cyrilzakka/clinical-trials huggingface dataset:
The Effects of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training in Patients With TBI

Long-term sequelae in TBI is a well-recognized burn. We designed a proof of concept study, randomized, double-blind, placebo-controlled to evaluate 36 adult TBI patients. To evaluate the early and late effects of 10 days of 20 minutes applying transcranial direct-current stimulation (tDCS) in the dorsolateral prefrontal cortex (DLPFC), bilateral temporal cortex (CTB) and compare to sham stimulation, and online cognitive training. We expect that the active group will differ from the sham group, showing larger effect sizes in the cognitive assessment.

Method: proof of concept study, randomized, double-blind, placebo-controlled. 36 adult patients will be recruited, with closed TBI for at least 6 months, of both sexes. The sequence of randomization will provide the allocation 1: 1: 1 in parallel groups: G1 n = 12 active (CTB), G2 n = 12 active (DLPFC), and G3 n = 12 (Sham). The tDCS will be held with the intensity of 2 mA for 20 minutes per session and online cognitive training (concurrent with the ETCC). All patients, after the screening and randomization, will make a baseline neuropsychological assessment (T0) and receive 10 sessions of stimulation concomitant to cognitive training. Patients will undergo neuropsychological reassessment one week (T1) and two months (T2) after the last tDCS session. We will evaluate performance on episodic memory tests, working memory and attention in the three periods (T0, T1, and T2). The significance adopted is the level of 5% (α = 0.05), analysis of 80% power and bicaudal curve. Analysis of the results will be done by intention to treat (ITT).

Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis closed traumatic brain injury, cognitive complaints reported by the patient or caregiver.

Exclusion Criteria:

metal implants in the head, seizures, abnormal EEG, depressive symptoms
Resiliency Training for Patients With NF2 Via Videoconferencing With Skype

The aim of this study is to determine, whether the 3RP is feasible, accepted and efficacious and durable when delivered via Skype to patients with neurofibromatosis type 2 (NF2) who are deaf or have severe hearing loss using Communication Access Realtime Translation (CART) and/or American Sign Language (ASL).

This will be a substudy of the IRB-approved protocol #2013P002605. It is the same study except it is looking at a particular sub-population: patients with NF2 who are hard of hearing.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Can read and speak English at or above the 6th grade level
3. Patients with NF2 who are deaf or have severe hearing loss.

Exclusion Criteria:

1. Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
2. Recent (within past 3 months) change in antidepressant medication
3. Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months.
4. Unable or unwilling to sign the informed consent documents
5. Unable or unwilling to complete psychological assessments online via the REDCap system.
6. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.
7. Unwilling to use either CART or ASL for communication during the Skype groups.
Predictors of Health Service Utilizations Among Key Population in Washington DC

The primary objective of the proposed study is to investigate how PrEP use might result in an increase in the utilization of health and social services offered at a local community-based organization. Our primary hypothesis is that the investigators will observe higher utilization of sexual health (STI screenings), psychosocial health (psychotherapy, and substance use treatment) and other social services (emergency cash assistance, food pantry, transportation assistance, clothing,and housing resources) among PrEP users (LAI-PrEP or daily oral) compared to participants who are PrEP naïve over the 12-month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* age of 18 years or above;
* confirmed HIV-negative status;
* residence in the Washington, DC metropolitan area;
* one of the following PrEP profiles (PrEP naïve \[no history of any PrEP use in the past\] currently on daily oral PrEP or receiving LAI-PrEP).

Exclusion Criteria:

* being younger than18 years of age
* being unable to speak and/or read English
* a reported residence outside of the defined Washington, DC metropolitan area
* being unable or unwilling to provide written informed consent
* being unable to comply with the requirements of the protocol (i.e. persons with mental health conditions, persons who are intoxicated or incoherent for other reasons)
* evidence of suspected hepatoxicity
Interactive Group Drumming (IGD) in Hospital Experience of Patients Undergoing Hematopoietic Stem Cell Transplant - A Pilot Study

The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the drumming sessions.

The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the drumming sessions.

Eligibility Criteria:
Inclusion Criteria:

* People who are at least 18 years old and are scheduled for HCT
* Individuals must be able to understand and willing to sign a written informed consent form

Exclusion Criteria:

* People who are too ill to participate, i.e., while they are in contact isolation or have low platelets (less than 20,000/mcl) will not participate until their condition has improved.
* Patients receiving outpatient HCT except patients with multiple myeloma. Patients with multiple myeloma may participate in the study even though they tend to spend nights away from the hospital.
Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools

The objectives of this study are:

1. To determine the difference in genetic profiling of subjects with breast cancer recurrence
2. To determine the comprehensive genetic profiling of subjects with late stage breast cancer
3. To determine the potential biomarkers for early detection and prognosis for breast cancer
4. To determine the genetic profiling of immune system in different subtypes of breast cancer

By integrating and analyzing the data generated using the methods of NGS, these information can be used for:

1. Understanding the genetic profiling of different subtypes of breast cancer in Taiwan
2. Assessing the efficacy of different treatments in breast cancer subjects
3. Defining the molecular risk factors and predicting the potential risk of breast cancer recurrence
4. Assessing the immune repertoire and the potential effects of immunotherapy in breast cancer subjects
5. Developing new strategies in treating patients with triple negative or late stage of breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged over 20 years old
* Subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer. However, subjects with breast cancer recurrence at screening will be enrolled if meet both the following conditions:

  1. Subjects had received surgery for primary breast cancer within 3 years prior to screening \[i.e. recurrence within 3 years after surgery (mastectomy or BCS)\];
  2. Subjects diagnosed with stage IV breast cancer beyond 3 years after surgery (mastectomy or BCS) or who had received or are currently receiving treatments for breast cancer. And subjects with primary tumor FFPE tissues available and pass the RNA quality check.
* Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 3
* Life expectancy ≥ 3 months
* Subject agrees to provide the written informed consent. If a subject has breast cancer recurrence within 3 years prior to screening, she will be eligible if she agrees to provide the paired FFPE tissues (primary and recurrent tumors)

Exclusion Criteria:

* Subjects will be excluded if they had primary cancer other than breast cancer within 5 years prior to screening
Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients

The purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery.

To compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients treated with preoperative topical ketorolac tromethamine 0.45%.

To compare the macular thickness changes in diabetic and non diabetic patients treated with preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

Diabetic patient group

1. Type 2 diabetes mellitus with no diabetic retinopathy
2. If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
3. Listed for phacoemulsification cataract surgery

Non diabetic patient group

1. No history of diabetes
2. If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
3. Listed for phacoemulsification cataract surgery

Exclusion Criteria:

1. Smoker
2. Presence of immune disease, local or systemic inflammation
3. Presence of retinal diseases, glaucoma
4. Previous surgical procedure on the eye
5. Intra-operative complications
Gene Expression in Patients With Epiretinal Membranes

The purpose of this study was to investigate the expression of selected genes both in epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Possible correlations between messenger ribonucleic acid (mRNA) levels of these genes were also identified.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian race,
* both males and females,
* aged ≥ 55 years,
* suffering from idiopathic ERMs or secondary ERMs in proliferative diabetic retinopathy (PDR).
* Presence of ERM was proven in optical coherence tomography (OCT) examination.

Exclusion criteria:

* aged \< 55 years,
* systemic connective tissue disease,
* active inflammatory process
Examination of Trends in Multiple Myeloma Trial Patient Experiences

Historically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited.

This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested.

Data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future multiple myeloma patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Patient has been diagnosed with multiple myeloma
* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
* Pregnant, breastfeeding or expecting to conceive within the projected duration of the study
The Global En Bloc Resection of Bladder Tumour Registry

The study aims to collect data on ERBT globally in order to clarify its role in the management of bladder cancer over a 5-year observation period.

Bladder cancer is a prevalent disease globally, and it is the 9th most commonly diagnosed cancer in men worldwide. It has a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. This disease represents a significant burden to the healthcare system.

Bladder cancer is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) according to its depth of invasion. Conceptually, NMIBC is amenable to complete resection by transurethral resection of bladder tumour (TURBT) alone, while MIBC requires more aggressive treatment in the form of radical cystectomy. The gold standard in local staging is by histology, and this can be achieved by TURBT. However, conventional TURBT creates charred tissue chips in a piecemeal manner which may hinder pathologists' judgment of the tumour base clearance. Second-look TURBT has been shown to detect residual disease in 33-55% of the patients, and upstaging of disease in 4-45% of the patients following the first TURBT; it has also been shown to improve recurrence-free survival in patients with T1 non-muscle-invasive bladder cancer. In addition, tumour fragmentation and reimplantation may lead to early disease recurrence. All these highlighted the limitations of the conventional TURBT procedure.

Transurethral en bloc resection of bladder tumour (ERBT) represents a novel surgical technique in which the bladder tumour is resected in one piece. Theoretically, ERBT may prevent recurrence by minimizing the risk of tumour reimplantation and ensuring complete resection based on proper histological assessment. Although ERBT has been practised in many centres worldwide, there is a lack of high quality evidence in proving its superiority over conventional TURBT. Also, the optimal indications, best energy modality, the need for routine tumour base biopsy, intravesical chemotherapy, second-look TURBT and the optimal follow-up protocol remain uncertain for this technique. Therefore, there is a need for a well-planned prospective multi-centre study to evaluate the role of ERBT in the management of bladder cancer.

Investigators propose to conduct a prospective, multi-centre, registry study to expedite understanding of ERBT and to establish its role in management of bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>=18 years old with informed consent
* Presence of bladder tumour undergoing transurethral ERBT

Exclusion Criteria:

* Presence or previous history of upper tract urothelial carcinoma
* Presence of other active malignancy
* Pregnancy
Safety Study in Outpatient Japanese Children With ADHD

Evaluate the safety and efficacy of atomoxetine in Japanese pediatric patients with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 6 - 18 years of age
* Patients must meet DSM-IV diagnostic criteria for ADHD
* Patient must be able to swallow capsules
* Patients must be of normal intelligence
* Laboratory results must show no significant abnormalities

Exclusion Criteria:

* Patients who weigh less than 15 kg or more than 75 kg at study entry
* Patients who have a documented history of bipolar disorder or any history of psychosis
* Patients taking any antipsychotic medication within 26 weeks of visit 1
* Patients with a severe history of allergies
* Patients taking methylphenidate
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis

This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥18 years of age, who has a diagnosis of active UC for at least 6 months prior to screening
* A rectal/colonic biopsy obtained previously and consistent with a diagnosis of UC
* Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
* Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
* Active UC despite previous treatment with at least one 5-ASA compound at a dose of ≥2000 mg/day for at least 4 weeks or documented intolerance to such therapy

Exclusion Criteria:

* Diagnosis of indeterminate colitis, Crohn's disease, or clinical findings suggestive of Crohn's disease (fistula or granulomas on biopsy) or microscopic colitis (collagenous colitis or lymphocytic colitis)
* Subject whose symptoms are likely caused by factors other than inflammatory UC, including infection or irritable bowel syndrome (IBS)
* History of dysplasia on colonic biopsy
* Subject with ≥ 8 year history of pancolitis or ≥ 15 year history of left sided colitis unless a colonoscopy with surveillance biopsies to screen for colon cancer has been performed within the past year
* Subject ≥ 50 years of age who has not had a colonoscopy to screen for colorectal polyps and colon cancer within the past 5 years
* Subject who has had any prior surgical resection of any part of the colon excluding the appendix
* Previous treatment with any biologic product including investigational biologic products within 1 year prior to baseline visit
* The subject is taking Systemic corticosteroids, Azathioprine/6-mercaptopurine/methotrexate, immunosuppressants, Oral 5-ASA compounds unless they have been on a stable dose of sufficient duration prior to Baseline. If recently discontinued the subject must have had a wash-out periods of sufficient duration prior to Baseline
* Rectally administered corticosteroids or 5-ASA, antibiotics for the treatment of UC and probiotics within 14 days of the Baseline Visit and throughout the study
* The subject has with a stool culture positive for pathogenic ova or parasites, enteric pathogens or Clostridium difficile toxin at the Screening Visit
* Presence of, or history of cancer, with the exception of skin cancer
Surgery of Melanoma Metastases After Systemic Therapy

To evaluate if surgical removal of residual disease adds benefit in stage IV melanoma patients with partial response or stable disease after a minimum 9 months of first-line PD-1 inhibition. Primary endpoint: Disease-free survival (DFS) at 12 months.

A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial. Patients with metastatic melanoma, stratified for stage M1a or M1b/M1c, that have received first-line treatment with PD-1 inhibitors for a minimum of 9 months resulting in either partial response or stable disease according to RECIST 1.1 will be eligible. Patients will be screened for operability based on CT-scans examined by a multidisciplinary team, with the criteria that complete (R0) resection of all metastases should be possible. If the multidisciplinary team find that this would be possible, patients will be included and randomized 1:1 to either surgery with continued PD1-inhibition or current standard of care with continued PD1-inhibition only. At progression, treatment will be according to the treating medical oncologist. Active follow-up will be performed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Signed and dated written informed consent before the start of specific protocol procedures
* Biopsy or cytology proven metastatic melanoma stage M1a, M1b or M1c
* Have received a minimum of 9 months of immunotherapy (PD1-inhibitor alone or in combination) resulting in stable disease or partial response according to RECIST 1.1
* Metastases judged to be radically resectable by surgery at a multidisciplinary conference
* ECOG performance status 0-2

Exclusion Criteria:

* Brain metastasis (M1d)
* Previous treatment with BRAF/MEK inhibitors
* Inability to understand given information or undergo study procedures according to protocol
Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)

Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy

Delayed gastric emptying is one of the main complications occurring after pancreatodudodenectomy, the incidence of which is estimated between 10 and 40% in the literature. Its occurrence leads to an alteration in post-operative quality of life (maintenance or resting of the nasogastric tube) and is the primary reason an increase in the length of hospital stay and therefore the cost of treatment. In addition, it predisposes to the risk of inhalation pneumopathy, which increases the risk of post-operative death. Various technical surgical points have been suggested by retrospective studies to reduce its incidence (pyloric preservation, respect for the left gastric vein, ante-colic positioning of the Child's handle, making a Y-shaped handle) but without ever being validated in randomized prospective studies.

Recently three retrospective studies have highlighted the interest of performing a side to side l rather than an end to side gastro-jejunal anastomosis to reduce the rate of post-operative delayed gastric emptying.

Eligibility Criteria:
Inclusion Criteria:

* patient over 18 years old
* to benefit from a cephalic duodenopancreatectomy whatever the indication (benign and malignant tumor)
* affiliated with a health insurance system
* having received oral and written information about the protocol and having signed a free and informed written consent.

Exclusion Criteria:

* associated organ resection except for portal vein or hepatic artery resection.
* history of gastric or esophageal resection
* person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
* pregnant or breastfeeding women
* patient participating in another clinical trial that may interfere with the protocol.