cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease

This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular disease


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus.
* Cardiovascular disease
* Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment

Exclusion Criteria:

* Patients with type 1 diabetes or diabetes insipidus
* Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
* Any clinically significant illness, which would compromise the patient's safety and their participation in the study
Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge

in patent have deeply impacted lower third molar ,dose computer guided enhance surgical outcome versus conventional surgical remove of wisdom teeth

P- Patient with deeply impacted mandibular molar I- Computer guided surgical cutting stent C- Conventional extraction O- Clinical outcome sound radiographic outcomes primary outcome

- pain : each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain.

Secondary outcome

* evaluation of maximum inter incisal opening: assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisor by using tape graduated method.
* evaluation of edema throw use nylon thread.

Eligibility Criteria:
Inclusion Criteria:

* patient with deeply impacted mandibular third molar
* patients should be free from any systematic disease that affect normal healing

Exclusion Criteria:

* -Patient with soft tissue impaction and impaction class A position 1
* Medical problem that may interfere with the procedures such as bleeding disorder \& pregnant.
* Uncooperative patient.
Measuring Nutrition Literacy in Clinical Practice: Evaluating Effects Upon Providers and Patients

This study evaluates the effects of assessing patient nutrition literacy prior to an initial session with an outpatient dietitian on the patient-centeredness of the session. We will randomize 6 dietitians, 4 of whom will have access to their participating patients' nutrition literacy scores. These dietitians will use this information to better inform their interventions, and hopefully improve their patients' nutrition literacy as a result.

Nutrition Literacy Assessment Tool (NLit): a validated, 64-question survey that assesses nutrition literacy across 6 subscales:

* Nutrition and Health
* Energy Sources in Food
* Household Food Measurement
* Food Label and Numeracy
* Food Groups
* Consumer Skills

Dietitians who work within 6 different outpatient clinics (1 dietitian per clinic) will be recruited to the study; each dietitian will recruit 19 patients from their clinic. All patient participants will take the NLit survey prior to an initial visit with their dietitian. Dietitians randomized to the intervention arm (n=4) will have access to their participating patients' NLit results, and tailor their intervention to the patient's nutrition literacy weaknesses. Dietitians randomized to the control group (n=2) will not have access to their participating patients' NLit scores, and will provide the same standard-of-care intervention usually provided.

All participating patients will then re-take the NLit a month after their initial session with their dietitian, and we will examine the results to see if a) nutrition literacy improved within groups, and b) if the patients of the intervention dietitians showed more improvement in nutrition literacy than their counterparts being treated by the control dietitians.

We will also collect dietary pattern information from participating patients before their initial session with their dietitian, and again one month after their initial session with their dietitian. We will examine the results to see if a) dietary patterns improve with increased nutrition literacy, and b) if the dietary patterns of patients in the intervention group improve more than patients in the control group.

Finally, we will collect survey information from patients pertaining to the perceived patient-centeredness of the session with their dietitian. We will also collect audio recordings of the sessions between patients and dietitians, which will be analyzed for patient-centeredness. We will also analyze readability and clearness of printed materials used by dietitians during their interventions with patients.

Eligibility Criteria:
Inclusion Criteria:

* subjects must be at least 18 years old
* subjects must be able to read English
* subjects must be scheduled with a participating dietitian

Exclusion Criteria:

* subjects with cognitive disabilities or overt mental illnesses
* subjects with vision issues severe enough to disrupt reading of the NLit.
Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases

The purpose of this study is to gather information about the size and shape of patients' hearts in order to design a device.

Correct device design depends on getting good information about the shape and size of the different parts of the heart. Measurements from computed tomography images of hearts will be studied. By looking at measurements from a wide range of patients, an understanding of the differences in the size and shape of the heart chambers will be gained.

Eligibility Criteria:
Inclusion Criteria:

* Patients deemed suitable for treatment of atrial fibrillation by catheter-based ablation who have received cardiac CT imaging as part of normal care.

Exclusion Criteria:

* Patients who have not received cardiac CT imaging as part or normal care.
Utilizing Augmented Reality as an Adjunct for Smoking Cessation

The purpose of the study is to develop an preliminary test a tobacco smoking-related augmented reality (AR) paradigm for eventual development as an adjunctive tobacco cessation intervention.


Eligibility Criteria:
Inclusion Criteria:

* Currently smoking ≥ 3 cigarettes per day for the past year
* Breath carbon monoxide (CO) level ≥ 5 ppm
* Motivated to quit smoking
* Aim 1 \& 2 Only: Valid home address in the Tampa Bay area
* Functioning telephone number
* Can speak, read, and write in English
* Aim 3: Must have a smartphone that participant is willing to use during the study
* Aim 3: Motivated to quit smoking within the next month

Exclusion Criteria:

* Regular use (e.g., no more than 1/3 of month) of other tobacco products (cigars)
* Household member already enrolled in the study
Comparison of the Efficiency of Classical and I-GEL LMAs Selected by Different Methods in Providing a Safe Airway

In recent years, the use of laryngeal masks has been increasing in operating room and non-operating room anesthesia applications. Patients with inappropriate LMA may develop high leakages, gastric distension and inadequate ventilation during ventilation. If the laryngeal masks used to provide a safe airway in the patient are not selected in the appropriate size, adequate ventilation may not be provided, which may lead to various complications such as increased morbidity and mortality. In order to prevent and predict the bad results that may occur, we foresee which method can be chosen more appropriately for the patients and will guide the clinicians.

The laryngeal mask (LMA) is a subragglottic airway device commonly used to provide lung ventilation during general anesthesia. In this study, we aimed to compare the efficacy of classical and I-GEL LMA selected with different techniques.

Successful placement of the Laryngeal Mask Airway (LMA) largely depends on the correct size selection.

The size of the laryngeal mask airway is usually determined by the weight of the patient. However, in some cases an alternative method can be used. The weight of the patient is sometimes unknown (eg, obese, malnourished, sedentary or unconscious patients) and can be unpredictable, especially in children. Therefore, it will be useful to have alternative ways (according to 1. body weight, 2. thyromental distance, 3. dimensioning with three fingers) in determining the appropriate size of the laryngeal mask size. These different methods should be simple to perform and easy to remember.

LMA is increasingly used in elective surgery, resuscitation, difficult airway and emergency situations. Successful use of the LMA largely depends on the correct size selection, method of insertion, and cuff sealing. Placing an improperly sized LMA can result in incorrect positioning and incorrect ventilation

Eligibility Criteria:
Inclusion Criteria:

* Elective cases between the ages of 18-65,
* ASA I-II,
* who will be fitted with an LMA by the anesthesia clinic,
* and whose consent has been obtained

Exclusion Criteria:

-\>65 years old,

* excessive cachectic or body mass index (BMI) \>30 kg/m2,
* those with high risk of regurgitation or aspiration (large hiatal hernia, Zenker's diverticulum, scleroderma, pregnancy, history of gastroesophageal reflux disease, uncontrolled diabetes mellitus and obesity),
* potentially difficult airway (history of airway difficulty, mouth opening \<2 cm,
* Mallampati class 4,
* limited neck extension or cervical spine pathology),
* airway pathology,
* decreased presence of pulmonary or chest wall compliance,
* preoperative sore throat,
* planned operation Patients with a duration of \>2 hours and who need a prone position during surgery will not be included in the study.
Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study

In France, 26% of women of childbearing age use an intrauterine device (IUD) containing copper or levonorgestrel as a method of contraception. Failures of IUD contraception are mainly due to shifting or expulsion of the IUD. The risk factors for expulsion of IUDs most often found in the literature are young age (\<25 years), the existence of menorrhagia, dysmenorrhea, being a carrier of a copper IUD rather than a levonorgestrel IUD , a history of IUD expulsion, nulliparity, and an anomaly of the uterine cavity unrecognized (fibroma, adenomyosis).

More and more women are turning to menstrual cups (MCs) as a means of periodic protection. But the use of MC has also been mentioned as a risk factor for IUD expulsion (via a suction effect). In May 2013, reports of displacement, rupture, or even expulsion of copper IUDs in CM users were reported to ANSM.

However, few studies have examined the risks associated with the concomitant use of an MC and an IUD. The data are contradictory and insufficient to provide a clear answer to women. Hence the interest in carrying out a larger prospective study to explore the relationship between IUD expulsion and the use of MC.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over
* Consultant for one of the following reasons:

  * IUD control
  * IUD expulsion
  * Pregnancy on IUD
  * Other reason that required an ultrasound for the IUD
* Consent to participate in the study

Exclusion Criteria:

* Patient benefiting from a legal protection measure
Study of HL-085 in NRAS Mutant Advanced Melanoma

This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with NRAS mutant advanced melanoma .


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma according to AJCC (Version 7, 2010).
2. Subjects must have NRAS mutation in melanoma.
3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
4. ECOG performance status of 0-1.
5. Life expectancy ≥ 3 months.
6. Ability to take the medicine orally.
7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Prior therapy with a MEK-inhibitor
2. Patients with known hypersensitivity to study drug ingredients or their analogues.
3. Active central nervous system (CNS) lesion.
4. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome.
5. Subjects with bleeding symptoms at Grade 3 (NCI-CTCAE v4.03) within 4 weeks prior to starting study treatment.
6. Uncontrolled concomitant diseases or infectious diseases.
7. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
8. History of HIV,HCV,HBV infection.
9. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
10. Serum HCG test is positive.
11. Other conditions that influence the results and increase the risk of study.
The Impact of Legally Enforced Embryo Transfer Policy (Belgian Law 2003) on Cumulative Delivery Rate.

Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher than the 1% after natural conception, related to the number of embryos transferred, and preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh ART cycles are reimbursed for female patients younger than 43 with a Belgian insurance number since July 2003, but only if a limited number of embryos is transferred depending on female age and cycle rank. Although this policy has resulted in a significant reduction in the MPR after ART in Belgium from 24 % to 13 %, available data are cycle based and it is unknown if the cumulative delivery rate per patient is affected by this legislation. The aim of this study was to test the hypothesis that Belgian ART legislation since 2003, coupling lab reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when compared to the situation before 2003.


Eligibility Criteria:
Inclusion Criteria:

* patients with their first IVF/ICSI cycle

Exclusion Criteria:

* cycles without oocytes or sperm, oocyte reception cycles, embryo reception cycles, cycles with preimplantation genetic diagnosis/screening
Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth

This project is designed to test a brief therapy to reduce suicidal ideation among a diverse sample of youths ages 12 to 17 who experience anxiety or depression. The goal of the study is to conduct a clinical trial testing whether this therapy reduces suicidal ideation and related beliefs that one is a burden on others. This project will contribute to the field by potentially showing evidence supportive of a brief strategy to reduce suicidal ideation in a way that can be readily understood and used by mental health providers in the community.

This project tests the ability of a brief therapy module to engage youth perceived burdensomeness (PB) in a rigorous randomized controlled trial (RCT) of the intervention, the \&#34;Give to Others (GO)\&#34; module. The investigators will target PB among 60 ethnically/racially diverse clinic-referred youths (ages 12-17) who experience subacute suicide ideation SI (i.e., positive suicide risk screen; stable safety status). Youths will be recruited from the clinical and community settings and will be randomized to one of the following 2 arms: an assessment and suicide risk management condition (Safety Planning control arm); and a Safety Planning plus GO module condition. The investigators hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared with youths who receive the control arm. The investigators also hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared to pre-treatment levels.

Eligibility Criteria:
Inclusion Criteria

Adolescents must:

* be between ages 12 and 17 years
* score at or above 4 on the Interpersonal Needs Questionnaire- Burdensomeness Scale
* have a positive screen for suicide risk (i.e., endorsement of suicidal ideation via self-report or parent-report).

Exclusion Criteria

For adolescents to be excluded, they must:

* have cognitive impairment or developmental delay which does not allow for the completion of basic study procedures (i.e., reading and filling out questionnaires; talking to a clinician)
* show imminent risk or a history of hurting themselves or others requiring intensive and restrictive services
* be involved currently in a psychosocial treatment
A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations

This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form;
2. Histologically verified diagnosis;
3. Age between 18 and 80 years; If the patient had previously received chemotherapy for these indications, then it should be completed at least 30 days before the first administration of the study drug;
4. ECOG performance 0-2;
5. Haematology:

   * ANC ≥ 1,5 х 10(9) /L;
   * Platelets ≥ 100 х 10(9) /L;
   * Hemoglobin ≥ 90 g/L;
6. Biochemistry:

   * Creatinine ≤ 1,5 ULN;
   * Total bilirubin ≤ 1,5 ULN;
   * AST/ALT ≤ 2,5 ULN;
   * Alkaline phosphatase ≤ 5 ULN;

8. Life expectancy of at least 6 months from the date of the first drug administration in the study; 9. Ability of the patient to comply with the Protocol requirements.

Exclusion Criteria:

1. Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs;
2. Systemic use of antibiotics less than 72 hours before the first drug administration in the study;
3. Concurrent or less than 30 days before the start of the study, radiation therapy (with the exception of point radiation therapy for bone metastases); study;
4. Concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study;
5. Surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking any experimental medications less than 30 days before enrollment in this study;
6. History of bone marrow or hematopoietic stem cell transplantation;
7. Presence of acute or active chronic infections;
8. Other diseases (with the exception of the main one) that could affect the assessment of the severity of the symptoms of the underlying disease: that may mask, enhance, change the symptoms of the underlying disease or cause clinical manifestations and changes in the data of laboratory and instrumental research methods;
9. Inability to administer the drug by intravenous infusion or subcutaneous injection.
Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool

This goal of this observational study is to develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool. The tool will be an opioid medication risk screener and decision support platform that will be used by pharmacists upon dispensing prescription opioid medication. Once the Opioid Risk Reduction has been developed, we will examine the impact of the ORRCDS within two divisions of a large chain retail pharmacy. Pharmacies will be randomized to using the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool or standard of care opioid dispensation. We hypothesize that patients at pharmacies randomized to the ORRCDS tool will be more likely to reduce their risk status to low or moderate compared to the patients at standard of care pharmacies.

In our previous research, patients have reported a willingness to answer questions and discuss opioid medication use with pharmacists in these settings. Therefore, community pharmacy settings are an underused resource with great promise for screening and engaging patients to reduce opioid medication misuse. Currently, prescription drug monitoring programs (PDMP) are the most available tool to pharmacists for monitoring opioid use among patients. As a result, PDMP users must rely on their "best judgment" in clinical decision-making and often provide patient care and referrals with a limited evidence base. The question of highest importance in the field of prescription medication misuse is: How can PDMP information/output be most usefully utilized for patient intervention within an evidence-based opioid risk reduction clinical decision support (ORRCDS) tool.

This study will develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool and examining facilitators and barriers to sustainability and broader dissemination. The study is organized into 3 aims:

Aim 1: ORRCDS Tool development which will include a universal opioid medication risk screener and decision support platform.

Aim 2: Once the ORRCDS has been developed, we will conduct a type-1 cluster 2-arm randomized trial to examine the impact of the ORRCDS tool within two divisions of a large chain retail pharmacy. We hypothesize that patients with moderate or high opioid risk will be more likely to reduce risk status to low or moderate following ORRCDS implementation compared to standard care.

Aim 3: Following the completion of the cluster randomized trial, qualitative interviews will be conducted with pharmacists and leaders from a large chain retail pharmacy and PDMP vendor about the potential barriers and facilitators to the sustainability (continued use at the stores in this project) and broader dissemination (implementation at other stores outside of those in this project) of the ORRCDS.

Eligibility Criteria:
Inclusion Criteria:

* A large chain retail pharmacy chain in the Cincinnati or Columbus, Ohio area

Exclusion Criteria:

* None

This study does not involve individual patients as randomization will occur among pharmacies.
Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.

In this experiment, patients with chronic pure tone tinnitus were divided into three groups to receive auditory stimulation, somatosensory stimulation, vestibular stimulation and combined stimulation, in order to find an effective way to treat tinnitus

120 patients with chronic pure tone tinnitus over 6 months were randomly divided into 6 groups, one group was given auditory stimulation, one group was given somatosensory stimulation, one group was given auditory stimulation + somatosensory stimulation, one group was given auditory stimulation + vestibular stimulation, the last group was given auditory stimulation + somatosensory stimulation + vestibular stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Pure tone tinnitus
* Unilateral and bilateral
* female and male
* Tinnitus has a history of more than 6 months

Exclusion Criteria:

* Pulsatile tinnitus of blood vessel
* Meniere's disease
* Chronic headache
* Neurological diseases (such as brain tumors)
* Patients with mental / mental illness undergoing treatment
* Pregnant women and patients with other untreatable diseases