cyrilzakka/clinical-trials huggingface dataset:
Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological confirmation of non-small-cell lung carcinoma.
* Complete surgical resection of the disease.
* Tumoral tissue available for molecular analysis.
* N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative piece.
* Men or women age 18 years or older.
* Patients with a performance status of 2 or less according to the ECOG classification.
* Patients with the following laboratory results: ANC \< 1500/L, Hb \< 10 g/dL, platelets \<100,000/L, bilirubin \< 1.0 mg/dL, AST and ALT \< 1.5 upper limit of normality, creatinine clearance \< 60 mL/min.
* Complete recovery from surgery within 6 weeks.
* Patients who have given written informed consent before initiating any specific study screening procedure.

Exclusion Criteria:

* Patients who have received previously chemotherapy or radiotherapy for the study disease.
* Impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
* Patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
* Women who are pregnant or in the period of lactation.
* Patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.
* Patients under treatment with investigational agents.
Intravenous Iron in Adults With Cystic Fibrosis

This pilot interventional cohort study will examine the effects of intravenous iron in adults with cystic fibrosis and iron deficiency.

Iron deficiency is common in adults with cystic fibrosis, and is associated with adverse outcomes. Oral iron supplementation is poorly tolerated and may be ineffective. In some centres, intravenous iron is used to correct iron deficiency, but concerns have been raised about the safety of this treatment in the setting of chronic airways infection. The investigators are therefore planning a pilot interventional cohort study examining the effects of intravenous iron in a group of adults with cystic fibrosis. Patients will be recruited in Oxford and studied prospectively over 16 weeks, with iron given at week 4. The primary focus of this single-centre pilot/feasibility study is safety, specifically in relation to infection.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years with established diagnosis of cystic fibrosis
* Iron deficiency (transferrin saturation ≤16 % or ferritin \<15 μg/l, within last 4 months)

Exclusion Criteria:

* Urgent (\<6 weeks) need for iron supplementation
* Active infection (currently requiring IV antibiotics)
* Previous intravenous iron supplementation (within last 4 months)
* Current oral iron supplementation
* Hypersensitivity to ferric carboxymaltose
* Active non-tuberculous mycobacterial pulmonary disease (as defined by ATS-IDSA criteria)
* Liver failure
* Ferritin \>300 μg/l or transferrin saturation \>45%
* Pregnancy or breast feeding
* Previous transplantation
* Judged by member of trial team to be unlikely to comply with safety aspects of trial
The Effect of Radiation on Semen Quality and Fertility in Men With Prostate Cancer

Many younger men are diagnosed with prostate cancer. These patients are often choosing radiation therapy as their primary treatment. The effect of this therapy on fertility will have a direct impact on their decision about therapeutic options and fertility preservation. The researchers hypothesize that when patients are treated with radiation for localized prostate cancer, infertility can occur due to direct damage to seminiferous tubules affecting sperm quality.

Prostate cancer is the most common malignant disease among men. Many young men are diagnosed with localized prostate cancer. Some of these men are choosing to manage their prostate cancer with radiation therapy. The radiation therapy delivers minimal dose exposure to adjacent organs. We hypothesize that when patients are treated with radiation therapy for localized prostate cancer, decreased fertility can occur due to damage of seminiferous tubules, which may affect sperm quality. This study will assess the impact of radiation therapy on semen and seminal fluid.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically confirmed low risk to moderate stage prostate cancer (Gleason 6 - 7) treated with brachytherapy or external beam radiation
* \> 12 months ago

Exclusion Criteria:

* Subjects with a prior history of infertility
* Subjects who have undergone vasectomy
* Subjects who have received LHRH therapy for prostate cancer \< 6 months ago
* Subjects who have received anti-androgens \< 3 months ago
* Subjects using alpha blockers within 7 days of specimen provision
* Subjects who have taken finasteride or dutasteride within the previous 4 months.
Charlotte Retention in Care Study

The objective of the Charlotte Retention in Care study is to assess if clinical decision support systems (CDSS) that produce standardized alerts for measures of retention in care across clinics in the city of Charlotte, North Carolina have the ability to increase retention in care measures within clinics and in surveillance reports.

