cyrilzakka/clinical-trials huggingface dataset:
Neoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer

This is a single-center, prospective, single arm phase II study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. The primary objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample size is 30.


Eligibility Criteria:
Inclusion Criteria:

* Female, between 18 and 70 years old
* Life expectancy is more than 12 months
* Breast MRI or ultrasound confirmd tumor over 3cm and biopsy comfirned invasive breast caner of stage II-III (inflammatory breast cancer excluded)
* Not accompanied with other malignancies（except for controlled carcinoma in situ of the cervix or skin basal-cell carcinoma）
* A normal bone marrow: absolute neutrophil count≥1.5\*10E9/L, hemoglobin≥100g/L, PLT≥100\*10E9/L
* Normal liver and renal functions: AST≤60U/L, total biliruin≤1.5\*upper limit of normal, serum creatinine≤110umol/L, urea nitrogen≤7.1mmol/L
* Normal blood coagulation function
* ECOG performance status of 0-1
* Willing to coordinate with a punch biopsy before treatment and accept neoadjuvant therapy
* Women of child-producing potential must agree to use effective contraceptive methods during the study, and a negative serum or urine pregnancy test must be obtained within 7 days prior to administration of the drugs
* Written informed consent
* For HER-2 positive patients, the HER-2 status must be determined by ICH +++ or FISH/CISH. For patients treated with trastuzumb, LVEF≥55% by ultrasonic cardiogram or MUGA scan

Exclusion Criteria:

* Previous systematic or local therapy including chemotherapy for breast cancer
* Distant metastases of breast cancer are observed
* Concurrent uncontrolled lung disease, severe sepsis, active peptic ulcer requring treatment, blood coagulation disorders, serious uncontrolled diabetes, connective tissue disease or bone marrow depression, unable to tolerate neoadjuvant therapy and related treatment
* \>Grade 1 peripheral neuropathy caused by any reason
* History of CHF, uncontrolled symptomatic angina, history of arrhythmias or myocardial infarction, poorly controlled hypertension (systolic pressure \> 180mmHg or diastlic pressure \> 100 mmHg)
* Lactational or gestational breast cancer
* Not willing to accept a punch biopsy before treatment and neoadjuvant therapy
* Psychopath or any other reasons that would preclude compliane with treatment
* Known serious allergy to any of the study drugs or excipients
* Participation in another study requiring administration of an in investigational drug or biological agent at present or recently (within the last 30 days prior to screening visit)
Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate

This is a non-interventional pilot study with the following objectives:

* Establish scalable methodology for collection of retinal images, blood pressure (BP) and laboratory-based assessments
* Compare the results of a machine-learning algorithm in predicting BP, glycated haemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR) from digital retinal images with clinical and laboratory-based measures
* Determine the required sample size needed to support a future study to fully validate the machine-learning algorithm


Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥ 35 years of age, at the time of signing the informed consent.
* With or without DM (at least 50% of participants will have an HbA1c ≥ 6.5%\* and/or a known diagnosis of DM)
* Male or female (at least 40% of participants must be male, and at least 40% must be female)
* Capable of giving signed informed consent as described in Appendix A

Exclusion Criteria:

* As judged by the investigator, any evidence of a medical condition which in the investigator's opinion makes it undesirable for the participant to participate in the study for example, but not limited to, if a participant is critically unwell or requiring ongoing emergency treatment
* Any known eye condition that may preclude clear imaging of the retina for example; cataracts
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
* Previous enrolment in the present study with the exception of roll-in participants who may be re-screened and re-enrolled.
An Acupuncture Study for Breast Cancer Survivors With Joint Pain on Hormonal Therapies

The purpose of this study is to see whether acupuncture is a practical (feasible) treatment for breast cancer survivors with joint pain on hormonal therapies.


