cyrilzakka/clinical-trials huggingface dataset:
Investigating the Effect of Training With a Virtual Reality Driving Simulator

The proposed study aims to investigate the use of a driving simulator in a virtual reality (VR) environment to improve the cognition state and spatial navigation of individuals with mild/moderate memory impairment.

All volunteers will be assessed by the Montreal Cognitive Assessment (MoCA),Montgomery-Asberg Depression Scale (MADRS) and Morris Water orientation tests for baseline assessment after they sign the consent form and are enrolled into the study. Participants will also be scheduled for post-intervention assessments (MADRS, Morris Water Orientation and a simple questionnaire on how they evaluate the experiment).

Participants of the study will play the driving simulator daily (5 days/week) for 15-20 minutes/day over a period of 2 consecutive weeks. Participants' daily performance data are recorded and uploaded on the secure server of the Priciple Investigator (PI).

Simulator Sickness Questionnaire (SSQ) test will also be run after the first session of the experiment and at the end of the training period.

After obtaining their consent and enrolling into the study, participants of the study will commit themselves to use the driving simulator daily (5 days/week), and 15-20 minutes/day for a period of 2 consecutive weeks. The location for these simulation sessions will be one of the Family rooms of the Lindenwood Retirement Community. During the experiment, the research assistant (RA) of the study will be present and monitor participants for any plausible simulator sickness. In case if a participant presents any simulator sickness symptom, the experiment will be stopped and the RA will remain with the participant until s/he feels alright to go back to his/her room or with a caregiver. The RA and PI may withdraw the participant from the study if it is for their benefit.

Participants' performance data and the duration of which they practice are all being recorded and uploaded on the secure server of the PI. After the end of the 2-week exercise program, participants will be assessed again by Morris Water orientation test, SSQ, and MADRS; SSQ test will also be run after the first session of the experiment.

Furthermore, their feedback about using the driving simulator will be collected through a

Eligibility Criteria:
Inclusion criteria:

We will recruit up to 30 volunteers with mild/moderate memory impairment. Inclusion/Exclusion Criteria

* Age: 50+ years
* Have a score of 7\< MoCA \< 25
* Except the MCI/Alzheimer's diagnosis, have no known or diagnosis of major depression, bipolar disorder, schizophrenia, mood disorder, Parkinson's disease, Huntington disease, Amyotrophic Lateral Sclerosis (ALS), Multiple sclerosis (MS), and/or any other neurological disorder.
* Fluency in reading/understanding English

Furthermore, in this study we do not need to label participants as healthy or demented; we only use the MoCA range between 7 to 25 to enroll participants. Many healthy adults do have some memory impairments and have a MoCA score less than 25 but still consider themselves healthy. Thus, we do not label anyone in this study as healthy or demented.
Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation

Using a randomized controlled design, standard treatment of group cognitive-behavioral therapy (CBT) according to the Hesslinger protocol is compared to a newly developed group treatment specifically designed for adult patients with ADHD inattentive presentation (ADHD-I) called CBT for ADHD-I (CADDI). Research setting is psychiatric outpatient clinics. Research hypotheses include: 1. The CADDI protocol is more effective than standard treatment in terms of behavioral activation, procrastination, depressive symptoms, functional impairment, and quality of life, 2. Is equally effective in terms of ADHD symptoms, 3. Is more appreciated and tolerable, and 4. Outcome is mediated by mindful awareness. Effects are followed up at 6 and 12 months post treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Principal diagnosis of ADHD inattentive presentation
2. 18 years of age or older
3. If on medication, it needs to be well-established since three months, and
4. Prior psycho-educational intervention

Exclusion Criteria:

1. Intellectual impairment
2. Substance use disorder
3. Difficulties in adherence to medical or other treatment
4. Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or
5. Simultaneous psychological treatment
Trial of VLTS-589 in Subjects With Intermittent Claudication

The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.


Eligibility Criteria:
Inclusion criteria:

* Men or women between 40 and 80 years of age,
* Must give informed consent,
* Current medical history of peripheral arterial disease, which includes the following symptoms: leg pain, leg discomfort or leg weakness

Exclusion criteria:

* Ulcers or gangrene,
* History of cancer (except skin cancer) within the past 5 years,
* Participation in another clinical trial within 30 days of enrollment in this trial,
* Unwillingness or inability to comply with all study requirements
A Multicenter Randomized Placebo-Controlled Double-Blind Study to Assess Efficacy and Safety of Glutamine and Creatine Monohydrate in Duchenne Muscular Dystrophy (DMD)

To establish a collaborative group of clinical trial centers, with standardized equipment and protocols, able to conduct both drug and gene therapy trials in DMD. To evaluate the therapeutic effect of glutamine and creatine monohydrate on muscle strength in children with DMD. To validate the use of QMT (quantitative muscle strength testing) and gait analysis in children with DMD as reliable tools to quantify muscle strength, monitor disease progression and assess therapeutic response.

Duchenne muscular dystrophy (DMD) is the most common lethal inherited disorder worldwide. Despite the exponential increase in our understanding of the disorder since the discovery and characterization of the causative gene and its product dystrophin in 1987, current therapeutic management remains largely supportive. Awaiting a final genetic cure to be available in the future, further investments in developing better drug therapies for DMD remain important. Not only because the uniform use of prednisone (the only drug proven to be beneficial) is hampered by potential adverse effects, but also because it may very well be the case that ultimately a combination of both gene and drug therapy will be needed to cure Duchenne children. Here, we test two compounds that have shown promise in a 45-drug screen in the mdx mouse model of Duchenne dystrophy.

The effect of glutamine (0.6/kg/day) and creatine monohydrate (5g/day) on muscle strength will be evaluated in a multi-center randomized double-blind placebo-controlled 3-arm study. Ambulant children aged 5-10 years with an established DMD diagnosis will be studied. Patients will undergo 2 screening evaluations within 2 weeks. Patients will be randomized into treatment groups on the second screening visits, followed by a 6-month treatment period. During the treatment period, patients will be evaluated at monthly intervals. The primary endpoints are percentage change in average muscle strength score and QMT performance for specific muscle groups. Secondary endpoints include timed function tests, functional grades for arms and legs, and pulmonary function tests.

Eligibility Criteria:
Ambulant children age 5-10 years with an established diagnosis of Duchenne Muscular Dystrophy
Reducing Children's Racial Biases Via a Parent-Led Intervention

The goal of this clinical trial is to test a parent-led program for reducing children's racial biases in White families. The main question it aims to answer is: With training, can parents effectively address their children's racial biases? Parent will receive training and tools for addressing their children's racial biases. Researchers will study effects on both parents' and children's racial biases.


Eligibility Criteria:
Inclusion Criteria:

* The child is 5.00 to 7.99 years of age
* The child participant and their parent are both non-Hispanic White

Exclusion criteria are:

* Non-proficiency in English on the part of the parent or the child
* The parent is \<18 years old
* The child or parent identifies with another racial/ethnic identity in addition to White
Survey: COVID-19 Patients Managed in the Operating Theatre of Belgian Hospitals

COVID-19 pandemic has an important impact on the health care provided by the anesthesiologists. Different societies of anesthesiology have provided guidelines and recommendations on how to manage patients who have been tested positive for COVID-19 or suspected to be infected. It is therefore important to know whether these guidelines have been implemented or were possible to be implemented. Otherwise patients who are presenting COVID-19 often show pulmonary complications. The airway management and the ventilation management of these patients can be therefore challenging and can possibly influence their outcome. It is thus important to obtain a large database with information about the characteristics of these patients, how these patients have been managed and their in-hospital outcome. Information regarding the correct implementation of guidelines is as well necessary for future guidance of health care providers.


Eligibility Criteria:
Inclusion Criteria:

* All patients (pediatric/adults/parturients) who are tested positive for COVID-19 or who are suspected to be infected

Exclusion Criteria: No oral consent

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Empowering Cancer Survivors Through Information Technology

This is a randomized controlled trial of a web-based informational intervention (UMFollowUp) for adolescent and young adult survivors of childhood cancer to improve cancer knowledge and psychosocial functioning.

Individuals randomly assigned to the control group will receive standard of care for the duration of their participation. This means they will continue to receive information regarding their diagnosis, treatments and ongoing health needs from their provider (no access to website).

Individuals randomly assigned to the treatment group will receive access to UMFollowUp, a secure, HIPAA-compliant website.

All participants will be asked to complete paper-and-pencil surveys at baseline and 9 months later to determine the impact of the web-based intervention.

Eligibility Criteria:
Inclusion Criteria:

* History of diagnosis of hematologic malignancy or malignant neoplasm, and in disease free remission at time of recruitment.
* Must be English-speaking and have access to a computer with internet access, and must have completed treatment at University of Minnesota Medical Center-Fairview for cancer.

Exclusion Criteria:

* Individual with significant visual impairments and neurologic/cognitive difficulties which limit their ability to see and under our outcome questionnaires or website content will be excluded from participation.
Urolithin A Supplementation to Boost Immune Health

To show that a natural mitophagy activator (Urolithin A) given orally can modulate mitochondrial activity in immune cells in healthy adults and this results in better immune function


Eligibility Criteria:
Inclusion Criteria:

Healthy Adults that do not suffer from an uncontrolled chronic medical condition that carries metabolic consequences (as assessed by the study physician)

* BMI\<35kg/m2
* Provide informed consent
* Adults aged 45-70 years, both genders
* Subjects who have not received any systemic immunosuppression in the past 6 months
* Subjects with any medical condition that in the opinion of the investigators would compromise the study outcome or the safety of the research participant

Exclusion Criteria:

Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;

* Clinically significant abnormal laboratory results at screening
* Participation in a clinical research trial within 30 days prior to randomization
* Allergy or sensitivity to study ingredients
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Any condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
* Current gastrointestinal condition which could interfere with the study (e.g. IBS/IBD, diarrhea, acid reflux disease, dysphagia etc.);
* Excessive alcohol consumption and/or a smoker
* Concomitant use of statins
* Engage in regular moderate or vigorous physically activities (i.e. Category 3 as per the IPAQ activity classification)
* Concomitant use of corticosteroids, antibiotics, any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs), immune-boosting(Vitamin C, Zinc) or mitochondrial (COQ10, NAD+) supplements within 45 days prior to screening
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332

The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are classically healthy having no clinically relevant abnormalities. No known or suspected hepatic impairment
* Stable hepatic impairment that meets the criteria for Class B of the Child-Pugh Classification

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
* Participants who have been vaccinated with COVID-19 vaccines within the past week of dosing
* A positive urine drug test, for illicit drugs, at Screening
* History of sensitivity reactions to ritonavir or any of the formulation components of PF-07321332 or ritonavir.
* eGFR \<60 mL/min/1.73m2 based on the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥ upper limit of normal (ULN) (for healthy participants); AST or ALT \> 5x ULN (for hepatic impairment participants)
* Albumin \> ULN (for healthy participants);
* Prothrombin time \> ULN (for healthy participants);
* Total bilirubin level ≥1.5 × ULN \[NOTE: Participants with a history of Gilbert syndrome (and hence elevated total bilirubin) are eligible provided direct bilirubin level is ≤ ULN).
Study on Ultrapro vs Polypropylene: Early Results From a Multicentric Experience in Surgery for Hernia

With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to investigate the benefits in terms of incidence of pain and discomfort, improvement in the quality of life for the patient after the use of the newly introduced semi-absorbable prosthesis (ULTRAPRO® meshes) compared with the prosthesis of totally nonabsorbable material (conventional meshes in polypropylene "Prolene®"), and in terms of the costs for the hospital, the National Health System (NHS), and the society of associates for the use of the ULTRAPRO® in inguinal hernia surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* Males and females
* Adults over 18
* All primitive inguinal hernia

Exclusion Criteria:

* Emergency surgery
* Impossibility to complete the follow-up
* Patients with acquired immunodeficiency symptoms
* Patients with relapsed inguinal hernia
Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients

This is a randomized,controlled,prospective phase III clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
* Clinical stage III\~IVb(UICC/AJCC 7th)
* No distant metastasis
* Karnofsky Performance Status Scale≥70
* WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L
* ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN, Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
* Sign the informed consent.

Exclusion Criteria:

* Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
* Younger than 18 years old or older than 70 years old
* Are receiving other drugs treanment
* kidney disease
* Have suffered from other tumor or now suffering from other tumor
* Have recieved chemotherapy or radiotherapy
* Pregnancy or lactation
* unstable heart disease need timely treatment
* Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
Enhanced Tuberculosis Case Detection Among Substitution Treatment Patients

The purpose of this study was to determine the prevalence of latent tuberculosis infection among injecting drug users and to conduct randomized controlled trial to evaluate a case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program in Estonia.


Eligibility Criteria:
Inclusion Criteria:

* Participation in substitution treatment program,
* Age 18 years or more,
* Able to read and write in Estonian or Russian,
* Able to provide informed consent
B-Fit Intervention to Improve Brain Health

An accumulating body of research indicates that activities such as exercise, active cognitive and social engagement, good sleep hygiene, stress reduction and proper nutrition are associated with the maintenance of cognitive health. Emerging data also suggests that healthy lifestyle behaviors may promote brain plasticity. Despite nationwide efforts to raise public awareness about brain health, there remains a gap concerning how to best promote behavioral change and help at-risk middle-aged and older adults adopt effective, evidence-based brain health behaviors into their everyday lives to maximize cognitive health. The objective of this study is to evaluate the efficacy of a 7-week group brain fitness intervention (B-Fit) for increasing preventative brain health behaviors and enhancing cognitive health in participants at-risk for cognitive impairment. We will also examine mechanisms of action of the B-Fit intervention through tracking of behavioral responses in the real-world environment using wearable sensors.

Participants will be middle-aged and older adults. Participants will be randomized to one of three conditions (B-fit, education only, wait-list). Outcome measures will be administered at baseline, post-treatment and at a one-year follow-up. Participants will also be asked to wear an actigraph for 7 days at baseline, post intervention and follow-up. One or two clinicians will lead the intervention groups, which will each have 8-12 group members. Both the B-Fit and education control conditions will meet 2 hours per week for 7 weeks. Participants in both conditions will receive identical educational materials provided in the form of weekly learning packets and presented to the group by the study clinician(s). At the first meeting, group members will be presented with an overview of the brain, cognitive aging, mild cognitive impairment, and dementia. Each subsequent group meeting will cover a specific topic. The topics will be presented to all groups in the following order: cognitive engagement, exercise and cardiovascular risk factors, nutrition, social engagement, sleep and stress reduction, and compensatory strategy use. The control condition will include presentation of the educational materials followed by expanded discussion about the materials among group members. In contrast, each meeting of the B-Fit intervention will follow a highly structured format. The format is designed to aid participants in identifying and setting realistic and valuable individualized brain health goals and in obtaining group support through problem-solving, modeling and encouragement.

Eligibility Criteria:
Inclusion Criteria:

* Age 40+ (midlife and older adults)

Exclusion Criteria:

* Adults under the age of 40
* Adults who meet criteria for dementia
* Adults who cannot provide own informed consent
* Adults who cannot complete assessments or participate in the intervention protocols due to vision, hearing, communication or other difficulties
* Adults unable to read and comprehend information in English.
Constitution of Cerebrospinal Fluid and Blood Database/Specimen in Acute Stage of Subarachnoid Hemorrhage (aSAH) Patients

Neuropeptide Y (NPY) may play a major role in the pathophysiology of aneurysmal subarachnoid hemorrhage (aSAH). To investigate the correlation of NPY in cerebrospinal fluid (CSF) and blood (serum) and the neurological outcome in the acute stage of aSAH.

Evaluation of Neuropeptides in CSF and serum in SAH patients

Eligibility Criteria:
Inclusion Criteria:

* spontaneous or aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

* age younger than 18 years or older than 70 years
* inflammatory disease
* history of former SAH
* no ventricular drainage