cyrilzakka/clinical-trials huggingface dataset:
ETMR One: An International Registry and Research Platform for Children With Embryonal Tumor With Multilayer Rosettes

This research is being done to find out more information about a brain tumor called Embryonal Tumor with Multilayer Rosettes (ETMR) by collecting medical information from children who have this disease.

The purpose of this research study is to create and maintain a research database for patients with ETMR. The database will include information about occurrence rates, patient information, tumor tissue information, and response to treatment. This will help advance our understanding of this rare disease.

In addition, this study will include obtaining survival data and evaluating therapeutic response to expert consensus therapy, and procuring patient tumor tissue.

All patients with ETMR are eligible for inclusion within the registry, regardless of their disease status or treatment plan. Epidemiologic, clinical, and molecular data from each patient will be obtained following enrollment. Patients will then be followed longitudinally to obtain clinical outcome data. In an effort to best achieve the registry's secondary objectives, it is preferable, but not required, for patients to be registered soon after their diagnosis, prior to the initiation of any tumor-directed therapy.

This registry protocol contains recommendations for a consensus therapy derived from the ETMR medical literature, the investigators' own experience, and clinical data from other infant brain tumor protocols. The recommended therapy can thus not be viewed as investigational, but rather as a consensus recommendation derived from available data. While not mandated, it is strongly encouraged that patients enrolled in the registry be treated according to the recommended consensus therapy, as this will facilitate the prospective evaluation of ETMR patients using a uniform treatment approach.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of any age
2. Patients must have either a histologically confirmed primary intracranial CNS Embryonal Tumor with Multilayer Rosettes (as agreed upon by central review or local pathologist OR
3. Patients must have tumor tissue that possesses C19MC amplification . Central Review is not required (but is strongly recommended) if the patient's tumor does not demonstrate C19MC amplification.
4. Patients may be enrolled at point following diagnosis
Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic

Pregnancy and early parenthood are life changing periods characterized by intense emotions and a high vulnerability to emotional problems. Overall 10 - 20 % of pregnant women and women in early postpartum period suffer from mental health problems.

In the first months of 2020 , pregnant and breastfeeding women have also needed to face the COVID19 pandemic including the exceptional quarantine measures that have disturbed private and professional life . In addition to the fear of infection , these measures might have negatively impacted the emotional wellbeing of women . As depressive symptoms and anxiety in the pre and peripartum period have been associated with adverse maternal , neonatal and infant outcomes , the psychological impact of COVID19 , and its associated quarantine measures , on pregnant women and new mothers is cause for concern


Eligibility Criteria:
Inclusion Criteria:

All pregnant women presented to the Antenatal care clinic, will be included in the study irrespective of the gestational age of the pregnancy

Exclusion Criteria:

Women previously diagnosed with any psychiatric disorder.
Very Low Dose Caudal Morphine for Postoperative Pain Management

This is a chart review. The aim of this study is to investigate the effectiveness and side effects of very low dose morphine administered caudally to children that went to surgical procedures that used caudal anesthesia. The study compares caudal block with Bupivacaine (1 ml kg_1 of bupivacaine 0.25% and saline 0.02 ml kg_10) with very low dose morphine (a mix of 1 ml kg_-1 of ropivacaine 0.2% and preservative-free morphine: 10 µg kg-1).

Caudal anesthesia is the most common technique of epidural anesthesia in children. Caudal anesthesia is recommended for most surgical procedures of the lower part of the body, including herniorrhaphies; operations on the urinary tract, anus, and rectum; and orthopedic procedures on the pelvic girdle and lower extremities. Many anesthetic agents have been used for caudal anesthesia in pediatric patients, with lidocaine and Bupivacaine being most common. The major problems associated with this technique are the limited duration of analgesia and unwanted motor blockade.

Addition of medications that prolong analgesia after a single shot caudal block has been investigated. Several authors have mentioned a special interest in using an opioid like morphine in caudal block for postoperative analgesia. When low dose morphine is used, the side effects are lower than when higher dose of morphine are used. A larger and definitive study is needed to compare very low dose morphine via caudal administration and caudal block without Opioid with regard to duration of analgesia and frequency of side effects. We plan to conduct a chart review in our center on pediatric patients that went to urological, orthopedic, and general surgery procedures for which caudal block were given and compare the effectiveness and side effects of very low dose morphine and caudal block without Opioid.

Eligibility Criteria:
Inclusion Criteria:

* The subject did have elective Urological procedures such us circumcision, orchidopexy and inguinal hernia repair, orthopedic and general surgery procedures for which caudal block are usually administered for pain management.

Exclusion Criteria:

* Subjects with non elective or emergency surgery (must have the surgery no matter what).
* Subjects with surgical procedures that are not planned to be conducted with the use of general anesthesia. Subjects that are not allowed to receive the anesthesia agents indicated per protocol and general anesthesia.
* American Society of Anesthesiologists, Physical Status classification greater than 2 (uncontrolled systemic disease or more than one systemic disease).
* Patients with a history of chronic pain conditions.
* Infection around the sacral hiatus.
* Coagulopathy.
* Anatomic abnormalities.
* Patient with mentally retardation.
* Patient with history of attention deficit and/or behavioral problems.
Clinical Validation of New Commercial Sleep Monitoring Devices

This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is considered the gold standard for sleep assessment. This research is being done because if proven to accurately analyze sleep,these devices may make conducting in-home sleep studies easier and more affordable in the future.

This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), considered the gold standard assessment for sleep physiology. The investigators emphasize here that the commercial sleep monitoring devices (Fitbit, Jawbone UP, and Microsoft Band) are used in addition to PSG and not in place of it. Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Data will be transferred from the sleep monitoring device(s) for later statistical analysis and comparison with scored polysomnogram. Device(s) will be cleaned (using antiseptic wipes), reset,recharged, and otherwise prepared for reuse.

Eligibility Criteria:
Inclusion Criteria:

* Attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine.

Exclusion Criteria:

* Not attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
* Under 18 or over 80 years old.
* Pregnancy
* Unable to provide informed consent.
School Based Health Promotion Program in Secondary Schools

The purpose of the study is to determine whether a school based health promotion program in secondary schools is effective with respect to an increase of physical activity, physical fitness and health.

Current understanding of physical activity in childhood demonstrates the health benefits of regular exercise, such as improved cardiovascular fitness, skeletal health and prevention of overweight and obesity. The children obtained weekly health education lessons from their teachers to increase the physical activity in and outside of school and to improve health behavior (healthy food, no drugs) as well as the general well-being of children.

Monthly training for teachers and regular training (2-3x/year) for the parents complete the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Children in the 1. grade of secondary General Schools or Intermediate Schools with written consent from the parents in the greater Munich area

Exclusion Criteria:

* Children without written consent from their parents
Lower Laser Therapy in Orthognathics Surgery

This study will examine the use of lower laser therapy to reduce edema and pain in orthognathics surgery.


Eligibility Criteria:
Inclusion Criteria:

* Dentofacial deformity
* Healthy
* Mandibular surgery
* no medication use
Multisensory Integration and Cognitive Awareness in Post-Stroke Unilateral Spatial Neglect

The primary aim of this study is to investigate whether multisensory integration (MSI) mechanisms observed in patients with right hemisphere lesions without neglect remain intact compared to patients with Unilateral Spatial Neglect (USN).

This study also allows for a direct comparison between results from paper-based tests and computerized tests, as well as between patients with right hemisphere lesions without neglect and USN patients. The secondary objectives are:

To compare these results in order to obtain a more refined definition of USN at both the unisensory level (as computerized tests are rarely used in hospital settings but have proven effective in diagnosing USN) and the multisensory level (since USN is not generally tested in the auditory modality).

To measure eye movements in all patients in the study, as this can provide useful information for characterizing patient deficits.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included in the study if they have:
* Right hemisphere stroke
* Presence of USN assessed through the Apple Cancellation
* Age between 18 and 85 years
* Signed informed consent
* Both male and female participants

As a control group, patients will also be included if they have:

* Right hemisphere stroke
* Absence of USN assessed through the Apple Cancellation
* Age between 18 and 85 years
* Signed informed consent
* Both male and female participants.

Exclusion Criteria:

* Both patients with USN and control patients will be excluded if they:
* Are minors
* Are unable to give their consent to participate in the study
* Have significant language deficits (production and comprehension) (e.g., unable to give a verbal response or understand instructions)
* Have hemianopia
* Have severe hearing impairments that cannot be corrected (e.g., with hearing aids)
* Have severe uncorrected visual impairments (e.g., glaucoma)
* Have a history of psychiatric disorders or substance abuse.
Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics

The purpose of this study is to determine the impact of two-way short message service (SMS) on glycemic control in low-income, poorly-controlled adult diabetic patients.

This multi-center, unblinded, prospective randomized controlled trial will enroll adult diabetic patients of the Wilson Community Health Center, Harvest Family Health Center, and Freedom Hill Community Health Center living below 200% of 2013 poverty level with a serum hemoglobin A1C \>9% and who currently own a mobile device with text messaging capacity. After written informed consent has been obtained, subjects will be randomized to intervention or control group (1:1), stratified based on insulin initiation within 1 week of study inclusion. Participants randomized to the intervention group will be further divided into subgroups as "insulin user" or "non-insulin user" and both will receive SMS messages every 7 days. The content of the message consist of medication reminders, reporting of blood glucose results, insulin technique assessment (if applicable), or d) medication adherence assessment. Participants will be asked to respond with a simple text within 7 days. The intervention group will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the Health Center PLUS a unidirectional text message two business days prior to scheduled health center appointments. Control group participants will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the health center. All participants in the study (control and intervention) will undergo venipuncture at 3 months (+/-) 2 weeks for the determination of hemoglobin A1C. Demographic information, and frequency of hemoglobin A1C concentrations in the past 6 months will be assessed at baseline. Each week for 12 weeks, the number of texts sent per week and by type, percent of respondents weekly by text or by phone, content of participant responses, number of patients unable to be reached via text, total investigator time spent per week, and time spent per contact will be recorded. At the three month visit, the hemoglobin A1C concentration, blood transfusions since study initiation, and medication changes will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* New or existing patient of Carolina Family Health Centers Inc. (Wilson Community Health Center, Harvest Family Health Center, Freedom Hill Community Health Center)
* Diagnosis of diabetes
* Single serum hemoglobin A1C equal to or greater than 9% within 2 weeks of study enrollment
* Below 200% of 2013 poverty level
* Currently own a mobile device with text messaging capacity and anticipated service for duration of 12 week study period

Exclusion Criteria:

* Anemia diagnosed within past 3 months
* Blood transfusion within the past 3 months
* unable to read English at the fifth grade level
Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple oral administrations.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years
* body mass index (BMI) between 18-29.9 kg/m², inclusive.
* normal values of testosterone (2.49-8.36 ng/mL) and LH (1.7-8.6 U/L)

Exclusion Criteria:

* smoking
* drug or alcohol abuse
* hypersensitivity to any of the ingredients of the study drug
Collagen-based Filler for Trapeziometacarpal Osteoarthritis

Introduction. Trapeziometacarpal osteoarthritis (TMC OA) is a degenerative condition characterized by pain, stiffness, and reduced hand function, significantly impairing daily activities. Non-surgical management strategies include activity modifications, nonsteroidal anti-inflammatory drugs (NSAIDs), splinting, and corticosteroid injections. When conservative treatments fail, surgical options are considered. The Eaton-Littler classification stratifies TMC OA into four stages based on radiographic joint degeneration.

ChondroFiller Liquid®, a cell-free collagen scaffold composed of native type I collagen and chondrostimulating factors, facilitates cartilage regeneration by creating a protective environment for chondrocyte proliferation. It is indicated for treating cartilage lesions up to 3 cm². A prior study demonstrated its efficacy in alleviating pain, improving grip strength (Jamar test and pinch test), and enhancing Patient-Reported Outcome Measures (PROMs) using the Disabilities of the Arm, Shoulder, and Hand (DASH) score.

Aims. This study aims to extend the follow-up to 24 months to evaluate the long-term sustainability of clinical improvements following ChondroFiller Liquid® infiltration.

Materials and Methods. A total of 40 patients from the initial study were enrolled and categorized into two severity groups based on the Eaton-Littler classification. Clinical evaluations were conducted at 18 months post-infiltration (T1) using the Numeric Rating Scale (NRS) and DASH score. A subsequent assessment at 24 months (T2) included the Jamar test, pinch test, NRS, and DASH score. An additional cohort of 51 patients underwent infiltration with a mean follow-up of 14 months, including 9 patients previously treated in the preliminary study.


Eligibility Criteria:
Inclusion Criteria:

* patients with rhizarthrosis diagnosed on X-rays performed in the last year;
* patients aged \> 18 years;
* enrollment in the study through informed consent;

Exclusion Criteria:

* patients who have undergone cortisone and/or hyaluronic acid infiltrations in the last 6 months;
* patients following trauma involving the ATM;
* patients with underlying rheumatological diseases;
* patients under 18 years of age
* ongoing pregnancy;
* patients affected by metabolic disorders (e.g. diabetes)
A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis
* At least one measurable lesion
* Life expectancy \> 3 months
* ECOG performance status 0-2
* Adequate hematologic, cardiac, renal, and hepatic function
* Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study

Exclusion Criteria:

* Evidence of metastasis
* Serious infection
* Evidence of bleeding diathesis
* Significant cardiovascular disease
* Pregnant or lactating woman
* Allergic to E.coli preparation
Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients

Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the disease. They effect personal life. Their management may be overlooked. The evidence-based program proposes exercises to both stimulate preserved functions and develop new abilities compensating for cognitive disabilities.

Aim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed for MS patients, compared to an interactive discussion program(DISINT) 140 multiple sclerosis patients will be randomly assigned in one the program for 13 sessions over a 6-month period.

Main outcome criteria is evolution of SRT-LIST before and after program.


Eligibility Criteria:
Inclusion Criteria:

* 18 ≤Aged ≤ 60 at baseline
* Must be able to understand and read french language
* Must sign the informed consent form
* Must be affiliate to French social security
* multiple sclerosis confirmed by Mac Donald criteria
* EDSS ≤ 6.0 at baseline
* Duration of multiple sclerosis ≤ 30 years at baseline
* mild cognitive disorder ( at least 2 cognitive tasks, at most 5 )

Exclusion Criteria:

* under legal protection
* treatment by corticosteroids in the past 4 weeks
* cognitive remedial program already done
* neuropsychologic assessment in the past 2 months
* having an other chronic disease
* having an other neurologic disease
* alcohol or drug addiction
Effects of Pregnenolone on Perceived Social Isolation

No studies to date have examined the effects of pregnenolone on hypervigilance for social threat in individuals with perceived social isolation (PSI). We therefore are conducting a double-blind randomized research study combining three validated behavioral paradigms on social threat attention, perception of others, and emotion regulation with high-density electrical neuroimaging to probe the neuro-circuitry of social threat processing in young adults high in perceived social isolation two hours after the oral administration of 175mg pregnenolone (N = 24), 400mg of pregnenolone (N = 24), or placebo (N = 24). Such research has the potential to yield important insights into the neurobehavioral mechanisms of pregnenolone on hypervigilance for social threat and perception of others--- a first key step toward the development of adjunctive pregnenolone therapy in individuals with PSI.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-80
* At least a score of 42 on the UCLA Loneliness scale.
* Right handed
* Normal or corrected eye sight

Exclusion Criteria:

* Medical history of cancer
* Steroid use
* Psychotropic drugs
* History of heart irregularities
* Have a counter indication to EEG
* Age \<21 or \>32
* Score less than 42 on UCLA loneliness scale
* Left handed
* Meet MINI criteria for anything but untreated major depressive disorder
* Uncorrected vision
* Current or past neurological disorder including epilepsy or traumatic brain injury
* Have a counter indication to electrical neuroimaging
* Under hormonal therapy (including, but not limited to, testosterone)
* Unstable mental illness
* History of bipolar disorder, schizophrenia, or psychotic disorder
* Current or recent (past 3 months) substance use or dependence
* Currently taking any medications that may have unfavorable interactions with pregnenolone
BIOLUX P-III All-Comers Passeo-18 Lux Registry

BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

The Passeo-18 LUX Paclitaxel Releasing BalloonCatheter is a novel drug-releasing balloon that received CE-mark in January 2014. Its safety and efficacy has been investigated in two randomized First-in-Man trials in patients with stenosis or occlusion of the femoropopliteal (BIOLUX P-I) and infrapopliteal (BIOLUX P-II) arteries when compared to an uncoated device.

The purpose of the BIOLUX P-III all-comers registry is to collect short and long-term clinical performance data on the Passeo-18 Lux DRB in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or minimum age as required by local regulations
* Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable
* Lesion(s) in the infrainguinal arteries suitable for endovascular treatment treated with or scheduled to be treated with the Passeo-18 Lux drug releasing balloon

Exclusion Criteria:

* Life expectancy ≤ 1 year
* Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet
* Subject is pregnant or planning to become pregnant during the course of the study
* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations