cyrilzakka/clinical-trials huggingface dataset:
The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

The goal of this food intervention study is to screen/validate the whole grain food intake biomarker in health Chinese's population.

Although increased consumption of whole grains (WGs) is associated with improved health outcomes, the dietary intake assessment and health mechanisms for WGs or WG-containing food remain unresolved. In addition, information regarding its consumption and health effects in Chinese people is scarce. Biomarkers of WGs intake would allow a more accurate assessment of its consumption in nutrition studies. The investigators want to perform a crossover study where participants were subjected to a WG-wheat flour or a refine wheat-flour Chinese diet. Using a metabolomics approach, the investigators aimed to identify the WG-specific metabolites present in plasma/urine after consumption WG or WG foods, including new candidate biomarkers of WG intake.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* age 18-40 years
* BMI 18.5-23.9 kg/m2.

Exclusion Criteria:

* pregnancy or breastfeeding
* vegetarian;
* smokers;
* acute and chronic diseases;
* allergic to wheat;
* frequent nutrients supplement use;
* medication use of antibiotics within 1-month;
* more than 3 kg weight change within 3-month;
* unwillingness to follow dietary restrictions;
Randomized Trial on Resin Infiltration in Deciduous Teeth

It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of treated caries lesions, compared to fluoride varnish therapy only.

* To determine the number of patients, sample size was based on data from studies assessing fluoride varnish efficacy in children with deciduous teeth (progression of caries reduction by 33 %)(95% CI, from 19 to 48%, P\<0.0001); (α = 0.05; power = 80%; chi-square test2). The calculated sample size was 60 children and 120 white spot lesions. The initially planned number of participants was increased by expected 20% drop-out after 1 year, at least 72 children; the minimal number of treated active caries lesions amounted to 144.
* Participants were allocated to the "test" and to the "control" group, respectively, by computer-generated randomly permuted blocks using package blockrand in R statistical software, sealed in envelopes.
* The children were re-examined clinically by the same 2 examiners as at baseline evaluation.
* Statistical analyses were performed using statistical software STATISTICA 10 (StatSoft), the level of significance was set at 0.05. Intra-examiner reliability was assessed by kappa statistics.
* To compare average values between two independent groups U Mann-Whitney test was used (for e.g. to compare experimental group with the control one); Wilcoxon signed-rank test was used for paired samples (for e.g. to compare first measurement with final measurement for experimental group). Comparison of fractions was conducted using Pearson's chi-square test of independence and Z test. The 95% confidence intervals were calculated on the basis of normal approximation.

Eligibility Criteria:
Inclusion Criteria:

* at least two active smooth-surface caries lesions in deciduous teeth (ICDAS II code 2)
* a written consent of parents/ guardians for participation in the research study

Exclusion Criteria:

* age above 5.9 years
* systematic disease
* cavitated lesions
* enamel defects
* current participation in another study
* a planned change of residence within one year
Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting

A randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to standard autologous bone block grafting.

A phase III multi center clinical trial, randomized and controlled.The study subject is lacking one or more sheet behind the canine in the upper or lower jaw, and the alveolar ridge is too narrow to place a dental implant. The test objects will have augmentation using autologous mesenchymal stromal cells and a biomaterial, biphasic Calcium Phosphate. The control is the traditional bone block from the ramus.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non smoking patients in need of dental implants in the upper or lower jaw, with loss in vertical height and less that 4 mm in lateral width.

Exclusion Criteria:

* General contraindications for dental and/or surgical treatments
* Contraindications for both bone marrow harvesting and bone grafts
* History of any malignant diseases
* Concurrent or previous radiotherapy of head and neck region
* History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection)
* Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient's history and concurrent HbA1c levels (HbA1c \> 53 mmol/mol).
* Inflammatory and autoimmune disease of the oral cavity.
* Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.
Gut Microbiome in Fecal Samples From Patients With Metastatic Cancer Undergoing Chemotherapy or Immunotherapy

This research trial studies the gut microbiome in fecal samples from patients with cancer that has spread to other parts of the body who are undergoing chemotherapy or immunotherapy. Studying samples of feces from patients with metastatic cancer in the laboratory may help doctors learn if the make-up of the gut microbiome has a positive or negative influence to a patient's response to chemotherapy or immunotherapy.

PRIMARY OBJECTIVES:

I. To quantitatively determine the composition of the microflora and their gene and protein expression levels in patients with metastatic colorectal cancer being treated with fluorouracil (5-FU) based chemotherapy, or anti-PD1 immunotherapy.

SECONDARY OBJECTIVES:

I. Compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with response to chemotherapy or immunotherapy.

II. Compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with toxicities and side effects resulting with chemotherapy or immunotherapy.

OUTLINE:

Patients undergo collection of fecal specimens at baseline, prior to start of each course of chemotherapy or immunotherapy, at the end of weeks 2, 4, 6, and 8, at the end of course 3 and courses thereafter of chemotherapy or immunotherapy, and at the time of disease progression or going off-treatment. Fecal specimens are analyzed via 16S ribosomal ribonucleic acid (RNA) gene sequencing, meta-transcriptomics analysis, and meta-proteomics analysis.

Eligibility Criteria:
Inclusion Criteria:

* Must be willing and able to provide fecal samples according to protocol schedule
* COHORT A
* Diagnosis of metastatic colorectal cancer, where the metastatic disease has not been previously treated
* Scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or folinic acid-fluorouracil-irinotecan (FOLFIRI) based chemotherapy for the advanced disease
* Must have radiologic evidence of disease
* COHORT B
* Diagnosis of metastatic cancer
* Scheduled to begin pembrolizumab or another anti-PD-1 or anti-PD-L1 antibody as single agent therapy for the treatment of the advanced disease
* Must have physical or radiologic evidence of disease

Exclusion Criteria:

* Patients with a colostomy or any other issues that may prevent the standard methods for collection of stool are not eligible for this study
* Patients are not enrolled or a research protocol for treatment
Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.

Respiratory distress syndrome (RDS) is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural immaturity in the lungs. Exogenous surfactant therapy has become well established in newborn infants with RDS. Surfactant replacement therapy, either as a rescue treatment or a prophylactic, reduces mortality and several aspects of morbidity in babies with RDS. It is known that infants who are at a significant risk of RDS should receive prophylactic surfactant therapy, but the optimal timing and strategy for prophylactic surfactant therapy remains controversial. When administered immediately after delivery, surfactant mixes with the fetal lung fluid and reaches the alveoli before the onset of lung injury potentially created by the first applied positive pressure ventilation. As another approach, surfactant prophylaxis may be administered after resuscitation and stabilization.

Eligibility Criteria:
Inclusion Criteria:

* Premature infants born before 28 weeks' gestation
* Premature infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery

Exclusion Criteria:

* Infants died at delivery room
Method Evaluation Study of Truview Picture Capture Device(PCD) Versus MacIntosh Laryngoscope

Aim:

The aim of the method evaluation study is a comparing study of Truview PCD™ (Picture Capture Device) laryngoscope vs. Macintosh laryngoscope. The result of this study will form a basis for a possible recommendation of the Truview PCD™ laryngoscope in our organisation.

The laryngoscopes are compared according to their ability to visualize the glottis area measured by the Cormack Lehane (CL) grade and the time used to get the best CL grade.

A registration of any damage of tissue/teeths caused by the laryngoscopes, and a possible decrease of the saturation will also be made.

Hypothesis:

The Truview PCD™ laryngoscope provides a better view of the vocal cords and thereby makes the intubation les difficult.

CL 1 is achieved in 90 percent of intubations with the Macintosh laryngoscope, and the hypothesis of the study is that CL 1 can be increased to 98 percent by use of the Truview PCD™ laryngoscope.

The unexpected difficult intubation is, like the difficult mask ventilation, a feared complication to anaesthesia.

A difficult intubation occurs in approx. 1.2 - 3.8 percent of all anaesthesias .

The standard procedure of intubation in Denmark is to use the curved Macintosh blade. This method, however, has some limits, as it requires a direct view of the area of the vocal cords. For that reason we are looking for new methods of intubation that can give a better overview.

The Truview PCD™ laryngoscope is a commercially available laryngoscope with an integrated optical lens that can be connected to a camera head, and gives a better view of trachea during intubation under a general anaestetic. Furthermore it is possible to connect 8-10 liters of oxygen per minute to the Truview PCD™ laryngoscope, which will prevent fog on the viewtube and slow down the rate of desaturation.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age who are to undergo a surgery at the ENT department, Aalborg Hospital.
* Patients who understand and accept the trial information.
* SARI score 2-5.

Exclusion Criteria:

* SARI score 0-1 and \> 5.
* A need for acute initiation. (By acute initiation the endotracheal tube will be placed in trachea during the first laryngoscopy without prior spraying with local anesthesia).
* If unexpected difficulties during the initiating anesthesia arise, the trial will be interrupted, and the patient will be treated according to the department's guidelines for the situation
Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?

The purpose of this exploratory study is to characterize the postoperative pain profile of patients undergoing operation with internal fixation of an ankle fracture under nerve block anaesthesia. Special attention is payed towards the possible existence and clinical relevance of a rebound pain phenomenon upon cessation of the nerve block.

Results are used to guide the set up of a randomized controlled trial on the subject.

Peripheral nerve blocks (PNB) are widely used as anaesthesia and postoperative pain control for surgery. Several studies have suggested multiple benefits of PNB's but primarily shown in elective surgery. Acute conditions like ankle fractures have a different pain profile and risks and benefits of PNB's have not been sufficiently researched in these cases.

A recent study (Goldstein et al. 2012) suggested that a rebound pain effect occur upon cessation of PNB effect defined as a pain increase to a significantly higher level than observed in patients with no PNB at the same point after surgery.

With this prospective, exploratory study we aim to examine the postoperative pain profile after PNB anaesthesia for ankle fracture surgery with focus on plausibility of a rebound pain effect (as defined above) upon PNB cessation.

Secondarily to explore a variety of factors related to postoperative pain profile and feasibility of PNB anaesthesia for ankle surgery including efficacy, risk factors, time factors as well as postoperative recovery and overall patient satisfaction. Results will provide focus for a following randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years old scheduled for internal fixation of an ankle fracture as defined above.
* Ability to read and understand Danish and give informed oral and written consent

Exclusion Criteria:

* Multitrauma patients / other simultaneous fractures
* Cognitive or psychiatric dysfunction causing expected inability to comply with study protocol
* "CAVE" nonsteroidal antiinflammatory drugs (NSAID) or Morphine or Local Anaesthetics as evaluated by anesthesiologist for any reason
* Primary investigator unavailable for PNB administration at scheduled time of operation
* Infection at PNB injection site
* Time from fracture to operation \> 5 days
* Existing neuropathy with functional impairment of the fractured extremity
* Bodyweight \< 50 kg
* Daily use of opioids \> 2 weeks preoperatively
* Pregnancy
* Nephropathy requiring dialysis
A Trial Comparing Qam With Qpm Dosing in Assisted Reproductive Technologies (ART)

This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI when taking their gonadotropin dosage in the morning (am) or evening (pm).


Eligibility Criteria:
Inclusion Criteria:

* women between 21-42 undergoing IVF

Exclusion Criteria:

* women \> 45,
* women with one ovary,
* donor egg,
* surrogacy,
* FET cycles,
* uterine problems,
* large fibroids
Omega-3 and Vitamin D Supplements in Childhood T1D

The study was conducted in 64 patients with T1D of which 26 had the onset in 2017, and 38 in 2016, 2015 and 2014. All received vitamin D 1000 IU /day since disease's onset. Moreover in the 2017 group omega-3 were supplemented, starting within 3 and 6 months from the disease's outbreak, and those were considered cases; the other 38 were enrolled as controls. Four cases and one control dropped out. Finally in 59/64 were compared data of glycosylated hemoglobin percentage (HbA1c%), average insulin daily requirement (IU/Kg/day), and IDAA1c \[Insulin Daily dose Adjusted for HbA1c, a surrogate index of residual endogen insulin secretion, calculated as insulin daily dose (IU/Kg/24 h) x 4 + HbA1c%\] at recruitment (T0), and 3 (T3), 6 (T6), 12 (T12) months after. T0 in cases was at the start of supplementation of omega-3, and consequently 3, 6 and 12 months after; in controls were found data in clinical records of outpatient beginning from the 3rd month and 3-6-12 months thereafter. Then 22 cases and 37 controls were compared.

Was assessed the comparability of cases and controls at baseline for gender, age, body weight, HbA1c% and device for insulin therapy.

The preparation of omega-3 administered was a highly purified fish oil to avoid pollutants, containing a mixture of omega-3 long chain fatty acids standardized for contents of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a 2: 1 ratio, in capsules or in liquid form. The liquid preparation was used in the case of difficulties in swallowing capsules or concomitant celiac disease because it was certified as gluten-free (Ener Zone Omega 3 RX® Equipe Enervit). The preparations contained antioxidants to preserve omega-3 LCFA, tocopherol (1 mg in 1 g of omega-3 LCFA), palmitate, and rosemary extract. EPA and DHA were administered at 50-60 mg/kg/day for 12 months. The investigation of Arachidonic Acid (AA)/EPA ratios was performed in cases on recruitment (T0), and repeated after 3 (T3), 6 (T6), and 12 months (T12).

Cholecalciferol supplementation was fixed at 1000 IU/day (25 mcg/day), both in cases and controls. Vitamin D level was determined as 25(OH)D level at the clinical onset of T1D, at T0, T3, T6, and T12 in cases, and at clinical onset of controls.

Eligibility Criteria:
Inclusion Criteria:

* All T1D patients aged 1-18 years whose disease onset had been in 2017, 2016, 2015, 2014 affering to the Pediatric Diabetology of AOU Novara (Italy)
* written consents of parents
* without assumption of omega 3 supplementation before 2017

Exclusion Criteria:

* renal cysts
* sarcoidosis
* histoplasmosis
* hyperparathyroidis
* lymphoma
* tuberculosis
* Patients treated with drugs that could affect immunity or glucose metabolism, including corticosteroids, ciclosporin and tacrolimus
Reliability of Ultrasound Examination of the Inferior Caval Vein

The purpose of this study is to compare validity of examination and measurement of inferior caval vein from different views in critically ill patients on mechanical ventilation.

A maximal and minimal diameter of inferior caval vein will be measured by transthoracic echocardiography in critically ill patients on mechanical ventilation hospitalised in the intensive care unit from four different views:

1. Subcostal view on the inferior caval vein in the long axis,
2. subcostal view on the inferior caval vein in the short axis,
3. right lateral view on the inferior caval vein in the long axis,
4. right lateral view on the inferior caval vein in the short axis.

Comparison between the results of measurements in the subcostal view in the long axis and other views will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients
* Patients on mechanical ventilation indicated for transthoracic echocardiographic examination

Exclusion Criteria:

* Age \<18 years
* Insufficient imaging quality
* Refusal of echocardiographic examination by patient
Maintenance Optimization of the Fully Implanted Venous Catheter

Central venous catheter (CVC) are intravascular devices used in clinical practice, namely to administer fluid therapy, parenteral nutrition, drugs, blood products, hemodynamic monitoring, also being a gateway to the collection of blood samples or laboratory monitoring.

The fully implanted central venous catheter (CVCTI) is a type of central venous access surgically placed, which is characterized by containing a subcutaneous reservoir that is accessed by puncturing the camera with a blunt needle, widely used in cancer patients. The fully implanted central venous catheter is recommended when there is a need for intermittent vascular access and of long duration.

The maintenance of the CVCTI, as it's the necessity, frequency, and method is subject of some controversy, with discrepancies between the various cancer centers and guidance documents, once they occur several different intervals and maintenance methods.

The objective of this study is to assess the necessity of frequent maintenance of fully implanted central venous catheter, still assuring its viability and holding the same or lower number incidence of complications.

Participants in this study are cancer patients with a CVC fully implanted for chemotherapy, in follow-up phase. Participants will be randomized in one of two arms: Maintenance with saline solution and no maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Cancer patients, undergoing placement of CVCTI for chemotherapy, in follow-up, who finished chemotherapy up to a maximum period of 10 weeks.
* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Evidence of signed and dated informed consent indicating that the patient has been informed of all relevant aspects of the study and agrees to participate.

Exclusion Criteria:

* Presence of metastases or any other condition that may be an indication for intravenous treatments or additional chemotherapy regimens
* History of CVCTI-related adverse events during the treatment phase
* Patients on anticoagulant medication
* History of thrombophilia
* Pregnancy/Breastfeeding
Treatment Reality of Tension Band Wiring and Locked Plate Fixation of the Olecranon

The incidence of the olecranon fracture (OF) in adults is around 12 per 100,000 inhabitants per year.1 The anatomical shape of the proximal ulna is largely responsible for the stabilization of the humeroulnar joint and reconstruction is therefore obligatory, but often challenging. Surgical treatment of the olecranon fracture is performed using tension band wiring (TBW) or locking plate fixation (LPF) osteosynthesis. It is not yet clear, which procedure is superior for a specific patient. In future, an individualized and objectified assessment of expected general and fracture-specific complications should enable the treatment to be individually adapted to the patient\&#39;s risk profile. This shall prevent complications, unnecessary treatments, and treatment costs. In the project presented here, the reality of care for surgically treated patients with olecranon fractures will be analyzed using routine data collected by the BARMER health insurance fund.

The aim of the study is to analyze differences in the outcome of patients with an olecranon fracture treated with TBW compared to LPF and to identify independent risk factors for unfavorable course.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient coded diagnosis of olecranon fracture (ICD S52.01)

Exclusion Criteria:

* Incomplete basic information
* Incomplete insurance status within two years before index
* Previous treatment of olecranon fracture
* Unclear treatment of olecranon fracture
* Age \&lt; 18 years
* Coded polytrauma
* Bone tumors/ bone metastasis
* Both sides injured or missing information of surgery side
Diagnostic Value of Hand Ultrasound Versus MRI in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is one of the most common autoimmune rheumatic diseases, affecting one in 100 individuals worldwide. It is considered a complex systemic multifactorial inflammatory process in which the immune system targets synovial joints and causes mild to severe joint destruction with extra-articular manifestations.

If left untreated, RA leads to deformity, considerable disability, and major comorbid conditions, including cardiovascular disease and increased mortality.

Early treatment with targeted therapies can alter long-term outcomes by minimizing disease activity, preventing joint damage and disability, and improving patients' quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Adult-onset disease.
2. Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis.

Exclusion Criteria:

1. Any patient with any collagen disease rather than Rheumatoid arthritis.
2. Patients with joints deformities.
3. Patient's with implanted metal clips or wires or artificial pacemaker.