cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type.
* Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months).

Exclusion Criteria:

* Patients receiving or having previously received an organ transplant other than a kidney.
* Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade \>50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons.
* Cold ischaemia time of the donor kidney \>30 hours.
Neurokinin Receptor Antagonist Associated to Ondansetron in PONV

The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.

High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* high risk patients for nausea and vomiting

Exclusion Criteria:

* cardiovascular disease, or hypersensibility to any of the drugs involved in the study
Implant Placement in Mandibular Molar Xenograft Versus PRF

20 recruited patients indicated for immediate implant placement in mandibular molar patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone after molar extraction and immediate implant placement, while the other group we use Platelet-rich fibrin as space filling material.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with non-restorable mandibular molars
2. Both sexes

   -

   Exclusion Criteria:
   * • Heavy smokers more than 20 cigarettes per day.5

     * Patients with in sufficient interseptal bone height and width

       * Patients with systemic disease that may affect normal healing.
       * Patients with completely resorbed buccal cortical plate.
Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia

This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works better in treating patients who have blast phase chronic myelogenous leukemia. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for blast phase chronic myelogenous leukemia

PRIMARY OBJECTIVES:

I. Determine the anti-leukemic activity of bevacizumab, idarubicin, and cytarabine in patients with blastic phase chronic myelogenous leukemia.

II. Determine the toxicity profile of this regimen in these patients. III. Determine the effect of bevacizumab on angiogenesis in these patients.

OUTLINE:

Patients receive bevacizumab IV over 90 minutes once on day -13. Patients then receive bevacizumab IV over 90 minutes and idarubicin IV on days 1 and 15 and cytarabine subcutaneously (SC) once daily beginning on day 1. Treatment repeats every 4 weeks for a maximum of 3 courses. Patients with responding disease receive maintenance therapy comprising bevacizumab IV over 90 minutes on days 1 and 15, idarubicin IV on day 1, and cytarabine SC once daily beginning on day 1. Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML), defined by 1 of the following:

  * At least 30% blasts in peripheral blood and/or bone marrow
  * Presence of extramedullary disease
* Performance status - Zubrod 0-2
* At least 8 weeks
* No prior coagulopathies
* Bilirubin no greater than 1.5 mg/dL
* INR less than 2
* PTT no greater than 60 seconds
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No nephrotic syndrome
* No uncontrolled hypertension
* No New York Heart Association class II-IV heart disease
* No prior thrombotic events
* LVEF ≥ 50%
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No more than 2 prior chemotherapy regimens (no more than 1 regimen containing cytarabine) for CML in blast crisis
* Prior hydroxyurea allowed
* Prior imatinib mesylate allowed
* At least 10 days since prior anticoagulants
* No concurrent anticoagulants
Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy With oXiris Membrane

The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in septic shock patients with severe acute kidney injury, compared with standard membranes. However, its hemodynamic stability or benefits have not been thoroughly evaluated although this is reasonable.

The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in patients with severe acute kidney injury or sepsis, compared with standard membranes. Based on this benefit, the use of oXiris may confer better outcomes than other membranes.

The patient outcomes include cardiovascular, respiratory, renal, and overall survivals, but this information of oXiris are insufficient. Although cytokine and endotoxin removal rates are great in oXiris, the beneficial effects on the hard outcomes are needed to use oXiris in real clinical practice.

The inflammatory and cardiovascular systems have intensive crosstalk, and thus if there are remission in inflammatory process, the patients can have hemodynamic stability. Regarding this, the investigators would like to compare the hemodynamic stability between oXiris and other standard membrane such as polysulfone, using our new real-time monitoring registry.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Sepsis related acute kidney injury requiring continuous renal replacement therapy

Exclusion Criteria:

• No monitoring of blood pressure and ECG
Socio-economic, Meteorological and Environmental Factors Associated With the Incidence of COVID-19

Socio-demographic factors in relation to the diagnosis of COVID cases are increasingly mentioned in the role of transmission, but unfortunately with a small number of conclusive publications on French data. Our objective is to analyse the distribution of cases according to these factors and their possible role during the first 6 weeks of 2021 when the Alpes Maritimes was the department with the highest incidence rate. The collaboration between ARS06 and the Public Health Department in the field of COVID-19 has made it possible to have a departmental bulletin for monitoring the evolution of the epidemic (incidence, screening, hospitalisation). Knowledge of the socio-demographic, meteorological and environmental factors associated with the transmission of SARS-CoV2 would make it possible to reflect on how to act on these factors and to implement a public health policy.


Eligibility Criteria:
Inclusion Criteria:

Any person, adult or not, residing in the Alpes-Maritimes between 03/01/2021 and 14/02/2021 with a COVID-19 diagnosis.

Exclusion Criteria:

Non resident in the Alpes-Maritimes
Journey Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer

This study looks at how well the Journey Ahead intervention works in improving coping and communication skills in participants with gynecologic cancers.

Primary goals of this project are:

Objective 1: Phase 1: To collect feedback from patients on CCI online and to assess patient's evaluation of CCI online.

Objective 2: Phase 1: To examine the feasibility and acceptability of a CCI online.

Objective 3: Phase 1/2: To collect preliminary data on changes in distress and coping associated with participation in CCI online.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer or experienced a recurrence in the past 5 years;
* Diagnosed with High Grade Stage 2, any grade Stage 3 or higher endometrial cancer or experienced a recurrence in the past 5 years;
* Diagnosed with Stage 2 or higher cervical cancer or experienced a recurrence within the past 5 years;
* Diagnosed with any stage Uterine Cancer (both Sarcoma and carcinosarcoma) or experienced a recurrence in the past 5 years;
* At the time of recruitment the patient has received chemotherapy or radiation in the past 5 years, or is less than 5 years post-cancer surgery;
* At the time of recruitment, a Karnofsky Performance Status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) (80) score of 0 or 1;
* 18 years of age or older;
* English speaking;
* Has internet access, able to view the online intervention sessions and attend telephone or video/telehealth chats to discuss the session content and provide feedback;
* Must give informed consent within 5 years of diagnosis.

Exclusion Criteria:

-
Bifidobacterium Supplementation for Very Low Birth Weight Infants

Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.


Eligibility Criteria:
Inclusion Criteria:

* Infants with birth weight less than 1500g

Exclusion Criteria:

* Sever bacteremia
* Congenital anomaly
* Not suitable for the trial defined by an attending neonatologist
Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)

Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)

Patients with non-small cell lung carcinoma (NSCLC) in stage III A and III B showing at least stable disease after RCTx will be enrolled into the clinical trial. The aim of the study is to show the efficacy of an adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine). Patients will be randomized 1:1 either to the interventional study group to receive 4 cycles of autologous immunotherapy with activated NK cells or to the control group (BSC).

Eligibility Criteria:
Inclusion Criteria:

* First diagnosis of histologically and/or cytologically proven and unresectable NSCLC with clinically stage III A and III B
* Completion of radiochemotherapy no longer than 8 weeks ago
* Progression free according to RECIST criteria at the first assessment after completion of RCTx
* Confirmed presence of Hsp70 on patient´s tumors
* ECOG Status(Appendices) ≤ 2

Exclusion Criteria:

* Any severe heart disease or any severe concomitant disease (ECOG stage \> 2)
* NSCLC patients (stage IIIA/B) eligible for initial surgery with a confirmed consent of an interdisciplinary tumorboard
* Patients that show ALK positivity or an activating mutation of the EGFR-TK domain
* Patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology
* Receipt of immunosuppressive drugs including high dose systemic corticosteroids within 3 weeks before study entry. Low dose corticosteroids as they are a common treatment option for patients suffering from COPD are not an exclusion criterium
A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients

A retrospective analysis of Restasis® benefits in dry eye contact lens patients.

Charts of contact lens wearers with diagnosed dry eye who are being treated with Restasis will be evaluated to determine success in treatment by retrospectively looking at various outcome measures including but not limited to schirmer, staining and osmolarity levels

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, \> or = 18 years of age
* Subject was previously diagnosed (prior to Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1); or Subject was newly diagnosed (at Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1);
* Subject was prescribed Restasis® therapy at Baseline Visit (Visit 1) and commenced dosing immediately after Baseline Visit (Visit 1)
* Baseline Visit occured between 01 July 2012 and 01 January 2014;
* Subject had corneal staining and at least one dry eye sign (i.e., Schirmer's Test score \<10 mm, decreased tear lake, TBUT \<10 seconds, conjunctival staining, tear osmolarity \>310 mOsmol/L
* Subject had charted tolerability and efficacy data reflecting at least one follow-up visit following Restasis® treatment initiation; and
* Subject wore contact lens(es) concurrently while receiving Restasis® treatment for a minimum duration of 6 months post-Baseline (Visit 1)

Exclusion Criteria:

-
A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis

This crossover designed study evaluates the effects of microcurrent therapy on knee osteoarthritis. Ín a previous study patients were randomized into four different groups. Group 1 and 2 both received microcurrent therapy, but with different freqency and intensity parameters. Group 3 received treatment with the microcurrent treatment apparatus without current (sham). group 4 was a control group.

In the following, present study the controll group as well as the sham group will receive the microcurrent therapy (verum).

The objective of the previous randomized, controlled pilot study was to evaluate the effect of microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective was to compare the effects of different currents. (group 1 - 4) After receiving 10 sessions of microcurrent therapy the statistical calculation showed a slightly significant difference in the verum-group A (Parameters Channel A: Channel B, Frequency ...) After a wash-out-phase we are now trying to evaluate and possibly confirm the positive effect of the previous trial. Therefore the control - and sham group from the previous study will now receive microcurrent therapy of apparatus A.

The whole procedure (Number of session, duration of the treatments, main outcome measurements, secondary outcome measurements) of the following study is identical with the previous pilot study. Assessments four the group will be at the first day of treatment (T1) and at the end of Treatment (T2).

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee
* pain intensity \> 3 on the numerical rating scale (0-10)

Exclusion Criteria:

* knee arthroplasty
* gravity
* dermal Irritation at the skin of the knee
* carcinoma
* known osteoarthritis grade 4 (Kellgren and Lawrence score)
Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures

The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint.

The investigators hope to learn the following objectives from this study

1. Prospectively establish equivalence with respect to fracture union rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
2. Prospectively establish equivalence with respect Patient Reported Outcome Measurement Information System (PROMIS) scores after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
3. Prospectively establish superiority with respect to hardware related pain after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
4. Prospectively establish superiority with respect to the hardware removal rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.

Patients scheduled for open reduction and internal fixation for medial malleolus fracture by using Acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. Patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or Acutrak headless compression screws. At the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. After operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgical fixation


Eligibility Criteria:
Inclusion Criteria:

* Ankle fractures that undergo open reduction internal fixation of the medial malleolus

Exclusion Criteria:

* Tibial plafond (pilon) fractures
* Medial malleolar osteotomies to access the talus, perform an ankle fusion, or deal with a pathologic lesion, osteonecrosis, or infection due to their diversity in diagnosis, management, and weight bearing status
* Patients with prior surgical treatment of the ankle for fracture, deformity, infection, neoplasia, or other pathologic process on the ipsilateral extremity
* Patients that are non-weight bearing on one or both lower extremities prior to sustaining their ankle injury
A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.

This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer.

This Phase 1b trial will characterize the safety profile of ARGX 111 and will thus provide the first elements towards establishing an accurate risk-benefit assessment for ARGX 111 in cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Age ≥ 18 years.
3. Performance status of 0 or 1.
4. Histological diagnosis of malignancy.
5. Cancer relapsing after, or refractory to standard therapy.
6. Malignancy over-expressing the c Met protein.
7. Presence of circulating tumor cells (CTCs).
8. At least one tumor lesion \> 2 cm on PET/CT.
9. Serum albumin \> 35 g/L.
10. Absolute neutrophil count (ANC) \> 1.0 x 109/L.
11. Hemoglobin \> 90 g/L (0.9 g/dL).
12. Platelet count ≥ 75 x 109/L.
13. Coagulation parameters ≤ 1.5 x ULN.
14. Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
15. Creatine Phosphokinase (CPK) ≤ 2.5 x ULN.
16. Serum creatinine ≤ 1.5 x ULN.
17. Ability to comply with protocol-specified procedures/evaluations and scheduled visits.

Exclusion Criteria:

1. History or clinical evidence of neoplastic central nervous system (CNS) involvement.
2. Major surgery within 4 weeks of ARGX 111 first dose administration.
3. Systemic glucocorticoid administration at doses greater than physiological replacement (prednisone 20 mg equivalent) within 3 weeks of ARGX 111 first dose administration.
4. Cytotoxic chemotherapy within 3 weeks of ARGX 111 first dose administration.
5. Radiation therapy with curative intent within 3 weeks of ARGX 111 first dose administration.
6. Biological therapy (monoclonal antibodies) within 4 weeks of ARGX 111 first dose administration.
7. Biological therapy (other than monoclonal antibodies) within 5 half-lives of ARGX 111 first dose administration.
8. Unresolved Grade 3 or 4 toxicity from prior therapy, including experimental therapy.
9. History of recurrent Grade 3 or 4 toxicity from anti c Met therapy.
10. Uncontrolled diabetes, defined as fasting glycemia \> 150 mg/dl).
11. Active, untreated viral, bacterial, or systemic fungal infection.
12. Any clinical finding, including psychiatric and behavioral problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study.
13. Childbearing potential (unless using an adequate measure of contraception).
14. Pregnancy or lactation.
15. History of severe (Grade 3 or 4) hypersensitivity to recombinant proteins.
Diagnosis of Hepatic Tumors in Cirrhosis: Prospective Validation of the Noninvasive Diagnostic Criteria for Hepatocellular Carcinoma

This study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. All the patients who receive hepatomy in our department
2. Diagnose as HCC
3. Diagnosis of HCC is confirmed by noninvasive criteria for HCC as used by the American Association for the Study of the Liver guidelines
4. No history of previous treatments
5. No pathological diagnosis before treatment
Colombia Epidemiologic Surveillance Study

The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.

The study was stopped based on a decision to include PCV 10 in the National Immunization Program in Colombia. The study was designed to measure the impact of PCV 7 and 13 and is no longer feasible.

Eligibility Criteria:
Inclusion Criteria:

* Children 28 days to 36 months of age
* Presenting to a participating facility with a measured temperature of 39 degrees C or higher within 24 hours prior to screening, or with clinical suspicion of pneumonia, meningitis, bacteremia, sepsis, or other invasive pneumococcal disease

Exclusion Criteria:

* Any patient hat based on the clinical impression of the treating physician should not participate in the study: examples such as those with suspected dengue or urinary tract infection