cyrilzakka/clinical-trials huggingface dataset:
Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis

This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant left main (LM) coronary stenosis with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of 120 patients with intermediated left main coronary vessel diameter stenosis ≥30% and ≤80% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of left main coronary artery stenosis will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction
* Age ≥18 years
* Written informed consent
* Intermediated left main coronary lesions (diameter stenosis of 30%-80% by visual estimation from coronary angiography)

Exclusion Criteria:

* Ineligible for diagnostic IVUS or FFR examination
* Prior coronary artery bypass grafting of the interrogated vessels
* Myocardial infarction within 72 h of coronary angiography
* Severe heart failure
* Serum creatinine levels \>150 umol/L, or glomerular filtration rates \<45 ml/ kg/1.73 m2
* Allergy to the contrast agent or adenosine
* Life expectancy \< 2 years
* Proximal LAD diffuse lesions (diameter stenosis \> 50%)
* IVUS pullback not covering the entire lesion
* Severe myocardial bridge in the interrogated vessel
Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen

The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in patients with allergy on grass pollen after specific bronchial provocation. Therefore, the investigators will record the patients' nutrition habits and measure the blood level of long chained polyunsaturated fatty-acids.


Eligibility Criteria:
Inclusion Criteria:

* age \>12 and \<45 years
* informed consent
* Known allergy on grass-pollen

Exclusion Criteria:

* age \<12 and \>45 years
* Clinical asthma requiring regular inhalation
* vital capacity \>80%
* FEV1 \< 75%
* Chronic disease
* pregnancy
* Inhalative or systemic steroid use
* substance abuse
* incapability of understanding the study's purpose and performance
Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review

MARIENAIE study is a pilot study on the feasibility and appropriation of nocturnal naps by a team of paramedical caregivers alternating a 12-hour day/night work rhythm for a period of 1 year. To date no study on the impact of nap in ICU on a long period was published.

This study will also explore : the factors favouring or hindering the implementation of this strategy and its maintenance over time through a concomitant sociological qualitative study, the evolution over time of the parameters of perceived nocturnal sleepiness and the immediate impact of the realization of naps on this sleepiness and the evolution over time of the medium-term impact with the help of questionnaires exploring various dimensions concerning the working conditions and health (somatic health, stress, psychosocial risks, evaluation of the working environment).


Eligibility Criteria:
Inclusion Criteria:

* Paramedic working 12 hours alternating day and night in the ICU department of the Vendee departmental hospital center.

Exclusion Criteria:

* Pregnant woman.
* Caregiver with knowledge of a scheduled departure from the ICU within 2 months after the start of the project.
* Caregiver refusing to participate in the project.
SeniorWISE: Improving Everyday Memory in At-Risk Elderly

The purpose of this study is to determine whether classes on memory training will help older adults to improve or maintain their daily activities.

Volunteer participants will be randomly assigned to experimental (memory training) and comparison (health promotion) groups. Both groups will learn strategies for successful aging. Participants will be in the study for 27 months and will be interviewed on five occasions for 3 hours per interview. The classroom-based intervention is an 8-session, 1 1/2 hour course designed to teach older adults the use of strategies to improve everyday memory. Strategically-placed booster sessions will be provided to subjects within 3 months following the last class session.

Eligibility Criteria:
Inclusion Criteria:

* Reside in Austin, Texas or Travis County
* African, Caucasian, or Hispanic heritage
* Fluent in reading and speaking English
* Mini Mental Exam scores of 23-30
* Pass executive function test
* Adequate hearing and vision to enable participation in classroom learning
* Free of Alzheimer's disease or other conditions (e.g., certain cancers) likely to result in mortality before study completion

Exclusion Criteria:

* Under 65
* Score less than 23 on MMSE
* Fail the executive function tests
* Severe sensory losses, hearing or vision, that would prohibit testing or participation
* self-report a diagnosis of Alzheimer's disease or other conditions (e.g., certain cancers) likely to result in mortality before study completion
Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age
* Documented diagnosis of myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML), white blood cells (WBC) ≤ 13,000 /mm\^3, World Health Organization (WHO) that meets International Prognostic Scoring System (IPSS) criteria for low or intermediate-1 risk disease
* Anemia, Hemoglobin (Hgb) ≤ 9.0 g/dL or ≥ 2 units of Red Blood Cells (RBCs) within 84 days
* No response or loss of response to Erythropoiesis-Stimulating Agents (ESAs) or erythropoetin (EPO) \> 500 mU/ml
* Eastern Cooperative Group (ECOG) score ≤2.
* Creatinine \< 1.5 \* Upper Limit of the Normal (ULN)
* Total bilirubin ≤3.0 mg/dL
* Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) \& Alanine Aminotransferase (ALT)/Serum Glutamic Pyruvic (SGPT) ≤3.0 \* Upper Limit of Norma (ULN)
* Free of metastatic malignancy (other than MDS) for ≥2 years
* Highly effective methods of birth control for females and males

Exclusion Criteria:

* Chromosome 5q deletion
* Pregnant or breast feeding women and males who do not agree to use condom during the sexual contact with females of childbearing potential
* Major surgery within 30 days
* Incomplete recovery or incomplete healing of wounds from previous surgery
* Heart failure ≥3 (New York Heart Association (NYHA))
* Thromboembolic or myocardial infarction event within 6 months
* Concurrent anti-cancer cytotoxic chemotherapy
* History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant protein
* Known positive for Human Immunovirus (HIV) or infectious Hepatitis type C or active infectious Hepatitis type B
* Clinically significant anemia unrelated to MDS
* Thrombocytopenia (\<30,000/uL)
* Uncontrolled hypertension
* Treatment with another investigational drug or device within 28 days prior to Day 1
* Prior exposure to sotatercept (ACE-011)
* Any serious medical condition, lab abnormality or psychiatric illness
SOOTHER Trial to Treat Rectal Itch

Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani)


Eligibility Criteria:
Inclusion Criteria:

* Presence of pruritus ani (anal itch/discomfort) for at least 2 weeks, and a compatible physical exam.

Exclusion Criteria:

* Inability to understand informed consent, history of inflammatory bowel disease, known venereal disease, or immunodeficiency disease, history of or current anal or perianal abscess, anal or rectal surgery within the past 12 weeks, pregnancy or breastfeeding female, or signs of other rectal diseases such as anorectal fistula, infection, perianal eczema or tumors.
Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and paclitaxel in treating patients who have recurrent or refractory endometrial cancer, fallopian tube cancer, or sarcoma of the female reproductive tract.

OBJECTIVES: I. Determine the response rate and duration of response to doxorubicin HCl liposome and paclitaxel in patients with endometrial cancer, tubal cancers, and sarcomas and carcinosarcomas (mixed mesodermal tumors) of gynecologic origin. II. Define the safety profile of the combination of doxorubicin HCl liposome and paclitaxel in this patient population.

OUTLINE: Patients are stratified into two groups. Group 1 consists of patients with untreated endometrial and tubal cancers and Group 2 consists of patients with sarcomas and carcinosarcomas (mixed mesodermal tumors) of gynecologic origin subdivided into no or prior therapy. Patients receive doxorubicin HCl liposome intravenously on day 1 of each treatment course. Paclitaxel is administered intravenously weekly on days 1, 8, and 15 of each course. Courses are repeated every 21 days. Treatment continues in the absence of unacceptable toxic effects or disease progression. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 28-60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory carcinoma of the endometrium or fallopian tubes or sarcomas of gynecologic origin including mixed mesodermal sarcomas Documented recurrence or persistence of disease after appropriate surgical and/or radiation therapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Granulocyte count at least 1,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 3 times ULN Renal: Creatinine less than 2.5 mg/dL Cardiovascular: MUGA at least lower limit of normal Normal ejection fraction and/or stable cardiac status Other: No medical or social factors that would interfere with compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious concurrent illness requiring immediate therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior combined modality or adjuvant chemotherapy Prior doxorubicin allowed if cumulative dose is recorded Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since prior noncytotoxic experimental antiemetic or antifungal investigational drugs
Performance Study of a Non-invasive Glucose Monitoring Device Prototype

This clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in private homes of subjects.

Protocol consists of two parts:

Part A) Subjects will collect spectral Raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributed within a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.

