cyrilzakka/clinical-trials huggingface dataset:
Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV

The objectives of this first-in-human is to evaluate the safety and the immunogenicity of three administrations of a bivalent vaccine candidate against human cytomegalovirus, at three different dose levels.

Hookipa Biotech AG is developing a replication-deficient lymphocytic choriomeningitis virus (rLCMV) vector platform. HB-101 is a bivalent vaccine containing two recombinant, replication-deficient lymphocytic choriomeningitis virus (rLCMV) vectors, one expressing the pp65 protein of the human cytomegalovirus (HCMV) and one expressing the gB protein of human cytomegalovirus (HCMV).

This Phase 1 will enroll three successive cohorts of 18 healthy volunteers. Each cohort will receive either a low dose, a middle dose or a high dose of the vaccine (n=14 volunteers), or placebo (n=4). A DSMB will review the safety data for the low dose cohort, before progressing to the middle, and so before high dose. Eight DSMB meetings have been planned for the whole study.

The subjects will be followed up to 12 months post first administration.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or female, aged 18-45 years, in good health.
* Negative for HCMV
* Body mass index between 19 and 32 kg/m²
* Willing to forego receipt of other routine vaccinations (with the exception of seasonal influenza vaccination) for five months after study entry.
* For female volunteers: use of effective birth control for at least 2 months prior to study entry and willing to use effective birth control measures up to the Month 12 visit
* Comply with the requirements of this protocol (e.g. return for follow-up visits), as judged by the Investigator.

Exclusion Criteria:

* Works as a childcare provider.
* Pregnant or breastfeeding woman.
* Any screening safety laboratory value that is 2 times above the upper limit of normal value.
* Any confirmed or suspected immunodeficiency or autoimmune disorder.
* Treatment with any chronic immunosuppressive medication or other immuno-modifying drugs within 6 months prior to study entry. However, inhaled and topical steroids are allowed.
* Any vaccination other than for seasonal influenza within 3 months prior to study entry.
* Previous vaccination with an investigational HCMV vaccine.
* Receipt of blood, blood products and/or immunoglobulins within 3 months prior to study entry.
* History of severe allergic reactions and /or anaphylaxis
* Allergy to any component of the vaccine preparation.
* Expected to be unavailable to complete study follow up.
* Tested positive for HIV, HBsAg and/or anti-HCV.
* Participating in another clinical trial.
* Subject with a rash, dermatological condition or tattoos in the area of the injection site, as these may interfere with administration site reaction rating.
A Personalized Reminder Information and Social Management System

Although technology offers great potential for enhancing the health and well-being of older adults, robust studies are needed to quantify the value of technology and further the investigators understanding of barriers to technology access among older adults and of strategies that are effective in removing these barriers. This cross-site randomized field trial will evaluate a simple to use Personalized Reminder Information and Social Management System (PRISM) designed to support social connectivity, memory, skill building and resource access for older adults. The PRISM system (PRISM C condition) will be compared to an notebook information control condition (PRISM B condition). The target population is older adults who live at home alone and are at risk for isolation. The goal of the study is to gather systematic evidence about the value of technology for older adults and to identify factors that affect use and usability, acceptance and technology adoption. The investigators will also gather longitudinal data on the benefits of the system. Participants aged 65 - 85 years (100 per site) will be randomly assigned following baseline assessment to one of two conditions: PRISM C condition where participants receive the technology system or the PRISM B condition only control where participants receive a notebook that includes information similar to that provided in PRISM C (e.g., resource guide). The categories of information provided in the notebook is similar to the features provided on the system. Participants will include males and females who do not have a home computer and who have limited Internet experience. The intervention period is 12 months. A battery of measures that includes demographic information, attitudes towards technology (including computer self-efficacy and computer comfort), technology, computer and Internet experience, functional independence and well-being, emotional well-being social support/isolation, and quality of life will be administered at baseline, and 6 and 12 months post randomization. In addition, the investigators will assess cognitive abilities at baseline and twelve months. The investigators will also gather data regarding technology use and social interactions via a brief telephone interview at 18 months post randomization.


Eligibility Criteria:
Inclusion Criteria:

* 65+ years
* Live alone in the community in an independent residence
* Minimum computer and Internet use in the past three months
* English speaking
* Able to read English at the 6th grade level
* Has a telephone
* 20/60 Vision with or without correction
* Not employed or volunteering more than 5 hrs/week
* Does not spend more than 10 hrs./week at a Senior Center or Formal organization
* Planning to remain in the area in same living arrangements for duration of intervention period

Exclusion Criteria:

* Blind or deaf
* Cognitively impaired (MMSE) \< 26
* Fuld Object Memory Test \< 20 or 19
* Terminal illness
* Severe motor impairment
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis

To investigate the effect of CoDuSe balance training and step square exercises on the risk of falls in multiple sclerosis. BACKGROUND: risk of fall \& balance disabilities are considered serious problems in multiple sclerosis which results in loss of balance \& physical inactivity.

.........HYPOTHESES:

This study hypothesized that:

CoDuSe balance training and step square exercises will have a significant effect on the risk of falling in multiple sclerosis

RESEARCH QUESTION:

Is there an effect of CoDuSe balance training and step square exercises on risk of fall in multiple sclerosis?

Fifty-two patients with multiple sclerosis will participate in this study.

The patients will randomly be divided into two equal groups; the control group which received the conventional selected exercise program and the study group received the same exercise training program in addition to CoDuSe balance training and step square exercises, three times per week for four weeks.

The Evaluation will done pre and post interventions included:

Biodex balance system (Risk falling), Short Physical Performance Battery (SPPB) \& Morse Fall Scale.

Eligibility Criteria:
Inclusion Criteria:

* Fifty-two Remitting-relapsing multiple sclerosis RRMS patients,
* Age will range as (20:40) years old
* Illness duration not more than 10 years,
* with no relapses over the past three months,
* body mass index (25:35)

Exclusion Criteria:

* difficulty to communicate or to understand program instructions
* any other neurological deficits or orthopedic abnormalities,
* secondary musculoskeletal complication
* peripheral vestibulopathy, hepatic, renal, hemopoeitic, thyroid and cardiovascular diseases, cognitive dysfunction,
* hearing deficits, epilepsy or EEG abnormalities
Cognitive Flexibility Training for Persistent Pain: Neuroimaging Pilot (COFLEX-i)

To determine whether a 5-week computer-based cognitive training intervention results in changes in resting-state functional connectivity (rsFC) within the brain networks.

This project is a single-center prospective pilot study to assess whether cognitive flexibility training through a Lumosity®-based training module over the course a five week timeframe in patients with chronic hip, knee, and back pain results in detectable changes in resting-state functional connectivity (rsFC). The investigators will explore changes in rsFC particularly within the default mode (DMN), frontoparietal (FPN), and cingulo-opercular (CON) brain networks.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 to 70 years old with chronic hip, knee or back pain for \>3 months
* Documented moderate to severe chronic pain
* English fluency
* Access to a computer at home and an email account

Exclusion Criteria:

* Lack of email/lack of basic computer skills
* Diagnosed Alzheimer's or documented severe cognitive impairment
* Severely impaired vision or color blindness
* Unable to complete cognitive testing
* An interventional pain procedure within one week prior to enrollment testing
* Scheduled to undergo a pain procedure during the five weeks of cognitive training
* Self-reported claustrophobia
* Contraindication to an MRI scan (i.e. presence of metallic foreign body such as an artificial joint or aneurism clip, implanted pacemaker or spinal cord stimulator)
Virtual Reality Training for Heart Rate Variability and Recovery Heart Rate

To determine effects of VR training on Heart Rate Variability (HRV), Recovery Heart rate (RHR), Rate Pressure Product (RPP) and Rate of Perceived Exertion (RPE) in sedentary Individuals. Sedentary behavior is a significant public health concern associated with various chronic diseases and reduced quality of life. By elucidating the potential of virtual reality training as an innovative approach to promote physical activity and improve cardiovascular health, this research contributes to addressing the growing burden of sedentary lifestyle-related health conditions.

Virtual reality (VR) training in cardiopulmonary rehabilitation (CR) offers an innovative approach to traditional exercise programs by incorporating enjoyable activities. Utilizing VR enhances cardiopulmonary endurance training and promotes the beneficial effects of CR by engaging patients in fun and challenging activities. This approach aims to increase motivation and adherence to CR over an extended period, resulting in improved mental and physical outcomes compared to conventional CR programs

Eligibility Criteria:
Inclusion Criteria:

* Sedentary Individuals (IPAQ-short version) \< 3.3 METS daily
* Daily sitting time≤7 hours

Exclusion Criteria:

* Decline Consent
* Known cases of systemic or Cardiovascular Diseases.
* Obese (Asian BMI) \> 29.9
* Any contra-indication to exercise/ Pregnancy
Effectiveness of a Multidisciplinary Treatment and Structured Education Programme

This trial compared an structured education programme and multidisciplinary treatment vs an standard treatment in type 1 diabetes patient, the Primary outcome is glycemic control at 6-month follow up and secondary outcome are cardiovascular risk factors control, diabetes related distress, anxiety and depressive symptoms, hypoglycemia awareness.

Both groups will received individualized treatment in the clinic, the intervention group will consist of 12 educational sessions during 4 months, and multidisciplinary treatment each month given by endocrinology, nutrition and psychology during 4 months, the control group will received education in outpatient clinic of endocrinology and will be sent as referral to specialties of nutrition and psychology as standard follow-up of the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Diabetes duration \>1 year
* BMI 18.5-40kg/m2
* A1c 6.5-13%

Exclusion Criteria:

* Pregnancy
* Dementia or severe cognitive impairment
* Uncontrolled psychiatric disorder
* Absence of \>20% of the educational sessions
Hippocampus Avoidance PCI vs PCI

Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low. However, a clear relationship between radiation dose and damage to the hippocampal stem cells has not been established yet.

This study is initiated to investigate the early and delayed neurotoxicity of PCI and to assess in a randomised design the benefits and risks of sparing the hippocampus in Small Cell Lung Cancer patients who receive PCI.


Eligibility Criteria:
Inclusion Criteria:

* - Small Cell Lung Cancer patients (stage I-III or stage IV without clinical or radiological evidence of brain metastases) candidate for PCI, i.e. without progressive disease after chemo-radiotherapy in stage I-III or after a remission after chemotherapy in stage IV
* Sufficient proficiency in Dutch

Exclusion Criteria:

* Prior radiotherapy to the brain
* Clinical evidence for brain metastases or primary brain tumors- Evidence of progressive extracranial metastatic disease
* Previous malignancy \< 2 years ago except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
* Any systemic anticancer treatment during PCI or within 3 weeks before start PCI
* Pregnancy or lactation
Schizophrenia for "Life" - a Registry and Interview Study Among Elderly With Lifelong Schizophrenia

The elderly demographic is on the rise - and this includes elderly living with schizophrenia. Yet very little is known about their lives, how they cope with their condition and how it develops over time.

Research in this patient-group is sparse; overall there seem to be a tendency for elderly patients to manifest fewer psychotic symptoms and experiencing an increase in the psychological quality of life with older age. Opinions are divided on the degree and extent to which this tendency reflects remission and/or recovery in older patients.

In order to identify factors associated with a positive outcome we:

* Investigate the course and the outcomes of the illness over the lifespan, as well as the life course and outcomes.
* Investigate the current status of mental and physical health, quality of life as well as functional competence of elderly (55+ yr) with schizophrenia.

Also the investigators

- Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type 1 diabetes (a chronic somatic illness).

This study will yield vital insights into how schizophrenia develops over time, isolating factors that determine how well patients fare. The perspective is to advance knowledge of elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the interventions offered to this group.


Eligibility Criteria:
Inclusion Criteria:

Initial schizophrenia diagnosis between the ages 18-40 (both incl) in the period 1970-1979 (both incl) Interview study: Residence in Region of Southern Denmark

Exclusion Criteria:

Interview study: Mental retardation

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Gao's Triple Eversion Carotid Endarterectomy

Carotid endarterectomy (CEA), an important surgical approach for managing carotid plaque, has evolved over more than 70 years but still cannot be applied to all tandem carotid lesions (TCLs) because of the wide range of these lesions. Herein, the investigators introduce an innovative CEA, Gao's triple eversion CEA (GTE-CEA), for the treatment of TCLs.

The investigators retrospectively reviewed the charts of patients who underwent GTE-CEA performed by the same group of vascular surgeons since 17 September, 2021. Patients who did not meet the diagnostic criteria for carotid artery stenosis (CAS); those with asymptomatic CAS \< 50%, preoperatively confirmed by digital subtraction angiography (DSA) or computed tomography angiography (CTA); and those with stenosis at the opening of the common carotid artery (CCA) were excluded from our study.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for TCL stenosis.
* Above 70% asymptomatic CCA and ICA stenosis or \> 50% symptomatic CAS confirmed by DSA or CTA before surgery

Exclusion Criteria:

* Did not meet the diagnostic criteria for CAS
* Asymptomatic CAS \< 50% (as confirmed by DSA or CTA before surgery)
* With stenosis at the opening of the CCA.
A Study of MCAF5352A in Healthy Volunteers

This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15 and 29.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, 18 - 55 years of age
* Subjects in good health as determined by screening medical history, physical examination, vital signs, 12-lead ECG and laboratory tests
* Body weight between 45 kg and 110 kg
* Female subjects must be willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug

Exclusion Criteria:

* Pregnant or lactating women
* Positive for hepatitis B, hepatitis C or HIV infection
* History of significant chronic or recurrent infections
* History of clinically significant drug allergy and/or a known hypersensitivity to protein therapeutics or formulation components or a related drug
* History of alcohol or drug abuse within 12 months prior to Day 1, or evidence of such abuse
* Subjects who have previously received the study drug
* Participation in a clinical trial within 4 weeks prior to Day 1 or use of any experimental or biologic therapy within 12 weeks prior to Day 1 or within 5 half-lives of the product, whichever is greater
The Luveris In Vitro Fertilization Trial

The purpose of this study is to develop a new protocol using two different types of fertility drugs that is more similar to the way the hormones act in a normal menstrual cycle (period).

We are recruiting women who are trying to get pregnant through In Vitro Fertilization (IVF) who either have a high prolactin level (a hormone normally found in your blood that is produced in the brain) or have a condition known as hypothalamic amenorrhea in which one does not get regular periods due to low hormone levels.

The ovaries can be stimulated with Follicle Stimulating Hormone (FSH) alone and with FSH and Luteinizing Hormone (LH). FSH causes eggs to be made while LH causes estrogen (hormone) production. The women in this study have low hormone levels and need both FSH and LH. Luveris® (LH hormone) is a new drug approved for egg production and is used in IVF. There is no set amount of LH nor a set protocol for LH use. Therefore, we are testing this new regimen. One group of women will receive a fixed dose of LH throughout their cycle while the other will decrease the dose of FSH while at the same time increasing the LH dose which is what happens in the natural menstrual cycle.


Eligibility Criteria:
Inclusion Criteria:

1. 30 women under 38 years old at time of signing Informed Consent Form.
2. Evidence of hypothalamic amenorrhea (irregular menses and FSH and LH \<5 mIU/mL), uncorrected hyperprolactinemia (prolactin levels 10% above the upper limit of normal) or iatrogenic hypothalamic hypogonadism secondary to GnRHa suppression.
3. In good general health off of current medications which may confound response to study medications except GnRHa (Lupron Depot).
4. Desire to seek pregnancy actively during the study period.
5. A normal uterine cavity must have been confirmed by either hysteroscopy or hydrosonogram within two years of entering the study.
6. A semen analysis on the male partner deemed adequate for IVF by the attending physician within the past year or donor sperm available for insemination.
7. Only one treatment cycle per patient will be studied.

Exclusion Criteria:

1. uncorrected thyroid disease.
2. heart disease (New York Heart Association Class II or higher).
3. a history of, or suspected cervical, endometrial, or breast cancer. A normal Pap smear result within the last 24 months will be required.
4. enrolled into other studies that require medications, limit sex, or otherwise prevent compliance with the protocol at the same time.
5. to take other medications known to affect reproduction.
Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia

This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.

In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy. In this study, we seek to maximize blockage of the SDF-1/CXCR4 axis through the following:

1. Addition of G-CSF, which down regulates SDF-1 expression and acts synergistically with plerixafor in stem cell mobilization
2. Intravenous instead of subcutaneous dosing of plerixafor to improve kinetics of administration.
3. Dose escalation of plerixafor and twice daily dosing to maintain maximum CXCR4 blockade.

Eligibility Criteria:
Inclusion Criteria:

1. Acute myeloid leukemia diagnosed by WHO criteria with one of the following:

   * Primary refractory disease following no more than 2 cycles of induction chemotherapy
   * First relapse with no prior unsuccessful salvage chemotherapy
2. Age between 18 and 70 years old
3. ECOG performance status ≤ 3
4. Adequate organ function defined as:

   * Calculated creatinine clearance ≥ 50 ml/min
   * AST, ALT, total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia)
   * Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
5. Are surgically or biologically sterile or willing to practice acceptable birth control, as follows:

   * Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence.
   * Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period
6. Able to provide signed informed consent prior to registration on study

Exclusion Criteria:

1. Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
2. Peripheral blood blast count ≥ 20 x 103 /mm3
3. Active CNS involvement with leukemia
4. Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
5. Pregnant or nursing
6. Received any other investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within the preceding 2 weeks
7. Received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study
8. Severe concurrent illness that would limit compliance with study requirements