cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis

The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS.

This is a open label, dose escalation, single-center study. One eye of each participant will receive a single IVB102 injection by intravitreal injection. Participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Must be willing and able to provide written, signed informed consent.
2. Male individual at least 8 years of age with clinical diagnosis of XLRS caused by mutations in RS1.
3. Best corrected visual acuity (BCVA) in the study eye of less than or equal to 63 (corresponding to a Snellen acuity of 20/63).
4. Must agree to use effective barrier (male or female condom) of contraception before dosing and continuing one year after gene transfer.

Exclusion Criteria:

1. Lens, cornea, or other media opacities in the study eye that preclude adequate visualization and testing of the retina.
2. Pre-existing eye conditions that would contribute significantly to visual loss or increase the risk of an intravitreal injection (e.g. DR、RVO or large retinal detachment).
3. Any intraocular surgery in the study eye within 6 months prior to screening.
4. Use of topical carbonic anhydrase inhibitors within 3 months prior to screening.
5. Use of anticoagulants or anti-platelet agents within 7 days prior to study agent administration.
6. Prior receipt of any AAV gene therapy product.
7. Use of any investigational agent within 3 months prior to screening.
Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies

This is an open-label, multi-center, dose-escalation, Phase I study to evaluate the safety, tolerability, and pharmacokinetics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with gemcitabine. The study is sponsored by AstraZeneca.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* ECOG performance status of 0 or 1
* Patient and tumor type must be suitable for treatment with weekly standard gemcitabine.

Exclusion Criteria:

* Inadequate bone marrow reserve, inadequate liver function or impaired renal function
* Any troponin elevation (above normal range)
* Stage II, III, or IV cardiac status, according to New York Heart Association (NYHA) classification; recent history (ie, within 6 months) of coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infarction \[MI\])
* Any prior anthracycline treatment
SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults

The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice in patients with persistent asthma


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma \< 3 months
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1

Exclusion Criteria:

* Smoking history \> 10 pack-years
* Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
* Any significant disease or disorder that my jeopardize the safety of the patient.

Additional inclusion and exclusion criteria will be evaluated by the investigator.
Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate

This study will investigate the effect of a single dose of PF-04308515 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* BMI 17.5 to 30.5 kg/m2 and total body weight \>50 kg

Exclusion Criteria:

* Fasting glucose above the limits of the reference range for healthy individuals
* "No treatment" OGTT indicative of impaired fasting glucose or impaired glucose tolerance
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
Preventative/Preemptive Adoptive Transfer of Peptide Stimulated CMV/EBV Specific T-cells in Patients After Allogeneic Stem Cell Transplantation

In patients after allogeneic stem cell transplantation reactivation of latent herpesviruses such as Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) is a frequent and life threatening complication requiring antiviral treatment. The underlying problem is a severe suppression of the donors immune system after transplantation into the patient. Herpesviruses such as CMV and EBV persist after primary infection life long in the host and therefore require constant immunological control. This control is largely provided by the T-cell compartment of the immune system. After allogeneic stem cell transplantation the T-cell compartment requires a long time for its reconstitution since only a small fraction of the donor T-cells are transplanted. During this time Herpesviruses can reoccur due to the lack of effective T-cell control.

This study therefore aims at reconstituting the T-cell compartment with CMV and EBV specific T-cells at an early time point after allogeneic stem cell transplantation. It is mainly a phase I study to demonstrate that these in vitro generated T-cells can be applied safely in this patient population. The study also aims at demonstrating the efficacy of CMV/EBV specific T-cells by monitoring viral reactivation and use of antiviral drugs. The hypothesis is, that CMV/EBV specific T-cell can be applied safely and do not result in graft versus host disease and that they successfully prevent reactivation of CMV and EBV after adoptive transfer in patients after allogeneic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Indication for allogeneic stem cell transplantation
* HLA identical donor, related or unrelated, 10/10 match
* Stem cell source: G-SCF mobilized peripheral blood stem cells
* Presence of at least one HLA allele: A0101, A0201, B0702, B0801, B3501, C0702
* Positive EBV serology of the donor
* Positive CMV serology of the donor
* Adequate contraception

Exclusion Criteria:

* Donor CMV seronegative
* Donor EBV seronegative
* Stem cell source: bone marrow or cord blood
* Alemtuzumab for conditioning
* Sorror Score \>3
* Pregnancy
Periprosthetic Fracture Registry (PPFx)

This registry supports international data collection and research on PPFx treatments after hip and knee arthroplasty.

A registry such as this ultimately aims to provide far-reaching benefits to society including reduced morbidity and mortality, improved patient safety, improved quality of care and medical decision-making, reduced medical spending, and advances in orthopaedic science.

To close the gap of missing clinical evidence regarding the treatment of periprosthetic fractures after arthroplasty of the hip or the knee with osteosynthesis.

To drive further study hypotheses and to answer unforeseen questions.

