cyrilzakka/clinical-trials huggingface dataset:
BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR in patients with relapsed and/or refractory multiple myeloma and plasmacytoid lymphoma.

BCMA-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressing on a T-cell, directed against the surface proteins BCMA and CD19. BCMA-CD19 cCAR is also aimed to treat multiple myeloma, a challenging disease due to the heterogeneity of myeloma cells, which renders single-antigen targeting CAR T-cell therapy ineffective. BCMA-CD19 cCAR is proposed to target both bulky myeloma cells expressing BCMA, and myeloma stem cells expressing CD19 to effectively eradicate the disease.

BCMA-CD19 cCAR is also aimed to treat heterogeneous plasmacytoid lymphoma bearing two types of lymphoma cells, regular lymphoma cells expressing CD19 and plasmacytoid lymphoma cells expressing BCMA. The use of two different targets intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent; Patients volunteer to participate in the research
* Diagnosis is mainly based on the World Health Organization (WHO) 2008
* Patients have exhausted standard therapeutic options
* Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
* Female must be not pregnant during the study

Exclusion Criteria:

* Patients declining to consent for treatment
* Prior solid organ transplantation
* Potentially curative therapy including chemotherapy or hematopoietic cell transplant
* Prior treatment with BCMAxCD3 or CD19xCD3 bispecific agents
Rhomboid Flap Versus Primary Closure After Excision of Sacrococcygeal Pilonidal Sinus. (A Prospective Randomized Study)

To evaluate and compare between excision with primary closure of wound and excision with Rhomboid flap reconstruction in the treatment of pilonidal sinus as regard duration of operation, healing time, hospital stay, complications and recurrence rate.


Eligibility Criteria:
Inclusion Criteria:

* chronic pilonidal sinus

Exclusion Criteria:

* pilonidal abcess
A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem

The purpose of this study is to evaluate the abuse potential of seltorexant compared to placebo and two active comparators (zolpidem and suvorexant) in non-dependent, recreational sedative users.


Eligibility Criteria:
Inclusion Criteria:

* Be a current, recreational, not physically dependent, drug user
* Participant must be medically stable
* All female participants must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of the qualification phase and on Day -1 of each treatment period of the treatment Phase
* Blood pressure (after the participant is in a sitting position for 5 minutes) between 90 millimeters of mercury (mmHg) and 160 mmHg systolic, inclusive, and no higher than 100 mmHg diastolic at screening and Day -1 prior to qualification phase randomization
* A 12-lead ECG consistent with normal cardiac conduction and function, including: sinus rhythm, pulse rate between 40 and 100 beats per minute (bpm), QTc interval less than or equal to (\<=) 450 milliseconds (ms) for males, \<=470 for females, QRS interval of less than (\<) 120 ms, PR interval \<210 ms, Morphology consistent with healthy cardiac conduction and function

Exclusion Criteria:

* Known allergies to seltorexant, zolpidem, and suvorexant
* Previous history of recurrent fainting, collapses, syncope, orthostatic hypotension, or vasovagal reactions
* Prescription medications except for stable medical problems such as hypertension, elevated cholesterol, and non-insulin-dependent diabetes mellitus with stable medications for at least 1 month prior to screening
* Participants who have ever been in treatment for substance use disorders (except smoking cessation) or are currently seeking treatment for substance use disorders. In addition, currently seeking or participating in a substance rehabilitation program should be excluded
* Preplanned surgery or procedures that would interfere with the conduct of the study
Real-time Diagnosis of Colorectal Polyps Using Narrow-Band Imaging

Accurate optical diagnosis of colorectal polyps could allow a "resect and discard" strategy with surveillance intervals determined based on the results of the optical biopsy. The investigators perform education to characterize the histology of diminutive and small colorectal polyps by using narrow band imaging (NBI). After education program, the investigators prospectively evaluate real-time optical biopsy analysis of polyps with NBI by 15 gastroenterologists at a medical check up center.

This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of four periods.

First, a computer based education program on the accuracy of predicting polyp histology with NBI (NICE and WASP classification) will be performed by 15 endoscopists (less experienced in NBI) during Septepber 2015.

In the second period from October 2015 till Deceber 2015, 1st phase real- time optical diagnosis for diminutive and small colorectal polyps will be activated. All endoscopists will have weekly feedback on their accuracy of optical diagnosis for polyps, and discuss the NBI findings that mismatched by histologic diagnosis all together per one month.

Third, the result of 1st phase real-time optical diagnosis will be analyzed from January 2016 till April 2016. In this period, endoscopists with low accuracy of 1st phase real-time optical diagnosis will be re-educated.

The last period from May 2016 till September 2016, 2nd phase real-time optical diagnosis for polyps will be activated. Performance will be evaluated by comparing optically predicted diagnosis with actual histologic diagnosis. Cumulative sum analysis will be used to determine the learning curve for each endoscopist. Negative predictive value for the prediction of nonneoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Customers who received screening and surveillance colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from October 2015 to September 2016.

Exclusion Criteria:

* Age \<18 years
* Customers who refused to offer their health check up data
* History of inflammatory bowel disease
* History of familial adenomatous polyposis
* Customers who received Incomplete colonoscopy
* History of previous colorectal resection
* Incomplete data collection on optical diagnosis
Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

This study will evaluate the efficacy of ondansetron + BASICS Plus in reducing severe or binge drinking among emerging adults. BASIC Plus (Brief Alcohol Screening and Intervention for College Students) has been the most validated brief intervention among college students. The BASICS program provides personal feedback, motivation, and strategies that enhance normative drinking patterns

We propose to conduct a 9 week study to test the efficacy of ondansetron in a heavy drinking (non-dependent) emerging adult population. We will enroll individuals between the ages of 18 and 25 years as this period overlaps with the general population of those attending college and who can be defined as emerging adults. We will conduct a double-blind control study in which 150 individuals will be randomized into 2 groups, therefore the N will be 300.

Eligibility Criteria:
Inclusion Criteria:

* White Males and females who have given written informed consent.
* Ages 18 through 25;also, patients must weigh ≥40 kg and ≤140 kg.
* Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
* At least an average of one episode of binge or heavy drinking per week in the past month prior to enrollment. For men and women, that is ≥5 and ≥4 drinks/drinking day, respectively.They also need to report at least one day of heavy drinking within the 7 days prior to randomization.
* The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception.
* Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
* Answer an advertisement in the newspaper/radio/television, and express a wish to stop heavy drinking.
* Willingness to participate in behavioral treatments to stop heavy drinking

Exclusion Criteria:

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CT Residual Gastric Fluid Volume

Hypothesis: The investigators hypothesize that more than 50% of the patients receiving enteric contrast material (ECM) \< 2 hours of anesthesia/sedation would have residual gastric fluid volume (GFV) \> 0.4 ml/kg. The investigators also hypothesize that measuring GFV by using region of interest in the CT technique is accurate compared to blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.

The purpose of our study is to examine the residual gastric fluid volume when oral contrast is administered within 2 hours of anesthesia /sedation and to validate the accuracy of measuring the residual gastric volume by using region of interest in the CT image by using blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for CT abdomen with contrast and require anesthesia/sedation
* Subjects must be 1 month to 10 years of age (inclusive)
* The subject's legally authorized representative has given written informed consent to participate in the study

Exclusion Criteria:

* Subjects violate the institution fasting guideline before anesthesia /sedation with the exception of the oral contrast
Association Between TMAO and Diabetes

Background: The association of trimethylamine-N-oxide (TMAO), a microbiota dependent metabolite from dietary choline and carnitine, with type 2 diabetes was inconsistent.

Objective: The investigators planned to investigate the association between plasma TMAO and newly diagnosed type 2 diabetes as well as whether the association could be modified by the TMAO-generating enzyme flavin monooxygenase 3 (FMO3) polymorphisms.

Design: This is an age- and sex-matched case-control study of 2694 participants: 1346 newly diagnosed cases of type 2 diabetes and 1348 controls. The patients of newly diagnosed type 2 diabetes were consecutively recruited from those attending for the first time the outpatient clinics of Department of Endocrinology, Tongji Medical College Hospital, Wuhan, China, from 2012 January to December 2014. Concomitantly, the investigators recruited healthy individuals who were frequency-matched by age (±5 years) and sex to patients from an unselected population undergoing a routine health check-up in the same hospital. The inclusion criteria for controls and newly diagnosed type 2 diabetes were: age ≥ 30 years, body mass index (BMI) \< 40 kg/m2, no history of a diagnosis of diabetes and no history of receiving pharmacological treatment for hyperlipidaemia or hypertension. Patients with clinically significant neurological, endocrinological or other systemic diseases, as well as acute illness or chronic inflammatory or infective diseases, were excluded from the study. All the participants enrolled were of Chinese Han ethnicity. All the participants gave informed written consent to the study and did not take any medication known to affect glucose tolerance or insulin secretion before participation. The study was approved by the ethics committee of the Tongji Medical College. Concentrations of plasma TMAO were measured, and FMO3 E158K polymorphism (rs2266782) were genotyped.


Eligibility Criteria:
Inclusion Criteria:

* Concomitantly, we recruited healthy individuals who were frequency-matched by age (±5 years) and sex to patients from an unselected population undergoing a routine health check-up in the same hospital.
* The inclusion criteria for controls and newly diagnosed type 2 diabetes were: age ≥ 30 years, body mass index (BMI) \< 40 kg/m2, no history of a diagnosis of diabetes and no history of receiving pharmacological treatment for hyperlipidaemia or hypertension.

Exclusion Criteria:

* Patients with clinically significant neurological, endocrinological or other systemic diseases, as well as acute illness or chronic inflammatory or infective diseases, were excluded from the study.
Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year : Analysis of Filmed Sequences (PRE-PRURINEO)

Analysis of filmed sequences for the assessment of discomfort in atopic dermatitis in infants under 1year of age

Atopic Dermatitis (AD) is a chronic inflammatory and itchy dermatitis particularly common in childhood since it affects about 20% of the pediatric population, with revelation usually around the age of 3-6 months of life. However, there are very few pediatric population data on the prevalence of pruritus and associated discomfort in infants. Although the skin and the nervous system of the infant (\<6 months) are competent in the experiment of the pruritus, the acquisition of an intentional motricity allowing the targeted scratching of the affected body areas is done only from the age of 6 months, making it difficult to diagnose the intensity of the AD and assess the potential discomfort caused. Currently, the diagnosis and assessment of pruritus in children is based on a hetero-rating through scales, which are not at all applicable for infants under 6 months of age (population concerned by our study).

The visual scale Numeric Rating Scale, validated in adult population seems to be the one that most accurately assesses the severity of pruritus. In pediatric populations, the use of the Eppendorf Itch Questionnaire and the US version of the Childhood Atopic Dermatitis Impact Scale are recommended. Alternatives to the clinical and subjective rating of the severity of pruritus have been described via actigraphy: thus, a strong statistical correlation has been demonstrated between a nocturnal measurement of wrist motor activity as a reflection of the intensity of pruritus, and the analysis of videos filmed in infra-red. But, again, the technique is not suitable for young infants, because of the absence of voluntary motivated motor skills, and because of less organized sleep / wake cycles.

In order to better manage infants less than 1 year old, the analysis of their behavior in case of atopic dermatitis seems necessary to us to better identify a potential discomfort in these patients.

This is an essential preliminary study that will allow us to better define the judgment criteria necessary for the implementation of an observational study comparing infants with atopic dermatitis to healthy infants.

Eligibility Criteria:
Inclusion Criteria:

* Infants under 1 year old
* with atopic dermatitis
* No opposition from at least one of the patient's parents

Exclusion Criteria:

* Acute intercurrent pathology
* Severe malformation or genetic abnomalies
* Parent (s) minor (s) or unfit (s) to give their informed consent
* Refusal of patients
Electro- Hemodynamic Activity in Children: Combined Analysis by Video -EEG Spectroscopy and Near-infrared (NIRS )

Epilepsy in children is a major public health issue. It is the first neurological disease of the child.

Epilepsy in children is a major public health issue. It is the first neurological disease of the child. The specific incidence of epilepsy rates were highest during the first year of life, between 75,105 and 250,105 hab.an hab. year and remain high in the age group between 0 and 10 years. Epilepsies predictions are varied. They can be spontaneously benign, drug-, chemically dependent or drug-resistant. These, refractory epilepsies, represent 20% of epilepsy as a child and adolescent than adult is about 1200 children and 1200 adults Picardy. The validation of non-invasive investigative tools is becoming a necessity in the management of drug-resistant epilepsies especially when a surgical decision is envisaged. The aftermath (motor, cognitive, sensory) appear to rule early; but they are sometimes limited to learning deficits detected later in the school curriculum. The investigators know that defects in neuronal electrical activity (eg critical discharges) induce a metabolic response and conversely metabolic disturbances can cause abnormal electrical activity. It is therefore important to have tools to better characterize the interactions between these two mechanisms to better understand brain function in the brain during development and during pathological situations. The investigators lack quantitative criteria regarding the impact of crises on the metabolic activity and thus predictive criteria consequences of crises on brain function. The deleterious hazard must be considered at all ages in both structures to causing seizures than in those where the crisis spread. The functional characterization, electrical, metabolic and anatomic pathology of these networks is necessary and contributes to a better understanding of physiological and pathological brain function, and helps to define the most appropriate treatment strategy.

About childhood epilepsy, analysis of the EEG allows in 75% of cases to find predictive patterns characteristic of becoming. However in 25% of cases, we lack predictive objective criteria. This highlights the importance of developing analysis tools for more accurate and efficient brain function and to improve the management and evaluation of the prognosis of these children.

Eligibility Criteria:
Inclusion Criteria:

- Any child 0-16 years with partial epilepsy and / or interictal spikes located on the standard EEG recordings.

Exclusion Criteria:

* All children with severe congenital malformation
* Any refusal of a parent
* Any child with generalized epilepsy or diffuse interictal spikes
* Any child with a serious deterioration in the general condition and vital functions
* Any child with dermatitis of the face or scalp
Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented metastatic or unresectable urothelial carcinoma. Both transitional cell and mixed transitional cell histologies are allowed, provided urothelial component is ≥ 50%.
* At least 1 measurable target lesion per RECIST v1.1.
* Must be ineligible to receive cisplatin. Patients ineligible for any platinum-based chemotherapy are allowed.
* Known FGFR3 mutation or rearrangement confirmed by the central laboratory prior to randomization.
* Central laboratory test result of PD-L1 status is mandatory at screening.
* Have received no prior systemic chemotherapy for metastatic or unresectable urothelial carcinoma (except adjuvant platinum-based chemotherapy following radical cystectomy, with recurrence \> 12 months from completion of therapy, or neo-adjuvant platinum-based chemotherapy, with recurrence \> 12 months since completion of therapy).
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Prior receipt of a selective FGFR inhibitor for any indication or reason.
* Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor.
* Receipt of anticancer medications or investigational drugs for unresectable and/or metastatic disease.
* Concurrent anticancer therapy, except for treatment allowed per protocol.
* Has disease that is suitable for local therapy administered with curative intent.
* Has tumor with any neuroendocrine or small cell component.
* Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
* Has received prior radiotherapy to a metastatic site without the use of chemotherapy radiosensitization within 3 weeks of the first dose of study treatment, with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks before the start of study treatment.
* Has central nervous system metastases, unless the participant has completed local therapy (eg, whole brain radiation therapy, surgery, radiosurgery) and has discontinued use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.
* Known additional malignancy that is progressing or required active treatment within the past 3 years
* Laboratory values outside the protocol-defined range at screening.
* Clinically significant or uncontrolled cardiac disease.
* History of autoimmune disease that has required systemic treatment in past 2 years.
Latina Adolescent Depression Treatment Study

Despite experiencing higher rates of depressive symptoms and similar rates of Major Depressive Disorder (MDD), Latina (female) adolescents in the U.S. are significantly less likely than their non-Latina White peers to receive treatment for MDD. The purpose of this study is to identify facilitators of and barriers to depression treatment engagement among Latina adolescents across patient-, family-, and healthcare provider-levels from the perspectives of these individuals. Latina adolescent-parent dyads and healthcare providers will be recruited from community and healthcare settings. Separate individual semi-structured interviews will be conducted with Latina adolescents (n=12) and their parents (n=12). Two focus groups will be conducted with primary care providers (n=6) and mental health providers (n=6) who frequently care for Latina youth. Qualitative content analysis will be used to analyze the transcripts to determine common themes in facilitators and barriers across stakeholder groups.


Eligibility Criteria:
Adolescent Inclusion Criteria:

* Ages 13-17
* Self-identify as Hispanic/Latina
* Be first generation (i.e. born outside the US) or second generation immigrants (i.e. one or both parents born outside the US)
* Have been diagnosed with Major Depressive Disorder or Persistent Depressive Disorder/Dysthymia
* Have been referred to psychotherapy or prescribed medication for depression

Adolescent Exclusion Criteria:

* Currently experiencing acute psychological distress

Parent Inclusion Criteria

* Parent of Latina adolescent experiencing depression

Parent Exclusion Criteria

* Not fluent in English or Spanish

Healthcare Provider Inclusion Criteria

* Self-identify as regularly providing clinical care to Latina adolescents with depression
* Be in a role in which they can refer to or provide depression treatment