cyrilzakka/clinical-trials huggingface dataset:
The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma

To research and explore the antibody protection and immune memory after vaccination in children with KHE during sirolimus administration. To explore the feasibility (safety and efficacy) of vaccination in a timely manner during the administration of sirolimus in children with KHE. To search for back-up plans for vaccination regimens for KHE patients taking sirolimus in children who do not respond to primary vaccination.

Children with KHE have an early onset. KHE usually occurs in infants and young children less than 1 year old, of which neonates account for about 38.5%-60% of all cases. Due to the immunosuppressive effect of sirolimus, the vaccination was usually suspended after taking it, and children would be in a state of no immune protection. These children are at greatly increased risk of exposure to microorganisms and consequent infection. Therefore, it is necessary to vaccinate them against infectious diseases. However, vaccination with live vaccines has the potential to cause severe infections through reversion of the vaccine strain to a pathogenic form. Moreover, studies have also shown that protective antibodies are severely affected in transplant patients taking immunosuppressive drugs and in patients with solid tumors after chemotherapy. Loss of immune memory is very common, and marked deficits in B cell function and humoral immunity can persist even for years.

Eligibility Criteria:
Inclusion Criteria:

* Case groups:
* KHE patients treated with sirolimus.
* After immunoglobulin and flow cytometry assays, as well as outpatient evaluation and assessment, those participants will be vaccinated with live attenuated vaccines or inactivated vaccines in a timely order according to the advice.
* Control groups:
* Healthy children with no immune deficiencies.
* Participants are vaccinated according to the National Immunization Program in a timely manner.
* Participants are matched to the case group according to age.

Exclusion Criteria:

* HBsAg, HBeAg positive, or other active infectious diseases;
* History of immunodeficiency or low immunoglobulin levels;
* Autoimmune disease or fever during blood collection;
* Use of other medication or surgery;
* Suffering from other bleeding disorders;
* Suffering from other solid tumors or hematological tumors, etc.;
* Withdraw informed consent.
DEtection of Cellular Inflammation With FERumoxytol in the HEART

To non-invasively image myocardial accumulation of ultrasmall superparamagnetic particles of iron oxide (USPIOs) by an increase in R2\* values (compared to controls) within the myocardium of patients with:

i. cardiac transplantation ii. acute myocarditis iii. suspected cardiac sarcoidosis

Ferumoxytol is a 'smart' magnetic resonance contrast agent consisting of ultrasmall superparamagnetic particles of iron oxide (USPIOs) that are taken up by macrophages. Concentration of USPIOs within macrophages changes the tissue relaxation properties and this can be detected by magnetic resonance imaging using R2\* maps. In a recent early proof-of-concept study, we demonstrated that macrophages could be detected with USPIOs in the penumbra and infarct zone of the myocardium in patients with a recent myocardial infarction. The investigators therefore wish to establish whether USPIOs can be used to identify cellular inflammation within the myocardium in three distinct clinical conditions that currently lack a non-invasive diagnostic imaging test: cardiac allograft rejection, viral myocarditis and cardiac sarcoidosis. If successful, this would not only provide a useful diagnostic test but would also be a method of monitoring disease progression or response to therapy.

Eligibility Criteria:
Inclusion Criteria:

1. One of the four conditions below:

   * Patients having undergone cardiac transplant
   * Patients diagnosed clinically with myocarditis of any aetiology (eg viral, septic, post chemotherapeutic etc)
   * Patients clinically diagnosed with cardiac sarcoidosis
   * Healthy volunteers
2. Age \> 18 years.

Exclusion Criteria:

1. Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging safety questionnaire
2. Patients refusing or unable to give informed consent
3. Renal failure (estimated glomerular filtration rate \<30 mL/min)
4. Polycythemia
5. Contraindication to ferumoxytol (previous allergic drug reaction, any immune or inflammatory conditions (eg, systemic lupus erythematosus, rheumatoid arthritis, history of severe asthma, eczema or other atopic allergy)), evidence of known iron overload, hemochromatosis, known hypersensitivity to ferumoxytol or its components or anaemia not caused by iron deficiency.
6. Known allergy to dextran- or iron-containing compounds.
7. Diagnosis of myocardial infarction within 1 month.
8. Pregnancy or Breast-feeding.
9. Women of child bearing age not ensuring reliable methods of contraception. Female participants of child bearing age will be asked if they are ensuring reliable methods of contraception prior to each administration of USPIO and MRI scan. If use of reliable contraception cannot be confirmed, the participant will be withdrawn.
Brain Stimulation for Foot-sole Sensation in Older Adults With Foot-sole Somatosensory Deficits

In older adults, diminished sensation of the legs and feet is highly prevalent and causes poor balance and reduced mobility. This type of sensation is not only dependent upon the receptors and nerves in the legs and feet, but also upon a complex central nervous system pathway that includes the cerebral cortex of the brain. This project will use a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS) to test whether increasing the excitability of the brain networks that process sensory feedback can augment foot sole sensation, balance, and mobility in older adults suffering from mild-to-moderate foot sole sensory impairments.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥65 years.
2. Self-reported feeling of unsteadiness or difficulty when standing and walking.
3. Mild-to-moderate foot-sole somatosensory impairment: the ability to perceive 75g monofilament but inability to perceive 10g monofilament.

Exclusion Criteria:

self-reported 1) inability to stand or walk continuously for one minute without personal assistance (canes or walkers allowed); 2) history or presence of foot ulceration, amputation, or deformities; 3) self-reported uncontrolled pain or pain that is associated with mobility disability; 4) uncontrolled diabetes mellitus; 5) hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting balance; 6) persistent severe pain of lower extremity when standing or walking; 7) diagnosis of dementia, Parkinson's disease, or stroke that affects balance; 8) unstable medical condition; 9) legal blindness or deafness; 10) uncontrolled hypertension (i.e., systolic BP \>180, diastolic BP \>100 mm Hg, or prescription of ≥3 anti-hypertensive medications); 11) functionally limiting nephropathy, severe diseases or transplant of the kidney or liver, renal or congestive heart failure; 12) active cancer treatment; 13) balance disorders due to past use of chemotherapy or history of Guillain-Barré syndrome; 14) use of neuro-active or recreational drugs (e.g., sedatives, anti-psychotics), or alcohol abuse, which may affect the brain excitability; 15) contraindications to MRI or tDCS (e.g., personal or family history of seizures or epilepsy, metallic or electric bio-implants, claustrophobia, brain surgery); 16) persistent vertigo; 17) history of Charcot-Marie-Tooth nerve disease.
Frequency of Selected Single Nucleotide Polymorphisms in Huntington Disease Gene Expansion Carriers

For participation in this epidemiological study, a single-day visit at the study site is required. Participants will be recruited from Huntington Disease clinics, and they will be asked to answer questions regarding their demographics, including sex, age, race and ethnicity, and their medical and medication history. At the end of the visit, a blood sample will be drawn to allow testing with a sequencing assay that is specifically designed for phasing single nucleotide polymorphisms (SNPs) on the wild-type Huntington (wtHTT) and mutant Huntington (mHTT) alleles.


Eligibility Criteria:
Inclusion Criteria:

* Have signed the Informed Consent Form (ICF)
* Aged 25 to 60 years, inclusive, at the time of signing the ICF
* Confirmation of Huntington Disease (HD) gene expansion mutation carrier status
* Confirmation of Total Functional Capacity (TFC) ≥9 and Total Motor Score (TMS) \>6 within 12 months prior to signing the ICF
* Ability to tolerate blood draws

Exclusion Criteria:

* None
Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration

This study was designed to enroll a series of 10 consecutive patients who met the inclusion criteria. Patients were treated in the Department of Orthodontics and Dento-Facial Orthodopedics of the University of Liège. Two senior's orthodontists and two senior's periodontists were involved in the orthodontic treatment and in the surgical procedures respectively. All clinical, radiographic and periodontal measurements and all orthodontic parameters were performed at baseline and after the orthodontic treatments. Tree examiners collected the overall data.


Eligibility Criteria:
Inclusion criteria:

* Patients requiring at least mandible orthodontic treatment (both arches)
* Patient presenting alveolar bone thickness \< XX mm
* Adult patients with completed growth based on the Cervical Vertebral Maturation Method (CVM) as described by Baccetti et al. (Baccetti et al. 2002)
* Minimal to moderate mandibular anterior crowding at baseline (irregularity index≤6) (Little 1975)
* American Society of Anesthesiology I or II (I = Normal healthy patient; II = Patients with mild systemic disease)
* Adequate dento-oral health (i.e., the absence of periodontal diseases, peri-apical infection, or untreated caries).

Exclusion criteria were as follows:

* Controlled periodontitis with a loss of alveolar support \> 10%
* Gingival recession \> 2 mm
* Smokers
* Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
* Mental or motor disabilities
* Pregnancy
SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction


Eligibility Criteria:
Inclusion Criteria:

* Age: 20 - 80 years old
* Gender: Male or female
* Status: Outpatients
* Elevated Serum Creatinine

Exclusion Criteria:

* Patients suspected of malignant hypertension
* Patients with a clinically significant allergy
* Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply
A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants

The purpose of this study is to assess the efficacy and safety of the combination of nivolumab and ipilimumab in Chinese participants with malignant pleural mesothelioma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of Malignant Pleural Mesothelioma (MPM) with determination of epithelioid vs non-epithelioid histology
* Must have advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy)
* Available tumor samples for centralized testing
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
* Measurable disease

Exclusion Criteria:

* Primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma
* Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy
* Prior therapy for MPM (including chemotherapy, radical pleuropneumonectomy and non-palliative radiotherapy)

Other protocol-defined inclusion/exclusion criteria apply
Effect of a Short Nap During the Night Shift of Healthcare Workers on Endothelial Function

Night shift work is well known to cause health disruption in short and long term. It has been reported that among healthcare workers, nurses slept less than 6 h/24h. Consequences of such short sleep duration has been associated to long term issues such as endothelial dysfunction associated with cardiovascular diseases, arterial hypertension and type 2 diabetes. Countermeasures such as nap at work has potential effects on reducing the prevalence of cardiovascular diseases. However, to our knowledge, no studies have objectively investigated the effects of napping on endothelial function in a longitudinal design. Therefore, this study aims to investigate the effect of a 30 minutes on-duty nap during night work for 12 weeks on caregivers endothelial dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Being a paramedical caregiverr (nurse or care assistant) at Saint-Etienne University Hospital
* Be aAged between 18 and 65
* Working at least 80% of a full-time equivalent post
* Working 12-hour shifts (day/night) in continuous care services
* Being affiliated or entitled under a social security scheme
* Havinge received informed information about the study and have co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria:

* Have made a tTrans meridian journey in the last month prior to the study
* Have a mMedically diagnosed sleep disorder such asof the hypersomnia or insomnia type
* Have a diagnosed and treated mental pathology
* Usually take a nap in the workplace in a quiet room
* Be pregnant or breastfeeding
* Have medically diagnosed neurovascular or neuromuscular pathologies
Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)

Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.

Epileptic encephalopathy is very common in children and adolescent with epilepsy, but there is no data in clinical studies.The aim of this study is to evaluate the efficacy of the long-term vagus nerve stimulation for children and adolescent with epilepsy

Eligibility Criteria:
Inclusion Criteria:

1. age 4-18
2. Diagnostic criteria for epilepsia brain disorders
3. Having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and zt least 6 seizures per month
4. patients or his(her) families could understand this method and sign the informed consent
5. Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria:

1. the vagus nerve lesion and damage
2. patients with progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases,digestive system diseases
3. patients'mental state is not stable，
4. patients with or anesthesia contraindications,such as long-term use of anticoagulation antiplatelet drugs etc.
5. patients have or need other implantable devices, such as pacemakers,defibrillators, cochlear and spinal nerve root stimulator.
6. patients due to their own reasons for the need for nuclear magnetic resonance imaging in the future clinical trials
7. patients have participated in other clinical trials.
Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery

The aim of the current observational study is to better assess the relationships between neuromuscular blockade and multiple surgical outcomes in patients undergoing elective laparoscopic bariatric surgery.

Performing bariatric surgery as a short-stay procedure is an ongoing trend in many centers around the world. For morbidly obese (MO) patients, the anesthetic approach is based on choosing drugs that have the least potential for accumulation. This allows a more rapid and clear-headed recovery and contributes to reduced duration of perioperative time. However, when neuromuscular blockade (NMB) is required during surgery, complete recovery is a major factor that may prevent from a rapid fast-track discharge.

In Canada, reversal of NMB is achieved by using acetylcholinesterase (AChE) inhibitors, mostly neostigmine, which must be administered after a certain level of spontaneous recovery in order to ensure a complete reversal. This elongates the time spent in the operating room (OR), and prevent therefore from a fast track surgery procedure. On the other hand, in an effort to shorten the time spent in the OR, AChE inhibitors may sometime be administered too early before spontaneous recovery, and post-operative residual curarization (PORC) may then be observed. In the post-anesthesia care unit (PACU), PORC may be particularly problematic, because of the possible occurrence of critical respiratory events (CREs). This in turn is also associated with significant delayed discharges.

Because of the aforementioned inconveniences, Canadian anesthesiologists are reluctant to induce deep NMB. Consequently, intra-abdominal pressure remain non optimal during the surgery, which do not facilitate the surgeons work, in addition to increase perioperative time. This problem is particularly frequent in cases of bariatric surgeries.

The current study will explore this question from the perspective of the surgeon satisfaction and the patient quality of recovery.

Eligibility Criteria:
Inclusion Criteria:

MO patients \[body mass index (BMI)≤ 55kg/m2\] scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.

Exclusion Criteria:

* a physical status \>3 (ASA),
* a difficult tracheal intubation,
* a known or suspected disorder affecting NMB,
* a renal, pulmonary, cardiac, and/or hepatic dysfunction,
* malignant hyperthermia,
* pregnancy, breastfeeding,
* allergy or contraindication to narcotics, rocuronium, neostigmine, or other medications used during anesthesia
* patients with sleep apnea syndrome will also be excluded.
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound \[transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)\].
* Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) \> 80 mL during 1 menses in screening as measured by the alkaline hematin method.
* Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose.
* Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.

Exclusion Criteria:

* Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS) or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a clinically significant gynecological disorder.
* Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.
* Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
* Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
* Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.
Hearing Aids and the Brain

Hearing aids are being fit on inexperienced hearing aid users and the short-term and long-term effects are measured. This research aims to improve understanding of the individual factors that contribute to receiving benefit from hearing aids and lead to more individualized treatment of hearing loss.

Hearing aids are used to improve audibility for patients with hearing loss and improve speech perception. In addition to these immediate benefits, amplification has the potential to have long-term effects on higher level auditory processing abilities, such as cognition or other abilities required for complex listening tasks. These long-term acclimatization effects are not well understood and merit further behavioral and physiological examination. Hearing aids will be fit on inexperienced hearing aid users and outcome measures will be used to determine immediate and long-term effects of hearing aids. This research may provide a more detailed view of individual differences that contribute to receiving benefit from a hearing aid and may lead to more individualized treatment of hearing loss.

Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older
* Bilateral, mild to moderately severe hearing loss
* Inexperienced hearing aid users

Exclusion Criteria:

* Subject deciding that they do not wish to wear hearing aids as necessitated per study protocol
* Audiometric thresholds that suggest research stimuli would not be audible
* Conductive hearing loss and/or other significant ear or hearing problems
* Non-native English speakers
* Conditions or circumstances that would preclude a participant from wearing hearing aids consistently or finishing the study
* An inability to perform or complete the experimental tasks
A Study of the Pharmacokinetics of Black Cohosh

Black cohosh is a natural supplement that has been used to treat and prevent menopausal symptoms. Remifemin is a standardized form of black cohosh. The purpose of this study is to determine the levels of components of black cohosh obtained in the blood of healthy women taking Remifemin.

As per Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* No prior diagnosis of cancer other than non-melanoma skin cancer or carcinoma in-situ of the cervix
* No current prescription medication use
* Negative urine pregnancy test OR greater than age 50 with no menses for at least one year OR documented status post hysterectomy
* Competent to understand and sign informed consent
Avelumab Program Rollover Study

The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.


Eligibility Criteria:
Inclusion Criteria:

* Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research \& Development Institute, Inc. / Merck KGaA, Darmstadt, Germany

  * Merck Serono Co., Ltd (Japan)
* Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment
* Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Participants who are pregnant or breastfeeding
* Participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients
* Participant has been enrolled in the comparator arm of avelumab parent study
* Participant has been withdrawn from avelumab parent study for any reason
* Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study
* Other protocol defined exclusion criteria could apply.