cyrilzakka/clinical-trials huggingface dataset:
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR/CRh rate in these subjects.

Subjects who are at least 18 years and above at the time of signing informed consent may participate in this study. Subjects will be randomized in a 2:1 ratio to receive Clifutinib or salvage chemotherapy. Subjects will enter the screening period up to 28 days prior to the start of treatment. Prior to randomization, a salvage chemotherapy regimen will be pre-selected for each subjects; options will include low-dose cytarabine (LoDAC), azacitidine, decitabine, Ara-C±IDA or FLAG±IDA. The randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy. Participants will be administered treatment over continuous 28-day cycles.

After treatment discontinuation, participants will have a end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety. After that, long term follow-up will be done every 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age at the time of obtaining informed consent.
* Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification;
* Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant )
* Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion

Exclusion Criteria:

* Subject has received prior treatment with other FLT3 inhibitors
* Subject has AML that has relapsed after or is refractory to more than 1 line of therapy
* Subject has an active uncontrolled infection
* Subject is known to have human immunodeficiency virus infection
* Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation
Optimal Timing of Misoprostol Administration Prior to Office Hysteroscopy

The aim of this study was to determine whether misoprostol administered 12 hours before office hysteroscopy can relieve pain more effectively compared with misoprostol administered 3 hours before office hysteroscopy.

The interval between misoprostol administration and office hysteroscopy may have an influence on its effectiveness in pain reduction. There are limited data on the optimal interval from administration of misoprostol and office hysteroscopy. In previous studies, time interval from administration of misoprostol and office hysteroscopy ranged between 2 hours and 24 hours.

Till now no studies have yet investigated the optimal timing of misoprostol administration prior to office hysteroscopy or operative hysteroscopy. The aim of this study was to determine whether misoprostol administered 12 hours before office hysteroscopy can relieve pain more effectively compared with misoprostol administered 3 hours before office hysteroscopy

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous patients who have an indication for office hysteroscopy

Exclusion Criteria:

* Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, acute pelvic inflammatory disease, glaucoma, allergy to misoprostol, cardiac, liver or kidney diseases
The Health-Related Quality of Life in Patients With Hereditary Multiple Exostoses

The purpose of this study is to assess the health-related quality of life of subjects who have Hereditary Multiple Exostoses and to develop a disease specific quality of life survey. The investigators hypothesize that there are a wide range of quality of life experiences for patients with this syndrome.

At the time of recruitment, subjects will be asked to indicate whether they would like to participate in a one-time survey, or are willing to participate in the initial survey plus two additional questionnaire administrations, thereafter, which will be used to develop the disease-specific quality of life (QOL) score. All participants will complete either the SF-36 survey (for adult HME subjects) or the CHQ PF (for parents of children with HME), as applicable, in addition to a blank form with categorical subheadings (such as recreation, social function, etc.), which they will use to address any issues not covered in the standardized questionnaire. Standardized questionnaires will be scored and analyzed. The items listed on the second form will be compiled and reapplied to subjects that indicated interest in extended participation in survey completion. Subjects will be asked to determine which items apply to them and to rank these applicable items in order of importance. The results from this will be used to develop a 30 question, disease-specific questionnaire. The final step will be to readminister this survey, in conjunction with the SF-36 or CHQ PF, and follow up, in two weeks, with a second administration of the aforementioned surveys, in order to test the variability and validity of the disease-specific, health-related, quality of life score.

Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with Hereditary Multiple Exostoses
* Adult patients or parents of child patients
Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in etched dentin on the retention of noncarious cervical lesions restorations.

A randomized controlled split-mouth and blind trial will be carried out. Patients with at least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned according the type of teeth (incisors, canine or pre-molars) into two groups: control or experimental group (application of 2% CRX for 60 seconds after the acid etching procedure). Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture instructions, by previously trained operators. The restorations will be evaluated by a calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World Dental Federation (FDI) criteria. The outcome is retention of the restoration.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting at least two non-carious cervical lesions (NCL) in anterior, canine or pre-molars;
* Patients who had more than 20 teeth in the mouth;
* Patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent;
* NCL with at least 1 mm of depth in a vital permanent incisor, canine or premolar of the upper as the lower jaw.
* NCL in the facial surface of the teeth with sometimes a small part extending interproximally;
* Patients with good periodontal heath.

Exclusion Criteria:

* Patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (Angle Class II or Class III);
* Tooth with the NCL with the absent of antagonist;
* NCL wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition;
* Presence of caries or restorations in the area to be treated;
* Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing;
* Unwillingness to return for follow-ups or refuse to participate.
Comparison Between TICL and ICL+AK for High Myopic Astigmatism

To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high myopic astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* age ranged from 18 to 40 years,
* myopia greater than -8.00 diopters (D), and refractive cylinder in the range of 1.50D to 5.50D,
* for the patients who were planned to undergo AK+ICL implantation, the axial difference between the corneal astigmatism and the manifest refractive astigmatism was less than 10 degree,
* a stable refractive error during the previous 2 years,
* anterior chamber depth more than 2.8 mm,
* endothelial cell density (ECD) more than 2500 cells/mm2, and
* scotopic pupillary diameter less than 7 mm.

Exclusion Criteria:

* subjects had significant irregular astigmatism, corneal pathological changes, glaucoma, ocular inflammation, or previous ocular trauma or surgery.
A Study of FZ-AD005 in Patients With Advanced Solid Tumors

A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients able to give written informed consent;
2. Age ≥ 18 and ≤ 75 years old, male or female;
3. Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC);
4. Willingness to provide tumor tissue for testing ;
5. Have measurable lesions defined in RECIST v. 1.1;
6. Expected survival ≥ 3 months;
7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
8. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.

Exclusion Criteria:

1. Patients who have had previous treatment with any anti-DLL3 antibody；
2. Have had other malignant tumors in the past 5 years;
3. Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
4. Have active CNS (central nervous system) metastasis；
5. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
6. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
7. Patients have psychiatric history;
8. Female patients who are breastfeeding or pregnant;
9. Other reasons that researchers believe are inappropriate to participate in this study.
Family Experiences After International Adoption

The purpose of this study is to determine the types of experiences faced by families in France who have adopted a child internationally. In addition, internationally adopted adolescents are invited to respond to questions about their own personal experiences.

Microaggressions, or "unintended discrimination" related to adoption have been widely investigated in the USA. These microaggressions may relate to both adoptive status and country of origin, or both. However, the prevalence and qualitative characteristics of these events have been seldom studied in other countries. Differences in cultural norms and practices among countries might influence the type and frequency of microaggressions experienced by adopted children and their families. Brief anonymous questionnaires devised to elicit personal experiences related to microaggressions will be distributed by 4 clinical services serving this population (3 pediatric, 1 child psychiatric) and by 2 large adoptive family support networks to adoptive parents in France. Frequencies and relations between experience of micro-aggressions and other variables will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

Parents :

1. Parents of an internationally adopted child, whose placement occurred at least 6 months ago
2. Willing and able to complete a questionnaire

Adolescents :

1. Internationally adopted adolescents who were placed at least 6 months ago
2. Willing and able to complete a questionnaire

Exclusion Criteria:

Parents :

1. Unwilling or unable to complete the questionnaire

Adolescents :

1. Parents are unwilling for child to participate
2. Child is unwilling to participate
3. Unable to understand the questions
Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP

This research is conducted to compare the remineralization efficacy of eggshell powder gel and CPP-ACP (MI paste) on post-orthodontic white spot lesions.


Eligibility Criteria:
Inclusion Criteria:

* A patient who has just completed a comprehensive orthodontic treatment.
* Presence of at least one WSL, DIAGNOdent score (0-20).
* Age range between 13 and 35years.

Exclusion Criteria:

* Patients are unable to return for recall appointments.
* High caries risk.
* Have plaque accumulation and a periodontal problem
* In progress treatment of chronic disease.
* Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
* Presence of dentin caries, enamel hypoplasia or restorations on maxillary anterior teeth.
Drone Biological Samples Transport vs Walking (DBT - Drone Biology Transport)

The transport of biological samples is a key step in the pre-analysis process in health facilities and must meet quality requirements (NF:EN:ISO 151989) to ensure that samples are transported in are transported in good conditions.

Still in the experimental stage, drone-based air transport is participating in the aeronautical revolution of the development of unmanned aircraft on board in all areas of society, including health.

This first project, led by the Biology Centre and the INNOVABIO Biological Resources Centre of the CHU de CAEN in collaboration with the company Delivrone, will allow to evaluate the feasibility in real condition of the mode of transport by drone versus transport of reference on the quality of a varied panel of medical biology examinations (biochemistry, hematology and haemostasis), on the safety of people (potentially infectious samples), on the control of the delivery time, on the control of the transport temperature (15-25°C ). The samples will be taken on 30 healthy volunteers with a total panel of 23 blood tests performed.

Panel of blood tests performed on healthy volunteers samples include :

* Na, K, Cl, HC03-
* total protein
* Ca
* Creatinine, urea
* Albumine
* Bilirubin
* Liver transaminases (ALT, AST)
* Alkaline phosphatase
* GGT
* LDH
* C-reactive protein
* Complete Blood Count
* Sedimentation rate
* PT
* aPTT
* Fibrinogen
* D-Dimer

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, over 18 years old

Exclusion Criteria:

* Unhealthy volunteers previously known
* pregnant or breastfeeding woman
A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion

The purpose of this study is to determine whether a fluocinolone sustained drug delivery implant is effective in the treatment of central retinal vein occlusion that has caused persistent macular edema and decreased visual acuity.

Currently there is limited treatment for macular edema and vision loss due to central retinal vein occlusion. Case reports have shown some benefit of intravitreal steroid injections in improving vision and reducing macular edema in eyes with retinal vein occlusions.

Recently, a sustained drug release steroid implant has been investigated and FDA approved to treat macular edema in patients with non-infectious uveitis, eye inflammation. This implant is placed through an incision in the eye wall and is designed to deliver a steroid, fluocinolone acetonide, for up to three years. In animal studies there was no detectable steroid seen in the blood stream.

This pilot trial will recruit individuals who have had a central retinal vein occlusion in at least one eye. If the macular edema and vision improves with an initial intravitreal injection, the eye will be considered to receive the sustained drug release device. The dosage of fluocinolone acetonide used is 0.59 mg.

Eligibility Criteria:
Inclusion Criteria:

Patients are eligible to receive an implant if they met all the following criteria:

* A history of central retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and optical coherence tomography (OCT)
* Macular edema at least one disc area in size that involved the fovea
* Males and non-pregnant females at least 18 years of age
* Intraocular Pressure (IOP) controlled at \< 21 mmHg with no more than one topical ocular antihypertensive agent
* Ability and willingness to comply with treatment and follow up process and to understand and sign the informed consent form.
* Initially, patients with central retinal vein occlusion were not required to have previous therapy. However, the protocol was subsequently modified to require an intravitreal injection of triamcinolone acetonide \> 12 weeks prior to study entry, with an initial decrease in macular edema and improvement in visual acuity and subsequent decline in visual acuity accompanied by increased macular edema. This modification was added to avoid enrolling patients who might have had a long-lasting response to a single intravitreal triamcinolone acetonide injection.

Exclusion Criteria:

* Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status.
* Patents with disciform scars of the fovea or atrophic changes of the macula that in the investigator's opinion would preclude benefit from treatment are excluded from the study.
* Female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.
Infrared Photomodulation Therapy for Seasonal Affective Disorder

During winter months in northern latitudes use of Joovv device on self-reported non-clinical mental health (aka mood), sleep and energy levels. Participants will also submit Withings and Oura activity and sleep data.


Eligibility Criteria:
Inclusion Criteria:

* history of mental health issues including clinical depression
* US based
* reasonably active individuals (self report run/gym 3x per week or more)

Exclusion Criteria:

* average daily high temperature in zipcode above 60 degrees through end of March
Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older

To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.

LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older, female
* Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
* Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
* English speaking
* IRB approved, signed written informed consent
* Approval from their treating physician to engage in moderate-intensity physical activity
* Patient-assessed ability to walk and engage in moderate physical activity
* Willing and able to meet all study requirements.

Exclusion Criteria:

- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
Linagliptin and Mesenchymal Stem Cells: A Pilot Study

The purpose of the present study is to gather pilot data on the effects of linagliptin on the concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in humans, and to demonstrate the feasibility of such a study in patients with psychosis in our setting.

This study is a 13-week, open-label study of 8 participants with schizophrenia and minimal thought disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. The principal outcome measures will be the concentrations of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in blood.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM (Diagnostic and Statistical Manual) criteria for schizophrenia.
* Considered clinically stable, and on the same dose of antipsychotic for two weeks.
* A score no greater than 3 on the PANSS (Positive and Negative Syndrome Scale) Conceptual Disorganization item.
* Not taking any medications for diabetes, or any anti-inflammatories other than occasional aspirin or acetaminophen. Not taking Clozapine.
* Age 18-45 years.
* Can be available for regular morning appointments from 8:00 am to 10:00 am, preferably on Tuesdays, Wednesdays and Thursdays.

Exclusion Criteria:

* Does not meet DSM criteria for substance abuse or dependence.
* No serious current general medical condition, such as cancer, history of stroke or myocardial infarction, tuberculosis, HIV/AIDS, hemophilia, etc.
Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.

* Patients will be randomized into 2 groups. At the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo.
* Zometa is administered intravenously over a 15 minute prior once in this one year study.
* All patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.
* All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. At month 12, a bone mineral density test will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate
* Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months
* Corrected serum calcium \> 8.4mg/dl and \< 10.6mg/dl
* Serum creatinine \< 2.0mg/dl

Exclusion Criteria:

* History of bone metastases by bone scan
* Treatment with bisphosphonate within one year
* History of metabolic disease
* Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year