cyrilzakka/clinical-trials huggingface dataset:
EMAehealth Web Tool for Pregnancy and Puerperium: Effectiveness

The research team has designed, and will test, a web tool to support traditional Maternal Education (EM). This tool is organized into 4 areas: 1) Information área; 2) Communication área (with peers and with professionals) 3) Self-management health area(instruments to check or reflect on their own health needs, as well as decision algorithms to detect the time of delivery and postpartum alarm symptoms); 4) Clinical data área (the woman can have her clinical data, include it and share it with other professionals) The objective of the study is to evaluate the clinical effectiveness of the EMAeHealth tool and also its implementation in the real world (its usability and acceptability, by women and professionals).

The usefulness of Maternal Education, as it is currently being developed, is being questioned due to the obvious changes that have arisen in access to information by mothers and fathers, and due to the changes that have occurred in childbirth care and in the attitude towards the process of motherhood and fatherhood. There is no doubt, however, about the need to advise, care for and accompany couples in this stage of physical, family and social change. To respond to these new needs, the evidence indicates that a digital format may be the most appropriate. So, the research team has designed, and intends to test, a web tool, which is organized into 4 areas: 1) Information area: which will have information based on evidence, permanently updated by health services professionals ; 2) Communication area: allows women to contact other women in similar circumstances, through forums or conversations, or consult with professionals 3) Self-management health area : who have valid and reliable self-assessment instruments to check their own health needs, as well as decision algorithms to detect the time of delivery and postpartum alarm symptoms; 4) Clinical data area: in which the woman can collect clinical data, include the most recent and share it with other professionals if she so wishes. The first area is open access, but not the other three, which require a password. The objective is to evaluate the clinical effectiveness of the EMAeHealth tool, and also its implementation in the real world (its usability and acceptability, by women and professionals). Methods: The research team propose a hybrid implementation-effectiveness design, which allows us to evaluate aspects related to the context while evaluating the clinical efficacy of the tool. Discussion: A tool like the one described is of interest to women, to professionals and also to the health system. Note- Clinical Trials submision correspond to clinical effectiveness part of the study. Usability and acceptability is not included because it use qualitative methods.

Eligibility Criteria:
Inclusion Criteria:

* pregnant woman
* week 8-10 of gestation
* to speak and understand Spanish language

Exclusion Criteria:

• not meeting any of the inclusion criteria
Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

Fibromyalgia (FM) is a chronic musculoskeletal pain disorder with unknown causes. Our previous studies showed abnormal sensations of second pain (wind-up), indicating central hypersensitivity as an important mechanism of FM. Triggering events have been implicated as the cause of central hypersensitivity.

Increasing evidence has shown that the hypersensitivity of FM is not limited to painful stimuli but seems to extend to non-painful stimuli as well. These stimuli include smell, taste, touch, light, and sound. This study will provide detailed QST examinations of FM subjects and controls' responses to light using visually evoked potentials (VEP). In addition, careful characterization of experimental pain responding across multiple sensory modalities will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with FM will have pain of \> 3 months and meet the 1990 and 2011 Diagnostic Criteria for FM (ACR)
* Healthy, pain-free age and sex matched controls without chronic pain

Exclusion Criteria:

* Presence of chronic disease (e.g. cancer, cardiovascular disease, liver disease, kidney disease, diabetes, etc.).
* FM patients must be willing to discontinue or hold their FM related medications for a minimum of one day prior to the visit.
* Significant vision loss not corrected by eye wear
* Family history of photosensitive epilepsy
Maternal Marijuana Use and Fetal and Infant Outcome

Marijuana and cannabis-containing products are growing in popularity and availability in the United States, and use during pregnancy has increased dramatically. The overarching aim of this proposal is to provide pilot data for a submission which will explore the impact of chronic maternal marijuana use (primary or secondary) on fetal functioning, maternal reflective functioning and infant birth and neurodevelopmental outcomes. Chronically marijuana using pregnant women in treatment at the Center for Addiction and Pregnancy will be enrolled and asked to provide information about participants' marijuana and other licit and illicit substance use and feelings about parenting and participants' infant and undergo fetal monitoring at 36 weeks gestation. The neonates will undergo neurobehavioral examination during the first and fourth weeks of life.


Eligibility Criteria:
Maternal Inclusion Criteria:

* Singleton pregnancy less than 36 weeks of gestation
* Marijuana as a primary or secondary drug of choice

Maternal Exclusion Criteria:

* Significant fetal anomaly
* Multiple gestation
* Delivery prior to 36 weeks gestation
Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements

We wish to conduct two vascular ultrasound scans conducting vein measurements in two separate scanning rooms to assess if environmental temperature affects the vein diameter recorded.

Vascular surgeons are guided by vascular ultrasound scans when deciding treatment plans for their patients. In critical limb threatening ischaemia with infrainguinal disease, vein bypass has the best limb salvage and long term survival rates in patients who are appropriately selected. In lower limb "vein mapping", the vein is measured to assess suitability for use as a bypass conduit with the favoured bypass conduit being autologous, ipsilateral vein of good quality and length and a size of \>3mm is considered a good conduit.

The research team found one study which explored the effect of room temperature on upper limb vein measurements which was conducted in Singapore. This showed an underestimation of vein size at lower temperatures. We wish to add to the literature and irish research by conducting this study at University Hospital Limerick in order to optimise conditions for vascular assessments and therefore facilitate clinical decision making.

We aim to scan and record vein measurements on the lower limbs of vascular inpatients at University Hospital Limerick who are deemed suitable by the P.I.

Patients will have the ultrasound scan completed twice. The first room will have its temperature recorded and the vein measurements taken.

The second room will be set at a higher temperature which we have defined as being 6-10 degrees greater than ambient room temperature. We will achieve this through use of a portable heater.

We will compare the two recordings to assess if there is a difference in the diameter of the vein measured in the warmer room versus the standard room.

The importance of this is to assess the impact of environmental factors on vascular ultrasound scan results, therefore impacting on patient outcomes by use of the most suitable bypass conduit.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient at University Hospital Limerick under the care of a Vascular Consultant
* Aged 18 years and above
* Deemed suitable for two vascular ultrasound scans by the P.I

Exclusion Criteria:

* Those unable to give informed consent
* Aged under 18 years
* Patients with varicose veins/venous insufficiency
Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy

French prospective multicenter, open-label study involving newly diagnosed CML patients. Two assessments will be performed during the follow-up of these patients: individual frailty using geriatric tools and individual biological aging determined by DNA methylation analysis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* CML in chronic phase at time of diagnosis. Diagnosis must be made no more than 3 months (90 days) prior to inclusion. Diagnosis of chronic-phase CML (European Leukemia Network \[ELN\] 2020 criteria; Baccarani et al 2013) with confirmation of a Philadelphia chromosome (Ph1). A cryptic Ph1 chromosome must be confirmed by FISH.Criteria must meet the definition of chronic phase CML
* BCR ::ABL1 transcript quantifiable by quantitative PCR
* 1st-line treatment with tyrosine kinase inhibitor
* No tyrosine kinase inhibitor or hydroxyurea treatment received prior to first blood sampling (at diagnosis)
* Signature of informed consent for CML Observatory and signature of informed consent for BIO-TIMER protocol
* Read and understand French
* Enrolled in a social security plan or beneficiary of such a plan

Exclusion Criteria:

* CML in accelerated or blast phase
* Refusal to participate in the study
* Treatment started prior to inclusion
* Patients under guardianship, curatorship, deprivation of liberty or safeguard of justice
* Pregnant or breast-feeding women
A Rollover Study to Provide Chronic T-1249 to Patients Who Completed Study T1249-102

Patients who complete study T1249-102 (must be currently failing a T-20 containing regimen to participate in this study) will receive T-1249 at a dose of 200mg daily in combination with a background antiretroviral regimen for 96 weeks. Only patients that participated in study T1249-102 can participate in study T1249-105.


Eligibility Criteria:
Inclusion Criteria:

* Completion T1249-102;
* Currently failing a T-20 containing regimen

Exclusion Criteria:

* Non-completion of T1249-102.
Neural Mobilization With Task Based Activities on Upper Limb in Patients With Chronic Stroke.

Stroke is defined as sudden neurological disruption of blood supply to brain. It is most common disease that causes severe disabilities like hemiparesis which is most common motor impairment that leads to persistent upper limb dysfunction. In this study we use two techniques to improve upper limb motor dysfunction and reduce spasticity. One is task-based activities which is used to improve motor function and focus on active participation rather than normal movement pattern and other is neural mobilization which aims to reduce spasticity which is most common in stroke patients.

