cyrilzakka/clinical-trials huggingface dataset:
Exercise and Pain in AYACS

The purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in adolescents and young adults (AYA). Our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female AYA cancer survivors diagnosed with any type of cancer between the ages of 15 and 39 years old
2. AYA cancer survivors who have completed all standard/planned cancer treatment and are stable at the time of recruitment
3. AYA cancer survivors are \< 1-year post cancer therapy
4. AYA cancer survivors who have chronic pain (pain will be self-reported by the participant, will have to be ≥1 on a scale of 10 and lasting for 3 months or longer)
5. AYA cancer survivors who are age ≥18 years old at the time of enrollment
6. AYA cancer survivors who are and who are not non-ambulatory/wheelchair bound.
7. AYA cancer survivors must be able to speak, read and understand the English language
8. AYA cancer survivors must be able to provide and understand informed consent
9. AYA cancer survivors must be able to attend three visits (baseline, 8 and 16-week follow-up) at the Penn State Health Milton S. Hershey Medical Center
10. AYA cancer survivors must have access to a computer with wifi, smartphone with wifi or tablet with wifi

Note: The agreement of the attending oncologist will be required for the participation of AYA cancer survivors eligible for this study.

Exclusion Criteria:

1. AYA cancer survivors who have not completed all standard/planned cancer treatment and/or not in complete remission at the time of recruitment
2. AYA cancer survivors who are \> 1-year post cancer therapy
3. AYA cancer survivors who are \< 18 years old at the time of enrollment
4. cancer survivors who have evidence of an absolute contraindication to complete any of the physical assessments in their medical record. This exclusion criterion is at the oncologist's discretion when research staff will contact the medical oncologist via secure email or secure message through the electronic medical record for approval to approach their patients for the study and for medical clearance. The oncologists can update this information at any time during the study if there is evidence of an absolute contraindication to complete any of the physical assessments.
5. AYA cancer survivors who have history of refractory or recurrent cancer
6. AYA cancer survivors who are unable to speak, read, and understand the English language
Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis

The purpose of this study is to find out if weekly Avonex works as well as three times a week Rebif in subjects with relapsing multiple sclerosis.

This is a Phase 4, multicenter, prospective and retrospective, long-term observational study of Avonex® and Rebif® to determine the efficacy, tolerability, and safety in subjects with relapsing MS.

Eligibility Criteria:
Inclusion Criteria:

* Must have been receiving AVONEX® or Rebif®.
* Must have a confirmed diagnosis of relapsing-remitting MS using the Poser criteria.
* Must have experienced at least 2 relapses within the 3 year period prior to the initiation of treatment.
* Must have an EDSS score of 0.0 to 5.5, inclusive.

Exclusion Criteria:

* History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, or to other components of the drug formulation.
* History of poorly controlled hypertension and/or other clinically significant major disease.
* History of uncontrolled seizures within the 3 months prior to enrollment.
* History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment.
* Serious local infection or systemic infection within 8 weeks prior to enrollment.
* Treatment with certain other agents to treat MS symptoms or underlying disease.
* Treatment with any investigational product
* Previous participation in this study.
* Other Protocol-defined inclusion/exclusion criteria may apply.
A Phase 1 Study of BB3008 in Participants With Advanced Solid Tumors

This is a Phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics, efficacy and preliminary food effect of BB3008 as monotherapy in subjects with advanced solid tumors.

This first-in-human (FIH) study of BB3008 will evaluate safety, tolerability, pharmacokinetics (PK) efficacy and preliminary food effect of BB3008 in subjects with advanced solid tumors. The primary objective is to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of BB3008 as monotherapy, and to evaluate the safety and tolerability of BB3008. The secondary objectives include the assessments of PK profile, preliminary efficacy, preliminary food effect (FE) and preliminary metabolites identification of BB3008. The exploratory objectives are to explore biomarkers and C-QTcF analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Fully informed of the study and voluntarily signed the informed consent form (ICF), and willing to follow and have the ability to complete all trial procedures.
2. Subjects with histologically or cytologically confirmed advanced solid tumors who are lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.
3. ECOG score ≤1.
4. At least one evaluable or measurable lesion as defined by RECIST v1.1.
5. Expected survival ≥ 3 months.
6. adequate organ function.
7. Female subjects of childbearing potential must have a negative pregnancy test prior to the first dose and are required to use effective contraception from signing the ICF until 6 months after the last dose of study treatment.

Exclusion Criteria:

1. History of dual-source cancer within 5 years.
2. Presence of known active central nervous system (CNS) and/or leptomeningeal metastases.
3. History of clinically serious cardiovascular and cerebrovascular disease within 6 months.
4. Active infection (including, but not limited to HBV or HCV).
5. Received radical radiotherapy within 12 weeks.
6. Received live virus vaccination within 4 weeks.
Dose Escalation and Expansion of BBO-10203 in Advanced Solid Tumors (BREAKER-101)

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with trastuzumab in patients with advanced solid tumors.

This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-10203 as a single agent and in combination with trastuzumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. The study includes a dose escalation phase, and an expansion phase.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive, / HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)
* Measurable disease by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Adequate LVEF assessed by ECHO or MUGA
* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC).
* Patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after, all available SoC treatments or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate SoC therapy.

Exclusion Criteria:

* Patients with HER2+ aBC who have had more than 1 prior line of therapy with an antibody-drug conjugate
* Patients with KRAS mutant aCRC who have BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
* Patients with KRAS mutant aNSCLC who have tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
* Patients with untreated brain metastases (exceptions apply for HER2+ aBC per protocol)

Other inclusion/exclusion criteria are specified in the protocol
High-activity Natural Killer Immunotherapy for Small Metastases of Colorectal Cancer

The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of colorectal cancer.

By enrolling patients with small metastases of colorectal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Assessment of Quality of Life in Food Allergic Children

The purpose of this study is

1. To validate in french quality of life questionnaires for food allergic children
2. To evaluate if the quality of life of food allergic french speaking children aged 0-12 years is affected by their condition
3. To validate a didactic game for food allergic children


Eligibility Criteria:
Inclusion Criteria:

* French speaking children with confirmed IgE mediated food allergy
* Aged 0-12 years old

Exclusion Criteria:

* Inclusion in another trial
* Chronic severe diseases
Stent For Life Observatory

Observatory multicenter, prospective, to support the acute phase of acute coronary syndromes with ST segment elevation ST (myocardial infarction).


Eligibility Criteria:
Inclusion Criteria:

* Any patient with a myocardial infarction less than 48 hours during the November 2010 is eligible and should be considered for inclusion in the study.
* Every patient who agreed to participate in the study

Exclusion Criteria:

* Patients with myocardial infarction after a coronary revascularization, or after cardiac surgery or extra heartbeat.
* Patient denying that his personal data are subject to treatment automated
Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography

Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and post-operative AKI. The development of CI-AKI after cardiac catheterization is associated with a significant increase in both short-term and long-term mortality and morbidities, as well as an increase in length of stay and cost.

The only marker of renal function that has predictive ability is creatinine and it has significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic test for predicting CI-AKI risk would have widespread clinical utility.

The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac catheterization.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 yo) undergoing invasive coronary angiography with or without percutaneous coronary intervention (PCI), that are predicted to have ≥14% risk of developing AKI as defined by Mehran et al.
* Medically compliant and able to consent and follow detailed directions
* Agree to additional collection of blood sample 48-72h post cardiac catheterization

Exclusion Criteria:

* Presence of acute, active infection (e.g. HIV, pneumonia, septic shock).
* Contrast media exposure within last 48h
* Presenting with systolic time-segment elevation myocardial infarction.
* Presence of cardiogenic shock
* Presence of hemodynamic instability or requiring pressors or intra-aortic balloon pump
* Severe kidney disease with estimated glomerular filtration rate \<30 mL/min/1.73m2 or receiving dialysis for end stage renal disease
* Kidney transplant and liver transplant patients and all patients currently on immunosuppressants
* Severe heart failure with known ejection fraction \<25%
* Prior heart transplant
* Chronic liver disease /cirrhosis
* Patients actively undergoing chemotherapy or radiation treatment for any indication.
International Multicenter Study of In-hospital Outcome of Patients After ICU Discharge

Several patients die in the intensive care unit (ICU) due to their acute disease and comorbid conditions. Moreover, after ICU discharge, some ICU survivors still die in the wards.

Previous studies have shown that the clinical condition of the patient at the time of ICU discharge may influence in-hospital prognosis. Non-modifiable factors, such as age and comorbid conditions certainly play a role. But inflammatory status (especially C-reactive protein - CRP), Sequential organ failure score (SOFA) score and Therapeutic intervention scoring system (TISS) 28 score have also been related with the risk of hospital death.

Admission to a high dependency unit may reduce the ICU length of stay (LOS). This strategy may also help to improve prognosis contributing to further stabilize the patient, facilitate his autonomy and the removal of invasive devices. However the benefit of a step-down strategy (from ICU to a high dependency unit) has never been evaluated.

The development of a score to evaluate the risk of patients discharged from the ICU may help to improve the allocation of resources, either to prolong the ICU stay, or admission to a high dependency units or the ward.

Methods Prospective, observational, international, multicentre study to be conducted in 2 countries (Portugal, Brazil). Inclusion criteria: Each centre may include a maximum of 110 consecutive patients discharged from the ICU with length of stay (LOS)\>24h during a 6 month period.

Exclusion criteria: Limitation of care decision Primary objective: To determine the impact in hospital mortality and LOS (ICU and hospital) of a step-down strategy, from the ICU to a high dependency unit, before admission to the ward.

Secondary objectives: To develop and validate a score of the risk of death in the hospital after discharge from the ICU

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients discharged from the ICU with LOS\>24h

Exclusion Criteria:

* Presence of limitation of care decision
Cranial Nerves Tractography

Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves or vessels closely surround them. Recently, diffusion tensor imaging has developed with the tractography following white fibers and visualizing functional tracts. Cranial nerves tractography could allow predicting their displacement by skull base tumors that may help the surgeon to spare them along the surgery.

Methods: Preoperative cerebral MRI was performed on patients who presented with skull base tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32 directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128, b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically tracked with Mrtrix3. Cranial nerves were selected according to their location around the tumor. The "radiological" expected position of the cranial nerve was compared to its "operative" real position.


Eligibility Criteria:
Inclusion Criteria:

* Patients who present a skull base tumor that requires surgical removal
* Patients adult, informed and agreed

Exclusion Criteria:

* Pregnant women
* Patients under 18 years old, unable to legally consent
Atrial Sensing Capability for Better Detection of Atrial Fibrillation

This prospective multi-center randomized controlled study aims to compare atrial fibrillation detection and inappropriate therapy according to activation of atrial sensing capability in patients with implantable cardioverter defibrillator.

Implantable cardioverter defibrillators(ICD) therapy has been shown to reduce sudden cardiac death and improve survival in cardiac arrest survivors as well as in heart failure patients with left ventricular dysfunction.

Atrial fibrillation (AF) is commonly found in ICD implantation patients up to 50%. AF is an independent predictor of mortality, inappropriate shock, and embolic events. Therefore, early detection of AF in patients with ICD is essential for improving the quality of life and overall prognosis of the patients.

Conventional ICDs consist of a single chamber (SC) ICD with a lead only in the right ventricle (RV) and dual chamber (DC) ICD with each lead in the right atrium (RA) and RV. SC ICD has the advantage of shorter procedure time, lower cost compared to DC ICD. In contrast, DC ICD has the advantage of being able to monitor atrial arrhythmic events, but complication rates were higher and additional cost and longer procedure time are usually required than SC ICD. Sixty percent of ICD implantation patients who have are SC ICD Recently, a unique ICD lead with atrial sensing ring capable of monitoring the atrial electrical signals has been developed \[Intica 7 VR-T DX ICD (Biotronik., Germany)\]. Therefore, turning off the atrial sensing function makes it functionally the same as SC ICD whereas turning on makes it function similar to DC ICD without additional cost and procedure time.

Therefore, Detection of AF could be made earlier with VDD ICD versus conventional SC ICD without atrial sensing capability, providing a better chance to improve the prognosis of ICD patients. However, no study exists which shows whether VDD ICD is better for detecting atrial tachyarrhythmia than conventional SC ICD. Therefore, we designed a multicenter prospective randomized study comparing the AF diagnostic efficacy of VDD ICD (with atrial sensing 'ON') against conventional SC ICD. As the second phase, we also plan to compare inappropriate therapy rate according to atrial sensing status of VDD ICD.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 19 years
2. indication for ICD implantation according to guidelines
3. atrial fibrillation didn't detect by electrocardiogram or Holter test within the past 1 year from the ICD implantation, and
4. CHA2DS2VASc score ≥1 point in male or ≥ 2 in female

Exclusion Criteria:

1. persistent or permanent atrial fibrillation (AF)
2. atrial fibrillation detected by electrocardiogram or Holter test within the past 1 year from the ICD implantation
3. history of the catheter or surgical ablation of AF or taking antiarrhythmic drug
4. scheduled to undergo heart transplant within 1 year
5. life expectancy \< 1 year
6. requiring atrial pacing
Effectiveness of Video Messaging About Diet, Exercise and Weight Gain in Pregnancy in Regional and National Samples

The primary purpose of this study is to assess the responses of pregnant women and their social network to six videos about health in pregnancy. Our goal is to assess a) acceptability and b) understanding of core messages about healthy eating, exercise and weight gain during pregnancy. We will also assess c) non-clinical sources of health information during pregnancy.

Many women engage in suboptimal lifestyle behaviors during pregnancy. Many women do not realize that unhealthy diet, exercise and weight gain behaviors can be dangerous for their pregnancy and have harmful long-term consequences for their baby. There is great need for strategies to promote accurate knowledge about healthy behaviors during pregnancy. The purpose of this study is to assess responses to a brief (\<1minute) video about healthy behaviors during pregnancy. The study sample will include pregnant women and members of their social network. Participants will be asked to watch a brief video and complete an anonymous online survey measuring their response to the video, and their basic demographics. The surveys will also assess how family and friends impact pregnant women's health behaviors. Online surveys are entirely anonymous. We will recruit pregnant participants from two sources: the University of Michigan Health System's prenatal clinics and a social media website (Facebook).

Eligibility Criteria:
Inclusion Criteria:

* Women
* Currently Pregnant
* Age 18 or over
* English-speaking

Exclusion Criteria:

* Deny being currently pregnant
* Do not identify as living in the US and aged 18 years or older
* Report having previously participated in the study
A Reliability and Validity Study of Urdu Version of Lysholm Knee Scoring Scale.

The study will be intended to translate and check if the Urdu Version of Lysholm Knee Scoring Scale is reliable and valid in the Pakistani patients with anterior cruciate ligament injuries.

A detailed research will be conducted on nearly 100 patients after ethical approval from the Ethical Review Board of Riphah International University Faisalabad Campus. A total of 100 patients with Anterior Cruciate Ligament injuries will be selected from different areas of community and rehabilitation centers. Informed consent will be taken from each patient. The tool will be used three times in the same Pakistani population with Anterior Cruciate Ligament injuries to check inter and intra-observer reliability of the final Urdu-LKS. The Lysholm questionnaire translation will be carried out in 6 steps by the guidelines of the early researches and the Consensus-based Standards for the selection of health Measurement Instruments standard. Statistical Package of Social Sciences 23 will be employed to do data analysis.

Eligibility Criteria:
Inclusion Criteria:

* From17 years Old to 60 Years Old
* Presence of an Anterior Cruciate Ligament Injury or Ligament Repair
* No intervention between the test-retest assessments.

Exclusion Criteria:

* To complete the forms because of a psychological Impairment.
* Illiteracy or lack of understanding of Urdu Language
* Had a condition that couldn't be settled after a second assessment for different sicknesses like cancer, any other serious Infection, or inflammatory disease
* The presence of neurologic or musculoskeletal disorders other than the knee Condition.