cyrilzakka/clinical-trials huggingface dataset:
Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants

The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners


Eligibility Criteria:
Inclusion Criteria:

* Are between 18 and 75 years of age and Care Partner is at least 18 years of age at the time of signing consent
* Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Run-In Period
* In the opinion of the Investigator, have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min prior to the end of the Run-In Period
* In the opinion of the Investigator, can successfully complete a Skills Assessment with a Care Partner prior to the completion of the Training Period

Exclusion Criteria:

* Hgb level of \< 9 g/dL at Screening
* Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during the Run-In period defined as:

  1. Persistent pre-dialysis sitting SBP \< 100 mmHg despite medical therapy,
  2. Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg
  3. Nadir intradialytic SBP \< 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg
* Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study
Expansion of Invariant NKT Cells for a Cell Immunotherapeutic Approach Allowing the Control of Graft Versus Host-disease and Preserving the Graft Versus Leukemia Effect After Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic hematopoietic stem cell (HSC) transplantation remains the most efficient cellular immunotherapeutic approach for the treatment of myeloid hematological malignancies. However, its use is hampered by the risk of developing acute graft-versus-host disease (aGVHD). Invariant NKT cells (iNKT) represent a good candidate of immuno-regulatory cells that could control GVHD while preserving the anti-leukemic effect (GVL) of HSCT. Our team have shown that higher numbers and expansion capacity of CD4- iNKT cells contained in the HSC graft were associated with reduced risk of aGVHD but preserved GVL effect and that some healthy donors have low numbers and expansion capacity CD4- iNKT cells 1.

The objective of this project is to develop a strategy allowing to expand human CD4- iNKT cells from healthy donors of HSC grafts that would be transposable to GMP-validated cell production. Our team proposes to first determine the best strategy to expand the CD4- iNKT cell subset from G-SCF mobilized peripheral blood stem cells (PBSC) obtained from healthy donors, at little scale using cultures GMP validated conditions, by comparing the convention expansion protocol using IL-2 alone to IL-7, IL-15, IL-4 or combination of those cytokines involved in the expansion of T cells and by culturing the cells in a bioreactor. Our team will then explore the characteristics of cells after expansion in terms of phenotype, transcription signature and functions in vitro (in mixed lymphocyte reaction) and in vivo in a well-established xenogeneic model of GVHD.


Eligibility Criteria:
Inclusion Criteria:

Hematopoietic stem cells :

* from major donors after mobilization by G-CSF, informed of the research and not having opposed it
* Collected after verification by the cell therapy centre of the presence of a sufficient quantity of CSH for transplantation

Exclusion Criteria:

Hematopoietic stem cells (HSCs) from donors seropositive for HIV, HCV, HTLV1 and HBV (except post-vaccination profile)
Glycosade v UCCS in the Dietary Management of Hepatic GSD

To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management of hepatic glycogen storage diseases (GSD).

'Glyde' is a prospective, randomised, double-blind, crossover trial to compare the effects of two different starches used in the dietary management of GSD.

The study will recruit 64 patients from six centres in the UK, USA, France and The Netherlands. The planned duration per participant is 2 years.

Participants will be randomised into two equally sized groups:

Arm A- Glycosade intake given first, followed by UCCS 1-6 weeks later Arm B- UCCS intake given first, followed by Glycosade 1-6 weeks later.

The objective of this trial is to establish whether Glycosade® improves outcomes for patients with GSD compared to UCCS therapy by comparing the duration of normal blood sugars, lactate and ketone levels of patients with hepatic GSD (Types I, III, VI and IX) post equivalent intakes of UCCS and Glycosade®.

The first part consists of two (blinded) 12 hour starch load tests administered randomly within a maximum 6 week period. Participants will be randomised to receive either UCCS or Glycosade® for the initial intervention period crossing over to the other product for the second intervention period (part 1).

The second part (unblinded) is a 24 month open follow up whereby participant's will continue on the product considered most suitable by the clinician and patient.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed by either genetic mutation analysis or enzymology study (this includes patients with only a single mutation but who also have supportive enzymology consistent with the condition). For those whom mutation analysis is not completed this will be assessed during the study.
* Aged 2 years or older (5 years or older in the USA)
* Established on full intake of uncooked corn starch therapy for at least 6 months

Exclusion Criteria:

* Women who are pregnant or breastfeeding at the start of the study or planning to become pregnant during the study will be excluded.
* children less than 2 years of age
Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)

Patients were aged \>18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function. The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded. This study was an open, exploratory single-arm, phase II trial. Enrolled patients received anlotinib (12mg, po. qd, d1-14) combined with toripalimab (240 mg, inv, over 30 min once every 2 weeks).


Eligibility Criteria:
Inclusion Criteria:

Patients were aged \>18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function.

Exclusion Criteria:

The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded.
Comparison of the Malposition Rates of the Vertebral Pedicle Screws Using the PediGuard Technique: PediGuard Technique Associated With Fluoroscopy and Fluoroscopy Alone

Pedicular screwing has become the gold standard for intervertebral fixation required in degenerative, scoliotic, tumoral pathologies or for fractures. Several pedicular screwing methods exist.

The free hand pedicular screwing requires a high learning curve and has, as a consequence, a high malposition rate.

The placing of pedicular screws under fluoroscopic control is the most common technique as it is both reproducible and accessible. It is a two dimensional imaging technique. The profile incidence at the level of the spine is mostly used to spot the vertebral pedicle and the direction of the screw in the sagittal plane. However, there is no real control of the direction of the pedicular screw in the horizontal or frontal plane. The screw malposition rate is less important than with the 'free hand' technique but remains none of the less significant. Furthermore, fluoroscopy is an irradiating imaging technique, both for the patient and the staff.

New revolutionary techniques as the tridimensional navigation and the per-operatory tomodensitometry appeared in the last few years. The techniques give the best results when used concommitantly. The material has the advantage of being very precise. The pedicular screw malposition rate is minimal after a three-dimensional localisation. However, those systems require qualified staff and expose the patient and the nursing team to high radiation levels. The costs are higher and the surgery duration is globally longer. It is thus difficult to implement this technique in each belgian hospital.

Finally, the Pediguard technique appeared on the market. It is a guide for the perforation of the pedicular channel, with a probe at its extremity. This probe allows a real time measurement of the electric conductivity of the tissues that are being crossed. The conductivity measure is translated in a sound signal. Because the cortical bone has a low conductivity, the probe will emit a low intensity sound signal. The cancellous bone has a medium conductivity. Therefore, the probe will emit a medium sound signal. However, in the event of a breach in the pedicular cortical, as blood and periost have a high conductibility, the probe will emit a intense, rapid pace, sound signal.The Pediguard technique helps thus to anticipate a cortical effraction, by detecting the proximity of the cortical wall. It is efficient but remains relatively expensive.

The main objective of this study is to determine the precision of the placing of pedicular screws, with and without Pediguard system, under fluoroscopy.


Eligibility Criteria:
Inclusion Criteria:

* All patients needing vertebral instrumentation with pedicular screwing

Exclusion Criteria:

* Contra-indication to the placement of pedicular screws under fluoroscopy
Expression of Programmed Death Ligand-1 (PD-L1) in Nasopharyngeal and Hyypopharyngeal Carcinoma

Head and neck tumors comprise heterogeneous neoplasms that arise from surface epithelium of different anatomic subsites in head and neck region such as oral cavity, oropharynx, larynx and hypopharynx. Nasopharyngeal and hypopharyngeal carcinomas represent 0.26 % of all cancers in Egypt. Tobacco exposure and alcohol dependence, and infection with oncogenic viruses such as human Papilloma virus (HPV) are among the risk factors for development of these tumors. Currently, the main treatment of nasopharyngeal and hypopharyngeal carcinomas is radio-chemotherapy based in histological type, grade and stages of the tumors

Tumor infiltrating lymphocytes (TILs) are considered as cornerstone in cancer immunotherapy and as a biomarker with effectiveness predictive value. The intensity and quality of immune cells, especially lymphocytes, in tumor microenvironment are strongly related to the outcome of immune checkpoint blockade therapy .


Eligibility Criteria:
Inclusion Criteria:

* Patients with nasopharyngeal and hypopharyngeal carcinomas who underwent diagnostic biopsies.

