cyrilzakka/clinical-trials huggingface dataset:
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer

This study wants to focus on Carcinoma detection rates with blue laser imaging (BLI) for participants with head-neck cancer who need a percutaneous endoscopic gastrostomy (PEG). BLI is a new imaging technique that can easily be used within a standard gastroscopy.

Head-Neck cancers are a significant burden all around the world. Patients suffering from one tumor are at high risk for a second cancer or another precancerous lesion. Before or during cancer treatment a PEG is needed to maintain a sufficient calories intake. PEG is established by performing a standard gastroscopy.

This randomised study wants to compare the detection rates of standard white light endoscopy compared to the additional use of blue laser imaging for second cancers or precancerous lesions in participants presenting for PEG establishment.

Eligibility Criteria:
Inclusion Criteria:

* All participants with the need of PEG due to head neck cancers or esophageal carcinoma

Exclusion Criteria:

* Minors, pregnant women, contraindication for endoscopy, contraindications for establishment of a PEG
Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)

The goal of this clinical trial is to define the normal response to the 13C-Spirulina Gastric Emptying Breath Test (GEBT) in children, so that we can use this test to help diagnose children that are suspected of having a condition called gastroparesis, which means that food doesn't empty from their stomach normally.

Participants will blow into test tubes to collect breath samples before and after eating a scrambled egg GEBT meal that contains a small amount of specially grown Spirulina (a blue-green alga used as a dietary supplement) that contains mostly carbon-13 (a non-radioactive kind of carbon atom). Analysis of the amount of 13C in the carbon dioxide in breath before and after eating the GEBT meal can measure how fast food is emptying from the stomach.

Children will complete questionnaires to ensure that they are qualified to enter the study and are likely to have normal gastric emptying rates. Informed consent/assent will be obtained.

Breath samples will be collected by children blowing into test tubes before and after eating a 13C-Spirulina GEBT meal. Breath samples will be collected and the test will be administered via telehealth or at one of the children's hospital clinics.

Researchers will analyze results from different age groups to see if there are differences in normal gastric emptying in younger/older children and boys/girls.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 7 to 18 years who provide written assent and whose parents provide written consent for participation
* Healthy and without any significant prior medical history or developmental delays
* Able to eat the test meal and provide breath samples.-

Exclusion Criteria:

Any known physician-diagnosed medical (gastrointestinal, pancreatic, or liver disease that may cause malabsorption, neurological) or psychiatric disease

* Chronic pulmonary disease including moderate/severe reactive airway disease requiring treatment with a daily inhaler
* Type 1 or 2 Diabetes
* Chronic gastrointestinal symptoms or functional gastrointestinal disorders
* Mental retardation or pervasive developmental disorder
* Currently receiving prescription drug therapy that may affect gastric motor function or sensation
* Any over-the-counter or herbal supplements that may affect gastric motor function or sensation
* Allergy to Spirulina, egg, milk, wheat or gluten (unless consuming gluten free crackers with the test meal) or known intolerance to any ingredient in the test meal
Apico-coronal Position of the Implant in Edentulous Diabetics With Implant-retained Overdentures

Diabetes Mellitus (DM) is a recognized factor affecting implant complication rates, including peri-implantitis and peri-implant bone loss, and the apico-coronal position of implants seems interfere on the conditions of peri-implant tissues. However, the influence of the vertical implant position in type 2 diabetics (T2DM) is unclear. This split-mouth randomized controlled trial evaluated the impact of implants of machined-collar placed at crestal level or supracrestally in T2DM rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.

Considering the outcomes achieved with implants with machined-collar inserted supracrestally, it would be relevant to investigate whether this therapeutic strategy could be considered as a more effective approach in the rehabilitation with dental implants of individuals with type 2 DM, since these patients may be more disposed to peri-implant changes, both from the point of view of marginal bone remodeling as related to local variations in immunoinflammatory response. Thus, the propose of this split-mouth randomized controlled trial was to compare the impact of crestal level or supracrestally implant platform in T2DM rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included: patients aged between 50 and 80 years old, 2) totally edentulous in the mandible with previous mandibular dentures for at least 6 months and indicated for rehabilitation with overdenture, 3) patients with diabetes had to have had T2DM, diagnosed by a physician, for at least the past 5 years. Such individuals were either under a dietary regimen and/or were using oral hypoglycaemic agents (metformin or glybenclamin).

Exclusion Criteria:

* Exclusion criteria were: 1) pregnancy, 2) lactation, 3) current smoking or ex-smokers, 4) other systemic conditions that could affect bone metabolism (e.g., immunologic disorders), 5) use of anti-inflammatory, immunosuppressive and anti-resorptive medications, 6) patients that required bone grafts before or concomitantly with implant surgery and 7) a history of previous regenerative procedures in the area designated for implant therapy. Patients with major complications of DM (i.e., cardiovascular and peripheral vascular diseases \[ulcers, gangrene, and amputation\], neuropathy, and nephropathy) were also excluded.
Effect of Cherry Concentrate on Vascular Function

Acute effect of cherry concentrate consumption on flow mediated dilatation in healthy young men


Eligibility Criteria:
Inclusion Criteria:

* no prescription medications

Exclusion Criteria:

* prescription medications
Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

Dexmedetomidine acts at central nervous system (specifically: at locus caeruleus), providing sedative and analgesic effects. It is widely used in intensive care. Surgery-related interventions elicit arousal ('nociceptive') reactions. The effects of dexmedetomidine on the neurophysiological signs of arousal are studied in surgical patients. Brain waves, electrocardiogram, Entropy Index, Bispectral Index, and fingertip pulse waves are recorded and analyzed later on. The course of anaesthesia and surgery are recorded.

The patients are randomized to receive either dexmedetomidine or saline infusion before and during anaesthesia (dexmedetomidine 0.1 mcg/kg within 10 minutes, thereafter 0.7 mcg/kg/h until 30 min after skin incision).

Multi-channel EEG, Entropy, BIS, multi-channel EMG, ECG, and plethysmogram are recorded on computer. Anaesthesia and surgery associated events are annotated on computer.

Time points of endotracheal intubation, skin incision, and course of surgery well be analyzed in detail. Additionally, tetanic stimulus of ulnar nerve will be applied for each patient, and reactions to the stimulus will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* males or females giving informed consent
* age range 18-70 years
* elective surgery: laparoscopy, laparotomy, breast surgery
* general anaesthesia
* ASA classification 1 or 2

Exclusion Criteria:

* pregnancy
* body mass index 30.1 or more
* diseases affecting CNS, autonomic nervous system, heart, heart rate, or circulation
* chronic use of drugs affecting CNS, autonomic nervous system, heart, heart rate, or circulation; except antihypertensives, which are acceptable in this study
* chronic use of clonidine
* serious psychiatric disease or condition
* overuse of alcohol
* use of illicit drugs
* unability of understand, read or use Finnish language
Interrupting Sitting Time During Postprandial State

The literature has shown that interrupting sitting time with frequent physical activities (e.g., cycling on a stationary bike for 3 minutes every 30 minutes of sitting) is effective for decreasing blood sugar levels. However, the optimal frequency and distribution of sitting interruption remains less clear. The purpose of this study is to compare the effects of two different protocols of sitting interruption (i.e., 3 minutes of cycling every 30 minutes versus 3 minutes of cycling every 15 minutes) on blood sugar levels.

This study will involve two different physical activity conditions and a control condition. Each participant will undergo the three conditions in a random order. The first protocol involves 3 minutes of cycling on a stationary bike at moderate intensity every 30 minutes for 6 hours, totaling 36 minutes of cycling exercise. The second protocol involves 3 minutes of cycling on a stationary bike at moderate intensity every 15 minutes for 3 hours to match the total exercise duration in the first protocol. Participants will remain seated for 3 hours to match to the total time spent in the lab. For the control condition, participants will remain seated. For each condition, participants will be provided with two meals, one before the protocol and another one in the middle of the protocol. The meals will be purchased from the cafeteria on campus based on the participant's own choice as long as carbohydrates account for 55-65% of total calories. Participants will eat identical meals across the three conditions.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy persons
* Sedentary lifestyle

Exclusion Criteria:

* Cardiovascular diseases
* Pulmonary diseases
* Metabolic diseases
* Other contraindications to exercise
Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring

The purpose of this study is to evaluate effects from a mandibular repositioning appliance on obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome and in patients with symptomatic snoring.

Mandibular repositioning appliances for the treatment of snoring and sleep apneas are increasingly used over the world, although the number of prescriptions of this therapy varies between countries. The appliance widens the upper airways during sleep in order to reduce sleep-disordered breathing. The device is easy to use and has become popular among patients. Despite this, the evidence for effects of this treatment is not very strong and based on only a few studies. The aim of this study is therefore to test the hypothesis that a mandibular repositioning appliance reduces sleep apneas, daytime sleepiness and other sleep apnea symptoms and increases the quality of life in sleepy patients with mild to moderate obstructive sleep apnea and in patients with symptomatic snoring. Secondary outcomes include effects on headaches, blood pressure and markers of stress, inflammation, cardiovascular health and oxidative stress. At baseline and after 4 month's treatment, the patients will respond to questionnaires about symptoms and quality of life. They will undergo measurements of sleepiness, sleep apneas and blood pressure as well as sampling of saliva, urine and blood. Factors that predict a successful treatment outcome will be analyzed in order to more exactly clarify the indications for this treatment modality in a group of patients who have been suggested to benefit from mandibular repositioning appliances according to previous studies and reviews.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea, apnea-hypopnea index of \<30 with excessive daytime sleepiness
* Snoring with excessive daytime sleepiness, apnea-hypopnea index of \<5
* Body mass index of \<35

Exclusion Criteria:

* Unable to give informed consent
* Psychiatric disorders including dementia that may interfere with the study protocol
* Other concomitant diseases that demand acute, effective treatment of sleep apnea
* Pharyngeal soft tissue abnormalities
* Living to far away from the University Hospital
* Professional drivers
* Pregnancy
* Included in other studies
* Other sleep apnea treatments
* Severe craniomandibular disorders
* Acute or advanced periodontal disease
* Insufficient number of teeth
A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
* Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening
* Have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening
* Lifetime history of meeting DSM-5 criteria for:
* Schizophrenia spectrum or other psychotic disorder
* Bipolar or related disorder
* Major neurocognitive disorder
* Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
* Dissociative disorder
* Posttraumatic stress disorder
* MDD with psychotic features
* Significant suicide risk, as judged by the Investigator.
The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

To show whether the artery first approach leads to equal or less rate of positive resection margins in pancreatic head cancer than the standard technique (ppWhipple only with standard Kocher's manoeuvre)

This is a prospective non-randomized trial with two study groups. The trial is designed to show if the ARTERY FIRST approach reduces the rate of R1 resections in patients undergoing surgery for cancer of the pancreatic head.

After the diagnosis of cancer of the pancreatic head by clinical, laboratory and imaging evaluation patients who are scheduled for resection will be screened for inclusion into the trial. Informed consent is obtained at least on the day before surgery and patients meeting the eligibility criteria will be enrolled into the study.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic head cancer (diagnosis by clinical, laboratory and radiological evaluation)
* Patients scheduled for curative resection
* No evidence of distant metastases
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Expected lack of compliance
* Impaired mental state or language problems
* patient having had neoadjuvant radiochemotherapy
A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)

This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients \>/=18 years of age
* Metastatic HER2 positive breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)
* Prior treatment with taxane-containing regimen
* Left ventricular ejection fraction (LVEF) \>/=50 percent
* For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment

Exclusion Criteria:

* Prior treatment with pertuzumab or capecitabine
* Concurrent treatment with other experimental drug
* Concurrent immunotherapy or anticancer hormonal therapy
* Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)
* Central nervous system (CNS) metastases, which are not well controlled
* History of exposure to anthracycline cumulative dose equivalent to 360mg/m2
* History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment
* History of myocardial infarction within 6 months prior to randomization
* History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab
* History of another cancer which could affect compliance or result interpretation
* Inadequate organ function
* Pregnant or breastfeeding women
* life expectancy \< 12 weeks
Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation

This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.


Eligibility Criteria:
Inclusion Criteria:

* \< 39 years of age
* BMI 18.5-29.9
* \<= 3 previous IVF cycles

Exclusion Criteria:

* PCOS
* Endometriosis
Treatment of Localized Low Grade Lymphomas

To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma

The standard treatment ol localized low grade lymphomas is Radiotherapy alone can offer long term remissions to some patients .

No study have clearly demonstrated the interest of chemotherapy. The purpose of the study is to determine wether prednisone administrated after first line local radiotherapy (30 GY) can pre in the treatment of localized low grade lymphomas of adult patients

Eligibility Criteria:
Inclusion Criteria:

* Low grade lymphoma defined according to the Ann Arbor classification
* localized

Exclusion Criteria:

* Subjects unable to signed informed consent
* Pregnancy
Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns

Newborn infants who require cardiopulmonary resuscitation at birth receive chest compression using a 3-Compression to 1-Ventilation (3:1 C:V) ratio. However, the optimal chest compression technique during cardiopulmonary resuscitation is uncertain and identified as a critical gap in evidence. The International Consensus Statement advises to use the 3:1 C:V ratio based on animal studies, and states that there are no clinical trials to support this approach and called for more research. There continues to be uncertainty about the optimal chest compression technique during cardiopulmonary resuscitation.

This trial will compare if in newborn infants with cardiac arrest in the delivery room does providing CC+SI (a new chest compression technique) compared to 3:1 C:V decreases the incidence of mortality at hospital discharge.

This will be a multi-centre international cluster randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Newborns with gestational age born between 28 to 43 weeks based on best available obstetrical estimate
* Newborns designated to receive full resuscitation, i.e., parental request or pre-determined decision to provide only comfort care at birth
* No known major congenital or chromosomal malformation. All newborns who meet inclusion criteria will be enrolled as the centres agreed to change their local hospital policy during the trial. The inclusion criteria are designed to be pragmatic and provide useful knowledge translation for most of the patient population in the future.

Exclusion Criteria:

- Newborns born outside of study centers and transported to centers after delivery.

Sex, race, and ethnicity are not part of the exclusion criteria for this trial, and as such it should represent the combined demographics of all centers involved.
The Effect of Exercise on Hepatic Glucose Metabolism

It is known that obesity and/or physical inactivity greatly increase a person's risk of developing heart disease and other serious health problems. This is partly because diabetes is associated with inflammation, oxidative stress, and insulin resistance. Diabetes is also associated with high levels of triglycerides in the blood and tissues such as the liver (known as fatty liver or steatosis). This elevation of fat in the liver is known to cause liver insulin resistance and impair the function of the liver and this impairment contributes to the development of diabetes.

Studies have shown that both aerobic exercise and weight loss have beneficial results on insulin resistance. However, the cause of this benefit remains unclear. We know that both aerobic exercise and/or weight loss can improve how muscle responds to insulin. However, it is also known that aerobic exercise and/or weight loss lowers liver fat content, thereby making it possible that the liver's response to insulin is also improved by weight loss and/or exercise training. An improved responsiveness of the liver to insulin could lower blood sugar levels after a meal and it could also lower morning blood sugar levels. However, very little is known about how exercise and/or weight loss improves liver function in people with type 2 diabetes.

Hypothesis 1: Improved hepatic insulin sensitivity, as a result of exercise training will increase the amount of glucose from an oral load that is taken up by the liver in subjects with DM.

Hypothesis 2: Increases in hepatic insulin sensitivity as a result of exercise will cause reductions in EGP during the fasted state, and will improve the suppression of EGP seen in response to hyperinsulinemia.


Eligibility Criteria:
Inclusion Criteria:

* 40-60 yrs of age
* sedentary lifestyle
* stable weight
* BMI 30 - 40kg/m2
* Hgb A1c \<8.5
* Type 2 diabetes

Exclusion Criteria:

* Use of insulin
* Use of TZDs