cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy

This single-center, prospective, open-label, randomized, controlled clinical trial is designed to assess the efficacy and safety of the Thoracoscopic Morrow procedure in the treatment of hypertrophic obstructive cardiomyopathy. The primary objectives include investigating:

Question 1: The efficacy and safety of two surgical modalities in patients presenting with left ventricular outflow tract obstruction and mid-left ventricular hypertrophy.

Question 2: The impact of the two surgical procedures on hemodynamics in patients with left ventricular outflow tract obstruction, mid-left ventricular obstruction, and in individuals with or without organic valvular lesions.

Question 3: The effects of the two surgical procedures on exercise capacity, quality of life, and long-term prognosis among patients with left ventricular outflow tract obstruction and central left ventricular obstruction, both with and without valvular lesions.

Participants will be stratified into two groups. The experimental group will undergo thoracoscopic Morrow surgery, while the control group will undergo median open modified enlarged Morrow surgery.

This study is a single-center, prospective, open-label, randomized, controlled trial designed to investigate the therapeutic value of thoracoscopic Morrow procedure in patients with hypertrophic obstructive cardiomyopathy (HOCM). The study focuses on HOCM patients, with the modified extended Morrow procedure via median sternotomy considered as the 'gold standard treatment' in the control group. The objective is to explore the efficacy of the thoracoscopic Morrow procedure in improving exercise tolerance in HOCM patients, assess the short-term and long-term effectiveness, safety, as well as changes in cardiac function, cardiac structure, and myocardial fibrosis levels associated with thoracoscopic Morrow procedure in treating obstructive HOCM.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with hypertrophic cardiomyopathy (HCM);
* age ≥18 years old;
* presence of left ventricular outflow tract/mid-ventricular obstruction, with a resting left ventricular outflow tract pressure gradient/left ventricular cavity pressure gradient ≥50 mmHg; significant symptoms persist despite optimal medical therapy, and surgical evaluation indicates the need for intervention;
* left ventricular ejection fraction (LVEF) ≥55%;
* signed informed consent, willing and able to return to the hospital for follow-up.

Exclusion Criteria:

* previously underwent septal reduction therapy (including surgical or interventional procedures);
* received or planning to receive an implantable cardioverter-defibrillator (ICD) in the past 3 months;
* individuals with concomitant conditions requiring simultaneous surgical intervention;
* New York Heart Association (NYHA) functional class IV;
* unwilling to undergo surgical treatment;
* pregnant or lactating or planning pregnancy;
* previously participated in other clinical trials before enrollment;
* individuals with concurrent diseases with an expected lifespan of less than 1 year.
Cambridge Liquid Biopsy and Tumour Profiling Study for Patients on Experimental Therapeutics Trials

This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive factor of response/resistance to anticancer treatment. The project will involve the collection and study of the archived tumour tissue where available (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) from patients taking part in an early phase clinical trial.

Some patients respond to anti-cancer drugs whilst others do not, despite having tumours with, apparently, similar characteristics such as site of origin. This variability in response can in some cases be explained by the genetic profile of the tumour. Therefore, studying the relationship between the molecular profiles of individual cancers and the response to therapy over time is of crucial importance in drug development. However, this endeavour is hampered by the difficulty in accessing suitable tumour material for analysis. Many patients' tumours are at anatomical sites which make biopsy difficult / hazardous which is in addition to the discomfort of a biopsy procedure. Therefore, this study will explore the potential of the circulating tumour DNA as a predictive factor of response/resistance to anticancer treatment.

For patients recruited to early phase clinical trials of experimental therapies, archival tumour tissue (mandatory), serial blood samples (mandatory) and fresh tumour biopsies (optional) will be collected according to the individual schedule of each clinical trial.

Blood plasma samples will be tested for cell-free and ctDNA levels and genomic profiles, which may include analyses of mutational profiles, copy number variations, translocations, chromosomal rearrangements and/or epigenetic profiles.

Molecular profiling of archival and fresh tumour biopsies will also be carried out to study the correlation with cell-free and ctDNA samples and investigate the potential predictor response/resistance to treatment.

