cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes

The aim of this trial is to evaluate the safety of single doses of a study drug known as LY3325656 that is given orally to healthy participants and participants with type 2 diabetes. Information about any side effects that may occur will be collected.

It will also investigate how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.

The study consists of two parts. Part A will study healthy participants over approximately 12 weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks, excluding screening. Screening is required within 28 days of the start of the study.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
* Have a screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²)
* Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

For participants with Type 2 Diabetes Mellitus:

* Have diabetes controlled on diet and exercise with or without metformin for at least 30 days prior to screening, or on sulfonylureas with or without metformin
* Have a glycated hemoglobin (HbA1c) value of greater than or equal to 7% and less than or equal to 11% at screening (exercise with or without metformin)
* Have a HbA1c value of greater than or equal to 7% and less than or equal to 8.5% at screening (sulfonylureas with or without metformin)

Exclusion Criteria:

For all participants:

* Are currently participating in another clinical study or completed one in the last 30 days
* Are allergic to LY3325656 or other related drugs
* Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
* Have electrocardiogram (ECG) readings that are not suitable for the study
* Are infected with hepatitis B
* Are infected with human immunodeficiency virus (HIV)
* Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
* Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic

For participants with Type 2 Diabetes Mellitus:

* Have had heart disease or stroke within 6 months before entering the study
* Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
* Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
* Have used insulin to control diabetes in the last 6 months
* Show symptoms of high blood sugar e.g. frequent urination, always feeling thirsty, or unexpected weight loss
Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma

Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.

Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged ≥ 18 years
* Presenting with solitary or multifocal resectable HCC
* Qualifying for both pure laparoscopic and open approaches

Exclusion Criteria:

* Physical or psychological status contraindicating the participation to the study
* Contraindication to surgery
* Contraindication to pneumoperitoneum
* ASA (American Society of Anesthesiologists) score IV-V
* Life expectancy \< 2 months
* Suspicion of mixed type tumor (Hepatocholangiocarcinoma) and fibrolamellar HCC
* Child-Pugh score \> B7
* Extra-hepatic involvement
* Liver resection requiring an associated vascular or biliary reconstruction
* Pregnancy and breast-feeding
* Tutorship, trusteeship
* Concurrent participation in other experimental trials concerning the same objective within 90 days following intervention
* No Affiliation to the French social security
* No Ability to give their consent and not written informed consent
Perceptions of Student Nurses About Professional Nursing Values of Creative Drama Education

Objective: This study will be carried out as a pre-test-post-test randomised controlled study to examine the effect of creative drama training on the perception of professional values in nursing students.

Materials and Methods: In the study, it was planned to collect data using Personal Information Form and Professional Values of Nurses Scale (HPVS) as data collection tools. SPSS 25.0 (Statistical Package for Social Science) programme will be used for data analysis.

Design: Randomised controlled.

Study Group: The study was planned to be conducted with student nurses studying at Istanbul Arel University, Faculty of Health Sciences, Department of Nursing. The sample size of the study was calculated as a minimum of 68, 34 in the experimental group and 34 in the control group, based on Cohen's standardised effect size of 0.80 and with a power of 0.90 with the 'G. Power-3.1.9.4' programme.

Professional values serve as a guide for actions accepted by professional groups and experts, providing a framework for assessing the values and beliefs that affect professional performance. For the nursing profession to achieve professional status and provide more qualified and effective care to individuals and, consequently, society, it is crucial for nurses to have a strong professional identity and professional values.

The quality of education and training plays a significant role in the development of professional professionalism. The acquisition of a professional identity begins during education and continues throughout a person's career. Therefore, creating awareness of the profession among nursing students during their student years will contribute significantly to the professionalization of the field in the future. It is essential for those who will pursue a nursing career to acquire professional values starting from their student years and to positively develop these values.

Research Question: Does the creative drama method have an effect on nursing students' perceptions of professional values (human dignity, responsibility, initiative, safety, autonomy) compared to the traditional teaching method?

Eligibility Criteria:
Inclusion Criteria:

* To have taken and successfully completed the Basic Concepts in Nursing course,
* To be registered in the Department of Nursing,
* Clinical Practice in Health Institutions,
* Volunteering to participate in the study,
* To know, understand and be able to speak Turkish

Exclusion Criteria:

-
The Montreal Cognitive Assessment.Test in Adults With Sickle Cell Disease

This study will assess the performances of the Montreal Cognitive Assessment (MoCA) to screen for cognitive impairment in adults with sickle cell anemia. The results of the MoCA and its subscores will be compared to a standardized neuropsychological evaluation using validated tests.

Sickle cell anemia is a monogenic disease affecting the beta-chain of hemoglobin. Cognitive impairment is more prevalent in patients with sickle cell disease than in matched unaffected individuals. Validated tests to screen for cognitive impairment are lacking in this population. Our goal is therefore to assess the performance of the Montreal Cognitive Assessment (MoCA) as a screening tool for cognitive impairment in adults with sickle cell anemia. The results of the MoCA and its subscales will be compared to a standardized neuropsychological evaluation using validated tests.

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease, SS or SBêta0 subtypes only
* Attending a consultation or a daycare hospitalization in the Tenon hospital sickle cell center
* Aged 18 years old or more
* Providing written informed consent
* With Health Insurance

Exclusion Criteria:

* Obvious cognitive impairment of neurologic (e.g. previous stroke) or psychiatric origin (e.g. psychotic disorder with negative symptoms)
* Insufficient French language fluency to understand the tests, inability to read and write or with no schooling beyond primary school
* Anticipated unavailability in the next 6 months
* Patients under supervision \& guardianship
A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria

A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.

This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese male or female subjects.
* Between 121 days to less than 72 months of age at the time of entry into the study.

Exclusion Criteria:

* Receipt of previous vaccine against Pneumo
* Previous anaphylactic reaction to any vaccine or part of a vaccine
* Previous proven invasive Pneumo infection
* Receipt of investigational drug or device within the proceeding 28 days
A Study of SHR-4394 Injection in Subjects With Prostate Cancer

This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age range: 18-85 years old, male;
2. ECOG score for physical condition is 0-1 points;
3. Expected survival period ≥ 6 months;
4. Prostate adenocarcinoma confirmed by histological or cytological examination;
5. Patients with at least one metastasis lesion;
6. Disease progression on or after the most-recent prior regimen;
7. Continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) or previous bilateral orchidectomy;
8. Testosterone was at castration level;
9. Adequate organ function.

Exclusion Criteria:

1. Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment;
2. Unresolved to CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy;
3. Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
4. Uncontrollable tumor-related pain;
5. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms;
6. Other serious concomitant disease;
7. Previous or co-existing malignancies;
8. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-4394;
9. Active hepatitis B or active hepatitis C;
10. Other inappropriate situation considered by the investigator.
A Spanish Medical Record Review of Clinical Characteristics and Outcomes in Non-small Cell Lung Cancer Participants With EGFR Exon 20 Insertion

The main aim is to evaluate sociodemographic and clinical characteristics of advanced Non-Small Cell Lung Cancer (NSCLC) in adults participants with epidermal growth factor receptor (EGFR) exon 20 insertions mutations during the 5 years before data extraction date (from 1-Jan-2017 to 1-Jan-2022).

Participants will not receive any drug. This study will only collect the data from the medical records via chart review.

This is an observational, non-interventional, retrospective study in participants with NSCLC with EGFR exon 20 insertions mutations. This study will assess the sociodemographic and clinical characteristics of advanced NSCLC participants.

The study will enroll approximately 60 participants. Participants who were evaluated and treated at the participating sites between 01 January 2017 and 30 September 2021 will be included. The data will be collected from the medical record of participants via medical chart review. All the participants will be assigned to a single observational cohort:

• Participants With Advanced NSCLC with EGFR Exon 20 Insertions Mutations

This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 27 months.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with a pathologically and/or cytologically confirmed diagnosis of advanced stage NSCLC (International Classification of Disease, 10th revision \[ICD-10\] C34.x), either primary, advanced or after relapse of initial non-metastatic disease, evaluated and treated during the last five years prior data extraction date from 1-Jan-2017 to 1-Jan-2022.
2. Participants with detection of an EGFR exon 20 insertion mutation, at any point.
3. Has documentation available for at least 2 visits since the initiation of the last treatment within the last five years (1-January-2017 to 1-January-2022).

Exclusion Criteria:

1. Participants do not meet any of the inclusion criteria.
Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain

The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.

Objectives: The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.

Experimental Design: Design: Randomized Control Trial

Methods: Twenty subjects with paraplegia will be recruited and randomized into two groups, a vibration dumbbell training (V-DT) group and a standard dumbbell training group (S-DT). Both groups will participate in a supervised 12-week (3 sessions per week) dumbbell (free-weight) strength training program consisting of nine exercises specifically designed to improve upper limb muscle function to support propulsion and transfer activities and protect the shoulders from developing pain. For each of the nine exercises the vibration group will hold a high-frequency (40 Hz) vibrating dumbbell in a static arm posture (isometric training) while the control group will move a non-vibrating dumbbell through the full range of motion for a given exercise (isotonic training). Both groups will follow a standardized protocol for assessing and progressing the amount of weight that is added to the dumbbell to achieve optimal training effects.

All participants will participate in laboratory testing for various outcome measures at baseline, 6 weeks and 12 weeks .

Eligibility Criteria:
Inclusion Criteria:

* have a neurological impairment secondary to spinal cord injury (SCI) or disease at T2 or lower
* greater than 6 months post injury
* use a manual wheelchair as primary means of mobility (at least 30 hrs. per week)
* 18 to 65 years of age
* provide signed medical release by primary care physician to engage in a high-intensity resistance training exercise program
* live within 60 minutes driving time (1 hour) from the research center
* able to perform a transfer independently to and from a wheelchair
* have normal range of motion in the upper limbs.

Exclusion Criteria:

* history of fractures or dislocations in the shoulder, elbow and wrist from which the subject has not fully recovered or joint replacement of any of the joints in the upper extremities
* upper limb pain that interferes with the ability to propel or transfer
* recent hospitalization for any reason (within the past three months)
* pregnant women
* history of coronary artery disease, coronary bypass surgery or other cardio-respiratory events
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules

The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users

The objective is to conduct a human factors validation study to demonstrate that the user interface of TOBI® Podhaler™ can support safe and effective use for the intended users. The human factors validation study will be conducted in patients with cystic fibrosis aged 6 years and older under simulated yet representative of realistic use conditions where patients with no prior training or use of TOBI® Podhaler™ will be asked to inhale the contents of placebo capsules through the Podhaler device. Due to the use of placebo capsules, the study is considered an interventional clinical study and will be conducted accordingly. The study is an open label, un-blinded, non-randomized study which consists of one visit.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent or, parent/guardian consent and where applicable pediatric assent, must be obtained before any assessment is performed
* Male and female subjects aged 6 years and older
* Confirmed diagnosis of CF by one or more of the following tests for CF as documented in the patient's medical history : (1) quantitative pilocarpine iontophoresis sweat chloride test of \> 60 mmol/L or 60 mEq/L, (2) genotype with identifiable CF-causing mutations on both chromosomes, (3) an abnormal nasal transepithelial potential difference characteristic of CF
* FEV1 value must be at least 25% of normal predicted values for age, sex, and height as documented in the patient's medical history (historical values within 3 months can be used for this criterion).
* Able to comply with all protocol requirements
* Clinically stable in the opinion of the investigator

Exclusion Criteria:

* Subjects currently enrolled in studies that are not considered as observational non-investigational studies
* Subjects or caregivers who have used the Podhaler device previously
* Hemoptysis more than approximately 60 mL at any time within 30 days prior to enrollment
* History of hypersensitivity to the inhaled placebo dry powder (DSPC and/or calcium chloride powder)
* Signs and symptoms of acute pulmonary disease, e.g. pneumonia, pneumothorax, bronchospasm, acute respiratory infection
* Clinically significant conditions or findings at enrollment that might interfere with the accurate and valid assessment of this study
* Subjects or caregivers who are considered potentially unreliable or considered unlikely to be compliant within the trial
* Pregnant women
GMA and Peri in Moderate-late Preterms

To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants

Analyze a sample of moderate and late premature infants using general movements and verify which of them would have an early diagnosis of cerebral palsy and relate it to their risk factors for this pathology.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were born between the week 32 + 0 days and the week 36 + 6 days and who are admitted to the Hospital Nuestra Señora del Prado de Talavera de la Reina or the Hospital Virgen de la Salud de Toledo.

Exclusion Criteria:

* Any type of pre and perinatal diagnostic neurological involvement.
* Any type of pathology associated with prematurity.
* Children who have prescribed any of the following medications (10):

  * Barbiturates
  * Antiepileptic
  * Indomethacin
  * Dexamethasone
Genetic Epidemiology and Energy Metabolism in Black Girls

To investigate the role of genes and energy metabolism in the pathogenesis of obesity in adolescent Black girls.

BACKGROUND:

The high prevalence of obesity in African-American (AA) women is of public health importance since AA women suffer higher mortality from cardiovascular and renal diseases than do white women. The reason for their marked susceptibility to obesity remains poorly understood though it is now known that AA women manifest lower resting energy expenditure than white women.

DESIGN NARRATIVE:

This is a multi-pronged metabolic and genetic epidemiologic study to examine two candidate genes (UCP3 and b3AR) implicated in energy metabolism. A total of 600 African American girls, aged 12-15 years, will be screened using buccal swabs as a non-invasive method of obtaining DNA, to determine their UCP3 genotypes as well as b3AR genotypes. An estimated 211 girls will be recruited, selected based on their UCP3 genotype, for measurements of resting energy expenditure and body composition (using dual energy X-ray absorptiometry \[DEXA\]) in a controlled setting of the Clinical Research Center at the Cincinnati Children's Hospital. Variation in resting energy expenditure will be examined across the genotypes of UCP3 with a large sample. The 2x3 design will allow the investigators to examine whether the effects associated with UCP3 variation are due to the UCP3 locus alone or due to the additive effect or interaction between UCP3 and b3AR. The study will help to elucidate the relationship between variation in two important candidate genes for energy metabolism, UCP3 and b3AR, and inter-individual variation in the levels of resting energy expenditure in this very high risk (for obesity) population.

Eligibility Criteria:
No eligibility criteria
Behavior During and After COVID-19 Crisis

A crisis situation leads to changes in life. During December 2019, many people contracted pneumonia in the Chinese city of Wuhan. On January 7, 2020, the novel coronavirus (Covid-19) was identified as the cause of this disease. Within five months, the virus spread around the globe and forced countries to restrict public life. Due to the high infection rates in Europe, a lockdown followed between March and April 2020 (except in Sweden). As the number of infections decreased, European countries began to gradually relax the lockdown from May 2020.

The lockdown and the later stages of loosening have an impact on lifestyle. Institutions of higher education must also adapt to this situation and have switched to distance learning.

The University of Applied Sciences of Bern (BFH), Department of Health Professions with the Departments (DHP) of Nutrition and Dietetics and Physiotherapy, considers the question of the degree to which nutritional and exercise behavior has changed.

The findings provide recommendations for future crises for students and employees of the BFH-DHP.

In order to achieve this, at the BFH-DHP two anonymous online surveys will be conducted.

There is little evidence of how physical activity and eating behavior changes during a pandemic period and in the period after a pandemic period of students and employees at the BFH-DHP. This observational study will assists to determine the impact of an immediate change within a pandemic on physical activity, nutrition, sleep and alcohol consumption and the consequences after a period of one year.

Eligibility Criteria:
Inclusion Criteria:

* Students from the Bern University of Applied Sciences, Department of Health Professions
* Students from the Bern University of Applied Sciences, Department of Health Professions

Exclusion Criteria:

-