cyrilzakka/clinical-trials huggingface dataset:
Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer

Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.

The CULTURE 3D study is a prospective, open labelled, multicenter trial. The aim is to evaluate the feasibility of ex vivo culture 3D (chemogram) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.

Patients will have biopsies in a metastasis or in the primitive tumor before treatment. The sample will be used for a 3D ex vivo cells culture. A chemogram will be made based on cells proliferation data (Ki67) and apoptosis (M30).

Results from this chemogram will not interfere with the treatment combination choice.

The treatment response will be evaluated by the RECIST assessment and will be then compared to the chemogram.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years old or more
2. Colorectal cancer with synchronous or metachronous metastases
3. Metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy
4. Measurable metastatic disease (echography, CT and/or MRI, PET-FDG)
5. Indication for treatment with a combination including FOLFOX/FOLFIRI associated to an anti VEGF drug (Avastin)
6. No adjuvant chemotherapy for the primitive colorectal cancer and no line of chemotherapy for metastatic disease during the year prior to inclusion.
7. Life expectancy \> 3 months (ECOG 0-1-2).
8. Informed and signed consent by the patient.

Exclusion Criteria:

1. Elevation of Carcinoembryonic antigen (CEA) without measurable metastatic disease
2. Medical contraindication to chemotherapy or biotherapy as FOLFOX/FOLFIRI or Avastin.
3. Treatment with FOLFOX/FOLFIRI and biotherapy anti-EGFR (epidermal growth factor receptor)(Erbitux) planned
4. Patient already enrolled in an other clinical trial with another first line of chemotherapy.
5. Pregnant women, breastfeeding or of childbearing age not taking contraceptive
6. Persons deprived of liberty.
7. Subject unable to make follow up schedule
EBMT ADWP Prospective Non Interventional Study : AutoHSCT in SSc Patients

The purpose of this study is to assess the effectiveness of Autologous Hematopoietic Stem Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis (SSc) as currently performed by different study protocols used across Europe in various EBMT centres through the careful recording and analysis of routinely collected clinical and biological data.

Different protocols are used in the different centres, it is not yet clear which approach will be the most efficient and the safest. Every centre will follow its own local protocol for AHSCT which usually refers to the recent update of the EBMT Guidelines for HSCT in autoimmune disease. Patient selection for AHSCT treatment technique with regard to the risk/benefit balance has to be carefully addressed by standard patient pretransplant evaluation, whereas treatment local regimen, follow-ups evaluation, supportive medication and prophylaxis will be recorded and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Autologous HSCT
* Age between 18 and 65 years at time of transplant.
* Established diagnosis of progressive systemic sclerosis according to ARA-criteria

Exclusion Criteria:

* Pregnancy or inadequate contraception
* Severe concomitant disease
* Reduced lung function
* Previously damaged bone marrow
* Uncontrolled severe infection
* Severe concomitant psychiatric illness
Study of Circulating and Tumor Biomarkers in Breast Cancer Patients

Aims: To evaluate the role of monoclonal antibodies in the detection of cancer specific antigens in blood and tumor tissue, and the potential use of these antibodies for future evaluation for therapy. Also, to evaluate the presence of circulating tumor cells (CTCs) and to study EMT (epithelial-mesenchymal) signature changes during chemotherapy.

Methods: To take 20mls of blood from advanced breast cancer patients before a new course of anti-cancer therapy, and another 20mls of blood 3 weeks after treatment. In addition, Consent will be obtained to cut 10-15 tissue sections from their archival tumor specimens. Whenever possible, the blood taking will be timed such that no additional needle prick will be done specifically for the purpose of the study, by coinciding it with standard blood taking which is required for the patient's treatment.

Importance of proposed research to science or medicine:Detection of tumor specific antigens in the blood may potentially reduce the need for more invasive biopsies for confirmation of diagnosis of cancer or follow-up of cancer in the future. The identification and development of antibodies specific to these tumor antigens or markers may offer future therapeutic options, or as a vehicle to deliver cytotoxic therapy. Identification of CTCs as well as understanding the changes that occur in EMT signature in these circulating tumor cells may serve as a means of potential means of prognostication and modification of therapy in the future.

Potential Benefits and Risks: Potential risks to the patient include that of blood taking (pain, feeling faint, infection). Patients will not benefit directly from the study but the knowledge gained may help the management of future patients.

