cyrilzakka/clinical-trials huggingface dataset:
Care-related Pain and Discomfort in People With Motor Disorder

The combination of motor disabilities, chronic pain, cognitive disabilities limiting the possibilities of communications and repeated potentially painful rehabilitation, exposes patients with motor disabilities to a high risk of induced pain in the specialized establishments. Induced pain is difficult to detect and is therefore little assessed and treated. Currently, little is known about the prevalence and conditions of occurrence of such induced pain as the clinical characteristics of patients (children, adults, severity of disability), the types of care and the nature of the institutional admission (medical or medico-social). Secondary objectives are to identify risk factors related to the induced pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain assessment tool in a routine clinical set-up.

All daily life procedures or treatment carried out in children and adults with motor disability are collected for 5 days and 1 night. Collected data are clinical and demographic characteristics of patients, the intensity of the pain assessed by the care professional (FLACC-r) or the patient himself (VAS).

Clinically, the uncomfortable and painful procedures and risk factors for pain identified by this study will help the development of targeted preventive measures within institutions. Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain, leading them to observe the behavior of patients, to admit any pain related to an act of daily life, and to ask for the medical profession to anticipate the painful experience.


Eligibility Criteria:
Inclusion Criteria:

* motor disorder
* institutionalized

Exclusion Criteria:

* chronical pain
Small Hyperplastic and Adenomatous Reliability Protocol

1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and adenomatous \<10 mm polyps with that of histology in an European multi-center study. To assess variability among endoscopists in NBI accuracy. We also aim to assess whether this technology impacts the appropriateness of surveillance intervals.

Design: 1) Before starting the patient enrollment, the participating endoscopists will attend an internet-based training program on the in vivo differentiation between hyperplastic and adenomatous polyps. Following this course, a qualifying examination will be required for each endoscopist to be included.

2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for inclusion. Patients with at least one histologically verified \<10 mm polyp will be included. In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in order to rank between a high- and a low- level of diagnostic confidence, and thereafter will be sent for histological assessment. NBI- and histological accuracy in differentiating between hyperplastic and adenomatous lesions will be analyzed and compared, in order to assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI feasibility and accuracy in the study population, and to assess the variability among the endoscopists. Secondary outcome measures will be a cost analysis on how much savings would be achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical inference on how many patients would be scheduled for an inappropriate post-polypectomy follow up, when follow up schedule is based on NBI classification. Clinical results will be analyzed using various statistical measures of significance.

Clinical Site Locations: 10 European centres with NBI-technology

1 NBI-expert endoscopist for each centre Enrollment: 160 small (\<10 mm) polyps at each site Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.


Eligibility Criteria:
Inclusion Criteria:

* 1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up; 2. The patient is at satisfactory risk to undergo abdominal surgery; 3. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

* 1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up; 2. The patient is at satisfactory risk to undergo abdominal surgery; 3. The patient must understand and provide written consent for the procedure.
Enhancing Heart Failure Self-Care

To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in an existing heart failure (HF) disease management program.


Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure, hospitalized for heart failure or hospitalized for heart failure within the past 30 days, speak and read English

Exclusion Criteria:

* Severe renal failure requiring dialysis, HIV-AIDS, psychosis, uncorrected hearing loss
The Detection of Circulating Tumor Cells (CTCs) in Patients With Breast Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment

Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in breast cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. In view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of breast cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method.

1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately 17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with breast cancer and healthy volunteers. The blood of the healthy volunteers will be used to evaluate the sensitivity and specificity and as negative control cells. To avoid contamination with skin cells, 2 mL blood will be discarded before the study samples will be taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for 20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR. Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to choose an adequate therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-75
2. Karnofsky performance status \>60
3. Diagnosis of breast cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery and/or DC-CIK treatment
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except lung cancer
2. History of coagulation disorders or anemia
The RESTORE-SIRIO Randomized Controlled Trial

Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for treating acute ST-segment elevation myocardial infarction (STEMI). The main goals are to restore epicardial infarct-related artery patency and to achieve microvascular reperfusion as early as possible. No-reflow is the term used to describe inadequate myocardial perfusion of a given coronary segment without angiographic evidence of persistent mechanical obstruction of epicardial vessels and it refers to the high resistance of microvascular blood flow encountered during opening of the infarct-related coronary artery.

