cyrilzakka/clinical-trials huggingface dataset:
The Role of Glass Stage Compared to WIFI Stage in Predicting Limb Salvage

compare between GLASS and WIFI Staging in predicting limb salvage in patients with chronic limb threatening ischemia ( CLTI) undergoing endovascular revascularization.

Peripheral arterial disease (PAD) is estimated to affect over 200 million people worldwide. These rates are expected to rise as increasing life expectancies continue to shift the population toward older age. At the most severe end of the disease spectrum, chronic limb-threatening ischemia (CLTI) affects 11% of patients with PAD and is associated with high rates of limb loss and mortality as well as high costs of care.(1) The Society for Vascular Surgery's WIfI (Wound, Ischemia, foot Infection) staging system was developed to classify threatened limbs using factors that affect amputation risk and clinical management in patients with chronic limb threatening ischemia . These include the extent of the wound, degree of ischemia, and severity of any foot infection. It has been validated as a predictor of limb salvage in peripheral artery disease.(2,3)

The Global Vascular guidelines 'GVG "proposes a new Global Anatomic Staging System (GLASS), which is a new method of quantifying the anatomic severity of infrainguinal disease in patients with chronic limb-threatening ischemia. But it has not been used for predicting limb salvage apart from use as a tool in deciding the mode of intervention for patients with chronic limb-threatening ischemia (CLTI).

Eligibility Criteria:
Inclusion Criteria:

-

Patients with CLTI who will undergo endovascular revascularization at our department:

• Rutherford stage 4 ( rest pain) ,stage 5 (ischemic ulceration not exceeding ulcer of the digits of the foot) , stage 6 ( severe ischemic ulcers or frank gangrene)

Exclusion Criteria:

* Rutherford stage 1,2,3 Aortoiliac level of occlusion Unsalvageable limb Patients with contraindications to contrast media Non Atherosclerotic lschemia as • Acute ischemia

  * Post Traumatic Ischemia
  * Chronic ischemia caused by connective tissue diseases or vasculitis
Clinical Study on Lymphaticovenous Anastomosis（LVA） for the Treatment of Alzheimer's Disease（AD）

The goal of this clinical trial is to explore the safety and efficacy of Lymphaticovenous Anastomosis (LVA) for the Treatment of Alzheimer's Disease (AD). The main questions it aims to answer are:

1. After LVA surgery treatment, do patients with AD show improvement in dementia, cognitive impairment, neurobehavioral symptoms?
2. What are the complications associated with LVA treatment for AD, including perioperative complications and long-term complications?
3. What is the mechanism of LVA treatment for AD patients, and what changes occur in AD-related biomarkers (Aβ42、 Aβ40、Aβ42/40、pTau217、pTau181) before and after surgery?


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with Alzheimer's Disease based on biomarkers, imaging, and clinical symptoms;
2. Male or female aged 50-85 years (inclusive);
3. At least one caregiver who can live with the patient for an extended period;
4. No severe systemic diseases affecting the heart, liver, kidneys, etc.;
5. Patients who voluntarily participate in clinical recruitment, accept the LVA surgical treatment plan, and sign the informed consent form.

Exclusion Criteria:

1. Poor overall health, unable to tolerate surgery;
2. Preoperative anesthetic assessment indicates inability to tolerate general anesthesia;
3. Presence of other neurological or psychiatric disorders;
4. Severe bleeding tendency due to coagulopathy;
5. Inability to comply with treatment and follow-up;
6. Other conditions that preclude tolerance to surgery.
GENomic PROfilation for Therapeutic Purposes in SARComas and Molecular Tumor Board (MTB): Retrospective/Prospective Study in Referral Centers

Multicenter noninterventional, translational study, retrospective/prospective designed in order to assess the aptitude to the use of genomic profiling methods for therapeutic purposes and evaluation by the institutional Molecular Tumor Board (MTB) of sarcoma patients with metastatic/locally advanced disease that is inoperable with no viable therapeutic alternatives or with histotypes known to be resistant to available in-label medical treatments and without already therapeutically validated driver mutations.


Eligibility Criteria:
Inclusion Criteria:

* Sarcoma patients of any age (inclusion of centers pediatric)
* Patients with any histotype of soft tissue sarcomas and bone
* Patients at any stage of the treatment pathway for disease that is localized or metastatic/inoperable
* Availability of follow-up data
* Written informed consent (prospective part/patients in follow-up)
Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response

This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy.

* Patient information and collection of a signed informed consent form
* Clinical data collection
* Blood samples of 35 mL:

  1. after registration, prior to the first fraction of radiotherapy
  2. within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions
  3. one week, 3 months, 6 months, 9 months and 12 months after the last radiotherapy session
* Storage of the blood samples at ambient temperature
* Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis
* Destruction of the samples at the end of the analysis

Eligibility Criteria:
Inclusion Criteria:

* Patient requiring a hypofractionated irradiation (≥ 3 fractions, dose ≥ 9 Gy per fraction) either for :
* hepatocellular carcinoma or hepatic lesion of metastatic Colorectal Cancer,
* metastasis from melanoma or renal cancer,
* Age ≥ 18 years old,
* Registered with a social security system,
* Signed written informed consent.

Exclusion Criteria:

* Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
* Pregnant or breastfeeding woman,
* Patient under guardianship or tutorship.
Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma

It is an observational, case-control study aimed at early-detection of multiple myeloma and constructing a prognostic model of multiple myeloma. The study will enroll approximately 398 participants including patients with multiple myeloma, patients with benign hematologic disorders and healthy participants.


Eligibility Criteria:
Inclusion Criteria for Cancer Participants:

* Age 40-75 years
* Ability to provide a written informed consent
* Pathologically confirmed diagnosis of multiple myeloma or highly suspicious cases of multiple myeloma
* No prior or ongoing anti-cancer treatment (local or systematic) prior to study blood draw

Inclusion Criteria for Benign Disease Participants:

* Age 40-75 years
* Ability to provide a written informed consent
* Pathologically confirmed diagnosis of benign hematologic disorders or highly suspicious cases with benign hematologic disorders
* No prior or ongoing radical treatment of the benign hematologic disorders prior to study blood draw

Inclusion Criteria for Healthy Participants

* Age 40-75 years
* Ability to provide a written informed consent
* No cancer-related symptoms or other uncomfortable symptoms prior to study blood draw

Exclusion Criteria for All Participants:

* Insufficient qualified blood samples
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
* Recipient of blood transfusion within 7 days prior to blood draw
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen)

Additional Exclusion Criteria for Cancer Participants:

• Other current malignant diseases or multiple primary tumors

Additional Exclusion Criteria for Benign Disease Participants:

• Current or history of malignancies

Additional Exclusion Criteria for Healthy Participants:

* Recipient of anti-infectious therapy within 14 days prior to study blood draw
* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
* Current autoimmune disease or clinically significant or uncontrolled comorbidities
A Study to Examine APL-130277 in Patients With Parkinson's Disease

The primary objective of this study is to evaluate the efficacy, tolerability and safety of single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Clinical diagnosis of Idiopathic PD
3. Receiving stable doses of L-dopa +/- other adjunctive PD therapy for at least 4 weeks before study participation.
4. At least one OFF episode per day and a total daily OFF time of \> 2 hours duration.
5. Experience predictable OFF episodes in the morning on awakening prior to receiving morning dose of levodopa.
6. Stage I to III on the Hoehn and Yahr scale in the "ON" state.
7. If female and of childbearing potential, must agree to use one of the following methods of birth control:
8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study.
9. Able to understand the consent form, and to provide written informed consent.

Exclusion Criteria:

1. Atypical or secondary parkinsonism
2. Changes in L-dopa or other PD drug dosing regimens 4 weeks before the screening visit.
3. Past treatment with any form of apomorphine within 30 days of Dosing Day 1 (patients who stopped apomorphine for reasons other than lack of efficacy OR tolerability issues may be considered for the trial).
4. Female who is pregnant or lactating.
5. Contraindications to APOKYN or hypersensitive to apomorphine hydrochloride or any of the ingredients of APOKYN (notably sodium metabisulfite), or Tigan®.
6. Participation in any other clinical trial within 14 days of the screening visit.
7. Receipt of any investigational (i.e., unapproved) medication within 30 days of the screening visit.
8. Currently taking, or likely to need to take at any time during the course of the study
9. Currently taking dopamine antagonists or depleting drugs excluding anticholinergics and/or antihistamines with anticholinergic effects.
10. Drug or alcohol dependency in the past 6 months.
11. Clinically significant orthostatic hypotension.
12. Malignant melanoma or a history of previously treated malignant melanoma within 5 years.
13. Clinically significant medical surgical or laboratory abnormality in the judgment of the investigator.
14. Psychiatric disorder, including but not limited to dementia or any disorder that, in the opinion of the Investigator requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
15. Dementia that precludes providing informed consent.
16. Potential for lack of compliance and follow-up in the judgment of the investigator.
17. Any other condition, current therapy, or prior therapy (within 30 days of the screening visit), which, in the opinion of the Investigator, would make the subject unsuitable for the study.
18. Previous neurosurgery for PD.
19. Donation of blood or plasma in the 30 days prior to dosing.
20. Presence of cankers or mouth sores.
Cognitive Remediation in Schizophrenia

The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with chronic schizophrenia or other psychoses.

Cognitive deficits are a problem for many people with schizophrenia. This study will use computerized cognitive remediation training (which the participant can carry out at home) over a period of a few months.

The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with schizophrenia. Pre and Post neuropsychological assessment and Magnetic Resonance Imagery (MRI) will be used to determine the effects of CR training on

1. Neuropsychological performance
2. Brain Structure using voxel-based morphometry (VBM)
3. Brain function using functional MRI (fMRI)
4. Social and occupational functioning

The cognitive remediation intervention is a computerised programme whose training level is dynamically varied to suit participants individual ability level. Motivation to learn and generalization to real world function are a particular focus of the intervention and are supported with ongoing therapist interaction in addition to personal training.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia
* History of Psychosis
* Subjective difficulties with memory or concentration
* Aged 18-60 Years

Exclusion Criteria:

* History of head injury resulting in loss of consciousness
* Substance misuse in the last 3 months
Nimotuzumab in Adults With Glioblastoma Multiforma

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient signed informed consent
* Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
* Condition is measurable by MRI in at least one dimension
* Age 18-70
* Karnofsky-Index \> 40
* Treatment in a study center
* Female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male patients admitted in the study must use a reliable method of contraception.
* Adequate haematological, renal and hepatic function:

  * Leucocytes \>2.0x10\^9/l
  * Hb\> 10g/dl
  * Billirubin total \< 2.5x upper limit of normal (ULN)
  * Creatinin i.S. \< 1.5x ULN
  * AST (GOT)/ALT (GPT) \< 5x ULN

Exclusion Criteria:

* Patients with history of anaphylactic reaction to murine or humanized antibody
* Patients with evidence second malignancy
* Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial
* Pregnancy and lactation
* Other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement
* No MRI for tumour evaluation
Identify Prognostic Biomarkers of Lung Cancer

Multi-omics and Clinical Data Analysis is potential to predict the prognosis of lung cancer patients.

Lung cancer is the leading cause of cancer-related death in China. In order to improve prognosis of lung cancer as well as provide new therapeutic targets, the identification of effective biomarkers for the prognosis of lung cancer is of great significance. It has been reported that some small molecules such as lncRNA, circRNA and polypeptides in human plasm have good prospects in diagnosing or evaluating the stage of diseases. In this study, we planned to use multi-omics combined with clinical data to discovery some small molecules that are potential to predict the prognosis of lung cancer patients. In addition, we want to construct a new risk score model that provide a candidate model for prognostic evaluation of lung cancer. And we hope our study can provide insights for precision immunotherapy of lung cancer by exploring the differences in clinical characteristics, tumor mutation burden, and tumor immune cell infiltration between different risk score groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lung cancer;
* Untreated lung cancer patients;
* No history of chronic or serious diseases, such as cardiovascular disease, liver disease, kidney disease, respiratory disease, blood disease, lymphatic disease, endocrine disease, immune disease, mental disease, neuromuscular disease, gastrointestinal system disease, etc.

Exclusion Criteria:

* Patients with other tumors;
* Lung cancer patients who had been treated;
* Abnormal liver and kidney function;
* Acute and chronic infectious diseases
Artificial Intelligence Based Melanoma Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults

The goal of this study is to develop supportive diagnostic artificial intelligence algorithms to distinguish melanoma from nevi or other benign pigmented skin lesions, especially in younger patients (below the age of 30). The main goals it aims to achieve are:

* development of an algorithm based on dermatoscopic images, targeting skin cancer screening in vulnerable populations
* development of another algorithm based on histological images, intended to be used by pathologists on lesions that are still suspicious of melanoma after dermatologic assessment
* implementation of explainability methods to enable the user to better comprehend the systems' decisions, avoid biases and increase trust in these applications

There is no additional time commitment for the study participants for this study, as the data used in this project will be collected in routine clinical practice anyway.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Patients without a melanoma or nevus diagnosis
* images with insufficient image quality
The Effect of Mindfulness-Based Mandala Activity on Anxiety and Spiritual Well-Being Levels of Senior Nursing Students

This research was conducted to determine the effect of mindfulness-based mandala activity on the spiritual well-being and anxiety levels of senior nursing students in a parallel-group pretest-posttest randomized controlled study design. The required institutional permission and ethics committee approval was received. The study group of the study consisted of 170 senior nursing students (intervention group \[n=84\], control group \[n=86\]). Mindfulness-based mandala activity was applied to the intervention group via the zoom online program. Data were collected using the descriptive features form, the Spielberg Trait, and State Anxiety Inventory, the Spiritual Well-Being Scale, and the scale of the positive-negative experience. The data were stored in the SPSS 24 program.

This research was conducted to determine the effect of mindfulness-based mandala activity on the spiritual well-being and anxiety levels of senior nursing students in a parallel-group pretest-posttest randomized controlled study design. The required institutional permission and ethics committee approval was received. The study group of the study consisted of 170 senior nursing students (intervention group \[n=84\], control group \[n=86\]). Mindfulness-based mandala activity was applied to the intervention group via the zoom online program. Data were collected using the descriptive features form, the Spielberg Trait, and State Anxiety Inventory, the Spiritual Well-Being Scale, and the positive-negative experiences scale. Students will be divided into groups of 6-10 and mandala activities will be carried out. 3 weeks of mandala activity, breathing exercises, affirmations, etc. a therapeutic application program was created and implemented. For the students in the control group, the standard support program given by the school administration and course instructors will be applied for clinical problems. At the end of the study, it is planned to apply mandala activities among the students in the control group. The research is based on Watson's "Human Caring" theory.

Eligibility Criteria:
Inclusion Criteria:

* Registering the theoretical and practical courses within the scope of Nursing Vocational Courses Application II,
* with internet access,
* Students who agree to participate in the study

Exclusion Criteria:

* Receiving psychiatric treatment (pharmacological and/or psychotherapy),
* with substance addiction,
* Must have participated in any meditation-based therapy program before.
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g

This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Completion of last visit (or early termination visit, if applicable) for Study Q2788g
* Signed Informed Consent Form
* Use of an effective method of contraception for females of childbearing potential
* Body weight ≥ 20 kg and ≤ 150 kg
* IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE \< 30 IU/mL will be dosed at the lowest level on the dosing table \[30 IU/mL\], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)

Exclusion Criteria:

* Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)
* Current participation in another investigational study
* Pregnancy or lactation
* History of brittle asthma
* Aspirin-sensitive asthma
* Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20)
* Have a polymorrphonuclear count \<1500/uL
* Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine
* Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer)
* Thrombocytopenia as evidenced by a platelet count \< 100,000/uL
* Any systemic condition requiring regular administration of an immunoglobulin