cyrilzakka/clinical-trials huggingface dataset:
COLOSPOT Study : Assessment by EPISPOT of Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer

Treatment of metastatic colorectal cancer needs chemotherapy in most of the cases. During these last years, many new chemotherapies and targeted therapies have been developed improving significantly the overall survival of patients. However, the choice of the therapeutic sequences becomes difficult due to the lack of validated predictive biomarkers of their efficiency. Indeed, only the mutation of the k-ras oncogene is a predictive factor of non-efficacy of the anti-EGFR antibodies. It is thus crucial to identify new biomarkers to propose the best personalized 1rst line therapeutic sequence. One idea would be to enumerate and characterize the circulating tumor cells (CTC) which, as it has been described in a recent study realized by Cohen et al. in patients with metastatic colorectal cancer, would give us an early evaluation of the therapeutic efficiency. In this context, the investigators have developed an innovative technology, the EPISPOT assay (patent of the University Medical Center of Montpellier), that allows the detection \& characterization of viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the breast and prostate cancer. Thus, the investigators would like to perform a prospective study on a cohort of patients with metastatic colorectal cancer to confirm, with this technology, the predictive value of CTC count for the efficacy of the treatment.

In the aim to study a homogeneous cohort of patients, the investigators will only recruit patients in first line of treatment and treated by 5-FU (IV), IRINOTECAN et BEVACIZUMAB combination.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Colon or rectum adenocarcinoma (based on the histology)
* Visceral metastases (synchronous and/or metachronous)
* Metastatic disease measurable with the RECIST 1.1 criteria
* WHO performance status 0, 1 or 2
* Life expectancy\>3 months when starting the treatment
* Chemotherapy in metastatic 1rst line combining a protocol of conventional chemotherapy combining 5-FU and IRINOTECAN (FOLFIRI, XELIRI) associated with bevacizumab
* Follow-up of at least one year
* Collection of the written consent
* Social security affiliation

Exclusion Criteria:

* 2nd line chemotherapy and beyond
* History of other cancers considered not cured
* Active and progressive infection or other serious disease that may not allow the patient to receive the treatment
* refusal to participate
* Patient unable to express his consent
* Pregnant women
* Patient unable to be followed-up for at least one year
* Current participation to another clinical trial
* Patients under guardianship
* Vulnerable people protected by the law
Clinical Surveillance Vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism

The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.


Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent as documented by signature
2. Age ≥18 years
3. Objective diagnosis of symptomatic or asymptomatic isolated SSPE

Exclusion Criteria:

1. Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)
2. Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months
3. ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
4. Clinical instability (systolic blood pressure \<100 mm Hg or arterial Oxygen saturation \<92% at ambient air) at the time of presentation
5. Active bleeding or at high risk of bleeding
6. Severe renal failure (creatinine clearance \<30ml/min)
7. Severe liver insufficiency (Child-Pugh B or C)
8. Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
9. Known hypersensitivity to rivaroxaban
10. Need for therapeutic anticoagulation for another reason
11. Therapeutic anticoagulation for \>72 hours for any reason at the time of screening
12. Hospitalized for \>72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)
13. Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)
14. Lack of safe contraception in women of childbearing potential
15. Refusal or inability to provide informed consent
16. Prior enrolment in this trial
Neurophysiological Dissection and Intervention of Freezing of Gait in Parkinson's Disease

Different conditions of gait ignition freezing, spontaneous freezing during walking and turning freezing on encountering obstacle will be investigated in fMRI study to examine whether different regions of brain will be involved under different conditions of freezing. We hypothesize that anterior cortical regions will engage in gait ignition failure, deep locomotion regions will be responsible for spontaneous freezing and schema regions will be involved in the generation of turning freezing on seeing the barrier. In the third part of the project, we will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the motor cortex of the FOG patients to examine whether the intervention will benefit the patients. Based on the signal source findings, we will investigate whether the possible tDCS beneficial effect will be different or similar in patients with different electric sources. In addition, how long the possible beneficial effect of tDCS can be consolidated after the 5-day course of stimulation is crucial and requires to be elucidated under the research project. We aim to peep the myth of FOG in PD by the multi-modality approach and hope the study will benefit the long suffering patients.


