cyrilzakka/clinical-trials huggingface dataset:
Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer

This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.


Eligibility Criteria:
Key inclusion criteria:

1. Female
2. At least 18 years of age
3. Locally advanced non-resectable or metastatic breast cancer
4. HER2 negative disease
5. Measurable disease per revised RECIST, Version 1.1
6. Eastern Cooperative Oncology Group performance status 0 or 1
7. Chemotherapy naïve, OR 1 prior chemotherapy regimen in the neoadjuvant or adjuvant setting provided the patient has had a disease-free interval of ≥ 12 months after ending this chemotherapy. If the neoadjuvant or adjuvant chemotherapy included a taxane, ≥ 2 years must have passed since this treatment ended.
8. Documented disease recurrence or progression
9. Adequate bone marrow, hepatic, and renal function
10. Ability to swallow an oral solid-dosage form of medication
11. Written informed consent

Key exclusion criteria:

1. Known metastasis to the central nervous system
2. Other cancer within the preceding 5 years other than curatively treated basal or squamous cell carcinoma of the skin or carcinoma of the cervix in situ
3. Significant medical disease other than breast cancer
4. Presence of neuropathy \> Grade 1 (NCI CTC)
5. History of hypersensitivity to a taxane or capecitabine, other fluoropyrimidine agents, or any of their ingredients
6. History of severe or unexpected reaction to fluoropyrimidine therapy
7. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
8. Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway
9. Known dihydropyrimidine dehydrogenase deficiency
10. Pregnancy or lactation
Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis

Lymphatic venous anastomosis could be applied on patients suffering from limb lymphedema after surgery or radiotherapy. The particular pathophysiology leads unconventional fluid treatment strategy and changes in urine output. Hemodynamic monitors shows the benefits in perianesthetic care in fluid maintenance and decrease postanesthetic complication.

Invasive hemodynamic monitors, such as arterial line and FlowTrac, have risks of hematoma, infection, nerve injury in puncture site. In this study, photoplethysmography is applied comparing with conventional mean arterial pressure for perianesthetic hemodynamic optimization in bispectral index (BIS)-guided target-controlled infusion sedation on lymphatic venous anastomosis.

After allocation, patients would be assigned to Standard group or ClearSight group. All patients will be sedative with BIS-guided Propofol/Alfentanil Target-Controlled Infusion. The BIS will be maintained between 40-70 with electromyography(EMG) \< 30%. Ce(effect site concentration) of Propofol is adjusted according to BIS score. Ce of Alfentanil is adjusted between 15-75 ng/ml. Patients have spontaneous respiration during the procedure with O2 simple mask. If the oxygen saturation by pulse oximetry(SpO2) \< 95%, prescribe chin lift first. Nasopharyngeal airways is given if chin lift can not improve the saturation. Crystalloid, usually Lactate Ringer, is infused with the rate 4ml/kg/hr. The goal of Standard group is to maintain mean arterial pressure(MAP) \> 60%. If MAP \< 60%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed. ClearSight group is to maintain stroke volume(SV). If SV decreases more than 10%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed.

Eligibility Criteria:
Inclusion Criteria:

* Subject receiving lymphatic venous anastomosis operation with Bispectral-guided Propofol and Alfentanil target-controlled anesthesia
* Subject agrees to participate the study

Exclusion Criteria:

* Age less than 18 years old
* Creatinine clearance \< 30ml/min
* Vulnerable populations, including children, pregnant women, inmates, and persons with no capacity or with limited capacity
Effect of Pulsed Electromagnetic Field Therapy as an Adjunct Modality to Warm-up Exercise

The goal of this clinical trial is to assess the effectiveness of pulsed electromagnetic field therapy as an adjunct to warm-up exercises, in healthy participants. Researchers will investigate both the immediate effect of one round of pulsed electromagnetic field therapy (PEMF) and after a warm-up exercise, on participants' range-of-motion (ROM) at the knee and quadriceps' muscle stiffness, measured through shear wave elastography, an ultrasound technique. This may be useful in future interventions to protect against sports injuries.

Participants will have their knee ROM and quadriceps' muscle stiffness measured thrice, once at baseline, once after PEMF/sham treatment, and once after 5 minutes of warm-up stationary bike exercises.

Researchers will compare with sham treatment to see if there are any significant effects from PEMF therapy.

The goal of this clinical trial is to assess the effectiveness of pulsed electromagnetic field therapy as an adjunct to warm-up exercises, in healthy participants. Researchers will investigate both the immediate effect of one round of pulsed electromagnetic field therapy (PEMF) and after a warm-up exercise, on participants' range-of-motion (ROM) at the knee and quadriceps' muscle stiffness, measured through shear wave elastography, an ultrasound technique. This may be useful in future interventions to protect against sports injuries.

Participants will have their knee ROM and quadriceps' muscle stiffness measured thrice, once at baseline, once after PEMF/sham treatment, and once after 5 minutes of warm-up stationary bike exercises.

* Baseline measurement of knee ROM and quadriceps' muscle stiffness
* Receive PEMF for ten minutes around their knee joint
* Interim measurement of knee ROM and quadriceps' muscle stiffness
* Perform 5 minutes of warm-up exercise on a stationary bike
* Final measurement of knee ROM and quadriceps' muscle stiffness

Researchers will compare with sham treatment to see if there are any significant effects from PEMF therapy.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 40
* Obtained written informed consent

Exclusion Criteria:

* History of major musculoskeletal or locomotor system disorder of lower limb
* History of traumatic or non-traumatic injury of lower limb
* History of surgical intervention of lower limb in the past 1 year
* Under any rehabilitation program at the time of investigation
* Contraindicated to physical exercises
Titanium Mesh Coated With Natural Hydroxyapatite Nanocrystals in Orbital Reconstruction

Reconstruction of maxillofacial continuity defects has always been a challenging task for scientists and surgeons over the years. The main goal of the reconstruction of the maxillofacial region is to restore facial form, function, and full rehabilitation of occlusion and articulation. A refinement in surgical technique and methods of reconstruction has improved patients' quality of life. Aim of this study: Evaluation of titanium mesh coated with natural hydroxyapatite in orbital reconstruction.

Twelve patients having orbital defects will be selected. Six defects will be reconstructed using titanium mesh coated with natural hydroxyapatite nanocrystals (study group) and the other six will be treated with uncoated titanium mesh (control group). Patients will be evaluated clinically, then a radiographic follow-up will be performed immediately postoperatively and after three months to evaluate the bone density at the defect. Also, the coated and uncoated titanium mesh will be mechanically evaluated to compare the tensile strength of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* All patients requiring reconstruction of acquired orbital defects using titanium mesh.
* Both genders with age group ranging from 18-60 years old.
* Limited size defects according to Cordeiro and Santamaria.
* Isolated unilateral or bilateral orbital fractures or combined with other facial fractures.
* Orbital reconstruction after removal of benign pathological lesions.

Exclusion Criteria:

* Infected fracture sites.
* Chronic systemic diseases such as uncontrolled diabetes, rheumatoid arthritis, metabolic bone disease, immunocompromised status etc.
* Defects requiring soft tissue reconstruction.
* Patients suffering from burns.
* Patients suffering from carcinomas and sarcomas in the oral cavity.
Sniper Intubation for Training of Undergraduate Medical Student

Students trained to focus on vocal cord before intubation

Student trained to spray vocal cords with 3 ml normal saline over 30 seconds before intubation then allow them to introduce endotracheal tube

Eligibility Criteria:
Inclusion Criteria:

* medical student

Exclusion Criteria:

* previous training on endotracheal intubation
Patient Satisfaction With Perioperative Anesthetic Care

The doctor-patient relationship, medical competence and patient expectations influence patient satisfaction with anesthesia. Preoperatively all patients are routinely assessed by an anesthesiologist. However, in many centers, the anesthesiologist who performs the preoperative evaluation will not necessarily be the anesthesiologist who provides the intraoperative service. This study evaluated the effect of this practice on patient satisfaction, level of confidence and anxiety among adult patients undergoing elective surgery.

Background: The doctor-patient relationship, medical competence and patient expectations influence patient satisfaction with anesthesia. Preoperatively all patients are routinely assessed by an anesthesiologist. However, in many centers, the anesthesiologist who performs the preoperative evaluation will not necessarily be the anesthesiologist who provides the intraoperative service. This study evaluated the effect of this practice on patient satisfaction, level of confidence and anxiety among adult patients undergoing elective surgery.

Methods: 100 patients scheduled for elective surgery under general anesthesia were randomly divided into 2 equal groups: In Group A patients were evaluated and anesthetized by the same anesthesiologist. In Group B the preoperative assessment and actual anesthesia was performed by two different anesthesiologists. On the first postoperative day all patients completed a questionnaire designed to evaluate their sense of preoperative security (confidence) and their overall satisfaction with the anesthetic experience.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective surgery under general anesthesia
* Period- 12.2018-03.2019
* ASA score 1 to3
* Hebrew is the patient mother tongue
* The patient was pre-operatively evaluated by an anesthesiologist at least one day before surgery
* Duration of surgery is more than 1 hour
* The anesthesiologist has more than 2 years experience at work

Exclusion Criteria:

* The patient suffers from severe cognitive decline or severe psychiatric illness
* The patient is unable to answer the questionnaire by himself/herself
* The patient received pre-operative sedation
Role of Auditory Cortical Oscillations in Speech Processing and Dyslexia

This study aims at investigating the role of low-gamma activity in phonemic encoding and its implication in dyslexia. Indeed, a phonological deficit, i.e. a difficulty in perceiving the sounds of speech, is strongly suspected in dyslexia but has never been conclusively associated with a specific underlying mechanism.

The study employs transcranial alternating current stimulation in adults with and without dyslexia to exploit the effect of the stimulation on phonemic processing and neural activity measured with electroencephalography. In doing so, it would be possible to establishing a causal link between gamma oscillations and the phonological deficit in dyslexia.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old;
* French native speakers;
* normally-hearing;
* intellectual quotient (IQ) around average;
* for the dyslexia group: previous diagnosis of dyslexia as assessed by a speech therapist.

Exclusion Criteria:

* Presence of metal or electronic implants in the brain/skull;
* Presence of metal or electronic device at other in other parts of the body;
* Have experienced a seizure or a loss of consciousness or a severe head trauma;
* Severe brain related illness ;
* Intake of central nervous system-effective medication;
* Pregnant and nursing women;
* Relatives affected by epilepsy.
Shiatsu Adjuvant Therapy And Placebo For Schizophrenia

In the current study we will study the effect of adding acupressure (shiatsu) to conventional therapy in treating individuals with schizophrenia.

Acupressure, also known as shiatsu, is a holistic form of medicine originating in Japan but now widely practiced throughout the world. The theory is based on Traditional Chinese Medicine (TCM), which sees meridians of life force (chi) running through the body, and aims to optimize health through manipulating the body into maximal alignment.

We are proposing a randomized double-blind placebo-controlled trial to examine the efficacy of acupressure as adjuvant therapy added to antipsychotics in the treatment of patients with schizophrenia.

The goals of this study are twofold:

1. To assess through the highest standards of empirical research whether acupressure can benefit patients with schizophrenia.
2. To furnish data relevant to the possible physiological mechanisms by which acupressure may produce a therapeutic effect.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV diagnosis of schizophrenia or schizoaffective disorder
2. Ages 18 and over
3. Clinical status stable, as reflected by changes in Brief Psychiatric Rating Scale (BPRS) (Overall \& Gorham, 1961) of less than 20% during a one month period prior to randomization, and at least one month of drug treatment without change of anti-psychotic drug or dosage.
4. Ability to cooperate with 40-minute sessions

Exclusion Criteria:

1. Unstable general medical conditions
2. Active bone fracture or other orthopedic problem
3. Skin condition that renders treatment unsafe or painful
4. Active infection in skin or soft tissues, such as cellulitis
5. Solid tissue malignancy
Swiss Early Intervention Project in Autism: An Evaluation of Early Intervention Outcome

This study aims to investigate the effectiveness of early (before the age of 5 years) and intensive intervention for children with Autism Spectrum Disorders.

This study aims to investigate the effectiveness of early (before the age of 5 years) and intensive intervention for children with Autism Spectrum Disorders. The type of intervention proposed in Switzerland differs greatly depending on where people live. Several international studies show positive outcomes in children with Autism after receiving early behavioural intervention.

However, Disability Insurance (DI) in Switzerland does not fully cover these scientifically proven interventions. Since January 2014 they cover 45 000 CHF per child for only two years of early treatment across five centres chosen by the Federal Social Insurance Office. The remaining costs are covered by the parents, foundations or by the cantons. In addition, families benefit from this early intervention only if their child is enrolled in one of the five selected centres.

There are currently various types of support for children with Autism in Switzerland before age five, early intensive behavioural interventions, eclectic early intervention and less intensive interventions with a treatment that is not specific to Autism (about 3 hrs./week), which includes occupational therapy, speech therapy and early curative education. Some children do not receive any treatment.

This research aims to evaluate the efficacy of these interventions (early intensive behavioural/ eclectic/treatment as usual) as has been done previously in international studies. The study also aims to include centres other than those selected by the Swiss Federal Social Insurance Office.

Eligibility Criteria:
Inclusion criteria:

* For all groups:
* parents speak English, German or French
* diagnosis of Autism or Pervasive Developmental Disorder not otherwise specified
* 5 years or younger at the start of Intervention
* parents consent
* Experimental Group:
* family was accepted by one of the participating Service Providers

Exclusion Criteria:

* Experimental Group:
* receipt of a second intervention that either interferes with the intensive Intervention or is also intensive (more than 10 hours a week)
* Comparison Group:
* receipt of any Intervention that is more than 10 hours a week
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound

The goal of this study is to determine whether the use of injectable osteoinductive/osteoconductive compounds (OOC) during Anterior Cruciate Ligament (ACL) reconstructive surgery, combined with an accelerated rehabilitation protocol (ARP) provides clinical outcomes superior to those attained via traditional ACL reconstruction and delayed rehabilitation protocols.


Eligibility Criteria:
Inclusion Criteria:

* any adult undergoing a surgical procedure for hamstring ACL reconstruction

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation

Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)

all patients coming to the LUPUS multidisciplinary consultation in brest ( France) will have a clinical examination, a biological and immunogical blood samples, cutaneous biopsies or renal biospies if necessary, an ultrasonographic articular and salivary glandular examination if needed. In case of articular involvement, some Xrays ( hands and feet) will be done at the inclusion and during the follow up each year during 5 years .

Eligibility Criteria:
Inclusion Criteria:

* women or men, more than 18 years old, coming to the multidisciplinary consultation in brest ( France).
* With written consentment

Exclusion Criteria:

* patients less than 18 years old
* refusing to participate
* Under legal protection
EBUS/Spectrum Analysis

To evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years or older
* Patients with known or suspected lung cancer who require EBUS-TBNA for lymph node staging

Exclusion Criteria:

* Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy
* Inability to give informed consent
* Patients who are pregnant
Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection

Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.

To compare the difference of operative time and complication between two operative methods in robot neck surgery and routine endoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

1. papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis;
2. patient's concerns of neck scars and cosmetic requirement.

The exclusion criteria were as follows:

1) tumor size \>4cm; 2) previous neck surgical history； 3）residual or recurrent tumors; 4) suspicious primary tumor or metastatic lymph node invasion of major vascular structures or recurrent laryngeal nerve.

5）metastatic lymph nodes occurred below the sternoclavicular joint.
ASH Research Collaborative Data Hub

Benign and malignant hematologic diseases are relatively rare conditions within the spectrum of medical practice in any one site of care. Nonetheless, recent research in hematologic conditions from basic, translational, clinical and population perspectives offer the possibility of improving the way that these diseases are treated, and the outcomes experienced by patients. A repository that aggregates and validates this data across institutions and other practice settings is needed in order to identify variation in care, new findings, and further research.

The ASH Research Collaborative (ASH RC) is a non-profit organization established by the American Society of Hematology (ASH) in 2018 that aims to improve the lives of those affected by blood diseases by fostering collaborative partnerships to accelerate progress in hematology. The foundation of the ASH RC is its Data Hub, a technology platform that facilitates the exchange of information by aggregating in one place, and making available for inquiry, research-grade data on hematologic diseases. In 2019, ASH RC launched its first research initiative, the Sickle Cell Disease (SCD) Clinical Trials Network (CTN), with the goal of optimizing SCD clinical research operations. As part of its core functions, the SCD-CTN leverages the Data Hub to collect key information and identify gaps that will help advance SCD research and treatment.

The primary goal of the Data Hub is to further the scientific knowledge base for the diagnosis, understanding, and management of benign and malignant hematologic conditions by assembling data collected in routine clinical care and closed clinical trials. Secondary goals are to characterize and study practice patterns for benign and malignant hematologic conditions in clinical practice, and to aggregate patient-reported data to further understand and improve the patient experience. These objectives will be fulfilled by amassing data from patients' electronic medical records and other data sources within institutions and networks to support prospective data collection efforts, such as those that include patient reported outcomes.

Eligibility Criteria:
To be included in the Data Hub, patients must have documented sickle cell disease and/or active multiple myeloma since 2015.
Contraceptive Pills and Retinal Vascularization

The main hypothesis is the taking of combined 1st and 2nd generation or 3rd and 4th generation oral contraceptives is associated with a change in retinal micro-vascularization compared to the absence of combined oral contraceptive intake.

Women of childbearing age will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to their medical and ophthalmologic history and their oestro-progestative contraceptive intake will be collected.

The objective is to find an association between retinal vascular density and combined oral contraceptives intake.


Eligibility Criteria:
Inclusion criteria

* for the control group : No Estro-progestin contraceptive treatment (oral, transdermal) for at least 6 months
* for the cases under combined 1st and 2nd generation pills : Estro-progestin contraceptive treatment for at least 6 months
* for the cases under combined 3rd and 2th generation pills: Estro-progestin contraceptive treatment for at least 6 months

Exclusion criteria:

* Menopausal woman
* Ametropia greater than + 3 hyperopia diopters or-3 myopia diopters
* Astigmatism greater than 2 dioptres
* Smoking patient (cigarette or e-cigarette)
* Caffeine intake within 2 hours prior to the OCT-A exam
* Any known retinal pathology
* Antecedent of deep vein thrombosis or deep arterial thrombosis