cyrilzakka/clinical-trials huggingface dataset:
Observatoire Des Patients Atteints De Laminopathies Et Emerinopathies (Observatory for PAtients with Laminopathies and Emerinopathies)

Laminopathies and emerinopathies are complex group of rare disorders due to mutations in A-type lamins (LMNA) and Emerin (EMD) genes. Among them, disorders affecting skeletal and/or cardiac muscles are the most frequent clinical manifestations, with cardiac disease being a major cause of death. Remarkable progress has been made in the description of the clinical and genetic spectrum of these diseases since the 1990's. Until now, precise phenotype/genotype relations remain elusive. As for several other neuromuscular disorders, apart from symptomatic treatments, there is currently no specific treatment to prevent or slow down the progression of the disease. The OPALE registry is a multicentre web-based registry dedicated to laminopathy and emerinopathy French patients. OPALE has been approved by ethical and regulatory authorities. Its main inclusion criteria is the presence of a proven pathogenic LMNA and/or EMD gene mutation.

The OPALE objectives are to provide a tool allowing detailed capture of patient genetic, neurological, cardiological, endocrinological and respiratory assessments, in order to allow i) precise disease natural history, ii) evaluation of different disease complication frequency and iii) identification of prognosis factors.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a proven pathogenic LMNA and/or EMD gene mutation
* Regular followup in France.
* Signed informed consent

Exclusion Criteria:

-Refusal to sign an informed consent.
Development and Verification of a Screening Tool for Comprehensive Geriatric Assessment of Elderly Tumor Patients

This study is an observational research. 1. The Delphi method is used to screen the evaluation dimensions of the CGA screening tool and determine the most suitable assessment questions/items. 2. Conduct a CGA for elderly cancer patients, including the evaluation content of the dimensions above. Analyze the items selected in the first round of screening to determine the optimal items for the screening tool; develop screening tool 1.0 by assigning weights and setting thresholds for each item. 3. Investigators use the initially formed screening tool to conduct one-on-one patient testing and consult with a clinical expert panel to provide feedback on the tool's clarity, relevance, clinical applicability (localization), and feasibility, refining and improving its content and management process, leading to the revision of screening tool 2.0. 4. Validate the reliability and validity of the screening tool to ensure the stability, reliability, and effectiveness of the scale tool in practical application. 5. Evaluate patients using both the G8 and the screening tool, conducting external validation of screening tool 2.0 against G8 as a benchmark, further assessing the sensitivity, specificity, and accuracy of the screening tool. 6. Clinical validation of the screening tool. Follow up with patients involved in the assessment during the study, comparing different evaluation results with the efficacy of anti-tumor treatment and the risk of related adverse reactions, exploring the predictive ability of the CGA screening tool for anti-tumor treatment. The research data is sourced from the electronic medical record database and hospital information system of Sichuan Cancer Hospital, collecting clinical pathological characteristics from medical records, including gender, age, clinical stage at diagnosis, and information related to anti-tumor treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65 years old
2. There are clear pathological data to diagnose malignant tumors, and follow-up anti-tumor therapy is determined in this institution
3. Have a certain enthusiasm for this study, and voluntarily participate in this study

Exclusion Criteria:

1. Unable to understand the content of the research
2. Unable to cooperate with CGA and screening assessments
Fimasartan Optimal Reduction Targeting Elevated Blood Pressure: the FORTE Study

The purpose of this study is to evaluate the effect of home blood pressure monitoring on controlling blood pressure and correlation between home blood pressure and clinic blood pressure in hypertensive patients receiving two or more concomitant antihypertensive agents including fimasartan

A multi-center, cluster-randomized, prospective, observational study

Eligibility Criteria:
Inclusion Criteria:

* Subjects who voluntarily signed informed consent for participating in this clinical study
* Male and female over the age of 19
* Hypertensive patients receiving two or more concomitant anti-hypertensive agents including fimasartan

Exclusion Criteria:

* Renal dialysis patients.
* Diabetic nephropathy patients taking angiotensin-converting enzyme inhibitor.
* Severe renal disorder
* Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* Medical history with hypersensitivity to Fimasartan
* Pregnant women or lactating female.
* Participate in another clinical trial.
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.