Cancer biomarkers, such as antigens and circulating tumor cells, may be a potential area to developing new methods of diagnosis and treatment of cancer. Monoclonal antibiotics are now able to be identified and isolated that may specifically target progenitors of breast cancer as well as CTCs. The changes that occur to CTCs during treatment may serve as a means of prognostication, as well as allow for therapeutic modifications. Clinical correlative studies into these areas (MAbs and CTCs) will serve to determine the role of these in clinical application in the future.


Eligibility Criteria:
Inclusion Criteria:

* Advanced breast cancer patients whose cancer have progressed and are due to start a new course of anti-cancer therapy.The patient needs to have had previous breast cancer surgery at NUH (lumpectomy or mastectomy) or a diagnostic core biopsy for breast cancer, and consent to allow for blood taking and access to archival tissue.

Exclusion Criteria:

* No available archival tumor specimen at NUH.
Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation

The purpose is to demonstrate the usefulness of WitCard and WitDisplayer in the diagnosis of AF but more generally in the qualification of the heart rhythm and the diagnosis of cardiac arrhythmias.

The main objective is therefore to demonstrate that at least 90 +/- 0.03% of ECGWs are interpretable by a physician and the primary endpoint will therefore be the ratio of the number of ECGWs that allowed a physician to make a diagnosis. rhythmic (ECGW interpretable) and the total number of ECGW recorded and viewed.

The clinical trial as part of the CE medical device certification process for secondary objectives and ancillary studies will be required to assess the diagnostic performance of the WitCard + WitDisplayer system, the quality of the ECGW recorded by the WitCard, the the safety of using the WitCard, the technical performance of the WitCard ECG recorder, the ergonomics of the WitCard, and finally the performance of automatic cardiac rhythm classification algorithms.

Monocentric, prospective, interventional study

Eligibility Criteria:
Inclusion Criteria:

Patient, male or female, over 18 years of age, presenting to the cardiology-rhythmology department (consultations and hospitalizations) or to the emergency department of the Timone 2 Hospital for the management of suspicion of disorder heart rate in front of:

* Palpitations
* Dyspnoea, acute pulmonary edema, non-ischemic heart failure
* Malaise, lipothymia, syncope

Exclusion Criteria:

* Patients with clinical criteria that do not warrant the use of WitCard:
* Immediate vital risk whatever its nature
* Rhythmic urgency requiring treatment without delay: respiratory, circulatory or neurological distress
* Acute Coronary Syndrome
* Pregnant women
* Non-beneficiaries of a social security scheme
* Persons deprived of their liberty
* Patient participating in another study
* Patient in a period of exclusion determined by a previous study
* Patient under the protection of justice, under guardianship or under guardianship
Tibio-talo-calcaneal Fusion by Hindfoot Nail Versus Open Reduction and Internal Fixation in Treatment of Complex Fractures Distal Tibial and Fragility Ankle Fractures in Elderly

Tibiotalar calcaneal fusion by hindfoot nail Vs open reduction and internal fixation in treatment of complex distal tibial fractures and ankle fragility ankle fractures in elderly


Eligibility Criteria:
Inclusion Criteria:

* pilon fractures complex distal tibial fractures ankle comminuted fractures age more than 65yrs osteoprotic fractures surgically fit patients

Exclusion Criteria:

Ankle fractures unimalleolar undisplaced Pathological fractures Young adults DVT Peripheral vascular diseases Age less than 65 Unfit patient for surgery

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Vestibular Treatment in Adolescents Following Sport Related Concussion

Each year, nearly 2 million children and adolescents have a sport-related concussion (SRC) in the U.S., but 57% of them do not receive appropriate clinical care following their injury. These injuries involve a wide range of symptoms including headache, dizziness, and sleep problems; and cognitive, emotional, visual, and vestibular impairment. The investigators have developed a clinical treatment model for SRC that addresses the heterogeneity of this injury using different clinical subtypes or profiles that inform precision interventions. To date, the investigators have identified cognitive, anxiety/mood, post-traumatic migraine, cervical, oculomotor, and vestibular clinical profiles. Patients with vestibular clinical profiles- involving dizziness, environmental sensitivity, and imbalance- are common (60-65% of concussions), and have worse outcomes and longer recovery following SRC. Consequently, the investigators have developed and applied precision vestibular treatments that can be matched to specific impairments and symptoms to actively treat patients with vestibular clinic profiles.

