cyrilzakka/clinical-trials huggingface dataset:
Effects of Testosterone and Fat Utilization

Evidence is accumulating that there are sex differences in energy and substrate metabolism. The positive or negative consequences of such metabolic differences between men and women need to be evaluated with respect to health outcomes. The importance of aberrant lipid metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes understanding the distinction between "normal" vs aberrant critical to future treatment and prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism and substrate oxidation in non-obese, healthy individuals, have been consistently observed. In addition, distinct differences in men and women exist in the distribution of body fat, with men typically having greater central adiposity than women. Accumulation of fat in the abdomen is associated with an increased risk for metabolic abnormalities such as hyperlipidemia and insulin resistance. In the current study, therefore, the role of testosterone in determining the sex differences in catecholamine mediated substrate metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots will be addressed.


Eligibility Criteria:
Inclusion Criteria:

* normal weight (BMI of 23-29.9 kg/m2)
* not be highly trained (\< 5hrs of moderate intensity, planned exercise per week).

Exclusion Criteria:

* Patients will be excluded if they have one or more of the following out-of-range values measured on a fasting blood sample:
* glucose \<65 or \> 110 mg/dl,
* insulin \> 20 uU/ml,
* thyroid stimulating hormone \<0.5 or \>5.0 uU/ml,
* growth hormone \>2.5 ng/ml.
* Subjects who may be:
* anemic (hemoglobin \< 14.5 g/dl men ),
* have abnormal liver function tests:

  * alanine amino transferase \> 47 U/l,
  * aspartate aminotransferase, \> 47 U/l,
  * alkaline phosphatase \<39 or \>117 U/l) or
  * creatinine (\<0.6 or \>1.1 mg/dl).
Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain

The investigators will evaluate the effectiveness and safety of acupuncture treatment in refractory neuropathic pain patients.

The purpose of this study was to evaluate the effectiveness of acupuncture treatment in the patients with the following neuropathic pain related syndrome.

* Postherpetic neuralgia
* Failed back surgery syndrome
* Diabetic neuropathy
* other peripheral neuropathy

Patients with refractory neuropathic pain who do not respond to conservative treatment for more than 3 months should be included. Acupuncture treatment is maintained for 2 months in oriental medicine hospital. The effect is evaluated through the numeric rating score and the validated questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients who can adequately write a reportable questionnaire
* Patients who have been diagnosed with one of the following neuropathic pain disease (postherpetic neuralgia, failed back surgery syndrome, diabetic neuropathy, other peripheral neuropathy)
* Patients who failed conservative treatment at Seoul National University Hospital for more than 3 months.
* Patients with NRS 5 points or more
* Patients with painDETECT score 19 points or more

Exclusion Criteria:

* Patients with major mental illness
* Patients with unstable medical conditions
* Pregnant
* Patients who received acupuncture treatment at the site within the past month
* Patients with bleeding tendency
* Patients taking immunosuppressive drugs
Determination of Threonine Requirements in Healthy School-aged Children

Threonine is an indispensable amino acid (nutrient containing nitrogen), which cannot be made in the body and must be consumed from food. Amino acids are the building blocks of protein in your body, and need to be eaten in required amounts to maintain health and growth. Deficiency in threonine can affect small intestine growth due to its structural importance in the intestinal protein mucin. While threonine is found in many foods, deficiency can occur in developing countries where nutrition is primarily plant based, and low in available protein.

Therefore, the purpose of this study is to determine the requirement of the indispensable amino acid Threonine, in school-aged children (6-10y). Secondly, we wish to determine the availability of threonine from three test proteins (soy, green pea, casein).

The threonine intake requirement for children are based on factorial calculations. In the current study we will use a new and modern technique, the indicator amino acid oxidation technique (IAAO), to determine threonine requirements in children.

This technique is a newer technique which involves the consumption of protein shakes composed of specific amounts of threonine mixed with a stable isotope tracer. The oxidation of this isotope will be measured in urine and breath to determine a breakpoint (requirement) of threonine.

Determining the requirement for threonine, as well as the availability of threonine from various food products will help us to develop better food recommendations for children.

Research Method This study will be carried out in a repeated measures design. Participants will be recruited and screened for eligibility. Six participants will be brought in for 6 testing visits with reference amino acid, where they will be randomized to a level of threonine intake. A further 3 visits will be carried out during which participants will be randomized to a level of threonine consumption derived from alternative proteins (casein, soy, peas) which is at a threshold below the requirement for threonine to determine availability.

