cyrilzakka/clinical-trials huggingface dataset:
Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines

This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of any race, 35-55 years of age
* Moderate to severe glabellar wrinkles (lines between the eyebrows)

Exclusion Criteria:

* Previous botulinum toxin therapy
* Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
* Subjects planning a facial cosmetic procedure or visible scars
* Previous cosmetic surgery to the upper face
* Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
* History of facial nerve palsy
* Allergy or sensitivity to any component of the study medication
A Study of Dasatinib Management Among CP-CML (Chronic Phase, Chronic Myeloid Leukemia) Participants Initiating Dasatinib in a Real Life Setting

This is a prospective, non-interventional study conducted in CP-CML patients receiving dasatinib who are enrolled by a sample of hematologists in France.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged greater than or equal to 18 years
* Patients diagnosed with CP-CML
* Patients who started dasatinib within the last month before inclusion, or on the day of inclusion or within the month after inclusion

Exclusion Criteria:

* Patients participating in an ongoing interventional trial
* Patients diagnosed with AP-CML (accelerated phase) or BP-CML (blast phase)
Effect of Actonel on Periodontal Health of Postmenopausal Women

Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial periodontal effects.

Women who use Actonel for osteopenia will show beneficial attachment loss, alveolar bone height and morphology as compared to those who do not when oral hygiene is corrected for.

Eligibility Criteria:
Inclusion Criteria:

* Osteopenia
* Postmenopausal

Exclusion Criteria:

* Male
* Diabetes
SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism

Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
* Written informed consent

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
* Other indication for VKA than PE/DVT
* More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)heparin or initiation of VKA treatment prior to randomization
* Participation in another pharmacotherapeutic study within the prior 30 days
* Creatinine clearance \<10 mL/min, severe hepatic disease, or bacterial endocarditis
* Life expectancy \<3 months
* Active bleeding or high risk for bleeding
* Uncontrolled hypertension: systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg
* Pregnancy or childbearing potential without proper contraceptive measures or women who are breastfeeding
* Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin, enoxaparin, or tinzaparin
Online Physical Therapy Management for Physiotherapists to Cope Psychological Distress During Covid-19 Pandemic

This project is aimed at physiotherapists and physiotherapy students who have been psychologically affected during the COVID 19 pandemic.

The objective of the approach is to generate a free intervention programme in virtual modality, from the approach of physiotherapy in mental health, which would help them to alleviate the negative effects of the pandemic, offer them coping tools and collaborate to improve their state of well-being.

The intervention group will consist of the Ínsula method. Insula method will be developed twice a week for 12 weeks online form through videoconference platform. The intervention will consist of twelve individual treatments. It is a program of Physiotherapy in Mental Health, created by the physiotherapists Eugenia de León (Guatemala) and Moisés Magos (Mexico) in conjunction with the Psychiatrist Roberto Martínez Porras (Guatemala). It has a progressive design, seeking to strengthen emotional self-regulation skills, connection with others and the environment, and to guide a self - knowledge process. All these objectives are worked through body resources, like conscious movement, breathing, posture, contact, relaxation exercises, etc. The program has influence of various other disciplines such as Tai - Chi, Chi Kung, Sensorimotor Therapy, Somatic Education, Mindfulness, BBAT, among others. Likewise, its principles and progression are based on theoretical models of Neurosciences

Eligibility Criteria:
Inclusion Criteria:

* they are physiotherapist with a moderate or severe psychological distress self-perceived regarding COVID-19 pandemic
* age \>18 years
* they can manage to stand from the position of "lying", "sitting", and "standing" without assistance
* they can have smartphone, laptop or device and internet access to follow the intervention

Exclusion Criteria:

* they could not follow the intervention due to cognitive or physical health
The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

The aim of this study is to assess which of two commonly used surgical procedures in the treatment of ovarian cysts called endometriomas (cutting out of the cyst - "cystectomy", or draining it and cauterising it's inner lining - "ablation") causes the least damage to the ovary and is therefore best at maintaining the future fertility potential of a patient.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing laparoscopic surgery for treatment of unilateral endometriomas measuring ≥ 3cm and ≤ 8cm in diameter

Exclusion Criteria:

* Patients who have received oestrogen suppressing drugs (e.g. oral contraceptive pills, GnRHa) during the previous six months
* Patients who have previously undergone surgical treatment of endometriomas
* Patients with bilateral endometriomas
* Patients with endometriomas of less than 3cm in size or more than 8cm in size
* Pre-surgical evidence of reduced ovarian reserve
* Pregnant patients
* Patients unable to give informed consent e.g. patients with mental incapacity
Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital

This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system in a paediatric outpatient population in KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.

RENEW's Surveillance Monitoring system is made up of two main components:

a patient-worn wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a central station software platform (Surveillance Station). The Aingeal device measures single lead ECG, heart rate, respiration waveform and rate, and skin temperature. A snapshot of data is transmitted by the devices intermittently to the Surveillance Station, enabling vital signs trends to be plotted. This proposal describes the evaluation of RENEW's Aingeal device in a paediatric outpatient population in KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. In the paediatric population, assessment of RENEW's Aingeal device will include the accuracy of the device at deriving heart rate from single lead ECG and at deriving respiratory rate when compared against a commonly used vital signs monitor. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Male or female paediatric patients, aged between 3 and 17 years
* Patients attending outpatient care at KK Women's and Children's Hospital, Singapore

Exclusion Criteria:

* Patients with active, implantable devices (such as a pacemaker or ICD)
* Patients with any skin condition or injury affecting the electrode placement site
* Patients that are pregnant
* Those patients who, in the opinion of the clinic staff, are not suitable to participate.
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).

A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.

Eligibility Criteria:
Inclusion Criteria:

1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
4. Age ≥18 years at the time of CERAB procedure.
5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -

Exclusion Criteria:

1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.

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Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)

The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).

The project aims to study protein turnover in glioblastoma using mass spectrometry after 13C-valine incorporation. This will allow to identify proteins in circulation secreted by tumor which could be diagnostic and pronostic biomarkers in patients With High-grade Glioma.

Eligibility Criteria:
Inclusion Criteria:

* more or equal than 18 years old
* patient affiliated to social security or similarly regime
* informed consent form signed
* High-grade Glioma tumor suspicion
* Resective surgery indication
* Hematological assessment :

  * neutrophils \> 1500/mm3
  * Platelet \> 150 000
  * blood Creatinin normal
  * alkaline Phosphatases and transaminases no more than two times normal
  * Bilirubin \< 1.5 times normal

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Precedent complete macroscopic tumor resective surgery
* No valid inclusion criteria
* Intratumoral hemorrhage MRI detected
* Treatment anticoagulant or antisludge treatments
* Active Infections and non controled or medical affection or psychiatric intercurrent non treated
* Evolutive cerebral oedema without corticoid response
* Non controled Epilepsy without antiepileptics response
* Karnofsky score \< 40%
* Weight \> 100 kg
* No possibility of resective surgery
Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers

The purpose of this research is to evaluate and compare the effectiveness of two parenting programs in reducing the ADHD symptoms and behavioral problems of preschool children with ADHD through a controlled study. One program is a home-based parent training intervention that is designed to enhance the parent-child interaction, constructive parenting skills, and the child's tolerance for delay. The other intervention is a clinic-based parent training program that focuses on reducing noncompliance in preschool children and improving parenting skills.

Both programs consist of private weekly parenting sessions with Clinical Psychologists - once a week for 8 weeks. The sessions are 1-1.5 hours in length. Both programs use behavior modification as a means of improving oppositional and non-compliant child behavior. Both interventions also involve procedures that focus on improving children's attention.

Neither program involves medication, and all families will receive one of the two parenting programs being evaluated. Study evaluations, as well as participation in the parenting programs, are provided at no cost to families. Evaluation and parenting sessions can be scheduled at times convenient to families.


Eligibility Criteria:
Inclusion Criteria:

* Age = 3.0 - 4.11
* In preschool program at least 2 half days per week
* Meets criteria for ADHD on clinical evaluation / DISC
* ADHD severity: \> 1.5 SD above mean for age/sex on CTRS-R
* ADHD severity: \> 1.0 SD above mean for age/sex on CPRS-R

Exclusion Criteria:

* Current Medication treatment for ADHD
* IQ \< 70 (Full Scale on WPPSI III)
* Pervasive Developmental Disorder
* Psychosis
* Severe receptive language impairment
* Neurological Disorder
* Significant medical disorder
* Primary caretaker is not able to participate
* Non-English speaking primary care taker
The Collection and Transmission of Electrocardiogram Using a Wearable Device

A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device

The collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male volunteers who can use an Android smartphone.
* The subjects who voluntarily agree to participate and give written informed consent.

Exclusion Criteria:

* The subjects who have hypersensitivity to adhesives, such as medical bandages, or have clinically significant skin lesions.
* The subjects who are judged to be inappropriate for the clinical trials to participate.
Motor Adaptation by Error Augmentation Force Field in Healthy Peoples' Upper Extremity

Inducing a systematic perturbation forces on the hand during arm reaching movement may improve adaptation. Error-augmentation (EA) training is relatively new concept in motor learning intended to promote the adaptation process. In this study participants will practice one session of training on 3D robotic device. Healthy volunteers will be randomly divided into two groups: study and control. The study group will carry out the training session with EA forces. The control group will carry out the same procedure with null force field. Outcome measure are the average size of trajectory error from the straight line and level of exertion (borg scale).

A single process involved in motor learning is adaptation. Hand reaching movement has been extensively used to evaluate the concept of motor adaptation. By inducing a systematic perturbation on the hand, it is possible to examine the implicit motor response on the trajectory of the hand. Error-augmentation (EA) training is relatively new concept in motor learning intended to promote the adaptation process. Applying these perturbating forces on the hand shift the hand trajectory form the straight line to a curve like shape. Making repetitive movement under the same conditions will results in a gradual correction of this faulty movement trajectory toward the straight line, e.g. motor adaptation.

Participants: Healthy volunteers, aged 20-50, males and females. The participants will be randomly assigned into two groups: study or control group.

Procedure: One practice session of 25 minutes on 3D robotic device. The study group will carry out the session with EA forces. The control group will carry out the same training without the EA forces.

Outcome Measures: Size of trajectory error from the straight line, level of exertion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Neurologic disease, orthopedic syndrome of the dominant upper extremity.
Description and Evaluation of Eating Disorders in Elite Athletes (TCA SHN)

Athletes in particular elite athletes have obsessional food and body concerns, in bond with a worship of the performance more and more invading, which lead to clinical and subclinical eating disorders. These eating disorders differ according to the disciplines and are difficult to diagnose in athletes because there are insufficiently described.

Our aim at estimating the frequency of eating disorders in athletes and describing eating disorders by means of somatic, dietetic and psychological evaluations.


Eligibility Criteria:
Inclusion Criteria:

* to have at least 12 years
* to be registered on the high level sportsmen list or to be in access to high level sport
* to have obtained the non opposition of the athlete if he is major (if not the legal person in charge of the athlete have to give is non opposition).
* to be affiliated to social security

Exclusion Criteria:

* presenting obvious cognitive disturbance
* not able to understand or/ and to read French language
* pregnant women
* subject under tutelage
The Effect of Renin Angiotensin System Blockage (RAS) Blockade On PTX3 Levels In Diabetic Patients With Proteinuria

Long pentraxin 3 (PTX3) is a recently discovered multimeric inflammatory mediator structurally linked to CRP and serum amyloid P-component. There is no data about the effects of Renin angiotensin system blockage (RAS) on PTX3 levels in diabetic patients with proteinuria. The aim of this study was to find out whether the beneficial effects of RAS blockage in diabetic proteinuria has any relation with the alteration of PTX3 levels. We searched for the effects of ACE inhibitor ramipril on the clinical and laboratory parameters of diabetic patients with proteinuria.

The patients who were non-obese (BMI\<30kg/m2), non dyslipidemic (total cholesterol \<200mg/dl, Triglyceride\<150mg/dl), and free of cardiovascular events (negative medical history, negative ECG findings) were investigated for enrollment. CKD stage 1 patients older than 18 years of age and willing to participate to the study were screened. From the 266 patients with established type 2 diabetes mellitus, 141 had proteinuria and/or hypertension (24 h protein excretion 1-2 g/day, systolic blood pressures ≥140mmHg and/or diastolic blood pressures ≥ 90 mmHg, respectively). All cases were first referrals and at the time of the study all were off treatment. Patients with history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. Of 141 screened patients 60 met the study criteria and were included in this study. The duration of proteinuria and diabetic nephropathy after initial diagnosis was not known.

The exclusion criteria were as follows: A)Nephrotic syndrome, B)coronary heart disease (patients with ischemic ST-T alterations and voltage criteria for LVH on electrocardiogram, and with history of revascularization or myocardial infarction), C) elevated liver enzymes (AST or ALT levels ≥ 40U/L) and D) renal failure (serum creatinine levels \> 1.3 mg/dl).

In order to evaluate the effect of RAS blockade on plasma PTX3 concentrations, patients with proteinuria were given an ACE inhibitor (ramipril 5 mg/day) for 12 weeks. The effect of RAS blockade on insulin sensitivity and proteinuria was also investigated.

After the intervention period, blood samples were obtained for assay of plasma PTX3 concentrations, HbA1c , and insulin resistance scores (HOMA-IR). Urine samples were also collected over a 24-hour period to determine the degree of proteinuria.

Eligibility Criteria:
Inclusion Criteria:

* CKD stage 1 patients
* Older than 18 years of age
* Type 2 Diabetic patients
* Proteinuria

Exclusion Criteria:

* History of coronary artery disease
* Smokers
* Taking statins or renin-angiotensin blockers
A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.

Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also be of importance in IMRT for recurrent and second primary head and neck cancers in previously irradiated territory.

This trial investigates the feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel (\[18F\]FDG-PET-voxel) intensity-based IMRT in reirradiation of patients with recurrent and second primary head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory.
* Primary unresectable tumor and/or patients refused surgery.
* No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer.
* Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer.
* Decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab)
* Karnofsky performance status ≥70%.
* Age ≥ 18 years old.
* Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

* Previous radiotherapy for cT1-2 cN0 M0 glottic cancer.
* Brachytherapy as treatment for second primary / recurrence.
* Distant metastases.
* Other second primary tumors that are not under control.
* Pregnant or lactating women.
* Elevated blood creatinine level.
* Allergy to the CT-contrast agents.
* Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.