cyrilzakka/clinical-trials huggingface dataset:
Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis

The goal of this study is to perform a feasibility study to show the effectiveness of the genicular artery embolization procedure in reducing bilateral or unilateral osteoarthritic knee pain at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index.

This is a single-center, pilot study to assess the feasibility of a study show the effectiveness of the genicular artery embolization (GAE) in reducing arthritic pain and dysfunction associated with mild to moderate Bilateral or unilateral osteoarthritis of the knee. Patients with bilateral or unilateral Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale, will be offered enrollment to the study. Following a screening questionnaire, these patients will then be enrolled in this study. Baseline MRI will be obtained prior to the GAE procedure. Follow up intervals will include 3, 6, 9, and 12 months with the primary objective measured by a clinician as the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index at the 12-month follow up visit. Patients will also undergo 1 year follow up MRI to be interpreted by a diagnostic radiologist with subspecialty training in musculoskeletal radiology. This radiologist will compare the treated knee to the baseline screening according to the WORMS classification (Whole Organ Magnetic Resonance Scoring) to assess for radiologic changes of osteoarthritis and any adverse effects.

Eligibility Criteria:
Inclusion Criteria:

We intend to include patients who meet the following criteria in the study:

1. Patients aged 40-80
2. Bilateral or Unilateral knee pain attributed to osteoarthritis
3. Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale
4. Knee pain \>6 months refractory to conservative medical management (NSAIDs, paracetamol, intra-articular injections, physiotherapy/exercise, weight loss, etc.)

Exclusion Criteria:

* We plan to exclude patients who meet any of the following criteria:

  1. Active malignancy
  2. Active infection of the affected knee
  3. Platelets \<50,000
  4. INR \>1.8 (unless on anticoagulation that can be reversed)
  5. Corticosteroid injection of the affected knee within 3 months
  6. Rheumatoid arthritis or other seronegative arthropathy
  7. Previous surgery (excluding arthroscopy) of the affected knee
  8. Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee
  9. Pregnancy or expected pregnancy
  10. GFR \<30
  11. Anaphylactic reaction to iodinated contrast
  12. Moderate to severe pain in other lower limb joints
  13. Body weight \>400 lbs. (Procedure table weight limit)
  14. BMI \>50
  15. Patients at high risk for contrast nephropathy
Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information in healthy adult smokers switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2) as compared to subjects continuing smoking cigarettes (CC) in a confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged ≥ 28 years.
* Subject is Caucasian.
* Subject is healthy, as judged by the Investigator.
* Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
* Subject has smoked at least for the last 10 years.
* Subject does not plan to quit smoking in the next 6 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.
Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis

The retinal vessels have been shown to reflect vascular changes inherent to systemic pathologies, even when no ocular disease is identified. As such, the eye's vasculature is ableto serve as a window to the vascular health of the human body and a means of assessing systemic endothelial function. Optical coherence tomography angiography (OCTA) employs optical means to image all the retinal vascular layers and the choroid, providing an extremely detailed image of the microvascular network in a fast, reproducible and totally non-invasive way. As such, it is currently the best non-invasive way of having an image of human capillaries. Recently, OCTA has been used to study the retinal vessels' structure and function in several cardiovascular diseases. As an example of its predictive potential, reduced retinal microvascular density has been associated with the cardiovascular risk profile in patients admitted to the hospital for an acute coronary syndrome. Recent studies have also shown the retinal microvasculature density to be reduced in patients with carotid artery disease (CAD), namely carotid stenosis, and that endarterectomy increases retinal flow and vessel density.

The authors hypothesize that FGF-23, GDF-15, VEGF-A, MMP-9 and retinal/choroidal microvascular density could predict cerebral ischemia, postoperative complications, long term major cardiovascular events and short term ophthalmologic alterations particularly in patients developing symptomatic neurologic ischemia after circulation shutdown.

The purpose of this study is to compare different cardiac risk scores in carotid endarterectomy. The main aim of this study is to test the risk factors individually and determine its discriminatory ability. Combinations of traditional preoperative risk factors and scores will be evaluated to enhance the assessment of major adverse cardiac events in vascular surgery patients.

Establish and validate biomarkers that improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive carotid stenosis

Exclusion Criteria:

* blind patients
* Radic stenosis
Digital Reminiscence for People With Dementia

The purpose of this study is to explore the feasibility and acceptability of a digital reminiscence therapy (DRT) intervention for people with dementia (PwD). The objectives of this study include:

1. To determine whether DTR can be delivered as planned in the care of PwD in Jordanian care homes.
2. To determine whether DTR is acceptable/tolerable to PwD and care home staff in Jordanian care homes
3. To identify the most appropriate outcome measures to evaluate the delivery of DRT to PwD in Jordanian care homes to be used in a subsequent definitive trial.

Reminiscence Therapy has been shown to be beneficial for people with dementia. The aim of this research is to develop and evaluate the feasibility of a digital application to aid reminiscence for people with dementia.

This study proposes to design an application, based upon reminiscence therapy, which can act as storage for personal and communal 'positive memories' in a range of media types. This includes pictures, videos and audio.

The target for this application is people with dementia and their staff caregivers. The study aims to recruit 40-50 participants (40 PwD and 10 staff caregivers). This research will look at the requirements for developing and evaluating a mobile application to see whether it might be used to aid reminiscence for people with dementia. Additionally, this research will ensure whether this digital reminiscence therapy can be delivered and accepted as planned in the care of people with dementia in Jordanian care homes. The acceptance of this digital reminiscence therapy will be assessed by using semi-structured interviews with approximately 15 people with dementia and staff care-givers. Quantitative measures will be used before and after the intervention to explore whether certain outcomes are sensitive to change. These outcomes include memory, communication, anxiety, depression, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* People who have been clinically diagnosed with dementia determined by psychiatrist in the selected care homes. The diagnosis will be recorded in their care home notes.
* People who are residents in the designated care home and they are anticipated to be resident in the care home for the coming year.
* People who have the capacity to understand and consent to participate in the study (including those who can consent in the moment), OR they will have a consultee who can be approached for their assent if they are not able to consent in the moment but meet the eligibility criteria.

Exclusion Criteria:

* People who are deemed too unwell to participate determined by care home staff.
* People with a diagnosis of an additional psychiatric disorder other that those identified in the inclusion criteria (e.g. schizophrenia, MDD) determined by care home staff.
NSAIDS Versus Opioids in Acute SER II Ankle Fractures

This study is being conducted to evaluate whether NSAIDS are more or less effective in bone healing than opioids in acute fracture pain. Participants will be randomized to one of three groups for first line treatment of pain related to the fracture.

Pain management in acute fractures is challenging and influenced by several factors contributing to pain perception. These factors include but are not limited to tissue damage by the local impact, mechanical stress at the fracture ends, and central perception of the noxious stimulus. Tissue damage and mechanical stress leads to inflammation and further to local swelling. Swelling itself is significant contributor in pain development.

Ideal pain management would attack pain development at most sites possible. The current clinical practice in the US applies a derivate of an opioid analgesic combined with acetaminophen, thereby influencing pain development at central perception by the opioid analgesic and acetaminophen and a peripheral analgesic effect of acetaminophen. The exact mechanism of the peripheral effect is not known.

This clinical practice disregards the positive effect of medications influencing the peripheral inflammatory response, namely nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs affect pain development by blocking the synthesis of arachidonic acid metabolites, inhibiting peripheral inflammatory response and central pain perception. The major reason for not applying NSAIDs in the treatment of acute fracture pain is an experimental animal study showing decreased bone healing in relation to NSAID usage.

However, clinical data thus far is inconclusive, whether bone healing is affected in humans and whether NSAIDs should be avoided in the setting of bone fractures.

This proposed study will give an answer whether the usage of NSAIDs in acute fractures has a negative effect on bone healing.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 to \< 60
* Isolated ankle fracture type SER II
* Ability to speak and understand English
* BMI\< 35

Exclusion Criteria:

* ASA\>3
* Previous or acute gastric bleeding
* Renal insufficiency (Creatinine: \>1.27mg/dl)
* Liver insufficiency (Child-Pugh-Wert: 10-15)
* Malignant tumor
* Rheumatoid arthritis
* Heart failure (NYHA III-IV)
* High frequency absolute arrhythmia
* Patients with known psychiatric illness
* Coagulopathy
* Asthma
* Function limiting disease of the lower extremity, besides what is mentioned in the inclusion criteria
* Adults unable to consent
* Pregnant women
* Prisoners
* Workers Comp patient
* Early fracture displacement (within first 2 weeks) indicating need for surgery
* Polytrauma
* Concurrent participation in another clinical trial
Efficacy of Nyaditum Resae(R) Against Active TB in Georgia

The use of a supplement food like "Nyaditum resae" is a reliable opportunity to stop the progression towards active TB through the most updated knowledge of this disease:the induction of tolerance.

In order to demonstrate the percentage of efficacy of this approach, different studies must be run to elucidate the percentage of protection in different setting all over the world. The strategy is to establish its efficacy through a simple clinical trial, aimed just to know the incidence of TB in Placebo and NR treated contacts of active TB cases.

Evaluation of a supplement food "Nyaditum resae" in the uincidence of TB. This is a ranzomized doube-blind controlled clinical trial to evaluate the efficacy and safety of a supplememt food in comparison to placebo in TB.

Eligibility Criteria:
Inclusion Criteria:

1. Have completed the written informed consent process prior to undergoing any screening evaluations.
2. Have ability to complete follow-up period as required by the protocol.
3. Willing to allow the investigators to discuss the subject's medical history with the subject's health care provider.
4. Close contact of an active TB case not eligible for chemoprophylaxis.

Exclusion Criteria:

1. Investigator assessment of lack of understanding or willingness to participate and comply with all requirements of the trial protocol.
2. Any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results on the effects of the vaccine.
3. Being eligible for chemoprophylaxis (children of \<5 years old and HIV-positive adults)
4. Pregnancy or lactation
5. Hypersensitivity to mannitol
6. Suffering active TB
A Gene Transfer Study to Evaluate the Safety, Tolerability and Efficacy of SRP-6004 in Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2B/R2 (LGMD2B/R2, Dysferlin [DYSF] Related)

The primary purpose of this study is to evaluate the safety of SRP-6004 administered by intravenous (IV) infusion in ambulatory participants with LGMD2B/R2 (DYSF related).


Eligibility Criteria:
Inclusion Criteria:

* Possess 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic DYSF Deoxyribonucleic acid (DNA) gene mutations as documented prior to screening visits.
* Participants must be ambulatory per protocol specified criteria.
* Ability to cooperate with motor assessment testing.
* Has accessible and intact lower and upper extremity musculature for biopsy.
* Have adeno-associated virus rhesus serotype 74 (rAAVrh74) antibody titers \< 1:400 (that is, not elevated) as determined by enzyme-linked immunosorbent assay (ELISA).

Exclusion Criteria:

* Exposure to gene therapy, investigational medication, or other protocol-specified treatment within the protocol specified time limits.
* Abnormality in protocol-specified diagnostic evaluations or laboratory tests.
* Presence of any other clinically significant illness, medical condition, or requirement for chronic drug treatment that in the opinion of the Investigator creates unnecessary risk for gene transfer.

Note: Other inclusion or exclusion criteria could apply.
Lianhua Qingwen for the Rehabilitation of Patient With Coronavirus Infection

The patients with coronavirus infection usually have fever, respiratory symptoms, headache, toothache, muscle soreness, physical decline, and so on, while others are asymptomatic patients. It is urgent to find drugs to improve the long-term rehabilitation of symptomatic patients with coronavirus infection and decrease the duration of viral shedding in both symptomatic and asymptomatic patients. This study aims to investigate the efficacy and safety of Lianhua Qingwen capsules in patients with coronavirus infection. The duration of viral shedding and symptoms before discharge, as well as the negative conversion ratio and disappearance ratio of main symptoms after 7-day treatment, will be evaluated. 6-month follow-up will be performed to evaluate the effect of Lianhua Qingwen on all infection events and the long-term rehabilitation of the symptoms induced by coronavirus infection.


Eligibility Criteria:
Inclusion Criteria:

* confirmed SARS-CoV-2 Infection by virus testing;
* ≥18 years of age;
* informed consent provided.

Exclusion Criteria:

* overt bacterial infection in the respiratory tract resulting from common pathologies, including primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development;
* asthma treated daily, chronic airway disease, respiratory bacterial infections (e.g., purulent tonsillitis), acute tracheobronchitis, sinusitis, otitis media, and further respiratory tract pathologies potentially affecting the trial's data analysis;
* common pulmonary diseases (e.g., severe pulmonary interstitial lesions and bronchiectasis) confirmed by chest CT;
* severe pneumonia requiring ventilator use;
* previous or present diseases potentially affecting trial participation or influencing study outcome, based on the investigator's judgment;
* pregnancy or lactation in women;
* participation in a clinical study in the past 3 months;
* history of allergy to ≥2 drugs or foods or known allergy to the drug's constituents.
Measurements to Assess Severity of Epicardial Stenoses

Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.

The pressure drop coefficient (CDP) is a functional index based on hyperemic dp and u measurements. The lesion flow coefficient (LFC) combines the functional index CDP with an atomic measure (percentage area stenosis) as a single parameter.

