cyrilzakka/clinical-trials huggingface dataset:
Clinical Studies of Gemcitabine-Oxaliplatin

These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory or relapsing pediatric solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed malignant solid tumor (at diagnosis)
* Relapsed or refractory tumors in which correct standard treatment approaches have failed
* Measurable primary and/or metastatic disease: at least one bi-dimensionally measurable lesion. For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993). For patients with osteosarcoma, measurable lesions are lung metastases and osseous lesions with soft tissue tumor, in exclusion of completely calcified or necrosed lesion at study entry. A patient with an unique osseous lesion without soft tissue mass can be included in the study if the lesion is operable and thus accessible for histological response assessment.
* No more than one salvage therapy for relapse
* Age at inclusion: 6 months to ≤ 20 years
* Lansky play score ≥ 70% or ECOG performance status ≤ 1
* Life expectancy ≥ 3 months
* Adequate organ function:

  * Adequate hematological function: neutrophil count \>= 1.0 x 10\^9/L, platelet count \>= 100 x 10\^9/L; in case of bone marrow disease: \>= 75 x 10\^9/L; hemoglobin \>= 8 g/dL
  * Adequate renal function: creatinine \> 1.5 x ULN for age; If serum creatinine is \> 1.5 ULN of age, then creatinine clearance (or radioisotope GFR) must be \> 70 ml/min/1.73 m2 Adequate hepatic function: bilirubin \> 1.5 x ULN; AST and ALT \> 2.5 x ULN (AST, ALT ≤ 5 x ULN in case of liver metastases).
* Wash out of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 4 weeks in case of prior radiotherapy. Patients must have recovered from the acute toxic effects of all prior therapy before enrollment into the study.
* Able to comply with scheduled follow-up and with management of toxicity
* All patients with reproductive potential must practice an effective method of birth control while on study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment.
* Written informed consent from patient, parents or legal guardian

Exclusion Criteria:

* Concurrent administration of any other antitumor therapy.
* Have previously completed or withdrawn from this study or any other study investigating gemcitabine or oxaliplatin.
* Have a serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient's ability to complete the study
* Pre-existing sensory or motor neuropathy \>Grade 2 (excluding neuropathy due to disease and/or surgery)
* History of allergic reaction to platinum compounds
* Are pregnant or breast feeding
* Presence of symptomatic brain metastases in patients with solid non-central nervous system (CNS) tumors
Effectiveness of Continuous Erector Spinae Plane and Intrathecal Opioid (ESPITO) Analgesia in Open Radical Cystectomy

Background: Bowel dysfunction is a major complication following open surgery for invasive cancer of the bladder that causes significant discomfort, complications and prolongs the length of stay in the hospital. Amenable factors that are responsible for postoperative bowel dysfunction include intravenous morphine given for pain relief and epidural infusion requiring excess intravenous fluids administration after surgery. The British Association of Urological Surgeons (BAUS) have published the Enhanced Recovery protocol (ERP) to reduce length of hospital stay following open surgery for cancer of the urinary bladder. The ERP is a care package that is provided to the patient from the day of the surgery till hospital discharge. At Leicester, we have modified the ERP and this has become the standard of care for our patients undergoing this surgery. The modified ERP care package includes a novel combination of two established pain relief techniques (erector spinae plane analgesia and intrathecal opioids) that will avoid the use of epidural analgesia, excess intravenous fluids administration and intravenous morphine in the postoperative period. The modified ERP has been well accepted by the patients and the clinical team looking after these patients. We would like to perform a formal evaluation of the modified ERP care package in the management of adult patients undergoing open bladder surgery through an observational pilot study.

