cyrilzakka/clinical-trials huggingface dataset:
A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Inclusion of new biomarkers to improve the personalized treatment approach for HPV-positive and -negative oropharyngeal squamous cell carcinoma (OPSCC) patients is urgently needed. Emerging evidences suggest that mutations in epigenetic regulators, as well as epigenetic changes, deeply influence the biology of OPSCC, thus representing attractive targets for the definition of novel molecular markers for this malignancy. Based on these considerations, our project aims to retrospectively identify a new mutational and epigenetic signature to identify OPSCC patients at high risk of early relapse, and to set up a new multicenter prospective study in order to validate it


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC, according to AJCC 7th Edition,
* managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy)
* minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment.
* neoplastic lesion contains ≥ 70% neoplastic cells

Exclusion Criteria:

Patients:

* with distant metastases at diagnosis,
* who have been managed with palliative intent;
* with previous history of head and neck cancer are not eligible
An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.

This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.

Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial

Exclusion Criteria:

* Receiving treatment with breast cancer resistance protein inhibitors
* Clinically relevant cardiovascular conditions
* Liver function impairment

Other protocol-defined inclusion/exclusion criteria apply
A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness

Primary Question: "When splinting is used to improve motion in post-traumatic stiff elbows, is there a significant difference in gains in motion achieved between static progressive or dynamic splint approaches?"

Secondary Question: "Is there a significant difference in patient compliance with static progressive versus dynamic splint use, and does this effect final ulnohumeral motion outcomes?"


Eligibility Criteria:
Inclusion Criteria:

* All adult patients with post-traumatic elbow contractures in the Hand and Upper Extremity Service at Massachusetts General Hospital are eligible to for enrollment in this study regardless of sex, race or ethnicity.

Exclusion Criteria:

* Only English speaking patients will be eligible for the study since questionnaires have not been validated in other languages.

  * Vulnerable populations will not be recruited.
Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5

Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an increased risk for developing bloodstream infections. Vancomycin is traditionally used as first-line therapy for treating these infections, but the emergence of less-susceptible bacterial strains necessitates the consideration of alternative antibiotic therapy. Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While dosing recommendations for telavancin are available for patients with normal kidney function, there are no published recommendations for CKD5 patients receiving hemodialysis. A pharmacokinetic study is needed to characterize the pharmacokinetic parameters of telavancin in these patients to determine the extent of drug removal by hemodialysis and to establish dosing recommendations for CKD5 patients on maintenance hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Within 50 - 150 % of ideal body weight and greater than 40 kg
* CKD5 receiving maintenance hemodialysis for ≥ 3 months
* Creatinine Clearance estimate \< 10 mL/min
* Not received telavancin within the past month
* No concurrent illness or evidence of infection
* Able to give informed consent

Exclusion Criteria:

* Pre-study Hemoglobin \< 9.0 g/dL
* Plasma Albumin \< 2.5 g/dL
* Pregnancy
* Breastfeeding
* QTc interval \> 470 msec on EKG obtained within the last 6 months
* Receiving concomitant QT prolonging agents
* Receiving warfarin or low molecular weight heparin products
* Known allergy to telavancin or vancomycin
* Unstable blood pressure control
* Need for routine large fluid removal during dialysis (\> 4 liters)
* Diagnosis of liver disease with a Child Pugh score of C or higher
* Dialysis isolation requirements due to Hepatitis B
* Participating concurrently in another investigational drug study
INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery

The aim of the study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of inflammatory response related complications in patients undergoing heart surgery with use of cardiopulmonary bypass.

Identified so far predictors of mortality and/or morbidity in patients who undergo heart surgery with cardiopulmonary bypass (CPB), used in previous risk prediction models (EUROSCORE, CABDEAL, Cleveland), will be compared with new candidate variables:

1. anamnestic: recent tooth extractions, chronic inflammatory diseases, specific drug use;
2. biochemical: C-reacting protein, interleukin-6, tumor necrosing factor alpha;
3. genetical: single nucleotide polymorphisms of 10 genes associated with inflammatory response; and
4. clinical from the 1. postoperative day: systemic inflammatory response syndrome, APACHE-III score;

against their predictive capability of selected clinical phenotypes of inflammatory response occuring after surgery, beginning from day 2. after surgery.

Eligibility Criteria:
Inclusion Criteria:

* adults (age \>=18)
* given and signed informed consent
* no previous cardiac surgery with opening the pericardium

Exclusion Criteria:

* previous cardiac surgery with opening the pericardium
* consent refused or not given
Community-based Individualized Homeopathic Rehabilitation in Post COVID-19 Patients

A growing number of studies identify a spectrum of persistent symptoms experienced by COVID-19 patients for months after recovery. Symptoms include cough, fatigue, dyspnea, pain, and brain fog (cognitive impairment, including confusion and memory loss), which have a negative impact on daily activities. Homoeopathic practitioners from around the world have documented a number of successful cases of Post COVID treatment. Even though evidence from practice-based research is limited, the purpose of the current study was to evaluate the effect of individualized homoeopathy treatment on post-COVID syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 history
* Persistent respiratory symptoms for more than three months after COVID-19
* Able to provide informed consent

Exclusion Criteria:

* Presence of respiratory issues without COVID-19 diagnosis
* On complementary and Alternative Treatment
* Symptoms of infection
* Pregnancy or Breastfeeding
* Cognitive impairment
Intravenous Infusion of Lidocaine in Gastroscopy

Intravenous infusion of lidocaine significantly reduces incidence of bucking when perfomed gastroscopy.

This study divide patients into two groups, the patients in lidocaine group will be given lidocaine; the control group will be given placebo .the primary endopiont was to investigate whether intravenous lidocaine can reduce incidence of bucking and movement in sedation of gastroscopy.

Eligibility Criteria:
Inclusion Criteria:

patients aged \>18 years who were scheduled for ERCP at Qilu hospital.

Exclusion Criteria:

patients with ASA (American Society of Anesthesiologists) Class 4 or 5, pre-existing hypoxemia (SpO2 \<90%), hypotension (systolic blood pressure \<90 mm Hg), bradycardia (HR\<50 beats/min), uncontrolled hypertension (SBP \>170 mm Hg, diastolic blood pressure\>100 mm Hg), severe renal or liver failure, pregnancy or lactation, allergy to lidocaine, atrioventricular block, epilepsy, and inability to give informed consen
Efficacy Trial of Healthy Together ("Juntos")

The purpose of this study is to assess the efficacy of a family-based digital (web and mobile phone-based) program known as Healthy Together ("Juntos") in preventing increases in body mass index and improving moderate-to-vigorous physical activity, diet quality, and percentage body fat among Hispanic adolescents.


Eligibility Criteria:
Inclusion Criteria:

Adolescent

1. Lives with participating biological parent or legal guardian;
2. Self-identifies as Hispanic;
3. Is between the ages of 12-15years old;
4. Has access to a smartphone;
5. Does not meet recommendations for physical activity as determined by a validated 2-item screener;
6. Does not meet recommendations for daily fruit and vegetable intake (proxy for diet quality) as determined by a validated 2-item screener;
7. Exceeds recommendations for screen time (proxy for sedentary behavior) as determined by a validated 6-item screener

Parent

1. Is the biological parent or legal guardian of and lives with the adolescent;
2. Self-identifies as Hispanic;
3. Has access to a smartphone;

Exclusion Criteria:

Adolescent

1. Has BMI \<5th (underweight) or ≥95th percentile (obesity);
2. Has a parent-reported chronic medical condition (e.g., type 2 diabetes) that requires more intensive intervention;
3. Has parent-reported responses on a physical activity readiness questionnaire (PAR-Q) that indicates a serious health issue, and a physician does not approve participation;
4. Has a parent-reported cognitive or developmental delay (e.g., Down Syndrome) that may interfere with understanding program materials.

Parent

1. Provides PAR-Q responses that indicate a serious health issue and a physician does not approve participation;
2. Reports family plans to move out of South Florida during the study follow-up period
New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry

The purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications.

