cyrilzakka/clinical-trials huggingface dataset:
Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study

Primary objectives:

* To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
* To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life.

Secondary objectives:

* To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.
* Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.


Eligibility Criteria:
Inclusion Criteria:

* women aged ≥18 and ≤ 55
* who underwent surgery for early stage breast cancer
* taking endocrine therapy for at least 3 months
* providing an informed consent and completing the study questionnaires.

Exclusion Criteria:

* withdrawal of the informed consent, at any time
Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment

This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended.

The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.

This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended. In cases where the patient continues on the treatment, the researcher will not modify the clinical management of the patient by participating in the study.

Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration. According to the records of the Spanish centres participating in this program, approximately 145 patients have been included.

The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration.
* Patients must have been treated with at least one cycle of lorlatinib within the compassionate use program.
* Alive patients must have signed, dated the ethics committee approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.

Exclusion Criteria:

* Alive patients who refuse to sign and date an ethics committee approved written informed consent form.
* Patients who were accepted in the compassionate use program , but did not receive treatment.
A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries(SPiM-RWS-GYN)

Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries Study purpose：This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robotic surgeries of gynecological benign and malignant tumors in the real world, providing a real world evidence for clinical application of the product in the Chinese population.

Study design：Retrospective + prospective, real-world study

English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients who have received or plan to receive gynecological surgeries with the SP single-port robot such as radical hysterectomy, salpingectomy/oophorectomy, vaginal hysterectomy, total hysterectomy, myomectomy, ovarian cystectomy, deep endometriosis resection, pelvic and abdominal lymphadenectomy, sentinel lymph node resection by image development, uterus/vagino-sacral colpopexy, and high uterosacral ligament suspension.
2. Patients who voluntarily participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).

Exclusion Criteria:

1. Patients with missing data on the primary endpoint in retrospective cases;
2. Patients having any contraindications of single-port robot surgery;
3. The intraoperative anatomy demonstrate that minimally invasive surgery is not suitable;
4. Patients who are considered inappropriate to participate in this Study by investigators.
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody

This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-C at screening ≥ 100 mg/dL and ≤ 190 mg/dL
* Fasting triglycerides ≤ 150 mg/dL
* Body mass index (BMI) between 18.0 and 32.0 kg/m\^2
* Framingham cardiac risk score 10% or less

Exclusion Criteria:

* Treatment with a lipid-regulating drug or over the counter supplement in the last 3 months prior to screening
* History of coronary heart disease (CHD) or CHD equivalent
* Uncontrolled hypertension
* Diabetes mellitus
Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.

This is a double masked, randomized, sham-controlled efficacy and safety study that will enroll approximately 800 subjects with recent-onset NAION. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure. Subjects will have a two in three (66%) chance of receiving active treatment (no sham procedure) and a one in three (33%) chance of receiving sham procedure (no active treatment). Total study time involvement is approximately 12 months.

Eligibility Criteria:
Key Inclusion Criteria:

* Positive diagnosis of first episode of NAION in the study eye with symptom onset within 14 days prior to planned study drug administration/sham procedure
* Best corrected visual acuity score in the study eye is better than or equal to 15 letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study drug administration/sham procedure.
* Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus examination

Key Exclusion Criteria:

* Present use or history of any treatment for the current episode of NAION, including systemic steroids, brimonidine, or traditional Chinese herbal medicine
* Prior episode of NAION in the study eye only
* Present use of drugs known to cause optic nerve or retinal toxicity at Day 1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin. Subjects who need to be prescribed any of these drugs during the course of the study will be discontinued from the trial.
* Any medical condition, concomitant therapy, or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye only
* Clinical evidence of temporal arteritis
What Are the Determinants of Explicit and Implicit Motor Imagery Ability in Stroke Patients?

