cyrilzakka/clinical-trials huggingface dataset:
Effect of CROW 3d Printed Sole on Charcot Foot Ulcer

The purpose of the study is to evaluate the therapeutic effect of the Charcot Restraint Orthotic Walker three-dimensional printed sole on Charcot foot ulcer healing.

Foot ulcerations, Charcot neuroarthropathy, and peripheral arterial disease frequently result in gangrene and lower limb amputation. Consequently, foot disorders are leading causes of hospitalization for persons with peripheral neuropathy. Although not all foot complications can be prevented, dramatic reductions in frequency have been achieved by taking a multidisciplinary approach to patient management, The reduction of pressure to the Charcot foot ulcer is essential to treatment. Proper off-loading and pressure reduction prevents further trauma and promotes healing. This is particularly important in the peripheral neuropathy patient with decreased or absent sensation in the lower extremities. Furthermore, recent studies provide evidence that minor trauma (eg, repetitive stress, shoe pressure) plays a major role in the causal pathway to ulceration.

* Off-loading approaches that deal with Charcot neuroarthropathy will decrease the significant psychological, social and functional impact on individuals.
* The need of this study is developed from the lack of controlled studies that reported the therapeutic effect of Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer.
* So the present study is designed to evaluate the Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer. Furthermore, the current study may help physical therapist, physicians, and clinicians to organize a protocol of treatment that would be safe, simple and economic for treating patients with Charcot neuroarthropathy.

Eligibility Criteria:
Inclusion Criteria:

* The subject selection will be according to the following criteria: • The patient's ages will range from 45 to 65 years.

  * Both sexes will be included in the study.
  * Informed consent for participation in this study will be obtained in writing from all patients.

Exclusion Criteria:

* The potential participants will be excluded if they meet one of the following criteria:
* Preceding surgical procedure on affected foot.
* Patients on hemodialysis.
* Patients who had any pathological conditions which may affect the results of the study as active malignancy, osteomyelitis and pes planus.
Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients

The study aims to describe the characteristics and the methods of management and follow-up of patients treated with fidaxomicin for Clostridium difficile infection (CDI).


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient
* Patient diagnosed with CDI

Exclusion Criteria:

* Patient already included in this study
* Patient is taking part in a clinical trial in the field of CDI
Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome

This trial is conducted in Asia. The aim of the trial is to investigate the long-term efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Japanese children with Noonan syndrome clinically diagnosed in one of the following ways: 1. Clinically diagnosed by at least two medical experts using van der Burgt score list, 2. Clinically diagnosed by one medical expert using van der Burgt score list and diagnosed by result of genetic testing for Noonan syndrome, 3. Clinically diagnosed by one medical expert using van der Burgt score list and diagnosed by the same medical expert based on the results of centralised evaluation of facial change using van der Burgt score list
* Height SDS (standard deviation score): -2 SDS or below (according to the Japanese reference data)
* Age: boys 3 to below 11 years, girls 3 to below 10 years
* Height records must be available within the period between 40 and 64 weeks prior to Visit 1 (screening)
* Prepubertal children (definition for girls breast and pubes of Tanner stage is I, and none of menses, and for boys testicular volume below 4 mL, and pubes and penis of Tanner stage is I)

Exclusion Criteria:

* Children with known or suspected hypersensitivity against human growth hormone (hGH) or related products (including any components of the trial products)
* Children with diabetic type diagnosed with the Japanese Diabetes Society Classification
* Children with history or presence of active malignancy
* Children who have received GH (growth hormone) treatment
* Children who have received systemic administration of the following medications within two years prior to Visit 1 (screening): Thyroid hormone (except replacement therapy), antithyroid hormone, androgen, oestrogen, progesterone, anabolic steroid, adrenocortical steroid treatment period for at least 13 weeks), derivative of gonadotropin releasing hormone and somatomedin C (IGF-I)
The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations

Patients with primary immunodeficiency disorders (PID) on intravenous immunoglobulin (IVIG) treatment may experience adverse events (AEs). Patients who experience AEs on any 10% IVIG solution will be changed to octagam 5% for six infusions to evaluate the potential benefit for reduction of AEs on a lower concentration IVIG product.