Despite optimal evidence-based PPCI, myocardial no-reflow can still occur, negating many of the benefits of restoring culprit vessel patency, and is associated with a worse in-hospital and long-term prognosis. Several strategies have been tested to revert the no-reflow including the use of thrombectomy, glycoprotein IIb/IIIa inhibitors and the use of intracoronary adenosine, but none has been demonstrated to effectively counteract the phenomenon.

The trial aims to show the effect of the administration of intracoronary adrenalin on myocardial reperfusion assessed by magnetic resonance in patients with STEMI undergoing PCI and with persistent coronary angiographic The Thrombolysis in Myocardial Infarction (TIMI) 0-1 flow during the interventional procedure after failure of standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* presentation within 6-7 h of symptom onset of STEMI
* eligibility for reperfusion by primary-PCI
* TIMI flow grade 0-1 during the interventional procedure in the culprit vessel after the initial opening of the vessel with the coronary wire

Exclusion Criteria:

* evident clinical arrhythmias (ventricular tachycardia/ventricular fibrillation)
* evidence of coronary dissection or spasm
* Parkinson symptoms
* closed angle glaucoma
* thyroid disorders
* known history to hypersensitivity to the drug
* pregnancy
* stage 4 or 5 CKD (eGFR \<30 mL/min/1.73 m2)
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women

This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female, in good health (at least 5 years since last menses)
* Age ≥45 and ≤70
* Weight + or - 20% of the Metropolitan Life weight table
* Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL
* Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range
* Willing and able to comply with all study requirements
* Willing and able to sign written informed consent
* Negative urine pregnancy test at screening
* Negative Screen for Hepatitis B and C, human immunodeficiency virus (HIV) and drugs of abuse

Exclusion Criteria:

* History of parathyroid, thyroid, pituitary or adrenal diseases
* History of musculoskeletal disease
* History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders
* History of cancer within 5 years of enrollment other than basal cell carcinoma
* History of regular use of non-steroidal anti-inflammatory drugs (NSAID)
* History of surgery within 60 days of enrollment
* History of hypersensitivity or allergies (other than seasonal allergies) within 5 years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications
* Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study
* Use of bisphosphonates within 6 months, selective selective estrogen receptor modulators (SERMS), estrogen or estrogen-like drugs 2 months, or calcitonin 1 month
* Presence of any clinically significant illness
* Unwilling or unable to comply with all study requirements
* Unwilling or unable to sign written, informed consent
* History of drug or alcohol abuse
* Participation in any clinical study of an investigational drug within 60 days of enrollment
* Plasma CTx-1 less than 0.25 ng/mL
Development and Validation of Perceived Fatigue Meaning Scale on Walking Program

The aims of this three-year study are to:

1. develop and validate a perceived meaning of fatigue scale
2. examine the effect of individualized patient education and walking programs on alleviating fatigue in patients with gastric or colorectal cancer,and further explore the relationship between the perceived meaning of fatigue and intervention outcome.

In the first year, patients will be recruited from oncology inpatient wards and outpatient clinics in two medical center hospitals in Taipei. Purposive sampling will be used to recruit outpatients or inpatients receiving chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, one-way analysis of variance, and exploratory factor analysis.

In the second and third years, an experimental design consisting of three groups including a control group, an education only group, and an education and walking program group will be used. Data will be collected at treatment weeks 1, 4,8,12,16 including three cycles of chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, and generalized estimating equations. At least 230 subjects will be interviewed in the first year.

At least 105 of patients with gastric cancer or colorectal will be classified into the three groups in the second and third year. We expect the results of this study to explore the meaning of fatigue and to help develop a common strategy to manage fatigue in Taiwan. The results can help clinicians and researchers to tailor interventions for cancer patients with severe fatigue.

Eligibility Criteria:
Inclusion Criteria:

* The patients with gastric cancer during receiving chemotherapy
* Those who are willing to participate in the research
* Aged above 18
Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis

Multiple sclerosis (MS) progressively leads to an increasing level of disability. That's why individuals faced with this chronic disease whose progression is unpredictable have to mobilize all their available resources. As a result, management of interpersonal relationships appears to be a key issue in adjustment to situations.

Although knowledge on cognitive abnormalities in MS has been growing in recent years, there is a lack of research about social behaviour regulation skills. The few studies conducted in this field are mainly interested in emotional processing (emotional facial recognition and empathy) and skills mentalizing (theory of mind) that appear disturbed in MS.

While some recent studies touch on the issue of the contextual analysis of language (that is to say, the social use of language) in MS, their assessment on a wide range of pragamtic skills has never been studied. However, the pragmatic aspects of language are known to play a major role in social adjustment.

This project has three main objectives : (1) to increase general knowledge of deficits in communication and in social cognition in patients with MS, (2) to propose new leads for the evaluation of these disorders and (3) to contribute to increasing knowledge of neural basis of communication and social cognition.

In order to address those objectives, the assessment will be focused on many various pragmatics skills : conversation, indirect language comprehension (indirect questions, idiomatic expressions, sarcasm) and metapragmatic knowledge in a population of 40 RR-MS patients. Those patients' performances will be compared to a group of healthy matched control subjects, potential relationships between pragmatic abilities, other aspects of social cognition (theory of mind and processing of emotional stimuli), cognitive functioning, psycho-behavioural aspects and the characteristics of the disease will be explore.

Social cognition tasks have been selected for their dynamic and ecologic aspects in order to match natural social interaction.

Finally, communication consideration, cognitive and cerebral skills of patients with MS will contribute to increasing knowledge of the neural basis of social cognition.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* Relapsing-remitting form as defined by the Mc Donald's Committee criteria (2005).
* EDSS between 0 and 5.5, out of relapses
* French mother tongue or having been schooled in France
* No disorders of formal language comprehension
* Not having participated to a similar protocol within the 9 months preceding the inclusion
The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities

Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.

Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.

Eligibility Criteria:
Patients must have biopsy-proven soft tissue sarcoma with one of the following diagnoses:

Liposarcoma (round cell or pleomorphic).

Fibrosarcoma.

Malignant fibrous histiocytoma.

Inflammatory malignant fibrous histiocytoma.

Myxoid malignant fibrous histiocytoma.

Malignant giant cell tumor.

Angiomatoid malignant fibrous histiocytoma.

Leiomyosarcoma.

Malignant hemangiopericytoma.

Rhabdomyosarcoma (embryonal, alveolar, pleomorphic or combined).

Soft tissue sarcoma resembling Ewing's sarcoma.

Synovial cell sarcoma.

Epithelioid sarcoma.

Clear cell sarcoma.

Neurofibrosarcoma.

Epithelioid schwannoma.

Malignant triton tumor.

Angiosarcoma.

Mixed malignant mesenchymoma.

Alvelar soft part sarcoma.

Malignant granular cell tumor.

All lesions must be Grade II or III. No patients with Grade I lesions will be acceptable.

Patients must have undergone a limb-sparing procedure in which all gross tumor has been removed.

Clinical evaluation must reveal no evidence of metastatic disease either in regional lymph nodes or more distant sites.

The soft tissue sarcoma must be on the extremity either at or distal to the shoulder joint or at or distal to the hip joint.

The definitive surgical procedure for a primary lesion or for a recurrence must have been performed no longer than four months from the date of randomization.

Patients must not have received any prior chemotherapy or radiotherapy for their sarcoma.