Intracranial aneurysm is a cerebrovascular disorder in which weakness in the wall of a cerebral artery or vein causes a localized dilation or ballooning of the blood vessel.WILLIS® intracranial stent graft system is indicated for the treatment of intracranial aneurysms.

This study is a multi-center, prospective registration study.

Recruiting 100 specific patients to undergo a treatment with the WILLIS intracranial stent graft system, while giving the anti-platelet aggregation drugs and other medical therapy.

Patients enrolled will undergo a one-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18;
* Arterial wall defects conformed by imaging examination due to internal carotid artery, vertebral artery aneurysms or various causes;
* Target lesion vessel reference diameter 3.5-4.5mm;
* Investigators believe that the patient is suitable for the interventional therapy of WILLIS intracranial covered stent;
* Participate in the study voluntarily, accept follow up study and signed Informed Consent Form.

Exclusion Criteria:

* Existence of branch artery (eg anterior choroidal artery, posterior communicating artery, posterior inferior cerebellar artery, etc.) of target lesion which may cause severe neurological dysfunction after occlusion;
* No suitable vessel entrance, or diseased artery extremely tortuous;
* Coagulation disorders or serious heart, liver, kidney dysfunction or systemic infection, which not suitable for interventional treatment;
* Life expectancy \<1 year;
* Contraindications to heparin, aspirin, clopidogrel, anesthesia, X-ray or contrast agents;
* Mental disorder
Self-Stigma of Mental and Physical Health

People with mental disorders often suffer from self-stigmatization. Self-stigma is associated with several negative outcomes such as low quality of life, lower rates of help-seeking as well as poorer treatment adherence. However, a lot of questionnaires only focus on specific mental disorders. There is no valid measurement which can be used for all kinds of mental disorders.

Furthermore, much less is known about self-stigma in people with organic diseases. Only little attention has been given to those who may experience self-stigma because of their physical condition. A main reason for this may be the lack of a valid measurement of self-stigma among people with physical health issues.

Therefore, the aim of this study is to develop and validate a self-report scale which is capable to do both - measuring self-stigma among people with all mental disorders and among people with physical health issues.

Items are derived from the Stereotype Content Model (SCM) and the Behaviors from Intergroup Affect and Stereotypes (BIAS) Map. Psychometric evaluation includes testing the reliability (intern consistency, test-retest reliability) and validity (exploratory and confirmatory factor analysis, construct validity incl. convergent and discriminant validity, criterion-related validity).

Participants take part in an online survey. They answer general questions about their mental and physical health condition and complete measurements of quality of life, mental health, depression, public stigma, expected stigma, self-stigma, intention to seek help and actual help seeking (behavior).

Eligibility Criteria:
Inclusion Criteria:

* Minimum Age: 18
* Fluent in German Language

Exclusion Criteria:

* Acute psychosis
* Suicidal ideation
DEpth of EPinephrine Delivery With Auto-injectors Devices

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Although there are several causes of fatal anaphylaxis, food allergy is one of the most common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A delay in epinephrine administration may contribute to an increased risk of death. Therefore, the World Allergy Organization recommends that, for the treatment of anaphylaxis, epinephrine solution be administered intramuscularly in the mid-anterolateral thigh.

In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight\> 30 kg, the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and Jext®.

Several studies suggest that the needle length needle is sometim


Eligibility Criteria:
Inclusion Criteria:

* a weight of over 30 kg at Baseline
* with food or an Hymenoptera venom allergy (diagnosed by skin tests or serum-specific IgE testing, requiring prescription epinephrine auto-injector pen according to European recommendations,

Exclusion Criteria:

* having a skin lesion on the lateral aspect of the thigh,
* with a known or suspected allergy to the contact gel
Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients

Multiple myeloma is an incurable malignant disease which evnetuelly will relapse after primary treatment. Clonal B-cells have been identified and in theory these cells might be sleeping during primary treatment and be responsible for later relapse. Fluarabine has documented effect on both resting and dividing cells including B-cells. The protocol aim at evaluating safety and toxicity of adding fludarabine to induction chemotherapy with cyclophosphamide and dexamethasone before high-dose melphalan with autologous stem cell support.