Patients with PID require life long immunoglobulin (Ig) replacement therapy with IVIG being the most common form. As more 10% IVIG products are FDA approved, the older and well characterized 5% IVIG products are becoming less used. Currently, the standard of care for patients who experience AEs on IVIG is to move to a subcutaneous (SCIG) delivery and product. This study will evaluate the AEs on a 10% product and octagam 5%. The study will enroll 15 patients after an AE on any 10% product who will then be infused with octagam 5% for six infusions. AEs will be documented and compared to the 10% product along with changes in biomarkers. The study data may document another therapeutic option for patients who experience AEs - SCIG and octagam 5%.

Eligibility Criteria:
Inclusion Criteria:

* Participants, or legal guardians with assent by underage children, will sign informed consent/assent and are willing to comply with all aspects of the study
* Diagnosis of CVID according IUIS Expert Committee
* Participants on a 10% product who experience AEs
* Ages between 10 and 75 years of age
* Participants on 10% IVIG therapy every 21±3 days or 28±3 days between 300 - 800 mg/Kg body weight

Exclusion Criteria:

* Acute infection requiring antibiotic therapy within 7 days prior to visit 1
* Presence of any condition that is likely to interfere with the evaluation of the study medication or satisfactory conduct of the trial
* History of anaphylactic or severe systemic reactions to human immunoglobulin
* IgA deficient patients with antibodies against IgA and a history of hypersensitivity
* Females who are pregnant or lactating
Renal Futility Following Simultaneous Liver-Kidney Transplantation

Liver transplantation in France represents a currently significant transplantation activity with a steady increase in the number of transplanted patients, with 1,294 liver transplants according to the Biomedicine Agency in 2022 compared to 806 liver transplants in 2000. 4% of these transplanted patients, or 54, underwent combined liver-kidney transplantation in 2022.

The indication for combined transplantation fits within several scenarios: patients indicated for liver transplantation with severe renal insufficiency as a comorbidity, which worsens the prognosis in the case of liver transplantation alone; patients with renal insufficiency indicated for kidney transplantation with decompensated liver disease as a comorbidity; and diseases affecting both organs in a combined and severe manner.

However, some American studies have highlighted the significant prevalence of kidney transplant failure during simultaneous liver-kidney transplantation, estimated at around 20% at 3 months post-transplant. This failure of renal function recovery after the double transplant is defined by the need for dialysis or the occurrence of death. This represents a major issue concerning the mortality and morbidity of patients who have undergone simultaneous liver-kidney transplantation.

The aim of this study is to identify the risk factors for failure of renal function recovery after combined liver-kidney transplantation, thus indicating the futility of the kidney transplant in this context of double transplantation.

The outcomes will be multiple. On one hand, we will identify the population most suitable to benefit from this intervention, which will improve recommendations on access to simultaneous liver-kidney transplantation. On the other hand, we will develop an optimized strategy for the use of available grafts, in order to better address the current organ shortage and the increasing number of patients waiting for transplants.


Eligibility Criteria:
* Inclusion Criteria \* :

  * adult patient
  * having undergone simultaneous liver-kidney transplantation between January 1, 2013, and December 31, 2022
  * in France
* Exclusion Criteria \* :

  * multi-organ transplant other than simultaneous liver-kidney transplantation
  * liver or kidney transplant alone
  * minor patient
  * refusal to participate in the study
Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain

Hemiplegic shoulder pain is the most common poststroke painful condition. Hemiplegic shoulder pain reduces range of motion (ROM) and hand function, resulting in limited daily life activity and decreased quality of life.

In the literature, the effectiveness of suprascapular nerve block and subacromial injection in hemiplegia patients with shoulder pain has been previously evaluated, but these injection treatments have not been compared.

Therefore, the aim of this study is to compare the effectiveness of suprascapular nerve block and subacromial injection on pain, shoulder (ROM), function and quality of life in hemiplegia patients with shoulder pain.

Patients will be randomly assigned Subacromial injection group or Suprascapular nerve block group

In the suprascapular nerve block group, suprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector.

In the subacromial injection group, subacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector.

A home exercise program will be given both groups. The exercise program consisted of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).

