cyrilzakka/clinical-trials huggingface dataset:
Metabolic Monitoring During Therapeutic Hypothermia (Cooling) for Hypoxic Ischaemic Encephalopathy

This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

In the UK approximately 1200 babies per year undergo 'cooling' for the treatment of 'birth asphyxia' or hypoxic ischaemic encephalopathy (HIE). HIE not only impacts on brain metabolism but disturbs the normal metabolic balance in these babies who are at risk of hypoglycaemia and hyperglycaemia, which may exacerbate the effect of their primary brain injury. The clinical significance of hypoglycaemia is dependent on the availability of alternative fuels such as ketones and lactate. Clinical management of glucose control in these extremely ill babies is challenging because of infrequent blood glucose measurements and inability to measure alternative fuels. We have used continuous glucose monitoring (CGM) to help target glucose control in extremely preterm infants who require intensive care. CGM however has not been used in babies who are being cooled. This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

Eligibility Criteria:
Inclusion Criteria:

* Hypoxic ischaemic encephalopathy Informed parental consent

Exclusion Criteria:

* Known significant congenital malformation
Massage To Improve Uterine Artery Blood Flow

This project will investigate the effects of massage therapy on depressed pregnant women. The investigators expect that massage therapy will improve blood flow from the mother to the fetus and reduce prematurity and depression.

Prenatal depression has been associated with adverse neonatal outcomes including preterm birth and low birthweight. Potential underlying mechanisms for prenatal depression effects on prematurity and low birthweight involve the elevated sympathetic nervous system SNS and Hypothalamic Pituitary Adrenal HPA Axis function noted in depressed pregnant women. These may lead to increased uterine artery resistance and the resulting limited blood flow, oxygen and nutrients to the fetus. Moderate pressure massage therapy may reduce this problem in depressed pregnant women by decreasing SNS and HPA axis function, resulting in decreased uterine artery resistance, increased oxygen and nutrients to the fetus and lower prematurity and low birthweight. An alternative model being explored here is that moderate pressure massage may increase progesterone/estriol ratios, which counteract the negative cortisol effects on gestational age. Eighty pregnant women with depression symptoms will be recruited at approximately 20 weeks gestation and randomly assigned to a moderate pressure massage therapy or to a SHAM light pressure massage touch/attention control group. The women will receive 20-minute weekly massage therapy sessions from 20 to 30 weeks gestation. At 20 and 30 weeks gestation, depressed symptoms will be assessed using the CES-D, and saliva samples will be collected to assay alpha amylase as an SNS marker, cortisol as an HPA axis marker and progesterone and estriol levels. Maternal Doppler ultrasound will be conducted to assess the uterine artery resistance index as an estimate of uterine artery blood flow. Upon delivery, the mothers' medical charts will be reviewed to record gestational age and birthweight. The investigators are hypothesizing that the moderate pressure massage group will elicit an increase in progesterone/estriol ratios and decreases in alpha amylase and cortisol levels, which in turn will lead to reduced uterine artery resistance and a lower incidence of prematurity and low birthweight.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated singleton pregnancy
* Depression
* \< 20 weeks GA at recruitment

Exclusion Criteria:

* Pregnancy complications
* HIV
* Smoking, drug use
Multi-factor Model Constraction for Early Warning and Diagnosis of MDD

Current research on the pathogenesis of depression shows that imbalanced inflammatory factors are closely related to Major Depressive Disorder(MDD). As reported, physical exercise, Ω-3 fatty acids, and sulforaphane can be complementary therapies for moderate-to-severe depression. In addition, imaging studies have found changes in the structure and functional connectivity of the brain. Therefore, this study intends to collect clinical and biological information from patients with depression and healthy controls to establish a multi-factor model for early warning and diagnosis of major depressive disorder

The immune imbalance has been reported in patients with unipolar and bipolar depression. There is no unified conclusion in the field and severity of the immune imbalance, and the cause of cognitive impairment is unknown, which may be related to many factors. Omega-3 fatty acids are immune modulators that possess antidepressant effects.

This study includes three steps.

1. We will enroll bipolar and major depressive disorder patients who are in a depressive episode and enroll healthy controls. All subjects will be assessed at baseline
2. We will give omega-fatty acid treatment based on immune indicators
3. The follow-up will last for one year with five sessions.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients in main-center and sub-centers
* Age between 18-65 years old
* Meet the DSM-IV diagnosis of depressive episode
* HAMD-17 score\>17 at baseline
* No antidepressant treatment within 6 weeks prior to enrollment
* Adequate cognition level to complete the tests necessary for the study
* Willing to sign the informed consent form

Exclusion Criteria:

* Have any contraindications to Ω-3 fatty acids
* Severe physical disease
* Diagnosed with schizophrenia, or other mental illness spectra
* Have received physical therapy
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management

The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.

Orthodontic pain is often reported for the first 4 days after the appliances are attached. This study will investigate two modes of pain management versus a placebo. Consented subjects will be randomly assigned to one of 3 groups: Group A, a combined and simultaneous therapy of 200 mg ibuprofen and 650 mg acetaminophen (3 pills total) taken orally at set time intervals (0 h, 6 h, 12 h, and 24h, 48h, 72h, and 96h); Group B, ibuprofen alone (200 mg) taken orally at same time intervals (1 ibuprofen and 2 placebo pills); Group C, placebo taken orally at the same time intervals (3 placebo pills).

The study will be blinded for the investigators, patients, and statisticians.

Eligibility Criteria:
Inclusion Criteria:

* scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch);
* extractions, if required, performed at least 2 weeks before appliance and archwire placement;
* healthy with no significant medical findings;
* no prophylactic antibiotic coverage required;
* currently not taking antibiotics or analgesics;
* no contraindications to the use of acetaminophen or ibuprofen; and
* minimum age of 12 years

Exclusion Criteria:

* Under the age of 12 or over the age of 80,
* prisoners,
* pregnant women,
* decisionally challenged individuals,
* allergy to either medication,
* history of kidney disease,
* liver damage or disease,
* alcoholism/use of 3 or more alcoholic drinks during study period,
* use of blood thinners,
* stomach ulcers or
* stomach bleeding.
Evaluation of Patients Who Underwent Sleeve Gastrectomy With Jejunoileal Anastomosis for the Treatment of Morbid Obesity

Laparoscopic sleeve gastrectomy operations performed for morbid obesity are among the most common methods in the world. Gastric or intestinal bypass surgery with or without sleeve gastrectomy is thought to be more effective in controlling both weight loss and metabolic diseases. For this purpose, Roux-en-y gastric bypass, transit bipartition, duodenal switch, jejunoileal bypass are performed. The aim of this study was to evaluate the effects of jejunoileal bypass surgery on weight loss and metabolic diseases in patients with sleeve gastrectomy.

Bariatric surgery results in more and more long-term weight loss than traditional treatment in moderate and severe obesity. Due to morbid obesity, jejunoileal bypass has been applied since 1970. Laparoscopic sleeve gastrectomy and jejunoileal anastomosis are among the rare techniques described in 2012. There are few studies on this technique.

Between 2015 and 2018, jejunoileal bypass operations with laparoscopic sleeve gastrectomy for morbid obesity will be evaluated in Inonu University gastroenterology surgery clinic. The patients' age, gender, body mass index, weight loss in follow-up periods, whether there is back weight gain, the effects on metabolic diseases, early and late complications will be evaluated.

Eligibility Criteria:
Inclusion Criteria:All patients who underwent the sleeve gastrectomy with jejunoileal bypass between 2015-2018 for the treatment morbid obesity

Exclusion Criteria:other operations for morbid obesity except sleeve gastrectomy with jejunoileal bypass
CKD-aP Among Adults on Dialysis in Switzerland

Chronic Kidney Disease Associated Pruritus (CKD-aP) represents a localized or a generalized skin itch, which is a common symptom occurring in end-stage renal disease and dialysis. The prevalence of CKD-aP in adults on dialysis varies between countries ranging between 20-42%. Swiss data on CKD-aP are unfortunately largely lacking, as Switzerland is so far not part of large registries, such as DOPPS.

The aging population, the increase in diabetes (69% by 2030), the increase in hypertension (60% by 2025) and poly-morbidity will probably lead to a rise in the number of patients on dialysis and subsequent CKD-aP.

CKD-aP is associated with sleep disturbances, compromised quality of life, emotional distress, and increased risks of hospitalization and death. Its management lacks approaches that are supported by strong evidence because its pathogenesis remains poorly understood and may be related to an increase in uremic toxins, skin inflammation. In this context, sweat composition deserves more attention.

Aim of the study The aim of the study is to determine the prevalence of CKD-aP in the population on dialysis, the association between CKD-aP and different electrolytes, and the potential role of the composition of sweat in CKD-aP.

Results will be used for building a CKD-aP symptom management program to improve the quality of care of patients on dialysis and will be incorporated in the nursing continuing education program.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old
* Diagnosed with end-stage renal disease and receiving hemodialysis for at least 6 months
* Able to communicate in French or availability of a French-speaking close relative for translation
* Signed informed consent

Additional inclusion criteria for the case-control study outcomes phase 2:

* Reporting moderate to severe CKD-aP for the participant considered as a case
* Reporting no or mild CKD-aP for the participant considered as a control Cases and controls will be matched by age-group, sex, and dialysis modality (hemodialysis or peritoneal dialysis).

Exclusion Criteria:

* Presence of cognitive impairment or cognitive disorder
Safety of Smartphones Among Patients With Cardiac Implantable Electronic Devices

Over the past year smartphones have developed from a niche product to a commoditized product and are now squeezing classic mobile phones out of market. According to a survey a quarter of the German population is making use of a smartphone at present.

An interference between smartphones and the functionality of pacemakers or implantable defibrillators is rather unlikely but cannot entirely be excluded. A systematic study regarding a possible interference between smartphones and modern pacemaker- and ICD-system with a better shielding against external influence has not taken place so far. In this study the investigators intend to investigate any interference between different smartphones produced by different manufacturers and diverse cardiovascular implanted electronic devices.


Eligibility Criteria:
Inclusion Criteria:

* Presence of an implantable pacemaker or defibrillator

Exclusion Criteria:

* Lead malfunction which can not reprogrammed
* Battery depletion
Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis

In this study the investigators sonicate the bearing components of the explanted hip prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and quantitatively). The hip prosthesis bearing components are composed from different material. The purpose of this study is to analyse the resistance against biofilm adhesion of ceramic, metal and polyethylene prosthesis components through microbiologic analysis of sonicates.

The main reasons for hip prosthesis failure are aseptic loosening and periprosthetic joint infection (PJI). The real frequency of PJI is probably largely underestimated because of non-standardized definition criteria, diagnostic procedure, treatment algorithm and other confounders. Therefore, data from joint registries are not reflecting the frequency of PJI and can be misleading; particularly low-grade PJI can be frequently misdiagnosed as aseptic failure.

Microbiological analysis of sonicate has in comparison with joint aspirate significantly higher sensitivity and specificity, which allows better detection of low grade infection. With aspiration only free-floating, high metabolically active, planktonic form of bacteria could be collected. Contrarily, the less metabolically active bacteria are hidden under the biofilm can remain undetected.

Sonication of prosthetic material mechanically dislodge the biofilm from surface and expose the sessile bacteria for the microbiological analysis.

All foreign materials provoke biofilm formation however, different materials showed different resistance for biofilm adhesion.

In this study patients with PJI are undergoing standard one- or two- stage revision procedure of the hip. The removed bearing components will be sonicated and sent in microbiological analysis. The ceramic, metal and polyethylene prosthesis components will undergo qualitative and quantitative microbiological analysis. The materials will be compared regarding to the presence of biofilm formation.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be aged 18 or more.
* Subject must be scheduled to undergo an explanation of the hip endoprosthesis during the 1- or 2- stage revision procedure because of the septic or mechanical indication.
* Subject must personally sign and date the informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patient not scheduled for the index Operation procedure with removal of hip endoprosthesis
Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer

Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small cell lung carcinoma.

This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where it is given weekly.

The purpose of the study is to determine the most effective and safe schedule for giving these drugs in non small cell lung carcinoma.


Eligibility Criteria:
Inclusion criteria:

* Confirmation of non-small cell bronchogenic carcinoma (epidermoid, squamous, adeno, large cell anaplastic carcinoma, but no small cell or carcinoid) must be histologically or cytologically confirmed.
* No prior antineoplastic chemotherapy, hormonal therapy or therapy with biological response modifiers
* No previous irradiation to the only area of measurable disease.

Exclusion Criteria:

* Past or current history of neoplasm other than the entry diagnosis. Exceptions are curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or other cancers treated by surgery or radiation with a disease free survival longer than 5 years.
* Patients who have undergone surgery less than 3 weeks prior to enrollment.
* History of serious cardiac disease not adequately controlled.
* Patients with serious active infections or other serious underlying medical condition.
* Uncontrolled diabetes mellitis.
The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism

The half-life of the parathyroid hormone is about 4min, blood pth test is use in operation to confirm that parathyroid tumor is removed. but the blood pth test is time consuming and unpractical in most of hospital. this study will compare the application of rapid PTH test paper in operation of hyperparathyroidism.PTH test were measured in operation in different way. it will test at the time of preoperation, 15 minutes after surgery, 1 hour after surgery and 24 hours after surgery. thus evaluate the reliability and accuracy of PTH test paper in evaluating the Miami principles with the linear relation of blood PTH and the PTH test paper method.

Primary hyperparathyroidism is a clinically common disease. At present, the gold standard for determining whether the operation is successful is based on the Miami principle. That means The PTH hormone decreased to 30% of the baseline level after 15min after the tumor was removed. However, due to the differences in PTH monitoring conditions in various hospitals, many hospitals cannot perform rapid PTH monitoring in the operation. Therefore many doctors choose rapid freezing pathology to confirm the lesion., This also led to the inability to evaluate PTH in the presence of multiple lesions,and resulting in the need for reoperations.

Eligibility Criteria:
Inclusion Criteria:

* Primary hyperthyroidism.
* Secondary hyperthyroidism
* Unilateral thyroidectomy.
* Total thyroidectomy and bilateral central compartment dissection

Exclusion Criteria:

* age Older than 70 or younger than 18.
Better Patient Selection to Transcatheter Aortic Valve Implantation

This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.

In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation.

Exclusion Criteria:

* Aortic valve endocarditis
* aortic annulus \>31mm
* preoperative pacemaker
* severe aortic insufficiency (\>grad 3)
* rapid atrial fibrillation
* unprotected left main coronary stenosis not suitable for percutaneous intervention.
* unstable angina
* life expectancy less than 12 months
* mental disorder including dementia and condition which interferes with protocol compliance.
* renal failure (glomerular filtration rate \< 45 ml/min/m2), only have T1 mapping by CMRI.
* Patients with metal not suitable for MRI.
Cyanide Poisoning in Fire Victims

Aim: To determine the incidence of cyanide poisoning in fire victims.

20 consecutive patients will have the rest of their blood sample analyzed for cyanide.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Exposed to smoke from fire and admitted to hospital

Exclusion Criteria:

None
Galectin Role in Periodontal Disease

This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1 and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers and/or therapeutic targets for periodontitis, in addition to revealing their possible role in the periodontal disease.

45 systemically healthy participants were enrolled in this investigation, equally subdivided into three groups of 15 patients each: gingivitis, periodontitis (stage III) and control group with healthy gingiva. Probing depth, clinical attachment level, gingival and plaque index were registered. GCF levels of galectin-1 and -3 were evaluated in all included groups (before and after non-surgical treatment for periodontitis group) using enzyme linked immune-sorbent assay (ELISA) kit.


Eligibility Criteria:
Inclusion Criteria:

1. Non-smokers from both genders.
2. Not suffering from systemic diseases, pregnancy/lactation.
3. Not taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs before inclusion in the study by 6 months.
4. Patients with only gingivitis or periodontitis stage III.
5. Periodontitis patients who did not receive any professional periodontal treatment in the last 6 months.

Exclusion Criteria:

1. smokers.
2. having systemic diseases, pregnancy/lactation.
3. taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs in the past 6 months.
4. Patients having periodontitis any other stage than stage III.
5. Periodontitis patients who receive any professional periodontal treatment in the last 6 months.
Color Perception in Dentistry (CPD)

Visual shade matching (VSM) is the most common procedure to select an adequate shade in dentistry. This clinical procedure requires the use of a shade guide, being Vita Classical (VC) the most popular among the available guides. VSM is a subjective and inconsistent process with many observer related variables (e.g. color deficiency, experience, gender and eye fatigue) that can influence on the final color appearance. The gender influence on the accuracy of VSM is controversial.

The purpose of this study is to evaluate the VSM performed by female (F) and male (M) students, using VC shade guide, testing the null hypothesis that VSM is not influenced by gender.

* Female and male observers will be analyzed.
* Human upper central incisors (UCI) will be shade matched to shade tabs from Vita Classical (VC) shade guide.
* The spectral reflectances from the four UCI and from the 16 VC shade tabs will be measured using a spectroradiometer (SP).
* Measurements will be performed over a gray background, inside a viewing booth and under D65 illuminant (diffuse/0º geometry).
* CIELAB coordinates (L\*, a\* and b\*) will be calculated according to CIE D65 illuminant and CIE 2º Standard Observer.
* Two color difference metrics (CIELAB and CIEDE2000(2:1:1)) will be used to find the best option for each UCI, using VC shade guide.
* Data will be analyzed using descriptive statistics and McNemar test (α=0.05).

Eligibility Criteria:
Inclusion Criteria:

* Dental students (DS) from University of Passo Fundo.
* DS with some knowledge and clinical experience with shade matching.
* DS from 20 to 35 years old.

Exclusion Criteria:

* DS with abnormal color vision.