louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02479009: Fluoroscopy vs. Computed Tomography for Diagnosis of Displacement and Instability of Acute Scaphoid Waist Fractures
Official title: Fluoroscopy vs. Computed Tomography for Diagnosis of Displacement and Instability of Acute Scaphoid Waist Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Scaphoid Waist Fractures
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Skane University Hospital
name: Ghaem Hospital
First posted: 2015-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim:

The aim of this study is to analyze if fluoroscopy is as accurate as computed tomography in diagnosing displacement of acute scaphoid waist fractures.

Primary null hypothesis:

Fluoroscopy has comparable sensitivity, specificity, accuracy, positive and negative predictive values compared with computed tomography for the diagnosis of displacement of acute scaphoid waist fractures.

Secondary null hypothesis:

All fractures diagnosed as non-displaced and treated without surgery are healed on radiographs and discharged from care within 6 months of injury.

Detailed description: The only confirmed risk factor for nonunion of a scaphoid waist fracture is displacement. There is consensus that displaced fractures should be treated with open or arthroscopically assisted reduction and internal fixation (ORIF). However, the optimal method to diagnose displacement is debated. Radiographic, computed tomography (CT), and arthroscopic diagnostic criteria for the diagnosis of displacement exist. There is no consensus regarding the imaging modality and measurements to use to diagnose scaphoid displacement. The definition of displacement in recent randomized trials is incompletely described and inconsistent. Fluoroscopy is more convenient, less expensive, and uses less radiation than CT scanning. If displaced fractures are unstable, then this should be apparent on fluoroscopy. The aim of this study is to analyze if fluoroscopy is as accurate as computed tomography in diagnosing displacement of acute scaphoid waist fractures.

Eligibility criteria: Inclusion Criteria:

* All patients (\>18 years) with a radiographically visible acute (\< 2 weeks since injury) scaphoid waist fracture will be included. The subject has to speak and write English or Spanish fluently to be able to provide informed consent

Exclusion Criteria:

* Pregnant women
* Women who are capable of becoming pregnant and not on birth control will be excluded due to the risk of pregnancy.

Primary outcomes:
measure: Accuracy of Fluoroscopy
timeFrame: Less than 2 weeks from injury date
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04089709: Well-arm Exercise in Distal Radius Fractures
Official title: Well-arm Exercise in Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Distal radius fracture
cross-education
immobilization
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
Primary purpose: TREATMENT

Brief summary: A single center randomized control study. Patients \>18 years with isolated distal radius fractures treated non-operatively will be randomly assigned to either the treatment group (exercise of contralateral "well" arm) or control group (standard fracture care and rehabilitation).

Detailed description: Distal radius fractures are common injuries, especially in the aging population. Fracture healing requires immobilization of the injury, which inevitably leads to muscle atrophy and joint stiffness. This strength lost during immobilization can be problematic in patients who are already de-conditioned at baseline. Previous research using healthy participants found that exercising a non-immobilized, "well", arm helped attenuate muscle atrophy in the contralateral immobilized arm. The study aims to answer the following questions: Does exercise of the contralateral arm prevent muscle atrophy and weakness of the injured arm? Does exercise of the contralateral arm improve pain scores in the injured arm

Eligibility criteria: Inclusion Criteria:

* Adults \>18 years with an isolated distal radius fracture treated non-operatively

Exclusion Criteria:

* Operative treatment, additional injures, previous injury to same arm, neuropathy or neuromuscular disease, dementia

Primary outcomes:
measure: Grip strength
timeFrame: 3 months
measure: Forearm Circumference
timeFrame: 3 months
Secondary outcomes:
measure: Pain scores of injured arm.
timeFrame: 3 months
Other outcomes:
measure: Wrist Range of Motion
timeFrame: 3 months
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital System
name: Stuart T Guthrie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01129609: Talent Converter Post-Approval Study
Official title: Talent Converter Post-Approval Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Aortic Aneurysms
Keywords: Post-approval observation of patients being treated according to the indications for use for the Talent Converter Stent Graft
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects who are treated with the Talent Converter Stent Graft according to the indications for use

Brief summary: The primary endpoint is successful secondary endovascular treatment with the Talent Converter stent graft of subjects having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated Stent Grafts, in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation.

Treatment success is defined as a composite of successful vessel access, successful insertion of the delivery system, successful deployment of the Converter stent graft at the intended treatment site and absence of Type I endoleak at the 1 month follow-up visit.

Detailed description: Converter PAS is an observational study. Patients will receive treatment regardless of study participation. In some cases, patients will be enrolled retrospectively, post implantation.

Eligibility criteria: Inclusion Criteria:

1. Subjects in whom a vessel access procedure was/will be performed with the attempted introduction of the Talent Converter Stent Graft for use according to the indications for use in the Instructions for Use (IFU) 0-365 days prior to enrollment.
2. Subjects who are able to understand the nature of the study and give voluntary informed consent.
3. Subjects who are available for follow-up visits.
4. Subjects 18 years of age or older.

Exclusion Criteria:

1. Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft other than (i.e., primary AUI) as a secondary endovascular intervention for patients having received prior endovascular repair with either a Talent or AneuRx bifurcated stent graft.
2. Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft as a secondary endovascular intervention for patients having received prior endovascular repair with a bifurcated stent graft other than (i.e., Cook Zenith or Gore Excluder) a Talent or AneuRx bifurcated stent graft.

Primary outcomes:
measure: Number of Subjects With Successful Secondary Endovascular Treatment
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06719609: Enovis High Ankle Sprain Brace Testing
Official title: Enovis High Ankle Sprain Brace Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Athletes in Cutting Sports
Keywords: syndesmosis
ankle sprain
ankle bracing
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Enovis Corporation
First posted: 2024-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if a new ankle brace impacts athletic motions. The main questions it aims to answer are:

* Does it impact motions such as running and cutting?
* Is it comfortable?

Researchers will compare 5 ankle bracing conditions.

Participants will:

* Perform a running activity
* Perform a cutting activity
* Complete a survey


Eligibility criteria: Inclusion Criteria:

* Age 18 to 40 at the time of data collection
* English-speaking
* Not currently pregnant
* No history of lower extremity surgery or chronic ankle instability
* No ankle injuries that required medical attention or ≥ 7 days of modified physical activity within the last 3 months
* Currently cleared for all physical activity
* Comfortable running on a treadmill for 10 minutes at a self-selected pace
* Have prior experience wearing an ankle brace and / or ankle tape during sport activities
* Shoe size US Men's 7.5-11.5 or Women's 9-13

Primary outcomes:
measure: Comfort of bracing condition - treadmill activity
timeFrame: 90 minutes
measure: Movement ability - treadmill activity
timeFrame: 90 minutes
measure: Ankle stability - treadmill activity
timeFrame: 90 minutes
measure: Likelihood of use during sport - treadmill activity
timeFrame: 90 minutes
measure: Comfort of bracing condition - shuttle test
timeFrame: 90 minutes
measure: Movement ability - shuttle test
timeFrame: 90 minutes
measure: Ankle stability - shuttle test
timeFrame: 90 minutes
measure: Likelihood of use during sport - shuttle test
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mikel Joachim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965809: Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD)
Official title: Double Blind, Placebo-Controlled Trial of THC as add-on Therapy for PTSD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Posttraumatic Stress Disorders
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stress Disorder (PTSD) is a chronic and debilitating anxiety disorder which is widespread in every social level and is very prevalent in outpatient and inpatient settings.

A recent open-label study showed that the synthetic cannabinoid receptor agonist Nabilone had beneficial effects abolishing or greatly reducing nightmares that persisted in spite of treatment with conventional PTSD medications. Furthermore, a big number of patients suffering from chronic PTSD report using smoked marijuana because its tranquilizing effect and sleep quality improvement. According to clinical and epidemiological data different derivates from the cannabis plant are illegally and pervasively consumed by PTSD patients in order to reduce distress.

The aim of the proposed study is to broaden the previous observations and to measure the extent to which Δ 9-THC will bring to significant improvement on the full spectrum of PTSD symptoms.


Eligibility criteria: Inclusion Criteria:

* Outpatients between the 19-60 years of age with a diagnosis of PTSD.
* Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study.
* Subjects must be on stable medication (4 weeks minimum) for their PTSD (symptomatic despite current treatment), must be able to provide written informed consent, must be able adequately understand and comply with the study's instructions and protocol .

Exclusion Criteria:

* Those not meeting the inclusion criteria and those not able to give informed consent.
* Women who are currently pregnant or nursing.
* Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness;
* currently abusing alcohol or drugs;
* currently being treated with an investigational medication or medication that is contraindicated with cannabinoids;
* have a known allergy to cannabis-based products.

Primary outcomes:
measure: Clinician Administered PTSD Scale
timeFrame: Baseline and end o ftreatment
Secondary outcomes:
measure: Nightmare Frequency Questionaire Score
timeFrame: Baseline Weeks 3 &6 (EOS)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT05986409: Indoor Artificial Light at Night and the Relapse Risk of Schizophrenia
Official title: The Role of Microbiota-gut-brain Axis as a Mediator in the Association Between Indoor Artificial Light at Night and the Relapse Risk of Schizophrenia: a Randomized, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Relapse
Light Pollution
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: A randomized crossover trial of ALAN intervention was conducted in patients with chronic schizophrenia in Anhui Mental Health Center from August 15 to September 30, 2022. All participants met the diagnostic criteria for schizophrenia in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). The enrolled patients were in the symptom-stable phase and were regularly prescribed antipsychotics (no change in medication regimen). The diets of all the participants were uniformly supplied during study. Patients with infectious diseases, eye diseases, or gastrointestinal diseases, or who used antibiotics at the time of recruitment, were excluded. The wards of the participants were all located in the same inpatient building. All included wards had the same size, layout, lighting and orientation of doors and windows. In normal conditions, each ward retains a small LED lamp (the same layout in all wards) at night as a source of lighting.

