cyrilzakka/clinical-trials huggingface dataset:
Value of Cardiac Magnetic Resonance (CMR) Derived Parameters for Diagnosing Left Ventricular Non-compaction Cardiomyopathy

Left ventricular non-compaction (LVNC) is a rare cardiomyopathy characterized by numerous excessively prominent left ventricular (LV) trabeculation and deep intertrabecular recesses communicating with the ventricular cavity and severely altering myocardial structure. Although most authors assume a developmental arrest in embryogenesis as the underlying pathology, the mechanisms of LVNC are not fully understood yet. Several gene mutations have been identified to be linked with LVNC and an autosomal dominant inheritance pattern is frequent To date the most commonly used imaging tool for diagnosing LVNC is echocardiography applying the criteria established by Jenni and coauthors However, qualitative parameters to differentiate normal compaction of the myocardium in healthy subjects from LVNC or from other cardiomyopathies like dilative cardiomyopathy (DCM) or hypertrophic cardiomyopathy (HCM) may fail due to highly variable LV trabeculation. Therefore, absolute quantification should be performed. Cardiac magnetic resonance (CMR) has been reported as a promising imaging modality to characterize patients with LVNC as it provides both a high spatial resolution and a good contrast between trabeculation and blood pool Jacquier et al. recently described a value of trabeculated LV myocardial mass above 20% of the global mass of the LV to be highly sensitive and specific for LVNC However, in their approach, a substantial degree of the LV cavity was included into calculated trabecular LV mass and led to systemic overestimation of the latter. Furthermore, the role and prognostic value of myocardial scarring as assessed by delayed enhancement (DE) CMR was not evaluated.

The aim of the retrospective study was to establish revised and extended CMR criteria to distinguish LVNC from DCM, HCM and a group of healthy controls and to improve the assessment of trabeculated mass by excluding intertrabecular blood pool.


Eligibility Criteria:
Inclusion Criteria:

* left ventricular non-compaction cardiomyopathy
* dilatative cardiomyopathy
* hypertrophic cardiomyopathy or healty controls

Exclusion Criteria:

* contraindications for magnetic resonance imaging like pacemakers or other metallic implants
A Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala

A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health clinic as the unit of randomization. No external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts.

The package includes 3 interventions: 1) To train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a social marketing strategy that promotes institution-based delivery; and 3) To integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (TBA) and public health units. A fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.

Overall goal

To evaluate the impact of a package of three interventions aiming to increase institution-based delivery and improve emergency obstetric and neonatal care on perinatal mortality, in the four districts with the highest maternal mortality ratios in Guatemala.

Specific objectives

* Measure the impact of this intervention package on perinatal mortality rates.
* Measure the impact of this intervention package on the proportion of institution-based delivery among study facilities.
* Evaluate the processes and success of implementing this combined package of interventions by analyzing process indicators related to the intervention element designed to improve emergency obstetric and neonatal care (PRONTO: emergency obstetric and perinatal training program).

Primary outcome of interest:

1. Increase in the proportion of institutional deliveries in intervention vs. control clusters.
2. Decrease perinatal death rate in intervention vrs control clinics

Eligibility Criteria:
Inclusion Criteria:

* rural women
* indigenous
* poor
* Facilities at rural area
* Clinic attending vaginal deliveries

Exclusion Criteria:

* Facilities considered too close geographically to risk contamination of intervention to control facilities
* Clinics visits by pregnant women who present to intervention or control clinics for reasons other that an obstetric event
* Clinic or hospital visits by women who present to intervention or control clinics in the post partum period
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
2. Patients having radiographically confirmed vertebral (T4-L4) fractures
3. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients having secondary osteoporosis or another condition that presents low bone mass
2. Patients having findings on X-ray that affect evaluation of vertebral fracture
3. Patients that have been administered bisphosphonate derivatives
4. Other exclusion criteria as specified in the study protocol
Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale

The objective of the present study is to evaluate the effectiveness of postnatal depression screening by comparing the mental health outcome (at 6 months postpartum) of mothers under the Edinburgh Postnatal Depression Scale (EPDS) screening programme versus usual clinical practice (usual practice), using randomized controlled trial design. With the use of the EPDS for the screening of postnatal depression, it is expected that more mothers in need of intervention (including mental health intervention, guidance in childcare and parenting, counseling in family relationships, etc) will be picked up and offered appropriate intervention, compared to the usual practice. It is hypothesized that the mental health of the group of women under the EPDS screening programme will be better than those under the usual practice, on subsequent follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese mothers of newborn babies \<= 2 months who are registered with the 4 Maternal and Child Health Centres under study;
2. Normally resident in Hong Kong (Hong Kong ID card holder, or HK Birth Certificate \[with status of permanent resident indicated established\] holder, or people who have been granted unconditional stay in Hong Kong, or passport holders having valid travel document showing the right to land in Hong Kong, or permission to land, or eligibility of HK permanent ID card verified, or entitlement to the right of abode in HK)

Exclusion Criteria:

1. Those who do not use the Chinese language (in both the written and spoken form);
2. Those who are under active psychiatric contact;
3. Those who delivered in hospitals which are still conducting their own EPDS screening programme.
The Effects of Losartan on Reward Reinforcement Learning

This study aims to investigate whether a single dose of losartan (50 mg) can affect learning from positive and negative outcomes and its related neural mechanisms.

