cyrilzakka/clinical-trials huggingface dataset:
Upstroke Time Measured by Photoplethysmography

Peripherial arterial disease (PAD) and diabetes are major public health issues. In 2020, according to the latest epidemiological data, it is estimated that there will be more than one million patients with PAD and more than 3.5 million diabetic patients in France.

In the diabetic patient, screening for PAD is carried out by calculating the Toe-Brachial pressure index (TBi), a technique that remains time-consuming and technically demanding, which limits its use for clinical routine screening.

A new photoplethysmographic method (PPG) makes possible to determine the quality of peripheral perfusion thanks to the automatic computation of the upstroke time (TMS in ms).

This method appears to be a promising, inexpensive, faster and easier technical alternative to improve the dissemination of the vascular screening in diabetics.

To date, no prospective study has established a relationship between the measurement of upstroke time using the PPG method and TBi in a specific diabetic population.We will perform a two-centre prospective study (Nice University Hospital and Antibes Hospital) comparing the two techniques. The main objective of our study will compare the values of the upstroke time obtained by a PPG method and the TBi in a population of diabetic patients.

The secondary objectives will be to compare the TBi values to the ratio of the TMS measurements at the toe to the reference TMS measured at the hand and to determine the sensitivity-specificity of the TMS measured by PPG compared to the TBi in the detection of a significant PAD in diabetics.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years, with no upper age limit
* Vascular assessment for PAD (screening or follow-up).
* Patient diagnosed with type 2 diabetes according to WHO diagnostic criteria (blood glucose \> 1.26 g/l (7.0 mmol/l) after an 8-hour fast and checked twice ; or the presence of symptoms of diabetes (polyuria, polydipsia, weight loss) associated with a blood glucose level (on venous plasma) \> 2 g/l (11.1 mmol/l); or a blood glucose level (on venous plasma) \> 2 g/l (11.1 mmol/l) 2 hours after an oral glucose load of 75 g), under medical treatment or under dietary treatment alone.
* Patient having signed the informed consent form for the study.
* Patient with social security coverage.

Exclusion Criteria:

* Patient under 18 years of age
* Major amputations including transfemoral and transtibial amputations
* Ankle or toe lesions
* Any clinical condition of the patient not allowing measurements (acute ischaemia, pain, tremors...).
* Pregnant women, pregnant and breast feeding women, persons deprived of their freedom by a judicial or administrative decision, persons hospitalised without consent who are not covered by the provisions of Article L. 1121-8, and persons admitted to a health or social establishment for purposes other than research.
Intravenous Fluid Therapy in Hospitals

The administration of intravenous fluids plays a crucial role in critically ill patients to support optimal management and ensure patient safety. Knowledge and conceptual frameworks will influence a clinician's accuracy in providing intravenous fluid therapy to patients. Accurate administration of fluid therapy to patients will reduce unwanted side effects and decrease the overall treatment costs during hospitalization. Various considerations in administering intravenous fluid therapy are influenced by a clinician's level of knowledge. In Indonesia, doctors working in hospitals may have different levels of education and professional status. However, it is currently unclear whether these professional differences among doctors influence their knowledge in administering fluids to patients.


Eligibility Criteria:
Inclusion Criteria:

* All anesthesiologist residencies and are willing to complete the questionnaire.
* All anesthesia specialists and subspecialists and are willing to complete the questionnaire until finished.

Exclusion Criteria:

* All doctors who are unwilling and do not complete the survey questionnaire.
Homeopathy for Post-operative (C. Section) Recovery

The planned study will be conducted in a prospective, randomized, double blind placebo controlled manner. Two "anti-traumatic" Homeopathic remedies (Arnica montana and Staphysagria) will be used. The selection of these remedies was based on a previous trial that showed a statistical difference in Hemoglobin levels favoring pregnant women treated with these drugs following delivery.

The proposed study will focus on the post-operative recovery of women undergoing Cesarean section. According to Homeopathic principles, these two remedies are believed to improve the "vital force", and will therefore improve convalescence following surgery in the study group. The study will include 90 women between the ages of 18 and 50 years who are scheduled for elective Cesarean Section. Exclusion criteria are: obesity (above 100kg), malignancy, psychiatric illness, diabetes and multipara pregnancies. Participants will be inducted following a detailed explanation by an MD and signing of an informed consent form, and then subdivided randomly into three groups numbering 30 in each: Two groups will be treated with homeopathic drugs of varied doses, and the third will get a placebo remedy which is indistinguishable from the other drugs. Outcome measures will include: 1. Blood loss - as estimated by a reduction in serum Hemoglobin levels. 2. Pain -to be evaluated by a numerical rating score (NRS) 3. Analgesic use 4. Length of post-operative stay and complications. 5. Quality of life outcomes - to be assessed using the MOS SF-36 questionnaire at one and four weeks following surgery. Although not expected, adverse events will be monitored.

If, as we anticipate, the homeopathic treatment proves to be both safe and effective in shortening the duration of post-operative healing, this will have significant implications, with respect to both healthcare costs and patient suffering. It will also open the door for further research in the field of trauma medicine, as well as other stress-related illness.


Eligibility Criteria:
Inclusion Criteria:

* women hospitalized for elective C. Section, from the 1st to 3rd pregnancies.
* Age \< 50 years
* Body weight \< 100 kg
* Signing of informed consent form

Exclusion Criteria:

1. suspected/proven malignancy
2. underlying Axis-1 psychiatric illness
3. age \< 18 years
4. diabetes mellitus (NIDDM/IDDM)
5. unable to comply with study proceedings
Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\&lt;12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).

Annually, \~8 million children receive emergency care due to injury, over 125,000 of whom experience pediatric traumatic injury (PTI) - injuries so severe that they are hospitalized, typically after motor vehicle crashes, falls, animal attacks, gunshot wounds, or being struck by a car or other object. Roughly 1 in 3 develop posttraumatic stress disorder (PTSD) and/or depression after PTI - risk factors for poor physical recovery, social and school-related impairment, and disruption of roles and routines. Moreover, \&gt;50% of caregivers of children with PTI are highly distressed in the acute stages of recovery and themselves have high risk of PTSD and depression. This is concerning because caregivers' mental health is highly correlated with children's outcomes. Interventions that improve families' quality of life and emotional and behavioral recovery after PTI are a public health priority. However, trauma centers do not currently have best-practice interventions in place to address this need. Studies led by our team found that few Level 1 pediatric trauma centers have embedded behavioral health programs and that there is high interest in learning how to implement such programs. Many centers are eager to implement cost-efficient models of care. The 2022 American College of Surgeons guidelines explicitly recommend mental health intervention. Pediatric trauma centers therefore are ideally positioned and motivated to embed best-practice care to address the emotional and behavioral needs of children and families.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers (≥18 years old) of children hospitalized with pediatric injury
* Children hospitalized with pediatric injury \&lt;12 years old
* Screen positive on the ASC-Kids (aged 8-11 years) or PDI Caregiver measure of acute distress.

Exclusion Criteria:

* A caregiver whose primary language is not English
* A cognitive challenge (caregiver or child) that would impair ability to consent
* Presence of a self-afflicted injury
* Presence of injuries resulting from caregiver abuse or neglect (these patients will follow an alternative treatment path).
Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise

This is an exploratory study based on the hypothesis that kidney transplant patients treated with an immunosuppressive therapy based on an inhibitor of the mammalian target of rapamycin (m-TOR) may increase resistance to physical exercise, which would result in an improvement in the quality of life of these patients.

The hypothesis of the present study is that, with respect to calcineurin inhibitors, the mTOR inhibitor-based immunosuppression may alter the physical exercise capacity in renal transplant patients.

This is based on recent data obtained. Regarding metabolism there is evidence that inhibition of mTOR, reduces muscle glucose utilization, as well as, increase fatty acid oxidation. On the other hand, has shown that drugs based on mTOR inhibitors in the context of excess of nutrients improves intracellular glucose uptake in skeletal muscle cells. Through these mechanisms could increase resistance to physical exercise, which would result in an improvement in the quality of life of patients. Nevertheless, there isn't any paper that has explored this hypothesis accurately.

Eligibility Criteria:
Inclusion Criteria:

1. Renal transplant patient's aged between 18 and 60 years old.
2. Heart rate in radial pulse and seated between 50 and 100 bpm.
3. Systolic blood pressure between 100 and 140 and diastolic between 50 to 90.
4. Absence of any clinical physical, psychological or psychiatric condition that would prevent from the protocol described follow-up.
5. Estimated glomerular filtration rate greater than 40 ml / min.
6. Proteinuria \< 0.5 g / d.
7. Renal transplantation at least 6 months ago.
8. Immunosuppressant based on calcineurin inhibitors.
9. Hemoglobin \> 11 g / dl.
10. Body mass index (BMI) \< 35 kg/m2.
11. Indication for conversion to everolimus and granting of written informed consent.

Exclusion Criteria:

1. Diabetes mellitus
2. Treatment with erythropoiesis stimulating drugs
3. Treatment with β blockers drugs
4. Participation in any clinical trial in the last 30 days prior to the inclusion.
5. Any other physical illness, psychological or psychiatric condition that could difficult the follow-up of the patient.
Dexamethasone & Bupivacaine vs Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Perioperative Analgesia in Patients Undergoing Lower Limb Surgeries

In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8 hours. Increasing the duration of local anaesthetic action is often desirable because it prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil were added to local anaesthetics, but the results are either inconclusive or associated with side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there is no evidence suggesting any neuritis when steroids are used in low concentration in peripheral nerve blocks.

Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural injection of steroids is reported to influence postoperative analgesia. They relieve pain by reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5% levobupivacaine in interscalene brachial plexus block showed improvement of postoperative analgesia for arthroscopic shoulder operation without any specific complications.

The objective of this study is to compare the effects of combining of dexamethasone and bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients undergoing lower limb vascular surgeries. The effects will be studied in terms of:

* Onset of sensory blockade and motor blockade
* Duration of analgesia / first request for analgesic
* Duration of motor blockade


Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 18 to 70 years
* American Society of Anesthesiologists (ASA) physical status I, II and III
* Patients scheduled for lower limb vascular surgeries

Exclusion Criteria:

* Patient refusal for the procedure
* Any bleeding disorder or patients on anticoagulant therapy
* Neurological deficits involving lumbar or sacral plexuses
* Patients with allergy to local anaesthetics
* Local infection at the injection site
* Patients on any sedative or antipsychotic drugs
* Body mass index \> 35
Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids

This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

Men and women 18 years of age or older who have been taking glucocorticoid treatment. Men and women who are less than 50 years of age must have had a fracture as an adult to be eligible. Men and women who are 50 years of age or older who have been taking glucocorticoids must meet protocol-specific BMD criteria.

Exclusion Criteria:

Use of agents affecting bone metabolism, use of more than one biologic agent for inflammatory disease, history of bone disease (except osteoporosis), low vitamin D level (one can enter the trial after vitamin D levels are corrected), abnormalities of blood calcium, an underactive or overactive thyroid condition that is not treated and stable, Addison's disease, any abnormality of the parathyroid glands (the glands that control blood calcium), currently pregnant or planning a pregnancy, currently breast feeding, and other criteria may apply.
A Comparison of Once a Day Dose Compared to 2 Doses/Day

The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.

Currently, in the US, Asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. A once daily dose is potentially beneficial to patients and physicians alike. This study will answer the following questions about once daily dosing: (1) does efficacy differ between once daily and twice daily dosing, (2) do patients prefer a once daily dosing regimen, and (3) is compliance better? This study will confirm whether there are benefits to once daily dosing beyond increased convenience. In order to understand how the QD regimen compares to BID in a "real life" practice setting, the patient will remain on the total daily dose of Asacol (1.6 g/day to 2.4 g/day) on which they were maintained in remission, but will be assigned to either a QD or BID regimen. This is an investigator-blinded study.

Eligibility Criteria:
Inclusion Criteria:

* Documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry
* At least one flare in the past 18 months
* Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months)
* Females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception

Exclusion Criteria:

* History of or current renal disease
* History of hepatic disease
* History of allergy or hypersensitivity to salicylates, aminosalicylates
* Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening
* Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening
Machine Learning Model to Predict Outcome in Acute Hypoxemic Respiratory Failure

Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death in 1,241 patients enrolled in the PANDORA (Prevalence AND Outcome of acute Respiratory fAilure) Study in Spain. The study was registered with ClinicalTrials.gov (NCT03145974). Our aim is to evaluate the minimum number of variables models using logistic regression and four supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron.

Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death in AHRF patients on mechanical ventilation (MV). Few studies have investigated the prediction of mortality in patients with AHRF.

For model development, the investigators will extract data for the first 2 days after diagnosis of AHRF from patients included in the de-identified database of the PANDORA cohort. We had a database with 2,000,000 anonymized and dissociated demographics and clinical, data from 1,241 patients with AHRF enrolled in our PANDORA cohort (Prevalence AND Outcome of acute Respiratory fAilure) from 22 Spanish hospitals and coordinated by the principal investigator (JV). The investigators will follow the Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) guidelines for model prediction. We will screen collected variables employing a genetic algorithm variable selection method to achieve parsimony. We evaluated the minimum number of variables models using logistic regression and 4 supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron. We will use a 5-fold cross-validation in the dataset of 1,000 patients selected randomly in training data (80%) and testing data (20%). For external validation, we will use the remaining 241 patients.

Eligibility Criteria:
Inclusion Criteria:

* endotracheal intubation plus mechanical ventilation (MV)
* PaO2/FiO2 ratio ≤300 mmHg under MV with positive end-expiratory pressure (PEEP) ≥5 cmH2O and FiO2 ≥0.3.

Exclusion Criteria:

* Post-operative patients ventilated \<24 h
* Brain death patients.
Clinical Study on Treatment of Chronic Persistent Bronchial Asthma

Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.

The incidence of asthma in China is high and the rate of control is low. Traditional Chinese medicine has a long history of treating asthma, and has a good clinical curative effect.The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.

In this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program for 28 days.Participants will undergo a physical examination, lung function, blood and sputum collection.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with chronic persistent asthma
* Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
* Conform to the predetermined 2 TCM Syndrome Types
* Patients who have given written informed consent

Exclusion Criteria:

* Smoking and continuous exposure to hazardous environment
* With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
* Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
* Patients who are allergic to therapeutic medicine
Steroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other.

Patients are being asked to participate in a research study because the patients are being treated for low back pain and the patients have decided to have an epidural steroid injection.

Low back pain has a tremendous impact on the individual and society. It not only affects the individuals quality of life, it also contributes to lost productivity and increased health care costs.

Epidural steroid injections (ESIs) are a common treatment option for many forms of low back pain. They have been used for low back problems since 1952 and are still being used as a non-surgical form of treatment for low back pain. The goal of the injections is reduction of pain, increased quality of life and improved function.

This study is being conducted to determine the outcomes of injections given at the "level of MRI Pathology" versus at the "level of clinical symptoms" to see if one is more effective than the other and to learn more about the characteristics of the two different injections.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Single level spinal stenosis.
* Single level radiculopathy with MRI findings at a different level than clinical pattern.
* Chronic low back pain with radicular symptoms of \> 4 weeks, but \< 6 months.
* Failure of conservative therapy to include physical and pharmacotherapy.
* Patient is at least 21 years of age.
* Patient is willing to be blinded to treatment until after the 3-month follow up visit.
* Patient is willing and able to review and sign the study's informed consent form.

Exclusion Criteria:

* Patient has a mental or physical condition that would invalidate evaluation results.
* Patient has had prior lumbar surgery at any level.
* Patient is pregnant.
* Patient has systemic infection or infection at the proposed injection site.