cyrilzakka/clinical-trials huggingface dataset:
Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.

Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning.

Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen.

Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
* Written informed consent of patient and donor obtained

Exclusion Criteria:

* Participant taking Prednisone (or equivalent steroid)
* Participant taking Prednisone (or equivalent steroid)
* Participant taking Mycophenolate Mofetil
* Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
* Progressive hematologic malignancy before transplant
* Second allogeneic transplant
* Acute GvHD ≥ grade 2
* Chronic moderate or severe GvHD (NIH consensus criteria)
* Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion criteria)
* Donor aberrant CD45RA expression due to a polymorphism in CD45 gene
* Participation in another interventional clinical trial within 30 days prior to inclusion
* Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of CD45RAneg DLI infusion
* Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia
VR Solace for Pain and Anxiety Using Survey and Biodata

The purpose of this study is to assess the therapeutic response to VR Solace in patients with chronic pain and anxiety using real-time clinical and survey data. Regression analysis of demographic characteristics, lab and survey data will be conducted to better understand the efficacy of VR Solace in treating chronic pain and anxiety. The investigator also aims to explore the possible association between the patient-reported changes in pain or anxiety levels with real-time physiological changes observed during VR Solace use.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey
* Diagnosis with chronic pain/anxiety

Exclusion Criteria:

* Exclusion of patients that are followed by CL Psychiatry team at Cedars-Sinai Medical Center to avoid overlap with another ongoing VR study
* No active diagnosis of medical conditions that may cause physiological variations in vital signs (i.e. sepsis, cardiogenic shock/arrhythmia)
* No active diagnosis of seizures, migraines, severe nausea, severe propensity for motion sickness, or facial/head deformities that would allow for comfortable placement of headset
* Exclusions of patient currently taking beta blockers
* Unable to communicate/read English for survey items
* Unable to use VR independently - patients will be expected to maneuver through questions/steps of the VR system during the session
Optic Nerve Sheath Diameter in Pre-Eclamptic Parturient Receiving Magnesium Sulfate Combined with Dexmedetomidine

Dexmedetomidine was reported to effectively reduce cerebral metabolism and ICP by decreasing cerebrospinal fluid pressure in patients with cerebral tumors or head injuries that require craniotomy. However, it was also reported to exhibit no effect on ICP. the effect of MgSO4 associated with dexmedetomidine on ONSD in severely pre-eclamptic parturient has been understudied . Though this study aims to evaluate the effect of dexmedetomidine infusion on raised ICP in severely pre-eclamptic parturients using ocular ultrasonography to determine ONSD as a measure of ICP.

Dexmedetomidine, a highly selective α-2-receptor agonist, is a first-line sedative medication in ICU and has been increasingly used for obstetric anesthesia. Dexmedetomidine, which provides light sedation, possesses analgesic, sympatholytic, anxiolytic properties and attenuates the stress response without significant respiratory depression. In addition, dexmedetomidine-induced stimulation of postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow. However, the effects of dexmedetomidine on ICP are controversial.

Clinical signs of raised ICP are not specific and often difficult to interpret, especially during pregnancy and pre-eclampsia. Though the use of invasive devices is considered a gold standard in the measurement of ICP, Ocular sonography is a promising bedside tool, which serves as a noninvasive, readily available, and cost-effective means for indirectly measuring ICP.

Bedside ultrasound can be used as a point-of-care tool for rapidly measuring the optic nerve sheath diameter (ONSD), which is a validated indirect means for measuring ICP. An increase in ICP reflects as a raised ONSD since the optic nerve is surrounded by Dural sheath and cerebrospinal fluid (CSF) containing subarachnoid space, which is distensible in the retrobulbar segment, particularly when CSF pressures rise.

Eligibility Criteria:
Inclusion Criteria:

* aged18 to 40 years with
* at least 36 weeks gestation
* admitted with diagnosis of severe pre-eclampsia and scheduled to receive Magnesium Sulphate therapy before delivery

Exclusion Criteria:

* Presence of ocular wound or Prior ocular surgery
* emergency cases, and evidence of fetal compromise
* HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet levels)
* Chronic hypertension
* Hyperthyroidism, and diabetes mellitus
* Presence of pre-existing chronic lung and/or cardiac diseases
* Presence of pre-existing chronic renal and/or hepatic diseases
* Presence of any chronic diseases of central nervous system.
* known allergies to the tested drug.
Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of a single dose of NP10679 when delivered intravenously in up to six escalating dose levels in comparison to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 to 55 years
* Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
* If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.

Exclusion Criteria:

* Clinical laboratory values greater than or equal to 2 times the upper limit of normal.
* Recent history (within 2 yrs) or current tobacco use.
A Study of [14C]IBI351 in Healthy Subjects

This study is to evaluate the mass balance of single oral dose of \[14C\] IBI351 in healthy subjects. Six to eight healthy male subjects were planned to be enrolled. After passing the screening, subjects were admitted to hospital and received training on medication, urine and feces collection and other procedures to ensure that they could perform relevant operations according to the protocol and SOP requirements. On the evening before medication, the patient had standard meals, and fasted uniformly overnight. On D1, the suspension containing recommended dose of \[14C\] IBI351 was administered in the morning on an empty stomach. Subjects have standardized meal during the trial and blood, urine, and feces samples were collected and safety laboratory tests were performed as scheduled.


Eligibility Criteria:
Inclusion Criteria：

1. Voluntarily sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial.
2. Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
3. Body weight is not less than 50 kg, and body mass index (BMI) is in the range of 19 \~ 26 kg/m2 (including both ends).
4. Vital signs, physical examination, laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation, etc.), chest radiography, 12-lead ECG and other results were unremarkable; or abnormal examination results but judged by the investigator as clinically insignificant.

Exclusion Criteria

1. allergic constitution; known hypersensitivity to any component of the test drug or its preparation.
2. have special requirements for diet and cannot abide by the unified diet; or lactose intolerance.
3. history of dysphagia or any gastrointestinal disease that affects drug absorption.
4. blood donation or massive blood loss (\> 200 mL) within 3 months before screening, or blood transfusion within 1 month.
5. Have taken an investigational product or participated in any clinical trial within 3 months before taking the study drug.
Comparison of Two Daily Disposable Soft Contact Lenses

The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.

This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.

Eligibility Criteria:
Inclusion Criteria:

1. They are between 18 and 40 years of age (inclusive).
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
5. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
6. They own a wearable pair of spectacles and wear them on the day of the initial visit.
7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
9. They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

1. They have an ocular disorder, which would normally contra-indicate contact lens wear.
2. They have a systemic disorder, which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
10. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis

The purpose of this study is to evaluate the long-term efficacy and safety of lozenges containing probiotics in reducing gingivitis. The primary purpose of this study is to support claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to read, understand and sign an Informed Consent form.
* Good general health as evidenced by the medical history.
* Between 18 and 65 years of age.
* Male or female.
* Minimum of 20 teeth, excluding crowns and third molar teeth.
* Mean whole mouth Modified Gingival Index of greater-than or equal to 2.0 at baseline.
* Willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits.
* Willing to abstain from eating and drinking in the morning of visits, only drinking water is allowed.
* Willing to abstain from interdental cleaning, chewing gums, oral whitening, mouth rinse and tobacco products for the study duration.
* Able to understand and follow study directions.
* No known history of allergy to dairy products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria

* Presence of orthodontic appliances.
* Intra-oral soft tissue lesions due to pathology or trauma
* Patients with aggressive periodontitis, acute necrotizing ulcerative gingivitis, or gross decay at discretion of PI.
* More than two sites with pocket depth \>5mm and concomitant attachment loss of \>2mm.
* Pregnant or lactating females or females of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
* Use of antibiotics within 3 months of enrollment
* History of drug use that is associated with gum overgrowth (i.e., Dilantin, nifedipine, etc)
* Chronic use of medication such as steroids, NSAIDs (more than 2-3 days/week), anti-coagulant medications, immunosuppressant medications or any other medications that in the opinion of the Investigator would interfere with the evaluation or confound interpretation of the study results. Use of low dose of acetylsalicylic acid (81 mg) is permitted.
* Unwilling to sign a confidentiality statement and/or return the test products.
* Medical condition which requires pre-medication prior to dental visits/procedures.
* Immune compromised individuals (HIV, AIDS, immunosuppressive drug therapy).
* Current use of probiotics or probiotic containing food (i.e., yogurt)
A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery

Epidural anesthesia for pain control during normal vaginal delivery is a blind maneuver and so we need a confirmatory sign for being in the correct epidural space.

Loss of resistance sign using air may guide us wrongly as it may occur if we entered into the paravertebral muscles or cavities in the interspinal ligaments.

So, additional confirmatory sign beside loss of resistance sign by air is strongly needed.

We noticed that after occurence of loss of resistance sign by air and insertion of the epidural catheter a dew was formed on the internal sides of the epidural catheter after aspiration to be sure that there are no blood or cerebrospinal fluid in the catheter.

This dew formation (Ramy sign) is characteristic for air in the epidural space when transferred from the warm epidural space (temperature about 38-39 celsius degree) to the colder aspect of the catheter outside the patient which nearly has the same operating room temperature (22 celsius degree).

This sign may be associated with correct placement and good function of the epidural catheter.

parturient for normal vaginal delivery are examined for correct epidural catheter placement by loss of resistance technique by air, observation of the dew sign and epidurogram.

Visual analogue score is used to test pain. blood pressure and heart rate after epidural injection will be monitored

Eligibility Criteria:
Inclusion Criteria:

* Parturient for normal vaginal delivery
* American society of anesthesiologists 2

Exclusion Criteria:

* patients refusal
* back infection
* anticoagulant non stopped
* platelets count less than 100000
* international normalization ratio more than 1.4
* severe cardiac or respiratory diseases
* haemodynamics unstable patients
Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder

To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination) compared to sertraline monotherapy in patients with major depressive disorders who have responded incompletely to sertraline monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are either inpatients or outpatients.
* Patients who are able to understand necessary information for giving consent to undergo examinations, observations, and evaluations specified in this clinical protocol, and who are able to give written consent based on a full understanding of the trial.
* Patients who have been given a diagnosis of "Major Depressive Disorder, Single Episode" or "Major Depressive Disorder, Recurrent" according to the DSM-5 and who have a current episode of major depression that has been continuing for at least 8 weeks
* Patients with a HAM-D 17 total score of 18 or more at the Screening Period evaluation

Exclusion Criteria:

* Female patients of childbearing potential who wish to become pregnant during the trial period or within 4 weeks after completion or discontinuation of the trial
* Pregnant or breast-feeding female patients, or female patients who may be pregnant
* Patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history
* Patients who have had electroconvulsive therapy
* Patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent
* Patients who have a medical history suggesting a risk of developing serious adverse events or symptoms that may hinder efficacy/safety evaluation (eg, symptoms of fibromyalgia, or premenstrual syndrome etc that overlap with depressive symptoms)
* Patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic

  * fasting blood glucose level ≥ 126 mg/dL
  * 2-hour glucose level in 75-g oral glucose tolerance test (OGTT) ≥ 200 mg/dL
  * non-fasting blood glucose level ≥ 200 mg/dL
  * HbA1c \[NGSP level\] ≥ 6.5%
* Patients who are undergoing treatment for thyroid disease (except for patients whose disease has been stabilized with drug therapy for 3 months or longer before the time of informed consent)
* Patients who have a history of neuroleptic malignant syndrome or serotonin syndrome
* Patients who have a history of seizure disorder (eg, epilepsy)
Facilitating Adaptive Expertise in Learning Computed Tomography

The main objective of this study is to demonstrate that Error Management Training improves adaptive expertise in head computed tomography interpretation. The investigators will conduct a randomized controlled trial comparing two learning strategies, Error Management Training vs Error Avoidance Training, in emergency medicine residents. The investigators hypothesize that Error Management Training, as compared to Error Avoidance Training, will improve adaptive expertise, as measured by skills transfer, when used to teach head computed tomography interpretation to emergency medicine residents.

Adaptive expertise is the ability to apply existing skills to novel situations. Adaptive expertise enables physicians to reduce preventable medical errors when managing clinical scenarios not encountered during training. However, residency curricula rarely address this learning outcome. Error Management Training improves transfer of skills to new contexts and develops adaptive expertise. Although this methodology has been shown to improve adaptive expertise in procedural skills, its impact on cognitive skills in medical training remains underexplored. Error Management Training promises to improve patient care by developing emergency physicians' adaptive expertise. However, the investigators need further evidence for its efficacy with cognitive skills in residency training. The investigators aim to demonstrate that Error Management Training improves adaptive expertise in a cognitive skill, using head computed tomography interpretation as a model.

Eligibility Criteria:
Inclusion Criteria:

* Study participation will be available to all current emergency medicine residents at Stanford and at thirteen external sites.

Exclusion Criteria:

* Adults unable to consent
* Pregnant women
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Medical students
* Residents from specialties other than emergency medicine
Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease

The purpose of this study is to determine how many patients with Parkinson's disease have compulsive behaviors, and what types of behaviors they have. This study will also determine if acamprosate can be used to treat compulsive behaviors in Parkinson's disease patients.


Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic Parkinson's disease
2. Active dopaminergic therapy at stable dose for one month (levodopa or dopamine agonist)
3. Able and willing to complete Rating Scales
4. Presence of one or more compulsive behavior based on responses to Rating Scales (defined as \>5 on the SOGS; \>17 on the YBOCS-SV and YBOCS-CUV; \>1.7 on the SCS for women and \>2.1 on the SCS for men; \>15 on the YBOCS-BE, \>5.5 on the CQ).
5. Written informed consent

Inclusion criteria (controls):

1. No significant psychiatric disease
2. Able and willing to complete Rating Scales
3. Written informed consent

Exclusion Criteria:

1. No anticipated need for adjustment of medications for Parkinson's disease
2. Current participation in another clinical study
3. History of unstable psychiatric disease (as determined by the Principal Investigator)
4. Women of childbearing age not using appropriate contraceptive methods (oral contraceptives, condoms, surgery)
Rilonacept in Diabetes Mellitus Type 1: Safety Study

This study is being done to see if an investigational drug called rilonacept is safe to use in patients with type 1 diabetes, and if it can slow the loss of the body's ability to secrete insulin in patients who are still able to make a small amount of insulin.


Eligibility Criteria:
Inclusion Criteria:

* Within 5 years of diagnosis of type 1 diabetes
* Between the ages of 16 to 45 years
* Have at least one diabetes-related autoantibody present
* Have mean C-peptide level \> 0.2 nmol/L on a mixed meal tolerance test
* Be taking insulin
* Complete written informed consent

Exclusion Criteria:

* Taking inhaled or oral steroids (for example Advair, Orapred)
* Have an active infection
* Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
* Have ongoing use of medications known to affect glucose tolerance
* Have a live vaccine 90 days prior to, or during this study
* Taking any other experimental medication within the past 28 days
* Have prior treatment with rilonacept
* Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
* Pregnant or lactating females
* Males and females unwilling to use an acceptable method of contraception for the duration of the study