The patient will conduct functional testing and answer questionnaires.

The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.

To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.

Eligibility Criteria:
Inclusion:

* Clinical condition included in the approved Indications For Use for the iTotal CR
* Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment
* Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
* \> 18 years of age

Exclusion:

* Subject will require a simultaneous bilateral procedure
* Other lower extremity surgery within 1 year
* Severe (\> 15º) fixed valgus or varus deformity
* Severe (\> 15º) extension deficit
* Severe instability due to advanced loss of osteochondral structure
* Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified
* Insufficient bone stock on the femoral or tibial surfaces
* Contralateral knee replacement surgery within the past 6 months
* BMI \> 40
* Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
* Poorly controlled diabetes (defined as HbA1c \>7 or surgeon discretion)
* Immunocompromised
* Other physical disability affecting the hips, spine, or contralateral knee that limits function
* Disabling chronic pain with narcotic dependence
* Compromised PCL or collateral ligament
* Prior history of failed implant surgery of the joint to be treated, including Unicompartmental Knee Arthroplasty (UKA), or Bicompartmental Knee Arthroplasty (BKA)
* Prior history of failed high tibial osteotomy (HTO)
* Participation in another clinical study which would confound results
* Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
Comparative Safety Study of New Sinecort Formulation Versus Positive Control

The study is focused to prove a favorable safety profile of the new formulation.


Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years
* Skin type I, II, or III according to Fitzpatrick
* Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.

Exclusion Criteria:

* Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.
* Known skin allergies.
* Dermatologic diseases that might interfere with the evaluation of test site reaction.
* Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.
* Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial
* Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device.
* Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, ß-receptor blocking drugs, antihistamines) should not be used.
Understanding and Overcoming the Racial/Ethnic Inequalities in COVID-19 Vaccination Acceptance

With the constant threat of new epidemic waves and the emergence of variants, COVID-19 resilience can only be attained when a sufficient level of immunity is achieved. Yet, in the US and the UK, COVID-19 vaccination campaigns have failed to secure consistent vaccination acceptance in racial/ethnic minority communities. Despite racial/ethnic minorities being more at risk from COVID-19, they are less vaccinated than the White majority. The investigators propose that current vaccination invitation messages are deemed less trustworthy by racial/ethnic minorities than the White majority and that this might partly explain reduced vaccination acceptance. To provide causal evidence of the role of trust and actionable insights, the investigators will experimentally assess the benefits of new invitation messages to receive the COVID-19 booster dose in large, racially/ethnically diverse samples in the US and the UK. Results will evidence how to increase message and source trustworthiness to foster trust and vaccination acceptance across racial/ethnic groups.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* if participants complete the study in less than 5 minutes
* if participants complete the study without paying attention (as indicated by their answers to two attention check questions)
Telemedicine Enabling Patients in Self-care Behaviors

The purpose of the study is to see if monthly telemedicine computer visits (visits using the computer) improve the time it takes to identify and treat an arrhythmia. The second purpose is to see if monthly telemedicine computer visits improves the participant's understanding of the arrhythmia and improves how the participant feels with daily activities.

Study will utilize the Telemedicine group and the Standard Visit group (30 patients each group) to determine

Endpoints:

1. Time of recognition, time of diagnosis and time of intervention for arrhythmia. These times will be noted for each patient in each group and look for any difference in these times based upon gaining information from telemedicine visits versus 6 month follow up visit.
2. Three surveys of patient Self efficacy of medications, activity, and arrhythmia knowledge utilizing three surveys in each group. Surveys will be answered at the start of the study and end of the study by every patient within each group.

Surveys:

MUSE- Medication Understanding and Self Efficacy Tool Shortened FSES- Functioning self efficacy scale ASTA- Arrhythmia specific symptoms and health related quality of life in connection with heart rhythm disturbance

Eligibility Criteria:
Inclusion Criteria:

* Read and speak English
* 18 years of age or older
* Have a cardiac arrhythmia diagnosis
* Are willing to participate in the study and answer a pre and post survey.

Exclusion Criteria:

* Any difficulty in understanding the study
* Does not have internet or a cell phone data plan
* Any life threatening arrhythmias
* Objection to working with nurse practitioners and physician assistants
Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology

This study highlights the global management of the various components of outpatient pain by hypnoanalgesia (pain management by hypnosis) in radiopediatrics.

