cyrilzakka/clinical-trials huggingface dataset:
Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer

Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.

Main objective: Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline.

Secondary objectives:

* evaluate diagnostic performance of FES PET/CT
* determine whether FES PET/CT is able to detect metastases that are not visible on FDG PET/CT. This point may constitute a direct benefit for the patient
* precise the nature of discordant FES/FDG foci
* validate and improve the interpretation criteria for FES PET/CT
* confirm the perfect tolerance

Eligibility Criteria:
Inclusion Criteria:

* Post menopausal
* age \> 17
* WHO 0-2
* Metastatic adenocarcinoma of the breast
* Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment
* Life expectancy \> 6 months
* Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour
* Presence of oestrogen receptors proven with immunohistochemistry (\> 10%) and HER2 determined by immunohistochemistry or FISH (on primary tumour or a metastasis)
* Metastatic recurrence on FDG PET dating less than 1 month, confirmed by another modality (contrast-enhanced CT, MRI, ultrasonography, bone scintigraphy or PET/CT, other)
* FDG PET/CT available on PACS or CD DICOM III format 11
* Informed consent obtained

Exclusion Criteria:

* Other evolutive malignant disease or acute or chronic infectious disease
* Chemotherapy during the last 3 months or change in treatment since FDG PET/CT.
* Isolated liver metastasis (high FES uptake by normal liver)
Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue (ETUVVE)

Ulcers of the lower limbs are a major public health problem whose management needs to be further improved, particularly in terms of healing time, prevalence and recurrence rate. Ulcers of venous origin, or mixed arteriovenous and predominantly venous, represent the majority of leg ulcers with an estimated proportion of 70 to 80% of cases. These are painful, disabling conditions that are difficult to treat in a lasting way.

This study focuses on a treatment strategy with endovascular glue. The advantage of treating ulcers with cyanoacrylate glue is the possibility of occluding the great saphenous vein over its entire length, freeing itself from neurological complications secondary to endovenous thermal techniques (laser, radiofrequency), as well as the possibility of treating by direct puncture any perforators or tributaries feeding the ulcer.

This treatment strategy would improve the healing process for a lasting resolution of this pathology. This study aims to describe the feasibility and tolerance of this type of treatment in the resolution of varicose ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Primary insufficiency of the great saphenous vein (GVS) by a reflux\> 0.5 second from the inter-fascial saphenous trunk to the upper 1/3 of the thigh extending over the entire height of the thigh either in the saphenous compartment or in at least one extra-fascial tributary, in a standing patient, by compression of the calf
* CEAP: C6, ulcer present on a single leg whose size can be captured by a simple photograph
* Diameter of the GVS at the saphenofemoral junction ≥3 or ≤12 millimeters
* Patient affiliated or beneficiary of a social security scheme
* Patient having signed the informed consent

Exclusion Criteria:

* Patient with a circumferential ulcer
* Patient with ipsilateral small saphenous vein insufficiency
* Presenting a serious current pathology and / or a life expectancy of less than 5 years
* History of deep or superficial vein thrombosis in the previous 6 months
* Patient with arteriopathy obliterating of the affected lower limb, with an IPS \<0.8 or\> 1.3
* With post-thrombotic obstructive syndrome in the popliteal and / or femoral and / or iliac stage on the ipsilateral lower limb
* Presenting primary or post-thrombotic axial deep venous reflux on the ipsilateral lower limb
* Suspicion of non-post-thrombotic iliac compression on Doppler ultrasound
* Contraindication to the intended treatment technique
* Known allergy to cyanoacrylate glue or xylocaine
* Patient with a BMI greater than 40 (morbid obesity)
* Patient whose geographical distance is not compatible with the follow-up of the study
* Pregnant or breastfeeding woman
* Patient participating in another clinical study
* Patient linguistically or psychically unable to understand the information given, to give informed consent or to answer the study questionnaires.
* Protected patients: Adults under some guardianship or other legal protection; Hospitalized without consent
Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification

Novel wireless technology has created inexpensive tools that allow both accurate monitoring of adherence to pills as well as real-time interventions such as automated reminders in the event of a missed dose. In this study, the investigators will use Vitality GlowCaps, an electronic pill bottle. These pill bottles provide an unbiased assessment of pill bottle opening and a valid approach to verifying self-administered pill taking, reflecting not only daily use but also patterns of drug use and timing. At the prescribed times, bottle will electronically transmit whether a subject opened the pill cap to take the immunosuppressant medication via a built-in transmitter to the central server. The investigators will randomize participants to usual care, customized reminders, and customized reminders paired with provider notification in the event of low adherence.

The investigators' aim: To improve immunosuppression (IS) medication adherence in kidney transplant recipients.

The investigators' hypotheses: a) Automated reminders will improve adherence to immunosuppression compared to usual care, and b) Automated reminders, paired with provider notification about patients with poor adherence, will improve adherence to immunosuppression compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years or older) kidney or kidney-pancreas transplant recipient
* Hospital of the University of Pennsylvania (HUP) kidney transplant recipient (KTR)
* Recruitment within 2 weeks of discharge date
* Living within 120 miles of HUP

Exclusion Criteria:

* Vulnerable populations
* HIV seropositive status
* Poor English communication (which might hinder necessary communication with study coordinators)
* Discharge to care facility that handles patient medications
* Demonstrates inability or unwillingness to manage own medications
Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease

The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.


Eligibility Criteria:
Inclusion Criteria:

* SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
* Patients must have maintained eligibility requirements throughout their participation in SL0007
* Written informed consent signed prior to initiation of any study-specific assessments at visit 1

Exclusion Criteria:

* Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
* Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
* Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine \>2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria \>3.5gm/day
* Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
* Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.
Influence of Opioid Analgesia on Circulating Tumor Cells in Open Colorectal Cancer Surgery

To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing open radical surgery for colorectal cancer
* age over 18 years
* signed informed consent

Exclusion Criteria:

* intolerance of the study drugs
* history of CRC surgery
* neoadjuvant therapy
* contraindications to epidural analgesia
* other malignancy not in permanent remission
* chronic opioid medication or opioid administration within 7 days preoperatively
* immunosuppressive or corticosteroid therapy
* surgery within 30 days preoperatively (except minor)
* chronic or acute infection
OTAGO Exercise Program and Motivational Interviewing

The goal of this study is to see if OTAGO instructors, who have been trained in a special communication method called motivational interviewing, can help older adults start and stick with the OTAGO exercise program. The results will help guide future research on how behavior change techniques can support other fall prevention strategies.

The objective of this study is to evaluate the feasibility and impact of OTAGO instructors who are trained in motivational interviewing communication approach to facilitate older adult's uptake of the OTAGO exercises. This study will create the basis for future trials that will explore the impact of behavior change interventions on other fall prevention strategies.

We propose a single-arm quasi-experimental trial with older adults with high fall risks. The study intervention consists of OTAGO visits by study staff (MI-trained OTAGO instructor) over 6 months to improve older adults' engagement in fall prevention behaviors with a focus on OTAGO exercises. Participants will be followed for additional 6 months for the total study duration of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60
* At high fall risk: At least one "Yes" to 1) had a fall in the past year; 2) answer "difficult" to the question "do you find it hard to stand without using your hands"; 3) worry about falling
* Able to converse audibly and coherently in English
* Ambulatory with or without assistive device use
* Self-report challenges navigating the environment outside of the home
* At least one "some or much difficulty" or "unable to do" to:Walking one block?; Stepping up onto a curb?; Getting out of a straight back chair? Climbing one flight of stairs? Getting out of the house

Exclusion Criteria:

* o Receiving ongoing physical therapy with a primary focus on improving balance and strength of lower extremities

  * Experiencing acute health issues such as fracture, pain, or infection that prohibits them from participating in exercises
  * Able to stand on one foot for more than 10 seconds without holding onto something
  * 6-item Callahan cognitive assessment over the phone: Patients with scores of 2 or less, positive for dementia criteria, will be excluded.
  * Patients participating in other studies that may impact fall-related behavior change.
  * Participants engaged in routine moderate or vigorous physical activities that require lower extremity balance and strength (e.g., \>100 minutes/week for more than 3 months)
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.

This study has multiple primary endpoints.


Eligibility Criteria:
Inclusion Criteria:

* Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
* Lung function capacity capable of tolerating the proposed lung surgery
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Available tissue of primary lung tumor

Exclusion Criteria:

* Presence of locally advanced, inoperable or metastatic disease
* Participants with active, known or suspected autoimmune disease
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria apply
Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery

The aim of this study is to reveal the factor associated with failed spinal anaesthesia in cesarean delivery. We conduct the retrospective case-control study to elucidate the involving factors.

Spinal anaesthesia is the anaesthetic technique of choice of patients undergoing cesarean delivery due to its rapid onset, good reliability and good efficacy. However, the inadequate or failed spinal anaesthesia can occur. The previous literatures revealed incidence of failed spinal anaesthesia was as high as 0.5-6%. Failure of spinal anaesthesia leads to numerous maternal and neonatal consequences. Those failed spinal anaesthesia patients required general anaesthesia with endotracheal tube which may cause several complications such as hypoxia, difficult intubation, failed intubation and pulmonary aspiration. Also, a recent network meta-analysis showed general anaesthesia decreasing neonatal Apgar score.

The factors that associated with failed spinal anaesthesia in cesarean delivery has been studied. The amount of local anaesthetic, needle type, patients' body mass index (obesity), and experiences of the anaesthetist performing spinal block influenced the failure of spinal anaesthesia. The details and factors of failed spinal anaesthesia in our hospital was scarce. It has not yet been published in the literature.

Therefore, the aim of this study is to reveal the factor associated with failed spinal anaesthesia in cesarean delivery. We conduct the retrospective case-control study to elucidate the involving factors.

Eligibility Criteria:
Inclusion Criteria:

* Age \>,= 18 years
* Undergoing cesarean delivery
* Failed spinal anaesthesia and received general anaesthesia with endotracheal tube

Exclusion Criteria:

* Gestational age \< 24 weeks
* Received combined spinal-epidural anaesthesia
* Received peripheral nerve blockade
Treatment of Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy

This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Non-Hodgkin lymphoma treatment.

CD19-TriCAR contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T/SILK to simultaneously targeting the CD19 positive Non-Hodgkin lymphoma，blocking the inhibitory PD-L1 signal and stimulating innate T/NK cell activation and expansion, thus make it a tri-functional CAR (Tri-CAR). CD19-TriCAR-T is an autologous tri-functional CAR-T cell therapy, CD19-TriCAR-SILK is an Allogeneic tri-functional CAR-NK cell therapy, patients ineligible for leukapheresis or CAR-T therapy will be recommended for CD19-TriCAR-SILK therapy.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
2. All subjects must be able to comply with all the scheduled procedures in the study;
3. Refractory or relapsed malignant Non-Hodgkin lymphoma, defined as one or more of the following: Relapsed in 6 months after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed in ≤12 months of ASCT;
4. At least one measurable lesion per revised IWG Response Criteria;
5. Aged \<70 years;
6. Expected survival ≥12 weeks; Eastern cooperative oncology group (ECOG) performance status of≤2;
7. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
8. All other treatment induced adverse events must have been resolved to ≤grade 1;
9. Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB\>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);

Exclusion Criteria:

1. Presence of fungal, bacterial, viral, or other infection that is hardly to control（defined by investigator）;
2. Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
3. Lactating women or women of childbearing age who plan to conceive during the time period;
4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
5. Known history of infection with HIV;
6. Subjects need systematic usage of corticosteroid;
7. Subjects need systematic usage of immunosuppressive drug;
8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
9. Other reasons the investigator consider the patient may not be suitable for the study.
Early and Late Implant Failure

The aim of this study was to evaluate the early and late implant loss rate in a sample of patients who had received implant-supportive restorative therapy in a university setting. Moreover, the study aimed to identify patient- and implant-related variables for implant failure


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old
* Partially or totally edentulous patients with at least one implant placed at the university and at least 7 years before.
* Cemented, screwed, or mechanically retained prosthesis.
* Single and partial prostheses, as well as complete arch prosthesis (fixed and removable).

Exclusion Criteria:

-
Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens

This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
* Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
* Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
* HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
* BMI (Body Mass Index) below or equal to 45 kg/m\^2
* Ability and willingness to adhere to the protocol including self measurement of plasma glucose

Exclusion Criteria:

* Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
* Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
* Known or suspected hypersensitivity to trial products or related products
* The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
* Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
The Efficacy of Botulinum Toxin in Spastic Neuropathic Bladder

To assess the efficacy of botulinum toxin in spastic neurogenic bladder.

Neurogenic detrusor overactivity (NDO) can result in lower and upper urinary tract complications and eventually even in end-stage kidney failure. Since the driving force of this clinical cascade is high bladder pressure, controlling intravesical pressure in NDO patients improves both quality of life and life-expectancy in these patients. Botulinum toxin A (BTX-A) has proven its efficacy in reducing intravesical pressure and in reducing incontinence episodes. BTX-A also improves quality of life in patients with NDO. Both onabotulinumtoxinA (Botox®, Allergan, Irvine, USA) and abobotulinumtoxinA (Dysport®, Ipsen, Paris, France) have a level A recommendation for NDO-treatment. The recommended dose for intradetrusor injections in NDO patients is 200 U of onabotulinumtoxinA or 500 U of abobotulinumtoxinA. The drug is generally administered extratrigonal in the detrusor muscle, via cystoscopic guided injection at 20 sites in 1 mL injections. Intradetrusor BTX-A injections are safe, with mostly local complications such as urinary tract infection and high post-void residual or retention. The effect of the toxin lasts for approximately 9 months. Repeat injections can be performed without loss of efficacy. Different injection techniques, novel ways of BTX-A administration, eliminating the need for injection or new BTX-A types with better/longer response rates could change the field in the future.

Botulinum toxins are neurotoxins produced by the facultative anaerobe Clostridium botulinum that block the release of acetylcholine into the synaptic gap of the neuromuscular junction. Their injection near the nerves that supply the target organ selectively and temporarily paralyzes the organ. In particular, the subtype botulinum-A toxin is widely used in neurology to release spastic dystonia in adults and children . In urologic disorders, botulinum-A toxin reliably diminishes external sphincter or detrusor overactivity.

Eligibility Criteria:
Inclusion Criteria:

-1- patients with spastic neurogenic bladder due to upper motor neuron lesion as (spinal cord lesions ,multiple sclerosis ,strokes,parkinsonism...........).

2- patients with spastic neurogenic bladder diagnosed clinically and urodynamically.

Exclusion Criteria:

* 1-patients with associated lower motor neuron lesions. 2-atonic bladder. 3-patients with diabetes mellitus.