cyrilzakka/clinical-trials huggingface dataset:
Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)

This is a multi-center, phase II study to evaluate the efficacy and safety of CTL019 in Chinese adult patients with relapsed or refractory DLBCL.

Disease assessments will be performed at screening, after bridging, 1, 3, 6, 9 and 12 months after tisagenlecleucel infusion, and every 6 months in the second year, and annually up to 60 months after infusion. Efficacy will be assessed until progression; safety will be assessed throughout the study. A long term follow-up up to 15 years after CTL019 infusion will continue under a separate protocol (CCTL019A2205B)(NCT02445222).

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Patients must be ≥18 years of age at the time of ICF signature
3. Histologically confirmed DLBCL at last relapse (including DLBCL transformed from follicular lymphoma and double-triple hit lymphoma)
4. Relapsed or refractory disease after at least 2 lines of systemic therapy, including anti-CD20 antibody and an anthracycline, or having failed or being ineligible for autologous HSCT
5. ECOG performance status that is either 0 or 1 at screening
6. Measurable disease at time of enrollment:

   * Nodal lesions greater than 15 mm in the long axis, regardless of the length of the short axis or
   * Extra nodal lesion (outside lymph node or nodal mass, but including liver and spleen) at least 10 mm in long and short axis
7. Adequate organ function
8. Must have a leukapheresis material of non-mobilized cells available for manufacturing

Exclusion Criteria:

1. Prior treatment with anti-CD19 therapy, adoptive T cell therapy, or any prior gene therapy product
2. Primary mediastinal large B-cell lymphoma, EBV+ DLBCL, Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, T cell / histiocyte rich large B-cell lymphoma, primary cutaneous DLBCL.
3. Eligible for and consenting to autologous HSCT
4. Prior allogeneic SCT
5. Active CNS involvement by disease under study, except if the CNS involvement has been effectively treated (i.e. patient is asymptomatic) and local treatment was greater than 4 weeks before enrollment
6. Active neurological autoimmune or inflammatory disorders (e.g. Guillain-Barre syndrome)
7. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to screening
Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557)

Physicians counsel women participants who are candidates for hormonal contraception about available combined hormonal contraceptive methods (the combined pill, the contraceptive vaginal ring \[i.e., the etonogestrel + ethinylestradiol vaginal ring\] and the contraceptive transdermal patch). Effects of this counseling on women's contraceptive use decisions are to be evaluated by 1) recording which method is chosen after information is provided about all three available combined hormonal methods, 2) comparing the final chosen contraceptive method used by a participant after counseling with the method originally intended to be used by that participant before the counseling, and 3) evaluating the criteria used by women participants to choose their contraceptive method after the counseling, including evaluation of social and demographic predictors of contraceptive choice. The differences among participants in the number of contacts made by the participants to physician offices for purposes of obtaining information regarding the use of their final chosen hormonal contraceptive (e.g., requests for clarification, questions, expressing doubt or reservations for using the method, or requests for other help/advisement by the physician) will also be evaluated over four months following the physician counseling.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women ≥ 18 years of age and ≤ 40 years of age who consult their physician for contraception and would consider a combined hormonal contraceptive method
* Women who are using the hormonal method for the first time or who have previously used and suspended it for at least 1 month
* Women on one combined pill who would consider switching to another combined pill (Women who attend their physician to stop one of the combined hormonal methods can not participate)
* Women who request a combined hormonal contraceptive method but for whom the physician considers another method more appropriate (e.g. contraindications for combined hormonal contraception) will be counseled about these methods but still complete the questionnaire
* Women who are not interested in becoming pregnant in the next 4 months
* Women who agree to complete a questionnaire and that the questionnaire data are reviewed and analyzed by staff participating in the project

Exclusion Criteria:

None
Effect of Tourniquet on Sensory Nerve Conduction Threshold (sNCT) and OxyNeuroGram (ONG) Index- A Volunteer Study

There are a number of risk factors for development of chronic pain that have been evaluated including age, gender, type and duration of surgery, duration of pain prior to surgery and tourniquet application. There is some scientific evidence from animal studies demonstrating that prolonged tourniquet application can result in lack of oxygen supply to nerves, and subsequent nerve damage resulting in chronic pain. This theory has not been proven in humans. In this study the investigators will indirectly assess the evidence for abnormalities caused by tourniquet application on subjects' nerves using well established devices to determine the function of these nerves.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Over 18 years of age

Exclusion Criteria:

