cyrilzakka/clinical-trials huggingface dataset:
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (ADL) function. Improving outcome for this group may preserve some patients' ability to work and reduce community expenses.

During the last two decades less severe ankle fractures have been shown not to need operative treatment in general. The total number of ankle fracture surgeries has gone down. Therefore, surgically treated ankle fractures nowadays are on average more complex. The understanding of these injuries implies a recognition of the role of the deep deltoid ligament as a main stabilizer of the ankle joint. Deltoid ligament repair is documented to be a good option to regain ankle joint anatomy from smaller studies. This repair also compensates for syndesmotic injury to some extent. The effect of deep deltoid ligament repair in Weber B ankle fractures and its effect on long term function and arthritis is not yet known from clinical studies.

The investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures. This will be performed as a multicentre randomized controlled study.

Eligibility Criteria:
Inclusion criteria; fluent in oral and written Norwegian language

* isolated Weber type B fractures and Weber B+ posterior malleolar Mason Molloy class I.
* Initial medial clear space (MCS)\>=7mm or weightbearing x-ray evaluated as unstable or primary reposition after fracture dislocation.
* Pre-injury walking ability without aids.

Exclusion criteria

* assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
* previous history of ipsilateral ankle fracture or ipsilateral major ankle-/foot surgery.
* open fx Gustilo Anderson II or more, multi-trauma and pathologic fracture.
* neuropathies and generalized joint disease such as Rheumatoid Arthritis or other more severe condition in same extremity
* fixation of tibial fragment or syndesmotic screw or suture button
Fusion UltraSound Imaging Of the Thyroid GlaNd With I-124 PET. Evaluation of Nodule Allocation.

Regular thyroid diagnostics versus augmented thyroid work-up with additional I-124 PET/US fusion for metabolic-sonographic nodule allocation in patients with benign thyroid diseases


Eligibility Criteria:
Inclusion Criteria:

* patients with thyroidal nodules,
* euthyroidism
* Uptake \>0,5% on Tc-99m-pertechnetate- scintigraphy

Exclusion Criteria:

* thyroid medications in the last 6 months
* Iodine exposition in the last 6 months
* thyroid surgery or radioiodine therapy
Correlation of Cardiac Computed Tomography Angiography Dimensions and Ethnicity in Trinidad

The aim of this study is to compare coronary artery dimensions on Cardiac CT angiography amongst different ethnicities in Trinidad.

The aim of this study is to compare coronary artery dimensions on Cardiac CT angiography amongst different ethnicities in Trinidad.

Eligibility Criteria:
Inclusion Criteria:

1. CCTA for chest pain
2. All ethnicities
3. All genders

Exclusion Criteria:

1. Patients who did not provide consent.
The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)

We propose to determine the acute metabolic effects of intensive insulin therapy when administered to AKI patients with a particular focus on its effects on protein metabolism. We hypothesize that the degree of insulin resistance correlates with protein catabolism in critically ill patients with AKI, and that intensive insulin therapy will result in substantial reductions in both whole-body and skeletal muscle protein breakdown thereby improving overall protein balance. We also hypothesize that this therapy will have favorable effects on the inflammatory and oxidative stress profile of patients with AKI. The metabolic response to these interventions will be assessed through stable isotope infusion techniques, allowing for the most precise assessment of protein and energy homeostasis.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age admitted to the intensive care unit
* New onset acute kidney injury (AKI) or AKI superimposed on chronic kidney disease. AKI will be defined as:

  * an abrupt (within 48 hours) sustained increase (\>24 hours) in serum creatinine of 2X baseline or
  * a reduction in urine output (documented oliguria of \< 0.5 ml/kg/hr for \>12 hours)
* Patients will be recruited for the study within 3-5 days following establishment of AKI

Exclusion Criteria:

* Institutionalized patient
* Unable to obtain consent from subject or legally recognized representative
* Pregnancy
* Patients receiving insulin within 12 hours of the study or patients with known diabetes mellitus.
* Patients receiving immunosuppressive medication including steroids (prednisone or equivalent dose ≥ 5 mg PO QD)
* AKI from urinary tract obstruction or a volume responsive pre-renal state.
* Liver Failure, defined as transaminase levels 3 times above the limit of normal or a total Bilirubin greater than 4 mg/dl.
* Evidence of active bleeding, defined as admission for bleeding (ex. GI bleed, ruptured aneurysm, trauma-related) coupled with an explained or unexplained decrease in hemoglobin of \>2 points in the past 24 hours, or Hgb\<8/Hct\<24
* Ongoing myocardial ischemia or heart failure
* Life expectancy \< 48 hours
* Patients without existing central venous access
* Hemodynamically unstable patients requiring active pressor titration, defined as an increase in current pressor dose by \>20% or addition of a new pressor within 12 hours of initiating the study.
* History of Phenylketonuria (PKU) or other documented inborn errors of metabolism
* Hypokalemia, defined as a serum potassium of \<3.0 mg/dl.
* Uncontrolled seizure disorder, defined as having seizure as a reason for admission, ongoing delirium tremens, or having had a seizure within 1 month of the study.
Wear-documentation and Orthodontic Appliance Compliance

This randomized controlled trial aims to evaluate whether thermosensory wear-time documentation improves patient compliance of removable orthodontic appliances treated in a public health care clinic. The patients are children and adolescents.

Qualitative subjective evaluation of appliance wear comfort and compliance is recorded, in addition to objective wear-time documentations.

Eligibility Criteria:
Inclusion Criteria:

* orthodontic treatment with removable appliances planned

Exclusion Criteria:

* non-compliance to participate in the study
Functional Lumen Opening With Self-Forming Magnetic Anastomosis

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.

This is a multicenter, pivotal study in which clinical outcomes will be prospectively evaluated for a minimum of 70 subjects undergoing anastomosis creation using the Flexagon SFM system plus OTOLoc.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 22 years or older at screening
2. Candidate for laparoscopic small bowel surgery requiring small bowel anastomosis with cardiac/medical clearance for surgery
3. Able to understand and sign informed consent document
4. American Society of Anesthesiologists (ASA) score \< IV at time of procedure
5. Lives, and intends to remain, within a 185-mile radius of study center for the duration of the study
6. Able to refrain from smoking during study follow-up period

Exclusion Criteria:

1. Known or suspected allergy to silicone, nickel, titanium or Nitinol
2. BMI \> 55 kg/m2
3. Uncontrolled diabetes (defined as HbA1c \>10%)
4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation
5. Diagnosed with obstructed or perforated colon cancer
6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
8. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL
9. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis
10. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
11. Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
12. Active H. pylori infection
13. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
14. Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician
15. Contraindication to general anesthesia
16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
17. Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
18. Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis

This study will look at children with dehydration secondary to gastroenteritis requiring IV rehydration and determine whether the proportion rehydrated after two hours is greater in the children who receive rapid intravenous rehydration (RIVR) or in the children who receive standard IV rehydration.

Despite a movement toward increased use of enteral rehydration, many children still receive prolonged IV rehydration in the emergency department (ED). These children commonly receive a single IV bolus of normal saline followed by the administration of a hypotonic solution at a maintenance rate.

The mean time spent in the ED by children receiving IV rehydration is significantly longer than the mean time required to treat all other conditions. ED overcrowding has been associated with poor outcomes, prolonged pain and suffering, and dissatisfaction. One of the solutions proposed in the American Academy of Pediatrics Policy Statement on ED overcrowding is that hospitals should strive to improve the efficiency of the care provided. One small step in this direction may be to improve our management of gastroenteritis and dehydration.

Eligibility Criteria:
Inclusion Criteria:

* Acute gastroenteritis as determined by the supervising physician.
* Age greater than 90 days
* Dehydrated and unable to consume sufficient oral fluids to overcome their dehydration state

Exclusion Criteria:

* Weight less than 5 kg or greater than 33 kg
* Underlying disease which may limit the amount of IV fluids given,including but not limited to: hypoalbuminemic states, renal insufficiency, heart disease requiring pharmacotherapy or lesions that may predispose to congestive heart failure, hypertension, chronic lung disease (excluding asthma), diabetes mellitus, severe anemia, and chronic inflammatory disease
* Clinical suspicion by the attending physician of myocarditis or previously undiagnosed cardiac or renal disease.
* History of abdominal surgery or concern regarding an acute surgical abdomen
* Significant head, chest or abdominal trauma within the preceding 7 days
* Bilious or bloody vomitus
* Evidence of hemodynamic compromise (BP \< 80 + 2 \* age (yrs)) requiring \> 20 mL/kg 0.9% normal saline to be administered in the 1st hour
* Bedside glucose \< 2.8 mmol/L (see Section 8.3)
* Unable to provide a telephone number or unavailable for follow-up
* Previously enrolled in this trial
A Simple Intervention to Increase Persistence on PrEP in MSM to Improve Decision Making

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality that requires individuals to take a daily tablet to prevent themselves acquiring HIV. In South Africa while this is freely available in the public sector, persistence (that is continuation after initiation) is low amongst vulnerable populations, including men who have sex with men (MSM).

This study is a feasibility and acceptability study of a behavioral economics informed intervention to improve persistence amongst MSM newly initiating PrEP in South Africa. The goal of this study is to show that this approach is possible in a routine setting and gather the necessary data for a fully powered effectiveness trial.

Study participants will complete a baseline questionnaire and then be randomized to either receive standard of care (control) or to receive the intervention. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. The intervention package aims to address present bias, optimism bias and salience. The intervention is delivered and the enrollment visit and then through mobile phone reminders / text messages. There is no further in person interaction after the initial interaction. Participants may be contacted for a telephonic enplane questionnaire. Outcome data is obtained from passive followup through routine medical record review with the primary end point being persistence at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Not currently on pre exposure prophylaxis (PrEP); no PrEP within the last 12 months
* Initiating PrEP on the date of enrolment
* Access to a mobile phone
* Willing and able to provide written informed consent in English

Exclusion Criteria:

* PrEP status unknown
* Previous PrEP experience within the last year (12 months from enrolment)
Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm

Exclusion Criteria:

* Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
* Renal artery stenosis greater than 50 percent
Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.

The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.

According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples.

The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements.

Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.

The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.

Eligibility Criteria:
Inclusion Criteria:

General:

1. Male or female subject aged 18 years and above
2. Subject is able and willing to provide informed consent
3. Subject is able to complete the breath test.

   Arm A:
4. Requiring a diagnostic or screening RT-PCR test for COVID-19.

   Arm B:
5. Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.

Exclusion Criteria:

1. Male of female subject under the age of 18.
2. Subject is unable to provide and informed consent, for any reason.
Validation of Triggered EMG Values for Pedicle Screws Using a Powered Screwdriver

Previous studies have shown how triggered electromyogram (EMG) pedicle screw stimulation can be used to effectively test correct pedicle screw placement in the lumbar and thoracic vertebrae. Most papers agree that if more than 6mA of current are needed to elicit a response the screw is correctly placed in the bone. If there is a response with less than 6mA there is a strong likelihood of a breach of the pedicle wall or invasion of the spinal canal. Typically this triggered EMG stimulation is done after all the screws have been placed with a ball-tipped probe and is paired with intraoperative fluoroscopy to ensure correct placement of the screws. Another method of testing the current for each screw is with a powered screwdriver, which can stimulate and give a reading as the surgeon places each screw. Both of these methods are currently used by surgeons, however the powered screwdriver has been found to be a faster method. The investigator's aim with this study is to compare these two methods of testing triggered EMG values. The investigators plan on doing this by testing each screw with both the ball-tipped probe and the powered screwdriver, in order to see if there are any statistically significant differences between the readings.

