cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects

This study will be an open-label, randomised sequence, 2-period, 2-cohort, 2-treatment in each cohort, cross-over study in healthy subjects (males and females of non-childbearing potential), performed at a single study centre.

The study will comprise:

* A screening period of maximum 28 days;
* Two treatment periods:

  * Treatment Period 1 starts with admission to the Clinical Unit on Day -1, followed by dosing on Day 1 with the assigned treatment (A, B, C, or D) as per assigned cohort and treatment sequence, followed by a washout period of at least 14 days.
  * Treatment Period 2 starts with admission to Clinical Unit on Day -1, followed by dosing on Day 1 with cross-over treatment as per assigned cohort, followed by a follow-up period of 7 to 10 days.
* A follow-up visit/early termination visit at 7 to 10 days after the last investigation medicinal product (IMP) administration.

Subjects will be assigned to either Cohort 1 (tacrolimus) or to Cohort 2 (cyclosporin). Each cohort will have 2 treatment periods. Subjects in each cohort will be randomly assigned to one of 2 treatment sequences (AB\|BA or CD\|DC) where,

* Treatment A: Tacrolimus
* Treatment B: Tacrolimus + SZC
* Treatment C: Cyclosporin
* Treatment D: Cyclosporin + SZC

Eligibility Criteria:
Inclusion Criteria:

• Healthy male and female subjects aged 18 to 50 years (both inclusive)

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important abnormalities in rhythm, conduction or morphology of the 12-lead safety electrocardiogram (ECG), at screening visit and/or admission to the Clinical Unit.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to SZC, tacrolimus, or cyclosporin.
* Subjects who have previously received SZC.
Vitamin D Insufficiency inVestigation Among hospitaLizeD Inpatients

Hypovitaminosis D is common in the adult population, it affects at least 1 billion people worldwide, and in particular 80% of the French population according to the National Institute for Public Health Surveillance. Hypovitaminosis D is accompanied or complicated by deleterious health manifestations such as bone, immune and cancer diseases, neuromuscular disorders and a propensity to fall, for example. Hypovitaminosis D has also been associated with more complicated care pathways (increase in the severity of the reason for hospitalization, length of hospitalization, risk of in-hospital death). Prevention of these clinical events depends on correcting vitamin D status.

In sick, dependent or fragile adults, natural intakes are generally insufficient. It is indeed accepted that hypovitaminosis D may not be treated effectively by dietary measures or by simple exposure to the sun in French latitudes. Drug supplementation is therefore necessary, with the objective of achieving a target concentration of circulating 25-hydroxyvitamin D (25 (OH) D) of 75 nmol / L (30 ng / mL) in this population.

Vitamin D supplementation, when properly conducted, corrects hypovitaminosis D, and has been associated with improved prognosis, especially life-saving, in therapeutic trials versus placebo. Such results lead the investigators to suggest that the identification and correction of hypovitaminosis D in hospitalized patients could represent a simple, effective and inexpensive strategy for improving hospital care pathways. In this perspective, the first step is to determine the prevalence, severity and clinical profile of hospitalized patients with hypovitaminosis D, as well as their course of care. To the investigators knowledge, there are no large-scale studies based on real-life data on this subject.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* have had a dosage of circulating 25-hydroxyvitamin D (plasma or serum) in a HUGO establishment
* consultant or hospitalized between 01/01/2015 and 12/31/2019 in one of the participating HUGOs.

Exclusion Criteria:

* None
Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access.

This study will evaluate using intraosseous vascular access and intravenous vascular access to give patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties. The investigators think the device operator will find the intraosseous and intravenous routes equal for drug delivery.

This observational study will evaluate the intubating conditions of patients receiving rapid sequence intubation when receiving paralytic drug delivery via intravenous or intraosseous vascular access from the perspective of the medical professional performing rapid sequence intubation. The investigators believe that medical professionals will find equal intubating conditions for intravenous and intraosseous drug delivery.

Eligibility Criteria:
Inclusion Criteria:

* Requires rapid sequence intubation
* Succinylcholine is chosen paralytic agent
* IV or IO access has been established for rapid sequence intubation
* For IV access patients, their rapid sequence intubation case is the next occurring IV rapid sequence intubation case following an enrolled IO RSI case.

Exclusion Criteria:

* Vascular access other than IV or IO has been established
Spontaneous Coronary Artery Dissection National Swiss Registry

Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting predominantly young women without traditional cardiovascular risk factors and is associated with major adverse outcomes including myocardial infarction, cardiac arrest, or death.

Timely diagnosis of SCAD as well as clinical follow-up are of the essence in this pathology associated with major cardiac adverse outcomes. Despite recent improvements in diagnosis and recognition of the importance of SCAD, it remains poorly studied and understood.

In this context, we designed the SwissSCAD registry, a large, observational, prospective, cohort study, to describe the natural history of SCAD, its outcomes and its treatments.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥18 years of age.
* Patient presenting newly diagnosed SCAD or diagnosed with SCAD within the last 5 years.
* Subject must be willing to sign a Patient Informed Consent (PIC).

Exclusion Criteria:

* Patient unwilling or unable to provide informed consent.
* Patients with atherosclerotic or iatrogenic coronary dissection.
Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers. VHT treatments will be provided as an adjunct to standard wound care. Subjects will receive VHT treatments until wound closure, or for the treatment period of 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic foot wound, graded by the Wagner Scale as a 1,2 or 3
* Wound has resisted healing with standard wound care for at least 6 weeks
* No symptoms of sepsis
* Able to maintain reasonable nutrition and hydration
* Able to maintain adequate home care between treatment visits
* Able to understand and follow basic wound care instructions, or has caregiver who can assist

Exclusion Criteria:

* Skin wounds cancer/neoplastic etiology
* Wounds that involve osteomyelitis or tendon involvement
* Diagnosis of methicillin resistant staph aureus by wound swab
* Acute skin conditions
* Surgery within 30 days of study onset
* Wounds where the end cannot be probed
* Participation in another clinical trial within 120 days prior to study onset
* Non-compliant patients
* Pregnancy
* Presence of co-morbid conditions that in the physician's opinion exclude the individual from the study
Marfan Syndrome (MFS) and Facial Dysmorphism: Non-invasive 3D Assessment

The goal of this study observational prospective study is to define the facial morphological features associated with Marfan syndrome (MFS). The main qustion it aims to answer are:

1. To describe the facial morphological features associated with MFS and their evolution over time;
2. To study the association between facial morphology and the features of reference for the diagnosis of MFS.

Marfan syndrome (MFS, OMIM # 154700) is a rare connective tissue disorder caused by mutations in the gene encoding fibrillin-1 glycoprotein (FBN1), involved in the development of microfibrils. Since FBN1 is a constituent of the connective tissue present at a systemic level, mutations in its gene lead to alterations of the connective tissue, even with pleiotropic effects. The clinical manifestations of MFS are heterogeneous and can occur at any time, from neonatal onset to infancy or adolescence. In this sense, the presence of facial dysmorphism could help in early diagnosis of the disease. Considering the craniofacial features, the phenotypic manifestation related to the syndrome MFS are: dolichocephaly, eyelid down-slanting, malar hypoplasia and retrognathia. However, Few studies have so far studied the facial features associated with MFS. Morevoer, there is a gap in the literature for the evaluation of the progression of facial morphology in the pediatric MFS population as well as potential correlations between facial dysmorphism and other manifestations of the disease.

Eligibility Criteria:
Inclusion Criteria:

* White european ethnicity;
* Signed informed consent;

Exclusion Criteria:

* Previous relevant traumas affecting the craniofacial district or maxillofacial surgery;
* Presence of beard and mustache;
* Pregnancy
"Optic Nerve Sheath Diameter; Low vs. Conventional Insufflation Pressures''

Objective: This study investigates the impact of carbon dioxide (CO2) pneumoperitoneum on optic nerve sheath diameter (ONSD) and intracranial pressure (ICP) in patients undergoing total laparoscopic hysterectomy. Previous research suggests that pneumoperitoneum can lead to elevated ICP, with the standard intracranial monitoring technique being invasive intraventricular catheter placement. In contrast, bedside ultrasound assessment of ONSD offers a noninvasive alternative for detecting increased ICP.

Methods: The Hypothesize will be standard gas insufflation pressure significantly increases ONSD, while low-pressure insufflation will maintain ONSD levels. The primary aim is to compare ONSD variations pre- and post-CO2 insufflation in patients subjected to both low-pressure and standard-pressure laparoscopic surgery. Secondary aims include evaluating end-tidal CO2 measurements between the two groups.

It has been shown in many studies that pneumoperitoneum containing carbon dioxide (CO2) during laparoscopy increases intracranial pressure (ICP). (1) Evaluation of the Effect of Intraabdominal Pressure on Optic Nerve Sheath Diameter in Patients Undergoing Total Laparoscopic Hysterectomy. The standard technique for monitoring ICP is the placement of an intraventricular catheter connected to an external pressure transducer. (2) Bedside evaluation of optic nerve sheath diameter (ONSD) with ultrasound technique is a more practical and noninvasive method used to determine high ICP (\>20 mmHg). The anatomical continuity of the dura with the optic nerve sheath (ONSD) allows the use of this technology, and thus an increase in ICP can be transmitted from the subarachnoid space to the ONSD. (3)

Low-pressure pneumoperitoneum reduces analgesic consumption after laparoscopic cholecystectomy in studies, but the effect of standard and low intraabdominal pressures on ICP has not yet been clarified. (4)

In our thesis, assuming that standard gas insufflation pressure will increase ONSD, but low gas insufflation pressure will not cause a change, the primary aim was to compare ONSD between two groups of low-pressure and standard-pressure laparoscopic surgery before and after CO2 insufflation preoperatively. Second, the end-tidal CO2 measurements between the two groups will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* The study will be conducted in patients under 18 years of age with American Society of Anesthesiologists (ASA) I-II.

Exclusion Criteria:

* Patients with a history of neurological disease, glaucoma, surgery exceeding 2 hours, known chronic obstructive pulmonary disease (COPD), heart disease, and previous lung surgery will be excluded from the study. Patients with intraoperative hemodynamic problems; ETCO2 greater than 45 mmHg, plateau pressure over 30 cmH2, and peak inspiratory pressure over 35 cmH2 will be excluded from the study.
A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure.

Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined exclusion criteria may apply.
Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy

Chemotherapy can damage bone marrow and therefore impair the production of white blood cells, platelets and red blood cells with the resulting anemia and osteoporosis.

Purposes of this study were:

1. To determine the therapeutic efficacy of the whole-body vibration (WBV) in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.
2. To determine the therapeutic efficacy of the weight bearing exercise in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.
3. To gain knowledge about the whole-body vibration (WBV) and the weight bearing exercise in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.
4. To share in designing an ideal protocol for the treatment of the osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis.
* Their age ranges from 35-55 years old.
* All patients will have the same medical and nursing care.
* All the patients will receive a good explanation of treatment and measurement device.
* They are neurologically free.

Exclusion Criteria:

Patients will be excluded from this study for any of the following causes:

* Uncooperative patients.
* Instability of patient's medical condition.
* Association of another medical problem.
* Patients who have diabetes.
* Patients who have history of medical chronic relevant diseases.
* Patients who have acute or chronic hepatitis.
* Patients who have pacemaker.
* Patients who have genitourinary infections.
Objective and Subjective Outcomes of a Trifocal IOL in Eyes With Different AL

This prospective cohort study enrolled patients with implantation of a trifocal IOL. Only one eye of each patient was enrolled. Eyes were devided into three groups according the axial length (AL), including the short AL group, the control group and the long AL group. Manifest refraction, uncorrected and distance-corrected visual acuity at different distances, contrast sensitivity, aberrations and IOL decentration were measured three months after surgery. Spectacle independence, adverse photic phenomena, overall satisfaction and life quality were assessed with a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were patients older than 40 years with significant bilateral or unilateral cataract seeking spectacle independence, with the AL between 21.00 to 30.00 mm, the prediction of postoperative corneal astigmatism less than 1.0 diopters (D), the angle kappa less than 0.50 mm, the corneal spherical aberration less than 0.5 μm and the corneal higher order aberration less than 0.5 μm.

Exclusion Criteria:

* Exclusion criteria were eyes with serious intraoperative complications, irregular corneal astigmatism, corneal scarring, uveitis, glaucoma, pseudoexfoliation syndrome, macular degeneration or other retinal impairment, amblyopia or patients having difficulties with examinations or 3 months' follow-up.
Evaluation of Mirtazapine and Folic Acid for Schizophrenia:

Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the effects of adding mirtazapine and folic acid to existing therapy for patients with schizophrenia

The combination of mirtazapine plus antipsychotic potentially offers considerable benefit for patients with schizophrenia. Folic acid is a promising adjunctive therapy for schizophrenia that may also provide benefits for patients with other mental disorders. Furthermore the effects of folic acid may be affected by genotype.

The trial will investigate the effects of adding mirtazapine and the effects of adding folic acid to treatments for schizophrenia. At randomisation, patients will be separately randomised to mirtazapine or placebo and to folic acid or placebo.

Randomised, double-blind, placebo-controlled 2x2 factorial trial with 12-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Inpatients or outpatients age 18 to 70 years;
2. Meet DSM-IV criteria for schizophrenia;
3. Signed an informed consent form by patients or their legally acceptable representatives;
4. PANSS total score \>=60 and at least one item of P1, P2, P3, P5 or P6 \>=4 to ensure subject has current active psychotic symptoms - i.e. hallucinations, delusions, thought disorder;
5. Subjects who are currently taking effective dose of antipsychotic;
6. Women must agree to practice an effective method of birth control if they are sexually active before entry and throughout the study.

Exclusion Criteria:

1. Meet any other DSM-IV Axis I disorders;
2. Meet DSM-IV criteria for substance abuse or dependence;
3. Have been treatment-resistant to 2 or more kinds of antipsychotics with sufficient dosage for at least 4 weeks, or require clozapine treatment, or have received clozapine treatment within 1 month prior to randomization;
4. Subjects are actively suicidal or judged clinically to be at risk of serious suicidal or violent behavior in the opinion of the investigator;
5. Have serious or unstable medical illness (e.g., cardiovascular disease, neurologic, hematologic, renal, hepatic, immunologic, endocrine, or other systemic illness), or have any clinically significant abnormality on laboratory test or ECG which indicate severe medical conditions;
6. Have received electroconvulsive therapy within 28 days before randomization;
7. Have received long acting antipsychotic within 1 treatment cycle before randomization;
8. Have received antidepressant within 14 days, or have received MAOIs within 4 weeks before randomization or require antidepressive treatment;
9. History of prostatic hypertrophy or dysuria;
10. History of narrow-angle glaucoma or elevation of intraocular pressure;
11. Known or suspected history of allergy or have contradiction to mirtazapine or folic acid;
12. Known have currently requirement of taking mirtazapine or folic acid;
13. Women who are pregnant or nursing;
14. Have previously completed or withdrawn from this study, or participated in a clinical trial of another drug within 30 days.
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1920 in Healthy Participants

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses (SADs) of ALXN1920 subcutaneous (SC) and of a single dose of ALXN1920 intravenous (IV) in healthy adult participants.

This is a first-in-human study in healthy adult participants.

Eligible participants will be randomly assigned in a 3:1 (ALXN1920:Placebo) ratio in each of the treatment cohorts. The first 2 participants randomized to each cohort will be dosed as a sentinel pair, with 1 participant on active treatment and 1 participant on placebo. At the discretion of the Investigator, up to 3 more participants will be added at least 48 hours after the dosing of the sentinel pair, followed by dosing of the remaining participants in the cohort no earlier than 72 hours after sentinel pair dosing.

The study will comprise:

A Screening Period of up to 28 days; A Dosing Period (single dose through to Follow-up Visit) of approximately 28 days; A Final Follow-up period and end of study Visit is planned on Day 29.

Each participant will be involved in the study for approximately 56 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* Body mass index within 18.0 to 32.0 kg/m\^2 (inclusive), with a minimum body weight of 50.0 kg.
* Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
* For Cohort 6, participants of Japanese descent, defined as having both parents and 4 grandparents who are ethnically Japanese.

Exclusion Criteria:

* Significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
* History of significant allergic reaction.
* History of any Neisseria infection
* Active systemic bacterial, viral, or fungal infection.
* Participants who at Day -1 are either testing positive for coronavirus disease 2019 (COVID-19), or have not had at least 4 weeks elapse of recovery time (a negative test), or are experiencing long-term COVID-19-related sequelae.
* Any major surgery within 8 weeks of Screening.
* Known or suspected history of drug or alcohol abuse.
* Current tobacco users or smokers.
* Positive Human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C viral infection.
* Female participant who are pregnant, breastfeeding, or intending to conceive during the course of the study.