cyrilzakka/clinical-trials huggingface dataset:
Hybrid Blood Pressure Monitor Validation

Assessment of the accuracy of a Blood Pressure Measuring Device with a digital display-column, NISSEI DM 3000, according to an adaptation of the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults".

According to the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults", 33 patients have their blood pressure measured by two observers using parallel connected mercury sphygmomanometers, blinded from each other's result, and then by the supervisor using the tested device, NISSEI DM 3000. The measurements using the mercury sphygmomanometers are repeated 5 times and in between them, 4 measurements using the tested device take place. If the results of the comparison of these measurements according to the analysis required by the protocol, meet the required criteria, the device is regarded as "Pass", otherwise as "Fail".

In this study, instead of consecutive, simultaneous measurements of the two mercury sphygmomanometers and tha tested device will be taking place. This will be so to exclude any inaccuracy due to blood pressure variability and because the tested device has a controllable deflation rate and allows simultaneous measurements with the mercury sphygmomanometers. In addition, the investigators will be performing 6 set of measurements instead of 4.

Eligibility Criteria:
Inclusion Criteria:

* Above 25 years of age
* Sinus rhythm
* Informed consent

Exclusion Criteria:

* Sustained arrhythmia
* Pregnancy
* Poor quality Korotkoff sounds
* Unavailable cuff size
* Completed blood pressure range (according to protocol)
THE EFFECT OF CREATIVE DRAMA ON THE DEVELOPMENT OF ANXIETY, EMPATHY AND COMMUNICATION SKILLS IN NURSING EDUCATION

This work; The aim of this study is to determine the effect of the education program, which was created with the creative drama method based on Travelbee's "human-to-human relationship" theory, on the teaching and practice of mental health and psychiatric nursing course, on reducing the anxiety of students and improving their empathy and communication skills.

In psychiatric nursing education; It is known that classical education methods are not sufficient to reduce students' anxiety and stigma, and to strengthen communication and empathy. For this reason, there is a need for training methods that will increase in-depth learning and communication skills and empathy in the field. In this research, the creative drama education method was arranged in accordance with the requirements of mental health and psychiatric nursing education and a training program was developed. Within the scope of the research, this training program was applied to the students who completed the theoretical education of psychiatric nursing. In order to measure the effectiveness of the research training program, it was planned in a quantitative design as a randomized controlled intervention study and in a mixed method in qualitative design in order to examine students' views on the method.

Eligibility Criteria:
Inclusion Criteria:

* Being residing in the city center of Ankara Volunteering to participate in the research, Being a 4th year nursing student and having completed the Mental Health and Diseases Nursing course, Lack of clinical experience in communicating with individuals with mental illness (Health Vocational High School graduate), Not having received training in communicating with individuals with mental illness before (students repeating a grade).

Not having been diagnosed with any mental illness No mental illness in first degree relatives

Exclusion Criteria:

* Living outside the city center of Ankara To fill in the research data collection forms incompletely, Not completing the creative drama education based on human-human relationship theory, Refusal to participate in the research Not meeting the criteria for inclusion in the research
Validity of an AI-based Program to Identify Foods and Estimate Food Portion Size

The purpose of this study is to test the accuracy of the Nutrition Artificial Intelligence in the Openfit app during meals in a controlled laboratory setting

For this pilot study, using a convenience sample, the investigators will recruit up to 25 adults to use the Nutrition AI technology in Openfit to identify and estimate portion size of foods plated in a laboratory setting at Pennington Biomedical Research Center (PBRC) and/or Louisiana State University (LSU). Laboratory members within the Ingestive Behavioral Laboratory will also test the ability of Nutrition AI to identify foods and to quantify foods provided in the laboratory. Meals will be simulated, and participants will not consume the foods provided.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-62 years
* Self-reported body mass index (BMI) 18.5-50 kg/m2

Exclusion Criteria:

* Any condition or circumstance that could impede study completion
* Unfamiliar with or not able to use an iPhone
BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

BOREALIS is a multicentre, prospective, observational cohort study designed to investigate the effectiveness, feasibility, safety and impact on pain and quality of life of curative-intent cryoablation for the treatment of bone metastases in patients with oligometastatic or bone oligo-progressive disease.