Eligibility Criteria:
Inclusion Criteria:

The diagnosis of freezing of gait will be made by the following criteria:

1. Without video:Is there any feeling that your feet are transiently glued to the floor while trying to initiate walking, making a turn or when walking through narrow spaces or in crowded places? (Sometimes it can be accompanied with trembling of the legs and small shuffling steps.)
2. Additional instructions with video:We will watch a short video together to see the many ways in which freezing can occur. Also, look carefully for how long these episodes last, as you can expect some questions on this later.
3. Patient is diagnosed to have freezing of gait if "I have experienced such a feeling or episode over the past month" was answered.

Exclusion Criteria:

1. Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations.
2. Moderate to severe medical disorders such as functional III or above congestive heart failure, or cancer with distant metastasis etc.
3. Hoehn and Yahr stage 5.
Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients.

Multi-centre one year trial for patients who have rising PSA while on Casodex 50mg daily dose. Casodex dosage escalated to 150 mg tablet daily. Treatment will be continued until patient demonstrates clinical benefit at one year, PSA progression, toxicity, or withdrawal. Treatment will be continued after one year if patient demonstrates continued clinical benefit.

The study will be a national, multicentre, open-label, phase II trial. Patients who have a rising PSA on MAB with bicalutamide 50 mg daily will be dose escalated to MAB with 150 mg bicalutamide daily. Subjects will receive trial treatment for 12 months, or until disease progression, unacceptable toxicity or withdrawal of consent. Open label treatment will be offered thereafter if the subject demonstrates clinical benefit at the end of one year.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent.
2. Men, over 18 years of age, with histologically-confirmed prostate cancer
3. Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1
4. Serum testosterone level \< 50 ng/ml
5. Current treatment with bicalutamide 50 mg daily.\*\*
6. Two consecutive rises in PSA above a nadir value, with the absolute value of the latest PSA \> 2.0 ng/ml.
7. Highest PSA level no greater than or equal to 30 ng/ml.
8. Life expectancy of greater than 1 year -

Exclusion Criteria:

1. Patients may not have received prolonged anti-androgen therapy other than with bicalutamide. Patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.\*
2. PSA level greater than 30 ng/ml.
3. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial.
4. Subjects who have received prior chemotherapy.
5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
6. Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L.
7. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR.
9. Serum creatinine greater than 1.5 times -
AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions

The goal of this clinical trial is to assess the overall usability of the Philips

AirWaze investigational device in patients indicated for CBCT-guided navigation bronchoscopy procedure. The main questions it aims to answer are to assess the:

* overall usability of the device
* accuracy of the tool-in-lesion confirmation scan Participants will undergo bronchoscopy with the new navigation device and additional confirmation scans. Follow-up visit at 7days will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at the time of informed consent.
* ASA physical status between 1 and 3.
* Subject is willing and able to give written informed consent for clinical investigation participation prior to the procedure.
* Subject has a pulmonary lesion with an indication for diagnostic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.
* Suitable for CBCT-guided endobronchial nodule biopsy under general anaesthesia.
* Pre-procedural (PET-)CT scan is available prior to the CBCT-NB intervention.

Exclusion Criteria:

* Aged 17 or younger at the time of informed consent.
* ASA physical status is equal to and greater than 4.
* Not willing or not able to give informed consent.
* Does not indicate diagnostic evaluation with navigation bronchoscopy.
* Not suitable for CBCT-guided endobronchial nodule biopsy via navigation bronchoscopy under general anaesthesia.
* There is no recent pre-procedural (PET-)CT scan available.
* Known bleeding disorders.
* Contra-indication for temporary interruption of the use of anticoagulant therapy, such as acenocoumarol, warfarin, therapeutic dose of low molecular weight heparins, clopidogrel, or analogues, NOACs).
* Known allergy for lidocaine or other allergies interfering with the procedure.
* Uncontrolled pulmonary hypertension.
* Recent and/or uncontrolled cardiac disease.
* Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for any reason such that endobronchial access is considered unsafe).
* Potentially confounding drug or device trial during the clinical study. Co-enrollment in concurrent trials may be allowed provided pre-approval is obtained from the Philips Clinical Study Manager.
* All vulnerable subjects, such as immune-compromised subjects, subjects lacking the capacity to provide consent, patients in emergencies, pregnant or breastfeeding women, or any other subject who meets exclusion criteria, according to applicable national laws, if any.
* Woman of childbearing potential who is known to be pregnant on admission.
* Any condition that in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the subject in the study.
* Subject is Philips employee or their family members residing with this Philips employee.
FAZA PET/MRI Sarcoma

This is a dual arm, single centre, investigator initiated study to investigate the use of FAZA-PET in combination with MRI. FAZA is an investigational radiotracer used in PET scans. FAZA PET/MRI will be used to measure hypoxia in sarcoma tissues and will occur for:

Arm A: before neo-adjuvant radiation/chemotherapy treatment; Arm B: before surgery (optional).

