cyrilzakka/clinical-trials huggingface dataset:
Hemodialysis Vascular Access Imaging Study

The goal of this study is to find the best techniques to take non-invasive images of the arteriovenous fistula (AVF) in hemodialysis patients.

The vascular access is at the same time both the 'lifeline' and the 'Achilles' heel' of hemodialysis patients. Despite improved understanding of the pathophysiology of stenosis and thrombosis of the vascular access, unfortunately translating these advances into either improved therapies or a superior process of care has not been very successful. As a result, there continues to be an epidemic of arteriovenous fistula (AVF) maturation failure, a proliferation of relatively ineffective interventions such as angioplasty and stent placement, an extremely high incidence of catheter use (1).

A major problem is the timely diagnosis of AVF access dysfunction, which - undiagnosed and untreated - will eventually result in its loss. Current methods of diagnosing impending AVF deterioration utilize measurement of access flow, access flow recirculation, ultrasound imaging and angiography. None of these methods are applicable on a per-treatment basis and require some sort of intervention.

Recent advances in video-imaging open the opportunity to non-invasively track AVF movements, possibly on a routine basis. These AVF movements are created by the arterial pulse and routinely checked manually prior to each AVF cannulation. In this research the investigators plan to film the actual AVF movements with the goal to explore the technical feasibility of video-imaging based access surveillance.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years; routinely cannulated AVF in place

Exclusion Criteria:

* inability to communicate in English
* skin maladies which render meaningful AVF imaging impossible
* vascular access procedures in the last 8 weeks
Comparison of Regimens MPIB, CIPCEA, PCEA

Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more than 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. Women who have increased pain tend to have lower successful patient bolus demands when patient controlled epidural analgesia (PCEA) is utilised and have dysfunctional labour requiring obstetric intervention such as Caesarean or instrumental delivery. Labour pain often escalates and worsens as labour progresses requiring an individualized, variable, flexible analgesic regimen. Bolus epidural administrations have been shown to improve uniform spread of local anaesthetics with better pain relief, compared to fixed background infusions.

The research team developed two novel epidural delivery regimens: computer-integrated PCEA (CIPCEA) and modified programmed intermittent bolus (MPIB) focused on individualization of analgesic requirements. This phase 3 double-blinded randomized controlled trial will compare the two novel regimens, and each with conventional PCEA with basal infusion (BI), in reducing breakthrough pain (failure of the regimen to provide adequate pain relief, necessitating unscheduled epidural supplementation) incidence as the primary outcome in nulliparous term women requesting labour epidural analgesia. In addition, a discrete choice experiment (DCE) in the format of a survey will be administered to estimate the women's preferences in treatment attributes related to epidural analgesia, including control over epidural dosage, chance of having breakthrough pain, motor block, instrumental delivery and out-of-pocket cost for epidural analgesia. We will also look into the association model for breakthrough pain that would take into account pre-delivery factors to better understand the mechanism of breakthrough pain during labor process.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy (ASA physical status 1 and 2) nulliparous parturients at term (≥36 weeks gestation);
2. Singleton foetus
3. Early labour (cervical dilation ≤5cm)
4. Request labour epidural analgesia
5. At least 21 years of age

Exclusion Criteria:

1. parturients with multiple pregnancies
2. non-cephalic foetal presentation
3. obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes, gestational diabetes on insulin) and uncontrolled medical (e.g. cardiac disease) complications
4. have contraindications to neuraxial blockade or have received parenteral opioids with the last 2 hours.
Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB

Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB). The previous registrational study (NCT03903796) has established the non-inferior virologic efficacy of TMF to tenofovir disoproxil fumarate (TDF), while demonstrating higher rates of alanine aminotransferase (ALT) normalization and improved bone and renal safety profiles. This study presented the long-term efficacy and safety of TMF in a phase IV study.

Participants from the Phase III registrational trial of TMF were enrolled and followed for another seven years, starting at week 144 in the Phase III study as the baseline. Once-daily oral dose of 25 mg TMF were maintained in all participants. Clinical assessments were conducted every 24 weeks. The primary efficacy endpoint was the percentage of patients with serum HBV DNA levels below the quantification limit at week (144+) 96.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HBeAg-positive or HBeAg-negative chronic hepatitis B who completed a pivotal Phase III clinical study of HS-10234-301

Exclusion Criteria:

* 1) Completion of HS-10234-301 pivotal Phase III clinical study Interruption of TMF treatment for more than 24 weeks or continuous use of alternative, commercially available hepatitis B antivirals for more than 24 weeks (Participants who have discontinued TMF for more than 24 weeks can only be enrolled in this study after investigator evaluation and confirmation) 2）Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging). 3)significant bone disease (e.g. osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or multiple bone fractures.

  4）Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.

  5）Known hypersensitivity to study drugs, metabolites, or formulation excipients.

  6) In the investigator's judgment, current alcohol or substance abuse may interfere with the subject's compliance with the study requirements 7）Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
A Study of Avastin (Bevacizumab) in Patients With Multiple Myeloma

This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 19-75 years of age
* Multiple myeloma.
* Progressive disease after at least 2 lines of prior therapy.

Exclusion Criteria:

* Non-secretory myeloma.
* History of malignancy, other than squamous cell cancer, basal cell cancer, or cancer in situ of the cervix within the last 5 years.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start.
* Clinically significant cardiac disease.
Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma

The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.

Multiple myeloma (MM) is the second most common malignant hematological cancer in the world, which begins with the malignant proliferation of plasma cells in bone marrow. It has been a difficult disease to treat, and most patients will eventually relapse, especially for those with high-risk genotypes. At present, the therapeutic drugs for MM include glucocorticoids, cytotoxic drugs, immunosuppressants, protease inhibitors, monoclonal antibodies and cell therapies. Among those, immunotherapy has been proven to be a revolutionary treatment with great potential of curing this disease. The frequently targeted MM antigens include CD38, CD138, CD19 and BCMA, and recently, GPRC5D.

BCMA, the B cell maturation antigen, also known as CD269 or TNFRSF17, is a member of tumor necrosis factor receptor superfamily, which is highly expressed on the surface of plasma cells and partially expressed on plasma cell-like dendritic cells. It has been an ideal target for MM immunotherapy.

GPRC5D, the G-protein-coupled receptor C57 subtype D and a seven-transmembrane protein, is highly expressed on the surface of plasma cells but not in other healthy cells, and thus it has become a potential target for the treatment of MM. The expression of GPRC5D is unrelated to BCMA, so the combination therapy targeting these antigens may bring a complementary and synergistic therapeutic outcome in patients.

This trial is aimed to test the safety and efficacy of combining these different CAR-T cells targeting BCMA and GPRC5D, and in combination with well-established therapeutics as a frontline treatment for the high-risk MM or plasmacytoma patients. Another goal of this study is to investigate the persistence and function of these CAR-T cells in the body.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with multiple myeloma or plasmacytoma
* Strictly complete remission (sCR) is a treatment goal
* Expected survival \> 12 weeks
* After prior auto-SCT is eligible regardless of other prior therapies
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given and commitment to continued follow-up

Exclusion Criteria:

* Pregnant or lactating women
* Uncontrolled active infection
* Active HIV, hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Any medical conditions that may preclude participation
Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response

Acute and chronic inflammatory eye diseases are difficult to diagnose and maintain quiescent with therapy. Proposed study is aimed to find on the one hand, novel factors for recurrence of the disease or remission of inflammation and evaluation of the impact of lifestyle and known factors on the other.

Each patient is treated in accordance to the best of medical knowledge and guidelines for each disease.

This prospective cohort study will enroll uveitic patients to the steroid only group (SG), combined (steroid and adjuvant drug) group (CG) or bilogic therapy group (BTG).

At baseline, patient data are recorded using patient-reported outcome measures and clinical assessments (ophthalomology) on disease activity (clinical scales), quality of life, and lifestyle together with registry data on comorbidity and medication. During follow-up evaluation of a successful treatment outcome response will be based on clinical scales and most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients in different treatment group.