Emerging evidence suggests that the renin-angiotensin system can impact dopamine (DA) transmission and its modulatory role in reward processing. For instance, recent animal models have found that the angiotensin antagonist losartan reduces rewarding effects of methamphetamine and nicotine by modulating DA release in the striatum.The present study thus will investigate losartan effects on reward reinforcement learning and the underlying neural mechanisms. In a double-blind, between-subject, placebo-controlled design, 60 healthy male subjects will be randomly assigned to receive single-dose losartan (50 mg) or placebo, 90 minutes before performing a probabilistic reinforcement learning task during fMRI.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders
* Right-handedness
* Normal or corrected-normal version

Exclusion Criteria:

* History of head injury
* Medical or psychiatric illness
* Hypertension
* General cardio-vascular alteration or diseases
* Allergy against medications
* Visual or motor impairments
* Claustrophobia
* Drug addiction
* Nicotine dependence
* FMRI contradictions
A Clinical Trial With a Self-controlled, Multicenter, Pediatric EEG Intelligent Analysis System to Assist in Diagnosis

A diagnostic accuracy study on Artificial intelligence EEG analysis system assisted doctors to diagnose pediatric epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years old
* Children with suspected epilepsy

Exclusion Criteria:

* During EEG monitoring, the patients had other serious neurological diseases and mental diseases concurrently
* Used medication that affect EEG data within 3 weeks, such as sedatives and anti-epileptic medications
* Substandard data quality, such as data lack of key records, electrode connection discontinuity, insufficient recording time, or the presence of serious artifacts
* Incomplete or missing data
* Equipment or operational abnormalities, data for which EEG monitoring has not been performed continuously
Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate on Dentinal Hypersensitivity

Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing calcium sodium phosphosilicate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

A total of 131 subjects were divided into 3 groups randomly. Group I was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group II was given the dentifrice containing calcium sodium phosphosilicate and group III was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of hypersensitivity to hot, cold, sour stimuli on at least two teeth with a VAS score of ≥4.

Exclusion Criteria:

* Patients with active cervical caries or deep abrasion requiring cervical filling, chipped teeth or fractured cusps, tender tooth in same quadrant as the hypersensitive teeth, Subjects using any type of desensitizing paste or desensitizing therapy for last 6 months, Pregnant/ lactating women or subjects with history of chronic use of anti-inflammatory and analgesic medications were excluded.
Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Serum Bactericidal Activity Assay Development

This is a study to collect blood from volunteers to assist in assay development.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers aged 18-64

Exclusion Criteria:

* Bleeding disorder
Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with interleukin-6 may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.

OBJECTIVES:

* Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6.
* Determine the safety and optimal dose of this regimen in these patients.
* Determine the toxicity of this regimen in these patients.
* Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays.

OUTLINE: This is a pilot study.

Patients receive recombinant interferon alfa subcutaneously (SC) once daily. Beginning 1 month later, patients also receive recombinant interleukin-6 SC once daily. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of recurrent multiple myeloma
* Must have received ≥ 2 prior therapies

PATIENT CHARACTERISTICS:

* Performance status 0-3

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Teleheath tDCS Approach to Decrease Cannabis Use

The study aims to evaluate the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) in decreasing distress and cannabis use. 46 participants with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD) and elevated distress (K10 score of 10-35) will be recruited.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 21-65 (inclusive)
2. Seeking treatment to reduce or discontinue current cannabis use (smoke/vape/ingest)
3. Current Cannabis Use Disorder per DSM-V (MINI for DSM-V)
4. K10 score 10-35, inclusive (mild to high moderate distress)
5. Definite MS diagnosis, relapsing remitting (RRMS) subtype
6. PDDS score 0-7 (mild to moderate neurological disability, established to be able to complete procedures)
7. All medications stable for ≥ 1 month prior to enrollment and throughout the trial
8. Ability to understand the informed consent process and provide consent to participate in the study
9. Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed)
10. Ability to use mobile devices
11. Fluent in English language (due to outcomes validated in English versions only)
12. WRAT-4 score ≥ 85

Exclusion Criteria:

1. MS clinical relapse or use of high dose of steroids in the past month
2. Patients under medical marijuana use prescribed by a clinician
3. Alcohol, tobacco, or substance use disorder other than cannabis
4. Primary neurologic, psychiatric or other medical disorder other than MS (entry MD screening)
5. Currently meets DSM-V criteria for moderate or severe substance use disorder in the past 6 months for any psychoactive substance.
6. Meets DSM-V criteria for current panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, and any other psychotic disorder or organic mental disorder
7. Current suicidal ideation or deemed to be of potential risk of self-injury
8. History of traumatic brain injury
9. Seizure disorder or recent (\<5 years) seizure history
10. Metal implants in the head or neck
11. Enrolled in group or individual therapy for substance use disorder concurrent to intervention
12. Any skin disorder or skin sensitive area near stimulation locations
13. Pregnant or breastfeeding
Study on COPD Corticosteroid-induced Hyperglycemia on Clinical Outcome in Patients With COPD

Hyperglycemia is a common complication of corticosteroid (cortisone) therapy. It is estimated that more than a third of patients with chronic pulmonary disease (COPD) exacerbation (16). Despite its frequency, the impact of corticosteroid-induced diabetes on clinical outcome and mortality is not known. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2006 provided very little information on the prevalence and outcome of corticosteroid-induced diabetes in patients with COPD. Therefore, the present study aims to evaluate the impact of corticosteroid-induced diabetes on clinical outcome in patients with COPD exacerbation. We will perform a retrospective chart review of all patients admitted to the hospital with COPD exacerbation from 1/01/05 to 06/30/06 at Grady Memorial Hospital. Medical records of all patients with COPD exacerbation treated with corticosteroids will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.

Hypotheses:

We hypothesize that COPD patients with corticosteroid-induced hyperglycemia experience higher morbidity (infections, ventilator associated pneumonia, length of stay, acute renal failure) and mortality compared to COPD patients with normal glucose levels.

Specific Aim:

To determine the impact of corticosteroid-induced hyperglycemia on clinical outcome (length of stay, disposition, APACHE score, need for ventilatory support and ICU admission, mortality) in patients with COPD exacerbation.

Eligibility Criteria:
Inclusion Criteria: Patients admitted with COPD exacerbation
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers

This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).

To assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Able and willing to provide informed consent.
3. Able and willing to comply with protocol visits and procedures.
4. A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.

Exclusion Criteria:

1. Ulcer of a non-venous hypertensive pathophysiology.
2. Known or suspected allergy to any of the components of MEBO.
3. Malignancy on target ulcer limb.
4. Received another investigational device or drug within 30 days of enrollment.
5. Non-compliance in the screening or run-in period.
Evaluation of a Tdap-IPV (Tetanus, Diphteria, Pertussis and Inactivated Polio) Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older

In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively.

The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older.

Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years or older
* Patients capable of understanding and giving informed consent to participate in the study
* Valid social security coverage

Exclusion Criteria:

* Patients under judicial safeguard measures
* Refusal to participate in the study
* Vaccination contra-indication
* Patient already included in the study
The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence

The primary aim of this study is to assess the effect of ConquerFear, a metacognition-based manualized intervention on fear of cancer recurrence, using the randomized controlled trial approach, among Chinese patients newly diagnosed with curable cancer. This study aims to (1) test the direct effect of ConquerFear intervention on fear of cancer recurrence and on maladaptive metacognition, and (2) to test the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

A randomized controlled trial will be conducted to test the effect of a metacognition-based manualized intervention on fear of cancer recurrence among Chinese breast, gynecologic and colorectal cancer patients with high levels of fear of cancer recurrence.

The aims are to test:

1. the direct effect of ConquerFear intervention on fear of cancer recurrence,
2. the direct effect of ConquerFear intervention on maladaptive metacognition
3. the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

Primary hypothesis:

1. Participants in the ConquerFear intervention will show a greater reduction in fear of cancer recurrence compared to participants in the control group
2. Participants in the ConquerFear intervention will show a greater reduction in maladaptive metacognition than the control participants
3. There will be an indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

Eligibility Criteria:
Inclusion Criteria:

1. Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with non-metastatic breast cancer, gynecologic cancer, or colorectal cancer
2. had surgery as a primary treatment
3. have had completed hospital-based adjuvant treatments including radiotherapy and chemotherapy within the past 18 months
4. with the cut-off scored ≥ 13 on Severity, the subscale of Fear of cancer inventory
5. are able to read and write Chinese
6. are over the age of 18 years

Exclusion Criteria:

1. non-Chinese ethnicity
2. Patients diagnosed with metastatic cancer
3. with a current diagnosis of depression or psychosis
4. currently receiving psychological treatment
5. with language difficulties or intellectual disability.
What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia

This project proposes to conduct the first study of the predictive utility of olfactory hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The information gathered from the project is of considerable public health relevance, in that, through simple, reliable olfactory assessment, it will provide knowledge about which individuals are most likely to benefit from these psychosocial interventions. Such information is crucial for tailoring existing interventions and developing new approaches to optimize outcomes in schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 to 65;
2. DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder

Exclusion Criteria:

1. the presence of a current organic brain syndrome;
2. a current and severe substance use disorder (DSM-5);
3. intellectual disability (DSM-5)