cyrilzakka/clinical-trials huggingface dataset:
Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients

In this study, we will explore the feasibility of a randomized controlled trial that will compare high protein dose from ICU day 6 to 14 with moderate protein intake.

Patients will be recruited on day 1-2 of ICU admission. On day 5, patients will be randomized into one of the two intervention arms;

Replenish Protein group:

Patients randomized to this group will receive 2 g of protein/kg/day (acceptable range 1.8 - 2.2 g of protein/kg/day) for day 6-14.

Standard Protein group:

Patients randomized to this group will receive protein at 0.8 - 1.0 g of protein/kg/day for day 6-14

Eligibility Criteria:
Inclusion criteria

1. Age ≥ 18 years
2. Mechanically ventilated
3. Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and
4. Expected to stay ≥ 1 week in the ICU

Exclusion criteria

1. Lack of commitment to ongoing life support, which includes;

   * Terminal Illness (Malignancy or irreversible condition with 6 month mortality \> 50%)
   * DNR order in the first 48 hours and brain death within 48 hours of admission) (Don't include the presence of a "Do Not Resuscitate" order alone, if there is a commitment to ongoing life support).
2. Patients not fed within 48 hours of admission
3. Patients on total parenteral nutrition (TPN)
4. Patients being fed orally
5. Chronic renal failure
6. Chronic liver disease
7. Renal replacement therapy
8. Pregnancy.
9. Kidney transplant
10. Post-liver transplant.
11. Post cardiac arrest.
12. Burn patients.
13. Prisoners

Screened patients will be screened again for eligibility at day 5, should be mechanically ventilated and expected to stay ≥ 3 days in the ICU. At this point, patients will be excluded if they meet the following;

1. New onset renal replacement therapy.
2. Acute Kidney Injury (serum creatinine \> 3 times the preacute level or serum creatinine \>350mmol/L with a recent increase of \>44 mmols/L)
3. Significant liver impairment
Combined Effects of Breathing Teach Back Training And Percussion In Patients With Pneumonia

Pneumonia, marked by lung inflammation, leads to symptoms like fever and difficulty breathing, affecting millions globally. It particularly impacts children and the elderly. Lung function is altered, reducing capacities and obstructing airflow. Post-recovery, patients may experience dyspnea due to lingering fluids-deep breathing exercises, using teach-back training, aid rehabilitation. Combining teach-back with chest percussion in physiotherapy aims to enhance respiratory outcomes in pneumonia patients. This will be a randomized clinical trial sample size calculated by epitool sample size calculator which is 30 patients 15 in each group. Regular chest percussion involves a clapping technique in five drainage positions, with assisted suction. Teach-back breathing exercises will also be implemented in this group In Group A, individuals will perform teach-back breathing exercises with chest percussion. In Group B, a similar protocol will be followed without the teach-back breathing exercises. Data analysis, using SPSS version 21, will include the Shapiro-Wilk Test for normality assessment. Descriptive statistics, paired sample t-tests, Wilcoxon signed-rank tests, independent sample t-tests, and Mann-Whitney U tests will be employed to analyze group measurements, changes over time, and differences between groups. This comprehensive approach aims to provide a thorough understanding of the study variables and measurements.


Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Age 35-45 years
* Diagnosed pneumonia

Exclusion Criteria:

* History of neurological disorders
* History of fractures
* History of other pulmonary complications (15)
* Patients having any chest infection will be excluded
Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method

The primary objective of the preliminary lead-in study is to determine whether circulating tumor cells in patients with metastatic progressive castration-resistant prostate cancer or metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based).

The primary objective of each comparative cohort (second stage, prostate cancer) is to compare the non-detection rate of circulating tumor cells between the standard and novel methods.


Eligibility Criteria:
Inclusion Criteria:

Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
2. Clinical or radiographic evidence of metastatic disease.
3. Castrate levels of testosterone (\<50 ng/dl)
4. Evidence of disease progression on or following most recent therapy as evidenced clinically by the treating physician or by either of the following:

   * Two consecutive PSA levels greater than the PSA nadir achieved on ADT, separated by greater than one week
   * Radiographic evidence of disease progression as defined by new bone scan lesions or growth of soft tissue/visceral metastases \>1 cm in diameter (2 cm for lymph nodes).
5. Age \> 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.

Breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

1. Histologically confirmed diagnosis of invasive breast cancer.
2. Clinical or radiographic evidence of metastatic disease.
3. Evidence of disease progression on the current or following the most recent therapy, determined either clinically by the treating physician or by radiographic evidence as defined by new bone scan lesions or soft tissue/visceral metastases \>1 cm in diameter (2 cm for lymph nodes).
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

1. History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
2. Treatment with an anthracycline or mitoxantrone within 1 week of CTC collection
Monitoring Cellular Immunity After Kidney and Liver Transplantation

After transplantation, if insufficient immunosuppression is achieved, rejection and graft loss follows. If to much immunosuppression is given, the patient suffers risk for infections and malignancies. Despite careful dosing and monitoring of drug levels, the biological effects of the immunosuppression given is difficult to predict and varies significantly. As a result, the degree of immunosuppression (or immunosuppressive status) remains unknown and clinical problems related to under- or over-immunosuppression are common. Thus, a method to determine the degree of immunosuppression would be of great and direct clinical importance and the results would be improved. T cells are the principal cells of the immunesystem causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell reactivity could reflect the biological effects of the immunosuppression and the immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence against viral diseases. Therefore, data on virus specific T cell reactivity could aid in diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a clinically useful method to monitor cellular immunity and the degree of immunosuppression after transplantation by determinations of the specific T cell reactivity to several clinically relevant viruses.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing kidney or liver transplantation at the Karolinska University Hospital

Exclusion Criteria:

* Abscence of informed consent
Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy

Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are at high risk of many serious diabetic complications, including cardiovascular disease, blindness, nerve damage and kidney damage. Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose compared to placebo, but with less impact on weight gain and oedema than pioglitazone (Actos®) 45 mg.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO criteria for at least 3 months
2. Age ≥ 18 years
3. BMI ≥ 25.0 kg/m2
4. HbA1c ≥ 7.0 %
5. Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least 75 days

Exclusion Criteria:

1. Prior or current use of any PPAR-γ agonist
2. Recent use (\< 3 months) of an investigational drug
3. Pre-existing medical condition judged to preclude safe participation in the study
4. Contraindication/intolerance to study medication
5. Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
6. Diagnosed or receiving medication for heart failure, NYHA I to IV
7. Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention
8. Uncontrolled treated/untreated systolic blood pressure \>180 mmHg and/or diastolic blood pressure \> 95 mmHg
9. Known diabetic macular oedema
10. Hematuria
11. Serum creatinine \>130 μmol/l
12. ALT, AST, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal
13. Haemoglobin significantly (in the Investigators opinion, but not more than 1 mmol/L) below the lower limit of normal or haemoglobinopathy interfering with valid HbA1c assay
14. Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives)
15. Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation
16. Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocols
17. Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
Safety and Feasibility of Prima-Temp Thermometer Patch

The purpose of this study is to test the safety and feasibility of the Prima-Temp Thermometer Patch in determining baseline temperatures of research subjects in a hospital intensive care unit (ICU).

Primary Objective: Assess safety of the Prima-Temp temperature patch with nursing staff skin site assessments.

Secondary Objective: Establish individual subject baseline temperature using intermittent temperature measurements (every 5 minutes) with the Prima-Temp thermometer patch and wireless transmission of the data to a receiver box and HIPAA compliant, centrally located personal computer (PC) and compare research subject's baseline temperature with temperatures taken in the ICU in the normal course of care.

The manifestation of fever and its characteristics is essential to the care of intensive care unit patients. As a marker for infection or other disease process, the presence of a fever and its temperature peak must be reliably obtained in ICU patients and must be monitored closely to optimize effective therapy. Inherent variability of different temperature measurement methods can lead to a difficulty in determining the optimal timing of medical interventions. Ideally, nurses and medical staff in acute care hospital facilities could have a temperature monitoring system that aids recognition of fever and systemic infection that is not labor intensive and provides consistent and reliable temperatures. Automatic transmission to a data recorder lessens the chances of manual entry error into the medical record. Frequent measurements allow establishment of a patient's individual baseline temperature to provide individualized guidelines for medical interventions with an increase of 2°F above baseline as documentation of a fever. Finally, the frequent temperature monitoring should be minimally invasive and comfortable to the patient.

Eligibility Criteria:
Inclusion Criteria

1. Men and women of any race.
2. Men of age \> 18 years
3. Women with no childbearing potential (age \> 50, age ≥ 18 s/p hysterectomy)
4. Arm circumference \>23 cm and \< 38 cm

Exclusion Criteria

1. Patient with known or documented adhesive, Tegaderm allergies.
2. Abnormal axillary integument such as rashes, burns, laceration.
3. Hidradenitis suppurativa and/or dermatologic diseases that might interfere with the evaluation of the test site reactions.
4. Non-English speakers
5. Pregnant women
6. Patient requiring hypothermic therapy, with the exception of non-steroidal anti-inflammatory treatment (acetaminophen, ibuprofen, aspirin, etc).
Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.

Primary Purpose - other: Protocol designed to assess the safety, tolerability, immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-986089 in healthy subjects

Enrollment: Single ascending dose panels: 48 subjects, Multiple ascending dose panels: 96

Minimum age: 18 years (Elderly MAD Panel 65 years of age) Maximum age: 55 years (Elderly MAD Panel 70 years of age)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations
* Men and women who are not of childbearing potential (ie, who are postmenopausal or Surgically sterile WOCBP) ages 21 to 55 years
* Women must not be breastfeeding
* Men who are sexually active with women of child bearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year

Exclusion Criteria:

* Any significant acute or chronic medical illness Any major surgery within 6 weeks of study drug administration
* Any condition that will clearly require medical or surgical treatment during the period of study participation
* Any bone trauma or bone surgery within 3 months of study drug administration
* Known or suspected autoimmune disorder
* Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 6 weeks of study
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.


Eligibility Criteria:
Inclusion criteria:

- Healthy male or female subjects

Exclusion criteria:

- Any relevant deviation from healthy condition
Risk of Exposure and Prevention of Ticks and Tick-borne Diseases Among Foresters in Alsace

Ticks are blood-sucking arthropods that feed on vertebrate hosts. Although wild and domestic animals are the primary source of tick blood meals, humans can be an accidental host. During a blood meal, a microorganism can be transmitted to the host who can develop a disease. All infectious diseases transmitted by ticks are referred to as tick-borne diseases (TBDs). They are the most prevalent vector-borne diseases in the Northern Hemisphere. Among these diseases, Lyme borreliosis is the most common.

In Europe, Lyme borreliosis does not cause high fevers (\> 38°C). Therefore, when a patient presents with a high fever with the notion of exposure to ticks, another etiology must be suspected. Anaplasma phagocytophilum and the tick-borne encephalitis virus are classically described as causing febrile syndromes.

In France, ticks and tick-borne diseases are increasing, particularly those associated with the Ixodes ricinus tick. This tick is mainly present in forest ecosystems with a peak of activity in May. Foresters represent a population with biting ticks and tick-borne diseases, notably Lyme borreliosis.


Eligibility Criteria:
Inclusion Criteria:

* Major forester (≥18 years old)
* Male or female gender
* ONF (National Forestry Office) staff
* Regularly exposed to ticks in Alsace (exclusively)
* Practicing regular forestry activities in a group
* Agreeing to participate in the study.

Exclusion criteria:

* Refusal to participate in the study
Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

AZ202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
* Evidence of meibomian gland obstruction
* Reported dry eye signs and symptoms within the past 3 months

Exclusion Criteria:

* Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
* Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening ≥24 mm Hg or has planned insertion/removal of glaucoma filtration shunts/devices during the study
* Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
* BCVA worse than 20/40 in either eye
* Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer

Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.

All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.

Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.


Eligibility Criteria:
Inclusion Criteria:

Patients who answer TRUE to the following criteria may be eligible to participate in this study.

* Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
* Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
* Currently receiving treatment with surgical or medical castration

Exclusion Criteria:

Patients who answer TRUE to the following may NOT be eligible to participate in this study.

* Currently using opiate based pain killers for cancer related pain
* Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
* Suffering from heart failure or had a myocardial infarction within last 6 months
* A history of epilepsy or seizures
Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression

The purpose of this study is to determine if the use of pedometers can help depressive inpatients in psychiatric clinics to increase their level of physical activity. Therefore patients are given a pedometer and instructions how to raise their level of daily steps. Intervention group is compared with a control group that is receiving treatment-as-usual. The intervention is hypothesized to increase number of daily steps and have positive effects on mood, depression and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Major Depression, moderate to severe as main diagnosis
* Inpatient status
* Prospected inpatient treatment of at least 4 weeks
* Able to understand german

Exclusion Criteria:

* Physical disease or disability that makes it impossible to reach the goal 5000 steps per day
* Borderline personality disorder
* Bipolar Disorder
* Schizophrenia
* Anorexia Nervosa
* Dementia
* Psychotic Depression
* Pregnancy
* Acute suicidality
* Substance dependancies with actual consumption (except nicotine)
* Current pedometer-use
* More than 10.000 steps per day