cyrilzakka/clinical-trials huggingface dataset:
Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery

A prospective, randomized study was performed. The patients were randomized into 2 groups: those patients undergoing subcutaneous vitamin E ointment application (Group 1) and those patients who not (Group 2).

Incisional surgical site infection (SSI), microbiological cultures from the infected surgical wounds, postoperative pain and acute phase reactants were investigated.

A prospective, randomized study was performed. The patients were randomized into 2 groups: those patients undergoing a subcutaneous sterile vitamin E acetate ointment application (Group 1) and those patients who did not receive this vitamin E ointment application (Group 2).

Before the skin stapling and after the subcutaneous irrigation with normal saline, sterile Vitamin E acetate ointment (FilmeOft, Hulka SRL, Rovigo, Italy) was applied in the subcutaneous tissue; 2 ml were applied in the suprapubic incision and 0.5 ml in the rest of port sites.

Incisional SSI, microbiological cultures from the infected surgical wounds, postoperative pain was evaluated 24 hours after surgery by means of a Visual Analogic Scale (VAS), ranging from 0 mm (complete absence of pain) to 100 mm (unbearable pain) and acute phase reactants (white cell count (WBC), fibrinogen and C reactive protein) 48 hours after surgery were investigated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of colorectal neoplasms and plans to undergo an elective laparoscopic surgery with curative aims

Exclusion Criteria:

* Open surgical approach or conversion to laparotomy
* Performance of a stoma
* Immunodepression status
* Anastomotic leak
Digestive Events in Duchenne Muscular Dystrophy Patients

Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients

Clinical Data of the disease Digestive events (pseudo occlusion, gastrostomy, cholecystectomy) Nutritionnal parameters Genetic of dystrophin (approved genetic nationnal Data base, CHU Cochin, Paris France)

Eligibility Criteria:
Inclusion Criteria:

* all Duchenne muscular dystrophy patients in our center

Exclusion Criteria:

* none
Diffusion Weighted Magnetic Resonance Imaging for the Characterization of Solitary Pulmonary Lesions

The purpose of this study, is to investigate the value of diffusion weighted imaging on the differential diagnosis of solitary pulmonary lesions.

When a patient is diagnosed with a lung lesion, the differential diagnosis is important, since the treatment is determined by the lesion character. The goal in the evaluation of solitary pulmonary lesions is to distinguish malignant lesions from benign lesions in as non-invasive a manner as possible. As computed tomography is widely used, the diagnosis of solitary pulmonary lesions has become easier. The size, features of the edges, shape, internal structure (calcification, fat content, cavitation, etc.), density, satellite nodule, growth rate and contrast involvement of the lesion are important properties which help to distinguish benign lesions from malignant ones. However, as the distinction is not absolute at all times, other imaging methods such as positron emission tomography and magnetic resonance are preferred. The importance of this issue is the high five-year survival rate in early-diagnosed lung cancer cases.

Diffusion is the randomized microscopic motion of water molecules. It is known that diffusion is a sensitive parameter of tissue characterization at a microscopic level. Nowadays, diffusion is measured in vivo with diffusion weighted MRI and ADC measurements.

Diffusion weighted imaging has a wide use on oncologic patients for the purpose of diagnosis. In addition, it is used in the distinction of acute cerebral infarction and epidermoid or arachnoid cysts. Recently, it has also been used in the characterization of cystic or solid lesions in the thoracic cavity. In this study, the investigators aimed to evaluate the accuracy of differentiation of solitary pulmonary lesions.

Eligibility Criteria:
Inclusion Criteria:

* All patients had a solitary pulmonary nodule or mass.

Exclusion Criteria:

-
Postprandial Fatty Acid Metabolism in Subjects With Lipoprotein Lipase Deficiency

Lipoprotein lipase (LPL) is an enzyme that plays an important role in removing triglycerides (TG) (molecules that transport dietary fat) from the blood. Patients with LPL deficiency (LPLD) display during their whole life very high plasma TG levels often associated with episodes of postprandial abdominal pain, malaise, blurred vision, dizziness (hyperchylomicronemia syndrome) that may lead to recurrent pancreatitis episodes. Because of their very slow clearance in blood of their chylomicron-TG, these patients need to severely restrict their dietary fat intake to avoid these complications. Fortunately, novel treatments are being developed to circumvent LPL deficiency (LPLD) metabolic effect on chylomicron-TG clearance. However, there is no data on how LPLD affect organ-specific dietary fatty acid metabolism nor how the novel therapeutic agents may change this metabolism. For example, it is currently not understood how subjects with LPLD store their DFA into adipose tissues and whether they are able to use DFA as a fuel to sustain their cardiac metabolism, as healthy individuals do. This study aims to better understand theses two questions.

The study protocol includes 3 visits: the screening visit and 2 postprandial metabolic studies performed in random order at an interval of 7 to 14 days, and performed with (A1) and without (A0) an intravenous (i.v.) heparin bolus followed by 250 IU/h i.v during 6 hours. Each metabolic study will last 9 hours (with 6 hours postprandial) and will include PET and stable isotopic tracer methods. At time 0, a low fat liquid meal will be ingested over 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* 8 healthy LPL-deficient individuals (LPLD subjects) with history of fasting TG \> 5 mmol/l and homozygote or compound heterozygote for a LPL-gene mutation;
* 8 control subjects (fasting glucose \< 5.6, 2-hour post 75g OGTT glucose \< 7.8 mmol/l and HbA1c \< 5.8%; fasting TG \< 1.5 mmol/l);
* age 18 to 75 yo;
* To be willing and able to adhere to the specifications of the protocol;
* To have signed an informed consent document indicating that they understood the purpose

Exclusion Criteria:

* age \< 18 yo;
* overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
* Treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin, and other antihypertensive agents that can be safely interrupted);
* Treatment with anti-hypertensive medication (only for LPL-deficient individuals);
* presence of liver or renal disease; uncontrolled thyroid disorder;
* previous diagnosis of heparin-induced thrombocytopenia;
* Treatment with oral anticoagulation medication or platelet aggregation inhibiting drugs;
* A history of major hemorrhagic event;
* smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day;;
* Female of child-bearing potential who is pregnant, breast feeding or intends to become pregnant or pre-menopausal female with a positive serum pregnancy test at the time of enrollment.
Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection

The purpose of this study is to determine whether the transversus abdominis plane (TAP) blocks are effective in postoperative pain control of adult patients undergoing laparoscopic colectomy.


Eligibility Criteria:
Inclusion Criteria:

* aged 20\~80
* undergoing laparoscopic colectomy

Exclusion Criteria:

* allergic history to local anesthesitcs
* tolerance to opioid
* cannot use IV-PCA
* previous abdominal surgery
* intestinal obstruction
* emergency
RCT: Added Value of Coordinator for the Management of Hip Fracture Patients

Introduction: Hip fracture due to osteoporosis is associated with an extremely high mortality morbidity and loss of quality of life. The risk of future fracture after a first hip fracture is increased. Several studies reported that patients who suffered from a fracture are not optimally treated and do not receive osteoporosis treatment after the first fracture episode.

Aim: To evaluate whether a coordinator increases the optimal management of osteoporotic fracture patients and hip fracture patients.

Material and methods: Population: Identification in the "IRIS public hospital network of all patients above 50 years" who suffer from hip fracture. Exclusion of those due to high energy fractures and due to known cancer.

First observational phase of treatment followed by randomized controlled trials of 2 years.

Intervention (RCT): Added value of a coordinator. Measured outcomes : A. New fractures. B. A score of optimal management of osteoporosis.

Definition of the score and management: 1. Realization of a bone density measurement. 2. Identification of secondary osteoporosis. 3. Identification of risk factors and calculation of the probability of a future fracture using FRAX score. 4. Attempt to correct risk factors of osteoporosis when possible. 5. Prevention of falls. 6. Prescription of calcium and vitamin D. 7. Prescription of a medical osteoporosis treatment. 8. Report to the general practitioner.

Eligibility Criteria:
Inclusion Criteria:

* Identification in the "IRIS public hospital network of all patients above 50 years" who suffer from hip fracture.

Exclusion Criteria:

* Exclusion of those due to high energy fractures and due to known cancer.
Blood Flow in Individuals With Down Syndrome

This study focuses on physiological explanations of difficulties with physical activity and exercise in individuals with Down syndrome, by non-invasively examining cardiac output and the regulation of blood flow to working muscles during exercise.

Work capacity is an important predictor of declining health or physical function, and of mortality, and is commonly measured as peak oxygen consumption. Peak oxygen consumption is very low in individuals with Down syndrome, the most prevalent genetic cause of intellectual disability. Previous research suggests individuals with Down syndrome may experience a double disadvantage when they are exercising: they may not be able to increase cardiac output sufficiently and they may not be able to allocate adequate blood flow to the working muscles.

The aim of this research study is therefore to determine the impact of limitations in central and peripheral regulation of blood flow on work capacity in individuals with DS. The results of this project will aid our understanding of the underlying mechanisms and determine the potential to improve health across the lifespan of individuals with Down syndrome by tailoring exercise interventions.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 45 years old
* generally healthy
* sedentary or low-active (defined as being involved in less than 30 minutes of moderately-intense physical activity per day)
* additionally for the participants with Down syndrome:

  * diagnosis of Down syndrome trisomy 21 and
  * normal thyroid function or stable thyroid function (and medications) for at least 6 months.

Exclusion Criteria:

* atherosclerotic or other vascular disease;
* asthma or other pulmonary disease;
* hypertension (defined BP \>140/90 mmHg);
* blood pressure below 90/60 mmHg;
* history of pre-syncope or syncope;
* diabetes (defined as Hba1c of \>7.5% or use of glucose lowering medication);
* severe obesity (defined as BMI \>40);
* medications affecting heart rate, blood pressure or arterial function;
* anti-inflammatory medication including NSAIDS;
* current smoking and
* pregnancy.
To Determine the Ability of a New Product Formulation to Remineralize an Early Caries Lesion by an In-situ Study

This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Male and/or female subjects 18 to 50 years inclusive
2. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
3. Willing to wear retainer 24 hours per day
4. No active, unrestored cavities
5. Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry
6. Available throughout entire study
7. Willing to use only assigned products for oral hygiene throughout the duration of the study
8. Must give written informed consent
9. Must be in good general health
10. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

1. Advanced periodontal disease
2. Medical condition which requires premedication prior to dental visits/procedures
3. Not enough teeth to secure the oral retainer
4. Diseases of the soft or hard oral tissues
5. Wear an Orthodontic appliances
6. Impaired salivary function
7. Current use drugs that can affect salivary flow
8. Use antibiotics one (1) month prior to or during this study
9. Pregnant or breastfeeding
10. Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period
11. Use tobacco products
12. Allergic to common toothpaste ingredients
13. Allergic to amino acids
14. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)
Effect of Different Implant Surface Treatments on Bony Changes Around Mandibular Implants

The research will be conducted to report which type of surface treatment of dental implants that can be successful and aids in increasing bone to implant contact and how it affects the bony changes around the implants installed in mandibular arches for completely edentulous patients or whether there are specific precautions to be taken into consideration during implant planning concerned with the type of surface microstructure treatment and recommendations needed.

Primary objective:

PICO P: Completely edentulous patients I: Laser surface treatment of implants C: Sandblasted Acid etched surface treatment O: Bony changes

Each Participants will have 2 implants;one laser surface treated implants and another sandblasted acid-etched implant (split-mouth) installed in the intra-foraminal area of mandibular arch prosthetically driven by the prepared conventional denture. MS and AF are responsible for delayed-loading of the denture and will measure bony changes around laser treated surface implants using radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patients
* Angle's class 1 skeletal relationship
* Normal facial asymmetry
* Cooperative patients
* Adequate inter-arch spcae not less than 12mm

Exclusion Criteria:

* Tempromandibular joint disorder
* Uncontrolled diabetes
* Bleeding disorders or anticoagulant therapy
* Flabby tissues or sharp mandibular residual ridge
* Heavy smoker
* Patient's with neuromuscular disorders
* Patients on chemotherapy or radiotherapy
* Severe psychiatric disorders
Pancreatectomy for NET: External Evaluation of WHO 2017 Grading System

Aim: The aim of this study was to investigate the clinicopathological factors and to evaluate the prognostic accuracy of the new World Health Organization (WHO) 2017 grading system in pancreatic neuroendocrine tumor (PanNET) patients.

Methods: Data collected between 1997 and December 2017 were analyzed. Histological grading and staging was based on the WHO 2017 grading system. Outcome after surgery and predictors of overall survival (OS) and disease free survival (DFS) were evaluated.


Eligibility Criteria:
Inclusion criteria:

- patients with histologically proven neuroendocrine tumor located in pancreas who underwent pancreatic resection (by open, laparoscopic or robotic approach) even in case of distant metastasis at time of surgery, with no previous or concurrent malignancy.

Exclusion criteria:

- Patients with tumors diagnosed as adenocarcinoma with scattered neuroendocrine cells or with focal neuroendocrine component were excluded of this study.
ST- Depression on Electrocardiogram During Caesarean Section in Regional Anaesthesia in Women With Preeclampsia

The investigators examined whether there was a difference in the occurrence of ST depressions after injection of five or ten units of oxytocin, in preeclamptic patients delivered by caesarean section (CS) under regional anesthesia.

ST depression on electrocardiograms has been reported in healthy women undergoing cesarean section in regional anesthesia. The investigators examined whether there was a difference in the occurrence of electrocardiogram changes suggestive of myocardial ischemia (ST depressions) in preeclamptic patients randomized to five or ten units of oxytocin during cesarean section with regional anesthesia.

In a double-blind randomized controlled study preeclamptic patients undergoing cesarean section under spinal anesthesia were randomized to 5 or 10 units of oxytocin, given as an intravenous bolus. A Holter monitor was used to record electrocardiograms. Non-invasive blood pressure and heart rate were monitored.

Eligibility Criteria:
Inclusion Criteria:

* women with preeclampsia undergoing CS under spinal anesthesia. Preeclampsia was diagnosed if blood pressure was ≥ 140/90 mm Hg and if proteinuria of more than 1000 mg/day persisted.

Exclusion Criteria:

* multiple birth,
* obesity (body mass index \> 35),
* age \< 18 years,
* complications of the pregnancy other than preeclampsia or non-proficiency in the Swedish language
Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction

Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with life-threatening condition, and it is often related with bacterial overgrowth. Fecal microbiota transplantation (FMT) results in restoration of the normal intestinal microbial community structure. The investigators planned to observe the eﬃcacy of FMT in the treatment of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and gastrointestinal quality-of-life index(GIQLI) were evaluated.


Eligibility Criteria:
Inclusion Criteria:

Patients had to have a ﬁrm diagnosis diagnostic criteria for CIPO proposed by Ministry of Health, Labour, and Welfare, including documented pathological bowel dilatation on imaging in the absence of mechanical obstruction.

Exclusion Criteria:

None.
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist ropinirole for the treatment of hyperprolactinemia in patients with idiopathic hyperprolactinemia and prolactinomas.

Treatment of prolactin secreting pituitary tumors with traditional ergot dopamine agonist drugs can be limited by medication side effects, pharmacologic resistance, and by concerns regarding the potential risk of cardiac valve disease. The overall goal of this project is therefore to evaluate, for the first time, the efficacy and tolerability of the selective D2/D3 receptor non-ergot dopamine agonist ropinirole for the treatment of prolactinomas. This proposal will establish the pharmacologic profile of this medication when used to treat hyperprolactinemia in patients with prolactinomas and will determine the impact of long-term ropinirole administration on critical clinical parameters including serum prolactin levels, gonadal function, and tumor regression, in order to establish ropinirole's utility as a new, clinically efficacious, safer and more tolerable therapeutic option for the treatment of prolactinomas that may prove particularly useful in patients with underlying cardiac valve disease and in those with resistance or intolerance to ergot dopamine agonists.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70 years
* Prolactin level (PRL) ≥2 times upper limit of normal
* Pituitary adenomas on MRI ≤ 1.5cm in greatest diameter and ≥ 5mm from the optic chiasm
* Normal renal and liver function
* Agrees to barrier contraception if pre-menopausal

Exclusion Criteria:

* Use of medications known to interfere with PRL secretion and PRL and Ropinirole (ROP) metabolism
* Use of another dopamine agonist during the 4 weeks prior
* Pituitary stalk compression on MRI
* History of visual field abnormalities or previous radiation
* Untreated hypothyroidism
* Consumption of \> 2 alcoholic drinks per day
* Pregnancy
Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.

The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.

This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2011 and a register-based follow-up study for invasive disease, hospital-diagnosed pneumonia, tympanostomy tube surgery and outpatient antimicrobial treatment.

Eligibility Criteria:
Inclusion Criteria:

* age 3 to 7 years
* younger sibling at least 12 months of age living in the same household participates in the FinIP or 053 trial (regardless of the vaccination schedule)
* at least one parent with fluent Finnish
* informed consent from one parent

Exclusion Criteria:

* commercial PCV vaccination administered
* study-related PCV vaccination administered (open or blind)
* history of antimicrobial treatment within 4 weeks (the child can be enrolled later)