cyrilzakka/clinical-trials huggingface dataset:
The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar

This study explores the smart scar care pad's potential therapeutic effect in treatment hypertrophic scar while elucidating the adverse effects if there is any. Half of the participant receives traditional treatment of pressure garment and the other half receives the smart scar care pad together with pressure garment.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with Hypertrophic Scar(HS);
2. the HS had a total Vancouver Scar Scale (VSS) score of 4 or higher and the score of each item equal to or greater than 1;
3. subjects age between 20 and 70 years, cooperative, and good compliance with treatment.

Exclusion Criteria:

1. the HS area had an open wound or infection;
2. the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or
3. the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).
Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's disease appearing at different levels of levodopa infusion dose. The hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma.

By using duodenal infusion of levodopa/carbidopa, the plasma concentration of levodopa can be kept fairly constant. Different doses, 10-20% higher or lower than the individually optimized dose will be used. Motor performance is captured by video recordings to be compared to/correlated with plasma levodopa concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease
* Ongoing treatment with Duodopa
* Occurrence of dyskinesias, difficult to manage
* Age 30-90 years
* Hoehn \& Yahr stage 3-5 at worst

Exclusion Criteria:

* Treatment with dopamine agonist or glutamate antagonist
* Dementia
* Psychosis
* Treatment with typical neuroleptics
Biomarker Rule in/Out in Patients With Acute Diseases for Validation of AKI (BRAVA) Acute Kidney Injury

The presence or development of AKI impacts on outcomes in patients presenting with acute conditions to the ED. As a result, treating physicians are often concerned with the risk of AKI and take such risk in consideration when making subsequent therapeutic and diagnostic decisions which may result in delaying or withholding therapeutic measures in order to prevent further kidney damage (i.e. avoid imaging studies with contrast media).

If clinicians could be informed early that a patient is at minimal risk for AKI, they could deploy timely and optimal diagnostic and treatment procedures for the underlying disease of the patient without major concerns for causing or exacerbating kidney damage

In patients with acute diseases, it is mandatory for ED Physicians to immediately detect the presence of AKI or exclude; but unfortunately Serum creatinine (SCr) variations (based on KDIGO or AKIN criteria), take 24 to 48 hours to manifest the presence of acute renal ongoing damage. AKI is currently, infact, defined as an increase in SCr of 1.5-fold from baseline within 24 to 48 hours, and decrease in diuresis from admission in hospitalization, using KDIGO.

As consequence, similarly to other biomarkers, such as troponins in acute coronary syndrome and D-dimer in pulmonary embolism, a laboratory test to rule in or rule out AKI is needed in critical patients in ED and our primary objective would be to evaluate the role of urine TIMP-IGFBP7 in this setting.

Primary Objective of the BRAVA Study would be to evaluate the role of the urine biomarkers TIMP-IGFBP7 in predicting the occurrence of AKI in patients presenting to ED with different acute diseases and need for hospitalization.

Eligibility Criteria:
Patient Inclusion Criteria

* Age ≥ 21 years
* \>30% risk of developing AKI based on treating physicians' clinical evaluation AND/OR Presence of ONE OF the following conditions:
* Suspected or confirmed sepsis.
* Acute decompensated heart failure.
* Prolonged gastrointestinal losses from vomiting or diarrhea
* Major trauma
* Major bleeding (e.g. gastrointestinal, pulmonary, genitourinary)
* Severe burns
* Diabetic crisis (DKA, HHS)
* Decompensated liver cirrhosis
* Acute coronary syndrome
* Emergent need for iodinated contrast studies
* Shock from any cause

Patient Exclusion Criteria

* Age \< 21 years.
* Unable to give informed consent
* Undergoing hemodialysis or peritoneal dialysis
* Pregnancy
* Terminal illness with \< 6 months prognosis
* Do-not-resuscitate status
Efficacy and Safety of Perlane-L in the Correction of Midface Volume Deficit

The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.


Eligibility Criteria:
Inclusion Criteria:

* Loss of Fullness in Midface Area
* Other items as identified in the protocol

Exclusion Criteria:

* History of allergy or hypersensitivity to injectable hyaluronic acid gel or lidocaine.
* Other items as identified in the protocol
Dual Trigger Versus Booster Dose of HCG

To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared dual trigger with GnRH agonist plus 1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.


Eligibility Criteria:
Inclusion Criteria:

* High responder females undergoing antagonist protocol IVF/ICSI cycle
* More than 14 MII oocytes
* Estradiol more than 3500 pg/ml on day of trigger

Exclusion Criteria:

* Any other protocol
* Normal or poor responders
Evaluation of HEArt invoLvement in Patients With FABRY Disease

This study evaluates predictors for the incidence of arrhythmias and sudden cardiac death as well as terminal heart failure in patients with Fabry disease.

Fabry disease is a rare disease and part of the group of lysosomal storage disorders. Natural history of Fabry disease has proven poor survival to ages \>50 years outlining the importance to evaluate cardiac symptoms and outcomes of patients with Fabry disease.

This study is a prospective cohort study and observes patients since 2001. Through this long-term experience and the relative high number of patients this study is suggested to help estimating the risk of cardiac arrhythmias and sudden cardiac death (SCD) as well as death or heart transplantation due to terminal heart failure.

All patients in treatment in the Fabry Center Wuerzburg (FAZiT) are included in this study if informed consent is provided.

Eligibility Criteria:
Inclusion Criteria:

* Fabry disease (genetically confirmed)
* Signed informed consent
* 18 years and older

Exclusion Criteria:

* No informed consent
* Withdrawal of informed consent
Treatment Patterns Among Patients With Venous Thromboembolism in the United States

The purpose of this study is to assess outpatient treatment patterns following hospitalization for venous thromboembolism (VTE). VTE is a condition that occurs when blood clot forms in the vein.

This is a retrospective study (assessments on events that have already occurred) of healthcare claims from databases. The study sponsors will assess healthcare claim records of patients treated with either apixaban or warfarin. Assessment includes treatment persistence, switch, and stopping therapy, along with recurrent VTE and bleeding.


Eligibility Criteria:
Inclusion Criteria:

* inpatient hospitalization with primary discharge diagnosis of venous thromboembolism (VTE) (this is the index hospitalization)
* treatment with apixaban or warfarin during the hospitalization
* at least 18 years of age

Exclusion Criteria:

* Hospitalization for VTE within 6 months prior to the index hospitalization
* Diagnosis of atrial fibrillation/flutter or procedure for mechanical heart valve in the 6 months prior to the index hospitalization
* Procedure for inferior vena cava filter or diagnosis of pregnancy during the study period
* Prior use of oral anticoagulants or parenteral anticoagulants
Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

The purpose of this study is to determine whether Cinnamon from the Cassae Plant is effective in the body as insulin could lower blood sugar levels.

Insulin resistance is a condition in which body cells do not fully respond to the action of insulin, a hormone that controls the amount of sugar (glucose) in the blood. As a result, blood sugar levels become abnormally high. Insulin resistance is common in women with polycystic ovary syndrome (PCOS). This study involves the administration of a nutritional supplement (cinnamon extract). The cinnamon extract like regular cinnamon powder comes from the bark of Cinnamon Cassae plant. It is believed that cinnamon may act in the same way as insulin and therefore could potentially improve insulin resistance and help to lower blood sugar (glucose) levels.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 40 years of age
* Have a body mass index 25-40 kg/m2
* Have a sedentary lifestyle (participated in less than 30 minutes of physical activity 3 days per week over the last 6 months)
* History of irregular menstrual cycles (fewer than 6 cycles in past year)
* Excess androgen (to be measured at screening)
* Willing to supplement normal diet with cinnamon extract and a placebo for 12 weeks
* You can stay overnight at Pennington Center three times over the next six months

Exclusion Criteria:

* Do not meet our diagnostic criteria for polycystic ovary syndrome
* Have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible.
* Have cancer (active malignancy with or without concurrent chemotherapy).
* Abuse alcohol or illegal drugs.
* Smoke or have smoked within the previous 6 months. No smoking will be permitted during the study.
* Have donated blood within 30 days prior to randomization date.
* Have a hemoglobin, hematocrit, red blood cell, or iron level below the normal lower limit at screening.
* Taking medications that alter your glucose metabolism, (30 minute or more, 4 or more times per week over the past year.)
* Unwilling or unable to adhere to the clinical evaluation schedule over the entire six-month follow-up period.
Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal

Macular epiretinal membrane (ERM) is a semitranslucent, avascular, fibrocellular membrane on the inner surface along the internal limiting membrane (ILM) of the retina. ERM may cause symptomatic visual disturbances and vision loss. Since the 1970s, pars plana vitrectomy has been performed to remove the membranes with few complications, and surgical results are generally good. Recurrence rates of 5-16% have been reported. Recently, ILM peeling in ERM surgery have been popularized by a number of retrospective studies and one prospective case series to minimize the rate of ERM recurrences (16% recurrence in ERM surgery with ILM peel compares to 0% recurrence in ERM surgery without ILM peel). Surgical removal of the friable and transparent ILM is difficult and increases the risk of trauma to the retina. In addition, indocyanine green (ICG), a dye commonly used intra-operatively to enhance ILM visualization, is costly and has been shown to be toxic to the retina. The investigators study will be the first randomized-controlled multi-centred clinical trial to compare the outcomes of ERM surgery with and without ILM peeling. The results will help guide and standardize the surgical treatment of macular ERM; to minimize unnecessary surgical risks, as well as to help economize healthcare cost.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* ERM on clinical exam and/or macular OCT
* Visual acuity of 20/40 or worse (attributable to ERM)

Exclusion Criteria:

* Prior surgery for ERM in the "study eye"
* Macular edema secondary to arterial/venous occlusion(s)
* Central serous retinopathy
* Age related macular degeneration
* Diabetic cystoid macular edema
* Proliferative Diabetic Retinopathy
* Uveitis
Toric Eye Strain and Stability Study

The purpose of this study is to determine the benefits of fitting low astigmats with soft toric contact lenses versus spherical contact lenses with regard to visual comfort, eyestrain, fitting efficiency, and visual performance.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must have read, understand, and sign the statement of informed consent and receive a fully executed copy of the Informed Consent Form.
2. The subject must appear able and willing to adhere to the instructions set forth in this protocol.
3. The subject must be between 18 years and 45 years of age (inclusive).
4. The subject must have best-corrected Snellen visual acuity of 20/30 or better in each eye.
5. If the subject has ever worn contact lenses, the subject must be a current wearer of soft spherical contact lenses for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
6. Subjective refraction must result in a vertex-corrected astigmatic contact lens prescription requiring at least -0.75 DC but not more than -1.75 DC cylindrical contact lens correction in each eye.
7. Subjective refraction must result in a vertex-corrected spherical contact lens prescription between +0.25D to +4.00D or between-0.50D to -9.00D in each eye.
8. The subject must not have the need for presbyopic correction (i.e., they must not be using as add in spectacles or wearing multifocal or monofocal contact lenses).
9. The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
10. The subject must have access to the internet throughout the day (either desktop and/or smartphone) and be willing to answer a web-based survey within 1 hour of receiving a text message based notification throughout the day for up to 8 days, throughout the study duration.

Exclusion Criteria:

1. Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued)
2. Any previous ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
3. Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. greater than or equal to grade 3 finding of edema, corneal neovascularization, corneal staining, conjunctival injection, blepharitis/meibomian gland dysfunction) on the FDA classification scale or any other ocular abnormality that in the opinion of the investigator may contraindicate contact lens wear.
4. Any ocular infection
5. Current use of topical ophthalmic medications other than artificial tears/rewetting drops.
6. History of binocular vision abnormality or strabismus.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
8. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
9. Employee of the investigational clinic (e.g. investigator, coordinator, technician)
10. Subject does not have a wearable pair of spectacles.
Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population

Exercise program in serum Klotho levels

This study aims to analiyze the effects of acute exercise in serum Klotho levels attending physical fitness in healthy population

Eligibility Criteria:
Inclusion Criteria:

* healthy people between 20 and 45 years old

Exclusion Criteria:

* acute and chronic disease, people who take medication and supplements, smoker.
Acute Kidney Injury in Patients Hospitalized With COVID-19

The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 pneumonia patients diagnosed by WHO criteria

Exclusion Criteria:

* Patients who were younger than 18 years,
* Patients who had undergone renal replacement therapy (RRT) before admission,
* Patients whose entire stay lasted for less than 48 hours.
XELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Radiotherapy as Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

The purpose of this study is to determine the pathological complete response rate of addition of bevacizumab to induction therapy (xelox) and concomitant treatment (capecitabine+radiotherapy), followed by surgery.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from patients who are able to understand the study request
* Histologically confirmed diagnosis of locally advanced rectal adenocarcinoma; ≤12 cm from the anal margin; T3, operable T4 or TxN+
* Karnofsky PS Index ≥ 70%
* Life expectancy \> 6 months
* Adequate bone marrow, liver and renal function: ANC ≥ 1.5 x 10e9/l; Platelets ≥ 100 x 10e9/l; Hb ≥ 9g/dl; INR ≤ 1.5; Bilirubin ≤ 1.5 x ULN; ALT and/or AST ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis); Alkaline phosphatase ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis) or ≤ 10 x ULN (in case of bone metastasis); Creatinine clearance (Cockcroft-Gault) ≥ 30 ml/min or seric creatinine ≤ 1.5 x ULN

Exclusion Criteria:

* Distant metastases; previous neoplasm during last 5 years or previous infiltrating neoplasm; previous treatment with radiotherapy or study drugs; recruited for other clinical trial in 4 weeks before study entry
* Surgery, open biopsy or traumatic injury in 4 weeks before study entry; fine-needle aspiration in 7 days before study entry; major surgery planned during study
* Previous heart disease or uncontrolled hypertension, previous hemorrhagic diathesis or coagulopathy; full-dose oral or parenteral anticoagulant or thrombolytic agent (low-dose warfarin is allowed, INR ≤ 1.5); chronic use of high-dose aspirin (\<325mg/day) or non-steroidal anti-inflammatory treatment
* No integrity of the upper gastrointestinal tract, malabsorption syndrome or unable to take oral drugs
* Pregnant or lactating patients; SNC disease; allogeneic transplant with immunosuppressive drugs; bone fracture not healed, wound or severe ulcers; uncontrolled intercurrent severe infections; previous related-fluoropyrimide SAEs or DPD deficiency
Neoadjuvant Endostatin and Chemotherapy for Breast Cancer

This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy to chemotherapy could further enhance the cytotoxic activity in breast cancer.

This is an open labelled, prospective, randomized, phase II clinical trial. A total of 60 patients with core-biopsy confirmed breast cancer, stage ⅡA to ⅢC, and to be treated with neoadjuvant systemic therapy are eligible for entry into this study. Patients will be allocated randomly to two groups to receive either 3 cycles of neoadjuvant DE and endostar or 3 cycles of neoadjuvant DE. All cases receive mammography, contrast-enhanced ultrasound (CEUS), magnetic resonance angiography (MRA), and positron emission tomography (PET) scanning pre- and post-neoadjuvant therapy, and then undergo surgical resection. The primary endpoint is clinical/pathological response. The secondary endpoint is (1) the safety and tolerability of the regimens, (2) the role of mammography, CEUS, MRA and PET for response evaluation, and (3) angiogenic profile and biological information involved in tumor response.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
* Stage ⅡA-ⅢC
* Age 18-70
* ECOG performance status 0-2
* No evidence of distant metastasis
* No previous therapy
* Normal hematologic function
* left ventricular ejection fraction greater than 50 percent
* No abnormality of renal or liver function
* Written informed consent

Exclusion Criteria:

* With allergic constitution or possible allergic reflection to drugs to be used in this study
* Any concurrent uncontrolled medical or psychiatric disorder
* History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease.
* History of bleeding diathesis
* Being pregnant or nursing
Effect of Transmagnetic Stimulation on Conditioned Pain Modulation (CPM)

While some indications of the neural circuits involved in the Conditioned Pain Modulation (CPM) process are now available, there is still need to clarify what parts of the brain are essential for this process, whether the spino-brainstem loop is largely sufficient to explain CPM or whether other cerebral and spinal regions such as frontal, somatosensory and other cortical regions contribute substantially. Whereas mere observation of correlation between these circuits while activated by brain imaging is still of considerable interest, direct experimental manipulations by repetitive transcranial magnetic stimulation (rTMS) could even establish insights into causal relationships.

rTMS of different intensities, frequencies and location will be applied during CPM to evaluate the central mechanisms of pain modulation, their location and role in pain reduction through enhancement or suppression of activity in the relevant brain regions. In other words, cortical regions that may be implicated in CPM will be determined by augmenting or interrupting their activity via rTMSapplied to the areas under investigation. The regions will be the pain network sites, which are assumed to control the top-down influence on CPM and are superficial enough to be stimulated by the magnetic coil. These include primarily DLPFC (dorsolateral prefrontal cortex) and OFC (orbitofrontal cortex), with possible later addition of other relevant sites such as ACC (anterior cortex cinguli), insula and somatosensory cortices, etc. Since rTMS may be administered in a manner that either reduces or enhances the excitability of the stimulated cortical region, it should be possible to clarify the inhibitory or excitatory role of these regions in the CPM process. In summary, the planned studies should allow for identifying the cortical regions of the descending pain system, which are critical as starting points for the top-down modulation of CPM.

Eligibility Criteria:
Inclusion Criteria:

* age 18-70
* males and females
* right handed

Exclusion Criteria:

* metal in brain/skull
* cardiac pacemaker
* cohlear implants
* history of head trauma
* history of epilepsy or seizures
* pregnancy