Multiple Charlotte HIV Clinic providers are participating. "Primary" HIV provider will be defined as the primary physician or advanced care practitioner following a patient, as recorded in their respective Electronic Health Record (EHR) system and identified through CHORUS, a Clinical Decision Support System (CDSS) developed by Epividian. The CDSS will track patient case status as active or inactive (loss to follow-up, transferred medical care, or deceased). Providers will be informed of the study and sites will be contracted to participate in this collaborative research study. This study was approved by the Advarra Institutional Review Board.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1+
* Any gender
* 18 years old or older
* Residing in the Charlotte, North Carolina metropolitan area
* At least a single entry in the EHR in the last 2 years
Turkish Version of the Movement Imagery Questionnaire-3

Motor imagery is the mental representation of movement without any body movement. According to recent studies motor imagery contains three strategies to mentally simulate the movements: internal visual, external visual and kinesthetic imagery. Motor imagery is associated with cortical reorganization and functional improvements and it does not only related with motor performance, it also influces cognitions. Movement Imagery Questionnaire-3 (MIQ-3) is the recent, modified version of the Movement Imagery Questionnaire-Revised, Second Edition and measures imagery ability in terms of ease of imagery.

The aim of this study is to translate MIQ-3 into Turkish and evaluate its test-retest reliability for Turkish-speaking population.


Eligibility Criteria:
Inclusion Criteria:

* age above 18, consenting, with no limitation in mobility or movement disorder

Exclusion Criteria:

* refuse to attend to the study
Integrating the ESDM in ASD Preschools in Israel

The current study evaluates the effectiveness of the Early Start Denver Model (ESDM) when integrated in existing community preschools for children with ASD. The study compares developmental gains made a group of children receiving preschool-based ESDM compared to a group of children receiving eclectic interventions in their preschools (treatment as usual).

The Early Start Denver Model is a comprehensive treatment model for young children with Autism Spectrum Disorders (ASD), which builds upon behavioral, relationship, play-based and developmental theories and practices. Utilizing the plasticity of the young brain, while managing social attention, employing multi-modal teaching, and tapping into the child's motivation, the ESDM aims to alter the child's developmental trajectories by creating rich and meaningful learning experiences in daily and naturalistic routines. This model focuses on all areas of development, with significant stress on communication, language, social skills, play and imitation. In the ESDM, parents are seen as a main motivational factor for the child, and a focal part in planning and implementing key components of the intervention.

Currently, community preschool settings are the main providers of intervention programs for children with ASD in Israel. The prevalent mode of intervention in these settings is a multi-disciplinary eclectic model, in which professionals from various disciplines deliver intervention comprising several theories and practices. While quite ubiquitous, this type of intervention was shown in previous research as less effective than specialized, comprehensive treatment models.

The ESDM was previously shown efficacious in intensive home-based delivery, and effective as a center-based group model. However, there are currently no studies that assess the effectiveness of the ESDM when integrated in existing community preschool settings. Additionally, previous research in center-based group delivery of the ESDM did not focus on the effects of routine parental involvement in child treatment (when delivered in a preschool setting) on child and parental outcomes. The current study aims to explore the effects of ESDM implementation in community preschool settings, together with incorporation of parents in the treatment process.

Eligibility Criteria:
Inclusion Criteria:

* Children learning in ASD schools with a diagnosis of ASD validated by the Autism Diagnostic Observation Schedule - 2nd edition.
* ESDM group: parents who have agreed to participate in weekly joint sessions at the preschool.

Exclusion Criteria:

-
Evaluation of the Impact of Red Blood Cell Exchange on Thrombo-inflammation in Sickle Cell Disease

Sickle cell disease is the most common inherited blood disorder worldwide. It is a hemoglobinopathy characterized by chronic hemolysis, endotheliopathy, coagulation activation, and chronic inflammation. It is a multisystemic disease leading to acute (vaso-occlusive crisis, acute chest syndrome, stroke...) and chronic complications with multiorgan damage. Thrombo-inflammation is defined by the cooperation and interaction between hemostasis and the innate immune system. The platelet represents the cornerstone of this phenomenon, being at the interface of these two systems. In sickle cell disease, platelets are activated and release cytokines, leading to a pro-coagulant and pro-inflammatory state. Transfusion, whether occasional or chronic, is a major sickle cell disease treatment. It is common to distinguish simple transfusion from exchange transfusion. The latter involves replacing a given volume of sickle red blood cells with healthy red blood cells. Exchange transfusion allows avoiding an excessive increase in hemoglobin. The decrease of hemoglobin S under 30% achieved by red blood cell exchange reduces the risk of stroke by more than 90% in children with cerebral vasculopathy. Moreover, transfusion can be used in acute complications such as vaso-occlusive crisis and acute chest syndrome. Despite this efficacy, a subgroup of patients is not totally protected against acute and chronic complications. The persistence of chronic inflammation is suggested. To date, it is not known if red blood cell exchange can reduce the thrombo-inflammatory dynamic in sickle cell disease. The aim of this study is to evaluate the impact of red blood cell exchange on thrombo-inflammatory parameters in 20 adult sickle cell patients (10 patients on manual exchange and 10 patients on automatized exchange).

Prospective observational cohort with additional blood samples. This study is monocentric.

Eligibility Criteria:
Inclusion Criteria:

* Sickled Cell Disease patient with SS or S/beta thalassemia genotype
* Red blood cell exchange \> 3 months
* Up-to-date social security coverage
* Patient able to understand the purpose and constraints of the research project
* Patient has read the study information leaflet and does not object to the research.

Exclusion Criteria:

* Thrombopenia \< 50 G/L
* Non-steroidal anti-inflammatory drugs \< 7 days before enrolment
* Anti-platelet agents \< 7 days before enrolment
* Pregnancy or breastfeeding
* Patient objects to take part in the study
* Patient under guardianship, curatorship or safeguard of justice
* Patients with ongoing clinical trial requiring collection of additional blood samples
18F-FDG and 68Ga-FAPI PET/CT in Lung Adenocarcinoma

To evaluate the potential usefulness of 68Ga-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in lung adenocarcinoma, compared with 18F-FDG PET/CT.

Participants with lung adenocarcinoma underwent contemporaneous 18F-FDG and 68Ga-FAPI PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy. In addition, the investigators further investigate the performance of 68Ga-FAPI PET/CT for differentiating invasive adenocarcinoma from adenocarcinoma in situ (pre-invasive lesion) or minimally invasive adenocarcinoma in participants with solitary ground-glass opacity nodules.

Eligibility Criteria:
Inclusion Criteria:

* (i) aged ≥ 18 years, with newly detected GGNs ≤ 3 cm on LDCT and suspected to be lung cancer, and with no prior treatment;
* (ii) who accepted undergoing paired 18F-FDG and 68Ga-FAPI-46 PET/CT, with completion within one week of each other;
* (iii) with planned surgical resection within one month after PET/CT examinations;
* (iv) with an ability to provide informed consent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) without surgical treatment;
* (ii) receiving antitumor treatment prior to surgery;
* (iii) whose postoperative pathology revealed adenocarcinoma beyond stage IA or benign pulmonary lesions;
* (iv) with concurrent diagnosis of other malignant tumors;
* (v) with poor image quality or lesions difficult to measure.
Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (what the body does to the medication) and antiviral activity of JNJ-47910382 when administered in different dosing regimens in Caucasian genotype-1 chronic HCV-infected patients.

This is a Phase Ib, double-blind (neither physician nor patient knows the treatment that the patient receives), randomized (the study drug is assigned by chance), placebo-controlled study in treatment-naïve (someone who has never used drugs for HCV infection), Caucasian genotype 1 chronic HCV-infected patients. The study consists of a screening period, a 9-day treatment period (with 5 days of actual medication intake) and a 4-week follow-up period. The patients will be divided over 4 panels of 10 patients each that will be initiated sequentially. In each panel patients will receive JNJ-47910382 or placebo during 5 consecutive days. JNJ-47910382 or placebo will be administered once daily or twice daily. Within each panel, 5 patients of genotype-1a and 5 patients of genotype-1b will be enrolled. Patients will be randomly assigned to receive active treatment or placebo in such a way that 4 patients of each genotype receive active treatment and 1 subject of each genotype receives placebo. The pharmacokinetic profile of JNJ-47910382 will be assessed in each panel. HCV RNA kinetics (HCV RNA level) and HCV resistance will be studied and biomarkers at the messenger RNA (mRNA), protein and cell level will be explored. The entire study duration for each participant will be approximately four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (diagnosis of hepatitis C more than or 6 months before the screening period) HCV infection. Geno- and subtype should be determined or confirmed at screening, and should be 1a or 1b
* Never received (Peg) IFN, RBV or any other approved or investigational antiviral treatment for chronic HCV infection
* HCV RNA level of \>100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)
* Patients having good accessible veins

Exclusion Criteria:

* Evidence of liver cirrhosis or decompensated liver disease
* Patient coinfected with HIV-1 or HIV-2, or hepatitis A or B virus infection, or active tuberculosis at study screening
* Patient infected/coinfected with non-genotype-1 HCV at study screening
* Patient with any cardiac disease at screening, or any active clinically significant disease, or medical history or physical examination findings during screening
* Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, thyroid disease or disorders
Neurophysiological Molecular and Developmental Analysis of the Glutamate Synapse in Autism

Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism

Analysis about 50 genes in glutamate synapse

Eligibility Criteria:
Inclusion Criteria:

* have a Pervasive Developmental Disorder

Exclusion Criteria:

* N/A
Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy

The purpose of this study is to assess the efficacy of Diamel (dietary supplement) administration in the treatment of patients with type 2 diabetes receiving insulin therapy. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of patients to be recruited and randomized for the study is 116. Daily insulin requirements, blood glucose (fasting and post-prandial) concentrations, glycosylated hemoglobin (HbA1c), triglycerides and cholesterol will be assessed at the beginning and after 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with insulin therapy regimen of two daily doses.
* Signed informed consent.

Exclusion Criteria:

* Type 1 diabetes.
* Type 2 diabetes with glibenclamide treatment.
* Nephropathy or liver condition diagnosed by clinical and/or biochemical examination.
* Sepsis.
* Pregnancy.
* HbA1c values greater than 10%.
Study of South African Dialysis Patients

An observational study to describe the treatment of anaemia in patients with chronic kidney disease, who are receiving dialysis treatment at selected study centres in South Africa.

This multicentre, prospective, observational study will describe the treatment and clinical outcomes of of dialysis patients in South Africa. No formal hypothesis will be tested in this descriptive study. Eligible subjects will be receiving either peritoneal or haemodialysis, will have received Aranesp therapy between 3 and 6 months prior to enrolment into the study, do not need to be receiving Aranesp at the time of enrolment and will be followed for up to 12 months after commencement of Aranesp. Data to be collected includes ESA therapies, iron usage, relevant concomitant therapies, haemoglobin concentrations, other relevant clinical laboratory parameters and red cell transfusions.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing chronic haemodialysis or peritoneal dialysis
* Commenced Aranesp therapy 3-6 months prior to enrolment
* Erythropoiesis stimulating agent (ESA) naive or treated with another ESA prior to commencing Aranesp
* Informed consent obtained

Exclusion Criteria:

* Received Aranesp in an interventional study within 6 months prior to start of observation period
* Receive investigational product during the observation period
Modified Diaphragmatic Plication Rectifies Dyspnea

Traditional diaphragmatic plication (DP) surgery is employed to ameliorate respiratory function in patients with diaphragmatic paralysis, which is rather complicated. This study introduces a modified method of DP. The efficacy of modified diaphragmatic plication (MDP) in preventing, treating, and relieving dyspnea in patients with phrenic nerve resection or injury due to extensive surgical intervention or local tumor invasion will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Preoperative chest X-ray suggesting diaphragmatic eventration, for which therapeutic MDP was performed;
* Mediastinal tumors encircling the phrenic nerve that could not be dissected or phrenic nerve injury occurring during intraoperative dissection, for which prophylactic MDP was performed;
* Diaphragmatic eventration and dyspnea following mediastinal surgery, for which salvage MDP was performed.

Exclusion Criteria:

* Congenital diaphragmatic deformity or diaphragmatic weakness due to poor general nutritional status;
* Morbid obesity with a BMI greater than 35 kg/m2;
* Neuromuscular diseases, including amyotrophic lateral sclerosis and myasthenia gravis;
* A history of upper abdominal surgery; and (5) Diaphragmatic calcification or fibrosis.
Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation

The primary goal of the study is to identify incidence and risk factors for PPMV in pediatric patients undergoing liver transplantation.

The vast majority of children undergoing orthotopic liver transplantation (OLT) are maintained on mechanical ventilation (MV) in the immediate postoperative period. Reasons for this practice include concerns about graft function, postoperative respiratory depression from opioids, preexisting malnutrition, and organ-recipient size mismatch as well as poor cooperation of young children with postoperative instructions. With current improvements in the perioperative care, there is increasing drive towards early extubation in both adults and children.

Although many children require only a few days of MV following OLT, some require a more prolonged course. In general, prolonged postoperative mechanical ventilation (PPMV) in intensive care unit (ICU) patients is marker of severe adverse events and is associated with higher morbidity and mortality as well as extraordinary resource utilization. Patients requiring PPMV have survived the acute phase of surgery but spend an increased amount of time in the ICU, consume about 50% of all intensive care unit (ICU) resources and are more likely to die. Consequently, investigating the incidence and factors predisposing to PPMV following liver transplant is an important area of research with potential to reduce cost of care and improve long-term outcome of patients.

To our knowledge, factors associated with PPMV following pediatric liver transplantation have not been comprehensively characterized.

Eligibility Criteria:
Inclusion Criteria:

* All Pediatric patients aged \<17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.

Exclusion Criteria:

* Patients who required mechanical ventilation during the 48 hr preceding surgery.
* Older than 18 yr at the time of transplantation
* Acute liver failure
* Acute on chronic liver failure