louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05337254: A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
Official title: A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Migraine With Aura
Migraine Without Aura
Keywords: dihydroergotamine
dihydroergotamine mesylate
migraine
Lead sponsor: Satsuma Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.

Detailed description: 36 subjects received a single dose of STS101, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 5-period crossover manner.

Eligibility criteria: Inclusion Criteria:

* 18 to 50 years of age at the time of enrollment.
* Signed the informed consent document.
* Subject judged to be healthy by a qualified physician

Exclusion Criteria:

* Abnormal physical findings of clinical significance at the screening examination
* Significant abnormal laboratory values at the Screening Visit.
* Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.

Primary outcomes:
measure: DHE Relative Bioavailability
timeFrame: Pre-dose through 48 hours Post-Dose
measure: DHE Comparative Bioavailability
timeFrame: Pre-dose through 48 hours Post-Dose
Secondary outcomes:
measure: Serious Adverse Events
timeFrame: Pre-dose through 48 hours Post-Dose
measure: Treatment-Related Adverse Events
timeFrame: Pre-dose through 48 hours Post-Dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences Miami Inc.
state: Florida
Study officials:
affiliation: Quotient Sciences Miami Inc
name: Jeffrey Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01315054: A Methadone Maintenance Treatment Outcome Study in Three Provinces in China
Official title: A Methadone Maintenance Treatment Outcome Study in Three Provinces in China: Comparative Evaluation of the Impact of an Intensive Health Care Provider Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Hepatitis C
Syphilis
Herpes Simplex Type II
Keywords: IDUs
high risk behaviors
HIV
MMT dosage and retention
psychosocial services
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: National Center for AIDS/STD Control and Prevention, China CDC
First posted: 2011-03-15
Enrollment: 4258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary goal of this PHE is to determine the effectiveness of a tailored education program for MMT service providers. It was to be evaluated through methadone dose levels prescribed to new patients after training completion. The effects of methadone dose, with and without the inclusion of additional counseling services, would be measured through MMT retention and illicit opioid use.

Detailed description: Methadone treatment has became one of main actions taken in China to control the spread of HIV among drug users. However，the average methadone dose used is relatively low. An intensive methadone maintenance treatment (MMT) provider training on methadone dosage may be effective in increasing the methadone dose levels prescribed to new patients. The study will evaluate the effectiveness of a tailored education program for MMT service providers using subsequent methadone dose prescribed to new patients. The effects of methadone dose, with and without the inclusion of additional psychosocial services, will then be measured through MMT retention and illicit opioid use.

Eligibility criteria: Inclusion Criteria:

* client participants will include both men and women who are opiate-dependent drug users who started MMT not more than one month prior to enrollment in the study
* 18 years of age or older
* residing in the study areas

Primary outcomes:
measure: MMT retention rate
timeFrame: 12 months
measure: Illicit opioid use rate
timeFrame: 12 months
Secondary outcomes:
measure: HIV, HCV, syphilis and HSV-2 infection seroconversion rate
timeFrame: 12 months
measure: High risk needle practice
timeFrame: 12 months
measure: High risk sexual practice
timeFrame: 12 months
measure: Quality of life（WHO Quality of Life -BREF）
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for HIV/STD Prevention and Control, China CDC
Study officials:
affiliation: US CDC GAP China
name: Marc Bulterys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02184754: Magnetic Endoscope Imaging in Single-balloon-enteroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Endoscope Imaging in Single-balloon-enteroscopy
Keywords: Magnetic endoscope imaging
single-balloon-enteroscopy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: endoscopy unit

Brief summary: Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in which scope navigation is particularly important. The MEI will be compared with x-ray which is still the current gold standard for scope navigation in small bowel enteroscopy.


Eligibility criteria: Inclusion Criteria:

* indication for enteroscopy

Exclusion Criteria:

* contraindication for enteroscopy
* patients with cardiac pacemaker or defibrillator
* pregnancy

Primary outcomes:
measure: Number of concordance of MEI- and x-ray-images
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
References:
Clinical trial NCT03705754: Carbon Black Tattoo in Colon Cancer
Official title: EFFECT OF ENDOSCOPIC TATTOOING WITH CARBON BLACK SUSPENSION ON THE STAGING OF COLON CANCER
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Tattoo of Suspected Colon Cancer
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tattoo arm vs. control arm
Primary purpose: DIAGNOSTIC

Brief summary: The study is designed to elucidate whether carbon black suspension endoscopic tattoo enhances visibility of lymph nodes or tumor tissue on dissection of colonic surgical specimen, thereby making improvement in staging defined as better pTNM stage via better visualisation of carbon marked metastatic or sentinel lymph nodes or marked primary tumor or adjacent tissues.

Detailed description: Other objectives are:

* to assess intraoperative visibility of carbon black tattoo in the tumor region and surrounding tissues
* to assess microscopic distribution of carbon ink in the layers of the colonic wall and adjacent tissues
* to assess complications related to carbon black tattoo procedure like microscopic fibrosis, micro- or macroscopic scarring, inflammatory reactions
* to assess long-term effects of ink injections on control endoscopies at 6 and 12 months
* to assess dissection time in tattooed-non tattooed lymphatic tissues

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years or above undergoing colonoscopy for suspected colonic malignancy
* Participant is able to give informed consent for participation in the study
* Patient is presumably selected for surgery within 30 days following tattoo injection

Exclusion Criteria:

* Patients under the age of 18
* Patients unable to give informed consent or ineligible for surgery
* Tumor in the coecum dome or in the rectum (\<15 cm)
* Known allergy to suspension ingredients

Primary outcomes:
measure: Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: 1st Department of Medicine, University of Szeged
state: Csongrád
Study officials:
affiliation: Szeged University
name: Matyas Czepan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Askin MP, Waye JD, Fiedler L, Harpaz N. Tattoo of colonic neoplasms in 113 patients with a new sterile carbon compound. Gastrointest Endosc. 2002 Sep;56(3):339-42. doi: 10.1016/s0016-5107(02)70035-7.
Clinical trial NCT05268354: Modification of Risk Factors Associated With Knee Injury in Netball
Official title: Modification of Characteristics Associated With the Noncontact Knee Injury Mechanism in Adult Recreational Netball Players
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Injuries
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Noncontact knee injuries are a concern in netball. As such, it is important to devise appropriate injury prevention programs that players will complete to reduce the risk of injury. Previous research suggests that the most common situation of noncontact knee injury in netball involves a stiff landing or apparent knee valgus collapse, trunk rotation, and lateral flexion. Therefore, the aim of this study is to investigate the effect of a neuromuscular training program on biomechanical risk factors during a netball-specific landing.


Eligibility criteria: Inclusion Criteria:

* Female
* 18-45 years
* No history of lower limb injury in the last 6 months
* No history of concussion in the last 6 months
* No history of any knee surgery
* Currently playing recreational netball at least once per week

Exclusion Criteria:

* Male
* Under 18 years or over 45 years of age
* Suffered from a lower limb injury in the last 6 months
* Suffered from concussion in the last 6 months
* Any history of knee surgery
* Not currently playing recreational netball at least once per week

Primary outcomes:
measure: Peak knee flexion angle
timeFrame: From baseline to end of six-week training program
measure: Peak vertical ground reaction force
timeFrame: From baseline to end of six-week training program
measure: Joint position sense
timeFrame: From baseline to end of six-week training program
measure: Peak hamstring torque
timeFrame: From baseline to end of six-week training program
measure: Peak quadriceps torque
timeFrame: From baseline to end of six-week training program
measure: Peak hip abductor torque
timeFrame: From baseline to end of six-week training program
measure: Time to stabilization
timeFrame: From baseline to end of six-week training program
measure: Peak horizontal jump distance
timeFrame: From baseline to end of six-week training program
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02903654: Prevalence of Heterozygote Mothers for Pompe's Disease Among Mothers Having Delivered in French Guiana
Official title: Prevalence of Heterozygote Mothers for Pompe's Disease Among Mothers Having Delivered in French Guiana
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pompe's Disease
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 925
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women having delivered in French Guiana whose child was enrolled in the depipomp1 study

Brief summary: Given the high incidence of Pompe's Disease in French Guiana (100 times higher than in mainland France) the aim is to determine the prevalence of heterozygotes among women having just delivered in French Guiana who accepted that their newborn child enters the depipomp1 study. In these women the specific mutations p.Gly648Ser and p.Arg854X will be sought using PCR in order to calculate the prevalence of these mutations and estimate the risk factors associated with them in order to improve genetic counselling.


Eligibility criteria: Inclusion Criteria:

* women having delivered in French Guiana whose child was enroled in the depipomp1 study

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: prevalence of p.Gly648Ser and p.Arg854X
timeFrame: Within 3 days after birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05043454: Improving Age-Related Cognitive Decline with Exercise in Hypertensive Older Adults
Official title: Improving Age-Related Cognitive Decline with Exercise in Hypertensive Older Adults: a Pilot Study to Investigate a Retinal Microvascular Biomarker and the Role of IGF
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigator aims to assess the extent to which a brief exercise intervention improves systemic growth factor concentrations, reverses loss of systemic vascular networks and hypertension, and by extension, improves neurocognition. To test the investigator's hypothesis that increased cardiovascular fitness will correlate with improved vascular density, the investigator proposes the innovative use of retinal density scans.


Eligibility criteria: Inclusion Criteria:

* adults between 55-75 years of age
* essential hypertension (as determined by referring physicians)
* engages in less than 150 minutes of moderate intensity exercise/week (as determined by CHAMPS Questionnaire)
* physically able to exercise
* access to an upright cycle ergometer at home or via gym access
* access to smart device (iOS or Android phone or tablet with ability to install and use Polar Beat and Polar FlowTM applications).

Exclusion Criteria:

* diagnosis of dementia
* resting systolic blood pressure \<120, or \>180 mm Hg
* disease or condition that would preclude exercise
* untreated depression or anxiety disorders
* severe respiratory disease
* disease of the eye
* refractive error \> 6 diopters or +6 diopters (as assessed by 1st retinal scan).

Primary outcomes:
measure: Changes in graded exercise stress test
timeFrame: 16 weeks
measure: Retinal microvascular density changes
timeFrame: 16 weeks
measure: Cognitive changes
timeFrame: 16 weeks
measure: Serum growth factor changes
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ronald Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008254: Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers
Official title: Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pressure Ulcers
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2009-11-05
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Musical reminder will raise compliance with mobility in the long-term care setting and reduce facility-acquired pressure ulcers.


Eligibility criteria: Inclusion Criteria:

* Long-term care resident
* MDS qualified

Exclusion Criteria:

* Self pay long-term care residents

Primary outcomes:
measure: Reduction of Facility Acquired Pressure Ulcers
timeFrame: 2 years
Secondary outcomes:
measure: Organizational Change
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Cincinnati College of Nursing
name: Tracey L Yap, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yap TL, Kennerly SM, Simmons MR, Buncher CR, Miller E, Kim J, Yap WY. Multidimensional team-based intervention using musical cues to reduce odds of facility-acquired pressure ulcers in long-term care: a paired randomized intervention study. J Am Geriatr Soc. 2013 Sep;61(9):1552-9. doi: 10.1111/jgs.12422. Epub 2013 Aug 26.
Clinical trial NCT00039754: A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients With Multiple Myeloma
Official title: A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Transplant
Skeletal Targeted Radiotherapy
Holmium
Lead sponsor: Poniard Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-06-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Multiple myeloma is a disease that resides primarily in the bone and has shown to be sensitive to radiation. Administration of a radiotherapy agent that targets the bone, such as Holmium-166-DOTMP, in conjunction with melphalan and an autologous stem cell transplant, may improve the patient's chance of responding to treatment. The purpose of this study is to determine the amount of Holmium-166-DOTMP that localizes in the bone and in normal organs, and to evaluate the safety and efficacy of Holmium-166-DOTMP in the treatment of patients with multiple myeloma.

Detailed description: The purpose of this study is to estimate the radiation absorbed dose to the bone marrow and kidneys based on whole-body gamma camera image data for comparison with that obtained using mathematical models based on whole body counting from a small gamma detection device called a thyroid probe; to obtain pharmacokinetic data following administration of 166Ho-DOTMP; and to evaluate safety and efficacy in patients who receive 25 Gy targeted therapy of 166Ho-DOTMP and 200 mg/m2 melphalan followed by autologous peripheral blood stem cell transplant (PBSCT).


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05653154: Preoperative Survey
Official title: Preoperative Concerns in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Keywords: Elderly, surgical
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 264
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients

Brief summary: This study will examine preoperative concerns in older adults through the use of a self-administered questionnaire. The development of this questionnaire will involve adapting survey questions from previously validated studies, creating new questions, and generating a comprehensive questionnaire.

Detailed description: The primary objective is to assess the preoperative concerns in older adults. This objective will be assessed by using a self-administered questionnaire.

The secondary objective is to examine older adults' attitudes toward preoperative cognitive assessments, functional assessments, and prehabilitation programs. Similarly, this objective will be assessed by using a self-administered questionnaire.

Survey administration will be completed online and in person. Recruited participants will receive an email that contains an external link to the online version of the survey that will be administered on Research Electronic Data Capture (REDCap), an online platform to complete secure surveys. Once received, participants will be able to anonymously complete the survey and not have to provide any identification information except for general sociodemographic variables. Alternatively, study personnel will administer the questionnaire online/ in person at the preoperative clinic to assess surgical population at Mount Sinai Hospital.

Eligibility criteria: Inclusion Criteria:

* Older adults, who are aged 65 or older and
* Medical patients in geriatric clinic or surgical inpatients in pre-operative clinics

Exclusion Criteria:

• Lack English language capability

Primary outcomes:
measure: preoperative concerns
timeFrame: 1 day
Secondary outcomes:
measure: Cognitive assessments
timeFrame: 1 day
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: 399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Frances Chung, MBBS MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: