cyrilzakka/clinical-trials huggingface dataset:
Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients

The purpose of this research study is to find out what effects (good or bad) may come from a new way of doing radiation therapy for lung cancer. This study is for patients who are not able to get surgery or chemotherapy with their radiation. The way of doing radiation therapy in this trial is called hypofractionated radiation therapy which is a standard approach, but this study allows the actual tumor to get an extra radiation dose while still protecting the organs that are near the tumor.

Primary Objective:

• To determine the in-field control of hypofractionated radiotherapy consisting of 70 Gy in 25 fractions without concurrent chemotherapy measured at two years after the first post- radiotherapy scan.

Secondary Objective(s):

* To determine the toxicity profile of thoracic hypofractionated radiotherapy consisting of 70 Gy in 25 fractions as graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
* To determine proportion with local, regional, and distant progression at 1 and 2 years after the first post-radiotherapy scan, and compute progression-free and overall survival (progression-free survival and overall survival, respectively).

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of non-small cell lung cancer by either biopsy or cytology
* American Joint Committee on Cancer (AJCC) 8th Edition Stage II-III or ultracentral Stage IB disease as determined by PET/CT and MRI Brain
* Ultracentral disease will be defined as edge of gross visible tumor within 1.0 cm of the proximal bronchial tree.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
* Participant is not eligible for or has declined surgical resection or stereotactic body radiotherapy as determined by the treating physician
* Participant is not eligible for or has declined concurrent chemotherapy as determined by the treating physician
* While investigators expect it to be an uncommon event, sequential use of systemic therapy after completion of radiation therapy is permissible if the participant's status improves such that they become eligible for such therapies, per the discretion of a multidisciplinary tumor board.
* Negative serum or urine pregnancy test within 2 weeks of the date of enrollment for women of child-bearing potential.
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

* History of previous thoracic radiotherapy with the exception of prior radiotherapy for breast cancer without overlap of the fields with the cancer to be treated.
* Prior systemic therapy or surgery for the study cancer.
* Prior malignancy within the past two years except for non-melanoma skin cancer, prostate cancer, or any in-situ malignancy.
* Receipt of anti-angiogenic therapy, such as bevacizumab, within 6 months of enrollment.
* Pregnant women are excluded from this study because radiation therapy has known potential for teratogenic or abortifacient effects.
Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma

This study uses molecular imaging and novel immune monitoring to identify a biomarker of response for melanoma patients receiving immunotherapy with anti-PD-1 immunotherapy. Prior to treatment, FDG and FLT PET/CT will be obtained, together with blood and tumor biopsies from each patient. A follow-up FDG and FLT PET/CT will be obtained, together with blood and tumor biopsies, 10-12 weeks after starting treatment with anti-PD-1 antibody. Additional tumor biopsies and blood samples for immune monitoring will be obtained 4-6 weeks after starting treatment with anti-PD-1 antibody as well as 16-18 weeks after starting anti-PD-1 treatment for patients still receiving anti-PD-1 antibody at that time.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a metastatic melanoma diagnosis (stage IV) for which treatment with nivolumab or pembrolizumab, either alone or in combination with other therapies, is planned. No additional laboratory testing is needed for the imaging in this study apart from the standard laboratory testing routinely obtained for treatment with nivolumab or pembrolizumab, either alone or in combination with other therapies.
* Participants must have at least 2 subcutaneous or lymph node melanoma metastases that are 2 cm in greatest diameter and are amenable to being biopsied in clinic without requiring image-guidance.
* Participants must be able to provide informed consent
* Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.

Exclusion Criteria:

* Not able to receive treatment with either nivolumab or pembrolizumab.
* Women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days of the first study FLT PET/CT and must not be breast feeding for the duration of study participation.
Effect of Steroids on Post-tonsillectomy Morbidities

This study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy morbidities. Half of the patients who comply with the inclusion criteria were selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo.

The effect of preoperative systemic steroids on post-tonsillectomy morbidities such as pain, nausea, vomiting and delayed feeding was proven. However, this study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on the aforementioned morbidities and on decreasing the duration and costs of hospital stays. patients who were in the waiting list for tonsillectomy procedure were screened for medical history and those who comply with the inclusion criteria were randomly assigned into two equal groups of 50 patients each. One group was selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo. Questionnaires investigating postoperative pain, nausea, vomiting, and oral intake were answered by patients, parents or guardians where applicable.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study.

Exclusion Criteria:

* Patients who are allergic to steroids or those who have medical conditions which contraindicate the use of steroid i.e diabetes mellitus, gastritis, or hypertension and those who were on exogenous steroid supplements.
Investigation of a Link Between Heart Rate Variability and Frailty in Geriatric Patients

The aim of this study is the evaluation of differences in heart rate variability (both time- and frequency-domain) \[a\]: between frail and non-frail patients and \[b\] at the beginning and end of a geriatric therapy which included rehabilitation components. Moreover, the suitability of new camera-based technology with regard to measurement of vital signs (heart rate, heart rate variability, respiratory rate) will be evaluated.

Frailty is an important geriatric syndrome, which indicates a reduced maximum resilience of patients and their organ system against external stressors. According to Fried's classification, frailty comprises of unintentional weight loss, exhaustion, muscle weakness, slowness while walking and low levels of activity. In geriatric patients, frailty is associated with a higher mortality and morbidity. Moreover, frailty patients are more often dependent on assistance after hospitalisation than non-frailty patients.

During geriatric therapy, geriatric patients are treated with multimodal rehabilitation comprising of activating nursing, physiotherapy, occupational therapy, psychiatric and speech therapy in order to increase mobility and patients' ability to help themselves. Success of rehabilitation measures is measured using the geriatric assessment (e.g. Barthel Index, Timed up and go test, Mini-Mental State Examination, Geriatric Depression Scale, measurement of hand power) at the beginning and end of the therapy. This geriatric therapy including the named geriatric assessment is not study-specific and is not prescribed by a study protocol, but is a routine treatment for frail patients.

Apart from these routinely used tests, recent literature indicated that heart rate variability, which can be easily measured with an ECG, could be an indicator for frailty. Beyond the medical problem whether heart rate variability can be used as a surrogate parameter for frailty, this study also has a technical aspect. In biomedical engineering, non-contact monitoring of vital signs has been an important and promising development in the last decade. Therefore, this study will also investigate if camera-based technologies such as photoplethysmography imaging (PPGI) and infrared thermography (IRT) can be used in a clinical environment for non-contact measurement of vital signs (heart rate, heart rate variability, respiratory rate) in geriatric patients. In this study, monitoring (with conventional and contactless technologies) should not trigger any observable/examining effect, but is merely a means to the end of observing the already existing HRV (and other vital parameters).

Eligibility Criteria:
Inclusion Criteria:

* Group 1: aged above 70 if they have typical geriatric multimorbidity, otherwise aged above 80, patient on the geriatric ward in the hospital "Franziskhospital Aachen"
* Group 2 (Healthy volunteers): aged above 70, healthy and in good physical condition
* Written informed consent by patient / volunteer

Exclusion Criteria:

* Inability to consent
* Pace maker
Metabolic Signatures and Biomarkers in Schizophrenia

We plan to use a metabolomics lipid platform to map biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations induced by risperidone. These drugs have inherently different risk for metabolic adverse effects and patients respond to them differently. Metabolic signatures for the drugs capture significant biochemical information that could explain part of the basis for varied drug response within individuals and will highlight pathways implicated in drug action and in disease pathogenesis possibly enabling new drug design strategies. In addition, we will compare patients to healthy controls at baseline in regard lipid profiles.

Schizophrenia (SCH) is a devastating mental disease that affects the human population worldwide with an incidence of about 1%. Most individuals with this illness benefit from long-term pharmacotherapy, however, the therapeutic effects of antipsychotic treatment are inconsistent, incomplete, and often countered by significant side-effects associated with long-term physical morbidity (e.g., tardive dyskinesia, obesity, hyperglycemia, hyperlipidemia. Metabolomics is a powerful new technology that provides a snap shot of biochemical pathways at a particular point in time. It has been earmarked as an important area to develop under the NIH roadmap initiative. We plan to use this platform to map biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations induced by risperidone. These drugs have inherently different risk for metabolic adverse effects and patients respond to them differently. Metabolic signatures for the drugs capture significant biochemical information that could explain part of the basis for varied drug response within individuals and will highlight pathways implicated in drug action and in disease pathogenesis possibly enabling new drug design strategies.In addition, we will compare patients to healthy controls at baseline in regard lipid profiles, to assess whether lipid profiles differ between unmedicated schizophrenia patients and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Diagnosis of schizophrenia
* Actively psychotic
* No more than a single dose of antipsychotic in the preceding 2 weeks

Exclusion Criteria:

* Mental retardation, epilepsy or history of head trauma
* Substance use disorder that explains the majority of the psychopathology
* Pregnant or lactating females
Root Caries Prevention Using Fluoride Varnish Fortified With SBGC

The goal of this 36-month double-blind randomized controlled trial is to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.

This 36-month, double-blind, two-arm randomized controlled trial is aimed to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.

Participants will be divided in to two groups, The main question it aims to answer is: Is fluoride varnish with SBGC more effective than that without SBGC on prevention root caries in community-dwelling older adults? Participants will be divided into two groups, experimental group and controlled group after randomization. Subjects in the experimental group will receive fluoride varnish with SBGC quarterly, and subjects in the controlled group will receive fluoride varnish without SBGC quarterly.

It is hypothesized that community-dwelling older adults who receive quarterly fluoride varnish applications containing SBGC will develop fewer root caries.

Eligibility Criteria:
Inclusion Criteria:

* Adult \> 60 years old
* good collaborative relationships

Exclusion Criteria:

* less than 8 natural teeth
* have severe medical conditions
* are in use of high fluoride toothpaste
Developing Enhanced Prediction Models

In this study, patients will be prospectively enrolled for data collection to design prediction models that integrate claims data (inpatient, outpatient, and pharmacy), electronic health record data (on clinical, social, and behavioral indicators), and patient-generated activity data. Patients will be randomized to use either a smartphone or a wearable activity tracking device to capture patient-generated health data.

Many hospital readmissions could be prevented if higher risk patients were identified and effective interventions then targeted towards these individuals. However, most existing claims-based predictive models perform poorly and do not provide timely and actionable information. In this study, researchers will prospectively enroll patients for data collection to design prediction models that integrate claims data (inpatient, outpatient, and pharmacy), electronic health record data (on clinical, social, and behavioral indicators), and use wearable devices or smartphones to collect patient-generated data (physical activity and sleep patterns). Patients will be randomized to use either a smartphone or a wearable activity tracking device to capture patient-generated health data.

Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older
2. Be able to provide informed consent
3. Be admitted to the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center
4. Have a smartphone or tablet compatible with activity tracking devices
5. Plan to be discharged to home

Exclusion Criteria:

Have no medical condition which prohibits them from ambulating or plan for any medical procedure over the next 6 months that would prohibit them from ambulating.
Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients

The purpose of this study in patients with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the long-term efficacy and safety of subcutaneously applied, pegylated granulocyte colony stimulating factor (Pegfilgrastim, PEG-G-CSF; Neulasta®, Amgen Switzerland) with regard to the promotion of collateral growth.

Coronary artery disease (CAD) is the leading cause of death in industrialized countries. Current revascularization therapies are PCI or surgical revascularization. However, inherent to them are procedure-related risks and the fact, that progression of CAD is not prevented. Additionally, up to one fourth of all CAD patients are not amenable to standard revascularization therapies. Thus, there is a need for alternative therapies. The coronary collateral circulation is prevalent in humans, and in CAD the amount of collateral flow is a pivotal protective factor with respect to infarct size, all-cause- and cardiac mortality. Coronary collateral growth promotion is an alternative to conventional revascularization which can be achieved by cytokine-based approaches (e.g. with colony-stimulating factor-therapy) in humans. The goal of collateral promotion is to reduce myocardial damage in case of a coronary occlusion.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. 1- to 3-vessel coronary artery disease (CAD)
3. Stable angina pectoris
4. At least 1 stenotic lesion suitable for PCI
5. No Q-wave myocardial infarction in the area undergoing CFI measurement
6. Written informed consent to participate in the study

Exclusion Criteria:

1. Acute myocardial infarction
2. Unstable CAD
3. CAD treated best by CABG
4. Patients with overt neoplastic disease
5. Patients with diabetic retinopathy
6. Liver or kidney disease
7. Pre-menopausal women
Predicting Disease Progression and/or Recurrence in Cancer

This is a prospective study addressing the challenge of predicting disease progression and/or recurrence in patients diagnosed with metastatic colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy.

This research study is evaluating how patient-reported outcomes (e.g. symptoms, quality of life) and biomarkers compare to standard of care clinical assessments such as imaging and tumor markers in predicting the clinical outcomes (e.g. disease progression and survival) in patient populations with colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy Massachusetts General Hospital Cancer Center

* Patient reported outcomes will be collected through a series of self-administered questionnaires and blood draws will be used to obtain bio and tumor marker information.
* Information will also be collected from the participants electronic medical record.
* Tissue may be obtained for next-generation sequencing.
* The study will conclude after participants are no longer receiving anti-cancer therapies.
* It is expected that about 200 people will take part in this research study

Eligibility Criteria:
* Inclusion Criteria:

  * Patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer.
  * Diagnosed with metastatic disease
  * Age \> 18 years.
  * Patients must be starting new line of anti-cancer therapy.
  * Patient must be English-speaking.
* Exclusion Criteria
* Unwilling or unable to participate in the study
* Non-metastatic disease
* Not starting new anti-cancer treatment
* Cognitive issues interfering with ability to participate.
* Active, unstable, untreated serious mental illness interfering with ability to participate.
* Patient does not speak English.
INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
* Phase 1: Subjects with advanced or metastatic solid tumors.
* Phase 1: Subjects who have disease progression after treatment with available therapies.
* Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma.
* Presence of measurable disease based on RECIST v1.1.
* Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion Criteria:

* Laboratory and medical history parameters not within the Protocol-defined range
* Prior treatment with any tumor necrosis factor super family agonist.
* Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
* Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
* Active autoimmune disease.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
* Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy

Incidence of ankle edema is high during pregnancy, If left untreated, it may lead to difficulty walking; stiffness; stretched skin which can become itchy and uncomfortable. Acupressure promotes the condition of the circulatory and lymphatic system leading to the elimination of edema. The aim of this study is to investigate the efficacy of acupressure versus traditional physical therapy treatment on ankle edema during pregnancy.

Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into three equal groups, Group A will receive only traditional physical therapy protocol in the form of advice including elevation, wearing supportive stocking, and avoiding standing in one position for extended periods, and Group B will receive the same traditional treatment as group A in addition to circulatory exercises, 3times per week for 4 weeks; while Group C will receive the same conventional physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women in their third trimester,
* age ranged from 25-35 years and
* BMI was ≥30Kg/m2.

Exclusion Criteria:

* Pregnant women with skin diseases
* irremovable bracelet,
* decreased functional active range of motion in the affected lower extremity
* any mental or physical disorders.