Any patient with ostium secundum ASD \& RV volume overload

Exclusion Criteria:

* Any other type of atrial septal defects Any other associated congenital anomaly

Primary outcomes:
measure: recording any complication during transcatheter secundum atrial septal defect closure
timeFrame: during the procedure
Secondary outcomes:
measure: assess the duration of the procedure and if this affects the cost of the procedure by any means
timeFrame: during the procedure
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
affiliation: Cardiology departement-Tanta University hospital
name: Raghda El sheikh, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06330935: Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury
Official title: Clinical Trial Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Pediatric Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Traumatic Brain Injury
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population.


Eligibility criteria: Inclusion Criteria:

1. Age Less than 18 years old
2. Clinical diagnose of trauma to the Head and GCS score less than or equal to 13 with associated intracranial haemorrhage on cranial CT scan
3. Time of admission within 3 hour of injury.

Exclusion Criteria:

1. Patient Known pregnancy.
2. patient had Cardiac arrest prior to randomization
3. GCS score of 3 with bilateral unresponsive pupils
4. Known bleeding/clotting disorders.
5. Known seizure disorders.
6. Known history of severe renal impairment
7. Unknown time of injury
8. Prior TXA for current injury
9. Known venous or arterial thrombosis

Primary outcomes:
measure: The early traumatic brain injury-related death in the hospital
timeFrame: 24 hour and 48 hour after injury
measure: The difference between treatment group in the Intracranial haemorrhage growth
timeFrame: 24 hour
measure: The difference between the treatment groups in the incidence of mortality
timeFrame: 28 days
Secondary outcomes:
measure: Need for neurosurgical management
timeFrame: 28 day
measure: Days in the intensive care unit
timeFrame: 28 day
measure: Need for blood transfusion
timeFrame: 48 hour
measure: Adverse events
timeFrame: 28 days
measure: Pediatric Quality of Life (PedsQL)
timeFrame: 6 months
measure: Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds)
timeFrame: 6 months
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Al-Azhar University Hospital in New Damietta
Study officials:
References:
Clinical trial NCT00373035: Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy
Official title: Biomarkers of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-09-07
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Collecting and storing samples of blood and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers in patients undergoing transrectal ultrasound prostate biopsy.

Detailed description: OBJECTIVES:

Primary

* Identify unique proteins or peptides that are associated with prostate cancer by comparing the proteomic or metabolomic analysis of serum, plasma, and urine from patients with histological evidence of prostate cancer to those without prostate cancer (after transrectal ultrasound prostatic biopsy).

Secondary

* Collect seminal fluid from a subset of patients to test the hypothesis that the fluid collected from the "target organ of injury" in prostate cancer will have a higher signal of proteins/peptides that are different from those without cancer and may help guide the identification of these differences in the serum, plasma, and urine.

OUTLINE: This is a pilot study.

Patients undergo collection of serum, plasma, and urine for biomarker/laboratory analysis. Samples are examined by proteomic/metabolomic analysis (by mass spectrometry) and immunoassays. Patients then undergo a transrectal ultrasonography prostatic biopsy.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Indication for a transrectal ultrasonography prostatic biopsy (as part of normal patient care) due to elevated prostate-specific antigen, or abnormal digital rectal examination, or surveillance for prostate cancer

PATIENT CHARACTERISTICS:

* No prior or other concurrent malignancy except for curatively treated basal cell carcinoma of the skin
* No serious medical or psychiatric illness that would preclude informed consent
* No concurrent acute illness

PRIOR CONCURRENT THERAPY:

* No participation in another clinical trial within the past 30 days
* No more than one enrollment into this study

Primary outcomes:
measure: Unique proteins or peptides associated with prostate cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: SurroMed Incorporated
state: California
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Frank M. Torti, MD, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT04674735: Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
Official title: Multicentre, Open Label, Phase I Clinical Trial to Evaluate the Safety of APSLXR for the Treatment of Vertigo of Vestibular Origin or Meniere's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Meniere Disease
Vertigo
Vertigo Vestibular
Lead sponsor: Apsen Farmaceutica S.A.
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of APSLXR in participants with Meniere's disease or other Verigo of vestibular origin. Pharmacokinetics will also be evaluated in a small group.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;
* Voluntarily consent to participate in the study;

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding;
* Participants presenting uncontroled systolic hipertension (\>140/90 mmHg);
* Participants presenting uncontroled diabetes (blood glucose \>200 mg/dL).

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: during 60 days
Secondary outcomes:
measure: Pharmacokinetic parameters in steady state
timeFrame: at Day 60
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00947635: Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention
Official title: Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Immunosuppression
Hyperlipidemias
Diabetes Mellitus, Type 1
Keywords: Type 1 diabetes
Transplants
Immunosuppression
Hyperlipidemia
Nutrition Therapy
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-07-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to investigate possible mechanisms of increased blood lipid levels following transplantation, and also to see if a comprehensive dietary intervention is effective in reducing blood lipid levels in post-transplant patients.

