cyrilzakka/clinical-trials huggingface dataset:
Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique

This comparative efficacy study will be based on a 3-armed controlled trial: bilateral robotic priming combined with bilateral arm training (bilateral RT+BAT), bilateral robotic priming combined with mirror therapy (bilateral RT+MT), and the control intervention (bilateral RT+IOT). The goal of this 4-year project is to provide scientific evidence of the comparative efficacy research of hybrid interventions based on unilateral vs. bilateral approach to upper limb rehabilitation in subacute and chronic stroke.

This proposed research fits in the NHRI research priority 4-1 by addressing innovative treatment strategies for stroke that is in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that lead to long-term disability and causes heavy health care and financial burden. Advances in clinical and translational neurosciences have led to the new development of stroke rehabilitation. Current stroke rehabilitation programs such as robotic therapy, mirror therapy, and bilateral arm training are bilateral approaches to intensive practice based on the tenet of practice-dependent neuroplasticity. Bilateral robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery. This proposed research project will: (1) examine the effects of bilateral robotic priming combined with bilateral arm training approach versus bilateral robotic priming combined with mirror therapy, relative to the control intervention approach (bilateral robotic priming combined with impairment-oriented training) on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of robotic priming combined with contemporary rehabilitation approaches (i.e., bilateral arm training and mirror therapy) and the control intervention, and (3) identify the potential predictors of functionally relevant changes after therapy.

Eligibility Criteria:
Inclusion Criteria:

(1) ⩾3 months onset from a first-ever unilateral stroke; (2) age range from 18 to 80 years; (3) baseline upper extremity motor score on the Fugl-Meyer Assessment \>10 (Fugl-Meyer et al., 1975); (4) no severe spasticity in any joints of the affected arm (Modified Ashworth Scale ⩽ 3) (Charalambous, 2014); (5) able to follow study instructions (Mini Mental State Examination Score ⩾24) (Skidmore et al., 2010); (6) no serious vision deficits and no other neurologic or major orthopedic diseases; (7) able to participate in a rehabilitation intervention program for 6 weeks; and (8) no participation in other studies during the study period and willing to provide written informed consent.

Exclusion Criteria:

(1) acute inflammation and (2) major medical problems or poor physical conditions that might interfere with participation.
TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers

TTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.

TTX-080 is a fully human mAb designed to block the interaction of HLA-G with its known ligands, ILT2 and ILT4 molecules. The Phase 1a was an open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, MTD or OBD, and the RP2D of TTX-080 when administered as a single agent. The Phase 1b is a dose expansion of TTX-080 monotherapy and in combination with either pembrolizumab or cetuximab in adult subjects with advanced refractory/resistant solid malignancies, including Head and Neck squamous cell carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Colorectal cancer (CRC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), and acral melanoma. Additionally, the Phase 1b includes randomized arms with TTX-080 in combination with FOLFIRI plus cetuximab compared to FOLFIRI plus cetuximab in metastatic Colorectal cancer. The study will seek to evaluate the pharmacokinetics and immunogenicity of TTX-080, and characterize the anti-tumor activity of TTX-080 as a monotherapy and in combination with pembrolizumab, cetuximab or FOLFIRI plus cetuximab.

Eligibility Criteria:
Abbreviated Inclusion Criteria:

1. Subject with histological diagnosis of advanced/metastatic cancer
2. Age 18 years or older, is willing and able to provide informed consent
3. Evidence of measurable disease
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks

Abbreviated Exclusion Criteria:

1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
2. Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study
3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
4. History of severe autoimmune disease
5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
Critical Illness Related Cardiac Arrest (CIRCA)

CIRCA aims to determine the incidence and outcomes of in-hospital cardiac arrest (IHCA) in UK intensive care units (ICUs) and explore associated risk factors with ICU and hospital survival and quality of survival following hospital discharge.

Cardiac arrest is often categorised by location, out-of-hospital or in-hospital (IHCA), as there are important differences in population characteristics and aetiology. The National Cardiac Arrest Audit (NCAA) was established to audit resuscitation teams in response to IHCA, and collects information about patient characteristics, resuscitation processes, and patient outcomes. However, it does not audit IHCAs that are not attended by the resuscitation team.

Critically ill patients managed in ICUs are experiencing failure of one or more organs and therefore more intensive and invasive therapies are needed to support these failing organs. As a result, ICUs have higher nursing and medical staffing ratios, and monitoring is usually continuous. Moreover, the skill mix of the multidisciplinary team is geared to advanced life support. Thus, the risk of cardiac arrest occurring, the involvement (or not) of the resuscitation team, and the probability of return of spontaneous circulation are all likely to be different to other IHCAs.

Accurate data on cardiac arrests in ICU are lacking and the investigators do not know how many IHCA occur in ICU in the UK, nor is the impact of an IHCA in ICU on outcome known. In addition, it is not known if these IHCAs in ICUs represent an unavoidable consequence of critical illness or, more importantly, whether they can be predicted and/or prevented.

CIRCA is a prospective, multi-centre observational cohort study nested in the Case Mix Programme (CMP) and NCAA national clinical audits. The investigators aim to determine the incidence and outcomes of IHCA in UK ICUs and explore associated risk factors with ICU and hospital survival and quality of survival following hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old or more; and either
2. Cardiac arrest (defined as receipt of chest compressions or defibrillation) occurring while in-hospital and within intensive care (defined as either ICU, HDU or combined ICU/HDU); or
3. Family member of a patient surviving to discharge from intensive care after a cardiac arrest within ICU

Exclusion Criteria:

There are no exclusion criteria
The Virtual Visit for Women With Gestational Diabetes

This is a feasibility study of care for women with gestational diabetes (GDM) using electronic equipment to participate in virtual office visits.

Participants will be trained in the use of glucose meters, scales, and sphygmomanometers which are Bluetooth connected to an app on their cellphones. Fetal well-being will be assessed with Dopplers and kick counts. Care will be delivered by alternate in-office and telephone visits.

The core elements of a prenatal visit for any pregnant woman include assessment of BP, weight, and presence of fetal heart activity. The treatment of GDM additionally requires the measurement of and review of maternal glycemia. Technology exists for patients to measure these parameters and to relay this information securely directly from these devices via the internet to the healthcare provider's office. A key element of antepartum care for GDM, self-monitoring of blood glucose (SMBG), has for some years been conducted with memory-based portable glucose meters. To assure accuracy in reports of patient measurements, it is important that all devices be of a design wherein results of measures of patient parameters are transmitted in unedited fashion directly devices to the health care provider. While no data exists about the accuracy of self-reporting of patient weight and blood pressure, intentional or unintentional alteration in reports of self-monitored glucose results is a known risk of reliance on patient self-reported data. This pilot study will explore the feasibility of the use of this technology from patients' homes in lieu of an office visit.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of gestational diabetes
2. Singleton pregnancy
3. \<32 weeks gestation
4. Age 18-45 years
5. Fluent and literate in English or Spanish
6. Have a cellphone with capability of internet access.

Exclusion Criteria:

1. Multiple gestations (twins or higher)
2. Have a history of fetal demise
3. Have a history of chronic health problems that might affect outcomes (such as HIV, treatment with steroids, significant cardiac or renal disease, or chronic hypertension), and those who had bariatric surgery.
Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy

This prospective study was was divided into 2 parts and carried out at 2 sites in Germany.

Part 1 assessed Repeatability in healthy, non-diabetic population (Group "control").

Part 2 collected data to evaluate the diagnostic and prognostic value of using Heidelberg Engineering Retina Tomograph (HRT) 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E) in subjects with early to moderate DPN (Groups"none" and "mild", respectively).

Part 1 aimed to evaluate the diagnostic and prognostic value of the optimized dynamic composite corneal nerve plexus image acquisitions done with HRT RCM-E compared to standard static composite image acquisition with Heidelberg Engineering Retina Tomograph (HRT) 3 with the Rostock Cornea Module (HRT RCM).

The part 2 (research part) evaluated changes in corneal nerve plexus parameters in diabetes patients without or with early to moderate Diabetic Peripheral Neuropathy (DPN) and correlated the observed changes with progression of early DPN.

Eligibility Criteria:
Inclusion Criteria:

* All

  * Able and willing to undergo the test procedures, give consent, and to follow instructions.
  * Signed informed consent.
  * ≥18 years.
* Part 1, Site 1

  * Normal eyes of patients without Diabetes Mellitus
  * Fasting blood glucose \< 100 mg/dl
  * HbA1c ≤ 6.5%
* Part 2, Site 2

  * Diabetes Mellitus Type 2 without coexisting DPN (NSS score ≤2 and / or NDS score ≤2)
  * Diabetes Mellitus Type 2 with coexisting early to moderate DPN. (NSS score 3-4 and / or NDS score 3-5)
  * 6.5% \< HbA1c ≤ 9.5%

Exclusion Criteria:

* Vulnerable subjects (Such as: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel (if linked to CI site), employees of the sponsor, members of the armed forces (if linked to CI site or sponsor), and persons kept in detention.)
* Subjects unable to read or write
* Contact lens wearers (soft and rigid)
* Patients with symptomatic dry eye
* Patients with conjunctivitis at the time of inclusion
* Patients with history of corneal surgery
* Patients with diabetic retinopathy
* Patients with history of neuronal diseases that according to the expertise of the investigator might have an influence on corneal nerve fiber plexus
Effect of Laughter Yoga Therapy on Postpartum Depression

Laughter yoga sessions, stretches and stretches, songs, clapping and body It starts with light warm-up techniques that include movements. These are to break down all kinds of inhibitions and It is aimed at developing the feelings of childlike play. breathing exercises lungs they are ready to laugh and are combined with the following series of laughing exercises. LY In order to provide group dynamics in therapy, the group should consist of at least 5-12 people.

provided. Real laughter is often experienced during laughter meditation; it's contagious and may trigger laughter in other people in the group, hence the group can establish greater connections with its members. Laughter yoga sessions are always held at the same time and in the same place to encourage the participation of individuals.

has been done.

Laughter yoga sessions, stretches and stretches, songs, clapping and body It starts with light warm-up techniques that include movements. These are to break down all kinds of inhibitions and It is aimed at developing the feelings of childlike play. breathing exercises lungs they are ready to laugh and are combined with the following series of laughing exercises. LY In order to provide group dynamics in therapy, the group should consist of at least 5-12 people.

provided. Real laughter is often experienced during laughter meditation; it's contagious and may trigger laughter in other people in the group, hence the group can establish greater connections with its members. Laughter yoga sessions are always held at the same time and in the same place to encourage the participation of individuals.

has been done. Therapy sessions are between 40-45 minutes. Sessions started on time and was completed on time. In the research, a total of 6 sessions of laughter, once a week, yoga was done. The experimental group was interviewed in an online meeting prepared by a certified LY trainer.

She received LY exercises once a week (40 minutes per session) for 6 weeks (6 sessions). Each The meeting was organized with a maximum of 12 people.

Eligibility Criteria:
Inclusion Criteria:

* have a healthy baby

Exclusion Criteria:

* Absence of a psychiatric illness No chronic disease The newborn has no health problems
Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.

Results prepared and posted by Takeda on behalf of Hillevax, the IND holder.

The drug being tested in this study is called NoV vaccine. NoV vaccine is being tested for protection against acute gastroenteritis (AGE) due to norovirus.

The study will enroll maximum of approximately 575 participants. Participants who previously received NoV vaccine in studies NOR-107, NOR-210 and NOR-204 will be enrolled. Participants from study NOR-107 will enter the study at the time of their 3rd year post-primary vaccination, and from studies NOR-210 and NOR-204, at their 2nd year post-primary vaccination. The duration of participation in the study will be different for each participant.

This multi-center trial will be conducted in Belgium and the United States. The overall time to participate in this study is maximum 5 years after primary NoV vaccination. Participants will have a maximum of 4 visits over 3 years

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants who previously received at least 1 dose of NoV vaccine in trials NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490), have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially described.

Exclusion Criteria:

1. Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
2. In the opinion of the investigator, the participant is not medically eligible to provide blood specimens.
3. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.
Harnessing Sleep/Circadian Rhythm Data as a Biomarker to Mitigate Health Risks

The overall goal of this study is to investigate associations between sleep/circadian disturbances and psychiatric health among adolescents recruited from primary and specialty health clinics.

This project will involve recruitment of 100 adolescents from primary and specialty health clinics. Participants will participate in 3 phases: screening/intake visit, sleep study, and follow-up visit.

The 1-hour screening/intake visit will be conducted at the Duke ADHD clinic at 2608 Erwin Road, Pavilion East, Suite 300, Durham, NC 27705. During the screening/intake visit, participants and their parents will complete questionnaires regarding the adolescent's psychiatric health. Participants' vitals (i.e., height, weight, resting heart rate, blood pressure) will also be assessed and recorded.

Eligible participants will enter the 7-day sleep study, during which they will be asked to wear an actigraph watch 24 hours/day, apply a EEG sleep recorder each night, and complete a daily sleep diary.

Following the final night of the sleep study, participants and parents will be asked to return for a follow-up visit and will complete questionnaires about the participants' sleep over the past week.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Between the ages of 11 years 0 months to 17 years 11 months (inclusive), at the time of parental informed consent.
3. Ability to follow written and verbal instructions (English), as assessed by the PI and/or study coordinator.
4. Ability to comply with all testing, requirements, study procedures, and availability for the duration of the study.

Exclusion Criteria:

1. Participants who have a diagnosis of occult sleep disorders (i.e., sleep apnea, periodic leg movement syndrome)
2. Participants who currently use prescribed or over-the-counter sleep aids (i.e., melatonin)
3. Participants who have acute or chronic medical illnesses or medications that may interfere with sleep as determined by the research team.
4. Unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the principal investigator.
Creatine Supplementation and Diabetes

Creatine supplementation is capable of improving glucose tolerance in healthy subjects. The researchers aim to investigate whether this supplement can affect metabolic control in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* males and females type 2 diabetic patients
* glycated hemoglobin between \> 9%
* non insulin users
* physically inactive
* only metformin and/or sulfonylurea users
* BMI \> 30 kg/m2
* age of years \> 50 y
Early Molecular Detection Technique Coupled With Urinary Test of Infectious Agents Responsible of Children CAP

Community-Acquired Pneumonia (CAP) of children are a recurrent pathology with multiple severity scores. The etiology is never really identified, and the initial treatment is always based on probabilistic antibiotics, in the case of an bacterial infection, and by the way, potentially severe.

Molecular tests ("multiplex") allow the simultaneous detection of a huge number of pathogenic agents, virus and bacteria, are now available.

This project is based on a new strategy of diagnostic, using a multiplex PCR with quick results, coupled to an antigenic urinary test to allow a complete, quick, etiologic diagnostic as soon as children are supported in emergency.

Children are randomized in two groups during inclusions : quick diagnostic strategy versus usual practice. Analyse will be centralized on anti-infectious treatment optimization, with the aim to better treat patients, minimize the costs, and decrease selection pressure of multi-resistant bacteria.

Community-Acquired Pneumonia (CAP) of children are a recurrent pathology with multiple severity scores. Almost two out of three cases identified at emergency are treated in ambulatory because patients present a reassuring clinical state. The etiology is never really identified, and the initial treatment is always based on probabilistic antibiotics re-evaluated at H48, in the case of an bacterial infection, and by the way, potentially severe. This old conception is opposed to the new discoveries, more particularly in pediatric units where strictly viral pneumonia are more important than predicted (at least 30 to 50%) that leads to an hyper prescription of antibiotics, useless.

Molecular tests ("multiplex") allow the simultaneous detection of a huge number of pathogenic agents, virus and bacteria, are now available.

Aware of the non specificity of the clinical data to guide the diagnostic, this project is based on a new strategy of diagnostic, using a multiplex PCR with quick results (less than 2 hours, for 20 pathogens, including 17 viruses) coupled to an antigenic urinary test to allow a complete, quick, etiologic diagnostic as soon as children are supported in emergency.

Children are randomized in two groups during inclusions : quick diagnostic strategy versus usual practice. Analyse will be centralized on anti-infectious treatment optimization (antibiotics and antiviruses), with the aim to better treat patients, minimize the costs, and decrease selection pressure of multi-resistant bacteria.

Eligibility Criteria:
Inclusion Criteria:

* In emergency for a Community-Acquired Pneumonia (according to the international rules based on an hyperthermia \> 38,5°C associated to a radiological opacity)
* Informed Consent
* Possibility to take samples

Exclusion Criteria:

* Nosocomial pneumonia
* Pleuropneumopathy
* Pneumonia occurring in immunosuppressed and transplanted
* Patient with proven allergy to antibiotics
* Inability to perform certain microbiological samples
Antimicrobial Pastes and Clinical Cases of Apexogenesis

The aim of this study was to perform a clinical and microbiological evaluation of teeth with incomplete apexogenesis and traumatic necrosis that were treated with a revascularization technique, evaluating the microbial reduction after the use a double antibiotic paste. Furthermore, the investigation also aims to identify the presence of Enterococcus faecalis and Porphyromomas gingivalis within the root canal system.

This investigation is a longitudinal prospective interventional study of a series of cases. Patients who sought treatment at the Faculty of Dentistry from June 2011 to September 2015 were selected. They should have one permanent tooth with traumatic necrosis.

Eligibility Criteria:
Inclusion Criteria:

* They should have one permanent tooth with traumatic necrosis, which in turns should show color alteration, fistulae, periapical lesion, and/or internal or external root resorption, pain, or absence of pulp response to sensitivity tests at a clinical examination to be considered necrotic. Male and female patients who had not undergone antibiotic therapy 3 months before the treatment were included and clinical and radiographic examinations confirmed pulp necrosis.

Exclusion Criteria:

* Patients who did use antibiotics
* Patients who did loss of temporary coronary sealing between treatment sessions
* Patients who give up the research