cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies

The objective of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents with developmental and epileptic encephalopathies.

This is a randomized, double-blind, parallel-group, dose-escalation, placebo-controlled study of LP352 in adults and adolescents with developmental and epileptic encephalopathies (DEE) with an average of ≥ 4 observed/countable motor seizures per 4-week period during the 12 weeks before screening while on stable antiseizure medicine (ASM).

Subjects will be randomized 4:1 to LP352 or placebo. The study will have a baseline period of 28 days, followed by a 15 day up-titration period during which time subjects will titrate up to their highest tolerated doses, and a 60-day maintenance period. After Day 75, subjects will be tapered down over a period of up to 15 days, with a follow-up visit 30 days after last dose. Enrolled subjects will be allowed to continue treatment with up to 4 concomitant ASMs at a stable dose.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, age 12 to 65 years
2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
3. Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure medications
4. All medications and epilepsy interventions must be stable for 4 weeks before screening and are expected to remain stable during the study
5. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed

Key Exclusion Criteria:

1. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure
2. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject
3. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior
4. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss
5. Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol
Xerotic Dermatitis in Aged People

The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population


Eligibility Criteria:
Inclusion Criteria:

* Aged from 70 years
* With xerotic dermatitis, clinically assessed ,
* At least on the anterior part of lower and/or upper limbs,
* Presenting itching xerotic dermatitis evolving from at least 3 weeks
* Intensity of itching ≥ 4 on VAS (0-10) at th inclusion time
* With MMSE score ≥ 20 dating less than 6 months
* Affiliated to a social security system, or is a beneficiary (as applicable in the national regulation)

Exclusion Criteria:

* Criteria related to pathologies

  * Severe form of other dermatitis requiring either systemic treatment

    -- Itching xerotic dermatitis from iatrogenic origins
  * Dermatological disease other than xerotic dermatitis which could interfere with the assessment,
  * Systemic disease that may generate xerotic dermatitis and /or pruritus
  * Immunosuppression condition,
  * History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
* Criteria related to treatment

  - Use of treatment which could interfere with the evaluation of the disease or the course of the disease
* Criteria related to the population

  * Ongoing participation to another clinical trial or participation in the previous month before the inclusion
  * Patient under guardianship or trusteeship
Family and Personal History of Malignancy in Intraductal Papillary Mucinous Neoplasm (IPMN)

This is a retrospective observational study to determine the proportion of patients with a family history of pancreatic cancer and other malignancies among patients who have intraductal papillary mucinous neoplasm (IPMN).

The investigators will be reviewing the demographic, clinical, radiologic, pathologic, and follow-up information from the Pancres Center database. The investigators will also conduct a chart review to collect information recorded by clinicians on each subject's family history of malignancy and personal history of malignancy. Results of this database and chart review will be incorporated into a datasheet in which all patient identifiers have been removed.

The primary outcome will be the percentage of IPMN patients with at least one first-degree relative with pancreatic cancer or IPMN, or at least two first or second degree relatives with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes, including colorectal, gastric, breast, ovarian, and melanoma neoplasms. Secondary outcomes will be the relative risk of IPMN subtypes of higher malignant potential (main duct or mixed type location), more advanced histology (carcinoma in situ or invasive carcinoma), and recurrence following surgical resection amongst subjects with a family history.

Intraductal papillary mucinous neoplasm (IPMN) is a cyst-like cancer of the pancreas that is increasingly being identified in medical practice, including during the screening of individuals at high risk of pancreatic cancer. It has been established that 10 to 20% of pancreatic cancers are familial. In comparison, there has been little research into the importance of genetic risk in IPMN incidence. The investigators will perform a retrospective chart review of patients with IPMN who were evaluated for surgical intervention at our tertiary referral center. The investigators are interested in determining the proportion of IPMN patients with a family history of pancreatic and other cancers. In addition, the investigators will assess if familial cancer risk is associated with increased risk for malignant IPMN and recurrence, relative to those patients without an inherited predisposition.

Eligibility Criteria:
Inclusion Criteria:

* Tissue-confirmed diagnosis of intraductal papillary mucinous neoplasm or imaging suspicious for IPMN
* Seen in consultation for IPMN at Columbia-Presbyterian Medical Center between 2002 and 2008

Exclusion Criteria:

* Not meeting the inclusion criteria.
Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique.

A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared to the FDA-approved spatula/cytobrush when used as the cell collection device in screening for cervical cancer.

The InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector

The e2TM (SoftPAP) Collector collects only cells that have been exfoliated from the cervix whereas spatulas, brushes and broom-style collection devices collect cells by scraping or abrading the cervix. THis trial is to determine whether the purely exfoliated sample collected using the e2TM Collector is equivalent to samples obtained by scraping or abrading the cervix for purposes of cervical cancer screening and HPV detection.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18 years old and above
* Women scheduled to undergo colposcopy

Exclusion Criteria:

* Patients who have had a hysterectomy
* Patients who are pregnant.
Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy

RATIONALE: Vaccines may help the body build an effective immune response to kill cytomegalovirus infections.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who have undergone a donor stem cell transplant and have cytomegalovirus infection that has not responded to therapy.

OBJECTIVES:

Primary

* To determine the safety of infusing cytomegalovirus (CMV) pp65-specific cytotoxic T-lymphocytes (CTL) generated using pp65 peptides in patients who have undergone allogeneic stem cell transplantation and have persistent CMV infections.

Secondary

* Characterize CMV pp65-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter.
* Characterize the levels of CMV DNA in recipients of CMV pp65 CTL and observe whether the CTL infusion has any impact on the level of virus.

OUTLINE: This is a multicenter study.

Patients receive cytomegalovirus (CMV) pp65 cytotoxic T-cell infusion on day 1. Patients may receive up to 2 more doses at least 2 weeks after previous dose.

Blood samples are collected and analyzed by quantitative CMV PCR, chromium release assays for CMV pp65-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56, CD19, and CD45 RA/RD. Intracellular cytofluorometry is used to assess IL-2, IL-4, IL-10, and IFN-γ production by CD4 and CD8 CMV-specific effector cells.

After completion of study treatment, patients are followed periodically for up to 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cytomegalovirus (CMV) seropositive

  * Patient has had CMV antigenemia for ≥ 2 weeks OR CMV DNA levels ≥ 600 copies/μg of DNA despite antiviral therapy targeting CMV (ganciclovir or foscarnet)
* No prior allogeneic stem cell transplantation before the most recent transplantation
* CMV seropositive donor negative for HIV-1, HIV-2, HTLV-1/2 available

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2 (for patients ≤ 16 years of age) OR Lansky performance status 70-100%
* Bilirubin \< 2.0 mg/dL
* AST and ALT \< 2.5 times upper limit of normal
* Creatinine clearance \> 50 mL/min
* Pulse oximetry \> 95% without supplemental oxygen
* No history of graft-vs-host disease (GVHD) ≥ grade 2
* Not moribund
* No patients not expected to survive 1 month after T cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction

PRIOR CONCURRENT THERAPY:

* No concurrent systemic immunosuppressive agents for the treatment of GVHD
WEAICOR: Wearables to Investigate the Long Term Cardiovascular and Behavioral Impacts of COVID-19

This is an observational COVID-19 study that uses wearable health monitoring technology to follow COVID-19 positive individuals to monitor persistent symptoms and any potential long-term complications or cardiovascular and behavioral impacts from the disease.

Participants will wear a Biostrap wristband device that captures high-fidelity, raw photoplethysmography (PPG) waveforms and collects important indicators of heart and mental health, including heart rate, heart rate variability, pulse points, oxygen saturation and sleep patterns. Biometric data will be collected and participants will be alerted if any measurements are outside their normal range.

Researchers are recruiting 200 participants who were diagnosed with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Positive COVID-19 diagnosis
* Ages 18 to 120
* Access to WiFi

Exclusion Criteria:

* Negative COVID-19 diagnosis
* Age younger than 18 and older than 120
* Lack of access to WiFi
Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation

The main objectives of this study were :(1) to comprehensively and systematically evaluate the nutritional status of patients after hematopoietic stem cell transplantation. (2) to explore the effect of nutritional factors on the prognosis of patients treated by hematopoietic stem cell transplantation.

This study is devised to investigate nutritional status in patients who have undergone hematopoietic stem cell transplantation in the First Affiliated Hospital of Soochow University. Evaluation time points include the day before receiving conditioning regimen, post-transplantation 180 days, the nutritional status of patients were systematically evaluated from the aspects of food intake, physical activity level, body composition, blood biochemistry, etc. Also, the effect of nutritional factors on prognosis of hematopoietic stem cell transplantaion patients will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo hematopoietic stem cell transplantation in the First Affiliated Hospital of Soochow University.
* Having a life expectancy of more than 3 months

Exclusion Criteria:

* Not willing to participate in the investigation
* Age less than 15 years old or more than 80 years old
Contraceptive Counselling: Impact on Awareness of the Risk of Unwanted Pregnancy and on the Appeal of Contraception

The hypothesis of this study is that the generalisation of minimal contraceptive advice in general medical consultations among women of childbearing age in Reunion Island who do not use contraception but who have sexual relations and do not wish to become pregnant within the year could induce an awareness of the risk of unwanted pregnancy and lead to a change in behaviour with regard to contraceptive methods.


Eligibility Criteria:
Inclusion Criteria:

* Women from 18 to 50 years old
* Consulting in a general practice in Reunion Island
* French or Creole speaking
* Not having any contraceptive means
* Having sexual intercourse
* Not having any desire to become pregnant within the year
* Collection of non-opposition

Exclusion Criteria:

* Consultation for a desire or follow-up of a pregnancy
* Consultation for an abortion
* Consultation for a contraceptive method
* Known infertility
* Inability to answer the telephone (hearing impaired, mute)
* Severe cognitive disorder (mental retardation, dementia, active psychosis)
* Women under guardianship or curatorship
Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye

Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown that glucose present in the fluid in the front of the eye, called the aqueous humor, correlates well with blood glucose. As blood glucose changes, the optical properties of the aqueous humor change, causing a change in the appearance of the iris of the eye.. The data collected in this study will be shared with IRISense to assist in validating the algorithm being used to develop the database needed. The data collected so far is in a narrow band of the normal glycemic range (healthy volunteers). We will collect standard digital photographic images of the eyes of subjects with diabetes along with corresponding blood glucose concentrations using the finger stick glucose monitoring method. In order to do this we will use standard digital photography techniques that is embedded in our benchtop prototype device


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Diabetes Type 1 and 2 and can be verified by the principal investigator

Exclusion Criteria:

* Patients with any disease or abnormality of the eye
* Patients who are mentally incapacitated, cognitively impaired or with severe psychological disorders and cannot sign consent on their own
Correlative Study on Incidence and Risk Factors of Glaucoma-related Adverse Event at Various Durations After Congenital Cataract Surgery

A retrospective chart review of 264 eyes from 177 patients was performed who underwent congenital cataract surgery before the age of 14 years. All patients' surgery was performed by the same experienced surgeon at the Eye Hospital of Wenzhou Medical University from May 2011 to March 2019. We recorded patient demographics and incidence and risk factors for glaucoma-related adverse event. This study to identify the incidence of and risk factors associated with postoperative glaucoma at various durations after congenital cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent lensectomy combined with limited anterior vitrectomy, with or without IOL implantation for congenital cataract, all by one surgeon

Exclusion Criteria:

* Patient had a preoperative IOP above 21mmHg, glaucoma, coexistent uveitis, metabolic syndromes/diseases or exposure to radiation.
Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS in the Highland

The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

18 to 80 years of age Meet the diagnostic criteria Receive invasive mechanical ventilation within 48 hours

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Exclusion Criteria:

Patients with those disease will be excluded ： chronic obstructive pulmonary disease Pulmonary embolism Chronic heart failure Idiopathic pulmonary fibrosis Pulmonary hypertension Pregnant women will be excluded too.

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A Notch Signalling Pathway Inhibitor for Patients With T-cell Acute Lymphoblastic Leukemia/Lymphoma (ALL)(0752-013)

A Notch signalling pathway inhibitor study in pediatric and adult patients with relapsed (worsening) or refractory (not responding to treatment) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pathologically documented precursor T-cell acute lymphoblastic leukemia/lymphoma (T-ALL), relapsed or refractory to standard therapy, or not be a candidate for standard myelosuppressive chemotherapy due to age or comorbid disease.
* Patient must have performance status \<2 on the ECOG performance status for patients \>16 years old; Lansky performance level \>50 for patients 12 months to less than or equal to 16 years old.
* Patient must have adequate renal and liver function as indicated by the laboratory values performed within 14 days of receiving the first dose of study drug.
* Patient must have fully recovered from any chemotherapy and be greater than 2 weeks from radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea, intrathecal therapy, or immunosuppressant therapy for chronic graft-versus-host disease prophylaxis following allogeneic bone marrow transplant.
* Patient must be greater than 2 months following bone marrow or peripheral blood stem cell transplantation and off all immunosuppressant therapy (with the exception of patients taking immunosuppressant therapy for chronic graft-versus-host disease prophylaxis following allogeneic bone marrow transplant).
* Men and women of reproductive potential must use an effective contraceptive method while enrolled in the study.
* Patient or the patient's legal representative must be able to understand the study and give written informed consent.

Exclusion Criteria:

* Patient has had treatment with any investigational therapy during the preceding 30 days.
* Patient has uncontrolled congestive heart failure, angina, or had a myocardial infarction in the preceding 3 months.
* Patient has known hypersensitivity to the components of study drug, its analogs, or to allopurinol.
* Patient has active or uncontrolled infection.
* Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Patient is pregnant or lactating.
* Patient has any other severe concurrent disease which would make the patient inappropriate for entry into this study.
* Patient is known to be HIV positive or who has an AIDS-related illness.
* Patients with a "currently active" second malignancy, other than non-melanoma skin cancer should not be enrolled.
* Patient has isolated CNS disease.
C11 Sodium Acetate PET/CT Imaging of PCa

The investigators propose to conduct Carbon-11 Sodium Acetate PET/CT studies. The purpose of our study is to evaluate the impact of Carbon-11 Sodium Acetate PET/CT studies on patient management in patients with prostate cancer.

This is an expanded access study under an IND with a total of 300 participants with prostate cancer. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 11C-Sodium Acetate and will undergo a PET/CT imaging study. All patients referred by Oncologists and Urologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate. The following steps will take place.

1. Informed consent will be obtained.
2. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded.
3. Participant will be injected with 20 - 40mCi of 11C-Sodium Acetate intravenously (i.v.).
4. PET/CT Scans will be performed with or without oral and IV contrast. All investigational scans will be read by at least one board-certified nuclear medicine physician with established expertise in PET/CT of at least 5 years' experience. Fifteen minutes after injection of 11C-Sodium Acetate, the investigators will acquire a scan. Emission images will be acquired for 3-5min/bed position. Intravenous and oral contrast will be given for the CT portion of the study.
5. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded following the completion of the scan.
6. Within 24-48 hours of PET/CT imaging, a follow-up telephone call or email will be conducted to discuss any side effects or reactions to the investigational agent.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed prostate cancer
* Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria:

* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Effects of Intensive Chiropractic Care to Usual Care for Children With Cerebral Palsy.

To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in spastic cerebral Palsy children.


Eligibility Criteria:
Inclusion Criteria:

Participants will be recruited into the study according to the following criteria.

* Both gender (Male and Female).
* Age between 2 to 15 years.
* Spastic Cerebral Palsy children.

Exclusion Criteria:

Participants will be excluded from the study according to the following criteria.

* Cerebral Palsy children due to Traumatic Brain Injury.
* Patients having cognitive impairments.
* Patients having associated Neurological Pathologies.
* Patients who are unable to follow treatment plan.