Eligibility Criteria:
Inclusion Criteria:

* Children between 6 and 10 Y
* No history of chronic disease or metabolic disorders
* No food allergies
* No recent illness or antibiotic consumption
* Children with a normal, healthy, body weight (between 3rd and 85th percentiles for their age group for weight) (Dietitians of Canada, 2015)

Exclusion Criteria:

* Children under 6 years' old
* Children over 10 years' old
* Children with a history of disease or metabolic disorders
* Children with any food allergies
* Children taking prescription medication
* Children with a history of being underweight, overweight, or obese (Dietitians of Canada, 2015; Onis et al., 2007)

  o Below 3rd percentile for weight, Above 85th percentile for weight
* Female children who have commenced menstruation
LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)

The purpose of the study is to test the effectiveness and safety of TTFields therapy, delivered using the NovoTTF-200T device, concomitant with pembrolizumab in subjects with metastatic NSCLC previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.


Eligibility Criteria:
INCLUSION CRITERIA:

* ≥18 years of age
* Histologically or cytologically confirmed diagnosis of NSCLC.
* Documented positive tumor PD-L1 expression (TPS≥1%).
* Eastern Cooperative Oncology Group (ECOG) Score of 0-1.
* Diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease.
* Subjects must have received one line of PD-1/PD-L1 inhibitor therapy for advanced or metastatic NSCLC. PD-1/PD-L1 inhibitor may have been given alone or in combination with other therapy.
* Subjects who received PD-1/PD-L1 inhibitor for advanced disease, must have had a best response on PD-1/PD-L1 inhibitor of stable disease (SD), partial response (PR) or complete response (CR).
* Subjects must have experienced disease progression more than 84 days following Cycle 1 Day 1 (C1D1) of their most recent PD-1/PD-L1 inhibitor therapy.

EXCLUSION CRITERIA - All individuals meeting any of the following exclusion criteria will be excluded from study participation:

* Mixed small cell and NSCLC histology.
* Subject must not have leptomeningeal disease or spinal cord compression.
* Subject must not have untreated, symptomatic brain metastases, or residual neurological dysfunction.
* Subjects must not have received more than one line of PD-1/PD-L1 inhibitor for advanced disease.
* Subjects with a known sensitizing mutation for which the Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1) are excluded unless previously received at least one of the approved therapy(ies).
* Subjects with more than 2 lines of therapy in the advanced setting.
* Pregnant or breastfeeding.
* Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso.
* Known allergies to medical adhesives or hydrogel.
Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke

For the breathing intervention, participants completed two experimental sessions at least two weeks apart. The experimental sessions were randomized between the slow-breathing condition (6 breaths/min) or the control breathing condition (12 breaths/min). Breathing interventions were 15 minutes in length and completed with the assistance of the breathing app, Breathe Deep (Mineev, Bizi Apps LLC).

The breathing intervention is currently completed.

The reliability and validity study of AFAS is ongoing. This is a one-time visit for participants in which participants will undergo screening of sensation and movement as well as fill in some questionnaires.

All participants had two visits for the breathing exercise. The only planned intervention was the breathing exercise, which is now concluded.

The protocol for the breathing intervention was as follows: The breathing protocol lasted 15 minutes. It was a guided breathing awareness session with a registered nurse (PhD student) who is also trained in integrative therapies and yoga instruction.

In parallel, during one of the visits the reliability and validity of a new scale for stroke to measure quality of movement and body awareness is tested.

This part is still ongoing and thus this becomes a one-time visit.

Eligibility Criteria:
Inclusion Criteria:

* Females and males ages 18-99 years of age
* People with stroke who are medically stable with one or more ischemic or
* hemorrhagic stroke(s)
* left or right hemiplegia
* willing and able to attend a one-time behavioral testing session
* willing and able to sign consent to participate
* able to hear, read and comprehend instructions given during the study
* English speaking (or willing to work with a (student) translator)

Exclusion Criteria:

* cognitive impairment (Mini-mental State Exam-brief version, \<13/16)
* contractures in the tested arm that would hinder testing arm movements
* adults lacking capacity to consent
* severe neglect, aphasia, apraxia
* other medical conditions that preclude participation
Cerebral Edema in Pediatric Diabetic Ketoacidosis

The purpose of this trial is to compare two different rates of fluid administration during diabetic ketoacidosis (DKA) treatment in children to determine which fluid administration rate is more beneficial for brain metabolism and for preventing or decreasing brain swelling during DKA.

Cerebral edema (swelling of the brain) is the most frequent serious complication of diabetic ketoacidosis (DKA) in children. The cause of cerebral edema during DKA is not well understood. Recent studies suggest that it may result from lack of adequate blood flow to the brain during DKA, before treatment starts. Brain injury, resulting in edema, may occur before treatment because of lack of adequate blood flow to the brain and additional injury may occur when adequate blood flow is re-established during treatment (called reperfusion injury). Because additional injury may occur during treatment, it is important to understand whether the rate of administration of intravenous fluids, and, therefore, the speed of reperfusion of the brain, is related to the degree of brain swelling and injury. Most current treatment protocols indicate that intravenous fluids should be administered slowly, but it may be possible that brain injury and swelling might be lessened if adequate blood flow is established more quickly.

In this study, researchers will use magnetic resonance (MR) imaging to compare two different rates of fluid administration during DKA treatment in children. The investigators will use MR imaging to measure brain swelling and metabolism at three time points-twice during treatment and once after recovery from DKA-and will compare these measurements to determine which fluid administration rate has more beneficial effects on brain metabolism and brain swelling.

The study's researchers hypothesize that more rapid re-establishment of blood flow to the brain (via more rapid administration of intravenous fluids) will result in less brain swelling and injury than slower rehydration with delayed re-establishment of adequate brain blood flow will.

Eligibility Criteria:
Inclusion Criteria:

* age 8-18 years
* diagnosis of diabetic ketoacidosis
* able to cooperate with MR scanning

Exclusion Criteria:

* pre-existing cerebral injury or brain structural abnormality
* dental hardware or other metal devices which would interfere with MR imaging
Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations

Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine and improve the patients pain score after operation.

We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively in patients getting a new hip alloplastic.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for primary total hip replacement in spinal anaesthesia
* between the age of 55 and 75,
* ASA 1-3, and with
* BMI between 18 and 35.

Exclusion Criteria:

* are unable to cooperate;
* does not speak Danish;
* has allergy for drugs used in the trial;
* has drug and/or medicine abuse;
* epilepsy;
* diabetes treated with medicine;
* treatment with systemic steroids within 4 weeks prior to the operation;
* daily use of antacids;
* daily use of analgesics except for NSAID, Cox2 inhibitors and Paracetamol;
* known kidney disease;
* use of antidepressants
Effect of Heart-lung-machine on Selenium Status of Cardiac Surgical Patients Undergoing Coronary Bypass Surgery

Since selenium has demonstrated significant characteristics for a series of biochemical processes, for antioxidant activity and immune stimulation, this observational study should represent the effect of heart-lung-machine on selenium status of cardiac surgical patients undergoing coronary bypass surgery. It will be examined in (approximately 100) adult patients, under which 50 patients are operated conventionally (meaning with the use of heart-lung-machine). Another 50 patients are operated on beating heart without the use of heart-lung-machine (OPCAB = "off pump coronary artery bypass"). The allocation of individual patients in these two groups is done according to clinical criteria and is undertaken by the operating surgeon.

To produce two comparable groups of patients, the characteristics are recorded using EURO-Score; additionally the groups are "matched" (Matched-Pairs-Analysis).

All patients are operated by the same surgeon (senior physician Dr. A.K. Menon) under general anaesthesia through median sternotomy with elective or urgent indications.

After induction of anaesthesia, within the first hour after admission to the Intensive Care Unit (ICU) and every further morning in the ICU or Intermediate Care Station (IMC), 10ml blood are removed by a central venous catheter, allowing to measure blood selenium levels in whole blood by electrothermal atomic absorption spectrometry.

All blood draws will be held on vascular access, which is lying independently of the study participation for surgery or for intensive care treatment. The blood samples will be stored until completion of the study and its evaluation (up to 24 months) and are discarded afterwards. All data collected are recorded on a documentation sheet.

Eligibility Criteria:
Inclusion Criteria:

* Coronary-3-vessel-disease
* Written informed consent
* Age of 18 years or older
* Study inclusion at the latest on the last evening before surgery

Exclusion Criteria:

* Other serious cardiac diagnosis (i.e. aneurysm, valvular-diseases)
* ischemic cardiomyopathy
* Patients not capable of consenting
* Pregnant or lactating women, women of child-bearing potential in whom pregnancy can not be excluded
The HEP-OKS Study - Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients

Spatial neglect represents one of the major cognitive disorders following stroke. Patients patients fail to be aware of objects or people to their left and orientate instead to their right side. Enduring neglect has been found to be a poor prognostic indicator for functional independence following stroke. Despite some promising experimental accounts there are no established treatments for this condition.

The aim of this study is to test whether a combined treatment with hemifield eye patching (HEP) and optokinetic stimulation (OKS) can permanently reduce neglect behaviour and improve functional outcome in patients with hemispatial neglect following stroke.

The investigators hypothesise that the treatment with HEP and OKS will lead to a greater reduction of neglect scoring in the neglect test battery as well as a greater improvement in functional independence scores as compared to the spontaneous clinical course of the usual-care control group.

To specify, this study should answer the following main question: Does the daily wearing of hemifield eye patches over a period of 1 week in combination with daily sessions of optokinetic stimulation lead to a significant reduction of neglect behaviour as measured by total scores in a paper-and-pencil neglect test battery and/or an improvement in functional independence scores (Catherine-Bergego-Scale, Barthel Index) in a cohort of stroke patients with acute hemispatial neglect as compared to the spontaneous course of the disease in a control patient group without a neglect-specific treatment?

Eligibility Criteria:
Inclusion Criteria:

* Right hemisphere stroke
* Spatial neglect as determined by pathological scores in at least two tests of a neglect test battery (Azouvi et al., JNNP, 2004)
* Age \> 18 years old
* Informed consent signature

Exclusion Criteria:

* Bilateral or previous unilateral stroke lesions
* Pre-existing neurodegenerative disease
* Inability to give informed consent
Efficacy of the Implementation of a Food and Nutritional Support Strategy Adapted to Dependent Elderly Subjects

Malnutrition particularly affects people who delegate the preparation of their meals with 46% of persons living at home and using a meals-on-wheels service, or those in old people's homes (Etablissement d'Hebergement pour Personnes Agees Dependantes - EHPAD) at risk of malnutrition, compared with 16% in persons who have help, but not for their meals, and 8% in independent persons (Aupalesens Survey). This proportion, which is particularly high, is essentially due to the absence or insufficient level of individual monitoring of the nutritional status of these "dependent" populations despite the different recommendations. EHPAD (old people's homes) are invited to respect meal rhythms, to adapt the nutritional and gustatory qualities of the food, to propose a pleasant environment (Survey CLCV 2012: data collection in 2012); in parallel, few professionals are really trained in the needs of the elderly. In meals-on-wheels services, apart from the distribution of meals, no nutritional follow-up is proposed (Guide 2012).

Symmetrically, the constant search to control costs in western healthcare systems has led managers to systematically reduce care costs, in particular those that are not directly related to medico-pharmaceutical or care personnel expenditure in the strictest sense. In the collective catering services, there is, for example, a systematic effort to reduce daily "costs/materials", without measuring the global cost related to the efficacy of care.

The present work is part of the RENESSENS project: these studies will be conducted in two elderly populations, one living at home and receiving meals on wheels daily and a regular visit of a dietician, who will propose individual nutritional follow-up and the second living in an old people's home (EHPAD) that will benefit from the improved management of its catering service (good culinary practices, including specific training for personnel and meals adapted to the needs of residents). The principal aim of these two studies will be common and will be to evaluate the efficacy of this specific type of management of meals and nutrition compared with a reference meals-on-wheels service and a reference EHPAD.


Eligibility Criteria:
Inclusion Criteria:

* persons or their persons of trust who have given oral consent
* Age ≥ 65 years
* Persons living at home using a meals on wheels service every day or living in an old people's home (EHPAD)

Exclusion Criteria:

* Persons without national health insurance cover
* Persons requiring enteral or parenteral nutrition
* Persons in an exclusion period for a previous study
cNEP for the Treatment of Obstructive Sleep Apnea

The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea


Eligibility Criteria:
Key Inclusion Criteria:

* PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying PSG")
* on that PSG, AHI must be 10 - 50/hr and \>80% of the apneas and hypopneas must be obstructive
* no significant changes in health, medications, or lifestyle since the qualifying PSG

Key Exclusion Criteria:

* previous major surgery, injury or radiation to the neck
* beard or excessive hair on the area of the neck where the collar will be applied
* carotid artery disease
* serious medical conditions
* pregnancy
* use of home oxygen
* silicone allergy
* sleep disturbance other than obstructive sleep apnea
Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study

In this study, 20 regional neurosurgery centers across the country will be included, and the study cohort will be constructed on the basis of the IARP-CP cohort.The artificial intelligence platform was used to analyze the clinical, morphological, hemodynamics, aneurysm wall characteristics and other factors of unruptured aneurysms, as well as the relationship between these factors and the risk of aneurysm instability, seek the potential risk factors, and finally establish a multi-dimensional prediction model of rupture risk of intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old;
2. At least one unruptured intracranial aneurysm was found by CTA;
3. No relevant symptoms, receiving non-operative and conservative observation treatment;
4. Signing the informed consent.

Exclusion Criteria:

1. Other cerebrovascular structural lesions (such as cerebrovascular malformation and arteriovenous fistula) or craniocerebral tumors;
2. Fusiform or dissecting aneurysms;
3. Traumatic, mycotic and atrial myxoma associated aneurysms;
4. Suffering from systemic connective tissue diseases, such as polycystic kidney disease;
5. Expectant survival of no more than 3 years due to other diseases or poor general conditions;
6. Patients refuse to follow up or cannot communicate with them due to mental diseases;
7. Pregnant women or participating in other aneurysm related studies.