cyrilzakka/clinical-trials huggingface dataset:
Psychometric Evaluation of the Traditional Chinese Version of Resilience Scale-14

This study will aim to translate the original RS-14 (English version) into traditional Chinese. It will then test the psychometric properties of the newly translated RS-14 to examine its factorial structure using both exploratory factor analysis (EFA) and CFA.

Mental health problems in adolescents reflect a global problem that is becoming more prevalent in Hong Kong. In Hong Kong, there is a significant change in family structure to small nuclear families. Children receive more attention and may even be overprotected by parents. Also, parents' great expectations for high academic achievement also contribute to the increase in mental health problems among adolescents in Hong Kong. The Polytechnic University and the Christian Family Service Centre conducted a mental health survey study of 12,518 Form 1 to Form 7 pupils from 2011 to 2014. Of the respondents, 62.1% demonstrated slight to very serious depression symptoms. Evidence has shown that depressive symptoms predict suicidal tendencies among adolescents.

Resilience effectively prevents the development of mental health problems and is associated with positive mental health outcomes in adolescents. Assessing resilience in adolescents is therefore crucial for developing a thorough understanding of their responses to stress and adversity. The literature reports various instruments used to assess resilience, such as the Connor-Davidson Resilience Scale (CD-RISC) and the Resilience Scale (RS). And translated version of RS-14 is also developed because of linguistic and cultural differences.

The proposed study will aim to translate the original RS-14 (English version) into traditional Chinese. It will then test the psychometric properties of the newly translated RS-14 to examine its factorial structure using both exploratory factor analysis (EFA) and CFA. Furthermore, using the newly validated RS-14, a survey will be conducted to assess the resilience level of a large sample group of Hong Kong Chinese adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Form 1 students (Grade 7, 12 to 13 years of age) from six secondary schools

Exclusion Criteria:

* Those with chronic illnesses or identified cognitive or learning problems will be excluded.
Clinical Investigation to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions

This is an open, single arm, prospective clinical investigation to evaluate the performance of CONNETTIVINA HI TECH, in terms of safety and efficacy in the management of superficial cutaneous lesions. The study will be conducted in one center, in Italy and will enroll 50 subjects . Subjects will be followed until confirmation of complete wound closure, and for a maximum of 26 days, with a follow up of 4 days after re-epithelization will be confirmed.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Male or female ≥ 18 and ≤ 85 years
* Having a superficial cutaneous lesion of different etiology, with the following characteristics:

Wound bed appearance of grade ≥15 of WBS (Wound Bed Score: Falanga 2006) Absence of clinical signs or symptoms of local infection (as defined by CDC/NHSN) Size: between 5 and 32 cm2 that can be covered by a dressing of 4x8cm

* In case of multiple lesions per patient, only one lesion will be considered for the treatment (the better choice for self-evaluation of lesion by patient)
* Patient able to maintain a Patient's Diary during the study
* Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing and able to comply with the study requirements
* Ensured compliance of subjects for the study period

Exclusion Criteria:

1. Patients who not sign the informed consent form
2. Patients with non-superficial wounds exposing bones, tendon or muscle bundles.
3. Patients with WBS score under or equal to 14 ("severe exudate amount", or "moderate exudate amount" and "moderate per-wound dermatitis" or "moderate callous peri-wound")
4. Presence of signs of infection as defined by CDC/NHMS
5. History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
6. Uncontrolled congestive heart failure
7. Active malignant disease
8. Active sickle cell disease
9. Patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
10. Known allergy to any of the devices' constituents
11. Women who are pregnant, breastfeeding or who have not reached menopause and are not abstinent or practicing an acceptable means of birth control as determined by the Investigator for the duration of the study
A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures

Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.


Eligibility Criteria:
Inclusion Criteria:

* Gustilo type II-IIIa tibia fracture
* age greater than 15 years
* fractures amenable to intramedullary nailing

Exclusion Criteria:

* excessive wound contamination
* patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention
* impaired or absent consciousness
* refusal of consent
Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors

This study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. Results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Black or Hispanic
* Age 18 years or older
* English or Spanish speaking
* Patients who have had an ischemic or hemorrhagic stroke
* Modified Rankin scale score of ≤ 3
* Average screening SBP ≥ 140 mm Hg from three BP readings taken at two separate visits with a validated automated device
* Receiving care at the study site for at least 6 months and planning to continue receiving care at the site for the next two years.

Exclusion Criteria:

* Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks including using the HBPTM or interacting with the NCM if he/she were to be randomized to the intervention group)
* Participation in other clinical trials
* Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record)
* Patients with upper arm circumference ≥ 52 cm, the maximum limit of the extra-large BP cuff
* Diagnosis of dialysis or end stage renal disease
* Relocating out of area or extended travel during study period
* Significant verbal speech impairment; unable to participate in intervention telephone sessions
* Pregnant women
Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma

Early stage diagnosis of gastric cancer has ensued different approaches in its resection strategies. In order to increase the proportion of cases that undergo radical resection and reduce the recurrence rate, different pre-operative treatments are introduced. Here, the investigators investigate an active preoperative chemotherapeutic regimen to in patients with locally advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Tissue diagnosis of gastric or gastroesophageaql junction Adenocarcinoma
* T3, T4 any N with non metastatic condition
* Age 18 - 70 years
* Performance status 0,1 according to ECOG criteria
* Adequate bone marrow , liver and renal function
* Hemoglobin ≥ 11 g/dl
* Platelets ≥ 100000 / mm3
* Absolute Neutrophil Count ≥ 1500/mm3
* Normal Bilirubin
* Normal Transaminases
* Normal creatinin
* Absence of active co-morbid illness (uncontrolled infection, uncontrolled DM, cardiopulmonary disease)

Exclusion Criteria:

* Any metastatic disease, T1, T2, N0
Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis

This is a three-week crossover study that will compare how the body absorbs and tolerates two different forms of lipoic acid: R form and racemic form.

This three-week double-blind crossover trial will compare two different forms of lipoic acid (LA). Every participant will take one week of daily oral 600mg R LA, have a one week washout period without LA, and take one week of daily oral 1200mg racemic LA. The order of LA type will be determined by randomization. Blood analyses will be performed to determine which form is better absorbed and a side effects questionnaire will be completed at each visit in order to determine which form is better tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Progressive Multiple Sclerosis
* 18 years of age or older
* Able to give informed consent and adhere to the study activities
* Able to swallow large oral capsules

Exclusion Criteria:

* Clinical Multiple Sclerosis relapse in the prior 1 year
* Oral or IV steroids in the prior 3 months
* Have taken LA in last 30 days
* Clinically significant kidney disease as determined by the PI including, but not limited to, major kidney disease diagnoses, abnormal laboratory values related to renal function, or other related conditions
* Insulin-dependent diabetes
* Other significant ongoing medical illness that may interfere with study procedures
* Taking oral anticoagulants (e.g. Coumadin). Aspirin, clopidogrel, and dipyridamole are acceptable to take
* Pregnant or breast-feeding
* Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study
HEmiplegia Arrhythmia Retrospective Trial

Alternating Hemiplegia of Childhood (AHC) is a rare and severe disease that is in need of effective, and hopefully even curative, therapies. Afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, frequently severe developmental and psychiatric/psychological disabilities and other comorbidities, such as cardiac disturbances. Recent data indicate that AHC genotype is in relation to cardiac repolarization troubles and to cardiac arrhythmias. The primary hypothesis to explore is that there is an association between genotype and cardiac phenotype in AHC.


Eligibility Criteria:
Inclusion Criteria:

* Patients that meet the clinical diagnostic criteria (Aicardi et al, 1995) for typical alternating hemiplegia with or without identified mutations in ATP1A3.
* At least one ECG study is required.
* Patients ages yearand more

Exclusion Criteria:

* Informed consent or assent not obtainable
* ATP1A3 testing not performed
* No ECG studies are available
Oxidized Cellulose hEmostAsis evaluatioN

The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some countries marketed as Tabotamp®)


Eligibility Criteria:
INCLUSION CRITERIA AT SCREENING:

1. Participants and/or legal representative has/have provided signed informed consent. An assent form should be signed by Participants less than 18 years of age, if possible;
2. Participants undergoing planned (non-emergency) open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery;
3. Participants of childbearing potential present with a negative serum pregnancy test, and agree to employ adequate birth control measures for the duration of the study. Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products;
4. Participants are willing and able to comply with the requirements of the clinical investigation plan (CIP).

   INCLUSION CRITERIA INTRA-OPERATIVE:
5. Soft tissue, vascular/anastomotic or parenchymal bleeding is present after primary surgical hemostasis has been achieved. The TBS is defined as intra-operative bleeding where conventional methods for achieving hemostasis are ineffective (based on the type of tissue) or impractical (based on the location) and where treatment with topical hemostatic adjuncts such as Traumastem is deemed appropriate for use.

EXCLUSION CRITERIA:

1. Emergency surgery;
2. Transplantation surgery;
3. Minimally invasive surgery;
4. Neurological and ophthalmological surgery;
5. Major arterial bleeding at the target bleeding site (TBS);
6. Major intra-operative complications that require resuscitation or deviation from the planned surgical procedure;
7. Severe local inflammation at the operating field;
8. Any prior radiation therapy to the operating field;
9. Known severe congenital or acquired immunodeficiency (eg, human immunodeficiency virus \[HIV\] infection or long-term \[\> 3 months\] treatment with immunosuppressive drugs);
10. Known hypersensitivity to components of the investigational device;
11. Participant is pregnant or lactating at the time of enrollment or becomes pregnant prior to the planned surgery. If the participant becomes pregnant during the 30 days following treatment exposure, attempts will be made to follow her through completion of the pregnancy. The investigator will record a narrative description of the course of the pregnancy and its outcome;
12. Participant has a clinically significant medical, psychiatric, or cognitive illness, or drug/alcohol abuse that, in the opinion of the investigator, would affect participant's safety or compliance;
13. Participant has participated in another clinical study involving an investigational device/drug within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational device/drug during the course of this study.
Effectiveness of TENs Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients

To study the effectiveness of transcutaneous electrical nerve stimulation (TENS) combined with occupational therapy on restoring the function of the weakened limb in subacute stroke patients.

To study the effectiveness of transcutaneous electrical nerve stimulation (TENS) combined with occupational therapy on restoring the function of the weakened limb in subacute stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with a first-ever stroke, presenting with unilateral weakness and accompanying arm weakness, in the subacute phase (2 weeks - 6 months).
* Able to follow commands and cooperate in an active training program.
* Patients must consent to participate in the research project by signing a consent form.
* Aged between 18 and 80 years.
* Exhibiting mild to moderate muscle spasticity (Modified Ashworth Scale \< 3).

Exclusion Criteria:

* Patients with other neurological disorders, such as traumatic brain injury or spinal cord injury, or those experiencing severe complications from treatment.
* Unable to tolerate the use of TENS.
* Contraindications for using TENS, such as having a pacemaker or infected skin lesions.
* Unstable or uncontrolled vital signs or other comorbidities.
* Communication difficulties that prevent following commands or cooperating in training.
* Participants who refuse or withdraw from the research.
Early Immunotherapy with Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients with Anti-Hu-associated Paraneoplastic Sensory Neuronopathy

Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* "Possible" sensory neuronopathy according to the criteria of Camdessanché et al. \[2\] with ONLS score ≥ 1
* Dominant picture of sensory ataxia (damage to the central nervous system and/or the neuromuscular junction is allowed, provided that it has a minor impact on the patient's disability)
* Positive anti-Hu antibodies in blood and/or cerebrospinal fluid
* Outpatient (modified Rankin Score (mRS) 2 or 3)
* Onset of neurological symptoms less than 3 months ago
* Free, informed, written and signed consent
* Affiliation to a social security or beneficiary scheme (except AME)

Exclusion Criteria:

* Known hypersensitivity to one of the treatments under study, to their metabolites, or to one of the excipients
* Absolute contraindications to IVIg: selective IgA deficiency, known thrombophilia, patients suffering from type I or II hyperprolinemia, hypersensitivity to human immunoglobulins
* Absolute contraindications to cyclophosphamide: vaccination against yellow fever in the 3 months preceding inclusion, acute urinary infection, pre-existing hemorrhagic cystitis, urinary tract obstruction, acute bone marrow failure
* Contraindication to methylprednisolone: live vaccines, or live attenuated vaccines within 3 months, infectious state or evolving virus (hepatitis, herpes, chickenpox, shingles)
* More than two courses of IVIg administered within 3 months before recruitment
* Other concomitant immunotherapy
* Other cause of immunosuppression (acquired or congenital)
* Treatment with checkpoint inhibitors in progress or completed less than 3 months previously
* Woman or man without effective contraception
* Pregnant or breastfeeding woman
* History of psychiatric or general illnesses that may contraindicate treatment
* Patients unable to complete the follow-up required by the study
* Patients under guardianship or curatorship
* Patient deprived of liberty by a judicial or administrative decision
Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Dyspnea is a symptom that is growing in incidence, as respiratory and heart diseases are becoming more frequent. Patients suffering from dyspnea have a significant disabling due to chronic refractory dyspnea and crisis of irruptive dyspnea. Although there are several tools that may produce an improvement of symptom intensity, they are underused.

We sought to investigate whether if teaching interventions specifically addressed to medical staff improve the well-being of dyspneic patients. The MAIN GOAL of this study is to evaluate the effect of two talks (conveyed to doctors and nurses of Cardiology and Respiratory Medicine Departments) on the patient-perceived dyspnea. The contents of these talks will be prepared and supervised by Palliative Care specialists.

This is a four-staged study that includes a first observational phase (prevalence study of dyspnea) followed by intervention and a third phase that will determine the effect of this teaching intervention. The fourth phase consists in the elaboration of specific protocols for management of dyspnea.

A pharmacovigilance study of opioids will also take place.

Eligibility Criteria:
Inclusion Criteria:

* Hospital admission with dyspnea as main symptom
* Acceptance of participation in the study
* Diagnosis of Chronic Respiratory Disease
* Diagnosis of Chronic Heart Failure
* Chronic Refractory Dyspnea higher than 1/10 and Irruptive Dyspnea higher than 2/10 degree by Rating Numerical Scale

Exclusion Criteria:

* Cognitive Impairment
* Voluntary dropout.
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* At least 18 years of age
* Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation
* Subject had a baseline ATIII level of less than 100% and equal to or above 60%
* Subject signed the informed consent form
* Subject was willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study

Exclusion Criteria:

* Documented congenital ATIII deficiency or ATIII levels below 60%
* Subject had a baseline ATIII level of 100% or higher
* Subject needed emergency (non-elective) surgery
* Subject needed heart transplantation
* History of anaphylactic reaction(s) to blood or blood components
* Allergies to excipients
* Subject was pregnant
* Subject had any medical condition that according to the investigators judgment worsens the surgical outcome above the expected
* Subject had any medical condition which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment
* Subject had participated in any another investigational study within the last 30 days previous to the inclusion