Patients without a history of any other malignant disease except basal cell carcinoma.

Patients who have not had a serious infection, active bleeding disorders, or concomitant severe disease such as cirrhosis, ischemic heart disease, or evidence of severe impairment of renal function.

Patients must be above the age of 30 and do not have a diagnosis of embryonal rhabdomyosarcoma.
Gastrointestinal Tolerance Evaluation of an Infant Formula

Prospective, double-blind, randomized study of 2 infant formulas.

Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn singleton infant
* Full-term (\> 37 weeks gestation)
* Birth weight ≥ 2500 grams and ≤ 4500 grams
* 9-19 days of age on enrollment
* Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Known or suspected cow-milk allergy
* Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula
* Currently not tolerating (as perceived by the caregiver) their formula
* Currently being treated for reflux
* Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
* Congenital illness or malformation that may affect infant feeding and/or growth
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Receiving prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted).
* Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
* Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.
Clinical Evaluation of Efficacy of Shield Force Plus Varnish VS Sodium Fluoride on Dentin Hypersensitivity

The aim of the study to compare the clinical effectiveness of Shield Force Plus (SFP) versus sodium fluoride varnish in the management of hypersensitivity of cervical dentin in adult patients for 8weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with good oral hygiene.
* The age range of 18-65 years.
* Patients from both gender.
* Patients suffering from pain due to dentin hypersensitivity.
* Patients with sound first upper molars.

Exclusion Criteria:

* Patients with teeth exhibiting mobility (grade 2 or 3).
* Patients with constant use of analgesic, carious lesions, fractured teeth, defective restorations or prosthesis.
* Patients with orthodontics appliance.
* Patients with allergy sufferers with any of the materials will be used in the study as shield force plus and sodium fluoride.
* Patients with carious, crowned upper first molars.
Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring

To investigate intervention with early application of non-ablative laser to prevent scarring in the skin

To intervene in scar formation at three different time-points

Eligibility Criteria:
Inclusion Criteria:

* good health
* men
* Skin type 2-3
* non-smokers
* presenting full medical record

Exclusion Criteria:

* active skin disease in test area
* resent UV-exposure in test area
* history of keloid
* current or resent cancer
* uncontrolled systemical disease
Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease

An increase prevalence of CMV, EBV and or HHV-6 in diseased tissue of inflammatory bowel disease would suggest a role for these viruses in the etiology and/or exacerbation of IBD, whereas their absence would preclude such association.

The protocol is designed to evaluate the following objectives:

1. The prevalence of cytomegalovirus, Epstein Barr virus and human herpes 6 virus DNA in inflamed intestinal mucosa of patients with Crohn's colitis and ulcerative colitis compared to their prevalence in healthy intestinal mucosa of patients not affected by these conditions;
2. To evaluate the prevalence of cytomegalovirus, Epstein Barr virus and human herpes 6 virus DNA in the intestinal mucosa of patients with Crohn's colitis and ulcerative colitis compared to that in inflamed mucosa caused by other conditions (non specific colitis);
3. To compare the prevalence of cytomegalovirus, Epstein Barr virus and human herpes 6 virus DNA in inflamed and healthy tissue in the same patients with Crohn's colitis and ulcerative colitis;
4. To determine whether the presence of cytomegalovirus, Epstein Barr virus and human herpes 6 virus DNA detected by nPCR correlates with immunohistochemical detection of viral protein in colonic tissue.
5. To determine whether the relative viral quantity of CMV, EBV or HHV-6 is related to severity of disease activity.

Eligibility Criteria:
Inclusion Criteria:

* Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed.
* Participants, male or female, aged 18-70, identified as having Crohn's colitis, UC and patients undergoing biopsy for other inflammatory disorders (non specific colitis) and for suspected intestinal malignancy.

Exclusion Criteria:

* Known human immunodeficiency virus (HIV) infection
* Post organ transplant patients.