To determine using a RCT design the effectiveness of standard of care behavioral management (i.e., sleep, walking, nutrition, stress management) to standard of care behavioral management (i.e., sleep, walking, nutrition, stress management) (STANDARD OF CARE) plus vestibular exercises (i.e., balance, eye-head movements, and dynamic walking exercises) (VESTIBULAR) for reducing recovery time, symptoms, and vestibular (balance, eye-head movements) and cognitive (e.g., memory, processing speed) impairment in adolescent patients with vestibular clinical profiles following sport--related concussion (SRC).

Eligibility Criteria:
Inclusion Criteria:

* Must be 12-18 years of age.
* Must be diagnosed with a sport-related concussion within the last 3-10 days.
* Must be identified by UPMC Sports Medicine clinicians as having clinical presentation of a vestibular profile of concussion.
* Must report an increase of +2 of symptom provocation on VOMS (from baseline symptom report) on either VOR or VMS measurements during VOMS assessment.

Exclusion Criteria:

* More than 3 concussions including presenting injury;
* Current history or pre-existing vestibular disorder;
* Current orthopaedic injury;
* History of brain surgery or TBI (based on Glasgow Coma Scale of \<13);
* History of substance abuse;
* History of neurological disorder (seizure disorder, epilepsy, brain tumors or malformations);
* Current concussion is non-sport related.

The above exclusion factors are known to influence recovery and thus if any one exclusion criterion is met, the athlete will be unable to participate in the current study.
Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.


Eligibility Criteria:
Inclusion criteria:

-Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible).

First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.

* ECOG inferior or equal to 1 at screening.
* Further inclusion criteria apply

Exclusion criteria:

* Patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic NSCLC.
* Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or patients known to be positive for ALK translocation
* Further exclusion criteria apply.
A Cohort of Patients With Chronic Pulmonary Disease

This is a longitudinal study of following chronic pulmonary disease patients to observe and predict the clinical outcomes of these patients.

In patients with chronic pulmonary disease, impaired pulmonary function and limited exercise capacity, is a complex clinical syndrome with a wide range of underlying causes, which may result in worse quality of life and high economic burden. This is a longitudinal study of following chronic pulmonary disease patients, recording the clinical, pathophysiology, and psychological parameters, to observe and predict the clinical outcomes of these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80, males and females
2. Patients are diagnosed as the obstructive pulmonary disease according to the clinical practice.
3. Willing to participate in the study.
4. Being able to provide informed consent.

Exclusion Criteria:

1. Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.
2. Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
3. Subjects who participated in another trial within 30 days prior to the planned start of the study
4. Subjects with cancer or have had cancer in the 5 years prior to study entry.
Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS

The purpose of this study is the validation of an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.

Inclusion criteria study population

1. Age \> 18 years old.
2. Acute stroke symptoms onset within 2 weeks of inclusion, and as proximate to event as possible and as long as there was no neurological deterioration (ΔNIHSS\>4) from symptoms onset to inclusion.
3. Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS \< 4 at the time of enrolment)
4. More than 3 of the following:

Blood pressure \>140/90 or unknown, Irregular heartbeat, Atrial Fibrillation, Smoker, Cholesterol \>240 or unknown, Has Diabetes, Lack of physical exercise, Overweight, Has Stroke in the family

OR between 4 and 6 of the following:

Blood pressure 120-139/80-89, Unknown Irregular heartbeat, Atrial Fibrillation, Trying to quit smoking, Cholesterol 200-239, Borderline Diabetes, Some exercise, Slightly overweight, Not sure if Stroke occurred in family

Exclusion criteria study population

1. Intracranial hemorrhage on admission by CT.
2. Previous major hemispheric stroke.
3. Patients with pure sensory symptoms,
4. Significant movement disorder.
5. Local skull or skin affliction which prevents sensor application.
6. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Eligibility Criteria:
Inclusion criteria study population

1. Age \> 18 years old.
2. Acute stroke symptoms onset within 2 weeks of inclusion, and as proximate to event as possible and as long as there was no neurological deterioration (ΔNIHSS\>4) from symptoms onset to inclusion.
3. Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS \< 4 at the time of enrolment)
4. More than 3 of the following:

Blood pressure \>140/90 or unknown, Irregular heartbeat, Atrial Fibrillation, Smoker, Cholesterol \>240 or unknown, Has Diabetes, Lack of physical exercise, Overweight, Has Stroke in the family

OR between 4 and 6 of the following:

Blood pressure 120-139/80-89, Unknown Irregular heartbeat, Atrial Fibrillation, Trying to quit smoking, Cholesterol 200-239, Borderline Diabetes, Some exercise, Slightly overweight, Not sure if Stroke occurred in family

Exclusion criteria study population

1. Intracranial hemorrhage on admission by CT.
2. Previous major hemispheric stroke.
3. Patients with pure sensory symptoms,
4. Significant movement disorder.
5. Local skull or skin affliction which prevents sensor application.
6. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
Tecfidera Lymphocyte Chart Review

The primary objective of the study is to retrospectively investigate changes in lymphocyte counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes in lymphocyte subtypes other than CD4+ and CD8+ T cells.


Eligibility Criteria:
Key Inclusion Criteria:

* Initiated Tecfidera treatment for the first time on or after 27 March 2013 and received at least 6 months of continuous treatment with Tecfidera
* Clinical diagnosis of a relapsing form of MS
* A baseline measurement for ALC and absolute CD4+ or CD8+ count within 6 months prior to Tecfidera initiation
* At least 1 measurement for ALC and absolute CD4+ or CD8+ count while on Tecfidera therapy for at least 6 months

Key Exclusion Criteria:

* Clinical diagnosis of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) prior to Tecfidera initiation
* Participation in DEFINE 109MS301 (NCT00420212) or CONFIRM 109MS302 (NCT00451451)

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Sub Occipital Inhibition Technique on Postural Balance

In the present study the investigators want to verify if the inhibition of the suboccipital muscles improves the postural balance in subjects with cervical pain objectified by stabilometry.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who suffer neck pain for at least 3 months
* Come to receive physiotherapy treatment at Clinica Osteomed (NRS: 8415-CV), Elche, Alicante, Spain.
* Age between 18 and 65 years old.
* Sign the informed consent.

Exclusion Criteria:

* Suffering or having suffered pathologies of the postural control system (postural sensors, central nervous system or locomotor system)
* Presenting deformities or orthopedic injuries in the lower limbs or rachis
* Presenting pain at the moment of study
* Present contraindications to the intervention under study
* Have received physiotherapy treatment in the last six months
* Have undergone surgical treatment of any kind.
Sedation for Endoscopic Procedures

Endoscopic procedures for biliary strictures, stenting or drainage (ERCP) and ultrasonic imaging or biopsies (EUS) are performed under sedation or anesthesia. The main purpose of the study is to evaluate aspects of procedure treatability and patients´ quality of recovery.

The main aim of this study is to evaluate the effects on treatability and procedure failur; also aspects of post-procedure quality of recovery from patients cognitive function and from the choice of sedation/anesthesia for ERCP and EUS-procedures.

Before endoscopic procedures, patients do not always read the written information sent to them. That´s a problem since patients tend to be insufficient prepared for the procedures. Therefore, evaluation of patients' health literacy was performed.

Patients are sedated (patient-controlled sedation or by nurse anesthetists) or in general anesthesia. No randomisation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Patients cheduled for ERCP or/and EUS
* Patients who have given their informed and written concent to participate

Exclusion Criteria:

Patients with

* confusion
* dementia
* communication problems.
Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All information regarding this procedure has been retrospective. Our objective is to evaluate prospectively the diagnostic accuracy of the test, alone and when associated to clinical and/or radiologic data.

This is a prospective diagnostic test study. Inclusion criteria are all consecutive patients with parotid gland masses referred for treatment at our center, from January 2003 to December 2007.

The gold standard for the diagnosis of malignancy is the surgical pathology report of the parotidectomy specimen.

Cytologist and pathologist will be blind. Diagnostic accuracy is determinded by Bayesian analysis.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with parotid gland masses
Dietary Intervention and Adults With Intellectual Disabilities

Goal The overall aim of the study is to improve the health of persons with Intellectual disabilities

Purpose

There are two main purposes of the study The first is to study the diet and heath of persons with intellectual disabilities. The second is to increase their knowledge on nutrition and health and that of service providers in municipalities housing facilities and to test, in an intervention, the effects of a method for weight reduction in adult persons with intellectual disabilities with overweight and obesity. Physical activity is also an important factor in weight reduction, but this study focuses only on nutrition, to obtain new information on this one factor in weight reduction. A combined study with many changes in a short period of time is very challenging for the group in question.

The vision is that results from this study will lead to improved health promotive and preventive services in the municipality in the future, to adult persons with intellectual disabilities and that this study also can have effects on services also for other groups, such as those with the fields of psychiatry and drug problems.

Eligibility Criteria:
Inclusion criteria:

* Mild intellectual disability and overweight
* Moderate intellectual disability and overweight

Exclusion Criteria:

* Metabolic diseases
* Hypertension
* Diabetes