Exclusion Criteria:

* Patients received chemotherapy or radiotherapy.
* Patients with insufficient clinical data.
* Specimens with extensive necrosis
* Tiny specimens which are insufficient for accurate diagnosis.
Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture

Accidental dural puncture is an uncommon complication of epidural analgesia and can cause postdural puncture headache.

The aim of this study the effectiveness of a protocol implemented in our department, according to the recommendations of good practice, on the reduction of the use of blood patchs in patients who have had an accidental dural puncture during the implementation of their spinal anesthesia, in order to prevent the use of the blood patch. In addition, intensity of headaches is evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients having an accidental dural puncture during the installation of an epidural anesthesia

Exclusion Criteria:

* Patients without accidental dural puncture
Imaging Study of Anatomical Variations of the Superficial Temporal Artery (EVATSI)

This study focuses on the anatomy of the superficial temporal artery, an artery of the head. Knowledge of the anatomy of this artery, and the evaluation of methods for exploring it, have implications for clinical medical and surgical practice.

The study will be divided into several parts:

* The aim is to study the reproducibility of anatomical measurements of the superficial temporal artery using CTA.
* The aim is to study the contribution of CTA for the anatomical assessment of the superficial temporal artery.
* The aim is to evaluate the performance of MRI in the anatomical study of the superficial temporal artery.

Eligibility Criteria:
Inclusion Criteria:

* No opposition expressed
* Examination analyzable

Exclusion Criteria:

* Refusal to participate
Non Substitutive Strategies to Improve Haemophilia Care in Developing Countries. Experience in Ivory Coast.

This study aims to make an inventory of the condition and care of patients with haemophilia and carriers for haemophilia in Ivory Coast and to promote the use non substitutive strategies that are not costly and available in Ivory Coast, to improve the management of haemophilia in this country. The purpose of this project is to evaluate the extent to which the active promotion of these various measures will improve the care of patients with haemophilia and carriers in Ivory Coast.

1. Establish a baseline of the condition of haemophilia in Ivory Coast (number of patients, demographics, reassessment of diagnosis, joint status...).(year 1)
2. Develop tools to assess the intervention (eg transcultural validation of QoL questionnaires, develop booklets to record bleedings...). (year 1)
3. Intervention phase that will focus on education of patients and their family, education of caregivers, training of the laboratory to the diagnosis of haemophilia and promotion of non substitutive strategies to improve haemophilia care in Ivory Coast (DDAVP, antifibrinolytics, physiotherapy, dental care,...).
4. Follow-up phase during 2 years.
5. Outcome analysis

Eligibility Criteria:
Inclusion Criteria:

* Males with severe and moderate haemophilia A and B in Ivory Coast (any age).
* Females over 12 years who are carriers for severe and moderate haemophilia A and B in Ivory Coast.
* Exclusion Criteria: subjects not willing to participate.
A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer

The purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 70 years old
2. singed the information consent form
3. Expected survival time \>3 months
4. Recurrence for at least 6 months after receiving initial platinum-based chemotherapy and without cytoreductive surgery indications.

Exclusion Criteria:

1. Recurrence within 6 months after receiving initial platinum-based chemotherapy
2. without radiographic evidence for tumor recurrence
3. receiving other chemotherapy, hormone therapy, immunotherapy, or radiation therapy
Prevention of Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Receiving a Bone Marrow Transplant

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment with sirolimus, methotrexate, and cyclosporine may prevent this from happening.

PURPOSE: Phase I/II trial to study the effectiveness of sirolimus plus methotrexate and cyclosporine in preventing graft-versus-host disease in patients with hematologic malignancies who are receiving a bone marrow transplant.

OBJECTIVES: I. Estimate the maximum tolerated dose of rapamycin that can be safely combined with standard methotrexate/cyclosporine prophylaxis for graft-versus-host disease (GVHD) in patients with hematologic disorders who have received a bone marrow transplant from a related donor who is mismatched for 1 HLA-A, -B, or -DR antigen in the GVHD direction.

OUTLINE: This is a dose escalation study. Groups of 6-12 patients receive escalating doses of rapamycin until the maximum tolerated dose of rapamycin given in combination with methotrexate/cyclosporine is determined. All patients receive cyclosporine from the day prior to transplant until day 50 post-transplant; the dose is then tapered over 130 days. Methotrexate is given on days 1, 3, and 6 post-transplant. Rapamycin is given every other day, days 7-59. Bone marrow transplantation occurs on day 0. Patients may not receive concurrent therapy with agents that could interfere with rapamycin metabolism, intravenous lipids, FK506 or other immunosuppressive agents (prednisone allowed), NSAIDs, or other cytotoxic agents. Patients are followed at 6 months for 2 years, then annually.

PROJECTED ACCRUAL: 12-36 patients will be accrued over 1-2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: Age: 13 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac disease No clinically significant cardiac abnormality No ischemia No recent injury on EKG Other: No intolerance or unresponsiveness to rapamycin No hypersensitivity to macrolide antibiotics, e.g., erythromycin, azithromycin, clarithromycin No requirement for medications that may significantly affect rapamycin metabolism, i.e.: Carbamazepine Ketoconazole Primidone Cimetidine Nicardipine Rifampin Diltiazem Phenobarbital Valproic acid Erythromycin Phenytoin Verapamil No uncontrolled systemic infection No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients during and for 3 months after study Able to tolerate less than 400 mL of liquid oral intake

PRIOR CONCURRENT THERAPY: At least 1 week since any investigational drug
Observation of Initial Procalcitonin and the Clinical Course of Patients With Acute Respiratory Tract Infections

Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.

Primary endpoint:

* initial Procalcitonin values of patients with Acute Respiratory Tract Infections

Secondary endpoints:

* correlation of initial Procalcitonin values to classify Acute Respiratory Tract Infections
* correlation of initial Procalcitonin values to subjective severity of Acute Respiratory Tract Infections
* correlation of initial Procalcitonin values to antibiotic- prescriptions
* correlation of initial Procalcitonin values to frequency of admission to hospital
* correlation of initial Procalcitonin values to frequency of referrals (radiology, pneumology)

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* all types of respiratory tract infection according to investigator´s diagnosis

Exclusion Criteria:

* pretreatment with antibiotics in the past 2 weeks
* portal hypertension
* Major surgeries or multiple trauma which require hospitalization, in previous 4 weeks
* Autoimmune disease and systemic diseases (lupus erythematodes, wegener´s disease)
* Peritoneal dialysis
* Acute treated or recently operated medullary c-cell-carcinoma, SCLC, carcinoid
* Other inflammatory diseases (e.g. urinary tract infection, pyelonephritis, pancreatitis
A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
2. Subjects who can provide written informed consent.
3. Males or females aged 18-55 years (both inclusive).
4. Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg.
5. No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.

Exclusion Criteria:

1. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
2. Known or suspected history of drug abuse.
3. Addiction to tobacco and alcohol.
4. Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
5. Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
Relationship Between Muscle Strength and Physical Function in ICU

This observational study aims to assess the relationship between muscle strength and physical function in critical ill patients. Grip and quadriceps strengths are measured using a standardized protocol of dynamometry. Physical function is assessed using the validated ICU mobility scale.


Eligibility Criteria:
Inclusion Criteria:

* ICU stay of at least 48h
* Collaborative (RASS score -1 to +1)

Exclusion Criteria:

* Refusal
* Coma
* Non collaborative
* Hemi / tetra paresis or plegia
COVID-19 Nasal Swab Trial

The purpose of this trial is to compare 2 types of nasonasopharyngeal swabs (a new design to a conventional nylon-flocked nasopharyngeal swab) for effectiveness.

Compare the Precision ADM "CanSwab" nasopharyngeal swab to a conventional nylon-flocked nasopharyngeal swab on the basis of:

1. The amount of SARS-CoV2 virus (COVID-19) collected by swabs, measured in CT (thermal cycles)
2. Clinical concordance rate
3. Patient comfort during nasopharyngeal sampling procedure

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Ability to provide informed consent
* COVID-19 positive cohort only: a previous, positive COVID-19 test in the last 5 days and patient remains symptomatic

Exclusion criteria:

* Malformation of the base of the known skull
* Active nosebleed before the start of the sample