Eligibility Criteria:
Inclusion criteria:

* Histological or cytological confirmation of cancer
* Patient being considered for participation in an experimental therapeutic trials
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule (such conditions should be discussed with the patient before registration in the study)

Exclusion criteria:

* Age below 18 years old
* Patient not physically and mentally able to give informed consent.
Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis

Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called "Bannwarth syndrome". This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Current European guidelines issued by the European Federation of Neurological Societies (EFNS) recommend the following triad for the diagnosis of "definite NBL": (i) Neurological symptoms suggestive of NBL without any other obvious cause; (ii) CSF pleocytosis; (iii) Intrathecal production of specific anti-Borreliella antibodies. CXCL13, C-X-C chemokine motif ligand 13, is a chemokine implicated in B cell chemotaxis. Extensive literature exists on the analysis of CXCL13i as a diagnostic marker for acute NBL. A recent meta-analysis from 2018, published by Rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. In this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the Borrelia CNR.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject having consulted at the HUS between 01/01/2013 and 31/12/2018
* Subject not having, after being informed, expressed their opposition to the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject under guardianship or curatorship
* Subject under safeguard of justice
Radiographic Findings and Their Temporal Changes in COVID-19 Positive Changes Patients: A Prospective Study

All Patient irrespective of age with confirmed COVID-19 admitted to hospital and who underwent chest radiograph will be enrolled in the study to find raduigraphic findings and their temporal changes in COVID-19.

In this prospective trial the investigator will work on radiology findings and their temporal changes in COVID-19 positive patients and who underwent chest radiograph will be enrolled in our study.

Patient selection will be consecutive in addition of age , gender and comorbid conditions clinical information will included travel,expose and contact history. All patients should be positive for COVID-19 via laboratory testing with real time reverse transcriptase polymerase chain reaction(rRT-PCR) In addition, the number of rRT-PCR tests performed on each patient, on which test a positive result was found,and the number of days between symptomology onset and date of first positive test will be recorded.

In view of the current dynamics, any other reliable diagnostic test(s) if added to the clinical protocol will also be considered for inclusion in this study.

Tabulation of radiographic findings for all consecutive X-rays will be done along with the temporal changes of these findings. further, the clinical findings with the outcomes(duration of hospital findings, ventilatory support and discharge/death).

Eligibility Criteria:
Inclusion Criteria:

1.Patients confirmed positive for COVID-19 by rRT-PCR irrespective of age.

Exclusion Criteria:

1.Patients with flu like symptoms but negative for COVID-19 by rRT-PCR.
Botulinum Toxin for Erectile Dysfunction

To evaluate the safety and efficacy of intra-cavernosal Botulinum toxin injection as an alternative line of treatment in patients with erectile dysfunction - not responding to oral PDE5i - through cavernosal smooth muscle relaxation.

The initial Phase 1 study demonstrated safety and efficacy of Botulinum toxin type A in the treatment of Erectile dysfunction in a small randomized controlled trial of 24 men.

The investigators conduct a phase 2 trial to confirm the initial results in a larger group of men.70 males will be included in the study. The participants will be subjected for full history taking, general and genital examination. Penile duplex will be performed to assess a vascular etiology before the treatment and 2 weeks later. The patients will be randomized into a treatment group (35 patients) and a control group (35 patients).

All patients will sign an informed consent. The treatment group will be injected IC with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color Doppler assessment, followed, next day by 50 units of BTX-A. The control group will be injected with the trimix solution during penile color Doppler assessment followed next day with a normal saline injection. The erection hardness score (EHS) will be assessed during the Doppler exam.

Procedure: At least 1 day after the penile color Doppler test, the patient is placed in the supine position flaccid and stretched penile length and girth would be measured from tip of the penis to the pubic bone will be done. A rubber band will be applied to the base of the penis. The skin will be prepped with alcohol swabs followed by the IC injection of 100 units of BTX-A. Direct pressure will be applied for 2 minutes. The rubber band will be removed after 15 minutes.