Eligibility Criteria:
Inclusion Criteria:

* Abnormal Myocardial stress perfusion (SPECT) LV EF \> 25%

Exclusion Criteria:

* LV \< or + to 25% Serum Creatinine \> 2.5 gm/dL Type II HIT Significant co-morbidities Pregnant women
Surgery Before Embryo Transfer in ERROR (Endometrioma Related Reduction in Ovarian Reserve)

This prospective study evaluates the pregnancy results after laparoscopic endometriosis operation in infertile patients with ERROR (endometrioma related reduction in ovarian reserve)

This study consists of two groups. Patients will be randomly enrolled into the groups by ART (assisted reproductive technology) centre nursery. All patients will sign a consent form about procedure.

Patients diagnosed with endometrioma (larger than 3 cm diameter) and ERROR (endometrioma related reduction in ovarian reserve - Antimullerian Hormon \< 1.2 ng/ml, Antral follicle count \< 7 , Day3 Follicle Stimulating Hormone \> 10 IU/dl, Low response to ovarian hyper stimulation \< 3 oocytes) will be enrolled in study. Patients with age \>40, with male factor, with undefined adnexal mass, malignity suspicion will be excluded from study.

The study group consists of patients who will undergo laparoscopic endometriosis surgery after ICSI procedure with freezing all embryos. The patients will wait about 6 months for spontaneous conception, if there is no pregnancy during this period, frozen embryo transfer will be performed. The control group consists of patients who will be performed IVF\&ICSI procedure with fresh embryo transfer without surgery. If there is no pregnancy, patients will be operated then.

As the primary; result positive b-hCG rates will be compared between groups.

In conclusion we will find out whether laparoscopic endometriosis operation improves or worsens the pregnancy results in patients with ERROR.

Eligibility Criteria:
Inclusion Criteria:

* Presence of Endometrioma at least in one ovary, larger than 3 cm diameter
* Endometriosis Related Reduction in Ovarian Reserve (ERROR)
* Presence of endometriosis related infertility

Exclusion Criteria:

* Presence of chronic systemic disease
* Presence of male factor infertility
* Suspicion of ovarian malignancy or undefined ovarian mass
Impact of CPAP Treatment on Arterial Stiffness in Patients With T2DM and Newly Diagnosed Obstructive Sleep Apnoea

The purpose of the trial is to investigate the effects of three months' treatment with a CPAP-device versus control group on change in arterial stiffness in type 2 diabetes (T2D) patients with newly detected Obstructive Sleep Apnoea (OSA).

Background: Obstructive sleep apnoea (OSA) is a common disorder characterised by recurrent episodes of apnoea or hypopnoea during sleep. OSA is associated with excessive daytime sleepiness and linked to increased cardiovascular morbidity and mortality. OSA can be alleviated with Continuous Positive Airway Pressure (CPAP) treatment.

Cardiovascular disease is the major cause of decreased life expectancy, morbidity and reduced quality of life in patients with type 2 diabetes (T2D). Increased stiffness of the aorta has been associated with increased cardiovascular morbidity and mortality in diabetic patients.

Previous studies have reported a much higher frequency of OSA in patients with obesity and T2D compared with non-diabetic subjects, and found that OSA was associated with arterial stiffness. However, whether CPAP treatment improves arterial stiffness and insulin sensitivity in T2D patients remain to be elucidated.

Objective: To investigate the effects of three months' treatment with a CPAP-device versus sham CPAP on change in arterial stiffness in T2D patients with newly detected OSA.

Design: Randomised, controlled, multicentre study of intervention with CPAP treatment versus control group. The treatment period is three months with a subsequent 9 months open extension.

Patient population: 70 patients with T2D and newly diagnosed OSA recruited from Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Department of Endocrinology, Gentofte University Hospital, Department of Endocrinology and Internal Medicine, Aarhus University Hospital Nørrebrogade and Department of Internal Medicine, Silkeborg Sygehus.

Intervention: CPAP treatment versus control group.

Endpoints:

Primary endpoint: Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV) from start to end of 12 weeks intervention.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (WHO criteria)
* Obstructive sleep apnea defined as apnoea-hypopnoea index (AHI) \> 15 diagnosed with ApneaLink+® measured within three months or less prior to visit 0.
* Signed informed content.

Exclusion Criteria:

* Contraindications to CPAP treatment.
* Treatment with CPAP within the last 6 months prior to visit 1.
* Works in a transportation-related industry
* C-peptide \< 300 pmol/l - measured less than 6 months prior to visit 0
* HbA1c:\< 7% or \>10% - both exclusive - at visit 0
* Changes in antidiabetic treatment during the last four weeks prior to visit 0.
* Unstable bodyweight, i.e. \>5% change during the last three months prior to visit 0.
* Other sleep breathing disorder