cyrilzakka/clinical-trials huggingface dataset:
Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial

This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical function in older (greater than or equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake results in faster loss of muscle mass and physical functioning in older adults. A novel approach to improving physical function in older cancer survivors (OCS) is to utilize online, tailored education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein intake, diet quality) and participation in resistance exercise. The purpose of this study is to help researchers learn whether an online dietary and resistance training intervention improves diet, exercise, physical function, and health outcomes in OCS.

PRIMARY OBJECTIVES:

I. Determine the feasibility and acceptability of implementing a 12-week online dietary and resistance training randomized trial with 70 older cancer survivors.

II. Examine the preliminary efficacy of this 12-week online dietary and resistance training intervention with the intervention participants.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.

ARM 2: Patients receive educational materials at baseline.

After completion of study intervention, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* \>= 65 years of age
* A primary diagnosis of stage I-III breast, colorectal, and prostate cancer
* Completion of primary curative treatment
* Reported at least 1 physical function limitation on the RAND-36 Physical Function Subscale (PFSS) ("limited a little", "limited a lot")
* No evidence of progressive disease or second cancers
* Community-dwelling
* Able to provide consent

Exclusion Criteria:

* Currently receive cancer treatment (e.g., chemotherapy, radiation)
* Have liver and/or renal disease limiting their protein intake
* Are under the care of a Registered Dietician (RD)/nutritionist
* Participating in other diet/exercise interventions
* Consume protein supplements
* Have contraindications to unsupervised exercise (e.g., walker/wheelchair use)
Pain Control In First Trimester Medical Abortion: A Randomized Trial

This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain.

This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain. Secondary objectives include comparing the regimens for the total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, overall satisfaction with the abortion procedure.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a gestational age of 63 days or less
* Desire a medical abortion with mifepristone and misoprostol

Exclusion Criteria:

- Have contraindications to ibuprofen
CirQPOD Shoulder Study

Intrathoracic pressure regulation (IPR) therapy, delivered by impedance threshold devices (ITDs) or intrathoracic pressure regulators (ITPRs), increases venous return, preload, cardiac output, blood pressure, and cerebral perfusion pressure by intermittently creating negative intrathoracic pressure, which improves circulation in hypotensive animals and humans. By increasing systemic pressure and cerebral perfusion as well as promoting venous return, IPR therapy potentially improves cerebral oxygenation. The lower intrathoracic pressures may also reduce pulmonary artery pressure, although there is currently little evidence one way or the other. Use of an ITPR can counteract the multifactorial intraoperative hypotension common during surgeries under general anesthesia, and reduce the need for other measures to treat such hypotension; however, they might simultaneously promote pulmonary complications.

The investigators will therefore assess whether the use of intrathoracic pressure regulation in adults having shoulder surgery under general anesthesia in the sitting position reduces vasoactive medication requirements compared with routine clinical practice. Simultaneously, the investigators will assess the effect of intrathoracic pressure regulation on pulmonary circulation, cerebral oxygenation, and postoperative atelectasis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* American Society of Anesthesiologists (ASA) physical status class ≤3
* Scheduled for surgery in sitting/ beach-chair positions under general anesthesia in the Cleveland Clinic main campus
* Planned length of surgery \>60 minutes

Exclusion Criteria:

* Severe peripheral vascular disease or other contraindication for use of vasopressor infusion
* Obstructive lung disease - moderate or severe asthma or COPD
* Baseline hypoxemia (SpO2\<92% on room air)
* Body Mass Index (BMI) \>35
* Congestive heart failure
* Pneumothorax or hemothorax
* Uncontrolled hemorrhage
* Planned intraoperative hypotension
* Contraindication to trans-esophageal echocardiography (esophageal stricture, surgery involving the esophagus or stomach)
Efficacy of G-CSF-Priming in Elderly AML Patients

Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine, Idarubicin and Etoposide (IdAV) given in parallel with (G-CSF priming) and followed by G-CSF versus the same IdAV chemotherapy only followed by G-CSF (without priming) in elderly patients with de novo AML, secondary AML and advanced MDS. Moreover, the ability to mobilize sufficient numbers of peripheral blood stem cells (PBSC) for autologous PBSC transplantation after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of de-novo AML, FAB M0, 1, 2, 4-7 or
* Diagnosis of secondary AML after previous chemotherapy and/or radiation therapy or after preceeding MDS or
* Diagnosis of an advanced MDS, i.e. RAEB-t according to the FAB classification or
* Extramedullary AML (chloroma, "granulocytic sarcoma")
* Age greater than 60 years (not including 60 years)
* ECOG performance status 0, 1, or 2
* Written informed consent

Exclusion Criteria:

* Patients with a t(15;17) translocation
* Patients with severe cardiac disease (e.g. cardiac failure NYHA III/IV, myocardial infarction within the last 6 months; severe ventricular arrythmias (Lown III or IV)
* Patients with severe complications of the leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock.
* Severe pulmonary disease (diffusion capacity for CO2 of less than 50%)
* Significant renal dysfunction (creatinine clearance \< 60/min/min)
* Bilirubin \> 2mg% (\>34.2 mmol/l)
* Patients with a clinically active second malignancy
* Patients with a psychiatric, addictive, or any disorder wich compromises ability to give truly informed consent for participating in this study
* HIV positivity
* Known refractoriness to platelet transfusion, inability to adequately substitute blood products
A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects

The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112.


Eligibility Criteria:
Inclusion Criteria:

Main Inclusion Criteria:

* Non-smoking, Japanese, male participants, ≥20 and \<45 years old at the time of obtaining informed consent
* Have a Body Mass Index (BMI) ≥18.5 and \<25.0 kilograms per meters squared (kg/m\^2) at Screening
* Able to provide written informed consent of their free will
* Males who were given a full explanation of all the requirements of the protocol, and are willing and able to comply with them

Exclusion Criteria:

Main Exclusion Criteria:

* Male and his partner who do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
* Male who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing.
* Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
* Any history of surgical treatment that may affect pharmacokinetic (PK) profiles of study drug at Screening
* Any suspected clinically abnormal symptom or organ impairment that require medical treatment at Screening or Baseline
* Receipt of vaccination within 4 weeks prior to dosing
* History of drug or alcohol dependency or abuse prior to Screening
* Intake of caffeinated beverages or food within 72 hours prior to dosing
* Use of prescription drugs within 4 weeks prior to dosing
* Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing
* Male who is currently being enrolled in another clinical study or used any investigational drug or device in another clinical study within 16 weeks prior to dosing
* Male who underwent a blood transfusion within 12 weeks prior to dosing, who donate 400 milliliters (mL) or more of whole blood within 12 weeks prior to dosing, who donate 200 mL or more of whole blood within 4 weeks prior to dosing, or who made a component donation within 2 weeks prior to dosing
Modelling of the Upper Airway in Children With Controlled Asthma

Asthma in children is recognized as a disease area with a high medical need. As the investigators move into this field it is necessary to improve the investigators knowledge of upper airway anatomical structure in paediatric patients. This study will provide airway/facial morphologies from controlled asthmatic patients. Limited facial morphology can be used in order to build models to study the delivery of medication through a device that requires for example a facemask. In this study the anatomical structure of the upper airway and the facial geometry will be evaluated using a Cone Beam Computed Tomography (CBCT) scan. The scan will be taken in a population of 20 asthmatic children between 6 and 12 years old.


Eligibility Criteria:
Inclusion Criteria:

* Male and pre-menarchial female children aged 6-12yrs on visit 1. Pre-menarchial females are defined in this study as girls with breast stage 1 or 2 and no menarche.
* Parents or guardian must be able to understand and complete to protocol requirements, instructions and protocol-stated restrictions. Parents/guardians must give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Diagnosis of asthma at least 6 months previous prior to screening.
* Children must be controlled on their existing asthma treatment at screening as defined by ACT or childhood ACT score of ≥ 20 and PEF\>80%.
* Children must be taking a stable regime of SABA/ LABA on an as need basis, with or without Leukotriene Antagonists and inhalation corticosteroids.
* All children must be competent to perform the required tests.
* Children must be available to complete the study and comply with study primary objective investigations.
* Children must be able to withhold from short acting bronchodilators for 6 hours.

Exclusion Criteria:

* As a result of the medical interview, physical examination or screening investigations, the responsible physician considers the patient unsuitable for inclusion to the study.
* Children who have a past or present disease, or have had previous surgery which as judged by the Investigator, may affect patient safety or influence the outcome of the study.
* The child has received an investigational drug or participated in any other research trial within 30 days, or twice the duration of the biological effect of any drug (whichever is longer).
* The child has had a respiratory tract infection within two weeks of the start of the study.
* Children who have had an exacerbation of disease requiring hospitalization for \> 24 hrs within four weeks prior to inclusion.
* Children who are unwilling or unable to follow any of the procedures outlined in the protocol.
* Child is mentally incapacitated.
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors

The purpose of this study is to find out if a psychotherapy method called behavioral activation (BA) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in Older Adult Cancer Survivors (OACS)


Eligibility Criteria:
Inclusion Criteria:

* As per self-report or medical record, ≥65 years old
* As per self-report or medical record, has a history of cancer
* As per medical record and/or clinician confirmation:

  * a patient in MSK Survivorship Clinics AND/OR
  * no evidence of disease (NED) AND/OR
  * 6 months or more post-treatment (patients on maintenance hormonal therapies are eligible)
* Fluent in English, as per self-reported fluency of "well" or "very well"\*
* As per self-report, able to communicate over video-conference and/or phone for sessions
* Elevated score on the PHQ-9: ≥5 (N/A for Training Case participants)
* Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for Training Case participants)

Exclusion Criteria:

* As per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of \> 0 on item 9 of the PHQ-9, they will be referred to study PI for further evaluation. They will be excluded from participation in this study if the PI determines they would be appropriate for a higher level of care than BA may be able to provide.
* As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
* As per self-report or medical record, currently taking antidepressant medication for \< 3 month
* As per medical record, patient has impaired decision-making capacity
Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese

This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese
* Considered generally healthy based on medical history and physical examination
* Body Mass Index (BMI) between 18 and 27 kg/m\^2 (both inclusive)
* Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)

Exclusion Criteria:

* Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
* Any serious systemic infectious disease that occurred during the last 4 weeks before trial
* Any inter-current illness that may affect blood glucose
* Subject with a first degree relative with diabetes mellitus
* Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks
Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.

An important part of staging and deciding the method of treatment is knowing areas of how cancer is involved. Diagnostic imaging is often used to determine the location of the cancer using techniques like nuclear medicine, MRI (magnetic resonance imaging), CT (computerized tomography), and ultrasound. Each technique looks for cancer in different ways and are often used together to make a better determination of the extent of disease.

One of the techniques used in cancer imaging is PET/CT. This technique combines a nuclear medicine study (PET or positron emission tomography) with CT performing both scans at the same time. PET/CT most commonly uses a radioactive sugar (FDG or fluorodeoxyglucose) to detect the cancer. The problem with FDG is that it is excreted by the kidneys and collected in the bladder. Even though the bladder is emptied prior to the scan, the FDG activity present there may interfere with the detection of small areas of cancer involvement in lymph nodes or adjacent areas. It is because of this that PET/CT using FDG is infrequently used in gynecological cancers.

This purpose of this study is to evaluate if 18F-fluciclovine can be used to help determine the extent of gynecological cancers. 18F-fluciclovine (also known as AXUMIN) is a radioactive tracer which has been approved by the FDAFood and Drug Administration (FDA) for use in patients with prostate cancer. 18F-fluciclovine has much less excretion through the kidneys which improves the PET/CT imaging of the pelvis.


Eligibility Criteria:
Inclusion Criteria:

* GYN cancer (ovarian, endometrial, or cervical) was biopsy-proven and/or schedule for subsequent surgery based on clinical presentation (imaging, markers)
* Age ≥ 18 years.
* Can tolerate 18F-fluciclovine PET/CT exam (can lie on her back for the duration of the scan).
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Ongoing systemic therapy for cancer
* Systemic therapy for cancer in the past 3 months
* Inability to tolerate 18F-fluciclovine PET/CT exam
* Pregnant or lactating women
Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults

After consolidation therapy adult patients (≥18 yr) with Ph-negative ALL will be treated with continuation chemotherapy or allogeneic hematopoietic stem cell transplantation (alloHSCT) according to both measurable residual disease (MRD) and results of genetic study performed at baseline.

Patients will be uniformly treated with four drug-induction: vincristine (VCR), prednisone (PDN), pegylated asparaginase (PegASP), daunorubicin (DNR).

Resistant patients will receive a second induction with fludarabine, Ara-C, G-Colony-Stimulating Factor (G-CSF) and idarubicin (FLAG-IDA).

Patients with adequate MRD clearance after induction will receive 3 blocks of early consolidation. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification, reinduction and maintenance. The remaining patients will receive early or delayed alloHSCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-60 yr with de novo Ph-neg ALL
* Eastern Cooperative Oncology Group (ECOG) 0-2 (or \>2 if due to ALL)
* Informed consent

Exclusion Criteria:

* Mature B-ALL, Ph+ ALL or blast crisis of chronic myeloid leukemia (CML), ALL of ambiguous lineage
* ECOG \>2 not due to ALL
* Impaired cardiac, respiratory, hepatic or renal function not due to ALL
* Pregnancy
* HIV positivity
* Severe psychiatric disease
* Negative to sign informed consent.
Pediatric Hypothalamic Obesity

This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones). The purpose of this trial is to see how an investigational treatment controls the hormone insulin by lowering the level of insulin in the body resulting in a weight loss in children who are at least 6 years of age but less than 18 years of age. Some children in this trial will receive placebo.

To qualify for this study, you and your child's doctor must feel that your child's weight is inadequately controlled within a year from the time of injury to the hypothalamus or tumor of the hypothalamus. This study will help to determine if an investigational treatment is of benefit in controlling a child's weight.


Eligibility Criteria:
* Male and female patients ages 6 to less than 18
* Patients who have experienced any form of cranial insult related to cranial trauma, or to a tumor or it's treatment (i.e. surgery, radiation, and/or chemotherapy)
* Patients who are at least one year out following therapy for their tumor
* Patients who have severe cardiovascular dysfunction (for example cardiomyopathy, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation) will be excluded
* Patients with severe neurologic handicaps which preclude normal physical activity will be excluded.
* Patients confined to bed and those patients who are wheelchair bound which prevents them from activities of daily living or normal physical activity, i.e. walking, will be excluded from the trial
* Your child must be greater than 120% of their ideal body weight for their height or have a body mass index that is greater than or equal to 27.
SABR Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)

Current treatment options for high risk localized prostate cancer include radical prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3 Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater sensitivity to large fraction sizes and high dose per fraction radiotherapy theoretically allows for biological dose escalation with fewer visits and no additional toxicity. Therefore, we hope to determine the toxicity, quality of life, biochemical and pathological control of SBRT for high risk prostate cancer incorporating ENI.


Eligibility Criteria:
Inclusion Criteria:

* informed consent obtained
* men \> 18 years of age
* histologically confirmed prostate adenocarcinoma (centrally reviewed)
* high risk prostate cancer, defined as at least one of clinical stage T3 or Gleason 8-10, or PSA \> 20ng/mL

Exclusion Criteria:

* prior pelvic radiotherapy
* anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* diagnosis of bleeding diathesis
* large prostate (\>90cm3) on imaging at time of gold seed insertion
* no evidence of castrate resistance (defined as PSA \< 3ng/mL while testosterone is \< 0.7nmol/L
* definitive regional or distant metastatic disease on staging investigations