cyrilzakka/clinical-trials huggingface dataset:
Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014

This is a non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls).

Investigators will explain the purpose of the study to the eligible patients, still alive, and will inform them verbally and in writing, using the information note, of their possibility of refusal. No information will be made for deceased patients.

The investigators will complete the case report forms on paper and then will send them by mail.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 or over
* Confirmed histological diagnosis of invasive breast cancer
* No known metastasis
* For the cases :

  * Patients pregnant at the time of the first diagnosis
  * 1st diagnosis between 2000 and 2014
* For the controls :

  * Patients not pregnant at the time of the first diagnosis
  * 1st diagnosis between 2000 and 2009

Exclusion Criteria:

* Patients who have undergone an induced abortion after the diagnosis of breast cancer
* Patients with a history of breast cancer
Zomig - Treatment of Acute Migraine Headache in Adolescents

The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures.
* Established diagnosis of migraine.
* History of a minimum of 2 migraine attacks (moderately or severely disabling)per month.

Exclusion Criteria:

* Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments.
* A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache.
* Have had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug.
A Study of Nilotinib Versus Imatinib in GIST Patients

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:

   * have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
   * recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
2. At least one measurable site of disease on CT/MRI scan
3. Performance status ≤ 2 (capable of self-care but unable to carry out any work)
4. Normal organ, electrolyte and marrow function

Exclusion Criteria:

1. Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
2. Disease progression during adjuvant therapy with imatinib
3. History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
4. Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply
Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment

This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension.

Idiopathic intracranial hypertension (IIH) is a condition characterized by elevated pressure within the skull for reasons that are not yet understood. This condition does not involve abnormalities in the cerebrospinal fluid or any structural brain damage. Individuals with this condition commonly experience persistent headaches, and some may face the potential of irreversible vision loss, significantly impacting their psychological well-being and overall quality of life. At present, the efficacy of medications like acetazolamide and topiramate in managing IIH is constrained by practical clinical constraints. Recent studies have indicated that glucagon-like peptide-1 receptor agonists show promise as a potential treatment option for IIH. Semaglutide, as a long-acting glucagon-like peptide-1 formulation, has a half-life of up to 160 hours and only needs to be injected once a week. It is easy to administer and has good safety and tolerability. Hence, the objective of this study is to investigate the effectiveness and safety of semaglutide in managing idiopathic intracranial hypertension, laying the groundwork for subsequent extensive, multicenter research endeavors.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 18 to 75 years old, both male and female.
* Confirmed definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria.
* Voluntarily sign a written informed consent form.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Currently using any hypoglycemic drugs, including glucagon like peptide-1 receptor agonists.
* Known to be allergic to the active ingredients or any excipients in Semaglutide.
* History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasias (MEN1/MEN2).
* Diabetes, ketoacidosis, severe gastrointestinal diseases, pancreatitis, severe heart failure.
* Vision loss caused by other diseases, such as diabetes retinopathy, iritis, cataract, etc.
* Malignant IIH with vision at risk necessitating surgical intervention.
* Unable to cooperate in completing imaging examinations.
* History of bariatric surgery or cerebrospinal fluid diversion.
* Have used any drugs known to increase intracranial pressure within the past 3 months (including vitamin A, tetracycline drugs, lithium, etc).
* Have participated in other clinical trials within the past 3 months, or did not withdraw from other clinical trials at the time of signing the informed consent form.
* Other situations determined by the researcher that may pose a threat to the patients' life safety or may have an impact on the study.
Addressing Patients' Expectations of Total Hip Arthroplasty in a Randomized Trial

The goals of this study are to develop and test an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty.

The first goal of this study is to develop an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty. The intervention will be structured according to the expectations listed in the Hospital for Special Surgery Total Hip Replacement Expectations Survey. The second goal is to test the intervention in a randomized trial. An additional goal is to compare patients' self-reported hip symptoms with radiographic findings.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for this study if they are 55 years of age or older and are scheduled for primary total hip arthroplasty at the Hospital for Special Surgery.

Exclusion Criteria:

* Patients will be excluded from this study for the following reasons: if they are not fluent in English; if they are not going to attend the preoperative hip replacement class; if they are unable to complete the surveys; if they refuse to participate.
Long-term Ophthalmic Outcomes in Ex-premature Infants

There is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely. This study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood.

Every year, around 18.000 children in the Netherlands are born prematurely, which means that they were born before 37 weeks gestational age. The WHO defines three different categories of prematurity: moderate to late preterm (32-37 weeks), very preterm (\<32-28 weeks), and extremely preterm (\<28 weeks). Preterm birth is associated with numerous health problems, which can have both short-term and long-term consequences on the development of the child. A relatively rare complication of (very or extreme) preterm birth is lifelong visual impairment or blindness due to retinal detachment as a result of prematurity retinopathy (ROP). ROP is a vasoproliferative condition that affects the vessels in the retina. An inventory study shows that 305 children were diagnosed with ROP in the Netherlands in 2017. The majority of these children experienced spontaneous regression of the condition, but 13% of cases required treatment to prevent retinal detachment. In the long-term, ROP predisposes for ocular conditions such as visual field abnormalities, refractive error, strabismus, amblyopia, glaucoma and retinal detachment. However, research also indicates that prematurity, regardless of ROP diagnosis, can also be associated with adverse ophthalmological outcomes such as refractive error, strabismus, amblyopia and cerebral visual impairment (CVI). Although there are various publications on the ophthalmological outcomes of ROP and prematurity at school-age, less is known about these outcomes in the adult population. This study aims to investigate the anatomy and functionality of the eye in ex-premature infants who were born between 1991 and 2006. In addition, the differences in outcomes between ex-premature infants with and without ROP, and the differences in outcomes between treated and spontaneously regressed ROP, will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible for ROP screening, and admitted to Erasmus MC between 1991 and 2007.

Exclusion Criteria:

* Subjects born after 2008,
* Subject has passed away before the start of the study
* Subject resides outside of the Netherlands
* Subject has a physical or mental disability that makes it impossible to participate in a routine eye exam, or has a disability that classifies the subject as an incapacitated adult.
A Phase IV Study of Elunate® (Fruquintinib) in Chinese Patients

A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients

This study is a prospective, open-label, multi-center, study design to obtain the safety information of participant after medication. The follow-up time points for each participant include first time signing the informed consent form,1 month after signing the informed consent form, 6 months after signing the informed consent form or 30 days after the last dose (whichever occurs first).

Eligibility Criteria:
Inclusion Criteria:

* Currently using Elunate®(Fruquintinib) or will use Elunate®(Fruquintinib) within a week;
* Provision of informed consent by the patient.

Exclusion Criteria:

• Unsuitable for the study according to investigator's judgement.
Self-Reports of Executive Functions in Persons With Parkinson's Disease and Their Significant Others

The investigators are conducting a study to compare the self-reports of executive functions (that is to say, what role cognitive processes such as working memory and attention) in persons with Parkinson's Disease to the reports of executive functions completed by their significant others.

To conduct this study, the investigators need the participation of persons who are diagnosed with Parkinson's Disease and their significant others.

The purpose of this study is to explore the relationship between the self-reported executive functions (EFs) in persons with Parkinsons disease (PD) and their significant others. Executive functions include basic cognitive processes such as attention, inhibition, working memory, and cognitive flexibility. As this proposed study will test not only cognitive functioning, but specific aspects of it (i.e., EFs) without excluding persons with PD who have identified cognitive impairments, outcomes gathered could provide valuable information to better assist all types of persons with PD. Comparing their self-reported EFs to the EF ratings completedy by their signifiant others can help determine if a disparity exists between self-perceptions and actual observed EF abilties. This study would assess EFs through inhibition responses of participants via computerized versions the Comprehensive Executive Function Inventory-Adult Self-Report and Observer forms.

Eligibility Criteria:
Inclusion Criteria:

* For persons with PD,confirmed diagnosis of PD) For significant others - relationship with person with PD

Exclusion Criteria:All participants will be screened to ensure they do not have:

* any known cognitive disorders other than those associated with PD
* impairments in vision that would affect their ability to safely participate in the study
* recent history of neuromuscular injury/ damage that could affect their ability to complete the CEFI
* the participant will be excluded if he or she is unable to follow commands well enough to complete the CEFI
Spectral Domain Optical Coherence Tomography Analysis for Glaucoma

The aim of this study is to examine whether there is a difference in macular ganglion cell complex thickness and retinal nerve fiber layer thickness in early-stage Primary open angle glaucoma and normal tension glaucoma with spectral domain OCT.

Glaucoma is a progressive optic neuropathy characterized by gradual degeneration of neuronal tissue in which retinal ganglion cells (RGCs) are injured, leading to the loss of the visual field.Recent studies have separately demonstrated a reduction in the macular retinal thickness and in the retinal nerve fibers in both POAG and NTG.It has been demonstrated that in early stage NTG macular GCC thickness showed a strong correlation with thickness of the RNFL. However there have yet to be any reports regarding the comparison of macular thickness, ganglion cell complex and retinal nerve fiber layer between POAG and NTG with RS-3000 RetinaScan at early stage.

Eligibility Criteria:
Inclusion Criteria:

The POAG group inclusion criteria were;

* IOP higher than 21 mmHg before treatment on three different visits,
* Best corrected VA of 20/25 or better with a spherical equivalent within ±5 D and a cylinder correction within +3 D;
* An open angle confirmed by gonioscopy.
* Glaucomatous optic disc damage defined as by the presence of glaucomatous optic neuropathy like rim thinning (diffuse or local), cupping, notching, and a cup/disc ratio \>0.2 with asymmetry.

NTG group were included if;

• They had the same optic disc and visual field criteria as for the POAG patients with the exception that their IOP was as ≤21 mmHg on three separate visits without any glaucomatous treatment.

The control group

* Who had no ocular disease
* Who had not undergone ocular surgery or laser procedures.
* With a normal anterior segment, open angles, and normal posterior segment findings also normal optic nerve head appearance in their ophthalmic examination.
* The IOP measurements were lower than 21 mmHg, and full-threshold 30-2 HFA were also within normal limits in the control group.

Exclusion Criteria:

* Subjects with any retinal disease, diabetes mellitus, or neurological disease or who had undergone ocular surgery and laser procedures.
* Subjects with pseudoexfoliation glaucoma and pigmentary glaucoma were excluded.
Development of an Intranasal Proteosome Influenza Vaccine

A study to compare multiple dosage regimes of a protesomal intranasal vaccine.

A Proteosome-adjuvanted trivalent inactivated influenza vaccine (P-TIV) administered intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both systemic and mucosal compartments - and effective at preventing influenza illness.

In two separate studies using the Human Viral Challenge Model, subjects were selected for susceptibility to A/Panama/2007/1999 (H3N2) virus and then dosed with one of three regimens: (A/New Caledonia/20/1999 (H1N1), A/Panama/2007/1999 (H3N2), B/Victoria/504/2000 or B/Shangdong/7/1997) or placebo via a nasal spray. One or two doses were given, 14 days apart, before subjects were challenged with \~8.5 x 105 EID¬50 of A/Panama/2007/1999 (H3N2) virus. Immune responses to the vaccine antigens were measured, namely serum IgG (via the aemagglutination inhibition assay (HAI)) and nasal wash secretory IgA (sIgA) antibodies (via ELISA). Viral titres in nasal washes and symptoms of influenza illness were assessed after viral challenge and compared.

Eligibility Criteria:
Inclusion Criteria:

* Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
* Female subjects were required to provide of a history of reliable contraceptive practice.
* Susceptibility to A/Panama/2007/1999 (H3N2) (a serum reciprocal HAI titre ≤10) was confirmed at screening. -

Exclusion Criteria:included;

* asthma,
* hypersensitivity to mercurials or chicken eggs,
* anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, \* chronic nasopharyngeal complaints,
* abnormal electrocardiogram (ECG),
* febrile illness or significant symptoms of upper respiratory infection on the day of vaccination or between admission to quarantine and administration of the challenge inoculum.
* Subjects using medication or other products for rhinitis or nasal congestion,
* Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start.
* Subjects agreed not to smoke during the quarantine phase.
MK0457 in Patients With Leukemia (0457-003)

In this study participants with relapsed/refractory leukemia will be given MK-0457 in sequential cohorts and with varying treatment duration to determine the maximum tolerated dose (MTD) for MK-0457.


Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Patients with relapsed/refractory acute myelogenous leukemia (AML), poor risk myelodysplastic syndrome (MDS), B-cell acute lymphocytic leukemia (ALL), myeloproliferative diseases, or chronic myelogenous leukemia (CML) in blast crisis

Part 2:

* Acute myelogenous leukemia (with FLT-3 mutation ), and myeloproliferative diseases only
* At least 2 weeks since the last cytotoxic therapy
* Acceptable renal and hepatic function
* Ambulatory, capable of all self-care, and out of bed for more than 50% of waking hours
* More than 2 months since autologous bone marrow or peripheral blood stem cell transplantation

Exclusion Criteria:

* Not fully recovered from previous anti-leukemia therapy
* Previous allogeneic bone marrow transplant
* Uncontrolled congestive heart failure
* Myocardial infarction within the last 3 months
* Active or uncontrolled infection
* Pregnancy or lactation
* Currently active second malignancy, other than non-melanoma skin cancer
* History of hepatitis B or C, known HIV positivity, or AIDS related illness
Quality of Vision and Quality of Life With LASIK

The investigators are administering a validated questionnaire looking at patient reported quality of life and quality of vision after LASIK surgery

The purpose of the study is to evaluate the prevalence of any functional limitations and their associated factors at one, three, six, and twelve months after LASIK surgery and finally the level of patient satisfaction, including the prevalence of any dissatisfaction and its associated factors at one, three, six and twelve months following LASIK surgery using two questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Are aged 21 years or older.
* Have the ability to give informed consent.
* Speak and read English fluently.
* Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.
* May benefit from increased spectacle independence.
* Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations.
* Have a treatment target of bilateral emmetropia.
* Express willingness and potential ability to return for all follow-up examinations through the 12-month follow-up exam under the care of the treating investigator.
* Are not enrolled in any other research study.

Exclusion Criteria:

* Subjects under the age of 21.
* Patients with excessively thin corneas.
* Patients with topographic evidence of keratoconus.
* Patients with ectactic eye disorders.
* Patients with autoimmune diseases.
* Patients who are pregnant or nursing.
Inventory of Inappropriate Prescriptions of Proton Pump Inhibitors (PPIs) in People Over 75 Years of Age

This study would have as a starting point the results of a request carried out by the Medical Service Grand Est of the Health Insurance aiming to evaluate the number of boxes of PPI reimbursed in town pharmacy, in patients over 75 years old in the Grand Est of France from 01/01/2018 to 31/12/2018.

It aims to highlight and quantify a possible inappropriate use of PPIs in private practice.


Eligibility Criteria:
Inclusion criteria:

* Patient over 75 years of age
* Patient with a PPI in the initial prescription
* Patient seen at least once between 01/01/2018 and 31/11/2019 in the general practice
* Patient who has not expressed his opposition, after information, to the reuse of his data for the purpose of this research.

Exclusion criteria:

* Patient having expressed his opposition to participate in the study
* Impossibility to give the patient informed information (difficulties in understanding the subject, ...)
* Patient under legal protection
* Patient under guardianship or curatorship
* Patient who is no longer followed up in the office following an entry into an institution (EHPAD)