* Neurological disease
* Diabetes mellitus
* History of nerve injury
* Chronic pain
* Alcoholism
* Blood pressure measurements greater than 140/80 and infection in the monitored area
Serotonergic System and Violent Video Games

Aggressive behavior (AB) is a major burden to society with severe socio-economic consequences. Genetic studies suggest a high heritability of AB; in particular, the low expressing allele of the MAOA gene (MAOA-L) has been associated with increased AB. Recent neural aggression models have suggested a dysfunctional emotion regulation circuit including amygdala, orbitofrontal, and anterior cingulate cortex. Dysregulated serotonergic (5-HT) projections from the anterior cingulate cortex to the amygdala have been suggested to promote aggressive behavior. This finding is well in line with the observation that the MAOA-L allele leads to a reduced expression of monoamine oxidase A and thus to an overflow of 5-HT in serotonergic cortico-amygdalar projections. However, due to methodological and ethical constraints, the neural substrates of AB are difficult to assess. A possible solution is the use of virtual violence which permits AB against virtual characters without direct consequences for any real person and can be easily applied in functional imaging experiments. There is evidence that virtual and real aggression share common neural substrates. AB in violent video games inhibits rostral anterior cingulate cortex (ACC) and amygdala in line with the suggested neurophysiological circuits underlying real-life AB.

Our study plan comprises the assessment of brain activation patterns during virtual AB in a violent video game with functional magnetic resonance imaging under three experimental conditions in randomized, double-blind fashion:

1. Increase of synaptic 5-HT with a selective serotonin reuptake inhibitor (SSRI, Cipralex ®);
2. reduction of synaptic 5-HT with the Rapid Tryptophan Depletion Test (RTD); and 3) Placebo.

A blood sample genotyping will assess the allelic expression of the MAOA gene. We hypothesize

1. a modification of the ACC-amygdala system by the serotonergic intervention and
2. an interaction with the genotype concerning the MAOA gene. The results of this study will give valuable insights into the neurogenetic biology underlying aggression which will open new perspectives for therapeutical and pharmacological intervention.

Eligibility Criteria:
Inclusion Criteria:

* male
* age 18-60 (adults), age 12-17 (juveniles)
* right-handedness
* German native language

Exclusion Criteria:

* any contraindications against MR investigations
* any contraindications against application of SSRIs
* any history of neurological or psychiatric illness
* history of drug abuse
* history of psychopharmacological therapy
WEUSKOP6166: Lamotrigine and Aseptic Meningitis

The objective of the study is to quantify the number of cases of aseptic meningitis among users of Lamotrigine. This study is a cross-sectional study design using data on lamotrigine patients within the Thomson Reuters MarketScan® Commercial database (MarketScan database). The MarketScan database is a US-based insurance claims database representative of a US insured population and includes supplemental datao n Medicare patients. This cross-sectional study will evaluate the number of cases of aseptic meningitis among lamotrigine users during the duration of lamotrigine therapy, with an extended exposure window of 30 days after completing therapy.

The MarketScan® Database is an US insurance claims database that is held in-house at GSK, which can be interrogated to examine rates of prescribing and medical conditions that can be captured via ICD-9 diagnoses codes. The MarketScan database captures person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The annual medical databases include private sector health data from approximately 100 payers. In 2011, there were approximately 35 million patients on the database. The Commercial Claims and Encounters Database represents the medical experience of insured employees and their dependents for active employees, early retirees, COBRA continues, and their dependents insured by employer-sponsored plans (i.e., non-Medicare eligibles). In addition, a linked Medstat Medicare database contains predominantly fee-for-service plan data in insurance plans where both the Medicare-paid amounts and the employer-paid amounts were available and evident on the claims.The data are HIPAA compliant thus all patients have been anonymized.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be using lamotrigine for epilepsy or bipolar disorder.
* Patients must have at least 180 days history on the database prior to the index of lamotrigine use.
* Patients must have medical and pharmacy coverage throughout the study, with no gaps in eligibility.

Exclusion Criteria:

* None
The United Kingdom Multiple Sclerosis Register Covid-19 Substudy

The aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.

Study objectives

1. To identify the incidence of upper respiratory tract symptoms: fever, cough and breathing difficulties, other symptoms suggestive of COVID-19 infection, respiratory tract infections suggestive of COVID-19, and COVID-19 confirmed by laboratory testing among the UK MS population
2. To establish if some DMDs increase the risk of COVID-19 infection
3. To determine the incidence and effectiveness of self-isolation in the MS population. To examine the impact self-isolation has on mood, fatigue, and other routinely collected patient reported outcome measures from the MS Register.
4. To determine the clinical outcome of respiratory tract infections, including confirmed and suspected cases of COVID-19, in terms of symptoms, time to recovery, hospital admission, requirement for ventilation, and death.
5. To determine the longer-term impact of COVID-19 on MS, using routinely collected MS outcomes in the MS register, including impact on disability, relapses and changes in DMDs as assessed at 3 monthly intervals.
6. To determine where people are obtaining their health information during the COVID-19 outbreak.
7. To establish changes in DMDs prior to and as a result of symptoms related and unrelated to COVID-19

Eligibility Criteria:
Inclusion Criteria:

* \>18 and confirmed diagnosis of MS, enrolled on UK MS Register

Exclusion Criteria:

* None of the above
A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H® Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3

Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream).

Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control product usage: according to label, 3-4 times daily application to rectal region.

At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge, swelling, itching, discomfort and painkiller usage.

Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are examined by study physician who assesses hemorrhoid severity.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70
2. Bleeding hemorrhoids with / without pain
3. Diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids
4. Signed Informed Consent

Exclusion Criteria:

1. Known rectal sensitivity
2. Rectal infection
3. Grade IV hemorrhoids
4. Use of anti-coagulants (except Aspirin or Plavix) within 30 days prior to enrollment
5. Known inflammatory bowel disease
6. Anal fissure
7. Military personnel
8. Female patients that are pregnant, or are not using a reliable method of birth control, or are nursing
9. Patients who have been involved in another experimental trial within the past 30 days
10. Patients presently diagnosed with cancer
The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma

This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of stage I hepatocellular carcinoma
* Child-Pugh class A, B
* Radical resection is feasible
* Patients with adequate renal, hepatic, and hematologic function
* Written informed consent

Exclusion Criteria:

* Allergic to chemotherapy drugs
* No measurable lesion
* Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment
* Evidence of serious infection
* Renal or hepatic dysfunction, significant cardiovascular disease
* Pregnant or lactating women
Self-collected Swabs for HPV Testing in 18-24 Year Old Women

The purpose of this study is to compare methods for transporting self-collected swabs for HPV testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year old women.

We propose a cross-sectional study among 150 women in the United States who have used Internet dating sites in the past year in order to examine risk factors for high-risk HPV infections in 18-24 year old online daters, and evaluate strategies for transporting and storing self-collected samples for HPV testing. We will ask participants to complete a written questionnaire on their health, sexual behavior, and attitudes toward self-collecting vaginal swabs, HPV vaccination, and cervical cancer screening. Also, we will ask the women to self-collect two sequential vaginal swab samples that will be transported and stored according to the two strategies described above. Each sample will be tested for type-specific HPV DNA using a PCR-based assay.

Eligibility Criteria:
Inclusion Criteria:

* Have had sex with men
* Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)

Exclusion Criteria:

* Pregnant or breastfeeding
Neuropattern - Assessment of a Translational Diagnostic Tool for Depression, Adjustment- and Somatoform-disorders

Neuropattern is a first translational tool in stress medicine. Neuropattern is a diagnostic tool, which can be applied by in- and outpatients and physicians to detect dysregulation in the stress response network. The physician provides anamnestic and anthropometric data, while the patient takes other measures at home, e.g. psychological, symptomatic, and biological data. Among the biological data are ECG measures for analyses of heart rate variability, and salivary cortisol measures before and after a dexamethasone challenge test. All data are analyzed in a central laboratory, which generates a written report for the physician, including a disease model, from which personalized recommendations for pharmacological and psychological treatments are derived. Neuropattern additionally offers individualized internet modules to inform the patient about the disease model and to teach him/her what he/she can do to improve his/her medical conditions. The current study applies Neuropattern in 2000 patients of family doctors, suffering from major depression, depressive episodes, adjustment disorders, and somatoform disorders. The patients receive either unspecific or individualized internet modules in a randomized order.


Eligibility Criteria:
Inclusion Criteria:

* native speakers
* ICD-F diagnoses 32, 33, 43.2, and 45

Exclusion Criteria:

* patients under glucocorticoid treatment
* patients taking antidepressants and anxiolytics
* patients under psychotherapeutic treatment
* pregnant women
* severe medical conditions
* mental retardation
* arrhythmia absoluta
* intolerance of dexamethasone
Livedoid Vasculopathy: Strong Association With Smoking, Weak Association With Thrombophilia

A screening of patient histories at the clinics of Dermatology of the universities of Zurich, Basel and Bern is performed in order to identify patients with a history of Livedoid vasculopathy. Patients with a history of livedoid vasculopathy are asked to participate in the study. After reading the patient information and if the informed consent is signed patients are included in the study. Patients are questioned about their smoking history and blood is drawn in order to perform a screening for thrombophilia.

A screening of patient histories at the clinics of Dermatology of the universities of Zurich, Basel and Bern is performed in order to identify patients with a history of Livedoid vasculopathy. Patients with a history of livedoid vasculopathy are asked to participate in the study. The presence of Livedoid vasculopathy must be confirmed by a histologic specimen. After reading the patient information and if the informed consent is signed patients are included in the study. Patients are questioned about their smoking history and blood is drawn in order to perform a screening for thrombophilia. The presence of a history of smoking and thrombophilia is compared to the general Swiss population.

Eligibility Criteria:
Inclusion Criteria:

* History of livedoid vasculopathy

Exclusion Criteria:

* Diagnosis was not proved by biopsy specimen
* A different reason than livedoid vasculopathy has been found for the symptoms of the patient
* No informed consent by the patient
Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease

This study is investigating the usefulness of using functional magnetic resonance imaging (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease, Essential tremor, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. The study may determine the relationship between patterns of brain activation and therapeutic outcome and/or side effects.

Deep brain stimulation (DBS) is an effective neurosurgical approach for treating motor disorders including Parkinson's disease (PD), Essential Tremor (ET), and dystonia. Its therapeutic benefit has led to the application of DBS to a wide spectrum of disorders including psychiatric conditions, epilepsy, Alzeimer's disease, headache, obsessive-compulsive disorder (OCD), Tourette syndrome, depression and intractable pain. However, because the nature of its underlying mechanisms and clinical effects are not fully understood, precision targeting, decreasing adverse effects, and improving clinical outcomes represent major clinical and scientific challenges in PD and other disorders treated by DBS. Our goal is to investigate the inter-relationships between site-specific neural activation and clinical outcomes during DBS. To do so, we will perform non-invasive functional Magnetic Resonance Imaging (fMRI) to investigate DBS-mediated activation of neural network circuitry. Our proposed protocol involves the addition of intraoperative fMRI to the standard DBS or battery change protocol in order to determine the major sites of activation during application of clinically effective DBS to the subthalamic nucleus (STN), ventral intermediate thalamus (VIM), globus pallidus interna (GPi), fornix, nucleus accumbens (NAc), anterior thalamus and periaqueductal gray matter. Patients will undergo clinical assessment to determine the relative efficacy of DBS stimulation parameters, applied during the fMRI and at regularly scheduled post-operative programming visits up to 6 months of follow-up. Our Specific Aims are to: (1) Identify fMRI-activated brain regions by DBS in patients who undergo DBS surgery (Patients diagnosed with PD, ET, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. (2) Correlate fMRI activation with clinical outcomes and side effects. With the goal of improving DBS electrode targeting for optimal and reproducible clinical outcomes, these experiments will be the first attempt to relate site-specific DBS with functional in vivo imaging data and quantitative longitudinal clinical outcome measures in DBS patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients with medically intractable Parkinson's Disease who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.

Exclusion Criteria:

* Pregnant patients, prisoners, children (age less than 18), and any patients identified as unsuitable for this protocol by the Mayo DBS committee.
Analgesic Effect of Non Invasive Stimulation : Comparison of rTMS and tDCS Efficacy

The aim of this study is to compare analgesic efficacy of two non invasive techniques based on motor cortex stimulation in neuropathic pain patients. High frequency repetitive transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to induce an analgesic effect significantly different from placebo; this effect is clinically useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its efficacy in neuropathic pain has been not yet established. The investigators propose to compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed before and after the five sessions of rTMS and tDCS, in order to reveal the potential plasticity induced within motor somatotopic map of the primary motor cortex.


Eligibility Criteria:
Inclusion Criteria:

* patients aged from 18 to 80 years, male or female, fully informed and having given their written consent
* pharmacoresistant neuropathic pain during at least one year, without any change of the pharmacological treatment since at least one month

Exclusion Criteria:

* drug addiction, headache, epilepsy history
* ferromagnetic intracranial device
* implanted stimulator
* absence of contraceptive method for women of childbearing age