Motor imagery (MI) might be described as a dynamic process in which an individual mentally stimulates an action without any overt movement. After stroke, motor imagery ability is impaired and also due to structure of MI, not every stroke patients is able to perform MI. Therefore, the aim of the study is a) to compare both explicit and implicit motor imagery ability (MIA) between patients with stroke and healthy subjects, b) to examine predictive effects of clinical characteristics for MIA after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-80,
* Having a unilateral stroke for the first time and 0-6 months since stroke onset
* 24 points and above in Mini Mental State Examination (MMDM)
* Not having a disease that may interfere with the study such as cardiac diseases, orthopedic conditions,etc.

Exclusion Criteria:

* Multiple strokes
* Sever cognitive dysfunction (\<24 points in MMDM)
* Unilateral neglect
* Upper extremity pain that interferes with the study or aggravated with movement
* Visual problems, aphasia or another sequel that might limit the assessment
Feasibility of CGM Use in Hospitalized Youth

This study is assessing the feasibility of a continuous glucose monitor during hospital admissions in youth with hyperglycemia due to diabetes or other underlying conditions that requires frequent glucose monitoring, through pediatric patient/family and nursing staff feedback on their perspectives and usability of the system in the hospital will be assessed through surveys. In addition, retrospective glycemic comparisons between CGM data and POC will be conducted.

Pediatric patients admitted to the hospital for any reason, but require glucose monitoring during the hospitalization will be enrolled in this study. Participant diagnosis can include type 1 diabetes, type 2 diabetes, medication-induced diabetes, cystic fibrosis-related diabetes, or other causes of hyperglycemia that it has been determined by the hospital team requires frequent glucose monitoring, with or without insulin management.

Enrolled participants will wear a blinded continuous glucose monitor for up to 28 days (2 sensors) or until the end of their hospitalization. In addition, enrolled participants will complete a survey to assess their perspectives on the CGM wear experience and interest in future CGM use during hospitalizations. Nursing staff of the enrolled participant will also be invited to complete a survey regarding their perspectives of CGM use in the hospital setting.

Eligibility Criteria:
Inclusion Criteria:

1. Participants will be 2 to less than 18 years of age at the time of enrollment.
2. Participants will have a diagnosis of type 1 diabetes, type 2 diabetes, diabetes/hyperglycemia due to an underlying condition (such as in cystic fibrosis, monogenic diabetes), or medication induced diabetes/hyperglycemia (such as steroid-induced hyperglycemia or PEG-asparaginase induced hyperglycemia) and would benefit clinically from close glucose monitoring during hospitalization due to fluctuations in blood glucose values.
3. Participant is expected to be in the hospital for longer than 12 hours after study enrollment with a goal of 36 hours or more as determined by study investigator or trained staff.
4. Participant is willing to wear the continuous glucose monitor for the duration of the hospital admission or the lifespan of a continuous glucose monitor (7-14 days).

Exclusion Criteria:

1. Has had a history of a significant skin reaction to the adhesives of a continuous glucose monitor in the past or concerns that one may occur due to underlying skin conditions (ie severe eczema, uncontrolled psoriasis, etc).
2. Planned MRI or surgery during the study device use (can be enrolled pre or post procedure if sufficient time for sensor wear as determined by investigator \[i.e. 24-48 before planned procedure\]).
3. Admission to inpatient psychiatry.
4. Pregnancy.
5. Currently using hydroxyurea.
6. A condition that the investigator determines would prevent the patient from participation.
Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy

* Reduce the trauma and the time taken for patient rehabilitation.
* The prevailing trend is to perform a mitomycin- C (MMC)-augmented trabeculectomy and trabeculectomy with ologen implants in a trial to decrease bleb failure as a common post- trabeculectomy complication.
* Is to develop a measurement protocol by OCT-A imaging and characterization of the bleb vascularity changes in glaucoma patients before and after surgery.

The main purpose of this project is to compare bleb vascularity changes using optical coherence tomography (OCT-A) between mitomycin- C (MMC)-augmented trabeculectomy and develop trabeculectomy with ologen implants to determine whether bleb vascularity measurements during preoperative and early postoperative periode could act as surrogate parameters to predict surgical outcomes.

Glaucoma often existent in the elderly population. Measuremets of bleb vascularity beginning to become an essential part of the glaucoma specialist's clinical and operative took. As investigators continue to collect data both clinically and in the laboratory, these various imaging modalities will shepherd surgeons into a more precise and predicable era of glaucoma surgeries.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years of age with primary or secondary open-angle glaucoma.
* Primary OAG (POAG) diagnosed on the basis of IOP measurements more than 21 mmHg, open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes.
* PNAG was diagnosed by the presence of narrow or occludable angle on gonioscopy (Grade 2, or 1 on Schaffer grading system for angle width in at least 180° of the total circumference of the angle in primary position without indentation), glaucomatous optic disc changes, visual field defects and IOP more than 21 mmHg

Exclusion Criteria:

* pregnant or lactating female.
* previous intraocular surgery
* one-eyed patients.
* previous ocular trauma.
* uveitis-induced glaucoma, neovascular glaucoma, aphakic/pseudophakic glaucoma
* systemic connective tissue disease and missing more than 3 follow-up visits.
* Trabeculectomy augmented by either MMC or Ologen implant was indicated to study subjects if they had uncontrolled IOP under maximum antiglaucoma medications (3 antiglaucoma drugs) or due to poor socioeconomic status.
Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit hearing aids and aural habilitation.


Eligibility Criteria:
Inclusion Criteria:

* Children 7 months to 5 years 11 months of age at the time of implantation
* Bilateral, severe to profound sensorineural hearing loss (SNHL) in the high frequencies and

  * For subjects implanted under 12 months of age: bilateral, severe to profound SNHL in the low frequencies
  * For subjects implanted at 12 months to 5 years 11 months of age: bilateral, mild to profound sensorineural hearing loss in the low frequencies
* Insufficient functional access to sound with appropriately fit amplification and aural habilitation
* Objective measures consistent with repeatable unaided audiometric thresholds for subjects under 12 months of age
* Radiologic evidence of potential for full insertion with one of the included electrode arrays
* Ability to undergo general anesthesia
* At least one parent/guardian who is fluent in one of the available languages of the LEAQ
* Parental commitment to study parameters

Exclusion Criteria:

* Magnetic Resonance Imaging (MRI) evidence of cochlear nerve deficiency
* Active middle ear infection
* Permanent conductive hearing loss
* Treatable mixed hearing loss
* Current or history of meningitis
* Common cavity
* Skin or scalp condition precluding use of external audio processor
* Suspected cognitive impairment, organic brain dysfunction, or syndromic etiology that may affect performance
* ASA (American Society of Anesthesiologists) Class 3 or higher in subjects under 12 months of age
* History of prior use of a hearing implant
* Unrealistic parental/patient expectations
* Child is not able to complete speech perception testing in English
Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)

The main objective is to evaluate the efficacy and safety of three doses of tinzaparin (prophylactic, intermediate and therapeutic) in hospitalized patients with COVID-19 pneumonia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to hospital with COVID-19, PCR and/or Antigens Test + SARS-CoV-2 infection or (presence of infiltrate compatible with Chest X-ray or TC)
2. Patients with, at least, one of the following evolution disease risk criteria:

   * Sat 02\<94%
   * Need for oxygen therapy or pAO2/FiO2\<300mmHg or estimated PaO2/FiO2 based on SpO2/FiO2\<300 mmHg.
   * DD\>1000µg/L
   * PCR \>150mg/L
   * IL6 \>40pg/ml
3. Age \> 18 years
4. Weight 50-100 Kg
5. After receiving oral and written information about the study, patient must give Informed Consent duly signed and dated before performing any activity related to the study.

Exclusion Criteria:

1. Patients who need mechanical ventilation (invasive or non-invasive), high flow nasal cannula or admission to ICU at the moment of randomization.
2. Current diagnosis of acute bronchial asthma attack.
3. History or clinical suspicion of pulmonary fibrosis.
4. Current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis.
5. Patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation.
6. Patients with pneumonectomy or lobectomy.
7. Renal failure with Glomerular filtration \<30 ml/min/1.73m2
8. Patients with contraindication for anticoagulant treatment.
9. Congenital bleeding disorders.
10. Hypersensitivity to tinzaparin or UFH or some of its excipients.
11. History of heparin-induced thrombocytopenia.
12. Active bleeding or situation that predispose to bleeding.
13. Moderate or severe anaemia (Hb\<10 g/dl)
14. Low platelet count \< 80000/µl
15. Patients with life expectancy less than 3 months due to primary disease evaluated by the physician.
16. Patients currently intubated or intubated between the screening and the randomization.
17. Pregnancy.
The Effectiveness and Cost-effectiveness of Motion Style Acupuncture Treatment (MSAT) for Acute Neck Pain: A Multi-center Randomized Controlled Trial

The investigators will evaluate the comparative effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) therapy for acute neck pain compared to acupuncture.

This is a multi-center, randomized, controlled, comparative effectiveness clinical trial for acute neck pain. Motion style acupuncture requires a part of the patient's body to move passively or actively while acupuncture needles are retained.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain onset or worsen within one month
* VAS of neck pain on movement or at rest of 5 or higher
* Age between 19 and 70 years old
* Participants who wrote a informed consent

Exclusion Criteria:

* Participants who diagnosed with the serious disease that can cause pain (e.g. Migration of cancer reaching to spine, fracture of spine, dislocation of spine)
* Progressive neurologic deficits or severe neurologic deficits
* Participants who diagnosed with a soft tissue disease that can cause pain (Cancer, fibromyalgia, RA, or goat)
* Chronic disease (e.g. Cardiovascular disease, kidney disease, dementia, diabetic neuropathy, or epilepsy)
* Participants taking steroids, immunosuppressants, or psychotropic medication
* Participants who could be inadequate or unsafe at acupuncture (e.g. Hemorrhagic disease, severe diabetes or taking anticoagulant drug)
* Participants who took NSAIDs or acupuncture within 3 days
* Participants who had undergone cervical surgery within 3 months
* Participants who had a traffic accident within a month
* Pregnant or women who planned to conceive
* Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial within 6 months from enrollment
* Participants who can not write informed consent
* Participants who is difficult to participate in the trial according to investigator's decision
Arrhythmia in on Pump vs. Off Pump Coronary Artery Bypass Grafting

The aim of this research is to know the incidence of arrhythmias in on vs. off pump CABG and to know their relations to the patient's morbidity and mortality, hospital stay and hospital costs.

On pump vs. off pump CABG has been a topic of debate for many years regarding the benefits and the risks of each technique .Off pump CABG began 30 years ago. Its promotion was based on its potential benefits over some of the limitation of traditional on pump CABG. It avoids the trauma of cardiopulmonary bypass (CPB) and minimizing aortic manipulation and reducing length of hospital stay and morbidity.

There is a criticism regarding completence of revascularization in off pump vs. on pump CABG, this is no longer valid in the current era as technology to safely perform multi vessel off pump has improved tremendously over the past decade.

One of the debates between these two techniques was the incidence of arrhythmias in and after the operation and its relation to morbidity and mortality at the operation and hospital stay after the operation.

As known atrial fibrillation (AF) is still the most common arrhythmia that occur after CABG and although in some studies it has been considered a benign and self-limiting complication, some suggest serious morbidity and mortality from this complication, it is said that it affects more than 40% of patients underwent CABG. Atrial fibrillation (AF) may lead to thromboembolic complications, additional pharmacotherapy, longer hospital stay, increase cost, anxiety and stroke.

Most AF post CABG are found in the second to third post-operative day. SO, on this study the investigators focus one the incidence of arrhythmias, especially AF in those two techniques and their relations to patients' morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients subjected to CABG

Exclusion Criteria:

* Associated valvular heart disease
* Emergency cases
* Previous AF