cyrilzakka/clinical-trials huggingface dataset:
Ginsenoside-Rd for Acute Ischemic Stroke

The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.

A major contributor to brain injury after stroke is disordered inward flow of Ca2+ and its toxic accumulation in the nervous system following cerebral ischemia. Ginsenoside-Rd, a purified component from total saponins of Panax notoginseng, has a molecular formula of C48H82O18•3H2O with a molecular weight of 1001.2. Ginsenoside-Rd has been shown to inhibit receptor-operated Ca2+ influx through receptor-and-store-operated Ca2+ channels (ROCC) , attenuate oxidative stress in stroke, reduce the size of the cerebral infarction and preserve brain functioning in animal models of acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* between 18 to 75 years
* the first episode
* from onset to admission within 72 hours
* NIHSS scores:5\~22

Exclusion Criteria:

* had other intracranial pathologies (e.g., tumor, infection)
* had a neurologic or psychiatric disease
* had a coexisting condition that limited their life expectancy
* had significant drug or alcohol misuse
* had high-grade carotid artery stenosis for which surgery was planned
* were pregnant or nursing
* participated in a clinical trial with an investigational drug or device within the past 3 months
* were unlikely to be available for follow-up
Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

Abnormal high expression of fibroblast activating protein (FAP) has been found in inflammatory reactions and benign fibrosis tissue. Autoimmune nephropathy such as lupus nephritis (LN) can lead to tubular atrophy and excessive deposition of extracellular matrix, which may be accompanied by abnormally increased expression of activated FAP in kidney tissue, and lead to renal fibrosis and long-term renal failure. This makes 68Ga-labeled FAP inhibitor (FAPI) positron emission tomography (PET) imaging the potential to early assess disease severity, predict disease progress and aid treatment planning in patients with LN. Compared to renal pathological puncture, 68Ga-FAPI PET is a new tool for non-invasive, repeatable assessment of renal fibrotic activation.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18-80 years old;
* Confirmed SLE: meet the 2019 EULAR/ACR classification standards;
* There are signs of renal involvement and indications for renal puncture: proteinuria\> 0.5g/24 hours (or urine protein creatine ratio (UPCR) \>500mg/g), unexplained decrease of glomerular filtration rate (GFR)

Exclusion Criteria:

* The pathology of renal puncture is not consistent with lupus nephritis;
* Previous history of other kidney diseases;
* There are contraindications to renal puncture: (1) obvious bleeding tendency, (2) severe hypertension, (3) psychosis or non-cooperative patients, (4) isolated kidney, (5) small kidney;
* History of malignant tumors within 5 years.
Community Based Treatment for (ComBaT) Glaucoma

The purpose of this research is to evaluate if intervention and education can change the behavior of someone's willingness to see an eye care provider to prevent blindness and glaucoma. The researchers are investigating if adding additional resources improves participant access to care.

Outcome measures related to acceptability and feasibility are exploratory. They will not be registered or results reported.

Eligibility Criteria:
Inclusion Criteria:

* Black or African American
* Participated in the screening examination portion of the study

Exclusion Criteria:

* Current eye pain (\> 8 out of 10)
* Sudden decrease in vision (within 1 week)
* Double vision that doesn't stop when you blink and stops no matter what eye you cover (not blurred, but seeing 2 objects)
* Pregnant women
* Prisoners
* Cognitive impairment- unable to give an ocular and social history
* Moving outside of Michigan or driving distance to the church within 6 months
Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study

Erectile dysfunction, the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is estimated to affect up to 30 million men in the United States. The disorder is age-associated. The available treatments include oral therapy, vacuum-constriction devices; shockwave therapy, intracavernosal injections of vasoactive agents, including alprostadil (prostaglandin E1, transurethral delivery of alprostadil, Implantation of penile prostheses.

The OhhMed Company has developed the Vertica device that provides treatments for improvement of erectile function in patients with erectile dysfunction. This study assess the safety, efficacy, ease of use, and satisfaction of the Vertica device by men with mild to moderate erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* IIEF-EF score of 11-24 with or without the use of medication (PDE5 inhibitors).
* Erectile dysfunction for at least 3- months
* Steady relationship for at least 3-months.
* patient without sensory disorders
* patient with established organic of erectile dysfunction

Exclusion Criteria:

* investigator's impression of expected poor patient compliance or anatomic inadequacy (penile size/girth)
* Premature ejaculation
* Any psychiatric disorder
* Epilepsy
* Peyronie 's disease/ penile curvature
* Coagulopathy
* Any tumor in the pelvic or penile region within the last 3 years
The Effect of PCA on PONV After Microvascular Decompression

This study is a randomized, controlled, double-blinded, and parallel design study. A total 94 patients will be randomized to receive ketorolac or fentanyl based patient-controlled analgesia after microvascular decompression surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo elective microvascular decompression surgery
* American Society of Anesthesiologists grade 1 or 2
* 19 - 65 years old

Exclusion Criteria:

* Refuse to participate to the study
* Refuse to use Patient-controlled analgesia
* Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
* history of craniotomy or chemotheraphy
* Patients who used preoperative antiemetics within 24h before surgery
* Severe renal or hepatic dysfunction
* Pregnant
TINN Pharmacokinetics (PK) Study Treat Infections iN Neonates

Phase I, open-label study to evaluate the pharmacokinetics, tolerability and short-term safety of ciprofloxacin in neonates with suspected (or proven) Gram Negative infection. Objectives: To evaluate the multiple-dose pharmacokinetics of ciprofloxacin in neonates and young infants (24 - 52 weeks postmenstrual age) with suspected or proven Gram Negative infection.

To evaluate the tolerability and describe short-term safety of ciprofloxacin in neonates and young infants with suspected (or proven) Gram Negative infection.

To describe the clinical outcomes of neonates treated with ciprofloxacin

This study is part of TINN 'Treat Infections in Neonates' a comprehensive project that is evaluating the safety of ciprofloxacin and how it is tolerated by neonates. Ciprofloxacin is an antibiotic that has been used for many years in newborn babies and infants less than 3 months old to treat bacteria that are resistant to other antibiotics. Ciprofloxacin is unlicensed for this age group. The European Medicines Agency and WHO have prioritised research about this drug. The TINN consortium aims to conduct the work required for a license (marketing authorization) in newborn babies and infants less than 3 months old. The aim of this study is to describe how newborn babies and young infants deal with this medicine. Blood samples will be taken at the beginning of the course of antibiotics and at the end. A minimal amount of blood will be required (less than half a teaspoon) in total and collected by staff experienced in blood sampling from neonates in a way that causes the least disruption to the baby. The levels of ciprofloxacin in the blood will be measured. The levels will be used to work out how quickly the body gets rid of the medicine. This will allow recommendations about the best dose and how often the medicine should be given.

We aim to recruit 50 neonates and infants under the age of 3 months who have been prescribed Ciprofloxacin as inpatients for suspected or proven infection. They will be recruited over 2 years from the neonatal unit at Liverpool Women's NHS Foundation Trust and Alder Hey Children's NHS Foundation Trust. Consent will be requested for babies to have more detailed investigation to see if there if genetic factors affect the way the body handles ciprofloxacin.

Eligibility Criteria:
Inclusion Criteria:

* Receiving ciprofloxacin following clinical decision by attending physician

Exclusion Criteria:

* Likely not to survive 48 hours in the judgement of attending physician
* Ciprofloxacin commenced before 5th day of life
Comparison of Static Stretching and Deep Kneading Massage Among Plantar Fasciitis Patients

Comparison of Static Stretching and Deep Kneading Massage Among Plantar Fasciitis Patients

To find out the better type of intevention in Static Stretching and Deep Kneading Massage for the betterment of Plantar Fasciitis Patients

Eligibility Criteria:
Inclusion Criteria:

* A person with phytoplitis by a doctor, physiotherapist or orthopedic surgeon.
* Determine the patient's age between 40 and 60 years.
* The patient's fracture, fracture, most cancers and various metabolism disorders are not used. Male and female victims can be involved.

Exclusion Criteria:

* Inflammatory arthritis patients.
* Nerve distortions
* Another disease caused in the case of March.
* Patients with various basic muscle problems and the effects of red science
* Does not use the patient's latest records and footprint.
Trapeziectomy Suspensionplasty Versus Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis

This study compares and evaluates differences in movement analysis, patient-reported outcome, radiological assesment and muscular function between patients undergoing carpometacarpal joint arthroplasty with use of modern implants and trapeziectomy with suspensionplasty

Osteoarthritis of first carpometacarpal joint is the most common degenerative disease of upper limb. According to data available in literature, it affects about 30% of women and 6% of men at the age of 45. Increasing with age, it rises up to 90% in people by the age of 80. Due to more widely spread electronic devices in offices, at work, at home which requires usage of thumb, increase in numbers mentioned above is strongly probable. The main symptoms are: pain, loose of grip strength and loose of function. The latter is most important fact, since about 50% of hand function is possible only with healthy thumb.

In many cases osteoarthritis can be treated by combined NSAIDs and splinting with rehabilitation. Sometimes when symptoms do not respond to non-operative treatment, there is a need for surgery. Trapeziectomy is the most common choice for operative treatment for end-stage basal thumb osteoarthritis. However, many other techniques were developed, there is continuous dispute over selecting the optimal . One of the most promising is arthroplasty using prosthesis. Last years many important advances were made in a design of implant and materials. Moreover the investigators now have many longer outcomes of such operation made in the past. All this data make us think more about using this technique often, since there are papers which show superiority over classical trapeziectomy. Even though there are several studies comparing functional and objective outcome of those techniques, there is a lack of evidence in terms of biomechanical analysis, thenar muscle activity and changes in movement patterns. Moreover there is no study published so far which considers modern implants and trapeziectomy with suspensionplasty. The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) and X-ray measurement, electromyography both pre- and post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of carpometacarpal joint III or III/IV in Eaton classification assessed by two different radiologists
* symptoms that do not respond to non-operative treatment for 8 weeks
* no counterindications for anaesthesia
* signed agreement for taking a part into trial

Exclusion Criteria:

* patient do not agree to take a part into study
* problems with communication with patient
* unstable cardiac disease
* reoperations
* previous surgical interventions in hand
* neuro-muscular diseases
* rheumatological background of disease
* diagnosed cervical spine disorders
Factors Associated With Dermatoporosis

Dermatoporosis is a chronic syndrome of skin insufficiency or fragility. It is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. Dermatoporosis prevalence is 37% in ≥65 years.

The objective was to determine factors associated with this diagnosis in \>60 years old patients of the outpatient clinic in the Hospital Central "Dr. Ignacio Morones Prieto " San Luis Potosí, México.

An observational, cross-sectional, descriptive, and analytical study was performed. Patients \>60 years old were selected. A clinical history, clinical examination, and application of a validated diagnostic self-questionnaire were performed.

Dermatoporosis is a chronic syndrome of skin insufficiency or fragility. It is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. Dermatoporosis prevalence is 37% in ≥65 years.The objective was to determine factors associated with this diagnosis in \>60 years old patients of the outpatient clinic in the Hospital Central "Dr. Ignacio Morones Prieto " San Luis Potosí, México.

An observational, cross-sectional, descriptive and analytical study was performed. Through consecutive non-probabilistic sampling, patients \> 60 years old were selected, who underwent a clinical history, clinical examination, and the application of a validated diagnostic self-questionnaire. To determine the association of the factors, a multivariate logistic regression analysis, it will be used the PRIMERv6 software with the PERMANOVA package. A p \<0.05 was considered significant. The normality of the distribution of the continuous variables was evaluated with the Shapiro Wilk test. The Student's t test was performed on variables that met the homogeneity of variance requirements. In the variables that did not meet this criterion, a non-parametric analysis was performed with the Mann U Whitney test. For the analysis of categorical variables, Fisher's exact test or chi-square test was used. Continuous variables were reported by mean (median) \[Q1, Q3\] (min - max) and by standard deviations as their distribution corresponds. Nominal categorical variables were expressed as frequencies

Eligibility Criteria:
Inclusion Criteria:

* Patients over 60 years

Exclusion Criteria:

* Patients in whom physical examination cannot be performed due to the use of orthopedic devices such as splints, bandages, etc.
* Patients with whom interviewer-patient verbal communication is difficult due to some hearing or neurological deficit.
* Patients with neurological, psychiatric disorders who are unable to provide reliable information. (disorganized, incoherent speech, cognitive deficit)
sPERMIdine supplemenTation on Metabolic, Neuronal and Cardiovascular Response to Exercise TRAINING

This study explores whether spermidine supplementation improves the metabolic, neurological-cognitive and cardiovascular response to structured exercise training in patients with heart failure with preserved ejection fraction. The investigators aim to show that a faster adaptation to exercise may improve long term adherence to a more active lifestyle.

Heart failure with preserved ejection fraction is the largest unmet need in medicine. Exercise training is a pivotal lifestyle intervention which has been shown to have beneficial effects with regards to metabolic, neurological-cognitive and cardiovascular outcomes in these patients. Yet, not every patients responds equally fast to an exercise training intervention. This trial explores whether the supplementation of spermidine can increase the response to a structured aerobic exercise training. The investigators will recruit 30 patients who will either receive a spermidine supplement or a placebo. The study participants are invited for a first follow-up visit after four weeks. The exercise intervention starts at week 5 and continues for 12 weeks. Hence, overall there are three visits (baseline, week four and week twelve).

Eligibility Criteria:
Inclusion Criteria:

* diastolic heart failure (E/e' \> 8, left ventricular ejection fraction (LVEF) =\> 50 %, dyspnea)

Exclusion Criteria:

* nutritional supplements with polyamines
* acute myo-, endo- or pericarditis
* aortic valve stenosis (2nd degree)
* cardiomyopathy or severe left ventricular hypertrophy (Interventricular septal end diastolic thickness or posterior wall thickness \> 17 mm)
* AV block (second degree)
* pulmonary hypertension
* thromboembolic event in the last six months
* anemia
* infection (with fever) within the last four weeks
* cancer
The Usefulness of Tacrolimus Without Basiliximab in Well Matched Living Renal Transplantation in Korea

Basiliximab has been a routine induction therapeutic agent even for well-matched living kidney transplantation(KT) with tacrolimus-based immunosuppression in Korea. As tacrolimus is a different drug from cyclosporine, the investigators study the usefulness of tacrolimus-based immunosuppression without basiliximab in well matched living KT.

The investigators omit basiliximab induction therapy in patients who underwent one to three-HLA mismatched living donor renal transplantation. Participants should receive ABO compatible and T-flow negative transplants. The investigators compare the results of intervention group with conventionally treated control group (age and sex matched patient who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy).

Eligibility Criteria:
Inclusion Criteria:

* ABO compatible and T-flow negative transplants
* Living kidney transplantation
* Tacrolimus based immunosuppression

Exclusion Criteria:

* Multiorgan transplantation
* Zero-mismatch transplantation (we use cyclosporine instead of FK506)
Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers

Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo measured activity in PD patients. The purpose of the study is to provide validation of the ActiMyo, an innovative home-recording device enabling use in clinical trials and as an innovative tool for PD patient care.


Eligibility Criteria:
Patients:

Inclusion criteria

* Clinical diagnosis of idiopathic PD (UKPDSBB criteria)
* On stable parkinsonian medication regimen including levodopa for at least 4 weeks
* Male of female aged ≥18 years old
* Experiencing motor fluctuations and dyskinesia
* MoCA (Montreal Cognitive Assessment) ≥ 26
* Willing to adhere and comply to the protocol requirements as evi-dence by written informed consent
* Capable and willing to accurately using Actimyo
* Capable and willing to complete diaries
* Unlimited broadband internet access at home
* Agrees to be filmed
* Affiliated to or a beneficiary of a social security scheme
* PD patients subgroup #1 only: levodopa acute test scheduled as part of usual care

Exclusion Criteria

* Undergone surgery for the treatment of PD
* Apomorphine or Levodopa Pump in place
* Deep brain stimulation or transcranial magnetic stimulation
* Drug-induced parkinsonism
* Vascular parkinsonism
* Parkinson plus syndromes (such as multiple system atrophy, pro-gressive supranuclear palsy, and corticobasal degeneration)
* Other neurodegenerative disorders
* Any other significant medical or psychiatric illness that could inter-fere with study evaluation
* For women: pregnancy or current breastfeeding
* Under legal protection

Healthy subjects:

Inclusion criteria

* Male of female matched by age with PD patients ; aged ≥ 18
* Willing to adhere and comply to the protocol requirements as evi-dence by written informed consent
* Capable and willing to accurately using Actimyo
* Capable and willing to complete diaries
* MoCA (Montreal Cognitive Assessment) ≥ 26
* Unlimited broadband internet access at home
* Agrees to be filmed
* Affiliated to or a beneficiary of a social security scheme

Exclusion Criteria

* Any significant medical or psychiatric illness that could interfere with study evaluation
* For women: pregnancy or current breastfeeding
* Under legal protection
* Close or near relation of investigators, Institute of Myology employ-ees, or AFM-Telethon members.
Sacral Neuromodulation for Male Overactive Bladder (MOAB)

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).

Eligibility Criteria:
Key Inclusion Criteria:

1. Participants aged ≥ 18 years at the time of enrollment
2. Able to complete bladder diaries and patient questionnaires
3. Primary diagnosis of Urinary Urgency Incontinence (UUI)
4. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year
5. Underwent prostatectomy for prostate cancer at least 6 months prior to enrollment
6. Underwent radiation therapy for prostate cancer at least 6 months prior to enrollment
7. Underwent cytoreductive surgical intervention for BPH at least 6 months prior to enrollment

Key Exclusion Criteria:

1. Any patient that is not a suitable candidate per investigator discretion
2. Recent prostate therapy or procedure within the last 6 months at the time of enrollment
3. Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices
5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)
6. Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment
7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician
8. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain)
9. Uncontrolled diabetes
10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone