cyrilzakka/clinical-trials huggingface dataset:
AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients

Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is progressive over many years and is largely irreversible. Advanced COPD is associated with arterial oxygen desaturation leading to a series of complications and, ultimately, decreased survival. Long-term oxygen therapy can improve clinical outcomes in these patients, but the exact target of oxygen saturation that actually translates into improvements is not known. The basis for the work in this proposal is to focus a new approach to measure oxygen desaturation linked to daily activity. Accelerometers are used to measure daily activity and then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation profile for individual patients. The three main objectives of this study are 1) determine the feasibility of AOM as a measurement of the temporal profile of oxygen saturation in patients with chronic lung disease; 2) determine if serial AOM-derived data is reliable and reproducible; and 3) determine thresholds of oxygen desaturation that are associated with different activity profiles


Eligibility Criteria:
Inclusion Criteria:

1. Veteran patients with a diagnosis of COPD or other chronic lung disease
2. able to read and understand English
3. \> 45 years old
4. ambulatory and able to perform functional testing

Exclusion Criteria:

1. unable or unwilling to give informed consent
2. daily use of a motorized cart
3. impairment of cognition or communication
4. history of drug or alcohol treatment within the past 6 months
5. poor peripheral blood flow to the finger rendering oxygen saturation by pulse oximetry unreliable
6. Recent acute medical events (chest pain, discomfort, etc) that would suggest a contraindication to participate at the scheduled time
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients

This study comparing both of the investigational device and reference device to gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each the overall mean root mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor are evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.

The testing will be conducted in three periods. In the Accuracy Tests (periods 1 and 2), one of the contact-free devices will be used to monitor the HR and RR, while being compared with the Patient Monitor. The RHEA investigational device and reference device will be used to monitor the same subject at different times, as the sensors of the two devices are placed at a similar location of the bed. HR and RR will be recorded for all three devices.

The primary hypotheses for HR, are as follows:

Adults HO: μ = 3.25 vs. HA: μ \< 3.25, Children HO: μ = 3.5 vs. HA: μ \< 3.5,

The primary hypotheses for RR, are as follows:

Adults HO: μ = 2.25 vs. HA: μ \< 2.25, Children HO: μ = 2.5 vs. HA: μ \< 2.5, where μ represents the population mean HR or RR. If the upper bound of the confidence interval is less than the hypothesized value, the corresponding null hypothesis will be rejected. Comparison of the performance of the two contact-free devices will be performed on the recorded results via statistical analysis.

The hypothesis here is that the two devices have equivalent performance. The third test will assess the ability of the RHEA device to accurately detect motion on or exit from the bed, as compared to the manual observation. Motion and no motion accuracy will each be calculated along with their respective two-sided 95% confidence intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years old and above.
2. Provide written informed consent.
3. Weight ranging from 20 to 150 kg inclusive.
4. Are located in a non-ICU hospital setting.
5. Agree to not eat during the testing period.
6. Agree to keep still.

Exclusion Criteria:

1. Are connected to a device which may interfere with the device monitoring in this study.
2. Are receiving any bedside care which may be incompatible with the study procedures.
3. Sleep apnea.
4. Pregnant or breastfeeding.
5. A likely need to receive or undergo a procedure during the testing period.
6. Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
7. A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
8. Are wearing pacemaker or defibrillator.
Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.

Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays.

The focus of this phase 2-trial is set on feasibility as well as early and late toxicity rates. One possible disadvantage of extreme hypofractionation could be an increased rate of fibrosis within the irradiated region. Therefore, a closer look will be taken with this prospective trial.

In addition, we are planning an accompanying translational research program since hypofractionated schedules are suggested to be more immunogenic in breast cancer.

Secondary objectives therefore are: cosmetic outcome, local tumor control, quality of life, dynamic immune status, importance of tumor infiltrating immune cells, overall survival, disease-free survival, feasibility of breath-hold radiation technique.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer or ductal carcinoma in situ (DCIS)
* pT-category pT0-3
* complete resection (R0)
* Absence of distant metastasis (M0)
* Absence of contralateral breast cancer/ DCIS
* Karnofsky Performance Score ≥ 60%
* Age ≥ 18 years at time of study entry
* Written informed consent

Exclusion Criteria:

* All patients not fulfilling inclusion criteria
* Morbus Paget or pathological skin infiltration
* Earlier or synchronous breast cancer
* Pregnant or breast-feeding women
* Increased radiosensitivity or any genetic disposition for increased radiosensitivity, e.g. ataxia telangiectatica
* Judgement by the investigator that the patient is unlikely to comply with study procedures and requirements
Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery

To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery

Preliminary qualitative and quantitative studies suggest that there are benefits (reduced length of stay, improved cardiorespiratory function, reduced postoperative complications and improved quality of life) when prehabilitation is used with the context of cancer care. In 2017 Macmillian Cancer Support developed a strategic 'Evidence and Insight' review on prehabilitation. The outcome of this was to incorporate prehabilitation into routine cancer care and to develop principles and guidance for prehabilitation. This study aims to support this vision and answer some of the questions on the patients who are most likely to benefit from prehabilitation and to quantify some of these benefits by investigating the molecular processes that influence clinical changes

This study primarily seeks to assess the cardiovascular and biological impact of prehabilitation (exercise, nutrition) on patients undergoing hepatobiliary and colorectal cancer surgery. The investigators aim to assess whether there is an improvement in various cardiopulmonary exercise testing (CPET) variables such as maximum oxygen consumption and anaerobic threshold. The investigators also aim to study the inflammatory cytokines associated with cancer and how these markers respond to exercise. These inflammatory markers are thought to play a role in influencing some clinical outcomes such as wound infection and recovery.

The study will also assess secondary outcomes including hospital stay, post operative complications and quality of life. The investigators aim to better understand the biological relationship between anti-inflammatory cytokine levels and the previously mentioned outcomes by measuring and analysing these mediators and performing selected muscle biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-85
* Sex: male/female
* Radiological/tissue cancer diagnosis
* Curative cancer of the colon, rectum, colorectal liver metastases (CRLM) of 2 or more segments
* elective surgery (planned a minimum of 3 weeks from the date of first clinic meeting)
* Access to digital technology(mobile phone, tablet or laptop, home computer) to participate in supervised home exercise

Exclusion Criteria:

Exclusion

* Palliative disease
* Haematological malignancy
* Pregnancy
* Emergency surgery
* Physically unable to undergo CPET
* Part of any other trial with similar interventions unless previously agreed on with all CIs
* synchronous disease (operation on HPB \& colorectal cancers at the same operation)
* No access to digital technology(smart phone, tablet, laptop or home computer)
Autonomic Responses of Amateur Child Athletes to Aerobic Exercise Test

The aim of our study was to investigate the relationship between aerobic capacity, which will be revealed by aerobic exercise test, and HRV, blood pressure, heart rate and pulmonary function parameters in healthy children interested in different sports branches (boxing, weightlifting, taekwando, swimming). The main questions it aims to answer are:

* Is there any relationship between aerobic capacity demonstrated by 20 m shuttle test and heart rate variability, blood pressure, heart rate and respiratory parameters in different sports branches?
* Is there a relationship between the month/year that children/adolescents are involved in sports and HRV, blood pressure and respiratory parameters?

Participants:

* Before the exercise test, ECG, blood pressure, heart rate and pulmonary function test will be performed.
* A 20 meter shuttle run test will be performed.
* Measurements will be repeated after the exercise test.


Eligibility Criteria:
Inclusion Criteria:

* 6-18 years old, registered to a club in boxing, weightlifting, taekwando and swimming (4 groups), children and adolescents who have been actively participating in their training for at least 3 months

Exclusion Criteria:

* People with neurological, orthopedic, cardiovascular diseases, those with any acute or chronic illness, smokers or drug users, elite level athletes
Comparison of the Effects of Morton's Neuroma on Foot Pressure Distribution and Gait Parameters in Pes Planus and Pes Cavus Patients

The aim of our study is to compare the effect of Morton's neuroma in feet with pes planus and pes cavus on foot pressure and temporal and spatial gait parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with bilateral pes planus or pes cavus
* Diagnosis of unilateral Morton neuroma
* Confirmation of the diagnosis of Morton's neuroma with Magnetic Resonance Imaging (MRI)
* Pain level of the patients during walking is at least 3 according to the Visual Analogue Scale (VAS).

  * Volunteer to study over the age of 18

Exclusion Criteria:

* Having Symptomatic musculoskeletal disease in the lower extremity
* Having peripheral nervous system disease
* Presence of rigid deformity in the foot
* Extremity or contralateral extremity surgery with Morton's neuroma
* Having received physiotherapy in the last 3 months
The Effect of Education and Counseling Given to People With Stoma by Telephone on Stoma Compliance and Complications

The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. Based on the f values of the methods to be studied in the literature review, the total sample size found using the GPOWER program with an effect size of 0.4 (Cohen), 90% power and 0.05% margin of error was found to be n = 44. The sample of the research was determined as 52 in this direction. "Informed Consent Form, State-Trait Anxiety Scale, Adaptation Scale for Individuals with Ostomies" will be filled out. Scales will be collected for both groups on postoperative day 1, day 15, and 1 month after surgery. The patients were called by phone on the 7th, 14th and 21st postoperative days and education and counseling services were provided. SPSS package program will be used to analyze the data.


Eligibility Criteria:
Inclusion Criteria:

* Having undergone stoma surgery in a university hospital,
* No vision or hearing problems,
* Verbal communication is possible,
* Without diagnosed psychiatric problems.

Exclusion Criteria:

* Want to leave the research
Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis

The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on thiol disulfide homeostasis when compared to standard care in elective cesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.

The concept of enhanced recovery after surgery (ERAS) has been gradually extended from surgery to the field of obstetrics. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. Although these effects of the preoperative carbohydrate loading has been studied, the thiol disulfide homeostasis effects after carbohydrate loading has not been investigated yet. Thiol-disulfide homeostasis (TDH) plays a critical role in the mechanisms of antioxidant defense, detoxification, apoptosis, regulation of enzyme activities, transcription, and cellular signal transduction. Since the newborns are very susceptible to harmfull effects of reactive oxygen species, the effect of carbohydrate loading on the reactive oxygen species gain importance.

All mothers undergoing a planned caesarean section in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancies,
* Planned elective ceserean sections,
* Under spinal anesthesia,
* Pregnants who can read and write Turkish.

Exclusion Criteria:

* Preterm pregnants,
* Pregnants with reflux,
* obesity,
* hiatus hernia,
* ileus,
* enteral nutrition,
* alcohol or substance abuse,
* prolonged delivery,
* systemic chronic diseases,
* malignancy,
* GDM,eclampsia,preeclampsia,
* fetal anomaliy,
* prolonged delivery
Expressive Arts as a Social and Community Integration Tool for Youth Recovering From Brain Injury

This study utilizes a novel technique-expressive arts therapy-to facilitate social integration for youth recovering from acquired brain injury (ABI). Expressive arts therapy is defined as the use of the arts and artistic media to explore psychological aspects of life. An expressive art (also referred to as 'creative arts' or even just 'arts') encompasses drama, music, art (visual arts such as painting, sculpture etc) and dance/movement. It has great potential to improve community integration for youth recovering from ABI, through facilitating skills required for successful social communication and social cognition. It is hypothesized to improve social and emotional functioning compared to a less structured creative arts program. It is expected that a combination of directed group activities and self-reflection within a creative learning context will improve emotional awareness and social and community integration to a greater degree than a non-expressive creative arts therapy group, in youth who have suffered an ABIAs community integration enables meaningful and productive occupational engagement, enabling opportunities for occupational engagement through increased community integration would greatly enhance the quality of life of adolescents with ABI.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 months post injury
* Difficulties in social and emotional functioning
* Entering Grades 10 and 11 in 2007
* English fluency

Exclusion Criteria:

* Extreme behaviour, mood and cognitive disturbance
Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)

This is an observational study to deeply phenotype the disorder of POTS using multiple testing modalities.

This comprehensive multimodality deep phenotyping will improve the diagnostic approach, inform the development of new treatments, and allow the targeting of therapies to specific POTS patients. The investigators will further identify the diagnostic tools, biomarkers, and clinical outcome measures most relevant to defining the disorder in clinical practice.

The specific aim is to (1) Define clinical POTS classifications from multimodal clinical and laboratory data, (2) address exercise tolerance in POTS using metabolomic assessments, (3) evaluate novel POTS-specific patient outcome measures and (4) evaluate one year outcome data for POTS

Specific research tests will include blood work (for immunophenotyping and neurohormonal assessments), autonomic function testing, skin biopsy (to evaluate intraepidermal nerve fiber density), CO (Carbon Monoxide) rebreathing (for quantitative measurement of plasma volume and red blood cell mass), patient surveys (to characterize symptom profile and disease impact). Blood biosamples will be stored as a repository for future research questions.

Eligibility Criteria:
Inclusion Criteria:

POTS Patients

* Age ≥ 14 years, able to provide informed consent (assent with parental consent for age \< 18) and comply with procedures
* Meets consensus criteria for POTS: (1) sustained increase in heart rate ≥ 30 bpm above supine baseline within 10 min of quiet standing or upright tilt (≥ 40 bpm in individuals 12 to 19 years of age) OR sustained upright HR (heart rate) \>120 bpm, (2) absence of orthostatic hypotension, (3) symptoms with standing that improve with sitting or lying down, (4) resting supine heart rate \< 100 bpm, (5) orthostatic symptoms present for at least 6 months
* Stable oral medication regimen for at least 14 days

Non-POTS Control Patients

* Healthy women, age 18 - 30 years, able to provide informed consent and comply with study procedures
* Does NOT meet consensus criteria for postural tachycardia syndrome
* No symptoms of orthostatic intolerance or dysautonomia. No history of other major medical disorder
* Resting supine heart rate \< 100 bpm

Exclusion Criteria:

None of the following exclusion criteria:

* Use of amphetamine-type stimulants, diuretics, selective norepinephrine reuptake inhibitor, anticholinergic medications (including tricyclic antidepressant medications), fludrocortisone, desmopressin in past 14 days
* Use of other autonomic drugs (adrenergic agents, pyridostigmine, droxidopa, triptans, ivabradine) in past 48 hours
* Currently receiving IVIG (Intravenous immunoglobulin), subcutaneous IgG (Immunoglobulin G), or any investigational medication (in past year)
* Infusion of iv fluids in past 7 days
* History or evidence of another condition explaining symptoms or orthostatic tachycardia (e.g. structural heart disease, CSF (Cerebrospinal fluid) hypovolemia, or severe traumatic brain injury)
An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer

This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>/= 18 years
* Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment
* Patients for whom the investigator has decided to start a treatment with Herceptin SC
* Trastuzumab treatment naive or non-naive (previously intravenous treatment)
* Informed consent

Exclusion Criteria:

* Patients previously treated with Herceptin SC treatment
ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk

The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.

The study will include participants aged 18 years and older who are at increased risk for HCC, including individuals with liver cirrhosis or non-cirrhotic individuals with chronic hepatitis B infection.

Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years of age or older.
2. Understand the study procedures, be able to provide written informed consent to participate in the study, and have authorization for release of data, including personal health data and images, to the study Investigator, Sponsor, and regulatory authorities.
3. Present for surveillance imaging due to increased risk for HCC, including either:

   1. Diagnosis of cirrhosis based on at least one of the following:

      * Histology from a liver biopsy.
      * Ultrasound, CT, or MRI showing a cirrhotic liver combined with portal hypertension (as evidenced by the presence of intra-abdominal varices, or recanalized umbilical vein, or ascites or splenomegaly or thrombocytopenia \[defined as Platelet count \< 150,000\]). The imaging results must have been obtained within 5 years of study enrollment.
      * Liver stiffness ≥4.71 kilopascal (kPa) by Magnetic Resonance (MR) elastography or ≥12.1 kPa by vibration controlled transient elastography.
      * Presence of varices on endoscopy or imaging and presence of a chronic liver disease. OR
   2. Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for \>6 months)

Exclusion Criteria:

1. Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer.
2. Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.
3. Known Child-Pugh class C liver function at the time of enrollment, except for those on the waiting list for transplant.
4. Solid liver nodule \>1 cm by ultrasound or elevated Alpha-fetoprotein (AFP) (\>100 ng/mL) in 12 months preceding the qualifying surveillance imaging visit without subsequent documentation of HCC negative or LIRADS 1 (Liver Imaging Reporting and Data System) by diagnostic CT/MRI.
5. Females known to be pregnant at the time of enrollment.
6. Illness that the Investigator believes poses a significant risk of mortality during the study period, including but not limited to

   1. Congestive heart failure with ejection fraction \<50%
   2. Chronic lung disease requiring supplemental oxygen.
   3. History of recent stroke.
7. Sustained virologic response (SVR) for Hepatitis C Virus (HCV) (undetectable HCV RNA 12 to 24 weeks after completion of antiviral therapy) for \>10 years prior to enrollment.
8. Not able to have IV contrast for CT or MRI due to

   1. Allergy to IV contrast and unwilling or unable to receive IV contrast after pre-medication.
   2. Estimated glomerular filtration rate \<35 mL/min and not on hemodialysis.