This is a randomised, placebo controlled, phase II study evaluating toxicity and safety of fludarabine added to CyDex (cyclophosphamide+dexamethasone) as induction therapy in younger patients with untreated and treatment demanding multiple myeloma. The treatment regimen Patients will be randomised at diagnosis either to CyDex + Placebo (control Arm A) or CyDex + Fludarabine (Experimental Arm B).

OBJECTIVES:

* Primary:To determine the toxicity and safety of fludarabine when added to induction therapy by registration of side effects and adverse events in accordance with the common toxicity criteria (CTC).
* Secondary:To quantitate clonal cells in bone marrow and blood by flow cytometry (MRD)and to study new potential prognostic markers identified by cytomic, genomic and proteomic analysis.
* Tertiary: To estimate the efficacy of fludarabine when added to induction chemotherapy(CyDex) in patients with multiple myeloma by clinical end points: disease response and progression free survival.

Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma, stage I-III, previously untreated, and eligible for induction therapy followed by high dose treatment supported by autologous stem cell transplantation.

Exclusion Criteria:

* Severe uncontrolled clinical or microbiological evidence of infection at the time of enrolment.
* Other active malignancy.
* Severe coincident heart or lung disease including uncontrolled hypertension, unstable angina, congestive heart failure, coronary angioplasty within six months, myocardial infarction within the last six months, or uncontrolled cardiac arrhythmia.
* Other severe illness including poorly controlled diabetes.
* Haemolytic anaemia (Coombs positive without evidence of haemolysis is accepted).
* Idiopathic thrombocytopenic purpura.
* Terminal illness.
* Allogenic transplantation planned within 6 months.
* Chemotherapy before inclusion.
* Pregnancy or breast-feeding, or inadequate contraceptive precautions.
* Psychiatric disease, abuse of alcohol or narcotics, or any other disorder that might compromise the patients ability to give informed consent.
Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months

From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.

The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.

This study, defined as a pilot study, proposes to evaluate the innovative "TrueGreen" BIO infant formula based on a new whey extraction method on the growth and tolerance of infants from 0 to 6 months compared to the conventional BIO infant formula. As no growth and tolerance data are currently available for this new TrueGreen BIO formula, this study aims to determine them.


Eligibility Criteria:
Inclusion Criteria:

* 0 to 3 weeks
* Child followed by a general practitioner or pediatrician
* Informed consent form signed by the legal representatives of the subject
* Commitment of legal representatives to follow the constraints generated by the study
* Insured

Exclusion Criteria:

* Infant born prematurely before 37 weeks of amenorrhea
* Child allergic to cow's milk proteins
* Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
* Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
* Incapacity for the legal representative(s) to understand or adhere to the protocol
* Subject involved in another clinical study or in an exclusion period from another study
* Legal representatives deprived of liberty
* Legal representatives in a position to judicial protection
* Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
* Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards
* BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
* Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO (World Health Organization) Child Growth Standards
* The investigator considers that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study.
RBANS-H in Older Patients Before and After Cochlear Implantation: A Protocol for a Prospective Study

The cognitive profile of older adults with a severe to profound hearing impairment is determined by means of the Repeatable Battery for the Assessment of Neuropsychological Status, adjusted for Hearing impaired subjects (RBANS-H) before and after cochlear implantation. In this prospective, longitudinal study the participants are tested preoperatively, at six months and twelve months postoperatively and from then on yearly up to 10 years after implantation. In addition to the RBANS-H an audiological examination and an semistructured interview is conducted concerning the cochlear implant use and the self-reliance of the patient and subjective questionnaires are filled out by the subjects to assess quality of life and hearing benefit.


Eligibility Criteria:
Inclusion Criteria:

* age: 55 or older
* cochlear implant candidate (speech understanding in quiet worse than 60% at 65 decibel sound pressure level (dB SPL) in the best aided condition)