cyrilzakka/clinical-trials huggingface dataset:
Exercise Regimens and Neoadjuvant Chemotherapy

The purpose of this study is to assess the effectiveness of exercise therapy for patients undergoing neoadjuvant chemotherapy for primary gastrointestinal (GI) tract cancer, providing a reproducible exercise regimen designed to improve or preserve aerobic fitness, strength, and quality of life. In addition, this study will address shifts in healthcare delivery needed as a result of the coronavirus disease 2019 (COVID-19) pandemic, evaluating the effectiveness of telehealth instruction as a method for exercise therapy.

The study hypotheses are:

1. To evaluate the effectiveness of exercise therapy for cancer patients undergoing neoadjuvant treatment when delivered via telehealth, as compared to an in-person setting.
2. To assess stair test instrumentation, previously validated in a healthy population, as a measure to gauge health status in cancer patients undergoing neoadjuvant treatment.
3. To assess patient satisfaction with exercise therapy when delivered via telehealth, as compared to an in-person setting.

After being informed about the study and potential risks and benefits, all patients meeting inclusion criteria who provide written informed consent will be randomized at the time of enrollment to one of two cohorts engaged in a standardized exercise regimen based on delivery method, either in-person or via telehealth. Patient function will be assessed using the Timed Up and Go (TUG) test; Stairs Test; which evaluates aerobic ability, resistance, agility, balance, and posture; and given a score on the Karnofsky Performance Status Scale. Patient quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) survey. Outcomes for the cohorts will be compared over time.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age
* Primary language is either English or Spanish
* Primary cancer diagnosis of GI cancer
* Undergoing neoadjuvant chemotherapy prior to surgical resection.
* Patients are being treated by medical oncologist at Simmons Cancer Center at Moncrief Cancer Institute in Fort Worth

Exclusion Criteria:

* Patient has had systemic cancer treatment in the past year
* Patient initiated neoadjuvant chemotherapy treatment prior to study enrollment
The VIRTUE Post Marketing Surveillance Registry

The purpose of this post-market release registry is to collect additional information concerning safety, performance and health economic data with respect to the Medtronic VALIANT Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of descending thoracic aortic dissections.

The patient device for use in this registry is the Medtronic VALIANT Thoracic Stent Graft System that received CE mark approval in March 2005.

The Medtronic VALIANT Thoracic Stent Graft with Xcelerant Delivery System is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The VALIANT Stent Graft is designed to exclude the aneurysm, the false lumen or site of rupture and restore the blood flow through the stent graft lumen. The device is intended for use either in patients who are candidates for conventional surgical repair, and in patients who are not candidates for conventional surgical repair due to pre-existing risk factors.

This registry is a prospective, non-randomized, single-arm, multi-center, European clinical registry with patients diagnosed with descending thoracic aortic dissection.

For this registry standard hospital procedures with respect to patient interventional care for thoracic aortic diseases will be followed.

This is a descriptive registry in which no specific hypotheses will be statistically tested.

Eligibility Criteria:
Inclusion Criteria:

* Patient will be more than or equal to 18 years of age; or older if required by local regulations.
* Patient has an indication for treatment by either endovascular stent graft implantation for either an acute, sub-acute or chronic Type B dissection.
* Patient is amenable for stent-graft treatment (in accordance with the IFU).
* The patient is willing and able to cooperate with registry procedures and required follow-up visits.
* The patient or legal guardian has signed a patient informed consent form, including data privacy authorization (this criteria is not applicable for patients presenting in emergency with ruptured dissection and for whom legal representative is not available informed consent can be requested after surgical procedure).

Exclusion Criteria:

* Patients with a thoracic dissection for which optimal treatment is observation and medical management.
* Patient with current - non aortic - medical condition with a life expectancy less than one year.
* The patient is participating in another device or drug study (patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this registry).
* Time interval between medical indication for surgical intervention and endovascular procedure exceeds 4 months (122 days).
Standardization of a Novel Self-administered Tablet Computer-based Clinical Screening Tool for Adverse Postoperative Cognitive Outcomes

Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) are common complications after surgery and may affect elderly patients in particular. CogCheck, an application for tablet computers, was developed with the intention to assist preoperative risk screening for POD and POCD in surgical patients. The aim of this study is to generate normative data with cognitively healthy participants for the application.

Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) are common complications after surgery and may affect elderly patients in particular. Prior studies found risk factors for POD and POCD which are present preoperatively, e.g. older age and pre-existing cognitive impairment. However, the preoperative risk of postoperative adverse cognitive outcomes (POD and POCD) is often not screened in routine clinical practice as it is time-consuming and requires trained personnel.

In 2014, the application for tablet computers "Delirium Risk Profile" (DRP) was developed at the University Hospital Basel to assist preoperative screening in surgical patients. The application was later renamed CogCheck as the scope of the tool was extended to POD and POCD risk assessment.

The aim of this study is to provide normative data for the application. Ultimately, the objective is to assist health care providers in the evaluation of patients' cognitive functions by routinely using the application in preoperative clinics.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Education ≥ 7 years
* Fluency in the German language
* Written informed consent

Exclusion Criteria:

* History of cognitive impairment
* Signs of depression
* Severe sensory or motor impairment interfering with cognitive testing
* Serious somatic disease, disease or event affecting the central nervous system (head trauma with loss of consciousness \> 5 minutes, any brain surgery, general anesthesia within the last 3 months, alcoholism, intoxication with neurotoxic substances)
* Cerebrovascular disease
* Regular medication with psychoactive drugs except for benzodiazepines
* Participation in any cognitive study within the last 3 months or previous participation in a study using the application.
Identification Sepsis Related Single Nucleotide Polymorphism (SNP) by Whole Exome Sequencing

Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. Single nucleotide polymorphism (SNP) was promising genetic biomarker for sepsis patients. The present study was designed to screen several SNP by whole exome sequencing which evaluate the sepsis related snp site in order to be a new target for the treatment of sepsis.

The study is a non-intervention, prospective observational study. Purpose of this sudy is to screening several SNPs by whole exome sequencing which can be used as genetic marker for sepsis patients. We will collect whole blood samples from patients with sepsis inRespiratory Intensive Care Unit (RICU), the Emergency Intensive Care Unit (EICU), or the Department of Surgery's ICU 301 Hospital since January 2013, and then whole exome sequencing was used to Screen SNPs which were related to sepsis. Then another 500 sepsis patients and 500 normal controls were used to validated the sequencing results.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of sepsis
* Patients who agree with the study

Exclusion Criteria:

* Aged \<18 years;
* Into the group who died within 24 hours;
* Agranulocytosis (\<0.5 × 109 / L);
* Combined HIV infection.
An Observational Study of Patients with Chronic Gastrointestinal Disease

TARGET-GASTRO is an observational research study to conduct a comprehensive review of outcomes for patients with the chronic gastrointestinal (GI) diseases: eosinophilic gastrointestinal disease (EGID), ulcerative colitis (UC) or Crohn's disease (CD).


Eligibility Criteria:
Disease Cohort

Inclusion Criteria:

* Adult\* patients at the time of enrollment with a diagnosis or major symptom of EGIDs, UC, or CD by ICD-10 code in the EHR interface

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years.

Engaged Cohort

Inclusion Criteria:

* Adult\* patients diagnosed and managed for these conditions invited to participate
* Ability to provide written informed consent

Exclusion Criteria:

* Patient expressed desire to withdraw consent to complete PROs
* Failure to complete PROs within 24 weeks of initial invitation
* Greater than 24 months lapse of survey completion after baseline surveys completed
* Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort.
Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children

The purpose of this study is to examine the effects of current standard of care Polyethylene Gylcol powder (PEG-P)colonoscopy preparation on a patient's serum electrolytes, tolerance of the prep, and how well the bowel is cleansed. The primary aim is to determine the proportion of patients with clinically significant serum electrolyte abnormalities at the time of colonoscopy and how well the prep is tolerated. Secondary objectives include: 1) how well the bowel is cleansed with this preparation, and 2) to determine the most effective way to communicate instructions about the bowel preparation with the child and family.

Design is prospective, descriptive observational study involving a single clinical encounter in the Endoscopy suite at CHOP Main at the time of colonoscopy. Patients prescribed the standard of care dosage for PEG-P by their primary gastroenterologist are considered for this study. Study procedures include collection of data from patients that are prescribed the PEG-P dose. In order to evaluate the safety, tolerability, and adherence to PEG-P bowel preparation, data collections include the following: review of medical records, tracking of communication from subjects/parents, blood draw, questionnaire and quality of prep will be assessed. Questionnaire results will be obtained at the initial and only visit. Patients will be given a questionnaire prior to colonoscopy to rate symptoms, ease of preparation and to rate the effectiveness of communication about the preparation. On the day of colonoscopy, prior to the procedure, patients will have an IV placed per standard procedure. At the time of IV placement, a basic metabolic panel and serum magnesium and phosphorus levels will be drawn through the IV for assessment of electrolyte abnormalities. Serum glucose will be captured from medical records as this is collected with standard of care. Patient/parents will grade the preparation tolerance filling out a questionnaire prior to colonoscopy. During colonoscopy, the endoscopist will grade the quality of preparation on a validated residual stool survey (Aronchick scale).

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 1 - 18 years
* patients receiving standard of care dosing for polyethylene glycol powder
* patients who had electrolyte results within the last 60 days of enrollment
* parental / guardian permission (informed consent)

Exclusion Criteria:

* Patients on the GI inpatient or consult service
* Weight less than 10 kg
* Pregnant or lactating females
* Non-English speaking patient or parent
* 5) Parents/guardians or subjects who, in the opinion of the Investigator/Study team, may be non-compliant with study schedules or procedures
Respiratory Restriction in Prader-Willi Syndrome

The main aim of this study is therefore to evaluate the impact of Prader Willi Syndrome (PWS) on lung and thoracoabdominal volumes, respiratory muscle strength and awake ventilatory pattern, and to quantify and localize the PWS-induced respiratory restriction.

The aim is to study lung function in obese PWS patients using both volitional (spirometry, nitrogen wash-out, and maximal pressure measurements (MIP and MEP)) and non-volitional (awake ventilatory pattern by opto-electron plethysmography) tests, both in sitting and supine positions.

Spirometry, nitrogen wash-out, and MIP and MEP measurements are comprehensive assessments, while optoelectronic plethysmography allows restriction location through accurate measurement of thoracoabdominal volumes.

The results of the study could provide useful information about the calculation of the volumes enclosed by the grid of markers (in particular, the volume of the rib cage, which reflects the action of the intercostal muscles, the volume of the abdomen, which reflects the action of the diaphragm in the inspiratory phase and of the abdominal muscles during exhalation and their sum, which represents the total variation of the thoraco-abdominal wall. All these finds could be useful for respiratory rehabilitation protocols for obese PWS patients.

Eligibility Criteria:
Patients with Prader Willi Syndrome

Inclusion Criteria:

* Age 20-50 years
* Prader Willi Syndrome
* Body Mass Index \> 30 kg/m2

Exclusion Criteria:

* Lack of signed consent form

Control subjects

Inclusion Criteria:

* Age 20-50 years
* Body Mass Index \< 25 kg/m2

Exclusion Criteria:

* Lack of signed consent form
Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma

Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.

This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .

The duration of the treatment period is approximately 25 weeks and patients are followed until Death.

From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130).

The final analysis was performed in June 2005.

Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification).
* Aged from 18 to 59 years, eligible for transplant.
* Patient not previously treated.
* Age adjusted International Prognostic Index equal to 2 or 3.
* Having previously signed a written informed consent.
* Women of childbearing potential currently practicing an adequate method of contraception.

Exclusion Criteria:

* Any other histological type of lymphoma.
* Any history of treated or non-treated indolent lymphoma.
* Central nervous system or meningeal involvement by lymphoma.
* Contra-indication to any drug contained in the chemotherapy regimens.
* Poor renal function (creatinin level\>150mmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l, unless related to bone marrow infiltration.
* Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
* Any serious active disease (according to the investigator's decision).
* HIV, HTLV1 or HBV related disease.
* Any organ transplantation before inclusion.
* Pregnant women.
Rational Fluid Therapy in Germany

The purpose of this observational study is the prospective documentation and evaluation of the status quo of volume therapy in German intensive care units.

The purpose of RaFTinG is the prospective documentation and evaluation of the demographic, diagnostic and therapeutic characteristics of unselected patients and their treatment in intensive care units (ICU) in Germany.

Documentation will not only include their stay in the ICU but a follow up query 90 days after discharge from the ICU.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients with an indication for fluid/volume therapy

Exclusion Criteria:

* Patients hospitalized by order of a court of law or a government agency
Symptoms and Function During and After Pregnancy

The purpose of this study is to:

1. describe degree of symptoms and disability during and after pregnancy
2. to examine if women with pelvic girdle pain are able to correctly mark their pain location on a pain drawing
3. to examine the responsiveness of The Pelvic Girdle Questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy week 32-36
* Understand and read/write a questionnaire in Norwegian or English

Exclusion Criteria:

* Not able to understand and fill in a questionnaire
Leucine Supplementation Strategies to Enhance Muscle Anabolic Responses in Older Age

Sarcopenia describes the progressive decline of muscle mass and strength with advancing age and is associated with increased frailty and morbidity, however we do not currently have an effective treatment. Protein feeding and exercise is known to increase muscle mass, but aged muscle shows a lower response to these stimuli leading to muscle loss over time. We do know that ingesting leucine, a building block of protein, can overcome this reduced response to protein feeding and exercise leading to increased muscle mass in older people. However, we do not understand when the optimum time to ingest leucine is to maximise muscle mass after exercise in older people. In this study we will examine the effect of feeding leucine after exercise either with a meal or between meals.


Eligibility Criteria:
Inclusion Criteria:

* Male, 65-75 years of age
* BMI 18-28 kg/m2
* Non smoker
* Not performing regular resistance type exercise
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* A BMI \<18 or \>28 kg·m-2
* Active cardiovascular disease: uncontrolled hypertension (BP \> 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt or recent cardiac event
* Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial)
* Respiratory disease including pulmonary hypertension or chronic obstructive pulmonary disease (COPD)
* Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes (treated and untreated), inborn/ congenital errors of metabolism (e.g. phenylketonuria (PKU), galactosaemia)
* Active inflammatory bowel disease
* Acute infection
* Acute or chronic renal disease
* Malignancy (or history of malignancy with 5 y)
* Recent steroid treatment (within 6 mo), or hormone replacement therapy
* Coagulopathy
* Musculoskeletal or neurological disorders
* Known allergies to any of the product ingredients
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes.

Following a run-in period of 2 weeks, participants will be randomised to control or hybrid automated insulin delivery (AID) using the 780G system and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week AID or Control and finally 4-week AID). The total duration for each participant will be 14 weeks. There are 5 study visits (combination of face to face or/and remote) and two telephone visits in total.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years of age or older
* Type 1 diabetes confirmed on the basis of clinical features
* Type 1 diabetes for greater than 1 year
* On an intensified insulin regimen with multiple dose injection or insulin pump for \> 3 months
* HbA1c \>7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L \<52% for participants already using a continuous glucose sensor)
* Gastroparesis Cardinal Symptom Index (GCSI) ≥ 18 or evidence of delayed gastric emptying on nuclear medicine gastric emptying study

Exclusion Criteria:

* Enrolled in other clinical trials
* Estimated glomerular filtration rate of ≤30ml/min
* Pregnant or planning pregnancy
* Have active malignancy or under investigation for malignancy
* Severe visual impairment
* Reduced manual dexterity
* Use of any automated insulin delivery system
* Unable to participate due to other factors, as assessed by the Chief Investigator