Eligibility Criteria:
Inclusion Criteria:

* English- or Spanish-speaking
* Black and/or Hispanic women with a history of stage I, II, or III BC (transgender males are eligible to enroll)
* No evidence of current BC disease
* Receiving AI for at least 28 days with plan to continue for another 14 weeks
* Worst pain rated ≥4 on a 0-10 scale in the preceding week
* ≥15 days with pain in the past 30 days
* Pain lasting ≥1 month
* Pain attributed to AI as reported by the patient
* Willing and able to complete questionnaires and other study activities
* Willing and able to provide informed consent for the trial

Exclusion Criteria:

* All Stage IV Cancer
* Active oncological disease
* Completed chemotherapy, surgery, or radiation \<4 weeks prior to study
* Pain attributed to inflammatory arthritis (e.g., rheumatoid arthritis, gout)
* Procedures involving affected joints within the last month or planned in the next 14 weeks
* Acupuncture use for pain in the past year
* Implanted electronic device (e.g., pacemaker)
Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

Oxidative stress has been implicated in the development and complications of diabetes. Hyperglycemia and insulin resistance or insufficiency in diabetes can cause oxidative stress by excessive reactive oxygen species and can increase damage and alter antioxidant status in nerve cells. Antioxidant defense mechanisms protect against damage or restore oxidative damage. Glutathione, a powerful antioxidant plays a key role in the first line of antioxidant defense and seems to be a sensitive indicator of oxidative stress in various diseases such as diabetes. Glutathione functions in the regeneration of vitamin C which is another crucial antioxidant. Both hyperglycemia and insulin insufficiency inhibit uptake of vitamin C. The brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. Since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C will be studied.

The brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. Since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C will be studied.

Eligibility Criteria:
Inclusion Criteria:

* 30-55 years of age
* Diabetic being treated with diet and any of the following: insulin, or other diabetic specific drug such as metformin, sulfonylurea or sitagliptin.
* Healthy subjects age and gender matched to diabetes patient

Exclusion Criteria:

* Use of any anti-inflammatory or antioxidant medications other than small daily doses of Aspirin (ASA:325 mg) and a daily multivitamin
* Co-existing chronic inflammatory conditions such as Crohn's disease, rheumatoid arthritis, chronic or acute infections
* Any concurrent neurological disease except for mild diabetic autonomic or peripheral neuropathy
* Postmeal C peptide \> 0.3 mg/dl
* Normal healthy subjects who have any abnormal inflammatory marker, hyperlipidemia, or concurrent disease
* Diseases associated with abnormal glutathione metabolism
* Elevated serum creatinine levels, abnormal complete blood count (CBC), abnormal liver function tests or elevated serum homocysteine
* Morbid obesity
* History of hypoglycemic unawareness
* Pregnant women and women who are breastfeeding
* Patients with poor venous access
* Smokers
* Subject who consumes an excess of alcohol or abuses drugs
* History or or presence of bleeding disorder or use of anticoagulant drug
* History of oxalate renal calculi
Standard Follow-up Program (SFP) for Breast Cancer Patients

Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients.

Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer Patients receiving a radiotherapy dose

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria
Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons

Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI).

Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. They received either nabilone or placebo during the first four-week period (0.5mg OD with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week washout, subjects were crossed-over to the opposite arm.

The primary outcome was the Ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .


Eligibility Criteria:
Inclusion Criteria:

* Patients with spinal cord injury were eligible for the study if they are 18-65 years old, have C5 (ASIA A-D) and below and the injury occurred greater than 1 year previously. They had to have stable neurological level of injury with moderate spasticity (Ashworth \>/= 3) and no cognitive impairments. The spasticity medications needed to be unchanged for at least 30 days before inclusion, and no botulinum toxin injections for \> 4 months.

