cyrilzakka/clinical-trials huggingface dataset:
Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer

Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer

The primary objective of this phase II trial is to estimate the rate of complete pathologic response as determined by surgical resection or post treatment endoscopy (for patients not undergoing resection) for the treatment regimen being tested. With a total accrual of 28 evaluable patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.
* Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric lymphadenopathy.
* There must be no evidence of distant organ metastases.
* No prior radiation for gastric or esophageal cancer.
* Patients must be \> 18 years of age, and nonpregnant
* Patients must have an ANC \> 1,500/ul, platelets \> 100,000/ul, creatinine \< 2 x upper limit normal (ULN) and bilirubin \< 1.5 x ULN, and AST \< 3 x ULN.
* ECOG performance status 0-2.
* Patients must not have significant infection or other coexistent medical condition that would preclude protocol therapy.
* Female patients, must either be not of child bearing potential or have a negative pregnancy test within 7 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible.
* All patients must sign informed consent

Exclusion Criteria:

Any of the following criteria will make the patient ineligible to participate in this study:

* Acute hepatitis or AIDS.
* Active or uncontrolled infection.
* Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
* Prior therapy which specifically and directly targets the EGFR pathway.
* Prior severe infusion reaction to a monoclonal antibody.
* Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C

The response rate to interferon-based anti-viral therapy for chronic hepatitis C is lower in patients who are obese. However, it is not clear whether this is related to suboptimal dosing of the medication or alterated response in obese patients. Alterated immune response had been reported in obese patients. The goal of current study is to determine the immune response to interferon in obese compared to non-obese chronic hepatitis C in an tissue culture system.

To examine our hypothesis, we will incubate PBMC samples from obese and nonobese patients with IFN, followed by microarray analysis to compare the IFN response patterns in both groups of patients and to identify genes differentially regulated between these two groups. Identification of such genes will provide important insight to the mechanism of the antiviral effect of HCV. The identified genes will have the potential of serving as targets for pharmaceutical intervention aiming at enhancing the efficacy of IFN therapy for obese patients.

This is an open-label study. Ten obese and 10 nonobese patients with chronic hepatitis C will be recruited. For the purpose of this study, obese is defined as body weight \>85 kg and BMI \>30, and nonobese as body weight \<75 kg and BMI\<25.

Eligibility Criteria:
Inclusion Criteria:

* obese (weight \> 85kg and BMI\>30) or non-obese patients (\<75kg and BMI \<25) with chronic Hepatitis C
* Chronic Hepatitis C infection with documented HCV RNA
* Body habitat either as obese or non-obese as defined above
* Currently not under IFN therapy
* Non-African American

Exclusion Criteria:

* Body habitat neither obese or non-obese as defined for the purpose of this study
* Unable to give consent
* On immunomodulatory agents such as prednisone
* Active infection other than Hepatitis C
* Co-infection with HBV or HIV
* Active or excessive alcohol use
* Other cause of chronic Hepatitis
A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus

This study is to test the efficacy and safety of PHX1149T in combination with metformin, a glitazone, or metformin and a glitazone in subjects with Type 2 diabetes for 12 weeks. After completing the 12 week double blind part of the study, subjects can enter an open label extension study


Eligibility Criteria:
Key Entry Criteria:

* Type 2 diabetes mellitus, diagnosed at least 4 months but not more than 12 years prior to screening.
* Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 25 to 48 kg/m2, inclusive. For India the BMI is 23 to 48 kg/m2, inclusive.
* Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of 1500 mg or more (or the highest tolerated dose), or TZD (any labeled dose), or metformin + TZD at doses used in accordance with product labeling for at least 4 weeks (metformin) or 10 weeks (TZD) prior to screening (Visit 1).
* Fasting plasma glucose of 118 - 220 mg/dL (6.6 - 12.2 mmol/L), inclusive; HbA1c 7.3% - 11.0%, inclusive; and a fasting plasma C peptide greater than 0.26 nmol/L at screening. For Argentina the allowed upper limit of HbA1c is ≤ 10.5%. For Canada the upper limit will be 10.0%
* No Type 1 diabetes mellitus or marked diabetic long-term complications.
Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort

Biomarkers are important for early and precise diagnosis of dementia. However, the causes of dementia in different age are different. We designed an age stratified dementia cohort and tried to explore biomarkers of different groups of dementia, incorporating neuropsychology, multi-model neuroimaging, metabolics and proteomics based fluid biomarkers as well as genetic biomarkers. Autopsy after clinical follow up help to verify the biomarkers.

