cyrilzakka/clinical-trials huggingface dataset:
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS

To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 55 years old, inclusive, at the time of informed consent.
2. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
3. Be ambulatory.

Exclusion Criteria:

1. Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS).
2. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, renal, oncologic, anaphylaxis or other major diseases, as determined by the Investigator.
3. Current enrollment in any other drug, biologic, or device study or treatment with another investigational drug within 6 months or 5 half-lives of the investigational product, whichever time period is longer.
4. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
5. Pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.
A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty

The purpose of this prospectively randomized multicentre study was to prove the efficacy and safety of mycophenolate mofetil (MMF) to preventing graft rejection and improvement of clear graft survival following high-risk keratoplasty.

The patients of the MMF group receive MMF orally 2x1 g daily for 6 months. Endpoints were immune reaction free and clear graft survival and the occurence of side-effects.


Eligibility Criteria:
Inclusion Criteria:

* Keratoplasty with increased risk for immunologic graft rejection in the abscence of other risk factors for graft failure. (repeat keratoplasty, steroid-response, limbo-keratoplasty, oversized graft.

Exclusion Criteria:

* Normal risk cases. Herpes-Keratitis. Glaucoma. Limbus stem cell deficiency.
High-field MR Imaging in Migraine, Visual Snow and Epilepsy

In this project, the aim is to recruit patients with drug resistant epilepsy and those suffering from migraine. Interestingly, patients suffering from epilepsy are also more often reporting to suffer from migraine. The pathobiology is understudied, but it is believed that both etiologies results from brain networks changes. A clinical certified 7T Terra Siemens scanner will be employed to assess in all participants (including healthy controls) how the microstructure differs in disease specific areas. Patients will further be clinically assessed as well as undergo questionnaires.

Migraine is also a common comorbidity to visual snow syndrom and has been shown to impact similar brain regions. However, the pathophysiology is still understudied and a better understanding of the two diseases is needed.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Patient must be able to read and sign the informed consent form
* Stable prophylactic medication for 2 months prior to MRI
* At leat one of the two criteria applies:
* Patients diagnosed with migraine (with or without aura, episodic or chronic). Diagnosis is ensured by clinical interview (at least 8 weeks prior to MRI). Also, patients complete a migraine questionnaire (HARDSHIP) (at least 8 weeks before MRI). Migraine frequency ≥ 2 migraine attacks/month.
* Patients with drug resistent epilepsy accroding to ILAE crtieria
* Patients with diagnoses of Visual snow syndrome

Healthy participants;

* No migraine (validated by questionnaire) or epilepsy
* Participants must be able to read and sign the informed consent form

Exclusion Criteria:

* Treatment of migraine disease with Botox within \< 4 months before baseline and during the study period
* Pregnant or breastfeeding women
* Intention during the course of the trial to become pregnant
* Women with bilateral ovariectomy, with or without hysterectomy, and postmenopausal women (\>2 years of age) are not considered childbearing.
* Other clinically significant comorbidities (e.g., renal insufficiency, hepatic dysfunction, cardiovascular disease, etc.),
* Known or suspected noncompliance with the protocol, drug or alcohol abuse,
* Patient's inability to follow trial procedures, e.g., due to language problems, mental illness, dementia, etc.,
* Prior participation in the clinical trial
* Enrolment of the investigator, his/ her family members, employees and other dependent persons of the test personnel
* Metallic objects in the body (e.g., splinters, MR incompatible implants).
* Pacemaker
* Claustrophobia
* Obesity (body mass index \> 35 kg/m2)
Biochemical Mediators After Implant Loading

This study evaluates the nitric oxide and arginase levels in patients with dental implants. Peri-implant sulcular fluid and saliva samples were collected after loading of the implants

Nitric oxide (NO) metabolism is associated with the clinical inflammatory state of peri-implant tissues and also affected by the mechanic stimulus. Therefore, The NO content of PISF reflects two different measures and can serve as an indicator of peri-implant soft tissue inflammation and/or bone response to force application and loading Arginase may reduce NO production by depleting the common substrate. Thus, increased salivary arginase activities detected in periodontitis patients may cause decreased NO synthesis and lead to a decrease in the antibacterial property of saliva.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ≥ 20 teeth, no systemic diseases that could affect bone metabolism, no smoking habits, and had one or more implants
Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

The purpose of this study was to evaluate the efficacy and safety of hysteroscopic Mirena fixation in patients with adenomyosis with enlarged uterus, compared with simple Mirena placement under hysteroscopy. Whether the curative effect is not inferior to and reduces the incidence of Mirena expulsion.

This study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Pain due to adenomyosis (lower abdominal pain and low back pain) visual analogue scale (VAS) ≥40mm or menstrual volume score (PBAC) ≥100;

  * Adenomyosis was confirmed by ultrasound or magnetic resonance imaging (MRI);

    * The uterine volume measured by transvaginal gynecological three-dimensional ultrasound was more than 150cm3 and less than 280cm3 (the volume was about 280cm3 at 10 weeks of pregnancy); ④ A strong desire to preserve the uterus; ⑤ No fertility requirements within nearly one year;

      * Premenopausal women aged ≥18 years old; ⑦ Willing and able to abide by the study protocol, and have the ability to clearly judge the amount of menstruation and the degree of pain.

Exclusion Criteria:

* Presence of contraindications to Mirena (known or suspected pregnancy, current pelvic inflammatory disease or recurrent pelvic inflammatory disease, lower genital tract infection, postpartum endometritis, infectious abortion within the past 3 months, cervicitis, cervical dysplasia, uterine or cervical malignant lesions, progestin-dependent tumors, abnormal uterine bleeding of unknown cause, congenital or acquired uterine abnormalities, these include fibroids that deform the cervix, conditions that increase susceptibility to infections, acute liver diseases or tumours, allergy to active ingredients or excipient);

  * Malignant tumors (including reproductive system and other systems);

    * Acute stage of heart, liver and kidney failure or other patients who cannot tolerate operation;

      * The history of Mirena displacement or expulsion;

        * Ultrasound showed the presence of ovarian chocolate cyst; ⑥ The presence of deep endometrial nodules by gynecological examination;

          * The presence of intramural or subserous myoma ≥3cm or any size of uterine submucosal myoma (type 0, 1, 2); ⑧ Patients who are unwilling to participate in the study or who were considered by the investigators to be unsuitable for the study.
Role of CBC Parameters in Early Diagnosis of Pediatric Pneumonia

Detection of the role of Complete Blood Count (CBC) parameters in early diagnosis of pediatric pneumonia

-Testing the ability of Complete Blood Count (CBC) parameters (N/L ratio, PLT /MPV ratio, MPV and other parameters) to differentiate between viral and bacterial pneumonia.

Pneumonia is the leading cause of hospitalizations and death among children with nearly 120 million new cases and one million deaths every year.

* Viruses are the main cause of pneumonia in infants and toddlers between 30 days and 2 years old.
* Children 2 to 5 years old, respiratory viruses are also common with the rise of cases related to S. pneumoniae and H. influenzae type B and other bacterial organisms.

Viral pneumonia caused by , respiratory syncytial virus, which are the most common cause of community- acquired pneumonia in children younger than 5 years. Streptococcus pneumoniae is the most common bacterial cause across all age groups. Other important bacterial causes in children younger than 5 years include Hemophilus influenzae, Streptococcus pyogenes, Staphylococcus aureus, and Moraxella catarrhalis.

Parapneumonic effusion/empyema (PPE/EP), necrosis of lung parenchyma (NC), and lung abscess (AB), are serious complication of pediatric pneumonia. Because of these serious complications, early diagnosis of the causative organism is very important to start the proper treatment and avoid these serious complications.

Complete Blood Picture (CBC) is one of the most important preliminary routine investigations for diagnosis and monitoring of infection.

Recently, CBC parameters, especially Total Leucocyte Count (TLC), ANC, and platelet count all showed significant associations with neonatal sepsis. Besides, the TLC,Absolute neutrophils count (ANC), and platelet counts had good sensitivity and specificity in diagnosing neonatal sepsis

Another study have assessed the utility of C-reactive protein (CRP), White Cell Count (WCC), Neutrophil/Lymphocyte ratio (N/L), Platelets/ Mean Platelets Volume ratio (PLT/MPV ratio), Mean Platelets Volume (MPV), Monocyte Distribution Width (MDW) and many other CBC ratios to differentiate probable bacterial infections from non-bacterial infections and also assessed the severity of illness.

- In this study, we are going to test the role of Complete Blood Picture (CBC) parameters and ratios as an early detection tool of bacterial and viral pneumonia. This might have a role in early prediction and diagnosis of the causative organism. Which in turn leads to rapid intervention, and better prognosis.

Eligibility Criteria:
Inclusion Criteria:

-

Newly suspected cases of pneumonia from age o 1 month to 5 years in 2 age groups

Exclusion Criteria:

* Age group \>5 years
* Already diagnosed patient who is under treatment
Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology

During a previous therapeutic trial, investigators showed that the bumetanide improved significantly autism. This trial showed that a therapeutic response was obtained in 75% of cases.

These first results were reinforced by a study led with adult patients for whom the eye tracking measurements as well as the functional MRI showed a diminution of the response time and a modification (amplification) of the cerebral response during an emotions recognition test.

Finally, investigators confirmed the physiological mechanism behind the action of the bumetanide in a study in two mouse models of autism.


Eligibility Criteria:
Inclusion Criteria:

* Children and teenager from age 5 to age 17, with a diagnosis of typical autism or Asperger syndrome according to the criteria of diagnosis of the WHO's classification (CIM-10),
* With a known etiology,
* Patients for whom the CARS results are strictly Superior or equal to 30,
* Of whom the parents have given their free, informed and written consent,
* Affiliated or beneficiary of the French social security.

Exclusion Criteria:

* Patients under treatment by inlet diuretic either at the time of the study or before,
* Patients with electrolytic disorders,
* Patients with a known hypersensitivity to sulfa drugs,
* Patients with a hepatic or renal failure,
* Patients with an epilepsy not controlled by a treatment (comitial crisis in the past 6 month at the time the trial starts despite a treatment),
* Patients under treatment by psychotropic exception made of the melatonin,
* Allergy to the bumetanide or one of its excipients,
* Patient under a treatment by lithium, diphemanil, erythromycin IV, halofantrine, pentamidine, sultopride, vincamine, aminoglycoside,
* Pregnant and lactating women.

Secondary exclusion criteria:

* QT prolongation noticed on the ECG at Day0,
* Anomaly on the biological check up (Day 0) made before including the patient that would contraindicated the prescription of bumetanide,
* Patients for whom the CARS results are strictly inferior to 30.
Mother-Baby Study - Caloric Compensation Index (COMPX)

The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.

To participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.

This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months. In the observational study there are 240 participants (120 mothers and 120 children). In this trial only data from the children is collected and therefore only 120 participants are listed.

Eligibility Criteria:
The child is a participant in the observational study (NCT06039878).
Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus

Palmoplantar keratoderma (PPK) associated to livid telangiectatic erythema during systemic lupus erythematosus (SLE) and subacute cutaneous lupus erythematosus (SCLE) is a rare phenomenon seldom reported in literature. The investigators hypothesize that clinic-immunologic assessment and detailed investigation of cutaneous biopsy specimen of PPK and erythema of patients suffering from SLE and SCLE could lead to determine more precisely nosological settings of this injury. Report the different therapeutics with efficacy assessment could be helpful to highlight useful treatment for these patients.

Context: Palmoplantar keratoderma (PPK) associated to livid telangiectatic erythema during systemic lupus erythematosus (SLE) is a rare phenomenon seldom reported in literature. To our knowledge no case has been described in subacute cutaneous lupus erythematosus (SCLE) so far. Pathogeny and etiologic origin are not clear: it could be no-specific cutaneous manifestation of SLE, verrucous chilblain lupus, lichen planus, discoid lupus erythematosus lesions, overlap syndrome or coexistence of both diseases.

Objective:

1. Determine clinical immunological and histopathological features of patients with PPK and livid telangiectatic erythema-associated suffering from SLE and SCLE
2. Describe the different therapeutics used and efficacy assessment Methods: Multicentric retrospective descriptive study reporting 14 patients with SLE or SCLE suffering from an acral livid erythematosus keratoderma, with clinical data regarding lupus erythematosus and acral keratoderma, immunological blood samples findings and histopathological results of keratoderma and livid erythema biopsies with direct immunofluorescence if performed. The treatments set down in order to heal are noted followed by efficacy assessment: total failure, partial remission, complete remission.

Eligibility Criteria:
Inclusion criteria:

* \> 18 years old
* suffering from SLE or SCLE according to 2019 ACR/EULAR criteria
* With palmar and or plantar keratoderma with livid telangiectatic erythema

Exclusion criteria:

* \< 18 years old
* suffering from lupus lesions without SLE or SCLE criteria
* without palmar and or plantar keratoderma with livid telangiectatic erythema
Effect of PNF on Selective Motor Control and Balance in CP

Cerebral palsy is attributed to non-progressive disturbances that occurred in the developing infant brain or fetal characterized by abnormalities of muscle tone, movement and motor skills. PNF technique is thought to have an impact on voluntary motor control and balance through stimulation of proprioceptors, so the aim of this study is to determine the effects of proprioceptive neuromuscular facilitation technique on selective motor control and balance on children with cerebral palsy.

A case study was conducted in 2021 to determine the effects of PNF training for improving lower limb coordination in 7 years old cerebral palsy child. After the intervention, significant improvement is seen in gait parameters, balance, and gross motor functional classification score.

A case report was conducted in 2020, to determine the effectiveness of PNF technique in improving lower extremity function in spastic diplegic cerebral palsied adolescent. Patient was treated with tone inhibitory and movement facilitatory techniques. There was significant change in balance and lower extremity function before and after the treatment.

There are multiple impairments in spastic cerebral palsy children; the inability to perform purposeful voluntary movements is a critical factor in determining functional ability of children. Since selective voluntary motor control is an important factor that must be achieved in cerebral palsy children, PNF may be considered as a technique to gain selective voluntary control and balance proving an important intervention for cerebral palsy children.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed as spastic diplegic cerebral palsy
* Age between 5-12 years and both genders.
* Gross motor function level II and III according to gross motor functional classification scale (GMFCS).
* Spasticity range between 1 and 1+ grade according to modified ashworth scale
* Children who are able to follow simple verbal instructions

Exclusion Criteria:

* Children with uncontrolled epilepsy
* Children who show no cooperation
* Children receiving botulinum toxin injections or surgery no earlier than 6 months before project starts.
* Subjects with presence of shortening or deformities of lower limb
Observational Study of Patients With Subarachnoid Hemorrhage

This prospective, observational study aim to identify :

* Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit
* The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, ...)


Eligibility Criteria:
Inclusion Criteria:

* Subarachnoid hemorrhage

Exclusion Criteria:

* None
Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome

The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)
* LDL-Cholesterol \> 130mg/dl
* HDL-Cholesterol \< 40mg/dl in males and \<50mg/dl in females
* Triglycerides \< 400 mg/dl

Exclusion Criteria:

* With a concomitant coronary disease
* Currently under statin therapy or previously treated with statins within the last 6 months
Lingual Nerve Injury in Patients With Difficult Intubation

The aim of this study is to investigate the incidence of lingual nerve injury and related factors in difficult intubation cases.

Demographic data of difficult intubation cases and body mass indices, thyromental and sternomental distances, mallampati classification, neck circumference, maximum mouth opening be recorded.Numbness of the tongue and metallic taste will be questioned

The lingual nerve is the anterior descending branch of the posterior trunk of the mandibular division of the trigeminal nerve.

Lingual nerve injury is a recognised complication of orotracheal intubation and has been associated with forceful laryngoscopy.

Although left-sided neuropraxia has been reported, right-sided lesions are thought to be more common because the standard Macintosh laryngoscope exerts pressure on the right side of the tongue.

Lingual nerve injury following orotracheal intubation was first described in 1971 by Teichner who reported a right-sided neuropraxia which was attributed to direct pressure from the laryngoscope.

Eligibility Criteria:
Inclusion Criteria:

All adult patients undergo general anesthesia who have difficulty in intubation will be included in the study. The same number of patients without intubation difficulties will be included in the study as a control group.

Exclusion Criteria:

1. Patients who are not intubated under general anesthesia
2. Patients undergoing regional anesthesia or peripheral nerve block
3. Patients with laryngeal mask placed will not be included in the study.
A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells

This is a prospective study for the Long-Term Follow-Up (LTFU) of safety and efficacy of all participants exposed to gene modified (GM) T cell therapy in accordance with Health Authorities' guidance for participants treated with gene therapy products.

Participants who received at least one infusion of gene modified T cells in a 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study will be asked to participate in this LTFU protocol, upon either premature discontinuation from, or completion of the parent treatment protocol.

Participants enrolled in this LTFU protocol will have safety assessments, laboratory evaluations, and complete patient-reported outcome (PRO) questionnaires at scheduled intervals as applicable.


Eligibility Criteria:
Inclusion Criteria:

1. All participants who received at least one GM T cell infusion in a previous 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study, and have completed the post-treatment follow-up period on the parent treatment protocol, or discontinued follow-up on the parent protocol after completing at least 6 months of safety monitoring, as applicable.
2. Participant (and legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF)/Informed Assent Form (IAF) prior to any study related assessments/procedures being conducted.

Exclusion Criteria:

Not applicable.
A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris

The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris
* Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
* Subjects with ≥ 30 facial inflammatory lesions

Exclusion Criteria:

* Subjects with \< 10 or \> 75 facial non-inflammatory lesions
* Subjects with \> 3 facial nodular or cystic lesions at Baseline
* Standard exclusion criteria