Exclusion Criteria:

They were excluded if they had:

* Heart disease as cannabinoids can reduce heart rate and blood pressure
* History of psychotic disorders, schizophrenia or any active psychological disorder
* Previously documented sensitivity to marijuana or other cannabinoid agents
* Severe liver dysfunction
* Cognitive impairment
* Major illness in another body area
* If they were pregnant or nursing mother
* Had history of drug dependency
* Used smoked cannabis \< 30 days before the onset of the study or were unwilling not to smoke during the study; OR
* If they fixed tendon contractures
Functional Magnetic Resonance Imaging (fMRI) Study of Memory in Children

Memory is a cognitive function whose development is still poorly documented in children, but which is often disturbed in temporal epilepsy. There are no studies about the disorders of episodic memory. The investigations using functional MRI (fMRI) are scarce, they do not involve this field and none are dedicated to children. The objectives of this project are to study the neuronal networks involved in episodic memory in normal children, as well as the disorders of episodic memory in children with epilepsy and the mechanisms of cognitive and cerebral reorganization in epilepsy.

Twenty children aged from 6 to 18 years with temporal and/or frontal epilepsy and 20 normal children in the same age range will undergo the following examinations in a unique day in the Unit Hospital F. JOLIOT(CEA in ORSAY, France):

1. complete neuropsychological evaluation including episodic memory,
2. structural MRI to quantify, using VBM, the potential abnormalities of the anatomical structures, to perform cognitive-morphological correlations, and to localize the neuronal networks activated on fMRI,
3. functional MRI using an original task of episodic memory, specifically dedicated to children and being under behavioural validation laboratory.

The analysis of fMRI data will be performed using SPM and taking into account the existence of epilepsy or not, of cerebral lesion or not, age, handedness, the side and location of epileptogenic focus, the age of seizure onset, and the type of antiepileptic treatment.

This study has been approved by the Ethic Committee in september 2004 (CCPPRB BICETRE, promotion of ASSISTANCE PUBLIQUE - HOPITAUX de PARIS).

Eligibility Criteria:
Inclusion Criteria:

* Parents or legal tutors of the children having given written consent to participate to the study, after having being fully informed.
* Patients presenting with a temporal and/or frontal epilepsy and being able to perform the tasks of the protocol.
* Controls being recruited among brothers, sisters, and friends of the patients and being right-handlers, without any neurological history or learning disorders.

Exclusion Criteria:

* Any contra-indication to MRI or being claustrophobia or blind.
Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation

Medical images used to guide treatment of tumor(s) are presently displayed on flat-panel monitors (like screens used with computers). This protocol will evaluate, using a new headset to view the images in true 3D ("360 degrees"), while using standard flat panel monitors as usual (in accordance with standard of care). The headset is combined with a mini-global positioning system (GPS)-like system to help navigate to treat tumor(s). This evaluation is to show that the headset has potential to provide guidance and navigation information that can improve the treatment of tumor(s) with heat.

This protocol will clinically evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors to ultimately overcome limitations of displaying images on 2D flat-panel monitors ("flat screens"). 3D Holographic percutaneous ablation (3D HPA) provides real-time, 360° visualization for guidance and navigation of tracked interventional instruments augmented to the operative site. In this preliminary protocol, 3D HPA will be evaluated as an adjunct to flat-screen display of conventional images used for guidance (ultrasound, fluoroscopy, CT), in accordance with standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Not pregnant
* Willing and able to give informed consent prior to enrollment. This includes media release form.
* Has met all criteria to undergo percutaneous tumor ablation.

Exclusion Criteria:

* Not willing or able to give informed consent
* Patients with pacemakers or automated implantable cardioverter defibrillator (AICDs).
TheraSphere for the Treatment of Liver Metastases

This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies
* unresectable liver metastases
* target tumors measurable using standard imaging techniques
* tumor replacement \< or = 50% of total liver volume (visual estimation by investigator)
* Hypervascular tumors (visual estimation by investigator)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
* minimum one month since most recent prior cancer therapy with the exception of patients receiving Sandostatin for neuroendocrine cancer
* patient informed consent

Exclusion Criteria:

* At risk of hepatic or renal failure within 21 days of treatment (serum creatinine \> 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin \< 2.0 mg/dL or any history of hepatic encephalopathy)
* contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine
* severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease
* cirrhosis or portal hypertension
* prior external beam radiation treatment to the liver
* prior TheraSphere treatment to the liver
* any intervention for, or compromise of the Ampulla of Vater
* clinically evident ascites (trace ascites on imaging is acceptable)
* any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before first TheraSphere treatment
* significant life-threatening extrahepatic disease in judgment of physician
* concurrent enrollment in another study
* alternative available therapies in judgement of physician
* evidence on technetium-99m macroaggregated albumin scan that shows lung shunting \> 30 Gy cumulative limit
* evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques
* positive serum pregnancy test in women of childbearing potential
* co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician
Fatty Liver Disease in Obese Children

Although weight reduction through physical activity-based interventions is the mainstay therapy for nonalcoholic fatty liver disease (NAFLD), its maintenance is difficult and typically unsuccessful. This affirms the extreme need for alternate and/or adjunct therapies. Although convincing data from animal studies and a few adult human studies on the benefits of a natural product, N-acetyl cysteine (NAC), in a variety of liver conditions including NAFLD have emerged, studies in children are scarce. Therefore, the aim of the study is to test the use NAC as an innovative approach to attenuate the progression of NAFD in obese children with biopsy proven NASH. The central hypothesis is that NAC supplementation will reduce liver fat and liver enzymes and ameliorate risk factors of cardiometabolic disease in children with NAFLD.

Physical activity (PA)-induced weight reduction, the suggested therapy for noalcoholic liver disease (NAFLD), is difficult and its maintenance is typically unsuccessful in children, affirming the acute need for alternative/adjunct therapies. Although few promising approaches have been reported, the benefits are incongruent and mostly marginal. N-acetyl cysteine (NAC), a derivative of the natural amino acid, cysteine, appears to be promising as an adjunct therapy to PA. Animal and a few adult human studies suggest NAC-induced attenuation of liver abnormalities, oxidative stress, insulin resistance and inflammation. The primary aim of the proposal is to determine in obese children with biopsy proven NASH and elevated liver enzymes the effect of NAC at two different doses on liver fat using magnetic resonance imaging (MRI), liver enzymes and risk factors of cardiometabolic disease. We hypothesize that NAC will produce beneficial effect on these parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age 7 years and older
* NASH confirmed in a previous biopsy
* HbAIc \<6.4%
* ALT \> 60 U/L or 1.5 times the upper limit of normal

Exclusion Criteria:

* Chronic liver disease including alpha-1-antitrypsin deficiency, Wilson's disease, autoimmune and viral hepatitis
* Medications such as adrenergic β-blockers, steroids and other drugs known to interfere with the measurement of liver enzymes and risk factors for cardiovascular disease
* Heart disease, chronic renal disease, adrenal, hepatic or thyroid dysfunction; active malignancy; and anemia
* History of prior treatment with NAC
* Evidence of hypersensitivity/allergy to NAC
* Alcoholism or drug abuse and smoking
* Inter-current illness over 7 days before the study \& surgery in the past 3 mo.
The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers (HDJ-SPI)

The main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI).


Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥ 18 years old with advanced solid tumor
2. Addressed for the first time to the palliative care team according to current criteria (medico-psycho-social symptoms, progressive risks)
3. With or without anti-cancer treatment
4. With estimated life expectancy of more than 2 months and less than 12 months
5. Able to communicate in French and answer questionnaires
6. Affiliated with a social security system
7. Having signed informed consent, co-signed by the partner if designated by the patient

Exclusion Criteria:

1. Patient with primitive brain tumor or malignant hemopathy
2. Severe psychopathological disorders
3. Pregnant patient or childbearing potential without effective method of birth control
4. Unable to be followed at the cancer center until death
5. Patient deprived of liberty or under guardianship -