cyrilzakka/clinical-trials huggingface dataset:
Fractional Radiofrequency for Reduction of Surgical Scar Formation

Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation

The study will evaluate up to 20 subjects scheduled to undergo breast reduction or breast mastectomy in which scar assessment can be made after pre-surgical treatment in a split-body design. The study will involve a single treatment of radiofrequency (RF) applied to one side of the surgical area(s) within 24 hours prior to the procedure. The subject will act as their own control, where one surgical area will be treated, and the other will not be and will act as the control. Tissue samples will be biopsied from the RF treated skin, as well as non-treated skin, at follow up visits. The samples will be used for histological evaluation to assess tissue structure and regeneration following surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
2. Able to read, understand and voluntarily provide written Informed Consent.
3. Able and willing to comply with the treatment/follow-up schedule and requirements.
4. Willing to avoid direct sunlight to the treatment area for the duration of the study.
5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.

Exclusion Criteria:

1. Subjects with any implantable metal device in the treatment area
2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
3. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
4. Current or history of any kind of cancer, or dysplastic nevi.
5. Severe concurrent conditions, such as cardiac disorders.
6. Pregnancy or intending to become pregnant during the study and nursing.
7. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
8. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
9. Poorly controlled endocrine disorders, such as diabetes.
10. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
11. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
12. History of bleeding coagulopathies, or use of anticoagulants.
13. Use of isotretinoin (Accutane®) within six months prior to treatment or at physician discretion.
14. Treating over tattoo or permanent makeup.
15. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
The "Motoric Cognitive Risk" Syndrome in the Canadian Population

Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that "motoric cognitive risk" (MCR) syndrome, which has been described in cognitively healthy individuals and combines subjective cognitive complaint with objective slow gait speed, is a pre-dementia syndrome. The uniqueness of "motoric cognitive risk" (MCR)syndrome is that it does not rely on a complex evaluation or laboratory investigations. Thus, it is easy to apply in population-based settings. The overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (MCR) syndrome, in the Quebec population using the database of the NuAge study.


Eligibility Criteria:
Inclusion Criteria:

* Individuals eligible for this study will be participants of the NuAge study

Exclusion Criteria:

* Individuals not eligible for the NuAge study
* dementia
* mobility disability
* no information about cognitive complaint
* no measure of walking speed
A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects

This is a phase I study to evaluate drug-drug interactions (DDIs) of JAB-21822 as a perpetrator combined with midazolam , rosuvastatin, and digoxin and to evaluate DDIs of JAB-21822 as a victim combined with itraconazole， rifampicin， and omeprazole in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ；Healthy subjects aged 18 to 50 years (including both ends) at the time of signing informed consent
2. Male subjects weighed ≥50kg, female subjects weighed ≥45kg, body mass index (BMI) was between 19.0 and 26.0kg/m2, BMI= weight (kg)/height 2 (m2), including boundary values.
3. Subjects voluntarily signed written informed consent and were able to communicate well with the investigator

Exclusion Criteria:

1. History of severe systemic diseases, history of liver and kidney insufficiency, history of mental illness, history of drug dependence;
2. Patients with a history of interstitial pneumonia, pulmonary fibrosis or other interstitial lung diseases who were not eligible for admission by the investigators;
3. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, and have digestive diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months before the first dose;
4. The investigator believes that the subject has any other circumstances that make him or her unfit to participate in this clinical trial
Factors Related to the Progression of Non-target Coronary Lesions

The goal of this observational study is to learn about correlation between traditional risk factors and emerging risk factors on the progression of non-target coronary lesions in patients with non-target lesions on at least two coronary angiographies at the First Affiliated Hospital of Shandong First Medical University. The main question it aims to answer is what the correlation between emerging risk factors and progression of coronary non-target lesions, and try to explore the powerful predictors of progression of coronary non-target lesions and cardiovascular events.

Participants will be divided into two groups based on coronary angiography results:

1. progress group:There is at least one major coronary artery (left main artery, left anterior descending artery, left circumflex artery or the right coronary artery) had non-target lesions, and the coronary artery stenosis rate reached the progressive level on follow-up angiography.
2. Non-progress groups: On repeat angiography, the rate of coronary stenosis did not reach progressive levels.