Baseline data collection and cohort establishing: Detailed clinical information including demographic data, clinical history, past history and physical examination are collected. Formatted neuropsychological battery is used in all patients, including screening tests (MMSE, MoCA-PUMCH, ADL, HAD) and domain specific evaluation (Memory, executive function, visual spatial, calculation, language). Samples including serum, CSF, urine, skin, saliva are stored. Every patient is followed up every 6 months. Autopsy brain tissue will be collected if patients died.

Multi-model neuroimaging evaluation: Structure and functional brain 3T-MRI; 7T-MRI； PET-CT including FDG, Aβ（18F-AV45）,tau（18F-THK5317, 18F-T807）; EEG

Multi-omics biomarkers research:

CSF AD biomarkers (Aβ40,42, ptau181, ttau, NfL, Neurogranin), comparison of different methods, including ELISA, Electrochemical, Mass Spectroscopy. The standardization of CSF biomarkers analysis in China.

Exploring new fluid biomarkers: CSF and Urine proteomics; CSF and serum glycomics and metabolomics. To explore new biomarkers in differentiation of different causes of dementia, age onset and prognosis of dementia.

Genetic biomarkers evaluation: including pathogenic gene mutation panel examination and WES.

Data analysis and biomarkers evaluation: Dementia patients are stratified based on age onset, cause of dementia, cognition severity, effect of therapy, prognosis. Identify multi-omics biomarkers in different groups. Comparing the relationships between biomarkers and clinical presentations as well as neuroimaging. Autopsy based accurate diagnosis help further defining biomarkers.

Acquiring stratified biomarkers with high sensitivity and specificity.

Eligibility Criteria:
Inclusion Criteria:

* Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia
* Fixed care giver and can follow up regularly

Exclusion Criteria:

* Not demented, including MCI
* Systemic severe diseases and severe vision or hearing problem effecting follow up and neuropsychological evaluation
* Without fixed care giver
* Reject informed consent
* Expected life shorter than 2 years
Stress Free Now in a Corporate Call Center

Psychosocial stress increases the risk for a multitude of diseases, including obesity, hypertension, and cardiovascular disease. Stress may also result in increased utilization of health care services. In the workplace, stress leads to emotional exhaustion, job dissatisfaction, lower productivity and impaired performance. Stress management programs and those based on mindfulness meditation have gained popularity in recent years. The purpose of this study is to evaluate the feasibility of an 8-week web-based mindfulness stress reduction program and its effectiveness in reducing work related stress and improving well-being in a large corporate call center.


Eligibility Criteria:
Inclusion Criteria:

* Frontline employee of large corporate call center
* Internet access

Exclusion Criteria:

* Manager or supervisor of large corporate call center
An Exploration of Antenatal Hand Expression.

The study is an exploration of mother's experiences of antenatal hand expression of colostrum, and the effects upon breastfeeding continuation and maternal emotional health

Second-line feeding strategies including hand expression and syringe feeding are used as an aid to breastfeeding, however little is known about their efficacy. This research explores the experiences of women who have used antenatal hand expression to identify how it affects maternal emotional health and breastfeeding continuation. UK women with recent experience of the practice were interviewed and the data analysed using thematic analysis. The results identified five themes in relation to these experiences including; The emotional distress of struggling with breastfeeding, Support as panacea but inconsistent, A crisis of confidence, Discord between knowledge, expectations and reality, and Syringe feeding as challenging but constructive. The study concludes that hand expression and syringe feeding supports women to establish breastfeeding, however, those struggling with breastfeeding need extra practical and emotional support to protect breastfeeding self-efficacy, emotional health and breastfeeding continuation. The findings highlight the importance of realistic, antenatal breastfeeding education to achieve this. Further research into second-line strategies and antenatal education programmes could contribute to the improvement of women's infant feeding experiences and improve UK breastfeeding rates.

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18,
* Women with experience of antenatal hand expression within the last three months,
* Women with a good grasp of the English language.

Exclusion Criteria:

* Mothers of babies born before 37 weeks or with a medical issue (eg. tongue tie),
* Women with a mental health diagnosis
Treatment Positioning in Vulvar Cancer Radiation Therapy

The study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using Volumetric Arc Therapy (VMAT) modality with curative intent. Our aim is to compare straight-leg versus frog-leg position in terms of RTOG acute skin toxicity. Also, the study investigators will evaluate if positioning has an impact on the total treatment time and deviation on Cone Beam CT (CBCT) that might warrant re-simulation and consequently re-planning.

Vulvar cancer is a rare tumor with a prevalence of about 3-5% of gynecological malignancies with squamous cell carcinoma being the most common histopathologic subtype. It is more common among elderly and postmenopausal women.

Surgery is the cornerstone for the management of patients with early stage vulvar cancer. Radiotherapy is an integral part of the management of vulvar cancer both in the definitive and adjuvant settings.

Several studies have shown that intensity modulated radiotherapy IMRT is associated with better locoregional control compared with 3-dimensional conformal radiotherapy 3DCRT. In addition, it is associated with dosimetric advantage and better sparing of the organs at risk.

Historically, frog-leg position was the standard to provide better access for electron boost in conventional era. After evolution of inverse planning, electron boost is not further needed. Some centers have adopted straight-leg position.

There is paucity of literature regarding vulvar cancer in general and there is lack of data addressing radiation therapy treatment position specifically.

The study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using Volumetric Arc Therapy (VMAT) modality with curative intent. Our aim is to compare straight-leg versus frog-leg position in terms of RTOG acute skin toxicity. Also, the investigators will evaluate if positioning has an impact on the total treatment time and deviation on Cone Beam CT (CBCT) that might warrant re-simulation and consequently re-planning.

If both positions proved to be similar in terms of skin toxicity, then the investigators will adopt supine position in the treatment of all patients with vulvar cancer. It will be more comfortable position, and so more reproducible and this reproducibility will be reflected on better treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* ECOG PS = 0-1
* Women with Bx confirmed vulvar cancer FIGO stage I-IVA (treated with curative intent)

Exclusion Criteria:

* Patients whom radiotherapy plans do not cover inguinal lymph nodes will be excluded.

Vulnerable patients will be excluded (pregnant)
Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator

To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke
* NIHSS between 5-22
* Persistent clinical deficits following administration of rt-PA

Exclusion Criteria:

* Planned thrombectomy
* Aortic pathology
* Severe heart disease
* Other conditions the doctor will assess
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia

Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a master negative regulator of skeletal muscle mass. If the role of myostatin in cancer cachexia is now well established in murine models, no study has focused on muscle expression of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin a biological marker of cachexia in patients with cancer of digestive system. The main objective is to compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of cachexia in cancer of digestive system patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be determined in a muscle sample taken during the resection under general anaesthesia. Skeletal muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6 months postoperatively. Blood sampling will also be performed on these 4 occasions.


Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 40-80.
* Diagnosis for cancer of digestive system requiring surgery with neoadjuvant treatment or not.
* Signature of consent
* Affiliate or beneficiary of social security

Exclusion Criteria:

* Administration of corticosteroids.
* Thyroid disease treated.
* Severe chronic pathology during treatment (neuro-muscular pathologies, renal insufficiency requiring dialysis, COPD under continuous oxygen therapy).
* Psychological, familial, social or geographical conditions that could affect the participation of the subject throughout the duration of the protocol.
* BMI\> 30 due to the difficulty of interpretation of BMI variations in obese patients
Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery

After any surgery, there is a chance of complications. After lung surgery to remove tumours, there is a particularly high chance of a person developing an infection or needing help breathing, called post operative pulmonary complications. Currently, the risk of these complications is reduced through the completion of light physical and deep breathing exercises and walking around as soon as possible after surgery. Another possible way of helping these patients is to use a small device called an Incentive Spirometer to encourage and measure deep breathing. This study wants to compare how often postoperative pulmonary complications happen after major lung surgery between a group completing the exercises alone and a group using the Incentive spirometer in addition to the exercises. It is hoped that the combined therapy will reduce the amount of time patient must stay in hospital, have fewer complication events and have fewer patients re-admitted back into the hospital after they go home, so that patients overall have better outcomes.

This study is a prospective blinded randomized control trial (RCT) where two arms will be assembled. Consenting eligible patients will be randomized to either the physiotherapy + incentive spirometry (PT+IS-intervention) arm or physiotherapy only (PT-control arm). Patients will be randomized with an equal (1:1) chance of being allocated to either the PT (control) arm or PT+IS (intervention) arm. Both the treating surgeon and data interpreter will be blinded to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at minimum age 18
* Patient must be undergoing pulmonary resection surgery for malignant or benign disease
* Patients must be able to understand English
* Patients must be able to demonstrate aptitude and willingness to comply with describes study procedures

Exclusion Criteria:

* Patients who are unable to read and communicate in English
* Home oxygen usage prior to operation
* Previous pulmonary resection or any thoracic surgery
* Radiological evidence of atelectasis or pneumonitis on preoperative imaging
* Radiological evidence of pleural effusion prior on preoperative imaging
* Prior exposure to pulmonotoxic drugs such as amiodarone or belomycin
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent
Optimization of a Mobile Transdiagnostic Emotion Regulation Intervention for University Students

This study will explore the functioning of a mobile transdiagnostic emotion regulation intervention designed for university students to optimize the uptake and the effectiveness of the intervention.

It is estimated that globally between 12 and 50% of all university students are affected by mental health problems, the most common ones being anxiety, depression, and substance abuse. Over the past years online-based interventions have been spotlighted by researchers and clinicians as an avenue for a better outreach and provision of low threshold interventions aimed at primary and secondary prevention of mental health problems among the university students population.

As part of a student wellbeing program at the Erasmus University Rotterdam (EUR), a transdiagnostic mobile intervention consisting of a suite of preventative self-guided tools is being developed. Its' goal is to help students better manage their mental health by teaching them adaptive emotional regulation strategies.

The intervention includes exercises from different therapeutic approaches, and targets transdiagnostic factors such as negative self-referential thoughts, rumination, experiences of prolonged negative emotional states, and mental health literacy. The intervention is delivered via a smartphone and consists of 20 therapeutic exercises teaching students strategies like upregulation of positive affect, staying present in the moment, cognitive defusion, relaxation and breathing techniques, and self compassion skills.

The main goals of the study are to evaluate whether the intervention and its components have the intended effects on student's emotional states as well as get insight into students' engagement patterns and experience with the intervention. This will be done by utilizing an explanatory sequential mixed methods approach combining novel methods of online-intervention assessment, specifically Micro Randomized Trials (MRT) with semi-structured interviews, which will provide information on the lived experiences of the participants with the intervention and provide explanation of the quantitative results. The results of this trial will support the optimization and further development of the mobile application that will later be evaluated for its full-scale effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Willing to provide informed consent
* Currently enrolled as a student at the Erasmus University Rotterdam
* Own a smartphone with an active phone number
* Feel comfortable speaking and writing in the English language
* Having a score between 5 (mild) and 19 (moderately severe) on the PHQ-9

Exclusion Criteria:

Participants are not eligible for this study if they:

* Experience significant suicidal thoughts over the past month
* Have a medical diagnosis of psychosis or bipolar disorder, severe clinical depression or anxiety disorder
* Are undergoing psychopharmacological treatment or treatment with experimental drugs
Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.


Eligibility Criteria:
Inclusion Criteria:

* Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.
* Previous cerebral ischemic attack (stroke or TIA, \>30 days prior to randomization)
* Previous systemic embolism.
* Symptomatic congestive heart failure (CHF)
* Impaired left ventricular systolic function
* Diabetes mellitus
* Hypertension requiring anti-hypertensive treatment.

Exclusion Criteria:

* AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
* Known contraindication to VKA treatment
* Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment
* Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization