louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06236815: High Confusion: Cannabis & Driving
Official title: High Confusion: Evaluating Effects of Popular Cannabis Isolates on Driving Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Impairment, Cognitive
Impairment of Attention
Impairment, Psychomotor
Keywords: cannabis
impairment
tetrahydrocannabinol
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to assess the feasibility of administrating Δ9-THC and Δ8-THC isolates and simultaneously adopting several data harmonization measures to generate uniquely translatable data. This project aims to (1) evaluate the feasibility and acceptability of administering ∆9-THC and Δ8-THC isolates using standardized cannabis dosing units to quantify ∆9-THC and Δ8-THC pharmacokinetics; and (2) evaluate the feasibility and acceptability of adopting standardized impairment detection methods and driving performance definitions and measures on quantifying ∆9-THC and Δ8-THC driving impairment compared to a placebo.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age, no older than 49 years of age
* Recent cannabis use (within past two years)
* Good mental health as determined by self-reported responses to the Psychopathology Screener
* Absence of any major medical, cardiovascular, endocrine, and neurological condition as determined by self-reported responses to the Medical History Screener
* In possession of a valid drivers' license with at least two years of driving experience
* English-speaking (able to provide consent and complete questionnaires)
* Written Informed Consent

Exclusion Criteria:

* Any serious prior adverse response to cannabis
* History of or current substance use disorder as determined by self-reported responses to the Internalizing, Externalizing, and Substance Use Disorder Screener
* Pregnancy or lactation (pregnancy test, if needed)
* Use of medications that may impact driving ability (e.g., mood stabilizers, sedatives)

Primary outcomes:
measure: Quantify analyte concentrations
timeFrame: 9 months
measure: Quantify impairing effects of cannabinoids
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Heather Barkholtz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01754415: Evaluation of Exercise Benefits to Promote Health Aging Among Chronically Ill Geriatrics in a Community
Official title: Evaluation of Exercise Benefits to Promote Health Aging Among Chronically Ill Geriatrics in a Community.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Osteoporosis
Osteoarthritis
Keywords: Aging
Chronic illness
Resistance circuit training
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to evaluate the effect of hydraulic resistance circuit training for elderly people with chronic illness.

Detailed description: This study is divided into three years. The aim of the first year is to analyze the types and percentage of chronic illness in middle- and old-aged population in communities and the impact on their physical and mental function. The Second year, we will use proper exercise prescriptions with exercise equipment available for chronic illness population and examine the improvement of their physical and mental functions after exercise intervention. The third year, we will adopt the concept of social marketing to promote knowledge about health-related fitness and exercise to communities and help to establish exercise center. To chronic illness people, the study seeks to delay the progression of disease and disability by encouraging them to participate in prescribed exercises. To relatively healthy people, exercise can achieve the purposes of healthy aging, decreased chronic illness, and improved ADLs function and life quality.

Eligibility criteria: Inclusion Criteria:

Subjects were recruited at the age of 45-80, and can communicate verbally and in writing.

Exclusion Criteria:

Subjects had physical limitation in sports and were advised not to exercise by doctors.

Primary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: three years
Secondary outcomes:
measure: Body composition measurement
timeFrame: three years
measure: The physical fitness assessment
timeFrame: three years
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Tsung-Ching Lin
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Tsung-Ching Lin, Master
role: STUDY_CHAIR
References:
Clinical trial NCT01335815: High Sensitive Troponin T (hsTnT) and Copeptin as Prognostic Parameters in Patients With Elective Total Endoprosthesis
Official title: High Sensitive Troponin T (hsTnT) and Copeptin as Prognostic Parameters in Patients With Elective Knee and Hip Endoprosthesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Myocardial Infarctions
Pulmonary Embolism
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with elective knee and hip endoprothesis

Brief summary: Summary: The purpose of the study is to prove if the biomarker high sensitive troponin T (hsTnT) and the biomarker of endogenous stress copeptin can serve as surrogate parameter of prognosis in patients with elective knee and hip total endoprosthesis.

Detailed description: Consecutively, high sensitive troponin T and copeptin will be measured in all patients with elective knee and hip endoprosthesis in the orthopedic department of the University of Heidelberg. The blood is taken during the routine blood testes if possible, on admission and the days 1-4 following the operation. Usual baseline characteristics are taken as well as usual blood results (hb, cholesterol and so on). Primary endpoint is the detection of perioperative myocardial infarction and pulmonary embolism.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with elective knee and hip endoprosthesis

Exclusion Criteria:

* Not willing or not able to take part in the observational trial
* No written inform consent

Primary outcomes:
measure: Prevalence of perioperative myocardial infarction and pulmonary embolism
timeFrame: Until 96h after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Heidelberg University
name: Evangelos Giannitsis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00896415: Interscanner Variation in Musculoskeletal Computed Tomography (CT) Measures
Official title: Inter-scanner Comparison of Muscle Attenuation Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accidental Falls
Loss of Muscle Strength
Keywords: on two models of CT scanner acquire CT images of the abdomen pelvis and midthigh in 20 Postmenopausal female volunteers
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this project we will study women 60-70 years old because they have the highest risk of bone fractures resulting from falls.

