cyrilzakka/clinical-trials huggingface dataset:
Design of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures

The primary aim of the study is to create a model; in order to examine the effects of neural trauma in patients that are healthy individuals, induced by controlled nasal fractures during rhinoplasty, and the regeneration process in the weeks/months that follow. This study includes monitoring of subjective nasal symptoms with a visual analogue scale (VAS) score, peak nasal inspiratory flow (PNIF) measurements, collection of nasal secretions and nasal provocation (response to capsaicin and cold dry air (CDA) exposure).

The investigators will set up a prospective mono-center study. The investigators will utilize objective and subjective parameters in order to assess trigeminal nerve function at the level of the nasal mucosa before and after septorhinoplasty (as a model of controlled nasal fractures). The subjective parameters involve a visual analogue scale (VAS) score for each individual nasal symptom (nasal obstruction, facial pain/pressure, headache, rhinorrhea, sneezing, pruritus, post nasal drip, and loss of smell). An objective assessment includes measurement of PNIF (Peak Nasal Inspiratory Flow), the presence of neuropeptides in nasal secretions, (by introducing merocels and removing them 5 minutes later), short cold dry air (CDA) provocation and capsaicin provocation with subsequent measurements of PNIF and VAS scores and neuropeptides.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing septorhinoplasty, with planned bilateral osteotomies
2. No rhinological symptoms/complaints (rhinorrhea, sneezing, itchiness, nasal obstruction)
3. Age \> 18 and \< 65 years
4. Written informed consent
5. Willingness to adhere to visit schedules
6. Adequate contraceptive precautions in female patients with childbearing potential

Exclusion Criteria:

1. Age \< 18 and \> 65 years
2. Patients with nasal symptoms at baseline, defined as having more than 2,5 on VAS score

   for individual nasal symptoms related to mucosal pathology
3. Nasal endoscopic signs of inflammatory pathology (rhinitis, rhinosinusitis with/without

   nasal polyps)
4. Use of systemic steroid treatment, intranasal steroid treatment, oral leukotriene antagonists

   or long acting antihistamines?
5. Asthma
6. Pregnancy or breastfeeding
7. Any disorder of which might compromise the ability of a patient to give truly informed

   consent for participation in this study.
8. Enrollment in other investigational drug trial(s) or is receiving other investigational

   agent(s) for any other medical condition.
9. Contra-indications for local anaesthesia (Cocaine 5%)
10. Smoking
11. Systemic disease with lesions in ENT domain
12. Malignancies or severe comorbidity
Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease

Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to ischeamia heart disease (IHD). Most of the attention in treating IHD in type 2 diabetes is understandably directed toward treating coronary artery conditions. However there are other treatable culprits in these patients.

Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with IHD, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel coronary disease or impaired left ventricular function. Regression of LVH has been associated with an improved prognosis, independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with IHD might will be reduced if we can find novel therapies to regress LVH.

Pioglitazone can improve atherosclerosis. Therefore, we hypothesied that pioglitazone can regress the left ventricular mass (LVM) in type 2 diabetes with IHD.Therefore, in this study, we will treat patients with pioglitazone, and we will also metformin as control.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* aged 40～75 years old
* with IHD

Exclusion Criteria:

* heart failure
* renal failure
* hypertension (\>130/80 mmHg)
* hemoglobin A1c 9%
Partnership in Resilience for Medication Safety (PROMIS)

The trial is to assess the impact of two patient partnership tools: (1) a one-page 'visit prep guide' given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making; and (2) a series of short educational videos that clinic staff can encourage patients to watch.

Preventable patient harms from medications are significant threats to patient safety in ambulatory and community settings and contributed 700,000 emergency department visits each year. More than a third of community-dwelling 65 years or older adults take 5 or more prescription medications. In ambulatory and community settings, more so than in inpatient settings, medication safety is shaped by interactions among patient/caregivers and different professionals across locations. We developed a set of patient partnership tools to encourage and empower patients to make use of their office visits through setting expectations of information sharing, learning basics of medication self-management, and working with community pharmacy resources. The trial will be conducted at private and safety-net primary care clinics to assess the impact of the partnership tools: 1) a one-page 'visit prep guide' given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making; and (2) a series of short educational videos that clinic staff can encourage patients to watch. A step-wedge design will be used, with medication use self-efficacy as the primary outcome, as measured by a validated tool. Secondary outcomes are issues identified by medication review.

Eligibility Criteria:
Inclusion Criteria:

* Community dwelling (e.g., not in skilled nursing facilities)
* Age 50 years or older
* Taking 5 or more medications
* English or Spanish speaking

Exclusion Criteria:

* Non-English and non-Spanish speaking
* Impaired decision making capacity
* Non-consenting
Oxford Partial Knee Kinematics Gait Analysis Study

The objective of this study is to compare the effect on gait of unicompartmental knee arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.


Eligibility Criteria:
Inclusion Criteria:

* Patients with medial knee compartment arthritis

Exclusion Criteria:

* Patients with diagnoses other than osteoarthritis (i.e., rheumatoid arthritis, psoriatic arthritis, etc.)
* Patients with significant diseases of other joints of the lower extremity
* Patients with a diagnosed disorder with gait disturbance (e.g. lower extremity weakness, prior lower extremity arthrodesis, diagnosed movement disorders, etc.).
The STAR Prospective Clinical Series

Prospective clinical series to gather post tumor ablation clinical outcomes from subjects with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.


Eligibility Criteria:
Inclusion Criteria:

* The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Exclusion Criteria:

* The device is contraindicated in subjects with heart pacemakers, or other electronic device implants.
* The device is contraindicated in vertebral body levels C1-7.
Impact of Crutch Type on Gait and Functional Outcomes Post-knee Surgery

Study withdrawn

Study withdrawn

Eligibility Criteria:
Inclusion Criteria:

* Subjects 45-75 years old planning to get their first total knee replacement
* Subjects 18-45 years old planning to get their first anterior cruciate ligament reconstruction

Exclusion Criteria:

* Previous injury to shoulder, elbow, or wrist
* Current pain in shoulder, elbow, or wrist
* Inflammatory arthritis (i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis),
* History of cerebral palsy, stroke, significant cognitive impairment, or significant visual impairment
* Problems with the heart or lungs
* Currently using a crutch or crutches, walker, or other gait aid
* History of using a crutch or crutches for 4 or more weeks
* Inability to communicate in English
* Current smoker
* Currently pregnant
A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery

Pain after ambulatory surgery remains an unsolved problem in The United States and Europe. It is associated with delayed hospital discharge and it can result to an increased opioid consumption with adverse side effects. The concept of multimodal analgesic technique was introduced more than 15 years ago and several techniques have been studied over the years including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids, ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal nociceptors and C-fibers, producing pain which is further increased by neurogenically mediated release of substance P from afferent pain fibers. Several non-selective or H1 -selective histamine receptors antagonists have been demonstrated in animal models and clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing properties without adverse sedative effects in patients undergoing abdominal hysterectomy.

Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative pain and other important outcomes after ambulatory surgery such as time to meet discharge criteria have not being studied.

The MQOR 40 is a validated instrument that was specifically design to evaluate patient recovery after anesthesia and surgery. This instrument can be particularly valid to examine interventions which affect different spheres of patient recovery as is the case of diphenhydramine. The objective of this study is to determine a dose response effect of preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery. The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease postoperative pain, opioid consumption and opioid related side effects after ambulatory surgery.

The research question: Does a preoperative dose of diphenhydramine improve postoperative quality of recovery after ambulatory surgery? The hypothesis of this study is that preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and vomiting (PONV), sleep which will translate in a better overall quality of recovery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-64 years
* Patients undergoing ambulatory surgery
* ASA PS I, II.

Exclusion Criteria:

* Chronic opioid use
* pregnant patient or lactating patients
* allergy to diphenhydramine
* glaucoma
* uncontrolled hypertension
* asthma
* hyperthyroidism
* cardiovascular disease
Assessment of Novel Biomarkers in Participants Undergoing Targeted Lung Health Checks

Low-dose CT (LDCT) screening for lung cancer (LCS) has been shown to reduce lung cancer specific mortality in multiple randomised controlled trials. However, although LDCT screening has been demonstrated to reduce cancer- specific mortality, there remain outstanding questions regarding how screening can be implemented. In particular, indeterminate nodules are common, and can be challenging to distinguish from benign nodules on CT appearances alone. Furthermore, distinguishing cancers which are likely to become clinically significant from those that will remain indolent is challenging, but essential to prevent over-treatment and overdiagnosis. There is significant interest in using a multi-modal approach to LCS, incorporating biomarkers obtained from minimally-invasive samples alongside LDCT to improve ability to recognise clinically-significant lung cancers at an early stage.

The Targeted Lung Health Check (TLHC) programme is an NHS programme with the aim of using LDCT screening in appropriately high-risk individuals to improve early diagnosis and survival in lung cancer. The North Central London TLHC programme started in December 2022.

The purpose of the ALPINE study is to develop a platform to allow collection of minimally-invasive samples from participants undergoing screening within the North Central London TLHC programme. The use of such biomarkers in the diagnosis of lung cancer is a rapidly developing field and novel techniques and technologies are continuously under development. The ALPINE study will generate a cohort with matched biosamples, CT scans and clinical data which will be uniquely well placed to serve to develop or validate biomarkers in lung cancer screening and risk prediction.


Eligibility Criteria:
Inclusion Criteria:

* Attended one of more visits as part of the NCL NHS TLHC programme
* Adults aged between 55 years and 74 years and 364 days
* Have capacity and can provide written consent

Exclusion Criteria:

* Declines participation in ALPINE
* Lacking capacity and unable to provide written consent
* Patients who are considered by the clinician to be unfit/not suitable for enrolment in ALPINE
Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

Patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. All subjects were inpatients. Subjects were randomized into two groups. patients in group A were first treated with HFNC on top of conventional treatment, and after 24 hours, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. patients in group B were treated with a non-invasive ventilator on top of conventional treatment, and after 24 hours of treatment, patients were treated with HFNC until discharge. Patient information was collected during treatment.

Patients who met the inclusion criteria were included and signed the informed consent, which met the requirements of the ethics committee of our unit. All subjects were hospitalized patients. Subjects were randomly divided into two groups. Patients in group A were treated with HFNC on the basis of conventional treatment. The initial parameters were: temperature:31-37℃, flow: 30-40l /min, SpO2 \> 92% maintained, the oxygen concentration was adjusted according to the patient's oxygen saturation, and the treatment time was 24h. Twenty-four hours later, the patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. On the basis of conventional treatment, patients in group B were given a non-invasive ventilator with the following initial parameters: BiPaP mode, initial inspiratory pressure (IPAP) of 8-15cmH2O, initial expiratory pressure (EPAP) of 4-8cmH2O. The parameters were adjusted according to the specific conditions of the patients. After 24 hours of treatment, the patient was treated with HFNC until discharge. Patient information was collected during treatment.

Eligibility Criteria:
Inclusion Criteria:

1. . PaO2 \< 60mmHg, SpO2 \< 92%(without oxygen inhalation);
2. Mild to moderate type I respiratory failure (100 mmHg \< PaO/Fi02≤300 mmHg);

Exclusion Criteria:

1. Missing primary outcome measures
2. Terminal stage of various chronic diseases;
3. The patient or family members do not agree to NIV or HFNI treatment;
4. Severe type I respiratory failure (PaO2/Fi02≤100 mmHg)
5. Ventilation dysfunction (pH\<7.30)
6. Contradictory breathing
7. The patient abandons or terminates treatment, automatically discharges or transfers to another hospital;
8. Serious diseases, such as organ function damage and sepsis;
A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery

The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing DBS
* Diagnosis of clinically established or clinically probably PD as defined by MDS criteria
* Age 45-75, inclusive
* Able to tolerate the surgical procedure
* Able to undergo all planned assessments
* Available access to the sural nerve

Exclusion Criteria:

* Any condition that would not make the subject a candidate for DBS
* Dementia diagnosis
* Previous PD surgery or intracranial surgery
* Unable to undergo an MRI
* An obstructed trajectory path to the substantia nigra and nucleus basalis of Meynert
Evaluation of Quality of Vision and Spectacle Independence With the AcrySof® Panoptix® Intraocular Lens

This is a study to assess the spectacle independence and quality of vision of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility Criteria:
Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option
* Gender: Males and Females.
* Age: 40 or older.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
* Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or a toric IOL in the approved ranged for the Panoptix lens.
* Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Irregular astigmatism (e.g. keratoconus)
* Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
* Monocular status (e.g. amblyopia)
* Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
* Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
* Diabetic retinopathy
* Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
* History of retinal detachment
* Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
* Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System

The zLOCK Facet Stabilization System is a fixation device intended to provide posterior stability in the lumbar spine fusion procedure. The system can be placed either as an adjunct to an inter-vertebral anterior cage or as stand-alone with/ without additional decompression of the dural sac or nerve roots as appropriate for the specific patient and surgeon's discretion. The zLOCK implant is placed inside the facet to stabilize the motion and enhance the bony fusion of the joint. The zLOCK Facet Stabilization System is intended for single-level stabilization of a spinal motion segment in order to promote bony fusion of the joint. The zLOCK system is indicated for use from L1-L2 to L5-S1 joints.

The zLOCK implant is inserted into the facet joint space while adapting to the joint's changing geometry. Stabilization is achieved by a firm grip of each joint bone and resisting any relative motion. The zLOCK implant is placed percutaneously and requires only one incision per side, thereby reducing the invasiveness procedure duration and shortening the recovery period.

This pivotal study was designed in order to assess the safety and effectiveness of the zLOCK system.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is scheduled for spine surgery with at least one of the following:

   * Degenerative Spondylolisthesis grade 1;
   * Mild to Moderate stenosis;
   * Degeneration of the facets.
2. When used stand-alone disc height should be maximum 50% of the adjacent disc height.
3. 18\< Age \<75
4. Weight \< 100Kg
5. Signed informed consent form
6. At least 3 months of unsuccessful conventional treatments

Exclusion Criteria:

1. Fusion procedure performed or required in more than one motion segment.
2. Acute or chronic spinal infections.
3. Osteoporosis when used in adjunct to an anterior interbody cage (DEXA \< -2.5).
4. Absence of posterior spinal elements including the pedicle, pars interarticularis, facet joints, spinous process and the majority of the lamina which make it unstable or not possible to place.
5. Any entity or conditions that totally preclude the possibility of fusion, i.e. cancer or kidney dialysis.
6. Obesity (BMI ≥30)
7. Unilateral application of device, except in combination with anterior interbody cages.
8. Known sensitivity to Titanium.
9. Alcoholism, or drug abuse
10. Subject with a cardiac pacemaker or other implanted electro medical device
11. Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)
12. Concurrent participation in another clinical trial using any investigational drug or device.
13. Mental disorders.
14. Tumor
15. Fracture or other instabilities of the posterior elements.