cyrilzakka/clinical-trials huggingface dataset:
Real-time Feedback of SYNTAX Score Category During Coronary Angiographies to Improve Appropriateness of Coronary Revascularization for Patients With Stable Coronary Artery Diseases: a Before-and-after Controlled Study

The SYNTAX score (SS) has been recommended by clinical guideline and appropriate use criteria for coronary revascularization (CR) to provide guidance on optimal treatment strategies for patients with stable coronary artery diseases (CAD). However, discrepancy in SS between angiographic core lab (ACL) and cardiologists has been found. Whether the misestimate will lead to inappropriate CR and whether a SS intervention will improve CR appropriateness in patients with stable CAD remain unknown.

Thus, our study aims at evaluating whether a real-time feedback from ACL rightafter the angiographies will improve CR appropriateness. A before-and-after controlled trial was designed. In the first period of time, stable CAD patients undergoing elective coronary angiographies with at least one coronary lesion stenosis ≥ 50% from one Chinese cardiac center will be continuously recruited as the control group. In the second period, eligible patients will be recruited continuously and a real-time SS category feedback from ACL rightafter the angiography will be given to the cardiologists. Appropriateness of treatment strategies in two groups will be analyzed to determine whether a real-time SS feedback can improve the treatment appropriateness. The appropriateness of treatment strategies will be adjudicated by Chinese version appropriate use criteria for CR.


Eligibility Criteria:
Inclusion Criteria:

1. Undergo elective coronary angiography with at least one coronary lesion stenosis ≥ 50%;
2. Patients with stable coronary artery diseases (stable angina, no or non-ischemic symptom);
3. Written informed consent.

Exclusion Criteria:

1. Have prior CABG;
2. Have stage PCI;
3. Have no assigned scenario in Chinese appropriate use criteria.
Endometrial Ablation With Non-hysteroscopic Methods

Endometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. This study aims to prove that amenorrhoea rates using Novasure are higher than those observed in microwave endometrial ablation, one year following intervention.


Eligibility Criteria:
Inclusion Criteria:

* Women presenting with dysfunctional uterine bleeding having completed their family planning(no wish for further childbearing)

Exclusion Criteria:

* Endometrial pathology
* FSH \> 20 day 2 -day 3 of the cycle
* Clotting Disorders
* Thyroid Dysfunction
Breastfeeding and Complementary Feeding in Relation to BMI and Overweight

This study examines the associations between different types of infant feeding and BMI and overweight in childhood. The study is based on the Danish National Birth Cohort, established in 1996.

The objective of the study is to examine whether duration of breastfeeding, timing of introduction of complementary food and protein intake at 18 months are associated with BMI and overweight at ages 7 and 11 years, independent of BMI during infancy.

Children participating in the Danish National Birth Cohort were followed-up at ages 7 and 11years. Information on infant feeding, protein intake at 18 months, Ponderal Index at birth, child BMI (5 months, 12 months, 7 and 11 years) and several parental factors was available.

Path analysis was used to assess the direct and indirect effects of infant feeding on BMI z-scores at ages 7 (n= 36,481) and 11y (n=22,047). Logistic regression analyses were used to examine associations with overweight.

Eligibility Criteria:
Inclusion Criteria:

* The women were invited at their first antenatal visit at the general practitioner.Women were included if they intended to carry the pregnancy to term, had a permanent address in Denmark, and spoke Danish well enough to participate in telephone interviews.

Exclusion Criteria:

* Women who were not pregnant.
VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors

A more recent competing technology for implementing the DIBH technique is real-time surface photogrammetry using the AlignRT system (Vision RT Ltd., London, UK). AlignRT system use non-ionization near infrared light to track patient surface motion. The system has one projector projecting near infrared optical pattern on patient surface. The optical pattern is imaged by optical cameras (two per pod) at \~25 Hz. The user selects a region-of-interest (ROI) on the surface and the software calculates and displays the real-time position in six degrees (3 translations and 3 rotations) in real-time. Once the patient has matched the pre-determined DIBH position (within threshold accuracy), the radiation beam is enabled to be turned on for treatment.

VRT-DIBH has already applied to left breast radiotherapy to spare lung and heart. Compared to ABC-DIBH, VRT-DIBH has several potential advantages:

1. VRT monitors patient (surface) position in addition to DIBH signal, while ABC only check the tidal volume, which can remain the same even if the patient shifts slightly on the couch;
2. VRT is more cost effective, as patient tubing needs to be replaced daily for ABC;
3. VRT potentially has advantage on patient compliance, as with ABC breath is forced impeded while with VRT breath-hold is voluntary.

In this study, we renovate the established DIBH motion management strategy by adopting AlignRT system. The purpose of this study is to develop, validate, and prove the feasibility of VRT-DIBH technique for lung and liver SBRT.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be willing and capable to provide informed consent to participate in the protocol.
2. Patient with presumed pulmonary function capable of holding breath for at least 30 seconds - later to be confirmed.
3. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and until study imaging is complete. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

3.1 A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

3.2 Patients must be compliant to all required pretreatment evaluations

Exclusion Criteria:

1. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
2. Patients are not compliant to all required pretreatment evaluations
Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks

Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required for a 50% difference with the standard deviation of the control group, a significance level of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35 patients per group.

The expected benefit is the reduction of pain at the skin puncture during the realization of BAX.

Improving professional practice and quality care


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized for upper extremity surgery scheduled
* Having an axillary block anesthesia.
* Free subject, without subordination or guardianship
* Patients undergoing a social security system or benefiting through a third party
* Informed consent and signed by the patient after clear and honest information on the study

Exclusion Criteria:

* Age \< 18 years
* Hypersensitivity to lidocaine, prilocaine, to one of the excipients, castor oil and its derivatives
* Hypersensitivity to local anesthetics of the amide
* Congenital Methemoglobinemia
* Porphyrias
* Glucose-6-phosphate dehydrogenase
* Hypersensitivity to any component of Dexeryl ®
* Disorders of atrioventricular conduction requiring permanent pacing not yet realized.
* Epilepsy uncontrolled by treatment
* Patients on anticoagulants
* Skin infection from the puncture site
* Patients with psychiatric disorders or dementia
* Cons-indication for infusion Isofundine ®:
* Severe congestive heart failure
* anuria
* oligoanuria
* Fluid retention
* hyperkalemia
* hypercalcemia
* Metabolic alkalosis
* Patients not receiving a social security system or not qualifying through a third party
* People receiving more protection ie minors, persons deprived of liberty by a judicial or administrative decision, guests staying in a hospital or office, adults under legal protection,
* Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, oophorectomy total )
Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment

The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.

Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.

Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to analyze the safety and usability of the EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.

A test phase will be conducted in order to make some final modifications and improve the device. Some participants of the sample will use the device in 1-3 occasions in a controlled environment.

After these modifications, participants will use the final version of the device in 8 different occasions in their homes and the community in order to prove its safety and usability.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebral palsy, acquired brain injury or spinal muscular atrophy
* Medical authorization for standing, gait training and weight bearing.
* Informed consent signed by legal guardians.
* Maximum user weight of 60 kg.
* Hip width (between greater trochanters) ≤40 cm.
* Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 21cm to 36cm.
* Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 20cm to 35cm.
* Shoe size ≤40 (EU)

Exclusion Criteria:

* Medical contraindications for standing or walking.
* Non-reducible contractures or heterotropic ossifications above the degrees allowed by the device or out of the trajectory imposed by the device
* Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
* More than 20º of hip and/or knee non-reducible contractures at the time of using the exoskeleton.
* Necessity to walk with more than 5º of hip abduction.
* Impossibility to reach 5º of ankle dorsiflexion with ir without orthoses.
* Lower length dysmetria that cannot be mitigated with a wedge under the foot.
* Skin lesion on parts of the lower extremities that are in contact with the device.
* History of fracture without trauma.
* Presence of other conditions causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease).
* Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness.
* Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.
Communication Skill Training Program for Occupational Therapy Interns

Effective communication is one of important skills in occupational therapy (OT) practice, affecting the effectiveness and quality of therapy. Although there are only a few courses on communication skills related to OT, there is a lack of a complete, suitable, and evidence-based OT communication skills teaching programs that can effectively improve the interns' communication skills. The purpose of the study is to develop a communication skills training program for occupational therapy interns in physical dysfunction practice (COPE), and examine the effectiveness of COPE.


Eligibility Criteria:
Inclusion Criteria:

\[interns\]

* age ≥ 20 years
* an intern of occupational therapy

\[patients\]

* age ≥ 20 years
* enable to communicate with the others

Exclusion Criteria:

\[interns\]

* unwilling to be recorded

\[patients\]

* have communication barriers
* unwilling to be recorded
PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.

Primary Objectives:

* To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for reducing the cumulative incidence of grade lymphedema among breast cancer patients after ALND compared to routine screening. Secondary Objectives:
* To estimate the direct costs associated with the Lymphedema Screening Initiative
* To determine the association of the Initiative on patient productivity
* To determine patient satisfaction with the Lymphedema Initiative in the context of their cancer care
* To determine patient understanding of lymphedema-associated symptoms
* To determine patient self-reported compliance with treatments and measures to prevent lymphedema
* To determine the incidence of breast cancer-related lymphedema among a cohort of breast cancer patients treated with ALND To analyze clinical and pathological features associated with the development of lymphedema

Eligibility Criteria:
Inclusion Criteria:

a Cohort A:

* Breast cancer patients with a baseline (preoperative perometer measurements) who have undergone axillary lymph node dissection
* English speaker
* Patients who participate in Cohort A will be eligible for enrollment in Cohort

b Cohort I:

* Breast cancer patients who have undergone axillary lymph node dissection who have a clinic visit in the Nellie B. Connally Breast Center approximately 12 months (+/- 4 months) following axillary lymph node dissection
* English speaker

c Cohort II:

* Breast cancer patients who have undergone axillary lymph node dissection who are having a follow-up visit in the Nellie B. Connally Breast Center within 0-6 months following surgery who intend to continue follow-up care at MD Anderson
* English speaker

Exclusion Criteria:

Inability to complete a self-administered questionnaire
A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug)

This is a multicenter, randomized, double-blind, parallel group, 48-week follow-up, Phase IIa clinical study. This study has been designed to evaluate the change in HBsAg (log10 IU/mL) after administration of hzVSF-v13 50 mg/dose and hzVSF-v13 200 mg/dose in combination with an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) compared to an oral antiviral agent in combination with a placebo (normal saline) in patients with chronic hepatitis B who are stably receiving an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) for at least 24 weeks.

Among the subjects who provided a voluntary written consent to participate in this clinical study, the patients with chronic hepatitis B who are stably receiving an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) for at least 24 weeks prior to the screening visit can be considered as potential subjects of this study. Only the subjects who completed the final eligibility evaluation at the baseline visit (Visit 2) after the screening tests will be randomized to the hzVSF-v13 50 mg combination group, hzVSF-v13 200 mg combination group (study group) and placebo combination group (control group) at a 1:1:1 ratio at each site. The randomized subjects will receive intravenous administration of hzVSF-v13 or the placebo to match hzVSF-v13 four times with 4 weeks interval for a total of 12 weeks, and oral administration of 1 tablet of an oral antiviral agent will be given once daily for a total of 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Those who have a history of a diagnosis of chronic hepatitis B more than 24 weeks prior to screening and have been maintaining HBsAg positive at screening
2. Those who have an HBV DNA level that is below \<20 IU/mL
3. Those who have been receiving tenofovir (including Tenofovir's salt-free or salt-modifying drugs), or entecarvir (including Entecavir's salt-free or salt-modifying drugs) stably for ≥24 weeks prior to screening and anticipated to maintain the identical drug with equivalent dosage and administration during the clinical trial.

Exclusion Criteria:

1. Those with a history of clinically significant chronic liver disease caused by other than chronic HBV infection at the time of screening
2. Patients with a signs of loss of liver function and decompensation of liver disease
3. Patients with uncontrolled diabetes (HbA1c \>7.5%)
4. Patients with uncontrolled hypertension
Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss

The purpose of the study is to determine whether AM-111 is effective in the treatment of acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL).


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral acute sensorineural hearing loss (ASNHL) with onset 48 hours or less ago
* Mean earing loss compared with the unaffected contralateral ear of at least 30 dB in the 3 most affected contiguous frequencies
* Age ≥ 18 years and ≤ 60 years
* Negative pregnancy test for women of childbearing potential
* Able to attend the on-study visits
* Written informed consent before participation in the study

Exclusion Criteria:

* Bilateral ASNHL, if not resulting from acoustic trauma
* Suspected perilymph fistula or membrane rupture
* Barotrauma
* Average air bone gap higher than 20 dB in 3 contiguous frequencies
* History of Meniere disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion or fluctuating hearing loss
* Previous ASNHL incident within the past 6 weeks
* Evidence of acute or chronic otitis media or otitis externa on examination
* Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks
* Any ongoing or planned concomitant medication for the treatment of tinnitus until 30 days after administration
* Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months prior to study inclusion
* History of drug abuse or alcoholism
* Any clinically relevant respiratory, cardiovascular, neurological (except vertigo or tinnitus), or psychiatric disorders
* Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
* Women who are breast-feeding, pregnant or who plan a pregnancy during the trial
* Women of childbearing potential who declare being unwilling or unable to practice contraception such as combined oral contraceptives, injectables, hormonal intra-uterine devices, vasectomised partner or sexual abstinence
* Concurrent participation in another clinical trial or participation in another clinical trial within 30 days prior to study entry
* Any current anticoagulant therapy (e.g. Aspirin, Marcumar, etc)
Basal Tumours in Bladder Cancer, Response to chemoTherapy

Determine the sensitivity/resistance to chemotherapy of the various subgroups of muscle-invasive bladder cancers, including the basal subgroup (about 25% of these tumours) according to 4 different classifications based on molecular or immunohistochemical classifiers.


Eligibility Criteria:
Inclusion Criteria of Patients enrolled in VESPER study:

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort and :

* having signed an informed consent form for the participation to the collection or
* dead/lost to follow-up without prior opposition expressed against research program,
* genetic analysis will only be carried out for patients who have signed the genetic consent form.

Inclusion Criteria of Patients from St Louis cohort not enrolled in VESPER study:

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort and :

* having received an informed form for the participation to the collection and not having expressed opposition against research program within 1 month or
* dead/lost to follow-up without prior opposition expressed against research program,

Exclusion Criteria:

-Patients enrolled in VESPER study:Tumors from patient having withdrawn his/her informed consent form for the participation to the collection and/or VESPER project.

OR

-Patients from St Louis not enrolled in VESPER study:Tumors from patient having expressed opposition against research program after 1 month for the participation to the collection.
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

Primary Objective:

Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).

Secondary Objectives:

* Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.
* Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with hepatic impairment and in matched subjects with normal hepatic function.

Total duration of the study per subject (excluding screening) is about 12 weeks.

Eligibility Criteria:
Inclusion criteria :

* Male or female, between 18 to 75 years of age, inclusive.
* Patients with mild and moderate hepatic impairment based on Child-Pugh score and stable chronic liver disease.
* Healthy subjects with normal hepatic function.

Exclusion criteria:

* Patients with acute hepatitis, hepatic encephalopathy grade 2, 3, and 4.
* Patients with history or presence of uncontrolled clinically relevant illness.
* Healthy subjects with history or presence of clinically relevant illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.