The purpose of the study is to compare two methods of testing triggered EMG values. All study measurements will be recorded during the surgical procedure. No follow up is required with the patient involved and no personal health information will be recorded from the patients.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 8-21 years
* diagnosis of adolescent idiopathic scoliosis (AIS)
* scheduled to receive a spinal fusion

Exclusion Criteria:

* diagnosis of any other type of scoliosis (infantile, juvenile, congenital, neuromuscular, etc)
Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments

The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Weight within +/- 20% from normal for height and weight for body frame
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating
Paracetamol Route in Palliative Care Patients (PARASCIVPALLIA)

Background: Among palliative-care patients, subcutaneous route is often an alternative to intravenous route yet pharmacological and clinical data are lacking. Many French palliative crew are now using empirically paracetamol by subcutaneous route also there is no data to support this practice. The aim of the present study is to compare pharmacokinetics parameters between intravenous and subcutaneous route for palliative-care patients.

Methods/design: A randomized, open, crossover, bicenter study in two palliative care centers. The aim is to demonstrate the pharmacokinetic equivalence between the two routes of administration. Data analysis will be performed by Wilcoxn's signed Rank Test with an alpha risk of 5 percent. All adverse events will be reported for a safety analysis.

Discussion: This trial may permit, if a pharmacokinetic equivalence is established, to build randomized controlled trials to then assess the efficacy and tolerability of subcutaneous paracetamol administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old, hospitalized
* Patients in a palliative care situation
* Patients having an intravenous device with the presence of a venous reflux (be implantable venous site, picc-line, central track)
* Patients having a spontaneous pain, not related to care, with a numeric pain rate scale (NPRS) \> 3/10 or have a systematic prescription of paracetamol in the usual treatment
* Patients able to do an auto-evaluation of their pain by NPRS
* No contraindications of paracetamol
* No contraindications of alternative antalgic (low opioids, strong opioids, Non-steroidal anti-inflammatory)
* Possibility to not take paracetamol in the previous 24 hours before inclusion
* Patients with a blood test dating back less than 7 days, with no severe renal or hepatic failure
* Patients related with a French social security regime
* Patients accept to participate in the study, with written consent.

Exclusion Criteria:

* Patients under legal protection
* Patients who participate in another study less than 30 days before
* Patients weighing less than 50 kg
* Patients having a contraindication to subcutaneous route
* Pregnant or breastfeeding woman
* Patients who having a paracetamol administration less than 24 hours before the beginning of the inclusion
* Patients who having a low opioid less than 2 hours before or a strong opioid less than one hour before the beginning of administration of paracetamol
* Patients having a fever
* No possibility of communication
Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation

The study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls.

The study will use t2 weighted MRI, Near-infrared fluorescence imaging, and plethysmography to examine the above-mentioned question.

The study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls.

Subjects will be examined at one occasion using t2-weighted MRIs to evaluated lymphatic anatomy and Near-infrared fluorescence imaging for evaluation of superficial peripheral lymphatic function. Finally, the capillary filtration rate will be estimated using plethysmography.

Eligibility Criteria:
Patients:

Inclusion criteria:

* Patients with moderate to severe tricuspid regurgitation
* Age ≥18 years
* Informed consent

Exclusion criteria:

* Reduced ejection fraction (\<50%)
* Congenital heart disease
* Left sided valve disease
* MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)
* Claustrophobia
* Peripheral edema
* BMI\>30
* Age\<18.

Controls:

Inclusion criteria:

* Healthy
* Age ≥18 years
* Age, gender and weight matched with included patients.

Exclusion criteria:

* Cardiovascular disease
* MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)
* Claustrophobia
* Peripheral edema
* BMI\>30
* Age\<18.