Eligibility Criteria:
Inclusion Criteria:

* Bone metastases in patients with oligometastatic disease (\<5 bone/visceral metastases) or bone oligo-progressive disease (visceral or osseous multi-metastatic disease stable under systemic treatment except 1-3 progressing bone metastases) from solid tumours;
* Number of target lesions ≤ 3
* Size of target lesion(s) \< 5 cm (largest diameter);
* Referral to local ablative treatment by multidisciplinary tumour board (MDTB);
* Treatment by percutaneous cryoablation with curative intent (i.e., complete tumour destruction) assessed as technically feasible by the IR in charge;
* Procedure performed with a cryoablation system from Boston Scientific.

Exclusion Criteria:

* \< 18 years old;
* Incapacity or refusal to give informed consent;
* Ongoing pregnancy;
* Health status not compatible with the minimum meaningful follow-up period (i.e., 12 months):

  * Karnofsky Performance Scale \< 60%, or
  * Bone metastases originating from rapidly evolving tumour histologies not allowing reasonable life expectancy of at least 12 months, or
  * Life expectancy \< 12 months
* Infection of treatment site or systemic infection;
* Uncorrectable coagulopathy;
* Haematological disease (including multiple myeloma and plasmacytoma);
* Concomitant radiation therapy or radiation therapy within 12 weeks before the planned cryoablation procedure.
Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.

Patients participating in this study were rehabilitated by mucosa supported maxillary complete denture and mandibular overdenture supported by two different surface treated implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by ball attachments. The marginal bone height changes around RBM and acid etched surface treated dental implants retaining mandibular complete overdenture were assessed by cone beam computed tomography.


Eligibility Criteria:
Inclusion Criteria:

* Free from any systemic diseases affecting the bone metabolism.
* Healthy, firm covering mucosa which is free from any signs of Inflammation or ulceration.
* Residual alveolar ridge with adequate height and width.
* Angel's class I classification maxillo - mandibular relationship.
* Sufficient inter arch space

Exclusion Criteria:

* Smoker.
* Patients with parafunction habits (clenching or bruxism).
Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)

The primary objectives of this study are to evaluate the safety and tolerability of emerfetamab in adults with relapsed/refractory acute myeloid leukemia (AML) and to estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose \[RP2D\]).

This is a first-in-human, open-label, phase 1, sequential dose escalation study. Emerfetamab will be evaluated as a short term intravenous (IV) infusion in adults with relapsed/refractory AML The study will consist of a dose escalation phase and a dose expansion phase. The study was terminated prior to the start of the expansion phase.

Eligibility Criteria:
Inclusion Criteria

* Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
* Subjects ≥ 18 years of age at the time of signing consent.
* AML as defined by the World Health Organisation (WHO) Classification persisting or recurring following 1 or more treatment courses except promyelocytic leukemia (APML).

  * More than 5% myeloblasts in bone marrow.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

Exclusion Criteria

* Known hypersensitivity to immunoglobulins.
* Autologous hematopoietic stem cell transplantation (HSCT) within 6 weeks prior to start of AMG 673 treatment.
* Allogeneic HSCT within 3 months prior to start of AMG 673 treatment.
* Non-manageable graft versus host disease.
* Known positive test for human immunodeficiency virus (HIV).
* Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 15 weeks after receiving the last dose of study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women). Males who are unwilling to abstain from sperm donation while on study through 5 half-lives after receiving the (last \[multiple-dose studies\]) dose of study drug.
* Females who are lactating/breastfeeding or who plan to breastfeed while on study through 15 weeks after receiving the last dose of study drug.
* Females with a positive pregnancy test
* Females planning to become pregnant while on study through 15 weeks after receiving the last dose of study drug.
11C Topotecan PET Imaging

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET scan) using 11C topotecan, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase I/II trial is studying how well a PET scan using 11C topotecan predicts response to treatment in patients with brain metastases due to ovarian, small cell lung, or other cancer.

OBJECTIVES:

Primary

* Determine if tumor uptake of \^11C topotecan occurs quickly enough and at sufficient concentration to be measured immediately following infusion in patients with brain metastases secondary to ovarian cancer, small cell lung cancer, or other cancers.
* Determine, preliminarily, if \^11C imaging has potential to be an early predictor of response to topotecan therapy in these patients.

Secondary

* Determine the whole-body biodistribution of \^11C topotecan in these patients.

OUTLINE:

* Phase I: Patients receive \^11C topotecan IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan. Within 4 weeks after initial imaging, patients also undergo a CT scan.
* Phase II: Patients receive \^11C topotecan and undergo imaging as in phase I. Patients also receive fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian cancer, small cell lung cancer, or other cancers

  * Metastatic brain disease
* Eligible for topotecan therapy
* Measurable disease by CT scan and/or MRI

PATIENT CHARACTERISTICS:

Performance status

* ECOG 0-2

Life expectancy

* More than 3 months

Hematopoietic

* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Not specified

Renal

* Creatinine clearance ≥ 50 mL/min

Other

* Not pregnant or nursing
* Adequate end-organ function
* Able to tolerate lying on a radiology table for ≥ 1 hour
* No serious medical or psychiatric illness that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY: Not specified
A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.

The Dose Escalation portion of this study will identify the maximum tolerated dose, or if different, the recommended Phase 2 dose of SNDX-5613 to be used in combination with intensive chemotherapy and in maintenance monotherapy following intensive chemotherapy in participants with newly diagnosed AML harboring alterations in KMT2A, NPM1, or NUP98 genes.

In the Dose Expansion portion of the study, safety and preliminary efficacy of SNDX-5613 may be explored in expansion cohorts at tolerated dose levels.

In both Dose Escalation and Dose Expansion, the treatment period will consist of an induction phase (up to 2 cycles), a consolidation phase (up to 4 cycles and could include hematopoietic stem cell transplant for participants who are transplant eligible and have an available donor), and a maintenance monotherapy phase with SNDX-5613. The cycle duration will be 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
* Previously untreated AML and eligible to receive intensive chemotherapy.
* KMT2Ar, NPM1c, or NUP98r mutations identified by local laboratory prior to the first dose of SNDX-5613.
* Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if \>65 years old .
* Adequate liver, kidney, and cardiac function.

Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia.
* Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms).
* Fridericia's corrected QT interval (QTcF) \>450 milliseconds (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
* Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion.
* Cirrhosis with a Child-Pugh score of B or C.
* Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
* Hepatitis B, Hepatitis C, or HIV-positive with detectable viral load.
* Documented active, uncontrolled infection.
* Uncontrolled disseminated intravascular coagulation.
* Lactating/breast feeding or pregnant.
* Use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy.
* Use of strong CYP3A4 inducers or inhibitors (except for Itraconazole, Ketoconazole, Posaconazole, or Voriconazole).
Study to Evaluate the Use of a Probiotic in SCORAD Reduction in Young Patients With Atopic Dermatitis

The study's objective is to confirm that an oral probiotic treatment reduces the signs and symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 4 to 17 years, as compared to placebo. It will also be examined if the probiotic treatment, as compared to placebo, reduces the quantity of topical steroids used to treat disease flares, and increases the time till the first disease flare after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 4 to 17 years, both inclusive.
* Diagnosed with atopic dermatitis according to Hanifin and Rajka criteria.
* SCORAD index of 20-40, both inclusive.
* Patients whose parents or legal guardian sign the informed consent.
* The minor over 12 years must also give their consent to participate in the trial.

Exclusion Criteria:

* Pregnancy.
* Breast feeding.
* Women of childbearing age who, in the opinion of the investigator, do not commit to using an effective method of contraception, if they have an active sex life or start during the trial.
* Treated with phototherapy for the atopic dermatitis in the previous 2 months.
* Treated with systemic corticosteroids in the previous 2 months or need for corticosteroids anticipated during the first 12 weeks of the study.
* Having undergone cytotoxic or immunosuppressive therapy in the previous 2 months or having an anticipated need for cytotoxic or immunosuppressive therapy during the first 12 weeks of the study.
* Treated with probiotics in the previous two months.
* Treated with systemic antibiotics in the previous four days.
* Patients with a fever (temperature \> 37.5°C, axillary or equivalent).
* Serious allergic diseases.
* Diseases related to immunodeficiency processes or cancer.
* Other skin diseases that can make assessment of the atopic dermatitis difficult or which require the continuous use of topical corticosteroids.
* Patients in whom any of the study products is contraindicated according to its summary of product characteristics.
* Patients who have participated in research studies with medicinal products during the previous 3 months.
* Patients with gluten or lactose intolerance or inflammatory bowel disease (Crohn's disease or ulcerative colitis).
The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure

The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure.

There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women

Exclusion Criteria:

* history of heart disease
* have had heart surgery
* high blood pressure
* diabetes
* cancer
* any other disease such as kidney or neurological diseases
* taking medications such as aspirin or medicines for your heart or blood pressure
* have asthma or are allergic to sulfa drugs
* body mass index greater than 30
* use tobacco
* pregnant
* women using oral contraceptives or hormone replacement therapy
Early Vascular Adjustments During Hypertensive Pregnancy

Paradoxical fetal and maternal results of studies have led to inconsistent use of antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in the Netherlands. However, none of the studies have taken the individual maternal circulatory state or the contemplated blood pressure response into account. Hypertension may be accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of low (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not restricted to one circulatory profile. Therefore antihypertensive drugs should be viewed upon as correctors of the hemodynamic state rather than solely reducers of blood pressure. Without taking the maternal hemodynamic profile and condition into account, generic antihypertensive treatment can be expected to result in disappointing, inadequate and paradoxical results. The investigators hypothesize that in mild to moderate hypertension, personalized hemodynamically guided antihypertensive therapy (with target systolic and diastolic blood pressure \<130/80mmHg), prevents the progression to severe hypertension and/or preeclampsia compared to no treatment, without the alleged side-effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients ages 18years or older
* Before 37 weeks of gestational age;
* Diagnosed with mild to moderate gestational hypertension

Exclusion Criteria:

* Women with severe hypertension: systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 110mmHg.
* Women with chronic hypertension who are already on antihypertensive drugs. If no antihypertensive drugs are used yet, women with pre-existent hypertension are eligible to participate.
* Women diagnosed with preeclampsia or eclampsia in the current pregnancy.
* Women who are not able to comprehend the study outline.
* Women who have already participated in this study cannot be included a second time.
* Women who have a (relative) contra-indication for one of the possible prescribed medications (for example women who have tested positive for antinuclear antibodies, which is a contraindication for Methyldopa).
* Women who intend to terminate the pregnancy
* Women who have a fetus with a major anomaly or chromosomal abnormality
Pain Severity in Fibromyalgia Syndrome

Fibromyalgia Syndrome (FMS) is a complex syndrome that mainly includes the musculoskeletal system and is characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions, regional pain syndrome, psychiatric disorders. The existence and importance of the multidimensional nature of chronic pain in FMS has been demonstrated. Factors such as pain intensity, persistence of pain, pain-related disability, and novelty of onset are all important characteristics of a chronic pain condition. Therefore, there was a need for a global measure of chronic pain severity that summarized different measures of pain and a graded classification of chronic pain was proposed. Patients with chronic pain such as FMS are known to have a greater negative impact than many chronic medical conditions. Chronic pain severity in FMS has been found to be associated with various conditions such as function and health status, and it has been shown that reduction in pain severity provides broadly beneficial results on these conditions. However; there are no studies in which chronic pain severity in FMS is classified by grading and investigating the relationship of different pain severity degrees with disease severity and other symptoms.

The aim of this study is to evaluate whether the severity of the disease, kinesiophobia, and concerns about pain differ in individuals with different pain severity by grading the severity of pain in individuals with fibromyalgia syndrome.


Eligibility Criteria:
Inclusion Criteria:

* to be aged between 18-65,
* to be diagnosed with fibromyalgia syndrome according to the criteria of 2016 ACR
* to be volunteer to participate in the study.

Exclusion Criteria:

* Having cognitive impairment
* Illiterate people
* Diagnosed severe mental and psychological disorders