cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

The primary objective of the study is to demonstrate a reduction in intravascular hemolysis by REGN3918 over 26 weeks of treatment in patients with active PNH who are treatment-naive to complement inhibitor therapy or have not recently received complement inhibitor therapy.

The secondary objectives of the study are:

* To evaluate the safety and tolerability of REGN3918.
* To evaluate the effect of REGN3918 on parameters of intravascular hemolysis
* To assess the concentrations of total REGN3918 in serum.
* To evaluate the incidence of treatment-emergent anti-drug antibodies to REGN3918 over time
* To evaluate the effect of REGN3918 on patient-reported outcomes (PROs) measuring fatigue and health-related quality of life


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) confirmed by high-sensitivity flow cytometry
* PNH granulocytes \> 10% at screening visit
* Active disease, as defined by the presence of 1 or more PNH-related signs or symptoms (eg, fatigue, hemoglobinuria, abdominal pain, shortness of breath \[dyspnea\], anemia \[hemoglobin \<10 g/dL\], history of a MAVE \[including thrombosis\], dysphagia, or erectile dysfunction) or history of red blood cell (RBC) transfusion due to PNH within 3 months of screening.
* Lactate dehydrogenase (LDH) level ≥ 2 × upper limit of normal (ULN) at screening visit.

Key Exclusion Criteria:

* Prior treatment with a complement inhibitor either within 6 months prior to screening visit or at any time where the patient was refractory to complement inhibitor therapy, in the opinion of the investigator (with the exception of eculizumab refractory patients due to the C5 variant R885H/C)
* History of bone marrow transplantation
* Body weight \< 40 kilograms at screening visit
* Peripheral blood absolute neutrophil count (ANC) \<500/μL \[\<0.5 x 109/L\] or peripheral blood platelet count \<50,000/μL
* Documented history of systemic fungal disease or unresolved tuberculosis, or evidence of active or latent tuberculosis infection (LTBI) during screening period
* Any contraindication for receiving Neisseria meningitidis vaccination and antibiotic prophylaxis therapy as recommended in the study
* Any active, ongoing infection within 2 weeks of screening or during the screening period
* Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases, or patients with short life expectancy
* Women who are pregnant, breastfeeding, or who have a positive pregnancy test at screening visit or day 1

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood

To our knowledge, few cases of relapse in adulthood are described in the literature except in patients with sickle cell disease and the epidemiological, clinical, laboratory, radiological features and the management of osteomyelitis relapsing in adulthood are not described. The aim of this retrospective multicentric cohort study : in France is to describe the epidemiological, clinical, laboratory, and radiological features and the management of adult patients who experienced a relapse between 2003-2015 of an acute hematogenous osteomyelitis acquired in the childhood (description of characterization of the period between the first episode of osteomyelitis and the second episode, description of signs of relapse and description of treatments used in the relapse). The data are analysed with non-comparative descriptive statistics.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years) who presented a relapse between 2003-2015 of a hematogenous osteomyelitis acquired in childhood.
* the time limit between the 2 episodes must be at least 2 years
* antecedent of osteomyelitis before 16 years

Exclusion Criteria:

* inability to give the information to the patient
* patients opposed to the use of their data
Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent Document.
* Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
* Currently wear soft contact lenses.
* Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
* Manifest cylinder less than or equal to 1.00 D.
* Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
* Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
* History of corneal or refractive surgery.
* Biomicroscopy findings greater than Grade 2 at baseline.
* A pathologically dry eye that precludes contact lens wear.
* Monocular (only one eye with functional vision).
* Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
* History of intolerance or hypersensitivity to any component of the investigational products.
* Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
* Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
* Other protocol-defined exclusion criteria may apply.
Do Self-Rated Performance Status Scores Correlate With Health-Care-Provider-Scores?

The purpose of this study is to determine if patients are able to self-rate their physical abilities and how these ratings compare to the ratings of their health-care provider.

The Karnofsky Performance Scale (KPS) is a highly validated and essential measuring tool across the cancer population. The scale relates to purely physical ability and covers 11 stages, ranging from normal health to death, with each stage scored as a percentage. The score is determined by the health-care provider and is based on observation and narrative patient descriptions. The purpose of this study is to compare the scores rated by the health-care provider to the scores that patients assign to themselves.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of brain or spinal tumor.
* Receiving medical care under the supervision of the Principal Investigator.
* Written informed consent.

Exclusion Criteria:

None.
the Real World Study of Orelabrutinib in the Treatment of CLL/SLL

This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China

Orelabrutinib is a novel BTK inhibitor with high selectivity and has been approved in China for relapsed/refractory CLL/SLL,, The purpose of this study is to describe the effectiveness and safety of orelabrutinib of chronic lymphocytic leukemia (CLL) in real world.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Patients with a definite diagnosis of CLL/SLL
3. Prior or current use of orelabrutinib for ≥3 months
4. At least one follow-up was recorded during orelabrutinib treatment

Exclusion Criteria:

1.Patients who received orelabrutinib in a prospective clinical trial
L-Arginine Supplementation and Exercise; L-Arginine Supplementation and Renal Function

* exercise capacities are still altered after heart transplantation partly due to peripheral endothelial dysfunction
* cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and can be reversed in an animal model by L-arginine supplementation
* to determine the potential beneficial effect of L-arginine supplementation on exercise capacity and renal function of heart transplant recipients


Eligibility Criteria:
Inclusion Criteria:

* Male (\> 18 years old) stable heart transplant recipient for at least 6 weeks
* Stable treatment for at least 3 months
* Sedentary people

Exclusion Criteria:

* Unstable cardiac pathology
* Obesity (IMC \> 40)
* Participation in another study in the last month
* Chronic renal failure (creatinine clearance \< 20 ml/min)
* Renal transplantation
* Diabetes
* Impossibility to practice exercise test
* Nitrate therapy
Senior Health Clinic Study

Turku Senior Health Clinic study The Turku Senior Health Clinic Study was targeted to 75-year-old citizens with an underlying idea that at that age it would be almost the last moment to nudge people towards healthy lifestyle and taking care of their health and functional ability to maintain independent living.

The short-term aims of the Turku Senior Health Clinic Study are to survey health and functional statuses and prevalence of specified risk factors for CVDs, dementia, frailty, and functional decline of 75-year-old independently home-dwelling citizens of the city of Turku. The aims also include assessment the frequency of follow-up treatments needed, and recommendations given for lifestyle changes and evidence-based drug treatment, as well as fulfillment of these recommendations. Also, participants feedback on the Turku Senior Health Clinic will be assessed. In addition, based on the results, recommendation for the content and implementation of preventive health clinic targeted to older people will be provided. The long-term aim of the research project is to assess the effects of the Turku Senior Health Clinic on the need of institutional care and home care as well as the cost-effectiveness of the clinic during the 10-year follow-up. For this purpose, participants of the Senior Health Clinic Study will be compared to that of non-participants and earlier cohorts of 75-year-olds in terms of the use of home care and institutional care.


Eligibility Criteria:
Inclusion Criteria:

* citizens of Turku
* home-dwelling

Exclusion Criteria:

* use of munical home care
Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale

Purpose of the study is the validity and reliability of the Turkish version of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an assessment tool for dysphagia patients.

The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured scales. There are many questionnaire and scales for assessment of swallow but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Pharyngeal Residue Severity Rating Scale as known as Yale Pharyngeal Residue Severity Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years
* at least having undergraduate education on health profession
* agree to participant

Exclusion Criteria:

* out of age 18-70 years
* out of having undergraduate education
* mental disorder
* cognitive limitations
* visual limitations
The Phosphodiesterase 5 Inhibitor Sildenafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Antidepressant-like effects of sildenafil to its ability to modulate transduction pathways responsible for neuroplasticity. Treatment with sildenafil was shown to be PKG-dependent and lead to increased expression of cGMP, pCREB, BDNF and VGF in the hippocampus and prefrontal cortex (PFC), brain areas relevant to mood disorders pathophysiology. Sildenafil produces antidepressant-like effects by inhibiting oxidative stress in the hippocampus and by decreasing the levels of IL-1β in the hippocampus and striatum.


Eligibility Criteria:
Inclusion Criteria:

* Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
* Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion Criteria:

* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
* Patients with concurrent active medical condition
* Patients with history of seizures
* Patients with history of receiving Electroconvulsive therapy (ECT)
* Patients with inflammatory disorders
* Patients with allergy or contraindications to the used medications
* Patients with finally pregnant or lactating females
* Cardiovascular disorders
* Severe renal impairment: creatinine clearance of ≤ 25 ml/min
* Moderate or severe hepatic impairment
The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly

Past studies have pointed out that adequate intake of calories and protein in the elderly can deferred sarcopenia and debilitating conditions. Therefore, this study intends to use oral nutrition as a way of nutritional supplements, without affecting the subjects' normal meal intake, and supplements with snacks It is expected that there will be benefits in protein and muscle synthesis.

However, the palatability of oral nutritional products will affect the effectiveness of nutritional supplements. Therefore, this test provides nutrients that are easy for the subjects to ingest with a variety of flavors, in order to achieve the test calories and protein needs.

In order to investigate and compare the nutritional status, serum zinc and vitamin D status in healthy (MUST score 0) elderly and at risk of malnutrition elderly, we recruited healthy elderlies in the nursing home.

In this study, subjects were randomly assigned. Through a multi-center research method, a total of 100 eligible subjects were recruited, and their consent was obtained and a subject consent form was signed. The subjects were divided into two groups according to the way of nutritional intervention, including nutritional education (NE) and nutritional supplement drink (NSD), with 50 people in each group. The NE group is given regular nutrition education by qualified clinical nutritionists to ensure the effectiveness of nutrition education. In the NSD group, in addition to nutrition and health education, daily oral supplements (Meiji Mei Balance, Meiji Co., Ltd., Tokyo, Japan) are provided daily, and snacks are supplemented between lunch and dinner and before bedtime, 2 per day. bottle. The two groups were divided into groups by lottery, and the intervention period was 12 weeks. During the intervention period, blood will be drawn at the beginning, 6th, and 12th week of the case, and blood pressure, body position, body composition and muscle strength will be measured, and dietary intake will be assessed. At the same time, a quality of life survey will also be conducted. survey, QoL survey.

Moreover, we recruited 50 healthy elderly to investigate and compare the nutritional status, serum zinc and vitamin D status in healthy elderly and at risk of malnutrition elderly. This group was considered as a control group and we didn't do any intervention after blood collection and physical measurements.

Eligibility Criteria:
Inclusion Criteria:

1. age \>65 years old (regardless of gender)
2. Malnutrition risk judgment: Subjects were assessed as moderate and high malnutrition risk with the malnutrition risk screening tool MUST (Malnutrition Universal Screening Tool)

Exclusion Criteria:

1. chronic diseases such as diabetes, end stage of chronic kidney disease, cancer.
Whipple Procedure: Standard of Care vs. Thunderbeat

The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation, and stenosis (narrowing) near the head of the pancreas. This is a prospective study to assess whether or not use of the Thunderbeat™ device may decrease blood loss and postoperative morbidity (the presence of illness or disease). The findings will then be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.

As the pancreas is fed by many vessels, it is necessary to use lots of ligatures, clips and sutures for hemostasis after dissection. This dissection technique is very time consuming and requires numerous changes of instruments. The devices the investigators currently have available for use in the operating suite are EnSeal and LigaSure. A new type of surgical scissors that delivers ultrasonically generated frictional heat energy and electrically generated bipolar energy simultaneously, known as the Thunderbeat™ (Olympus, Japan), is now an available alternative for dissection and hemostasis.

Thunderbeat™ was provided FDA clearance in March 2012 for use in open, laparoscopic, and endoscopic surgery, or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed.

The Thunderbeat™ device provides the first integration of both bipolar and ultrasonic energies delivered simultaneously from a single multi-functional instrument. This integration provides the surgeon the ability to rapidly cut tissue with ultrasonic energy and to create reliable vessel seals with bipolar energy without having to change devices. The current is provided by a special generator and contains a very high capacity with a low voltage. The body's proteins, such as collagen and elastin, are converted so a permanently sealed zone results. As the tissue between the branches is sealed, lateral thermic tissue damages can be limited to a minimum. Several authors have described a tendency of reduced intraoperative blood loss with bipolar energy devices. Other trials show reduced operating time when a bipolar device is utilized in several surgical procedures, such as thyroid, hepatic, urologic, hemorrhoidectomy and gynecology surgery.

Correct dissection in the operating field is very important to avert secondary bleeding or other complications, which might cause re-operation or elevate the patients' morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo an elective open or laparoscopic Whipple procedure
* At least 22 years of age.
* Karnofsky performance status greater than or equal to 80%.
* Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Surgeon's opinion at the time of dissection that the subject's well being (e.g. bleeding or other independent acute health problems) would be compromised.
Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2

This study is designed to test the hypothesis that poor cerebral perfusion during critical illness is a risk factor for acute and long-term neurological dysfunction among survivors. We use near-infrared spectroscopy to measure brain tissue oxygenation as a non-invasive surrogate marker for cerebral perfusion. Acute neurological dysfunction is defined as the presence of delirium, which is assessed using the Confusion Assessment Method-Intensive Care Unit (CAM-ICU). Chronic neurological dysfunction is defined as having quantitative impairments on robotic testing (KINARM robot) and traditional neuropsychological screening (Repeatable Battery for the Assessment of Neuropsychological Status).


Eligibility Criteria:
Inclusion

1. Adults ≥ 18 years old
2. Admitted to a critical care unit requiring one or more of the following:

   (a) Respiratory failure requiring invasive mechanical ventilation with an expected duration \>24 hours (b) Shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: (i) Dopamine ≥7.5 mcg/kg/min (ii) Dobutamine ≥5 mcg/kg/min (iii) Norepinephrine ≥5 mcg/min (iv) Phenylephrine ≥75 mcg/min (v) Epinephrine at any dose (vi) Milrinone at any dose (if used in conjunction with another agent) (vii) Vasopressin ≥0.03 u/min(if used in conjunction with another agent)

Exclusion:

1. Admission to the ICU \> 24 hours
2. Life expectancy \<24 hours
3. Admitting diagnosis that affects the central nervous system
4. Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)
Ketamine in Acute Brain Injury Patients.

Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice.

The BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in TBI patients.

In this study the effects of ketamine as an adjunct to an standard sedation regime in adult TBI patients will be investigated on the therapy intensity level and intracranial pressure. All patients will receive propofol for sedation to control ICP, to a maximum dose of 4 mg/kg/h. If the ICP is not controlled at the maximum dose of propofol, midazolam will be added, to a maximum dose of 0.3 mg/kg/h, as part of the current standard of care in the Participating Sites. All patients will receive remifentanil, fentanyl or sufentanil infusions for pain relief. The study medication (ketamine or placebo) will be started after randomization.

As part of the current standard of care in the Participating Sites, the decision for decompressive craniectomy and/or barbiturate coma will be taken after multidisciplinary consultation between the treating intensivist and neurosurgeon.

The decision to stop or reduce sedation, lies with the treating physician, based on the level of ICP control, the absence of clinical or radiological signs of deterioration of the neurologic state. In the case of barbiturate coma, the study drug will be discontinued. During and following decompressive craniectomy, the sedative regime (propofol/midazolam/study drug/ opioids) will be continued. In case of suspected or threatening Propofol-Related Infusion syndrome, propofol will be stopped and switched to midazolam. In case of hypertriglyceridemia \>200 mg/dL, propofol will be reduced and if necessary, midazolam will be associated to allow control of sedation. During surgical procedures related to the traumatic brain injury or not, the study drug will not be discontinued. The use of open label administration of ketamine is not allowed during the course of the trial, i.e until hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury patients
* Age \>= 18 years
* Admitted to the ICU
* Within 72 hours after admission to the initial hospital:

  * ICP monitoring in place (parenchymal probe, ventricular catheter, or both)
  * Requiring sedation

Exclusion Criteria:

* Known pregnancy and/or lactation
* Imminent or actual brain death upon inclusion
* Allergy or intolerance to the study medication
* Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction.
* Inability to obtain informed consent
* Inclusion in an interventional randomised controlled trial of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited.
* Therapy restriction code upon inclusion.
* Porphyria
* Glaucoma