Part B) Subjects will perform four daily measuring sessions in which optical Raman readings are paired with capillary Blood Glucose comparator. Measuring sessions are performed in subjects' own home while maintaining usual diabetes management routines. Subjects will collect data for 30 days during a 60 days' period.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 years of age or older
* Diabetic patients (all types), insulin requiring
* Skin phototype 1-4

Exclusion Criteria:

* For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* For female participants: Breastfeeding
* Subjects not able to understand and read Danish
* In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
* Rejection by optical screenings
* Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
* Diagnosed with reduced circulation
* Extensive skin changes, tattoos or diseases on probe application site
* Known allergy to medical grade alcohol
* Known allergy to adhesives, applicable to subjects in RSP-13-01
* Systemic or topical administration of glucocorticoids for the past 7 days
* Subjects undergoing dialysis treatment
* Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
* Participants currently enrolled in another study
Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation.

Background: The incidence of breech presentation in pregnant women is 4%. The situation can be treated by two methods. The first is a version of the fetus from breech presentation to head presentation, which can be performed in several ways, such as, an action called EXTERNAL CEPHALIC VERSION as well as the Knee-Chest position by the pregnant mother and the second is a cesarean section. In this study we wish to investigate if the Knee-Chest position is as effective as the ECV action and as a result to decrease the need for ECV.

Hypotheses: According to our assumption, the Knee-Chest position can reduce the need for the ECV action.

Objectives: Investigate whether daily Knee-Chest position is as effective as ECV.

Methods: The investigators will conduct a "randomized clinical trial" study. Every pregnant woman in a breech presentation with a singleton between weeks 28-32 will be randomly assigned into one of two groups. In the first group the women will perform daily the Knee-Chest position between weeks 32-37. In week 37 the investigators will check via ultra sound if there was a successful version (if not, the woman would go to ECV) in the second group we will perform ECV without doing maternal Knee-Chest position before. Every woman will fill a questionnaire which includes gynecological history and details regarding the degree of persistence and performance of the activity. At the end of this process the investigators will analyze the results and will come to the conclusions.

Significance: With ECV there are number of risks and complications such as fetal distress, placental abruption, rupture of membrane, amniotic fluid embolism or damage to the uterus. The frequency of these complications is 1%-2%. If it is discovered that the Knee-Chest position is effective as the ECV action, the investigators will recommend every patient to persist with this position and avoid the ECV action and the risks it entails.


Eligibility Criteria:
Inclusion Criteria:

Pregnant woman in a breech presentation with a singleton between weeks 28-32.

Exclusion Criteria:

* Antepartum Hemorrhage.
* Premature rupture of membranes.
* Placenta Previa.
* Oligohydramnios.
* Twin Pregnancy.
* Uterine malformation.
Expanded Access [11C] Methionine PET Imaging

The participants are being asked to get this PET scan because the participants have or may have cancer in the central nervous system (head, neck, or spine), and the investigator and the patient's physician thinks that this scan may provide useful information for the participant's treatment.

Primary Objective

To provide expanded access to L-\[11C\]methionine as a positron-emitting tracer in children and young adults for the positron emission tomography (PET) imaging of neoplasms of the central nervous system (CNS) and head and neck to guide therapeutic management of disease.

Participants receive an intravenous injection of a small (tracer) dose of L-\[11C\]methionine. Approximately 10 minutes later, patients undergo PET scanning to evaluate localization of the tracer.

Eligibility Criteria:
Inclusion Criteria:

* All participants under the care of a SJCRH physician with known or suspected neoplastic disease of the CNS or head and neck are eligible for participation.
* No limit on age.
* Patients of all genders and all ethnic groups under the care of a SJCRH physician.
* Female participants of child-bearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
* Informed consent signed by participant, parent, or guardian according to the guidelines of the Institutional Review Board.

Exclusion Criteria:

* More than six L-\[11C\]methionine PET scans within the previous 12 months.
* Inability or willingness of patient, parent, or guardian to consent.
Pain Perception of Needle-free System

The purpose of this study is to evaluate and compare the pain perception associated with a needle-free injection system( Comfort-In) and dental injection method in filling and pulpotomy treatments

Needle-free injection system(Comfort-In) and dental injection method was applied on the teeth of children who need dental treatment.70 patients were included in the study. Patients were randomized into two grups according to the injection technique.

Group1: Needle-free injection system(Comofrt-In) 2:Dental injection method. The pain intensity was assessed during anesthesia, during treatment and at the end of thetreatment by the Wong Baker Faces Pain Scale.

The datas were analyzed with a three-way variance method in repeated.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 4-11 years
* Having no developmental or systemic disorder or no history of allergy
* Having "positive" or "definitely positive" cooperation level according to the Frankl Behavior Scale
* Having sufficient mouth opening
* Operation only on primary teeth
* Having decayed teeth that require anesthesia

Exclusion Criteria:

* Patients younger than five years, older than 11 years,
* Patients with systemic or developmental disorders
* Children with an allergy history
* 'Negative' or 'definitly negative' behavior rating according to the Frankl scale
* Patients whose mouth opening is not sufficient for dental treatment
* Operating only on permanent teeth
* Teeth that are beyond the treatment stage
* When pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded.
Healthy Eating & Active Living for Diabetes in Primary Care Networks

The investigators aim to establish the effectiveness of a prescribed, community-based lifestyle modification program for those with recently diagnosed diabetes. The investigators hypothesize that those who enter a 6 month program will report greater levels of physical activity compared to a group who do not enter the program but who continue to receive usual care.


Eligibility Criteria:
Inclusion Criteria:

* adult, recent type 2 diabetes diagnosis according to a diabetes patient registry, received a referral to a group-based lifestyle program or some provider-based diabetes related education.

Exclusion Criteria:

* physical limitation, cardiovascular contraindication, participation in any other research study
Prospective Cohort Study of Children With GSD1b Receiving Empagliflozin

This is a prospective cohort study of children with GSD1b to evaluate their outcome after using empagliflozin for neutrophil defects.

Glycogen Storage Disease Type 1b (GSD1b) is an ultra-rare inborn error of carbohydrate metabolism, characterized by low neutrophil count, neutrophil dysfunction, and the associated recurrent infections and inflammatory bowel conditions.

The current standard treatment with granulocyte colony-stimulating factor (GCSF) only increases neutrophil count but does not improve neutrophil function. It achieves only partial clinical response. Fever, recurrent infections, and gastrointestinal upset remain significant problems. Long-term regular GCSF injection is needed to sustain the clinical effect, but is also associated with development of serious complications including massive spleen enlargement, acute myeloid leukemia and myelodysplastic syndrome.

Accumulation of a toxic metabolite called 1,5-anhydroglucitol-6-phosphate (1,5AG6P) is recently discovered as the cause of neutrophil problems in GSD1b. Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor widely used as anti-diabetic drug, is known to promote excretion of 1,5-anhydroglucitol (1,5AG) in kidney. Since 1,5AG is the precursor of 1,5AG6P, empagliflozin also reduces the accumulation of 1,5AG6P. This is confirmed by animal studies that empagliflozin is shown to improve neutrophil count and function in GSD1b mouse model. Similar benefits are also recently reported in human cases (3 adults and 2 children with GSD1b), that GCSF dose could be significantly reduced or even stopped.

This is a prospective cohort study of children with GSD1b to examine their outcome after receiving empagliflozin treatment. The objective is to evaluate the short to medium term safety and efficacy of empagliflozin. The ultimate goal is to assess if SGLT2 inhibitor could be an effective alternative of GCSF with less side effects and risks, and to improve the clinical outcomes and quality of life for patients and families with GSD1b.

Eligibility Criteria:
Inclusion Criteria:

- Subject (aged 6 months to 18 years) is enzymatically/genetically confirmed to have GSD 1b and has been on regular GCSF treatment for \>= 1 month

Exclusion Criteria:

* Subject fails to provide relevant background medical information, or comply with all requirements of the clinical trial, or sign the informed consent
* Subject has any co-morbidity or condition that could increase the risk of empagliflozin treatment (e.g. renal failure with eGFR \<30 mL/min/1.73m2 or requiring dialysis, diabetes requiring insulin \&/or oral hypoglycemic agents, dyslipidemia requiring pharmacological intervention)
* Subject is pregnant, or a sexually active female who does not consent to use effective contraception during the study
* History of liver transplantation is NOT an exclusion criterium