cyrilzakka/clinical-trials huggingface dataset:
Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients

The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment serological markers of inflammation and assess for correlation with AI-MS.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent.
* Postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration.

Exclusion Criteria:

* History of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints.
* Treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration.
* Prior treatment with an AI (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw)
* Active or ongoing infection
* Known metastatic disease
* Known history of HIV or hepatitis infections
* Ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an AI)
* Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer)
* Pregnant or lactating
* Unable to speak, read, and write in English
Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia

The purpose of this study is to explore the efficacy and safety of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.

PRIMARY OBJECTIVES:

To determine the Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates, the measurable residual disease (MRD) rates, the complete molecular remissions (CMR) rates and the progression-free survival (PFS) of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.

SECONDARY OBJECTIVES:

To describe the toxicities of the OVD regimen. To assess the quality of life and overall survival of the OVD chemotherapy-free regimen in patients with newly-diagnosed Ph+ALL.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of newly-diagnosed Ph+ acute lymphoblastic leukemia
* Age \>= 18
* Adequate hepatic function
* Adequate renal function
* Adequate heart function
* Life expectancy of more than 3 months
* Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity from the time of signing the informed consent for through 120 days after the last dose of study medication.
* Women of childbearing potential have negative pregnancy test within 72 hours of initiating study drug dosing.
* Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy.
* All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program.

Exclusion Criteria:

* Current or anticipated use of other investigational agents.
* Female patients who are lactating or have a positive serum pregnancy test during the screening period.
* Major surgery within 3 weeks prior to first dose
* Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
* Known or suspected HIV infection, known HIV seropositivity
* Active hepatitis infection
* Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal
* Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance, including difficulty swallowing
Macroscopic Deciduosis in Pregnancy is Finally a Common Entity

The purpose of this study is to determine the prevalence of macroscopic deciduosis found randomly in Cesarean sections and the secondary objective to determine the association with any obstetrical complications or adverse effects.

Ectopic decidua or deciduosis is defined as the extrauterine location of decidual tissue and can occur in the cervix, vagina and various abdominal organs like the ovary omentum, appendix, peritoneum, the pelvic lymph nodes. Other rare sites with deciduosis include the kidneys , the lungs and even the skin . Decidualization is a physiologic process during pregnancy, under the influence of ovarian and placental steroid secretion, with total involution in the four to six week post partum period.

Eligibility Criteria:
Inclusion Criteria:

* All cesarean section

Exclusion Criteria:

* Patients refusing to participate
Clobazam Use in Epilepsia Partialis Continua - Pilot Study

The purpose of this study is to evaluate whether clobazam, brand name Onf®, is more effective as an adjunctive or monotherapy in terminating Epilepsia Partialis Continua (EPC) than either lorazepam and/or clonazepam.

First approved in the United States in 2011 for use in treating Lennox-Gastaut syndrome, clobazam is the only 1, 5-benzodiazepine that is currently approved for clinical use in the United States. In previous clinical trials clobazam has been shown to have a greater efficacy and produce fewer side effects in individuals when it's adverse event profile is compared to the traditional 1,4-benzodiazepines such as diazepam, lorazepam, and clonazepam. As a benzodiazepine, clobazam has been found to have anticonvulsant properties, and structural differences as a 1,5-benzodiazepines that appear to have a broader spectrum of anticonvulsant activity than those found in 1,4-benzodiazepines. In previous reports, clobazam has been seen to be effective in ether terminating or reducing both EPC in particular and partial status epilepticus.

Eligibility Criteria:
Inclusion Criteria:

•≥ to 18 yrs of age

•Diagnosis of EPC by a Neurologist

Exclusion Criteria:

* Previous exposure to clobazam prior to presentation
* Seizure generalization
* Patients who are intubated and on IV sedation such as Versed®, Propofol or Presedex®.
* Female subjects who are pregnant and/or breast-feeding
* Subject has an unstable and/or serious or psychiatric illness
* Subject has an unstable and/or serious medical illness
* Subject has any of the following but not limited to conditions:

  * A life threatening medical condition
  * Severe sepsis or septic shock
  * Severe Renal impairment
  * Severe Hepatic impairment
  * Sleep apnea
  * Narrow angle glaucoma
  * Severe respiratory insufficiency
  * Myasthenia gravis
  * Metastatic cancer
  * Organ failure
  * Severe progressive nervous system disease
  * A clinically significant EKG abnormality that would be affected by and/or affect the patient's participation in the trial
* Subject has active suicidal ideation at Screening and Baseline visits
* Subject has a history of suicidal thoughts or behaviors, which would be indicated by a positive response to questions 4 and/or 5 on the CSSR-S. Exclusionary actions include but are not limited to:

  * Previous intent to act on suicidal ideation with a specific plan
  * Previous preparatory acts or behavior
  * A previous actual attempt, interrupted attempt or aborted suicide attempt
* Subject has a history of alcohol and/or substance abuse in the previous 12 months, or the subject is unable to refrain from alcohol and/or substance abuse during the study.
* Subject admits to present illicit drug use or has a positive drug screen
* Subject is currently enrolled in or has been enrolled in any clinical trial within the past 30 days
* Subject has a known allergy to any component of the study medication(s)
Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

This research study will assess cruciferous vegetable intake in patients presenting for screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC) expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of cruciferous vegetable intake.


Eligibility Criteria:
Inclusion criteria:

* scheduled for screening colonoscopy
* off NSAID or aspirin therapy in accordance with OHSU endoscopy clinic guidelines
* INR 0.90-1.20
* hemoglobin ≥ 13.5 (men) or 12.0 (women)
* platelets ≥100,000/μL
* Chem screen results within normal limits
* negative (serum or urine) pregnancy test done ≤7 days prior to colonoscopy for women of childbearing potential only
* ASA performance status \<2

Exclusion criteria:

* history of colon cancer or adenomatous polyps
* current smoker
* medical history of chronic obstructive pulmonary disease
* current oral steroid therapy
* current therapy with valproate or other pharmacological drugs associated with HDAC inhibition
* use of oral antibiotics within 3 months prior to entry into study
* significant active medical illness which in the opinion of the investigator would preclude collection/interpretation of colon tissue
* diagnosis of hemophilia, van Willebrand's disease or other bleeding disorder
* use of warfarin or other blood thinning agents
* inflammatory bowel disease.
Brain Visual Perception Training for Prevention and Control of Premyopia

The goal of this clinical trial is to investigate whether brain visual perception training can effectively prevent myopia in children with pre myopia. It will also learn about the safety of brain visual perception training.

The main questions it aims to answer are: Does brain visual perception training slow down the growth of axial length? What medical issues may participants encounter when using the brain visual perception training system? Researchers will compare participants who receive brain visual perception training with a control group to see if the training group can delay the onset of pre myopia in children Participants will: The training group will receive 20 minutes of brain visual perception training once a day for a period of one year. Follow up check ups at the hospital every 3 months. Keep a diary of the values of axial length and refractive diopter.


Eligibility Criteria:
Inclusion Criteria:

Children aged 6-10 years with premyopia, defined as a cycloplegic spherical equivalent refraction (SER) of the more myopic eye in the range of -0.50 to 0.75 (inclusive) diopters (D) and having at least 1parent with an SER in either eye of -3.00D or less.

Exclusion Criteria:

Children have astigmatism of 1.50D or more, anisometropia of 1.50 D or more, strabismus and other ocular abnormalities, any systemic diseases, or a history of any myopia interventions.
Obesity Hypoventilation Syndrome Prevalence Study

This is an observational study to characterize the prevalence of Obesity Hypoventilation Syndrome in patients referred to the sleep lab.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 21 yrs. of age
* Referred to sleep lab for diagnostic PSG, initial titration PSG or split night PSG as routine clinical care
* BMI greater than or equal to 30kg/m2

Exclusion Criteria:

* Acutely ill or medically unstable to participate per PI
* Current positive airway pressure(PAP therapy)users
* Medical History of Chronic Obstructive Pulmonary Disease(COPD)
* Incapable of providing own informed consent
* BMI less than 30kg/m2
One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections

The results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,..

A puncture could allow to identify the bacteria involved in the prosthetic joint infection (PJI) and an antibiotherapy for a few days can be given to the patient in order to decrease the inoculum. Then, a one-step exchange can be performed.

The purpose of this study is to describe the management of patients who had a pre-treatment before a one-step exchange of their prosthetic joint.


Eligibility Criteria:
Inclusion Criteria:

* patient with prosthetic joint infection and having had a pre-treatment, managed at the Croix-Rousse Hospital
* \> 18 years old

Exclusion Criteria:

-
Gait Characteristics Following a Fall

The purpose of this study is to quantify the safety degree of the patient's gait, to detect the reason for the fall and quantify the biomechanical parameters related to fall. This study also aims to evaluate the effect of different rehabilitation treatments and their effect on the risk of falling.

In this study, patients suffering from motor disabilities as a result of orthopedic or neurologic impairments will be tested at the gait and motion laboratory. Each patient will be secured with a ceiling-mounted safety harness and will walk on the path wearing passive light-reflecting markers and surface electrodes. High-speed cameras will record the subject's movements and the markers will be tracked to produce data of joint angles, velocities and accelerations. Dynamic EMG will be recorded from various muscles.

During the examination, the gait of the subjects will be disturb by either (i) a visual or sound signal that requires the subject to stop immediately, or (ii) walking different terrains, or (iii) tying a string to the foot and pulling it shortly to induce a trip.

Eligibility Criteria:
Inclusion Criteria:

* Individuals suffering from gait impairment following injury to the central or peripheral nervous system, as well as following orthopedic injuries. The subjects will be able to understand and independently sign a consent form.

Exclusion Criteria:

* Subjects who are unable to understand and independently sign a consent form
* Subjects who are wheelchair bound.
* Pregnant women.
Stimulate One Hand to Improve Tactile Perception on the Other

The study is a comparative study, to show that the administration of RSS stimulation on one hand compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the other hand in patients with tactile acuity impairment of the hand due to stroke.


Eligibility Criteria:
* Inclusion Criteria:

  * Age: 30-80 years old
  * Patients with diagnosis of unilateral (both right and left) ischemic or hemorrhagic stroke
  * Stroke event dates at least 3 months before the date of inclusion to the study
  * Severe-to-mild sensory loss at the fingers of the hand contralateral to the stroke lesion (affected hand)
  * Capacity to provide written consent
  * Affiliation to a social security scheme
* Non inclusion Criteria \* :

  * Sensory impairment attributable to diabetes history, peripheral vascular disease or neuropathy
  * Severe speech disorder, global aphasia and/or cognitive impairment
  * Multiple stroke events
  * Bilateral stroke event
  * History of neurological or psychiatric illness
  * Other experimental procedure is forbidden during the weeks where the study is performed
  * Pregnant, parturient and lactating women
  * Persons deprived of their liberty
  * Adult persons subject to a legal protection measure: guardianship, curatorship
  * Persons in psychiatric care
  * Congenital or acquired malformation/injury of the test fingers
  * Impossibility to maintain hand position necessary for the tests due to severe spasticity

Exclusion Criteria:

• Severe impairment of the sensibility of the index finger of the spared hand preventing the administration of the RSS
Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection

The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate the security of treatment, the QoL of patients and the influence to the PFS and OS.

Scheme:

Patients will receive different chemotherapy regimens depending on the pathological type.

Squamous cell carcinoma:Docetaxel/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Docetaxel/Cisplatin 2 cycles.

Non-squamous cell carcinoma:Pemetrexed/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Pemetrexed/Cisplatin 2 cycles.

Eligibility Criteria:
Inclusion Criteria:

* 18≤Age≤65;
* ECOG performance status of 0 or 1;
* Pathological diagnosis with Stage IIIA-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT;
* WBC≥4.0×109/l, ANC≥1.5×109/l, PLT≥100.0×109/l, Hb≥90g/l;hepatorenal function is normal;
* Without a history of other malignancies before enrollment, except for non-melanoma skin cancer, in situ cervical cancer;
* The patient can understand the research and sign the informed consent.

Exclusion Criteria:

* Female in pregnancy or lactating;Female of childbearing age without contraception;
* With acute infection or other serious underlying disease;
* With a significant history of neurological of psychiatric disease，including the dementia which may affect the ability to understand and sign the informed consent;
* Have received other treatment within the last 30 days before enrollment;
* With uncontrollable diabetes(blood glucose is unstable after treatment or FBG≥8mol/L).
Normative Assessment of Adaptable Mouthguards.

The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.

The current state of knowledge in the areas of mouthguards shows that type II (adaptable) models account for 90% of the mouthguards of the sporting population. But a majority of these devices do not appear to comply with the European Directive 89/686 / European Economic Community.

A previous work consisted of the production of prototypes of mouthguards meeting the essential requirements of the directive. These prototypes were the subject of a patent filed by the Bordeaux University and the Bordeaux University Hospital.

The aim of this study is to the validate the prototypes for a future launch on the market.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged 18 to 35,
* Subject affiliated to a social security,
* Subject who has signed the free and informed consent form.

Exclusion Criteria:

* Subject with a pathology incompatible with the performance of the test, namely: Recent infarction,Threat syndrome, blood pressure resting\> 200/120 mmHg, uncompensated cardiac insufficiency, atrioventricular block 3rd degree acquired, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac Tumor or Thrombus, Deep Vein Thrombosis, Pulmonary Embolism,
* Subject under B-mimetic drug treatment,
* Subject under safeguard of justice,
* Subject participating in another search,
* Subject during pregnancy.
REVITIVE for the Treatment of Patients With Venous Insufficiency

To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.

This is a pilot randomised control trial to assess the efficacy of a neuromuscular electrical stimulation device to improve venous blood flow and patients' symptoms in patients with chronic venous insufficiency. The Revitive IX device is a neuromuscular electrical stimulation device that gives wide pulse pattern electrical stimulation via foot pads. A cycle of treatment consists of a 30 minute programme of 15 varying waveforms that last a minute each.

Twenty patients with venous insufficiency will be screened according the eligibility criteria. Patients will be randomised to either treatment or control (sham device) group. Patients are advised to use the device 30 minutes a day, everyday, for 6 weeks. Compliance will be monitored with a data logger and diary card.

Primary outcome measure:

a) improvement in venous haemodynamics.

Secondary outcome measures:

1. improvement in lower limb oedema
2. improvement in clinical symptoms
3. reduction in lower limb pain and discomfort
4. improvement in quality of life measures
5. device satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the study and provide meaningful written informed consent for the study.
* Willing, able, and committed to participate in the procedures for the full length of the study.
* All ethnic groups, male or female above the age of 18 years.
* Diagnosis of chronic venous insufficiency (C2-C5 CEAP classified)
* Be of non-childbearing potential; or using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the device.
* Blood pressure currently under moderate control (\<160/100mmHg)
* No current foot ulceration.

Exclusion Criteria:

* Has insufficient ability to understand the subject information sheet, consent form and verbal instruction.
* Has an unstable condition (eg psychiatric disorder, a recent history of substance abuse or otherwise thought to be unreliable or incapable of complying wight he requirements of the clinical investigational plan (CIP).
* Has any metal implants.
* Pregnant.
* Has a cardiac pacemaker, AICD or other implanted electrical device.
* Has an existing DVT.
* Has an acute medical condition other than chronic venous insufficiency.
* Has recent lower limb injury or lower back pain.
* Has current foot ulceration or other skin ulcers.
* Has cardiovascular disease.
* Has foot deformities.
* Has any disorder that, in the opinion of the investigator, might interfere with the conduct of the study.
* Has an ABPI \< 0.8.