Aim of the study is to evaluate the incidence of postoperative bowel dysfunction and the median length of hospital stay in adult patients undergoing(open radical cystectomy Methods: Prospective, observational pilot study that will be conducted at Leicester General Hospital over 24 months. Adult patients scheduled to undergo open radical cystectomy will be included in the study. Patients who will have laparoscopic surgery will be excluded. After providing written consent, the participants will receive an enhanced recovery protocol (ERP) care package that will commence from the day of their surgery till they are discharged from the hospital. Participants will be asked to report time of opening their bowel, pain scores on movement, presence of nausea and vomiting, bowel dysfunction, length of hospital stay and any complication from day of surgery till 30 days after surgery. Participation in the study will end at 30 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients scheduled to undergo open radical cystectomy
2. American Society of Anesthesiologists (ASA) 2 or 3

Exclusion Criteria:

1. Lack of consent including from those participants who lack mental capacity to give informed consent
2. American Society of Anesthesiologists (ASA) 4
Assessment of Insulin Sensitivity in Healthy Adults by a 13C-glucose Breath Test : Method Development and Validation

The current research project aims to assess the insulin resistance (less sensitivity), from measures of insulin and glucose in response to a standard oral intake of glucose (standardized oral glucose tolerance test). For this, we wish to test and validate the method of glucose labelled 13-C (stable isotope) breath test in comparison with standardized methods to measure glucose and insulin. Comparative methods that will be used are measures of glycemia from venous blood withdrawal and continuous glucose measurement in the skin tissue (external face of the arm) using the Abbott's freestyle libre system.

Repeatability and reliability of the 13-C glucose breath test will be checked from repeated measures over time.

The current research project aims to assess the insulin resistance (less sensitivity), from measures of insulin and glucose in response to a standard oral intake of glucose (standardized oral glucose tolerance test). For this, we wish to test and validate the method of glucose labelled 13-C (stable isotope) breath test in comparison with standardized methods to measure glucose and insulin. Comparative methods that will be used are measures of glycemia from venous blood withdrawal and continuous glucose measurement in the skin tissue (external face of the arm) using the Abbott's freestyle libre system.

Repeatability and reliability of the 13-C glucose breath test will be checked from repeated measures over time.

Eligibility Criteria:
Inclusion Criteria:

Healthy male adults aged 18-40 Able to understand and to sign a written informed consent

Exclusion Criteria:

* EXCLUSION CRITERIA
* Known type 1 or type 2 diabetes, by anamnesis
* Family history of type 2 diabetes (parents)
* History of gestational diabetes
* Any other metabolic disease possibly impacting the postprandial glucose and insulin response (anamnesis)
* Any medication impacting the energetic metabolism, to the opinion of the investigator
* Pregnant or lactating women (anamnesis)
* Smoking
* Allergy or intolerance to any food or compound used in this study
* Currently following a strict exercise program (more than three times per week) in order to either lose weight, gain muscle or reach competition standards for a chosen sport
* Having given blood in the past three months or willing to give blood in the 3 months following the completion of the study
* Currently participating or having participated in another clinical trial during the past month.
* Volunteer who cannot be expected to comply with the protocol
Fetal Abdominal Subcutaneous Tissue Thickness in Prediction of Fetal Weight in Term Pregnant Women

Fetal Abdominal subcutaneous tissue thickness (FASTT) can be easily measured during the routine ultrasound examination of pregnant women. Numerous reports have shown FASTT measurement to be a good way of evaluating subcutaneous fat tissue.

However, to the best of our knowledge, no studies have investigated the association of FASTT with abnormal fetal growth in nondiabetic. For this reason, in this study we evaluated whether FASTT can predict birth weight or diagnose LGA and/or LBW infants in the third trimester.

The fetal weight assessment by ultrasound is essential in obstetric practice to determine the labor mode, time, and management. It is an important to detect fetal growth abnormalities such as small for gestational age (SGA), fetal growth restriction (FGR) and large for gestational age (LGA) fetuses; thus, it could help in decreasing the perinatal morbidity and mortality rates \[1\]. Many methods have been introduced to estimate the weight in utero, and many studies have evaluated their effectiveness to detect the most accurate method \[2\]. Abnormal fetal growth can be diagnosed by ultrasound. Conventional ultrasonic measurements, such as estimated fetal weight (EFW) and abdominal circumference (AC) can distinguish LGA/macrosomia or LBW infants. Many studies have demonstrated that expected fetal weight (EFW) by the traditional techniques is not a reliable indicator of growth abnormalities; consequently several other sono graphic measurements have been proposed \[3\]. Ultrasound has its limitations despite the use of more than 50 different formulae to estimate fetal weight as their performance is poor at the extremes of fetal weight. There has been emerging interest in studying fetal soft tissue measurements to improve the detection of growth abnormalities \[4\].