Indeed, pain is induced by sclerosis of cutaneous angiomas in interventional radiology. It is managed by MEOPA (an equimolar mixture of oxygen nitrous oxide) or by general anesthesia.

For four years, the medical electroradiology technologist of the Mother and Child Hospital (HFME) of the Hospices Civils de Lyon offer patients in addition a pain management by hypnoanalgesia.

The investigator propose a multicenter open randomized study comparing two pain management strategies, in children aged 7 to 18 years treated for cutaneous angioma by sclerosis in interventional radiology at the HFME. The two strategies studied are: Hypnoanalgesia and MEOPA (the reference strategy).

The main objective is to evaluate the efficacy of hypnoanalgesia compared to the standard of care of pain, which is the use of MEOPA, in the treatment of sclerosis of cutaneous angioma in pediatric interventional radiology.


Eligibility Criteria:
Inclusion Criteria:

* Child requiring a first treatment with sclerosis cutaneous angioma whose location allows treatment in interventional radiology room,
* Child from 7 to 18 years old on the day of treatment,
* Free and informed consent of the child and his parents (or legal representative),
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Child under tutorship or guardianship,
* Child suffering from severe psychotic disorders or under psychotropic drug treatment,
* Child who has already had angioma sclerosis in the interventional radiology room. Indeed, the child can remember a previous support and have a priori, positive or negative, on the new support (memory bias),
* Child not speaking French,
* Deaf child or hearing impaired not allowing easy listening
EEG Biomarkers for Predicting Response to Antidepressant Therapy

The purpose of this study is to evaluate the potential early EEG predictors of an individual's response to treatment with antidepressant medications.

Objectives:

* Prospectively confirm accuracy of current EEG biomarker algorithm
* Determine preferred clinical intervention for subjects with negative indicator
* Identify predictors of worsening suicide ideation

According to recent clinical studies sponsored by the NIH, fewer than half of subjects diagnosed with a major depressive episode respond to the first trial of an antidepressant medication. While the majority of subjects eventually respond to treatment with an antidepressant, failure with the first line medication puts subjects at increased risk for never receiving adequate treatment of their depression.

Several lines of reasoning support the rationale for further investigating EEG as a means of predicting response and resistance to antidepressants. Prior studies suggest that changes in neuronal activity in the anterior cingulate and prefrontal regions are related to depression and that changes in brain response to treatment may also produce alterations that can be detected by recoding frontal EEG activity.

In this protocol, we proposed to identify possible neurophysiologic indicators of treatment outcome in depression, particularly indicators of brain response that appear early (within 7 days) during treatment with antidepressants. We will test whether quantitative EEG (QEEG) biomarkers can be reliably associated with response or non-response to treatment with antidepressant medications, using both monotherapy and combination drug treatments.

Comparison(s):

Selecting the best treatment for subjects with resistance to an initial antidepressant poses a considerable challenge for clinicians. The most widely prescribed antidepressants usually require 4-6 weeks of therapeutic dosing before a marked clinical improvement in symptoms is observed. Therefore, determining the optimal regimen can take several weeks or months for subjects who are resistant to the first line antidepressant. A tool for predicting eventual clinical response to antidepressants could help inform and accelerate the process of identifying the most efficacious treatment option for a given subject.

Eligibility Criteria:
Inclusion Criteria:

* Subject has diagnosis of Major Depressive Disorder

Exclusion Criteria:

* Subject is suffering from cognitive, bipolar, or psychotic disorder
* Subject has had a course of ECT within the past six months
* Subject has any known contraindication for use of any of the study drugs
* Subject has a known drug dependency or substance abuse within the past six mon ths
* Subject is currently pregnant or not using a medically acceptable means of birth control
Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma

RATIONALE: Diagnostic procedures may improve the ability to detect the presence or recurrence of disease.

PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood of patients who have melanoma.

OBJECTIVES:

* Determine the feasibility of performing reverse transcriptase-polymerase chain reaction (RT-PCR) for five different tumor antigen genes using lymph node samples or peripheral blood from patients with melanoma.
* Determine the ability of PCR-positive lymph nodes or peripheral blood to predict relapse of disease in these patients.
* Determine the correlation of positive PCR results from peripheral blood with disease stage.

OUTLINE: Lymph node biopsies or peripheral blood are obtained from patients. These specimens are examined by nested reverse transcriptase-polymerase chain reaction (RT-PCR) and analyzed for various tumor antigens.

Patients may choose to be told the results of this testing, but the results do not influence or change the planned therapy. Brief counseling is required to discuss the results and their potential implications.

Patients are followed for at least 2 years.

PROJECTED ACCRUAL: A total of 30 patients for the lymph node portion and 80 patients (20 per stage of disease) for the peripheral blood portion will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Clinically proven melanoma with indication to perform sentinel lymph node biopsy or elective lymph node dissection OR
* Histologically proven or diagnosis highly suspicious for melanoma

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Platelet count greater than 50,000/mm\^3
* Hemoglobin greater than 7 g/dL

Hepatic:

* PT less than 15 sec
* PTT less than 30 sec

Renal:

* Not specified

Other:

* No psychiatric illness that precludes compliance
* No other concurrent malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Effects of Electro Dry Needling Versus Dry Needling in Levator Scapulae Syndrome

Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. The aim of study will be to compare the effects of Electro Dry Needling and Dry Needling on pain, muscle strength, disability and range of motion in patients with Levator Scapulae Syndrome.

A Randomized Clinical Trial will be conducted at Shalamar Hospital, (SIHS Physiotherapy Clinic Lahore) through convenience sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will receive Electro Dry Needling along with conventional physiotherapy in which parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated and Group B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes. Standard Physiotherapy will include a Hot pack (10 min), Stretching of levator scapulae (3 times with 30 second hold), and Scapular stabilization exercises (10 times with 5 second hold).There will be 3 sessions per week, Needling in both groups will be for performed 2 times per week for total 3rd week of treatment comprising of 6 sessions, 3rd session will comprise of standard physical therapy. Pre and Post treatment measures will be recorded.Outcome measures will be conducted through pain, \*muscle strength,\* disability and range of motion questionnaire. Data will be analyzed during \*SPSS software version 25.After assessing the normality of data by the Shapiro-Wilk test, it will be decided whether a parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age ranges of 18-45 years
* Both genders, males and females
* Positive Levator Scapular length Test (7)
* Positive Simon's criteria for Levator scapulae
* Neck pain -NPRS \< 7 (8)
* Neck and upper back pain for at least 3months.
* Examination - Increased muscle tone and tenderness at neck and upper back
* Reduced ROM-Side flexion and Rotation of neck
* Non traumatic unilateral mechanical neck pain of three or more months of duration, presenting an latent MTrP in the levator scapulae muscle on the painful side

Exclusion Criteria:

* Neuropathies
* Radiated pain towards the arm
* Vertebral fractures
* Traumatic neck injury
* whiplash injury (9)
* previous surgical procedures in the cervical spine
* Previous cognitive and functional disorders
* psychological disorders (mood and psychotic disorders such as schizophrenia, depression,and anxiety disorders),
* Fibromyalgia
Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy

Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction.

the use of antifibrinolytics (AFs) to limit blood loss peri-operatively has been popularized in certain subspecialties. AFs have been studied extensively in adults undergoing various orthopedic procedures including spine and total joint arthroplasty, and have been proven to reduce blood loss and reduce the risk of blood transfusion. Similarly, AFs are used in pediatric patients undergoing cardiac surgery as well as craniofacial operations. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that works by reversibly blocking plasminogen and thereby promoting hemostasis through the prevention of fibrin degradation. Current literature investigating the safety and effectiveness of TXA in children undergoing orthopedic procedures is limited.

We hypothesize that patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA.

Eligibility Criteria:
Inclusion Criteria:

* ASA I - II
* Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.

Exclusion Criteria:

* Patient's guardian refusal to participate in the study.
* Children known to have pre-existing bleeding or coagulation disorders.
* Children with anemia; defined according to (WHO ) cutoffs as Hb level\<11g/dl for girls and \<12g/dl for boys
* History of epilepsy.
* History of renal insufficiency or failure