cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Duration of diabetes for at least 12 months
* Current treatment with human insulin or insulin analogues for at least 6 months
* BMI equal to or below 35 kg/m2
* HbA1c equal to or greater than 10.0 %
* No clinically significant cardiovascular event as judged by the Investigator within the last 6 months prior to the study

Exclusion Criteria:

* History of any illness that, in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the trial products to the subject
* Current treatment with systemic corticosteroids
* Any positive reaction of drug of abuse or alcohol screen
* Cardiac problems defined as: decompensated heart failure and/or angina pectoris
* Uncontrolled treated/untreated hypertension as judged by the Investigator or blood pressure \> 180 mm Hg systolic and/or \> 110 mm Hg diastolic
* Known or suspected allergy to trial product or related products
* Blood donation of more than 500 ml within the last 12 weeks
* The receipt of any investigational drug within 4 weeks prior to this trial
NTX Wireless Patient Monitoring System

* Determine the accuracy of the NTX wireless monitoring system alerts
* Evaluate patient compliance with wearing device
* Determine false alarm rates

Approximately 150 patients will have wireless monitors attached to their arm. They will have their vital signs filtered through software that generates alerts and records data. The alert engine will produce pager and application based pop-up alerts which will be sent to the research nurse. Low and high limit alarms will be set according to the published guidelines (Hillman, K. et. Al., Resuscitation 48(2): 105-10, 2001) and adjusted at will by the response team.

During this portion of the study, the following research related procedures will be performed:

* begin continuous vital signs monitoring (BP - 1x per hour, 3 lead ECG -continuous, HR - continuous, SpO2 - continuous)
* PI or Co-PI will review each alert that's generated. The clinical significance will be determined and recorded in the study database
* Record patient's signs and symptoms daily
* Assess concomitant
* Assess AE's, SAEs

Eligibility Criteria:
Inclusion Criteria:

* Ability to give written informed consent
* Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing
* Patients must be ≥18 years of age

Exclusion Criteria:

* ICU patients
* Female subjects who are pregnant
* Patients \< 18 years of age
* Patients that have a contradiction for continuous Blood Pressure monitoring
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic

The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.

Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants
* Subjects appropriate for gestational age between 35 and 41 weeks
* Subjects between 15-60 days old
* Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week)
* Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)
* Subjects exclusively bottle-fed at study entrance
* Day care of the child only by mother/father
* Provide written informed consent in accordance with legal requirement

Exclusion Criteria:

* Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)
* Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis)
* Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period
* Subjects receiving formula for special medical purposes
* Exclusively breast-fed infants
* Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion
* Allergic diseases (manifest atopic dermatitis, cow's milk allergy)
* Participation in any other clinical intervention
The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs

The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception.

Thirty adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week. A familiarization session will also occur one week before starting the treatment period. Each subject will undergo a series of tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). The exercise trial will consist of sets of dumbbell wall squats performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the supine limb occlusion pressure (LOP) with 1-minute rest intervals. Assessments will be performed immediately before and after the exercise bout during each treatment session. Two-way ANOVAs will be used to examine the main effects of treatment and treatment-order interaction on pulse wave velocity, muscle cross-sectional area, and perceptual response.

Eligibility Criteria:
Inclusion Criteria:

1. Physically active (\> 1,000 MET/min/wk) for at least six months.
2. Weight stable for previous 6 months (+/-2.5 kg)
3. Female subjects only- reported regular menstrual cycles for the last 2 years

Exclusion Criteria:

1. BP\>140/90 mmHg
2. BMI\>40 kg/m2
3. Diabetes
4. Familial hypercholesterolemia
5. Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
6. Women must not be pregnant, plan to become pregnant during the study, or be nursing
7. Active renal or liver disease
8. All medications and supplements that influence dependent variables\*
9. Recent surgery \< 2 months
10. Alcohol abuse
11. Sleep apnea
12. Claustrophobia
Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy

Optimal fluid balance is critical to minimize anastomotic edema in patients undergoing pancreaticoduodenectomy. This study examined the effects of decreased fluid administration on rates of postoperative pancreatic leak and delayed gastric emptying.

Retrospective study of 10564 patients undergoing pancreaticoduodenectomy at a single institution from January, 2015 through July, 2016. Stroke volume variation (SVV) was tracked and titrated during the procedure.

All patients were seen preoperatively in the department clinic setting, and indications for pancreaticoduodenectomy were for pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign. benign and malignant disease.

Patients were excluded if they had any of the following during surgery: venous resection and reconstructive involving the portal venous system; estimated blood loss exceeding two liters; high dose steroid administration; use of irreversible electroporation for margin enhancement; lack of SVV equipment or inconsistent SVV recordings; use of the robotic surgical system.

Primary outcomes measures were recorded for each patient were: pancreatic leak and delayed gastric emptying. Pancreatic leak was defined according to the international study group for pancreatic fistulas: "an external fistula with a drain output of any measurable volume after postoperative day three with an amylase level greater than three times the upper limit of the normal serum value." Delayed gastric emptying was defined clinically as persistent postoperative emesis requiring nasogastric tube placement, prokinetic agents, or hospital readmission for endoscopic gastrostomy placement.

A comparative analysis of postoperative complications was performed between patients with a median SVV \< 12 during the extirpative and reconstructive phases of the procedure compared with patients with an SVV \> 12. The investigators chose an SVV value of greater than 12 to represent a "dry" state because previous studies have shown that this value represents decreased fluid administration.

Eligibility Criteria:
Inclusion Criteria:

• pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign lesion

Exclusion Criteria:

* venous resection and reconstructive involving the portal venous system
* estimated blood loss exceeding two liters
* high dose steroid administration
* use of irreversible electroporation for margin enhancement
* lack of SVV equipment or inconsistent SVV recordings
* use of the robotic surgical system
Mechanisms and Treatment of Exercise Intolerance and Persistent Fatigue in Spinal Muscular Atrophy

This study will focus on the pathophysiological underpinnings of reduced exercise capacity and fatigue in ambulatory patients with spinal muscular atrophy (SMA). There has been laboratory evidence to suggest that the molecular mechanisms underlying mitochondrial biogenesis may be vulnerable to survival motor neuron (SMN) protein deficiency. This is an observational, single visit study including 34 ambulatory SMA patients treated with SMN repletion therapies (risdiplam or nusinersen) for at least 6 months at enrollment.

SMN depletion affects muscle mitochondria and thus muscle function as a result. The relationship between these and their effect(s) on fatigue in the context of SMN repletion treatment has not been evaluated. If muscle function is vulnerable to SMN insufficiency, treatment strategies targeting muscle in addition to the central nervous system (motor neurons) may ameliorate fatigue and improve exercise capacity, thereby improving quality of life and bringing SMA treatments closer to a cure. This project explores such an idea by comparing the effects of the two different SMN repletion modalities in patients. This is an observational cross-sectional study involving ambulatory SMA children and adults treated for at least 6 months with SMN repletion therapy, either (1) systemically with risdiplam, or (2) intrathecally (central nervous system-only), with nusinersen.

Eligibility Criteria:
Inclusion Criteria:

* Genetic confirmation of SMA with laboratory documentation of homozygous deletion of survival motor neuron (SMN1) exon 7;
* At least 8 years of age at time of signing Informed Consent Form (or assent)
* Children or adults currently receiving treatment, for at least 6 months, with SMN repletion therapy, either with

  (1) risdiplam, or (2) nusinersen
* Able to walk independently at least 25 meters
* Able to tread a stationary cycle ergometer.

Exclusion Criteria:

* Unable to walk 25 meters independently.
* Use of investigational medications intended for the treatment of SMA within 30 days prior to study entry.
* The presence of any contraindication to exercise according the American College of Sports Medicine (ACSM) criteria.
Non-pharmacological Treatment of Insomnia in Nursing Homes.

The study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians.


Eligibility Criteria:
Inclusion Criteria:

* Male and female nursing home residents of age 55+ with insomnia, defined as difficulty in getting to sleep, difficulty in staying asleep, early wakening, or non-restorative sleep

Exclusion Criteria:

* insufficient cognitive ability for self-reflection
* dementia
* insomnia caused by a medical disorder (hyperthyroidism, congestive heart failure, peripheral arterial disease, GORD, COPD/asthma, angina pectoris, benign prostatic hyperplasia, arthritis, other
* insomnia caused by medication
* substance misuse
* other sleep disorder: restless legs syndrome, periodic limb movement disorder, sleep apnoea, narcolepsy
* psychiatric disorder: psychotic or bipolar disorder in anamnesis, major depression present or more than 2 episodes in anamnesis
* short stay
Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH

The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension..


Eligibility Criteria:
Inclusion Criteria:

* essential hypertension
* left ventricular hypertrophy
* under candesartan treatment

Exclusion Criteria:
Effectiveness of Team Treatment of Depression in Primary Care

Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.

Background:

Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.

Objectives:

This effectiveness study adapted collaborative care to the VA primary care setting ("collaborative care") and compared it with consult-liaison care ("CL care").

Methods:

Patients within a VA primary care clinic were randomly assigned by firm to the two interventions.

In collaborative care, existing staff resources were reorganized to form a multidisciplinary mental health specialist team. The team developed a treatment plan based on an initial assessment and suggested the plan to the primary care provider. Primary care providers' treatment efforts were then supported by brief Social Work telephone calls designed to support adherence and monitor symptomatology. Treatment results were systematically reviewed and suggestions for treatment modification were fed back to the primary providers. In CL care, the primary care providers were informed of the diagnosis and study clinicians facilitated referrals to Psychiatry residents in-clinic as requested. Mailed and in-clinic surveys and provider referral were used to recruit 168 collaborative care and 186 CL care patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, or had primary alcohol abuse. Outcome data on the SCL-20 depression symptomatology measure, Veterans SF-36, and Sheehan Disability Scale were collected at baseline, 3 and 9 months. VA utilization and costs of care were analyzed.

Status:

Complete. Final Report submitted June 30, 2001.

Eligibility Criteria:
Inclusion Criteria:

Several screening methods including mailed and in-clinic surveys and provider referral were used to recruit 168 team and 188 CL study patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, had primary alcohol abuse, or were too impaired to participate in the screening interview. Outcome data on the SCL-20 depression symptomatology measure, SF-36V, and Sheehan functional impairment measure were collected at baseline, 3 and 9 months.

Exclusion Criteria:
Air Q Laryngeal Airway Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation

The study aims to compare the efficacy of the Ambu AuraGain to that of the Air Q ILA as a conduit for endotracheal intubation assisted by tube exchanger. The comparison will be in terms of total intubation time, success rate of insertion of the tube exchanger as well as endotracheal intubation and complications.

Very few studies discussed assisted endotrachealc intubation using certain tools as bougie through the Air Q ILA .

the hypothesis in this study is that the use of flexible, small calibre tube exchanger introduced through both supraglottic devices into the trachea as guidance for endotracheal intubation, will have shorter intubation time with the Ambu AuraGain than the Air Q ILA and less complications in both devices.

Eligibility Criteria:
Inclusion Criteria:

* Age : 18 to 60
* ASA physical status 1 and 2
* body weight less than 90 kilos
* Ganzouri airway score less than or equal to 3.

Exclusion Criteria:

* Active respiratory or cardiac disease
* Any expected airway difficulties
* Craniofacial abnormalities or fractures
* patients with abnormal coagulation profile
Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.

The purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS).


Eligibility Criteria:
Inclusion Criteria:

* PCO - ESHRE/ASRM criteria:oligomenorrhea (\<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone \> 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study
Ketones for Pulmonary Hypertension - Effects on Hemodynamics

In the present study, patients with idiopathic pulmonary hypertension (IPAH) and chronic thromboembolic pulmonary hypertenion will be investigated in a randomized cross-over design with ketone infusions and placebo. Invasive and non-invasive hemodynamics will be evaluated

Pulmonary hypertension (PH) is a debilitating disease that affects both the pulmonary vasculature and the heart. It is associated with increased mortality and hospitalization and impairs daily life for the affected patients. Despite substantial advances in treatment within the past decade the prognosis remains poor with an 1-year mortality of more than 10%.1 The pathophysiology of PH is multifactorial and can be caused by left sided cardiac disease, pulmonary pathophysiological changes in the pulmonary vessels, respiratory diseases and pulmonary embolism.The treatment is targeted at the underlying cause. Hence, left sided heart disease is treated with anticongestive medications4 and respiratory disease by pulmonary medications. However, pulmonary vascular diseases such as chronic thromboembolic pulmonary hypertension (CTEPH) and idiopathic pulmonary arterial hypertension (IPAH) are treated with pulmonary endarterectomy and vasodilators targeting the pulmonary vasculature, respectively. However, not all patients have an optimal pulmonary hemodynamic response on treatment. If patients are left with persistent pulmonary hypertension the disease may progress further and cause right heart failure which worsens the prognosis.

Data from a recent study conducted at the investigator's institution demonstrated 40% increase in cardiac output during infusion of the ketone body 3-hydroxybutyrate (3-OHB). Intriguingly, this was associated with an increase in RV function and a decrease in the pulmonary vascular resistance of approximately 20%.

In the present study, 10 patients with IPAH and 10 patients with CETPH will be subjected to placebo and 3-OHB infusion in a randomized cross-over design. Each of the infusions will be given for 2.5 hours and cross-over will be carried out on the same day. Echocardiography and right sided heart catheterization will be applied and blood will be sampled.

Eligibility Criteria:
Inclusion Criteria:

* Persistent pulmonary hypertension (defined as PVR \> 3 WU, pulmonary capillary wedge pressure (PCWP) \< 15 mmHG, mean pulmonary arterial pressure (mPAP) ≥25 mmHg) on the most resent right heart catheterization.
* Preserved left ventricular ejection fraction (\<50%) on most recent echocardiography
* Able to give informed consent

Exclusion Criteria:

* Other Significant pulmonary, mitral or aortic valve disease
* Other disease or treatment making subject unsuitable for study participation