Eligibility Criteria:
Inclusion Criteria:

* Brunstrom stage 2 to 5
* spasticity \<4 according to the modified Ashworth scale
* having hemiplegia less than 12 months
* Presence of shoulder pain lasting more than 3 months
* Conservative treatment for painful shoulder before injection

Exclusion Criteria:

* Patients over 75 years old, under 30 years old
* Anti-coagulant or antiaggregant use
* Presence of diabetes mellitus
* Patients who could not be cooperated and Mini-mental Test (MMSE) score \<24
* Having previously had suprascapular block or subacromial injection
* Presence of complex regional pain syndrome (type I),
* The presence of neglect syndrome
Indoxyl Sulfate Induces Leukocyte-endothelial Interactions Through Up-regulation of ICAM-1 in Acute Kidney Injury

Indoxyl sulfate (IS) is an anionic uremic toxin that is accumulated in the serum of patients with uremia. In previous study, the investigators successfully induced AKI animal model. IS enhanced intercellular adhesion molecule-1 (ICAM-1) expression in IL-1β-treated human umbilical vein endothelial cells (HUVECs) that this may play a critical role in the progression of AKI. However, the molecular mechanisms of ICAM-1 expression in IS-treated IL-1β-treated HUVECs need to be elucidated. HUVECs incubated with 0.2 or 1 mM IS for 24 h did not cause cytotoxicity. The IL-1β-induced ICAM-1 expression in HUVECs was significantly enhanced by IS pretreatment. Furthermore, the regulation of adhesion molecule expression involves a complex array of intracellular signaling pathways including mitogen-activated protein kinase (MAPKs), reactive oxygen species (ROS) and transcriptional factors. A better understanding of this might provide important insights into the prevention of AKI.

Over the past decade, acute kidney injury (AKI) has acquired much attention because of their potentially devastating problems in clinical medicine. When kidneys lost their filtering function, a lot of dangerous metabolites were accumulated in the body, including urea, nitrogenous waste products and uremic toxins. Indoxyl sulfate (IS) is an anionic uremic toxin that is accumulated in the serum of patients with uremia. In previous study, the investigators successfully induced AKI animal model. IS enhanced intercellular adhesion molecule-1 (ICAM-1) expression in IL-1β-treated human umbilical vein endothelial cells (HUVECs) that this may play a critical role in the progression of AKI. However, the molecular mechanisms of ICAM-1 expression in IS-treated IL-1β-treated HUVECs need to be elucidated. HUVECs incubated with 0.2 or 1 mM IS for 24 h did not cause cytotoxicity. The IL-1β-induced ICAM-1 expression in HUVECs was significantly enhanced by IS pretreatment. Furthermore, the regulation of adhesion molecule expression involves a complex array of intracellular signaling pathways including mitogen-activated protein kinase (MAPKs), reactive oxygen species (ROS) and transcriptional factors. A better understanding of this might provide important insights into the prevention of AKI.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients

Exclusion Criteria:

* Less than 20 years old
A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before screening, and during screening period.

Exclusion Criteria:

* previous therapy with epoetin within 8 weeks prior to screening;
* overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
* RBC transfusions within 8 weeks before screening or during screening period;
* active malignant disease except non-melanoma skin cancer.
Duke Conte Center for the Neuroscience of Depression in Late Life

The proposed Silvio O. Conte Center for Neuroscience of Depression will focus on understanding the neurobiological mechanism of depression. A total of 5 projects are proposed. The center is focused on a single hypothesis. The first project examines localization of lesions, structural changes in critical regions subserving the circuit, alterations in the white matter tracts relevant to the circuit and changes in glutamate. The second project uses post mortem cell counting and cellular localization in serotonin receptors and assessment of the type of cell loss in the orbitofrontal cortex. The third project uses cognitive paradigms and functional MRI to probe the circuit and the role of brain lesions and serotonin on the functioning of this circuit. The fourth project uses transgenic and knockout mice to examine to role of norepinephrine and serotonin as it relates to the circuit. The final project is designed to assess in these transgenic mice using multielectrode array of single neuron recordings of the firing pattern of the circuit neurons in various states and tasks and the role of monoamines in modulating this circuit.

Three shared resources, administrative, research and assessment and data management/statistics are proposed to facilitate the conduct of these projects and to ensure integration at the conceptual, analytical and resource availability level, and flow to the various projects. Findings from the center should greatly enhance our understanding of the biology of depressive disorders and help improve the treatment of these disorders. In addition, the technological innovations developed in the context of this project are likely to be of major importance and relevant to other studies of brain function.

Eligibility Criteria:
Inclusion Criteria:

For depressed group:

1. Age \> 60 years
2. Major depression, single episode or recurrent
3. Ability to read and write English
4. MMSE \>25
5. Willingness to participate in the follow-up study for at least two years.

