cyrilzakka/clinical-trials huggingface dataset:
Computational Neuroscience of Language Processing in the Human Brain

Language is a signature human cognitive skill, but the precise computations that support language understanding remain unknown. This study aims to combine high-quality human neural data obtained through intracranial recordings with advances in computational modeling of human cognition to shed light on the construction and understanding of speech.

The neural architecture of language is the foundation for the highest form of human interaction. Prior work has identified a network of frontal and temporal brain areas that selectively support language processing, but the precise computations that underlie our ability to extract meaning from sequences of words have remained unknown. The standard approaches in human cognitive neuroscience lack the spatial and temporal resolution necessary for precise comparisons to computational models. To bridge this gap in knowledge, neural responses to language stimuli will be collected from epileptic patients undergoing intracranial monitoring. Overall, these data will be used to identify cortical maps of different linguistic manipulations and to better understand properties of the human language network.

Eligibility Criteria:
Inclusion Criteria:

* clinical indications to proceed with intracranial monitoring involving the left cerebral hemisphere, as determined by a multidisciplinary epilepsy surgery team
* the ability to comply with test directions and provide informed consent
* between ages 18 - 85

Exclusion Criteria:

* inability to understand or perform the task outlined in the protocol, or who are unwilling or unable to participate
The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients

Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases.

Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases. The exercise program will be a total of 6 weeks, 3 days a week. Online access will be carried out synchronously by telephone or computer, and training sessions will not be recorded in order to protect patient personal information. The cases will be evaluated online at the beginning of the study and at the end of the 6-week exercise program. The selected evaluation parameters have been selected considering the ease of online application.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-75
* Being diagnosed with COVID19 and being discharged by being treated
* Having technological facilities suitable for telerehabilitation access

Exclusion Criteria:

* Any presence of comorbidity that may prevent them from exercising
* Not agreeing to be included in the study
Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia

The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, Bipolar Disorder, or Depressive Disorders.
* Have a clinical diagnosis of neuroleptic-induced TD.
* Have moderate or severe TD.
* If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or bipolar disorder, or depressive disorders, be on stable doses.

Exclusion Criteria:

* Have an active, clinically significant unstable medical condition in screening period.
* Have a significant risk of suicidal or violent behavior.
* Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
* Are currently pregnant or breastfeeding.
Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening

Objectives: To examine the effects of linguistically appropriate decision aids on decisional conflicts, risk perception, clarity of values, screening decisions and screening uptake among South Asian women in Hong Kong Design and subjects: A randomised controlled trial. A sample of 270 South Asian women aged 25-64 will be recruited to one of the two intervention groups or control group.

Instruments: A survey will be conducted to collect data on the variables of concern (decisional conflicts, risk perception, clarity of values, screening decision and screening uptake).

Interventions: Ethnically match community health workers (CHWs) will deliver the printed or mobile application decision aids to intervention group participants and briefly explain how to use the decision aid. The participants will choose a time and place of their convenience to read the decision aid. The participants will be contacted by CHWs within 2 weeks and asked if they have experienced any problems. Navigation assistance will be given as requested.

Main outcome measures: Decisional conflicts, risk perception, clarity of values, screening decision and uptake.

Data analysis: The repeated-measure outcomes of risk perception, clarity of values, decisional conflicts and screening decision will be compared between the three groups while adjusting for the stratifying variable (ethnicity) using a generalised estimating equation model, and a multivariable logistic regression with adjustment for ethnicity will be used to compare the screening uptake of the three groups.

Expected results: The decision aid will clarify the participants' values and help them to make screening decisions and increase the uptake.


Eligibility Criteria:
Inclusion Criteria:

1. Indian, Pakistani or Nepalese;
2. aged 25 to 64;
3. no history of cervical cancer or total hysterectomy;
4. have a history of sexual activity;
5. cannot understand Chinese but can read or communicate in English, Hindi, Urdu or Nepali;
6. have not had a Pap/HPV test in the past 3 years;
7. have and are willing to use a smartphone in this intervention.

Exclusion Criteria:

* NA
Brain Computer Interface Control of a Robotic Device

Noninvasive Brain-Computer Interfaces (BCIs) have been used to control a number of virtual and physical objects through the voluntary modulation of brain rhythms. Current issues with noninvasive BCIs include exhausting motor imagery tasks and long training times required to achieve competent control. The investigators will address these issues within this protocol, examining new approaches to reduce the effort required by subjects to control a physical object in the task.

The PI's hypothesis is: Control of a physical robotic device will increase the performance of subjects in BCI tasks that are analogous to virtual tasks due to greater engagement with a physical output.

Subjects will be recruited to participate in controlling a physical robotic device such as a quadcopter or a robotic arm using imagination of movement or other activities as detected by brain waves that can be used to control a robotic device.

The subjects will be able to observe the controlling of a robotics device using one's thought and participate in multiple sessions to learn the skills to better control such a device.

Eligibility Criteria:
Inclusion Criteria:

* Subjects for this study will be healthy, English speaking adult volunteers (18-64 years old).

Exclusion Criteria:

* History of neurological deficit or traumatic brain injury.
Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis

This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.

The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA).

Portions of this study may be completed remotely.


Eligibility Criteria:
Inclusion Criteria:

* Stable and continuous access to internet service at home
* Adequate home facilities (enough space, access to quiet and distraction free area)
* Definite MS diagnosis, subtype relapsing-remitting (RR-MS)
* Disability Status Scale (EDSS) from 1 to 6.5 with clinically significant gait deviations
* Clinically stable and stable on treatment with disease modifying agents at least from 6 months
* Able to independently walk with or without an assisting device (i.e. cane, crutches or walking frames) for medium-long distance
* Absence of other associated medical conditions that would prevent participants from performing physical activity, such as cardiorespiratory and severe osteoarticular disorders
* Able to use study equipment
* Able to commit 10 consecutive daily sessions of tDCS while performing physical program with baseline and follow-up visits
* Able to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

* Visual, auditory and motor deficits that would prevent full ability to understand study, as judged by treating neurologist or study staff
* Primary psychiatric disorder that would influence ability to participate
* Receiving current treatment for epilepsy
* Uncontrolled headaches and migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded
* History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
* Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
* Treatment for a communicable skin disorder currently or over the past 12 months
* History of uncontrolled or labile hypertension
* Other serious uncontrolled medical condition (e.g. cancer or acute myocardial infarction)
* Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score \< 85
* History of clinically significant abnormalities on electrocardiogram (EKG)
* Presence of chronic medical illness and/or severe ataxia
* Botulinum toxin injection within the past 4 months or functional surgery in the past 6 months
* Alcohol or other substance use disorder
* Pregnant or breastfeeding
Personalized Sequence for Thoracic, Esophageal, and H&N Cancer

The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.

To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling.

Eligibility Criteria:
Inclusion Criteria:

* metastatic, histologically confirmed NSCLC, head \& Neck Cancer, Esophageal cancer

Exclusion Criteria:

-
Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Cystic Fibrosis
* FEV1 at screening must be between 25 and 75 percent of normal predicted values for age, sex and height based on the Knudson equation
* Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or bronchoalveolar lavage within 6 months prior to screening and in the sputum/deep-throat cough swab culture at screening

Exclusion Criteria:

* History of sputum culture or deep cough throat swab culture yielding Burkholderia cenocepacia complex within 2 years prior to screening and /or sputum culture yielding Burkholderia cenocepacia at screening
* Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
* History of hearing loss or chronic tinnitus deemed clinically significant
* Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
* Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal antibiotic
* Any use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to study drug administration
* Use of loop diuretics within 7 days prior to study drug administration

Other protocol-defined inclusion/exclusion criteria may apply.
Breathing Adapted Radiotherapy for Mediastinal Lymphoma

In this study, radiation therapy plans will be made for 20 consecutive patients with mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphoma. One plan is done using a breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan and another plan is done using the standard procedure with pre-chemo PET-CT fused with post-chemo planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in each patient. The best radiation therapy plan will be used to treat the patient.

Radiotherapy using a breathing adapted therapy scan is a routine technique in breast cancer. Breathing adapted radiotherapy may also reduce radiation dose to organs at risk, e.g. heart and lung, in patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas.

Optimal radiation therapy of these lymphoma patients includes radiotherapy planning using pre-chemotherapy PET-scanning, fused with a post-chemo planning CT-scan. This makes accurate treatment of pre-chemo involved volume possible and also accurate radiation of the post-chemo involved volume possible. Thus, the optimal breathing adapted radiation requires planning using a breathing adapted pre-chemo PET-CT scan fused with a breathing adapted post-chemo planning CT scan. In this study, 20 consecutive patients with mediastinal Hodgkin lymphoma and aggressive non-Hodgkin lymphomas will have combination therapy with chemotherapy and radiation therapy to involved nodes. Two radiation therapy plans will be made for each patient: one using a breathing adapted pre-chemo PET-CT scan fused with a post-chemo planning CT scan, and one using the standard procedure of a pre-chemo PET-CT scan fused with post-chemo planning CT scan. Dose levels to the lymphoma and to the organs of risk will be compared in each patient. The best radiation therapy plan will be used to treat the patient.

Eligibility Criteria:
Inclusion Criteria:

* Stage I/II mediastinal Hodgkin lymphoma or aggressive non-Hodgkin lymphomas
* Treatment plan includes radiotherapy

Exclusion Criteria:

* Not able to comply to breathing adapted therapy
Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Background

Despite the low prevalence of serious complications associated with non-steroidal anti-inflammatory drugs (NSAIDs) use, there is a widespread use of gastroprotective proton pump inhibitors (PPIs) in order to prevent adverse effects. Inappropriate prescribing of PPIs includes overprescribing for inappropriate indications and the misuse of first choice in their class in terms of efficacy, safety and cost. A series of recommendations, based on the best available scientific evidence, has been established to justify prophylaxis with PPIs associated to NSAIDs. Therefore, there is the need to encourage the incorporation of this knowledge to guide decisions of physicians with the objective of improving patient health and sustainability of the Public Health Service. Although since long ago there is a great concern regarding rational use of drugs, the available evidence for the most appropriate strategies to improve prescribing is scarce. Passive dissemination of research findings are generally ineffective and at best result in small changes in practice. Multifaceted intervention targeting different barriers to change are more likely to be effective than single intervention.

Objectives

The objective of this study is to evaluate the effectiveness of two educational multifaceted strategies aimed at improving PPIs prescription associated to NSAIDs use in primary care. We will also compare the cost-effectiveness of such strategies.

Hypothesis

It is hypothesized that a quality improvement intervention directed to primary care physicians will decrease inappropriate PPIs prescriptions associated to NSAIDs prescription.

Methodology

A three-arm prospective quasi-randomized controlled trial will test the effectiveness of two strategies for improving PPI prescription associated to NSAID in primary care context. Three of the Canary Islands will be selected and randomized to either a experimental multifaceted intervention (group education+audit-feedback+CCDSS) group, a experimental multifaceted intervention (audit-feedback+CCDSS) group, or a control group (usual intervention). From each of these islands, 6-8 primary care centers will be randomly selected to received the intervention practices. All family physicians working at each randomly selected primary care center were mandatorily included. Primary outcome measure is reduction of inappropriate PPI prescription. The efficacy of the intervention will be examined within a 3, 6 and a 12 month follow up.


Eligibility Criteria:
Inclusion Criteria:

* Primary care physicians

Exclusion Criteria:

* Participating as a subject in any other clinical research study
* Have received any other intervention on the subject within the last 6 months
Does ACL Augmented With LEAT Better Controls Rotational Laxity Than Isolated ACL Reconstruction?

It has been suggested that adding a Lateral Extra-Articular Tenodesis (LEAT) to Anterior Cruciate Ligament (ACL) reconstruction has the advantage of better controlling the rotational laxity. The objective of this study is to compare the the sagittal and rotational knee laxity using the Porto Knee Testing Device (PKTD) - a MRI-compatible arthrometer - at 2 years follow-up (side-to-side and to baseline comparison) in patients that underwent isolated ACL reconstruction (isolated ACL) versus ACL reconstruction combined with LEAT (ACL+LEAT). Patient-reported outcome measures using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and graft failure (re-tear) will also be assessed at 2 years follow-up.

This study is a non-randomized clinical trial including 40 patients with anterior cruciate ligament injury who are undergoing surgery and will be allocated 1:1 to either isolated ACL reconstruction (control group) or ACL reconstruction combined with lateral extra-articular tenodesis (experimental group). The principal outcome of this work is the sagittal and rotational knee laxity analysis and side-to-side and 2-year improvement. The secondary outcomes include graft failure (re-tears) and the patient-reported outcome measures (KOOS) at 2 years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* no previous knee surgeries
* contralateral healthy knee
* positive pivot-shift (++)

Exclusion Criteria:

* revision ACL surgery
* ACL reconstruction using allograft or synthetic grafts
* multi-ligament injury
* pregnant female
* other injuries or conditions that may alter the knee function (eg. severe osteoarthritis)
* requiring concomitant osteotomy
* requiring concomitant cartilage surgery (other than debridement)
A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder

This trial is comprised of a 4-week randomized, double-blind, placebo-controlled treatment period followed by an optional 8-week open-label extension (OLE) period.

This trial will evaluate the efficacy and safety of oral PRAX-114 flexibly dosed at 40 to 60 mg for 4 weeks compared to placebo in adults with PTSD. The OLE period consisting of treatment with 40 mg PRAX-114 for 8 weeks will provide additional efficacy and safety data.


Eligibility Criteria:
Inclusion Criteria:

1. DSM-5 diagnosis of PTSD with duration \>6 months, as confirmed by psychiatric evaluation.
2. CAPS-5 total score ≥30 at Screening and Baseline.
3. Body mass index (BMI) of 18 to 38 kg/m2.

Exclusion Criteria:

1. Experienced the index traumatic event before age 16.
2. Has an active legal, worker's compensation, or disability claim for PTSD.
3. Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive-compulsive disorder or a history of a psychotic mood episode in last 2 years.
4. HAM-D17 score of \>18 at Screening or Baseline.
5. Any current psychiatric disorder (other than PTSD).
6. Lifetime history of seizures, including febrile seizures.
7. Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.