cyrilzakka/clinical-trials huggingface dataset:
Eurbio-Alport (RaDiCo Cohort) (RaDiCo Eurbio-Alport)

Alport syndrome is a rare, inherited condition characterized by a combination of glomerular nephropathy progressing to kidney failure, deafness, and eye involvement. This disease is associated with mutations in the genes encoding one of the three IV collagen chains expressed in the glomerular basement membrane. Significant progress has been made in understanding the molecular mechanisms responsible for the disease, but relatively little in understanding the progression of renal failure and in the area of therapeutics. We have shown in a retrospective European study that blockers of the renin angiotensin system may slow disease progression, but no controlled studies have been performed. Finally, innovative therapies (anti-micro-RNA, stem cells) have recently shown their effectiveness in animal models of the disease, and industrials are planning to quickly carry out phase 1 trials to test molecules. Carrying out therapeutic trials in humans will require full knowledge of the natural history of the disease (isolated hematuria, microalbuminuria, macroalbuminuria, renal failure and its progression) and gathering a sufficient number of patients, especially in the early stages. These trials and the indications for treatments would be greatly facilitated by the discovery of biomarkers that make it possible to predict the progression to renal failure earlier than the onset of proteinuria.

The study aims to:

* Establish a European database on Alport syndrome to assess the natural history of the disease.
* To investigate the impact of the disease on the educational and professional life of patients and their families, and on the adherence and tolerance to renin-angiotensin system blockers prescribed to proteinuric patients.
* Investigate access to molecular diagnostics and genetic counseling, as well as identify biomarkers that can predict progression of kidney disease.

This project will be carried out at a French level with the support and participation of the very active renal rare disease sector, in collaboration with various countries wishing to participate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AS based on electron microscopic examination of the renal biopsy and/or molecular studies and/or abnormal expression of type IV collagen chains on skin and/or glomerular basement membranes.
* Signed informed consent

Exclusion Criteria:

- No exclusion criteria
Short- and Long-term HRV Measurements After Osteopathic Myofascial Thoracic Manipulations

The adaptation of the heart to react to any stimulus is called heart rate variability (HRV). Moreover, HRV is now used as a health index. In fact, among the pathologies affecting HRV the most, there are the cardiovascular diseases and depressive disorders that take a predominant part in the investigator's actual societies, According to a recent literature overview, many factors influence HRV and they need to be determined in order to plan efficient research protocols. Moreover, the control of these factors can improve the HRV and therefore help the heart to have maximum capacity to fulfill its physiological functions. Valorizing a good HRV seems, according to the effects reported by several studies, to be a good opportunity to take into consideration and to apply.

Visceral osteopathy, even if it goes back to the founder of Osteopathy himself, Andrew Taylor Still, is at its debuts in terms of acknowledgement from a scientific point of view. The evidence of efficacy of osteopathy is not to be done anymore. However, it is now necessary to define the action mechanisms of the osteopathic techniques, particularly by using physiological variables, and starting from a biomechanical angle. In fact, Jean-Pierre Barral and others has developed visceral manipulation techniques based on the viscera anatomy.

The originality of this research can be found in the technical protocol, not used yet, the use of witness group, the measurements over four weeks to evaluate the effect of this protocol with time on chosen dependant variables, its reproducibility but also its inter-therapist variance. This objective if this study is to reinforce the proof level of the osteopathic approach on the cardiac physiology. HRV is a solid tool recognized for research, the variable is well isolated and the control group ensures an isolation of some confounding variables.


Eligibility Criteria:
Inclusion Criteria:

* man or woman
* between 25 and 35 years old
* healthy
* non smoking

Exclusion Criteria:

* diagnosed with anxiety or psychological disorder
* smoker, drug consumption
* diagnosed with renal disorder, cardiac disorder, functional somatic disorders, diabetes, chronic alcoholism, cancer or immunosuppressive disorders, stroke, aortic aneurysm,
* pregnant
* high level athletes
* thoracic trauma or surgeries
* does not fit Hexoskin vest for HRV measurements
* does not complete all sessions
* cannot stay lying down for 1 hour
* below 25 or above 35 years old
* student in manual therapy
Walking Skill Training Program Effects in Patients With Total Hip Arthroplasty

Rehabilitation plays an important part after total hip arthroplasty. In this common practice few studies have been performed on this issue.

The aims of this study were:

1. to examine the immediate effects of a walking skill training program on walking, stair climbing, balance, self-reported physical functioning physical functioning, pain and self-efficacy compared to a control group without supervised physiotherapy
2. to examine whether the effects persisted 12 months after surgery


Eligibility Criteria:
Inclusion Criteria:

* Primary cox arthrosis
* Good written and oral Norwegian language

Exclusion Criteria:

* Severe hip arthrosis in the other hip or severe gon arthrosis that restricted walking
* Neurological disorders
* Rheumatoid arthritis
Protective Effects of Oral L-Arginine CI-AKI

This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in chronic kidney disease (CKD) patients.