The study was divided into two stages. In the first stage, 10 wards were randomly selected as the intervention group (opaque black tape covering part of the light source), and another 10 wards were selected as the control group (no intervention). After a two-week washout interval, the second stage was carried out, with the two groups interchanging interventions. At the end of each intervention, participants completed a structured questionnaire scale to assess the relapse risk of schizophrenia, and then their fecal samples were collected.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia
* Regularly taking antipsychotics

Exclusion Criteria:

* Infectious diseases
* Gastrointestinal diseases
* Using antibiotics

Primary outcomes:
measure: Relapse risk
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Cognitive function
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Weizhuo Yi
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Rubing Pan, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01123109: 3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females
Official title: 3-D Endoanal Ultrasound: Normative Anatomy of the Anal Sphincter in Nulliparous Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal (no Known Injury) Anal Sphincter Female Anatomy
Keywords: nulliparous women
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this research study is to measure the muscles that make up your anal sphincter (muscles that control bowel movements) by using ultrasound. The most common way for women to injure these muscles is through childbirth. Some physicians think about 30% of women delivering their first baby develop some anal sphincter damage, which may or may not lead to symptoms such as anal urgency or incontinence (involuntary loss of gas or stool). The purpose of the study is to measure muscles in normal women who have never given birth or had an injury to their anal sphincter.

Detailed description: Participants will be asked to complete a one page questionnaire. This questionnaire will address whether perineal trauma, sphincter lacerations, anal incontinence, and fecal urgency impact the subject on any level. Subjects will also be asked about their bowel habits and history of problems with bowel movements. Subjects will then be asked to undergo an ultrasound study of the anal sphincter at the time of enrollment. Completing the entire study will take no more than 15 minutes. This will be done at the doctor's office. Answering the questionnaire will take no more than 5 minutes.

The endoanal ultrasound is a probe with a diameter equivalent to the index finger. It is inserted in the rectum and measures the length and width of the sphincter muscles.

Eligibility criteria: Inclusion Criteria:

* nulliparous women over the age of 18.

Exclusion Criteria:

* any history of anal incontinence, chronic constipation, anorectal disease or trauma, neuromuscular or neuropsychiatric disease, diabetes, gastrointestinal disorders, or previous anorectal or pelvic surgeries.

Primary outcomes:
measure: To establish normative data for the anal sphincter complex in asymptomatic nulliparous females without sphincter disruption sphincter.
timeFrame: 15 minute exam
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCI Women's Healthcare
state: California
Study officials:
affiliation: UCI Medical Center
name: Karen Noblett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05886309: Measurement of Serum Ferritin With a Cryo Detector Mass Spectrometer (CDMS)
Official title: Measurement of Serum Ferritin With a Cryo Detector Mass Spectrometer (CDMS): Pilot Study and First Experience in Testing Human Serum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serum Ferritin
Keywords: Cryo Detector Mass Spectrometer
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Metromol SA
First posted: 2023-06-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cohort will include 20-25 experienced blood donors (not first-time donors) distributed among three groups according to SF values obtained from at least two previous measurements:

* low SF levels: \< 20 ng/ml
* normal SF levels: 50-200 ng/ml (women) or 50-300 ng/ml (men)
* high SF levels: \> 200 ng/ml (women) or \> 300 ng/ml (men)

Brief summary: The study will explore the performance of the CDMS (Cryo Detector Mass Spectrometer) method in measuring SF (serum ferritin) in human serum of healthy individuals. This will be the first experience of testing SF with this method using biologic material of human origin.

Detailed description: A clear interpretation of hyperferritinemia is difficult in many clinical situations. Crucial for the correct treatment of patients is the differentiation between reactively elevated ferritin and effective iron overload.The measurement methods that are routinely used provide quantitative results of the measurement of total ferritin molecules independent of their actual iron content.With a modified mass spectrometric method (CDMS), this should be possible.

In this study the investigators would like to apply this measurement technique for the first time with human serum as the investigators would like to test healthy blood donors with known normal, low or elevated ferritin levels.

Eligibility criteria: Inclusion Criteria:

* age 18-75 years
* SF (serum ferritin) values known from a previous determination that must not be older than twelve months and not followed by a blood donation
* fulfillment of the eligibility criteria for blood donation
* negative serology for HBV (hepatitis B virus), HCV (hepatitis C virus), HIV (human immunodeficiency virus) as assessed in the context of a blood donation

Exclusion Criteria:

* acute illness
* chronic inflammatory disease

Since pregnancy is a contraindication for blood donation, no pregnant women will be included in the study.

Primary outcomes:
measure: Assessment of the mass of serum ferritin molecules (kDa)
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Laura Infanti, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: