cyrilzakka/clinical-trials huggingface dataset:
Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer

This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.

PRIMARY OBJECTIVES:

I. To determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. (Pilot) II. To determine the percent increase in fitness as measured by the 6 minute walk test in women receiving radiation therapy for breast cancer randomized to an exercise program at 1 year. (Phase II)

SECONDARY OBJECTIVES:

I. Percent adherence to exercise at 1 year as measured by the International Physical Activity Questionnaire and exercise logs.

II. Subjective arm health at 1 year as measured by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4).

III. Arm lymphedema at 1 year as measured by arm circumference. IV. Arm range of motion at 1 year as measured by goniometry. V. Quality of life at 1 year as measured by FACT-B+4. VI. Percent increase in arm strength as measured by one repetition maximum at 1 year.

VII. Change in weight and body mass index (BMI) 1 year after completion of radiation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.

ARM II: Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.

After completion of study, patients are followed up at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Stage II-III breast cancer
* Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection
* Prior chemotherapy in the neoadjuvant or adjuvant setting
* Radiation plan consisting of regional nodal radiation
* Must be suitable for an exercise program

Exclusion Criteria:

* Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician
* Physical handicap that would prevent participation in program
* Patients with metastatic breast cancer
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures

This study was designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver procedure. The hypothesis is that there will be no clinically relevant difference between the error measurements obtained during the laparoscopic procedures in this study when compared with those obtained during previous open liver registration studies.

The surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The surgeon will accept or reject the registration accuracy.

The Pathfinder System used during this study is used for data collection purposes only and is not used during the surgical procedure as an image guided system.

Preoperative computed tomography (CT) scans, obtained as standard of care, will be used to generate the image guided liver system 3D liver surface images used during the study.

During the laparoscopic procedure, the Pathfinder device will be inserted through the standard laparoscopic ports (5mm or 10mm) being used for the staging procedure.

A total study population will include 20 subjects that complete the laparoscopic procedure scheduled.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for laparoscopic procedure
* Had a preoperative CT image that includes the liver

Exclusion Criteria:

* Severe cirrhosis of the liver
* Kidney failure or dialysis
* Unable to consent
A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.

This was a prospective 4-day study of oxalate absorption in subjects with secondary hyperoxaluria. Subjects visited the research center three times for outpatient visits (Screening, Test Day 3, Day 4).

Subjects were instructed to follow a low-oxalate diet, consuming only study-specified food choices that had low or no oxalate and controlled calcium content Days 1 through 4 (Baseline Period through the Day 4 clinic visit) and, on Test Day 3, consumed an oxalate-rich test meal.

Subjects performed three 24-hour urine collections during Screening, Baseline Day 2, and Test Day 3. Test Day 3 included the oxalate-rich test meal and the subject collected a 24-hour urine separated into 4 urine collection intervals. (Pre-test meal, post-test meal to 4 hours, 4-6 hours post test meal and remaining time to complete 24 hours).

Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant and non-lactating females
* History of hyperoxaluria secondary to a known underlying enteric disease (e.g., Crohn's disease, bariatric surgery, and others) or without a known underlying cause (idiopathic), and kidney stones.
* Urinary oxalate ≥ 40 mg of oxalate/24 hr at screening.
* If taking drugs for the prevention of stone disease, including pyridoxine, thiazides (chlorthalidone, hydrochlorothiazide, and indapamide), citrate supplements, and allopurinol, there must have been no changes in these medications for at least one month prior to screening and no changes are anticipated for the duration of the study.
* Able to understand and provide written informed consent.

Exclusion Criteria:

* Under or over-collection on screening 24-hour urine collection (mg creatinine/kg body weight outside of gender-specific range).
* Estimated glomerular filtration rate (eGFR) \<40 mL/minute/1.73 m\^2 or acute renal failure.
* Primary hyperoxaluria.
* Allergy, intolerance, or any other factors limiting ability to consume the study foods or adhere to the study meal schedule.
* Positive pregnancy test during Screening.
* Clinically significant findings (including acute renal colic), an ongoing clinically significant illness requiring changes in management, or any planned medical/surgical procedure during the study.
* Malignancy undergoing active therapy; patients in remission on chronic suppressive or maintenance therapies are not excluded.
* Investigational compound within 30 days prior to screening.
* Investigator determined that the subject would not be able to adhere or to complete the study procedures , or could not discontinue Vitamin C supplements, calcium supplements, or other medications that could interfere with oxalate absorption and/or excretion.
Prediction of Drug Response in Gastric Cancer Based on 3D Bioprinting

The therapeutic regimens for adjuvant and neoadjuvant chemotherapy in gastric cancer (GC) predominantly hinge on clinical experience. Consequently, there is an imperative need for preclinical models to facilitate the guidance of individualized medicine. The investigators plan to establish three-dimensional (3D) bioprinted GC models derived from surgically resected tumor tissues of GC patients. These in vitro 3D models will be subjected to treatment with the identical chemotherapy drugs administered to the corresponding patients from whom the models are sourced. The sensitivity of the chemotherapy drugs will be assayed within the in vitro models, and the actual response to chemotherapy in patients will be meticulously evaluated. This observational study aims to substantiate the potential utility of 3D bioprinted tumor models in prognosticating the response to chemotherapy in GC.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* Patients previously diagnosed with gastric cancer or confirmed by pathology as having gastric cancer postoperatively.
* Patients who have undergone preoperative imaging examinations, including plain and contrast-enhanced CT scans of the chest, abdomen, and pelvis, as well as gastric MRI for tumor staging, and who are planned for preoperative (neo)adjuvant therapy after multidisciplinary team (MDT) discussion; patients with advanced gastric cancer who are confirmed by postoperative pathology to require (neo)adjuvant therapy.
* The patient or their family members are able to comprehend the research protocol and are willing to participate in this study, providing written informed consent.

Exclusion Criteria:

* History of other malignancies or serious medical conditions
* Inability to provide independent informed consent
Preventing Cognitive and Functional Decline Among Seniors at Risk

This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a psycho-education workshop for improving everyday life performance in older adults with subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of these approaches.

Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia. Many of these individuals report difficulties with complex activities of daily living.

RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive training approach that compensates for age-related executive changes. The approach is provided within the context of individually identified everyday-life difficulties.

The psycho-education approach is a Brain-Health Workshop supplemented by intellectually stimulating activities such as doing Sudoku and/or word searches. This approach provides information people may use to inform health behaviour changes.

Eligibility Criteria:
Inclusion Criteria:

* Have subjective cognitive complaints
* Be fluent in written and spoken English
* Able to self-identify areas of their everyday lives in which they would like to improve.

Exclusion Criteria:

* Diagnosis of neurological conditions (e.g. dementia, mild cognitive impairment, Parkinson's)
* Presence of severe depression
* Presence of substance abuse
* History of hospitalization for psychiatric reasons
Gastric Emptying in Neonates and Infants After Formula Feeding

Ultrasound imaging will be used to evaluate time for gastric emptying in healthy, fasting newborns, and infants following feeding of clear liquids and/or milk (including breast or formula).

The study involves serial ultrasounds over several visits. Healthy newborns in the Newborn Nursery will be recruited to conduct this study. The study will include a total of 50 healthy newborns who will be given formula feeding of known volume, and then serial ultrasound imaging of gastric antral volume will be performed until gastric emptying.

The study originally was designed to perform follow up of these newborns at two later time intervals (between ages 4-6 months, and 9-12 months). The purpose of follow-up is to evaluate whether there are age-related changes in gastric emptying. Due to the pause/suspension of research activity during the pandemic, these follow up studies of the original newborn cohort could not be completed. The protocol is thus revised as follows:

The study will recruit 50 4-6 months old and 50 9-12months old infants and perform gastric emptying serial ultrasound to evaluate if there are age-related changes in gastric emptying.

Eligibility Criteria:
Inclusion criteria for study cohort are pediatric patients from Allen Hospital and Morgan Stanley Children's Hospital of New York Presbyterian Hospital who are receiving feeding by formula

1. healthy full-term (postmenstrual age ≥ 36 weeks) newborns aged 0-5 days or
2. healthy infants (4-6 months old and 9-12 months old)

Exclusion criteria are individuals who have

1. newborn history of requirement resuscitation at delivery
2. newborn history of admission to the Neonatal Intensive Care Unit
3. any history of hospital admission
4. history of gastroesophageal reflux or other feeding difficulty
5. receiving any medication known to accelerate or delay gastric emptying, including but not limited to opioid-containing medications and antacids.
Study of Reserves After Traumatic Brain Injury

It is hypothesized that the long-term results of rehabilitation and subsequent aging after Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive, emotional) reserves.

The purpose of this study are:

1. to determine whether such reserves exist.
2. to study their convergent and discriminant validity.
3. to study their characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Moderate-Severe Traumatic Brain Injury according to at least 1 the following:

  * Duration of loss of consciousness (LOC) - more then 1/2 hour
  * Glasgow Coma Scale (GCS) - less then 13
  * Post Traumatic Amnesia (PTA) - more then 24 hours.
* At least 1 year after the injury.

Exclusion Criteria:

* Mild Traumatic Brain Injury
* the present state of Post Traumatic Amnesia
* dementia
* the age less than 18 years on the moment of injury
* less than 1 year since the injury
* incapacity of the patient to cooperate in the study (incapacity of any source including physical, mental, and language problems)
* premorbid diagnosis of Mental Retardation
Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients

This study will enroll 40 symptomatic outpatients tested positive for Coronavirus 2019 (COVID-19). Patients to be randomized 1:1 to Telmisartan (40 mg) vs placebo to be administered orally once daily x 21 days. Daily, the study patients will be asked to keep a record of the severity of their fever, dyspnea and fatigue and take their blood pressure (BP) and temperature. Study visits to occur on day 1 (entry), day 4, day 10 and day 21. Oro-pharyngeal swabs, and approximately 25 cc of blood will be collected at each study visit for safety labs and for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of inflammation, coagulation and fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent prior to initiation of any study procedures.
* Understands and agrees to comply with planned study procedures including self testing of blood pressure daily
* Male or non-pregnant female adult ≥18 years of age at time of enrolment.
* Has laboratory-confirmed severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection as determined by FDA-approved commercial or public health assay in any specimen collected ideally \< 72 hours prior to randomization. Exceptions to the \<72 hr inclusion criteria may be made at the discretion of the investigator.
* Positive for COVID-19 symptoms: fever defined as a temperature of \>100.4 on study screening or self-report of daily fever at home OR shortness of breath of any degree OR fatigue causing greater than minimal interference with usual social \& functional activities
* Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study
* Able to easily swallow pills

Exclusion Criteria:

* Immediate need for hospitalization on screening
* Systolic blood pressure less than 100 mmHg
* Self-reported presence of chronic kidney disease or requiring dialysis
* Self-reported history of liver failure or untreated hepatitis B or C
* Pregnancy or breast feeding
* Allergy to the study medication
* Current use of angiotensin receptor blocker (ARB) or angiotensin converting enzyme (ACE) Inhibitor medications. Other blood pressure medications will be permitted in the systolic BP is higher than 90 mmHg
* Prior reaction or intolerance to ARB or ACE Inhibitor
* Use of aliskiren in patients with diabetes
* Current use of and on-going need for lithium, digoxin, potassium sparing diuretics such as spironolactone
* Current use of and need for potassium supplements
* Current or past participation in a research study within 12 weeks prior to the Screening Visit unless cleared by Study Team
* Inability to drive safely for study visits
* Subjects, who, in the opinion of the investigator, are unable to comply with the protocol evaluation, or for whom study participation may not be advisable
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds

The investigation is designed as a prospective, open, non-controlled clinical investigation.

Wounds to be treated under this protocol should be acute non-infected wounds or post surgical infected wounds in hospitalized subjects. One ulcer per subject will be treated for a maximum duration of 3 weeks. All subjects will receive continuous negative pressure treatment with the new NPWT system with a pressure level of -120 mmHg or according to clinicians' instruction based on the indication.

10-15 subjects at two sites will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and who have signed and dated a written informed consent.

The subjects will be consecutively allocated to a specific subject identification code. The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation.

Subject pain will be measured by using the Visual Analogue Scale, VAS. Subject and investigator convenience will be assessed by convenience surveys. Diagnosis and treatment of wound infections according to clinical routine.

Eligibility Criteria:
Inclusion Criteria:

1. Acute non infected wound or infected post surgical wound suitable for Negative Pressure Wound Therapy according to the investigator's judgment
2. 3 cm2 ≤ Wound size ≤ 300 cm2
3. Male or female ≥18 years
4. Signed Informed Consent Form

Exclusion Criteria:

1. Need for frequent dressing changes, i.e.\<48 hours between the changes
2. Dry wounds
3. Malignancy in the wound and/or wound margin
4. Untreated osteomyelitis
5. Untreated infection waiting for other intervention
6. Unexplored fistulas
7. \> 10% necrotic tissue with eschar present after debridement
8. High risk for bleeding complications (including subject treated with anticoagulants that are associated with high risk for bleeding complications)
9. Exposed blood vessels, organs or nerves
10. Current or within 3 months treatment with chemotherapy or irradiation
11. Known hypersensitivity to the dressing material
12. Expected technically impossible to seal the film to achieve a vacuum treatment
13. Expected non compliance with the Clinical Investigation Plan
14. Pregnancy
15. Subjects previously included in this investigation
16. Subjects included in other ongoing clinical investigation at present or during the past 30 days
17. Target ulcer previously not successfully treated with NPWT within 48 hours from NPWT start
18. Subject unable to understand written patient information due to medical condition
Study of Olfaction / Vision Interactions in Expert and Novice Populations

The aim of this research project is to better understand the reciprocal influence of visual and olfactory systems on cerebral activity evoked by odors and visual stimuli. Given the importance of olfacto-visual learning in expert situations, the degree of expertise in olfaction will also be considered. In addition, the investigators will try to better understand the differences between expert and non-expert populations in olfaction through different levels of approach: sensory, genetic and cerebral. To achieve this, the investigators will use psychophysical tests, genetic analyzes and a non-invasive technique, functional magnetic resonance imaging (fMRI) to measure the brain activity of human subjects - novices or experts in olfaction - in response to different visual and olfactory stimuli.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* men and women, aged 18-85 years old
* subjects with social security cover
* expertise in olfaction for half of the subjects (60)

Exclusion Criteria:

* subjects younger than 18 and older than 85
* subjects with contraindications to fMRI, i.e. with pacemaker / insulin pump / metal prosthesis / intracerebral clip / neurosensory stimulator / implantable defibrillator / cochlear implants / ferromagnetic ocular or cerebral foreign body close to the nerve structures / ventriculoperitoneal neurosurgical bypass valves / braces and other non-removable metallic dental device / claustrophobic, non-cooperating or agitated subjects.
* pregnant or breastfeeding women
* subjects with known olfactory disorder
* subjects with known neurological disorder
Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer

This is a self-controlled, open, multiple-center clinical trial.


Eligibility Criteria:
Inclusion criteria

1. Age is over 18 years old , men or women
2. Erosive lesions or flat lesions with thin white coating in acute gastritis, acute stage of chronic gastritis with over three lesions (including three lesions) by endoscopy prior to study in 3 days or diagnosed by clinical symptoms and signs;
3. Signed the informed consent forms.

Exclusion criteria

1. Patients without inclusion criteria
2. Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease
3. Patients with other digestive diseases.
4. Patients with operation on stomach and duodenum.
5. Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
6. Patients with severity trauma, surgery, infection and shock.
7. Patients with any kind of tumor
8. Women either pregnant or breast feeding
Significance of Early Mobilization After VATS-L

The main endpoint is physiological rehabilitation after VATS-L under early mobilization. The secondary endpoints are exploring the effect of early mobilization on postoperative physiology.

Investigators hypothesis that early mobilization is clearly advantaged to advance the physiological recovery.


Eligibility Criteria:
Inclusion Criteria:

1. VATS lobectomy;
2. Speak and understand Danish or English;
3. Informed consent obtained.

Exclusion Criteria:

1. Co-VATS lobectomy (more than one lobe resection);
2. Supplementary oxygen therapy later 6 h after surgery;
3. No willing to wear electronic device;
4. No willing to exam arterial oxygen saturation.