cyrilzakka/clinical-trials huggingface dataset:
Triple Therapy in Type 2 Diabetic Patients

The treatment of type 2 diabetes mellitus often requires the use of one or more hypoglycemic agents to reach the adequate glycemic control. The aim of the study is to evaluate the effects of a triple therapy with metformin, pioglitazone and sitagliptin on glycemic variability compared to metformin monotherapy, and compared to a combination of metformin and pioglitazone. To assess glycemic variability a continuous glucose monitoring system will be used.

In an estimated temporal space of about 3 years, 64 not well controlled, type 2 diabetic patients will be recruited.

Patients will be instructed to take metformin 500 mg three times a day for the first three months, then pioglitazone 15 mg twice a day will be added for further three months, and finally sitagliptin 100 mg once a day will be added for the last three months. At the baseline, and every three months a continuous glucose monitoring system will be performed.

At any stage of the study, if the value of glycated hemoglobin reach the desired goal (\<6.5%), participation in the study will be stopped and the patient will not be subjected to further adjustments of hypoglycemic therapy or additional continuous monitoring glucose.

After collection of written informed consent, the following data will be collected:

* History: type of diabetes, comorbidities, current medication, duration of diabetes and complications, voluptuary habits such as tobacco smoke (both number of packets/year and n° packets/day), alcohol consumption, coffee consumption, physical activity.
* Physical exam, general anthropometric parameters such as weight, height, circumference, body mass index, waist-hip ratio, and blood pressure.
* Assessment of glycemic variability every three months using a continuous glucose monitoring system.
* Collection of blood and urine samples to assess: glycated hemoglobin, fasting plasma glucose (FPG), post-prandial glucose (PPG), fasting plasma insulin (FPI), HOMA-index (HOMA-IR and HOMA-β), high sensitivity C-reactive protein (hs-CRP), total cholesterol, LDL-cholesterol, HDL-cholesterol, tryglicerides, lipoprotein (a) \[Lp(a)\], metalloproteinase-2 (MMP-2), metalloproteinase-9 (MMP-9), soluble adhesion molecules (sICAM-1, sVCAM-1), sE-selectin, adiponectin (ADN), complete urinalysis, 24-hour microalbuminuria.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic patients
* naive to therapy
* glycated hemoglobin \> 6.5 and \< 9.0 %

Exclusion Criteria:

* hepatic and renal diseases
* recent cardiovascular diseases
* previous pancreatitis
* history of cancer
Patterns of PTSD in Adult Patients After Intensive Care

This study aims to describe adult patients' patterns of Post-traumatic stress disorder (PTSD) at discharge, 3, and 12 months after intensive care.

The present study is a secondary analysis of the RAPIT-trial study treating data from patients on Post-traumatic stress disorder (PTDS) (Jensen et al., 2016).

Design Observational study based on data from the RAPIT trial that is a non-blinded, multicentre, parallel-group RCT conducted between December 2012-2015, at 10 intensive care units (ICUs) in four out of five regions in Denmark.

Participants Patients were consecutively recruited during the first 18 months of the study. We included Danish-speaking adults (≥18 years) who received mechanically ventilated ≥48 hours and did not meet the baseline criteria of dementia. We excluded delirious patients unable to give informed consent at randomization, or patients, who were enrolled in other studies. A total of 386 adult patients were randomized to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC).

Outcomes In this study, we will describe variations in patients, who experience symptoms of PTSD at ICU-discharge, 3 and 12 months after intensive care based on the data collection in the RAPIT-trial (Jensen et al., 2016). We will report trial participants' symptoms of PTSD at baseline, three months and twelve months after Intensive care using the Harvard Trauma Questionnaire (HTQ) supplemented with descriptions of patients' experiences of PTSD. Symptoms of anxiety and depression were collected at 3 and 12 months, and utilization of healthcare services including mortality were obtained from hospital charts combined with self-reported data from patients. We will use descriptive statistical methods to analyze data.

Symptoms of PTSD by HTQ-IV consisted of 17 items covering three core symptoms corresponding to DSM-IV criteria for PTSD: re-experience (5 items), avoidance (7 items), and arousal (5 items). This was supplemented by four additional items: one functional and three related to stress. We used a total score, and a cut-off of ≥40 is categorized as "positive PTSD". Symptoms of anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) covering two dimensions: anxiety (7 items) and depression (7 items); subscale scores were 0-21 with higher scores reflecting greater psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Non-invasive or invasive ventilation ≥ 48 hours ( Non-ivasive ventilation (NIV) from current guidelines)
* Undiagnosed dementia

Exclusion Criteria:

* Delirium at randomization (positive CAM-ICU score)
* Participations in scientific projects which include patient interviews
* Not speaking or understanding danish.
The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases. Phase 1 will use SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.' Phase 2 will evaluate the algorithms developed to estimate cardiac output from SimpleSense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.

Patients undergoing right heart catheterization for a clinical indication including but not limited to prognosis for advanced heart failure, during endomyocardial biopsy, candidacy for heart transplant or management of cardiogenic shock.

Study Design:

The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases. Phase 1 will use SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.' Phase 2 will evaluate the algorithms developed to estimate cardiac output from SimpleSense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.

Number of subjects and sites:

The Nanowear SimpleSense study will enroll up to 100 subjects to collect data at Westchester Medical Center. The testing will include a SimpleSense device recording and simultaneous measurement of Cardiac Output, and Pulmonary Artery Pressure by right heart catheterization.

Duration of study:

The duration of the Nanowear SimpleSense study is expected to be 1 year.

Study Population:

Subjects of legal age to give informed consent who are undergoing right heart catheterization for a clinical indication including but not limited to :

* Prognosis of advanced heart failure
* During endomyocardial biopsy
* Candidacy for heart transplant
* Management of cardiogenic shock

Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided informed consent
2. Male or female over the age of 18 years
3. The patient is undergoing right heart catheterization

Exclusion Criteria:

1. Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System.
2. Subjects who are pregnant
3. Severe aortic stenosis.
Effects of Oral Nutritional Supplements in Nursing Home Residents

Although oral nutritional supplements (ONS) are known to be effective to treat malnutrition in older persons, evidence from nursing home populations including demented residents is rare, especially with regard to functionality and well-being. A known barrier for ONS use among older persons is the volume that needs to be consumed, resulting in low compliance and thus reduced effectiveness.

Thus, this study aimed to investigate the effects of a new, low volume, energy- and nutrient-dense ONS on nutritional status, functionality and quality of life of nursing home residents with malnutrition or at risk of malnutrition.

In 6 nursing homes in Nuremberg and Fuerth, Germany, a standardized screening was performed to identify all residents with malnutrition or at risk of malnutrition who might possibly benefit from nutritional intervention. All subjects with either a Mini Nutritional Assessment (MNA®) score below 24 points, BMI ≤22 kg/m², a low food intake according to the nurses' perception or weight loss of ≥5% in the last 3 or ≥10% in 6 months, respectively, were invited to participate and asked for informed consent.

Eligible residents with informed consent were randomly assigned to the intervention group (IG) which received two bottles of the ONS per day (250 mL, 600 kcal) in addition to usual nutritional care or to the control group (CG) which received usual nutritional care only.

Assessment of nutritional parameters included body weight, BMI, arm- and calf-circumference and Mini Nutritional Assessment (MNA). Cognitive status, depression, activities of daily living, handgrip strength, gait speed and quality of life were examined using standardized instruments and protocols. All measurements and tests were performed at baseline, after 12 and 24 weeks.

Compliance and tolerance were documented daily by nursing staff and regularly controlled by the study team.

Statistical analysis was performed following the intention-to-treat (ITT) approach including all residents originally assigned to either the IG or CG unless residents died during the study. A sample size calculation was performed with body weight as the primary outcome parameter (0.8 power to detect a significant difference p\<0.05, two-sided) based on an estimated mean body weight 55 kg and a mean difference in body weight between the groups after 12 weeks of 1.5±2.2 kg comparable to results previously observed in this population. To detect a significant difference between IG and CG, 35 subjects were needed for each group. While sample size calculation aimed at ensuring adequate power to detect meaningful differences, the actual statistical analysis was of exploratory nature.


Eligibility Criteria:
Inclusion Criteria:

* nursing home resident
* Mini Nutritional Assessment (MNA®) score \<24 points or BMI ≤22 kg/m² or low food intake according to the nurses' perception or weight loss of ≥5% in the last 3 or ≥10% in 6 months
* informed consent

Exclusion Criteria:

* anticipated hospital stay (\>1 week)
* renal disease (dialysis)
* end-stage disease
* intolerance to ONS according to previous attempts to administer these
Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function

This study aims to investigate the effects of a single dose of the glucagon-like 1 receptor agonist semaglutdie/Rybelsus on the hypothalamo-pituitary-adrenal axis, thus cortisol levels and other stresshormones in healthy males.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18-60 years
* BMI 18.5-30 kg/m2
* No regular medication

Exclusion Criteria:

* participation in a trial with investigational drugs within 30 days
* vigorous physical exercise within 24 hours before the study participation
* alcohol intake within 24 hours before the study participation
* a history of intake of glucocorticoids or GLP-1 RA within the last 8 weeks.
* Known allergy towards GLP-1 RA
Evaluation of Plant-based Nutritional Products on Stem Cells

The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design.

The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design. The research involves testing of acute effects of single doses of antioxidant-rich berry-based extracts, compared to a placebo. Blood samples are taken at baseline and 1 and 2 hours after consuming a single dose. The blood will be used to measure the numbers of different types of stem cells, to evaluate potential effects of stem cell mobilization and homing after consuming plant-based extracts. Adult stem cells are a type of cells that play a role in repairing and rejuvenating various tissue and organs in the body. At NIS Labs, we have shown that many types of plant-based nutritional products have small but reproducible and significant effects on stem cells, cytokines, and regenerative growth factors.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 20-75 years of age;
* Body weight higher than 110 pounds;
* BMI below 35;

Exclusion Criteria:

* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem);
* Currently taking daily OTC medications, such as NSAIDs, Tylenol, allergy medications, and others (birth control and 81 mg aspirin not a problem);
* Taking medications that affect the mind (such as anti-depressants) or nervous system (such as gabapentin);
* Currently experiencing intense stressful events and life changes;
* Actively depressed;
* Experiencing sleep disturbances;
* Working night shift;
* Pregnant, nursing, or trying to become pregnant;
* Food intolerances or allergies currently causing discomfort (such as Celiac's disease), due to ongoing inflammatory reactions that may negatively affect product absorption within the 3 hours of testing;
* Food allergies related to ingredients in test product.
Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates

Newborn infants experience pain after surgical procedures,prevention and management of pain in neonates is important due to its deleterious consequences. Fentanyl is a widely used analgesic which promotes rapid analgesia,however, is not free of adverse effects including chest wall rigidity, hypothermia, hypotension, respiratory depression and tolerance.Dexmedetomidine is a selective α 2-adrenergic agonist can cause sedation, anxiolysis, analgesia and minimal respiratory depression.Therefore, the objective of the study is to evaluate the safety and efficacy of dexmedetomidine compared to fentanyl in postoperative mechanically ventilated neonates.

A prospective, randomized trial, which was conducted upon neonates who needed postoperative mechanical ventilation in Neonatal Intensive Care Unit, Mansoura University Children's Hospital.The patients were randomized to two groups according to the drug they received for postoperative sedation. The first group received dexmedetomidine infusion and the second group received fentanyl infusion.Our primary outcome was the efficacy of postoperative sedation score, and the secondary outcomes were plasma cortisol level, time to extubation, time to reach 100ml/kg enteral feed, need for adjuvant sedative and skeletal muscle relaxant, length of the hospital stay, side effects of sedative drugs and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Neonates need postoperative ventilation.

Exclusion Criteria:

1. Major congenital cardiovascular anomalies.
2. Chromosomal anomalies.
3. Grade IV intraventricular hemorrhage.
4. Tracheoesophageal fistula with wide gap (distance between proximal and distal end more than two centimeters).
The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly

The primary objective of this investigation was to evaluate \& compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA.

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components.

Using RSA, is it possible to evaluate the performance of both the all polyethylene and metal backed tibia components to determine whether there are differences in migration, if present, across the tibial components.

The original protocol intended to perform clinical assessment using the Nottingham Knee Score and the Knee Society Clinical rating system pre-and post-operatively, at six months, 1 year, and annually thereafter. Per Protocol Amendment 01 (effective June 18, 1999) clinical data would also be collected via the SF-12 questionnaire. Radiological evaluation would also use the Knee Society scoring system at the same time points. However, data collected included only the SF-12 and Oxford Knee Scores, comparing change from baseline at 6, 12, and 24 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects requiring a primary knee replacement.
* Subjects aged 65 years or more.
* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
* Subjects with a primary diagnosis of osteoarthritis or rheumatoid arthritis.

Exclusion Criteria:

* Subjects who have had a previous surgery of the operative knee except menisectomy and arthroscopy.
* Subjects who have had a renal transplant.
* Subjects with a metabolic bone disorder.
* Subjects who, in the opinion of the Clinical Investigator, have an existing condition, e.g. Paget's disease etc. that would compromise their participation and follow-up in this clinical investigation.
* Subjects whose contralateral knee is already included in this study.
* Subjects who have a history of active joint sepsis.
* Subjects who have a recent history of high dose systemic corticosteroids.
* Subjects with psycho-social disorders or physical disabilities that would limit rehabilitation.
* Subjects requiring a bone graft.
Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects

This will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects.

Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8 (168 hours post dose). On Day 1, subjects will receive a single oral dose of \[14C\]-CYC065. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥90% mass balance recovery, and ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site until all discharge criteria are met up to a maximum of Day 15.

Eligibility Criteria:
Inclusion Criteria:

1. Males, of any race, between 18 and 55 years of age, inclusive.
2. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, with a total body weight ≥50 kg.
3. In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
4. Males will agree to use contraception.
5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
6. History of a minimum of 1 bowel movement per day.

Exclusion Criteria

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
3. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
4. Confirmed (eg, 2 consecutive measurements) systolic blood pressure \>140 mmHg or \<90 mmHg, diastolic blood pressure \>90 mmHg or \<50 mmHg, and pulse rate \>100 beats per minute or \<40 beats per minute.
5. Positive hepatitis panel and/or positive human immunodeficiency virus test.
Velphoro and Impact on the Oral Cavity and Gut Microbiome

This pilot study will be carried out to determine if the regular intake of iron-based Velphoro® by hyperphosphatemia patients influences the microbiome in the oral cavity and/or the gut.

The aim of this study is to investigate potential changes in the microbiome of the oral cavity and/or gut in patients with hyperphosphatemia following Velphoro® intake for one month. The principal intention of this study is to assess consequences of Velphoro® medication beyond phosphate control. Adherence to the drug might be compromised by e.g. staining of teeth and biofilm after chewing the product more than recommended. Most likely this is a cosmetic problem only and easy to solve by optimizing oral hygiene. The increased level of iron may have an effect on the gut microbiome which could lead to mild diarrhoea. However, the present study will assess, whether the microbiome both oral and gut changes significantly due to some iron bio-availability, although this is expected to be low with sucroferric oxyhydroxide.

The ultimate goal is to improve patient adherence to the drug and to resolve potential safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Suffering from hyperphosphatemia
* Current treatment with a stable dose of a non-iron containing phosphate binder,
* No or only parenteral iron application
* Age of ≥ 18 years
* Written informed consent prior to study participation
* The subject is willing and able to follow the procedures outlined in the protocol

Control group:

* Normal renal function
* No hyperphosphatemia
* Age- and sex-matched and oral disease status-matched (dental caries and periodontal disease) in comparison to the hyperphosphatemia group
* Written informed consent prior to study participation
* The subject is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

* Age less than 18 years
* Currently on oral iron application
* Antibiotic treatment within the last two months
* Severe medical events within the last three months
* Planned surgery for the duration of the sampling
* Acute/chronic gastrointestinal infections
* Smokers
* Oral candidiasis
* Oral cancer
* Pregnant and lactating females
* Haemochromatosis history
* Committed to an institution by legal or regulatory order
* Participation in a parallel interventional clinical trial
* Receipt of an investigational drug within 30 days prior to inclusion into this study
* The subject is mentally or legally incapacitated

Only for the patient group:

* Never got any phosphate binder
* Allergy to Velphoro®
* Celiac disease or any other chronic inflammatory bowel disease
* Previous major surgery in the gastrointestinal tract