For non-depressed group:

1. Age \> 60 years
2. Ability to read and write English
3. MMSE \>25
4. Willingness to participate in the follow-up study for at least two years

Exclusion Criteria:

1. Lifetime alcohol or drug dependence
2. Conditions associated with MRI abnormalities such hydrocephalus, benign and cancerous brain tumors, epilepsy, Parkinson's disease, Huntington's chorea, dementia, demyelinating diseases, etc.
3. Endocrine disorder (other than diabetes mellitus)
4. Any physical or intellectual disability that may affect completion of self rating instruments
5. Established clinical diagnosis of dementia
6. Other primary psychiatric disorders, including panic disorder, social phobia, OCD, non-affective psychosis (including schizo-affective disorder), schizophrenia, bipolar disorder
7. Any metal or pacemaker in the body which precludes MRI.
Ventrointermediate Nucleus (VIM DBS) and Working Memory

This is part of a larger study for which participants have already completed memory and thinking tests. In this study, investigators are trying to learn how deep-brain stimulation affects memory skills in essential tremor (ET) patients. We are especially trying to figure out how stimulation on each side of the brain may affect working memory.


Eligibility Criteria:
Inclusion Criteria:

ET PATIENTS:

* Clinical diagnosis of essential tremor affecting the upper extremities.
* Previous unilateral or bilateral DBS of the VIM
* Ages 40 -70
* A useable pre-surgical MR scan

CONTROLS:

* Spouse or acquaintance of enrolled patient participant
* Ages 40 - 70

Exclusion Criteria:

ET PATIENTS:

* Clinical evidence of other neurological conditions
* Significant psychiatric condition

CONTROLS:

* Clinical evidence of other neurological conditions
* Significant psychiatric condition
Study Evaluating Rhapsody Registry in Patients With Depression and Anxiety

The purpose of this study is to assess the prevalence of Major Depression and/or Anxiety Disorder in patients consulting the General Practitioner with acute or chronic painful physical symptoms and to identify risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient must be at least 18 years of age
* Consulting a General Practitioner for painful physical symptoms
* Written informed consent

Exclusion Criteria:

* Patient is unable to understand and comply with procedures of the study
* Patient is unable to complete the patient ratings
* Patient has an acute pain with an obvious cause
Noninvasive VNS to Facilitate Excitability in Motor Cortex

Transcranial Magnetic Stimulation (TMS) positively influences motor rehabilitation in stroke recovery. Transcutaneous auricular vagus nerve stimulation (taVNS) has shown effects on cortical plasticity. We investigate whether combination of TMS and taVNS is more effective at motor cortex excitability than either modality alone.

The investigators aim to determine the effects of taVNS on motor cortex excitability. The hypothesis is that taVNS alone (sham rTMS + active taVNS) will induce increases in motor cortex excitability (post-stimulation compared to baseline). The investigators expect these changes will be of a lesser magnitude than those of TMS alone (active rTMS + sham taVNS) due to the indirect mechanistic approach of taVNS. Another aim is to determine whether taVNS-paired TMS is more effective at inducing cortical excitability than TMS alone, as it is hypothesized that pairing two forms of neuromodulation (active rTMS + active taVNS) will increase TMS-induced cortical excitability in the motor cortex when compared to single modality approaches (active rTMS + sham taVNS; sham rTMS + active taVNS). Furthermore, it is expected that this increase is timing sensitive, and the paired approach will induce larger TMS-induced cortical excitability compared to unpaired neuromodulation (active taVNS + active taVNS).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* endorsing good health

Exclusion Criteria:

* no TMS-induced motor cortex excitability changes in response to 20Hz motor cortex rTMS
* active psychiatric or neurological disorders
* history of CNS disease, concussion, overnight hospitalization, or other neurologic sequelae, tumors, seizures, frequent or severe headaches
* metal implanted above the neck
* currently taking seizure reducing medications
* currently taking psychotropic medications
* any psychotropic medication taken within 5 half-lives of procedure time
* abuse or dependence of drugs (excluding nicotine and caffeine)
* currently taking medications that lower the seizure threshold
* taking any of the stimulants, thyroid medication, or steroids
* implanted devices/ferrous metal of any kind
* history of seizure or seizure disorder
* inability to determine motor threshold.
* Pregnant females and children under the age of 18 will be excluded for safety reasons
* No vulnerable populations or special classes of subjects will be considered for participation.