cyrilzakka/clinical-trials huggingface dataset:
Malnutrition Clinical Characteristics Validation Study

Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide and results in poor outcomes. However there is no universal method for diagnosing malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition. The goal of this project is to determine whether these characteristics are the best indicators to identify malnutrition or if there are other factors that may better identify malnutrition. Because there is no gold standard definition for malnutrition, the investigators will compare the characteristics against outcomes such as length of stay, hospital readmission and death. Outcomes are also influenced by disease state, therefore, information on what brought the patient to the hospital and what happened to them in the hospital will be collected that allows the investigators to separate the effect of malnutrition from disease. The hypothesis for this study is that the malnutrition clinical characteristics and diagnosis criteria, as presented by the experts, are valid and reliable principles for the diagnosis of adult under-nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Patient on inpatient dietitian consult list
* Able to speak English to answer questions
* Ability to provide informed consent (or provided by family member)
* Expected remaining admission time \> 24 hours (determined by no mention of pending discharge in physicians notes)
* Age ≥ 18 years

Exclusion Criteria:

* Seen previously by Registered Dietitian during current admission
* Patient on hospice or palliative care, in a psychiatric, maternity, pediatric or day surgery area, or in dedicated trauma or burn unit.
* Life expectancy \<7 days per physician note or Registered Dietitian (RD) judgment
* Participated in the study during a previous admission
Resistive Exercise and Stretching in Women With Dysmenorrhea

This study highlights the importance of exercise for young women with primary dysmenorrhea. Exercise can help relieve the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. A comprehensive comparison of the effects of especially resistant exercises and stretching exercises on menstrual pain is based on limited findings in the literature. Therefore, this study aims to make a significant contribution to clinical practice by evaluating the effectiveness and feasibility of these exercise types.

Primary dysmenorrhea is a common condition that seriously affects women's quality of life, and alternative methods other than pharmacotherapy are often investigated. Exercise may play a potential role in reducing the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. However, studies comparing the specific effects of resistance exercises and stretching exercises on dysmenorrhea are limited and do not provide clear guidance on this subject. The aim of this study is to evaluate the effectiveness and feasibility of these two types of exercise in young women with primary dysmenorrhea. The results of the research can guide healthcare professionals by providing information on which type of exercise may be more effective in clinical practice. The importance of exercise as a non-pharmacological treatment option is emphasized, and it is aimed at making a significant contribution to the wide acceptance and application of such treatments.

Eligibility Criteria:
Inclusion Criteria:

* Having a score of 60 points or above on the menstrual symptoms scale
* Having a regular menstrual cycle (24-35 days)
* Not doing any exercise regularly
* Being between the ages of 18 and 25
* Nulliparity
* Being cooperative and oriented
* Volunteering to participate in the study

Exclusion Criteria:

* Having a medical history of chronic disease (cardiopulmonary, neurological, thyroid gland diseases)
* Having a history of regular exercise
* Engaging in regular sexual activity
* Having undergone gynecological surgical procedures
* Using hormonal contraceptive drugs or intrauterine devices
* Using a drug that causes dysmenorrhea
* Pelvic pathology, pelvic inflammatory diseases, endometriosis, etc. Having a disease that causes secondary dysmenorrhea
* Using antidepressant medication
* Having acute musculoskeletal system problems
Virtual Reality (VR) During Peripheral Nerve Evaluation (PNE) Procedure

The purpose of this research is to evaluate whether or not wearing a virtual reality headset affects pain and anxiety in patients undergoing percutaneous nerve evaluation (PNE).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective peripheral nerve evaluation studies for pelvic floor dysfunction

Exclusion Criteria:

* Have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study
* Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancers, etc., which could compromise the physical function of the headset
Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms

The purpose of the study is to investigate the effect of the amino acid-based blend on growth hormone levels (measured by IGF-1) and clinical symptoms in individuals with treatment-resistant FM and low-normal hGH.

Low hGH levels have been observed in approximately 1/3 of individuals with FM. Low hGH levels are hypothesized to contribute to inadequate treatment outcomes in many individuals with FM and several studies have demonstrated symptom improvement in individuals with FM and low hGH who received rhGH therapy. The amino acid-based blend represents a novel mechanism for increasing endogenous hGH production. It has been shown to produce an increase in endogenous hGH levels in healthy individuals by attenuating the inhibitory effect of somatostatin on hGH release. The amino acid-based blend may be a safe and effective treatment for FM in individuals with poorly controlled FM and low-normal hGH.

This study will investigate the effect of taking the amino acid blend on IGF-1 levels (a surrogate marker of the body's growth hormone levels), fibromyalgia symptoms, stress symptoms, body weight, and other cardiometabolic biomarkers in individuals with treatment-resistant FM and low-normal hGH.

After being informed about the study and potential risks, all eligible participants giving written informed consent will administer the amino acid-based blend daily. Standard care for fibromyalgia will continue.

Eligibility Criteria:
Inclusion Criteria:

1. Have a clinical diagnosis of FM for at least 10 years, poorly controlled FM symptom, and receiving standard of care treatment at the Private Medical Practice of Susan Pekarovics, MD
2. Have low to normal levels of hGH (screening IGF-1 levels between the 15th and 50th percentile for age-appropriate levels)
3. Female participants of childbearing potential will agree to avoid pregnancy during the study.
4. Capable of giving signed informed consent

Exclusion Criteria:

1. Human growth hormone deficiency (GHD)
2. Individuals with a total score of ≥15 (indicating the presence of moderately severe major depression) or a score of \>0 on Item 9 (suicidal ideation) on the Patient Health Questionnaire-9 (PHQ-9)
3. Pregnant women or women who wish to become pregnant
4. History of substance abuse
5. Previous treatment with recombinant human growth hormone (rhGH)
6. Individuals belonging to the following vulnerable populations: people with disabilities, people who cannot read, educationally disadvantaged, individuals with a serious or life threatening illness, prisoners, non-English speakers, economically disadvantaged individuals, employees of the study sponsor/site.
Neonatal Infection Surveillance Database

NeonIN is a is a neonatal infection surveillance database which will facilitate active surveillance for bacterial infections through a network of neonatal units, using standardised definitions, proformas and microbiological techniques. The centralised and secure web-based database will allow real-time entry of data and rapid and timely analysis of results.

The neonIN surveillance network captures data on episodes of invasive neonatal infection on a web-based database (www.neonin.org.uk). Over 25 UK neonatal units currently contribute to this database in real-time. An episode of neonatal infection is defined as a positive culture collected from a normally sterile site such as the blood, cerebrospinal fluid (CSF) or urine (via catheter or suprapubic aspirate) for which clinicians prescribed at least five days of appropriate antibiotics. Clinical, demographic and microbiological data (including antimicrobial susceptibilities) are collected using a standardised online questionnaire, and denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit.

Eligibility Criteria:
Inclusion Criteria:

* Infants on participating Neonatal Units who have an episode of infection with a positive culture

Exclusion Criteria:

-
A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing

The purpose of this study is to show that the performance of the new digital signal processing system is better than the system used in the currently CE marked devices. Speech in narrowband noise and acceptable levels of noise should be improved with the new system, and speech understanding overall should not be negatively affected. There should be no artefacts or unwanted noises caused by the new system.

This is a controlled, double-blinded, comparative clinical evaluation conducted monocentric at the premised of Bernafon AG in Bern, Switzerland.

For this study, Bernafon AG will carry out testing with participants with hearing loss to validate the performance of a new digital signal processing (DSP). System testing of the DSP shows an improved signal, yet it must be tested with humans to be sure of an improvement in real-life situations. The current study will compare the new DSP to the one that is used in the Bernafon hearing aids that are CE- marked and currently available on the market. The goal is to determine whether the new DSP is better in real-life situations than the current system.

Primary Endpoint: The primary objective is to assess the new DSP system with various hearing losses and levels of amplification. Speech testing will be used to analyse the speech perception of participants.

Secondary Endpoint: The secondary objective is to verify the overall performance of the new device. Acceptable noise levels will be measured as well as further speech testing. Questionnaires will be used to measure subjective responses to the performance.

Other Endpoints: The subjective performance of an optimized fitting versus a standard fitting and the acceptance of new domes will be measured with questionnaires.

Safety Endpoint: The study aims to identify any new risk factors and to ensure the safety of the device with the newly implemented DSP system before releasing it to the market.

Eligibility Criteria:
Inclusion Criteria:

* Hearing loss (sensorineural, conductive, mixed-must have doctor approval for mixed and conductive Hearing loss)
* Severity of Hearing loss ranging from mild to profound
* German speaking
* Current Hearing aid users
* Ability and willingness to sign the consent form

Exclusion Criteria:

* Contraindications for amplification
* New Hearing aid users
* Inability to follow the procedures
* Inability to attend Weekly study Appointments
* Strongly reduced dexterity
* Central Hearing disorders
* Bernafon employees
* Family members of Bernafon employees
Organizational Infrastructure Pediatric Plan in Bronchiolitis Epidemics

Acute bronchiolitis is a frequent respiratory viral infection of infants, responsible for 460,000 new cases per year in France. Over the years, the number of hospitalizations during the epidemic season appears to be increasing. Bronchiolitis epidemics lead to recurrent hospital disruption. The current trend towards a reduction of hospital beds is exacerbating the pressure on bronchiolitis epidemics on healthcare systems.

In this context, the pediatric departments of Montpellier University Hospital, France, designed in 2014 a common organizational infrastructure pediatric plan (OIPP) to to adapt to these multiple constraints while respecting the quality of care.

This plan includes a referral flowchart for hospitalized children, an increase in medical and paramedical staff and a restructuring of the pediatric units, with a specific stratification into 4 levels of care.

The study aims to assess the impact of our OIPP on the overall length of stay for children hospitalized for bronchiolitis. The investigator also intend to measure the impact of the OIPP on the length of stay within each unit, the number of transfers from one unit to the other and the number of readmissions within 30 days after hospital discharge. The cost of the implementation of the OIPP in the structure will be analyzed.

The investigator compared data between two periods of time, e.g. the two consecutive years before the beginning of the OIPP (winters 2012-2013 and 2013-2014) and two first years after the beginning of the OIPP (winters 2015-2016 and 2016-2017).

Eligibility Criteria:
Inclusion criteria:

* age \< 2 years
* hospitalization for bronchiolitis

Exclusion criteria:

* None
Evaluation of Clinical Results of Patients Treated Conservatively for Distal Biceps Tendon Lesions

A clinical evaluation of the results of conservative treatment after distal biceps tendon rupture with a minimum follow up of 1 year.

The results will be evaluated with clinical scores (MEPS, DASH and SF-12) and strenght and fatigue evaluations with dynamometers for both flexion and supination of elbow and forearm. The results of the affected side will be compared with the controlateral side


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old at time of injury
* Complete acute distal biceps tendon rupture diagnosed and evaluated at IRCCS Istituto ortopedico Rizzoli between 2000 and 2024 treated conservatively

Exclusion Criteria:

* \&lt; 18 years at time of injury
* Patients who present controindications to the strenght evaluation
* Patients who have developed other non correlated injuries to the affected arm (e.g. fractures or tendon injuries)
* Patients treated surgically for distal biceps tendon rupture
Post-authorisation Safety Study in Patients With Type 2 Diabetes to Assess the Risk of Liver Injury, Kidney Injury, Urinary Tract and Genital Infections, and Diabetic Ketoacidosis in Patients Treated With Empagliflozin, Compared to DPP-4 Inhibitors

Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic control in adults. As part of the risk management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a post-authorisation safety study (PASS) to evaluate the liver and renal safety of empagliflozin. The study will also evaluate the risks of severe complications of urinary tract infections (UTIs) and genital infections. To evaluate the association between empagliflozin use and mentioned outcomes routinely collected health information from the Clinical Practice Research Datalink (CPRD), the Hospital Episodes Statistics, and Office of National Statistic will be used. This PASS will be conducted through an observational cohort study among adult patients with T2DM and at least 12 months of continuous enrolment in the CPRD where new users of empagliflozin will be compared to new users of dipeptidyl peptidase-4 (DPP4) inhibitors. Estimations will be made on the crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and secondary outcomes.


Eligibility Criteria:
Inclusion criteria:

* Patients will have T2DM, be initiating treatment with a study medication, and have at least 12 months of continuous registration in CPRD.
* Further inclusion criteria apply

Exclusion criteria:

* Patients will not have T1DM, will have no prior use of an SGLT2 inhibitor or DPP4 inhibitor, and will not be initiating a SGLT2-DPP4 fixed-dose combination.
* Additional different exclusion criteria will be applied according to each outcomes of interest.
Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF

This study analyses the effect of intravenous branched chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators plan to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone in the medical management of overt HE in patients with ACLF and its impact on overall survival and improvement in grade of HE.

Acute on chronic liver failure (ACLF) is a distinct clinical entity in the spectrum of chronic liver disease associated with high short term mortality. Hepatic encephalopathy (HE) is commonly seen in patients with ACLF and its treatment mainly involves non-absorbable disaccharides (lactulose/lactitol).Treatment of HE in ACLF is based on extrapolation of data available from cirrhotic patients. No studies have compared different treatment options for HE in patients with ACLF.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years
2. Either gender
3. Patients with ACLF (CANONIC definition) of any aetiology with HE ≥grade 2 as per West-Haven Criteria or Hepatic encephalopathy scoring algorithm (HESA)

Exclusion Criteria:

1. Those who do not consent to participate in the study
2. Patients with structural brain lesions or stroke
3. Inability to obtain informed consent from patient or relatives
4. Severe preexisting cardiopulmonary disease
5. Renal dysfunction (S. Creatinine ≥ 2mg/dL)
6. Pregnancy/Lactation
7. Post liver transplant patients
8. HIV infection
9. Patients who are on psychoactive drugs, like sedatives or antidepressants
10. Patients who are too sick to carry out the protocol

As the study was carried out during the peak of the COVID-19, patients who developed COVID-19 after randomization were excluded from the analysis as they were shifted to dedicated COVID-19 ICU's.
The Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure

The Researchers are doing this study to find out if the cardiac rehabilitation program can improve measurements of frailty and improve independence, functional abilities, and feelings about health. Frailty can be measured by weakness (as measured by hand grip strength), slowness (as measured by walking speed), low level of physical activity, low energy or self-reported exhaustion, and unintentional weight loss.

Participants with advanced heart failure with a New York Heart Association class of III or IV symptoms within the last 3 months will be identified by either their outpatient heart failure clinic notes or inpatient cardiology notes. Patients will be approached for participation if cardiac rehab is mentioned in the notes and inclusion/exclusion criteria it met. Once the consent is signed, the baseline visit will be scheduled, this will be done before cardiac rehab has started. The baseline visit include frailty assessment measured by a walk time/gait speed test and handgrip strength test, and quality of life assessment measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Minnesota Living with Heart Failure (MLHF) questionnaire. Patients will then attend cardiac rehabilitation for six week program. The cardiac rehab program will be designed by the individual facility due to the variation in exercise tolerance of each patient, no universal protocol will be used. After the six weeks of cardiac rehab, up to 16 weeks post-completion, the patient will return to Mayo Clinic Rochester to complete the frailty and quality of life assessment.

Eligibility Criteria:
Inclusion criteria:

* Advanced heart failure patients.
* These include patients with Current NYHA class III-IV symptoms at the current time or within the preceding three months.
* Outpatient heart failure clinic with mention of cardiac rehab in patient medical record in the past year OR patients admitted to the hospital to any inpatient cardiology service (including the coronary care unit (CCU)) and mention of cardiac rehab from service.

Exclusion criteria:

* Unable to perform physical activities due to anatomic or musculoskeletal comorbidities
* Physical activity is contraindicated
A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China

Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels between plasma components and cellular component of coagulation. And through the platelet mapping, it can help provide a picture of patients' function of platelet. This study aims to explore the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.


Eligibility Criteria:
Inclusion Criteria:

* patient with previously diagnosed or undiagnosed HBV related chronic liver disease/cirrhosis
* INR≥1.5 and total bilirubin≥85μmol/L

Exclusion Criteria:

* INR≤1.5 or total bilirubin≤85μmol/L;
* underlying chronic liver disease was other than chronic HBV infection related;
* those who had hepatocellular carcinoma or other types of malignancies;
* obstructive biliary diseases or other disease lead to bilirubin evaluation;
* those who had acute hemorrhage one week before admission
* those who received platelet, cryo transfusion or plasmapheresis one week before admission
* using steroid or immunosuppressant or antiplatelet or anticoagulant drugs in 4 weeks
* any kind of decompensation which persisted over a month
* pregnancy and breastfeeding
* those who received liver transplantation or kidney transplantation;
* combine with other disease lead to organ failure including heart failure (NYHA IV),respiratory failure（PaO2\<60mmHg),renal insufficiency(CKD 5) and conscious disturbance (GCS\<8)
* readmission;
* death within 24 hours.
Xenograft with or Without Erythropoietin in Immediate Dental Implant

The aim of this study is to evaluate changes in buccal bone thickness after immediate implant placement with xenograft mixed with erythropoietin in the anterior maxilla with a thin buccal bone

PICO:

Population: Patients with non-restorable tooth in anterior maxilla with thin buccal bone (less than 1mm) Intervention: Immediate implant placement with Xenograft mixed with Erythropoietin.

Control: Immediate implant placement with Xenograft alone.

Eligibility Criteria:
* Inclusion criteria

  * Adult (≥18 years) with non-restorable maxillary teeth in the esthetic zone (upper right second premolar to upper left second premolar).
  * Intact with thin labial plate of bone (≤1mm).
  * The recipient site of the implant should be free from any pathological conditions.
  * Patients who are cooperative, motivated and hygiene conscious.
  * Appropriate crown height space to maintain favorable crown : implant ratio
* Exclusion criteria

  * Systemic conditions/diseases that contraindicate surgery.
  * Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
  * Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
  * Patients with periodontal disease.
  * Alcohol or drug abuse.
  * Pregnant and lactating women.