cyrilzakka/clinical-trials huggingface dataset:
Karolinska Interventional Study of Mammograhic Density (Karisma-1)

A feasibility study, randomising to either 10 or 20 mg of tamoxifen. The primary aim is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim is to evaluate if there is a density change from 10 mg of tamoxifen equivalent to 20 mg.

The investigators want to conduct a feasibility study including 42 women who will be randomised to either 10 or 20 mg of daily oral tamoxifen. The primary aim of the study is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of daily tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim of the pilot study is to see if there is a density change from 10 mg of tamoxifen equivalent to 20 mg and if there is a difference in adverse reactions between the two doses. Interim analysis will be performed at 6 months, monitoring both safety and level of mammographic density change.

Eligibility Criteria:
Inclusion Criteria:

* Previously participated in the Karma study
* Attending the national mammography screening program, i.e. aged 40-74
* A mammogram, including a stored raw image, must have been taken within 3 weeks of baseline and start of therapy
* Having a mammographic volumetric density above the lowest 1/6, measured by Volpara
* Informed consent must be signed before any study specific assessments have been performed

Exclusion Criteria:

* Being pregnant or planning to become pregnant during the study
* Any previous or current diagnosis of breast cancer (including carcinoma in situ)
* Recalled (mammographic code 3 or above) after baseline screening mammography
* Any previous diagnosis of cancer, with the exception of non-melanoma skin cancer and in situ cancer of the cervix
* Currently using oestrogen and progesterone-based hormone replacement therapy
* Current use of hormone contraceptive with hormones, e.g. hormonal contraceptive pills, or progesterone implants. Hormonal intrauterine devices are accepted.
* A history of thromboembolic disease such as embolism, deep vein thrombosis, stroke, TIA or cardiac arrest.
* A history of immobilization, e.g. using wheelchair
* Uncontrolled diabetes defined as known untreated diabetes
* Hypertension at baseline, defined as systolic pressure higher than 140 mm Hg and diastolic higher than 90 mm Hg
* Use of drugs that interfere with CYP2D6 expression such as paroxetine, fluoxetine and bupropion
Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR

In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.


Eligibility Criteria:
Inclusion Criteria:

* Presence of PDR with the indication of full PRP according the intend of investigator
* Best corrected visual acuity of 20/320 or better
* Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT

Exclusion Criteria:

* History of prior PRP with more than 100 burns outside the posterior pole
* Tractional retinal detachment involving the macula
* Evidence of neoplasia of angle on examination
* Macular edema due to a cause other than DME
* Any ocular condition which may change visual acuity during the study
* Substantial cataract which has declined the vision by 3 lines or more
* History of intravitreal injection of anti-VEGF agent in past 2 months
* History of any use of corticosteroid during past 4 months
* History of major intra-ocular surgery except cataract surgery
* History of YAG laser capsulotomy during past 2 months
* Aphakia and uncontrolled glaucoma according to investigator judgment
Scalar Localization Cochlear Electrode Array Using 64 Slice CT

Insertion of electrode array in scala vestibuli, rather than the preferred location within scala tympani, leads to loss of native hearing in those patients with isolated high-frequency hearing loss undergoing cochlear implantation.

We aim to determine the surgical placement in patients with high frequency who had long electrode array insertions because they did not meet audiometric criteria for short array devices.

From this basis we will be able to determine if suboptimal insertion (e.g., in the scala vestibuli) leads to loss of low-frequency hearing in these patients. We also will look at the possibilities of using this data in predicting outcomes, modifying implant design, and perfecting surgical technique.

Eligibility Criteria:
Inclusion Criteria:

* Registered in the Cochlear Implant Database.
* Patient has short or long electrode cochlear implant for high frequency hearing loss.

Exclusion Criteria:

* Inability to provide consent.
* Patients with underlying otospongiosis, extensive labyrinthitis ossificans or cochlear dysplasia. (These patients would have been identified with pre-operative imaging prior to cochlear implantation).
To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer

This project proposes to elucidate the functional impact of T cells in cancer progression and treatment through a comprehensive TCR profiling study and a longitudinal cohort study in patients with advanced epithelial ovarian cancer. Our findings aim to provide clinical insights for monitoring treatment response in a non-invasive way and demonstrate the association of TCR diversity with clinical outcomes and the potential role of TCR profiling in cancer prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with advanced EOC, 18-75 years of age: including patients with preoperative assessment of stage III-IV EOC, who underwent initial tumour cytoreduction and 6-8 courses of postoperative chemotherapy with paclitaxel + carboplatin/docetaxel + carboplatin;
* Eastern Cooperative Oncology Group (ECOG) physical strength status (PS) score of 0 or 1;
* Cooperation in the treatment process by providing clinicopathological data and imaging data required for the study process;
* Cooperate with follow-up visits and collection of node blood for clinical efficacy assessment, and agree to use the test data for subsequent research and product development.
* The initial and follow-up treatment processes are in accordance with NCCN guidelines;

Exclusion Criteria:

* Neoadjuvant chemotherapy patients;
* Splenectomy patients;
* Patients with contraindications to radiotherapy;
* Any other patients who, in the judgement of the investigator, may have poor compliance with the procedures and requirements of the study;
* Unacceptable or unavailable means of assessing specified efficacy such as imaging;
* Vaccination within 2 months; antibiotics for infection within 2 weeks; history of blood transfusion within 2 weeks;
* Long-term use of recombinant human erythropoietin, recombinant human interleukin, Ricodin tablets and other drugs affecting the composition of blood cells;
* Severe organ dysfunction;
* Infectious diseases such as immunodeficiency syndrome, active tuberculosis, HIV infection, and other infectious diseases not suitable for participation;
* Pre-cancerous diseases of the blood, such as myelodysplastic syndromes;
* Have received immunosuppressive therapy within 2 weeks;
* Suffering from blood clotting disorders.
Position and Communication Skills Simulation

The goal of this study was to compare two different simulation applications in developing the positioning skill, one of the most common nursing practices, and the communication skill, which forms the basis of nursing practices.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* First-year nursing students
* Not have training in simulation

Exclusion Criteria:

* Not meeting the inclusion criteria
the Effect of Opioid-free General Anesthesia

This study is performed to investigate the effect of opioid-free general anesthesia on the recovery quality after gynecological laparoscopy.

The quality of recovery after the surgery is assessed using the QoR 40. In addition, the various kinds of cytokine are assessed for the ancillary study.

Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for gynecological laparoscopic surgery

Exclusion Criteria:

1. refusal to participate in this study
2. emergent surgery
3. chronic pain requiring for pain killer
4. psychiatric disease
5. preoperative bradycardia or hypotension
6. allergy or history of the adverse effect to study drug
7. pregnancy or lactation
Hemorrhoid Radiofrequency

Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Among these techniques, radiofrequency is one of the most recent and is gradually gaining ground. It involves applying a radiofrequency current to the internal haemorrhoidal tissue in order to induce its involution.

The literature has shown that this technique leads to symptomatic improvement in over 60% of cases and a high satisfaction rate, even though some patients still seem to have haemorrhoidal symptoms postoperatively.

The aim of this study is to evaluate the efficacy of this technique in patients with haemorrhoidal pathology operated on at our centre, using "hard" criteria which are thought to be more rigorous ("cure" rather than "improvement").


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Presence of haemorrhoidal pathology
* Patient operated on between March 2017 and March 2023, using the radiofrequency technique
* French-speaking patient

Exclusion Criteria:

* ano-perineal involvement in Crohn's disease
* perianal fistula
* non-quiescent IBD
* radiation-induced rectitis
* psychiatric pathology.
* under guardianship or curatorship
* deprived of liberty
* under court protection
* Patient objecting to the use of his/her data for this research
Deep Brain Stimulation (DBS) Retrospective Outcomes Study

The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

The purpose of this study is to characterize

1. real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Eligibility Criteria:
Inclusion Criteria:

* Must be previously treated with or eligible for implantation with a deep brain stimulation system

Exclusion Criteria:

* No Exclusion Criteria
Different Implant Positions for Implant Retained Mandibular Overdenture

This study will aim to evaluate the effect of two different implant positions, lateral incisors, and canine areas, on anterior and posterior ridge resorption and bone remodeling after different periods of denture insertion.

Twelve patients will be recruited from a previous study (14), having two-implant mandibular overdentures. Patients recalled from the database set of the clinic of the Removable Prosthodontic Department, Faculty of Dentistry, Mansoura University. The patients will be grouped based on the position of the two implants.

All patients will be informed about all prosthetic procedures that will be done. Also, they will sign the consent form of the ethical committee of the faculty of dentistry, at Mansoura University.

All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will excluded from the study Patients will be divided into two groups Group A (6 patients): Patients having two mandibular implants in lateral incisor positions.

Group B (6 patients): Patients having two mandibular implants in canine positions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mandibular two implants retained overdenture opposing complete edentulous maxillary arch,
* attended the previous follow-up recalls with previous CBCT examination.

Exclusion Criteria:

* Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.
FLuticasone in cOvid Treatment (FLOT)

A multicenter, open-label, randomized controlled trial to evaluate the efficacy of fluticasone propionate (metered dose inhaler - MDI) added to standard care at early stage of COVID-19 in reducing the incidence of adverse outcomes (any of those following: oxygen therapy, systemic corticosteroids, hospitalization, mechanical ventilation, and mortality) in symptomatic patients either from 18 to 49 years of age with risk factors or older than 50 years.

This study has 2 arms: the standard care group followed the COVID-19 guidelines of the Ministry of Health of Vietnam and the interventional group: Fluticasone propionate MDI with spacer, twice a day for 14 days.

The study participants will be monitored via video call from day 1 to day 14, day 21, and day 28 after randomized.

Eligibility Criteria:
Inclusion Criteria:

1. Signing consent to participate in the study
2. Having COVID related-symptoms within 5 days prior to randomization
3. Confirmed diagnosis of COVID-19 by rapid antigen test or polymerase chain reaction (PCR) test within 5 days prior to randomization
4. Over 50 years old OR 18-49 years old and have one or more of risk factors for severe COVID-19

Exclusion Criteria:

1. Pregnant or breastfeeding woman
2. Allergy and/or contraindications to inhaled Fluticasone
3. Current or previous administration of inhaled corticosteroids within the 15 days prior to randomization
4. Current or previous administration of high dose systemic corticosteroids (higher than 3.75 mg dexamethasone/day or equivalent doses of other corticosteroids) and/or anticoagulants etc.. more than or equal to 2 days within 15 days prior randomization, or taking any other antiviral drugs (such as remdesivir, favipiravir, etc..)
5. Indication for start of systemic corticosteroids or oxygen therapy or hospitalization dut to COVID-19 within next 24 hours
6. Already participated in other interventional COVID studies
7. Any conditions for which the investigator believes that the patient should not participate for the benefit of the patient or that would prevent, limit, or distort the evaluation of the study procedure
Fall Prevention Program for Non-ambulatory Wheeled Mobility Device Users Living With MS

A research study to examine the effectiveness of a fall management program to prevent falls and develop fall recovery strategies for wheeled mobility device users living with Multiple Sclerosis.

Falls are a serious concern for wheelchair and scooter users with Multiple Sclerosis (MS). Approximately 75% of the population reports at least one fall in a 6-month period and nearly half report frequent falls. Falls can result in physical injuries and contribute to activity curtailment. Despite the negative consequences, limited evidenced-based fall prevention programs designed specifically for wheelchair and scooter users with MS exist.

Recognizing the threat falls pose to health and well-being and the dearth of fall prevention programs, the purpose of this study to perform a structured process evaluation and examine the feasibility and efficacy of a community-based intervention specifically designed to reduce fall incidence among wheelchair and scooter users with MS. Secondary aims of the intervention are to improve functional mobility skills associated with fall risk (e.g. transfer and wheelchair skills, balance), increase knowledge of fall risk factors, decrease fear of falling and enhance quality of life and community participation.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Multiple Sclerosis
2. \>18 years old
3. Main form of mobility is via a wheeled mobility device (Patient Determined Disease Steps Level 7)
4. Self reported ability to transfer with moderate assistance or less
5. Self-reported fall history (at least 1 fall/12 months)

Exclusion Criteria:

1. MS exacerbation in the past 30 days
2. Received a score of 10 or above to the Short Blessed Test (attached)
3. Inability to sit upright for at least 1 hour.
Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy

The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.

During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited.

Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.

Eligibility Criteria:
Inclusion Criteria:

* Indication for laparoscopic hysterectomy
* Patients BMI \< 40
* Signed consent

Exclusion Criteria:

* Estimated uterus weight \>400 g
* No combination with other procedures
* No underlying malignant condition
Oral Health Related Quality of Life of Patients with Rare Diseases: a Qualitative Approach

The main objective of the study is to assess the oral health-related quality of life of patients with rare diseases and followed in the rare disease centers of expertise at Necker Hospital in Paris by semi-structured interviews.

To date, few studies have used the qualitative method to analyze the oral health-related quality of life and the oral health care pathways of patients with rare diseases, all health sectors combined. The quantitative studies carried out using standardized questionnaires offer only a partial view of how patients feel, both children and adults.

The main objective of the study is to assess the oral health-related quality of life of patients with rare diseases and followed in the rare disease centers of expertise at Necker Hospital in Paris by means of a semi-structured interview.

Eligibility Criteria:
Inclusion Criteria:

* Minor and adult patients with rare diseases aged of at least 6 years old and followed at the Necker Enfant Malades Hospital, Paris
* Patients with the 3 most frequent rare diseases of each rare disease Necker reference center participating in the study (10 centers : Chronic And Malformative Disorders Of The Esophagus / Inflammatory diseases of the bile ducts and autoimmune hepatitis / Constitutional Bone Diseases / Inherited Metabolic Diseases / Biliary Atresia And Genetic Cholestases / Vascular Diseases Of The Liver / Developmental Anomalies and Malformative Syndromes of Ile-De-France / Rare Causes Intellectual Disabilities / Complex congenital heart defects / Childhood cerebrovascular pathologies)
* Patients who consulted between 1.1.2017 and 1.1.2020 the relevant rare disease reference center at Necker hospital
* Patients seen at least once in the medical genetics department of Necker Hospital
* Information and non-opposition of adult patients / holders of parental authority of minor patients and minor patients to participate in the study

Exclusion Criteria:

Patients who do not speak French
DNA Methylation Biomarkers for Cervical Cancer Screening

The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* women with age ≥20 and sexual experience
* Agree to sign ICF

Exclusion Criteria:

* women had received Hysterectomy
* women had destructive therapy for cervical lesions in 6 months, for examples: conization, Laser or cryotherapy, chemotherapy, and radiation therapy
* Women are at pregnancy or had baby delivery in 6 weeks
MAGIC Cell-5-Combicytokine Trial

Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.


Eligibility Criteria:
Inclusion Criteria:

* ST elevation acute myocardial infarction
* \< 80years
* successful revascularization of culprit vessel

Exclusion Criteria:

* uncontrolled congestive heart failure
* uncontrolled myocardial ischemia
* uncontrolled ventricular arrhythmia
* malignancy
* serious hematologic disease
* chronic renal failure
Patient Outcomes After Hepatic Artery Infusion Pump Placement

The purpose of this study is to evaluate the surgical outcomes and the quality of life (QOL) in patients undergoing hepatic artery infusion pump placement for colorectal liver metastases (CRLM).


Eligibility Criteria:
Inclusion Criteria:

* Patients who receive a Hepatic Artery Infusion Pump at Mayo Clinic Rochester for liver metastases from colorectal cancer.
* Written consent.

Exclusion Criteria:

* Absence of written consent.
* Systemic disease.
* Pregnancy.