cyrilzakka/clinical-trials huggingface dataset:
Shock Wave Therapy for Osteoporosis

Rationale: Osteoporotic fractures are associated with high morbidity and mortality. This is why prevention of these fractures is important. The investigators have shown in animal studies that a single treatment with unfocused extracorporeal shock wave therapy leads to highly increased bone mass and improved biomechanical properties. Unfocused extracorporeal shock wave therapy could have important implications for the prevention of osteoporotic fractures.

Objective: To assess the effect of unfocused extracorporeal shock wave therapy on bone mass.

Study design: A clinical pilot study. Study population: Twelve female patients are eligible if they are undergoing elective surgery of the lower extremity or elective spinal surgery under general anesthesia in the investigators hospital.

Intervention: When the patient is under general anaesthesia he/she will receive 3000 unfocused extracorporeal shock waves (energy flux density 0.3mJ/mm2) to one distal forearm. The contra lateral forearm will not be treated and serves as a control.

Main study parameters/endpoints:

The investigators will examine the effect on bone mass with the use of repeated dual energy X-ray absorptiometry measurements. These results are necessary to calculate the number of patients that are needed for larger studies. Furthermore, the investigators will assess patient's discomfort.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: General anaesthesia is performed during treatment and pain after the procedure will be evaluated using pain scales and, if necessary pain medication will be prescribed by the orthopaedic surgeon. The dual energy X-ray absorptiometry-scans and X-rays will cause very low radiation exposure to the patient.


Eligibility Criteria:
Inclusion Criteria:

* female sex, age 50-80 years, normal dietary intake inclusive calcium and/or milk products and willing to participate

Exclusion Criteria:

* skin disease, systemic corticosteroid use, known systemic disease that interacts with bone (eg. rheumatoid arthritis, multiple myeloma, hyper(para)thyroidism, Paget's disease or Cushing's disease) or a previous wrist fracture
Gait Adaptability Training, Using Augmented Reality, for Individuals in the Chronic Phase After Stroke

Background: The majority of stroke survivors regain walking ability, however the ability to adapt their gait to meet environmental demands remains impaired. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. Treatment targeting these gait deficiencies is, therefore, critical for allowing safe and independent community ambulation in people with stroke. Rehabilitation programs targeting gait adaptability have gained interest in clinical practice. Besides, the use of augmented and virtual reality in rehabilitation programs becomes more common. Concerning gait adaptability, training programs are developed using the Cmill, an instrumented treadmill with augmented reality. Even though the efficacy of these interventions is limited to small, pilot trials, results are promising. Based on these results we hypothesize that a gait training program using the Cmill will improve gait adaptability and daily-life gait performance in people in the chronic phase after stroke.

Objective: The primary objective of this study is to evaluate the efficacy of a gait training program using an instrumented treadmill with virtual and augmented reality for improving gait adaptability in people in the chronic phase after stroke. A second objective is to identify patient characteristics that predict a more favorable response to training.

Study design: Randomized, waiting-list controlled trial to evaluate gait adaptability training

Study population: 84 stroke patients in the chronic phase after stroke


Eligibility Criteria:
Inclusion Criteria:

* \> 6 months after first unilateral supratentorial stroke (chronic phase)
* Able to walk at least 10 minutes independently

Exclusion Criteria:

* Any other neurological or musculoskeletal disease affecting gait or balance (e.g. Parkinson's disease, knee osteoarthritis)
* Contractures or spasticity requiring other treatment (e.g. botulinum toxin treatment) within the duration of the training period.
* Has received multiple training sessions on C-Mill or GRAIL in the past 12 months
* Severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments
The Efficacy of Brief Motivational Interviewing for Trauma Patients Related to Alcohol or Other Abuse Drugs.

The purpose of this study is to determine whether the Brief Motivational Interview will produce a significantly reduction in risk behavior than usual treatment 3 months after discharge from hospital in people who have survived a traumatism.

Objectives:

1. To determine the efficacy of Brief Motivational Interview against an usual hospital treatment (no psychological treatment) in patients who have suffered an accident under the influence of drugs (1) to reduce risk behaviors and drug consumption and (2) to increase motivation to change behavior and risk perception.
2. To investigate the mediating role of impulsive personality and decision making in the impact of Brief Motivational Interview on reduction of risk driving.
3. To assess the economic viability of the results of Brief Motivational Interview through a cost-utility analysis.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patients who have had: 1) A road crash, 2) A sport injury, 3) Occupational accident.
* Tested positive on alcohol and/or other abuse drugs tests.

Exclusion Criteria:

* Cognitive or brain-damage that prevent assessment and Brief Motivational Interview
* Psychopathological disorders
* Residence status that prevents follow-up (residence outside of Spain, homeless).
Biomarkers for Therapy Response in Drug-resistant Tuberculosis

Multi-center, observational, prospective cohort study including patients with multidrug-resistant tuberculosis at different sites in Germany.

The aim the study is the identification of biomarkers for therapy response.

The increasing rates of multidrug-resistant (MDR) tuberculosis (TB) are causing great concern. The current study that will be conducted at different centers in Germany. Biomarkers for treatment response during the course of the tuberculosis therapy will be evaluated. The study will be conducted with funding of the German Center for Infection Research (DZIF).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with confirmed pulmonary MDR-TB
* Subject able and willing to give informed consent

Exclusion Criteria:

* HIV infection
* physical or mental inability preventing study participation at the discretion of the investigator
* member of a vulnerable or special population (prisoner, soldier, mentally ill, under guardianship)
* age \<18 years.
Effect of Skill Birth Attendant Training to Improve the Competency of Service Providers

This clinical trial's primary goal is to compare birth attendants' competencies. It aims to answer the questions:

* Does the new modular training package enhance the competencies of skilled birth attendants?
* Does the competencies of skilled birth attendants relates to improving maternal and neonatal health outcomes in Nepal?
* Is this training module a cost-effective intervention?

Participants' knowledge, attitude, and skills will be assessed and it will be compared with standard training groups: Researchers will compare the competencies of birth attendants who receive modular training versus standard training to see if an increment in competencies is associated with maternal and neonatal health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Health workers should be Auxiliary Nurse Midwives and Nurses working in birthing centers where at least 10 birth managed in the last year
* Health workers (Auxiliary Nurse Midwives and Nurses) who are committed to providing maternal and neonatal health services and priority for permanent service holders.
* Who passes at least the first module (Online module) to participate in modular training

Exclusion Criteria:

* Health workers (Auxiliary Nurse Midwives ad Nurses) who do not provide maternal and neonatal health service
* Health workers other than Auxiliary Nurse Midwives and Nurses though they provide maternal neonatal health services in government health facilities
* Health workers working in private health facilities
Clinical Impacts of Burnout Syndrome Among Anesthesiology Residents

This study aimed to determine the relationship between burnout levels and clinical performances of anesthesiology residents.

Fifty-five second until fourth year anesthesiology residents, who were not on any mental medication treatment, were recruited consecutively and asked to fill out questionnaires which are; the Maslach Burnout Inventory (MBI) questionnaire to assess burnout levels, Best Practice Anesthesiologist questionnaire to assess positive clinical performance, Anesthesiology Residents' Self-Reported Errors and Quality of Care questionnaire to assess negative clinical performance.

Eligibility Criteria:
Inclusion Criteria:

* second until fourth year anesthesiology residents
* not on any mental medication treatment
* willing to participate

Exclusion Criteria:

* on paid leave
* rejected to become the sample
* had their shift in 24 hours prior to this study
Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus

This study evaluates the expression of the neonatal fc receptor (FcRn) in white blood cells and antigen-presenting cells (APC) in active lupus patients compared to inactive lupus patients and control to investigate if it's upregulated or not.

FcRn is an intracellular receptor which binds the Fc of immunoglobulins G (IgG) and albumin which induce an upgraded half-life of this two proteins.

It's extended role involve the regulation of immune complexes and anti-tumoral immunity, some studies showing a direct correlation between it's expression and the tumor surface and prognosis.

Recently a role in the upregulation of humoral response with a increase of the antibodies's diversity and a more efficient priming of lymphocyte B have been evocated.

The lupus erythematosus is an auto-immune disease mediated by IgG and immune complexes characterized by a high diversity of autoantibodies and a large dysregulation of the immune system in all it's components.

In this study, by analogy with the founding in anti-tumoral immunity, the investigators hypothesised that in an active lupus disease the expression of FcRn is upregulated in the white blood cells and in APC.

This is followed by an extended half life of IgG autoantibodies and immune complexes inducing direct damages by their deposit in tissues and indirectly by upregulating the humoral response, leading to anormal production of a large panel of autoantibodies.

Eligibility Criteria:
Inclusion criteria:

* Lupus erythematosus newly diagnosed or active
* Inactive lupus erythematosus
* Needing a blood sample for diagnosis or follow up
* Signed informed consent

Exclusion criteria:

* Other auto immune disease
* Pregnant or brest feeding
* Legal protection or protected adults
Efficacy of a Web-based Lifestyle Modification Program in Obese Patients With Cardiovascular Risk Factors

To evaluate the effect of a 6-month web-based lifestyle modification program with and without telephone counseling versus usual care in obese patients with cardiovascular risk factors on:

* Weight Loss
* Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.
* Physical activity and eating habits
* Quality of life


Eligibility Criteria:
Inclusion Criteria:

1. Male or female 25-70 years of age
2. Obese (BMI ≥ 30 kg/m2 and \<40 kg/m2)
3. At least 2 cardiovascular risk factors (diabetes, hypertension or dyslipidemia) i) Hypertension defined by a history of hypertension, treatment of hypertension or BP values \>140/90 mmHg in two consecutive office visits ii) High cholesterol defined by an LDL-C ≥130 mg/dL and/or HDL-C \<40 mg/dL and triglycerides ≥150 mg/dL iii) Type 2 Diabetes Mellitus defined by a history of diabetes, treatment of diabetes or fasting glucose ≥126 mg/dL in two consecutive office visits
4. Participant must be willing and able to provide written informed consent
5. Participant must be willing and able to comply with study related procedures
6. Participant must have access to Internet and e-mail

Exclusion Criteria:

1. Stage 1 or 2 on Patient Activation Measures tool
2. Weight change of more than 5 kg during the 3 months preceding the screening visit
3. History of bariatric surgery
4. Fasting Plasma Glucose at screening \> 250 mg/dL (\> 13.9 mmol/L)
5. Hemoglobin A1c at screening \>8.5%
6. Treatment of type 2 diabetes with insulin (except for history of intermittent acute use, no more than 2 weeks usage in previous 6 months)
7. Uncontrolled or inadequately controlled hypertension at the time of screening with blood pressure \>160/100 mmHg
8. Secondary hypertension
9. Changes in lipid, blood pressure or diabetes modifying agents including introduction, change in dose or cessation in the 3 months prior to Screening Visit
10. Personal history of coronary heart disease, congestive heart failure, serious arrhythmias and stroke
11. Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
12. Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study
13. Presence of history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer
14. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
15. Use of any investigational agent (drug, biologic, device) within 3 months prior to screening
Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives

The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with Targiniq.


Eligibility Criteria:
Inclusion criteria:

* Male or non-pregnant female ≥18 years of age
* Malignant or non-malignant opioid sensitive pain
* Must sign an informed consent form (ICF)
* Must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts)
* Use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect
* BFI ≥30 and state a discomfort caused by the constipation at screening
* Ability to answer the patient questionnaires and have an estimated overall life expectancy of at least six (6) months

Exclusion criteria:

* History of, or on-going, abuse of alcohol and/or drugs
* Inability to read and understand written instructions, ICF or questionnaires
* Constipation not related to opioid use
* Unsuitable patient for other reason(s) in the opinion of the investigator
* Inpatients, if admission and/or discharge is expected during study period
Vitamin D Supplementation and Muscle Characteristics in Trained Subjects

This study evaluates the effect of vitamin D supplementation on outcomes muscle performance and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be allocated to ingest either vitamin D (35) or placebo (35) in a double-blinded fashion

Vitamin D insufficiency compromises muscle functionality, leading to changes in muscle mass and strength, manifested at the cellular level. While this is increasingly recognized as a problem for individuals with vitamin D deficiency (typically 25(OH)D \< 25 nmol/l), there is no general consensus for the remainder of the vitamin D-spectra. This lack of knowledge is probably linked to the variation in protocols of studies that have investigated the physiological role of vitamin D. These variations vary from aspects such as interventional vs observational studies to aspects related to subject characteristics such as age, health and training status. In this project, we will evaluate the effects of 12 weeks of vitamin D supplementation (2000 IU/day) on muscle performance and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be allocated to either a vitamin D (35) or a placebo group (35) in a double-blinded manner. They will be instructed to continue their ordinary modes and frequency of training.

We anticipate baseline vitamin D levels in blood (and hence changes in vitamin D obtained through supplementation), measured as 25(OH)D, to be a major determinant of the efficacy of the intervention. This means that we expect individuals with low baseline levels of 25(OH)D to display more pronounced changes in functional and biological outcome measures than those with high baseline values. Such a scenario could be related to an inability of our protocol to increase blood levels of 25(OH)D in individuals with higher physiological levels of vitamin D (which essentially means that ingestion of vitamin D3 is leveled out or exceeded by elimination of vitamin D derivatives). Alternatively, it may be related to inabilities of tissues to respond to the resulting elevation in vitamin D levels. To study the individual variation in vitamin D responses, data on both functional and biological variables will be divided into quartiles based on baseline 25(OH)D-levels, whereupon comparisons will be made between the low-end and high-end quartile. Individual variation will also be assessed using a mixed model approach.

Eligibility Criteria:
Inclusion Criteria:

- Individuals that have performed strength and / or endurance exercise training at least 3 X week for at least 6 months prior to the study
Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction

Obesity and heart failure with preserved ejection fraction (HFpEF) have multiple pathologic associations that affect the prognosis of HFpEF. Chinese people are more prone to visceral obesity, resulting in varying degrees of true obesity in individuals with the same body mass index (BMI). There are no prognostic studies of VFA/BMI in the HFpEF population.

A total of 298 patients with HFpEF who were hospitalized in the Department of Cardiovascular Medicine of the First Affiliated Hospital of Chongqing Medical University from September 2020 to August 2023 were included in this prospective cohort study.All patients were followed up on November 30, 2023.The primary endpoint of the study was all-cause mortality and secondary endpoints were rehospitalization for heart failure and composite endpoints of both.After a median follow-up of 564 days, a total of 30 (10.1%) patients died and 82 (27.5%) were rehospitalized for heart failure. Patients with HFpEF were categorized into two groups according to median VFA/BMI (VFA/BMI \<5.49; VFA/BMI ≥5.49).The aim of this study was to elucidate whether VFA/BMI has prognostic value in patients with HFpEF by Kaplan-Meier survival analysis and cox regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adule aged≥18 years old;
* Diagnosed with HFpEF.

Diagnostic criteria including:

1. left ventricular ejection fraction ≥50%;
2. with signs and/or symptoms of heart failure;
3. Sinus rhythm：BNP≥35pg/mL and/or NT-proBNP≥125pg/mL;Atrial fibrillation rhythm：BNP≥105pg/mL and/or NT-proBNP≥365pg/mL；
4. at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction.

Exclusion Criteria:

* Age ≤18 years;
* malignant tumor;
* comorbid severe hepatic and/or renal insufficiency;
* lost to follow-up.
e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71

To develop a real-time diagnostic technique with e- Ab sensor for Entervirus 71 detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Entervirus 71, the investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. With such technique, the investigators hope to make early diagnosis and give EV71 patients early treatment to reduce the complications and case-fatality rate.

Entervirus 71 is one of the most important infectious diseases in children and the important concern in public health. Since 1998, EV71 has become an endemic disease in Taiwan and caused hundreds of severe cases and dozens of fatal cases each year due to lack of EV71 vaccine. Family transmission study also showed that it is highly contagious among households as well as in daycares or kindergartens. Therefore, a rapid diagnosis is clinically necessary and can provide clinicians the rapid answers and make early treatment possible to reduce the complications and case-fatality rate. In addition, early diagnosis of the patients will alert parents and public health workers to prevent the contacts earlier and to limit the EV71 spread.

Electrosensing antibody probing system (e- Ab sensor), which was developed for the rapid and sensitive detection of hapten, proteins or viral antigen in medical samples, will be used for analyzing the interaction kinetics between Q.anti-EV71 and its antigen EV71 present in EV71 patients and normal sample. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eVchip) or lateral flow through (eVsignal) formats. In electrosensing virus probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds EV71 epitope target molecules in the test serum. In comparison with results from direct sequencing of EV71, the investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. e- Ab sensor threshold decisions must maximize its sensitivity. Therefore, the threshold value in the test group is to find the decision could have 90% sensitivity and 90% specificity. With such technique, the investigators hope to make early diagnosis and give EV71 patients early treatment to reduce the complications and case-fatality rate.

Eligibility Criteria:
Inclusion Criteria:

* A: The patients with confirmed or suspected infection.
* B: The patients without disease.

Exclusion Criteria:

* Patients will be excluded if they couldn't sign the consent.
Addressing Disparities in Diabetes Care

The purpose of this research is to find out if using a continuous glucose monitor and working with a clinical pharmacist can help improve the health of uninsured minority patients with type 2 diabetes.

The objective of this research is to determine the effectiveness of a targeted intervention that integrates continuous glucose monitors and pharmacist-led comprehensive medication management services among uninsured adult patients with poor glycemic control on basal insulin, specifically focusing on Black and Hispanic populations. This pilot study is designed to help justify implementing this intervention on a larger scale within our healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic or non-Hispanic Black
* Diagnosis of Type 2 diabetes
* HbA1c ≥8% within the past 3 months
* Active prescription for insulin and injecting at least 1 time daily

Exclusion Criteria:

* Gestational diabetes
* Type 1 diabetes
* Receiving care by endocrinologist
* Continuous glucose monitor use within the past 6 months
* Receiving long term, hospice, or palliative care services
* Malignant cancer