cyrilzakka/clinical-trials huggingface dataset:
Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery

This study is to compare the sustained post-discharge nutritional support to reach individual energy and protein goals to usual care home nutrition in medical patients at nutritional risk.

Malnutrition is a strong and independent long-term risk factor for mortality, rehospitalisation and functional decline, particularly in the elderly, polymorbid medical patient population. The randomized-controlled Effect of early nutritional support on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial (EFFORT, Lancet 2019) included 2028 patients in eight Swiss hospitals and found that nutritional support during the inhospital stay reduces very efficiently the risk for complications and mortality with numbers needed to treat (NNT) of 23 and 37, respectively.

Yet, the nutritional intervention was not continued after hospital discharge of patients and long-term follow-up data of patients showed a lack of sustained effect of the initial nutritional support strategy. There is a current lack of trial data investigating whether long-term use of nutritional support has a sustained effect on clinical outcomes in this patient population. This study is to compare the continuous use of nutritional support with the use of approved oral nutritional supplements to reach protein and energy goals and to analyze whether medical patients at nutritional risk show a sustained benefit from long-term nutritional support after hospital discharge, and why and how nutritional support affects the course of disease from a mechanistic physio-pathological standpoint.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Adult (age ≥18 years), medical patients
* Nutritional risk screening using the Nutritional Risk Screening (NRS): total score ≥3 points consisting of ≥1 points for impairment of the nutritional status \[weight loss \>5% in 3 month or food intake of 50-75% in the last week before hospital admission\] plus ≥1 for the severity of the disease (i.e., cancer, chronic kidney disease, chronic heart failure, COPD) and other chronic diseases according to the definition of the "National Center for Chronic Disease Prevention and Health Promotion": Chronic diseases are defined broadly as conditions that last 1 year or more and require ongoing medical attention or limit activities of daily living or both .

Exclusion Criteria:

* after surgery
* unable to ingest oral nutrition
* need for long-term nutrition,
* terminal condition
* acute pancreatitis or acute liver failure
* patients discharged to a nursing home
* patients unlikely to comply with nutritional support treatment (e.g., dementia)
* COVID-Hospitalisation requiring intensive care
The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients

The aim of this study is to describe the development of symptomatic and asymptomatic incisional hernias after emergency midline laparotomy over time in high-risk patients evaluated by consecutive MRI-scans.

All patients operated with an emergency midline laparotomy in our clinic are potential participants and will be screened for participation. Potential participants will be briefly informed about the project by the hospital staff. If the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge.

Data will be obtained from the participants hospital files and by patient survey/interview. All data will be entered into a database using RedCap by trial investigators or their delegates.

Enrolled patients will be followed for two years. The trial involves four consecutive MRI-scans one month, three months, six months and two years after surgery. Change in quality of life, physical functioning and pain-score are also obtained by patient survey/interview at each visit. A concluding physical examination and abdominal wall ultrasound examination will be performed two years after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and Crohn's disease), abscesses, non-traumatic intraabdominal bleeding or any emergency re-operation to elective surgery
* Age of 18 years or above
* BMI above 27
* At least one risk factor for incisional hernia i.e. earlier midline laparotomy, BMI \> 30, abdominal aortic aneurysm or prior surgery for abdominal aortic aneurysm, active smoking, liver cirrhosis, re-laparotomy, age \> 75, history of primary ventral hernia (treated or untreated before index surgery), large laparotomy involving more than 2/3 of the abdominal wall as measured from the xiphoid process to the pubic bone

Exclusion Criteria:

* Malign, incurable disease
* Other reasons for short life expectancy \<2 year as evaluated by the investigator
* Midline-incisions \<15 cm
* Mesh augmentation of abdominal wall closure at index surgery or earlier mesh augmentation of the abdominal wall
* Severe claustrophobia or any other mental habitus, making it impossible to perform MRI-scan without sedation
* Metallic magnetic implants that serves as a contraindication for MRI-scan (including pacemakers, large tattoos, insulin pumps, etc.)
* Metallic prosthetic non-magnetic implants that are suspected to create severe artefacts on the MRI-scan of the abdominal wall
0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse

VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.

The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.

Eligibility Criteria:
Inclusion Criteria:

* women with vaginal prolapse
* capable of having a surgery - assessed by an anesthesiologist
* women who approve of having the surgery

Exclusion Criteria:

* BMI over 40
* women who have recurrent PID (pelvic inflammatory disease)
* women with oncology records
TXA in Revision Total Shoulder Arthroplasty

This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.

The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years old
2. Patients younger than 90 years old
3. Patients undergoing scheduled revision total shoulder arthroplasty
4. Patients who consent to be randomized

Exclusion Criteria:

1. Patients younger than 18
2. Patients older than 90 years old
3. Patients who are pregnant or breast-feeding women
4. Patients who are allergic to tranexamic acid
5. Patients with proximal humerus fracture or fracture sequelae
6. Patients who use estrogen containing medications (i.e. oral contraceptive pills)
7. Patients who have acquired disturbances of color vision
8. Patients with a history of any of the following diagnosis: '

   * Subarachnoid hemorrhage
   * Active intravascular clotting
   * Severe pulmonary disease (FEV \<50% normal)
   * Plasma creatinine \> 115 μmol/L in males, \> 100 μmol/L in females, or hepatic failure)
   * (Renal impairment serum creatinine \> 1.5 times the upper limit of normal NYU)
   * Preoperative anemia \[Hemoglobin (Hb) \< 11g/dL in females, Hb \< 12 g/dL in males\]
9. Patients who refuse blood products
10. Patients undergoing hormone replacement therapy
11. Patients with diagnosed or self-reported cognitive dysfunction;
12. Patients who are unable to understand or follow instructions;
13. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
14. Patients with BMI over 50
15. Any patient that the investigators feel cannot comply with all study related procedures.
Magnesium Citrate Supplementation on Hand Grip Strength

The purpose of this research study is to determine the effectiveness of magnesium on handgrip strength using the more bioavailable magnesium citrate.

In this single-blind, randomized trial, participants will take a daily dose of either 200 or 400 milligrams of magnesium citrate supplement for four weeks, perform three separate handgrip strength tests using a dynamometer, complete a demographics questionnaire, a physical activity questionnaire, and a compliance log.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy community adults
* Individuals age 18 and over
* Male and female participants

Exclusion Criteria:

* Individuals currently on magnesium supplements
* Individuals currently on a multivitamin supplement
* Individuals who currently suffer from hand pain or hand injury
* Individuals who currently suffer from arthritis in their hands
* Individuals suffering from a gastrointestinal disorder complicated by diarrhea, nausea, or abdominal cramping
Compassionate Access of the Miltenyi Device for CD34+ Cell Selection

Objectives:

Primary Objective

To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients who experience poor graft function after stem cell transplantation (SCT).

The therapy that you will receive involves you being given an infusion of CD34 positive stem cells.

Below is a detailed explanation of the therapeutic procedures that will be performed.

CD34 positive stem cells infusion:

The CD34 positive stem cells are collected from a donor's blood. The blood cells go through CD34 (stem cell) selection process that collects the stem cells that are needed for the infusion. This process collects the early immune cells your body will need to regrow your immune system, and makes sure that other cells will not be infused. This process will decrease (but not eliminate completely) the other types of cells. If you agree to receive this treatment, the CD34 cells will then be infused into your body.

The CD34 positive cells will be given by vein in either an inpatient or outpatient treatment area. The infusion will last about 10-30 minutes.

Before the infusion, you will receive Tylenol (acetaminophen) by mouth and Benadryl (diphenhydramine hydrochloride) by mouth or vein about 30-60 minutes before the infusion. These drugs will be used to help lower the risk of side effects. If side effects occur during the infusion, the doses of the drugs may be adjusted (up or down) until the symptoms are gone. Also, if you have side effects during the infusion, you will be observed for 2 hours after it is given or until the symptoms have stopped completely (whichever is later). During this time, your blood pressure, heart rate, breathing rate, temperature, and the level of oxygen in your blood will be checked every 15-30 minutes.

About 4-6 weeks after the first infusion, you may receive an additional infusion, if your doctor thinks it is needed.

Clinic Visits:

One (1) time a week after the infusion, until your doctor thinks it is no longer clinically needed, you will have the following tests:

* Blood (about 1 teaspoon) will be drawn for routine tests.
* You will be checked for signs of graft versus host disease (GVHD). Symptoms of GVHD include skin rash, nausea, vomiting, diarrhea, and abnormal liver function.

This is an investigational study. The CD34 positive stem cell infusion to help boost cell counts is not FDA approved.

Up to 75 patients will be enrolled on this treatment.

Eligibility Criteria:
Inclusion Criteria:

1) Patients who have poor or no graft function post stem cell transplantation.

Exclusion Criteria:

N/A
Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults

Using a randomized controlled trial (RCT) design, we will test feasibility and outcomes following an remotely delivered, nationwide 8-week prolonged nightly fasting (PNF) intervention compared to an health education control (HEC) in 50 obese, stressed mid-life adults to explore outcomes related to cognitive function, metabolism and associated lifestyle behaviors.


Eligibility Criteria:
Inclusion Criteria:

* 40-59 years old
* experiencing memory loss
* BMI 30-45.9
* PSS-4 score ≥5
* access to smartphone, zoom, and wifi
* lives in United States

Exclusion Criteria:

* diabetes
* pregnant,
* neurological disorder
* eating disorder within last 20 years
* In current weight loss program
* previously had bariatric surgery
* works a night shit
* health condition not conducive to nightly fasting
Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.

With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study.

The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patient indicated for an ear level bone anchored sound processor
* Bone thickness at the implant site of at least 4 mm

Exclusion Criteria:

* Inability to participate in follow-up
* Psychiatric disease in the medical history
* Mental disability
* Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
* Patients with natural skin height of \>10 mm
Comparison of Respiratory Muscle, Pain, Functional Performance and Cognitive Status in Obstructive Lung Diseases

In the literature, there are a limited number of studies evaluating postural awareness, cognitive status, respiratory muscle strength and endurance, functional capacity, and pain in people with obstructive pulmonary disease, and comparing these parameters with each other and with healthy subjects, and most of the studies are on chronic obstructive pulmonary disease patients. There we will evaluate these parameters in different obstructive lung diseases and compare the findings of healthy individuals.


Eligibility Criteria:
Inclusion Criteria for obstructive lung diseases

1. To be diagnosed with obstructive pulmonary disease,
2. Have not experienced acute exacerbation in the last 3 months,
3. Being between the ages of 18-65,
4. Not having chronic pain problems,
5. Volunteer for research,
6. To be able to walk and cooperate.

Exclusion criteria for obstructive lung diseases

1. To be able to diagnose neurological disorder,
2. To have an advanced orthopedic disease that may affect functional capacity measurement.

Criteria for Non-Inclusion for healthy group

1. To have any cardiopulmonary disease,
2. To have an advanced orthopedic disease that may affect functional capacity measurement.
Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Primary Objectives:

* To compare the neuropsychiatric (NP) and neurocognitive (NC) symptoms and assess the quality of life (QOL) in older patients (age \> 18) with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) receiving different therapies, chemotherapy (Clofarabine + ara-C) or targeted therapies (PKC412 + low-dose ara-C, or R115777 + low-dose ara-C, or decitabine, or STI + low-dose ara-C).
* To determine whether there is a correlation between the number of packed red blood cell (PRBC) transfusions and cognitive scores and/or QOL.

You will participate in a series of neurocognitive tests. For these tests, you will be asked to complete certain tasks that require the use of your hands, eyes, and ears. The neurocognitive testing will take about 30 minutes.

You will answer some questionnaires about disease symptoms and your quality of life. It will take about 30 minutes to complete the questionnaires.

You will participate in these neurocognitive tests and fill out the questionnaires before you begin cancer therapy. Your interval testing will coincide with your clinic visit evaluations, which will be approximately at 1 month, 3 months, and 6 months. If you do not receive therapy, you will be asked to complete the neurocognitive tests at baseline and then again on your follow up clinic visit evaluations, which will be approximately at 3 months and at 6 months. You may be asked to continue your participation in these neurocognitive tests and fill out questionnaires approximately every 3 months thereafter.

This is an investigational study. About 306 patients will take part in this study. All will be enrolled at UTMDACC.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed AML or MDS. Patients who fail an MDS/AML therapy and receive other therapies may be asked to continue participation in this neurocognitive study.
2. Patients who are 18 years of age or older.
3. Patients who are seen in the MDACC adult Leukemia clinic. Patients who do not enroll onto therapy protocols are also eligible.
4. Patients must sign the informed consent.

Exclusion Criteria:

1) Not applicable
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.

The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.


Eligibility Criteria:
INCLUSION CRITERIA

* history of pregnancy within 5 years of the study visit
* had healthy pregnancy OR had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes.

EXCLUSION CRITERIA

* skin diseases,
* current tobacco or electronic cigarette/vape pen use,
* diagnosed or suspected hepatic or metabolic disease including diabetes,
* statin or other cholesterol-lowering medication,
* current antihypertensive medication,
* history of preeclampsia or gestational hypertension
* current hypertension,
* current pregnancy,
* body mass index \<18.5 kg/m2,
* allergy to materials used during the experiment.(e.g. latex), known allergies to study drugs.
Pharmacokinetics and Safety/Tolerability of CKD-379

A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

A randomized, open-label, single dose, 2-period, 2-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Eligibility Criteria:
Inclusion Criteria:

* Between 19 aged and 50 aged in healthy adult
* 50.0kg≤Body weight≤90.0kg and 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2

Exclusion Criteria:

* Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis etc.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness
* Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis
* Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
* Those who are pregnant or breastfeeding
* Those who are deemed inappropriate to participate in clinical trial by investigators