cyrilzakka/clinical-trials huggingface dataset:
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France

This study is a national, multicenter, prospective, non-interventional study in women with HR+/HER2- locally advanced or metastatic breast cancer (BC), for which a prior clinical decision to initiate ribociclib + endocrine therapy (ET) treatment according to the marketing authorization has been taken and was taken independent and prior to study participation decision.

Included patients will be followed until the end of study, death or lost to follow-up even if ribociclib and ET are discontinued. The end of the study is defined as 3 years after the first visit of the last patient included (Last Patient First Visit \[LPFV\]). The total duration of the study will be 4 years and half (18 months of inclusion + 3 years of follow-up). Thus, a patient included at the beginning of the inclusion period will be followed for 4 years and half and a patient included at the end of the inclusion period will be followed for at least 3 years.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following criteria will be included in the RosaLEE study:

1. Adult women aged ≥ 18 years old at inclusion.
2. Pre-/Peri-/Postmenopausal women with locally advanced or metastatic HR+/HER2- BC.
3. Prior clinical decision (independent of study participation)to initiate ribociclib + ET treatment according to the marketing authorization.
4. Patients having given their non-objection to participate in the study.
5. Patients presenting with medical conditions to be treated with ribociclib + ET according to the summary of product characteristics.

Exclusion Criteria:

1. Patients for whom ribociclib + AI in treatment combination has been initiated before inclusion.
2. Patients for whom ribociclib + fulvestrant in treatment combination has been initiated before inclusion.
3. Patients for whom AI or fulvestrant in monotherapy has been initiated \> 28 days before inclusion.
4. Participation in any clinical study involving investigational therapy except for the Trans-RosaLEE study, conducted by the IPC.
5. Patient who is pregnant or has expressed desire for pregnancy during Ribociclib treatment.
Effectiveness of the Transversus Abdominis Plane Block Associated With Opioid Spinal Anesthesia on Analgesia After Cephalic Duodenopancreatectomy

Duodenopancreatectomy is a major, risky surgery that causes significant post-operative pain. Optimizing perioperative analgesia remains a challenge, and requires multimodal management, notably involving locoregional analgesic techniques.

The thoracic epidural helps reduce perioperative pain, as well as certain postoperative complications. However, epidural analgesia is not without effects, and the data remains quite heterogeneous depending on the studies regarding its benefits and risks: more frequent hypotension, significant technical failures, length of hospitalization depending on the series, marginal benefit clinically of little relevance... And the existence of contraindications to the epidural such as the performance of vascular resections requiring curative intraoperative anticoagulation also limit its daily use.

The search for alternatives to the epidural in this context has seen the emergence of the use of intrathecal injection of Morphine and the performance of TAP Block perioperatively for duodenopancreatectomies. Morphine spinal anesthesia is an analgesic technique that is simpler and just as effective as the thoracic epidural. The TAP Block has also proven its effectiveness in major colorectal surgeries.

The literature on the subject remains poor and very few studies have focused on alternatives to thoracic epidurals. If the superiority of TAP Block and spinal anesthesia have been evaluated in isolation, no study has yet compared the effectiveness of the combination of TAP Block-Spinal anesthesia compared to that of TAP Block alone in the management of post pain. duodenopancreatectomy.

At the Strasbourg University Hospital, the Anesthesia team in hepatic and pancreatic surgery made a change in practice in June 2023: from a TAP Block, the team performs a TAP-Block combined with a unique Morphinic spinal anesthesia preoperatively for cephalic duodenopancreatectomy (CDP). The objective of the study is to evaluate the effectiveness and safety of this change in practice.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Planned cephalic or total duodeno-pancreatectomy surgery, associated or not with additional vascular procedures or liver resections by laparotomy, at the Strasbourg University Hospital for the period from June 1, 2022 to May 31, 2024.
* Subject who has not expressed opposition to the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Admission to intensive care following the operation
* Drug addiction withdrawn or not
* Surgery shortened by surgical decision
Mesenchymal Stem Cells for Treatment of Refractory Acute Graft-versus-host Disease

The purpose of this study is to evaluate the utility of treating patients experiencing refractory acute graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. The objective was to evaluate the effect and safety of such treatment on refractory acute graft-versus-host disease.

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although great progress has been made in the prevention and treatment of side effects associated with transplantation,acute graft-versus-host disease(aGVHD) remains an important complication that occurs in 35-80% patients. The mortality of aGVHD is positively correlated with its severity. At present, glucocorticoids is still the first line treatment of aGVHD. If glucocorticoids treatment is ineffective, second line drugs would be taken, such as tacrolimus(FK506), mycophenolate mofetil (MMF)and antithymocyte globulin (ATG). However, no method could be continuously effective. The effective rates of second line treatment to aGVHD is only about 60%. The effective rates and prognosis of refractory aGVHD are even worse.

Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating GVHD after allo-HSCT and so on. However, the efficacy of treatment of refractory aGVHD using expanded BM-derived MSCs from a third-party donor is rarely reported. If such treatment could be shown to be effective and safe, BM-derived MSCs could potentially be used as an universal donor material. This would have a major impact because the generation of donor-specific MSCs is time-consuming, costly, and often impractical if the clinical status of a patient is urgent.

In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded BM-derived MSCs from third-party donors in treating patients with refractory aGVHD.

Eligibility Criteria:
Inclusion Criteria:

* A patient age of 12-65 years
* Recipients of allogeneic hematopoietic stem cell transplantation
* Patients with refractory aGVHD
* On a voluntary basis, patients are divided into MSCs and Non-MSCs group
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN

The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
* Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
* Best corrected visual acuity of -0.6 logMAR or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Treatment with BAK preserved artificial tears within 30 days of Visit 1.
* Known or suspected Sjogren's disease.
* Uncontrolled IOP.
* History or evidence of infectious or inflammatory ocular conditions.
* Progressive retinal or optic nerve disease.
* Ocular laser surgery within 3 months of Visit 1.
* Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.
* Current use of punctal plugs or punctal cautery.
* Use of systemic medications that has not been stable for 30 days prior to Visit 1.
* Use of contact lens within 30 days of Visit 1.
* Other protocol-defined exclusion criteria may apply.
A Phase II, Randomized, Double-blind, Placebo-controlled, in Parallel Groups Clinical Trial to Assess the Safety and Efficacy of Dietary Supplementation With Tryptophan to Achieve Weight Loss, and Its Neuropsychological Effects in Adolescents With Obesity

A phase II, randomized, double-blind, placebo-controlled, in parallel groups clinical trial to assess the safety and efficacy of dietary supplementation with tryptophan to achieve weight loss, and its neuropsychological effects in adolescents with obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Both male and female patients, attending the Pediatric Endocrinology Service on an out-patient basis.
2. Age from 12 to 17 years, inclusively.
3. Presence of a BMI \> or = to 2SD and \< or = to 4SD (standard deviations) for their age and sex (Spanish cross-sectional growth reference tables of 2008)
4. Patients must have an educational level that permits adequate communication and must agree to cooperate in all the tests and examinations included in the protocol.
5. Subjects of reproductive potential must use an effective birth control method during the study. Women of reproductive age will be recruited after a negative pregnancy test.
6. The informed consent of the parents or legal representative and of the young adults is required.

Exclusion Criteria:

1. Obesity secondary to an endocrine disease (hypothyroidism, Cushing?s syndrome, polycystic ovary, hypothalamic syndromes, hypogonadism) or the use of medications such as cortisol.
2. Concomitant administration of other psychotrophic medication such as antidepressants or anxiolytics.
3. Patients included in the study must not be taking any vitamins or nutritional supplements or any anti-obesity preparations, including herbal remedies, pharmacy products or homeopathic products.
4. Patients with a known psychiatric disorder.
5. Patients treated with any kind of structured psychotherapy regime.
6. Patients with type 2 DM, arterial hypertension (blood pressure above the 95 percentile for gender and height) or steatotic liver (hypertransaminasemia with echographic image of fatty liver).
7. Patients with any severe food intolerance, or with a known allergy to any of the substances used in the study.
8. Patients in treatment with oral hypoglycemiants.
9. Pregnant or breast-feeding.
Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study

The purpose of this study is to see if fetal head circumference can be used as a predictor for who will experience a sphincter laceration while delivering.

Even though much work has been invested in trying to identify risk factors that can predict which population will suffer from sphincter tears and other pelvic floor trauma, the epidemiology is still poorly understood. Factors that have been implicated to include operative vaginal delivery, birth weight, and primaparity. Up to this point little focus has been placed on antenatal factors that would help predict and prevent sphincter disruptions. At the time of birth the infant's head is the largest part of the body. Thus, head circumference of the infant may be able to predict which subjects is more likely to suffer from sphincter disruption. Thus, this study aims to determine whether or not fetal head circumference measured antenatally is predictive of pelvic floor trauma.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous subjects at least 18 years of age
* Gestational age greater than or equal to 36 weeks and upto 42 weeks gestation
* Subjects must have give written informed consent to participate in this study
* Subjects must be planning to deliver at UCI

Exclusion Criteria:

* Subjects less than 18 years of age
* Subjects with a previous delivery
* Subjects with previous colorectal surgery or hemorrhoidal surgery
* Subjects with a history of irritable bowel syndrome, ulcerative colitis, or Crohn's disease
* Subjects with a history of colon or rectal cancer
* Gestational age less than 36 weeks
* Cesarean section
A Study to Understand the Usage of an Artificial Intelligence Technology Called DARWEN for Eye Disorders and to Find Out the Factors Influencing Treatment Frequencies in People With nAMD and RVO

This is an observational study in which data already collected from people with the eye disorders below are studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.

Neovascular age-related macular edema (nAMD): an eye disorder caused by the lack of oxygen in the retina. The lack of oxygen leads to the increase of a protein called vascular endothelial growth factor (VEGF). VEGF causes new, weak blood vessels to grow. These vessels can leak fluid or blood into the central part of the retina at the back of the eye (macula). This leads to blurring or a blind spot in the central (straight ahead) vision needed for reading or threading a needle.

Retinal vein occlusion (RVO): an eye disorder where a blood vessel that carries blood away from the retina (vein) becomes blocked. The blocked vein causes a lack of oxygen in the retina which leads to the increase of VEGF and then vision disturbances.

These eye disorders can be treated with a type of medicine called anti-vascular endothelial growth factor (anti-VEGF). Anti-VEGF treatment helps control the growth of new blood vessels in the eye and is given via injection into the eye.

DARWEN AI is a system using artificial intelligence (AI) technology. It has been proven that DARWEN AI can be used to extract data accurately and efficiently in multiple disease areas, including breast cancer, lung cancer, ambulatory care diseases and skin disorders.

The main purpose of this study is to validate if DARWEN AI can extract and sort through information from participants' health records accurately to identify those who need more frequent injections and those who do not.

The secondary purpose of this study is to use DARWEN AI to describe the factors influencing treatment frequencies in participants with nAMD or influencing treatment discontinuation in participants with RVO.

The data will come from the participants' information stored in EyeDoc Electronic Medical Records (EMR) at St. Joseph Health Care in London. Data collected are from January 1, 2009, to May 31, 2023.


Eligibility Criteria:
Inclusion Criteria:

* All patients with the diagnosis of nAMD or RVO (Branch or Central) who are patients of Dr. Tom Sheidow listed in the EyeDoc EHR with available patient records from Jan 1, 2009 to May 31, 2023.

Exclusion Criteria:

* Not applicable.
Acute Achilles Repair With or Without OrthADAPT Augmentation

The purpose of this study is to assess the clinical performance of the OrthADAPT Bioimplant in patients with acute mid-substance Achilles tendon tears requiring surgical repair.


Eligibility Criteria:
Inclusion Criteria:

* A transverse, full thickness, acute mid-substance Achilles tendon tear that requires surgical repair
* Achilles tendon tear is repairable by surgery using primary means as determined by intra-operative assessment
* Achilles tendon rupture with viable ends of the tendon that are suitable for primary repair
* Isolated Achilles tendon rupture without poly trauma
* Patient must be 18 to 70 years of age
* Life expectancy greater than or equal to 12 months
* Patient is able to provide voluntary informed consent
* Patient is willing and able to return for all follow-up visits and study related exams
* Patient is willing to comply with prescribed physical therapy regimen

Exclusion Criteria:

* Emergency, poly trauma patients
* Previous Achilles tendon surgical procedure on that tendon
* Deficit in the contralateral extremity that prevents a comparison with the treated extremity
* Repair requires tendon lengthening, gap filling or tendon transfer
* BMI greater than 40
* Peripheral arterial disease
* Uncontrolled Diabetes Mellitis
* Patients whose injury is known to involve litigation
* Known allergy to equine derived product
* Systemic collagen disease
* Neurological disease
* Active infection - systemic or at the intended surgical site
* Acute use of immunosuppressive agents
* Rupture resulting from fluoroquinolone induced tendinopathy
* Alcohol or drug abuse
* Participant in another investigational drug or device trial
* Pathologic soft tissue conditions that would prevent secure surgical fixation
* Patients who are unwilling or unable to return for follow-up visits and study related exams
* Pregnant women
* Cancer patients
* Decisionally impaired patients
* Institutionalized patients
* Prisoners
Cardiac, Pulmonary and Diaphragm Sonography for the Early Diagnosis of the Different Etiologies Underlying Failure of Weaning From Mechanical Ventilation

Weaning patients off ventilation in an ICU is sometimes difficult, because of three major inter-related etiologies: impaired lung, heart and diaphragm function. In this context, ultrasonography during tests to wean patients off ventilation could make it possible to diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus reduce the number of failures at extubation.

The study will be carried out in 100 patients on mechanical ventilation following abdominal or heart surgery, who will have echocardiography, and pulmonary and diaphragm ultrasonography.


Eligibility Criteria:
Inclusion Criteria:

* Patients on mechanical ventilation for at least 48 hours
* Age ≥ 60 years
* Patients who have undergone abdominal or heart surgery

Exclusion Criteria:

* Patients with a known neuromuscular disease
* Patients younger than 60 years
* Duration of mechanical ventilation \<48h
* Non-surgical patients
* Patients with severe COPD
DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.

To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia.

To evaluate the influence of ICD-based diagnostic information on the long term treatment and management of primary prevention ICD-patients.

Evaluate the positive predictive value of single nucleotide polymorphisms (SNPs) in the genes GNB3, GNAS and GNAQ as predictors of ventricular arrhythmia \<400 msec.

1. Evaluate the positive predictive value of Single Nucleotide Polymorphisms as predictor for death, cardiac death and atrial fibrillation/flutter in the genes GNB3, GNAS, GNAQ and other SNPs involving signal transduction components which impact on the activity of cardiac ion channels.
2. Evaluate the best combination of genetic parameters, baseline data and follow-up data as predictor of primary endpoint, All cause Mortality, cardiac death and atrial arrhythmia.
3. Evaluate the usage of ICD-system diagnostics (battery status, impedance, pacing threshold, sensing) resulting in medical consequences\*.
4. Evaluate the usage of ICD-based patient diagnostics (arrhythmia, IEGM, heart frequency, %pacing, Cardiac Compass) resulting in medical consequences\*.
5. Evaluate the frequency of programming changes involving AF-prevention and AF-therapy algorithms.
6. Evaluate the frequency of pacing-parameter programming changes and the resulting medical consequences\*.

   * Medical consequences include: Hospitalization, medical interventions, medication, surgery, additional diagnostics and ICD-programming changes.

Eligibility Criteria:
Inclusion Criteria:

* Implantation of a market approved Medtronic Dual-chamber ICD with long term clinical trends Cardiac Compass,
* Subjects requiring the implantation of an ICD for primary prevention according to the current AHA/ACC/ESC guidelines,
* Subject able to comply with the Clinical InvestigationPlan,
* Subject is expected to remain available for follow-up visits,
* Subject has signed the informed consent form within 10 days of implant,
* The system implanted for this study is the first ICD implant for patient.

Exclusion Criteria:

* Women who are pregnant, or women of childbearing potential not on a reliable form of birth control,
* Subject is enrolled in a concurrent study that may confound the results of this study,
* Subject has a life expectancy less than two years,
* Subject is post heart transplant or awaiting heart transplantation,
* Subject is anticipated to demonstrate poor compliance,
* Subjects with syndromes known to be associated with ion channel pathologies such as:

  * Long- or short-QT Syndrome
  * Brugada Syndrome
  * Catecholaminergic Polymorphic Ventricular Tachycardia (CPTV ).
Effect of Two Irrigation Protocols Applied Prior to Furcation Repair

Perforations are mishaps that might occur during the course of endodontic treatment mainly due to iatrogenic factors. However, they might also occur due to extensive decay of dentinal structure.

A perforation creates a pathological passage between the root canal system and the periodontium and jeopardizes the success of the endodontic therapy. The damage caused by the perforation may eventually result in the extraction of the compromised tooth

Chitosan is the most abundant biopolymer on the earth derived from chitin. It shows a remarkable effective broad spectrum antibacterial action attributed to its cationic nature. It interacts with the -ve charged bacterial cell membranes, leading to leakage of the intracellular constituents and ultimately cell death due to increasing the membrane permeability. Also, chitosan possesses a variety of other biological properties as being biodegradable, biocompatible and has chelating abilities, making it an interesting alternative to modern root canal irrigants.

Inadequacy of the repair materials has been a contributing factor to the poor outcome of repair procedures. On the basis of the recent physical and biologic property studies of the relatively new introduced mineral trioxide aggregate, this material may be suitable for closing the communication between the pulp chamber and the underlying periodontal tissues. There are few reports on repair of furcal perforation with MTA in molar teeth.

Several studies have stated the ability of chitosan as a chelating agent that potentially enhance the dentin wettability. At the same time, chitosan nanoparticles showed the potential to stabilize dentine collagen by providing resistance to bacterial collagenase degradation.

The null hypothesis: there is no difference in pain and healing between the two irrigation protocols of old fural perforations prior to application of Bio C repair material.

Eligibility Criteria:
Inclusion Criteria:

* Patients with old furcation perforation of mandibular molar.
* Size of perforation should be of average 1 to 2 mm.
* Period till treatment should be done within one month.
* Presence of polyp at the site of perforation is required in this study.

Exclusion Criteria:

* Teeth in need for post retained restoration.
* Immunocompromised patients.
* Pregnant women and smokers.
* Patients with a history of antibiotic or analgesics intake within the few days before the intervention and cases with previously initiated endodontic treatment.