cyrilzakka/clinical-trials huggingface dataset:
MS-DETECT: Early Detection of Multiple Sclerosis Progression with MSCopilot® Detect

The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).

The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution.

A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients.

Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL).

Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression.

The study will include 314 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France


Eligibility Criteria:
Inclusion Criteria:

* Adult patients living with RRMS or SPMS, aged 30 to 65
* EDSS score between 2.5 to 6.5 points
* With a disease duration \> 5 years
* Clinically stable during the last 3 months before inclusion (no relapses, no disability progression)
* No change in the DMT\* during the last 3 months before inclusion
* Receiving optimal symptomatic treatments at baseline (clinician's judgment)
* Owns a personal smartphone which mobile operating system is above 14 for IOS (iPhone) and 8 for Android included with a good internet connexion
* Able to use a smartphone
* Able to read language in wich the mobile application is available and able to understand pictograms.
* Applicable to patients enrolled in France only: affiliated to a social security system.

Exclusion Criteria:

* Medically unstable conditions that may hinder patient's ability to comply with the study procedures
* Inability to use a smartphone or MSCopilot® Detect application
* Patient with corrected visual acuity less than 4/10 (Monoyer) or 20/50 (Snellen at 20 feet) or +0,4 (LogMAR)
* Pregnancy and nursing women
* Persons under guardianship or curatorship
* Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
* Patients have participated in another clinical study within the previous 30 days of screening or are currently participating in another study that, in the opinion of the Investigator, might interfere with the patient's full participation in the study or confound the assessment of the patient or outcome of the study.
Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition

Background: Neuropsychiatric conditions, such as insomnia, anxiety, depression, and pain are the most common symptoms experienced by nurses after acute infection of COVID-19. Although medication can assist nurses to improve these symptoms simultaneously in a short period of time, they are at risk of overuse of benzodiazepine hypnotics. Previous research supports the usefulness of cognitive behavioral therapy for insomnia (CBT-I) as self-management strategies in adults with insomnia, anxiety, depression, and pain. However, their effects on post COVID-19 condition have not been researched, and no previous head-to-head study compared the effects on these two approaches on insomnia and neuropsychiatric symptoms.

Aim: To investigate the effects of CBT-I on insomnia, anxiety, depression, and pain in nurses with post COVID-19 condition.

Methods: In this two-arm, parallel randomized controlled trial, 100 participants will be 1:1 randomly assigned to one of two groups (CBT-I and control). The intervention phase will last 6 weeks, followed by a three-month follow-up. Primary outcomes are insomnia severity and sleep quality, whereas anxiety, depression, pain, and health-related quality of life are secondary outcomes. These variables will be assessed before and after the intervention, and at 1, 2, and 3 months after the end of the intervention. Additionally, discontinuing benzodiazepine hypnotics will be measured at 3 months after the end of the intervention.

Discussion: This study will provide evidence of the effects of CBT-I on improving insomnia, anxiety, depression, and pain among nurses with post COVID-19 condition. Results could also enhance means by which to discontinue benzodiazepine hypnotics.


Eligibility Criteria:
Inclusion Criteria:

* nurses with post COVID-19 condition

Exclusion Criteria:

* history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters

Hepatitis C virus is commona viral infection. Direct-acting antiviral (DAA) oral drugs has been used in treatment of HCVs. the effect of these drugs on male infertility is still under investigation.

Semen analysis will be done to male patients with HCV before and after treatment with DAA. The included men will take therapy for 3 months and HCV RNA titter will be evaluated. changes of seminal parameters will be recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

Men patients with HCV

Exclusion Criteria:

Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer

The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cervical cancer.

The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

* They were systematic reviews based on randomized controlled trials (rcts). They were phase II rcts comparing chemotherapy with other systemic therapy agents or with no further treatment for recurrent, metastatic, or persistent cervical cancer.

they reported at least one of these outcomes: complete or partial response rate, overall or progression-free survival rate, adverse effects, or healthrelated quality of life (rcts reporting on heterogeneous populations-for example, women at a range of disease stages-were included if results were given separately for patients with recurrent, metastatic, or persistent cervical cancer).

Exclusion Criteria:

* studies evaluating the role of radiotherapy administered with chemotherapy, or second- or subsequent-line therapy options.
Cost-effectiveness of Laser Doppler Imaging in Burn Care

Accurate early burn depth assessment is important to determine the optimal treatment. The most applied method to asses burn depth is clinical assessment. This method is the least expensive, but not very accurate. Laser Doppler imaging (LDI) has been shown to accurately assess burn depth. The clinical effects, the costs and cost-effectiveness of this device however, are unknown. The hypothesis is that an eary accurate diagnosis will lead to an earlier therapeutic decision: surgery or no surgery. Earlier excision and grafting probably leads to a decrease in wound healing time, in length of hospital stay and in costs.

Before the investigators decide to implement LDI in Dutch burn care a study of the clinical effects and cost-effectiveness of LDI is necessary. Therefore a multicenter randomized controlled trial will be conducted, including all patients with burns of indeterminate depth (burns that are not obviously superficial or full thickness) treated in the Dutch burn centres. In total 200 patients will be included in an 18 months period. The patients are randomly divided in two groups: 'new diagnostic strategy' versus 'current diagnostic strategy'. Burn depth will be diagnosed both by clinical assessment and laser Doppler imaging in all patients. The results of the LDI-scan will be provided to the treating clinician in the 'new diagnostic strategy' group only. Time to wound healing, diagnostic and therapeutic decisions, and costs are observed.


Eligibility Criteria:
Inclusion criteria:

* Patients with acute burns of indeterminate depth (=intermediate depth, not obviously superficial or full thickness) at presentation
* Outpatient treatment or admission in one of the three Dutch burn centres
* Presentation within 5 days post burn

Exclusion criteria

* A presence of both burns of indeterminate depth and full thickness at presentation
* Patients with peri-orbital facial burns, in which the eyes are unable to shield
* Patients or their next of kin if they are under aged or temporary incompetent who can not be expected to give informed consent e.g. because of cognitive dysfunction or poor Dutch proficiency.
* Patients with a TBSA burned \> 20%
The Evolution of Memories Across Wake and Sleep

To further understanding of the relationship between sleep and memory the investigators will address and attempt to answer three questions, (1) how memories evolve across wake and sleep, (2) how different aspects of this memory evolution are reflected both behaviorally and in the EEG signal, and (3) what stages and features of sleep affect memory evolution. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in memory consolidation. Such knowledge would be of practical importance for educational practices, whether in schools, on the job, or in the military, and would also provide valuable information to the fields of sleep medicine and psychiatry, where interactions between sleep disorders and cognitive functioning are of great importance.

Goal 1: How do memories evolve across wake and sleep? The investigators are interested in how specific memories are selected for change across periods of wake and sleep, and in characterizing the manner in which those memories change. There has been research into broad areas of memory, such as procedural and declarative memory, but other forms of memory, such as semantic memory, remain unexplored, as well as different subtypes of memory within these broad areas. Additionally, it is presently unknown how memories are selected for subsequent processing during sleep and wake. The investigators aim to characterize which memories change, how they are selected, and how they change differently over periods that include sleep versus periods during which participants remain awake.

Goal 2: How are these changes reflected behaviorally and in the EEG signal? The investigators will employ and develop specific behavioral and electrophysiological tasks and measures that allow one to probe the state of a particular type of memory and determine how it changes over periods of wake and sleep. EEG signals may be informative about the status of a memory during behavioral performance as well as during both waking and sleeping offline states.

Goal 3: What stages and features of sleep affect memory evolution? In the cases in which sleep in particular is found or suspected to influence memories in a unique way, the investigators will assess which stages and features of sleep are involved in that evolution. Generally, this will be accomplished by correlating measures such as time spent in a sleep stage, prominence of particular brain oscillations, or density of spindles with changes in behavior or in other EEG metrics

Eligibility Criteria:
Inclusion Criteria:

* willing and able to follow the protocol
* willing to refrain from alcohol and recreational drugs for the duration of the protocol
* in some cases, English as a first language, normal hearing, and/or normal or corrected to normal vision is required

Exclusion Criteria:

* self-reported sleep disturbances
* a history of mental illness
* the use of any drugs that could affect either sleep or cognitive functioning (e.g., sleeping pills or antidepressants)
Parents' Experience of Child Loss During Pregnancy or Birth

The investigators are conducting a participatory study with and for parents after child loss during pregnancy or birth. Their aim is to develop treatment recommendations for healthcare professional. These focus on question, how to deal with parents when experiencing child loss.

The entire study is following a participatory approach and including parents after stillbirth in the research team. Along a co-creative design, the investigators planned a multistep-explorative mixed-methods study.

In detail, three key steps will be conducted. First, workshops and focus groups will be carried out to identify central needs of affected parents. Afterwards, one investigator will interview the parents narratively to gain an in-depth understanding of their experiencs. Finally, these findings will be summarized and translated into treatment recommendations for healthcare professionals.

Eligibility Criteria:
Inclusion Criteria:

* German speaking
* Living in Austria, Germany or Switzerland
* Child loss during pregnancy or birth
* Child loss within last 12 months
* Legal capacity
* Voluntary participation

Exclusion Criteria:

* Loss of child after birth
* Not speaking and understanding German
* Not in a good mental condition to participate
A Study of KC1036 in Patients with Advanced Solid Tumors

The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed recurrent or metastatic solid tumors;
* Patients who have failed standard or conventional treatment, Including chemotherapy, targeted therapy, immunotherapy:

Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy;

* At least one measurable lesion (by RECIST 1.1);
* Eastern Cooperative Oncology Group performance status score of 0 or 1;
* Life expectancy \> 12 weeks;
* Patients should participate in the study voluntarily and sign informed consent.