Contrast-induced acute kidney injury (CI-AKI) is a common complication in hospitalized patients. Nitric oxide-signal transduction plays an important role in prevention of CI-AKI. L-Arginine is an amino acid involved in ammonia detoxification, and is well known as a precursor to nitric oxide, a key component of endothelial-derived relaxing factor.

This is a prospective randomized, double blind, placebo controlled trial among CKD stage 3-4 patients undergoing computer tomography. Eligible patients were randomly assigned to two groups: (1) arginine 3 g/day or 6 capsules per day, and (2) placebo 6 capsules per day for 3 days before contrast media injection. Serum cystatin C, serum creatinine and estimated GFR was measured at baseline and 48 hours after procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Stable CKD stage 3-4 patients
* Patients undergoing elective contrast media injection

Exclusion Criteria:

* History of arginine allergy
* Acute kidney injury diagnosed within 4 weeks
* Active infection/sepsis
* Severe liver disease
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)

This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)

To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE) meeting the definition of refractory epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of refractory epilepsy
* Body weight 26 to 111 kilogram (kg) inclusive
* Other inclusion criteria apply

Exclusion Criteria:

* Male or female subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product
* Female subject who is pregnant, breastfeeding, or planning to become pregnant
* Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
* Other exclusion criteria apply
Evaluation of TTP399 in Patients With Type 1 Diabetes

The purpose of this study is to evaluate the safety and efficacy of TTP399 in Type 1 diabetics. This study will be in 2 phases: phase 1 will evaluate the safety of different TTP399 dosage regimens over 1 week of daily dosing. Phase 2 will evaluate the safety and efficacy of a TTP399 dosing regimen over 12 weeks of daily dosing.


Eligibility Criteria:
Inclusion Criteria:

* People diagnosed with T1DM, confirmed diagnosis prior to 40 years of age and a diagnosed for minimum of 1 year.
* Type 1 diabetics using either continuous subcutaneous insulin infusion (with lispro or aspart) or multiple daily doses of insulin
* Willing to use adequate contraception
* No major surgeries or significant injuries within the past year and without an active infection.

Exclusion Criteria:

* Diagnosis of T2DM, severely uncontrolled T1DM, maturity-onset diabetes of the young, insulin-requiring T2DM, other unusual or rare forms of diabetes mellitus, diabetes resulting from a secondary disease
* Receipt of an investigational product within 30 days of the Screening Visit or any therapeutic protein or antibody within 90 days prior to Screening Visit or any previous treatment with TTP399.
* Living in the same household or related to another participant in this study.
* Two severe episodes of hypoglycemia that required assistance by a third party within 3 months of Screening Visit
* Use of antidiabetic medications other than insulin 3 months prior to Screening Visit, systemic corticosteroids 1 month prior to Screening Visit, weight loss medication 2 weeks prior to Screening Visit, and antipsychotic medications 3 months prior to Screening Visit.
* Participation in any formal weight loss program or contemplating such therapy during the trial.
* Recent history of use of non-prescribed controlled substances or illicit drugs.
* Current alcoholism or a history of excessive alcohol consumption within 2 years prior to screening
* History or presence of symptomatic autonomic neuropathy or chronic gastrointestinal disease.
* Personal history of long QT syndrome.
* Blood donation of approximately 1 pint (500 mL) within 8 weeks before Screening Visit
* History of hemolytic anemia or chronic transfusion requirement.
* History of cancer, other than non-melanoma skin cancer or uterine cervical cancer that required therapy in the past 5 years.
* Breastfeeding
Mechanisms And Prognosis of Stroke-Heart Syndrome

The incidence of stroke-heart syndrome following acute stroke, which encompasses both acute ischemic stroke and acute intracerebral hemorrhage, is notably high and is strongly associated with increased mortality and poor outcomes in stroke patients. However, the underlying mechanisms remain unclear, and there are currently no effective prevention or treatment strategies. This study aims to elucidate the neuro-humoral mechanisms of stroke-heart syndrome through multimodal imaging and multi-omics blood analysis. Additionally, it seeks to observe the progression of stroke-heart syndrome and its impact on functional outcomes, cognitive abilities, and emotional issues post-stroke. The research is expected to uncover novel blood biomarkers and brain network mechanisms associated with stroke-heart syndrome, providing potential targets and theoretical foundations for pharmacological treatments or physical interventions. Furthermore, it aims to establish a risk early-warning system for major cardiovascular complications post-stroke, enabling early identification, early intervention, and integrated brain-heart management to improve clinical outcomes for stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted within 48 hours of onset, confirmed by CT/MRI as having a stroke (including acute ischemic stroke and hemorrhagic stroke).
2. Moderate-to-severe stroke with NIHSS ≥ 5.

Exclusion Criteria:

1. Previous focal brain injury (such as stroke, brain surgery, traumatic brain injury, etc.).
2. Brain dysfunction caused by other major neurological disorders than stroke (such as brain tumors, epilepsy, Parkinson's disease, etc.).
3. Transient ischemic attack (TIA) and subarachnoid hemorrhage (SAH).
4. History of cardiac diseases (such as coronary heart disease, heart failure, severe arrhythmias, congenital heart disease, cardiac surgery, valvular heart disease, or undiagnosed significant cardiac symptoms).
5. Concomitant systemic diseases such as renal failure (eGFR \< 30), autoimmune disorders, severe infections, etc.
6. History of dementia, depression, or other psychiatric disorders.
7. Poor compliance and inability to cooperate with follow-up.
Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)

To describe the natural history of peripheral neuroblastic tumour presenting with SCI and evaluate the combined effects of different risk factors on the eventual neurologic and orthopaedic outcomes

Multi-centre, observational, prospective study registry. About 15% of patients with peripheral neuroblastic tumour present with extradural SCI, of whom approximately 60% are symptomatic. Since SCI may progress to irreversible paraplegia, early diagnosis and prompt treatment is of critical importance.1-3 The treatment options include chemotherapy, neurosurgical decompression and radiation therapy. All may relieve epidural compression, but there is no consensus on which to use first in the individual patient. However, the choice of the treatment could be relevant in the perspective of reducing to the minimum the risk of long-term sequelae.4 Guidelines for the diagnostic work-up and treatment of SCI for International Society of Paediatric Oncology European Neuroblastoma (SIOPEN) neuroblastoma patients were already available in the "guidelines for the treatment of patients with localized resectable neuroblastoma and analysis of prognostic factors" (LNESG1 Protocol), back in 1994,5 although it is unknown how they were applied in the SIOPEN Centres. These guidelines have been reformulated in occasion of the recently activated "European Low and Intermediate risk Neuroblastoma" (LINES Protocol).

There are few publications addressing the diagnosis and treatment of SCI; most are retrospective studies, case reports, or reviews that may be affected by reporting bias.1-9 Therefore new guidelines could be designed based on the information derived from a prospective data collection of newly diagnosed patients.

For this study Spinal Canal Involvement (SCI) is defined when, referring to an axial plane of the spinal cord MRI scan (Figure 1), the tumour extends into the vertebral canal and goes beyond a mentally drown ellipsoid (red circle) passing through the cortical bone of both anterior and posterior arches of the vertebra. This involvement is called "intraspinal" or, better, "intracanal".

Patient data to be collected and included in the corresponding Forms

1. work-up at diagnosis, including radiology report (Computed Tomography or Magnetic Resonance Imaging)
2. treatment administered
3. response to treatment, including radiology report
4. follow-up
5. outcome

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of peripheral neuroblastic tumour - peripheral neuroblastic tumour (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) presenting with SCI, symptomatic or asymptomatic, independent of disease extension (stage), and clinical course (first diagnosis or relapse/progression)
* No previous chemotherapy, except steroids, in the last 6 months
* Age \<18 years
* Minimal planned follow-up of 5 years
* Parent/patient written informed consent (Appendix 1(A,B,C))

Exclusion Criteria:

* Invasion of intervertebral foramina only
Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan

This was a retrospective study using the Taiwan's National Health Insurance Research Database (NHIRD). The study employed two study designs for different purposes as follows:

* A cross-sectional analysis was conducted to explore the annual incidence trends.
* A longitudinal cohort study was conducted to assess baseline characteristics, treatment patterns, long-term healthcare utilization, and cause-specific mortality among incident AMI patients.

In each part, the study was conducted for AMI, and separately for ST-segment elevation and non-ST- segment elevation myocardial infarction (STEMI and NSTEMI)


Eligibility Criteria:
Inclusion Criteria:

Cross-sectional analysis:

* Patients aged 20 years and older.
* Patients who had been admitted for AMI, defined as primary or first secondary diagnosis of AMI between 2014 and 2020.
* The diagnosis of AMI/ STEMI/ NSTEMI was identified by the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes and 10th revision (ICD-10-CM) codes.
* Incident cases of AMI hospitalization were defined as no history of AMI-related hospitalization or outpatient visit within 1 year before admission.

Longitudinal analysis:

Patients aged 20 years and older.

* Patients who had been admitted for AMI, defined as primary or first secondary diagnosis of AMI between 2014 and 2017.
* The diagnosis of AMI/ STEMI/ NSTEMI was identified by ICD-9-CM codes and ICD-10-CM codes. (The ICD-9-CM code and ICD-10-CM codes were the same as above)
* Incident cases of AMI hospitalization were defined as no history of AMI-related hospitalization or outpatient visit within 1 year before admission.
* The cohort entry date was defined as the admission date of incident AMI hospitalization, and the index date was defined as the discharge date of incident hospitalization.

Exclusion Criteria:

None specified
Anlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer

This study evaluates the safety and efficacy of anlotinib in combination with nivilumab as second-line treatment in advanced NSCLC patients. The primary endpoint of the study is progression-free survival (PFS);the secondary endpoints are disease control rate (DCR), objective response rate (ORR), overall survival (OS) and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18-75 years old;
2. ECOG PS：0-1,Expected Survival Time: Over 3 months;
3. Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC, with measurable nidus(using RECIST 1.1);
4. For local advanced or advanced NSCLC, disease progression occurred after first-line systemic treatment previously;
5. The negative patients in EGFR\&ALK can participate or who positive in EGFR\&ALK, have or have not drug tolerance after the treatment with relative targeted drugs;
6. main organs function is normal;
7. Signed and dated informed consent.

Exclusion Criteria:

1. have used Anlotinib before;
2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer);
3. examined as positive in EGFR\&ALK mutation detection and never take the treatment of TKIs;
4. Previously (within 5 years) or presently suffering from other malignancies;
5. Symptomatic or uncontrolled brain metastases;
6. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;
7. Pregnancy or lactation.
Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations

Preclinical data and limited clinical evidence suggest that Head and Neck Squameous Cell Carcinoma tumors harboring certain mutations may respond well to PI3K/mTOR inhibition (phosphatidylinositol-3-kinase/ mammalian target of rapamycin inhibition).

The current study enrolls patients with refractory and / or metastatic Head and Neck Squameous Cell Carcinoma based on the mutational status of their disease to assess the response to treatment with bimiralisib, an orally available pan-PI3K/mTOR inhibitor (phosphatidylinositol-3-kinase/ mammalian target of rapamycin inhibitor).


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytological confirmed diagnosis of Head and Neck Squameous Cell Carcinoma, for which no standard curative or life prolonging therapy is available
2. Available CLIA-certified sequencing results of the NOTCH gene in Head and Neck Squameous Cell Carcinoma (HNSCC) tumor material. The tumor must harbor a NOTCH1 LOF mutation as confirmed by central review (MD Anderson Cancer Center, MDACC)
3. ECOG performance status of ≤ 2
4. Adequate bone marrow, liver, and renal functions
5. Measurable disease according to RECIST version 1.1
6. Patients of reproductive potential must agree to use effective contraception from screening until 90 days after discontinuing study treatment.

Exclusion Criteria:

1. Has received any anti-cancer treatment including hormonal and investigational agents within 21 days prior to first dose of bimiralisib.
2. Major surgery within 28 days prior to first dose of bimiralisib or persisting side effects that have not improved to NCI-CTCAE grade 1 or better.
3. Pregnant or nursing (lactating) women.
4. Poorly controlled diabetes mellitus, steroid-induced diabetes mellitus
5. Has other active malignancies that require systemic treatment.
6. Has a known history of HIV infection
7. Any of the following cardiac abnormalities:

   * History of, or current, documented congestive heart failure (New York heart association functional classification iii - iv), documented cardiomyopathy
   * Symptomatic (NYHA class II or higher) left ventricular ejection fraction (LVEF) \< 40% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (echo)
   * Myocardial infarction ≤ 6 months prior to enrolment
   * Unstable angina pectoris
   * Serious uncontrolled cardiac arrhythmia
   * Symptomatic pericarditis
8. Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
9. Patient has a history of non-compliance to medical regimen or inability to grant consent.
10. Medically documented history of an active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or ≥ CTCAE grade 3 anxiety
11. History of interstitial pneumonitis or patients who require chronic oxygen supplementation.
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.

The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have previously met ≥4 of the 11 revised ACR criteria
* Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening
* Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥6

Exclusion Criteria:

* Have received prednisone \>20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)
* Have received the following medications within 28 days before Visit 2 (Day 1):

  * Systemic cyclophosphamide at any dose
  * Cyclosporine at any dose
  * Tacrolimus at any dose
  * Thalidomide at any dose
  * Mycophenolate mofetil \>2 g/day
  * Methotrexate \>15 mg/week
  * Azathioprine \>2 mg/kg/day
* Women who have a positive pregnancy test (serum hCG) at Visit 1