Brief summary: Maintaining strong muscles is important for the independence and quality of life in our older population. Strong muscles provide mobility and reduce the chance of falls that lead to injury. Many researchers are carrying out studies to examine different types of exercise and drug treatments to prevent loss of muscle strength in older people. Often, these research studies use x-ray computed tomography (CT) scans to measure the size and the amount of fat in different muscles. These factors are known to reflect muscle health. Large studies can involve many research subjects recruited at many different clinics with different CT scanners. To ensure that these studies provide reliable results, the investigators must have procedures to make sure that different CT scanners measure the same results for the same amount of fat or muscle. The goal of our study is to develop these procedures. In this project, the investigators will study women because they have the highest risk of bone fractures resulting from falls. Thus, the subjects are being asked to volunteer for a study where the subjects will be scanned on different scanners.


Eligibility criteria: Inclusion Criteria:

* age 60-70 years old
* healthy

Exclusion Criteria:

* no history of spine surgery
* no history of hip implantation or replacement
* no scoliosis or other spine deformity
* not using walking canes or wheelchair

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01662115: Nicotine Gum Recovery After Colorectal Surgery
Official title: Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Post-operative Ileus
Keywords: ILEUS
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative period influences surgical outcome in patients undergoing colorectal surgery.

Detailed description: The main hypothesis of this study is that use of nicotine gum after colorectal surgery will accelerate recovery of bowel function. Eligible patients include all patients undergoing segmental small bowel or large bowel resection with a planned primary anastomosis, planned removal of the nasogastric tube at the end of the surgery, and administration of clear liquids on post-operative day one. Patients who have an ileostomy or colostomy created will be excluded. Patients enrolled in the study will be randomized to one of three groups: nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will chew the gum three times a day for 1 week. The main outcome measure is time to first bowel movement or flatus.

Eligibility criteria: Inclusion Criteria:

* Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
* Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy;

Exclusion Criteria:

* Prior intestinal surgery
* Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
* American Society of Anesthesiologists (ASA) Class IV or V;
* History of abdominal carcinomatosis;
* History of radiation enteritis;
* Children \< 18 or adults \> 85 years of age
* Pregnant women
* Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than 3 months ago.
* Patients requiring postoperative ventilation, pressor requirement or ICU stay
* Patients with prior cardiovascular disorders

Primary outcomes:
measure: Bowel Function Recovery
timeFrame: 7 days
Secondary outcomes:
measure: Hospital Stay
timeFrame: 30 days
measure: Post-operative Vomiting
timeFrame: 30 days
measure: Use of NG Tubes
timeFrame: 30 days
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: ERIC G WEISS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05911815: Evaluation Of The Diagnostic Role Of Hysterosalpingography In Cesarean Scar Niche Diagnosed By Hysteroscopy
Official title: Evaluation Of The Diagnostic Role Of Hysterosalpingography In Cesarean Scar Niche Diagnosed By Hysteroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women undergoing Office Hysteroscopy at Early cancer Detection and Gynecological Endoscopy Unit at Ain Shams Maternity Hospital was checked to meet the inclusion criteria for the study.

Brief summary: The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. Hysterosalpingography is an important component in the diagnostic evaluation of the infertile woman. The number of hysterosalpingography examinations performed has significantly increased in recent years, likely due to the trend for women delaying pregnancy until later in life and the popularity of technical advances achieved in reproductive medicine.The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. The main purpose of the study is to evaluate the diagnostic role of HSG to early detect cesarean scar niche. To evaluate diagnostic role of hysterosalpingography (HSG) in cesarean scar niche at Early Cancer Detection and Gynecological Endoscopy Unit at Ain Shams Maternity Hospital within 6 months.


Eligibility criteria: Inclusion Criteria

* Age more than 18 years.
* Previous history of cesarean delivery.
* Cesarean scar niche confirmed by Hysteroscopy.
* Premenopausal status

Exclusion Criteria:

* Pregnancy.
* Contrast allergy.
* Active pelvic infection.
* Medical history interfering with HSG.

Primary outcomes:
measure: Cesarean section niche appearance
timeFrame: baseline, pre-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams U
Study officials:
References:
Clinical trial NCT03226015: Autologous Oral Mucosa Transplantation for Limbal Stem Cell Deficiency
Official title: Autologous Oral Mucosa With Amniotic Membrane Transplantation for Limbal Stem Cell Deficiency: Clinical and Immunohistochemical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limbal Stem-cell Deficiency
Keywords: Limbal Stem-cell Deficiency
Oral mucosa transplantation
Amniotic membrane
Mesenchymal stem cells
Lead sponsor: Klinikum Chemnitz gGmbH
Sponsor class: OTHER
Collaborators: name: Institute of Anatomy TU Dresden
First posted: 2017-07-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with oral mucosa with amniotic membrane transplantation in Klinikum Chemnitz 2015-2017

Brief summary: PURPOSE: To report clinical and histochemical results of oral mucosa graft transplantation in eyes with limbal stem cell deficiency.

DESIGN: Prospective observational study.

METHODS: 32 eyes of 27 patients with limbal stem cell deficiency underwent direct oral mucosa graft transplantation with amniotic membrane transplantation with a mean follow-up of 19 months. Clinical course of the disease including emergency surgeries, planned curative procedures, conjunctival inflammation, acute inpatient treatment and best corrected visual acuity were assessed at 3 months postoperatively and at last follow up visit. The unneeded parts of oral mucosa graft were analyzed immunohistochemically with staining for mesenchymal stem cell markers and pericytes (CD 90, CD 146, CD 166, CD 31, CD 68, protein gene product).


Eligibility criteria: Inclusion Criteria:

* limbal stem cell deficiency at least in one eye
* undergoing oral mucosa with amniotic membrane transplantation
* obtained written informed consent

Exclusion Criteria:

* no written informed consent

Primary outcomes:
measure: change in number of acute surgeries
timeFrame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
measure: change in days of acute inpatient treatment
timeFrame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
Secondary outcomes:
measure: change in number of curative surgical procedures after oral mucosa transplantation
timeFrame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
measure: change in conjunctival inflammation
timeFrame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
Other outcomes:
Locations:
Study officials:
affiliation: Klinikum Chemnitz
name: Katrin Engelmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03684915: Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals
Official title: Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Infection
Keywords: Rotary instrumentation
pulpectomy
primary teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the most important concerns in pediatric dentistry is the loss of necrotic primary molars leading to space loss. pulpectomies for primary teeth with severe pulpal involvement should be considered as the treatment of choice.

Bacteria plays an essential role in the initiation and perpetuation of pulpal and periapical disease. The investigator's target when cleaning and shaping the root canal system is to remove bacteria-containing tissue.

The removal of organic debris is the main purpose of instrumentation in pulpectomy procedures in primary teeth, this could be achieved using manual or rotary Ni-Ti files. A practical pulpectomy technique for the primary teeth should include the following:1) Fast procedure with short treatment time and minimal number of appointments.2) Effective debridement of the root canal without weakening the tooth structure or endangering the underlining permanent teeth.3) Minimal procedural complications. 4) Maintaining tooth function until it is naturally exfoliated.

Manufacturers using rotary files highlight their cleaning efficiency for root canal preparations, simple procedures, and decreased procedure time, which is especially important in children.

Considering that preparation time is an important clinical factor in pediatric patient management, the use of rotary instruments for pulpectomies in primary teeth is recommended.


Eligibility criteria: Inclusion Criteria:

* primary molars with fistula / chronic abscess
* teeth which if lost possibility of space maintainer construction exists
* pre-operative radiograph showing absence of severe root resorption

Exclusion Criteria:

* teeth with non-restorable crowns
* expected shedding time within one year

Primary outcomes:
measure: Resolution of fistula
timeFrame: 3 months
Secondary outcomes:
measure: assessment of tooth mobility
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05547685: Methylene Blue Intra-vital Nerve Staining
Official title: Harmonic Generation Microscopy Observation of Intradermal Injection Nerve Fibers by Methylene Blue Intra-vital Staining
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurologic Findings
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In previous studies, we know methylene blue (MB) stains nerves, and oxidized MB has near-infrared (NIR) fluorescence for fluorescent observation. In this trial we using MB on human skin and combining MB and third-harmonic generation imaging (THG) to label cutaneous nerve fibers.

Detailed description: Intravital images were obtained before injection and then taken at 0.5, 1, 1.5, 2, 2.5, and 3 h after intradermal 0.03% (0.3 mg/mL, 1500μM) MB (10mg/mL "Astar") injection using a 0.5-mL 29-gauge insulin syringe needle (Becton, Dickinson and Company, USA). The participant lay down and the skin was imaged 10 cm above the ankle in the lower leg and above the wrist in the middle forearm; three sites in each limb were randomly selected for each time point. SHG or THG captured MB signals with two-photon excitation microscope at the Molecular Biomedical Imaging Research Center of National Taiwan University.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers

Exclusion Criteria:

* used serotonin agonist medication

Primary outcomes:
measure: intravital staining
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hosipital
Study officials:
References: