cyrilzakka/clinical-trials huggingface dataset:
Exploring IHG Training in CR

Research has shown that isometric (constant squeeze) exercise training using an isometric handgrip (IHG) device lowers resting blood pressure (BP) in those with and without high BP. The purpose of this study is to explore if IHG training will lower resting BP in people doing cardiac rehabilitation more than doing only cardiac rehabilitation. Once eligibility is confirmed participants will be randomly assigned to one of two groups for the study. One group will do IHG training in addition to cardiac rehabilitation (Group 1), and the other group will do only cardiac rehabilitation (Group 2). Participants assigned to Group 1 will be asked to do IHG training on their own with an inflatable ball three days per week for 12 weeks with intensity set based on rating of perceived exertion (RPE) or rating of effort. Participants will self-measure and report their resting BP to investigators. The acceptability of doing IHG training will also be explored by conducting interviews with participants as will the impact that IHG training may have on psychological wellbeing by administering surveys to participants.


Eligibility Criteria:
Inclusion Criteria:

* Component adult (greater ≥ 18 years) who can provide informed consent.
* Proficient in English (speaking, writing, and reading).
* Medically cleared by the cardiac rehabilitation program to participate in exercise-based cardiac rehabilitation.
* History of only coronary artery disease, the most common cardiovascular disease (CVD), which may include individuals with a previous myocardial infarction and/or procedure such as a percutaneous coronary intervention and/or coronary artery bypass grafting.
* Minimum of "blue" level of technology capability (assigned by the cardiac rehabilitation program) indicating ability to use a phone and email for correspondence. Note: The majority of individuals who enroll in the cardiac rehabilitation program are assigned to this level.
* No physical limitation(s) that would hinder the performance of isometric handgrip training.
* Access to a blood pressure monitoring device to record at home measures.

Exclusion Criteria:

* If the participant does not meet the inclusion criteria (identified above).
* Moreover if an individual has a history of a CVD or disease-related complications (e.g., heart failure, atrial fibrillation, ventricular arrhythmias, aortic aneurysm, valve repair and/or replacement) and/or related procedures (e.g., placement of a pacemaker and/or implantable cardiac defibrillator) that is not coronary artery disease (as described in the inclusion criteria) they will be excluded.

Note: Individuals may have other comorbidities.
Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T

To explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

Atezolizumab plus bevacizumab is the first-line treatent for patients with advanced hepatocellular carcinoma. However, the second-line treatment is absent for patients who progressed on atezolizumab plus bevacizumab. Candonilimab is a humanized bisspecific monoclonal antibody against PD-1/CTLA-4 IgG1. Candonilimab plus lenvatinib showed strong anti-tumor effect, with objective response of 44%. This single-arm, prospective, phase 2 trial is to explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* Patients have received atezolizumab plus bevacizumab and the tumor have progressed. Patients have not received other treatmets except for the atezolizumab plus bevacizumab.
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Validation of Novel Predictive Score for Patients With Spinal Metastases

The investigators are prospectively validating a prognostic clinical tool that uses a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine.

Recently, the investigators proposed a clinical prediction score that used a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. This prognostic utility was developed using one-year mortality as the sole outcome measure. While the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. To further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum
3. Able to consent for themselves at the time of the intake evaluation
4. Speaks English

   Exclusion Criteria:
5. Primary bone tumors or leukemia
6. Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum
7. History of prior spine surgery for metastatic disease
Evaluation of Pulmonary Complications in Liver Transplantation Patients Based on Machine Learning

The main objective of this study is to develop a machine learning model that predicts moderate-severe prediction model of pulmonary complications in liver transplantation patients within 14 postoperative day using a real-world, local preoperative and intraoperative electronic health records, not administrative codes.

Postoperative pulmonary complications can increase the length of hospital stay and medical costs. In particular, moderate to severe pulmonary complications, which often require clinical intervention, once occur, will lead to significantly prolonged postoperative hospitalization or even cause permanent damage or death in severe cases. A number of risk-stratified cation models have been developed to identify patients at increased risk of postoperative pulmonary complications. However, these models were built by using the traditional regression analysis. However, the traditional prediction methods have the disadvantages of limited processing power of nonlinear models and outlier, and relatively single selection variables. The obtained models have poor accuracy, and the quantification degree is not enough, so it is difficult to popularize clinical application. Artificial machine learning can use it by analyzing a large number of specific features in the rich data set to identify and learn to accurately predict the diagnosis and prognosis of diseases, and surpass traditional prediction models in dealing with classification problems. The algorithms are flexible, and it is more and more widely used in clinical practice research. However, there are few reports on machine learning models predicting prognostic models related to postoperative pulmonary complications in liver transplantation patients. Therefore, we aimed to build predictive models using artificial machine learning methods to screen for their risk factors in order to provide early intervention and individualized treatment for high-risk patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years)
* Undergoing liver transplantation

Exclusion Criteria:

* Re-transplantation
* Multi-organ transplants
* Intra-operative deaths
* severe encephalopathy (West Haven criteria III or IV)
* Incomplete clinical data
Investigation on Diagnosis and Treatment of Helicobacter Pylori Infection by Gastroenterologists in Shandong Province

Helicobacter pylori can lead to a variety of digestive system diseases.The eradication of Helicobacter pylori plays an importment role for the treatment of gastrointestinal ulcer and prevention of gastric cancer .Compared with other countries and regions in the world, the infection rate of Helicobacter pylori in China can reach more than 50%. The non-standard diagnosis and treatment of Helicobacter pylori greatly reduces its eradication rate and increases its drug resistance.Therefore, it is very important to strengthen the standardization of diagnosis and treatment to improve the eradication rate.

The purpose of this study is to investigate the diagnosis and treatment status of Helicobacter pylori among gastroenterologists in general hospitals in Shandong Province.It can help us to understand the actual situation of diagnosis and treatment of Helicobacter pylori in hospitals at all levels, and to provide targeted diagnosis and treatment training for doctors.


Eligibility Criteria:
Inclusion Criteria:

* All the gastroenterologists in secondary and tertiary general hospitals of Shandong province

Exclusion Criteria:

* A hospital that does not include gastroenterology
* Hospitals and gastroenterologists that refuse to sign informed consent
The Effect of Music on Maternal Stress and Milk Amount

Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. It is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. This stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. Mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; It causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. In order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. Music improves endothelial function by dilating the vessels; It has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. This study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk.


Eligibility Criteria:
Inclusion Criteria:

* Mothers whose babies are born prematurely (gestational age between 32-37 weeks), -whose babies do not have any congenital anomalies,
* whose babies are not connected to mechanical ventilation,
* who are over 18 years of age, who are not diagnosed with any psychological disease and
* who agree to participate in the study will be included in the study.

Exclusion Criteria:

* Greater than 32-37 weeks of gestation
Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects

The purpose of this study is to determine whether the number of circulating EPC is different between healthy women and men.

Study design: Open pilot study in health volunteers in the Hospital Saint-ANTOINE's Clinical Investigation Centre (CIC).

Recruitment and course of the study: The subjects will be recruited among the CIC's pool of healthy volunteers. Volunteer people will then have biological and clinical baseline examinations. If they match the inclusion criteria, an appointment will be taken for the blood sample intend for the characterization of the EPC and hormonal plasma levels evaluation. The participation will not exceed 2 months. Young women will have to come between the 9th and the 11th day after the beginning of menses). A total of 150 ml of peripheral blood will be collected. The study will last 18 months.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 19 and 25 kg/m²
* non menopausal women :
* age 18 to 40 years,
* regular menstrual cycles
* no hormone therapy as contraceptives
* postmenopausal women :
* age above 55 years old
* amenorrhoea since 5 years at least
* no hormone therapy since at least 3 month

Exclusion Criteria:

* no medical insurance
* inclusion in another study
* smoking, Statins treatment, uncontrolled diabetes or hypertension and personal history of cardiovascular disease.
Induction and Stabilization of Gamma Oscillations With 40 Hz External Brain Stimulation

The goal of the present studies is to develop and validate novel stimulation protocols for the entrainment of gamma oscillations, which are associated with many cognitive functions and critically involved in cognitive impairment such as Alzheimer's disease. In this proposal, combination of repetitive transcranial magnetic stimulation (rTMS) and transcranial alternating current stimulation (tACS), which has been shown effective for the induction, and stabilisation of alpha and theta frequencies in our forgoing studies, will be adopted to the gamma frequency range and applied on prefrontal regions as well as model-based cortical areas to enhance and stabilize gamma oscillations, thereby facilitating cognition

Neuropsychiatric disorders are a leading cause of global disability-adjusted life years, and treatment solutions are lacking. Recent findings suggest that non-invasive brain stimulation may be a valuable option in conditions such as epilepsy or Alzheimer's disease (AD). Still, a better understanding of mechanisms and patient-specific factors is needed. Personalized hybrid brain models uniting the physics of electromagnetism with physiology - NeuroTwins (NeTs) - are poised to play a fundamental role in understanding and optimizing the effects of stimulation at the individual level. The purpose of this project is to deliver solutions through model-driven, individualized therapy. A computational framework - weaved and validated across scales and levels of detail - will be proposed to represent the mechanisms of interaction of electric fields with brain networks and assimilate neuroimaging data. This will allow us to characterize the dynamical landscape of the individual brain and define strategies to restore healthy dynamics. The work package, which will take place at IfADo, is part of the consortium collaborating with labs across Europe and USA, aiming to validate and optimize the realistic hybrid brain models developed by NeTs. The targeted subject groups of the IfADo project will be healthy young and old participants. Non-invasive brain stimulation including repetitive transcranial magnetic stimulation and transcranial alternating current stimulation will be applied with electroencephalography, and magnetic resonance spectroscopy as outcome measures. The results are to be translated into a technology pipeline for the design of new personalized neuromodulation protocols which will further be tested in a cohort of AD patients by another clinical consortium member, delivering model-driven breakthroughs in basic and clinical neuroscience, with patients ultimately benefiting from safe, individualized therapy solutions.

Eligibility Criteria:
Inclusion Criteria:

* normal or corrected to normal eye vision
* right-handed
* non-smokers
* being 18-60 years old
* providing written informed consent

Exclusion Criteria:

* history of neurological or psychiatric disorders including seizures or epilepsy,
* Taking CNS medication
* having metal implants
* current pregnancy
Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation

Severe pre-amputation pain is associated with phantom pain development, and phantom pain models assign major importance to central and peripheral nervous system changes related to pre-amputation pain. Several interventions have been evaluated for phantom pain prevention, including continuous brachial plexus blockade5, intravenous6 or epidural ketamine administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9, but their true effect remains unclear.

In a prospective, randomized, double-blind trial, 65 patients undergoing elective lower limb amputation were assigned to one of five analgesic regimens. Patients in groups 1-4 had lumbar epidural catheter placed 48 hours before amputation, and received epidural bupivacaine/fentanyl or saline infusion before and/or after amputation. Patients receiving epidural saline also had IV Fentanyl Patient-Control Analgesia, whereas patients receiving epidural analgesia also had IV saline. Group 5 (control) received IM meperidine and oral codeine/acetaminophen. VAS and McGill Pain Questionnaire (MPQ) scores (for ischemic, phantom and stump pain) were recorded starting 48 hours before, continuing until 48 hours after amputation, and at 4 days, 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity and frequency were the main study endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18, Visual Analog. Scale (VAS) pain score \>70mm which was frequent or continuous one week before scheduled major (above or below knee) amputation, and patient consent.

Exclusion Criteria:

* No written patient consent
* Age \< 18 years
* Age \> 82 years
* Antiplatelet medication
* Mental status not acceptable
* Exclusion criteria were age \>85
* Emergency amputation
* Ipsilateral re-amputation
* Foot or toe amputation
* Inability to complete a detailed pain questionnaire
* History of chronic pain or substance abuse
* Active psychiatric disease requiring treatment
* Any contraindication to epidural catheter placement (anticoagulation, anti-platelet medications, previous lumbar spine surgery).
Midfoot Fusion Bolt (MFB) in the Early Stage of Diabetic-neuropathic Charcot Feet

Randomized clinical trial (RCT) to compare treatment failure rates of surgical arthrodesis with MFB against cast treatment in patients suffering from early stage Charcot neuroarthropathy (CN) of the midfoot (Sella and Barrette stages 0, 1 or 2) within the first 2 years after initial treatment. Treatment failure is defined as the occurrence of one or more of the following: 1. Amputation, 2. Occurrence of ulcer or worsening of existing ulcer, 3. Surgical intervention for correction of deformity after initial treatment. The secondary aims are to compare foot function, radiologic outcome, quality of life, complications and foot temperature between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients with Diabetes Mellitus Type I or II
* CN stages 0, 1 or 2 of the midfoot (Sella and Barrette classification)
* Willingness and ability to participate in the study follow-up according to the protocol
* Ability to understand and read local language at elementary level
* Signed informed consent

Exclusion Criteria:

* Legal incompetence
* Previous Charcot foot on the affected side
* Active osteomyelitis in the affected foot
* Above knee amputation on the contralateral side
* Patient health status not adequate for surgery
* Active malignacy
* Severe peripheral arterial disease (ankle-brachial index \<0.7 or absent digital waveforms on Doppler)
* Ulcer grade 2 or more on the Wagner classification system
* Alcohol or drug abuse
* Life-threatening co-morbidities
Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment

Graft-versus-host disease is a complication of allogeneic hematopoietic cell transplantation with high morbidity and mortality. The standard treatment is corticosteroids, and based on the response within 3 to 7 days, a second-line therapy is added, which is expensive and not easily accessible. The administration of human chorionic gonadotropin has shown therapeutic effectiveness in 50% of patients in reported clinical cases.

The study will include 20 patients with recent-onset allogeneic hematopoietic cell transplantation and GVHD who attend the Hematology Service at the University Hospital and meet the inclusion criteria, to receive conventional treatment with steroids (prednisone 1 mg/kg/day for 14 days) or combined treatment (hCG 2500 IU, IM + prednisone 1 mg/kg/day for 14 days).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Any gender.
* Post-allogeneic transplantation status (haploidentical or identical) of hematopoietic cells.
* Presenting recently onset aGVHD, grades 2 to 4, and requiring systemic steroid use as determined by the treating physician.
* Have not received steroids (Prednisone ≥1 mg/kg/day or equivalent dose of another steroid) for more than 3 days in the last week.
* Willing to participate in the study by signing informed consent.
* If the subject is female and has the potential to procreate (a woman is considered fertile from menarche to postmenopausal stage or after undergoing a permanent contraceptive method), she agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: oral hormonal contraception, intrauterine device, barrier methods (diaphragm, male or female condom, and foam, sponge, or spermicide film), or agrees to remain abstinent. Women who have been postmenopausal for more than a year, undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy are not considered to have reproductive potential.
* If the subject is male, he agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: male condom, or remain abstinent.

Exclusion Criteria:

* Arterial or venous thrombosis in the past 3 months.
* History of thromboembolic disease requiring full-dose anticoagulation.
* Diagnosis of active malignant disease.
* Uncontrolled infection.
* Chronic use of supplemental therapy with sex hormones (estrogen, progesterone, and/or testosterone).
* Women with a positive pregnancy test at the time of the initial evaluation.
* Women or men of reproductive age who are unwilling to take appropriate precautions to avoid an unwanted pregnancy from the start of the protocol until 30 days after the protocol.