cyrilzakka/clinical-trials huggingface dataset:
Effects of Oxytocin Administered Orally Using a Medicated Lollipop on Peripheral Concentrations and Attention

The study will investigate whether oxytocin (24IU) administered orally using medicated lollipops results in increased peripheral oxytocin concentrations and can modulate social attention in an anti-saccade paradigm in the same way as when it is administered by intranasal or lingual routes.

In a triple-blind, placebo-controlled experiment, 72 adult male subjects will be randomly allocated to either receive oral oxytocin (24IU - medicated lollipop - n = 36) or placebo (lollipop without oxytocin - n = 36). After treatment allocation, all subjects will first fill out a set of questionnaires as a control for potential confounders, including Beck Depression Inventory-II (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), the Second Version of Social Responsiveness Scale (SRS-2), Childhood Trauma Questionnaire (CTQ), Toronto Alexithymia Scale (TAS), and Positive Affect Negative Affect Scale (PANAS). Immediately before and 30 minutes after oral treatment administration, subjects will have 5 ml blood samples taken for assay of oxytocin concentrations. Subjects will sit quietly and relax in between blood samples. After the second blood sample, subjects will be positioned sitting in front of an eye-tracking machine and briefly practicing the anti-saccade task. Subjects will then perform the full anti-saccade eye-tracking task, which includes both social (emotional faces - angry, fear, happy, sad, and neutral) and non-social (oval shapes or houses) stimuli (similar to previous studies using intranasal -see NCT03486925 and NCT04493515). After the task, subjects will be asked to guess which treatment they received, and their ability to do so analyzed using chi-squared. Treatment effects on primary (anti-saccade and pro-saccade errors and response latencies) outcomes will be analyzed using ANOVAs. In a secondary analysis, associations between primary outcome measures and basal and altered oxytocin concentrations will be analyzed using Pearson or Spearman correlations. Additionally, a comparison between the effects of oxytocin administered intranasally, lingually (using previously published data), and orally (medicated lollipop) on outcome measures will be analyzed using ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

1. History of brain injury
2. Head trauma
3. Substance abuse
4. Medication
Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (HaploHCT) Following Reduced Intensity Conditioning (RIC) for Selected High Risk Non-Malignant Diseases

This is a Phase II study for the use of T-cell replete reduced intensity conditioning (RIC) haploidentical donor allogeneic hematopoietic cell transplantation (HaploHCT) for individuals with high-risk non-malignant diseases who lack a suitable HLA-matched sibling donor.


Eligibility Criteria:
Inclusion Criteria:

* Sickle Cell Disease (SCD)

  \* If diagnosis of SCD must meet one or more of the following disease characteristics:
  * Stroke, CNS hemorrhage or a neurologic event lasting longer than 24 hours, or abnormal cerebral MRI or cerebral arteriogram or MRI angiographic study and impaired neuropsychological testing
  * Acute chest syndrome with a history of recurrent hospitalizations or exchange transfusions
  * Recurrent vaso-occlusive pain 3 or more episodes per year for 3 years or more years or recurrent priapism,
  * Impaired neuropsychological function and abnormal cerebral MRI scan
  * Stage I or II sickle lung disease,
  * Sickle nephropathy (moderate or severe proteinuria or a glomerular filtration rate \[GFR\] 30-50% of the predicted normal value)
  * Bilateral proliferative retinopathy and major visual impairment in at least one eye
  * Osteonecrosis of multiple joints with documented destructive changes
  * Requirement for chronic transfusions
  * RBC alloimmunization
* Transfusion Dependent Alpha- or Beta-Thalassemia
* Other Non-Malignant Hematologic Disorders:

Transfusion dependent or involve other potential life-threatening cytopenias, including but not limited to Paroxysmal Nocturnal Hemoglobinuria, Glanzmann's Thrombasthenia, Severe Congenital Neutropenia and Shwachman-Diamond Syndrome

* cALD

  * Diagnosis of ALD by abnormal plasma very long chain fatty acid (VLCFA) profile or ABCD1 gene mutation
  * Cerebral disease on MRI
  * Absence of a Major Functional Disability (cortical blindness, loss of communication, wheelchair dependence) on the ALD Neurologic Function Scale
* Other inherited metabolic disorders:

Any other inherited metabolic disorder for which alloHCT is indicated and for whom, in the opinion of the treating physician, the patient's best treatment option is with a haploidentical donor following non-myeloablatve conditioning.

* Age, Performance Status, Consent

  * Age: 0-55 years
  * Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70
  * Consent: voluntary written consent (adult or parental/guardian)
* Adequate Organ Function

  * Renal: Creatinine \<2.0 mg/dl for adults or glomerular filtration rate \> 50 ml/min for children
  * Hepatic: Bilirubin and ALT \<3 times the upper limit of institutional normal
  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 40%.

Exclusion Criteria:

* Availability of a suitable HLA-matched related donor
* Uncontrolled infection
* Pregnant or breastfeeding
* HIV positive
IpsiHand System for Rehabilitation of the Arm and Hand After Stroke

This study aims to assess whether the NeuroLutions Upper Extremity Rehabilitation System (known as IpsiHand) will help stroke patients regain strength and functional movements in their arm. The IpsiHand system involves using a hand robotic device that is controlled by brain waves, known as a Brain-Computer Interface (BCI). By using the device, participants will be harnessing brainwaves from the side of their brain not affected by stroke to control the robotic device on the hand that is weaker from the stroke.

This trial aims to assess the effectiveness of the NeuroLutions Upper Extremity Rehabilitation System, known as IpsiHand, on functional motor recovery and neuroplasticity for chronic stroke survivors with hemiparesis (N=27). The IpsiHand system involves a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis. Participants will complete 16-32 weeks of home therapy with the IpsiHand system.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke(s), with most recent stroke at least 6 months prior to study start (can be ischemic or hemorrhagic)
* PROM: Full extension of digits 2 and 3 at MPs, PIPs, and DIPs
* English speaking
* Intact cognition to provide informed consent
* Intact language skills to comprehend and follow directions
* Experiencing difficulty performing ADLs with affected upper limb
* Upper extremity Botox allowable, but not required

  * Botox users must continue regimen at regular intervals for duration of study
  * Botox users will provide clinic note for each injection (date, dose, and muscle location)
  * Botox + Study Schedule
* At study initiation, Botox injection will occur between 3-7 days prior to baseline measurement and initiation of device use
* Repeat Botox injections must be completed at least 3 days prior to any administration of the outcome measures

Exclusion Criteria:

* Concurrent participation in another study
* Co-morbid orthopedic condition/pain limiting functional use of the impaired upper limb
* History of neurological disorder other than stroke
* Botox user unable to comply with above noted requirements
* Ongoing physical or occupational therapy addressing the upper limb
* Ongoing electric stimulation or other rehabilitative devices (e.g. robotics, virtual reality) to upper limb
* Cognitive impairment: Short Blessed Test Score 9
* Significant spasticity: Modified Ashworth Scale score 3 at the elbow
* Significant hemispatial neglect: Mesulam Cancellation Test 3 unilaterally
* Insufficient Strength: Motricity Index score for shoulder abduction 18
* Significantly impaired sensation of impaired upper limb: National Institutes of Health Stroke Scale - Item 8 (Sensory) score of 2
* History of cranioplasty
* History of seizure disorder
* No changes to usual exercises, splint use, or oral baclofen/anti-spasticity medication use during trial
Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder.

Depersonalization disorder is characterised by a profound disruption of self-awareness. Depersonalization symptoms may occasionally arise (30 to 70% of the population) or may become chronic in depersonalization disorder. Its prevalence is around 2.4% in the general population. This disorder is particularly resistant to pharmacological treatments. This study is a randomized, double-blind, placebo-controlled study, and the investigators are testing the therapeutic efficacy of neuronavigated repetitive Transcranial Magnetic Stimulation (TMS) of right angular gyrus in patients with depersonalization disorder.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Outpatients aged over 18 years old
* Suffering from depersonalization disorder according to DSM IV-TR
* Patients currently on DPD medication must be at the same stable dose(s) at least 2 months and must be continued at the same dose(s) through the duration of the study.
* Patient provided informed written consent
* Patient covered by a contributory social security scheme

Controls:

* Aged over 18 years old
* Absence of a personal history of psychiatric disorders
* Provided informed written consent
* Covered by a contributory social security scheme

Exclusion Criteria:

* Patients:
* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
* Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
* history of neurosurgery,
* neurosurgical ventriculoperitoneal bypass valves
* personal and / or family history of seizures or epilepsy
* Dental device
* Pregnant woman
* Claustrophobic subjects
* Not cooperating or agitated patients
* Medications that reduce the seizure threshold, such as clozapine, bupropion, methadone and / or theophylline
* Alcohol abuse and / or toxic substances in the last 12 months
* Substance dependence except tobacco

Controls:

* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
* Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
* neurosurgical ventriculoperitoneal bypass valves
* Claustrophobic subjects
* Pregnant woman
* Not cooperating or agitated patients
* Dental device
Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.

To determine how venoarterial extracorporeal membrane oxygenation (ECMO) affects cerebral blood flow velocity (CBFV) measured by transcranial doppler (TCD), to determine whether specific changes in cerebral blood flow velocity may be associated with neurologic injury and to determine modifications of CBFV after withdrawal of ECMO.

Venoarterial Extracorporeal membrane oxygenation (ECMO) is used in adult with refractory cardiac failure as a life-saving measure. Adults treated with ECMO survived to hospital discharge in 21,8% to 65,4% of cases. Neurologic complications such as intracranial hemorrhage, anoxia and ischemia are major causes of death and long-term disability in ECMO patients (7% to 14%). Current neurological monitoring techniques are insufficient to predict which critically ill patient receiving ECMO therapy will suffer from neurologic injury. Even after a clinical suspicion of neurologic injury, diagnosis can be difficult. TCD is commonly used to monitor the CBFV of traumatic brain injury. There are no reports that evaluate CBFV of patients requiring ECMO therapy. Patient will have to do both echocardiography and TCD to evaluate cardiac output and CBFV. We will repeat these dopplers every 24 hours until ECMO withdrawal and one day after explantation.

Eligibility Criteria:
Inclusion Criteria:

* adult patient who receiving ECMO therapy

Exclusion Criteria:

* cervico-encephalic vasculopathy
* lacked an acoustic window allowing for adequate TCD examination
* stroke in medical past.
Collection of Tissue & Blood From Patients w/ Benign & Malignant Tumors of the Soft Tissue & Gastrointestinal Tract

Doctors at Memorial Sloan Kettering Cancer Center and at other institutions study normal and cancer cells. To study these cells we need to have human tissue, body fluids, and blood. The patient will be having or have had a procedure to remove tissue. The doctors would like to use some of this tissue. The doctors will use it for laboratory studies on the causes, prevention, diagnosis and treatment of sarcoma, gastrointestinal or other intra-abdominal cancers. They will only use extra tissue left over after all needed testing has been done. They would also like to study components of the immune blood cells and blood serum (the liquid portion of the blood). In some patients they will take a blood sample before the tissue or body fluid is removed, usually at the same time that other routine pre-procedure blood tests are drawn. If thet need more blood, it will be drawn when the patient is seeing the doctor anyway. We will not draw more than 50cc (4-5 tablespoons) at any one time. With the patient's permission, thet may also send a small portion of the blood and/or a sample of the tissue to a repository at the National Cancer Institute. This will be used to identify special proteins in the blood or tissue that may be useful for diagnosing cancer. Information about the treatment and the response to treatment may be linked to the tissue specimens obtained. This information may be important for the research studies that will be done on the tissue, body fluid and blood specimens. All of this information will be kept in strictest confidence; they will use it only for biomedical research. The patient's name will not be used in any report.


Eligibility Criteria:
Inclusion Criteria:

For patients:

* All patients with benign or malignant tumors of the soft tissues, gastrointestinal tract, and other intra-abdominal sites who will have or have had tissue, peritoneal, pleural, cyst, urine, and/or other gastrointestinal fluid removed for therapeutic or diagnostic purposes.
* Patients will be entered without preference for any particular racial/ethnic group.
* Patients may have received prior hormonal therapy, cytotoxic chemotherapy, irradiation, immunotherapy or surgical therapy.
* Tissue and body fluid specimens must be a large enough quantity to allow routine pathological analysis, with the research laboratory specimen removed from the residual specimen which would otherwise be discarded.

Healthy Control Subjects:

* Any male or female with no concurrent malignancies (except for localized basal cell or squamous cell skin cancer) within 5 years of enrollment.
* \> or = to 18 years of age
* Any MSKCC employee will be allowed to participate as a healthy control, provided they fulfill the above inclusion criteria and they enroll willfully and voluntarily

Exclusion Criteria:

Healthy Control Subjects:

* Attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g. mentally impaired) reasons.
Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.

The investigators hypothesize that incorporation of a colorimetric scale on urine collection bags to estimate degree of hematuria would allow better characterization of urine by healthcare staff thus leading to improved patient care.


Eligibility Criteria:
Inclusion Criteria:

* The participant is at least 18 year old
* Nurses recruited voluntarily in the CHU Nimes outside of the Urology department of any duration of experience
* Urologist working in the Languedoc-Roussillon region

Exclusion Criteria:

* The participant has color-blindness
* Nurse or urologist from the urology department of Nimes
Glycemic Monitoring in Cystic Fibrosis

Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2 diabetes. Increasing evidence supports treating early glucose abnormalities in cystic fibrosis patients to target CF specific outcomes, including lung function and nutrition (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in the 'prediabetic' state are unclear. A more accurate characterization of blood sugar variability in youth with and without CF will help the investigators better interpret continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and more accurately identify those individuals at greatest risk for disease progression.


Eligibility Criteria:
Inclusion Criteria:

Healthy controls (n=45) -

1. Age 10-25 years
2. BMI \<85th percentile
3. Baseline health at enrollment

CF controls (n=45) -

1. Age 10-25 years
2. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
3. Baseline health at enrollment (no inclusion/exclusion criteria for CF patients based on lung function, BMI, pancreatic insufficiency, or genotype)

CF prediabetes \& CFRD (n=70)

1. Age 10-25 years
2. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
3. History of abnormal oral glucose tolerance testing (2h-glucose \>140, fasting plasma glucose \>100,1hr glucose \>200)
4. If taking medication that affects glucose metabolism (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics), should be on a stable dose over the past 3 months

Exclusion Criteria:

Healthy controls -

1. Known diagnosis of diabetes or prediabetes (including type 1, type 2, MODY), abnormal oral glucose tolerance test (OGTT) (ie. fasting plasma glucose ≥100 or 2hr ≥140 mg/dl) or HbA1c ≥ 5.7%
2. BMI ≥85th percentile
3. Chronic disease that may affect glucose metabolism or use of medications affecting glucose metabolism in the past 3 months (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics)
4. Presence of type 1 diabetes auto-antibodies in any individuals with a first degree relative with type 1 diabetes (will only include first degree relatives if they have had previous negative auto-antibody screening performed as part of participation in other studies such as the Trial Net studies at the Barbara Davis Center)
5. Acute illness (ex. Asthma exacerbation, gastroenteritis, febrile illness)
6. Pregnancy

CF participants -

1. Diagnosis of type 1 diabetes, type 2 diabetes, or MODY
2. Varying doses of medication affecting glucose metabolism in the past 3 months
3. Pulmonary exacerbation associated with hospitalization, or systemic steroid requirement in the preceding 6 weeks
4. Pregnancy
Study of KBP-7072 in Healthy Male and Female Subjects

This is a double-blind, randomized, placebo-controlled, single and multiple IV dose study conducted in two parts. Part A (SAD) will comprise an ascending single dose, sequential group design. Each subject will participate in 1 treatment period only. Subjects will reside at the study site from check-in on Day -1 (the day before dosing) to discharge on Day 8. In Part A, serial blood and urine collections will be obtained on Day 1 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings. Part B (MAD) will comprise an ascending multiple dose, sequential group study. Each subject will participate on one treatment period only and reside at the study site from check-in on Day -1 until discharge on Day 17. In Part B, serial blood and urine collections will be obtained on Day 1 pre-dose through 24 hours post start of infusion and on Day 10 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Trough blood sample collections for analysis of plasma concentrations of KBP-7072 and KBP-6079 will be obtained pre-dose on Days 3, 4, 5, 6, 7, 8 and 9. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 30 kg/m2 at the time of screening
* In good health, determined b no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements and clinical laboratory evaluations
* Females of nonchildbearing potential defined as permanently sterile or postmenopausal.

Males will agree to use contraception.

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine or psychiatric disorder as determined by the investigator.
* Abnormal results of ophthalmologic examination within 3 months prior to dosing self-reported by subject.
* Supine systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg.
* Triglycerides \> 200 mg/dL
* Total cholesterol \> 240 mg/dL or LDL \>190 mg/dL or HDL \< 40 mg/dL
* Positive urine drug screen at screening or check-in or positive blood alcohol test result at check-in.
* Positive hepatitis panel and/or positive HIV test
* Administration of a Covid-19 vaccine in the past 28 days prior to dosing
* Interpretation of liver ultrasound with presence of fatty liver disease
ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer

The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.
* Patient newly diagnosed with localized prostate cancer confirmed with an image guided biopsy (MRI and/or micro-ultrasounds).
* Gleason ≤ 4+3.
* Patient scheduled for HIFU treatment as determined by the physician.
* Patient with healthcare coverage. Spanish-speaking patients with the ability to provide informed written consent

Exclusion Criteria:

* Patient with bilateral prostate cancer requiring whole gland treatment.
* Patients clinically detected metastasis.
* Patient with an extension of cancer or seminal vesicle invasion.
* Patient with contraindications for HIFU treatment: please refer to the complete Focal One user manual.
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant

The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.


Eligibility Criteria:
Inclusion Criteria:

* Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
* Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
* Be statin-intolerant (unable to tolerate 2 or more statins)

Exclusion Criteria:

* Total fasting triglyceride ≥500 mg/dL
* Renal dysfunction or nephrotic syndrome or history of nephritis
* Body Mass Index (BMI) ≥50 kg/m2
* Significant cardiovascular disease or cardiovascular event in the past 3 months