cyrilzakka/clinical-trials huggingface dataset:
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.
* Measurable disease as defined per RECIST v. 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented.
* HPV- negative SCCHN tumor as determined per institutional standard (eg, p16 IHC; multiplex nucleic acid sequence based amplification \[NASBA\] or other polymerase chain reaction \[PCR\]-based assays).
* Documented progressive disease according to RECIST v1.1 (Appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for R/M disease (min. 50 mg/m2 for cisplatin, minimum area under the curve \[AUC\] \> 4 for carboplatin).
* Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue \[block preferred, or 15 unstained slides\]), which will be used for centralized, retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.

Key Exclusion Criteria:

* Prior nasopharyngeal cancer, salivary gland or sinus tumors.
* More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed.
* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
* Progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced SCCHN.
* Difficulty swallowing capsules.
* Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)
Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation

Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a numeric result can be calculated.

Since atrial fibrillation (AF) has been linked with an increased risk for the development of neurocognitive deficits, a longer period of AF might be associated with a higher risk for neurocognitive deficits.

It is hypothesized that there is an increase in the regional cerebral oxygen saturation (rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.

Written informed consent by the patient is asked before cardioversion and participation in the study. Patient anamnesis is assessed by standardized questionnaire.

Patients perform several standardised neurocognitive tests to obtain a general view on the neurocognitive status (auditory verbal learning test, mini-mental state examination, trail making A and B, digit-symbol coding and RAND 36 Health Survey).

Cerebral oxygenation is observed during cardioversion by means of the SenSmart Model X-100 (Nonin). Additional parameters (pulse oximetry, cardiac output, arterial blood pressure, 6-lead electrocardiography (ECG), left ventricular ejection fraction) are recorded. All measurements are performed non-invasively. Patients receive standard treatment following the clinical guidelines.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years and able to give informed consent
* diagnosis of paroxysmal or persistent atrial fibrillation
* scheduled for electrical cardioversion or atrial fibrillation development in the first days after cardiac surgery followed by pharmacological treatment with amiodarone
* Dutch speaking

Exclusion Criteria:

* younger than 18 years or not able to give informed consent
* diagnosis of permanent atrial fibrillation
* atrial fibrillation with thrombus in left atrial appendage
* chronic obstructive pulmonary disease GOLD class 3 or 4
* airway manipulation during cardioversion
* pregnant women
* medical history of cerebrovascular accident or brain injury
* medical history of cardiopulmonary resuscitation
A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer

This is a single arm, open label study of up to 24 prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.


Eligibility Criteria:
Inclusion Criteria:

* Male aged 21 years or older.
* Ability to provide signed informed consent and willingness to comply with protocol requirements.
* Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
* Participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.
* Have had, or will undergo diagnostic CT or MRI imaging prior to surgery.
* Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after study drug administration, if engaged in sexual activity.

Exclusion Criteria:

* Participants for whom participating would significantly delay the scheduled standard of care therapy.
* Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
* Participants with any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
Exploring the Effect of an Intervention on Women's Physical Activity Behaviour

Physical activity has been shown to reduce the risk of chronic diseases and promote physical and mental health and wellbeing, yet few women are active enough to see these benefits. Wearable activity trackers show promise for helping people increase their physical activity levels by supporting self-monitoring. However, few researchers have examined how providing people with these devices impacts physical activity levels, or motivation for physical activity which is a significant and robust predictor of physical activity. Based on previous research, it is possible that women's physical activity levels would be more likely to increase if they received an autonomy-supportive intervention to enhance motivation in addition to a wearable activity tracker. A pilot, three-armed randomized controlled trial was developed to test this hypothesis and to assess if changes in perceived autonomy-support, basic psychological need satisfaction/thwarting, motivational regulations, wellbeing indicators are associated with changes in physical activity over time.


Eligibility Criteria:
All participants will need to meet the following inclusion criteria to participate in the intervention:

1. Are a woman between the ages of 18 and 65 years
2. Can understand, read, and speak in English
3. Are able to safely engage in physical activity
4. Are not currently pregnant or lactating
5. Currently participating in less than 150 minutes of moderate or vigorous intensity physical activity and less than two strength training sessions per week
6. Are overweight or obese (i.e., have a body mass index greater than 25kg/m2)
7. Have access to the Internet and an email account
8. Have not used a wearable activity tracker within the past year (e.g., Fitbit, Apple Watch, Garmin, Polar)
9. Live within 50km of the University of Ottawa
Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2

The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Eligibility Criteria:
Inclusion Criteria:

* healthy adult subjects who signed informed consent

Exclusion Criteria:

* Subjects has a history of allergy reaction of study drug ingredient
* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01)

The purpose of this Phase 1 study is to evaluate the safety and potential efficacy of Gene Mediated Cytotoxic Immunotherapy for pancreatic cancer. The approach uses an adenoviral vector (disabled virus) engineered to express the Herpes thymidine kinase gene (AdV-tk), followed by an antiherpetic prodrug, valacyclovir.

The AdV-tk vector is injected into the tumor or tumor bed at the time of biopsy or standard tumor surgery after which valacyclovir pills are taken for 14 days. Two courses of AdV-tk, each followed by valacyclovir, are given as adjuvant to standard of care therapies (surgery and/or chemoradiation) which have been shown to work cooperatively with AdV-tk to kill tumor cells. Arm A is for resectable tumors in which the first course is given prior to surgery and the second is at the time of surgery. Arm B is for locally advanced disease in which both AdV-tk injections are administered by needle injection into the tumor before and during chemoradiation. The hypothesis is that this combination therapy can be safely delivered and will lead to improvement in the clinical outcome for patients with pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Must have presumed pancreatic adenocarcinoma based on clinical and radiologic evaluation with identifiable tumor accessible for injection (pathologic diagnosis of pancreatic adenocarcinoma must be made prior to AdV-tk injection
* For Arm A, resectable disease. Arm B for locally advanced disease has completed accrual.
* Performance status must be ECOG 0-2
* SGOT (AST)\<3x upper limit of normal
* Serum creatinine\<2mg/dl and calculated creatinine clearance \>10ml/min
* Platelets\>100,000/mm3 and WBC\>3000/mm3 and ANC\>1500/mm3
* Must give study specific informed consent prior to enrollment

Exclusion Criteria:

* Primary hepatic dysfunction including active hepatitis but not to exclude patients due to obstructive jaundice. If obstructive jaundice is clinically significant, bilirubin should be stable or decreasing prior to enrollment.
* Evidence of clinically significant pancreatitis as determined by the investigator.
* Patients on corticosteroids or other immunosuppressive drugs
* Known HIV+ patients
* Patients with acute infections (viral, bacterial or fungal infections requiring therapy)
* Pregnant or breast-feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy
* Evidence of distant metastatic disease at the time of enrollment or other malignancy (except squamous or basal cell skin cancers) and no prior abdominal radiation therapy or prior treatment for pancreatic cancer
* Other serious co-morbid illness or compromised organ function
Prospective Use of Real-time MRI

This research study is being done to look at a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a percutaneous MR guided procedure

Exclusion Criteria:

* Pregnant Women
Effectiveness of Buddhist Intergrated Group Intervention on Minefulness in Adolescents

The pupose of the study is to determine the effectiveness of the Buddhist integrated group intervention improve the mindfulness in adolescents by a randomized controlled trial.The study divede the adolescents in two groups group A recieved the 8 time Buddhist group interventions.Group recieved nothing.The measurement were done pre and post intervention at week1 and week8.The mindfulness score ,the EQ,the MASS score were compared between both groups.

Adolescence behavioural problems are increasing including learning disabilities,game addiction,intolerance etc.The improvement of mindfulness ,the emotional quotient(EQ) proved to be effective to reduce the problems.The original teaching methods in school or in the temple are inadequate from increasing number of adolescent problems. The new technique integrated between Buddhism and group intervention is proposed to improve the mindfulness and EQ in adolescence.

Eligibility Criteria:
Inclusion Criteria:

* adolescents

Exclusion Criteria:

* incomplete qeustionaire and intervention
Special Drug Use Surveillance of Entresto Tablets (Hypertension)

This is a single arm, multicenter, observational study to evaluate the safety and efficacy of Entresto Tablets during the first 52 weeks of treatment in Japanese patients with hypertension.

This study is a special drug use surveillance to collect information on the safety specifications under the actual clinical practice of Entresto Tablets in patients with hypertension in Japan to confirm the occurrence and timing of onset of events related to the safety specifications and investigate their risk factors.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have given written consent to participate in this study before the start of treatment with Entresto
2. Patients who used Entresto for the first time for the indication of hypertension

Exclusion Criteria:

1. Patients who have received a formulation containing the same ingredient as Entresto (including investigational product or post-marketing clinical study drug)
2. The following patients for whom administration of Entresto is contraindicated in the package insert:

   * Patients with a history of hypersensitivity to any of the ingredients of Entresto
   * Patients who are receiving angiotensin-converting enzyme inhibitors (alacepril, imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride, cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride, trandolapril, benazepril hydrochloride, perindopril erbumine, and lisinopril hydrate) or who discontinued these drugs within 36 hours.
   * Patients with a history of angioedema (angioedema due to angiotensin II receptor antagonists or angiotensin converting enzyme inhibitors, hereditary angioedema, acquired angioedema, idiopathic angioedema, etc.)
   * Patients with diabetes mellitus who are receiving aliskiren fumarate
   * Patients with severe hepatic impairment (Child-Pugh class C)
   * Pregnant or possibly pregnant women
3. Patients with a history or complication of cardiac failure
4. Patients who have been hospitalized at the start of treatment with Entresto
Probiotics in PBC Patients of Poor Response to UDCA

The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response.

PBC patients with poor ursodeoxycholic acid (UDCA) response are selected and randomly assigned into probiotic group and control group. Patients in probiotic group receive probiotic(Micro V Probiotics) combined UDCA for 6 months and then continue to take UDCA alone. Patients in control group continue to take UDCA alone. Biochemical indicators, immunological indicators, liver stiffness, and ultrasound of the two groups of patients were collected. GLOBE and UK-PBC scoring system are used to assesse prognosis.The feces and serum of all patients are collected to observe the differences in fecal microbial polymorphisms in the two groups of patients. Metabolomics are used to study the differences in the bile acids and short chain fatty acid metabolites of the serum and feces of the two groups of PBC patients.

Eligibility Criteria:
Inclusion Criteria:

1. PBC patients (diagnosed with PBC according to 2009 AASLD PBC PRACTICE GUIDANCE), take UDCA more than 12 months and have poor response;
2. Age 18-70 years.

Exclusion Criteria:

1. Any other liver disesases (viral hepatitis, HIV positive, alcohol abuse, hemochromatosis, hepatolenticular degeneration, α1-antitrypsin deficiency and so on);
2. Important organ dysfunction such as heart, lung and kidney which affect the life expectancy;
3. Have congenital galactosemia, glucose malabsorption syndrome or lactase deficiency.
4. Patients allergic to research drugs or excipients;
5. Pregnant or lactating women;
6. Not signed informed consent;
7. Have antibiotics one month before enrollment;
8. Microecological preparations (probiotics, prebiotics, synbiotics, etc.) were used before the enrollment;
9. Malignant tumors, nerves and mental disorders;
10. Those who participated in other drug clinical trials in the past 3 months.
The Change of NK Cell Activity After Head and Neck Cancer Surgery

Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical procedures significantly reduces the immune function in proportion to the degree of tissue injury. In addition, the use of opioids as analgesics during the perioperative period depress cellular immunity, in particular the activity of the natural killer (NK) cells. This perioperative immunosuppression may cause deleterious consequences on postoperative outcome in cancer patients. The aim of this study is to confirm the presence or extent of the change of NK cell activity between before and after head and neck surgery. Additionally, investigators will identify the clinical or genetic factors related to the change of NK cell activity.


Eligibility Criteria:
Inclusion Criteria:

1) The patients undergoing head and neck surgery including tumor removal and reconstruction with flap

Exclusion Criteria:

1. patients refusal
2. patients not able to read, or understand the consent form
3. History of Active viral or bacterial infection
4. History of use of immunosuppressive drugs within the last six months
5. History of chemotherapy
6. History of autoimmune disorders
7. Known HIV, Hepatitis B, or Hepatitis C infection
8. Female who is pregnant, nursing
9. ethnicity, other than asian
Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography

Randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.

In summary, the aim of the study is to examine the effect of the immunosuppressive agent Everolimus (Certican) on the development of cardiac allograft vasculopathy (CAV).

Therefore the study is divided in three sections:

Substudy 1: Evaluation of morphological differences between between CAD and CAV.

Substudy 2: Analysis of cardiovascular risk factors (e.g. hypertension) under a specific immunosuppressive protocol in patients with CAV.

Substudy 3: Prospective, randomized analysis of the influence of different immunosuppressive protocols in patients with CAV.

Primary endpoint of the study will be the adaption of intimal thickness after 10 years, analysed by means of optical coherence tomography.

In addition to the explanations above the most important in- and exclusion criteria are listed below:

Inclusion Criteria:

* Patients after heart transplantation
* Patients with coronary artery disease (CAD)
* Age 18-80 years

Exclusion Criteria:

* Contraindication of Everolimus/Sirolimus or adjuvants
* Renal insufficiency (Creatinine \> 265 µmol/l)
* Cardiogenic shock or patients with Killip\*-Class III or IV (\*name)
* Pregnant or breast feeding females
* insufficient contraception (only for substudy 3)

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart transplantation
* Patient with coronary artery disease
* Age between 18 and 80 years

Exclusion Criteria:

* Renal insufficiency (\> 265 µmol/l)
* Incapability to give informed consent
* Cardiogenic shock of patient with KILLIP III or IV
* pregnant or breast feeding females
* insufficient contraception (only for substudy 3)
Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Variables in COPD Patients

Transcutaneous electrical diaphragmatic stimulation (TEDS) has been used to improve respiratory muscle strength in patients with respiratory muscles weakness. However, this physiotherapeutic resource has not been studied in chronic obstructive pulmonary disease (COPD) yet. The objective of this study is to evaluate the respiratory pattern during the session of TEDS besides its effect in respiratory muscle strength and in spirometric variables as much healthy patients as in COPD patients. Methods: healthy and COPD patients are selected and submitted to TEDS treatment. The plethysmographic analysis (LifeShirt System - VivoMetric), respiratory muscle strength and spirometry will be made. The hypothesis is that the TEDS can helps COPD patients that shows respiratory muscle weakness.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable COPD (diagnosed by accepted criteria)
* Healthy patients

Exclusion Criteria:

* FOR THE COPD PATIENTS:
* Over 80 years of age
* History of recent exacerbation
* Patients with pacemakers
* Uncontrolled arterial hypertension
* Requiring home oxygen therapy.
* FOR THE HEALTHY PATIENTS:
* Pulmonary diseases
* Cardiovascular diseases
* Orthopedic diseases
* Neurologic diseases.
Intracranial Aneurysms Treatment With the OPTIMA Coil System

International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy


Eligibility Criteria:
Inclusion Criteria:

1. Patient with small or large intracranial aneurysm, ruptured or unruptured, intended to be selectively treated with the OPTIMA coil system. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible. Balloon and stent assisted coiling are allowed at index procedure.
2. In case of multiple aneurysms, patient can be included when only 1 aneurysm is treated during the procedure and none of the other aneurysms are treated up to 30 days post-procedure
3. Patient older than 18 years
4. Patient who has been informed of the study and has signed an informed consent form where applicable according to local regulations.

Exclusion Criteria:

-