cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine

The purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent influenza vaccine in hemodialysis patients. The final aim is that of gathering information needed for planning a following confirmatory study on the efficacy and safety of Thymosin alpha 1 in the same indication.

The emergence and spread of the novel influenza A (H1N1) virus has been of great concern globally.

Uremic patients are especially vulnerable to infections and it is generally recommended to vaccinate patients with chronic renal insufficiency yearly against influenza. In patients on haemodialysis (HD) the vaccination response has been considered suboptimal.

Decreased antibody response to T-cell dependent antigens may be one factor that accounts for insufficient efficacy of certain vaccination programs (eg, influenza). Diminished antibody responses have also been reported in patients with end-stage renal disease. The evidence for impairment of cell-mediated immunity in hemodialysis patients has been attributed to incompetence in T-cell-mediated immune responses.

Since Zadaxin can enhance T-cell-dependent specific antibody production, the addition of Zadaxin (Thymosin alpha 1)to vaccination programs for immunocompromised individuals should be effective.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. Age \> 18 .
3. Chronic dialysis for ESRD .
4. Life expectancy of at least 6 months.

Exclusion Criteria:

1. They have any serious disease
2. They are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
3. They have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
4. Within the past 3 days, they have experienced fever (i.e., axillary temperature _ 38°C).
5. They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Cerebral Contributions to Symptom Progression in PD

Motor symptom progression in early-stage Parkinson's disease varies substantially between individual patients. This progression correlates poorly with striatal dopamine depletion, which is largely complete four years post-diagnosis. Identification of alternative mechanisms, such as cortical compensatory processes, may enable more accurate predictions of individual motor progression.

Striatal dopamine depletion leads to dysfunction in the cortico-striatal motor circuit and is an important contributor to motor symptoms in Parkinson's disease (PD). However, dopamine depletion in striatal motor regions is already severe at symptom onset and tends to correlate poorly with progressive worsening. This indicates that the severity of motor symptoms in PD may not be solely dependent on basal ganglia dysfunction. In PD, the deleterious effect of basal ganglia dysfunction on motor control may be partially counteracted by neuroplasticity and the compensatory recruitment of parieto-premotor areas of cortex that drive movement based on sensory cueing and goal-directed cognitive control. The efficacy of cortical compensation could therefore be a core determinant of motor impairment in PD.

This study utilizes longitudinal clinical and brain imaging data from early-stage PD patients included in the Personalized Parkinson Project (ClinicalTrials.gov Identifier: NCT03364894) to test whether motor symptom severity and progression can be predicted by action selection-related brain activity in parieto-premotor cortex, basal ganglia, or a combination of both.

Additional control analyses will be performed to investigate the effects of disease and medication on action selection-related brain activity. Action selection-related brain activity will be compared between PD patients and a cohort of healthy controls to assess the effect of disease (PD vs Healthy). Effects of medication (on vs. off) on action selection-related brain activity will be investigated through within-subject comparisons in subset of PD patients who underwent functional brain imaging in both on- and off-medicated states.

Eligibility Criteria:
Inclusion Criteria (patients):

* Subject is included in the Personalized Parkinson Project and has already participated in all baseline measurements (this means that inclusion and exclusion criteria of the Personalized Parkinson Project have already been fulfilled)
* Subject has completed the Informed Consent Form, as approved by the Ethics Committee

Exclusion Criteria (patients):

* Subject is not taking dopaminergic medication

Inclusion Criteria (healthy controls):

* Subject is at least 40 years old
* Subject can read and understand Dutch
* Subject has completed the Informed Consent Form, as approved by the Ethics Committee
* Subject is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule.

Exclusion Criteria (healthy controls):

* Subject has no co-morbidities that would negatively influence the interpretability of results from a comparison with PD patients (e.g. other neurodegenerative diseases or mental health disorders)
Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery

Ocular surgery may be performed under topical, regional, or general anesthesia. The first recorded use of regional anesthesia for surgery was the instillation of cocaine into the conjunctival sac in 1884 by an Austrian ophthalmologist.

Davis and Mandel in 1986 described the peribulbar block, peribulbar block has delayed onset and need a higher volume of local anesthetic (LA) than a retrobulbar block. But the peribulbar block is away from intra-conal space and so produce fewer complication.

Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. A more recent study using dexmedetomidine (50 μg) with the peribulbar block before cataract surgery demonstrated an IOP decrease similar to IV dexmedetomidine administration and greater than a peribulbar block without dexmedetomidine.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery

Exclusion Criteria:

* Patients who are younger than 18 years
* The usual contraindications for regional anesthesia such as patients refusing LA
* Clotting abnormalities
* Impaired mental status
* Allergy to any of the study medications
* patients had the severe cardiac disease
* chronic obstructive lung disease and a history of sleep apnea
* contraindications to the use of dexmedetomidine
* history or significant cardiovascular disease risk factors
* significant coronary artery disease or any known genetic predisposition
* history of any kind of drug allergy
* drug abuse
* psychological or other emotional problems
* special diet or lifestyle
* clinically significant abnormal findings in physical examination
* electrocardiographic (ECG) or laboratory screening
* known systemic disease requiring the use of anticoagulants.
Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)

The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.

Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.

Eligibility Criteria:
Inclusion Criteria:

* \>= 50 Years Old
* MMSE 24 - 30
* Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
* Participation of a caregiver / care partner
* Amyloid Positive PET Scan

Exclusion Criteria:

* Profound hearing or visual impairment
* Seizure Disorder
* Use of memantine (Namenda or Namzaric)
* Implantable devices (non-MR compatible)
Caries Prevention and Side Effects of Gum Arabic and Licorice Extracts Versus Chlorhexidine in High Caries Risk Patients

This trial is to test the caries prevention effect of Arabic gum and Licorice root extracts compared to Chlorhexidine in high caries risk patients. The antimicrobial efficacy and oral side effects from using these mouthwashes will also be tested.

To evaluate the effect of Arabic gum (Acacia gum) and Licorice (Glycyrrhiza Glabra) mouthwashes in comparison to Chlorhexidine mouthwash on reducing caries incidence (development of new caries lesions), antimicrobial efficacy and the prevalence of oral side effects (adverse events) in high caries risk patients.

P: Population with high caries risk patients I1: Arabic Gum mouthwash I2: Licorice mouthwash C: Chlorhexidine mouthwash O1: (Primary outcome) incidence of new caries lesions O2: (secondary outcome) antimicrobial efficacy O3: oral side effects (adverse events) from mouthwash use

Eligibility Criteria:
Inclusion Criteria:

* High caries risk patients according to CAMBRA caries risk assessment tool
* Baseline of at least 2-3 active non-cavitated or cavitated carious lesionssz
* Baseline salivary Mutans streptococci count ≥ 106 CFU/ml
* Baseline salivary Lactobacilli count ≥ 104 CFU/ml
* Baseline DMF index of at least 3-5
* Cooperative patients approving to participate in the study

Exclusion Criteria:

* Any systemic conditions, severe medical complications
* Significant past or current medical condition that may affect oral health or oral flora
* Current medications (may affect the oral flora or salivary flow)
* Allergy to any of the ingredients of the study products
* Use of any antibiotics within the past 3 months
* Use of any mouth rinses within the past 3 months
* Current periodontitis (sites of probing pocket depth ≥ 5 mm)
* Evidence of parafunctional habits
* Dysfunction of temporomandibular joint
* Presence of developmental dental anomalies
* Presence of orthodontic appliance or removable prosthesis
* Pregnancy
* Xerostomia
* Heavy smoking
* Drug or alcohol addiction, or conditions that may decrease adhering to study protocol
* Lack of compliance
Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine whether a non-drug intensive program can help improve control of type 2 diabetes mellitus.

This study is based on the creation of two groups of patients with type 2 diabetes mellitus over a period of six months .

In one of the groups an intensive program be developed through : group medical consultations , workshops , informative talks, " expert patient " telephone inquiries .. etc. Meanwhile , the control group that will be followed in the consultations as usual.

We will make a determination of HbA1c at 3 months and 6 months later to assess whether there are significant differences between the two groups .

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus with poor control of their disease.
* No changes have been made in pharmacological previous 3 months.

Exclusion Criteria:

* Changes in their drug treatment in the past 3 months.
Comparison of Propofol to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery

Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery, will improve patient management through the anesthesia postoperative recovery period determined by improvement in patients? tolerance of the endotracheal tube.

Secondary hypothesis: The use of a Precedex infusion, in addition to propofol during surgery will provide improved hemodynamic stability.

The purpose of this study is to compare the addition of Precedex to a propofol intravenous anesthetic for emergence from anesthesia in patients having craniotomy surgery for brain tumors.

Eligibility Criteria:
Inclusion Criteria:

* ASA status 1, 2, and 3

Exclusion Criteria:

* ASA status 4 and 5 patients
* Patients with positive pregnancy tests
A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Advanced solid tumors
* Histological or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or PCWG3 (prostate only).
* At least 1 lesion accessible for biopsy in addition to the target lesion
* Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion Criteria:

* Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll)
* Participants with carcinomatous meningitis
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
* Active, known, or suspected autoimmune disease
* Uncontrolled or significant cardiovascular disease
* Participants with known allergies to egg products, neomycin and tetanus toxoid.
* Prior adverse reaction to tetanus toxoid- containing vaccines.

Other protocol defined inclusion/exclusion criteria could apply
Impact of an Early Palliative Approach

Rationale: Medicalized end of life rose profound society questions and debates. Major Laws and scientific society recommendations emerged from those reflections. These texts help withholding/withdrawing life-sustaining treatments allowing a palliative approach and to favor comfort treatments for end of life patients.

Main Objective: To evaluate the impact of a procedure to support reflection on the level of therapeutic involvement for surgical patient (who undergone surgery or not) in ICU after having identified vulnerability criteria early.

Secondary objectives: To assess the usual care of the control group and the impact of the procedure according to ICU type (medical, surgical, mixed); the characteristics of surgical patients concerned by a palliative strategy; the impact of an incentive approach on length of mechanical ventilation and length of stay in the ICU; To measure the extent of information collected concerning the collegial process; the impact of the procedure on caregivers' satisfaction; To count the number of identified conflicts Study type: Prospective, controlled, cluster randomized study of routine care Purpose: Study the implementation of the Act "Leonetti" released on 22 April 2005 calling for a compassionate approach and palliative care for patients at end of life.

Inclusion criteria: Surgical patients (who undergone surgery or not) hospitalized in ICU during the study period Non-inclusion criteria: Patients hospitalized less than 24h; non-surgical patients; patients who don't need ICU care or surveillance; minors; brain-dead patients (at the time of admission) Primary endpoint: Rate of deaths with palliative strategy (withholding or withdrawing treatments) Randomization process: each center is randomized adjusting on type of ICU (medical, surgical, mixed) and number of annual hospitalization volume.

* Control group: ICU usual care
* Intervention group: vulnerability criteria lead to reflection on level of therapeutic involvement, with the help of a written guide.

Number of patients: 2750 surgical patients Number of centers: 45 Study design: usual data will be collected in a secured web-based Case Report Form (CRF) at ICU admission and each time therapeutic strategy will change. Additional data will be collected for the intervention group according to the initial presence or the later apparition of predefined criteria, a standardized reflection procedure will start helped by the implementation of a guide for collegial approach and decision making.

Length: 30 months


Eligibility Criteria:
Inclusion Criteria:

* Surgical patients (who undergone surgery or not) hospitalized in ICU during the study period
* No opposition to the use of data collected from the patient or a relative or inclusion in emergency and non-opposition collected offline

Exclusion Criteria:

* Patients admitted legally dead or brain-dead
Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-1 (TRACK-LVO-1)

The aim of this study is to establish an academic, real-world, single-center, observational registry of consecutive patients hospitalized with acute ischemic stroke (AIS) due to large vessel occlusions (LVO), treated with either endovascular therapy (EVT) or best medical management (BMM).

Stroke is a major threat to public health and is exacerbating socioeconomic development. It is the leading cause of mortality among residents in China. Large vessel occlusion (LVO) is a predictor of unfavorable outcomes and can account for up to 52% of patients with acute ischemic stroke (AIS). The definition of LVO and its optimal screening imaging modalities remain controversial. In this registry, the investigators defined LVO as an occlusion of the intracranial ICA with or without the involvement of the terminal bifurcation, M1 and/or M2 segment of the MCA, A1 and/or A2 segment of the ACA, VA, BA, or P1 and/or P2 segment of the PCA.

TRACK-LVO is an academic, real-world, single-center, observational registry, in which consecutive patients hospitalized with AIS due to LVO will be treated with either EVT or BMM. Baseline information and clinical follow-up information at 90 days from stroke onset are collected. The key baseline items in this registration for both EVT and BMM groups include basic demographic profiles, past medical history, NIHSS score, treatment with intravenous alteplase, type of stroke onset, time from stroke onset to admission/imaging, imaging characteristics such as the volume of the ischemic core and occlusion site, and treatment-related complications. Additional information collected in EVT groups includes details of EVT procedure and angiographic images.

The investigators enrolled patients with LVO screened under different imaging modalities to further reveal the optimal imaging modalities in the detection of LVO. The investigators also tend to compare the prognosis of AIS patients with LVO receiving endovascular therapy and the best medical management respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Patient admitted from Jan. 1st, 2018 to June. 1st, 2021;
2. Age ≥ 18;
3. Ischemic stroke confirmed by head CT or MRI;
4. Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
5. Patients receiving either endovascular therapy or best medical treatment;

Exclusion Criteria:

-
Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome

This clinical study will evaluate the clinical performance and the safety of the CE-marked casting and padding materials when used in routine fracture care without any additional invasive methods and within the intended use. As primary objective the cast therapy´s influence on skin microbiome during fracture management will be investigated. Further, the influence of the padding material on the skin microbiome, device comfort, skin conditions, and impact on daily life activities as well as HCP´s and patient´s satisfaction and general product safety and performance are considered as secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥ 18 years of age
2. Patient is physically and mentally able to participate in this study
3. Proper understanding of the Dutch language
4. Signed informed consent
5. Fractures to be treated with a short-arm cast without thumb inclusion for the period of 3 weeks (e.g. 2R3A1 = radial styloid avulsion, 2R3A2 = Simple radial fracture, 2U3A1 = Ulnar fracture of the base of the styloid process, 2U3A2= Simple distal ulna fracture, 2R3B1 = Intraarticular fracture of the styloid process of the radius (not displaced) or Triquetrum fracture (non AO classified))

Exclusion Criteria:

1. Subject \<18 years of age
2. Pregnancy, breast feeding
3. Participation in other clinical trials
4. Patient is neither physically nor mentally able to participate in this study
5. Non-intact skin in treatment area (including dermatological issues)
6. Patients with impaired (e.g. Cortisone skin, extremely dry skin, parchment skin) or damaged skin with either a surgical wound or a traumatic wound
7. Medical treatment prior casting which could influence the microbiome
8. Known Blood Circulatory Diseases
9. Known Lymphedema or any general disorder of the lymphatic system
10. Known Osteoporosis
11. Known Diabetes
12. Knowing of one of the following illnesses that might require regular systemic medication: cancer, rheumatic disease
13. Intolerability or documented allergies against cast materials
14. Subjects with not "normal" (unusual) hygienic behavior
15. Suspected drug addiction or alcohol abuse
16. Patients diagnosed HIV-positive or with infectious hepatitis based on self-declaration by subjects