Patients and controls will fill the Sexual Health Inventory for men (SHIM) questionnaire and answer the the Sexual Encounter Profile questions 1 and 2 (SEP 2 \& SEP 3), and the global assessment question (GAQ) before and 4 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* 70 males will be included in the study recruited from Andrology, Sexology \& STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of ED.
* Unable to develop erections sufficient for intercourse.
* Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
* Age between 18 to 80 years.

Exclusion Criteria:

- Significant cardiovascular disease interfering with sexual activity
Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma

Purpose: To investigate intravitreal aflibercept (IVA) injection as an adjunctive treatment to trabeculectomy with mitomycin C (TMC) and panretinal photocoagulation (PRP) for neovascular glaucoma (NVG).

Setting: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand Study design: Prospective interventional case series Methods: PRP and IVA (2 mg/0.05 ml) injection were given, and TMC was performed within 2 weeks after IVA. Additional PRP, laser suture lysis, subconjunctival 5-fluorouracil injection, and bleb needling were performed after TMC if indicated. Best-collected visual acuity (BCVA), intraocular pressure (IOP), surgical complications, and number of anti-glaucoma medications were collected.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with neovascular glaucoma who presented at the Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand during November 2018 to October 2019.
* Aged more than 18 year-old

Exclusion Criteria:

* Patients who received any anti-vascular endothelial growth factor treatment before participation
Effect of Realistic Simulation and Digital Educational Platforms for Learning Nursing Student

Teaching modalities that integrate digital educational technologies, such as educational games, dummies and simulated environments, develop critical thinking in students, the absorption of significant learning and the consequent reduction in the exposure of patients to the damage associated with health care. Thus, this study will evaluate the effectiveness of simulation strategies and digital educational platforms in the teaching-learning process, in self-confidence and its implications for the physiological variables and stressful feelings of undergraduate nursing students. Our hypothesis is that students submitted to the use of digital platforms will present lower levels of self-efficacy, capacity for clinical judgment and retention of knowledge when compared to those who were submitted to the simulation strategy.

The study will be carried out in the simulation laboratory of two Higher Education Institutions, one public and the other private in the city of Brasília, Brazil. The sample will consist of 100 students randomized into an experimental group (n=50) and a control group (n=50). Students enrolled in the undergraduate nursing course, aged 18 years or over, will be eligible; have minimal approval in a discipline related to the content of "Nursing Care for Adult Patients". Students who work actively in the scenario of patient care in critical and risk situations will be excluded; members of the Academic League of Realistic Health Simulation and those with prior training in the health field. It is expected that nursing students, through active and innovative strategies, will be able to obtain and retain greater knowledge, raise levels of self-efficacy and clinical judgment, for their performance in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

Aged over 18 years;

Students approved in the discipline related to nursing care for adult and elderly patients.

Exclusion Criteria:

Students who actively work in the scenario of patient care in critical and risk situations; Members of the Realistic Health Simulation League; Students with previous training in the health area (nursing technicians, firefighters, among others) ; Participants who for some reason are absent from one of the project stages.

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Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)

This pilot study aims to examine the feasibility and acceptability of adding a cardiovascular health module to the existing Nurse Family Partnership (NFP) home visitation program delivered by trained nurses in the Northern Appalachian region of Central Pennsylvania.

The Promoting Cardiovascular Health of Northern Appalachian Mother-Infant Dyads: Pilot Study is a single arm pilot study that will enroll women with infants (\<1 month of age) participating in the NFP home visitation program in the Northern Appalachian region of Central Pennsylvania. This pilot study will include an enhanced version of the NFP standard care plan delivered by trained nurses to promote cardiovascular health by targeting soothing, feeding, sleep, and physical activity behaviors during infancy. The intervention delivered by trained visiting nurses will include behavior change strategies (e.g., goal setting, problem solving barriers). This pilot study will also examine the feasibility and acceptability of a digital device (actigraphy) during this same time period.

Eligibility Criteria:
Inclusion Criteria:

1. Mother-infant dyad enrolled in and receiving the Nurse Family Partnership program through one of the study teams community partner offices throughout Central Pennsylvania
2. Mother age ≥ 18 years at time of delivery
3. Mother English speaking
4. Singleton infant born at ≥ 35 weeks' gestation
5. Infant age \< 1 month at time of consent
6. Mother with reliable access to the internet for consent and data collection purposes

Exclusion Criteria:

1. Unable or unwilling to comply with the study visits and procedures.
2. Participation in a concurrent intervention study.
3. Infants with known chromosomal abnormalities, complex congenital heart disease, or birth defects inconsistent with survival to age 2 years.
4. Infant with substantial feeding difficulty (e.g., those requiring tube feeding)
Single-Dose Safety Study of APD791 in Healthy Volunteers

The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women, ages 19-45
* Non smokers

Exclusion Criteria:

* History of a bleeding disorder
* Recently donated blood or had significant blood loss
* Current use of a prescription medication
* Pregnant females
A 2 Period Cross-over Pharmacokinetic Study of SB204 in Acne Vulgaris

This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204.

This is a single-center, double-blind, randomized, 2 period cross-over study to be conducted in 18 subjects (18 years of age and above) each of whom will receive SB204 8% and Vehicle Gel. Subjects who satisfy the entry criteria will be randomized to SB204 8% or Vehicle Gel in a 1:1 ratio for the first treatment period. Study drug will be applied to the face, upper chest, upper back and shoulders (approximately 17% BSA) twice daily on Days 1- 4 approximately 12 hours apart. On Day 5, the study drug will be applied to the same areas only once, in the morning. Pharmacokinetic (PK) profiling will be performed on Day 1 and Day 5. After a wash out period, subjects will be treated with the alternate product and undergo similar treatment and assessments. The primary assessment is the pharmacokinetic profile of nitrate and silicon as markers for systemic exposure to nitric oxide (nitrate) and NVN1000 (silicon) after topical application of SB204 8% to approximately 17% of the total body surface area.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with an acne severity of moderate or severe and a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face, trunk and shoulders
* 18 years of age and older

Exclusion Criteria:

* Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
* Subjects who smoke or use tobacco products
* Subjects with methemoglobin level greater than 2% at Screening or Baseline by pulse co-oximeter.
* Subjects with a previous history of methemoglobinemia
* Subjects being treated with nitrates or any drug associated with methemoglobinemia
* Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens.
Effect of Home-exercise Programs Versus Supervised Core Stability Exercises on Hypertensive Patient With Low Back Pain

Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain.


Eligibility Criteria:
Inclusion Criteria:

* hypertensive patient
* patient with chronic back pain
* The patients aged 30 to 50 years

Exclusion Criteria:

* Patients with vertebral fractures
* patient with surgical spinal fixation
* patient with rheumatic disorders
* patient with systemic diseases
* patient with multiple sclerosis.
Effects of Basic Infection Control Skills License on Knowledge and Practice of Health Care Workers

Considering the importance of infection control practices, Madinah Public Health Department launched a new license program for healthcare workers, the Basic Infection Control Skills License program (BICSL). BICSL has been launched to train healthcare workers all over the region in a scientific standardized way.

To assess BICSL effectiveness, a non-randomized control study will be conducted in two of the general hospitals in Madinah. An electronic bilingual self-administrated valid and reliable questionnaire will be used to evaluate the workers knowledge and practices before and after three and six months of the intervention. The knowledge and practice answers were scored and the scores were categorized to facilitate the comparison. A BICSL certified trainer will be conducting the intervention, a one to one training session. A SPSS program will be used to analyze the data. Administrative and ethical approval was obtained from Madinah health authority. The participants will complete an electronic consent before they fill the questionnaire. Confidentiality and privacy as well as freedom to participate or not will be insured to all participants. This study will assess the license effectiveness in improve knowledge and compliance.


Eligibility Criteria:
Inclusion Criteria:

1. Working in the chosen hospitals.
2. Health care worker (Physician, nurse or technician) of any gender, age, or experience.

Exclusion Criteria:

1. Refuse to participate in the study.
2. Have BICSL certificate before the study implemented.
3. On leave during study period.