Main questions to be answered by the registry include (but are not exclusive) the following:

1. Influence of implants on outcome
2. Influence of surgical techniques on outcome
3. Influence of bone grafting on outcome
4. Identification of risk factors for failure
5. Identification of postoperative rehabilitation programs and its possible influence on the outcome
6. Influence of fracture type on outcome
7. To serve as a comparative dataset for future studies with improved implants and techniques

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years

  * Post-operative PPFx after total or hemi hip or total or unicondylar knee arthroplasty (including the acetabulum, femur, patella and proximal tibia) requiring

    * osteosynthesis alone or
    * component revision plus plate/nail osteosynthesis
  * Informed consent obtained, i.e.:

    * Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form
    * Signed and dated EC / IRB approved written informed consent
  * Ability to attend post-operative follow up visits

Exclusion Criteria:

* Pregnancy or women planning to conceive within the study period
* Prisoner
Evaluation of the Contribution of a DEMaterialized VIdeo-pedagogical SUpport in the Care Pathway of Lung Cancer Surgery Patients

Uni-centric, randomized, open-label, prospective interventional-comparative study, with a control arm (patients receiving standard preoperative information) and an experimental arm (patients receiving standard preoperative information and having access to a dematerialized educational video support).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or over,
* Patients requiring surgical management:

for therapeutic purposes (in the case of proven tumor histology) or for diagnostic and therapeutic purposes (in the absence of proven histology, but strong suspicion, after validation by RCP),

- Patients who have given their consent.

Exclusion Criteria:

* Patients under guardianship
* Patients with a history of thoracic surgery
* Patients on long-term analgesic medication
* Patients who do not speak French
* Patients unable to read or write
* Patients with major visual impairment
* Patients with chronic anxiety or depression at the time of admission
* Patients under guardianship
* Pregnant or breast-feeding women
Conservative Treatment in Patients with Supraspinatus Tendon Injury.

Rotator cuff injuries are a major cause of severe pain, often significantly impacting patients\&#39; sleep quality. For patients waiting for surgery or those not eligible for operative treatment, conservative treatment is recommended. In cases of minor injuries, physiotherapy is as effective as surgical intervention.

The aim of this study is: (1) to compare the speed, effectiveness, and durability of four implemented interventions in improving sleep quality, pain, and shoulder function, (2) to select the most optimal form of conservative treatment for patients with shoulder pain affecting sleep quality, and (3) to evaluate the expression of brain-derived neurotrophic factor (BDNF) and proBDNF (precursor) at the mRNA protein level before the planned intervention (T0), 1 month (T1), 3 months (T3), and 6 months (T6) after intervention.

The study results can assist physicians and physiotherapists in providing patients with therapy that not only relieves pain and improves function but also augments sleep quality, an aspect often overlooked in the literature yet greatly impacting patients\&#39; quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic partial incomplete thickness tear of the supraspinatus tendon, with a length below 1 cm and not exceeding 50% of the tendon thickness, confirmed by ultrasound examination.
2. Sleep disturbance symptoms for at least 1 month due to shoulder pain - PSQI score \> 5.
3. Shoulder pain disrupting the quality of sleep.
4. BMI \< 30.
5. Age 40-75.

Exclusion Criteria:

1. Other accompanying pain symptoms.
2. History of shoulder surgery.
3. Coexistence of psychiatric or neurological disorders.
4. Presence of comorbidities that may disrupt sleep.
5. Presence of risk factors impairing tissue regeneration and increasing the likelihood of injury progression - osteoporosis, diabetes, hypercholesterolemia.
6. Alcohol dependence, nicotine addiction, passive smoking.
7. Taking antibiotics from the fluoroquinolone group, sleep-affecting medications (such as melatonin, trazodone, zolpidem), antidepressants, antipsychotics, anxiolytics.
8. Lack of patient consent, lack of cooperation, or impaired verbal-logical communication.
Spectroscopy of Breast Tissue

RATIONALE: Diagnostic procedures, such as laser spectroscopy, may help find and diagnose breast cancer.

PURPOSE: This phase I trial is studying laser spectroscopy to see how well it works in diagnosing breast cancer in women with breast lesions.

OBJECTIVES:

Primary

* To determine whether laser spectroscopy of breast tissue performed ex vivo can effectively distinguish between benign and malignant breast tumors in women undergoing needle biopsy or surgical excision of a breast lesion identified clinically.

OUTLINE: Patients undergo tissue sample collection via needle biopsy or surgical excision of a breast lesion. A radiogram of the sample may be obtained to identify target areas for spectroscopic evaluation. The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy. After completion of the spectroscopic examination, the tissue samples are submitted for diagnostic pathologic evaluation. Hematoxylin and eosin stained sections of the tissue samples are examined by light microscopy for histopathological analysis. The results of the pathological examination are then compared with the spectroscopic findings and radiological findings (if the biopsy was performed for a suspect lesion on mammography) to determine if any correlation can be established and which spectroscopic technique provides the most useful diagnostic information. Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.

Patients' medical charts are reviewed to obtain clinical information (e.g., age, sex, and race; results of pathology reports and reports of ancillary studies, including estrogen receptor, progesterone receptor, and HER-2 receptor testing, for the surgical specimen being studied and for any other related surgical specimens; menstrual status and date of last menstrual period; clinical history of breast mass or abnormal mammogram and related mammography report; clinical history of hormone replacement therapy, birth control pills, or oophorectomy; and clinical history of chemotherapy or other adjuvant therapy for breast cancer).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Clinically identified breast lesion
* Planning to undergo needle biopsy or surgical excision of the breast lesion

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The Effects of Oxytocin on Affective Touch

The main aim of the study is to investigate whether intranasal oxytocin (24IU) increases the affective processing of touch in general or whether it's effect vary according to the affective valence of the touch (positive, neutral, negative). Moreover, associations with trait autism will be explored.

A double-blind, within-subject, placebo controlled design will be employed in this study. In a randomized-order a total of 40 healthy male subjects will receive oxytocin- and placebo-nasalspray (interval between the administration \> 2 weeks). 45 minutes after treatment subjects will be administered the touch-stimulation to the dorsal forearm by a trained experimenter (lengths: 8cm, rate 8cm/s). After each block of stimulation, the subjects will be asked to rate their subjective experience of the touch.The neural basis of touch processing will be measured via simultaneously acquired fMRI.

Levels of trait autism will be assessed using the Autism Spectrum Quotient (ASQ) and related scales such as the Empathy Quotient (EQ), Liebowitz Social Anxiety Scale (LSAS), or the Sensory over Responsivity Scale (SOR) and Under Responsively Scale (URS).

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

* History of brain injury Medical or mental illness
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).


Eligibility Criteria:
Inclusion Criteria:

* Must have completed the dosing planned in the primary pediatric guselkumab study
* Must have received benefit from continued guselkumab therapy in the opinion of the investigator
* Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure
* Parent(s) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate.

Exclusion Criteria:

* Participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication
* Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication
* Are pregnant, nursing, or planning pregnancy or fathering a child
* Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
Citrate Anticoagulation vs. Heparin-Coated Dialyzers

Hemodialysis causes contact activation of the coagulation pathway (1). For this reason, unfractionated or low molecular weight heparins are administered in daily practice to prevent thrombosis of the dialyzer and blood circuit, but the dose commonly used causes systemic anticoagulation. This can cause serious complications in patients with high risk of bleeding. Regional and low-dose heparinization, use of prostacycline, regional citrate anticoagulation (RCA), and high-flow-rate hemodialysis without anticoagulation have been shown to reduce bleeding complications. Each of these methods, however, is characterized by its own technical difficulties, limitations, or complications.

The present study aimed to compare the efficacy and safety of heparin-coated polyacrylonitrile membranes (AN69ST) and regional citrate anticoagulation in hemodialysis patients at risk of bleeding

1. Open label single centre prospective randomized trial including 33 patients aged over 18 years with chronic kidney disease stage 5 requiring intermittent hemodialysis at the University Hospital Leuven and at risk of bleeding. Exclusion criteria were: any haemostatic disorder favouring either bleeding or clotting, anti-vitamin K or heparin treatment, heparin induced thrombocytopenia and haemodynamic instability. Written informed consent before enrolment.
2. Random allocation (by sealed enveloppe) to RCA with a calcium free dialysate (RCA-Ca0), RCA with a calcium containing dialysate (RCA-Ca1,5) or to anticoagulant-free hemodiaysis with a heparin-coated polyacrylonitrile membrane (Nephral 300ST®).
3. At the end of each dialysis session, arterial and venous drip chambers and the filter will be inspected for visible signs of coagulation. Corresponding to the standard care at our dialysis unit, a semi-quantitative score with a range from 0 (no signs of clotting) to 4 (complete occlusion) will be used for evaluation of the dialyzer. By definition, the drip chamber will be considered clotted when a thrombus was visible after the rinse back procedure. A fibrin ring against the wall of the drip chamber will be considered normal.
4. Blood samples for assessment of prothrombin fragment F1+2 and d-dimers will be collected from the inlet blood catheter prior to hemodialysis initiation and during hemodialysis at T15, T120 and T238.

Eligibility Criteria:
Inclusion Criteria:

* aged over 18 years
* chronic kidney disease stage 5 requiring intermittent hemodialysis
* at risk of bleeding
* written informed consent

Exclusion Criteria:

* any haemostatic disorder favouring either bleeding or clotting
* anti-vitamin K or heparin treatment
* heparin induced thrombocytopenia
* haemodynamic instability
Sculptra Chart Review

Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been treated at the site with Sculptra Aesthetic in non-facial areas
* Subjects with available information about treatment dates and treatment procedures

Exclusion Criteria:

* Subject that have actively asked not to be involved in a study or registry
* Other conditions that in the Investigator's opinion would exclude the subject from participation ; the condition should be recorded.