Detailed description: Post-transplantation patients frequently have an increase in blood lipid levels presumed to be due to immunosuppressive agents, however it is currently unknown the mechanisms by which this occurs. Dietary interventions have frequently been unsuccessful in these patients, which may be due to single-nutrient interventions and lack of support and guidance. This research will use stable isotope methods to estimate cholesterol and fatty acid synthesis to determine if these pathways are affected by immunosuppression in patients before and after islet and liver transplant. In addition, it will be determined if a multi-nutrient dietary intervention will be implemented post-transplant can reduce blood lipid levels in to prevent further polypharmacy these patients.

Eligibility criteria: Inclusion Criteria:

* on islet or liver transplant list
* post-transplant \>3 months
* physically able to participate in study and intervention

Exclusion Criteria:

* \< 18 years of age
* family history of premature cardiovascular disease or familial hyperlipidemia (control subjects)
* cholestatic diseases (liver transplant patients)
* type 2 diabetes

Primary outcomes:
measure: Cholesterol and fatty acid synthesis
timeFrame: Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)
Secondary outcomes:
measure: Blood lipid levels
timeFrame: Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Michael T Clandinin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03563235: Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules
Official title: Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Postmenopausal Osteoporoses
Keywords: Osteoporosis
kidney deficiency and blood stasis syndrome
Xuling Jiangu Granules
Lead sponsor: Fujian Academy of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoporosis is a common senile disease with a high incidence. The Chinese medicine differentiation treatment has small side effects and can be taken for a long time, which has certain advantages. This project adopts the experience of the person in charge of the project-Xulin Jiangu Granules and clinically collects patients with postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome).

Detailed description: Randomized control method was used to observe the clinical efficacy of the treatment of postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome) with jiujian jiangu granules, combined with the gene expression of bone metabolism markers BALP, PINP, TRACP and S-CTX, and RANK, RANKL and OPG Detection, compared with the control group of ossification trihydrate capsules, to explore the mechanism of the treatment of postmenopausal osteoporosis by the continued Xulin Jiangu granules, and lay the foundation for the development of new drugs.

Eligibility criteria: Inclusion Criteria:

* at least 2 years prior and met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis
* met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine

Exclusion Criteria:

* patients who did not meet the diagnostic criteria for osteoporosis or CM standards
* patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
* patients with abnormal liver and/or Shen function test results
* patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.

Primary outcomes:
measure: Bone density（BMD）
timeFrame: Xulin Jiangu treats for up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Academy of Trational Chiness Medicine
state: Fujian
Study officials:
References:
Clinical trial NCT03776435: CT Carcinogenic Risk in Patients With Appendicitis
Official title: Carcinogenic Risk of CT in Patients With Appendicitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Computed Tomography
Carcinogenesis
Radiation Exposure
Appendicitis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2018-12-14
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent appendectomy under the diagnosis of appendicitis

Brief summary: The purpose of this study is to compare the incidence rate of leukemia between CT-exposed and CT-unexposed group in patients who underwent appendectomy in South Korea.

Detailed description: South Korea has a single-payer healthcare system, administered by National Health Insurance Service (NHIS). As healthcare providers in South Korea need to claim reimbursement to NHIS for the vast majority of diagnostic and therapeutic procedures, the NHIS database enabled us to construct a large cohort who did or did not undergo CT for appendicitis. The purpose of this study is to compare the incidence rate of cancer between CT-exposed and CT-unexposed group in patients who underwent appendectomy in South Korea.

Eligibility criteria: Inclusion Criteria:

* Patients will be entered in the cohort on the date of appendectomy under the diagnosis of appendicitis

Exclusion Criteria:

* (a) patients who had a cancer diagnosis before the date of appendectomy,
* (b) those who had prior experience of CT examination more than 7 days before appendectomy,
* (c) those who had syndromes or diseases predisposing cancers,
* (d) those whose diagnosis was changed to appendiceal cancer and
* (e) those whose follow-up duration was shorter than a lag period.

Primary outcomes:
measure: Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system
timeFrame: Cancer occurrence after a lag period (2 years)
Secondary outcomes:
measure: Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organs
timeFrame: Cancer occurrence after a lag period (2 years)
measure: Age and sex-standardized incidence rate ratio (IRR) for all cancers
timeFrame: Cancer occurrence after a lag period (2 years)
Other outcomes:
measure: Sensitivity analysis
timeFrame: Cancer occurrence after different lag periods (6 months, 1 year, 3 years and 5 years)
measure: Subgroup analysis by subsequent CT scans conducted more than 7 days after appendectomy
timeFrame: CT undergone more than 7 days after appendectomy will be counted.
measure: Subgroup analysis
timeFrame: Cancer occurrence after a lag period (2 years)
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul National University Bunadang Hospital
state: Gyeonggi-do
Study officials:
References: