cyrilzakka/clinical-trials huggingface dataset:
Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria

This protocol has two parts - the Main Study which is 42 days in length and the Treatment Extension which allows the patients who complete the Main Study to continue receiving treatment with uridine triacetate. The purpose of this study is to replace oral administration of uridine with oral administration of uridine triacetate in patients with hereditary orotic aciduria who have received (or would reasonably be expected to receive) clinical benefit from treatment with exogenous uridine. It is also to document the continued clinical benefit of exogenous uridine when patients are switched from oral administration of uridine to oral administration of uridine triacetate.

Data to be collected during the Main Study include demographic, baseline disease information and medical history including all prior disease-directed therapy. In addition, vital signs, laboratory values and adverse events information will be collected and recorded. Urine samples will be obtained and measured for orotic acid and orotidine levels. Systemic levels of uridine will be evaluated from plasma samples collected at set timepoints.

Upon successful completion of the Main Study and entry into the Treatment Extension, physical exams and vital signs will be performed every six (6) months. Additionally, plasma samples to measure systemic levels of uridine and urine samples to measure levels of orotic acid and orotidine will be collected every (6) six months.

Eligibility Criteria:
Inclusion Criteria (Main Study):

* Patients with diagnosed hereditary orotic aciduria
* Judged by the investigator to have the initiative and means to be compliant with the protocol
* Able to take oral medications
* Able to provide written informed consent (patient or legally authorized representative)
* Females of childbearing potential must have a negative pregnancy test at screening
* Females of childbearing potential or males with partners of childbearing potential are to use one of the following acceptable birth control methods:
* Surgically sterile or partner is surgically sterile
* Using adequate contraception (hormonal contraceptives, double barrier methods, or intra-uterine devices)
* Patients who claim to be sexually inactive agree to use an acceptable method of contraception should she or he become sexually active from 14 days prior to first dosing, throughout the study and for 14 days after the last dose administration

Exclusion Criteria (Main Study):

* Has a known allergy to uridine triacetate or any of its excipients
* Known to have ornithine transcarbamoylase deficiency
* Unable to have the initiative and means to be compliant with the protocol
* Unable to be compliant with taking oral medications
* Unable to provide written informed consent (patient or legally authorized representative)
* Female who is pregnant or lactating

Inclusion Criteria (Treatment Extension)

* Patient successfully completed the Main Study

Exclusion Criteria (Treatment Extension)

* Patient did not successfully complete the Main Study
Evaluation of the Ambulatory Medical Assistance Nurse Program in Chronic Lymphocytic Leukemia

The emergence of targeted therapy (ibrutinib, venetoclax, acalabrutinib) has revolutionized the management practices of chronic lymphoid leukemia due to their effectiveness. However, targeted therapy induces a significant additional cost compared to treatment with immunochemotherapy and their use can be problematic due to the frequent occurrence of side effects, which can be serious. In order to improve the current management of patients treated with targeted therapy, the aim of this study is to evaluate the ambulatory medical assistance nurse program. Ambulatory medical assistance is based on regular telephone calls to patient's homes by a specialist nurse and consists of the monitoring, detection and early management of possible adverse effects of targeted therapy, in link with the hematologist. The main objective of this clinical research is to determine efficiency of the ambulatory medical assistance nurse program.

This research is a prospective randomized multicenter comparative study in 2 parallel groups (1: 1) : patients benefiting from the ambulatory medical assistance nurse program in addition to conventional care versus patients benefiting from conventional care. For each patient, data will be collected during 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 18
* Patients with chronic lymphoid leukemia and starting treatment with targeted therapy: ibrutinib, venetoclax or acalabrutinib, alone or in combination with obinutuzumab or rituximab in 1L or R/R according to the indications of the Marketing Authorization.
* Be able to understand the objective and the constraints related to the research
* Patient having signed the consent form
* Patient with Social Security affiliation or equivalent
* Person able to speak on the phone

Exclusion Criteria:

* Patient who has already benefited from ambulatory medical assistance nurse program with a previous treatment
* Pregnant women
* Patients under judicial protection
CEFID-I (CEra Flow Improves DVT-1)

The study is a single center clinical trial to evaluate the efficacy and safety of blood circulation improvement using an investigational medical device, which is a product on the market and it's name is Ceragem Master V6, for the risk group of Deep Vein Thrombosis (DVT) and the ordinary person. The study compares before and after the application by one time application.

The efficacy and safety evaluation are conducted before and after (or during) the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day.

Eligibility Criteria:
Inclusion Criteria for all subjects; 1. Adult men and women over 19 years of age 2. Subjects who have not been diagnosed with deep vein thrombosis in the lower extremities through the following test results prior to the application of medical devices.

1. Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea
2. D-dimer negative test result (Even if the D-dimer test is positive, the subject can be selected through the additional test at the discretion of investigator.)

3. Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent

Additional Inclusion Critetia for the DVT risk subjects;

1. Subjects have two or more points of venous thromboembolism (hereinafter referred to as VTE) clinical prediction score (Two-level wells scroe) at the time of screening

Exclusion Criteria:

1. Subjects who complain of a decrease in the sensation of the lower extremities or who is unable to feel the sensation of pain
2. Subjects who have inflammation or trauma on the skin that directly touches the device
Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy

Prospective, monocentric study evaluating the impact of a nurse-led sexological follow-up on sexual function in patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy.

The study procedure will consist of nurse-led sexological consultations, beginning before brachytherapy and until 2 months after brachytherapy.

Evolution of female sexual function and vaginal symptoms will be done through clinical examinations and completion of quality of life and female sexual function questionnaires during radiation oncologist consultation and/or nurse-led sexological consultations until one year after end of brachytherapy.

Study participation of each patient will be 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Woman diagnosed with cervix or vaginal cancer, for whom a treatment by radiotherapy and brachytherapy has been decided
3. Patient receiving for the first time an utero-vaginal or vaginal brachytherapy at "Institut Universitaire du Cancer de Toulouse - Oncopole"
4. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 2
5. All patients are eligible, regardless of their relationship status (in couple or not), their sexual orientation, and their hormonal status
6. Patient willing to give informed consent before the study and before performing any study-related procedures
7. Patient affiliated to a Social Health Insurance in France

Exclusion Criteria:

1. Patient not understanding the French language
2. Patient for whom surgical treatment and brachytherapy has been decided
3. Any psychological, familial, sociological or geographical condition that potentially hampers compliance with the study protocol and follow-up after treatment discontinuation schedule
4. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.

Eligibility Criteria:
Inclusion Criteria:

* Complicated skin and skin structure infection (cSSSI)
* Require initial hospitalization, or treatment in an emergency room or urgent care setting

Exclusion Criteria:

* Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components
* Concomitant use of adrenergic or serotonergic agent
* Uncomplicated skin and skin structure infection
* Concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction
* More than 24 hours of treatment with an antimicrobial within 96 hours before randomization
* Known or suspected endocarditis, osteomyelitis, or septic arthritis
* Severely impaired renal function
* Evidence of significant hepatic, hematologic, or immunologic disease
Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers

The main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.


Eligibility Criteria:
Inclusion Criteria:

* Mild or greater dry eye symptoms.
* Evidence of evaporative dry eye

Exclusion Criteria:

* Known allergy or sensitivity to the study product(s) or its components
* Current contact lens wearer
* Systemic or ocular allergies
* Use of systemic medication which might have ocular side effects.
* Any ocular infection.
* Use of ocular medication.
Modifications in Cardiovascular Risk Factors When Performing Physical Exercise in Hypertensive and Dyslipidemic Patients

Single-center, randomized, parallel-group, controlled, open-label study. The aim of the study was to evaluate the effects of an exercise training program intervention of different intensities (high intensity versus low-moderate intensity) on blood pressure reduction as a complementary strategy in hypertensive individuals being treated with at least one antihypertensive drug.

All participants included in the study were referred by their primary care physicians, who prescribed physical exercise as a healthy lifestyle intervention added to the antihypertensive regimens in the framework of the "ACTIVA-Murcia Program".

Participants in the HIT and LMIT groups followed the same physical training program, with the only difference being the intensity of the training. The program included two phases of physical exercise lasting 12 weeks and 16 weeks, respectively, separated by a 7-week rest period, which coincided with a holiday period. The times of both phases were not equal in terms of duration, since it is a community physical exercise program established by the Region of Murcia, and does not depend on the researchers.

The program was developed by graduates in Physical Activity and Sport Sciences, who were in charge of teaching the exercises and supervised each training session.

Participants assigned to the HIT and LMIT groups were given guidelines to continue physical exercise during the 7-week rest period, while participants in the control group were offered to participate in the program after the study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 65 years.
* Under treatment with at least one antihypertensive drug for hypertension. Treatment should have lasted at least 12 months prior to inclusion in the study.
* Diagnosed with dyslipidemia under pharmacological treatment or with a specific hypercholesterolemia (\> 200 mg/dL) in the past and a cholesterol level at the start of the study greater than 200 mg/dL.
* Patient in Primary Prevention.
* Subjects who do not develop physical exercise scheduled on a weekly basis.
* Subjects who have given written informed consent to participate in the study.

Exclusion Criteria:

* Serious or terminal illnesses.
* Diagnosis of ischemic and/or cerebrovascular heart disease.
* Presence of chronic diseases that prevent the performance of a physical exercise program or a stress test (disabling arthropathies, chronic moderate/severe pneumopathies, arrhythmias, etc).
* Severe mental illnesses: psychosis, severe depressive disorder, neurosis.
* Diabetes mellitus.
* Presence of absolute or relative contraindications dictated by the American College of Sports Medicine (ACSM, 1995), during the performance of the stress tests.
* Pregnant or breast-feeding women
* Inability to understand the informed consent.
Innovations in Respiratory Muscles Training in Patients With Chronic Obstructive Pulmonary Disease. (INNOTORIO)

Respiratory muscle weakness and fatigue are related to clinical deterioration in patients with Chronic Obstructive Pulmonary Disease (COPD). Respiratory muscle training (RMT) is a key therapeutic strategy in these patients. It is necessary therefore to increase its dissemination on a large scale, improve patient´s adherence and optimize the control of the implementation of training. The aim of this project was to design a RMT device including light and sound incentives, digital registration application and analysis of the training sessions, and studying the effectiveness of a new shortened RMT scheme of high intensity that could provide added value to enhance the implementation of training in patients with COPD. From an operational point of view, researches were organized into three packages of complementary work focused on the design of a new portable dual valve with electronic lighting and auditory incentives components. The conceptualization and design of a software to analyze the performance and individual continuous use of the valve, and the evaluation of the feasibility, safety and efficacy of a shortened schedule of respiratory muscle training in adult patients with COPD were realized.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis from moderate to severe COPD muscle weakness inspiratory Must be able to do exercises

Exclusion Criteria:

* Positive bronchodilator response Cardiovascular, neuromuscular, or metabolic disease Hospital admission for any pathology in the last two months have completed a rehabilitation program in the last year
Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers

Cross - Sectional study requiring one visit at the investigators office for the data collection.

* Target Group: Patients that suffer from Bipolar Disorder Type 1.
* YMRS - HAMILTON and GAF scales are going to be used to assess the clinical outcome. The findings are going to be based on the different scores reported by Specialists (before the patients started to use as a therapy atypical antipsychotics / at the time that the visit actually takes place for the cause of the study.) We predefine the time period that the patient should be using atypical antipsychotics at minimum (2 months).
* The first 9 consecutive patients that visit the Specialist and meet the entry criteria and signs the ICF will be recruited in the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients that are diagnosed with Bipolar Disorder Type 1 according to diagnostic criteria DSM - IV
* Patients that have started therapy with atypical antipsychotics as monotherapy or cotherapy with mood stabilizers the last three months, but have completed 2 full months of therapy.
* Patients with anxiety disorder can be recruited in the study unless it is dominant.

Exclusion Criteria:

* Patients that use antidepressant medication
* Patients who were treated with depot antipsychotic in the last quarter before their enrollment in the study.
* Patients who are addicts of toxic substances.
* Patients who suffer from other serious diseases.
Pulsed Dye Laser (PDL) vs. Microsecond 1064-nm Nd:YAG Laser for Treatment of Diffuse Facial Redness

The primary objective of this study is to compare the efficacy of PDL and the 1064-nm Nd:YAG laser in the treatment of facial redness.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients 18-55 years of age with erythematotelangiectatic rosacea (as verified by the the PI).
* Subjects who are willing to provide informed consent for participation in the study.

Exclusion Criteria:

* Pregnant or lactating individuals
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects who have a known history of photosensitive conditions (e.g. Systemic lupus, polymorphous light eruption)
* Subjects who have facial telangiectasia of diameter greater than 2 mm.
* Subject who have significant (as determined by the PI) acute inflammatory papules, pustules, and vesicle involving the central face.
Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses

This will be a double-blind, randomized placebo-controlled study. 253 children were recruited and randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidobacterium longum and Lactobacillus rhamnosus GG. The primary aim is to assess the effect of early administration (from birth) of probiotics on the incidence of allergic sensitization, eczema, asthma and rhinitis.

One of the most important early influences on the immune system is the intestinal microflora. The gastrointestinal tract, being the largest body area interacting with the environment, is one of the earliest to be colonized and is quantitatively the most important source of microbial stimulation for the immature immune system. Probiotics are helpful bacteria from healthy intestinal tract, and have shown potential in reducing allergy. This is extremely important as allergic diseases are on the rise worldwide. Probiotics are safe, easy to administer and can be used early for intervention as allergic sensitization, once established, is difficult to reverse.

This double-blind, randomized placebo-controlled study has recruited 253 children from birth. These babies, with a family history of atopic disease, will be randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidobacterium longum and Lactobacillus rhamnosus GG. The formula will be consumed postnatally for 6 months, after which the child will continue with normal follow-on milk. Children will be examined at the neonatal period and at 1, 3, 6, 12 and 24 months. Blood samples will be collected at birth (cord blood) and at 1 year of age. Blood will be analyzed for cytokines, total IgE and specific IgE. Skin prick test for common allergens will also be performed at 1 year of age. Stools will be collected at 5 days, 1, 3, 12 months and analyzed for the pattern of stool colonization.

Eligibility Criteria:
Inclusion Criteria:

* Parents agree to the subject's participation in the study and informed consent has been obtained.
* Either parent or sibling (i.e. first degree relative) has a history of atopy. This will be evidenced by a doctor-diagnosis of asthma, allergic rhinitis or eczema and a positive skin prick test to any of a panel of common allergens.
* The subject is born at above 35 weeks of gestation and weighs above 2 kg.
* The subject does not have major congenital malformations/major illness.
* Family appears to be able to successfully complete this trial.

Exclusion Criteria:

* Mother has a medical illness, which in the opinion of the investigator, will interfere with the results of the study.
* The parent is unable/unwilling to comply with procedures.
* The parents choose to totally breast-feed the child.
Transvaginal Radiofrequency Ablation for Overactive Bladder

To assess the effectiveness of transvaginal radiofrequency oblation by the Morpheus device at varying depths of penetration for improving urge predominate and urinary incontinence symptoms in women with overactive bladder .


Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years old
* Urinary incontinence for ≥ 3 months
* Reporting at least "moderate bother" on Item 2 on the Urinary Distress Inventor questioner, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
* If mixed urinary incontinence, urge is reported predominant symptom on MESA score.
* \>10 micturition per 24 hours and \>3 urgency episodes on 3-ay bladder diary
* \> 1 UUI episode on 3-day bladder diary
* Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2-week wash-out period)

Exclusion Criteria:

* Non-English speakers
* Severely impaired mobility or cognition
* Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease
* Repair of pelvic organ prolapse in the previous 6 months
* Received intravesical botulinum injection within the previous 12 months
* History of implanted nerve stimulator for incontinence
* History of prior sling or vaginal mesh placement, UNLESS onset of UUI was completely unrelated to placement and severity was unaffected by mesh placement.
* Previous diagnosis of Interstitial cystitis
* Active pelvic organ malignancy
* History of pelvic radiation
* Urethral obstruction
* Urinary retention or prolonged catheter use
* Less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months
* Untreated symptomatic urinary tract infection
* Unevaluated hematuria
* Medical instability
* Allergy to anesthetics used in the study
* Not available for follow-up in 6 months
* Participation in other research trials that could influence results of this study
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the requirements of the study and provide written informed consent
* A clinical diagnosis of COPD
* A current or prior history of at least 10-pack years of cigarette smoking
* Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study

Exclusion Criteria:

* A clinical diagnosis of Asthma
* Other significant disease than COPD
* Subjects who radiation or chemotherapy within the previous 12 months
* Subjects who had any lung resection
* QTcB greater than 0.460 seconds
* History of illegal drug abuse or alcohol abuse within the past 5 years