After the FAZA PET/MRI scan, patients will be followed up via telephone, 48 hours after the scan, to see if there are any side effects due to FAZA.

Up to 30 patients enrolled in Arm B will receive pimonidazole approximately 16-20 hours before surgery.

Mutliple studies show that hypoxia in sarcoma has been consistently associated with poor treatment outcomes. Subsequently, there has been a study that shows inhibition of hypoxia-induced transcription factor (HIF-1 alpha), with radiation, was effective in disease treatment in pre-clinical models. This shows how important hypoxia was in playing a role in overall disease outcome and survival.

As a means of examining tumor features, such as hypoxia, hybrid PET/MR imaging combines the advantages of MRI's soft-tissue and contrast resolution with PET's functional metabolic capabilities. There have been few reports of using 18F-FDG in diagnostic PET/MRI. with the use of 18F-FAZA in this study, parameters such as diffusion, micro-perfusion, and contrast enhancement (as a surrogate marker for viable tumour tissue) can be simultaneously compared with the FAZA-derived pattern, in a single procedure.

The study is being conducted to measure the volume of hypoxic tumor in high-risk STS patients, using FAZA-PET/MRI, before and after neoadjuvant radiotherapy/chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients with either: high-risk extremity STS (g2-3, \> 10 cm largest dimension, and leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumour, or undifferentiated pleomorphic sarcoma), or: high-risk RPS (g2-3, and leiomyosarcoma or dedifferentiated liposarcoma)
3. Intention to treat using radiotherapy/chemotherapy/surgery according to the current treatment policies of the Sarcoma Site Group of PM
4. A negative serum pregnancy test within the two-week interval immediately prior to PET-MR imaging, for women of child-bearing age
5. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

1. Previous radiotherapy to intended treatment volumes.
2. Previous systemic therapy
3. Active malignancy other than sarcoma
4. Unable to remain supine for at least 60 minutes
5. Pregnancy or breast feeding
6. Age less than 18 years old
7. Failure to provide written informed consent
8. Contraindication for MR as per current institutional guidelines.
Muscle Treatment for Management of Pain & Disability in Tension-type Headache

The purpose of this study is to determine the effectiveness of treatments (massage therapy or ultrasound) directed at skeletal muscle for alleviating pain associated wtih tension headache.

Chronic or episodic forms of tension-type headache affect a high percentage of the population. Pain from tension-type headache (TTH) not only impacts personal well-being, but also poses a significant socioeconomic burden in terms of workdays lost and decreased worker productivity. Although TTH is the most prevalent of the headache disorders, there is a distinct lack of research with regards to specific treatments for this ailment in comparison to all other headache classifications, such as migraine. A muscular involvement is associated with TTH and is reported in the research literature as elevation in skeletal muscle tenderness, increased presence of active myofascial trigger point's, and physical abnormalities in cervical and cranial muscles. Thus, a treatment approach that addresses the skeletal musculature could be an important component in the management of TTH. The purpose of this randomized trial is to determine the effectiveness of two muscle oriented treatments on reducing pain and disability associated with TTH: massage therapy and ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* 2 or more tension-type headache episodes per week
* Headache episodes of 2 hours or longer
* Experiencing tension-type headache for 6 months or longer

Exclusion Criteria:

* Migraine \>1/month
* Presence of alternate forms of headache (e.g. cluster headache, medication-induced headache, headache caused by injury)
* The diagnosis of fibromyalgia, major depression, other neurological or cardiovascular disease
* Pregnancy
* Prior massage or ultrasound treatment for headaches
Benefits of Cycling Wheelchair Training for Elderly With Physical Disability

To investigate the feasibility of cycling wheelchair training as an exercise for elderly disabled patients, and to determine its effects on cognition, quality of life, aerobic capacity and physiological markers. We measure SF-12. Other outcome measures included the Mini-Mental State Examination, Aero bike workload test, resting blood pressure (systolic and diastolic), and heart rate.


Eligibility Criteria:
Inclusion Criteria:

1. age \>65 years old
2. with a functional ambulation category scale (FAC) level 4 or below
3. muscle strength of both lower limbs was \>3 as the , or the muscle strength of one lower limb was 4 or above, as rated by the Medical Research Council Scale (MRC).