Exclusion Criteria:

* Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
* Other kinds of malignancies;
* Hematologic, renal, and hepatic function abnormities;
* Risk of bleeding;
* Gastrointestinal abnormalitiest;
* Cardiovascular and cerebrovascular diseases;
* Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks of enrollment;
* Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia;
* Involved in other clinical trials within 4 weeks of enrollment;
* Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks days of enrollment;
* History of organ allograft;
* Need immunosuppressive agents or systemic or absorbable topical hormone therapy for immunosuppression;
* Uncontrolled ongoing or active infection;
* Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
* Pregnant or lactating women or those who do not take contraceptives, including men;
* Suffering from mental and neurological diseases;
* Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
* Inability to comply with protocol required procedures.
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_12

A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa


Eligibility Criteria:
Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
* colour blinded
Studying Tissue Samples to Learn More About Drug Resistance in Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.

PURPOSE: This laboratory study is examining tissue samples from patients with acute myeloid leukemia to learn more about drug resistance in these patients.

OBJECTIVES:

* Ascertain whether assessments of P-glycoprotein (P-gp) status using the accumulation assay find greater than 10% positive specimens among 30 specimens (collected from patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999) found to be negative using only the efflux assay.

OUTLINE: This is a multicenter study.

Cryopreserved bone marrow specimens are examined for P-glycoprotein (P-gp) by the accumulation assay and the efflux assay using DiOC_2 dye. Flow cytometry is used for measuring activity in both assays.

PROJECTED ACCRUAL: A total of 40 specimens will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cryopreserved bone marrow specimens collected from patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999 meeting the following criteria:

  * Appreciable levels of either CD34+ OR CD117+ blasts
  * Appreciable staining with anti-P-gp antibodies
* 30 specimens must exhibit low to moderate dye loading for the Rh123 efflux assay
* 10 specimens must exhibit positive Rh123 efflux activities

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis

Evidence has shown that knee osteoarthritis causes an increase in base of support and a decrease in stride length and gait velocity which results in an increase in energy expenditure during walking. This increase in energy cost of walking is suggested to result in walking related performance fatigability. However, fatigue is not commonly considered in the clinical settings in term of neither assessment nor management of knee osteoarthritis. One common tool used to evaluate walking relate performance is six minute walk test and the purpose of this study is to determine the reliability of using six minute walk test to determine walking related performance fatigability in persons with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years
* Knee OA with history not less than three months.
* Radiological evidences of grade III or less on Kellgren classification.
* Knee pain on VNRS no more than 8/10.

Exclusion Criteria:

* Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis
* Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).
* History of trauma or fractures in lower extremity.
* Signs of lumbar radiculopathy or myelopathy.
* History of knee surgery or replacement.
* Patients on intra-articular steroid therapy within two months before the commencement of the study.
* Impaired skin sensation and renal function.
Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A

The primary objective of this study is to test the feasibility of a large-scale clinical trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy outcomes so that we can better plan a large-scale study; we will estimate the effect size and variability of effect and resource utilization of once-daily prophylaxis to allow us to set a sample size for a definitive trial.

Hemophilia is an important and costly disorder; if left untreated, it may have serious consequences. The greatest impact of hemophilia occurs from recurrent bleeding into joints. The consequences of joint bleeding include pain associated with acute bleeding and later chronic arthropathy. Half of affected children with severe hemophilia have joint damage; joint damage is more frequent with increased bleeding. The prevention and treatment of bleeding is very expensive and therefore finding a cost-effective treatment is of high priority.

Worldwide, two major treatment strategies have been used to prevent arthropathy - on demand therapy and factor prophylaxis. The goal of prophylaxis is to convert the severe to the moderate phenotype by providing circulating factor activity of greater than 1%. Patients with greater than 1% circulating factor VIII activity rarely have spontaneous hemarthroses. Therefore, the goal of providing circulating factor at this level is to eliminate spontaneous hemarthroses. The term primary prophylaxis suggests using preventative factor VIII replacement from a very early age. The term secondary prophylaxis is used to describe the application of prophylaxis at a later disease stage. In this study, secondary prophylaxis will be used.

Once-daily prophylaxis is a novel application of hemophilia factor prophylaxis for youth and young adults. Before embarking on a costly definitive trial we feel that it is necessary to demonstrate that subjects will be willing to enroll and will be compliant with the therapy. Moreover, we need to establish an estimate of the effect of once-daily prophylaxis on bleeding rates, quality of life, and joint damage progression in order to design a definitive trial.

Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A (\<1% factor VIII)
* Age 12 to 24 years inclusive
* Male
* No current factor VIII inhibitor (an inhibitor will be defined as ≥ 0.6 Bethesda Units) within the past year
* Able to participate in a home infusion program with adequate peripheral venous access as assessed ny the treating investigator

Exclusion Criteria:

* Important co-morbidities (Acquired Immunodeficiency Syndrome or symptomatic HIV infection, symptomatic hepatitis B or C infection)
* Other concomitant acquired or congenital bleeding disorder (e.g. von Willebrand's Disease)
* Receiving factor VIII replacement through central venous catheter