cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters

Orthokeratology (ortho-k) is a clinical technique that uses reverse geometry rigid gas permeable contact lens exerting positive pressure on the central cornea to temporary reduce refractive error. Researchers have shown that this treatment is effective for myopia control in low to high myopes, with and without astigmatism. Most designs of ortho-k lenses in the market are fitted based on the Jessen formula. The compression factor was introduced to compensate for the regression of the ortho-k effect during the no lens-wear period, so that the wearer can obtain clear distance vision throughout the day and most lens designs use a compression factor of 0.50-0.75 D. However, in a retrospective study (mixed brands of ortho-k lenses), it showed that most patients did not achieve an over-correction of 0.75 D. In order to achieve an over-correction of 0.75 D, an extra flattening power of about 1.50 D instead of 0.75 D should be be targeted. The increased compression factor is expected to increase the target reduction and it may play a role in myopic control and providing a higher successful rate in fitting ortho-k lenses.

Subjects were fitted with ortho-k lenses of conventional (0.75 D) and increased (1.75 D) compression factor. The laterality of the compression factor for each subject was randomised.

Subjects were instructed and trained with proper lens handling and disinfection procedures. Lenses were given to the subjects only when they demonstrated proper techniques.

All subjects were required to attend regular follow-ups (baseline, first overnight, and weekly over one-month period). The follow-ups were scheduled (except for the first overnight which was scheduled in the early morning) at a similar time to the baseline visit (+/- 2 hours) to minimise any potential influence of diurnal variation on ocular biometrics.

Additional unscheduled visits were provided when necessary to ensure good ocular health and vision throughout the study period.

Eligibility Criteria:
Inclusion Criteria:

1. 6 to 10 years old
2. Myopia: between 0.50 D and 4.00 D in both eyes
3. Astigmatism: \<1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
4. Anisometropia: ≤ 1.50 D
5. Symmetrical corneal topography with corneal toricity \<2.00 D in both eyes
6. Agree for randomization

Exclusion Criteria:

1. Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
2. Any type of strabismus or amblyopia
3. Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
4. Rigid contact lenses (including orthokeratology lenses) experience
5. Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
6. Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
7. Poor compliance for lens wear or follow-up
A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex

To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and ARC. To measure steady state serum levels of rCD4 following continuous infusion therapy.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* Diagnosis of AIDS or AIDS related complex (ARC).
* Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
* The ability to sign a written informed consent form prior to treatment.
* A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
* A life expectancy of at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.

Concurrent Medication:

Excluded:

* Zidovudine (AZT).
* Corticosteroids.
* Nonsteroidal anti-inflammatory agents (NSAI).
* Other experimental therapy.

Patients with the following are excluded:

* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.

Prior Medication:

Excluded within 3 weeks of study entry:

* Zidovudine (AZT).
* Chemotherapy.
* Immunomodulators.
* Other experimental therapy.
Sunitinib Malate in Treating Patients With Kidney Cancer

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.

OBJECTIVES:

Primary

* To determine whether a link exists between the effectiveness of therapy with sunitinib malate and development of blood biomarkers, specifically the angiogenic factors VEGF and interleukin-8 (IL-8), in patients with kidney cancer.

Secondary

* To evaluate the link between the time to progression and the development of VEGF and IL-6 CXCL7 and CXCK5 blood levels in these patients.
* To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and disease-free survival of these patients after 3, 6, 9, and 12 months of treatment.
* To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and then every 6 weeks for pharmacokinetic analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed renal cell carcinoma
* Metastatic disease requiring first-line treatment with sunitinib malate

  * No prior therapy for metastatic disease
* No symptomatic or uncontrolled cerebral metastasis

PATIENT CHARACTERISTICS:

* Affiliation to the French Social insurance
* Life expectancy ≥ 3 months
* No heart failure
* No chronic unstable disease
* No long QT interval
* No history of another primary cancer
* No severe, uncontrolled acute infection
* No severe, uncontrolled hypertension
* No psychological disorder

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Salivary Biomarkers of Gastroesophageal Reflux in Infants

Gastroesophageal reflux (GER), defined as the backflow of gastric material into the esophagus, it is a condition with a high prevalence during the first year of life. The disease from Gastroesophageal reflux (GERD), a rarer condition, is defined as the presence of symptoms and complications caused by gastroesophageal reflux. For the diagnosis of GERD in infants it is necessary to perform instrumental diagnostic tests invasive. Several efforts have already been made to identify diagnostic strategies non-invasive but, at the state of the art, no non-invasive biomarker has yet been found of GERD in infants. Therefore, the aim of this pilot study is to identify possible biomarkers salivary gastroesophageal reflux in a population of infants with GER or GERD. Infants from 2 months to the first year of life, with age, will be prospectively enrolled postmenstrual \> 40 weeks, hospitalized, with symptoms of GER or GERD and undergoing 24-hour esophageal MII-pH.

Saliva samples will be collected during the execution of the MII-pH of the esophagus 24 hours, at defined time points, at least 2 hours after the last meal, so as to study the circadian variations of their composition.

A control group made up of healthy infants will also be enrolled and will be sampled a single saliva sample during a health assessment. The salivary pH, the buffer capacity, the electrolytes (Na, K, Cl, HCO3) and the saliva pepsin/pepsinogen concentrations of enrolled infants. The expected results include the description of the salivary biochemical profile of GER infants vs. GERD, so that the investigators can develop non-invasive diagnostic strategies and detect personalized therapeutic treatments.


Eligibility Criteria:
Inclusion Criteria:

* Infants with reflux symptoms undergoing MII-pH
* Consent of parents or legal representative

Exclusion Criteria:

* Infants being treated with PPIs
* Infants with postmenstrual age \< 40 weeks
* Infants with gastrointestinal disorders/diseases other than functional gastrointestinal disorders (FGID)
* Infants with otorhinolaryngological conditions potentially capable of altering salivary composition
* Infants with gastrointestinal malformations, such as esophageal atresia
* Infants with genetic, neurological, renal or endocrinological disorders
* Infants for whom the collection of salivary samples is not feasible
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy

The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥ 18 years
* Subjects who have received oral vitamin K-antagonist therapy
* Subjects who have acute major bleeding, defined as one of the following: life-threatening or potentially life-threatening, acute bleeding associated with a fall in hemoglobin (Hb) level ≥ 2g/dL, bleeding requiring blood product transfusion
* INR ≥ 2 within 3 hours before start of study treatment
* Informed consent has been obtained

Exclusion Criteria:

* Expected survival of less than 3 days, or expected surgery in less than 1 day
* Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control the acute bleeding event
* Use of unfractionated or low molecular weight heparin use from 24 hours prior to enrollment or expected need within 24 hours after start of infusion
* For patients with ICH: Glasgow coma score (GCS) \< 7; intracerebral hematoma volume \> 30cc as assessed by ABC/21; for subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm; for subarachnoid hemorrhage: any evidence of hydrocephalus; infratentorial ICH location; epidural hematomas; intraventricular extension of hemorrhage; modified Rankin score (mRS) of \>3 prior to ICH
* History of thrombotic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within 3 months of enrollment
* Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies
* Suspected or confirmed sepsis at time of enrollment
* Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study
* Large blood vessel rupture (e.g. in advanced cancer patient)
* Pre-existing progressive fatal disease with a life expectancy of less than 2 months
* Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C or protein S deficiency; or heparin-induced, type II thrombocytopenia
* Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study
* Presence or history of hypersensitivity to components of the study medication
* Pregnant or breast-feeding women
* Prior inclusion in this study or any other CSL Behring-sponsored Beriplex study
Non-Interventional Study of Xeloda (Capecitabine) in Patients With Gastric Cancer

This observational study will collect prospective data on the safety and tolerability of Xeloda in patients with advanced gastric cancer from every day clinical practice. Documentation of treatment for each patient is to continue until the end of treatment per oncologist's assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>/=18 years, with metastatic gastric cancer who are available for prospective documentation of their treatment (first-line chemotherapy)
* Informed consent

Exclusion Criteria:

* Contraindications to Xeloda per the Summary of Product Characteristics (SmPC)
Analysis of Risk Factors for Recurrence of Periprosthetic Infection in Megaprostheses Implanted for Sarcoma of Bone

The goal of this observational study is to collect a large and homogeneous case report of periprosthetic infections in megaprostheses in patients with a history of bone sarcoma.

The incidence of periprosthetic infections (PJI) is high in megaprostheses (MP), 3-30% after primary surgery, up to 60% after prosthetic revision. Patients with megaprosthesis implanted in a primary sarcoma of bone have an increased risk of infection, compared with joint prostheses implanted on arthrosis, due to several factors, including treatment with chemotherapy, extensive periarticular soft tissue sacrifice, and duration of surgery. PJI of an MP can result in important consequences: prolonged hospitalizations, expensive treatments, multiple surgeries, risk of amputation and reduced quality of life.

Diagnosis and treatment of MP infections are challenging. Surgery is the focus of treatment, and identification of the microorganism responsible for infection is necessary for diagnostic confirmation and to set up targeted antibiotic treatment.

Treatment, similar to standard joint replacement, includes surgical cleaning without implant replacement and complete revision of the prosthesis in one or two stages. Data currently available in the Literature about patients with infection of a megaprosthesis implanted after excision of a bone sarcoma is scarce; in particular, most case series are small and heterogeneous.

The aim of this study is to obtain more information about this condition by collecting a large and homogeneous data of PJI in MP, in order to identify predictive factors in the treatment of PJI.

The treatments to which the patients underwent and thus analyzed for the study are those expected by normal clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PJI caused by a megaprosthesis, implanted for a primary sarcoma of bone;
* Age \>= 18 years at the time of diagnosis;
* Megaprosthesis site: proximal humerus, proximal femur, total femur, distal femur, tibia proximal;
* Prosthetic revision in two stages;
* Obtaining informed consent for the study

Exclusion Criteria:

* Early infection (within 6 weeks after implantation of the prosthesis);
* Recurrence of infection;
* Follow-up \< 12 months after prosthetic re-implantation;
* Reconstruction other than a megaprosthesis (e.g., bone graft, composite prosthesis)
Comparison of the Effectiveness of Supervised, Video-based and Home-based Resistance Exercise Program in Patients With Prostate Cancer

The aim of this study was to compare the effects of video-based application method of resistance exercise training and supervised exercise training on mobility, body composition, quality of life, fatigue, muscle strength and physical performance in patients with prostate cancer receiving androgen deprivation therapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with prostate cancer with at least 1 year of Androgen deprivation therapy treatment
* 65 years of age or older
* No speech and hearing problems

Exclusion Criteria:

* Presence of metastatic cancer focus
* Carrying a pacemaker
* Mental and coordination problems
* Patients with neurological or orthopedic pathology that would prevent participation in exercise
Clinical Outcomes of Treatment With Immunomodulator Plus Cancer Therapies for Patients With Colorectal Cancer

This study aims to evaluate the survival and treatment outcomes among colorectal cancer patients undergoing anti-cancer treatment, both with and without an immunomodulator.

Colorectal cancer (CRC) is the third most common cancer worldwide. The clinical outcomes from CRC treatments are often unsatisfactory for the majority of patients. The tumor microenvironment (TME) plays an important role to regulate tumor growth, progression, and metastasis and can limit the efficacy of cancer therapies. Therefore, targeting TME could provide an efficient approach for cancer treatment.

Astragalus Polysaccharide Injection, an immunomodulator, which can stimulate medullary hematopoiesis and enhance immune function. It also can modulate TME. Astragalus Polysaccharide Injection has been approved as a prescription drug for alleviating cancer-related fatigue by the Taiwan Food and Drug Administration (TFDA).

In this retrospective study, we will collect clinical data and survival status of colorectal cancer patients undergoing anti-cancer treatment from their medical records with and without immunomodulator, Astragalus polysaccharide Injection. It can be used to understand the possible clinical benefit of immunomodulator plus anti-cancer therapies for patients with colorectal cancer, and physicians can refer to these results to give patients the suitable treatment recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years and older.
* Patients who have been given a diagnosis of colorectal cancer.
* Patients had previously initiated anti-cancer therapies between January 1, 2020, and Apr 30, 2024.

Exclusion Criteria:

* None
Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database

Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted a specific funding from the European Union in the framework of the Horizon 2020 programme (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools to support decision making in health. Such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological data relevant for the creation of the composite indices.

The database will be used to answer the following specific objectives, with priority given to the two first ones (sepsis and maturation) :

1. Early diagnosis of sepsis for the following cases : Late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
2. Cardio-respiratory and neurobehavioral maturation (movements, sleeping cycles)
3. Influence of environmental factors and developmental care on selected parameters
4. Influence on care organisation of the possibility to access videos and movement analyses by medical teams
5. Influence of glycemia on selected parameters
6. Influence of neurological lesions and broncho-pulmonary dysplasia on selected parameters
7. Indices correlation with medical images MRI (T1, T2, diffusion, Arterial Spin Labelling) from neonatal units and with health evaluated after 1 and 2 years with the Ages \& Stages Questionnaires (ASQ)
8. Evaluation of the acquisition system's user-friendliness

Eligibility Criteria:
Inclusion Criteria:

* Newborn hospitalised in the neonatology services of participating hospitals
* One of the legal representatives gave its signed agreement to take part to the study
* New born aged of less than 6 weeks in corrected term

Exclusion Criteria:

* No signed agreement from the legal representative
Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome

The purpose of this study is to determine whether 7-valent pneumococcal conjugate vaccine safely induces immune responses and immunological memory in children with idiopathic nephrotic syndrome in remission.

Idiopathic nephrotic syndrome (INS) is the most frequent glomerular disease in children under 16 years old with incidence rate 2-7/100,000 patients/year depending on ethnicity. Those patients are susceptible to invasive pneumococcal disease (IPD) including peritonitis, pneumonia with or without pleural effusion and meningitis. Due to increased mortality and risk of relapses associated with IPD, it has been recommended that children with INS should be immunized with pneumococcal conjugate vaccine \[1\]. However, concerns on vaccine safety and impaired immunogenicity due to INS pathogenesis and immunosuppressive treatment are a hurdle for universal implementation of existing guidelines.

To thoroughly evaluate safety of 7-valent pneumococcal conjugate vaccine (PCV7) in children with INS in remission, we will investigate a possible association of vaccination with increased risk for recurrences of INS. We will also study immunogenicity and kinetics of immune response in INS patients and healthy subjects and the effect of different types of treatment on primary immune response and antibody persistence at 12-14 months following vaccination with PCV7.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Between 2-20 years of age

Exclusion Criteria:

* serious allergic reaction to previous vaccination
* history of invasive pneumococcal disease
* vaccination with pneumococcal conjugate vaccine
* vaccination with pneumococcal polysaccharide vaccine
* administration of intravenous immunoglobulin or other blood products during the last 3 months