Exclusion Criteria:

1. hospitalized for acute medical problems within the past 3 months
2. having cardiopulmonary disease that could cause exercise hazards
3. unable to perform repetitive pedaling exercise due to diseases of the lower limbs
4. with pressure ulcers around hip area
5. with impaired cognitive function that did not allow completion of our questionnaires.
Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans

The purpose of this study is examine the effect of fat tissue-released miRNA on skeletal muscle and if abnormal fat tissue-released miRNA contributes to insulin resistance in obese individuals. This information will be important for our understanding of how the body's sugar metabolism is regulated and why people who are obese become insulin resistant and are more likely to develop type 2 diabetes.

Study Objectives:

1. To establish and optimize the methodology for measuring adipose tissue miRNA release.
2. To establish and optimize the methodology for measuring the effect of adipose tissue-released miRNA on skeletal muscle biology and insulin sensitivity.
3. To profile adipose tissue-released miRNA in lean insulin-sensitive and obese insulin-resistant healthy individuals.
4. To examine the effects of adipose tissue-released miRNA from lean insulin-sensitive individuals and obese insulin-resistant individuals on skeletal muscle biology and insulin sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Able to communicate meaningfully with the investigator and legally competent to provide informed written consent
* 18-65 years of age
* BMI of 20-25 kg/m2 (lean subjects); 30-35 kg/m2 (obese subjects)
* Stable body weight (\< 3 kg change in the last 8 weeks)
* homeostatic model assessment (HOMA)-insulin resistance \<2.7 if lean; homeostatic model assessment (HOMA)-insulin resistance ≥2.7 if obese

Exclusion Criteria:

* Lactation or pregnancy, current and/or within last 6 months, per participant's report
* Female subjects postmenopausal
* Cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months)
* Liver disease (AST or ALT(alanine aminotransferase)\>2.5 times the upper limit of normal)
* Kidney disease (creatinine \>1.6 mg/dl)
* Anemia (hemoglobin \<12 g/dl in men, \<11 g/dl in women)
* Thyroid dysfunction (abnormal TSH)
* HbA1c ≥6.5%
* Uncontrolled hypertension (systolic BP\>160 mmHg, diastolic BP\>100 mmHg)
* History of coagulopathies
* History (within the last 5 years) or presence of malignancy, (skin cancers, with the exception of melanoma, may be acceptable)
* Current or history of drug abuse or alcohol abuse (\>2 drinks/day)
* Prior treatment (within last 3 months) with systemic glucocorticoids (\>2 weeks), beta-blockers, drugs for weight loss, niacin or fibrates
* History of HIV, active Hepatitis B or C, or Tuberculosis (participant reported)
* Smoke \> 5 cigarettes per day
Acute Phase Proteins as Early Markers in Sepsis

Monitoring of different serumproteins after severe trauma and during trauma-induced sepsis.

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria:

* Patients with severe trauma (ISS score \> 16), both genders, patients on ICU

Exclusion criteria:

* Moribund patients (pH \<7,1, lactate \>15mmol, Basedeficit \> 15mEq/L, severe heart or liver injuries, GCS never over 5 after trauma)
* Severe head injuries (AIS head \>4)
* Patient with severe infectious diseases, or diseases which severely affect the immune system (diabetes, Alkohol or nicotine abuse)
* Non-german speaking patients
HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial

Most trauma deaths are related to traumatic brain injury (TBI). Although the management of patients has improved, mortality remains unacceptably high, and half of survivors of moderate and severe TBI are left with major functional impairment. Current management guidelines are based on limited evidence and practice is highly variable. Most acutely ill patients with TBI will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed concerns regarding restrictive strategies, which may adversely affect clinical outcomes in TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion thresholds on neurological functional outcome. We hypothesize that a liberal transfusion strategy improves outcomes compared to a restrictive strategy.


Eligibility Criteria:
Inclusion Criteria:

* Acute moderate to severe blunt TBI
* Glasgow Coma Score \[GCS\] ≤ 12
* Hb level ≤ 100 g/L

Exclusion Criteria:

* Patient has received transfusion after ICU admission
* Contraindications or known objection to transfusions
* Glasgow Coma Scale (GCS) of 3 with dilated fixed pupils.
* Patient is brain dead
* Active life-threatening bleeding with hemorrhagic shock or requiring urgent surgical procedure
* A decision to withold or withdraw life-sustaining therapies was made
* No fixed address