This study will be randomized controlled trial. Participants having stroke past 6 month to 1 year and mini mental state examination score \>21 will be included in this study. And participants with severe orthopedic deformity, joint pain and visual impairment will be excluded from this study. The sample size will consist of 34 participants selected through non probability convenient sampling technique, which will further be randomized through sealed envelope method and will divide into two groups .Data will be collected using assessment tools, including the Fugl Mayer assessment scale, box and block test and wolf motor function test. 17 Participants will be assigned to the interventional group (A )which will undergo neural mobilization of median nerve with task based activities .Neural mobilization technique will be performed with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for 6 week.

while task based activities will be performed with the dosage of 45 minutes session 5 days weekly for 6 weeks and 17 participants will be assigned to control group (B

)which will undergo only neural mobilization of median nerve and will receive neural mobilization with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for 6 weeks. After applying both interventions motor function improvement and spasticity reduction will be measured by using BBT, wolf motor scale and fugl -Meyer assessment scale and data will be analyzed through sPss Version 25.

Eligibility Criteria:
Inclusion Criteria:

* Male and female stroke patients.
* 6 month to one year post stroke .
* Age 30-55
* Stable patients
* Mini - mental state examination\>2
* Modified ashworth Scale equal\<+1

Exclusion Criteria:

* Orthopedic deformity
* Patients undergo bottulinuminjection toxin injection
* Visual impairments
* Joint pain (elbow, shoulder, wrist)
Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs.

Digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy. Consequently, there are at least three types of DU: (i) those localized at the tips of the fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management.

This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis.

Aim of this observational trial is:

1. To identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria for very early diagnosis of systemic sclerosis
2. To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria

Thus, the observational trial consist of a prevention arm and a healing arm.


Eligibility Criteria:
Inclusion Criteria:

* Juvenile and adult patients with diagnosis of systemic sclerosis according to the ACR/EULAR SSc criteria or the PRES/ACR/EULAR juvenile SSc criteria for enrollment into the prevention and healing arm
* Patients with fulfilment of the preliminary criteria for very eary diagnosis of systemic sclerosis (VEDOSS criteria) for enrollment into the prevention arm

Patients with active digital ulcers will be allocated into the healing arm. Patients without previous or history of digital ulcers (but currently without active digital ulcers) will be allocated into the prevention arm.

Definition of digital ulcers (DU): DU are 1) loss of tissue, 2) DU derived from digital pitting scars and 3) DU derived from calcinosis.

IN THIS STUDY WE CONSIDER ONLY DU (1) LOSS OF TISSUE. THE OTHER DU (2) and DU (3) ARE REGISTERED IN THE DATA BASE IF THEY ARE PRESENT, BUT ARE EXCLUDED FROM EVALUATION.
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects voluntarily joined the study and signed the ICF.
2. Measurable disease, as defined by RECIST v1.1.
3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.
5. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.

Exclusion Criteria:

1. Symptomatic, untreated or active central nervous system metastases.
2. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..
3. Have uncontrolled or severe cardiovascular disease.
4. With any active autoimmune disease or history of autoimmune disease.
5. Patients with active hepatitis B or hepatitis C.
6. Severe infections within 28 days prior to initiation of study treatment.
7. Active tuberculosis within one year prior to initiation of study treatment.
Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg

The objectives of this study are:

* To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
* To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Male volunteers in the age between 20 and 45 years old
* Body Mass Index (BMI) in the range of 19 to 27 kg/m2

Exclusion Criteria:

* History of allergy or sensitivity to any drug, including amlodipine or valsartan
* History of clinically significant hepatic, renal, gastrointestinal, neurology, pulmonary, endocrine, musculoskeletal, hematologic, oncologic, psychiatric, especially cardiovascular disease
* History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
* Hypotension (Systolic Blood Pressure(SBP) ≤ 100 mmHg or Diastolic Blood Pressure(DBP) ≤ 65 mmHg)
* Hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
* Clinical laboratory test values are outside the accepted normal range

  * Aspartate Transaminase(AST) or Alanine Transaminase(ALT) \> 1.25 times to normal range
  * Total bilirubin \> 1.25 times to normal range
* Positive for Hepatitis B Virus surface Antigen(HBsAg), Hepatitis C Virus Antibody(HCVAb) or Human Immunodeficiency Virus Antibody(HIVAb)
Automated Reinforcement Management Systems, Phase II

The Automated Reinforcement Management Systems Phase II (ARMS II) study is a phase II trial is a randomized controlled, non-medicated assisted trial to determine the effectiveness of Contingency Management (CM) treatment for reducing alcohol drinking among adults who want to quit or reduce their alcohol consumption.

The Automated Reinforcement Management Systems Phase II (ARMS II) study is a phase II randomized controlled, non-medication assisted trial to determine the effectiveness of Contingency Management (CM) delivered remotely as a treatment for reducing alcohol consumption among drinking adults who want to reduce their consumption. The study will utilize an application developed by Managed Health Connections, Appropos Health, that connects to a Bluetooth breathalyzer to collect sample results and provide rewards to participants. Qualifying participants will be randomized into one of two groups, a Contingent or Non-Contingent group, and earn rewards based on the group they are randomized to. The contingent group will receive rewards on an escalating scale for submitting consecutive negative samples (0.00% BAC) at three time points per day: 11am, 4pm, and 9pm. The non-contingent group will earn rewards for submitting samples on time, independent of the test results. All rewards will be given in the form of electronic vouchers, which can be exchanged for a merchant of the participant's choosing. All participants will be invited to complete short, daily surveys, and will be called once per week by a research coordinator for a check in on the study's progress. All participants will be invited to the research clinic once per month. All participants will additionally receive positive messaging to reinforce positive behavior, or provide support to encourage a change in behavior.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Have consumed 3 or more drinks in once occasion 4 or more times in the previous 30 days 3
* Have the ability to read and speak English
* Have the ability to provide written informed consent
* Have a breath alcohol value of 0.00 during informed consent
* Owns a smartphone with an active service provider that is compatible with the study application.

Exclusion Criteria:

* Severe alcohol use disorder that our medical staff deems too risky for safe participation;
* Significant risk of dangerous alcohol withdrawal, defined as history of seizure due to alcohol withdrawal in the last 12 months and/or expression of concern by the participant about dangerous withdrawal
* Anyone aged 71 or older.
* Anyone with a suicide attempt in the last 2 years.
* Individuals who express concern regarding dangerous withdrawal or who exhibit dangerous withdrawal symptoms.
* Individuals who do not test BrAC = 0.00 on the breathalyzer during the baseline visit.
* Any other condition that investigators determine a medical or psychiatric condition that would compromise safe study participation.
Investigation of Cigarette Cravings in Smokers

Interventions to disrupt memory reconsolidation have held promise for the treatment of stress- and anxiety-related disorders. In the present study, the investigators will examine whether an intervention based on these principles, called memory updating, could be adapted for reward-seeking behaviors. To test this, non-treatment seeking tobacco smokers will be exposed to smoking cues and/or stress, two stimuli known to trigger smoking. It is predicted that exposure to a stress task will enhance the cues' motivational salience and yield greater susceptibility to the memory updating procedure.

As an add-on, the investigators will examine COVID-associated changes in substance use and whether participants in the memory updating groups might be more resilient to these effects. It is predicted that the changes in substance use will depend on whether the substances are used primarily in social settings.

Non-treatment seeking cigarette dependent smokers will be randomized to one of four testing conditions: 1) a non-stressful task followed by neutral cues, 2) the non-stressful task followed by smoking cues, 3) a stressful task followed by neutral cues, or 4) the stressful task followed by smoking cues. Ten minutes after the intervention, participants will undergo a 60-minute extinction procedure consisting of smoking-related videos, images and smoking paraphernalia. Cue reactivity test sessions will take place 24 hours, 2 weeks and 6 weeks following the intervention.

COVID-associated changes in substance use will be quantified over three telephone interviews: one at the end of March / beginning of April 2020 (at the start of the pandemic), one at the end of April / beginning of May, and a final one which will be instituted if feasible once the infection rates and social distancing policies have decreased.

Eligibility Criteria:
Inclusion Criteria:

* Scoring 5 or higher on the Fagerström Test for Cigarette Dependence
* Willingness to abstain from smoking for 4 hours prior to each laboratory visit

Exclusion Criteria:

* Currently using cigarette cessation products
* Endocrinological problems
* Significant mental or physical health conditions
* Pregnancy