cyrilzakka/clinical-trials huggingface dataset:
The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes

The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes.

This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze).


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 1 diabetes (diagnosed based on the WHO criteria) no later than 6 months after the diagnosis.
* Insulin therapy: multiple daily injections,
* In the investigator's opinion, the participant must be technically capable of using the FreeStyle Libre system

Exclusion Criteria:

* Current or past use of any continuous glucose monitoring system.
* Pump therapy.
* Known allergy to medical adhesives.
* Oral steroid therapy.
* Pregnancy or planning pregnancy within the study duration.
* Breast feeding.
* Dialysis treatment.
* Having a pacemaker.
* Unstable coronary heart disease.
* Cystic fibrosis.
* Cancer.
* Psychiatric disorders.
* Severe end-organ damage (kidney, liver, etc) or any uncontrolled disorder.
* Hospitalization for any reason other than the newly diagnosed type 1 diabetes 6 months prior to inclusion.
* Participating in another clinical trial that could affect glucose measurements or glucose management.
* In the investigator's opinion, if the participant is considered unsuitable for inclusion in the study for any other reason.
Probiotics in Children With Early Childhood Caries

The purpose of this study is to determine if probiotic lozenges taken once a day before bedtime for twelve weeks can decrease the numbers of Streptococcus mutans

Streptococcus salivarius is one of the commensal bacteria of the mouth and the main component of biofilm. Research indicates that some microorganisms present in plaque, which until recently were considered not to cause caries, including Streptococcus salivarius, present in the supragingival microbiome, can also cause tooth decay.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy children aged 3-6;
* recognized caries of early childhood, dmf\> 1,
* lack of active caries and inflammation of the mouth
* CFU\> 105 / ml Streptococcus mutans
* a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research.

Exclusion Criteria:

chronic diseases and chronically taken medicines in the past,

* planned change of residence during the year,
* age below 3 and above 6 years,
* healthy teeth, dmf = 0,
* CFU \<105 / ml Streptococcus mutans
* Patient during antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations
* no toothpaste with fluoride
* using xylitol
* lack of written consent of parents / legal guardians for participation in research.
The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold

Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain.The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain.Few studies have demonstrated an association between plasma levels of oxytocin and pain in humans. Since addictive properties of oxytocin have not been described, the drug may have important application in the management of acute and chronic pain. No studies have examined the effect of intranasal oxytocin on pain sensitivity and threshold.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females volunteers, English speaking

Exclusion Criteria:

* Pregnancy, lactation, allergy to preservatives, mental disease, any chronic pain and any current use of analgesics, anxiety or depression.
The Impact Of Periodontal Disease Treatment On The General Health Status In Chronic Haemodialyzed Patients

Several studies revealed a direct relationship between the severity of periodontal inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other source of inflammation but PDD, proper dental treatment of the disease decreased CRP to normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007) Moreover, a direct link between high levels of CRP and atherosclerotic complications has been found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig W, et al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999; Zimmermann J, et al. 1998).

Patients will be recruited according to eligibility criteria. Initial oral and general status will be evaluated and recorded. The evaluated parameters are listed at the study description section. Also, quality of life will be assessed by using the SF-36 and OHIP-14 questionnaires.

Patients will undergo a series of dental interventions with the final scope of eliminating all oral inflammation. Participants will also be instructed regarding correct oral hygiene habits.

Following dental and periodontal treatments, the oral and general status will be reassessed and the obtained dat analysed.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialyzed patients with periodontal disease

Exclusion Criteria:

* Malignancies, Diabetes
* Patient refusal to participate
Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer

This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
* Aged 18 years or older
* Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
* Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance.
* Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
* Received at least 1 but not more than 4 prior therapy regimens.

Note: Maintenance therapy OR hormonal therapies should not be counted as a separate therapy.

Note: Patients who have not received prior bevacizumab must be deemed medically inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.

* Measurable disease according to RECIST v1.1 criteria
* Normal gastrointestinal function.
* At least 28 days between termination of prior anticancer or hormonal therapy and first administration of batiraxcept.
* Full recovery from all treatment-related toxicities to Grade 1 or less, except alopecia.

Exclusion Criteria:

* Tumors in the breast or bone
* Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on \>10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
* Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen)
* Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
* Received prior therapy with PAC in the platinum-resistant recurrent setting
* Evidence of clinically significant third spacing (e.g., pleural effusions, ascites, anasarca, etc.) that requires therapeutic intervention within 28 days prior to first dose of batiraxcept/placebo
Trental for the Treatment of Vertigo/Dizziness/Imbalance

Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older. The symptoms have a severe impact on affected individuals with detrimental effects on work, travel, social and family life. These patients see doctors often with no relief in their symptoms.

The most promising help for these patients is to use medication that will increase blood flow to the inner ear. Pentoxifylline (Trental) has been shown to increase microvascular blood flow.

One potential cause of vestibular dysfunction is a decrease in or insufficient blood flow to the inner ear. Studies have shown that when the blood flow is decreased to the inner ear, patients will become dizzy and off balance. This study will use validated instruments to evaluate the effectiveness of Trental in patients that present to our providers with vertigo, dizziness, or imbalance and meet inclusion criteria. They will be blinded and randomized to treatment or placebo, which they will take for \~12 weeks. Patients will completed validated surveys 3 times (beginning, middle and end of study) as well as account for the number of times they have fallen and if they have missed any work due to their symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 40 years and older
2. English as primary language
3. Diagnosis of multisensory losses, presbystasis, bilateral vestibulopathy, central vascular insufficiency, small vessel circulatory disease, generalized imbalance, and idiopathic peripheral vertigo scoring at least 16 on the Dizziness Handicap Inventory
4. Willingness to complete surveys and take medication as prescribed

Exclusion Criteria:

1. Diagnosis of the following: benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine with headache, intracranial mass, perilymphatic fistula, or multiple sclerosis
2. history of cholesteatoma
3. Prior ear surgery other than myringotomy and tube placement
4. Prior radiation to head or neck
5. previous use of vestibulotoxic medications where the enrolling provider determines the drug exposure to be the cause of imbalance
6. Use of blood thinning medications
7. intolerance/allergy to pentoxifylline or methylxanthines, as well as recent cerebral or retinal hemorrhage (past 3 months)
8. Pregnant or lactating females.
Perceived Barriers to Exercise in Individuals Living With Spinal Cord Injury

Purpose: This project is designed to identify what the key barriers to participating in exercise are for the general population of people living with spinal cord injury (SCI) in the United States (US).

Purpose: This project is designed to identify what the key barriers to participating in exercise are for the general population of people living with spinal cord injury (SCI) in the United States (US).

Background: A previous study of 681 people living with SCI demonstrated that the majority of participants thought that exercise was important (97%), but that only 57% actually had access to exercise (K.D. Anderson. 2004. Targeting recovery: Priorities of the spinal cord injured population. J. Neurotrauma. 21:1371-1383). The next step in continuing that research is to determine in more detail what the perceived barriers to exercise are so that they can be addressed in multiple settings (research design of exercise protocols, community access and awareness, clinical effectiveness, etc.).

Methods: Internet-based survey of people with spinal cord injuries (SCI). Expected Results: It is expected that the perceived barriers will fall under 3 main categories (internal, resources, and structural). However, there may be other barriers we are unaware of, for example, societal or cultural factors or other factors completely unforeseen.

Relevance to Rehabilitation: The findings of this project will provide valuable information needed to design strategies aimed at improving participation in exercise by people living with SCI. SCI results in several secondary health conditions over time, which can likely be positively impacted by exercise.

Eligibility Criteria:
Inclusion Criteria:

* Any person with a spinal cord injury who is at least 18 years of age, lives in the United States of America, and can read English.

Exclusion Criteria:

* People who cannot read English will not be included because the website will be hosted in English and the survey software (phpQuestionnaire 2.2 by Chumpsoft, Inc.) default language is English.
Endotypic Stability in CRS

A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic sinusitis (with or without polyps)
* Undergoing endoscopic sinus surgery during the study period
* More than 18 years
* No chronic illness/ malignancy
Efficacy of Bilateral Ultrasonic Guided Sphenopalatine Ganglion Block in Maxilofacial Cancer Surgeries

Patients will be randomly allocated according to computer - generated tables to one of two groups, group (A) ultrasonic guided sphenopalatine block using local anasthetic, group (B) ultrasonic guided sphenopalatine block using saline. Before induction anesthesia the following will be assessed, time needed to perform the technique, time till onset of the block, distribution of the block (Opthalmic, Maxillary, Mandibular) by needle brick.Intra and post- operatively the following will be assesse the quality of operative filed every 30 min intra-operatively using a pre- defined average category scale (ACS) (from 0 to 5), End tidal Sevo Flurane concentration will be recorded intra- operatively every 5 minutes, The total amount of Nitroglycerine used to achieve the target MAP and frequency of propranolol usage will be recorded,emergence time, postoperative VAS score and amount of meperdine used for rescue analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients of ASA physical status I and II, aged 20-70 year who will be scaduled for Maxillo - facial cancer surgeries

Exclusion Criteria:

* patients with disfigurement and disturbed anatomy that will not allow easy access to the sphenopalatine ganglion, bleeding disorders, history of hepatic, renal or cardiopulmonary dysfunction, patients receiving drugs affecting coagulation or cardiovascular active medication are excluded also patients having infection or allergies to local anesthetics
Myeloid-derived Suppressor Cells in Colorectal Cancer

The aim of the study is to evaluate whether the preoperative level of myeloid-derived suppressor cells is associated with postoperative complications classified by Clavien-Dindo categories. Levels of all MDSC, polymorphonuclear MDSC (PMNMDSC), monocytic MDSC (MMDSC), early-stage MDSC (EMDSC) and monocytic to polymorphonuclear MDSC ratio (M/PMN MDCS) were established and compared in patients with postoperative complications, severe postoperative complications (\>= IIIA according to Clavien-Dindo) and severe septic complications.

Levels of all MDSC, polymorphonuclear MDSC (PMNMDSC), monocytic MDSC (MMDSC), early-stage MDSC (EMDSC) and monocytic to polymorphonuclear MDSC ratio (M/PMN MDCS) were established and compared in patients with and without postoperative complications. Then subgroup analysis was performed to compare levels of MDSC in patients with severe postoperative complications (\>= IIIA according to Clavien-Dindo) and those without severe complications. Another subgroup analysis will be performed for patients with severe septic complications that are defined as severe complications with accompanying infection. Levels of MDSC will be compared by means of U Mann Whitney test as their distribution is not normal. After above mentioned analyses it will be possible to evaluate the role of MDSC in patients with colorectal cancer in terms of postoperative complications. Additional analyse will be performed to compare levels of MDSC in patients who underwent neoadjuvant treatment (radiotherapy or chemoradiotherapy).

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18
* colorectal cancer confirmed by histological examination of biopsy specimen
* elective operation
* signed informed consent

Exclusion Criteria:

* Age \< 18
* Pregnancy or lactation
* Emergency operation
* General condition that precludes understanding and signing of the informed consent form
Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations

The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Age greater than or equal to 12 years;
* Minor recurrent aphthous ulceration with onset of symptoms within 48 hours;
* Moderate to severe baseline pain, with VAS ≥ 4 (EVA scale).

Exclusion Criteria:

* Any clinical findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participants diagnosed with: Behcet's disease, rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, Reiter's syndrome, Crohn's disease, ulcerative colitis);
* Participants with diseases that affect healing (e.g. diabetes);
* Immunocompromised participants;
* Participants with aphthous herpetiform ulceration or major aphthous ulceration;
* Participants using medication to treat oral ulcerations (systemic or local);
* Participants who used analgesics or anti-inflammatory drugs in the 6 hours prior to the beginning of the study;
* Participants who used systemic antibiotics in the 2 weeks prior to the beginning of the study;
* Participants using medications that can confuse pain assessment (psychotropics, antidepressants and sedative-hypnotics), except when on a stable dose for at least 30 days prior to the screening visit, and the dose cannot be changed during the clinical trial;
* Participants with current smoking habits.
* Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
* Known hypersensitivity to the formula components used during the clinical trial;
* Participants with current or medical history of cancer in the last 5 years;
* Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.
Effects of Three Airway Instruments on the Incidence of Postoperative Sore Throat

Postoperative sore throat (POST) is a common complaint after general anesthesia. POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia. This condition may affect recovery and patient satisfaction and is associated with many factors, including intubation tools. Previous studies have reported conflicting results on POST. This retrospective cohort study, with sample size of 10,382 patients, was conducted to confirm the hypothesis that the use of video laryngoscopy (VL) is associated with a lower incidence of POST compared with direct laryngoscopy (DL).

Background: Postoperative sore throat (POST) is a common complaint after general anesthesia. POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia. This condition may affect recovery and patient satisfaction and is associated with many factors, including intubation tools. Previous studies have reported conflicting results on POST. This retrospective cohort study, with sample size of 10,382 patients, was conducted to confirm the hypothesis that the use of video laryngoscopy (VL) is associated with a lower incidence of POST compared with direct laryngoscopy (DL).

Methods: Data were extracted from a prospectively maintained quality improvement database. A total of 10,382 patients were included in the study. Statistical analysis was conducted for comparisons of demographic characteristics and to determine the effect of intubation tools on the incidence of POST.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving inpatients surgery and general anesthesia with tracheal intubation

Exclusion Criteria:

* Having difficult airway,

  * Anticipated difficult airway:

    1. Abnormal cervical spine movement or temporomandibular joint movement
    2. Airway-compromising masses such as tumors, cysts, or hematomas
    3. A Mallampati score greater than 3
    4. A thyromental distance of less than 6 cm
    5. A lesion below vocal cord
    6. A previously identified difficult airway
  * Unexpected difficult airway

    1. difficult mask ventilation
    2. difficult vocal cord visualization after multiple attempts of laryngoscopy
* Receiving laryngeal surgery, such as laryngeal biopsy, laryngeal microsurgery, laryngoplasty or vocal cord surgery,
* Not being extubated at the end of anesthesia,
* Being pregnant,
* Being under 20 years of age,
* American Society of Anesthesiologists (ASA) physical status class greater than 3.