Fetal Abdominal subcutaneous tissue thickness (FASTT) can be easily measured during the routine ultrasound examination of pregnant women. Numerous reports have shown FASTT measurement to be a good way of evaluating subcutaneous fat tissue \[5\].Furthermore, some researchers have investigated links between FASTT and diabetes \[6\].

However, to the best of our knowledge, no studies have investigated the association of FASTT with abnormal fetal growth in nondiabetic. For this reason, in this study we evaluated whether FASTT can predict birth weight or diagnose LGA and/or LBW infants in the third trimester.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy.
2. Gestational age between 37-42 weeks.
3. Accepting to be included in the study

Exclusion Criteria:

1. Pre-gestational diabetes and gestational diabetes.
2. Other medical disorder as hypertensive disorder during pregnancy, cardiac diseases.
3. Congenital fetal malformation affecting birth weight or affecting clavicle.
Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial

The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.

Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO).

Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Legal capacity
* Age ≥ 18 years
* Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III or spondylolisthesis Meyerding grades I-III.
* Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability

Exclusion Criteria:

* Motor deficit
* Cauda equina syndrome
* Previous surgical intervention of the lumbar spine
* Relevant peripheral neuropathy
* Acute denervation subsequent to a radiculopathy
* Scoliosis with Cobb angle greater than 25°
* Spondylolisthesis \> Meyerding grade III
* Radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria)
* No radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria)
* Radiologic signs of degeneration in the adjacent segment of the intended fusion with \>Fujiwara grade II or \>Pfirrmann grade IV
* Signs of instability in any lumbar spine segment other than that undergoing fusion
* General contraindication for elective lumbar spine surgery
* Pathologic fracture
* Osteoporosis with pathologic fracture
* Active systemic infection
* Rheumatic disease
* Disease of bone metabolism (e.g. Paget's Disease)
* Bone metastasis
* Local infection focus lumbar spine
* Seizure disorder
* Chronic ischemia Fontaine classification IIb-IV
* Severe heart insufficiency (NYHA III-IV)
* Blood coagulation disorder or blood thinning therapy
* Cortisone intake more than one month in the last 12 months before randomization
* Simultaneous participation in another clinical trial in the 30 days before randomization
* Known allergy or intolerance to the implants
* Dependency on investigator
* Lack of familiarity with the German language
* Placement in an institution by governmental or juridical advice
* Absent legal capacity
* Pregnancy
A Clinical Study of 9MW2821 in Subjects With Advanced Malignant Solid Tumors

This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
2. Male or female subjects aged 18 to 80 years (including 18 and 80 years).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma).
5. For Cohort Expansion: Subjects must submit tumor tissue for Nectin-4 expression.
6. Life expectancy of ≥ 3 months.
7. Subjects must have measurable disease according to RECIST (version 1.1).
8. Adequate organ functions.
9. Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
10. Subjects are willing to follow study procedures.

Exclusion Criteria:

1. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug.
2. Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
3. Major surgery within 28 days prior to first dose of study drug.
4. History of uncontrolled diabetes mellitus.
5. Preexisting peripheral neuropathy Grade ≥ 2.
6. Received treatment of nectin-4 targeted ADC with MMAE payload.
7. Any live vaccines within 4 weeks before first dose of study drug or during the study.
8. Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
9. Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
10. Uncontrolled central nervous system metastases.
11. History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
12. History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
13. Has ocular conditions that may increase the risk of corneal epithelium damage.
14. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
15. Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug
16. Use of any investigational drug or device within 2 months prior to the first dose of study drug.
17. Condition or situation which may put the subject at significant risk.
A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in France

This is an open-label study to evaluate safety and tolerability and provide enzyme replacement therapy (ERT) with olipudase alfa to patients with acid sphingomyelinase deficiency (ASMD) who completed the DFI12712 or the LTS13632 Study in France until olipudase alfa reimbursement is granted in France.

Study and treatment duration:

The period between the patient's completion of Study DFI12712 or LTS13632 and olipudase alfa reimbursement is available in France.

In case reimbursement will not be obtained, this study will end 5 years after starting.

Visit frequency: every 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* The patient has completed Study DFI12712 (ASCEND) or LTS13632 in France
* The patient must provide signed, informed consent prior to performing any study-related procedures.
* The patient is willing to comply with the clinical protocol.
* The patient, if female and of childbearing potential, must have a negative pregnancy test result \[urine beta-human chorionic gonadotropin (β-HCG)\] at enrollment.
* Sexually active female patients of childbearing potential and male patients are required to practice true abstinence in line with their preferred and usual lifestyle or to use 2 acceptable effective methods of contraception for the entire duration of the treatment period and for at least 28 days after receiving the last study drug dose.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Any patient who has not participated in the Study DFI12712 or the Study LTS13632
* A patient who experienced any systemic hypersensitivity reactions to olipudase alfa in Study DFI12712 or Study LTS13632 which, in the opinion of the Investigator, could indicate that treatment continuation may present an unreasonable risk.
* The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
* The patient is unwilling or unable to abstain from alcohol for 1 day prior to and 3 days after each olipudase alfa infusion for the duration of the treatment period.
* Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
* The patient is concurrently participating in another clinical study of investigational treatment.
* Any of the following medical conditions:
* The patient has any new condition or worsening of an existing condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the patient's participating in or completing the study.
* Requirement for recurrent dose adjustment of anticoagulation treatment over the last 6 months.
* Pregnancy or breastfeeding.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Qualitative Evaluation of Pediatric Obesity Therapeutic Education Programs

Obesity concerns almost the entire planet and is considered in France as a major public health issue: 17% of children are overweight and 4% obese.

Because of this situation, the public authorities have set up programs in order to overcome obesity. Accompanying the child and its family in a process of change through Educational care program seems to be the most suitable. Unfortunately, the abandonment rate of these programs is often high.

The main aim of this study is to explore, describe and understand the phenomenon of attrition in different pediatric obesity Educational care program since 2017 by collecting their experience by describing and characterizing the reasons for attrition reported by the patients included.

Eligibility Criteria:
Inclusion Criteria:

* Children who have started an educational care program between 2017 and 2022 at one of the four participating centers.
* Children whose parents or legal guardians have signed the program participation letter.
* Children who have participated in at least one group session and have stopped the educational care program early.
* Children whose parents have agreed to take part in the focus group for themselves and their child.
* Children over 12 years of age at the time of the focus group.

Exclusion Criteria:

* Child who has completed the Educational Care program
* Parent/child pairs where at least 1 of the 2 refused to take part in the study
The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes

This study evaluates the effect of telemedicine intervention program upon glycemic control in type 1 diabetes mellitus children and their parents in Israel. Half of the participants will receive the telemedicine intervention for a period of six months while the other half will receive the regular treatment then vice versa. Each group will receive in the intervention period 6 telemedicine meeting with a dietician and six telemedicine meetings with a nurse.

The investigators hypothesized that the participants that are recieving the telemedicine intervention will have a better glycemic control after 6 months.

The prevalence of type 1 diabetes has been steadily increasing for the past few decades and is a relatively common chronic disease of childhood (1). Managing type 1 diabetes in young children presents unique challenges to the patient, parents, and to the pediatric health care provider. The diabetes regimen includes intensive blood glucose monitoring, multiple daily injections of insulin ,and frequent insulin dose adjustments according to the amount of carbohydrate eaten, blood sugar, and physical activity. The Diabetes Control and Complications Trail (DCCT) showed a significant link between blood glucose control and a slower onset and progression of diabetes complications, with improved glycemic control decreasing the risk of micro- and macro- vascular complication (2,3,4).

Glycosylated hemoglobin A1c (HbA1c) measures the

In the past decade a significant progress took place in therapy and treatment of diabetes. However poor glycemic control is recorded in a significant proportion of adolescents.

Telehealthcare is the use of telecommunications to deliver healthcare services and involves the remote interaction between a primary care provider and specialist. Telemedicine represents a useful and cost-effective solution to the strict follow-up required in diabetes management ,

Eligibility Criteria:
Inclusion Criteria:

diagnosed with typ1 1 diabetes for at least 6 months insulin dependent participants provided consent to participate in the study consent to use the Accu-Chek Connect diabetes management app -

Exclusion Criteria:

new onset of diabetes type 1 not specified as type 1 diabetes

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