Eligibility Criteria:
Inclusion Criteria:

* new diagnosis of uni or bilateral uveitis
* recurrence of the diagnosed previously uni or bilateral uveitis

Exclusion Criteria:

* not mentally able to reply the questionnaire
131I-MIBG With Myeloablative Chemotherapy and Autologous Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma

This trial is studying how well iodine I 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk or relapsed neuroblastoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Neuroblastoma and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
* High risk according COG (Children Oncology Group)OR Relapse OR Refractory
* As at least one I131-MIBG avid target lesion determined by diagnostic MIBG scan
* Glomerular filtration rate or creatinine clearance \> 60 ml/min
* No tumor cell in Bone Marrow by routine morphology aspiration and biopsy before peripheral stem cell collection
* No active infection

Exclusion Criteria:

* Impaired renal function
* No avid I131-MIBG lesion
* Active infection
Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography

The specific aim of this clinical trial is to translate the investigators new 4DE (three sptial dimensions pluse time) stress echocardiographic method to patients with coronary artery disease referred for clinically indicated dobutamine stress/rest echo to evaluate the reproducibility of the technique in this clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, referred for clinically indicated dobutamine rest/stress TTE
* Provide written informed consent to participate in the study
* Availability for repease rest/stress TTE within on eweek of clinically indicated study

Exclusion Criteria:

* Unable to give informed consent
* Unstable hemodynamics that would not allow for repease rest/stress dobutamine transthoracic imaging
* Recurrent life threatening arrhythmias
* Heart rate \>110 BPM
* Inadequate windows for transthoracic imagine
* Patients that have a narrow-angle glaucoma (contraindication for atropine)
* Change in cardiac medications or management including, coronary revascularization beween intial and repeat TTE study.
Home-based Balance Training Using Wii Fit After Stroke: A Feasibility Study

BACKGROUND: Virtual gaming systems offer new possibilities for home-based exercises (HBE) in rehabilitation. Pilot studies with stroke patients indicate that the application of Nintendo Wii® (WII) is practicable and can improve balance under clinical conditions. However, larger trials are necessary to verify these positive effects after discharge from the hospital.

AIM: This study aims to prepare and optimize a phase III trial which compares the effects of two HBE programs for stroke patients.

METHODS: A pilot study with randomized control design and repeated measures over three-months will be conducted. Twenty elderly stroke patients will be randomly allocated to an experimental group (EG) and a control group (CG). All participants will receive an introduction to a HBE program by an individual mentoring over 6 weeks. During the following 6 weeks the participants perform the HBE on their own. The EG will perform a balance exercise program using the WII, the CG will perform a balance exercise program without technical support.

Recruiting potential, the participants' acceptance of the intervention and economic aspects will be examined. Additionally, basic information about sensitivity of change and potential effect sizes regarding the proposed instruments to measure mobility are expected.


Eligibility Criteria:
Inclusion Criteria:

* cerebral infarction
* place of residence: Halle (Saale) and immediate surroundings
* television in household
* independent ambulatory (functional ambulation classification \> 3)
* self-selected walking speed \> 0,4 m/s

Exclusion Criteria:

* Strong visual impairment despite visual aid
* Deafness / verbal communication is not possible
* distinct mobility limitations due to comorbidity
* Body weight \>120kg
* Epilepsy
* Cardiac pacemaker
* Acute psychiatric, disease/dementia
the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Children

This research attempts to find the optimum dose of remifentanil that can prevent the unnecessary responses such as coughing, gagging, and movement when LMA is inserted during sevoflurane induction in pediatric patients.

Anaesthesia is induced by inhalation with 3% sevoflurane. A predetermined bolus dose of remifentanil is injected over 30 seconds. The LMA is attempted 60 seconds after bolus administration. The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1 or 2
* undergoing short elective surgery(i.e Strabismus surgery, Entropion surgery, Inguinal hernia surgery, etc) under general anesthesia

Exclusion Criteria:

* suspected difficult airways
* respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
* body mass index \> 30 kg/m2
* allergies to the study drugs
* a history of gastric reflux
Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy

The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy) by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii) postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs and medical outcomes and (vii) an estimation of the potential impact of new technology on the organization of operating rooms (operating time).


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 yrs
* With a toxic goiter or not, Graves' disease or thyroid nodule requiring a total thyroidectomy
* Thyroidectomy under cervicotomy
* No echographic criteria to suspect a cancer: poorly defined nodules, microcalcifications, cervical nodes
* Patient covered by social security
* Patient's informed and written consent
* Possible follow-up during 6 months

Exclusion Criteria:

* Minors and adults under guardianship
* Preoperatively known thyroid cancer by cytology
* Planned partial thyroidectomy
* Peri-operatively antiplatelet intake
* Preoperatively ENT examination (if performed) finding a vocal cords affection
* Diving goiter (\> 3 cm below the sternal notch)
* Surgery using videoscopy
* Lack of possible monitoring during the 6 months after surgery
* History of anterior cervical surgery
* Pregnancy and breast-feeding
* hypercalcemia (calcemia\> 2.6 mmol/l)
Impact of Ostracism on Prospective Memory in ADHD Children With or Without Emotional Dysregulation

Assess the effect of exposure to a situation of social exclusion or ostracism on the prospective memory of children with ADHD


Eligibility Criteria:
Inclusion Criteria:

* Child with attention deficit disorder with or without hyperactivity (ADHD) according to the following criteria: score greater than 27 on the ADHD-RS scale or score greater than 65 on the Conners scale, and after clinical staff discussion
* Social security
* non opposition of parents and children to the study

Exclusion Criteria:

* Subject presenting elements in favor of a depressive disorder according to a clinical evaluation and on an evaluation by the CBCL scale
* Minor and/or parents who do not understand French
* Person under legal protection, adult guardianship or curatorship.
Study of Efficacy of Association of Senna Alexandrina Mill and Associations on Functional Intestinal Constipation

The purpose of this study is to evaluate the efficacy of association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub. in patients with functional constipation.

This is a phase III trial, placebo-controlled with a parallel-group design.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-65 years with functional constipation by ROME IIII criteria
* In the opinion of the investigator the patient will adhere to the protocol
* Voluntary able to understand the nature and purpose of the study, including the risks and adverse effects and with intent to cooperate with the researcher and act in accordance with the requirements of the entire protocol, which was confirmed by signing the Consent Informed

Exclusion Criteria:

* hypersensitivity to any component
* pregnant or lactating
* abdominal pain of unknown etiology
* suspected intestinal occlusion and sub-occlusion
* suspected abdominal inflammatory conditions (as appendicitis, peritonitis, cystitis, endometritis)
* Crohn disease and colitis
* Suspected intestinal constipation due abdominal surgery, neurological disorders (as aganglionoses, Parkinson disease, medullar tumor, stroke, multiple sclerosis), systemic sclerosis, multiple myeloma, scleroderma
* Subjects with congenital mega colon, anorectal congenital malformation, inflammatory bowel disease or intestinal carcinoma
* history of mal-absorption diseases
* history of anemia, weight loss or anal bleeding
* history of hypothyroidism, hyperthyroidism and insulin-dependent diabetes mellitus
* known of positive result for human immunodeficiency virus test
* heart, liver, lung or kidney important condition
* drug or alcohol dependence
* knowledge or suspicion of malignancy
* body mass index \< 18
* body mass index \> 30
* participation on any experimental study 12 months prior this study
* familiar history of colon carcinoma or inflammatory disease
* Lack of adherence to the procedures of the protocol
Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Treatment of SCI

This study is expanded access to an Investigational New Drug (IND) for an individual patient with spinal cord injury (SCI) at cervical spine 5-6 (C 5-6) designed to provide access to autologous adipose-derived mesenchymal stem cells (HB-adMSCs)

This is an expanded access single-dose study with the primary goal of treatment submitted at the request of an individual patient with complete C5-6 spinal cord injury (SCI) resulting in quadriplegia who does not qualify for any current clinical trials and for whom there are no other FDA approved fully restorative treatments. The overall objective of this study is to evaluate patient's response, adverse events and serious adverse events (AE/SAEs), and cell expansion characteristics of a single intravenous (IV) infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in a subject with complete SCI resulting in quadriplegia.

Eligibility Criteria:
Inclusion Criteria:

* Cognitively intact, capable of giving informed consent
* Clinical diagnosis of a non-penetrating traumatic SCI
* Asia Impairment Scale grade of A, B, or C

Exclusion Criteria:

1. Prior history of:

   * Brain injury
   * Recent or ongoing infection
   * Clinically significant cardiovascular, lung, renal, hepatic or endocrine disease,
   * Neurodegenerative disorders
   * Cancer
   * Immunosuppression as defined by WBC\<3,000 cells/ml at baseline screening,
   * HIV+
   * Chemical or ETOH dependency
2. Having a contraindication to MRI scans
3. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration
4. Participation in other interventional research studies
5. Unwillingness to return for follow-up visits