cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia

Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances are associated in patients with fibromyalgia. By improving the quality of sleep, complaints of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this chronic pain disorder may be improved.

The purpose of this research study is to investigate the effectiveness and safety of 2 doses of the investigational product in subjects with sleep disorders with fibromyalgia as compared to placebo (a substance which contains no active ingredient). The study will last approximately 70 days and will include 7 office visits.

Eligibility Criteria:
Inclusion Criteria:

* Each patient must fulfill the diagnosis criteria of fibromyalgia according to the American College of Rheumatology
* Based on patient's information:
* The patient must complain of unrefreshing sleep for at least 3 nights per week over the past month.
* The patient spends at least 6.5 hours and not more than 9 hours, in bed, each night over the past 2 weeks.
* Female patients of childbearing potential must have a confirmed negative pregnancy test at the end of the screening period and use an acceptable method of birth control throughout the study
* Written, signed and dated informed consent must be obtained from each patient
* Willing to abstain from taking any medication or treatment prohibited as per the protocol

Exclusion Criteria:

* Females who are lactating or pregnant
* Night shift workers, and individuals who nap 3 or more times per week over the preceding month (nap: intentionally sleeping for more than 20 minutes during the day).
* Consumption of beverage with caffeine (i.e. tea, coffee, or cola) comprising more than 2 cups or glasses per day
* Past or Current medical history of any significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH)

This study is designed to evaluate the safety, tolerability, and efficacy of AAV5 based BBP-631 in adult participants diagnosed with classic congenital adrenal hyperplasia.

Participants will receive a single dose of AAV5 based intravenous (IV) BBP-631 and will be followed for safety and efficacy for at least 5 years after the date of treatment with BBP-631.

Eligibility Criteria:
Key Inclusion Criteria

1. Adult male and non-pregnant females with classic CAH (simple virilizing or salt-wasting) due to 21-OHD
2. Screening/baseline 17-OHP levels \> 5-10 × ULN and \< 40 × ULN (upper limit of normal)
3. Stable oral hydrocortisone (HC) regimen as the only glucocorticoid (GC) maintenance therapy
4. Naïve to prior gene therapy or AAV-mediated therapy

Key Exclusion Criteria

1. Positive for anti-AAV5 (Adeno-Associated Virus Type 5) antibodies
2. History of adrenalectomy and/or significant liver disease
Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma

This is an open-label, single arm study designed to evaluate the safety of tezepelumab administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with inadequately controlled severe asthma.

This is open-label, single arm study designed to evaluate the safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 66 subjects will be dosed in Japan. Subjects will receive tezepelumab administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

Age. 12-80 Documented physician-diagnosed asthma for at least 12 months Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.

Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.

At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.

Documented history of at least 1 asthma exacerbation events within 12 months. ACQ-6 score ≥1.5 at screening or on day of registration.

Exclusion Criteria:

Pulmonary disease other than asthma. History of cancer. History of a clinically significant infection. Current smokers or subjects with smoking history ≥10 pack-yrs. History of chronic alcohol or drug abuse within 12 months. Hepatitis B, C or HIV. Pregnant or breastfeeding. History of anaphylaxis following any biologic therapy. Subject randomized in the current study or previous tezepelumab studies
Methylprednisolone During the Switch Between Natalizumab and Fingolimod

Progressive multifocal leukoencephalopathy (PML) is the most feared complication when natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of PML increases after 18 months of treatment. When switching from NTZ to another disease modifying treatment (DMT) in these MS patients with an active disease, there is a high risk of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary before initiating a new DMT.

The primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between NTZ and Fingolimod (FTY).

Patients with MS receiving NTZ for at least 18 months and without any disease activity during the previous year will be eligible. Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo.

Every patient will initiate a treatment with FTY 7 weeks after the last NTZ perfusion. Methylprednisolone or placebo will be taken 4, 8 and 12 weeks (W4, W8 and W12) after NTZ discontinuation.

A spinal and brain MRI will be performed at baseline (last NTZ perfusion, noted W0) and 16 to 18 weeks after. The last clinical follow-up will be made after 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing-Remitting Multiple Sclerosis (Mc Donald's 2010 criteria)
* EDSS\<6.0
* At least18 natalizumab infusions
* Planned switch from natalizumab to fingolimod
* Aged between 18 and 65
* Patients must have received high dose IV methylprednisolone during the 5 previous years

Exclusion Criteria:

* Progressive MS
* Uncontrolled MS with natalizumab (existence of a relapse during the previous 12 months or existence of a gadolinium enhancing lesion on a MRI performed during the last 12 months)
* SEP de forme progressive
* Contra-indication to the use of high dose oral methylprednisolone
* Marked cognitive impairment altering protocole understanding
* Switch from natalizumab to a disease modifying treatment different from fingolimod
* Contra-indication to fingolimod use
* Existence of a disease or condition that could alter study completion
* Chronic treatment with steroids
* Acute treatment with steroids (more than 300mg during the month prior to inclusion)
* Contra-indication to gadolinium containing products injection
* Pregnancy
Retinal Function in Parkinson's Disease

Parkinson's disease (PD) is a neurodegenerative disorder characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement. The primary symptoms are the results of decreased stimulation of the motor cortex arising from the basal ganglia normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high level cognitive dysfunction and subtle language problems. Included in the symptomatology experienced by patients with PD, visual abnormalities are not uncommon. Visual changes among patients with PD appear not only dynamic in nature, but differentially affected based on the course of the disease and, perhaps more importantly, its treatment. Parkinson's disease has significant ramifications not only in observation of irregularities in vision, but how vision interacts with entrainment of the circadian clock. The purpose of this study is to examine the relationship between PD and operation of a unique set of retinal cells known to regulate the circadian clock and sleep-wake cycles in human subjects.


Eligibility Criteria:
Inclusion Criteria: age 18-64 best corrected visual acuity of 20/25 or better in each eye -

Exclusion Criteria: evidence of any form of eye disease, inability to understand and sign informed consent.

-
Real-world Evidence Study on the Performance and Safety of Halova Ovules

An open-label, multicentric, non-randomized, single-arm, pilot, interventional clinical investigation to confirm the tolerability and performance of the medical device Halova in lubrication of the vagina and vaginal atrophy treatment.

The primary objective of this investigation is to evaluate the therapeutic performance and tolerability of Halova ovules in treating vaginal atrophy and restoring the natural lubrication of the vaginal mucosa.

The secondary objective of this clinical investigation are to evaluate the performance of the medical device by clinical examination, and the degree of patient satisfaction related to the intended use (Likert scale).

Eligibility Criteria:
Inclusion Criteria:

* Adult women, aged between 18 and above, in pre-menopause or menopause;
* Adult women with atrophic vaginitis caused by estrogen hormone deficiency;
* Adult women who have vaginal dryness as a result of contraceptive treatment or other disorders;
* Subjects with a normal cervical cytology report, e.g. Negative for intraepithelial lesions or malignancy (NILM) or slightly changed to atypical squamous cells of undetermined significance (ASC-US) in the last 6 months;
* Subjects willing to provide signed informed consent for participation in clinical investigation.

Exclusion Criteria:

* Subjects with vulvar or cervical cancer.
Prospective Randomized Trial Between WBRT Plus SRS Versus SRS Alone for 1-4 Brain Metastases

The purpose of this study is to determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.

Whole-Brain Radiation Therapy (WBRT) had been a mainstay in the treatment of brain metastases. However, treatment strategy which rely on Stereotactic Radiosurgery (SRS) has becoming popular in Japan. It is not well understood if the Whole-Brain Radiation Therapy (WBRT) combined with Stereotactic Radiosurgery (SRS) resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. In orer to determine the role of WBRT, we conducted prospective randomized trial between WBRT+SRS and SRS-alone for 1-4 brain metastatic patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with 1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, and were derived from a histologically confirmed systemic cancer, Karnofsky Performance Status (KPS) score of 70 or more

Exclusion Criteria:

* Patients with metastases from small cell carcinoma, lymphoma, germinoma, and multiple myeloma were excluded.
The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension

The use of TRIple fixed-dose COmbination in the treatment of arteriaL hypertension: opportunity for effective BP control with cOmbined antihypertensive therapy.

The main aim of this study to assess the antihypertensive effectiveness effect on the 24-hour BP profile, as well as tolerability of and compliance to the treatment with a triple FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients in the real clinical practice.

Type of program: Multicenter, observational, non-controlled, open-label program.

Investigators: Cardiologists and outpatient (primary care) physicians (general practitioners).

Number of patients: 1,300 hypertensive patients.

It is multicenter, observational, non-controlled, open-label program. The baseline characteristics will be analyzed in all the patients who started the treatment (intention-to-treat \[ITT\] population). In case of significant differences between two treatment groups, the baseline characteristics will be provided for both of them.

Changes in the SBP and DBP (with the corresponding confidence intervals) will be assessed in the patients who completed the program without major deviations from protocol (per-protocol population \[PPP\]).

The analysis of parameters with normal distribution will be performed using the Student's t-test for paired measurements; otherwise the non-parametric Wilcoxon test will be used. The percentage of patients with normalized BP, as well as the percentage of patients who responded to treatment (with 95% confidence intervals), will be calculated.

Questionnaires: The score for each scale will be calculated as the sum of scores for questions constituting the scale.

Assessment of the AEs will be carried out in all the patients who started the treatment (ITT population).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 79 years
* Essential hypertension
* Patient's consent to participate in the program
* Doctor's decision to prescribe FDC of amlodipine / indapamide / perindopril arginine, according to the instruction for use, prior to the inclusion in the program.

Exclusion Criteria:

* Symptomatic, or secondary arterial hypertension
* Office BP ≥ 180/110 mm Hg on treatment (at V0 visit)
* History of myocardial infarction, unstable angina, or cerebrovascular accident within the past 1 year
* CHF of class III-IV NYHA
* Type I diabetes or decompensated type 2 diabetes
* Diseases with severe organ dysfunction (hepatic failure, renal failure, etc.)
* Contraindications to or known intolerance of dihydropyridine calcium channel blockers (including amlodipine) and/or indapamide and/or ACE inhibitors (including perindopril) and/or their fixed combination
* Inability to understand the nature of the program and/or to follow the doctor's recommendations, including ones for the BP self-monitoring.
A Registry Study on Biomarkers of Pulmonary Embolism

The purpose of the study is to evaluate the value of biomarkers in the diagnosis and risk stratification of patients with suspected pulmonary embolism.

Management of patients with acute pulmonary embolism is a serious problem. The rapid and accurate diagnosis and risk stratification of these patients is an important unmet clinical need. The aim of the study is to evaluate the value of biomarkers, alone or in combination, in the diagnosis and risk stratification of patients with suspected pulmonary embolism presenting to the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years that presents to an emergency department
* With suspected PE defined as new onset of or worsening of shortness of breath or chest pain

Exclusion Criteria:

* Hemodynamic instability
* Life expectancy less than 3 months
* First symptoms 15 day or more before inclusion
* Inability to the follow-up visits
* Therapeutic anticoagulation for any indication
Effect of Different Fixed Lingual Retainers on Tooth Stability

Objective: The aim of this study was to compare the effect of different fixed lingual retainers (LRs) on tooth stability after orthodontic treatment using a Periotest® device.

Materials and methods: A total of 82 patients (43 females and 39 males; mean age = 18.61 ± 3.71 years) with no missing teeth in the lower inter-canine region were treated with fixed orthodontic mechanics. At the completion of the orthodontic treatment, each patient was fitted with either Ortho FlexTech (Reliance; Group I), dead soft 8-braided (Bond-A-Braid, Reliance; Group II), or 5-stranded (PentaOne, Masel; Group III) LR wire. A control group consisting of people with a healthy periodontal condition and no bone loss was included (Control; Group C). The mobility of the lower anterior teeth on the right and left sides was measured using a Periotest® device before (T0), immediately after (T1), and 10 months after (T2) the application of the LR. Statistical analyses were performed using one-way ANOVA followed by post hoc LSD, repeated ANOVA with Bonferroni post hoc test, and Pearson χ2 tests.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of orthodontic treatment with optimum oral hygiene
* A duration of orthodontic treatment with fixed appliances of more than 12 months
* No missing teeth, restorations, or morphological crown anomalies
* No radiological alveolar bone loss in the mandibular inter-canine region.

Exclusion Criteria:

* Individuals with periodontal problems, such as gingival bleeding and recession, parafunctional habits (e.g., clenching and grinding),
* Any radiological pathology around the lower anterior teeth
Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device

The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.


Eligibility Criteria:
Inclusion Criteria:

The following criteria match the FDA-approved indications for use per PMA (P170013)

* Subjects treated with the LVIS® Device in accordance with currently approved indications for use;
* Treatment of wide-necked (neck ≥ 4mm or dome to neck ratio \< 2) intracranial saccular aneurysm arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device of researched sizes within the last 5 years.

(Device models: 212517-LVIS, 212525-LVIS, 213015-LVIS, 213025-LVIS, 213041-LVIS, 214035-LVIS, 214049-LVIS; 212912-LVIS, 212917-LVIS, 212922-LVIS, 212928-LVIS, and 212931-LVIS);

* Availability of Medical Health Records;
* Subject whose age is ≥ 18;
* Appropriate or Waived Consent:

  1. For retrospective review: Local Institutional Review Board approves the research as exempt, allowing an all-inclusive retrospective examination of medical records documenting treatments using the study devices and available clinical and imaging follow up;
  2. For prospective follow up: Subject or his/her Legally Authorized Representative consents to participation in the study follow up visits up to 5 years, and provides a signed informed consent form as applicable;.

Exclusion Criteria:

* Subjects not treated according to the currently approved indications for use
Eye Movement Desensitization and Reprocessing (EMDR) in Non-specific Chronic Back Pain

The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in non-specific chronic back pain.

The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in non-specific chronic back pain in a randomized controlled trial (RCT) with 6 months follow-up. The treatment consists of 12-sessions EMDR a 60 minutes using eye-movements for bilateral stimulation in addition to treatment as usual (TAU) that is compared to TAU alone.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years
* non-specific chronic low back pain \>= 45 days/3 months
* high emotional distress caused by psychological trauma
* German language skills

Exclusion Criteria:

* specific causes of chronic back pain
* application for retirement pension pending
* ongoing psychotherapy
* severe physical or psychiatric comorbidity
Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position

The genu pectoral position is a surgical position used for spine surgery. This surgical position will lead to physiological hemodynamic and respiratory changes during the procedure.

The knee-pectoral position notably induces an increase in CRF and improves pulmonary ventilation/perfusion ratios. On the other hand, it has been shown that it is accompanied by a reduction in cardiac output of approximately 15% Protective perioperative ventilation including a tidal volume between 6 and 8 ml/kg of theoretical ideal weight, PEEP and alveolar recruitment maneuvers is applied in the operating room to reduce postoperative pulmonary complications. The application of high PEEP and the performance of recruitment maneuvers induce arterial hypotension through changes in intra- and transpulmonary pressures. However, investigators hypothesize that the deleterious hemodynamic effects of PEEP seem to counterbalance its beneficial respiratory effects in this particular position.

The combination of the effects of the knee-pectoral position and protective ventilation could be potentiated and be the cause of the sometimes severe arterial hypotension observed in clinical practice. Since this position improves pulmonary ventilation perfusion ratios, the investigators hypothesized that a lower PEEP and the elimination of intraoperative recruitment maneuvers could be beneficial from a hemodynamic point of view without being deleterious in terms of perioperative pulmonary complications. An exploratory study was carried out at the CAEN University Hospital in 2021 under the name PEEP POSTURE (CLERS Agreement No. 2198 of February 17, 2021) on 90 patients aiming to collect hemodynamic and respiratory parameters in 3 surgical positions: supine decubitus, ventral decubitus , pectoral genu. No difference was found in the evolution of respiratory compliance. On the other hand, a significant drop in SBP, DBP and MAP in the pectoral position was shown compared to the supine group as well as greater vascular filling.

The investigators therefore hypothesize that a reduction in PEEP and optimization of vascular filling could help reduce the adverse effects on blood pressure linked to the surgical position.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years old
* Beneficiary of Social Security or CMU
* Surgical operation under general anesthesia requiring a knee-pectoral position
* Dated and signed informed consent

Exclusion Criteria:

* BMI \> 35 kg/m²
* Hemodynamic instability before placing the knee in the pectoral position.
* ASA class IV or V
* Prolonged intervention \> 2 hours
* Lack of consent
* Contraindications to the use of esophageal Doppler
* Concomitant third-party clinical trial that may induce a hemodynamic or respiratory change in the patient