cyrilzakka/clinical-trials huggingface dataset:
Development and Application of Virtual Reality (VR) and Human Computer Interaction System in the ICU Patients

By developing of VR and human computer interaction system of early rehabilitation exercise for ICU patients, this project aims to construct virtual scenes and realize the interaction between ICU patients and virtual scenes during active rehabilitation training for critically ill patients in long-term bed. This project can increase the patient's willingness to exercise rehabilitation, improve the training effect and improve clinical outcomes in critically ill patients.


Eligibility Criteria:
* Inclusion Criteria:

  * Over 18 years of age
  * Voluntary participation
* Exclusion Criteria:

  * Unable to walk independently before admission to ICU;
  * High dose of vasoactive drugs to maintain vital signs;
  * Acute stroke;
  * Upper limb fractures or amputations;
  * Patients with spinal fracture or pathological fracture;
  * Patients who have been hospitalized for 30 days or more before admission to ICU;
  * Plan to move out of ICU within 24 hours; In palliative care
Hospital Orientation Since SAMU Regulation Centre Call

Specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit

Anonymous, descriptive, longitudinal, resting study searching an association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call for patients with suspected sepsis and their subsequent hospital orientation

Eligibility Criteria:
Inclusion Criteria:

* adults (age\>18years)
* patients with suspected sepsis state at the regulation SAMU centre call

Exclusion Criteria: minor (age\<18years)
BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma

The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.

Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.

Eligibility Criteria:
Inclusion Criteria:

* Expected survival \> 12 weeks
* Diagnosis of Multiple Myeloma by MWG criteria 20
* Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days
* Important organs function enough to tolerate this therapy
* At least 90 days after stem cell transplantation
* Accessible to intravenous injection, and no white blood cell collection contraindications
* Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom
* Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

* Patients with symptoms of central nervous system
* Patients with second malignancies in addition to multiple myeloma
* Active hepatitis B or C, HIV infections
* Any other active diseases could affect the enrollment of this trial
* Suffering severe cardiovascular or respiratory disease
* Poorly controlled hypertension
* Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
* A history of mental illness and poorly controlled
* Screening showing target cell transduction efficacy is lower than 30%, or T cell proliferation is not enough for infusion (less than 5 fold)
* Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
* Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
* Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
* Active systemic infections or uncontrolled infection within 14 days prior enrollment
* Subjects suffering disease affects the understanding of informed consent or complying with study protocol.
Smart Boot Use to Measure Offloading Adherence

The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed.

The investigators will look at three groups of participants: the first group will wear a boot that can't be taken off. The second group will wear a boot that can be taken off, and they will get counseling about how important it is to follow instructions as to how often and when to wear the boot. The third group will wear a "smart" boot, which will interact with the person through a smart watch and smart phone, and give them direct feedback about how they are doing with following their boot wearing prescription.

The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 18 or older
* Diabetic Foot Ulcer requiring offloading
* Able to provide written informed consent

Exclusion Criteria:

* Wound present for more than one year
* HbA1c \> 12%
* Ankle Brachial Index (ABI) of index limb is \<0.9 and/or they are being considered for revascularization within the course of the study
* Ulcer involving bone or tendon
* Ulcer not caused by diabetes
* Unable or unwilling to attend prescribed clinic visits
* Fully confined to a wheelchair
Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms

Intrathecal analgesia is used in refractory cancer pain because of drug sides effects or intractable pain. The aim of this approach is to improve pain management, and also to improve patient comfort. This study will assess patient discomfort symptoms before and after setting up intrathecal analgesia.

Descriptive multicenter study including patients with refractory cancer pain (unmanageable drug sides effects or intractable pain) who will receive intrathecal analgesia Patient discomfort symptoms will be evaluated before and after the beginning of intrathecal analgesia at 15, 30, 60 and 90 days.

Moreover, the impact on patient close relatives and on return home will be assessed.

Eligibility Criteria:
Inclusion criteria:

* patients aged 18 and older
* obligation of affiliation or beneficiary of a social security scheme
* patients with cancer and refractory localized cancer pain because of drug side effects or intractable pain
* localized pain in topography accessible to intrathecal analgesia (legs, abdomen and pelvis, pancoast-tobias symdrom)
* patient's informed consent for the study
* patient able to complete the evaluation questionnaires
* estimed vital prognosis more than three month
* patient with all conditions for intrathecal anagelsia

Exclusion criteria:

* patient with intracranial hypertension
* refusal of patient to be included in the study
* refusal of patient to receive intrathecal analgesia
* patient with many refractory pain localizations not accessible to intrathecal analgesia
The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD)

Given the thicker cortical bone in the mandible compared to the maxilla, mandibular teeth cannot be effectively anesthetized via local infiltration anesthesia. Instead, clinicians typically perform regional anesthesia and most commonly, Inferior Alveolar Nerve block (IANB). However, the inferior alveolar nerve is deeply submerged by surrounding structures of bone, muscles, ligaments and vessels. Traditional IANB is a technique by using anatomical landmarks not directly related to Inferior Alveolar Nerve (IAN) to approximate the location of mandibular foramen, where IAN enters mandible. IANB is considered a blind technique and known for the lack of accuracy and precision. The failure rate can be as high as 30-45%. In contrast, the investigator's cone beam computed tomography (CBCT) guided IANB device (IANBD) effectively directs the needle to the mandibular foramen which improves the success rate of the IANB on the first attempt, minimizes injection tissue damage, and reduces patient discomfort.

In this proof of concept trial, a 3D printed CBCT guided IANBD will be used to administer anesthesia at three injection sites instead of the traditional IANB technique. Participants will be consented patients at the postdoctoral endodontic treatment center, Department of Endodontics, Boston University (BU) Henry M. Goldman School of Dentistry.

The goal of this research is to to evaluate the acceptability, safety, and effectiveness of guided anesthesia using the IANBD by enrolling 10 subjects who require non-surgical endodontic therapy with a simple, affordable and reliable prototype to be used by clinicians in the dental care setting.


Eligibility Criteria:
Inclusion Criteria:

* Patient of Henry M. Goldman School of Dentistry (GSDM)
* Medical History indicating American Society of Anesthesiology (ASA)1
* Need Non-surgical Endodontic Therapy on Mandibular Molar or Premolar
* Asymptomatic pulpal diagnosis (normal, necrotic, asymptomatic irreversible pulpitis, retreatment with no symptoms)
* The quadrant to be treated must have at least 3 vital teeth.
* Going to receive a CBCT required for clinical purposes
* Must be willing to receive guided IANB

Exclusion Criteria:

* Allergy to lidocaine or articaine
* Resin allergy
* Normal teeth unresponsive to thermal testing (ie calcified chamber)
* Prior jaw surgery
* Currently pregnant
Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is otherwise judged to be in general good health and who is currently taking nonsteroidal anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms
* Patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time

Exclusion Criteria:

* Patients with a disease or medical condition(s) that could worsen or interfere with the evaluation of the effectiveness of study medication are not allowed to participate
Mindfulness for Parents of OCD-affected Children

The purpose of this study is to investigate the role of a mindfulness-based skills training program for parents of children with obsessive compulsive disorder (OCD). The investigators will explore if parents involved in this group experience any change in their levels of stress, feelings of being an effective parent and family relationships compared to a waiting list control period. The investigators will look at how the family manages OCD in their lives. In particular, if mindfulness skills training will help increase the parents ability to tolerate distress in their child secondary to OCD and as such reduce the family accommodation of OCD. As family accommodation is an important negative prognostic predictor for children with OCD, changes in OCD symptom severity and functional impact in these child will also be measured.

Obsessive-compulsive disorder (OCD) is a debilitating psychiatric illness that frequently begins in childhood. It is characterized by obsessions and/or compulsions that are distressing, time consuming and significantly impairing. OCD is distinct in the extent to which it disrupts family functioning, in that there is intense parental pressure to become involved in rituals and to change home environments and schedules to avoid triggers, thus accommodating the OCD. It is also well known that OCD severity tends to worsen in the context of stressful environments and situations. While effective treatment approaches for pediatric OCD have been identified, partial response and treatment refusal are all too common, leading to chronicity of both the illness itself and of its deleterious familial effects.

The investigators plan to study a novel approach to help manage the stress of parenting a child with OCD, thus facilitating more effective resistance to OCD family accommodation and supporting the child in fighting this difficult illness. The investigators will explore the role of group-based mindfulness-based skills training (P-MBST) in supporting parents of OCD-affected youth, in particular investigating the possibility that increased distress tolerance as a result of mindfulness practice may help parents reduce OCD accommodation.

Eligibility Criteria:
Inclusion Criteria:

1. Parents (or step-parents or legal guardians) with care-giving role for an OCD-affected youth from our clinic
2. Participants must be able to converse in English
3. Participants willing to attend 8 sessions of a weekly 1.5 hour group, in addition to complete questionnaires at multiple time points during the group and waiting list period.

Exclusion Criteria:

1. Parents who have previously participated in mindfulness skills training.
2. Parents with active psychosis, mania, mental retardation, autism or current substance misuse.
3. Parents unwilling to provide consent.
4. Families who are not attending our program's group-family Cognitive-Behavioral Therapy treatment concurrently.
Melatonin on Anxiety and Sleep Quality in Adults Undergoing Coronary Artery Bypass Graft Surgery

The objective of this study is to evaluate the effect of melatonin on post operative sleeping quality, anxiety, and post-operative opioid requirements in adults post coronary artery bypass graft (CABG) surgery.

Sleep disturbance is common among patients undergoing coronary artery bypass graft (CABG), especially during the first week of the postoperative period. Sleep disorders result in important impacts on morbidity, mortality, and quality of life.

Many factors are thought to be the cause of sleep disturbance in patients who have undergone CABG. These factors include environmental stimuli (e.g. noise and uncomfortable beds), individual characteristics (e.g. primary sleep disorder and comorbid health), nature of cardiac illnesses, and surgical complications (e.g. incisional pain, use of diuretics and resultant nocturia, dyspnea, and difficulty in finding the proper position to sleep).

Furthermore, decreased plasma melatonin concentrations have been documented during surgery and the postsurgical period in patients having undergone CABG.

Melatonin is a neurohormone originating from the amino acid, tryptophan, and is mainly secreted by the pineal gland into the blood stream and the cerebrospinal fluid. It possesses a circadian secretion pattern with a low blood concentration during the day and a high concentration at night.

Eligibility Criteria:
Inclusion Criteria:

* Age from 40-60 years.
* Both sexes.
* Patients undergoing standard on-pump CABG with the same technique by the same surgical team.

Exclusion Criteria:

* Refusal of procedure or participation in the study by patients.
* Patients with known history of allergy to one of study drugs
* Patients taking psychiatric medications, CNS depressants, and hypnotic drugs.
* Patients with neurological disorders stroke, intracranial hemorrhage and surgery.
* Patients with a history of suffering from any sleep disorder.
* Severe circulatory or respiratory disease.
* Patients with obstructive sleep apnea.
* Cognitive or psychiatric illness that leads to inability to cooperate, speak or provide informed consent
Pinaverium and Herbs for Irritable Bowel Syndrome Treatment: an Onset and Offset Study (PHIBEST)

The purpose of this study is to test the onset of action, offset of action, efficacy, and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS) for a long term (over one year). Pinaverium has been in many countries, but there is no randomized, double-blind, large sample size, and placebo-controlled study on this medication yet. Tong Xie Yao Fang (Formula for pain and diarrhea) is a historically and contemporarily used traditional Chinese medicine that can be used for IBS. The hypothesis is that the two remedies are effective and safe for IBS treatment with no significant different onset and offset of actions when tested by modern clinical standards and criteria.

Pinaverium bromide (pinaverium), an antispasmodics, is one of the most commonly used IBS medication worldwide. However, original clinical studies on pinaverium are scarce. Only five original clinical studies from Europe, one from Latin America, and one from Asian were found. These studies were single-centered and small sample sized (19 - 53 IBS patients) studies.

Tong Xie Yao Fang has long been used in China. Its efficacy and safety has not been evaluated by modern scientific method.

Effectiveness, onset and offset of actions are the most considered factors when physicians choose medications for IBS. Yet, to our knowledge, there are no clinical studies studied the onset and offset of actions of pinaverium, which remains one of the most transcribed IBS medications, and herbs, which are becoming more popular for treating IBS.

This study is designed to evaluate onset and offset of actions, efficacy, and safety over a long term (\>1 year) of pinaverium and Tong Xie Yao Fang for IBS treatment in a double-blind, randomized, and large sample size clinical trial using placebo as a control.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old age group, male and female
* In accordance with the above Western medicine Rome III standards.
* In accordance with the above description of Deficient Spleen Qi and Liver Qi Stagnation
* Informed consent for treatment
* No change in appetite during treatments periods

Exclusion Criteria:

* Pregnant or lactation female patients, and Fertility male patients
* Present digestive system disease within current three months
* Take IBS medicines within ten days prior to treatment or during treatment
* Take depression medicine within ten days prior to treatment or during treatment
* Take pain reliever medicine within ten days prior to treatment or during treatment
* Have serious primary heart, liver, kidney, lung and blood system diseases, asthma, and Lung and liver dysfunction patients
* If an emergency occurs; a physician terminates the treatment
* Cannot comply with the rules and cannot cooperate
Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.

In spite of technological advances, PCI of complex calcified coronary lesions remain a challenge.

Observational studies demonstrate that moderate or severe calcifications in lesions to treat are associated with an increase in mortality, in myocardial infarctions, in stent thrombosis, and in complementary revascularizations. Rotational atherectomy is now part of therapeutic armamentarium of interventional cardiologists for the treatment of some complex calcified coronary lesions. Last recommendations of the European Society of Cardiology about revascularizations indicate that rotational atherectomy should be used for "the preparation of calcified or massive fibrotic lesions that cannot be crossed by a balloon or for an optimal dilatation before stenting". However, this technique is not frequently used and limited to high-volume PCI centers. Even though rotational atherectomy demonstrated an improvement in immediate success of complex lesions, the longterm reduction of cardiovascular events after active stenting has not been proved. In observational studies, the results are not consistent because of many selection biases that influence the choice of an angioplasty with rotational atherectomy device (calcifications, severity of the disease). Furthermore, this technique needs operators with a certain amount of experience. The fundamentals of an optimal use of rotational atherectomy remain to be defined (duration and speed of burr, anti-platelet treatments...).


Eligibility Criteria:
Inclusion Criteria:

* patients with angioplasty that requires the rotational atherectomy device
* agree to participate in this study

Exclusion Criteria:

* none