cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia

Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female, aged ≥18 and \<50.
* The subject is in good general health with no evidence of any medical problems.
* The subject is fluent in both written and spoken English.
* The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

* The subject is obese (BMI\>30).
* The subject has a known history of heart disease, lung disease, kidney or liver disease.
* Diagnosis of asthma, sleep apnea, or use of CPAP.
* Subject has diabetes.
* Subject has a clotting disorder.
* The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
* The subject has any other serious systemic illness.
* The subject is a current smoker.
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
* The subject has a history of fainting or vasovagal response.
* The subject has a history of sensitivity to local anesthesia.
* The subject has a diagnosis of Raynaud's disease.
* The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
* The subject is pregnant, lactating or trying to get pregnant.
* The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
* The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Clinical Investigation to Assess the Clinical Performance of the LumbaCure® Intervention on Chronic Low Back Pain Patients.

Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading cause of years lived with disability from 1990 to 2017. The highest incidence of LBP is in people in their third decade of age. LBP is a complex disease difficult to treat as most of these cases (80 - 90 %) are classified as non-specific meaning that the pain cannot be attributed to any specific injury or pathology.

Until now exercise therapy is commonly used as the treatment of choice in the revalidation program of LBP. The aim of physical treatment is to improve function and prevent disability from getting worse.

LumbaCure® is a robotic system driven by a proprietary movement algorithm to induce a specific and controlled mobilization of the hips and the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain.

The investigation include an intervention period of 4 weeks The main objective is to compare the impact on disability (Oswestry disability Index) and movement performance of the interventions (LumbaCure® vs physical exercises supervised by the physiotherapist) in two parallel groups of patients suffering from chronic low back pain.

The investigation includes an intervention period of 4 weeks and a follow-up period of 6 months (post intervention period).


Eligibility Criteria:
Inclusion Criteria:

* Chronic non-specific LBP (without red flag)
* Patient did not increase, on a long-term basis, his/her regular physical activity in the past 2 months.
* LBP is the principal musculoskeletal condition
* Aged between 18 and 65 years old
* Able to read and understand questionnaires and communicate with the physiotherapist.
* Average Back Pain intensity over the last week above 2, assessed on Numerical Pain Rating Scale from 0 to 10 anchored with "no pain" at 0 and "worst pain imaginable " at 10.
* ODI score \> 20

Exclusion Criteria:

* Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ....)
* Radicular pain
* Radiculopathy
* Cognitive impairment that precludes participant from consenting, completing investigation questionnaires or complying with recommendations
* Previous spine surgery in the last 3 months
* Pregnant women
* body weight \> 120 kg
* Neurological disease
* Fibromyalgia
A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent.
* Subject who is considered to be generally healthy (with the exception of conditions associated with diabetes mellitus), based on the medical history, physical examination, and the results of vital signs, ECG and laboratory safety tests, as judged by the investigator.
* Body mass index between 20.0 and 34.9 kg/m\^2 (both inclusive).
* Type 2 diabetes mellitus (as diagnosed clinically) for ≥12 months (365 days).
* No change in insulin treatment regimen during the last 90 days prior to screening.
* Current total daily insulin treatment between 0.3 and 1.0 (I) U/kg/day (both inclusive).

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products.
* Female who is pregnant, breast-feeding, or intending to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by regulation or practice)(highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation,hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner). Females who are not postmenopausal can participate in the study if they use adequate contraceptive methods. Postmenopausal is defined as women aged \<52 years and being amenorrheic for more than one year with serum follicle stimulating hormone (FSH level \>40 IU/L or aged ≥ 52 years and being amenorrheic for less than one year and with serum FSH level \> 40 IU/L or aged ≥ 52 years being amenorrheic for more than one year.
* Receipt of any investigational medicinal product within 3 months before the screening visit of this trial.
* History of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator.
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days.
* Use of oral antidiabetic drugs (OADs) or GLP-1 receptor agonists (e.g. exenatide, liraglutide) within 3 months prior to screening.
The Tryptophan Requirement in Healthy Adults

The aging population is growing rapidly. For the first time ever, Canadian seniors outnumbered young adults in 2016. Aging is associated with many physical and metabolic deteriorations including the loss of muscle mass and strength, insulin resistance, increased inflammation and oxidative stress.

The muscles of our bodies are composed of proteins and proteins are made of small building blocks called amino acids. Our bodies have the ability to make some amino acids which are called the non-essential amino acids. However, there are certain amino acids that our body's need to make protein but can only be supplied from the foods that we consume. These are called essential amino acids. Tryptophan is one of the essential amino acids that the body needs. Tryptophan is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. Therefore, there may be a need for more threonine in the diet of older adults. However, the current requirement for threonine is based on studies conducted exclusively in young adults. Thus, the purpose of this study is to find out how much tryptophan older adults need.

Tryptophan is an essential amino acid and must be obtained from the diet. It is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. It is of particular importance in the diet of people who receive a large percentage of their calories from cereal grains such as maize, as it is limiting in tryptophan. Therefore, accurate knowledge of tryptophan requirement is important for dietary planning particularly for older adults. In 1998, our lab determined the tryptophan requirement in young women to be 4.01 mg/kg/day, with a safe intake at 5 mg/kg/day, using the Indicator Amino Acid Oxidation method. Since then, the investigators have determined the tryptophan requirement and safe level in healthy school-age children to be 4.7 and 6 mg/kg/day. The investigators have recently found the requirements of essential amino acids such as leucine and total sulfur amino acids in older adults and have found to be higher than young adults and a difference between the sexes. Thus, there is a need to determine the threonine requirement in older adults.

Eligibility Criteria:
Inclusion Criteria:

* Consent provided.
* Aged 60 to 90 years old.
* In good general health as evidenced by medical history, physical health and blood draw.
* Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine.
* Willingness to participate in the study.
* BMI \<30 kg/m2.

Exclusion Criteria:

* Presence of chronic disease and/or acute illness known to affect protein/amino acid metabolism (e.g. HIV, diabetes, taking medications known to affect protein/AA metabolism (e.g. steroids).
* Inability to tolerate the diet (i.e. allergy).
* Significant weight loss during the past month or consumption of weight reducing diets.
* Significant caffeine consumption (\>2 cups per day).
* Significant consumption of alcohol (\>1 drink per day i.e. 1 beer or ½ glass of wine).
* Unwilling to have blood drawn from a venous access or using a ventilated hood indirect calorimeter for the purposes of the study.
Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain

Background and Purpose: The purpose of the study is to test the efficacy of an audio-visual stimulation program for sleep promotion in adults with chronic pain. The hypothesis is that hyper-arousal plays an important role in insomnia. Brainwave entrainment from 8 to 1 Hz reduces arousal, and thereby improves sleep. Improved sleep may change how people perceive pain.

Methods: Using a double-blind, randomized controlled trial design, we plan to enroll 30 adults (21-65 years old) experiencing both nonmalignant pain and insomnia. Exclusion criteria include: seizure disorder, sleep disorder, and night shift workers. After a one-week baseline measure, participants will be randomized to intervention or placebo group. Participants in both groups will be asked to self-administer the audio-visual stimulation program every night at bedtime for one month. Upon completion, post intervention measures will be collected.

Background: The purpose of this pilot study was to test the efficacy of an open-looped Audio-visual Stimulation program (AVS) for sleep promotion in older adults with osteoarthritis pain. In this study, the AVS program was tested in a randomized controlled design. Specifically, this pilot study examined a 30-minute audio-visual stimulation program that gradually ramped from 10 Hz down to 2 Hz, to be used at bedtime for delta brainwave induction, in a randomized controlled design. The placebo control AVS program consisted of 30-minutes of constant dim light that slowly changed in color, and a steady monotone at ultra-low (\<1 Hz) frequency (outside of the entrainment range).

Method: A total of 30 older adults (mean age 68 ± 5.1, 90% women) with comorbid insomnia and osteoarthritis pain participated in this 2-week study. Participants were randomly assigned to either AVS active program or AVS placebo control program. After the baseline assessment (which included questionnaires \[sleep, pain, depression\], and quantitative electroencephalogram (QEEG) during AVS induction), participants were asked to self-administer their group specific AVS program nightly at bedtime for two weeks. Post-treatment questionnaires (sleep, pain, depression) were then collected.

Eligibility Criteria:
Inclusion Criteria:

* 60 years or older
* Having difficulty sleeping over the past three months (Insomnia Severity Index ≥ 8)
* Having osteoarthritis pain (Brief Pain Inventory Worst pain ≥ 4)

Exclusion Criteria:

* Working night shift
* Previously diagnosed with a primary sleep disorder (Sleep Apnea or Restless Leg Syndrome).
* Seizure disorder
* Photosensitivity
* Dementia
* Diagnosis or other significant chronic illness beyond OA that would impact sleep
* Severe psychiatric disorder including a history of or current diagnosis of psychosis
Postpartum Thyroid Measures and Mood

Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more likely than their normal counterparts to have higher scores on a common postpartum depression screening test.

This small pilot study was an attempt to corroborate a relationship between quantified mood and thyroid measures, using the numerical scores obtained from a common depression screen, the Edinburgh Postnatal Depression Scale (EPDS), as a continuum. Mood scores were compared with presence of thyroid autoantibodies and plasma concentrations of free T4 and TSH.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* In third trimester of pregnancy when recruited
* Negative for the following drugs detected by a urine drug screen:

  * Amphetamines
  * Barbiturates
  * Benzodiazepines
  * Cocaine
  * Opiates
  * Phencyclidine metabolites (PCP), and tricyclic antidepressants
  * Vaginal delivery
  * Screened negative for major depressive disorder on the Edinburgh Postnatal Depression Scale (EPDS) at her prenatal enrollment in the study
  * Receiving a score of 12 or lower out of a possible 30

Exclusion Criteria:

* Under age 18
* Positive for any of the following drugs:

  * Amphetamines
  * Barbiturates
  * Benzodiazepines
  * Cocaine
  * Opiates
  * Phencyclidine metabolites (PCP), and tricyclic antidepressants
  * Cesarean delivery
  * EPDS score over 12 at prenatal screening test
Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia

This study is performed to determine the efficacy of ultrasound-guided fascia iliaca compartment block during positioning for spinal anaesthesia in patient undergoing repair of proximal femur fracture surgery comparing with intravenous fentanyl.

This a prospective, single-blind, randomized control study that compare the efficacy of ultrasound-guided fascia iliaca compartment block with intravenous fentanyl in positioning patient with femur fracture for spinal anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) score I and II
* Elective surgery of repair of unilateral, single femoral fracture under spinal anaesthesia performed in General Operation Theatre, Hospital Kuala Lumpur. The fracture may involve femoral neck or femoral shaft.

Exclusion Criteria:

* Patient with contraindication for spinal anaesthesia
* Known hypersensitivity or contraindication to medication used in this study
* Morbid obesity (body mass index (BMI) \> 35 kg/m2)
* Infection at the intended site of administration of fascia iliaca compartment block
* Patient with impaired cognitive function
Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

In response to the evidence supporting "tight" glucose control (70 - 110) in the critical care setting, the MMH ICU developed a protocol utilizing regular intravenous insulin. This protocol was initiated in 2002. Monitoring of the data collected revealed effective glycemic control when this protocol was used. However, limited utilization has led to overall ineffective glycemic control in this ICU. The poor utilization is largely due to a general reluctance of physicians to start their patients on an intravenous insulin infusion. As contributing to this poor compliance is the "open" nature of the ICU. The MMH ICU is an "open" ICU, meaning that many physicians across multiple subspecialties admit to this unit. Approaches to controlling hyperglycemia vary greatly, depending largely upon the treating physician. In an attempt to improve overall glycemic control in this "open" ICU, the Subcutaneaous Insulin Aspart Hyperglycemia Protocol (SIAP) was developed which incorporates a subcutaneous insulin aspart regimen that triggers the use of a regular insulin infusion protocol when the SIAP is not adequately controlling the patient's blood glucose.

This study aims to evaluate 1) the effect the SIAP on overall glycemic control in the ICU, 2) the effectiveness that the SIAP has on controlling blood glucose as compared with past practices using regular insulin, and 3) the effect the SIAP has on patient complications and outcomes in the MMH ICU.


Eligibility Criteria:
Inclusion Criteria: Valid physician order of the protocol. -

Exclusion Criteria: No valid phycician order for the protocol

-
Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events

To collect tumor tissue from patients with liver masses suspicious for primary liver cancer. The research biopsy will be used to identify biomarkers in future studies.

In this study patients are referred to the Department of Radiology for an image-guided (either CT or ultrasound) core needle biopsy of a liver mass suspicious for primary liver cancer as a part their clinical care. A written informed consent will be obtained for the clinical biopsy per standard protocol. Additional core biopsy of the liver mass will be performed for research purposes at the time of the clinical care biopsy. The additional research biopsy is not mandatory and is subject to a separate written informed consent, which will be obtained prior to the clinical biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned as a part of clinical care
2. Age ≥ 18 years.
3. ECOG performance status 0-2
4. Adequate organ and marrow function as defined below:

   INR ≤ 1.5 platelets ≥ 70,000/mcl
5. Ability to understand and the willingness to sign a written informed consent
6. Target liver mass not subcapsular in nature as determined by the participating biopsy team
7. Child Pugh Turcotte score A or B

Exclusion Criteria:

1. Previous treatment for HCC
2. Any contraindication for clinical-care liver biopsy, including anti-coagulation therapy that cannot be discontinued prior to biopsy or large volume ascites
Data Collection for Pacemaker Recognition Through Capacitive ECG

This study evaluates the signal quality of capacitive ECG (cECG) on pacemaker patients and whether paced rhythms of the pacemaker can be distinguished from the normal beats using cECG signals.

In contrast to classical gold-standard ECG, cECG electrodes can sense the electrical activity of the heart even over the clothing of the subject, which allows several applications in out-of-hospital monitoring. The proposed scenarios for cECG revolve around the unobtrusiveness of the measurement with an inferior signal quality to gold standard ECG. The electrical spikes, that come into existence due to the paced rhythms given by a pacemaker, are only visible in ECG signals recorded by adequate medical instrumentation. Whether cECG can deliver enough signal quality to identify the electrical spikes of the paced rhythms needs to be investigated by recording simultaneous normal and capacitive ECG signals.

Eligibility Criteria:
Inclusion Criteria:

* Subject has an implanted pacemaker
* Subject is under ambulatory or stationary treatment in Uniklinik RWTH Aachen
* Subject gives his/her written consent
* Subject is legally and mentally competent to follow the instructions

Exclusion Criteria:

* Subject has other electrically active implants
* Cardiopulmonary or hemodynamically unstable subjects
* Subject is placed in a judicial institution
* Subject is in a dependency or employment relationship with the examiner
* Subject is legally or mentally unable to give consent for the participation
The Effect of Diuretics on Mineral and Bone Disorder in Chronic Kidney Disease Patients

Chronic kidney disease (CKD) patients often have associated systemic hypertension due to volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in this population. One of the major complications of CKD is mineral and bone metabolism disorder (CKD-MBD), which include changes in the levels of calcium, phosphorus, vitamin D deficiency, increased circulating levels of fibroblast growth factor (FGF-23) and parathyroid hormone (PTH). These alterations are responsible for fractures, cardiovascular disease and mortality among patients with CKD. According to diuretic mechanism of action, sometimes increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of thiazide), it is expected that the serum calcium may be altered, even within the range of normality, with consequent impact on the levels of PTH. Although most studies have shown that the use of thiazide diuretics decreases the risk of fractures, some showed the opposite. Similarly, although most studies have shown increased risk of fracture in association to loop diuretics use, some have failed in demonstrated this outcome. Only one study, a cohort study in a population of CKD, showed that furosemide was directly related to increased calciuria and PTH levels and the use of thiazide, in turn, showed completely opposite effect. However, certain issues are still not completely solved, for example, the interference of renal function itself on calciuria. It is possible that calciuria is not a so simple explanation that justifies the PTH levels changes, as no correlation was seen between calciuria and PTH levels. Better understanding of the exact relationship between the use of diuretics and the impact on CKD-MBD may be an alternative intervention, easily accessible and relatively inexpensive. The purpose of this study is to evaluate the impact of diuretic, specifically hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.

This is a prospective randomized study to test the effects of thiazide and furosemide in bone parameters, which will be assessed by peripheral micro-tomography at baseline and 12 months later. The role of calciuria in these possible changes will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Estimated Glomerular Filtration Rate (calculated by CKD-EPI) between 30 and 60 ml/min

Exclusion Criteria:

* Diabetes;
* chronic use of: steroid, bisphosphonates and calcium carbonate