The laboratory and auxiliary examination indexes of the study participants were collected prior to two coronary angiography (CAG) procedures, encompassing blood cell counts, glucose metabolism, lipid metabolism, renal function, cardiac function, inflammatory factors, etc. Quantitative flow fraction (QFR) was employed for assigning values to coronary artery images and analyzing lesion information (including plaque progression and non-progression). The correlation between conventional risk factors, lipoprotein(a), homocysteine, and other emerging risk factors with the progression of non-target coronary lesions was analyzed; furthermore, the predictive value of emerging risk factors for non-target coronary lesion progression was evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old;
2. Participants underwent at least two coronary angiography examinations in our hospital, and the time interval between the two angiography examinations was ≥12 months;
3. At the first angiography, there is 20% to 70% stenosis in the coronary artery lesion, and no indication or condition for intervention.

Exclusion Criteria:

1. Participants had a documented medical history of various heart diseases, including congenital heart disease, pulmonary heart disease, valvular disease, cardiomyopathy, etc.
2. Angiography or serum collection was conducted within 7 days following the onset of acute myocardial infarction.
3. Exclusion criteria included uncontrolled severe arrhythmia and severe hepatic and renal dysfunction.
4. Patients with tumor or other autoimmune diseases were excluded from the study.
5. Incomplete clinical information, biochemical test information, coronary angiography data, and imaging data were considered as exclusion factors.
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy

The bilateral sagittal split osteotomy (BSSO) of the mandible is one of the most used surgical techniques to achieve a harmonious jaw relation in the context of orthognathic surgery. Nevertheless, one of its main complications is neurosensory damage to the inferior alveolar nerve, which can cause severe impact in the quality of life on patients who suffer from it permanently. The purpose of this randomized clinical trial is to provide rigorous scientific evidence of the pharmacological effect of 1) Melatonin, 2) combination uridine triphosphate (UTP), cytidine monophosphate (CMP), and hydroxycobalamin (UTP/CMP/hydroxycobalamin) and 3) hydroxycobalamin regarding neurosensory disturbances incidence and persistence after BSSO.

The study will be done according to the international standards of the Helsinki convention for medical research and approved by the scientific ethics committee of Universidad de los Andes Clinic.

All subjects will give their signed consent to participate of this clinical research.

This clinical randomized trial will be double-blinded as both the patient and the surgeon will not know the treatment used until the experiment is over. The randomization will be done using "random.org" software to assign participants into 4 groups. Groups A, B and C will receive the medication, whereas the Group P will receive a placebo.

Eligibility Criteria:
Inclusion Criteria: Patients with dentomaxillofacial anomalies who present a complete mandibular dental arch and who have not undergone previous mandibular surgery.

Exclusion Criteria:

patients who:

* do not have sufficient information in their clinical records
* cannot be contacted
* do not attend their check-ups (for at least 24 postoperative months in cases with DNS)
* have refused consent to the use of their information for purposes of research.
* already undergoing Orthognathic Surgery
* with systemic conditions prone to alter recovery patterns or serious systemic diseases (decompensated metabolic disorders; neoplasms; osteodysplasias; neuropathies).
* pregnancy
The Effect of SRS on Hemiplegia in Stroke Survivors

Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors.

A novel intervention that has shown immediate improvements in tactile sensation is called stochastic resonance stimulation. SRS is a phenomenon where cutaneous sensation can be enhanced with the presence of tactile noise in a nonlinear system. This theory suggests that the application of an imperceptible vibrotactile stimulation increases the synchronization of afferent neurons firing to the somatosensory cortex, ultimately increasing the excitability of mechanoreceptors in the skin suggesting that afferent signals from the periphery to the somatosensory cortex influence motor movements. However, more research is needed to document the changes in motor performance with the use of SRS and it is unclear how SRS stimulation changes different measurable sensory processing differences

Eligibility Criteria:
Inclusion Criteria:

* Stroke survivors over the age of 18
* At least six months post stroke
* Ability to provide verbal informed consent and written informed consent
* Score of at least 56 on the Fugl meyer assessment total motor scores
* Able to detect at least 6.65 (300 grams) on the Semmes Weinstein monofilament on both the pads of the thumb and index finger
* Able to complete the nine hole peg test
* Able to reliably express pain, discomfort, or fear
* Speak english

Exclusion Criteria:

* History of upper extremity orthopedic conditions, such as arthritis, surgery, etc.
* Aphasia caused by stroke
* Does not have AROM
* Currently have muscle contractures in upper extremity
* Participating in other research studies
* Patients with electrically operated implanted device (e.g. cardiac pacemaker/defibrillator, drug delivery pump, and neurostimulator)
* History of SMI (e.g. schizophrenia, schizoaffective disorder)
* History of neurodegenerative disability (e.g. Multiple Sclerosis, Parkinson's Disease)
* Have received botulinum injections in the paretic limb within the past three months
Energy Availability in Male and Female Elite Wheelchair Athletes Over Seven Consecutive Training Days

Low energy availability (LEA) is a major problem in sports as athletes ingest often a lower amount of energy compared to their actual needs. The availability of energy is calculated based on their daily energy intake and the energy cost of the daily training sessions in relation to their fat-free mass. Based on this calculation, it is known how much energy will available for the body (beside the fuel for training) to keep it in optimal physiological functioning. It has been shown, that LEA occurs very often in female athletes, in endurance athletes as well as athletes in weight-sensitive sports (i.e. jockeys, combat sports, gymnastics, ballet). The purpose of this study was to investigate, whether LEA is a problem in wheelchair athletes as well.

Energy availability will be assessed over 7 consecutive training days using a dietary and training record as well as the Leisure Time PHysical Activity Questionnaire for spinal cord injury. Resting Energy expenditure will be measured as well as body composition (by a DXA) before the start of data collection.

Eligibility Criteria:
Inclusion Criteria:

* athletes from a national team in wheelchair sports

Exclusion Criteria:

* unable to follow normal training routine
* unable to record diet or training
Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)

The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor \<=1.5 cm by magnetic resonance imaging (MRI).
* Age \>=18 years.
* Hemoglobin \>=10 g/dL.
* White blood cell count \>=1.5x10\^9/L.
* Platelet count \>=100x10\^9/L.
* Blood urea \<=1.5 x upper limit of normal values (ULN).
* Creatinine \<=1.5 x ULN.
* Bilirubin \<=1.5 x ULN.
* Aspartate aminotransferase \<=3 x ULN.
* Alanine aminotransferase \<=3 x ULN.
* Alkaline phosphatase \<=2 x ULN.

Exclusion Criteria:

* Tumor-specific pretreatment.
* Contraindication against radiotherapy and/or chemotherapy.
* Malignomas other than basaliomas.
* Existing or planned pregnancy or lactation or inadequate contraception.
* Psychiatric disease.
* Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.
Extension Study of Participants From SPG302-ALS-001

This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALS-101 with Amyotrophic Lateral Sclerosis (ALS)

This is an open-label extension study of SPG302-ALS-001 to investigate the long-term safety, tolerability, and efficacy of SPG302 administered orally in participants with Amyotrophic Lateral Sclerosis (ALS). This study will allow participants in the parent study to continue dosing. Enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer SPG302 orally every day for up to 52 weeks. Participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. An end of treatment visit will occur within 7 days of the last dose of SPG302. A final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.

Eligibility Criteria:
Inclusion Criteria:

• Must have participated in all study activities of SPG302-ALS-001, the parent study

Exclusion Criteria:

* Unable to reliably and regularly swallow whole oral medications on a daily basis.
* Medical conditions that investigator or sponsor determine would interfere with participation in clinical trial
Validation of a Making Decision Hybrid (ecologic and Virtual) Task

The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the "hybrid" task and the "virtual" task will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 65 inclusive
* Subjects with no neurological or psychiatric disorders
* Subjects with no addictive disorder except tobacco
* Signed informed consent indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the requirements and restrictions inherent in the study
* Affiliation with a French social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Men and women under 18 or over 65 years of age
* Subjects suffering from a neurological or psychiatric disorder
* Subjects suffering from an addictive disorder, with the exception of tobacco
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
* Subject without health insurance
* Pregnant
* Subject within the exclusion period of another study or on the "national volunteer list".
Safety Profile of Nulojix in Home Infusion Settings

The study is a retrospective cohort study that utilizes medical records from the BiologicTx. Data accrual starts upon initial home infusion nurse visit until the most recent home infusion nurse visit. Infusion related adverse events are quantified as number of patients with adverse event over the total number of patients and number of event over total number of home infusion visits.


Eligibility Criteria:
Inclusion Criteria:

* All adult kidney-only transplant recipients currently receiving NULOJIX in BiologicTx home infusion service settings
Understand the Difference Between Clinical Measured UF and Real UF.

The importance of ultrafiltration (UF) and fluid status in peritoneal dialysis has been increasingly aware of over the last two decades. There is growing body of observational evidence showing that low UF is related to unfavorable outcome especially in anuric patients. The other side of the problem of UF is excessive fluid removal could volume deplete patients and result in loss of residual renal function and overexposing the membrane to glucose unnecessarily. UF is a double-edged sword. The correct measure of UF is the bottom line of talking about target.

Measuring UF is supposed to be simple and straight forward. The most common way of measuring UF in clinical practice was to weight the effluent bag and minus the manufacture announced fill volume.

Until about 10 years ago, the society first aware that the measurement error in such way is not acceptable. Overfil (the actual volume of dialysate fill in the bag is more than announced) problem was raised from then.

However, there are several other problems around this issue. Firstly, when the product has just been produced overfill is different between manufactory.

Secondly, the overfill volume does change over transportation and storage. But it is not clear how big the change is.

Thirdly, most of the clinics weight the dialysate effluent rather than measure the volume in CAPD, although the specific gravity of dialysate is clearly not going to be 1g/ml.

Taking the fact measuring weight is much easier than measuring volume in CAPD, the question behind is to understand how big the difference is and consequently whether it is acceptable.

All the patients enrolled in the study would be asked to collect all dialysate effluent of the day of their routine peritoneal dialysis adequacy study and bring to the hospital. The exact weight of the bag for PET test (2.5% glucose concentration and dwell time of 4 hour) before and after the dwell and volume measured of the effluent. The dialysate electrolyte, glucose, protein and creatinine level would also be measured.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. on PD treatment for at least one month
3. signed the consent

Exclusion Criteria:

1. Peritonitis or recovery from peritonitis for less than one month.
2. On any intra peritoneal treatment apart from peritoneal dialysis.
3. Evidence of decompensated liver cirrhosis or heart failure.
4. Evidence of extra peritoneal leakage, eg. leakage to thoracic cavity, post peritoneal, hernia.
Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)

Open-label, randomized multicenter phase III non-inferiority study

Open-label, randomized, prospective multicenter phase III study to compare the role of HMT followed by HSCT vs HSCT upfront in HR-MDS with \<10% of BM blasts and of CHT vs HMT followed by HSCT in HR-MDS with \>10% BM blasts in terms of feasibility of HSCT (non-inferiority trial).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, and IPSS-R intermediate to very-high
2. Age 18-70 years
3. Previously untreated for HR-MDS
4. HSCT - eligible
5. Life expectancy ≥3 months;
6. Signed written informed consent according to ICH/EU/GCP and national local laws
7. Eastern Cooperative Oncology Group Performance Status Grade of 0-2

Exclusion Criteria:

1. Acute myeloid leukaemia with \>20% blasts in BM or peripheral blood (PB);
2. concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);
3. severe renal, cardiac, liver or lung impairment;
4. pregnant or lactating or potentially fertile (both males and females), who have not agreed to avoid pregnancy during the trial period; Women of childbearing potential and men must agree to use effective contraception during and up to 3 months after treatment with azacitidine.
5. HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis;
6. clinically relevant neurological or psychiatric diseases;
7. hypersensitivity (known or suspected) to AZA;
8. prior Treatments:

   1. prior investigational drugs (within 30 days);
   2. radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months;
   3. growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days;
   4. androgenic hormones during the previous 14 days;
   5. prior transplantation or cytotoxic therapy, including azacitidine, AZA or chemotherapy, administered to treat MDS (a previous treatment with Lenalidomide is admitted, provided that lenalidomide had been stopped at least 60 days before enrolment).